Law:Division 106. Personal Health Care (including Maternal, Child, And Adolescent) (California)

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Contents

Part 1. General Administration

Chapter 1. Patient Access To Health Records

Ca Codes (hsc:123100-123149.5) Health And Safety Code Section 123100-123149.5



123100. The Legislature finds and declares that every person having ultimate responsibility for decisions respecting his or her own health care also possesses a concomitant right of access to complete information respecting his or her condition and care provided. Similarly, persons having responsibility for decisions respecting the health care of others should, in general, have access to information on the patient's condition and care. It is, therefore, the intent of the Legislature in enacting this chapter to establish procedures for providing access to health care records or summaries of those records by patients and by those persons having responsibility for decisions respecting the health care of others.

123105. As used in this chapter: (a) "Health care provider" means any of the following: (1) A health facility licensed pursuant to Chapter 2 (commencing with Section 1250) of Division 2. (2) A clinic licensed pursuant to Chapter 1 (commencing with Section 1200) of Division 2. (3) A home health agency licensed pursuant to Chapter 8 (commencing with Section 1725) of Division 2. (4) A physician and surgeon licensed pursuant to Chapter 5 (commencing with Section 2000) of Division 2 of the Business and Professions Code or pursuant to the Osteopathic Act. (5) A podiatrist licensed pursuant to Article 22 (commencing with Section 2460) of Chapter 5 of Division 2 of the Business and Professions Code. (6) A dentist licensed pursuant to Chapter 4 (commencing with Section 1600) of Division 2 of the Business and Professions Code. (7) A psychologist licensed pursuant to Chapter 6.6 (commencing with Section 2900) of Division 2 of the Business and Professions Code. (8) An optometrist licensed pursuant to Chapter 7 (commencing with Section 3000) of Division 2 of the Business and Professions Code. (9) A chiropractor licensed pursuant to the Chiropractic Initiative Act. (10) A marriage and family therapist licensed pursuant to Chapter 13 (commencing with Section 4980) of Division 2 of the Business and Professions Code. (11) A clinical social worker licensed pursuant to Chapter 14 (commencing with Section 4990) of Division 2 of the Business and Professions Code. (12) A physical therapist licensed pursuant to Chapter 5.7 (commencing with Section 2600) of Division 2 of the Business and Professions Code. (13) An occupational therapist licensed pursuant to Chapter 5.6 (commencing with Section 2570). (b) "Mental health records" means patient records, or discrete portions thereof, specifically relating to evaluation or treatment of a mental disorder. "Mental health records" includes, but is not limited to, all alcohol and drug abuse records. (c) "Patient" means a patient or former patient of a health care provider. (d) "Patient records" means records in any form or medium maintained by, or in the custody or control of, a health care provider relating to the health history, diagnosis, or condition of a patient, or relating to treatment provided or proposed to be provided to the patient. "Patient records" includes only records pertaining to the patient requesting the records or whose representative requests the records. "Patient records" does not include information given in confidence to a health care provider by a person other than another health care provider or the patient, and that material may be removed from any records prior to inspection or copying under Section 123110 or 123115. "Patient records" does not include information contained in aggregate form, such as indices, registers, or logs. (e) "Patient's representative" or "representative" means any of the following: (1) A parent or guardian of a minor who is a patient. (2) The guardian or conservator of the person of an adult patient. (3) An agent as defined in Section 4607 of the Probate Code, to the extent necessary for the agent to fulfill his or her duties as set forth in Division 4.7 (commencing with Section 4600) of the Probate Code. (4) The beneficiary as defined in Section 24 of the Probate Code or personal representative as defined in Section 58 of the Probate Code, of a deceased patient. (f) "Alcohol and drug abuse records" means patient records, or discrete portions thereof, specifically relating to evaluation and treatment of alcoholism or drug abuse.


123110. (a) Notwithstanding Section 5328 of the Welfare and Institutions Code, and except as provided in Sections 123115 and 123120, any adult patient of a health care provider, any minor patient authorized by law to consent to medical treatment, and any patient representative shall be entitled to inspect patient records upon presenting to the health care provider a written request for those records and upon payment of reasonable clerical costs incurred in locating and making the records available. However, a patient who is a minor shall be entitled to inspect patient records pertaining only to health care of a type for which the minor is lawfully authorized to consent. A health care provider shall permit this inspection during business hours within five working days after receipt of the written request. The inspection shall be conducted by the patient or patient's representative requesting the inspection, who may be accompanied by one other person of his or her choosing. (b) Additionally, any patient or patient's representative shall be entitled to copies of all or any portion of the patient records that he or she has a right to inspect, upon presenting a written request to the health care provider specifying the records to be copied, together with a fee to defray the cost of copying, that shall not exceed twenty-five cents ($0.25) per page or fifty cents ($0.50) per page for records that are copied from microfilm and any additional reasonable clerical costs incurred in making the records available. The health care provider shall ensure that the copies are transmitted within 15 days after receiving the written request. (c) Copies of X-rays or tracings derived from electrocardiography, electroencephalography, or electromyography need not be provided to the patient or patient's representative under this section, if the original X-rays or tracings are transmitted to another health care provider upon written request of the patient or patient's representative and within 15 days after receipt of the request. The request shall specify the name and address of the health care provider to whom the records are to be delivered. All reasonable costs, not exceeding actual costs, incurred by a health care provider in providing copies pursuant to this subdivision may be charged to the patient or representative requesting the copies. (d) (1) Notwithstanding any provision of this section, and except as provided in Sections 123115 and 123120, any patient or former patient or the patient's representative shall be entitled to a copy, at no charge, of the relevant portion of the patient's records, upon presenting to the provider a written request, and proof that the records are needed to support an appeal regarding eligibility for a public benefit program. These programs shall be the Medi-Cal program, social security disability insurance benefits, and Supplemental Security Income/State Supplementary Program for the Aged, Blind and Disabled (SSI/SSP) benefits. For purposes of this subdivision, "relevant portion of the patient's records" means those records regarding services rendered to the patient during the time period beginning with the date of the patient's initial application for public benefits up to and including the date that a final determination is made by the public benefits program with which the patient's application is pending. (2) Although a patient shall not be limited to a single request, the patient or patient's representative shall be entitled to no more than one copy of any relevant portion of his or her record free of charge. (3) This subdivision shall not apply to any patient who is represented by a private attorney who is paying for the costs related to the patient's appeal, pending the outcome of that appeal. For purposes of this subdivision, "private attorney" means any attorney not employed by a nonprofit legal services entity. (e) If the patient's appeal regarding eligibility for a public benefit program specified in subdivision (d) is successful, the hospital or other health care provider may bill the patient, at the rates specified in subdivisions (b) and (c), for the copies of the medical records previously provided free of charge. (f) If a patient or his or her representative requests a record pursuant to subdivision (d), the health care provider shall ensure that the copies are transmitted within 30 days after receiving the written request. (g) This section shall not be construed to preclude a health care provider from requiring reasonable verification of identity prior to permitting inspection or copying of patient records, provided this requirement is not used oppressively or discriminatorily to frustrate or delay compliance with this section. Nothing in this chapter shall be deemed to supersede any rights that a patient or representative might otherwise have or exercise under Section 1158 of the Evidence Code or any other provision of law. Nothing in this chapter shall require a health care provider to retain records longer than required by applicable statutes or administrative regulations. (h) This chapter shall not be construed to render a health care provider liable for the quality of his or her records or the copies provided in excess of existing law and regulations with respect to the quality of medical records. A health care provider shall not be liable to the patient or any other person for any consequences that result from disclosure of patient records as required by this chapter. A health care provider shall not discriminate against classes or categories of providers in the transmittal of X-rays or other patient records, or copies of these X-rays or records, to other providers as authorized by this section. Every health care provider shall adopt policies and establish procedures for the uniform transmittal of X-rays and other patient records that effectively prevent the discrimination described in this subdivision. A health care provider may establish reasonable conditions, including a reasonable deposit fee, to ensure the return of original X-rays transmitted to another health care provider, provided the conditions do not discriminate on the basis of, or in a manner related to, the license of the provider to which the X-rays are transmitted. (i) Any health care provider described in paragraphs (4) to (10), inclusive, of subdivision (a) of Section 123105 who willfully violates this chapter is guilty of unprofessional conduct. Any health care provider described in paragraphs (1) to (3), inclusive, of subdivision (a) of Section 123105 that willfully violates this chapter is guilty of an infraction punishable by a fine of not more than one hundred dollars ($100). The state agency, board, or commission that issued the health care provider's professional or institutional license shall consider a violation as grounds for disciplinary action with respect to the licensure, including suspension or revocation of the license or certificate. (j) This section shall be construed as prohibiting a health care provider from withholding patient records or summaries of patient records because of an unpaid bill for health care services. Any health care provider who willfully withholds patient records or summaries of patient records because of an unpaid bill for health care services shall be subject to the sanctions specified in subdivision (i).

123111. (a) Any adult patient who inspects his or her patient records pursuant to Section 123110 shall have the right to provide to the health care provider a written addendum with respect to any item or statement in his or her records that the patient believes to be incomplete or incorrect. The addendum shall be limited to 250 words per alleged incomplete or incorrect item in the patient's record and shall clearly indicate in writing that the patient wishes the addendum to be made a part of his or her record. (b) The health care provider shall attach the addendum to the patient's records and shall include that addendum whenever the health care provider makes a disclosure of the allegedly incomplete or incorrect portion of the patient's records to any third party. (c) The receipt of information in a patient's addendum which contains defamatory or otherwise unlawful language, and the inclusion of this information in the patient's records, in accordance with subdivision (b), shall not, in and of itself, subject the health care provider to liability in any civil, criminal, administrative, or other proceeding. (d) Subdivision (f) of Section 123110 and Section 123120 shall be applicable with respect to any violation of this section by a health care provider.


123115. (a) The representative of a minor shall not be entitled to inspect or obtain copies of the minor's patient records in either of the following circumstances: (1) With respect to which the minor has a right of inspection under Section 123110. (2) Where the health care provider determines that access to the patient records requested by the representative would have a detrimental effect on the provider's professional relationship with the minor patient or the minor's physical safety or psychological well-being. The decision of the health care provider as to whether or not a minor's records are available for inspection or copying under this section shall not attach any liability to the provider, unless the decision is found to be in bad faith. (b) When a health care provider determines there is a substantial risk of significant adverse or detrimental consequences to a patient in seeing or receiving a copy of mental health records requested by the patient, the provider may decline to permit inspection or provide copies of the records to the patient, subject to the following conditions: (1) The health care provider shall make a written record, to be included with the mental health records requested, noting the date of the request and explaining the health care provider's reason for refusing to permit inspection or provide copies of the records, including a description of the specific adverse or detrimental consequences to the patient that the provider anticipates would occur if inspection or copying were permitted. (2) The health care provider shall permit inspection by, or provide copies of the mental health records to, a licensed physician and surgeon, licensed psychologist, licensed marriage and family therapist, or licensed clinical social worker, designated by request of the patient. Any marriage and family therapist registered intern, as defined in Chapter 13 (commencing with Section 4980) of Division 2 of the Business and Professions Code, may not inspect the patient's mental health records or obtain copies thereof, except pursuant to the direction or supervision of a licensed professional specified in subdivision (g) of Section 4980.03 of the Business and Professions Code. Prior to providing copies of mental health records to a marriage and family therapist registered intern, a receipt for those records shall be signed by the supervising licensed professional. The licensed physician and surgeon, licensed psychologist, licensed marriage and family therapist, licensed clinical social worker, or marriage and family therapist registered intern to whom the records are provided for inspection or copying shall not permit inspection or copying by the patient. (3) The health care provider shall inform the patient of the provider's refusal to permit him or her to inspect or obtain copies of the requested records, and inform the patient of the right to require the provider to permit inspection by, or provide copies to, a licensed physician and surgeon, licensed psychologist, licensed marriage and family therapist, or licensed clinical social worker, designated by written authorization of the patient. (4) The health care provider shall indicate in the mental health records of the patient whether the request was made under paragraph (2).

123120. Any patient or representative aggrieved by a violation of Section 123110 may, in addition to any other remedy provided by law, bring an action against the health care provider to enforce the obligations prescribed by Section 123110. Any judgment rendered in the action may, in the discretion of the court, include an award of costs and reasonable attorney fees to the prevailing party.


123125. (a) This chapter shall not require a health care provider to permit inspection or provide copies of alcohol and drug abuse records where, or in a manner, prohibited by Section 408 of the federal Drug Abuse Office and Treatment Act of 1972 (Public Law 92-255) or Section 333 of the federal Comprehensive Alcohol Abuse and Alcoholism Prevention, Treatment, and Rehabilitation Act of 1970 (Public Law 91-616), or by regulations adopted pursuant to these federal laws. Alcohol and drug abuse records subject to these federal laws shall also be subject to this chapter, to the extent that these federal laws do not prohibit disclosure of the records. All other alcohol and drug abuse records shall be fully subject to this chapter. (b) This chapter shall not require a health care provider to permit inspection or provide copies of records or portions of records where or in a manner prohibited by existing law respecting the confidentiality of information regarding communicable disease carriers.

123130. (a) A health care provider may prepare a summary of the record, according to the requirements of this section, for inspection and copying by a patient. If the health care provider chooses to prepare a summary of the record rather than allowing access to the entire record, he or she shall make the summary of the record available to the patient within 10 working days from the date of the patient's request. However, if more time is needed because the record is of extraordinary length or because the patient was discharged from a licensed health facility within the last 10 days, the health care provider shall notify the patient of this fact and the date that the summary will be completed, but in no case shall more than 30 days elapse between the request by the patient and the delivery of the summary. In preparing the summary of the record the health care provider shall not be obligated to include information that is not contained in the original record. (b) A health care provider may confer with the patient in an attempt to clarify the patient's purpose and goal in obtaining his or her record. If as a consequence the patient requests information about only certain injuries, illnesses, or episodes, this subdivision shall not require the provider to prepare the summary required by this subdivision for other than the injuries, illnesses, or episodes so requested by the patient. The summary shall contain for each injury, illness, or episode any information included in the record relative to the following: (1) Chief complaint or complaints including pertinent history. (2) Findings from consultations and referrals to other health care providers. (3) Diagnosis, where determined. (4) Treatment plan and regimen including medications prescribed. (5) Progress of the treatment. (6) Prognosis including significant continuing problems or conditions. (7) Pertinent reports of diagnostic procedures and tests and all discharge summaries. (8) Objective findings from the most recent physical examination, such as blood pressure, weight, and actual values from routine laboratory tests. (c) This section shall not be construed to require any medical records to be written or maintained in any manner not otherwise required by law. (d) The summary shall contain a list of all current medications prescribed, including dosage, and any sensitivities or allergies to medications recorded by the provider. (e) Subdivision (c) of Section 123110 shall be applicable whether or not the health care provider elects to prepare a summary of the record. (f) The health care provider may charge no more than a reasonable fee based on actual time and cost for the preparation of the summary. The cost shall be based on a computation of the actual time spent preparing the summary for availability to the patient or the patient' s representative. It is the intent of the Legislature that summaries of the records be made available at the lowest possible cost to the patient.

123135. Except as otherwise provided by law, nothing in this chapter shall be construed to grant greater access to individual patient records by any person, firm, association, organization, partnership, business trust, company, corporation, or municipal or other public corporation, or government officer or agency. Therefore, this chapter does not do any of the following: (a) Relieve employers of the requirements of the Confidentiality of Medical Information Act (Part 2.6 (commencing with Section 56) of Division 1 of the Civil Code). (b) Relieve any person subject to the Insurance Information and Privacy Protection Act (Article 6.6 (commencing with Section 791) of Chapter 1 of Part 2 of Division 1 of the Insurance Code) from the requirements of that act. (c) Relieve government agencies of the requirements of the Information Practices Act of 1977 (Title 1.8 (commencing with Section 1798) of Part 4 of Division 3 of the Civil Code).


123140. The Information Practices Act of 1977 (Title 1.8 (commencing with Section 1798) of Part 4 of Division 3 of the Civil Code) shall prevail over this chapter with respect to records maintained by a state agency.


123145. (a) Providers of health services that are licensed pursuant to Sections 1205, 1253, 1575 and 1726 have an obligation, if the licensee ceases operation, to preserve records for a minimum of seven years following discharge of the patient, except that the records of unemancipated minors shall be kept at least one year after the minor has reached the age of 18 years, and in any case, not less than seven years. (b) The department or any person injured as a result of the licensee's abandonment of health records may bring an action in a proper court for the amount of damage suffered as a result thereof. In the event that the licensee is a corporation or partnership that is dissolved, the person injured may take action against that corporation's or partnership's principle officers of record at the time of dissolution. (c) Abandoned means violating subdivision (a) and leaving patients treated by the licensee without access to medical information to which they are entitled pursuant to Section 123110.


123147. (a) Except as provided in subdivision (b), all health facilities, as defined in Section 1250, and all primary care clinics that are either licensed under Section 1204 or exempt from licensure under Section 1206, shall include a patient's principal spoken language on the patient's health records. (b) Any long-term health care facility, as defined in Section 1418, that already completes the minimum data set form as specified in Section 14110.15 of the Welfare and Institutions Code, including documentation of a patient's principal spoken language, shall be deemed to be in compliance with subdivision (a).


123148. (a) Notwithstanding any other provision of law, a health care professional at whose request a test is performed shall provide or arrange for the provision of the results of a clinical laboratory test to the patient who is the subject of the test if so requested by the patient, in oral or written form. The results shall be conveyed in plain language and in oral or written form, except the results may be conveyed in electronic form if requested by the patient and if deemed most appropriate by the health care professional who requested the test. (b) (1) Consent of the patient to receive his or her laboratory results by Internet posting or other electronic means shall be obtained in a manner consistent with the requirements of Section 56.10 or 56.11 of the Civil Code. In the event that a health care professional arranges for the provision of test results by Internet posting or other electronic manner, the results shall be delivered to a patient in a reasonable time period, but only after the results have been reviewed by the health care professional. Access to clinical laboratory test results shall be restricted by the use of a secure personal identification number when the results are delivered to a patient by Internet posting or other electronic manner. (2) Nothing in paragraph (1) shall prohibit direct communication by Internet posting or the use of other electronic means to convey clinical laboratory test results by a treating health care professional who ordered the test for his or her patient or by a health care professional acting on behalf of, or with the authorization of, the treating health care professional who ordered the test. (c) When a patient requests to receive his or her laboratory test results by Internet posting, the health care professional shall advise the patient of any charges that may be assessed directly to the patient or insurer for the service and that the patient may call the health care professional for a more detailed explanation of the laboratory test results when delivered. (d) The electronic provision of test results under this section shall be in accordance with any applicable federal law governing privacy and security of electronic personal health records. However, any state statute, if enacted, that governs privacy and security of electronic personal health records, shall apply to test results under this section and shall prevail over federal law if federal law permits. (e) The test results to be reported to the patient pursuant to this section shall be recorded in the patient's medical record, and shall be reported to the patient within a reasonable time period after the test results are received at the offices of the health care professional who requested the test. (f) Notwithstanding subdivisions (a) and (b), none of the following clinical laboratory test results and any other related results shall be conveyed to a patient by Internet posting or other electronic means: (1) HIV antibody test. (2) Presence of antigens indicating a hepatitis infection. (3) Abusing the use of drugs. (4) Test results related to routinely processed tissues, including skin biopsies, Pap smear tests, products of conception, and bone marrow aspirations for morphological evaluation, if they reveal a malignancy. (g) Patient identifiable test results and health information that have been provided under this section shall not be used for any commercial purpose without the consent of the patient, obtained in a manner consistent with the requirements of Section 56.11 of the Civil Code. (h) Any third party to whom laboratory test results are disclosed pursuant to this section shall be deemed a provider of administrative services, as that term is used in paragraph (3) of subdivision (c) of Section 56.10 of the Civil Code, and shall be subject to all limitations and penalties applicable to that section. (i) A patient may not be required to pay any cost, or be charged any fee, for electing to receive his or her laboratory results in any manner other than by Internet posting or other electronic form. (j) A patient or his or her physician may revoke any consent provided under this section at any time and without penalty, except to the extent that action has been taken in reliance on that consent.


123149. (a) Providers of health services, licensed pursuant to Sections 1205, 1253, 1575, and 1726, that utilize electronic recordkeeping systems only, shall comply with the additional requirements of this section. These additional requirements do not apply to patient records if hard copy versions of the patient records are retained. (b) Any use of electronic recordkeeping to store patient records shall ensure the safety and integrity of those records at least to the extent of hard copy records. All providers set forth in subdivision (a) shall ensure the safety and integrity of all electronic media used to store patient records by employing an offsite backup storage system, an image mechanism that is able to copy signature documents, and a mechanism to ensure that once a record is input, it is unalterable. (c) Original hard copies of patient records may be destroyed once the record has been electronically stored. (d) The printout of the computerized version shall be considered the original as defined in Section 255 of the Evidence Code for purposes of providing copies to patients, the Division of Licensing and Certification, and for introduction into evidence in accordance with Sections 1550 and 1551 of the Evidence Code, in administrative or court proceedings. (e) Access to electronically stored patient records shall be made available to the Division of Licensing and Certification staff promptly, upon request. (f) This section does not exempt licensed clinics, health facilities, adult day health care centers, and home health agencies from the requirement of maintaining original copies of patient records that cannot be electronically stored. (g) Any health care provider subject to this section, choosing to utilize an electronic recordkeeping system, shall develop and implement policies and procedures to include safeguards for confidentiality and unauthorized access to electronically stored patient health records, authentication by electronic signature keys, and systems maintenance. (h) Nothing contained in this chapter shall affect the existing regulatory requirements for the access, use, disclosure, confidentiality, retention of record contents, and maintenance of health information in patient records by health care providers. (i) This chapter does not prohibit any provider of health care services from maintaining or retaining patient records electronically.


123149.5. (a) It is the intent of the Legislature that all medical information transmitted during the delivery of health care via telemedicine, as defined in subdivision (a) of Section 2290.5 of the Business and Professions Code, become part of the patient's medical record maintained by the licensed health care provider. (b) This section shall not be construed to limit or waive any of the requirements of Chapter 1 (commencing with Section 123100) of Part 1 of Division 106 of the Health and Safety Code.


Chapter 2. Destruction Of Records And Exhibits Of Human Health

Ca Codes (hsc:123150-123155) Health And Safety Code Section 123150-123155



123150. The board of supervisors may authorize the destruction or the disposition to a public or private medical library of any X-ray photographs and case records that are more than five years old and that were taken by the county health officer in the performance of his or her duties with regard to tuberculosis if any of the following conditions are complied with: (a) The county health officer has determined that the X-ray photographs or a series of X-ray photographs in conjunction with case records do not show the existence of tuberculosis in the infectious stage. (b) The individual of whom the X-ray photographs were taken has been deceased not less than two years or the 102nd anniversary of the individual's birthdate has occurred and the county health officer cannot reasonably ascertain whether the individual is still living. (c) The place of residence of the individual of whom the X-ray photographs were taken has been unknown to the county health officer for 10 years.


123155. The board of supervisors of any county, in addition to its other powers and duties may acquire or construct exhibits and displays depicting all or parts of the human body and functions thereof for the purpose of educating the public with regard to human health, and maintain, operate and manage the exhibits and displays in any county or other public building. It may enter into contracts or leases with any other governmental agency or any nonprofit association or corporation, including a county medical association, for the construction and acquisition of the exhibits and displays, and for the maintenance, operation and management of the exhibits and displays in any county or other public building, without consideration except the agreement of the contracting or leasing agency, association or corporation to construct, acquire, maintain, operate and manage the exhibits and displays for the purpose of public health education and upon any other terms and conditions as may be agreed upon by the board and the contracting or leasing agency, association or corporation.


Chapter 3. Catastrophic Health Insurance

Ca Codes (hsc:123175-123220) Health And Safety Code Section 123175-123220



123175. The Legislature finds and declares as follows: (a) A catastrophic illness or injury may financially devastate an individual or the family of that individual because of extraordinary medical expenses. It is vitally necessary to the public health and welfare of the State of California that: (1) Its residents not be burdened with those financial costs. Most health insurance policies contain a monetary limitation on the amount of money that can be expended on a particular illness or individual, leaving any balance to be paid by the patient. The state has enacted this chapter to promote the availability of additional insurance to help pay extensive medical costs. (2) The state government not be financially burdened by residents who may become indigent due to these catastrophic health costs. (b) It is the intent of the Legislature in enacting this chapter to institute a program to inform state residents of the need for catastrophic health insurance, and to make this insurance available to residents through an independent insurer at no cost or liability to the state.

123180. As used in this chapter: (a) "Catastrophic health insurance" means a supplementary insurance contract that indemnifies a California resident for medical expenses, including at least the costs of the basic health care services that result from an illness, injury, or disease, and that are greater than fifty thousand dollars ($50,000), subject to a lifetime benefit limit of one million dollars ($1,000,000). (b) "Resident" means any individual who lives in California for at least 90 consecutive days. (c) "Insurer" as used in this chapter includes a disability insurer that covers hospital, medical, or surgical expenses, and a nonprofit hospital service plan. (d) "Basic health care services" includes, but is not limited to, the following: (1) Inpatient hospital treatment, including room and board, general nursing services, diagnostic tests, supplies, and other medically necessary services. (2) Outpatient services for surgery, presurgical diagnostic tests, emergency care, and chemotherapy. (3) Surgery and anesthesia. (4) Hospital and office visits and consultations. (5) X-rays and laboratory tests; allergy tests, injections, and sera. (6) Maternity care for the subscriber or enrolled spouse. (7) Psychotherapy. (8) Chemotherapy and radiation therapy. (9) Physical, speech, occupational and respiratory therapies. (10) Prescription drugs. (11) Prostheses and durable medical equipment, such as artificial limbs, hospital beds, and wheelchairs. (12) Cardiac rehabilitation program. (13) Local ambulance service. (14) Alcohol and drug abuse rehabilitation. (15) Rehabilitative care. (16) Outpatient skilled nursing care (up to two hours per day for up to 50 days per calendar year). (17) Home health care and hospice services provided by an approved home health agency or hospice agency.


123185. The director shall, in consultation with, and approval of the Department of Insurance, do all of the following: (a) Contract with an insurer or insurers to provide any resident catastrophic health insurance. (b) Inform residents of the availability of catastrophic health insurance. (c) Provide oversight for all contract obligations of the insurer. (d) Approve all advertising and marketing materials used by an insurer in connection with catastrophic health insurance provided under this chapter in order to ensure accuracy and fairness. The advertising standards used shall be those set out in Section 1360. (e) Determine the cost of the oversight function and make provisions to cover all administrative costs.


123190. The director may appoint a full-time employee, and other staff as required, to implement this chapter.


123195. (a) A contract provided for by this chapter shall not be required to cover a preexisting medical condition of the resident during the first 10 months the resident is covered by catastrophic health insurance provided under this chapter. Charges for a preexisting condition shall not apply toward the deductible during the first 10 months of coverage. Charges for other conditions during that initial period shall apply toward the deductible. (b) The contract shall also prohibit the insurer from discriminating against prospective insureds in their underwriting practices on the basis of demographic factors, such as age, or preexisting medical conditions.


123200. The state is not liable in any way for any claims arising out of an arrangement for insurance established under this chapter. The insurer shall bear the cost of all claims, and shall indemnify the state against all claims and the cost of defending against all claims in connection with an arrangement for catastrophic health insurance established under this chapter.


123205. The director shall enter into contracts pursuant to subdivision (a) of Section 123185 only with insurers that meet all of the following criteria, as determined by the director: (a) The insurer shall be actuarially sound. (b) The insurer shall be fully self-supported by its policy premiums or charges and investments. (c) The insurer shall use advertising that is accurate.


123210. (a) The term of any contract entered into pursuant to subdivision (a) of Section 123185 shall be determined by the director, but shall not exceed three years. (b) The contract shall contain a provision authorizing the director to terminate the contract upon giving 60 days' written notice to the insurer of any of the following causes for termination: (1) The department has determined that management practices of the insurer or the current financial condition of the insurer interferes with the efficient and timely payment of catastrophic health insurance benefits. (2) Continuing failure of the insurer to timely pay the benefits of its policies of catastrophic health insurance or provide catastrophic health insurance services in accordance with the contract. (3) Other continuing unsatisfactory performance by the insurer under the contract, based upon complaints received from insureds or other sources, if the insurer has failed to take reasonable, effective, and prompt actions to resolve the complaints. (c) The contract shall contain a provision authorizing the director to terminate the contract without cause upon any annual anniversary date of the contract by giving at least 60 days' notice to the insurer. (d) The director may give up to 120 days' notice to terminate if it is determined to be in the best interest of plan participants. (e) The director shall annually certify that participating providers meet the conditions of the program. In carrying out this requirement, the director shall consult with the Department of Insurance to obtain any audits performed by those agencies that may be used in evaluating the performance of each provider.


123215. Premiums or charges paid for catastrophic health insurance provided pursuant to this chapter shall include an increment to defray the reasonable administrative costs of the department in administering this chapter that shall be transmitted by insurers to the department as provided in the contract.


123220. If studies or research demonstrate that it is in the best interest of the program, the director may adopt regulations setting forth modifications to the coverage provided under the program. No modification shall apply to any coverage provided by a policy or contract issued prior to the operative date of the regulation, except that the modification shall apply to coverage provided after any renewal of the policy or contract occurring after the operative date of the regulation.


Chapter 4. Written Materials For Patients

Ca Codes (hsc:123222.1-123222.2) Health And Safety Code Section 123222.1-123222.2



123222.1. (a) Notwithstanding any other provision of law, any printed materials specified in subdivision (b), that are provided to a patient by an employee or authorized agent on behalf of a general acute care hospital, as defined in subdivision (a) of, a skilled nursing facility, as defined in subdivision (c) of, an intermediate care facility as defined in subdivision (d) of, a nursing facility, as defined in subdivision (k) of, Section 1250, or a residential care facility for the elderly, as defined in subdivision ( l) of Section 1569.2, shall be printed in at least a 12-point font that is clear and legible. (b) The section shall apply only to the following: (1) Admission and discharge papers and forms from general acute care hospitals, skilled nursing facilities, intermediate care facilities, and nursing facilities. (2) Medical and therapeutic instructions prepared by the facility specifically for an individual upon his or her discharge from a general acute care hospital, a skilled nursing facility, an intermediate care facility, or a nursing facility. (3) Any contract for consent for hospitalization, or agreement to assume financial responsibility between a patient and any of the facilities specified in paragraph (1). (4) Instructions and forms for advance health care directives, as defined in Section 4605 of the Probate Code. (5) Information produced by the hospital or facility regarding the rights and responsibilities of patients or residents while receiving care at the hospital or facility, and regarding grievances and appeals, including forms and instructions. (6) Correspondence written, printed, or produced by any of the facilities specified in paragraph (1), or a residential care facility for the elderly. (c) Any entity described in paragraph (1) of subdivision (b), and any residential care facility for the elderly, may continue to use its supply of materials that exists on January 1, 2003, until that supply is exhausted or until January 1, 2006, whichever occurs first, and thereafter shall comply with the requirements of this section. (d) The hospital's or facility's policies and procedures are specifically excluded from the requirements of this section.


123222.2. (a) (1) Upon admission of a patient to a skilled nursing facility, as defined in subdivision (c) of, an intermediate care facility, as defined in subdivision (d) of, or a nursing facility, as defined in subdivision (k) of, Section 1250, the facility shall ask the patient if he or she would like the facility to provide the patient's next of kin or agent under a durable power of attorney for health care with materials regarding patients' rights and responsibilities. If the patient states that he or she would like these materials to be provided, the facility shall do so, in accordance with paragraph (2). (2) (A) The materials provided by the facility pursuant to this subdivision shall include a comprehensive Patients' Bill of Rights, as described in subdivision (d) of Section 1599.61. Until subdivision (d) of Section 1599.61 is fully implemented by the State Department of Health Services, the Patients' Bill of Rights provided pursuant to this subdivision shall include all of the following: (i) The rights contained in Chapter 3.9 (commencing with Section 1599) of Division 2. (ii) The resident rights applicable to skilled nursing facilities, contained in Section 72527 of Title 22 of the California Code of Regulations. (iii) The resident rights applicable to intermediate care facilities, contained in Section 73523 of Title 22 of the California Code of Regulations. (iv) The resident rights applicable to long-term care facilities under Sections 483.10 to 483.25, inclusive, of Title 42 of the Code of Federal Regulations. (B) The facility may also provide written materials regarding the facility's expectations of patients and patients' responsibilities while the patient is receiving care at the facility. This paragraph shall not be construed to require the facility to create any additional written materials regarding the facility's expectations of patients and patients' responsibilities. (b) (1) Upon admission of a patient to a general acute care hospital, as defined in subdivision (a) of Section 1250, the hospital shall ask the patient if he or she would like the hospital to provide the patient's next of kin or agent under a durable power of attorney for health care with materials regarding patients' rights and responsibilities. If the patient states that he or she would like these materials to be provided, the hospital shall do so, in accordance with paragraph (2). (2) (A) The materials provided by the hospital pursuant to this subdivision shall include a comprehensive Patients' Bill of Rights, including the regulatory patients' rights for general acute care hospitals contained in Section 70707 of Title 22 of the California Code of Regulations, and the rights afforded to patients under Section 482.13 of Title 42 of the Code of Federal Regulations. (B) The hospital may also provide written materials regarding the hospital's expectations of patients and patients' responsibilities while the patient is receiving care at the hospital. This paragraph shall not be construed to require the hospital to create any additional written materials regarding the hospital's expectations of patients and patients' responsibilities. (c) Upon the request of the patient, or of the patient's next of kin or agent under a durable power of attorney for health care, a representative of any facility or hospital providing patients' rights information or other documentation described in this section shall explain the materials provided. (d) This section shall not be construed to require the disclosure of patient information that would otherwise be exempt from disclosure.


Chapter 5. Children's Medical Services Rebate Fund

Ca Codes (hsc:123223) Health And Safety Code Section 123223



123223. (a) The Children's Medical Services Rebate Fund is hereby created as a special fund in the State Treasury. (b) All rebates for the delivery of health care, medical supplies, pharmaceuticals, including blood replacement products, and equipment for clients enrolled in the state funded Genetically Handicapped Person's Program, Chapter 2 (commencing with Section 125125) of Part 5, and the California Children's Services Program, Article 5 (commencing with Section 123800) of Chapter 3 of Part 2, and, notwithstanding Section 16305.7 of the Government Code, interest earned on these moneys, shall be deposited in the Children's Medical Services Rebate Fund exclusively to cover costs related to services, and the administration of services, provided through the Genetically Handicapped Person's Program and California Children's Services Program. (c) Notwithstanding Section 13340 of the Government Code, moneys in the Children's Medical Services Rebate Fund shall be continuously appropriated without regard to fiscal year to the State Department of Health Services and available for expenditure for those purposes specified under this section.


Part 2. Maternal, Child, And Adolescent Health

Chapter 1. General Provisions

Article 1. Maternal, Child, And Adolescent Health

Ca Codes (hsc:123225-123255) Health And Safety Code Section 123225-123255



123225. The department shall maintain a program of maternal and child health.

123230. The department may investigate, and disseminate educational information relating to, conditions affecting the health of the children of this state.

123232. (a) The department shall develop or obtain a brochure to educate pregnant women and new parents about the important role in maintaining a healthy lifestyle and preventing chronic diseases of both of the following: (1) Eating a diet rich in fruits and vegetables. (2) Staying active every day. (b) The brochure shall address how proper nutrition and exercise help prevent the development of chronic disease in pregnant women, new mothers, and young children. The brochure shall also include information regarding the critical role of fruits and vegetables in a person's diet, especially as an important source of vitamins and nutrients to new mothers and their breast milk. (c) The department shall include the brochure on the department's Web site. (d) The brochure shall be distributed as follows: (1) By the department to each individual who contacts the BabyCal program and receives a package of information from the program. (2) By a provider to each participant in the Access for Infants and Mothers (AIM) program one time during the participant's pregnancy. (e) The brochure shall be available in both English and Spanish. (f) This section shall be implemented only if, and to the extent that, federal or private funding, or both, are available for that purpose.


123235. The program may include the provision of educational, preventative, diagnostic and treatment services, including medical care, hospitalization and other institutional care and aftercare, appliances and facilitating services directed toward reducing infant mortality and improving the health of mothers and children. The department may make grants or contracts or advance funds from any funds that are made available for the purposes of the Maternal and Child Health Program Act (Section 27).


123240. (a) The Maternal and Child Health Branch of the department shall conduct a pilot project to assess the effectiveness of daily ambulatory uterine monitoring devices and services in reducing preterm births in Medi-Cal eligible women. (b) The department shall implement the pilot program to assess the incidence of preterm births in 1,000 women at high risk of preterm birth, 500 of whom shall be provided daily ambulatory uterine monitoring services between the 23rd and 36th weeks of gestation and 500 of whom shall be provided routine prenatal care augmented by training in palpatation. Women participating in the pilot program shall be Medi-Cal eligible women. To the maximum extent possible these services shall be prescribed by providers participating in other programs administered by the Maternal and Child Health Branch of the department or the comprehensive perinatal program. (c) Women shall be deemed to be at high risk if they have multiple gestation or any two of the following risk factors for preterm labor; uterine malformation, a history of preterm labor or births, cervical incompetence, cervical dilation or effacement, and those patients who have been treated during the current pregnancy for preterm labor. (d) The department shall select five counties to participate in the project, at least one of which shall be a rural county, and shall reimburse providers of ambulatory uterine monitoring services a fee based on reasonable costs. (e) (1) The department shall also contract for an evaluation of the pilot project to ascertain whether use of the ambulatory uterine monitoring services significantly reduces the incidence of preterm births. The evaluation shall compare the experimental and control groups and identify the following for each group: (A) The number of preterm births. (B) The number of hospital days used by the mother prior to delivery. (C) The number of hospital days used by the mother and child after delivery, including neonatal intensive care. (D) The number of children born with developmental disabilities or conditions that may lead to developmental disabilities. (E) The costs of providing prenatal services. (2) The evaluation shall also project the costs associated with the health care provided to the mother and child during the course of the pilot project and, if feasible, shall project the longer term health care costs of children born prematurely, including costs of services provided to the developmentally disabled. (3) The department may enter into the contract on a sole source basis. (f) (1) The pilot project established pursuant to this section shall be considered successful if it shows that the experimental group, when compared to the control group, had all of the following: (A) A 20-percent reduction in the number of premature births. (B) A 20-percent reduction in the number of antepartum hospitalization days. (C) A 20-percent reduction in the number of neonatal intensive care unit days for premature births. (D) A 20-percent reduction in total patient costs. (2) The department shall submit the evaluation to the Legislature by September 1, 1990. (g) (1) The department shall immediately seek any federal waivers necessary to ensure full federal financial participation in the pilot program established pursuant to this section. (2) The department shall not implement the pilot program under this section until necessary federal waivers are received.


123245. The Maternal and Child Health Program Act (Section 27) does not give the power to force compulsory medical or physical examination of children.

123250. Upon request the department shall advise all public officers, organizations, and agencies interested in the health and welfare of mothers and children in the state.


123255. (a) The department may maintain a maternal and child health program in each county. (b) Notwithstanding any other provision of law, the department may allocate, for the purposes of maintaining a maternal and child health program, to a county an amount determined in a manner as the director shall provide. The total of all county allocations shall not exceed the annual appropriation for this purpose. (c) To be considered for an allocation, the county's governing board shall submit a plan and budget for the county's program in accordance with maternal and child health plans and priorities to be approved by the department under Title V of the Public Health Service Act (42 U.S.C. Sec. 701 et seq.). The department shall establish the procedures and format for submission of the plan and budget. The plan shall conform to the department's maternal and child health priorities that are in accordance with the core public health functions of needs assessment, policy development, and assurance. (d) The department shall establish minimum standards that govern the basis for allocations to counties, including, but not limited to, the services to be provided, administration, staffing, fiscal accountability, and eligibility for services. The department may recoup or withhold all or part of a county's allocation for failure to comply with those standards. (e) Claims for reimbursement shall be made in a manner as provided by the director for activities provided in accordance with the plan and budget for the fiscal year in which the expenses upon which the claim is based are incurred. (f) There shall be no reimbursement for any of the following: (1) Projects or programs identified unless previously approved by the department as part of the maternal and child health plan. (2) Capital improvements. (3) The purchase or construction of buildings except for the equipment items and remodeling expenses as may be allowed by the department on a case-by-case basis. (g) The department and counties shall maximize the use of federal funds available to implement this section, including using state or county funds to match funds claimable under Title XIX of the federal Social Security Act (42 U.S.C. Sec. 1396 et seq.). (h) (1) For purposes of this program, the department shall reimburse a county pursuant to this section in lieu of renewing or commencing a cooperative agreement with a county for the operation of a maternal and child health program. (2) It is the intent of the Legislature that cooperative agreements between the department and a county for the operation of a maternal and child health program pursuant to this section be replaced by the process described in this section beginning with the 1997-98 fiscal year.


Article 2. Women, Infants, And Children's Nutrition

Ca Codes (hsc:123275-123355) Health And Safety Code Section 123275-123355



123275. The Legislature finds that medical, educational and psychological evidence increasingly points to adequate nutrition as a determinant not only of good physical health but also of full intellectual development and educational achievement, with adequate nutrition in the earliest months and years being particularly important for full development of the child's mind and body, that problems of child nutrition cut across income lines and can result not only from low income but also from parental ignorance or neglect and that there is a need for a statewide child nutrition program that has the potential of reaching all pregnant women and mothers of infants.


123279. (a) It is the intent of the Legislature in adding this section to authorize the establishment of a program designed to implement the federal WIC Farmers' Market Nutrition Act of 1992 (Public Law 102-314), which is designed to accomplish the following: (1) Provide resources to persons who are nutritionally at risk, in the form of fresh, high-quality agricultural products from certified farmers' markets. (2) Expand the awareness and use of certified farmers' markets and increase sales at those markets. (b) The department may establish a program designed to implement the federal WIC Farmers Market Nutrition Act of 1992. (c) If the program is established, the department shall develop criteria to permit any producer authorized by the department to participate in the program to sell fresh nutritious foods to recipients in exchange for nutrition coupons. (d) If the program is established, the department shall authorize local agencies to distribute nutrition coupons to all recipients, as defined by subdivision (c) of Section 123285 of the Health and Safety Code. (e) If the program is established, the department shall design the nutrition coupon issuance process to ensure that nutrition coupons are bearer-only, nonnegotiable, and nontransferable by the recipient and that they may be redeemed by recipients only to purchase fresh produce and redeemed for reimbursement only by authorized producers. (f) It is the intent of the Legislature that the program established by this section to implement the federal WIC Farmers' Market Nutrition Act of 1992 (Public Law 102-314) be funded 70 percent by federal funds and 30 percent by private or other funds, as specified by the federal act.


123280. (a) The department may conduct a statewide program for providing nutritional food supplements to low-income pregnant women, low-income postpartum and lactating women, and low-income infants and children under five years of age, who have been determined to be at nutritional risk by a health professional, based on criteria established by the department. Any program established pursuant to this section shall do all of the following: (1) Comply with all the requirements of this article. (2) Be conducted only if a special project is authorized by inclusion in the Budget Act or notification is provided to the Legislature pursuant to Section 28 of the Budget Act, and federal funds are appropriated therefor. (3) Be known as the California Special Supplemental Food Program for Women, Infants, and Children. (b) The department shall administer this article and shall adopt minimum standards and regulations as necessary.


123285. As used in this article, the following definitions shall apply: (a) "Health professional" means a physician and surgeon, registered nurse, nutritionist, dietitian, or state or local medically trained health official, who is competent to professionally evaluate nutritional need and to authorize supplemental foods, as determined by the state department. (b) "Low income" means an income of not more than 185 percent of the poverty level as determined by the federal poverty income guidelines promulgated by the United States Department of Health and Human Services. (c) "Recipient" means low-income pregnant women, low-income postpartum and lactating women, and low-income infants and children under five years of age, who are determined to be at nutritional risk by a health professional, based on criteria established by the state department. (d) "Nutrition coupon" means a check that is limited as to value, food type, and food quantity and that has a limited period of validity.

123290. The department, under any program established pursuant to this article, shall do all of the following: (a) Establish guidelines to determine resource allocation giving consideration to an area's nutritional need. (b) Designate the counties within which a program will be conducted, with the approval of those counties. (c) Establish the minimum nutritional requirements for recipients. (d) Designate specific supplemental foods to meet the minimum nutritional requirements for recipients. (e) Develop and maintain a system for the delivery of supplemental foods to recipients through the distribution of supplemental foods designated in subdivision (d) and nutrition coupons when other methods of delivery are impractical. (f) (1) Develop and coordinate a smoking cessation component of program operations, with consideration of local agency plans, needs, and available tobacco education resources. (2) In consultation with the directors of local agencies and with other individuals with expertise in the field of smoking cessation, identify and promulgate a strategy for smoking cessation in the state plan of operation and administration of the WIC program, including, but not limited to all of the following: (A) Designating an agency staff member to coordinate smoking cessation efforts. (B) Providing training on smoking cessation and tobacco education to designated staff members of local agencies who are responsible for counseling participants in the program. (3) Develop and implement procedures to ensure that tobacco use screening and education, including, but not limited to, smoking cessation counseling and referrals where appropriate, are offered to all participants. (g) (1) Establish guidelines and criteria to be used by participating local agencies, when determining recipient eligibility, that require, in addition to a recipient being a low-income pregnant woman, or a low-income postpartum and lactating woman, or a low-income infant or child under five years of age, that the recipient be at nutritional risk. (2) A health professional on the staff of the local agency shall determine if a person is at nutritional risk through a medical or nutritional assessment. This determination may be based on referral data submitted by a health professional not on the staff of the local agency. The person's height or length and weight shall be measured, and a hematological test for anemia, such as a hemoglobin or hematocrit test, shall be performed. However, the tests shall not be required for infants under six months of age. In addition, the blood test shall not be required for children who were determined to be within the normal range at their last program certification. However, the blood test shall be performed on the children at least once a year. A breastfeeding woman may be certified if the child she is breastfeeding is determined to be at nutritional risk and the woman meets the income eligibility criteria. (h) Operate the program as an adjunct to existing health services. (i) Seek federal funds to carry out this article.


123295. Nutrition coupons in an amount sufficient to meet the nutritional needs of a recipient for one month shall be granted to a recipient by facilities and persons referred to in subdivision (g) of Section 123290 upon the written finding of nutritional need by the recipient's physician or other health professional.


123300. The department may, under any program established pursuant to this article, investigate the feasibility of contracting with one or more banks in the area served by the program for the redemption of nutrition coupons.

123302. (a) (1) Notwithstanding any other provision of law, the department may design, implement, and fund an electronic benefits transfer (EBT) system for the California Special Supplemental Food Program for Women, Infants, and Children. Sections 10066, 10067, and 10068 of, and subdivision (j) of Section 10072 of, the Welfare and Institutions Code, shall apply to the administration of this section. (2) The department may not implement any EBT system authorized by this section until the department completes a feasibility study, and funding for the system is provided in the annual Budget Act. (b) The department shall seek the advice of the Electronic Benefits Transfer Committee, created by Section 10067 of the Welfare and Institutions Code, in implementing this section, and shall obtain the approval of the United States Department of Agriculture, which is the federal governing agency, prior to the establishment of any EBT system. (c) The department shall develop a plan to determine the feasibility of implementing an EBT system for the California Special Supplemental Food Program for Women, Infants, and Children by January 1, 2003, and shall report its findings to the Legislature by July 1, 2003.


123305. The department, under any program established pursuant to this article, may collect data to determine the need for and the continuation of a supplemental nutritional program for recipients under this article.

123310. The department, under any program established pursuant to this article, shall authorize retail food vendors, by written agreement, to accept nutrition coupons and reimbursement according to the system developed by the department. The department shall authorize an appropriate number and distribution of food vendors in order to assure adequate participant convenience and access and to assure that state or local officials can effectively manage review of authorized food vendors in their jurisdictions. The department shall establish criteria to limit the number of retail food vendors with which the department enters into agreements. The criteria, at a minimum, shall include: (a) The prices the vendor charges for foods in relation to other vendors in its peer group. For purposes of this subdivision, "peer group" means a group of vendors with similar characteristics that may include, but shall not be limited to, any or all of the following: (1) Geographic location of the store. (2) Store size. (3) Type of store. (4) Number of cash registers. (5) Sales volume relating to any program established pursuant to this article. (6) Gross sales volume. (7) Inventory. (8) Other vendor characteristics established by the department. (b) The ability of the department to ensure that authorized supplemental foods will be provided through in-store compliance purchases. (c) The adequacy of the shelf stock of the authorized supplemental foods. (d) Past performance of the vendor in compliance with this article and with the Food Stamp Program.

123315. (a) The department, under any program established pursuant to this article, shall ensure that, at a minimum, the authorized vendor shall do all of the following: (1) Redeem nutrition coupons only from persons bearing appropriate identification provided by the department. (2) Redeem nutrition coupons for only those foods specified thereon. (3) Redeem nutrition coupons at an amount that is the same as, or lesser than, that charged other customers for identical foods. (4) Redeem and deposit nutrition coupons during specified valid periods. (5) Deposit the nutrition coupons directly in the vendor's bank account and not transfer them for cash payment, credit, or any other benefit to any party other than the vendor's bank or the state. (6) Maintain for a period of at least three years records that shall include, but not be limited to, all of the following: (A) Inventory records showing all purchases, both wholesale and retail, in the form of invoices that identify the quantity and prices of specified authorized supplemental foods. (B) Sales and use tax returns. (C) Books of account. (D) Other pertinent records that the department determines are necessary to substantiate the volume and prices charged to the state department through the nutrition coupons redeemed by the vendor. (7) Accept up to the maximum allowable department reimbursement as payment in full for the maximum allowable quantity of food listed on the food instrument. (8) Comply with department rules of vendor authorization, reimbursement, and monitoring that control program food costs, maximize participant access, and ensure program integrity. (b) The department shall adopt regulations to implement this section and Section 123310 in accordance with the rulemaking provisions of the Administrative Procedure Act (Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code). The adoption of any emergency regulations on or after January 1, 2000, shall be deemed to be an emergency and necessary for the immediate preservation of the public peace, health and safety, or general welfare. Emergency regulations adopted pursuant to this section shall remain in effect for no more than 180 days.


123320. (a) The department shall inform the retail food vendors of, and include in the written agreement with the vendors, guidelines consistent with Section 123315, and shall print on each coupon the following: (1) Specific supplemental foods and the quantities thereof for which the coupon may be redeemed. (2) The period of validity of the nutrition coupon. (3) The maximum value for which the nutrition coupon may be redeemed. (b) To the extent feasible, the information required pursuant to subdivision (a) shall be provided in a form that may be read by optical scanning technology readily available to vendors. The department shall, no later than March 15, 2002, report to the Legislature on the feasibility and costs of providing the information in this form. This subdivision shall be implemented only to the extent that funds for its purposes are appropriated in the annual Budget Act or another statute.


123325. A retail food vendor or any other person who knowingly redeems coupons in excess of the price charged other customers for identical foods, or who provides anything of value other than the specified foods, or who fails to provide inventory records to substantiate purchases for resale of authorized supplemental foods is subject to all sanctions set forth in federal regulation for the Special Supplemental Food Program for Women, Infants, and Children, that is provided for in Section 246 and following of Title 7 of the Code of Federal Regulations. The department may disqualify a food vendor who is currently disqualified from the Food Stamp Program.


123330. Any person or persons who have embezzled, willfully misapplied, stolen, or fraudulently obtained funds or benefits pursuant to this article shall be subject to the penalties set forth in federal regulations for the Special Supplemental Food Program for Women, Infants, and Children, that is provided for in Section 246 and following of Title 7 of the Code of Federal Regulations.


123335. Any officer, employee, or agent of the department may enter the place of business of any vendor transacting nutrition coupons to verify food prices, to witness or investigate procedures, to conduct financial audits, or to otherwise determine compliance of the vendor with this article and the vendor agreement.


123340. (a) Except as provided in subdivision (c), if any amount is due and payable and unpaid as a result of an overpayment to a vendor or local agency established under this article that is identified through an audit or examination conducted by or on behalf of the director and the department has issued an audit or examination finding, or an administrative decision resulting from an administrative appeal of the audit or examination finding that has become final, the director may file in the office of the County Clerk of Sacramento County and with the county clerk of the county in which the vendor has his or her principal place of business, a certificate containing the following: (1) The amount due and owing and unpaid plus the applicable interest at a rate equal to the monthly average of the rate received on investments in the Pooled Money Investment Fund commencing on the date that an audit or examination finding, made pursuant to Section 316.5 is mailed to the vendor or local agency. (2) A statement that the director has complied with this article prior to the filing of the certificate. (3) A request that judgment be entered against the vendor or local agency in the amount set forth in the certificate. The county clerk immediately upon the filing of the certificate, shall enter a judgment for the State of California against the vendor or local agency in the amount set forth in the certificate. Notwithstanding any provision of law to the contrary, the Special Supplemental Food Program for Women, Infants, and Children shall pay the normal fee charged by the county for the certificate of judgment. Nothing in this subdivision shall prevent the director from using any other means available in law to recover amounts due and owing and unpaid from the vendor or local agency. (b) The dates when the department may file the certificate and seek judgment from the county clerk, as provided in subdivision (a), depends on whether the audit finding is appealed by the vendor or local agency. (1) If the audit finding or lower level administrative decision is not appealed, the department may file the certificate the day after the end of the appeal period or anytime thereafter, but not later than three years after the payment became due and owing. (2) If the audit finding or lower level administrative decision is appealed to the director, the department may file the certificate no earlier than 90 days after the issuance of the final decision by the director, but no later than three years after the issuance of the final decision. (c) If the vendor seeks judicial review of the final decision of the director pursuant to Section 1094.5 of the Code of Civil Procedure, and notice of the action is properly served on the director within 90 days of the issuance of the final decision, the department shall not file any certificate as provided in subdivision (a). If the vendor does not seek judicial review of the final decision of the director or does not properly serve notice within 90 days from the date of the final decision of the director, the department may file the certificate and obtain judgment pursuant to subdivision (a).


123345. An abstract of judgment obtained pursuant to subdivisions (a) and (b) of Section 123340 or a copy thereof may be recorded with the county recorder of any county. From the time of recording, the judgment shall constitute a lien upon all real or personal property owned by the vendor at the time, or that the vendor may afterwards, but before the lien expires, acquire. The lien shall have the force, effect, and priority of a judgment lien and shall continue for 10 years from the time of recording of the abstract of judgment obtained pursuant to subdivisions (a) and (b) of Section 123340 unless sooner released or otherwise discharged. The lien may, within 10 years from the date of recording of the abstract of judgment or within 10 years from the date of the last extension of the lien in the manner herein provided, be extended by recording a new abstract in the office of the county recorder of any county. From the date of the recording the lien shall be extended for 10 years unless sooner released or otherwise discharged.


123350. The department shall arrange for the conduct of periodic audits of participating local agencies.


123355. The department shall provide a hearing procedure whereby any food vendor or local agency may appeal any adverse action taken by the department affecting the vendor's or local agency's participation in the California Supplemental Food Program for Women, Infants, and Children. The hearing procedure shall be in accordance with the requirements of the federal regulations for the Special Supplemental Food Program for Women, Infants, and Children, that is contained in Section 246 et seq. of Title 7 of the Code of Federal Regulations.


Article 3. Breast Feeding

Ca Codes (hsc:123360-123365) Health And Safety Code Section 123360-123365



123360. (a) The State Department of Public Health shall include in its public service campaign the promotion of mothers breast-feeding their infants. (b) The department shall develop a model eight-hour training course of hospital policies and recommendations that promote exclusive breast-feeding, incorporating available materials already developed by the department, and shall specify hospital staff for whom this model training is appropriate. The department shall also provide the model training materials to hospitals, upon request.


123361. To the extent that non-United States Department of Agriculture (USDA) federal funds and private grants or donations are made available for this purpose, the State Department of Public Health shall, no later than July 1, 2008, begin expansion of the breast-feeding peer counseling program at local agency California Special Supplemental Food Program for Women, Infants, and Children (WIC) sites. Plans for the expansion of the program shall take into account local WIC agency program models that have demonstrated the greatest improvement in breast-feeding rates, including exclusive breast-feeding rates. Program expansion shall be contingent upon the availability of non-USDA federal funds and private grants or donations being made available for this purpose. Nothing in this section shall impact USDA federal funding for the WIC Supplemental Food Program or the breast-feeding peer counseling program at local agency WIC sites.

123365. (a) All general acute care hospitals, as defined in subdivision (a) of Section 1250, and all special hospitals providing maternity care, as defined in subdivision (f) of Section 1250, shall make available a breast feeding consultant or alternatively, provide information to the mother on where to receive breast feeding information. (b) The consultant may be a registered nurse with maternal and newborn care experience, if available. (c) The consultation shall be made available during the hospitalization associated with the delivery, or alternatively, the hospital shall provide information to the mother on where to receive breast feeding information. (d) The patient may decline this consultation or information.


Article 4. Cord Blood Banking Education

Ca Codes (hsc:123370-123371) Health And Safety Code Section 123370-123371



123370. The department shall conduct the Umbilical Cord Blood Community Awareness Campaign to do all of the following: (a) Provide awareness, assistance, and information regarding umbilical cord blood banking options using brochures, television, print media, radio, Internet Web sites, outdoor advertising, and other media, where appropriate to disseminate information to licensed prenatal care providers, Family PACT providers, and pregnant women. (b) Establish an Internet Web site to provide information about umbilical cord blood banking options that is accessible to prenatal care providers, pregnant women, and the general public. (c) Undertake public education activities related to umbilical cord blood donation to targeted populations, as appropriate.


123371. (a) (1) The State Department of Public Health shall develop standardized, objective information about umbilical cord blood donation that is sufficient to allow a pregnant woman to make an informed decision on whether to participate in a private or public umbilical cord blood banking program. The information developed by the department shall enable a pregnant woman to be informed of her option to do any of the following: (A) Discard umbilical cord blood. (B) Donate umbilical cord blood to a public umbilical cord blood bank. (C) Store the umbilical cord blood in a family umbilical cord blood bank for the use by immediate and extended family members. (D) Donate umbilical cord blood to research. (2) The information developed pursuant to paragraph (1) shall include, but not be limited to, all of the following: (A) The current and potential future medical uses of stored umbilical cord blood. (B) The benefits and risks involved in umbilical cord blood banking. (C) The medical process involved in umbilical cord blood banking. (D) Medical or family history criteria that can impact a family's consideration of umbilical cord banking. (E) An explanation of the differences between public and private umbilical cord blood banking. (F) The availability and costs of public or private umbilical cord blood banks. (G) Medical or family history criteria that can impact a family's consideration of umbilical cord blood banking. (H) An explanation that the practices and policies of blood banks may vary with respect to accreditation, cord blood processing and storage methods, costs, and donor privacy. (I) An explanation that pregnant women are not required to donate their umbilical cord blood for research purposes. (b) The information provided by the department pursuant to subdivision (a) shall be made available in Cantonese, English, Spanish, and Vietnamese, and shall be updated by the department as needed. (c) The information provided by the department pursuant to subdivision (a) shall be made available on the Internet Web sites of the licensing boards that have oversight over primary prenatal care providers. (d) (1) A primary prenatal care provider of a woman who is known to be pregnant may, during the first prenatal visit, provide the information required by subdivision (a) to the pregnant woman. (2) For purposes of this article, a "prenatal care provider" means a health care provider licensed pursuant to Division 2 (commencing with Section 500) of the Business and Professions Code, or pursuant to an initiative act referred to in that division, who provides prenatal medical care within his or her scope of practice. (e) The department shall only implement this article upon a determination by the Director of Finance, that sufficient private donations have been collected and deposited into the Umbilical Cord Blood Education Account, which is hereby created in the State Treasury. The moneys in the account shall be available, upon appropriation by the Legislature, for the purposes of this article. No public funds shall be used to implement this article. If sufficient funds are collected and deposited into the account, the Director of Finance shall file a written notice thereof with the Secretary of State.


Chapter 2. Maternal Health

Article 1. Determination Of Pregnancy

Ca Codes (hsc:123375-123418) Health And Safety Code Section 123375-123418



123375. (a) Except as otherwise provided in subdivision (b), no person shall sell, offer for sale, give away, distribute, or otherwise furnish materials intended to determine the presence of pregnancy, unless that person has obtained a certificate of acceptability from the department declaring that the materials have been approved as to efficacy and safety by the department. (b) Subdivision (a) shall not apply to materials intended to determine the presence of pregnancy, that are sold, offered for sale, given away, distributed, or otherwise furnished to a physician and surgeon licensed to practice in this state, a pharmacist licensed to practice in this state, a licensed primary care clinic, a licensed health facility, or a public health agency. (c) Any person other than a person described in subdivision (b) who intends to sell, offer for sale, give away, distribute or otherwise furnish materials intended to determine the presence of pregnancy shall first make application to the state department for certification of the materials. The department shall also require that an application for certification shall be accompanied by samples of any materials that are the subject of the application as the department may reasonably require. Any violation of this section is a misdemeanor.


123380. Local public health agencies shall make pregnancy testing services available free or at cost to the person using the services. The results of any pregnancy test shall be confidential.


123385. It is the intent of the Legislature that the program authorized pursuant to this article be entirely self-supporting, and for this purpose the state department is authorized to establish a schedule of fees for applications for certificates of acceptability that shall provide revenues that shall not exceed the amount necessary, but shall be sufficient to cover all costs incurred in the administration of this article.


123418. Subject to all other provisions of this article, all residency programs in obstetrics and gynecology shall comply with the program requirements for residency education in obstetrics and gynecology of the Accreditation Council for Graduate Medical Education, which require that in addition to education and training in in-patient care, the program in obstetrics-gynecology be geared toward the development of competence in the provision of ambulatory primary health care for women, including, but not limited to, training in the performance of abortion services.


Article 2. Abortion

Ca Codes (hsc:123420-123450) Health And Safety Code Section 123420-123450



123420. (a) No employer or other person shall require a physician, a registered nurse, a licensed vocational nurse, or any other person employed or with staff privileges at a hospital, facility, or clinic to directly participate in the induction or performance of an abortion, if the employee or other person has filed a written statement with the employer or the hospital, facility, or clinic indicating a moral, ethical, or religious basis for refusal to participate in the abortion. No such employee or person with staff privileges in a hospital, facility, or clinic shall be subject to any penalty or discipline by reason of his or her refusal to participate in an abortion. No such employee of a hospital, facility, or clinic that does not permit the performance of abortions, or person with staff privileges therein, shall be subject to any penalty or discipline on account of the person's participation in the performance of an abortion in other than the hospital, facility, or clinic. No employer shall refuse to employ any person because of the person's refusal for moral, ethical, or religious reasons to participate in an abortion, unless the person would be assigned in the normal course of business of any hospital, facility, or clinic to work in those parts of the hospital, facility, or clinic where abortion patients are cared for. No provision of this article prohibits any hospital, facility, or clinic that permits the performance of abortions from inquiring whether an employee or prospective employee would advance a moral, ethical, or religious basis for refusal to participate in an abortion before hiring or assigning that person to that part of a hospital, facility, or clinic where abortion patients are cared for. The refusal of a physician, nurse, or any other person to participate or aid in the induction or performance of an abortion pursuant to this subdivision shall not form the basis of any claim for damages. (b) No medical school or other facility for the education or training of physicians, nurses, or other medical personnel shall refuse admission to a person or penalize the person in any way because of the person's unwillingness to participate in the performance of an abortion for moral, ethical, or religious reasons. No hospital, facility, or clinic shall refuse staff privileges to a physician because of the physician's refusal to participate in the performance of abortion for moral, ethical, or religious reasons. (c) Nothing in this article shall require a nonprofit hospital or other facility or clinic that is organized or operated by a religious corporation or other religious organization and licensed pursuant to Chapter 1 (commencing with Section 1200) or Chapter 2 (commencing with Section 1250) of Division 2, or any administrative officer, employee, agent, or member of the governing board thereof, to perform or to permit the performance of an abortion in the facility or clinic or to provide abortion services. No such nonprofit facility or clinic organized or operated by a religious corporation or other religious organization, nor its administrative officers, employees, agents, or members of its governing board shall be liable, individually or collectively, for failure or refusal to participate in any such act. The failure or refusal of any such corporation, unincorporated association or individual person to perform or to permit the performance of such medical procedures shall not be the basis for any disciplinary or other recriminatory action against such corporations, unincorporated associations, or individuals. Any such facility or clinic that does not permit the performance of abortions on its premises shall post notice of that proscription in an area of the facility or clinic that is open to patients and prospective admittees. (d) This section shall not apply to medical emergency situations and spontaneous abortions. Any violation of this section is a misdemeanor.


123425. The refusal of any person to submit to an abortion or surgical sterilization or to give consent therefor shall not be grounds for loss of any privileges or immunities to which the person would otherwise be entitled, nor shall submission to an abortion or surgical sterilization or the granting of consent therefor be a condition precedent to the receipt of any public benefits. The decision of any person to submit to an abortion or surgical sterilization or to give consent therefor shall not be grounds for loss of any privileges or immunities to which the person would otherwise be entitled, nor shall the refusal to submit to an abortion or surgical sterilization or to give consent therefor be a condition precedent to the receipt of any public benefits.


123435. The rights to medical treatment of an infant prematurely born alive in the course of an abortion shall be the same as the rights of an infant of similar medical status prematurely born spontaneously.

123440. (a) It is unlawful for any person to use any aborted product of human conception, other than fetal remains, for any type of scientific or laboratory research or for any other kind of experimentation or study, except to protect or preserve the life and health of the fetus. "Fetal remains," as used in this section, means a lifeless product of conception regardless of the duration of pregnancy. A fetus shall not be deemed to be lifeless for the purposes of this section, unless there is an absence of a discernible heartbeat. (b) In addition to any other criminal or civil liability that may be imposed by law, any violation of this section constitutes unprofessional conduct within the meaning of the Medical Practice Act, Chapter 5 (commencing with Section 2000) of Division 2 of the Business and Professions Code.


123445. (a) Except as provided in subdivision (b), at the conclusion of any scientific or laboratory research or any other kind of experimentation or study upon fetal remains, the fetal remains shall be promptly interred or disposed of by incineration. Storage of the fetal remains prior to the completion of the research, experimentation, or study shall be in a place not open to the public, and the method of storage shall prevent any deterioration of the fetal remains that would create a health hazard. (b) Subdivision (a) shall not apply to public or private educational institutions. Any violation of this section is a misdemeanor.


123450. (a) Except in a medical emergency requiring immediate medical action, no abortion shall be performed upon an unemancipated minor unless she first has given her written consent to the abortion and also has obtained the written consent of one of her parents or legal guardian. (b) If one or both of an unemancipated, pregnant minor's parents or her guardian refuse to consent to the performance of an abortion, or if the minor elects not to seek the consent of one or both of her parents or her guardian, an unemancipated pregnant minor may file a petition with the juvenile court. If, pursuant to this subdivision, a minor seeks a petition, the court shall assist the minor or person designated by the minor in preparing the petition and notices required pursuant to this section. The petition shall set forth with specificity the minor's reasons for the request. The court shall ensure that the minor's identity is confidential. The minor may file the petition using only her initials or a pseudonym. An unemancipated pregnant minor may participate in the proceedings in juvenile court on her own behalf, and the court may appoint a guardian ad litem for her. The court shall, however, advise her that she has a right to court-appointed counsel upon request. The hearing shall be set within three days of the filing of the petition. A notice shall be given to the minor of the date, time, and place of the hearing on the petition. (c) At the hearing on a minor's petition brought pursuant to subdivision (b) for the authorization of an abortion, the court shall consider all evidence duly presented, and order either of the following: (1) If the court finds that the minor is sufficiently mature and sufficiently informed to make the decision on her own regarding an abortion, and that the minor has, on that basis, consented thereto, the court shall grant the petition. (2) If the court finds that the minor is not sufficiently mature and sufficiently informed to make the decision on her own regarding an abortion, the court shall then consider whether performance of the abortion would be in the best interest of the minor. In the event that the court finds that the performance of the abortion would be in the minor's best interest, the court shall grant the petition ordering the performance of the abortion without consent of, or notice to, the parents or guardian. In the event that the court finds that the performance of the abortion is not in the best interest of the minor, the court shall deny the petition. Judgment shall be entered within one court day of submission of the matter. (d) The minor may appeal the judgment of the juvenile court by filing a written notice of appeal at any time after the entry of the judgment. The Judicial Council shall prescribe, by rule, the practice and procedure on appeal and the time and manner in which any record on appeal shall be prepared and filed. These procedures shall require that the notice of the date, time, and place of hearing, which shall be set within five court days of the filing of notice of appeal, shall be mailed to the parties by the clerk of the court. The appellate court shall ensure that the minor's identity is confidential. The minor may file the petition using only her initials or a pseudonym. Judgment on appeal shall be entered within one court day of submission of the matter. (e) No fees or costs incurred in connection with the procedures required by this section shall be chargeable to the minor or her parents, or either of them, or to her legal guardian. (f) It is a misdemeanor, punishable by a fine of not more than one thousand dollars ($1,000), or by imprisonment in the county jail of up to 30 days, or both, for any person to knowingly perform an abortion on an unmarried or unemancipated minor without complying with the requirements of this section.


Article 2.5. Reproductive Privacy Act

Ca Codes (hsc:123460-123468) Health And Safety Code Section 123460-123468



123460. This article shall be known and may be cited as the Reproductive Privacy Act.


123462. The Legislature finds and declares that every individual possesses a fundamental right of privacy with respect to personal reproductive decisions. Accordingly, it is the public policy of the State of California that: (a) Every individual has the fundamental right to choose or refuse birth control. (b) Every woman has the fundamental right to choose to bear a child or to choose and to obtain an abortion, except as specifically limited by this article. (c) The state shall not deny or interfere with a woman's fundamental right to choose to bear a child or to choose to obtain an abortion, except as specifically permitted by this article.


123464. The following definitions shall apply for purposes of this chapter: (a) "Abortion" means any medical treatment intended to induce the termination of a pregnancy except for the purpose of producing a live birth. (b) "Pregnancy" means the human reproductive process, beginning with the implantation of an embryo. (c) "State" means the State of California, and every county, city, town and municipal corporation, and quasi-municipal corporation in the state. (d) "Viability" means the point in a pregnancy when, in the good faith medical judgment of a physician, on the particular facts of the case before that physician, there is a reasonable likelihood of the fetus' sustained survival outside the uterus without the application of extraordinary medical measures.


123466. The state may not deny or interfere with a woman's right to choose or obtain an abortion prior to viability of the fetus, or when the abortion is necessary to protect the life or health of the woman.

123468. The performance of an abortion is unauthorized if either of the following is true: (a) The person performing or assisting in performing the abortion is not a health care provider authorized to perform or assist in performing an abortion pursuant to Section 2253 of the Business and Professions Code. (b) The abortion is performed on a viable fetus, and both of the following are established: (1) In the good faith medical judgment of the physician, the fetus was viable. (2) In the good faith medical judgment of the physician, continuation of the pregnancy posed no risk to life or health of the pregnant woman.


Article 3. Community-based Perinatal System

Ca Codes (hsc:123475-123525) Health And Safety Code Section 123475-123525



123475. The Legislature finds that a community-based system of comprehensive perinatal care, including prenatal care, delivery service, postpartum care, and neonatal and infant care are necessary services that have been demonstrated effective in preventing or reducing maternal, perinatal, and infant mortality and morbidity.


123480. It is the intent of the Legislature in enacting this article to maintain, to the extent resources are available, a permanent statewide community-based comprehensive perinatal system to provide care and services to low-income pregnant women and their infants who are considered underserved in terms of comprehensive perinatal care. It is also the intent of the Legislature that the statewide, community-based, comprehensive perinatal health care program be developed by the department to conform with the guidelines set forth in this article, and be integrated and coordinated with the perinatal access program in Article 2.5 (commencing with Section 288). It is further the intent of the Legislature that these guidelines allow each applicant the flexibility to design a system specific to the nature of the community and the needs of the clients. It is further the intent of the Legislature that the director, in allocating funds available for programs that provide comprehensive perinatal care, follow the guidelines and principles developed in this article.


123485. The following definitions shall govern the construction of this article: (a) "Community-based comprehensive perinatal care" means a range of prenatal, delivery, postpartum, infant, and pediatric care services delivered in an urban community or neighborhood, rural area, city or county clinic, city or county health department, freestanding birth center, or other health care provider facility by health care practitioners trained in methods of preventing complications and problems during and after pregnancy, and in methods of educating pregnant women of these preventive measures, and who provide a continuous range of services. The health care practitioners shall, through a system of established linkages to other levels of care in the community, consult with, and, when appropriate, refer to, specialists. (b) "Low income" means all persons of childbearing age eligible for Medi-Cal benefits under Chapter 7 (commencing with Section 14000) and all persons eligible for public social services for which federal reimbursement is available, including potential recipients. "Potential recipients" shall include the pregnant woman and her infant in a family where current social, economic and health conditions of the family indicate that the family would likely become a recipient of financial assistance within the next five years. (c) "Prenatal care" means care received from conception until the completion of labor and delivery. (d) "Perinatal care" means care received from the time of conception through the first year after birth. (e) "Qualified organization" means any nonprofit, not-for-profit, or for-profit corporation with demonstrated expertise in implementing the Nurse-Family Partnership program or similar programs in different local settings. (f) "Qualified trainer" means anyone who has been certified by the Nurse-Family Partnership to provide training. (g) "Department" means the State Department of Public Health, unless otherwise designated.

123490. (a) The department shall develop and maintain a statewide comprehensive community-based perinatal services program and enter into contracts, grants, or agreements with health care providers to deliver these services in a coordinated effort to the extent permitted under federal law and regulation. These contracts, grants, or agreements shall be made in medically underserved areas or areas with demonstrated need. Nothing in this section shall be construed to prevent reallocation of resources or use of new moneys for the development of new community-based comprehensive perinatal systems in underserved areas or areas with demonstrated need, and supplementation of systems already in existence. (b) As a condition of receiving funds from the Maternal and Child Health program, contractors shall bill the Medi-Cal program for services provided to Medi-Cal recipients.


123491. (a) There is hereby established a voluntary nurse home visiting grant program for expectant first-time mothers, their children, and their families, to be administered by the department pursuant to Section 123492. The program may be cited as the Nurse-Family Partnership program. (b) The goals and objectives of the program shall be the same as, but shall not be limited to, those in the community-based comprehensive perinatal health care system as set forth in Section 123505. (c) The department shall adopt regulations for the implementation of this section in accordance with Section 123516.


123492. The department shall develop a grant application and award grants on a competitive basis to counties for the startup, continuation, and expansion of the program established pursuant to Section 123491. To be eligible to receive a grant for purposes of that section, a county shall agree to all of the following: (a) Serve through the program only pregnant, low-income women who have had no previous live births. Notwithstanding subdivision (b) of Section 123485, women who are juvenile offenders or who are clients of the juvenile system shall be deemed eligible for services under the program. (b) Enroll women in the program while they are still pregnant, before the 28th week of gestation, and preferably before the 16th week of gestation, and continue those women in the program through the first two years of the child's life. (c) Use as home visitors only registered nurses who have been licensed in the state. (d) Have nurse home visitors undergo training according to the program and follow the home visit guidelines developed by the Nurse-Family Partnership program. (e) Have nurse home visitors specially trained in prenatal care and early child development. (f) Have nurse home visitors follow a visit schedule keyed to the developmental stages of pregnancy and early childhood. (g) Ensure that, to the extent possible, services shall be rendered in a culturally and linguistically competent manner. (h) Limit a nurse home visitor's caseload to no more than 25 active families at any given time. (i) Provide for every eight nurse home visitors a full-time nurse supervisor who holds at least a bachelor's degree in nursing and has substantial experience in community health nursing. (j) Have nurse home visitors and nurse supervisors trained in effective home visitation techniques by qualified trainers. (k) Have nurse home visitors and nurse supervisors trained in the method of assessing early infant development and parent-child interaction in a manner consistent with the program. (l) Provide data on operations, results, and expenditures in the formats and with the frequencies specified by the department. (m) Collaborate with other home visiting and family support programs in the community to avoid duplication of services and complement and integrate with existing services to the extent practicable. (n) Demonstrate that adoption of the Nurse-Family Partnership program is supported by a local governmental or government-affiliated community planning board, decisionmaking board, or advisory body responsible for assuring the availability of effective, coordinated services for families and children in the community. (o) Provide cash or in-kind matching funds in the amount of 100 percent of the grant award. (p) Prohibit the use of moneys received for the program as a match for grants currently administered by the department.


123493. (a) The department may accept voluntary contributions, in cash or in-kind, to pay for the costs in the implementation of the program under Section 123492. These private donations shall be deposited into the California Families and Children Account, which is hereby created in the State Treasury, in which, notwithstanding Section 13340 of the Government Code, is hereby continuously appropriated to the department for purposes of implementing Section 123492. No state funds shall be used in implementing Section 123492. (b) The department shall only distribute grants established under Section 123492 if the Director of Finance determines, in writing, that there are sufficient funds from private donations available in the account for expenditure for the purposes of the program. (c) The department's administration costs shall not exceed 5 percent of the moneys in the account created under subdivision (a). Any costs to the department incurred prior to the account receiving funds shall be reimbursed to the department from funds in the account. (d) The department shall not apply for grants or solicit private funds. (e) If, as of January 1, 2009, the Director of Finance determines pursuant to subdivision (a) that there are insufficient funds on deposit in the account to implement the voluntary nurse home visiting grant program, the account shall cease to exist.


123495. (a) The department shall seek any federal waiver or waivers that may be necessary to maximize funds from the federal government including, but not limited to, funds provided under Title 19 of the Social Security Act to provide funds for a full range of preventive perinatal services. (b) The department shall, in preparing its budget for submission each year, coordinate all funding sources intended primarily for perinatal care made available through the Budget Act to maximize the delivery of perinatal care services and to avoid duplication of programs and funding. (c) The department shall develop and implement a uniform sliding fee schedule for women provided perinatal care through the perinatal services program. The fee schedule shall be based on family size and income, but in no case shall the fee exceed the actual cost of the services provided. The department shall not implement any schedule developed pursuant to this section sooner than 30 days after the department has provided the chairperson of the Joint Legislative Budget Committee and the chairperson of the fiscal committee of each house with the developed schedule. All free clinics, as defined in paragraph (2) of subdivision (a) of Section 1204 shall be exempt from this subdivision. All organizations funded under the Public Health Service Act, Sections 254b and 254c of Title 42 of the United States Code, shall be permitted to utilize those sliding fee scales mandated by federal law or regulation in lieu of the sliding fee scale adopted by the department.


123500. The department shall monitor the delivery of services under contracts, grants, and agreements provided for in this article through a uniform health data collection system that utilizes epidemiologic methodology. The department may collect data from providers receiving funds through this program as necessary to evaluate program effectiveness.


123505. The goals of the community-based comprehensive perinatal health care system shall be: (a) To decrease and maintain the decreased level of perinatal, maternal, and infant mortality and morbidity in the State of California. (b) To support methods of providing comprehensive prenatal care that prevent prematurity and the incidence of low birth weight infants.

123510. The program objectives of the community-based comprehensive perinatal health care system shall be the following: (a) To ensure continuing availability and accessibility to early prenatal care within the areas presently served and to develop a community-based comprehensive perinatal system in other areas of the state that are medically underserved or have demonstrated need. (b) To assure the appropriate level of maternal, newborn and pediatric care services necessary to provide the healthiest outcome for mother and infant. (c) To ensure postpartum, family planning, and followup care through the first year of life, and referral to an ongoing primary health care provider. (d) To include support and ancillary services such as nutrition, health education, public health nursing, and social work that have been demonstrated to decrease maternal, perinatal, and infant mortality and morbidity, as components of comprehensive perinatal care. (e) To ensure that care shall be available regardless of the patient's financial situation. (f) To ensure, to the extent possible, that the same quality of care shall be available to all pregnant women. (g) To promote program flexibility by recognizing the needs within an area and providing for unique programs to meet those needs. (h) To emphasize preventive health care as a major component of any perinatal program, and to support outreach programs directed at low-income pregnant women that will encourage early entry into, and appropriate utilization of, the perinatal health care system.


123515. In processing and awarding contracts, grants, or agreements pursuant to this article, the department shall evaluate the ability of applicants to meet, to the maximum extent possible, the following criteria: (a) The applicant's prior experience in providing community-based, comprehensive perinatal care and services to low-income women and infants. (b) The applicant's ability to provide comprehensive perinatal care, either directly or through subcontract. Those services comprising comprehensive perinatal care include, but are not limited to, the following: (1) Initial and ongoing physical assessment. (2) Psychosocial assessments and counseling, and referral when appropriate. (3) Nutrition assessments, counseling and referral to counseling on food supplement programs, vitamins, and breast-feeding. (4) Health educational assessments, and intervention and referral, including childbirth preparation and parenting. (5) Outreach and community education. (6) Laboratory, radiology, and other specialized services as indicated. (7) Delivery, postpartum followup, and pediatric care through the first year of life. (c) The quality of care that is being, or has been provided to low-income women and infants by health care providers. (d) Whether the area that is, or that will be, serviced by the applicant is medically underserved or has otherwise demonstrated the need for comprehensive, community-based perinatal services. (e) The applicant's ability to use an appropriate multidisciplinary staff working as a team, in consultation with obstetricians, pediatricians, and family practitioners when appropriate, to provide a full range of comprehensive perinatal care services. Staffing patterns shall reflect, to the maximum extent feasible, at all levels, the cultural, linguistic, ethnic, and other social characteristics of the community served. This staff shall include at least one of those persons described in paragraphs (1) to (3), inclusive, of this subdivision, as follows, and may include, but not be limited to, a combination of those persons described in paragraphs (4) to (10), inclusive, of this subdivision, as follows: (1) An obstetrician. (2) A pediatrician. (3) A family practice physician. (4) Certified nurse midwives, public health nurses, nurse practitioners, or physician assistants. (5) Nutritionists. (6) Social workers. (7) Health and childbirth educators. (8) A family planning counselor. (9) Community outreach peer workers. (10) A translator.

123516. (a) The department, in consultation with the program administrators, may contract with one or more qualified organizations to assist the department in ensuring that grantees implement the program as established under Section 123491 and to conduct an annual evaluation of the implementation of the grant program on a statewide basis. The first evaluation shall be due 12 months after the award of grants pursuant to Section 123492. (b) (1) In conducting its monitoring and evaluation activities, the department shall be guided by program performance standards developed by the department in consultation with the Nurse-Family Partnership program. (2) The department shall submit the results of each annual evaluation to the Governor and the appropriate policy and fiscal committees of each house of the Legislature. (3) The annual evaluation shall contain, but not be limited to, the extent to which each grantee participating in the program has done each of the following: (A) Recruited a population of low-income, first-time mothers. (B) Enrolled families early in pregnancy and followed them through the second birthday of the child. (C) Conducted visits that are of comparable frequency, duration, and content as those delivered in the randomized clinical trials of the program. (D) Assessed the health and well-being of the mothers and children enrolled in the program according to common indicators of maternal, child, and family health.


123520. (a) In developing a comprehensive system, health care providers funded under this article may perform the following activities to ensure that a full range of program components of a comprehensive, community-based health care system are available, accessible, and utilized by pregnant women and infants: (1) Coordinate specific linkages with one another. (2) Subcontract the services specified in this article. (3) Provide additional services not specifically listed in this article. These additional services shall include, but shall not be limited to the Women, Infants, and Children (WIC) food supplement program, services offered by local health departments, and public and private social welfare agencies. Nothing contained in this article shall be construed to prohibit a subcontractor from being reimbursed pursuant to a fee for service, capitation, or other payment mechanism. (b) All services and educational materials shall be provided in the primary languages of the clients served, provided that there are at least 5 percent or 100 persons, whichever is less, of the total beneficiary population served annually by each facility, who share language other than English and who are limited-English speaking. "Limited-English speaking" means a person who uses a language other than English in order to communicate effectively. (c) Health care providers applying for a contract, grant, or agreement under this article shall indicate the manner in which their service elements will be coordinated with existing community resources and services and with hospitals of all levels in the area to ensure each client receives the appropriate level or care at the appropriate time. The department may require written agreements between contractors and hospital or hospitals in the area regarding delivery services, and protocols for referral and transfer when special treatment services are required. The department may, when requested by the grantee or contractor, assist in achieving coordination and written agreements pertaining to the delivery of these services.


123525. The provisions contained in this article shall be subject to the normal Budget Act process and shall be operative to the extent funds are appropriated for this purpose.


Article 4. Perinatal Health Care

Ca Codes (hsc:123550-123610) Health And Safety Code Section 123550-123610



123550. The Legislature finds and declares that prenatal care, delivery service, postpartum care and neonatal and infant care are essential services necessary to assure maternal and infant health. These services are not currently distributed so as to meet the minimum maternal and infant health needs of many Californians. A regionalized perinatal health system can provide these essential services; however, many underserved areas lack the staff or expertise to develop these systems.


123555. The department shall develop and implement a uniform sliding fee schedule, based on family size and income, for women provided perinatal care through the Perinatal Care Services Program. The department shall not implement any schedule developed pursuant to this section sooner than 30 days after the department has provided the Chairperson of the Joint Legislative Budget Committee and the chairperson of the fiscal committee of each house with the developed schedule.

123560. Unless the context otherwise requires, the definitions in this section govern the construction of this article: (a) "Perinatal health system" means all of the prenatal care, delivery care, postpartum care, and neonatal and infant care services available to a region identified by the department pursuant to this article. (b) "Regionalized perinatal health system" means coordinated measures intended to ensure that a perinatal health system provides at least minimum services necessary to meet the maternal and infant health needs of the region and intended to ensure that it does so as efficiently and cost-effectively as possible. (c) "High-risk pregnant woman" means a woman considered highly likely for any reason to suffer personal mortality or morbidity from her pregnancy, or to deliver a defective, disabled, high-risk, or stillborn infant. (d) "High-risk infant" means a newborn considered highly likely for any reason to suffer personal mortality or morbidity or to suffer long-lasting defect or disability. (e) "High-risk geographic area" means a region in this state in which the proportion of high-risk pregnant women or high-risk infants exceeds the average for the population of California as a whole. (f) "High-risk population" means a demographic group in which the proportion of high-risk women or high-risk infants exceeds the average for the population of California as a whole.


123565. The department shall maintain a program that addresses the special needs of high-risk pregnant women and infants. The program shall include the following: (a) Identification of high-risk geographical areas and populations. (b) Identification and evaluation of deficiencies in perinatal health systems. (c) Assistance in the development of regionalized perinatal health systems, particularly in underserved areas, to meet unmet needs. (d) Assistance in implementing regionalized perinatal health systems. (e) Collection and analyses of data on perinatal health systems and needs. (f) Monitoring of results. (g) Assist in implementing and maintaining a high-risk infant follow-up program.

123570. (a) In assisting in the development of the regionalized perinatal health systems, the department shall consult with the office, the State Department of Developmental Services, county health officials, health systems agencies, health professionals and health facilities expected to participate in the systems, and community groups. (b) In carrying out this article, the department shall coordinate the regionalized perinatal health systems with all other maternal and infant health programs conducted by or for the department, the office, the State Department of Developmental Services, and all other state agencies, to ensure full regional coordination.


123575. It is the intent of the Legislature that the program created by Sections 123550 to 123570, inclusive, be funded through the normal budgetary process beginning in the 1980-81 fiscal year.


123600. By July 1, 1991, the Health and Welfare Agency shall develop and disseminate a model needs assessment protocol for pregnant and postpartum substance abusing women in conjunction with the appropriate professional organizations in the areas of hospital administration, substance abuse prevention and treatment, social services, public health, and appropriate state agencies, including the State Department of Social Services, the department, the State Department of Developmental Services, and the State Department of Alcohol and Drug Programs. This model may be utilized by hospitals and counties pursuant to Section 123605.

123605. (a) Each county shall establish protocols between county health departments, county welfare departments, and all public and private hospitals in the county, regarding the application and use of an assessment of the needs of, and a referral for, a substance exposed infant to a county welfare department pursuant to Section 11165.13 of the Penal Code. (b) The assessment of the needs shall be performed by a health practitioner, as defined in Section 11165.8 of the Penal Code, or a medical social worker. The needs assessment shall be performed before the infant is released from the hospital. (c) The purpose of the assessment of the needs is to do all of the following: (1) Identify needed services for the mother, child, or family, including, where applicable, services to assist the mother caring for her child and services to assist maintaining children in their homes. (2) Determine the level of risk to the newborn upon release to the home and the corresponding level of services and intervention, if any, necessary to protect the newborn's health and safety, including a referral to the county welfare department for child welfare services. (3) Gather data for information and planning purposes.


123610. It is the intent of the Legislature that funding for Sections 123600 and 123605 be provided in the annual Budget Act.


Article 4.5. Fetal Ultrasound

Ca Codes (hsc:123620) Health And Safety Code Section 123620



123620. A person or facility that offers fetal ultrasound, or a similar procedure, for keepsake or entertainment purposes, shall disclose to a client prior to performing the procedure, in writing, the following statement: "The federal Food and Drug Administration has determined that the use of medical ultrasound equipment for other than medical purposes, or without a physician's prescription, is an unapproved use."


Article 5. Perinatal Care Guidance (reserved)

Chapter 3. Child Health

Article 1. Infant Mortality And Morbidity Prevention

Ca Codes (hsc:123650-123655) Health And Safety Code Section 123650-123655



123650. (a) The department shall develop a plan to identify causes of infant mortality and morbidity in California and to study recommendations on the reduction of infant mortality and morbidity in California. (b) The study plan shall be completed on or before July 1, 1988, and shall be developed in conjunction with, and reviewed by, each of the following organizations: (1) The California Medical Association. (2) The California Nurses Association. (3) The California Hospital Association. (4) The American College of Obstetrics and Gynecologists. (5) The American College of Nurse Midwives. (6) The California Academy of Family Physicians. (7) The American Academy of Pediatrics. (8) The California Association of Freestanding Birth Centers. (9) The American Public Health Association. (10) The Medical Board of California. (11) The Board of Registered Nurses. (12) The Department of Consumer Affairs. (13) The office. (14) The California Association of Midwives.


123655. The study plan shall incorporate in its design the findings of MCH Title V Research Contract DHS 8689088, the "Maternal Neonatal and Fetal Mortality Study." The department shall issue a report to the Legislature on or before July 1, 1989, concerning causal factors in infant mortality and morbidity.


Article 2. Black Infant Health (reserved)

Article 2.5. Infant Botulism Treatment And Prevention Program

Ca Codes (hsc:123700-123709) Health And Safety Code Section 123700-123709



123700. (a) Infant botulism is an acute, life-threatening paralytic disease of babies caused by a potent bacterial neurotoxin. (b) Half of all cases of infant botulism in the United States occur in California, where the causative bacterial spores are known to be highly endemic. In any given year between 30 and 50 infants with botulism are hospitalized in California, thus qualifying infant botulism as an "orphan disease" as defined by the federal Orphan Drug Act of 1983 (P.L. 97-414, as amended). (c) The cost of hospitalization of these afflicted babies for the five years 1988-92 were approximately fourteen million dollars ($14,000,000). Over two million seven hundred thousand dollars ($2,700,000) of these costs were paid by the State Department of Health Services through its Medi-Cal and California Children's Services programs, while over one million four hundred thousand ($1,400,000) of these costs were absorbed as operating losses by California hospitals. (d) Hospital stay for these critically-ill infants averages five weeks and costs approximately seventy thousand dollars ($70,000) per case. In 1992 a single case was hospitalized over six months at a cost in excess of five hundred five thousand dollars ($505,000). In 1988 a single infant was hospitalized for 10 months at a cost of over six hundred thirty-five thousand dollars ($635,000). (e) In an effort to reduce these costs, the State Department of Health Services began in early 1992 a four-year clinical trial of a potential new medicine, human Botulism Immune Globulin (BIG), specifically designed for the treatment of infant botulism. The funding for this clinical trial is being provided by the United States Food and Drug Administration. (f) As defined in the federal Orphan Drug Act, the State Department of Health Services is the official sponsor of BIG. As such, the department is responsible for providing and distributing an ongoing supply of BIG to infant botulism patients nationwide if the clinical trial shows that BIG is safe and effective treatment for infant botulism. The clinical trial is expected to end in 1996. (g) If human-derived BIG proves to be effective, then physicians can choose to use it to treat foodborne botulism and wound botulism, rather than using the existing horse-serum-derived botulism antitoxin, which has serious side effects. Foodborne botulism and wound botulism also qualify as "orphan diseases" under the federal Orphan Drug Act. (h) Other scientific evidence indicates that infant botulism and related illnesses may be responsible for one of every 20 sudden infant death cases in California. More sudden infant deaths occur in California each year than in any other state. (i) The Legislature finds and declares that the enactment of this article is necessary for the protection of the public's health, investigations and further research into the optimal medical treatment of infant botulism, including product improvement of BIG, and into the causes and prevention of infant botulism and related sudden infant death cases, and providing expert medical consultation for the care of infants with this disease.


123702. (a) The State Department of Health Services shall establish an Infant Botulism Treatment and Prevention Unit. This unit shall have responsibility for ensuring the production and distribution of BIG to patients in California and nationwide suspected of having infant botulism or other forms of human botulism in accord with applicable federal law. (b) As permitted by federal law, the state department shall charge a fee for BIG, and the fees shall be deposited in the special Infant Botulism Treatment and Prevention Fund established by Section 123709. (c) Notwithstanding any other provision of law, the funds generated by the sale of BIG are to be expended only for the purposes authorized by this article. (d) The amount of the fee shall be established by regulation and periodically adjusted by the State Director of Health Services in order to meet but not exceed the total costs of this article. This adjustment of fees shall not be subject to the requirements of Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, except that upon adoption of the adjusted fee by the director, the provision revising the fee shall be filed with the Secretary of State and shall be printed in the California Code of Regulations. (e) It is the intent of the Legislature that the state department consider providing BIG to low-income families at no charge.


123704. The Infant Botulism Treatment and Prevention Unit shall provide all the following services: (a) Produce, or cause to have produced, and maintain, a supply of BIG sufficient to treat the expected number of annual cases of infant botulism in the United States, and to store, or arrange storage for, same. (b) Distribute BIG to patients suspected of having infant botulism or other forms of botulism in California and in the rest of the United States on appropriate medical indications. (c) Investigate ways to improve the treatment of infant botulism and related illness, including technical improvement of BIG, and implement them as appropriate. (d) Provide diagnostic laboratory services and medical and public health expertise about infant botulism and related illnesses to all physicians, hospitals, laboratories, and parents statewide. (e) Investigate all cases or suspected cases of infant botulism with both field and laboratory techniques as appropriate, in order to acquire the broadest data base for prevention and optimal treatment. (f) Develop and implement control measures for the prevention of infant botulism and related illnesses. (g) Share with other public health agencies the expertise gained in the development of BIG as it relates to other toxin-mediated infectious diseases of public health importance, and apply that expertise as appropriate. (h) Establish scientific collaborations with university, forensic, hospital, public health, pharmaceutical, and biotechnology institutions, as appropriate as determined by the unit, that have resources and expertise to contribute to the study, prevention, or treatment of infant botulism and related illnesses.


123705. It is the intent of the Legislature that the program carried out pursuant to this article shall be fully supported from the fees collected for providing BIG to patients with suspected infant botulism or other forms of botulism and that these fees be made available for expenditure by the state department as appropriated by the Legislature in the annual Budget Act. However, it is the intent of the Legislature that until June 30, 1999, the Legislature may appropriate in the annual Budget Act the funds necessary for the support of programs authorized in this article in excess of fee revenues collected. It is, further, the intent of the Legislature that these appropriations be provided as a loan from the General Fund to be repaid with interest to the General Fund over the subsequent five years with interest at the rate earned by moneys invested in the Pooled Money Investment Account.


123707. (a) The State Department of Health Services may manufacture, test, distribute, and maintain licensure of the product Botulism Immune Globulin Intravenous (Human) if all necessary federal licenses are obtained. The department was issued United States License No. 1622 on October 23, 2003, by the United States Food and Drug Administration under the authority of Section 351(a) of the Public Health Service Act controlling the manufacture and sale of biological products. The product may be labeled with the proprietary name BabyBIG�. (b) The United States Food and Drug Administration license agreement stipulated the contracts and commodity purchases required to manufacture, test, distribute, and maintain licensure of Botulism Immune Globulin Intravenous (Human). Therefore, contracts and commodity purchases for any manufacture, testing, distribution, packaging, development, and licensure of Botulism Immune Globulin Intravenous (Human) by the department shall be exempt from competitive bidding and shall be exempt from the requirements of Part 2 (commencing with Section 10100) of Division 2 of the Public Contract Code. (c) Since the incidence of infant botulism in California can vary by as much as 60 percent from year to year, and since continuity of program operations is critical to the health and well-being of these infants, any funds not expended at the end of the fiscal year shall be carried forward into the next fiscal year, notwithstanding any other provision of law. (d) In carrying out this article, the Infant Botulism Treatment and Prevention Unit may adopt regulations, make and receive grants, and enter into contracts and interagency agreements.


123709. The Infant Botulism Treatment and Prevention Fund is hereby established as a special fund in the State Treasury. All moneys collected by the state department pursuant to this article shall be deposited in the Infant Botulism Treatment and Prevention Fund, and shall be made available to the state department for expenditure for the purposes of this article as appropriated by the Legislature in the annual Budget Act.


Article 3. Sudden Infant Death Syndrome

Ca Codes (hsc:123725-123745) Health And Safety Code Section 123725-123745



123725. (a) For purposes of this section, the following definitions shall apply: (1) "SIDS" means sudden infant death syndrome. (2) "SIDS Advisory Council" or "advisory council" means the Sudden Infant Death Syndrome Advisory Council established pursuant to subdivision (b). (b) The department shall establish a Sudden Infant Death Syndrome Advisory Council. The advisory council shall consist of nine members who shall be chosen by the director in consultation with regional SIDS parent advisory councils. At least one-third of the members of the advisory council chosen by the director shall be representatives of SIDS parents' groups. The membership of the advisory council shall also include, but not be limited to, a coroner, a medical examiner, a public health nurse, a physician and surgeon with expertise in SIDS, and a representative from a police or fire department. (c) The SIDS Advisory Council shall do all of the following: (1) Provide guidance to the state department in the development of training, educational, and research programs regarding SIDS. (2) Provide ongoing guidance to the Governor and the Legislature regarding the need for specific programs regarding SIDS for specific targeted groups of persons. (3) In conjunction with the state department or a person with whom the state department contracts to provide SIDS education, convene a statewide conference annually to examine the progress in discovering the cause of SIDS, explore the progress of newly established programs and services related to SIDS, identify future needs for legislation and program development regarding SIDS, and make recommendations on the needs of programs regarding SIDS. Conference participants shall include professionals and service providers in the area of SIDS, family members of SIDS victims, and the staff of members of the Legislature and departments of the state. (d) The members of the advisory council shall serve at the pleasure of the director. The members of the advisory council shall serve without compensation, but shall be reimbursed for necessary and travel expenses incurred in the performance of the duties of the advisory council. (e) The requirements contained in this section shall be subject to the annual Budget Act and shall be operative only to the extent that funds are appropriated for the purposes of this section.


123730. The department shall keep each county health officer advised of the most current knowledge relating to the nature and causes of sudden infant death syndrome.


123735. (a) As used in this section, "SIDS" means sudden infant death syndrome. (b) The department shall contract with a person to provide regular and ongoing SIDS education and training programs for those who interact with parents and caregivers following a death from SIDS, including, but not limited to, the following: (1) County public health nurses. (2) Coroners and coroners' investigators. (3) Forensic pathologists. (4) Emergency room physicians and surgeons, nurses, and other staff. (5) Licensed day care providers. (6) SIDS parent groups. (7) Medical examiners. (c) The department shall contract with a person to produce, update, and distribute literature on SIDS for specific target populations of persons who interact with parents and caregivers following a death from SIDS, including, but not limited to, the following: (1) Clergy. (2) Fire and police departments. (3) Emergency medical service staff. (4) Morticians. (5) Funeral directors. (6) SIDS parent groups. (d) The requirements of this section shall be subject to the annual Budget Act and shall be operative only to the extent funds are appropriated for the purposes of this section.


123740. (a) For purposes of this section the following definitions shall apply: (1) "Appropriately trained public health professional" means a public health nurse or a social worker who is knowledgeable about the incidence of sudden infant death syndrome and the care and support of persons who have experienced a death of this nature, and who has basic grief counseling skills. (2) "Contact" is a face-to-face visit, a group visit, or a telephone call that provides one or more of the following services: (A) An assessment of the family, child care provider, or both. (B) Crisis intervention and counseling. (C) A referral to a community service. (D) A followup assessment of the family's, the child care provider' s, or both family's and child care provider's progress. (3) "Immediately" means within three working days of receiving notice from the coroner or other reporting agent of a death presumedly caused by sudden infant death syndrome. (4) "Local health officer" means a health officer for a city, county, or city and county. (b) Upon being informed by the coroner pursuant to Section 102865 of any case in which sudden infant death syndrome is the presumed cause of death, the local health officer or his or her designated agent, who is an appropriately trained public health professional, after consultation with the infant's physician of record, when possible, shall immediately contact the person or persons who had custody and control of the infant, including foster parents, when applicable, for the purposes of providing to that person information, support, referral, and followup services relating to sudden infant death syndrome. If the infant was in child care, the local health officer or his or her designated agent who is an appropriately trained public health professional also shall immediately contact the child care provider. (c) The local health officer shall perform the duties required by this section throughout the jurisdiction of that local health officer.


123745. The department shall monitor, or contract with a person to monitor, whether the county health officer or his or her designated agent is performing the duties required by Section 123740 and whether they are being performed within the timeframes specified in Section 123740.


Article 4. Infant Medical Dispatch Centers

Ca Codes (hsc:123750-123775) Health And Safety Code Section 123750-123775



123750. The Legislature finds that intensive care nurseries for at-risk infants are often at capacity. It further finds that serious delays can occur in placing critically ill newborn infants in intensive care nurseries due to calls being placed to many hospitals. Additionally, valuable staff time is often taken by a capacity nursery in attempting to find another nursery with an available bed. It is further found that, due to the lack of a centralized dispatch system, at-risk infants are often not placed in the intensive care nursery nearest their homes. Therefore, the Legislature finds that in order to protect the health of critically ill newborn children and to more efficiently utilize space and staff in intensive care nurseries it is necessary to establish 24-hour-a-day, year-round medical dispatch centers linking all hospitals providing obstetrical services with intensive care nurseries.


123753. The department shall establish two dispatch centers, each to be located at a hospital containing an intensive care nursery that has been approved by the department.


123755. One of the centers established pursuant to Section 123750 shall be located to serve the region of the state north of the Tehachapi Mountains, and one of the centers shall be located to serve the region south of the Tehachapi Mountains.


123760. The centers shall locate bedspace for critically ill newborn infants nearest their homes, locate and dispatch transport for the infants and for appropriate medical personnel, advise the obstetrical nursery regarding maintenance care of the infant until transport is effected, and keep a daily record of the availability of bedspace in all intensive care nurseries. Nothing in this article shall obligate the state for transport costs other than those already authorized by law.


123765. Funds appropriated to carry out the purposes of this article shall be used for leasing or purchasing communication equipment or time; and for hiring, training, or contracting for personnel and administration of the centers.


123770. Public and private nonprofit health facilities, organizations, and educational institutions are eligible to receive center funds under this article.

123775. Each infant medical dispatch center established pursuant to this article shall annually report on the progress of the project, the status of the data base obtained pursuant to Section 123760, and any necessary changes to meet the goals prescribed in Section 123760 to the Legislature upon request of either the Joint Legislative Budget Committee or other interested committees or Members of the Legislature.


Article 5. California Children's Services

Ca Codes (hsc:123800-123995) Health And Safety Code Section 123800-123995



123800. This article shall be known and may be cited as the Robert W. Crown California Children's Services Act.


123805. The department shall establish and administer a program of services for physically defective or handicapped persons under the age of 21 years, in cooperation with the federal government through its appropriate agency or instrumentality, for the purpose of developing, extending and improving the services. The department shall receive all funds made available to it by the federal government, the state, its political subdivisions or from other sources. The department shall have power to supervise those services included in the state plan that are not directly administered by the state. The department shall cooperate with the medical, health, nursing and welfare groups and organizations concerned with the program, and any agency of the state charged with the administration of laws providing for vocational rehabilitation of physically handicapped children. The reference to "the age of 21 years" in this section is unaffected by Section 1 of Chapter 1748 of the Statutes of 1971 or any other provision of that chapter.

123810. The department succeeds to and is vested with the duties, purposes, responsibilities, and jurisdiction heretofore exercised by the State Department of Benefit Payments with respect to moneys, funds, and appropriations available to the department for the purposes of processing, audit, and payment of claims received for the purposes of this article.


123815. The department shall have possession and control of all records, papers, equipment, and supplies held for the benefit or use of the Director of Benefit Payments in the performance of his duties, powers, purposes, responsibilities, and jurisdiction that are vested in the department by Section 123810.

123820. All officers and employees of the Director of Benefit Payments who on July 1, 1978, are serving in the state civil service, other than as temporary employees, and engaged in the performance of a function vested in the department by Section 123810 shall be transferred to the department. The status, positions, and rights of these persons shall not be affected by the transfer and shall be retained by them as officers and employees of the department pursuant to the State Civil Service Act, except as to positions exempt from civil service.

123822. All claims for services provided under this article shall be submitted to the state fiscal intermediary for payment no later than January 1, 1999. The State Department of Health Services shall work in cooperation with the counties to develop a timeline for implementing the centralized billing system. If a department review of those counties participating in the centralized billing system demonstrates that as of January 1, 2000, any county has incurred increased costs as a result of submitting claims for services to the state fiscal intermediary, that county may be exempt from this section.

123825. It is the intent of the Legislature through this article to provide, to the extent practicable, for the necessary medical services required by physically handicapped children whose parents are unable to pay for these services, wholly or in part. This article shall also include the necessary services rendered by the program to physically handicapped children treated in public schools that provide services for physically handicapped children.


123830. "Handicapped child," as used in this article, means a physically defective or handicapped person under the age of 21 years who is in need of services. The director shall establish those conditions coming within a definition of "handicapped child" except as the Legislature may otherwise include in the definition. Phenylketonuria, hyaline membrane disease, cystic fibrosis, and hemophilia shall be among these conditions. The reference to "the age of 21 years" in this section is unaffected by Section 1 of Chapter 1748 of the Statutes of 1971 or any other provision of that chapter.


123835. The department shall keep the program abreast of advances in medical science, leading to the inclusion of other handicapping conditions and services within the limits of and consistent with the most beneficial use of funds appropriated for this purpose. With the approval of the agency administrator the department may carry out pilot studies to determine the need for, or the feasibility of, including other handicapping conditions and services in the program within the limits of available funds appropriated for the program.


123840. "Services," as used in this article, means any or all of the following: (a) Expert diagnosis. (b) Medical treatment. (c) Surgical treatment. (d) Hospital care. (e) Physical therapy. (f) Occupational therapy. (g) Special treatment. (h) Materials. (i) Appliances and their upkeep, maintenance, care and transportation. (j) Maintenance, transportation, or care incidental to any other form of "services."


123845. "California Children's Services Program," as used in this article, means the program of services established and operated pursuant to this article.

123850. The board of supervisors of each county shall designate the county department of public health or the county department of social welfare as the designated agency to administer the California Children's Services Program. Counties with total population under 200,000 persons may administer the county program independently or jointly with the department. Counties with a total population in excess of 200,000 persons shall administer the county program independently. Except as otherwise provided in this article, the director shall establish standards relating to the local administration and minimum services to be offered by counties in the conduct of the California Children's Services Program.


123853. (a) The department may enter into contracts with one or more manufacturers on a negotiated or bid basis as the purchaser, but not the dispenser or distributor, of factor replacement therapies under the California Children's Services Program for the purpose of enabling the department to obtain the full range of available therapies and services required for clients with hematological disorders at the most favorable price and to enable the department, notwithstanding any other provision of state law, to obtain discounts, rebates, or refunds from the manufacturers based upon the large quantities purchased under the program. Nothing in this subdivision shall interfere with the usual and customary distribution practices of factor replacement therapies. In order to achieve maximum cost savings, the Legislature hereby determines that an expedited contract process under this section is necessary. Therefore, a contract under this subdivision may be on a negotiated basis and shall be exempt from Chapter 2 (commencing with Section 10290) of Part 2 of Division 2 of the Public Contract Code and Chapter 6 (commencing with Section 14825) of Part 5.5 of Division 3 of the Government Code. Contracts entered pursuant to this subdivision shall be confidential and shall be exempt from disclosure under the California Public Records Act (Chapter 3.5 (commencing with Section 6250) of Division 7 of Title 1 of the Government Code). (b) (1) Factor replacement therapy manufacturers shall calculate and pay interest on late or unpaid rebates. The interest shall not apply to any prior period adjustments of unit rebate amounts or department utilization adjustments. Manufacturers shall calculate and pay interest on late or unpaid rebates for quarters that begin on or after the effective date of the act that added this subdivision. (2) Following the final resolution of any dispute regarding the amount of a rebate, any underpayment by a manufacturer shall be paid with interest calculated pursuant to paragraph (4), and any overpayment, together with interest at the rate calculated pursuant to paragraph (4), shall be credited by the department against future rebates due. (3) Interest pursuant to paragraphs (1) and (2) shall begin accruing 38 calendar days from the date of mailing the invoice, including supporting utilization data sent to the manufacturer. Interest shall continue to accrue until the date of mailing of the manufacturer's payment. (4) Interest rates and calculations pursuant to paragraphs (1) and (2) shall be identical to interest rates and calculations set forth in the federal Centers for Medicare and Medicaid Services' Medicaid Drug Rebate Program Releases or regulations. (c) If the department has not received a rebate payment, including interest, within 180 days of the date of mailing of the invoice, including supporting utilization data, a factor replacement therapy manufacturer's contract with the department shall be deemed to be in default and the contract may be terminated in accordance with the terms of the contract. This subdivision does not limit the department' s right to otherwise terminate a contract in accordance with the terms of that contract. (d) The department may enter into contracts on a bid or negotiated basis with manufacturers, distributors, dispensers, or suppliers of pharmaceuticals, appliances, durable medical equipment, medical supplies, and other product-type health care services and laboratories for the purpose of obtaining the most favorable prices to the state and to assure adequate access and quality of the product or service. In order to achieve maximum cost savings, the Legislature hereby determines that an expedited contract process under this subdivision is necessary. Therefore, contracts under this subdivision may be on a negotiated basis and shall be exempt from the provisions of Chapter 2 (commencing with Section 10290) of Part 2 of Division 2 of the Public Contract Code and Chapter 6 (commencing with Section 14825) of Part 5.5 of Division 3 of the Government Code. (e) The department may contract with one or more manufacturers of each multisource prescribed product or supplier of outpatient clinical laboratory services on a bid or negotiated basis. Contracts for outpatient clinical laboratory services shall require that the contractor be a clinical laboratory licensed or certified by the State of California or certified under Section 263a of Title 42 of the United States Code. Nothing in this subdivision shall be construed as prohibiting the department from contracting with less than all manufacturers or clinical laboratories, including just one manufacturer or clinical laboratory, on a bid or negotiated basis.


123855. The department or designated county agency shall cooperate with, or arrange through, local public or private agencies and providers of medical care to seek out handicapped children, bringing them expert diagnosis near their homes. Case finding shall include, but not be limited to, children with impaired sense of hearing. This section does not give the department or designated agency power to require medical or other form of physical examination without consent of parent or guardian.


123860. In accordance with applicable regulations of the United States Children's Bureau, the department and designated county agencies shall provide a diagnosis for handicapped children. Within the limits of available funds, the department and designated local agencies may accept for diagnosis a handicapped child believed to have a severe chronic disease or severe physical handicap, as determined by the director, irrespective of whether the child actually has an eligible medical condition specified in Section 123830. The department shall cause a record to be kept listing all conditions diagnosed by the program and shall publish the information annually, including data on the number and kinds of diagnosed medical conditions that do not come within the definition of "handicapped child" as specified in Section 123830.


123865. Whenever the parents or estate of a handicapped child is wholly or partly unable to furnish for the child necessary services, the parents or guardian may apply to the agency of the county that has been designated by the board of supervisors of the county of residence under the terms of Section 123850 to administer the provisions for handicapped children. Residence shall be determined in accordance with Sections 243 and 244 of the Government Code.


123870. (a) The department shall establish standards of financial eligibility for treatment services under the California Children's Services Program (CCS program). (1) Financial eligibility for treatment services under this program shall be limited to persons in families with an adjusted gross income of forty thousand dollars ($40,000) or less in the most recent tax year, as calculated for California state income tax purposes. If a person is enrolled in the Healthy Families Program (Part 6.2 (commencing with Section 12693) of Division 2 of the Insurance Code), the financial documentation required for that program in Section 2699.6600 of Title 10 of the California Code of Regulations may be used instead of the person's California state income tax return. However, the director may authorize treatment services for persons in families with higher incomes if the estimated cost of care to the family in one year is expected to exceed 20 percent of the family's adjusted gross income. (2) Children enrolled in the Healthy Families Program who have a CCS program eligible medical condition under Section 123830, and whose families do not meet the financial eligibility requirements of paragraph (1), shall be deemed financially eligible for CCS program benefits. (b) Necessary medical therapy treatment services under the California Children's Services Program rendered in the public schools shall be exempt from financial eligibility standards and enrollment fee requirements for the services when rendered to any handicapped child whose educational or physical development would be impeded without the services. (c) All counties shall use the uniform standards for financial eligibility and enrollment fees established by the department. All enrollment fees shall be used in support of the California Children's Services Program. (d) Annually, every family with a child eligible to receive services under this article shall pay a fee of twenty dollars ($20), that shall be in addition to any other program fees for which the family is liable. This assessment shall not apply to any child who is eligible for full scope Medi-Cal benefits without a share of cost, for children receiving therapy through the California Children's Services Program as a related service in their individualized education plans, for children from families having incomes of less than 100 percent of the federal poverty level, or for children covered under the Healthy Families Program.


123872. In addition to the other eligibility requirements set forth in this article, prior to being determined financially eligible for services under this article, the applicant family shall agree to repay the California Children's Services Program for any treatment services authorized by the program in an amount not to exceed the proceeds of any judgment, award, or settlement for damages as a result of a lawsuit or pursuant to an agreement relating to a California Children's Services medically eligible condition.


123875. When the California Children's Service medical therapy unit conference team, based on a medical referral recommending medically necessary occupational or physical therapy in accordance with subdivision (b) of Section 7575 of the Government Code, finds that a handicapped child, as defined in Section 123830, needs medically necessary occupational or physical therapy, that child shall be determined to be eligible for therapy services. If the California Children's Services medical consultant disagrees with the determination of eligibility by the California Children's Services medical therapy unit conference team, the medical consultant shall communicate with the conference team to ask for further justification of its determination, and shall weigh the conference team's arguments in support of its decision in reaching his or her own determination. This section shall not change eligibility criteria for the California Children's Services programs as described in Sections 123830 and 123860. This section shall not apply to children diagnosed as specific learning disabled, unless they otherwise meet the eligibility criteria of the California Children's Services.


123880. The department and designated agencies shall not deny eligibility or aid under the California Children's Services Program because an otherwise eligible person is receiving treatment services under a teaching program at an accredited medical school facility or accredited school or college of podiatric medicine, whether or not all or part of the treatment services are performed by the staff at the facility, school, or college, provided that treatment services at the facility, school, or college are under the general supervision of a California Children's Services Program panel physician and surgeon, including a family physician, and podiatrist.


123885. Panel members as set forth in Section 123880 shall be board-certified and have expertise in the care of children.


123890. (a) The state department shall not deny a hospital's request to provide treatment to burn victims who are eligible under the California Children's Services Program solely on the basis that the hospital does not have separate facilities for child and adult burn victims, provided that the hospital has approval from the department to operate a burn center pursuant to Section 1255. (b) Subdivision (a) shall only be applied to burn units located in hospitals where there are no regional burn centers, or any other existing burn center, within an 85-mile radius of the hospital. (c) Subdivision (a) shall only apply if the hospital seeking the exemption had a state-approved burn center in operation as of January 1, 1982, and if there is no hospital specializing in children's services within an 85-mile radius of the hospital seeking the subdivision (a) exemption. (d) Hospitals having qualified and received a subdivision (a) exemption, shall demonstrate, at the request of the department, that the nursing staff providing burn care to children victims have satisfactorily completed post-graduate training in pediatrics.


123895. The designated agency shall determine the financial eligibility of the family according to standards established by the department. The agency will also determine if the parents are residents of the county, if the guardian of the child is a resident of the county, or if the emancipated minor is a resident of the county where application for services is made. If the agency finds that the family, guardian, or emancipated minor is a resident of the county and financially eligible for services, it shall make a record of the facts and shall certify this child for care under the program.


123900. (a) Beginning September 1, 1991, in addition to any other standards of eligibility pursuant to this article, each family with a child otherwise eligible to receive services under this article shall pay an annual enrollment fee as a requirement for eligibility for services, except as specified in subdivision (f). (b) The department shall determine the annual enrollment fee, that shall be a sliding fee scale based upon family size and income, and shall be adjusted by the department to reflect changes in the federal poverty level. (c) "Family size" shall include the child, his or her natural or adoptive parents, siblings, and other family members who live together and whose expenses are dependent upon the family income. (d) "Family income" for purposes of this article, shall include the total gross income, or their equivalents, of the child and his or her natural or adoptive parents. (e) Payment of the enrollment fee is a condition of program participation. The enrollment fee is independent of any other financial obligation to the program. (f) The enrollment fee shall not be charged in any of the following cases: (1) The only services required are for diagnosis to determine eligibility for services, or are for medically necessary therapy pursuant to Section 123875. (2) The child is otherwise eligible to receive services and is eligible for full Medi-Cal benefits at the time of application or reapplication. (3) The family of the child otherwise eligible to receive services under this article has a gross annual income of less than 200 percent of the federal poverty level. (4) The family of a child otherwise eligible to receive services under this article who is enrolled in the Healthy Families Program (Part 6.2 (commencing with Section 12693) of Division 2 of the Insurance Code). (g) Failure to pay or to arrange for payment of the enrollment fee within 60 days of the due date shall result in disenrollment and ineligibility for coverage of treatment services 60 days after the due date of the required payment. (h) The county shall apply the enrollment fee scale established by the department and shall collect the enrollment fee. The county may arrange with the family for periodic payment during the year if a lump-sum payment will be a hardship for the family. The agency director of California Children's Services may, on a case-by-case basis, waive or reduce the amount of a family's enrollment fee if, in the director's judgment, payment of the fee will result in undue hardship. (i) By thirty days after the effective date of this section or August 1, 1991, whichever is later, the department shall advance to each county, as a one-time startup amount, five dollars and fifty cents ($5.50) for each county child who was receiving services under this article on June 30, 1990, and who was not a Medi-Cal beneficiary. This one-time payment shall be in addition to the 4.1 percent of the gross total expenditures for diagnoses, treatment, and therapy by counties allowed under subdivision (c) of Section 123955. (j) Each county shall submit to the state, as part of its quarterly claim for reimbursement, an accounting of all revenues due and revenues collected as enrollment fees.


123905. A county of under 200,000 population, administering its county program jointly with the department, shall forward to the department a statement certifying the family of the handicapped child as financially eligible for treatment services. The department shall authorize necessary services within the limits of available funds. Payment for services shall be made by the department, with reimbursement from the county for its proportionate share as specified in this article.


123910. The department may, without the possession of a county certification, pay the expenses for services required by any physically handicapped child out of any funds received by it through gift, devise, or bequest or from private, state, federal, or other grant or source. The department may authorize or contract with any person or institution properly qualified to furnish services to handicapped children. It may pay for services out of any funds appropriated for the purpose or from funds it may receive by gift, devise, or bequest. The department may receive gifts, legacies, and bequests and expend them for the purpose of this article, but not for administrative expense.


123915. When the department provides, or arranges for the provision of, services to physically handicapped children directly, as in the case of nonresident physically handicapped children, it shall enter into an agreement with parents, guardians or persons responsible for the care of handicapped children for payment of the enrollment fee.


123920. Upon the request of another state or of a federal agency, the department may pay the expenses of services required by any physically handicapped child who is not a resident of the state; provided, that the cost of the services is fully covered by special grants or allotments received from the state or federal agency for that purpose.


123925. The department and designated agencies shall maintain surveillance and supervision over the services provided handicapped children under authorization by the program to assure a high quality of service and shall cause a record to be kept showing the condition and improvement of these handicapped children.


123929. (a) Except as otherwise provided in this section and Section 14133.05 of the Welfare and Institutions Code, California Children's Services Program services provided pursuant to this article require prior authorization by the department or its designee. Prior authorization is contingent on determination by the department or its designee of all of the following: (1) The child receiving the services is confirmed to be medically eligible for the CCS program. (2) The provider of the services is approved in accordance with the standards of the CCS program. (3) The services authorized are medically necessary to treat the child's CCS-eligible medical condition. (b) Effective July 1, 2004, the department or its designee may approve a request for a treatment authorization that is otherwise in conformance with subdivision (a) for services for a child participating in the Healthy Families Program pursuant to clause (ii) of subparagraph (A) of paragraph (6) of subdivision (a) of Section 12693.70 of the Insurance Code, received by the department or its designee after the requested treatment has been provided to the child. (c) Effective July 1, 2004, if a provider of services who meets the requirements of paragraph (2) of subdivision (a) incurs costs for services described in paragraph (3) of subdivision (a) to treat a child described in subdivision (b) who is subsequently determined to be medically eligible for the CCS program as determined by the department or its designee, the department may reimburse the provider for those costs. Reimbursement under this section shall conform to the requirements of Section 14105.18 of the Welfare and Institutions Code.


123930. This article does not authorize any treatment service without the written consent of a parent or guardian except as a person under 18 years of age is an emancipated minor.


123935. A handicapped child shall not be denied services pursuant to this article because he or she is mentally retarded.


123940. (a) (1) Annually, the board of supervisors shall appropriate a sum of money for services for handicapped children of the county, including diagnosis, treatment, and therapy services for physically handicapped children in public schools, equal to 25 percent of the actual expenditures for the county program under this article for the 1990-91 fiscal year, except as specified in paragraph (2). (2) If the state certifies that a smaller amount is needed in order for the county to pay 25 percent of costs of the county's program from this source. The smaller amount certified by the state shall be the amount that the county shall appropriate. (b) In addition to the amount required by subdivision (a), the county shall allocate an amount equal to the amount determined pursuant to subdivision (a) for purposes of this article from revenues allocated to the county pursuant to Chapter 6 (commencing with Section 17600) of Division 9 of the Welfare and Institutions Code. (c) (1) The state shall match county expenditures for this article from funding provided pursuant to subdivisions (a) and (b). (2) County expenditures shall be waived for payment of services for children who are eligible pursuant to paragraph (2) of subdivision (a) of Section 123870. (d) The county may appropriate and expend moneys in addition to those set forth in subdivision (a) and (b) and the state shall match the expenditures, on a dollar-for-dollar basis, to the extent that state funds are available for this article. (e) Nothing in this section shall require the county to expend more than the amount set forth in subdivision (a) plus the amount set forth in subdivision (b) nor shall it require the state to expend more than the amount of the match set forth in subdivision (c).


123945. For those counties with a total appropriation of county funds not exceeding one hundred twenty-five thousand dollars ($125,000), and upon the expenditure of the county funds equivalent to a county appropriation pursuant to Section 123940, the department may, to the extent funds are available from state appropriated funds for the California Children's Services Program and upon certification of the county that there are insufficient revenues from the account established pursuant to Chapter 6 (commencing with Section 17600) of Division 9 of the Welfare and Institutions Code, pay for services for cases deemed by the department to represent emergencies or cases where medical care cannot be delayed without great harm to the child.


123950. The designated county agency shall administer the medical-therapy program in local public schools for physically handicapped children. As provided in Section 123940, the state and counties will share in the cost of support of therapist salaries in these schools in the ratio of one dollar ($1) of state or federal funds reimbursed quarterly to one dollar ($1) of county funds. The director shall establish standards for the maximum number of therapists employed in the schools eligible for state financial support in this program, the services to be provided, and the county administrative services subject to reimbursement by the state. The department may adopt regulations to implement this section as emergency regulations in accordance with Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code. For the purposes of the Administrative Procedure Act, the adoption of the regulations shall be deemed an emergency and necessary for the immediate preservation of the public peace, health, safety, and general welfare. Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, these emergency regulations shall not be subject to the review and approval of the Office of Administrative Law. Notwithstanding any other provision of law, if the department determines that emergency regulations are necessary to implement any part of this article, there shall be deemed to be good cause for the regulations to take effect prior to public notice and hearing. Notwithstanding subdivision (h) of Section 11346.1 and Section 11349.6 of the Government Code, the department shall transmit these regulations directly to the Secretary of State for filing. The regulations shall become effective immediately upon filing by the Secretary of State. The Office of Administrative Law shall provide for the printing and publication of these regulations in the California Code of Regulations. Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, these regulations shall not be repealed by the Office of Administrative Law and shall remain in effect until revised or repealed by the department.


123955. (a) The state and the counties shall share in the cost of administration of the California Children's Services Program at the local level. (b) (1) The director shall adopt regulations establishing minimum standards for the administration, staffing, and local implementation of this article subject to reimbursement by the state. (2) The standards shall allow necessary flexibility in the administration of county programs, taking into account the variability of county needs and resources, and shall be developed and revised jointly with state and county representatives. (c) The director shall establish minimum standards for administration, staffing and local operation of the program subject to reimbursement by the state. (d) Until July 1, 1992, reimbursable administrative costs, to be paid by the state to counties, shall not exceed 4.1 percent of the gross total expenditures for diagnosis, treatment and therapy by counties as specified in Section 123940. (e) Beginning July 1, 1992, this subdivision shall apply with respect to all of the following: (1) Counties shall be reimbursed by the state for 50 percent of the amount required to meet state administrative standards for that portion of the county caseload under this article that is ineligible for Medi-Cal to the extent funds are available in the state budget for the California Children's Services Program. (2) On or before September 15 of each year, each county program implementing this article shall submit an application for the subsequent fiscal year that provides information as required by the state to determine if the county administrative staff and budget meet state standards. (3) The state shall determine the maximum amount of state funds available for each county from state funds appropriated for CCS county administration. If the amount appropriated for any fiscal year in the Budget Act for county administration under this article differs from the amounts approved by the department, each county shall submit a revised application in a form and at the time specified by the department. (f) The department and counties shall maximize the use of federal funds for administration, of the programs implemented pursuant to this article, including using state and county funds to match funds claimable under Title 19 of the Social Security Act.


123960. The department shall require of participating local governments the provision of program data including, but not limited to, the number of children treated, the kinds of disabilities, and the costs of treatment, to enable the department, the Department of Finance, and the Legislature to evaluate in a timely fashion and to adequately fund the California Children's Services Program.


123965. A handicapped child placed for adoption, determined to be financially eligible for care at the time of placement, shall not be denied services pursuant to this article based upon the income of the adopting parents, nor shall the adopting parents be required to enter into any agreement to pay toward the costs of services authorized for the care. This section shall only apply to physical handicaps present, and diagnosed, at the time of adoption. Residence, for the purposes of this section, shall be that of the adopting parents.

123970. The department and the placing adoption agency at the time of placement shall notify all prospective adopting parents in writing, that funds received under the California Children's Services Program shall terminate if the adopting parents move out of the state. However, the department and the placing adoption agency shall advise the prospective adopting parents that they may be eligible for the funds in the new state, subject to any applicable qualifications.

123975. (a) The department, in consultation with selected representatives of participating neonatal intensive care units, shall establish a system to screen all newborns and infants for hearing loss as defined in subdivision (e) of Section 124116 and create and maintain a system of assessment and followup services for newborns and infants identified by the screening in approved neonatal intensive care units participating in the California Children's Services Program. Screening, assessment and followup services and reporting of these services shall be provided in a manner consistent with Article 6.5 (commencing with Section 124115) of Chapter 3. This section shall not be applicable to a newborn child whose parent or guardian objects to the tests on the ground that the tests conflict with his or her religious beliefs or practices. (b) It is the intent of the Legislature, in enacting this section, to ensure the establishment and maintenance of protocols and quality of standards. (c) The department shall implement this section for newborns and infants in neonatal intensive care units participating in the California Children's Services Program.


123980. If the recipient of services provided by the California Children's Services Program, his or her guardian, conservator, personal representative, estate, or survivors, or any of them brings an action against a third person who may be liable for the injury, notice of institution of legal proceedings, notice of settlement, and all other notices required by this code shall be given to the State Director of Health Services in Sacramento and to the county-managed California Children's Services Program. The director may provide notice to the Attorney General. All of these notices shall be given by the attorney retained to assert the beneficiary's claim, or by the injured party beneficiary, his or her guardian, conservator, personal representative, estate, or survivors, if no attorney is retained.


123982. Except as otherwise provided by law, the amount of any judgment, award, or settlement relating to a medical condition for which treatment services have been provided under the California Children's Services Program shall be subject to a claim by the state department and the designated county agency for reimbursement of the costs of the benefits provided, and to any lien filed against that judgment, award, or settlement. The department or the county designated agency, through its civil legal adviser, may, to enforce this right, institute and prosecute legal proceedings against the person who has received benefits under this article, his or her guardian, conservator, or other personal representative, or his or her estate. In the event of a judgment, award, or settlement in a suit or claim against a third person who is liable for the medical condition for which treatment services have been provided under the California Children's Services Program, the court or other agency shall first order paid from the judgment, award, or settlement the actual costs of the care and treatment furnished, or to be furnished, under the California Children's Services Program.


123985. (a) A bone marrow transplant for the treatment of cancer shall be reimbursable under this article, when all of the following conditions are met: (1) The bone marrow transplant is recommended by the recipient's attending physician. (2) The bone marrow transplant is performed in a hospital that is approved for participation in the California Children's Services program. (3) The bone marrow transplant is a reasonable course of treatment and is approved by the appropriate hospital medical policy committee. (4) The bone marrow transplant has been deemed appropriate for the recipient by the program's medical consultant. The medical consultant shall not disapprove the bone marrow transplant solely on the basis that it is classified as experimental or investigational. (b) The program shall provide reimbursement for both donor and recipient surgery. (c) Any county that has a population of not more than 600,000, as determined by the most recent decennial census conducted by the United States Bureau of the Census, shall be exempt from complying with the 25-percent matching requirement provided for under this article, for any bone marrow transplant reimbursable under this section.


123990. The department shall adopt regulations to implement the amendments of this article in 1991. The adoption of the regulations shall be deemed to be an emergency, and necessary for the immediate preservation of the public peace, health, safety, and general welfare.


123995. (a) The department shall require all applicants to the program who may be eligible for cash grant assistance or for Medi-Cal benefits to apply for Medi-Cal. (b) This section shall not be interpreted to prohibit the coverage of services in emergency cases.


Article 5.5. Assistance To Children At Home Demonstration Project

Ca Codes (hsc:124010-124015) Health And Safety Code Section 124010-124015



124010. (a) It is the intent of the Legislature to establish demonstration projects to assist medically fragile infants, children, and adolescents. (b) It is further the intent of the Legislature that these demonstration projects serve as models for methods of providing primary care services and coordination of health care for medically fragile infants, children, and adolescents. (c) The Legislature finds and declares that the use of care management services under these demonstration projects will lead to savings in medical costs through reduced emergency room visits, hospital admissions, and other medical indicators and measures.


124011. There is hereby established demonstration projects to provide a medical home and coordination of care model in order to reduce avoidable health problems of chronically, seriously ill infants, children, and adolescents. The demonstration projects may operate for a period of up to three years. Existing demonstration projects may be extended for up to two years, if outcome data display effectiveness as determined by the State Department of Health Services.

124012. The department shall award funding appropriated for purposes of this article, on a competitive basis, to any nonprofit children's hospitals, as defined in Section 10727 of the Welfare and Institutions Code, and other hospitals that operate at least 10 special care centers, as certified by the California Childrens' Services Program.


124013. The demonstration projects shall provide care management services to children enrolled in the demonstration projects pursuant to proposals accepted by the department. Demonstration projects shall meet all of the following requirements: (a) Establish and function as a medical home to a population of infants, children, and adolescents whose medical conditions requires multidisciplinary and multispecialty care. (b) Provide care coordination between primary care and specialty health care providers and community agencies for project enrollees. (c) Provide, or arrange for the provision of, health care services to maintain optimal health status. These services may include, but need not be limited to, physician office or home visits, psychosocial counseling, and medical nutrition evaluation and counseling. (d) Establish a relationship with an enrollee's parent or guardian in order to enhance the understanding of the child's condition and the parent or guardian's participation in the enrollee's medical treatment plan and decisionmaking. (e) Maximize the use of third-party reimbursement for the services provided to the population enrolled in the project.


124014. In order to most effectively assist children enrolled in the demonstration project, the demonstration project may employ the use of clinic visits, home visits, school visits, inpatient visits, and multidisciplinary conferences, as well as other innovative care management techniques.


124015. (a) The hospital receiving funding under this article shall submit a report to the department that evaluates the demonstration project and includes measures of medical costs and improved health outcomes of enrollees. (b) The report shall address the following outcome measures as identified in the hospital's demonstration project submitted to the department for approval. (c) The report required by subdivision (a) shall include a determination as to whether the demonstration project is deemed to be successful. Unless other outcome measures are used pursuant to subdivision (d), the demonstration project shall be deemed to be successful if all of the following have occurred: (1) The average number of school days missed is decreased by 50 percent. (2) The average number of emergency room visits is decreased by 50 percent. (3) The average number of hospitalizations and hospital days is decreased by 50 percent. (4) The number of children with up-to-date immunizations is increased by 50 percent. (d) The demonstration project may use other outcome measures in lieu of those identified in subdivision (c), if deemed appropriate by the department, to measure success. (e) The determinations made pursuant to this subdivision shall be based on a comparison of the preprogram utilization rates, which is data collected one year prior to enrollment in the program, with the utilization rates one year after enrollment.


Article 6. Child Health And Disability Prevention Program 124025-124110

Ca Codes (hsc:124025-124110) Health And Safety Code Section 124025-124110



124025. The Legislature finds and declares that many physical and mental disabilities can be prevented, or their impact on an individual lessened, when they are identified and treated before they become chronic and irreversible damage occurs. The Legislature finds and declares that a community-based program of early identification and referral for treatment of potential handicapping conditions will be effective in reducing the incidence of the conditions and will benefit the health and welfare of the citizens of this state. It is the intent of the Legislature in enacting this article and Section 120475 to establish child health and disability prevention programs, that shall be financed and have standards established at the state level and that shall be operated at the local level, for the purpose of providing early and periodic assessments of the health status of children. It is further intended that child health and disability prevention programs shall make maximum use of existing health care resources and shall utilize, as the first source of screening, the child's usual source of health care so that health screening programs are fully integrated with existing health services, that health care professionals be appropriately represented and utilized in these programs, that outreach programs be developed to stimulate the use of preventive health services, and that services offered pursuant to this article be efficiently provided and be of the highest quality.


124030. As used in this article and Section 120475: (a) "State board" means the State Maternal, Child, and Adolescent Health Board. (b) "Department" means the department. (c) "Director" means the director. (d) "Governing body" means the county board of supervisors or boards of supervisors in the case of counties acting jointly. (e) "Local board" means local maternal, child, and adolescent health board. (f) "Local health jurisdiction" means county health department or combined health department in the case of counties acting jointly or city health department within the meaning of Section 101185. (g) "Child Health and Disability Prevention provider" or "CHDP provider" means any of the following, if approved for participation in the Child Health and Disability Prevention program by the community Child Health and Disability program director in accordance with program standards and as certified by the department: (1) A physician licensed to practice medicine in California. (2) A family nurse practitioner certified pursuant to Sections 2834 and 2836 of the Business and Professions Code. (3) A pediatric nurse practitioner certified pursuant to Sections 2834 and 2836 of the Business and Professions Code. (4) A primary care center, clinic, or other public or private agency or organization that provides outpatient health care services. (5) A physicians' group. (6) A licensed clinical laboratory.


124033. (a) Commencing July 1, 2003, all applications for services under the Child Health and Disability Prevention program shall be filed electronically in accordance with subdivision (b) of Section 14011.7 of the Welfare and Institutions Code. (b) To implement the program described in subdivisions (b) to (e), inclusive, of Section 14011.7 of the Welfare and Institutions Code for the use of an electronic application for the Child Health and Disability Prevention program and for preenrollment into the Medi-Cal program or the Healthy Families Program, the following shall apply: (1) The department may contract with public or private entities, or utilize existing health care service provider enrollment and payment mechanisms, including the Medi-Cal program's fiscal intermediary, only if services provided under the program are specifically identified and reimbursed in a manner that appropriately claims federal financial reimbursement. (2) Contracts, including the Medi-Cal program fiscal intermediary contract for the Child Health and Disability Prevention Program, including any contract amendment, any system change pursuant to a change order, and any project or systems development notice shall be exempt from Part 2 (commencing with Section 10100) of Division 2 of the Public Contract Code, Chapter 7 (commencing with Section 11700) of Part 1 of Division 3 of Title 2 of the Government Code, Section 19130 of the Government Code, and any policies, procedures, or regulations authorized by these laws.


124035. The department shall administer this article and Section 120475 and shall adopt minimum standards for the approval of community child health and disability prevention programs and regulations as necessary. The standards shall allow necessary flexibility in the administration of county programs, taking into account the variability of county needs and resources. Standards shall be adopted for: (a) Education and experience requirements for directors of community child health and disability prevention programs. (b) Health screening, evaluation, and diagnostic procedures for child health and disability prevention programs. (c) Public and private facilities and providers that may participate in community child health and disability prevention programs. (d) The department shall develop a methodology for allocating child health and disability prevention funds to counties for the administration of this program.


124040. (a) The governing body of each county or counties shall establish a community child health and disability prevention program for the purpose of providing early and periodic assessments of the health status of children in the county or counties by July 1, 1974. However, this shall be the responsibility of the department for all counties that contract with the state for health services. Contract counties, at the option of the board of supervisors, may provide services pursuant to this article in the same manner as other county programs, provided the option is exercised prior to the beginning of each fiscal year. Each plan shall include, but is not limited to, the following requirements: (1) Outreach and educational services. (2) Agreements with public and private facilities and practitioners to carry out the programs. (3) Health screening and evaluation services for all children including a physical examination, immunizations appropriate for the child's age and health history, and laboratory procedures appropriate for the child's age and population group performed by, or under the supervision or responsibility of, a physician licensed to practice medicine in California or by a certified family nurse practitioner or a certified pediatric nurse practitioner. (4) Referral for diagnosis or treatment when needed, including, for all children eligible for Medi-Cal, referral for treatment by a provider participating in the Medi-Cal program of the conditions detected, and methods for assuring referral is carried out. (5) Recordkeeping and program evaluations. (6) The health screening and evaluation part of each community child health and disability prevention program plan shall include, but is not limited to, the following for each child: (A) A health and development history. (B) An assessment of physical growth. (C) An examination for obvious physical defects. (D) Ear, nose, mouth, and throat inspection, including inspection of teeth and gums, and for all children three years of age and older who are eligible for Medi-Cal, referral to a dentist participating in the Medi-Cal program. (E) Screening tests for vision, hearing, anemia, tuberculosis, diabetes, and urinary tract conditions. (7) An assessment of nutritional status. (8) An assessment of immunization status. (9) Where appropriate, testing for sickle-cell trait, lead poisoning, and other tests that may be necessary to the identification of children with potential disabilities requiring diagnosis and possibly treatment. (10) For all children eligible for Medi-Cal, necessary assistance with scheduling appointments for services and with transportation. (b) Dentists receiving referrals of children eligible for Medi-Cal under this section shall employ procedures to advise the child's parent or parents of the need for and scheduling of annual appointments. (c) Standards for procedures to carry out health screening and evaluation services and to establish the age at which particular tests should be carried out shall be established by the director. At the discretion of the department, these health screening and evaluation services may be provided at the frequency provided under the Healthy Families Program and permitted in managed care plans providing services under the Medi-Cal program, and shall be contingent upon appropriation in the annual Budget Act. Immunizations may be provided at the frequency recommended by the Committee on Infectious Disease of the American Academy of Pediatrics and the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention. (d) Each community child health and disability prevention program shall, pursuant to standards set by the director, establish a record system that contains a health case history for each child so that costly and unnecessary repetition of screening, immunization and referral will not occur and appropriate health treatment will be facilitated as specified in Section 124085.


124045. A city that operates an independent health agency may elect to provide the services described in this article with the approval of the department. In this instance, the powers granted a governing body of a county shall be vested in the governing body of the city.


124050. Each community child health and disability program shall have a director meeting qualification standards by the department, appointed by the governing body, except for counties contracting with the state for health services.

124055. Any community child health and disability prevention program may contract to furnish services to any other county if the contract is approved by the director.


124060. (a) On or before September 15 of each year, each county program director shall submit a budget update for the subsequent fiscal year that provides the following information: (1) A summary of the previous year's activity, including the number of children screened, the number of children referred for diagnosis and treatment, by condition, and the cost of screening services. (2) A summary description of the results of cases in that a treatable disability was identified and referral made. (3) A projection and cost estimates of the number of children to be screened for the fiscal year for which the budget is being submitted. (b) The multiyear base community child health and disability prevention plan shall include the following: (1) An assessment of the adequacy and availability of the facilities and providers to provide health screening diagnostic and treatment services. (2) A description of the child health and disability prevention program to be offered, including expected participating providers and outreach mechanisms to be utilized. (3) A summary description of the current year's activity, including the number of children screened, the number of children referred for diagnosis and treatment, by condition, and the cost of screening services. (4) A description of how existing school health resources, including school health personnel, are to be utilized for outreach and other services. (5) Budget estimates, including all sources of revenue, for the budget. (c) On or before September 15 of each year each governing board shall submit an update to the multiyear base community child health and disability prevention plan. The director shall determine the amount of state funds available for each county for specified services under an approved multiyear base community child health and disability prevention plan, as updated, from state funds appropriated for child health and disability prevention services. If the amount appropriated in the Budget Act for the fiscal year as enacted into law differs from the amount in the budget submitted by the Governor for the fiscal year, each governing board shall submit an additional revised update in the form and at the time specified by the department. Notwithstanding any other provision of this article, no new community child health and disability prevention plan shall be submitted by a county until September 15, 1983. Each county plan and budget approved for the 1981-82 fiscal year shall be updated on or before September 15 by the governing body of each county for the 1982-83 and 1983-84 fiscal years pursuant to regulations adopted by the department. On or before September 15, 1983, the governing body of each county shall prepare and submit to the department a multiyear base plan and budget for the 1984-85 fiscal year that shall be annually updated on or before September 15 of each subsequent year pursuant to regulations adopted by the department. The department shall develop and implement the format and procedures for the preparation and submission of a multiyear base plan update in order for the counties to have sufficient time prior to September 15, 1983, to prepare and submit their multiyear base plan by September 15, 1983. For the purposes of simplifying and reducing plan requirements, the Legislature intends that the annual update shall not duplicate any of the material in the multiyear base plan, but serve as a progress report both evaluating what has been accomplished over the past year and describing in more detail what will be accomplished in relation to each of the elements in the base plan during the coming year.

124065. Counties shall be reimbursed for the amount required by the county to carry out its community child health and disability prevention program in accordance with the approved community child health and disability prevention plan. Claims for state reimbursement shall be made in the manner as the director shall provide. Each claim for state reimbursement shall be payable from the appropriation made for the fiscal year when the expenses upon which the claim is based are incurred. There shall be no reimbursement for expenditures for the treatment of disabilities identified as a result of the program or for capital improvements or the purchase or construction of buildings, except for the equipment items and remodeling expenses as may be allowed by regulations adopted by the director.


124070. Counties shall be reimbursed for the amount required by the county to carry out its community child health and disability prevention program in accordance with the approved community child health and disability prevention plan. Claims for state reimbursement shall be made in a manner as the director shall provide. Each claim for state reimbursement shall be payable from the appropriation made for the fiscal year in which the expenses upon which the claim is based are incurred. There shall be no reimbursement for expenditures for the treatment of disabilities identified as a result of the program, except for the costs of immunizations necessary to bring the child current in his or her immunization status as provided for by regulations of the department, or for capital improvements or the purchase or construction of buildings, except for the equipment items and remodeling expenses as may be allowed by regulations adopted by the director.


124075. (a) In order to ensure the maximum utilization of the California Medical Assistance Program and other potential reimbursement sources, the department shall develop a schedule and method of reimbursement at reasonable rates for services rendered pursuant to this article. The reimbursement schedule shall include provision for well child examinations as well as for administrative expenses incurred by providers pursuant to meeting this article. Inquiry shall be made of all recipients of services under this article as to their entitlement for third-party reimbursement for medical services. Where an entitlement exists it shall be billed. Notwithstanding subdivision (c) of Section 14000 of the Welfare and Institutions Code and Section 14005 of that code, the California Medical Assistance Program shall be billed for services rendered pursuant to this article for every Medi-Cal eligible beneficiary. (b) The department and counties shall maximize the use of federal funds for carrying out this article, including using state or county funds to match funds claimable under Title 19 of the Social Security Act. Services and administrative support costs claimable under federal law shall include, but not be limited to, outreach, health education, case management, resource development, and training at state and local levels. Any federal funds received shall augment and not replace funds appropriated from the General Fund for carrying out the purposes of this article.


124080. The department may contract with a private entity for the performance of processing claims for state reimbursement, so long as the cost of the contract is no more than 85 percent of the cost of the service if performed in state service and there is compliance with other applicable provisions of the Government Code including, but not limited to, Sections 19130 to 19132, inclusive.


124085. On and after July 1, 1976, each child eligible for services under this article shall, within 90 days after entrance into the first grade, provide a certificate approved by the department to the school where the child is to enroll documenting that within the prior 18 months the child has received the appropriate health screening and evaluation services specified in Section 124040. A waiver signed by the child's parents or guardian indicating that they do not want or are unable to obtain the health screening and evaluation services for their children shall be accepted by the school in lieu of the certificate. If the waiver indicates that the parent or guardian was unable to obtain the services for the child, then the reasons why should be included in the waiver.


124090. Any child between birth and 90 days after entrance into the first grade and all persons under 21 years of age who are eligible for the California Medical Assistance Program shall be eligible for services from the child health and disabilities prevention program in the county where they are a resident. The department, with review and recommendation by the board, shall adopt regulations specifying age groups that shall be given certain types of screening tests and recommendations for referral. The first source of referral shall be the child's usual source of health care. If referral is required and no regular source of health care can be identified, the facility or provider providing health screening and evaluation services shall provide a list of three qualified sources of care, without prejudice for or against any specific source.

124095. Each community child health and disability prevention program shall provide the child or his or her parent or guardian with a copy of the results of the health screening and evaluation, as well as an explanation of the meaning of the results, and shall, where the need indicates, refer the child for further diagnosis and treatment.


124100. (a) In cooperation with the county child health and disability prevention program, the governing body of every school district or private school that has children enrolled in kindergarten shall provide information to the parents or guardians of all children enrolled in kindergarten of this article and Section 120475. (b) Each county child health and disability prevention program shall reimburse school districts for information provided pursuant to this section. The Superintendent of Public Instruction may withhold state average daily attendance funds to any school district for any child for whom a certification or parental waiver is not obtained as required by Section 124085.


124105. (a) This section shall be known and may be cited as the "Hughes Children's Health Enforcement Act." (b) The Legislature recognizes the importance of health to learning and to a successful academic career. The Legislature also recognizes the important role of schools in ensuring the health of pupils through health education and the maintenance of minimal health standards among the pupil population. Therefore, it is the intent of the Legislature that schools ensure that pupils receive a health screening before the end of the first grade. (c) The governing board of each school district shall exclude from school, for not more than five days, any first grade pupil who has not provided either a certificate or a waiver, as specified in Section 124085, on or before the 90th day after the pupil's entrance into the first grade. The exclusion shall commence with the 91st calendar day after the pupil's entrance into the first grade, unless school is not in session that day, then the exclusion shall commence on the next succeeding schoolday. A child shall not be excluded under this section if the pupil's parent or guardian provides to the district either a certificate or a waiver as specified in Section 124085. (d) The governing board of a school district may exempt any pupil from the exclusion described in subdivision (c) if, at least twice between the first day and the 90th day after the pupil's entrance into the first grade, the district has contacted the pupil's parent or guardian and the parent or guardian refuses to provide either a certificate or a waiver as specified in Section 124085. The number of exemptions from exclusion granted by a school district pursuant to this subdivision may not exceed 5 percent of a school district's first grade enrollment. It is the intent of the Legislature that exemptions from exclusion be used in extraordinary circumstances, including, but not limited to, family situations of great dysfunction or disruption, including substance abuse by parents or guardians, child abuse, or child neglect. (e) It is the intent of the Legislature that, upon a pupil's enrollment in kindergarten or first grade, the governing board of the school district notify the pupil's parent or guardian of the obligation to comply with Section 124085 and of the availability for low-income children of free health screening for up to 18 months prior to entry into first grade through the Child Health Disabilities Prevention Program. (f) It is the intent of the Legislature that school districts provide information to parents regarding the requirements of Section 124085 within the notification of immunization requirements. Moreover, the Legislature intends that the information sent to parents encourage parents to obtain health screenings simultaneously with immunizations.


124110. All information and results of the health screening and evaluation of each child shall be confidential and shall not be released without the informed consent of a parent or guardian of the child. The results of the health screening and evaluation shall not be released to any public or private agency, even with the consent of a parent or guardian, unless accompanied by a professional interpretation of what the results mean.


Article 6.4. Newborn Eye Pathology Screening

Ca Codes (hsc:124111-124112) Health And Safety Code Section 124111-124112



124111. (a) The Newborn Eye Pathology Screening Task Force is established and shall advise the State Department of Health Services on the newborn eye pathology screening protocol. (b) The task force shall be composed of the following 12 members: (1) The Director of Health Services as a nonvoting ex officio member. (2) The 11 voting members shall be appointed by the Director of Health Services as follows: (A) One ophthalmologist with a background in or knowledge of providing services to infants with retinoblastoma. (B) One pediatric ophthalmologist who sees general pediatric patients and is a designee of the American Association for Pediatric Ophthalmology and Strabismus. (C) One academic pediatrician with a background in or knowledge of infant eye pathology screening. (D) One parent representing families with a child with blindness or other ocular abnormalities affecting vision. (E) One representative from the California Academy of Family Physicians. (F) One representative recommended by the State Department of Health Services. (G) One representative from the American Academy of Pediatrics, California District. (H) One community pediatrician with a background in or experience with the routine instillation of dilating eye drops as part of red reflex screening. (I) One nurse with a background in or knowledge of the current department program for the instillation of eye drops to prevent conjunctivitis. (J) One retinal specialist with research experience in detecting the signs of treatable congenital eye disease. (K) One optometrist with a background in or experience with pupil dilation in infants and red reflex screening for intraocular pathology. (c) Task force members shall serve without compensation, but shall be reimbursed for necessary travel expenses incurred in the performance of the duties of the task force.


124112. (a) On or before June 30, 2002, the department shall adopt the protocol developed by the American Academy of Pediatrics to optimally detect the presence of treatable causes of blindness in infants by two months of age. If a protocol is not developed on or before June 30, 2002, the department, in consultation with representatives of the Newborn Eye Pathology Task Force, shall establish a protocol to optimally detect the presence of treatable causes of blindness in infants by two months of age on or before January 1, 2003. (b) If the American Academy of Pediatrics develops a protocol to optimally detect the presence of treatable causes of blindness by two months of age after the adoption of the protocol developed by the department, the department shall conform its protocol to the protocol adopted by the American Academy of Pediatrics. (c) Nothing in the section shall be construed to supersede the clinical judgment of the licensed health care provider. (d) Any screening examination recommended pursuant to subdivision (a) shall not be conducted on a newborn if a parent or guardian of the newborn objects to the examination on the grounds that the examination conflicts with the religious beliefs or practices of the parent or guardian.


Article 6.5. Newborn And Infant Hearing Screening, Tracking, And Intervention Program

Ca Codes (hsc:124115-124120.5) Health And Safety Code Section 124115-124120.5



124115. This article shall be known, and may be cited as, the Newborn and Infant Hearing Screening, Tracking and Intervention Act.


124115.5. (a) The Legislature finds and declares all of the following: (1) Hearing loss occurs in newborns more frequently than any other health condition for which newborn screening is currently required. (2) Early detection of hearing loss, early intervention, and followup services before six months of age, have been demonstrated to be highly effective in facilitating the development of a child's health and communication and cognitive skills. (3) The State of California supports the National Healthy People 2000 goals, which promote early identification of children with hearing loss. (4) Children of all ages can receive reliable and valid screening for hearing loss in a cost-effective manner. (5) Appropriate screening and identification of newborns and infants with hearing loss will facilitate early intervention during this critical time for development of communication, and may, therefore, serve the public purposes of promoting the healthy development of children and reducing public expenditure for health care and special education and related services. (b) The purposes of this article shall be to do all of the following: (1) Provide early detection of hearing loss in newborns, as soon after birth as possible, to enable children who fail a hearing screening and their families and other caregivers to obtain needed confirmatory tests or multidisciplinary evaluation, or both, and intervention services, at the earliest opportunity. (2) Prevent or mitigate delays of language and communication development that could lead to academic failures associated with late identification of hearing loss. (3) Provide the state with the information necessary to effectively plan, establish, and evaluate a comprehensive system of appropriate services for parents with newborns and infants who have a hearing loss.


124116. As used in this article: (a) "Birth admission" means the time after birth that the newborn remains in the hospital nursery prior to discharge. (b) "CCS" means the California Children's Services program administered through the State Department of Health Services. (c) "Department" means the State Department of Health Services. (d) "Followup services" means all of the following: (1) All services necessary to diagnose and confirm a hearing loss. (2) Ongoing audiological services to monitor hearing. (3) Communication services, including, but not limited to, aural rehabilitation, speech, language, social, and psychological services. (4) Necessary support of the infant and family. (e) "Hearing loss" means a hearing loss of 30 decibels or greater in the frequency region important for speech recognition and comprehension in one or both ears (from 500 through 4000 Hz). However, as technology allows for changes to this definition through the detection of less severe hearing loss, the department may modify this definition by regulation. (f) "Infant" means a child 29 days through 12 months old. (g) "Intervention services" means the early intervention services described in Part C of the Individuals with Disabilities Education Act (20 U.S.C. Sec. 1475 et seq.). (h) "Newborn" means a child less than 29 days old. (i) "Newborn hearing screening services" means those hearing screening tests that are necessary to achieve the identification of all newborns and infants with a hearing loss. (j) "Parent" means a natural parent, adoptive parent, or legal guardian of a child.


124116.5. (a) (1) Every general acute care hospital with licensed perinatal services in this state shall administer to every newborn, upon birth admission, a hearing screening test for the identification of hearing loss, using protocols approved by the department or its designee. (2) In order to meet the department's certification criteria, a general acute care hospital shall be responsible for developing a screening program that provides competent hearing screening, utilizes appropriate staff and equipment for administering the testing, completes the testing prior to the newborn's discharge from a newborn nursery unit, refers infants with abnormal screening results, maintains and reports data as required by the department, and provides physician and family-parent education. (b) A hearing screening test provided for pursuant to subdivision (a) shall be performed by a licensed physician, licensed registered nurse, licensed audiologist, or an appropriately trained individual who is supervised in the performance of the test by a licensed health care professional. (c) Every general acute care hospital that has not been approved by the California Children's Services (CCS) program and that has licensed perinatal services that provide care in fewer than 100 births annually shall, if it does not directly provide a hearing screening test, enter into an agreement with an outpatient infant hearing screening provider certified by the department to provide hearing screening tests. (d) This section shall not apply to any newborn whose parent or guardian objects to the test on the grounds that the test is in violation of his or her beliefs.

124117. The department or its designee shall approve hospitals for participation as newborn hearing screening providers. These facilities shall then receive payment from the department for the newborn hearing screening services provided to newborns and infants eligible for the Medi-Cal or CCS programs in accordance with this article.


124118. The department or its designee shall provide every general acute care hospital that has licensed perinatal services, or neonatal intensive care unit (NICU), as specified in Section 123975, written information on the current and most effective means available to screen the hearing of newborns and infants, and shall provide technical assistance and consultation to these hospitals in developing a system of screening each newborn and infant receiving care at the facility. The information shall also include the mechanism for referral of newborns and infants with abnormal test results.


124118.5. (a) The department shall establish a system of early hearing detection and intervention centers that shall provide technical assistance and consultation to hospitals in the startup and ongoing implementation of a facility hearing screening program and followup system. (b) The early hearing detection and intervention centers shall be chosen by the department according to standards and criteria developed by the California Children's Services (CCS) program. Each center shall be responsible for a separate geographic catchment area as determined by the program. (c) Each center shall be required to develop a system that shall provide outreach and education to hospitals in its catchment area, approve hospitals on behalf of the department for participation as newborn hearing screening providers, maintain a database of all newborns and infants screened in the catchment area, ensure appropriate followup for newborns and infants with an abnormal hearing screening, including diagnostic evaluation and referral to intervention services programs if the newborn or infant is found to have a hearing loss, and provide coordination with the CCS and local early intervention programs as defined in Title 14 (commencing with Section 95000) of the Government Code.

124119. (a) The department shall develop and implement a reporting and tracking system for newborns and infants tested for hearing loss. (b) The system shall provide the department with information and data to effectively plan, establish, monitor, and evaluate the Newborn and Infant Hearing Screening, Tracking and Intervention Program, including the screening and followup components, as well as the comprehensive system of services for newborns and infants who are deaf or hard-of-hearing and their families. (c) Every general acute care hospital with licensed perinatal services, or NICU in this state shall report to the department or the department's designee information as specified by the department to be included in the department's reporting and tracking system. (d) All providers of audiological followup and diagnostic services provided under this article shall report to the department or the department's designee information as specified by the department to be included in the department's reporting and tracking system. (e) The information compiled and maintained in the tracking system shall be kept confidential in accordance with Chapter 5 (commencing with Section 10850) of Part 1 of Division 9 of the Welfare and Institutions Code, the Information Practices Act of 1977 (Chapter 1 (commencing with Section 1798) of Title 1.8 of Part 4 of Division 3 of the Civil Code), and the applicable requirements and provisions of Part C of the federal Individuals with Disabilities Education Act (20 U.S.C. Sec. 1475 et seq.). (f) Data collected by the tracking system obtained directly from the medical records of the newborn or infant shall be for the confidential use of the department and for the persons or public or private entities that the department determines are necessary to carry out the intent of the reporting and tracking system. (g) A health facility, clinical laboratory, audiologist, physician, registered nurse, or any other officer or employee of a health facility or laboratory or employee of an audiologist or physician, shall not be criminally or civilly liable for furnishing information to the department or its designee pursuant to the requirements of this section.

124119.5. Parents of all newborns and infants diagnosed with a hearing loss shall be provided written information on the availability of community resources and services for children with hearing loss, including those provided in accordance with the federal Individuals with Disabilities Education Act (20 U.S.C. Sec. 1400 et seq.), through the reporting and tracking system followup procedures. Information shall include listings of local and statewide nonprofit deaf and hard-of-hearing consumer-based organizations, parent support organizations affiliated with deafness, and programs offered through the State Department of Social Services, Office of Deaf Access, State Department of Developmental Services, and the State Department of Education.


124120. The department may conduct a community outreach and awareness campaign to inform medical providers, pregnant women, and the families of newborns and infants on the availability of the newborn hearing screening program and the value of early hearing testing. The outreach and awareness campaign shall be conducted by an independent contractor.


124120.5. A newborn hearing screening test shall not be performed without the written consent of the parent.


Article 7. Childhood Lead Poisoning Prevention Act

Ca Codes (hsc:124125-124165) Health And Safety Code Section 124125-124165



124125. The Legislature hereby finds and declares that childhood lead exposure represents the most significant childhood environmental health problem in the state today; that too little is known about the prevalence, long-term health care costs, severity, and location of these problems in California; that it is well known that the environment is widely contaminated with lead; that excessive lead exposure causes acute and chronic damage to a child's renal system, red blood cells, and developing brain and nervous system; that at least one in every 25 children in the nation has an elevated blood lead level; and that the cost to society of neglecting this problem may be enormous. The Legislature further finds and declares that knowledge about where and to what extent harmful childhood lead exposures are occurring in the state could lead to the prevention of these exposures, and to the betterment of the health of California's future citizens. Therefore, it is the intent of the Legislature in enacting this article to establish a state Childhood Lead Poisoning Prevention Program within the department to accomplish all of the following: (a) To compile information concerning the prevalence, causes, and geographic occurrence of high childhood blood lead levels. (b) To identify and target areas of the state where childhood lead exposures are especially significant. (c) To analyze information collected pursuant to this article and, where indicated, design and implement a program of medical followup and environmental abatement and followup that will reduce the incidence of excessive childhood lead exposures in California.


124130. (a) A laboratory that performs a blood lead analysis on a specimen of human blood drawn in California shall report the information specified in this section to the department for each analysis on every person tested. (b) The analyzing laboratory shall report all of the following: (1) The test results in micrograms of lead per deciliter. (2) The name of the person tested. (3) The person's birth date if the analyzing laboratory has that information, or if not, the person's age. (4) The person's address if the analyzing laboratory has that information, or if not, a telephone number by which the person may be contacted. (5) The name, address, and telephone number of the health care provider that ordered the analysis. (6) The name, address, and telephone number of the analyzing laboratory. (7) The accession number of the specimen. (8) The date the analysis was performed. (c) The analyzing laboratory shall report all of the following information that it possesses: (1) The person's gender. (2) The name, address, and telephone number of the person's employer, if any. (3) The date the specimen was drawn. (4) The source of the specimen, specified as venous, capillary, arterial, cord blood, or other. (d) The analyzing laboratory may report to the department other information that directly relates to the blood lead analysis or to the identity, location, medical management, or environmental management of the person tested. (e) If the result of the blood lead analysis is a blood lead level equal to or greater than 10 micrograms of lead per deciliter of blood, the report required by this section shall be submitted within three working days of the analysis. If the result is less than 10 micrograms per deciliter, the report required by this section shall be submitted within 30 calendar days. (f) Commencing January 1, 2003, a report required by this section shall be submitted by hand, courier, postal mail, facsimile, or electronic transfer. Commencing January 1, 2005, a report required by this section shall be submitted by electronic transfer. (g) All information reported pursuant to this section shall be confidential, as provided in Section 100330, except that the department may share the information for the purpose of surveillance, case management, investigation, environmental assessment, environmental remediation, or abatement with the local health department, environmental health agency authorized pursuant to Section 101275, or building department. The local health department, environmental health agency, or building department shall otherwise maintain the confidentiality of the information in the manner provided in Section 100330. (h) The director may assess a fine up to five hundred dollars ($500) against any laboratory that knowingly fails to meet the reporting requirements of this section. (i) A laboratory shall not be fined or otherwise penalized for failure to provide the patient's birth date, age, address, or telephone number if the result of the blood lead analysis is a blood lead level less than 25 micrograms of lead per deciliter of blood, and if all of the following circumstances exist: (1) The test sample was sent to the laboratory by another medical care provider. (2) The laboratory requested the information from the medical care provider who obtained the sample. (3) The medical care provider that obtained the sample and sent it to the laboratory failed to provide the patient's birth date, age, address, or telephone number.


124150. The Legislature hereby finds and declares that the activities conducted by the department pursuant to Section 124130 have confirmed and supported the findings specified in Section 124125 and, in addition, have resulted in the following findings: (a) Very few children are currently tested for elevated blood lead levels in California. The lead registry established pursuant to Section 124130 has been effective at identifying incidents of occupational lead poisoning; however, because childhood lead screening is not now required in California, the registry is unable to serve as the exclusive mechanism to identify children with elevated blood lead levels. Additional blood lead screening needs to be done to identify children at high risk of lead poisoning. (b) Based on emerging information about the severe deleterious effects of low levels of lead on children's health, the lead danger level is expected to be lowered from 25 to 15 micrograms of lead per deciliter of human blood. (c) Lead poisoning poses a serious health threat for significant numbers of California children. Based on lead registry reports and targeted screening results, the department has estimated that tens of thousands of California children may be suffering from blood lead levels greater than the danger level. (d) The implications of lead exposure to children and pregnant women from lead brought home on the clothing of workers is unknown, but may be significant. (e) Levels of lead found in soil and paint around and on housing constitute a health hazard to children living in the housing. No regulations currently exist to limit allowable levels of lead in paint surfaces in California housing.


124155. (a) The department shall design and implement a screening program for lead exposure of children not older than seven years old in migrant labor camps where lead-based paint has been identified pursuant to Section 50710.5. (b) The department may implement the screening program through the local health departments utilizing the department's protocols. Notwithstanding any other provision of law, the department may contract with a nonprofit organization to assist in administration of the program. The contract shall not be subject to competitive bidding requirements.


124160. The department shall continue to direct the Childhood Lead Poisoning Prevention Program to implement a program to identify and conduct medical followup of high-risk children, and to establish procedures for environmental abatement and followup designed to reduce the incidence of excessive childhood lead exposures in California. In implementing this program, the department shall utilize its own studies, as well as relevant information from the scientific literature and childhood lead poisoning programs from outside California. The particular activities specified in this section shall be initiated by January 1, 1990, and completed on or before January 1, 1993. The program shall include at least all of the following components: (a) Lead screening. The department shall: (1) Design and implement at least one pilot blood lead screening project targeting children at high risk of elevated blood lead levels. In designing any pilot projects, the department shall give special consideration to conducting screening through the Child Health Disability and Prevention Program. (2) Conduct a pilot screening project to evaluate blood lead levels among children of workers exposed to lead in their occupations. (3) Develop and issue health advisories urging health care providers to conduct routine annual screening of high-risk children between the ages of one and five years of age. (4) Develop a program to assist local health departments in identifying and following up cases of elevated blood lead levels. (5) Develop and conduct programs to educate health care providers regarding the magnitude and severity of, and the necessary responses to, the childhood lead poisoning problem in California. (b) The department, in consultation with the Department of Housing and Community Development, shall adopt regulations governing the abatement of lead paint in and on housing, including, but not limited to, standards for enforcement, testing, abatement, and disposal. (c) The department shall conduct a study to evaluate whether abatement of lead in soil is effective at reducing blood lead levels in children.

124165. After January 1, 1993, the department, through the Childhood Lead Poisoning Prevention Program, shall continue to take steps that it determines are necessary to reduce the incidence of excessive childhood lead exposure in California.


Article 8. Female Genital Mutilation Prevention

Ca Codes (hsc:124170) Health And Safety Code Section 124170



124170. The State Department of Health Services, in consultation with the State Department of Social Services and the appropriate federal agency or department, shall establish and implement appropriate education, preventative, and outreach activities, focusing on the new immigrant populations that traditionally practice female genital mutilation, for the purpose of informing members of those communities of the health risks and emotional trauma inflicted by this practice and informing those communities and the medical community of the prohibition and ramifications of Section 273.4 of the Penal Code.


Article 9. Mercury-containing Vaccines

Ca Codes (hsc:124172) Health And Safety Code Section 124172



124172. (a) Except for an influenza vaccine described in subdivision (b), on and after July 1, 2006, a person who is knowingly pregnant or who is under three years of age shall not be vaccinated with a mercury-containing vaccine or injected with a mercury-containing product that contains more than 0.5 micrograms of mercury per 0.5 milliliter dose. (b) On and after July 1, 2006, a person who is knowingly pregnant or who is under three years of age shall not be vaccinated with a mercury-containing influenza vaccine that contains more than 1.0 microgram of mercury per 0.5 milliliter dose. (c) The Secretary of the Health and Human Services Agency may exempt the use of a vaccine from this section if the secretary finds, and the Governor concurs, that an actual or potential bioterrorist incident or other actual or potential public health emergency, including an epidemic or shortage of supply of a vaccine that would prevent children under three years of age and knowingly pregnant women from receiving the needed vaccine, makes necessary the administration of a vaccine containing more mercury than the maximum level set forth in subdivision (a), or subdivision (b) in the case of influenza vaccine. The exemption shall meet all of the following conditions: (1) It shall not be issued for more than 12 months. (2) At the end of the effective period of the exemption, the secretary may issue another exemption for up to 12 months for the same incident or public health emergency, if the secretary makes a determination that the exemption is necessary as set forth in this subdivision, the Governor concurs with the exemption, and the secretary notifies the Legislature and interested parties pursuant to paragraphs (3), (4), and (5). (3) Upon issuing an exemption, the secretary and the Governor shall, within 48 hours, notify the Legislature about the exemption and about the secretary's findings justifying the exemption's approval. (4) Upon request for an exemption, the secretary shall notify interested parties, who have expressed their interest to the secretary in writing, that an exemption request has been made. (5) Upon issuing an exemption, the secretary shall, within seven days, notify interested parties, who have expressed their interest to the secretary in writing, about the exemption and about the secretary's findings justifying the exemption's approval.



Article 10. Public School Health Center Support Program 124174-124174.6

Ca Codes (hsc:124174-124174.6) Health And Safety Code Section 124174-124174.6



124174. The following definitions shall govern the construction of this article, unless the context requires otherwise: (a) "Program" means a Public School Health Center Support Program. (b) "School health center" means a center or program, located at or near a local educational agency, that provides age-appropriate health care services at the program site or through referrals. A school health center may conduct routine physical, mental health, and oral health assessments, and provide referrals for any services not offered onsite. A school health center may serve two or more nonadjacent schools or local educational agencies. (c) For purposes of this section, "local educational agency" means a school, school district, charter school, or county office of education if the county office of education serves students in kindergarten, or any grades from 1 to 12, inclusive. (d) "Department" means the State Department of Public Health.


124174.2. (a) The department, in cooperation with the State Department of Education, shall establish a Public School Health Center Support Program. (b) The program, in collaboration with the State Department of Education, shall perform the following program functions: (1) Provide technical assistance to school health centers on effective outreach and enrollment strategies to identify children who are eligible for, but not enrolled in, the Medi-Cal program, the Healthy Families Program, or any other applicable program. (2) Serve as a liaison between organizations within the department, including, but not limited to, prevention services, primary care, and family health. (3) Serve as a liaison between other state entities, as appropriate, including, but not limited to, the State Department of Health Care Services, the State Department of Mental Health, the State Department of Alcohol and Drug Programs, the Department of Managed Health Care, the California Emergency Management Agency, and the Managed Risk Medical Insurance Board. (4) Provide technical assistance to facilitate and encourage the establishment, retention, or expansion of, school health centers. For purposes of this paragraph, technical assistance may include, but is not limited to, identifying available public and private sources of funding, which may include federal Medicaid funds, funds from third-party reimbursements, and available federal or foundation grant moneys. (c) The department shall consult with interested parties and appropriate stakeholders, including the California School Health Centers Association and representatives of youth and parents, in carrying out its responsibilities under this article.


124174.3. (a) The department shall establish standardized data collection procedures and collect data specified in subdivisions (c) and (d) from school health centers on an ongoing basis. (b) The data collected pursuant to this section shall be submitted in a format determined by the department in accordance with applicable state and federal requirements for confidentiality and protected health information. (c) Data collected pursuant to this section shall include the following: (1) The name of the primary contact person, telephone numbers, including facsimile physical address, and the e-mail address, if applicable, for each school health center. (2) The annual number of schoolage children receiving health services or mental health services from the school health center. (3) The type and volume of services provided by the school health centers. (4) The funding mechanisms used by the school health centers. (5) Information on other programs offered by school health centers with an emphasis on preventative health services that address health issues unique to schoolage children, including, but not limited to, childhood obesity, asthma, immunizations against communicable diseases, and child and adolescent mental health disorders. (d) To the extent feasible, the department shall collect data on health services provided at a local educational agency outside a school health center. (e) This section shall be implemented only to the extent funds are appropriated for this purpose in the Budget Act or pursuant to the enactment of legislation subsequent to the addition of this section.


124174.4. The State Department of Education, in collaboration with the department, shall perform the following functions: (a) Coordination of programs within the State Department of Education that support school health centers and programs within the State Department of Mental Health and the State Department of Alcohol and Drug Programs, where appropriate. (b) The provision of technical assistance to facilitate and encourage the establishment, retention, and expansion of school health centers in public schools. For purposes of this subdivision, "technical assistance" may include the provision of information to local educational agencies and other entities regarding the utilization of facilities, liability insurance, cooperative agreements with community-based providers, and other issues pertinent to school health centers.


124174.5. (a) The program, in collaboration with the State Department of Education, shall act as a liaison for school-based health centers. (b) Beginning on or before January 1, 2009, the program shall provide a biennial update to the appropriate policy and fiscal committees of the Legislature that includes information on all of the following: (1) The number and geographical distribution of school health centers. (2) The number of schoolage children who were served by school health centers. (3) The type and volume of health and mental health services provided by school health centers. (4) A description of state funds used by school health centers. (5) A description of any obstacles to the financial sustainability of school health centers and any necessary policy changes that would address those financial obstacles. (c) The department shall post on its Web site any written materials provided to the Legislature as part of the updates required by this section.


124174.6. The department shall establish a grant program within the Public School Health Center Support Program to provide technical assistance, and funding for the expansion, renovation, and retrofitting of existing school health centers, and the development of new school health centers, in accordance with the following procedures and requirements: (a) A school health center receiving grant funds pursuant to this section shall meet or have a plan to meet the following requirements: (1) Strive to provide a comprehensive set of services including medical, oral health, mental health, health education, and related services in response to community needs. (2) Provide primary and other health care services, provided or supervised by a licensed professional, which may include all of the following: (A) Physical examinations, immunizations, and other preventive medical services. (B) Diagnosis and treatment of minor injuries and acute medical conditions. (C) Management of chronic medical conditions. (D) Basic laboratory tests. (E) Referrals to and followup for specialty care. (F) Reproductive health services. (G) Nutrition services. (H) Mental health services provided or supervised by an appropriately licensed mental health professional may include: assessments, crisis intervention, counseling, treatment, and referral to a continuum of services including emergency psychiatric care, community support programs, inpatient care, and outpatient programs. School health centers providing mental health services as specified in this section shall consult with the local county mental health department for collaboration in planning and service delivery. (I) Oral health services that may include preventive services, basic restorative services, and referral to specialty services. (3) Work in partnership with the school nurse, if one is employed by the school or school district, to provide individual and family health education; school or districtwide health promotion; first aid and administration of medications; facilitation of student enrollment in health insurance programs; screening of students to identify the need for physical, mental health, and oral health services; referral and linkage to services not offered onsite; public health and disease surveillance; and emergency response procedures. A school health center may receive grant funding pursuant to this section if the school or school district does not employ a school nurse. However, it is not the intent of the Legislature that a school health center serve as a substitute for a school nurse employed by a local school or school district. (4) Have a written contract or memorandum of understanding between the school district and the health care provider or any other community providers that ensures coordination of services, ensures confidentiality and privacy of health information consistent with applicable federal and state laws, and integration of services into the school environment. (5) Serve all registered students in the school regardless of ability to pay. (6) Be open during all normal school hours, or on a more limited basis if resources are not available, or on a more expansive basis if dictated by community needs and resources are available. (7) Establish protocols for referring students to outside services when the school health center is closed. (8) Facilitate transportation between the school and the health center if the health center is not located on school or school district property. (b) Planning grants shall be available in amounts between twenty-five thousand dollars ($25,000) and fifty thousand dollars ($50,000) for a 6- to 12-month period to be used for the costs associated with assessing the need for a school health center in a particular community or area, and developing the partnerships necessary for the operation of a school health center in that community or area. Applicants for planning grants shall be required to have a letter of interest from a school or district if the applicant is not a local education agency. Grantees provided funding pursuant to this subdivision shall be required to do all of the following: (1) Seek input from students, parents, school nurses, school staff and administration, local health providers, and if applicable, special population groups, on community health needs, barriers to health care and the need for a school health center. (2) Collect data on the school and community to estimate the percentage of students that lack health insurance and the percentage that are eligible for Medi-Cal benefits, or other public programs providing free or low-cost health services. (3) Assess capacity and interest among health care providers in the community to provide services in a school health center. (4) Assess the need for specific cultural or linguistic services or both. (c) Facilities and startup grants shall be available in amounts between twenty thousand dollars ($20,000) and two hundred fifty thousand dollars ($250,000) per year for a three-year period for the purpose of establishing a school health center, with the potential addition of one hundred thousand dollars ($100,000) in the first year for facilities construction, purchase, or renovation. Grant funds may be used to cover a portion or all of the costs associated with designing, retrofitting, renovating, constructing, or buying a facility, for medical equipment and supplies for a school health center, or for personnel costs at a school health center. Preference will be given to proposals that include a plan for cost sharing among schools, health providers, and community organizations for facilities construction and renovation costs. Applicants for facilities and startup grants offered pursuant to this subdivision shall be required to meet the following criteria: (1) Have completed a community assessment determining the need for a school health center. (2) Have a contract or memorandum of understanding between the school district and the health care provider, if other than the district, and any other provider agencies describing the relationship between the district and the school health center. (3) Have a mechanism, described in writing, to coordinate services to individual students among school and school health center staff while maintaining confidentiality and privacy of health information consistent with applicable state and federal laws. (4) Have a written description of how the school health center will participate in the following: (A) School and districtwide health promotion, coordinated school health, health education in the classroom or on campus, program/activities that address nutrition, fitness, or other important public health issues, or promotion of policies that create a healthy school environment. (B) Outreach and enrollment of students in health insurance programs. (C) Public health prevention, surveillance, and emergency response for the school population. (5) Have the ability to provide the linguistic or cultural services needed by the community. If the school health center is not yet able to provide these services due to resource limitations, the school health center shall engage in an ongoing assessment of its capacity to provide these services. (6) Have a plan for maximizing available third-party reimbursement revenue streams. (d) Sustainability grants shall be available in amounts between twenty-five thousand dollars ($25,000) and one hundred twenty-five thousand dollars ($125,000) per year for a three-year period for the purpose of operating a school health center, or enhancing programming at a fully operational school health center, including oral health or mental health services. Applicants for sustainability grants offered pursuant to this subdivision shall be required to meet all of the criteria described in subdivision (c), in addition to both of the following criteria: (1) The applicant shall be eligible to become or already be an approved Medi-Cal provider. (2) The applicant shall have ability and procedures in place for billing public insurance programs and managed care providers. (3) The applicant shall seek reimbursement and have procedures in place for billing public and private insurance that covers students at the school health center. (e) The department shall award technical assistance grants through a competitive bidding process to qualified contractors to support grantees receiving grants under subdivisions (b), (c), and (d). A qualified contractor means a vendor with demonstrated capacity in all aspects of planning, facilities development, startup, and operation of a school health center. (f) The department shall also develop a request for proposal (RFP) process for collecting information on applicants, and determining which proposals shall receive grant funding. The department shall give preference for grant funding to the following schools: (1) Schools in areas designated as federally medically underserved areas or in areas with medically underserved populations. (2) Schools with a high percentage of low-income and uninsured children and youth. (3) Schools with large numbers of limited English proficient (LEP) students. (4) Schools in areas with a shortage of health professionals. (5) Low-performing schools with Academic Performance Index (API) rankings in the deciles of three and below of the state. (g) Moneys shall be allocated to the department annually for evaluation to be conducted by an outside evaluator that is selected through a competitive bidding process. The evaluation shall document the number of grantees that establish and sustain school health centers, and describe the challenges and lessons learned in creating successful school health centers. The evaluator shall use data collected pursuant to Section 124174.3, if it is available, and work in collaboration with the Public School Health Center Support Program. The department shall post the evaluation on its Internet Web site. (h) This section shall be implemented only to the extent that funds are appropriated to the department in the annual Budget Act or other statute for implementation of this article.


Chapter 4. Adolescent Health

Article 1. California Adolescent Family Life Act Of 1988 124175-124200

Ca Codes (hsc:124175-124200) Health And Safety Code Section 124175-124200



124175. The Legislature hereby finds and declares that: (a) Adolescent pregnancy and parenthood is a problem with significant social, medical, educational, and economic consequences to the teen parent and child, her family, and the State of California. (b) In an attempt to address the problems of pregnant and parenting adolescents, the Governor, in 1985, created the Adolescent Family Life Demonstration Program, that was designed to bring pregnant and parenting teenagers into programs that provide services of demonstrated cost benefit and effectiveness by organizing networks of local agencies focused on providing services to adolescents and ensuring the most timely and effective utilization of services. (c) Independent evaluations indicate that the program has been successful and effective in achieving its intended goals of providing pregnant adolescents with prenatal care, reducing the incidence of low birthweight babies born to adolescent mothers, keeping or reenrolling pregnant and parenting adolescents in school, and reducing the rate of repeat teen pregnancies.


124180. (a) The department may conduct the Adolescent Family Life Program to assure that pregnant adolescents receive comprehensive continuous prenatal care in order to deliver healthy babies; to establish networks within regions to provide to pregnant and parenting teens and their children necessary services including medical care, psychological and nutritional counseling, maternity counseling, adoption counseling, academic and vocational programs, and day care; to provide a continuous case manager to each family unit; and to maintain a data base to measure outcomes of adolescent pregnancies. Specific procedures to operate this program will be defined and carried out through standards and guidelines established by the department. (b) No grant funds may be used for essential services to pregnant adolescents or schoolage parents unless the services are not available in the county or are insufficient to meet the basic needs of the population to be served; in that case, funds may be used for essential services only as set forth in the approved grant application. No grant funds may be expended for abortions, abortion referrals, or abortion counseling.


124185. (a) The department, through its program of maternal and child health, shall award contract augmentations to four Adolescent Family Life Programs that meet the requirements of this section and develop plans for a comprehensive coordinated substance abuse prevention, intervention, and counseling program, designed specifically to meet the developmental, social, and educational needs of high-risk pregnant or parenting adolescents. The program shall, to the extent practicable, feasible, and appropriate, leverage existing programs and funding rather than creating new, duplicative programs and services. (b) The department shall adopt guidelines and criteria setting forth the terms and conditions upon which the department will offer contract augmentations pursuant to this section. The department also shall disseminate information designed to publicize the availability of contract augmentations for a comprehensive coordinated substance abuse prevention, intervention, and counseling program to high-risk pregnant or parenting adolescents. (c) The department shall encourage Adolescent Family Life Programs with small caseloads to develop plans and submit applications that reflect sharing of services among two or more programs. (d) At least one program that is awarded a contract augmentation shall be located in northern California, at least one program shall be located in central California, and at least one program shall be located in southern California. (e) This section shall become operative on July 1, 1994.


124190. A comprehensive coordinated substance abuse prevention, intervention, and counseling program, as used in Section 124185, shall include, but not be limited to, programs that: (a) Have demonstrated a capacity for developing interagency cooperative approaches to reduce the incidence of high-risk pregnant or parenting adolescents. This shall include documentation of program development and plans for coordination and collaboration with existing perinatal substance abuse programs in the county, including state pilot projects on perinatal substance abuse established under the direction of the Local Perinatal Substance Abuse Coordinating Council. (b) Employ maximum utilization of existing available programs and facilities. (c) Have developed goals and objectives for reducing the incidence of high-risk pregnant and parenting adolescents. (d) Are culturally and linguistically appropriate to the population being served. (e) Include staff development training by substance abuse counselors. (f) This section shall become operative on July 1, 1994.


124195. The department shall require reports to be prepared by all programs funded pursuant to this article.


124200. Funding for the purpose of this article shall be provided through funds appropriated to the department through the annual Budget Act.


Article 2. Child And Adolescent Resource Program

Ca Codes (hsc:124225-124230) Health And Safety Code Section 124225-124230



124225. (a) The Legislature finds that recent responsibilities for assessing and treating the mental disorders of children and adolescents have been required of county mental health programs creating an unmet need for personnel in the field of mental health who have expertise in preventing, diagnosing, and treating the mental and emotional disorders of children. (b) Recent attention to child abuse cases has increased the awareness of the special needs of children who are victims of abuse and of those who are then called to the courtroom as witnesses. Mental health personnel with special training are also needed for these children.


124230. It is the purpose of the Legislature, in enacting this article, to encourage the Regents of the University of California to augment the academic child and adolescent programs at the medical schools of the University of California. The programs shall include, but not be limited to, one or more of the following elements: (a) Clinical or postgraduate educational programs in child and adolescent psychiatry to instruct and train students in recognizing and treating children with mental and emotional problems, both organic and functional. (b) Provision of continuing education for specialists in the care and treatment of children and adolescents with mental and emotional problems. (c) Research into the causes, prevention, and treatment of mental disorders of children.


Article 3. Mental Health Services For Minors

Ca Codes (hsc:124260) Health And Safety Code Section 124260



124260. (a) As used in this section: (1) "Mental health treatment or counseling services" means the provision of outpatient mental health treatment or counseling by a professional person, as defined in paragraph (2). (2) "Professional person" means any of the following: (A) A person designated as a mental health professional in Sections 622 to 626, inclusive, of Title 9 of the California Code of Regulations. (B) A marriage and family therapist as defined in Chapter 13 (commencing with Section 4980) of Division 2 of the Business and Professions Code. (C) A licensed educational psychologist as defined in Chapter 13.5 (commencing with Section 4989.10) of Division 2 of the Business and Professions Code. (D) A credentialed school psychologist as described in Section 49424 of the Education Code. (E) A clinical psychologist as defined in Section 1316.5 of the Health and Safety Code. (F) A licensed clinical social worker as defined in Chapter 14 (commencing with Section 4991) of Division 2 of the Business and Professions Code. (G) A marriage and family therapist registered intern, as defined in Chapter 13 (commencing with Section 4980) of Division 2 of the Business and Professions Code, while working under the supervision of a licensed professional specified in subdivision (f) of Section 4980.40 of the Business and Professions Code as that subdivision read on January 1, 2003. (H) A board certified, or board eligible, psychiatrist. (b) Notwithstanding any provision of law to the contrary, a minor who is 12 years of age or older may consent to mental health treatment or counseling services if, in the opinion of the attending professional person, the minor is mature enough to participate intelligently in the mental health treatment or counseling services. (c) Notwithstanding any provision of law to the contrary, the mental health treatment or counseling of a minor authorized by this section shall include involvement of the minor's parent or guardian, unless the professional person who is treating or counseling the minor, after consulting with the minor, determines that the involvement would be inappropriate. The professional person who is treating or counseling the minor shall state in the client record whether and when the person attempted to contact the minor's parent or guardian, and whether the attempt to contact was successful or unsuccessful, or the reason why, in the professional person's opinion, it would be inappropriate to contact the minor's parent or guardian. (d) The minor's parent or guardian is not liable for payment for mental health treatment or counseling services provided pursuant to this section unless the parent or guardian participates in the mental health treatment or counseling, and then only for services rendered with the participation of the parent or guardian. (e) This section does not authorize a minor to receive convulsive therapy or psychosurgery as defined in subdivisions (f) and (g) of Section 5325 of the Welfare and Institutions Code, or psychotropic drugs without the consent of the minor's parent or guardian.



Chapter 5. Dental Disease(reserved)

Chapter 6. Domestic Violence

Ca Codes (hsc:124250) Health And Safety Code Section 124250



124250. (a) The following definitions shall apply for purposes of this section: (1) "Domestic violence" means the infliction or threat of physical harm against past or present adult or adolescent intimate partners, and shall include physical, sexual, and psychological abuse against the partner, and is a part of a pattern of assaultive, coercive, and controlling behaviors directed at achieving compliance from or control over, that partner. (2) "Shelter-based" means an established system of services where victims of domestic violence and their children may be provided safe or confidential emergency housing on a 24-hour basis, including, but not limited to, hotel or motel arrangements, haven, and safe houses. (3) "Emergency shelter" means a confidential or safe location that provides emergency housing on a 24-hour basis for victims of domestic violence and their children. (b) The California Emergency Management Agency shall administer a comprehensive shelter-based services grant program to shelters for victims of domestic violence pursuant to this section. This program shall comport with the requirements of Section 11135 of the Government Code. (c) The California Emergency Management Agency shall administer grants, awarded as the result of a request for application process, to shelters for victims of domestic violence that propose to maintain shelters or services previously granted funding pursuant to this section, to expand existing services or create new services, and to establish new shelters to provide services, in any of the following four areas: (1) Emergency shelter to victims of domestic violence and their children escaping violent family situations. (2) Transitional housing programs to help victims of domestic violence and their children find housing and jobs so that they are not forced to choose between returning to a violent relationship or becoming homeless. The programs may offer up to 18 months of housing, case management, job training and placement, counseling, support groups, and classes in parenting and family budgeting. (3) Legal and other types of advocacy and representation to help victims of domestic violence and their children pursue the appropriate legal options. (4) Other support services for victims of domestic violence and their children. (d) The agency shall collaborate closely with the advisory council established pursuant to Section 13823.16 of the Penal Code in the development of funding priorities, the framing of the Request for Proposals, and the solicitation of proposals. (e) (1) The California Emergency Management Agency shall administer grants, awarded as the result of a request for application process, to entities to conduct demonstration projects to serve victims of domestic violence and their children, including, but not limited to, creative and innovative service approaches, such as community response teams and pilot projects to develop new interventions emphasizing prevention and education, and other support projects identified by the advisory council. (2) For purposes of this subdivision, "entity" means a state agency, a local government, a community-based organization, or a nonprofit organization. (f) It is the intent of the Legislature that services funded by this program include services for victims of domestic violence in underserved communities, including the lesbian, gay, bisexual, and transgender community, and ethnic and racial communities. Therefore, the California Emergency Management Agency shall do both of the following: (1) Fund shelters pursuant to this section that reflect the ethnic, racial, economic, cultural, and geographic diversity of the state. (2) Target geographic areas and ethnic and racial communities of the state whereby, based on a needs assessment, it is determined that no shelter-based services for victims of domestic violence exist or that additional resources are necessary. (g) The director may award additional grants to shelter-based agencies when it is determined that there exists a critical need for shelter or shelter-based services. (h) As a condition of receiving funding pursuant to this section, shelters for victims of domestic violence shall do both of the following: (1) Provide matching funds or in-kind contributions equivalent to not less than 20 percent of the grant they would receive. The matching funds or in-kind contributions may come from other governmental or private sources. (2) Ensure that appropriate staff and volunteers having client contact meet the definition of "domestic violence counselor" as specified in subdivision (a) of Section 1037.1 of the Evidence Code. The minimum training specified in paragraph (2) of subdivision (a) of Section 1037.1 of the Evidence Code shall be provided to those staff and volunteers who do not meet the requirements of paragraph (1) of subdivision (a) of Section 1037.1 of the Evidence Code. (i) Notwithstanding subdivision (h), a shelter for victims of domestic violence that received funding pursuant to this section in the previous grant cycle shall be funded upon reapplication, unless its past performance history fails to meet the requirements in paragraph (2) of subdivision (h). (j) The California Emergency Management Agency may hire the support staff and utilize all resources necessary to carry out the purposes of this section. The agency shall not utilize more than 10 percent of any funds appropriated for the purpose of the program established by this section for the administration of this program.


Part 3. Family Planning

Ca Codes (hsc:124300) Health And Safety Code Section 124300



124300. Within any county where 10 percent or more of the population, as determined by the Population Research Unit of the Department of Finance, speaks any one language other than English as its native language, every local health department shall make copies of circulars and pamphlets relating to family planning that are made available to the public also available in the other language. The department, upon request, shall make a translation available in other than English those family planning informational materials normally distributed to the general public.


Part 4. Primary Health Care

Chapter 1. General Provisions

Ca Codes (hsc:124400-124440) Health And Safety Code Section 124400-124440



124400. (a) The Legislature makes the following findings and declarations: (1) There is a maldistribution of health services in California resulting in underserved rural and urban areas and underserved population groups. (2) Most rural areas of the state do not have adequate health services because there are insufficient personnel and facilities to provide the services. The lack of adequate services has a negative impact on the health and safety of the public. (3) In many urban areas of the state there are inadequate health services for low-income populations. Financial barriers create access problems. These barriers to health services have a negative impact on the health and safety of these groups and the public. (4) Population groups, such as American Indians and seasonal agricultural and migratory workers, lack access to adequate and appropriate health services. The lack of adequate services has a negative impact on the health and safety of these groups and the public. (5) State assistance will be needed to assure financial stability of primary care resources for these specified population groups. (b) It is therefore the intent of the Legislature that the state develop an overall strategy to ensure the maintenance of adequate primary health care resources for special population groups.


124405. (a) The department shall develop a statewide plan for health services for special population groups identified pursuant to subdivision (b) of Section 124425 by January 1, 1985, and shall evaluate and update the plan every two years. The plan shall include, but not be limited to, an assessment of resources, an assessment of unmet needs, an evaluation of prior years program goals and objectives, and a two-year action plan for at least the following program areas: (1) Health of seasonal agricultural and migratory workers and their families. (2) American Indian health services. (3) Rural health services. (4) California health services corps. (5) Grants-in-aid to clinics. (b) The plan shall describe the types, locations, and effectiveness of the programs specified in paragraphs (1) to (5), inclusive, and contain an assessment of resources needed to maintain the plan consistent with the Primary Care Services Act (Section 27). (c) The plan may be a consolidation of individual program reports due to the Legislature during the year the plan is updated. The plan may also be integrated with other plans the department is required to develop concerning maternal and child health programs and services for special population groups. (d) The statewide plan shall be initially developed in consultation with the Primary Care Clinics Advisory Committee and the California Conference of Local Health Officers and biannually updated as provided in this section in consultation with individuals and groups representing special populations and areas, with local governments, and with the office.


124410. Notwithstanding any other provision of law, the department may, if requested by the nonprofit or public agency and to the extent funds are available, provide for advance payments for services to be performed under any agreement entered into pursuant to the Primary Care Services Act (Section 27) and that is otherwise in compliance with the requirements contained in Section 100350. Individual advance payments made to any nonprofit or public agency that requests those payments shall be made in a timely fashion and shall not exceed 25 percent of the total amount of the grant award.


124415. Notwithstanding any other provision of law, the department may, in addition to the advance payment under Section 124410, provide for prospective payments for services to be performed under any agreement entered into pursuant to the Primary Care Services Act (Section 27). These prospective payments may be provided each month to a contracting agency on one of the following bases: (a) One-twelfth of the total funding award each month. (b) One-twelfth of 75 percent of the funding award, if a 25 percent advance payment is also provided. Prospective payments may be made to those nonprofit or public agencies that request prospective payments and may be adjusted if necessary during the project period after the submission and review of required program reports.

124420. Each agreement for a project shall require the contracting agency to seek third-party reimbursements, including Medi-Cal and private insurance, for any person served under the agreement and shall require that the reimbursements be used for purposes consistent with the Primary Care Services Act (Section 27). Each agreement may require the contracting agency to provide reports to the department on reimbursements.


124425. (a) It is the intent of the Legislature that funds authorized by the Primary Care Services Act (Section 27) be provided to organizations and agencies that are located in underserved areas or that are serving population groups identified pursuant to subdivision (b). (b) Every two years the director shall develop a list of underserved rural and urban areas and underserved population groups. The director shall take into consideration the list of urban and rural areas designated as medically underserved by the California Healthcare Workforce Policy Commission and by the office and federal medically underserved areas and population groups designated by federal agencies. (c) The director shall develop the list of underserved rural and urban areas and underserved population groups, set forth in subdivision (b), after consulting and receiving written recommendations from the Primary Care Clinics Advisory Committee and after consulting with appropriate groups and individuals, including individuals representing underserved populations and local government.


124430. (a) It is the intent of the Legislature that programs in the Primary Care Services Act (Section 27) be funded annually through the budgetary process. (b) In administering funds pursuant to the Primary Care Services Act (Section 27), the department shall use the funds only for the purpose of funding grants specifically authorized by that act. (c) No local assistance funds may be used for state administration purposes under the Primary Care Services Act (Section 27).


124435. An applicant for funds pursuant to the Primary Care Services Act (Section 27) shall transmit a copy of an application to any person who makes a written request therefor at the same time that the application is transmitted to the state.


124440. The department may enter into agreements with any clinic that is licensed under subdivision (a) of Section 1204 or exempt from licensure under subdivision (c) of Section 1206, and which requests the agreements, for up to three consecutive years. The contracts shall be limited to the provision of health services to persons authorized to receive health services under the programs specified in the Primary Care Services Act (Section 27). The department shall retain the right to terminate contracts under the general provisions of the contract language prior to the three years for failure to comply with the performance terms and conditions set forth in the contracts. The multiple-year contracts shall be modified to reflect any cost-of-living adjustments that are provided to the programs specified in this section, provided the cost-of-living adjustments are granted pursuant to the Budget Act. The contracts may also be amended to reflect changes in the base budget amount, scope of work, and other contract language changes as necessary. Nothing shall prohibit the department from establishing a three-year budget and annually amending the contract to change the budget amount, scope of work, and other contract language changes as necessary. Nothing shall prohibit the contract from being modified based on the mutual consent of the contractor and the department. Advance payments in the original contract and in each one-year extension are permitted, but shall not exceed 25 percent of the funds provided for each fiscal year. On or before January 1, 1990, the department at any time shall report to the Legislative Analyst as to the personnel-year and General Fund savings that have been associated with this authority.


Chapter 1.5. Clinic Services

Ca Codes (hsc:124450) Health And Safety Code Section 124450



124450. (a) In any emergency or disaster, as declared by the Governor, clinics funded under the seasonal agricultural and migratory workers program provided for by Chapter 3 (commencing with Section 124550), the rural health services development program provided for by Chapter 5 (commencing with Section 124600) or the expanded access to primary care program provided for by Article 2 (commencing with Section 124900) of Chapter 7 shall provide nonelective, primary health care services, utilizing a sliding-fee scale based on income, including a zero payment option, to all persons who are impacted by the emergency or disaster and who present themselves for treatment at the clinic. (b) The department shall deny or recoup payment under Chapter 3 (commencing with Section 124550), Chapter 5 (commencing with Section 124600), and Article 2 (commencing with Section 124900) of Chapter 7, assess civil penalties, revoke or suspend the license of the clinic pursuant to Section 1229, or impose other sanctions or other penalties authorized by law, when the clinic charges patients for care and fails to utilize a sliding-fee scale based on income, including a zero-payment option, to determine the fees to be charged to any patient pursuant to subdivision (a). (c) To the extent that the department enters into contracts or renews contracts with clinics identified in subdivision (b) on or after the effective date of this section, those contracts shall require clinics to utilize a sliding-fee scale based on income, including a zero-payment option, when determining fees to be assessed for patients.


Chapter 2. Primary Clinic Revolving Fund

Article 1. General Provisions

Ca Codes (hsc:124475-124485) Health And Safety Code Section 124475-124485



124475. The Legislature finds and declares all of the following: (a) Clinics are valuable partners in the state's efforts to improve access to health services. (b) Clinics have an established record of providing quality health services to medically uninsured persons at a reasonable cost. (c) Clinics are experienced in serving the culturally diverse populations of this state and have developed comprehensive health services packages that meet special population needs. (d) Clinics are major partners with all levels of government as contractors and grantees in programs that serve the poor, low income, minorities, and other target populations with special needs in both urban and rural areas of California. (e) The state's grant and contract approval process are so complicated and time consuming that clinics are faced annually with severe cash-flow problems. (f) The length of time required for the state to process and execute payment of claims submitted by clinics, creates severe cash-flow problems for the clinics. (g) Clinics often have no choice but to borrow funds to cover operations pending receipt of state funds and the resulting interest payments reduce the amount of funds available for direct services to the needy population. (h) Therefore, it is the intent of the Legislature that preliminary advance payment authority be established for the department in order to alleviate clinics' cash-flow problems to the extent possible. (i) It is the intent of the Legislature that a clinic revolving fund be established within the department to expedite the payment process and thereby alleviate the cash-flow problems of clinics.


124480. As used in this chapter, "clinic" means a primary care clinic as defined in Section 1200.


124485. (a) The department shall prepare and transmit to the Legislature a report of the department's activities relating to the utilization of clinics to provide comprehensive health services pursuant to the following programs: (1) Health of seasonal agricultural and migratory workers and their families program. (2) American Indian health services program. (3) Rural health services program. (4) Grants-in-aid to clinic program. (5) California health services corps program. (b) A report shall be transmitted to the Legislature by July 1, 1992, and by July 1 of every fourth year thereafter. (c) The report shall also include any grant funds expended and the resources allocated to the programs by the department, including staff, travel, and support services. (d) The report shall reflect activities, resources, and expenditures by fiscal year.


Article 2. The Clinic Revolving Fund

Ca Codes (hsc:124500-124515) Health And Safety Code Section 124500-124515



124500. The Clinic Revolving Fund of the department is hereby established for the purpose of expediting preliminary advance payments as authorized pursuant to Article 3 (commencing with Section 124525) and to reimburse clinics that are grantees or contractors for services rendered under grants or contracts issued pursuant to this part.


124505. (a) Notwithstanding Section 16400 of the Government Code or any other provision of law, the department may, to the extent local assistance appropriations are made by the Legislature for programs set forth in this part, without at the time furnishing vouchers or itemized statements, draw up to 50 percent of the funds appropriated for the purposes of the Clinic Revolving Fund, for purposes of preliminary advance payments pursuant to Article 3 (commencing with Section 124525). (b) The purpose of the Clinic Revolving Fund does not include expenses related to departmental administrative expenses, departmental travel expenses, departmental travel expense advances, or other departmental administrative costs.


124510. In lieu of actually withdrawing revolving fund moneys from the State Treasury, the Controller, upon the request of the department, shall apply and credit the amount of the Clinic Revolving Fund, or any portion thereof, as repayment and return of any existing funds in the revolving fund to the appropriation for which it was drawn by the department.


124515. The department shall remain fully accountable for the Clinic Revolving Fund. All disbursements shall be substantiated by vouchers filed with the Controller. Disbursements may be reported, substantiated by vouchers, from time to time to the Controller in connection with claims for reimbursements of the revolving fund. At any time, upon the demand of the Department of Finance or the Controller, the revolving fund shall be accounted for and substantiated by vouchers and itemized statements submitted to the Controller.


Article 3. Preliminary Advance Payments

Ca Codes (hsc:124525) Health And Safety Code Section 124525



124525. Notwithstanding any provision of law to the contrary, the department may, to the extent funds are available, provide for advance payments for services to be performed under pending grant agreements or contracts with clinics pursuant to the Primary Care Services Act (Section 27), at the time that the notice of award is issued if all of the following conditions are met: (a) The request for application or the request for proposals contains the terms and conditions under which advance payment may be received pursuant to this section. (b) That the total amount of the advance shall not exceed 25 percent of the amount of the proposed award, including any advance payments provided under authority of any other provision of law. (c) That the terms and conditions of the request for application or the request for proposal, specifies that the grantee shall repay the full amount of the advance if the grant or the contract is not finally approved. (d) That the department has evaluated the financial stability of the clinic and found it to be reasonably financially sound. (e) That advance payments be made only to those nonprofit agencies that request an advance in writing. (f) That the application or proposal contains the terms and conditions set forth in the request for application or the request for proposal. (g) That the application or proposal is signed by an authorized person representing the clinic.


Chapter 3. Health Of Seasonal Agricultural And Migratory Workers

Ca Codes (hsc:124550-124570) Health And Safety Code Section 124550-124570



124550. The department shall maintain a program for seasonal agricultural and migratory workers and their families, consisting of all of the following: (a) Studies of the health and health services for seasonal agricultural and migratory workers and their families throughout the state. (b) Technical and financial assistance to local agencies concerned with the health of seasonal agricultural and migratory workers and their families. (c) Coordination with similar programs of the federal government, other states, and voluntary agencies.

124555. (a) (1) It is the intent of the Legislature that funds distributed under this section promote stability for participating clinics, as a part of the state's health care safety net, and at the same time be distributed in a manner that best promotes access to health care to seasonal agricultural and migratory workers and their families. (2) The department shall grant funds, for a minimum of three years per grant, retroactive to funds appropriated in the Budget Act of 2002 (Chapter 379 of the Statutes of 2002), to eligible, private, nonprofit, community-based primary care clinics for the purpose of establishing and maintaining a health services program for seasonal agricultural and migratory workers and their families. The department may continue to pay any grantee whose grant expired on June 30, 2003, until June 30, 2004, as if the grant had been extended, provided that funds are appropriated for this purpose in the Budget Act of 2003 and the grantee agrees in writing to expend the money as if the grant had been extended. (b) In order to be eligible to receive funds under this program, a clinic shall, at a minimum, meet all of the following conditions: (1) The clinic shall be licensed under either paragraph (1) or (2) of subdivision (a) of Section 1204. (2) The clinic's patient population shall include at least 25 percent farmworkers and their dependents. (3) The clinic shall operate in a medically underserved area, including a Health Professional Shortage Area, or serve a medically underserved population, as designated by the United States Department of Health and Human Services, or shall be able to demonstrate that at least 50 percent of its patients are persons with incomes at or below 200 percent of the federal poverty level. (c) The department shall seek input from stakeholders in designing the methodology for distribution of funds under this section.


124560. (a) The Seasonal Agricultural and Migratory Workers Advisory Committee is hereby established in the State Department of Health Services. (b) The committee shall advise the department on the level of resources, priorities, criteria, and guidelines necessary to implement this chapter pertaining to the health of seasonal and migratory agricultural workers. (c) The committee shall be composed of 11 members, appointed by the Director of Health Services, who are knowledgeable concerning the health care needs of seasonal and migratory farm workers and their families. Committee members shall serve two-year terms. Two members shall be nominated by the Speaker of the Assembly, and two by the Senate Committee on Rules. The members of the committee shall be selected from the following categories of persons: (1) Seasonal and migratory farm workers and their families. (2) Health care providers from nonprofit community health centers that have a documented history of serving seasonal and migratory agricultural workers. (3) Health care professionals. (4) Private citizens with documented experience in serving the seasonal agricultural and migratory worker population.


124570. (a) Notwithstanding any other provision of law, the department shall, to the extent that funds are available, provide to a grantee semiannual prospective payments during a 12-month fiscal year. (b) An amount equal to not more than 50 percent of the total grant shall be processed for payment to the grantee following the enactment of the annual Budget Act, and upon formal execution of the grant by the state. The processing by the department of the grantee's first semiannual prospective payment shall also be contingent upon both of the following: (1) A written request for payment from the grantee. (2) Except as provided in this paragraph, the third quarter progress budget and expenditure report. If the grantee is currently under the first fiscal year of a three-year multiple grant, this requirement shall not apply as a condition for the grantee's first semiannual prospective payment, unless the grantee is a continuing grantee from the prior three-year multiple year of the grant. If the grantee is currently under the second or third fiscal year of a three-year, multiple-year grant, the department's processing of the first semiannual prospective payment for the current grant year shall be contingent upon the grantee's timely and accurate submission, and the department's approval of, the third quarter progress and budget expenditure report from the previous grant year. (c) Based upon the grantee's timely and accurate submission of the first quarterly progress and budget expenditure report from the grant year, and satisfactory performance under the grant, the processing of a second semiannual prospective payment of not more than 40 percent of the total grant shall be processed by the department for payment to a grantee no earlier than January 1 during the term of the grant year. The processing of the grantee's second semiannual prospective payment by the department shall be contingent upon all of the following: (1) A written request for payment from the grantee. (2) The grantee's timely and accurate submission, and the department's approval, of the first quarterly progress and budget expenditure report. (3) If the grantee is currently under the second or third fiscal year of a three-year, multiple-year grant, the grantee's timely and accurate submission, and the department's approval, of the fourth quarterly progress and budget expenditure report, and the annual reconciliation report, from the prior year. (d) An amount equal to 10 percent of the total grant award shall be retained by the department, pending satisfactory submission by the grantee of all quarterly progress and budget expenditure reports and an annual reconciliation report for the grant year. Payment of the withheld 10 percent shall be processed by the department for payment to the grantee upon the grantee's satisfactory completion and submission, and the department's approval, of these reports.


Chapter 4. American Indian Health Services

Ca Codes (hsc:124575-124595) Health And Safety Code Section 124575-124595



124575. The department shall maintain a program for American Indians and their families, consisting of all of the following: (a) Studies of the health and health services available to American Indians and their families throughout the state. (b) Technical and financial assistance to local agencies concerned with the health of American Indians and their families. (c) Coordination with similar programs of the federal government, other states, and voluntary agencies.

124580. The department shall cooperate with local governmental agencies and contract with voluntary nonprofit organizations in connection with the development of local health programs for American Indians and their families.

124585. (a) All moneys appropriated to the department for the purposes of this chapter shall be used to provide financial, training, and technical assistance to urban and rural American Indian health programs and to assist these programs in planning, implementing, and upgrading programs to attain a comprehensive health services delivery system for American Indians in urban and rural areas. (b) The department shall provide technical assistance and shall promote the provision of services for preventive health care, health education, and environmental health. (c) The department may expend funds, appropriated to it to carry out the purposes of this chapter, by contract or grant, or any combination thereof, to assist any urban or rural American Indian health program. (d) The department shall adopt regulations establishing criteria for reimbursement for direct services under this chapter, that shall include, but not be limited to, a definition of direct services that are reimbursable and a formula for allocation of funds appropriated to the department. (e) The department shall provide assistance to American Indian health services programs in maximizing utilization of third party payment systems and in developing programs in health education, nutrition, and family planning, if the assistance is not being provided by agencies of the federal government. (f) Funds appropriated to carry out the purposes of this chapter shall be supplemental to those available from the federal government and shall not duplicate, and they shall not replace, any commitments made by the federal government to provide health services to American Indians and their families in this state who receive health services pursuant to an urban or rural American Indian health program. (g) It is the intent of the Legislature that the program established by this chapter shall, commencing with the 1984-85 fiscal year, be funded according to customary budget procedures.


124586. (a) Notwithstanding any other provision of law, the department shall, to the extent that funds are available, provide to a grantee under this chapter semiannual prospective payments, as specified in this section, during a 12-month fiscal year. (b) The first semiannual prospective payment, in an amount equal to not more than 50 percent of the total grant, shall be processed for payment to the grantee following the enactment of the annual Budget Act, and upon formal execution of the grant by the state and shall be contingent upon both of the following: (1) A written request for payment from the grantee. (2) The grantee's timely and accurate submission, and the department's approval, of the progress reports required under the grant, budget expenditure report, and annual reconciliation report, from the prior year. (c) Based upon the grantee's timely and accurate submission of the progress reports and budget expenditure reports from the grant year, and satisfactory performance under the grant, the processing of a second semiannual prospective payment of not more than 40 percent of the total grant shall be processed by the department for payment to a grantee no earlier than January 1 during the term of the grant year. The processing of the grantee's second semiannual prospective payment by the department shall be contingent upon both of the following: (1) A written request for payment from the grantee. (2) The grantee's timely and accurate submission, and the department's approval, of progress reports and budget expenditure reports. (d) Any remaining amount, which shall be at least 10 percent of the total grant award, shall be retained by the department, pending satisfactory submission by the grantee of all progress reports required by the grant, budget expenditure reports, and an annual reconciliation report for the grant year. Payment of the withheld amount shall be processed by the department for payment to the grantee contingent upon both of the following: (1) A written request for payment from the grantee. (2) The grantee's timely and accurate submission, and the department's approval, of all progress reports required under the grant, budget expenditure reports from the grant year, the annual reconciliation report for the grant year, and satisfactory performance under the grant.


124590. The Legislature finds and declares that the health status of many American Indians in California is not adequate. It is, therefore, the intent of the Legislature to insure that in addition to funding provided pursuant to the American Indian Health Service program, sufficient funding is provided to American Indians from other programs in order to substantially improve their access to health services. These programs include, but are not limited to, the following: (a) Rural health services. (b) Mental health services. (c) Developmental disability programs. (d) Maternal and child health programs. (e) Alcoholism programs. (f) Programs for the aging. (g) Environmental health programs. The department shall report to the Legislature by July 1, 1984, and every two years thereafter, with respect to the extent to that funding for these programs is allocated to grantees receiving funding from the department pursuant to Section 124585.


124595. (a) The Indian Health Policy Panel, established by the director pursuant to Section 1520 of Title 17 of the California Administrative Code, is continued in existence and shall be renamed the American Indian Health Policy Panel. The policy panel shall advise the State Department of Health Care Services and the State Department of Public Health on the level of resources, priorities, criteria, and guidelines necessary to implement this chapter. The policy panel shall be composed of 10 members, appointed by the director. Four members shall be appointed from a list of persons submitted by the California Rural Indian Health Board, four members shall be appointed from a list of persons submitted by the California Consortium for Urban Indian Health, and two members shall represent the public. The persons appointed by the director to represent the public may be consumers, consumer advocates, health service providers, representatives of state or county health agencies, health professionals, or private citizens. The terms of the members shall be established pursuant to bylaws adopted by the policy panel. (b) The director may also seek advice from individuals and groups, other than the policy panel, on program issues. (c) Those persons who are members of the policy panel on December 31, 1983, shall continue to be members for the remainder of their terms and, upon expiration of their terms, shall be eligible for reappointment by the director.


Chapter 5. Rural Health Services Development

Article 1. Legislative Intent And General Provisions

Ca Codes (hsc:124600-124625) Health And Safety Code Section 124600-124625



124600. The Legislature makes the following findings and declarations: (a) There is a maldistribution of health services in California. Most rural areas of the state do not have adequate health services because there are insufficient health personnel and facilities and inadequate transportation to such services. (b) The lack of health services in rural areas has a negative impact on the health and safety of the public. (c) Existing public programs to meet the problem of inadequate health services in rural areas are not sufficient in scope or properly coordinated to significantly improve the availability of health services. (d) It is unlikely that the situation will improve without substantial state and local action. It is, therefore, the intent of the Legislature in enacting this chapter to establish a program of rural health services in the department. The purpose of the program is to improve the coordination of rural health services and to increase the amount and availability of the services. The Legislature intends that the program consist of all the following: (1) The California Health Services Corps in which health personnel are assigned to health care delivery organizations. (2) Health services development projects, in which new health care delivery organizations are established. (3) An organizational unit within the department to coordinate rural health programs.

124605. The department shall implement a program to remedy deficiencies in health services in rural areas. The department shall have responsibility for the following elements: (a) California Health Services Corps. (b) California Rural Health Services Development Projects. (c) Coordination of Rural Health Programs.


124610. The director shall administer this chapter and shall adopt any regulations and standards as are necessary to implement this chapter.

124615. No services provided under this chapter shall substitute for current services and obligations of a county including those required by state law.

124620. Funds expended pursuant to this chapter shall be supplemental to those made available by the federal government for the National Health Services Corps and shall not duplicate, or replace, but may supplement and complement, any commitments made by the federal government to provide health personnel as needed.


124625. (a) It is the intent of the Legislature that the Rural Health Services Development Program be funded annually through the budgetary process. (b) Notwithstanding any other provision of law, the department may, to the extent funds are available, provide for advance payments for services to be performed under any contract entered into pursuant to this chapter with any small community based public or private nonprofit agency with modest reserves and potential cash flow problems, where the department determines that such advance payments will further the purposes of this chapter. Advance payments shall not be made more than once a year.


Article 2. California Health Services Corps

Ca Codes (hsc:124650-124685) Health And Safety Code Section 124650-124685



124650. The director shall establish in the department, a California Health Services Corps. The purpose of the corps is to make available health personnel to rural areas that are presently receiving inadequate health services. The corps shall consist of physicians and surgeons, podiatrists, dentists, vision care providers, and other health professionals, such as nurse practitioners, physician assistants, nurses, dental hygienists, dental assistants, health educators, nutritionists, dietitians, health and nutrition aides, and other personnel as the director finds necessary to meet the purposes of the program.


124655. Members of the California Health Services Corps may be assigned to the following categories of health services programs: (a) Any nonprofit primary care clinic or licensed health facility. (b) Any health provider or group provider. (c) Any county health program or facility. (d) Any state health program or facility. (e) Any federal health program. Assignments may be made to a health provider or facility, to a health services development project established pursuant to Article 3 (commencing with Section 124700), or directly to an area in California where health services are inadequate.


124660. Assignments shall be made in accordance with the following: (a) The authority of any person to supervise any member of the corps shall be subject to approval by the director. (b) No member of the corps shall be placed in an assignment without the prior agreement of the person or governing board in charge of the health delivery program to which the corps member is assigned. (c) Corps members directly assigned to rural areas or to state-operated projects shall be contract employees of the California Health Services Corps. Corps members assigned to projects with a nonstate provider or facility may be employees of the provider or facility if specified by contract between the state and the provider or facility. The state shall provide malpractice insurance coverage for all corps personnel. (d) Local consumers shall be consulted in the placement of California Health Services Corps members. (e) In making the assignment of a corps member, the director shall seek to match the characteristics and preferences of the member with those of the area, population group, or medical facility where the member may be assigned to the maximum extent possible in order to increase the probability of the member remaining to serve the area, population group, or medical facility upon completion of his or her assignment period.

124665. The director shall, by regulation, specify the salary schedules, other terms and conditions of employment, and reimbursement policies with respect to the employment of corps members that shall be followed by institutions, providers, or programs where a member of the California Health Services Corps is assigned.


124670. Funds expended pursuant to this article may be used for any of the following purposes: (a) Expenses of the department in administering the program. (b) Salaries and employee benefits for members of the California Health Services Corps. (c) Supplies, equipment, minor capital outlay, and minor renovations.


124675. Assignments shall be made by the department without regard to ability of residents in areas to pay. Any provider or facility where a California Health Services Corps member is assigned, and any corps member, shall be required to seek third party reimbursements, including Medi-Cal and private insurance, for any person served by the corps member. Any such corps member, provider, or facility may be required to provide reports to the department concerning reimbursements and may be required to contribute all or part of the proceeds of reimbursements to the department for deposit in the State Treasury in accordance with regulations or contracts adopted by the department after regulations have been approved by the Director of Finance.


124680. No corps member may refuse needed service to any person because of inability to pay for such service, or refuse service to persons on account of their entitlement to medical benefits under Title XVIII or XIX of the United States Social Security Act.


124685. The director may, upon request, provide technical assistance to groups preparing applications for assignment of corps personnel.


Article 3. Health Services And Development Projects

Ca Codes (hsc:124700-124745) Health And Safety Code Section 124700-124745



124700. The department shall plan and put into operation a number of health services development projects. The purpose of the projects shall be to demonstrate effective ways of providing health care services in underserved rural health areas. The director shall make the final decision on approval of a project.


124705. Applications may be made for funds for health services development projects and the projects may be initiated and operated by any agency, including, but not limited to, the following: (a) A community agency, including a National Health Services Corps site. (b) An ongoing rural health program, including migrant health or American Indian health program. (c) A family practice education program. (d) A county health department. (e) The department. (f) Any health facility or licensed nonprofit primary care clinic.


124710. (a) (1) It is the intent of the Legislature that funds distributed under this section promote stability for participating clinics, as a part of the state's health care safety net, and at the same time be distributed in a manner that best promotes access to health care to geographically isolated populations. (2) The department shall grant funds, for a minimum of three years per grant, retroactive to funds appropriated in the Budget Act of 2002 (Chapter 379 of the Statutes of 2002), to eligible, private, nonprofit, community-based primary care clinics for the purpose of establishing and maintaining rural health services and development projects as specified under this article. The department may continue to pay any grantee whose grant expired on June 30, 2003, until June 30, 2004, as if the grant had been extended, provided that funds are appropriated for this purpose in the Budget Act of 2003 and the grantee agrees in writing to expend the money as if the grant had been extended. (b) In order to be eligible to receive funds under this program, a clinic shall, at a minimum, meet all of the following conditions: (1) The clinic shall be licensed under paragraph (1) or (2) of subdivision (a) of Section 1204. (2) The clinic shall operate in a "rural" Medical Study Service Area, as defined by the Health Manpower Commission. (3) The clinic shall operate in a medically underserved area, including a Health Professional Shortage Area, or serve a medically underserved population, as designated by the United States Department of Health and Human Services, or shall be able to demonstrate that at least 50 percent of its patients are persons with incomes at or below 200 percent of the federal poverty level. (c) The department shall seek input from stakeholders in designing the methodology for distribution of funds under this section. (d) If the funds that are available for purposes of this section for any fiscal year are greater than funds that were available for the prior fiscal year, the department shall establish a base funding level that is applicable to all sites funded in the prior fiscal year. To the extent that funds are available, the base funding level shall not be less than seventy-five thousand dollars ($75,000) for each site. To implement this section, the department shall not be required to reduce funding for clinics that are above the minimum awards.


124715. The department may assist community agencies to develop grant proposals.


124720. Project proposals shall be considered that address the health needs of rural populations, including, but not limited to, migratory and other agricultural workers, American Indians, and senior citizens, who have insufficient access to adequate levels of health care services due to geographical isolation or economic factors. Projects that are approved shall accomplish one or more of the following: (a) Provide primary health care, including preventive health services and diagnostic, treatment, referral, and followup services. (b) Provide comprehensive health care, including specialized physician services, inpatient and outpatient facilities, laboratory and X-ray services, home health services, and other specialized services. (c) Provide emergency medical services designed to meet the special problems of rural isolation. (d) Provide transportation appropriate to achieving the goal of making health care services available to residents of rural areas. (e) Provide electronic communication technology to improve health care delivery and emergency health services in the designated rural areas. (f) Establish regional health systems, including linkage with both rural and urban health programs and facilities. (g) Improve the quality of medical care and the administrative capabilities of agencies and management systems in rural areas. (h) Provide health education programs in the designated rural areas, including health and nutrition education, and continuing education for health professionals. (i) Promote nurse practitioner and physician assistants programs and other programs for training and placement of health professionals in the designated areas to respond to rural manpower shortages.


124725. Project funding shall be for up to three years. Continuation of funding for a project shall depend on progress toward achieving the goals of the project. The director shall make the final decision to continue or discontinue a project. In evaluating the success of a project, the director shall take into account the number of additional persons who are receiving quality health care as a result of the operation of the project and the improvement in health status of the population served by the project.


124730. Each applicant shall form an advisory committee for the project. The advisory committee shall participate in all of the following: (a) Planning the project. (b) Reviewing the progress of the project. (c) Proposing changes in the project. (d) Planning for the continuation of the project after the grant period through self-sufficiency. At least one-half of the members of the advisory committee shall be consumers, as defined by Public Law 93-641. The advisory committee shall include, where feasible, representatives of the health service agencies, the Seasonal Agricultural and Migratory Workers Advisory Committee, the American Indian Health Policy Panel, consumers selected from rural target populations, such as American Indians, senior citizens, Medi-Cal recipients, isolated rural residents, and agricultural and forestry workers, providers from rural areas, and persons with knowledge of rural areas from educational institutions, and state, county, and federal agencies.


124735. Each grant for a project shall require the grantee agency to seek third-party reimbursements, including Medi-Cal and private insurance, for any person served under the grant. Each grant shall require the grantee agency to provide reports to the department on reimbursements and may require the grantee agencies to contribute all or part of the proceeds of reimbursements to the department for deposit in the State Treasury in accordance with regulations to be adopted by the department after the regulations are approved by the Director of Finance.

124740. State-operated projects shall be established only in accordance with all of the following: (a) The health of the population in a rural area would be substantially improved by the establishment of a project. (b) There exists no local public or nonprofit agency willing and able to undertake the project. (c) The project contains two or more of the elements specified in Section 124720. A project may employ staff, and may purchase, rent, or lease supplies and equipment where required. A project may also rent or lease land and buildings where required.


124745. (a) Notwithstanding any other provision of law, the department shall, to the extent that funds are available, provide to a grantee semiannual prospective payments during a 12-month fiscal year. (b) An amount equal to not more than 50 percent of the total grant shall be processed for payment to the grantee following the enactment of the annual Budget Act, and upon formal execution of the grant by the state. The processing by the department of the grantee's first semiannual prospective payment shall also be contingent upon both of the following: (1) A written request for payment from the grantee. (2) Except as provided in this paragraph, the third quarter progress budget and expenditure report. If the grantee is currently under the first fiscal year of a three-year multiple grant, this requirement shall not apply as a condition for the grantee's first semiannual prospective payment. If the grantee is currently under the second or third fiscal year of a three-year, multiple-year grant, the department's processing of the first semiannual prospective payment for the current grant year shall be contingent upon the grantee's timely and accurate submission, and the department's approval of, the third quarter progress and budget expenditure report from the previous grant year. (c) Based upon the grantee's timely and accurate submission of the first quarterly progress and budget expenditure report from the grant year, and satisfactory performance under the grant, the processing of a second semiannual prospective payment of not more than 40 percent of the total grant shall be processed by the department for payment to a grantee no earlier than January 1 during the term of the grant year. The processing of the grantee's second semiannual prospective payment by the department shall be contingent upon all of the following: (1) A written request for payment from the grantee. (2) The grantee's timely and accurate submission, and the department's approval, of the first quarterly progress and budget expenditure report. (3) If the grantee is currently under the second or third fiscal year of a three-year, multiple-year grant, the grantee's timely and accurate submission, and the department's approval, of the fourth quarterly progress and budget expenditure report, and the annual reconciliation report, from the prior year. (d) An amount equal to 10 percent of the total grant award shall be retained by the department, pending satisfactory submission by the grantee of all quarterly progress and budget expenditure reports and an annual reconciliation report for the grant year. Payment of the withheld 10 percent shall be processed by the department for payment to the grantee upon the grantee's satisfactory completion and submission, and the department's approval, of these reports.


Article 4. Coordination Of Rural Health Programs

Ca Codes (hsc:124750-124785) Health And Safety Code Section 124750-124785



124750. The director shall ensure the coordination of state efforts in rural health in order to maximize effective use of scarce medical resources and to coordinate efforts to provide health services through the California Health Services Corps and health services development projects with existing program resources, including, but not limited to, migrant health programs, American Indian health programs, contract county health services programs, the National Health Service Corps, and other related programs administered by the department to ensure minimal duplication and maximum effectiveness.


124760. The California Healthcare Workforce Policy Commission shall establish a plan that integrates family practice residencies and other health sciences education programs established in rural areas pursuant to Article 8 (commencing with Section 31910) of Chapter 5 of Division 5 of Division 22 of the Education Code with the health services provided pursuant to Article 3 (commencing with Section 124700).


124765. The California Healthcare Workforce Policy Commission, in coordination with the Rural Health Section of the department, shall designate the geographical rural areas within California where unmet priority need for medical services exists.


124770. The director shall utilize the authority to establish health manpower pilot projects pursuant to Article 1 (commencing with Section 128125) of Chapter 3 of Part 3 of Division 107 to develop personnel with special health and medical skills that may effectively advance the objectives of the Primary Care Services Act (Section 27).


124775. Each proposal for health corps personnel or project application under Article 3 (commencing with Section 124700) shall be submitted to the appropriate county health officer or district health officer for review and recommendation. The review and recommendation shall be completed within 30 days of receipt. Any recommendations made shall be based upon the Health Systems Plan and Annual Implementation Plan as required for that area by Public Law 93-641.

124780. If the director decides to act contrary to the recommendation of a county or district health officer made pursuant to Section 124775, the director shall explain his or her action in writing to the appropriate board of supervisors.


124785. Nothing in the Primary Care Services Act (Section 27) shall affect the operation of local public health services contracted for by the department with other agencies pursuant to former Section 1157.


Chapter 6. Small And Rural Hospitals

Ca Codes (hsc:124800-124870) Health And Safety Code Section 124800-124870



124800. The Legislature finds and declares all of the following: (a) Rural hospitals serve as the "hub of health," and through that role attract and retain in their communities physicians, nurses, and other primary care providers. Because of economies of scale compounded by reimbursement reforms, many rural hospitals will close before the end of this decade. This will result in the departure of primary care providers and the loss of emergency medical services both to residents and persons traveling through the area. The smallest and most remote facilities are at highest risk. (b) The rural hospital is often one of the largest employers in the community. The closure of such a hospital means the loss of a source of employment. This has an economic impact beyond the health sector. Further, economic development of a rural area is, in part, tied to the existence of a hospital. People, for example, tend not to retire to areas where there is not reasonable access to physician and hospital-based services. (c) Rural hospitals, especially the smaller facilities, lack access to the sophisticated expertise necessary to deal with current reimbursement regulations and the associated bureaucracy. (d) Most rural hospitals are unable to participate in programs that provide access to short- and long-term financing due to lender requirements for credit enhancement. (e) Because of economies of scale compounded by regulations under Title 22 of the California Code of Regulations and other regulations, rural hospitals have high, fixed costs that, in the present reimbursement environment, cannot be offset by revenues generated from serving a relatively small population base. Further, in an economically depressed rural area, community contributions are not sufficient to offset deficits. (f) Rural hospitals are an important link in the Medi-Cal program, and without special consideration that takes into account their unique circumstances, rural hospitals will be unable to continue providing services to Medi-Cal patients. This is especially true for outpatient services that are reimbursed at less than 60 percent of costs. (g) While only a very small percentage of the Medi-Cal budget for inpatient and outpatient services is spent for services rendered by rural hospitals, their participation is essential to preserve the integrity of the entire Medi-Cal program.

124805. (a) The Legislature recognizes the need to strengthen, and in some cases salvage, rural hospitals to ensure that adequate access to services is provided to residents of rural areas as well as tourists and travelers who, at certain times, may outnumber the residents. Further, the Legislature recognizes that this will require a comprehensive approach. Therefore, the Legislature intends that: (1) Expertise be provided to endangered rural hospitals to both of the following: (A) Carry out a strategic assessment of potential business and diversification of service opportunities. (B) Develop a specific plan of action when feasible. (2) Access, when appropriate, be provided to special eligibility programs within the California Health Facilities Financing Authority. (3) Short-term technical assistance be available on fiscal and program matters. (4) The department continue to provide regulatory relief through program flexibility. (5) Inpatient reimbursement limitations be modified so as not to single out rural hospitals for application. (6) Reimbursement rates for outpatient services be set at a level that will provide incentives for rural hospitals to focus on the provision of outpatient services and that will reduce the financial losses incurred by the facilities in providing those services. (b) The Legislature recognizes that for certain rural settings, an acute care hospital as defined in subdivision (a) of Section 1250 may no longer be cost-effective. Therefore, a rural alternative model that preserves the primary and emergency care systems must be identified, studied through demonstration projects, and developed as a new category of health facility. (c) The Legislature recognizes that a rural alternative facility may not conform to what is now depicted in state or federal regulation. Therefore, to identify a model, implement demonstration projects, and establish the rural alternative hospital as a license category of health facility, a cooperative effort will be required between the department, the federal Health Care Financing Administration, and the health care industry. To this end, the Legislature intends that the department inform the federal Health Care Financing Administration of its interest in establishing the rural alternative hospital program and subsequently seek any necessary waivers.

124810. Unless the context otherwise requires, the definitions contained in this article govern the construction of this chapter.


124815. "Department" means the State Department of Health Services.


124820. "High-risk rural hospital," means a hospital as defined in subdivision (a) of Section 124840 that can demonstrate through audited and interim financial reports and projections that it is probable that it will need to cease operations within one year.


124825. The department shall, in consultation with an organization of interest, develop recommendations on the type and scope of technical assistance that needs to be available to small and rural hospitals from within the department. The recommendations of an organization of interest shall be given consideration by the department in development of subsequent budgets.


124830. "Director" means the State Director of Health Services.


124835. "Organizations of interest" means nonprofit organizations that typically represent the interests of hospitals and health systems.

124840. "Small and rural hospital" means an acute care hospital that meets either of the following criteria: (a) Meets the criteria for designation within peer group six or eight, as defined in the report entitled Hospital Peer Grouping for Efficiency Comparison, dated December 20, 1982. (b) Meets the criteria for designation within peer group five or seven and has no more than 76 acute care beds and is located in an incorporated place or census designated place of 15,000 or less population according to the 1980 federal census.


124845. "Strategically located" means a hospital as defined in subdivision (a) of Section 124840 that, by virtue of its location, or the location of a major portion of the hospital's service area, can demonstrate that its existence is essential to provide health services including emergency services and stabilization to the service area and transient populations.


124850. The department shall provide expert technical assistance to strategically located, high-risk rural hospitals to assist the hospitals in carrying out an assessment of potential business and diversification of service opportunities. In providing the technical assistance on business opportunities, the department shall consult with other appropriate agencies. The high-risk rural hospital, in cooperation with the department, may develop a short-term plan of action if, in its opinion, the results of the assessment so indicate. The department, in consultation with an organization of interest, shall do all of the following: (a) Establish a process for identifying strategically located, high-risk rural hospitals and reviewing requests from the hospitals for assistance. (b) Develop a standard format for the strategic assessment. (c) Develop a model action plan. (d) Establish criteria for review of action plans. (e) Request input and assistance from organizations of interest. (f) Make the strategic assessment format and model action plan available to all small and rural hospitals.


124855. Any small and rural hospital may apply to the California Health Facilities Financing Authority for consideration under special eligibility programs if the hospital has successfully completed the assessment and developed an action plan.


124860. (a) The department, after consultation with an organization of interest, shall select two strategically located, high-risk rural hospitals to plan and implement rural alternative hospital demonstration projects. To the extent possible, the department shall choose two demonstration sites, with one site serving an isolated mountainous area where access may be impeded by adverse weather conditions, and one site located in a rural agricultural community. Hospitals shall be selected on the basis of their interest in becoming a demonstration site and on their suitability as model rural alternative hospitals. The demonstration projects shall include, but not be limited to, identification of the following: (1) Appropriate mix and type of services to be provided locally and obtained on referral. (2) Types and numbers of personnel required. (3) Probability of, and the amount of, reimbursement under current regulations. (4) Statutory and regulatory changes necessary to license the facility and maximize reimbursement. (b) In administering the rural alternative hospital demonstration project, the department shall do all of the following: (1) Establish two demonstration sites on or before January 1, 1990, and operate the projects for a period of up to 18 months. (2) Grant exceptions to the licensure requirements for general acute care hospitals that are necessary to serve the purposes of this section when the granting of the exceptions do not jeopardize the health and welfare of patients. (3) Convey to the Federal Health Care Financing Administration its intent to establish the rural alternative hospital demonstration project and seek any necessary appropriate waivers. (4) Consider requests for grant funds made by demonstration site hospitals pursuant to subdivision (a) of Section 1188.86 as meeting criteria for priority funding. (5) Monitor and evaluate demonstration site projects as to the applicability of these models for statewide application. (c) The department, based on interim findings from the demonstration projects, shall do either of the following: (1) Prepare and adopt regulations establishing the rural alternative hospital as a licensed health facility by January 1, 1992. (2) Submit to the Legislature by that date a report detailing why a category of health facility should not be established.


124865. The department shall continue to provide regulatory relief when appropriate through program flexibility for such items as staffing, space, and physical plant requirements.


124870. (a) The department shall adopt regulations that will provide for an increase in reimbursement rates for outpatient services rendered to Medi-Cal patients by small and rural hospitals, as defined in Section 124840, over and above those reimbursement rates specified in Section 51509 of the California Code of Regulations. The amount of this increase shall be governed by the funding allocated for this specific purpose in the Budget Act, or in another specific appropriation measure. (b) The rate adjustment authorized by subdivision (a) shall be allocated to eligible hospitals as follows: (1) A separate percentage increase shall be calculated for minimum floor and nonminimum floor hospitals based on the ratio of each small and rural hospitals' Medi-Cal outpatient payments to the total of all small and rural hospitals' Medi-Cal outpatient payments during the preceding calendar year, as determined by the department. The percentage rate increase for minimum floor hospitals shall be 125 percent of the rate increase percentage calculated for nonminimum floor hospitals. The combined rate increases for minimum floor and nonminimum floor hospitals shall not exceed the funds appropriated for this purpose. (2) For purposes of this section, "minimum floor hospital" means a hospital (A) where Medi-Cal payments for outpatient services during the preceding calendar year were less than 1/2 percent of the total of Medi-Cal payments for outpatient services rendered by all small and rural hospitals during that period and (B) where the total gross patient revenue from all sources during that period was less than ten million dollars ($10,000,000). (3) For purposes of this section, "nonminimum floor hospital" means a hospital (A) where Medi-Cal payments for outpatient services during the preceding calendar year equaled or exceeded 1/2 percent or of the total of Medi-Cal payments for outpatient services rendered by all small and rural hospitals during that period or (B) where the total gross patient revenue from all sources during that period was ten million dollars ($10,000,000) or more. (c) For the purpose of calculating the percentage increase, if any eligible hospital had less than a full year of operation upon which to determine the ratio of Medi-Cal expenditures as defined in paragraph (1) of subdivision (b), the department shall extrapolate the Medi-Cal paid claims expenditures for that hospital to estimate a full year's Medi-Cal claims expenditure. (d) Payment under this section shall be contingent upon submission of approved claims for Medi-Cal outpatient services rendered after January 1, 1989. (e) The Director of Health Services shall adopt emergency regulations pursuant to Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code to implement the rate adjustments required under this section. The adoption of these regulations shall be deemed an emergency and necessary for the immediate preservation of the public peace, health, or safety. Notwithstanding any provision of Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, emergency regulations adopted by the department to implement the rate adjustments required under this section shall not be subject to any review, approval, or disapproval by the Office of Administrative Law at any stage of the rulemaking process. These regulations shall become effective immediately upon their filing with the Secretary of State. (f) Notwithstanding any other provision of law, reimbursement rates adopted pursuant to this section shall not exceed the hospital' s usual and customary charges for services rendered. (g) The department shall maximize federal financial participation in implementing this section. (h) This section shall become operative July 1, 1989.


Chapter 7. Grants In Aid For Clinics

Article 1. Clinics

Ca Codes (hsc:124875-124890) Health And Safety Code Section 124875-124890



124875. The Legislature finds and declares that: (a) In California there are approximately 300 community clinics and free clinics that provide primary health care at low cost for a significant portion of the medically underserved population. (b) These clinics account for more than 3,000,000 patient visits annually. (c) Increasingly large caseloads, the debilitating effects of inflation on purchased goods and services, and a lack of financial resources are forcing many community and free clinics to curtail services needed in their communities. (d) Recognizing the contribution of community and free clinics to the health care of Californians and the contribution of the clinics to lowering the costs of health care, it is in the interest of the people of this state to ensure continuation of clinic programs by providing necessary funding.


124880. The department shall conduct a program of grants-in-aid for the following purposes: (a) To assist in stabilizing the health care operations of community clinics and free clinics that provide a wide range of primary health care services. (b) To fund innovative and creative programs of such clinics designed to provide a high quality of health services at minimum cost. Eligibility for grants shall be limited to community clinics, free clinics, clinics exempt from licensure under subdivision (c) of Section 1206, and any nonprofit corporation that is comprised of not less than three such clinics having a combined service area covering an entire county or more. Grants authorized pursuant to this article shall be limited in purpose to defraying operating expenses of the recipient clinic, including personnel costs, and for technical assistance provided to the recipient. Grants shall not be made or used for purchase of equipment, facility renovations, or purchase of land or buildings. As a condition to making a grant pursuant to this chapter, the director shall require the applicant to match not less than 20 or more than 40 percent of the amount granted. The required matching funds shall be determined by the director, based upon the ability of the applicant to provide matching funds. The required match may be in cash or in-kind contributions, or a combination of both. In-kind contributions may include, but shall not be limited to, staff and volunteer services. The director may waive all or a portion of the grantee match in individual cases of demonstrated hardship if the director determines that making the grant would effectively serve the purposes of this chapter. The director shall adopt criteria to be applied in determining whether to grant requests for waivers.

124885. The department shall annually receive and process grant applications submitted by eligible applicants, and shall allocate grant moneys in accordance with the policies and priorities adopted pursuant to this article. Individual grants shall be limited to a maximum of sixty thousand dollars ($60,000), including grants to nonprofit corporations comprised of more than one clinic. However, grants may be renewed on an annual basis, subject to the submission and review of an annual renewal application, that shall be considered with, and subject to the same priorities as, new applications. No applicant shall receive more than one grant in any year. Each grant shall be subject to a contract between the department and the grantee prescribing the services to be provided by the grantee thereunder and other conditions of the grant. A contract may provide for periodic advance payments for services to be performed, but in no event shall advance payments exceed 25 percent of the grant.


124890. In developing policies and priorities pertaining to the allocation of grant funds, the department shall give primary consideration to the following factors: (a) The applicant's need for funds to continue its current level of operation. (b) The applicant's long-term prospects for financial stability. (c) The quality of services provided. (d) The high-risk or underserved population groups currently being served by the applicant. All of the above factors being present, clinics primarily serving population groups determined by the director to be medically underserved shall be entitled to first consideration in the allocation of grant funds. The department shall adopt guidelines for establishment of grant-supported activities, including criteria for evaluation of each activity and monitoring to assure compliance with grant conditions and applicable regulations of the department. The guidelines shall be developed in consultation with the Primary Care Clinics Advisory Committee and other advisory committees and persons as the department determines are appropriate.


Article 2. Primary Care

Ca Codes (hsc:124900-124945) Health And Safety Code Section 124900-124945



124900. (a) (1) The State Department of Health Care Services shall select primary care clinics that are licensed under subparagraph (A) or (B) of paragraph (1) of subdivision (a) of Section 1204, or are exempt from licensure under subdivision (c) of Section 1206, to be reimbursed for delivering medical services, including preventive health care, and smoking prevention and cessation health education, to program beneficiaries. (2) In order to be eligible to receive funds under this article a clinic shall meet all of the following conditions, at a minimum: (A) Provide medical diagnosis and treatment. (B) Provide medical support services of patients in all stages of illness. (C) Provide communication of information about diagnosis, treatment, prevention, and prognosis. (D) Provide maintenance of patients with chronic illness. (E) Provide prevention of disability and disease through detection, education, persuasion, and preventive treatment. (F) Meet one or both of the following conditions: (i) Be located in an area or a facility federally designated as a health professional shortage area, medically underserved area, or medically underserved population. (ii) Be a clinic that is able to demonstrate that at least 50 percent of the patients served are persons with incomes at or below 200 percent of the federal poverty level. (3) Notwithstanding the requirements of paragraph (2), all clinics that received funds under this article in the 1997-98 fiscal year shall continue to be eligible to receive funds under this article. (b) As a part of the award process for funding pursuant to this article, the department shall take into account the availability of primary care services in the various geographic areas of the state. The department shall determine which areas within the state have populations that have clear and compelling difficulty in obtaining access to primary care. The department shall consider proposals from new and existing eligible providers to extend clinic services to these populations. (c) A primary care clinic applying for funds pursuant to this article shall demonstrate that the funds shall be used to expand medical services, including preventive health care, and smoking prevention and cessation health education, for program beneficiaries above the level of services provided in the 1988 calendar year, or in the year prior to the first year a clinic receives funds under this article if the clinic did not receive funds in the 1989 calendar year. (d) (1) The department, in consultation with clinics funded under this article, shall develop a formula for allocation of funds available. It is the intent of the Legislature that the funds allocated pursuant to this article promote stability for those clinics participating in programs under this article as part of the state's health care safety net and at the same time be distributed in a manner that best promotes access to health care to uninsured populations. (2) The formula shall be based on both of the following: (A) A hold harmless for clinics funded in the 1997-98 fiscal year to continue to reimburse them for some portion of their uncompensated care. (B) Demonstrated unmet need by both new and existing clinics, as reflected in their levels of uncompensated care reported to the department. For purposes of this article, "uncompensated care" means clinic patient visits for persons with incomes at or below 200 percent of the federal poverty level for which there is no encounter-based third-party reimbursement which includes, but is not limited to, unpaid expanded access to primary care claims. (3) The department shall allocate available funds, for a three-year period, as follows: (A) Clinics that received funding in the prior fiscal year shall receive 90 percent of their prior fiscal year allocation, subject to available funds, provided that the funding award is substantiated by the clinics' reported levels of uncompensated care. (B) The remaining funds beyond 90 percent shall be awarded to new and existing applicants based on the clinics' reported levels of uncompensated care as verified by the department according to subparagraph (A) of paragraph (4). The department shall seek input from stakeholders to discuss adjustments to award levels that the department deems reasonable, such as including base amounts for new applicant clinics. (C) New applicants shall be awarded funds pursuant to this subdivision if they meet the minimum requirements for funding under this article based on the clinics' reported levels of uncompensated care as verified by the department according to subparagraph (A) of paragraph (4). New applicants include applicants for new site expansions by existing applicants. (4) In assessing reported levels of uncompensated care, the department shall utilize the data available from the Office of Statewide Health Planning and Development's (OSHPD's) completed analysis of the "Annual Report of Primary Care Clinics" for the prior fiscal year, or if more recent data is available, then the most recent data. If this data is unavailable for an existing applicant to assess reported levels of uncompensated care, the existing applicant shall receive an allocation pursuant to subparagraph (A) of paragraph (3). (A) The department shall utilize the most recent data available from OSHPD's completed analysis of the "Annual Report of Primary Care Clinics" for the prior fiscal year, or if more recent data is available, then the most recent data. (B) If the funds allocated to the program are less than the prior year, the department shall allocate available funds to existing program providers only. (5) The department shall establish a base funding level, subject to available funds, of no less than thirty-five thousand dollars ($35,000) for frontier clinics and Native American reservation-based clinics. For purposes of this article, "frontier clinics" means clinics located in a medical services study area with a population of fewer than 11 persons per square mile. (6) The department shall develop, in consultation with clinics funded pursuant to this article, a formula for reallocation of unused funds to other participating clinics to reimburse for uncompensated care. The department shall allocate the unused funds remaining on October 30, for the prior fiscal year to other participating clinics to reimburse for uncompensated care. (e) In applying for funds, eligible clinics shall submit a single application per clinic corporation. Applicants with multiple sites shall apply for all eligible clinics, and shall report to the department the allocation of funds among their corporate sites in the prior year. A corporation may claim reimbursement only for services provided at a program-eligible clinic site identified in the corporate entity's application for funds, and approved for funding by the department. A corporation may increase or decrease the number of its program-eligible clinic sites on an annual basis, at the time of the annual application update for the subsequent fiscal years of any multiple-year application period. (f) Grant allocations pursuant to this article shall be based on the formula developed by the department, notwithstanding a merger of one of more licensed primary care clinics participating in the program. (g) A clinic that is eligible for the program in every other respect, but that provides dental services only, rather than the full range of primary care medical services, shall only be eligible to receive funds under this article on an exception basis. A dental-only provider's application shall include a memorandum of understanding (MOU) with a primary care clinic funded under this article. The MOU shall include medical protocols for making referrals by the primary care clinic to the dental clinic and from the dental clinic to the primary care clinic, and ensure that case management services are provided and that the patient is being provided comprehensive primary care as described in subdivision (a). (h) (1) For purposes of this article, an outpatient visit shall include diagnosis and medical treatment services, including the associated pharmacy, X-ray, and laboratory services, and prevention health and case management services that are needed as a result of the outpatient visit. For a new patient, an outpatient visit shall also include a health assessment encompassing an assessment of smoking behavior and the patient's need for appropriate health education specific to related tobacco use and exposure. (2) "Case management" includes, for this purpose, the management of all physician services, both primary and specialty, and arrangements for hospitalization, postdischarge care, and followup care. (i) (1) Payment shall be on a per-visit basis at a rate that is determined by the department to be appropriate for an outpatient visit as defined in this section, and shall be not less than seventy-one dollars and fifty cents ($71.50). (2) In developing a statewide uniform rate for an outpatient visit as defined in this article, the department shall consider existing rates of payments for comparable outpatient visits. The department shall review the outpatient visit rate on an annual basis. (j) Not later than June 1 of each year, the department shall adopt and provide each licensed primary care clinic with a schedule for programs under this article, including the date for notification of availability of funds, the deadline for the submission of a completed application, and an anticipated contract award date for successful applicants. (k) In administering the program created pursuant to this article, the department shall utilize the Medi-Cal program statutes and regulations pertaining to program participation standards, medical and administrative recordkeeping, the ability of the department to monitor and audit clinic records pertaining to program services rendered to program beneficiaries and take recoupments or recovery actions consistent with monitoring and audit findings, and the provider's appeal rights. A primary care clinic applying for program participation shall certify that it will abide by these statutes and regulations and other program requirements set forth in this article.


124905. For purposes of this article, a "program beneficiary" is any person whose income level is at or below 200 percent of the federal poverty level as adjusted annually. Program beneficiaries shall not be required to provide any copayment for services that are funded pursuant to this article, except that clinics may charge beneficiaries on a sliding fee scale for services, but no beneficiary shall be denied services because of an inability to pay. The department shall annually adjust this income standard to reflect any changes in the federal poverty level. Payment pursuant to this article shall be made only for services for which payment will not be made through any private or public third-party reimbursement.


124910. (a) (1) Each licensed primary care clinic, as specified in subdivision (a) of Section 124900, applying for funds under this article, shall demonstrate in its application that it meets all of the following conditions, at a minimum: (A) Provides medical diagnosis and treatment. (B) Provides medical support services of patients in all stages of illness. (C) Provides communication of information about diagnosis, treatment, prevention, and prognosis. (D) Provides maintenance of patients with chronic illness. (E) Provides prevention of disability and disease through detection, education, persuasion, and preventive treatment. (F) Meets one or both of the following conditions: (i) Is located in an area or a facility federally designated as a health professional shortage area, medically underserved area, or medically underserved population. (ii) Is a clinic in which at least 50 percent of the patients served are persons with incomes at or below 200 percent of the federal poverty level. (2) Any applicant who has applied for and received a federal or state designation for serving a health professional shortage area, medically underserved area, or population shall be deemed to meet the requirements of subdivision (a) of Section 124900. (b) Each applicant shall also demonstrate to the satisfaction of the department that the proposed services supplement, and do not supplant, those primary care services to program beneficiaries that are funded by any county, state, or federal program. (c) Each applicant shall demonstrate that it is an active Medi-Cal provider by being enrolled in Medi-Cal and diligently billing the Medi-Cal program for services rendered to Medi-Cal eligible patients during the past three months prior to the application due date. This subdivision shall not apply to clinics that are not currently Medi-Cal providers, and were funded participants pursuant to this article during the 1993-94 fiscal year. (d) Each application shall be evaluated by the state department prior to funding to determine all of the following: (1) The applicant shall provide its most recently audited financial statement to verify budget information. (2) The applicant's ability to deliver basic primary care to program beneficiaries. (3) A description of the applicant's operational quality assurance program. (4) The applicant's use of protocols for the most common diseases in the population served under this article.


124911. (a) Commencing in the 1998-99 fiscal year, the department shall release a request for allocation of funds for a period of three succeeding fiscal years. The request for allocation shall include specifications for the clinics to submit uniform data on uncompensated patient visits. (b) Annual funding awards for a clinic provider in the second and third fiscal years of a three-year funding period shall be contingent upon the clinic's satisfactory performance under the program, and upon the availability of sufficient funds appropriated by the annual Budget Act.


124915. Services funded pursuant to this article shall be limited to the extent that funds are appropriated for this purpose.


124920. (a) The department shall utilize existing contractual claims processing services in order to promote efficiency and to maximize use of funds. (b) The department shall certify which primary care clinics are selected to participate in the program for each specific fiscal year, and how much in program funds each selected primary care clinic will be allocated each fiscal year. (c) The department shall pay claims from selected primary care clinics up to each clinic's annual allocation. Once a clinic has exhausted its annual allocation, the state shall stop paying its program claims. (d) The department may adjust any selected primary care clinic's allocation to take into account: (1) An increase in program funds appropriated for the fiscal year. (2) A decrease in program funds appropriated for the fiscal year. (3) A clinic's projected inability to fully spend its allocation within the fiscal year. (4) Surplus funds reallocated from other selected primary care clinics. (e) The department shall notify all affected primary care clinics in writing prior to adjusting selected primary care clinics' allocations. (f) Cessation of program payments under subdivision (e) or adjustment of selected primary care clinic's allocations under subdivision (d) shall not be subject to the Medi-Cal appeals process referenced in subdivision (g) of Section 124900. (g) A clinic's allocation under this article shall not be reduced solely because the clinic has engaged in supplemental fundraising drives and activities, the proceeds of which have been used to defray the costs of services to the uninsured.


124925. The department shall submit a report on its activities under this article to the Legislature no later than January 1, 1991, and annually thereafter.

124930. (a) For any condition detected as part of a child health and disability prevention screen for any child eligible for services under Section 104395, if the child was screened by the clinic or upon referral by a child health and disability prevention program provider, unless the child is eligible to receive care with no share of cost under the Medi-Cal program, is covered under another publicly funded program, or the services are payable under private coverage, a clinic shall, as a condition of receiving funds under this article, do all of the following: (1) Insofar as the clinic directly provides these services for other patients, provide medically necessary followup treatment, including prescription drugs. (2) Insofar as the clinic does not provide treatment for the condition, arrange for the treatment to be provided. (b) (1) If any child requires treatment the clinic does not provide, the clinic shall arrange for the treatment to be provided, and the name of that provider shall be noted in the patient's medical record. (2) The clinic shall contact the provider or the patient or his or her guardian, or both, within 30 days after the arrangement for the provision of treatment is made, and shall determine if the provider has provided appropriate care, and shall note the results in the patient's medical record. (3) If the clinic is not able to determine, within 30 days after the arrangement for the provision of treatment is made, whether the needed treatment was provided, the clinic shall provide written notice to the county child health and disability prevention program director, and shall also provide a copy to the state director of the program.


124940. The use of funds granted pursuant to this article for use by school-based clinics shall be limited to those school-based clinics that were licensed and in operation before January 1, 1990.


124945. Any entity or provider that receives funds pursuant to this article shall expend those funds in accordance with the requirements of Article 2 (commencing with Section 30121) of Chapter 2 of Part 13 of Division 2 of the Revenue and Taxation Code.


Part 4.5. Pain Patient's Bill Of Rights

Ca Codes (hsc:124960-124961) Health And Safety Code Section 124960-124961



124960. The Legislature finds and declares all of the following: (a) The state has a right and duty to control the illegal use of opiate drugs. (b) Inadequate treatment of acute and chronic pain originating from cancer or noncancerous conditions is a significant health problem. (c) For some patients, pain management is the single most important treatment a physician can provide. (d) A patient suffering from severe chronic intractable pain should have access to proper treatment of his or her pain. (e) Due to the complexity of their problems, many patients suffering from severe chronic intractable pain may require referral to a physician with expertise in the treatment of severe chronic intractable pain. In some cases, severe chronic intractable pain is best treated by a team of clinicians in order to address the associated physical, psychological, social, and vocational issues. (f) In the hands of knowledgeable, ethical, and experienced pain management practitioners, opiates administered for severe acute and severe chronic intractable pain can be safe. (g) Opiates can be an accepted treatment for patients in severe chronic intractable pain who have not obtained relief from any other means of treatment. (h) A patient suffering from severe chronic intractable pain has the option to request or reject the use of any or all modalities to relieve his or her severe chronic intractable pain. (i) A physician treating a patient who suffers from severe chronic intractable pain may prescribe a dosage deemed medically necessary to relieve severe chronic intractable pain as long as the prescribing is in conformance with the provisions of the California Intractable Pain Treatment Act, Section 2241.5 of the Business and Professions Code. (j) A patient who suffers from severe chronic intractable pain has the option to choose opiate medication for the treatment of the severe chronic intractable pain as long as the prescribing is in conformance with the provisions of the California Intractable Pain Treatment Act, Section 2241.5 of the Business and Professions Code. (k) The patient's physician may refuse to prescribe opiate medication for a patient who requests the treatment for severe chronic intractable pain. However, that physician shall inform the patient that there are physicians who specialize in the treatment of severe chronic intractable pain with methods that include the use of opiates.

124961. Nothing in this section shall be construed to alter any of the provisions set forth in the California Intractable Pain Treatment Act, Section 2241.5 of the Business and Professions Code. This section shall be known as the Pain Patient's Bill of Rights. (a) A patient suffering from severe chronic intractable pain has the option to request or reject the use of any or all modalities in order to relieve his or her severe chronic intractable pain. (b) A patient who suffers from severe chronic intractable pain has the option to choose opiate medications to relieve severe chronic intractable pain without first having to submit to an invasive medical procedure, which is defined as surgery, destruction of a nerve or other body tissue by manipulation, or the implantation of a drug delivery system or device, as long as the prescribing physician acts in conformance with the provisions of the California Intractable Pain Treatment Act, Section 2241.5 of the Business and Professions Code. (c) The patient's physician may refuse to prescribe opiate medication for the patient who requests a treatment for severe chronic intractable pain. However, that physician shall inform the patient that there are physicians who specialize in the treatment of severe chronic intractable pain with methods that include the use of opiates. (d) A physician who uses opiate therapy to relieve severe chronic intractable pain may prescribe a dosage deemed medically necessary to relieve severe chronic intractable pain, as long as that prescribing is in conformance with the California Intractable Pain Treatment Act, Section 2241.5 of the Business and Professions Code. (e) A patient may voluntarily request that his or her physician provide an identifying notice of the prescription for purposes of emergency treatment or law enforcement identification. (f) Nothing in this section shall do either of the following: (1) Limit any reporting or disciplinary provisions applicable to licensed physicians and surgeons who violate prescribing practices or other provisions set forth in the Medical Practice Act, Chapter 5 (commencing with Section 2000) of Division 2 of the Business and Professions Code, or the regulations adopted thereunder. (2) Limit the applicability of any federal statute or federal regulation or any of the other statutes or regulations of this state that regulate dangerous drugs or controlled substances.


Part 5. Hereditary Diseases/congenital Defects

Chapter 1. Genetic Prevention Services

Article 1. Hereditary Disorders Act

Ca Codes (hsc:124975-124996) Health And Safety Code Section 124975-124996



124975. The Legislature hereby finds and declares that: (a) Each person in the State of California is entitled to health care commensurate with his or her health care needs, and to protection from inadequate health services not in the person's best interests. (b) Hereditary disorders, such as sickle cell anemia, cystic fibrosis, and hemophilia, are often costly, tragic, and sometimes deadly burdens to the health and well-being of the citizens of this state. (c) Detection through screening of hereditary disorders can lead to the alleviation of the disability of some hereditary disorders and contribute to the further understanding and accumulation of medical knowledge about hereditary disorders that may lead to their eventual alleviation or cure. (d) There are different severities of hereditary disorders, that some hereditary disorders have little effect on the normal functioning of individuals, and that some hereditary disorders may be wholly or partially alleviated through medical intervention and treatment. (e) All or most persons are carriers of some deleterious recessive genes that may be transmitted through the hereditary process, and that the health of carriers of hereditary disorders is substantially unaffected by that fact. (f) Carriers of most deleterious genes should not be stigmatized and should not be discriminated against by any person within the State of California. (g) Specific legislation designed to alleviate the problems associated with specific hereditary disorders may tend to be inflexible in the face of rapidly expanding medical knowledge, underscoring the need for flexible approaches to coping with genetic problems. (h) State policy regarding hereditary disorders should be made with full public knowledge, in light of expert opinion and should be constantly reviewed to consider changing medical knowledge and ensure full public protection. (i) The extremely personal decision to bear children should remain the free choice and responsibility of the individual, and should not be restricted by the state. (j) Participation of persons in hereditary disorders programs in the State of California should be wholly voluntary, except for initial screening for phenylketonuria (PKU) and other genetic disorders treatable through the California newborn screening program. All information obtained from persons involved in hereditary disorders programs in the state should be held strictly confidential. (k) In order to minimize the possibility for the reoccurrence of abuse of genetic intervention in hereditary disorders programs, all programs offering screening programs for heredity disorders shall comply with the principles established in the Hereditary Disorders Act (Section 27). The Legislature finds it necessary to establish a uniform statewide policy for the screening for heredity disorder in the State of California.


124977. (a) It is the intent of the Legislature that, unless otherwise specified, the genetic disease testing program carried out pursuant to this chapter be fully supported from fees collected for services provided by the program. (b) (1) The department shall charge a fee to all payers for any tests or activities performed pursuant to this chapter. The amount of the fee shall be established by regulation and periodically adjusted by the director in order to meet the costs of this chapter. Notwithstanding any other provision of law, any fees charged for prenatal screening and followup services provided to persons enrolled in the Medi-Cal program, health care service plan enrollees, or persons covered by health insurance policies, shall be paid in full and deposited in the Genetic Disease Testing Fund or the Birth Defects Monitoring Fund consistent with this section, subject to all terms and conditions of each enrollee's or insured's health care service plan or insurance coverage, whichever is applicable, including, but not limited to, copayments and deductibles applicable to these services, and only if these copayments, deductibles, or limitations are disclosed to the subscriber or enrollee pursuant to the disclosure provisions of Section 1363. (2) The department shall expeditiously undertake all steps necessary to implement the fee collection process, including personnel, contracts, and data processing, so as to initiate the fee collection process at the earliest opportunity. (3) Effective for services provided on and after July 1, 2002, the department shall charge a fee to the hospital of birth, or, for births not occurring in a hospital, to families of the newborn, for newborn screening and followup services. The hospital of birth and families of newborns born outside the hospital shall make payment in full to the Genetic Disease Testing Fund. The department shall not charge or bill Medi-Cal beneficiaries for services provided under this chapter. (4) (A) The department shall charge a fee for prenatal screening to support the pregnancy blood sample storage, testing, and research activities of the Birth Defects Monitoring Program. (B) The prenatal screening fee for activities of the Birth Defects Monitoring Program shall be ten dollars ($10). (5) The department shall set guidelines for invoicing, charging, and collecting from approved researchers the amount necessary to cover all expenses associated with research application requests made under this section, data linkage, retrieval, data processing, data entry, reinventory, and shipping of blood samples or their components and related data management. (6) The only funds from the Genetic Disease Testing Fund that may be used for the purpose of supporting the pregnancy blood sample storage, testing, and research activities of the Birth Defects Monitoring Program are those prenatal screening fees assessed and collected prior to the creation of the Birth Defects Monitoring Program Fund specifically to support those Birth Defects Monitoring Program activities. (7) The Birth Defects Monitoring Program Fund is hereby created as a special fund in the State Treasury. Fee revenues that are collected pursuant to paragraph (4) shall be deposited into the fund and shall be available upon appropriation by the Legislature to support the pregnancy blood sample storage, testing, and research activities of the Birth Defects Monitoring Program. Notwithstanding Section 16305.7 of the Government Code, interest earned on funds in the Birth Defects Monitoring Program Fund shall be deposited as revenue into the fund to support the Birth Defects Monitoring Program. (c) (1) The Legislature finds that timely implementation of changes in genetic screening programs and continuous maintenance of quality statewide services requires expeditious regulatory and administrative procedures to obtain the most cost-effective electronic data processing, hardware, software services, testing equipment, and testing and followup services. (2) The expenditure of funds from the Genetic Disease Testing Fund for these purposes shall not be subject to Section 12102 of, and Chapter 2 (commencing with Section 10290) of Part 2 of Division 2 of, the Public Contract Code, or to Division 25.2 (commencing with Section 38070). The department shall provide the Department of Finance with documentation that equipment and services have been obtained at the lowest cost consistent with technical requirements for a comprehensive high-quality program. (3) The expenditure of funds from the Genetic Disease Testing Fund for implementation of the Tandem Mass Spectrometry screening for fatty acid oxidation, amino acid, and organic acid disorders, and screening for congenital adrenal hyperplasia may be implemented through the amendment of the Genetic Disease Branch Screening Information System contracts and shall not be subject to Chapter 3 (commencing with Section 12100) of Part 2 of Division 2 of the Public Contract Code, Article 4 (commencing with Section 19130) of Chapter 5 of Part 2 of Division 5 of Title 2 of the Government Code, and any policies, procedures, regulations or manuals authorized by those laws. (4) The expenditure of funds from the Genetic Disease Testing Fund for the expansion of the Genetic Disease Branch Screening Information System to include cystic fibrosis and biotinidase may be implemented through the amendment of the Genetic Disease Branch Screening Information System contracts, and shall not be subject to Chapter 2 (commencing with Section 10290) or Chapter 3 (commencing with Section 12100) of Part 2 of Division 2 of the Public Contract Code, Article 4 (commencing with Section 19130) of Chapter 5 of Part 2 of Division 5 of Title 2 of the Government Code, or Sections 4800 to 5180, inclusive, of the State Administrative Manual as they relate to approval of information technology projects or approval of increases in the duration or costs of information technology projects. This paragraph shall apply to the design, development, and implementation of the expansion, and to the maintenance and operation of the Genetic Disease Branch Screening Information System, including change requests, once the expansion is implemented. (d) (1) The department may adopt emergency regulations to implement and make specific this chapter in accordance with Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code. For the purposes of the Administrative Procedure Act, the adoption of regulations shall be deemed an emergency and necessary for the immediate preservation of the public peace, health and safety, or general welfare. Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, these emergency regulations shall not be subject to the review and approval of the Office of Administrative Law. Notwithstanding Sections 11346.1 and 11349.6 of the Government Code, the department shall submit these regulations directly to the Secretary of State for filing. The regulations shall become effective immediately upon filing by the Secretary of State. Regulations shall be subject to public hearing within 120 days of filing with the Secretary of State and shall comply with Sections 11346.8 and 11346.9 of the Government Code or shall be repealed. (2) The Office of Administrative Law shall provide for the printing and publication of these regulations in the California Code of Regulations. Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the regulations adopted pursuant to this chapter shall not be repealed by the Office of Administrative Law and shall remain in effect until revised or repealed by the department. (3) The Legislature finds and declares that the health and safety of California newborns is in part dependent on an effective and adequately staffed genetic disease program, the cost of which shall be supported by the fees generated by the program.


124980. The director shall establish any regulations and standards for hereditary disorders programs as the director deems necessary to promote and protect the public health and safety. Standards shall include licensure of master level genetic counselors and doctoral level geneticists. Regulations adopted shall implement the principles established in this section. These principles shall include, but not be limited to, the following: (a) The public, especially communities and groups particularly affected by programs on hereditary disorders, should be consulted before any regulations and standards are adopted by the department. (b) The incidence, severity, and treatment costs of each hereditary disorder and its perceived burden by the affected community should be considered and, where appropriate, state and national experts in the medical, psychological, ethical, social, and economic effects or programs for the detection and management of hereditary disorders shall be consulted by the department. (c) Information on the operation of all programs on hereditary disorders within the state, except for confidential information obtained from participants in the programs, shall be open and freely available to the public. (d) Clinical testing procedures established for use in programs, facilities, and projects shall be accurate, provide maximum information, and the testing procedures selected shall produce results that are subject to minimum misinterpretation. (e) No test or tests may be performed on any minor over the objection of the minor's parents or guardian, nor may any tests be performed unless the parent or guardian is fully informed of the purposes of testing for hereditary disorders and is given reasonable opportunity to object to the testing. (f) No testing, except initial screening for phenylketonuria (PKU) and other diseases that may be added to the newborn screening program, shall require mandatory participation, and no testing programs shall require restriction of childbearing, and participation in a testing program shall not be a prerequisite to eligibility for, or receipt of, any other service or assistance from, or to participate in, any other program, except where necessary to determine eligibility for further programs of diagnoses of or therapy for hereditary conditions. (g) Pretest and posttest counseling services for hereditary disorders shall be available through the program or a referral source for all persons determined to be or who believe themselves to be at risk for a hereditary disorder. Genetic counseling shall be provided by a physician, a certified advanced practice nurse with a genetics specialty, or other appropriately trained licensed health care professional and shall be nondirective, shall emphasize informing the client, and shall not require restriction of childbearing. (h) All participants in programs on hereditary disorders shall be protected from undue physical and mental harm, and except for initial screening for phenylketonuria (PKU) and other diseases that may be added to newborn screening programs, shall be informed of the nature of risks involved in participation in the programs, and those determined to be affected with genetic disease shall be informed of the nature, and where possible the cost, of available therapies or maintenance programs, and shall be informed of the possible benefits and risks associated with these therapies and programs. (i) All testing results and personal information generated from hereditary disorders programs shall be made available to an individual over 18 years of age, or to the individual's parent or guardian. If the individual is a minor or incompetent, all testing results that have positively determined the individual to either have, or be a carrier of, a hereditary disorder shall be given through a physician or other source of health care. (j) All testing results and personal information from hereditary disorders programs obtained from any individual, or from specimens from any individual, shall be held confidential and be considered a confidential medical record except for information that the individual, parent, or guardian consents to be released, provided that the individual is first fully informed of the scope of the information requested to be released, of all of the risks, benefits, and purposes for the release, and of the identity of those to whom the information will be released or made available, except for data compiled without reference to the identity of any individual, and except for research purposes, provided that pursuant to Subpart A (commencing with Section 46.101) of Part 46 of Title 45 of the Code of Federal Regulations entitled "Basic HHS Policy for Protection of Human Subjects," the research has first been reviewed and approved by an institutional review board that certifies the approval to the custodian of the information and further certifies that in its judgment the information is of such potentially substantial public health value that modification of the requirement for legally effective prior informed consent of the individual is ethically justifiable. (k) A physician providing information to patients on expanded newborn screening shall disclose to the parent the physician's financial interest, if any, in the laboratory to which the patient is being referred. ( l) An individual whose confidentiality has been breached as a result of any violation of the provisions of the Hereditary Disorders Act, as defined in subdivision (b) of Section 27, may recover compensatory and civil damages. Any person who negligently breaches the confidentiality of an individual tested under this article shall be subject to civil damages of not more than ten thousand dollars ($10,000), reasonable attorney's fees, and the costs of litigation. Any person who knowingly breaches the confidentiality of an individual tested under this article shall be subject to payment of compensatory damages, and in addition, may be subject to civil damages of fifty thousand dollars ($50,000), reasonable attorney's fees, and the costs of litigation, or imprisonment in the county jail of not more than one year. If the offense is committed under false pretenses, the person may be subject to a fine of not more than one hundred thousand dollars ($100,000), imprisonment in the county jail of not more than one year, or both. If the offense is committed with the intent to sell, transfer, or use individually identifiable health information for commercial advantage, personal gain, or malicious harm, the person may be subject to a fine of not more than two hundred fifty thousand dollars ($250,000), imprisonment in the county jail of not more than one year, or both. (m) "Genetic counseling" as used in this section shall not include communications that occur between patients and appropriately trained and competent licensed health care professionals, such as physicians, registered nurses, and physicians assistants who are operating within the scope of their license and qualifications as defined by their licensing authority.


124981. (a) No person shall use the title of genetic counselor unless the person has applied for and obtained a license from the department. (b) The applicant for a genetic counselor license shall meet minimum qualifications that include, but are not limited to, both of the following: (1) Has earned a master's degree or above from a program specializing in or having substantial course content in genetics. (2) Has demonstrated competence by an examination administered or approved by the department. (c) The license shall be valid for three years unless at any time during that period it is revoked or suspended. The license may be renewed prior to the expiration of the three-year period. (d) To qualify to renew the license, a licenseholder shall have completed 45 hours of continuing education units during the three-year license renewal period. At least 30 hours of the continuing education units shall be in genetics. (e) The license fee for an original license and license renewal shall not exceed two hundred dollars ($200). (f) Until the department has finalized regulations that are needed to implement subdivision (b), the department shall license, upon application and payment of the application fee specified in subdivision (e), a genetic counselor applicant who meets the requirements of subdivision (b), is currently credentialed and in good standing with the American Board of Genetic Counseling, and has no history of disciplinary action by the board. When the department has finalized the regulations needed to implement subdivision (b), genetic counselors who have received a license pursuant to this subdivision shall be subject to the regulations implementing this section and Sections 124980 and 124982, and this subdivision shall become inoperative. (g) The department may revoke the license of a genetic counselor who is licensed pursuant to subdivision (f) if either of the following occur: (1) The counselor loses his or her credential granted by the American Board of Genetic Counseling or is placed on probationary status. (2) The counselor has been convicted of a felony charge that is substantially related to the qualifications, functions, or duties of a genetic counselor. A plea of guilty or nolo contendere to a felony charge shall be deemed a conviction for the purposes of this paragraph. (h) This section shall remain in effect only until January 1, 2014, and as of that date is repealed, unless a later enacted statute, that is enacted before January 1, 2014, deletes or extends that date. (i) The amendments made to this section by the act adding this subdivision shall become operative on July 1, 2011.


124981. (a) No person shall use the title of genetic counselor unless the person has applied for and obtained a license from the department. (b) The applicant for a genetic counselor license shall meet minimum qualifications that include, but are not limited to, both of the following: (1) Has earned a master's degree or above from a program specializing in or having substantial course content in genetics. (2) Has demonstrated competence by an examination administered or approved by the department. (c) The license shall be valid for three years unless at any time during that period it is revoked or suspended. The license may be renewed prior to the expiration of the three-year period. (d) To qualify to renew the license, a licenseholder shall have completed 45 hours of continuing education units during the three-year license renewal period. At least 30 hours of the continuing education units shall be in genetics. (e) The license fee for an original license and license renewal shall not exceed two hundred dollars ($200). (f) This section shall become operative on January 1, 2014.


124982. (a) The department shall issue a temporary genetic counselor license to a person to practice as a licensed genetic counselor who meets all of the following: (1) The requirements for licensure set forth in subdivision (b) of Section 124981, except passing the certification examination as required by paragraph (2) of subdivision (b) of Section 124981. (2) Either of the following requirements: (A) The person meets the requirements to apply for and has applied for the first available certification examination offered. The department may require an applicant for a temporary genetic counselor license to provide documentation of acceptance for the examination. (B) The person meets the requirements to apply for the certification examination and plans to apply to sit for the examination in the year following the year of the first available examination. The department shall require the applicant to provide documentation showing registration for the examination, when the documentation is received by the applicant. After the applicant takes the exam, the department shall require the applicant to provide documentation showing that the applicant took the examination. (3) Payment of a fee of two hundred dollars ($200). (b) A temporary genetic counselor license shall be valid for 24 months and shall not be extended or renewed. (c) Notwithstanding subdivision (a), a temporary license issued pursuant to this section shall expire upon any of the following events, whichever occurs earlier: (1) The issuance of a license pursuant to Section 124981. (2) Thirty days after notification of the department that an applicant has failed the certification examination. (3) The expiration date on the temporary license. (d) A person holding a temporary genetic counselor license issued pursuant to this section, shall be required to work under the supervision of a licensed genetic counselor or a licensed physician and surgeon. (e) The department may revoke the temporary license of a genetic counselor licensed pursuant to this section if the person has been convicted of a felony charge that is substantially related to the qualifications, functions, or duties of a genetic counselor. A plea of guilty or nolo contendere to a felony charge shall be deemed a conviction for the purposes of this subdivision. (f) This section shall become operative on July 1, 2011.


124985. A violation of any of the provisions of the Hereditary Disorders Act (Section 27) or any of the regulations adopted pursuant to that act shall be punishable as a misdemeanor.


124990. For the purposes of the Hereditary Disorders Act (Section 27), hereditary disorders programs shall include, but not be limited to, all antenatal, neonatal, childhood, and adult screening programs, and all adjunct genetic counseling services.


124991. (a) (1) The Birth Defects Monitoring Program, within the State Department of Public Health, shall collect and store any umbilical cord blood samples it receives from hospitals for storage and research. For purposes of ensuring financial stability, the Birth Defects Monitoring Program shall ensure that the following conditions, alone or in combination, are met: (A) The fees paid by researchers pursuant to subdivision (c) shall be used for, and be sufficient to cover the cost of, collecting and storing blood samples, including umbilical cord blood samples. (B) The department receives confirmation that a researcher has requested umbilical cord blood samples from the Birth Defects Monitoring Program for research or has requested umbilical cord blood samples to be included within a request for pregnancy or newborn blood samples through the program and has provided satisfactory evidence that adequate funding will be provided to the department from the fees paid by the researcher for the request. (C) The department receives federal grant moneys to pay for initial startup costs for the collection and storage of umbilical cord blood samples. (2) The department may limit the number of umbilical cord blood samples the program collects each year. (b) (1) All information relating to umbilical cord blood samples collected and utilized by the department shall be confidential, and shall be used solely for the purposes of the program, or, if approved by the department, research. Access to confidential information shall be limited to authorized persons who agree, in writing, to maintain the confidentiality of that information. Notwithstanding any other provision of law, when the blood samples specified in subdivision (c), including those samples with any information identifying the person from whom the samples were obtained, are stored, processed, analyzed, or otherwise shared for research purposes with nondepartment staff, those samples may be shared by the program with department-authorized researchers for research purposes, and department representatives approved by the department, subject to the confidentiality and security requirements for confidential information established in this section and in Section 103850. (2) The department shall maintain an accurate record of all persons who are given confidential information pursuant to this section, and any disclosure of confidential information shall be made only upon written agreement that the information will be kept confidential, used for its approved purpose, and not be further disclosed. (3) A person who, in violation of a written agreement to maintain confidentiality, discloses information provided pursuant to this section, or who uses information provided pursuant to this section in a manner other than as approved pursuant to this section may be denied further access to confidential information maintained by the department, and shall be subject to a civil penalty not exceeding one thousand dollars ($1,000). The penalty provided in this section does not limit or otherwise restrict a remedy, provisional or otherwise, provided by law for the benefit of the department or a person covered by this section. (c) In order to implement this section, the department shall establish fees in an amount that shall not exceed the costs of administering the program and the collection and storage of these samples, which the department shall collect from researchers who have been approved by the department and who seek to use the following types of blood samples for research: (1) Umbilical cord blood. (2) Pregnancy blood collected by the Genetic Disease Screening Program, and stored by the Birth Defects Monitoring Program. (3) Newborn blood collected by the Genetic Disease Screening Program. (d) Fees collected pursuant to subdivision (c) shall be collected by the department and deposited into the Birth Defects Monitoring Program Fund, the Genetic Disease Testing Fund, created pursuant to Section 124996, or the Cord Blood Banking Fund, which is hereby created as a special fund in the State Treasury. The amount of fees deposited into each of these funds shall be based on the program that is providing those pregnancy blood samples, and the purpose for which the blood sample was obtained. Notwithstanding any other provision of law, the moneys in the Birth Defects Monitoring Program Fund, the Genetic Disease Testing Fund, and the Cord Blood Banking Fund that are collected pursuant to subdivision (c), may be used by the department, upon appropriation by the Legislature, for the purposes specified in subdivision (e). (e) Moneys in those funds shall be used for the costs related to data management, including data linkage and entry, and blood collection, storage, retrieval, processing, inventory, and shipping. (f) The department shall comply with the existing requirements in the Birth Defects Monitoring Program, as set forth in Chapter 1 (commencing with Section 103825) of Part 2 of Division 102. (g) The department, any entities approved by the department, and researchers shall maintain the confidentiality of patient information and blood samples in accordance with existing law and in the same manner as other medical record information with patient identification that they possess, and shall use the information only for the following purposes: (1) Research to identify risk factors for children's and women's diseases. (2) Research to develop and evaluate screening tests. (3) Research to develop and evaluate prevention strategies. (4) Research to develop and evaluate treatments. (h) (1) For purposes of ensuring the security of a donor's personal information, before any blood samples are released pursuant to this section for research purposes, the State Committee for the Protection of Human Subjects (CPHS) shall determine if all of the following criteria have been met: (A) The department, contractors, researchers, or other entities approved by the department have provided a plan sufficient to protect personal information from improper use and disclosures, including sufficient administrative, physical, and technical safeguards to protect personal information from reasonable anticipated threats to the security or confidentiality of the information. (B) The department, contractors, researchers, or other entities approved by the department have provided a sufficient plan to destroy or return all personal information as soon as it is no longer needed for the research activity, unless the program contractors, researchers, or other entities approved by the department have demonstrated an ongoing need for the personal information for the research activity and have provided a long-term plan sufficient to protect the confidentiality of that information. (C) The department, contractors, researchers, or other entities approved by the department have provided sufficient written assurances that the personal information will not be reused or disclosed to a person or entity, or used in a manner not approved in the research protocol, except as required by law or for authorized oversight of the research activity. (2) As part of its review and approval of the research activity for the purpose of protecting personal information held in agency databases, CPHS shall accomplish at least all of the following: (A) Determine whether the requested personal information is needed to conduct the research. (B) Permit access to personal information only if it is needed for the research activity. (C) Permit access only to the minimum personal information necessary for the research activity. (D) Require the assignment of unique subject codes that are not derived from personal information in lieu of social security numbers if the research can be conducted without social security numbers. (E) If feasible, and if cost, time, and technical expertise permit, require the agency to conduct a portion of the data processing for the researcher to minimize the release of personal information. (i) In addition to the fees described in subdivision (c), the department may bill a researcher for the costs associated with the department's process of protecting personal information, including, but not limited to, the department's costs for conducting a portion of the data processing for the researcher, removing personal information, encrypting or otherwise securing personal information, or assigning subject codes. (j) This section does not prohibit the department from using its existing authority to enter into written agreements to enable other institutional review boards to approve research activities, projects or classes of projects for the department, provided that the data security requirements set forth in this section are satisfied.


124995. The following programs shall comply with the regulations established pursuant to the Hereditary Disorders Act (Section 27): (a) The California Children's Services Program under Article 5 (commencing with Section 123800) of Chapter 3 of Part 2. (b) Prenatal testing programs for newborns under Sections 125050 to 125065, inclusive. (c) Medical testing programs for newborns under the Maternal and Child Health Program Act (Section 27). (d) Programs of the genetic disease unit under Section 125000. (e) Child health disability prevention programs under Article 6 (commencing with Section 124025) of Chapter 3 of Part 2 and Section 120475. (f) Genetically handicapped person's programs under Article 1 (commencing with Section 125125) of Chapter 2. (g) Medi-Cal Benefits Program under Article 4 (commencing with Section 14131) of Chapter 7 of Part 3 of Division 9 of the Welfare and Institutions Code.


124996. (a) The Genetic Disease Testing Fund is continued in existence as a special fund in the State Treasury. The department may charge a fee for any activities carried out pursuant to the Hereditary Disorders Act, including licensing activities conducted pursuant to Section 124980. All moneys collected by the department under the act shall be deposited in the Genetic Disease Testing Fund, that is continuously appropriated to the department to carry out the purposes of the act. (b) It is the intent of the Legislature that the program carried out pursuant to the act be fully supported from fees collected under the act. (c) The director shall adopt regulations establishing the amount of fees for activities carried out pursuant to the act. (d) The "Hereditary Disorders Act" or "act" referred to in this section is the act described in subdivision (b) of Section 27.



Article 2. Newborn Screening

Ca Codes (hsc:125000-125002) Health And Safety Code Section 125000-125002



125000. (a) It is the policy of the State of California to make every effort to detect, as early as possible, phenylketonuria and other preventable heritable or congenital disorders leading to mental retardation or physical defects. The department shall establish a genetic disease unit, that shall coordinate all programs of the department in the area of genetic disease. The unit shall promote a statewide program of information, testing, and counseling services and shall have the responsibility of designating tests and regulations to be used in executing this program. The information, tests, and counseling for children shall be in accordance with accepted medical practices and shall be administered to each child born in California once the department has established appropriate regulations and testing methods. The information, tests, and counseling for pregnant women shall be in accordance with accepted medical practices and shall be offered to each pregnant woman in California once the department has established appropriate regulations and testing methods. These regulations shall follow the standards and principles specified in Section 124980. The department may provide laboratory testing facilities or contract with any laboratory that it deems qualified to conduct tests required under this section. However, notwithstanding Section 125005, provision of laboratory testing facilities by the department shall be contingent upon the provision of funding therefor by specific appropriation to the Genetic Disease Testing Fund enacted by the Legislature. If moneys appropriated for purposes of this section are not authorized for expenditure to provide laboratory facilities, the department may nevertheless contract to provide laboratory testing services pursuant to this section and shall perform laboratory services, including, but not limited to, quality control, confirmatory, and emergency testing, necessary to ensure the objectives of this program. (b) The department shall charge a fee for any tests performed pursuant to this section. The amount of the fee shall be established and periodically adjusted by the director in order to meet the costs of this section. (c) The department shall inform all hospitals or physicians and surgeons, or both, of required regulations and tests and may alter or withdraw any of these requirements whenever sound medical practice so indicates. To the extent practicable, the department shall provide notice to hospitals and other payers in advance of any increase in the fees charged for the program. (d) This section shall not apply if a parent or guardian of the newborn child objects to a test on the ground that the test conflicts with his or her religious beliefs or practices. (e) The genetic disease unit is authorized to make grants or contracts or payments to vendors approved by the department for all of the following: (1) Testing and counseling services. (2) Demonstration projects to determine the desirability and feasibility of additional tests or new genetic services. (3) To initiate the development of genetic services in areas of need. (4) To purchase or provide genetic services from any sums as are appropriated for this purpose. (f) The genetic disease unit shall evaluate and prepare recommendations on the implementation of tests for the detection of hereditary and congenital diseases, including, but not limited to, biotinidase deficiency and cystic fibrosis. The genetic disease unit shall also evaluate and prepare recommendations on the availability and effectiveness of preventative followup interventions, including the use of specialized medically necessary dietary products. It is the intent of the Legislature that funds for the support of the evaluations and recommendations required pursuant to this subdivision, and for the activities authorized pursuant to subdivision (e), shall be provided in the annual Budget Act appropriation from the Genetic Disease Testing Fund. (g) Health care providers that contract with a prepaid group practice health care service plan that annually has at least 20,000 births among its membership, may provide, without contracting with the department, any or all of the testing and counseling services required to be provided under this section or the regulations adopted pursuant thereto, if the services meet the quality standards and adhere to the regulations established by the department and the plan pays that portion of a fee established under this section that is directly attributable to the department's cost of administering the testing or counseling service and to any required testing or counseling services provided by the state for plan members. The payment by the plan, as provided in this subdivision, shall be deemed to fulfill any obligation the provider or the provider's patient may have to the department to pay a fee in connection with the testing or counseling service. (h) The department may appoint experts in the area of genetic screening, including, but not limited to, cytogenetics, molecular biology, prenatal, specimen collection, and ultrasound to provide expert advice and opinion on the interpretation and enforcement of regulations adopted pursuant to this section. These experts shall be designated agents of the state with respect to their assignments. These experts shall receive no salary, but shall be reimbursed for expenses associated with the purposes of this section. All expenses of the experts for the purposes of this section shall be paid from the Genetic Disease Testing Fund.

125001. (a) The department shall establish a program for the development, provision, and evaluation of genetic disease testing, and may provide laboratory testing facilities or make grants to, contract with, or make payments to, any laboratory that it deems qualified and cost-effective to conduct testing or with any metabolic specialty clinic to provide necessary treatment with qualified specialists. The program shall provide genetic screening and followup services for persons who have the screening. (b) The department shall expand statewide screening of newborns to include tandem mass spectrometry screening for fatty acid oxidation, amino acid, and organic acid disorders and congenital adrenal hyperplasia as soon as possible. The department shall provide information with respect to these disorders and available testing resources to all women receiving prenatal care and to all women admitted to a hospital for delivery. If the department is unable to provide this statewide screening by August 1, 2005, the department shall temporarily obtain these testing services through a competitive bid process from one or more public or private laboratories that meet the department's requirements for testing, quality assurance, and reporting. If the department determines that contracting for these services is more cost-effective, and meets the other requirements of this chapter, than purchasing the tandem mass spectrometry equipment themselves, the department shall contract with one or more public or private laboratories. (c) The department shall report to the Legislature regarding the progress of the program on or before July 1, 2006. The report shall include the costs for screening, followup, and treatment as compared to costs and morbidity averted for each condition tested for in the program.

125002. (a) In order to align closely related programs and in order to facilitate research into the causes of, and treatment for, birth defects, the Birth Defects Monitoring Program provided for pursuant to Chapter 1 (commencing with Section 103825) of Part 2 of Division 102 shall become part of the Maternal, Child, and Adolescent Health program provided for in Article 1 (commencing with Section 123225) of Chapter 1 of Part 2 of Division 106. (b) It is the intent of the Legislature that pregnancy blood samples, taken for prenatal screening, shall be stored and made available to any researcher who is approved by the department for the following purposes: (1) Research to identify risk factors for children's and women's diseases. (2) Research to develop and evaluate screening tests. (3) Research to develop and evaluate prevention strategies. (4) Research to develop and evaluate treatments. (c) Before any pregnancy blood samples are released for research purposes, all of the following conditions must be met: (1) Individual consent at the time the sample is drawn to allow confidential use of the sample for research purposes by the department or the department's approved researchers. (2) Protocol review for scientific merit by the department or another entity authorized by the department. (3) Protocol review by the State Committee for the Protection of Human Subjects. (d) Since the pregnancy blood samples described in this section will be stored by the California Birth Defects Monitoring Program or another entity authorized by the department, the storage, analysis, and sharing of pregnancy blood samples for research purposes shall be done in compliance with Section 103850, pertaining to confidentiality of information. (e) The department shall adopt regulations specifying the protocols and conditions under which blood samples will be released for research purposes, in accordance with the procedures set forth in subdivision (d) of Section 124977. (f) Until such time that regulations are adopted by the department pursuant to subdivision (e), the Genetic Disease Screening Program and the Birth Defects Monitoring Program shall release blood samples to only those researchers who meet the requirements of this section, including all of the following: (1) The research project was approved by the State Committee for the Protection of Human Subjects. (2) The research project's protocol was approved by the State Committee for the Protection of Human Subjects, and specifically included a description of the number and type of blood samples requested from the Genetic Disease Screening Program or the Maternal, Child, and Adolescent Health Program, including the Birth Defects Monitoring Program for the project. (3) There is written documentation that the Genetic Disease Screening Program or the Maternal, Child, and Adolescent Health Program, including the Birth Defects Monitoring Program, approved a request for the blood samples for the research project approved by the State Committee for the Protection of Human Subjects. (4) The researcher has agreed to pay fees to the department to pay reasonable costs for processing the samples and information, including, but not limited to, costs of data management, including data linkage and entry, and costs of blood collection, storage, retrieval, inventory, and shipping. (g) Subdivision (f) shall become inoperative on the date that the department adopts regulations specifying the protocols and conditions for release of the blood samples for research purposes.


Article 3. Sickle Cell Anemia

Ca Codes (hsc:125025-125035) Health And Safety Code Section 125025-125035



125025. It is the policy of the State of California to make every effort to detect, as early as possible, sickle cell anemia, a heritable disorder that leads to physical defects. The department shall have the responsibility of designating tests and regulations to be used in executing this policy. These tests shall be in accordance with accepted medical practices. Testing for sickle cell anemia may be conducted at the following times: (a) Upon first enrollment of a child at an elementary school in this state, the child may be tested. (b) For any child not tested pursuant to subdivision (a), upon first enrollment at a junior high school or senior high school in this state, as the case may be, the child may be tested. (c) Upon application of any person for a license to marry, the parties seeking to be married may be tested. (d) At any other times that the department may designate. This section shall not apply if a parent or guardian of a minor child sought to be tested or any adult sought to be tested objects to the test on the ground that the test conflicts with his or her religious beliefs or practices.


125030. The department may require that a test be given for sickle cell anemia pursuant to Section 125025 to any identifiable segment of the population that the department determines is susceptible to sickle cell anemia at a disproportionately higher ratio than is the balance of the population.


125035. The department is authorized to make grants or contracts for demonstration projects to determine the feasibility of alternate methods of testing for sickle cell anemia, to provide counseling services, to evaluate the social consequences of the identification of sickle cell trait carriers, to provide training in genetic counseling, and to conduct research on the prevention of sickle cell anemia.


Article 4. Prenatal Testing

Ca Codes (hsc:125050-125119.5) Health And Safety Code Section 125050-125119.5



125050. The department shall administer a statewide program for the prenatal testing for genetic disorders and birth defects, including, but not limited to, ultrasound, amniocentesis, chorionic villus sampling, and blood testing for genetic disorders and birth defects.


125055. The department shall: (a) Establish criteria for eligibility for the prenatal testing program. Eligibility shall include definition of conditions and circumstances that result in a high risk of a detectable genetic disorder or birth defect. (b) Develop an education program designed to educate physicians and surgeons and the public concerning the uses of prenatal testing and the availability of the program. (c) Ensure that genetic counseling be given in conjunction with prenatal testing at the approved prenatal diagnosis centers. (d) Designate sufficient prenatal diagnosis centers to meet the need for these services. Prenatal diagnosis centers shall have equipment and staff trained and capable of providing genetic counseling and performing prenatal diagnostic procedures and tests, including the interpretation of the results of the procedures and tests. (e) Administer a program of subsidy grants for approved nonprofit prenatal diagnosis centers. The subsidy grants shall be awarded based on the reported number of low-income women referred to the center, the number of prenatal diagnoses performed in the previous year at that center, and the estimated size of unmet need for prenatal diagnostic procedures and tests in its service area. This subsidy shall be in addition to fees collected under other state programs. (f) Establish any rules, regulations, and standards for prenatal diagnostic testing and the allocation of subsidies as the director deems necessary to promote and protect the public health and safety and to implement the Hereditary Disorders Act (Section 27). (g) (1) The department shall expand prenatal screening to include all tests that meet or exceed the current standard of care as recommended by nationally recognized medical or genetic organizations, including, but not limited to, inhibin. (2) The prenatal screening fee increase for expanding prenatal screening to include those tests described in paragraph (1) is forty dollars ($40). (3) The department shall report to the Legislature regarding the progress of the program with regard to implementing prenatal screening for those tests described in paragraph (1) on or before July 1, 2007. The report shall include the costs of screening, followup, and treatment as compared to costs and morbidity averted by this testing under the program. (4) (A) The expenditure of funds from the Genetic Disease Testing Fund for the expansion of the Genetic Disease Branch Screening Information System to include the expansion of prenatal screenings, pursuant to paragraph (1), may be implemented through the amendment of the Genetic Disease Branch Screening Information System contracts, and shall not be subject to Chapter 2 (commencing with Section 10290) or Chapter 3 (commencing with Section 12100) of Part 2 of Division 2 of the Public Contract Code, Article 4 (commencing with Section 19130) of Chapter 5 of Part 2 of Division 5 of Title 2 of the Government Code, or Sections 4800 to 5180, inclusive, of the State Administrative Manual as they relate to approval of information technology projects or approval of increases in the duration or costs of information technology projects. This paragraph shall apply to the design, development, and implementation of the expansion, and to the maintenance and operation of the Genetic Disease Branch Screening Information System, including change requests, once the expansion is implemented. (B) (i) The department may adopt emergency regulations to implement and make specific the amendments to this section made during the 2006 portion of the 2005-06 Regular Session in accordance with Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code. For the purposes of the Administrative Procedure Act, the adoption of regulations shall be deemed an emergency and necessary for the immediate preservation of the public peace, health and safety, or general welfare. Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, these emergency regulations shall not be subject to the review and approval of the Office of Administrative Law. Notwithstanding Section 11346.1 and Section 11349.6 of the Government Code, the department shall submit these regulations directly to the Secretary of State for filing. The regulations shall become effective immediately upon filing by the Secretary of State. Regulations shall be subject to public hearing within 120 days of filing with the Secretary of State and shall comply with Sections 11346.8 and 11346.9 of the Government Code or shall be repealed. (ii) The Office of Administrative Law shall provide for the printing and publication of these regulations in the California Code of Regulations. Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the regulations adopted pursuant to this chapter shall not be repealed by the Office of Administrative Law and shall remain in effect until revised or repealed by the department.

125060. The participation by any individual in the prenatal testing program shall be wholly voluntary and shall not be a prerequisite to eligibility for, or receipt of, any other service or assistance from, or to participation in, any other program.


125065. All prenatal diagnosis centers shall meet standards developed by the department and shall agree to accept patients from state funded or administered programs, including, but not limited to, Medi-Cal, Regional Centers, Maternal and Child Health, California Children's Services, Genetically Handicapped Persons Program, and Family Planning. Only prenatal diagnosis centers meeting standards developed by the department shall be eligible for reimbursement under these state programs.


125070. Laboratories licensed by the department shall not offer the maternal serum-alpha fetoprotein screening test for prenatal detection of neural tube defects of the fetus until the department has developed regulations, under the authorization granted by Section 124980. However, laboratories providing this testing, as of July 21, 1983, may continue to provide this testing until these regulations become operative. The department shall adopt regulations pursuant to this section.


125075. Every licensed physician and surgeon or other person attending a newborn infant diagnosed as having had rhesus (Rh) isoimmunization hemolytic disease shall report the condition to the department on report forms prescribed by the department.


125080. A licensed physician and surgeon or other person engaged in the prenatal care of a pregnant woman or attending the woman at the time of delivery shall obtain or cause to be obtained a blood specimen of the woman. Prior to obtaining the blood specimen, the woman shall be notified of the fact that the blood specimen is going to be obtained. If the blood specimen is not obtained prior to delivery, it shall be obtained at the time of delivery.


125085. (a) As early as possible during prenatal care, a blood specimen obtained pursuant to Section 125080 shall be submitted to a clinical laboratory licensed by the department or to an approved public health laboratory for a determination of rhesus (Rh) blood type and the results shall be reported to both of the following: (1) The physician and surgeon or other person engaged in the prenatal care of the woman or attending the woman at the time of delivery. (2) The woman tested. (b) (1) In addition, as early as possible during prenatal care, a blood specimen obtained pursuant to Section 125080 shall be submitted to a clinical laboratory licensed by the department or to an approved public health laboratory for a test to determine the presence of hepatitis B surface antigen and the human immunodeficiency virus (HIV), and the results shall be reported to both of the following: (A) The physician and surgeon or other person engaged in the prenatal care of the women or attending the woman at the time of delivery who ordered the test, and who shall subsequently inform the woman tested. (B) A positive test result shall be reported to the local health officer, with the information required and within the timeframes established by the department, pursuant to Chapter 4 (commencing with Section 2500) of Title 17 of the California Code of Regulations. (2) In the event that other tests to determine hepatitis B infection or HIV infection become available, the department may approve additional tests.


125090. (a) Subdivision (a) of Section 125085 shall not be applicable if the licensed physician and surgeon or other person engaged in the prenatal care of a pregnant woman or attending the woman at the time of delivery has knowledge of the woman's blood type and accepts responsibility for the accuracy of the information. (b) Subdivision (b) of Section 125085 shall not be applicable if the licensed physician and surgeon or other person engaged in the prenatal care of a pregnant woman or attending the woman at the time of delivery has knowledge that the woman has previously been determined to be chronically infected with hepatitis B or human immunodeficiency virus (HIV) and accepts responsibility for the accuracy of the information. (c) Prior to obtaining a blood specimen collected pursuant to subdivision (b) of Section 125085 or this section, the physician and surgeon or other person engaged in the prenatal care of a pregnant woman, or attending the woman at the time of labor or delivery, shall ensure that the woman is informed of the intent to perform a test for HIV infection, the routine nature of the test, the purpose of the testing, the risks and benefits of the test, the risk of perinatal transmission of HIV, that approved treatments are known to decrease the risk of perinatal transmission of HIV, and that the woman has a right to decline this testing. (d) If, during the final review of standard of prenatal care medical tests, the medical records of the pregnant woman do not document a test for rhesus (Rh) antibody blood type, a test for hepatitis B, or a test for HIV, the physician and surgeon or other person engaged in the prenatal care of the woman, or attending the woman at the time of labor or delivery, shall obtain a blood specimen from the woman for the tests that have not been documented. Prior to obtaining this blood specimen, the provider shall ensure that the woman is informed of the intent to perform the tests that have not been documented prior to this visit, including a test for HIV infection, the routine nature of the test, the purpose of the testing, the risks and benefits of the test, the risk of perinatal transmission of HIV, that approved treatments are known to decrease the risk of perinatal transmission of HIV, and that the woman has a right to decline the HIV test. The blood shall be tested by a method that will ensure the earliest possible results, and the results shall be reported to both of the following: (1) The physician and surgeon or other person engaged in the prenatal care of the woman or attending the woman at the time of delivery. (2) The woman tested. (e) After the results of the tests done pursuant to this section and Section 125085 have been received, the physician and surgeon or other person engaged in the prenatal care of the pregnant woman or attending the woman at the time of labor, delivery, or post partum care at the time the results are received shall ensure that the woman receives information and counseling, as appropriate, to explain the results and the implications for the mother's and infant's health, including any followup testing and care that are indicated. If the woman tests positive for HIV antibodies, she shall also receive, whenever possible, a referral to a provider, provider group, or institution specializing in prenatal and post partum care for HIV-positive women and their infants. Health care providers are also strongly encouraged to seek consultation with HIV specialists who provide care for pregnant and post partum HIV-positive women and their infants. (f) The provisions of Section 125107 for counseling are equally applicable to every pregnant patient covered by subdivisions (c) and (d). (g) Nothing in this section shall be construed to permit a licensed physician and surgeon or other person engaged in the prenatal care of a pregnant woman or attending the woman at the time of delivery to unlawfully disclose an individual's HIV status, or to otherwise violate provisions of Section 54 of the Civil Code, the Americans With Disabilities Act of 1990 (Public Law 101-336), or the California Fair Employment and Housing Act (Part 2.8 (commencing with Section 12900) of Division 3 of Title 2 of the Government Code), which prohibit discrimination against individuals who are living with HIV, or who test positive for HIV, or are presumed to be HIV-positive.


125092. The department, in consultation with the Office of AIDS and with other stakeholders, including, but not limited to, representatives of professional medical and public health advocacy groups, providers of health care to women and infants infected with or exposed to HIV, and women living with HIV, shall develop culturally sensitive informational material adequate to fulfill the requirements of subdivisions (c) and (d) of Section 125090, in English, Spanish, and other languages used by the department when providing information to clients under the Medi-Cal program. This material shall also include information on available referral and consultation resources of experts in prenatal HIV treatment. This material shall be completed by December 31, 2004.


125095. The department may adopt regulations as it determines are reasonably necessary for the implementation of the Maternal and Child Health Program Act (Section 27).


125100. (a) Clinical laboratories licensed by the department, approved public health laboratories, local health departments, physicians and surgeons, or other persons engaged in the prenatal care of a pregnant woman or in the care of an infant shall maintain and make available to the department information necessary to evaluate, for public health purposes, the effectiveness of testing and followup treatment for the prevention of perinatally transmitted hepatitis B infection. (b) The department shall make available, to the extent state funds are appropriated therefor in the annual Budget Act or federal funds are available for that purpose, money to each county requesting funds for testing and followup treatment for the prevention of perinatally transmitted hepatitis B infection or for any functions performed pursuant to subdivision (a). The money shall be allocated by the department on the basis of the incidence of perinatally transmitted hepatitis B infection and the need for necessary followup treatment and evaluation in the requesting county.


125105. (a) The blood specimen and test results pursuant to subdivision (b) of Section 125085 shall be confidential and shall not be disclosed, except as otherwise provided by law. (b) No person shall be compelled in any state, county, city, or other local civil, criminal, administrative, legislative, or other proceeding to provide test results determined pursuant to Section 125080 and Section 125085.


125107. (a) For purposes of this section, "prenatal care provider" means a licensed health care professional providing prenatal care within his or her lawful scope of practice. This definition shall not include a licensed health care professional who provides care other than prenatal care to a pregnant patient. (b) The prenatal care provider primarily responsible for providing prenatal care to a pregnant patient shall offer human immunodeficiency virus (HIV) information and counseling to every pregnant patient. This information and counseling shall include, but shall not be limited to, all of the following: (1) A description of the modes of HIV transmission. (2) A discussion of risk reduction behavior modifications including methods to reduce the risk of perinatal transmission. (3) If appropriate, referral information to other HIV prevention and psychosocial services including anonymous and confidential test sites approved by the Office of AIDS. (c) Nothing in this section shall be construed to require mandatory testing. Any documentation or disclosure of HIV-related information shall be made in accordance with Chapter 7 (commencing with Section 120975) of Part 4 of Division 105 regarding confidentiality and informed consent. (d) Nothing in this section shall be construed to permit a prenatal care provider to unlawfully disclose an individual's HIV status, or to otherwise violate provisions of Section 54 of the Civil Code, or the Americans With Disabilities Act of 1990 (Public Law 101-336), or the California Fair Employment and Housing Act (Part 2.8 (commencing with Section 12900) of Division 3 of Title 2 of the Government Code), which prohibit discrimination against individuals who are living with HIV, or who test positive for HIV, or are presumed to be HIV-positive.


125110. The Maternal and Child Health Program Act (Section 27) shall not apply if the pregnant woman objects to the test required by that act on the ground that the test conflicts with her religious beliefs or practices.

125118. (a) The State Department of Public Health shall develop guidelines for research involving the derivation or use of human embryonic stem cells in California. (b) In developing the guidelines specified in subdivision (a), the department may consider other applicable guidelines developed or in use in the United States and in other countries, including, but not limited to, the Guidelines for Research Using Human Pluripotent Stem Cells developed by the National Institutes of Health and published in August 2000, and corrected in November 2000, and the Guidelines for Human Embryonic Stem Cell Research issued by the National Research Council and Institute of Medicine of the National Academies in 2005.


125119. (a) (1) All research projects involving the derivation or use of human embryonic stem cells shall be reviewed and approved by a stem cell research oversight committee prior to being undertaken. Any stem cell research oversight committee shall, in its review of human embryonic stem cell research projects, consider and apply the guidelines developed by the department pursuant to Section 125118. A stem cell research oversight committee may require modifications to the plan or design of a proposed human embryonic stem cell research project as a condition of approving the research project. (2) A stem cell research oversight committee for purposes of this article shall be established substantially in accordance with Guidelines for Human Embryonic Stem Cell Research issued by the National Research Council and the Institute of Medicine of the National Academies in 2005. This committee shall be established in accordance with standards issued by the California Institute for Regenerative Medicine (CIRM) as authorized by Article XXXV of the California Constitution. The intent of the Legislature is to avoid inconsistencies for stem cell research oversight committees established pursuant to this article with other existing standards for research conducted in California. (b) Not less than once per year, a stem cell research oversight committee shall conduct continuing review of human embryonic stem cell research projects reviewed and approved under this section in order to ensure that the research continues to meet the standards for stem cell research oversight committee approval. Pursuant to its review in accordance with this subdivision, a stem cell research oversight committee may revoke its prior approval of research under this section and require modifications to the plan or design of a continuing research project before permitting the research to continue. (c) A stem cell research oversight committee may provide scientific and ethical review of research consistent with this article.


125119.3. (a) Each stem cell research oversight committee that has reviewed human embryonic stem cell research pursuant to Section 125119 shall report to the department, annually, on the number of human embryonic stem cell research projects that the stem cell research oversight committee has reviewed, and the status and disposition of each of those projects, including the information collected pursuant to Section 125342. (b) Each stem cell research oversight committee shall also report to the department regarding unanticipated problems, unforeseen issues, or serious continuing investigator noncompliance with the requirements or determinations of the stem cell research oversight committee with respect to the review of human embryonic stem cell research projects, and the actions taken by the stem cell research oversight committee to respond to these situations.


125119.5. (a) The department shall at least annually review reports from stem cell research oversight committees, and may revise the guidelines developed pursuant to Section 125118, as it deems necessary. (b) The department shall provide a biennial review to the Legislature on human embryonic stem cell research activity. These biennial reviews shall be compiled from the reports from stem cell research oversight committees.


Chapter 2. Genetic Disease Services

Article 1. Genetically Handicapped Persons Program

Ca Codes (hsc:125125-125191) Health And Safety Code Section 125125-125191



125125. This article shall be known and may be cited as the Holden-Moscone-Garamendi Genetically Handicapped Person's Program.


125130. The Director of Health Services shall establish and administer a program for the medical care of persons with genetically handicapping conditions, including cystic fibrosis, hemophilia, sickle cell disease, Huntington's disease, Friedreich's Ataxia, Joseph's disease, Von Hippel-Landau syndrome, and the following hereditary metabolic disorders: phenylketonuria, homocystinuria, branched chain amino acidurias, disorders of propionate and methylmalonate metabolism, urea cycle disorders, hereditary orotic aciduria, Wilson's Disease, galactosemia, disorders of lactate and pyruvate metabolism, tyrosinemia, hyperornithinemia, and other genetic organic acidemias that require specialized treatment or service available from only a limited number of program-approved sources. The program shall also provide access to social support services, that may help ameliorate the physical, psychological, and economic problems attendant to genetically handicapping conditions, in order that the genetically handicapped person may function at an optimal level commensurate with the degree of impairment. The medical and social support services may be obtained through physicians and surgeons, genetically handicapped person's program specialized centers, and other providers that qualify pursuant to the regulations of the department to provide the services. "Medical care," as used in this section, is limited to noncustodial medical and support services. The director, with the guidance of the Advisory Committee on Genetically Handicapped Person's Program, may, by regulation, expand the list of genetically handicapping conditions covered under this article. The director shall adopt regulations that are necessary for the implementation of this article. The director, with the approval of the advisory committee, shall establish priorities for the use of funds and provision of services under this article.


125135. As used in this article, "genetically handicapping condition" shall mean a disease that is accepted as being genetic in origin by the American Society of Human Genetics.


125140. The program established under this article shall include any or all of the following medical and social support services: (a) Initial intake and diagnostic evaluation. (b) The cost of blood transfusion and use of blood derivatives, or both. (c) Rehabilitation services, including reconstructive surgery. (d) Expert diagnosis. (e) Medical treatment. (f) Surgical treatment. (g) Hospital care. (h) Physical and speech therapy. (i) Occupational therapy. (j) Special treatment. (k) Materials. ( l) Appliances and their upkeep, maintenance, and care. (m) Maintenance, transportation, or care incidental to any other form of services. (n) Respite care or other existing resources (e.g., sheltered workshops). (o) Genetic and long-term psychological counseling. (p) Appropriate administrative staff resources to carry out this article. The staff shall include, but not be limited to, at least one case manager per each 350 clients.


125145. The director shall appoint an 11-member Advisory Committee on Genetically Handicapped Person's Program composed of professional and consumer representatives who shall serve without compensation and at the discretion of the director. The director shall seek the advice of the advisory committee with respect to regulations to be adopted pursuant to this article.


125150. The director shall establish the rate structure for reimbursement of physicians and supportive services. The rates shall not be less than the amounts paid for provider services under the Medi-Cal Act (Chapter 7 (commencing with Section 14000) of Part 3 of Division 9 of the Welfare and Institutions Code).


125155. Reimbursement under this article shall not be made for any services that are available to the recipient under any other private, state, or federal programs or under other contractual or legal entitlements, except for those instances where the department determines that prolonged use of employer health insurance would jeopardize the recipient's employment. However, no provision in this article shall be construed as limiting in any way state participation in any federal governmental program for medical care of persons with genetically handicapping conditions.


125155.1. (a) Any person found eligible for services under this article whose employer-sponsored health coverage is later terminated or any person who applied for services provided under this article whose employer-sponsored health coverage was terminated during the six-month period prior to the date he or she applied for services pursuant to this article shall be determined ineligible for the services, unless the reason his or her employer-sponsored health coverage was terminated was because of one of the following: (1) The individual for whom the employer-sponsored coverage had been available lost coverage because of one or more of the following reasons: (A) A loss of employment or a change in employment status. (B) A change of address to a ZIP Code that is not covered by the employer-sponsored health coverage. (C) The individual's employer discontinued health benefits to all employees or dependents, or ceased to provide coverage or contributions for the category of employees or dependents applicable to the person or applicant. (D) The death of, or a legal separation or divorce from, the individual through whom the applicant was covered. (2) The applicant's employer-sponsored health coverage became unavailable because the services paid for under that coverage attained the lifetime coverage limit. (3) Coverage was under a COBRA policy and the COBRA coverage period has ended. (b) A person who applies for services provided pursuant to this article shall certify, at the time of application, under penalty of perjury, that he or she was not covered by employer-sponsored health coverage during the six-month period prior to the date of his or her application or, if he or she was covered by employer-sponsored health coverage, attest to why one of the reasons listed in subdivision (a) is applicable to him or her and provide documentation from the employer-sponsored health coverage that supports his or her attestation. (c) A person who has been found eligible for services provided pursuant to this article who is covered by employer-sponsored health coverage that is terminated shall notify the Genetically Handicapped Persons Program within 45 days of the effective date of the termination and, when applicable, provide the program with the certification described in subdivision (b). (d) An applicant or eligible person who fails to comply with subdivisions (b) and (c) shall be ineligible for services pursuant to this article for six months. The department shall provide written notice to all persons found to be ineligible pursuant to this section. The notice shall provide information on the ability of the person to appeal or seek a waiver of determinations of ineligibility. (e) The department shall provide a process to appeal decisions of ineligibility based on this section in accordance with the procedures for resolution of complaints and appeals established for applicants and persons eligible for services pursuant to Article 5 (commencing with Section 123800) of Chapter 3 of Part 2. (f) The director, on a case-by-case basis, may waive determinations of ineligibility pursuant to this section, or reduce the time periods set forth in subdivision (a) or subdivision (d), if the director determines that the determination or the time periods will result in undue hardship. (g) Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the department may implement this section by means of Genetically Handicapped Persons Program policy letters. Following consultation with a stakeholder workgroup consisting of, but not limited to, provider associations, provider representatives, and consumer groups to ensure stakeholder participation in the implementation of this section, including, but not limited to, any changes deemed necessary by the department and the stakeholder workgroup to update the application for enrollment form and the development of regulations, the department shall, within 18 months from the effective date of this section, adopt any necessary regulations in accordance with the requirements of Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code.


125157. (a) The department may require a client under this article to apply to enroll or otherwise participate in any other state or federal program or other contractual or legal entitlement that would provide services to the client that would otherwise be reimbursed pursuant to this article. (b) The department may, when it determines that it is cost effective, pay the premium for, or otherwise subsidize the subscriber cost-sharing obligation for, third-party health coverage for a person eligible for services under this article. (c) The department may, for a person eligible for services under this article, when the person's third-party health coverage would lapse due to loss of employment, change in health status, lack of sufficient income or financial resources, or any other reason, continue the health coverage by paying the costs of continuation of group coverage pursuant to federal law or converting from a group to individual plan, when the department determines that it is cost effective. (d) Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the department may implement this section by means of Genetically Handicapped Persons Program policy letters. Following consultation with a stakeholder workgroup consisting of, but not limited to, provider associations, provider representatives, and consumer groups to ensure stakeholder participation in the implementation of this section, including, but not limited to, any changes deemed necessary by the department and the stakeholder workgroup to update the application for enrollment form and the development of regulations, the department shall, within 18 months from the effective date of this section, adopt any necessary regulations in accordance with the requirements of Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code.


125160. The department shall receive and expend all funds made available to it by the federal government, the state, its political subdivisions or from other sources for the purposes of this article. Payment for genetically handicapped person's program shall be made by the department.


125166. (a) Commencing July 1, 2009, except as provided in subdivision (d), each client determined or redetermined by the department to be eligible for services provided pursuant to this article shall pay an annual enrollment fee to the department as set forth in this section. (b) (1) There shall be an annual enrollment fee based on the client's adjusted gross income or, if the client is a minor, the client's parents' or legal guardians' combined adjusted gross income, as reported on the relevant state or federal income tax forms for the previous tax year. In calculating the enrollment fee where both a state and a federal income tax form has been filed, the higher of the two adjusted gross income amounts shall be used. (2) For adjusted gross income between 200 and 299 percent of the federal poverty level, the annual enrollment fee shall be 1.5 percent of adjusted gross income. (3) For adjusted gross income equal to or greater than 300 percent of the federal poverty level, the annual enrollment fee shall be 3 percent of adjusted gross income. (4) In the event the annual enrollment fee determined pursuant to paragraph (2) or (3) exceeds the cost of care incurred during the applicable year, the department shall reduce the enrollment fee by refund or credit to an amount equal to the cost of care. (c) (1) Payment of the enrollment fee is a condition of program participation. (2) The department may arrange for periodic payment of the fee during the year. (3) The director, on a case-by-case basis, may waive or reduce the amount of an enrollment fee if the director determines payment of the fee will result in undue hardship for the family. Otherwise, failure to pay or arrange for payment of the enrollment fee within 60 days of the due date shall result in disenrollment and ineligibility for coverage of treatment services effective 60 days after the due date of the fee. (d) The enrollment fee shall not be charged in the following cases: (1) The client is eligible for the full scope of Medi-Cal benefits, without being required to pay a share of cost, at the time of enrollment fee determination. (2) The client who is otherwise eligible to receive services has, or if the client is a minor, the client's parents or guardians have, an adjusted gross income of less than 200 percent of the federal poverty level. (e) All enrollment fees shall be used in support of the program for services provided pursuant to this article. (f) Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the department may implement this section by means of Genetically Handicapped Persons Program policy letters. Following consultation with a stakeholder workgroup consisting of, but not limited to, provider associations, provider representatives, and consumers groups to ensure stakeholder participation in the implementation of this section, including, but not limited to, any changes to update the application for enrollment form and the development of regulations, the department shall, within 18 months from the effective date of this section, adopt regulations in accordance with the requirements of Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code.


125170. The department shall maintain sufficient, appropriate staff to carry out this article.


125175. The health care benefits and services specified in this article, to the extent that the benefits and services are neither provided under any other federal or state law nor provided nor available under other contractual or legal entitlements of the person, shall be provided to any patient who is a resident of this state and is made eligible by this article. After the patient has utilized the contractual or legal entitlements, the payment liability under Section 125165 or Section 125166, whichever shall be applicable at the time, shall then be applied to the remaining cost of genetically handicapped person's services.


125180. The department shall require all applicants to the program who may be eligible for cash grant public assistance or for Medi-Cal to apply for Medi-Cal eligibility prior to becoming eligible for funded services.

125190. Notwithstanding any other provision of law, the department is considered to be the purchaser, but not the dispenser or distributor, of blood factor products under the Genetically Handicapped Person's Program. The department may receive manufacturers' discounts, rebates, or refunds based on the quantities purchased under the Genetically Handicapped Person's Program. The discounts, rebates, or refunds received pursuant to this section shall be separate from any agreements for discounts, rebates, or refunds negotiated pursuant to Section 14105.3 of the Welfare and Institutions Code or any other program.


125191. (a) The department may enter into contracts with one or more manufacturers on a negotiated or bid basis as the purchaser, but not the dispenser or distributor, of factor replacement therapies under the Genetically Handicapped Person's Program for the purpose of enabling the department to obtain the full range of available therapies and services required for clients with hematological disorders at the most favorable price and to enable the department, notwithstanding any other provision of state law, to obtain discounts, rebates, or refunds from the manufacturers based upon the large quantities purchased under the program. Nothing in this subdivision shall interfere with the usual and customary distribution practices of factor replacement therapies. In order to achieve maximum cost savings, the Legislature hereby determines that an expedited contract process under this section is necessary. Therefore, a contract under this subdivision may be entered into on a negotiated basis and shall be exempt from Chapter 2 (commencing with Section 10290) of Part 2 of Division 2 of the Public Contract Code and Chapter 6 (commencing with Section 14825) of Part 5.5 of Division 3 of the Government Code. Contracts entered pursuant to this subdivision shall be confidential and shall be exempt from disclosure under the California Public Records Act (Chapter 3.5 (commencing with Section 6250) of Division 7 of Title 1 of the Government Code). (b) (1) Factor replacement therapy manufacturers shall calculate and pay interest on late or unpaid rebates. The interest shall not apply to any prior period adjustments of unit rebate amounts or department utilization adjustments. Manufacturers shall calculate and pay interest on late or unpaid rebates for quarters that begin on or after the effective date of the act that added this subdivision. (2) Following the final resolution of any dispute regarding the amount of a rebate, any underpayment by a manufacturer shall be paid with interest calculated pursuant to paragraph (4), and any overpayment, together with interest at the rate calculated pursuant to paragraph (4), shall be credited by the department against future rebates due. (3) Interest pursuant to paragraphs (1) and (2) shall begin accruing 38 calendar days from the date of mailing the invoice, including supporting utilization data sent to the manufacturer. Interest shall continue to accrue until the date of mailing of the manufacturer's payment. (4) Interest rates and calculations pursuant to paragraphs (1) and (2) shall be identical to interest rates and calculations set forth in the federal Centers for Medicare and Medicaid Services' Medicaid Drug Rebate Program Releases or regulations. (c) If the department has not received a rebate payment, including interest, within 180 days of the date of mailing of the invoice, including supporting utilization data, a factor replacement therapy manufacturer's contract with the department shall be deemed to be in default and the contract may be terminated in accordance with the terms of the contract. This subdivision does not limit the department' s right to otherwise terminate a contract in accordance with the terms of that contract. (d) The department may enter into contracts on a bid or negotiated basis with manufacturers, distributors, dispensers, or suppliers of pharmaceuticals, appliances, durable medical equipment, medical supplies, and other product-type health care services and laboratories for the purpose of obtaining the most favorable prices to the state and to assure adequate access and quality of the product or service. In order to achieve maximum cost savings, the Legislature hereby determines that an expedited contract process under this subdivision is necessary. Therefore, contracts under this subdivision may be entered into on a negotiated basis and shall be exempt from Chapter 2 (commencing with Section 10290) of Part 2 of Division 2 of the Public Contract Code and Chapter 6 (commencing with Section 14825) of Part 5.5 of Division 3 of the Government Code. (e) The department may contract with one or more manufacturers of each multisource prescribed product or supplier of outpatient clinical laboratory services on a bid or negotiated basis. Contracts for outpatient clinical laboratory services shall require that the contractor be a clinical laboratory licensed or certified by the State of California or certified under Section 263a of Title 42 of the United States Code. Nothing in this subdivision shall be construed as prohibiting the department from contracting with less than all manufacturers or clinical laboratories, including just one manufacturer or clinical laboratory, on a bid or negotiated basis.


Article 2. Long-term Care For Degenerative Genetic Disease 125200-125220

Ca Codes (hsc:125200-125220) Health And Safety Code Section 125200-125220



125200. The Legislature finds and declares that there are many persons in California who are victims of chronic and degenerative genetic conditions, who experience a wide range of degenerating conditions including mental and physical deterioration. For some of these conditions, there is no known prior detection or subsequent treatment. The Legislature further finds and declares that appropriate supportive care services, both in and out of the home, are very often unavailable, due to the lack of resource identification and referral, and the lack of case management services.


125205. The department and the State Department of Social Services shall, after consultation with the Genetically Handicapped Persons Program of the department, from the Genetically Handicapped Persons Program Advisory Committee, and from consumer organizations representing persons with chronic and degenerative conditions, as defined in Section 125210, compile a list of long-term care resources that serve adults with chronic and degenerative conditions, as defined. The list of resources shall include those that have already been identified by the Genetically Handicapped Persons Program as serving persons with Huntington's disease, Joseph's disease, and Friedrich's ataxia, and shall include those that have already been identified by consumer organizations representing persons with chronic and degenerative conditions. The list of resources shall include, but not be limited to, the following: (a) Public and private skilled nursing facilities and intermediate care facilities. (b) Public and private community residential care facilities. (c) Public and private out-of-home long-term care resources such as day activity programs, and in-home support service programs. Nothing in this section shall require the Department of Health Services to undertake a survey of long-term care facilities or programs in the state for the purposes of carrying out the requirements of this section. The information shall be made available to the public, upon request, through the Genetically Handicapped Persons Program of the department.


125210. For the purposes of this article, chronic and degenerative diseases shall include those conditions that are neurological and neuromuscular in origin, including such disorders as Huntington's disease, Friedrich's ataxia, Joseph's disease, and other disorders that are determined by the department to be similar in origin and clinical manifestation to the named disorders, and that affect adults.


125215. The department and the State Department of Social Services shall review regulations that currently provide disincentives to providers of in-home and out-of-home long-term care resources, as defined in Section 125205, to accept and serve persons with chronic and degenerative disorders. The review shall be conducted with assistance and input from the Genetically Handicapped Persons Program of the department, and from the Genetically Handicapped Persons Program Advisory Committee. These departments shall provide a list of those regulations to the Legislature by September 1, 1982. The regulations subject to review shall be those regulations that do the following: (a) Affect the admission of patients to state-licensed skilled nursing facilities, intermediate care facilities, and community residential care facilities. (b) Affect the staffing ratios necessary to care for persons with chronic and degenerative conditions, as defined, within those facilities. (c) Affect the likelihood of facilities, or of day care programs and in-home support service programs, to refuse the admission of persons with chronic and degenerative conditions, solely on the basis of anticipated jeopardy to their licensing, or on the basis of anticipated liability to the facilities arising from instances where a person's degenerative condition, by its own clinical merits, results in medical complications that are, in fact, entirely unrelated to the quality of care provided by the facility or program.


125220. The actions undertaken pursuant to this article shall not impose additional state obligations or expenditures for the care of persons with chronic and degenerative conditions, as defined by this article, unless the Legislature enacts a statute specifically appropriating money for the additional obligations or expenditures.



Article 3. Huntington's Disease Research And Workshop Grants

Ca Codes (hsc:125225-125250) Health And Safety Code Section 125225-125250



125225. The Legislature hereby finds and declares that: (a) Huntington's disease is a chronic progressive inherited disorder of the central nervous system. (b) The constellation of mental and physical symptoms, the insidious onset of the disorder, and the torment of those at-risk, waiting throughout their lives to learn if they have been spared, conspire to make "Huntington's disease one of the most diabolical diseases known to man." Each child of a patient with Huntington's disease has a 50/50 chance of getting the disease. (c) Males, females, and all ethnic groups may be affected and there is no effective treatment or cure. Because so little is known about the disease, many people are misdiagnosed and mistreated. (d) The suicide rate among Huntington's disease patients is estimated to be seven times the national rate. (e) The advancement of scientific knowledge about Huntington's disease, that, because of its extraordinary range of symptoms, serves as an excellent prototype for other major chronic genetic, neurologic, and psychiatric illnesses and diseases of aging, such as epilepsy, muscular dystrophy, and Parkinson's disease, will reveal fundamental scientific information that may lead to treatment, prevention, and ultimately a cure for an array of inherited disorders that affect millions.


125230. The director may establish any rules or criteria for grants under this article as the director deems necessary.


125235. There is hereby created a Scientific Advisory Review Committee. The membership of the committee shall be composed of 11 members who shall be representatives from each of the following: (a) Two from the University of California. (b) One from Stanford University. (c) One from the California Institute of Technology. (d) One from the Hereditary Disease Foundation. (e) One from the City of Hope. (f) One from the Health and Welfare Agency appointed by the Secretary of the Health and Welfare Agency. (g) One appointed by the Speaker of the Assembly. (h) One appointed by the President pro Tempore of the California Senate. (i) One from the National Huntington's Disease Association. (j) One from the Committee to Combat Huntington's Disease. Except as otherwise provided in this section, members of the committee shall be appointed by the director, who shall make the appointments based upon recommendations from the entity or organization represented. The members of the committee shall serve at the pleasure of the appointing power. The members of the committee shall serve without compensation, but shall be reimbursed for necessary and travel expenses incurred in the performance of the duties on the committee. The Scientific Advisory Review Committee is hereby abolished one year after the grants under this article have been made by the director.


125240. Pursuant to the rules or criteria as the director may deem necessary, the Scientific Advisory Review Committee shall review and recommend approval of grant applications and monitor programs receiving grants under this article.

125245. The director may make grants as follows: (a) Individual research grants to scientists and facilities residing in this state that have research experience with basic and clinical investigations on Huntington's disease and related disorders. Individual research grants shall not exceed twenty thousand dollars ($20,000). (b) Interdisciplinary workshop grants to scientists and facilities for the purposes of facilitating interchange among an interdisciplinary group of investigators regarding problems in the treatment and care of patients as well as basic research, all of which may be applicable to a variety of genetic or neuro-degenerative disorders in addition to Huntington's disease. Individual workshop grants shall not exceed twelve thousand five hundred dollars ($12,500).

125250. Not more than 10 percent of any money appropriated for purposes of this article shall be utilized for the administration of this article.


Article 4. Alzheimer's Disease

Ca Codes (hsc:125275-125285) Health And Safety Code Section 125275-125285



125275. (a) The Legislature finds that Alzheimer's disease, a devastating disease which destroys certain vital cells of the brain, affects more than 1,500,000 Americans. The Legislature also finds that Alzheimer's disease and related disorders are responsible for 50 percent of all nursing home admissions and Alzheimer's disease is the fourth leading cause of death in adults. The Legislature recognizes that the disease has serious emotional, financial, and social consequences for its victims and their families. (b) The Legislature recognizes that the cause of Alzheimer's disease is presently unknown, and there is no established treatment which can cure, reverse, or stop the progression of Alzheimer's disease. The Legislature also recognizes that research is the only hope for victims and families. The Legislature finds that existing diagnostic and treatment centers have improved the quality of care available to the victims of Alzheimer's disease and increased knowledge with respect to Alzheimer's disease and related disorders. These centers provide clinical opportunities for research and facilitate the collection of essential data regarding Alzheimer's disease and related disorders, while at the same time providing valuable services such as information and referral, counseling, and training to victims and their families. It is the intent of the Legislature, in enacting this article, to encourage the establishment of geographically dispersed diagnostic and treatment centers for Alzheimer's disease within every postsecondary higher educational institution with a medical center, and to encourage research to discover the cause of, and a cure for, Alzheimer's disease. (c) The functions of the diagnostic and treatment centers shall be designed to serve all of the following purposes: (1) To provide diagnostic and treatment services and improve the quality of care to victims of Alzheimer's disease. (2) To increase research by faculty and students in discovering the cause of, and a cure for, Alzheimer's disease. (3) To provide training, monitoring, consultation, and continuing education to the families of those who are affected by Alzheimer's disease. (4) To increase the training of health care professionals with respect to Alzheimer's disease and other acquired brain impairments to the extent that the centers have the requisite expertise. (d) The diagnostic and treatment centers may collaborate with the Statewide Resources Consultant designated pursuant to Section 4364 of the Welfare and Institutions Code, to the extent that the centers deem necessary in order to fulfill the functions set forth in subdivision (c).


125280. (a) Any postsecondary higher educational institution with a medical center may establish diagnostic and treatment centers for Alzheimer's disease subject to the department's grants review process. (b) The department shall administer grants to postsecondary higher educational institutions that establish diagnostic and treatment centers pursuant to subdivision (a). (c) Funds appropriated for the purposes of this article by the Statutes of 1987 shall first be used to maintain and enhance, as determined by the department, existing centers and to prevent program cutbacks under subdivision (b). (d) Alzheimer's disease grants for the purpose of establishing a diagnostic and treatment center shall be used only for the purposes of this article, including, but not limited to, all of the following: (1) Salary and benefits for faculty, residents, fellows, and staff of the diagnostic and treatment center. (2) Costs of supplies and equipment. (3) Research grants for faculty research to discover the cause of, and a cure for, Alzheimer's disease. (4) Research grants for students, residents, and fellows. (5) General administrative costs of up to 8 percent of the total grant. (e) The department shall establish criteria for requests for Alzheimer's disease diagnostic and treatment center grants and Alzheimer's disease research grants, and for program evaluation. (f) No grant awarded pursuant to this article shall be approved for any amount that exceeds 25 percent of the total amount of funds appropriated for this purpose in the 1987-88 Regular Session of the Legislature. (g) The department shall administer a grant program for the purpose of research into the causes, treatment, cure, strategies for coping with, prevention, incidence, and prevalence of Alzheimer's disease and related disorders. Priority shall be given to grant applications for feasibility studies, startup grants, and matching funds for federal and privately funded research grants. Consideration shall be given to proposals that link service delivery and collect data relative to patient care and the delivery of social services. This research may include, but is not limited to, examinations and recommendations for the improvement of the family, community-based and health care support systems available to Alzheimer's disease victims, and their caregivers. (h) Upon request, the department shall make available to the Legislature information regarding the progress of the grant programs established pursuant to this article. (i) The department shall reduce any grant pursuant to this article by the amount of any federal funds available for the same purposes to the same grantee.

125285. The department shall provide public and professional education on Alzheimer's disease to educate consumers, caregivers, and health care providers, and to increase public awareness. If the department determines that contracts are required to implement this section, the department may award these contracts on a sole source basis. The contracts shall not be subject to Part 2 (commencing with Section 10100) of Division 2 of the Public Contract Code. Notwithstanding any other provision of law, the balance of funds appropriated pursuant to the Budget Act of 2000 for Alzheimer's disease education shall be available for encumbrance and expenditure until June 30, 2003.


Chapter 3. California Stem Cell Research And Cures Bond Act

Article 1. California Stem Cell Research And Cures Act

Ca Codes (hsc:125290.10-125290.80) Health And Safety Code Section 125290.10-125290.80



125290.10. General--Independent Citizen's Oversight Committee (ICOC) This chapter implements Article XXXV of the California Constitution, which established the California Institute for Regenerative Medicine (institute).


125290.15. Creation of the ICOC There is hereby created the Independent Citizen's Oversight Committee, hereinafter, the ICOC, which shall govern the institute and is hereby vested with full power, authority, and jurisdiction over the institute.


125290.20. ICOC Membership; Appointments; Terms of Office (a) ICOC Membership The ICOC shall have 29 members, appointed as follows: (1) The Chancellors of the University of California at San Francisco, Davis, San Diego, Los Angeles, and Irvine shall each appoint an executive officer from his or her campus. (2) The Governor, the Lieutenant Governor, the Treasurer, and the Controller shall each appoint an executive officer from the following three categories: (A) A California university, excluding the five campuses of the University of California described in paragraph (1), that has demonstrated success and leadership in stem cell research, and that has: (i) A nationally ranked research hospital and medical school; this criteria will apply to only two of the four appointments. (ii) A recent proven history of administering scientific and/or medical research grants and contracts in an average annual range exceeding one hundred million dollars ($100,000,000). (iii) A ranking, within the past five years, in the top 10 United States universities with the highest number of life science patents or that has research or clinical faculty who are members of the National Academy of Sciences. (B) A California nonprofit academic and research institution that is not a part of the University of California, that has demonstrated success and leadership in stem cell research, and that has: (i) A nationally ranked research hospital or that has research or clinical faculty who are members of the National Academy of Sciences. (ii) A proven history in the last five years of managing a research budget in the life sciences exceeding twenty million dollars ($20,000,000). (C) A California life science commercial entity that is not actively engaged in researching or developing therapies with pluripotent or progenitor stem cells, that has a background in implementing successful experimental medical therapies, and that has not been awarded, or applied for, funding by the institute at the time of appointment. A board member of that entity with a successful history of developing innovative medical therapies may be appointed in lieu of an executive officer. (D) Only one member shall be appointed from a single university, institution, or entity. The executive officer of a California university, a nonprofit research institution or life science commercial entity who is appointed as a member, may from time to time delegate those duties to an executive officer of the entity or to the dean of the medical school, if applicable. (3) The Governor, the Lieutenant Governor, the Treasurer, and the Controller shall appoint members from among California representatives of California regional, state, or national disease advocacy groups, as follows: (A) The Governor shall appoint two members, one from each of the following disease advocacy groups: spinal cord injury and Alzheimer's disease. (B) The Lieutenant Governor shall appoint two members, one from each of the following disease advocacy groups: type II diabetes and multiple sclerosis or amyotrophic lateral sclerosis. (C) The Treasurer shall appoint two members, one from each of the following disease groups: type I diabetes and heart disease. (D) The Controller shall appoint two members, one from each of the following disease groups: cancer and Parkinson's disease. (4) The Speaker of the Assembly shall appoint a member from among California representatives of a California regional, state, or national mental health disease advocacy group. (5) The President pro Tempore of the Senate shall appoint a member from among California representatives of a California regional, state, or national HIV/AIDS disease advocacy group. (6) A chairperson and vice chairperson who shall be elected by the ICOC members. Each constitutional officer shall nominate a candidate for chairperson and another candidate for vice chairperson. The chairperson and vice chairperson shall each be elected for a term of six years. The chairperson and vice chairperson of ICOC shall be full- or part-time employees of the institute and shall meet the following criteria: (A) Mandatory Chairperson Criteria (i) Documented history in successful stem cell research advocacy. (ii) Experience with state and federal legislative processes that must include some experience with medical legislative approvals of standards and/or funding. (iii) Qualified for appointment pursuant to paragraph (3), (4), or (5) of subdivision (a). (iv) Cannot be concurrently employed by or on leave from any prospective grant or loan recipient institutions in California. (B) Additional Criteria for Consideration: (i) Experience with governmental agencies or institutions (either executive or board position). (ii) Experience with the process of establishing government standards and procedures. (iii) Legal experience with the legal review of proper governmental authority for the exercise of government agency or government institutional powers. (iv) Direct knowledge and experience in bond financing. The vice chairperson shall satisfy clauses (i), (iii), and (iv) of subparagraph (A). The vice chairperson shall be selected from among individuals who have attributes and experience complementary to those of the chairperson, preferably covering the criteria not represented by the chairperson's credentials and experience. (b) Appointment of ICOC Members (1) All appointments shall be made within 40 days of the effective date of this act. In the event that any of the appointments are not completed within the permitted timeframe, the ICOC shall proceed to operate with the appointments that are in place, provided that at least 60 percent of the appointments have been made. (2) Forty-five days after the effective date of the measure adding this chapter, the Controller and the Treasurer, or if only one is available within 45 days, the other shall convene a meeting of the appointed members of the ICOC to elect a chairperson and vice chairperson from among the individuals nominated by the constitutional officers pursuant to paragraph (6) of subdivision (a). (c) ICOC Member Terms of Office (1) The members appointed pursuant to paragraphs (1), (3), (4), and (5) of subdivision (a) shall serve eight-year terms, and all other members shall serve six-year terms. Members shall serve a maximum of two terms. (2) If a vacancy occurs within a term, the appointing authority shall appoint a replacement member within 30 days to serve the remainder of the term. (3) When a term expires, the appointing authority shall appoint a member within 30 days. ICOC members shall continue to serve until their replacements are appointed.


125290.25. Majority Vote of Quorum Actions of the ICOC may be taken only by a majority vote of a quorum of the ICOC.


125290.30. Public and Financial Accountability Standards (a) Annual Public Report The institute shall issue an annual report to the public which sets forth its activities, grants awarded, grants in progress, research accomplishments, and future program directions. Each annual report shall include, but not be limited to, the following: the number and dollar amounts of research and facilities grants; the grantees for the prior year; the institute's administrative expenses; an assessment of the availability of funding for stem cell research from sources other than the institute; a summary of research findings, including promising new research areas; an assessment of the relationship between the institute's grants and the overall strategy of its research program; and a report of the institute's strategic research and financial plans. (b) Independent Financial Audit for Review by Controller The institute shall annually commission an independent financial audit of its activities from a certified public accounting firm, which shall be provided to the Controller, who shall review the audit and annually issue a public report of that review. (c) A performance audit shall be commissioned by the institute every three years beginning with the audit for the 2010-11 fiscal year. The performance audit, which may be performed by the Bureau of State Audits, shall examine the functions, operations, management systems, and policies and procedures of the institute to assess whether the institute is achieving economy, efficiency, and effectiveness in the employment of available resources. The performance audit shall be conducted in accordance with government auditing standards, and shall include a review of whether the institute is complying with ICOC policies and procedures. The performance audit shall not be required to include a review of scientific performance. The first performance audit shall include, but not be limited to, all of the following: (1) Policies and procedures for the issuance of contracts and grants and a review of a representative sample of contracts, grants, and loans executed by the institute. (2) Policies and procedures relating to the protection or treatment of intellectual property rights associated with research funded or commissioned by the institute. (d) All administrative costs of the audits required by subdivisions (b) and (c) shall be paid by the institute. (e) Citizen's Financial Accountability Oversight Committee There shall be a Citizen's Financial Accountability Oversight Committee chaired by the Controller. This committee shall review the annual financial audit, the Controller's report and evaluation of that audit, and the financial practices of the institute. The Controller, the Treasurer, the President pro Tempore of the Senate, the Speaker of the Assembly, and the Chairperson of the ICOC shall each appoint a public member of the committee. Committee members shall have medical backgrounds and knowledge of relevant financial matters. The committee shall provide recommendations on the institute' s financial practices and performance. The Controller shall provide staff support. The committee shall hold a public meeting, with appropriate notice, and with a formal public comment period. The committee shall evaluate public comments and include appropriate summaries in its annual report. The ICOC shall provide funds for all costs associated with the per diem expenses of the committee members and for publication of the annual report. (f) Public Meeting Laws (1) The ICOC shall hold at least two public meetings per year, one of which will be designated as the institute's annual meeting. The ICOC may hold additional meetings as it determines are necessary or appropriate. (2) The Bagley-Keene Open Meeting Act, Article 9 (commencing with Section 11120) of Chapter 1 of Part 1 of Division 3 of Title 2 of the Government Code, shall apply to all meetings of the ICOC, except as otherwise provided in this section. The ICOC shall award all grants, loans, and contracts in public meetings and shall adopt all governance, scientific, medical, and regulatory standards in public meetings. (3) The ICOC may conduct closed sessions as permitted by the Bagley-Keene Open Meeting Act, under Section 11126 of the Government Code. In addition, the ICOC may conduct closed sessions when it meets to consider or discuss: (A) Matters involving information relating to patients or medical subjects, the disclosure of which would constitute an unwarranted invasion of personal privacy. (B) Matters involving confidential intellectual property or work product, whether patentable or not, including, but not limited to, any formula, plan, pattern, process, tool, mechanism, compound, procedure, production data, or compilation of information, which is not patented, which is known only to certain individuals who are using it to fabricate, produce, or compound an article of trade or a service having commercial value and which gives its user an opportunity to obtain a business advantage over competitors who do not know it or use it. (C) Matters involving prepublication, confidential scientific research or data. (D) Matters concerning the appointment, employment, performance, compensation, or dismissal of institute officers and employees. Action on compensation of the institute's officers and employees shall only be taken in open session. (4) The meeting required by paragraph (2) of subdivision (b) of Section 125290.20 shall be deemed to be a special meeting for the purposes of Section 11125.4 of the Government Code. (g) Public Records (1) The California Public Records Act, Article 1 (commencing with Section 6250) of Chapter 3.5 of Division 7 of Title 1 of the Government Code, shall apply to all records of the institute, except as otherwise provided in this section. (2) Nothing in this section shall be construed to require disclosure of any records that are any of the following: (A) Personnel, medical, or similar files, the disclosure of which would constitute an unwarranted invasion of personal privacy. (B) Records containing or reflecting confidential intellectual property or work product, whether patentable or not, including, but not limited to, any formula, plan, pattern, process, tool, mechanism, compound, procedure, production data, or compilation of information, which is not patented, which is known only to certain individuals who are using it to fabricate, produce, or compound an article of trade or a service having commercial value and which gives its user an opportunity to obtain a business advantage over competitors who do not know it or use it. (C) Prepublication scientific working papers or research data. (3) The institute shall include, in all meeting minutes, a summary of vote tallies and disclosure of each board member's votes and recusals on all action items. (h) Competitive Bidding (1) The institute shall, except as otherwise provided in this section, be governed by the competitive bidding requirements applicable to the University of California, as set forth in Article 1 (commencing with Section 10500) of Chapter 2.1 of Part 2 of Division 2 of the Public Contract Code. (2) For all institute contracts, the ICOC shall follow the procedures required of the Regents by Article 1 (commencing with Section 10500) of Chapter 2.1 of Part 2 of Division 2 of the Public Contract Code with respect to contracts let by the University of California. (3) The requirements of this section shall not be applicable to grants or loans approved by the ICOC. (4) Except as provided in this section, the Public Contract Code shall not apply to contracts let by the institute. (i) Conflicts of Interest (1) The Political Reform Act, Title 9 (commencing with Section 81000) of the Government Code, shall apply to the institute and to the ICOC, except as provided in this section and in subdivision (e) of Section 125290.50. (A) No member of the ICOC shall make, participate in making, or in any way attempt to use his or her official position to influence a decision to approve or award a grant, loan, or contract to his or her employer, but a member may participate in a decision to approve or award a grant, loan, or contract to a nonprofit entity in the same field as his or her employer. (B) A member of the ICOC may participate in a decision to approve or award a grant, loan, or contract to an entity for the purpose of research involving a disease from which a member or his or her immediate family suffers or in which the member has an interest as a representative of a disease advocacy organization. (C) The adoption of standards is not a decision subject to this section. (2) Service as a member of the ICOC by a member of the faculty or administration of any system of the University of California shall not, by itself, be deemed to be inconsistent, incompatible, in conflict with, or inimical to the duties of the ICOC member as a member of the faculty or administration of any system of the University of California and shall not result in the automatic vacation of either such office. Service as a member of the ICOC by a representative or employee of a disease advocacy organization, a nonprofit academic and research institution, or a life science commercial entity shall not be deemed to be inconsistent, incompatible, in conflict with, or inimical to the duties of the ICOC member as a representative or employee of that organization, institution, or entity. (3) Section 1090 of the Government Code shall not apply to any grant, loan, or contract made by the ICOC except where both of the following conditions are met: (A) The grant, loan, or contract directly relates to services to be provided by any member of the ICOC or the entity the member represents or financially benefits the member or the entity he or she represents. (B) The member fails to recuse himself or herself from making, participating in making, or in any way attempting to use his or her official position to influence a decision on the grant loan or contract. (j) Patent Royalties and License Revenues Paid to the State of California (1) The ICOC shall establish standards that require that all grants and loan awards be subject to intellectual property agreements that balance the opportunity of the State of California to benefit from the patents, royalties, and licenses that result from basic research, therapy development, and clinical trials with the need to ensure that essential medical research is not unreasonably hindered by the intellectual property agreements. All revenues received through the intellectual property agreements established pursuant to this subdivision shall be deposited into the General Fund. (2) These standards shall include, at a minimum, a requirement that CIRM grantees, other than loan recipients and facilities grant recipients, share a fraction of the revenue they receive from licensing or self-commercializing an invention or technology that arises from research funded by CIRM, as set forth below. All revenues received pursuant to this paragraph or regulations adopted to implement this paragraph shall be deposited in the General Fund for use consistent with Section 202(c)(7) of Title 35 of the United States Code, if applicable. (A) (i) A grantee that licenses an invention or technology that arises from research funded by CIRM shall pay 25 percent of the revenues it receives in excess of five hundred thousand dollars ($500,000), in the aggregate, to the General Fund. The threshold amount of five hundred thousand dollars ($500,000) shall be adjusted annually by a multiple of a fraction, the denominator of which is the Consumer Price Index, All Urban Consumers, All Items (San Francisco-Oakland-San Jose; 1982-84=100) as prepared by the Bureau of Labor Statistics of the United States Department of Labor and published for the month of October 2009, and the numerator of which is that index published for the month in which the grantee accepts the grant. (ii) If funding sources other than CIRM directly contributed to the development of the invention or technology, then the return to the General Fund shall be calculated as follows: The amount of CIRM funding for the invention or technology shall be divided by the total of funding provided by all sources, and that fraction shall be multiplied by 25. That numeral is the percentage due to the General Fund. (B) (i) A grantee that self-commercializes a product that results from an invention or technology that arises from research funded by CIRM shall pay an amount to the General Fund equal to three times the total amount of the CIRM grant or grants received by the grantee in support of the research that contributed to the creation of the product. The rate of payback of the royalty shall be at a rate of 3 percent of the annual net revenue received by the grantee from the product. (ii) In addition to the payment required by clause (i), the first time that net commercial revenues earned by the grantee from the product exceed two hundred fifty million dollars ($250,000,000) in a calendar year, the grantee shall make a one-time payment to the General Fund equal to three times the total amount of the grant or grants awarded by CIRM to the grantee in support of the research that contributed to the creation of the product. (iii) In addition to the payments required by clauses (i) and (ii), the first time that net commercial revenues earned by the grantee from the product exceed five hundred million dollars ($500,000,000) in a calendar year, the grantee shall make an additional one-time payment to the General Fund equal to three times the total amount of the grant or grants awarded by CIRM to the grantee in support of the research that contributed to the creation of the product. (iv) In addition to the payments required by clauses (i), (ii), and (iii), the first time that net commercial revenues earned by the grantee from the product equal or exceed five hundred million dollars ($500,000,000) in a calendar year, the grantee shall pay the General Fund 1 percent annually of net commercial revenue in excess of five hundred million dollars ($500,000,000) for the life of any patent covering the invention or technology, if the grantee patented its invention or technology and received a CIRM grant or grants amounting to more than five million dollars ($5,000,000) in support of the research that contributed to the creation of the product. (3) The ICOC shall have the authority to adopt regulations to implement this subdivision. The ICOC shall also have the authority to modify the formulas specified in subparagraphs (A) and (B) of paragraph (2) through regulations if the ICOC determines pursuant to paragraph (1) that a modification is required either in order to ensure that essential medical research, including, but not limited to, therapy development and the broad delivery of therapies to patients, is not unreasonably hindered, or to ensure that the State of California has an opportunity to benefit from the patents, royalties, and licenses that result from basic research, therapy development, and clinical trials. The ICOC shall notify the appropriate fiscal and policy committees of the Legislature 10 calendar days before exercising its authority to vote on the modification of the formulas specified in subparagraphs (A) and (B) of paragraph (2). (k) Preference for California Suppliers The ICOC shall establish standards to ensure that grantees purchase goods and services from California suppliers to the extent reasonably possible, in a good faith effort to achieve a goal of more than 50 percent of such purchases from California suppliers.


125290.35. Medical and Scientific Accountability Standards (a) Medical Standards In order to avoid duplication or conflicts in technical standards for scientific and medical research, with alternative state programs, the institute will develop its own scientific and medical standards to carry out the specific controls and intent of the act, notwithstanding subdivision (b) of Section 125300, Sections 125320, 125118, 125118.5, 125119, 125119.3 and 125119.5, or any other current or future state laws or regulations dealing with the study and research of pluripotent stem cells and/or progenitor cells, or other vital research opportunities, except Section 125315. The ICOC, its working committees, and its grantees shall be governed solely by the provisions of this act in the establishment of standards, the award of grants, and the conduct of grants awarded pursuant to this act. (b) The ICOC shall establish standards as follows: (1) Informed Consent Standards for obtaining the informed consent of research donors, patients, or participants, which initially shall be generally based on the standards in place on January 1, 2003, for all research funded by the National Institutes of Health, with modifications to adapt to the mission and objectives of the institute. (2) Controls on Research Involving Humans Standards for the review of research involving human subjects which initially shall be generally based on the Institutional Review Board standards promulgated by the National Institutes of Health and in effect on January 1, 2003, with modifications to adapt to the mission and objectives of the institute. (3) Prohibition on Compensation Standards prohibiting compensation to research donors or participants, while permitting reimbursement of expenses. (4) Patient Privacy Laws Standards to assure compliance with state and federal patient privacy laws. (5) Limitations on Payments for Cells Standards limiting payments for the purchase of stem cells or stem cell lines to reasonable payment for the removal, processing, disposal, preservation, quality control, storage, transplantation, or implantation or legal transaction or other administrative costs associated with these medical procedures and specifically including any required payments for medical or scientific technologies, products, or processes for royalties, patent, or licensing fees or other costs for intellectual property. (6) Time Limits for Obtaining Cells Standards setting a limit on the time during which cells may be extracted from blastocysts, which shall initially be 8 to 12 days after cell division begins, not counting any time during which the blastocysts and/or cells have been stored frozen.


125290.40. ICOC Functions The ICOC shall perform the following functions: (a) Oversee the operations of the institute. (b) Develop annual and long-term strategic research and financial plans for the institute. (c) Make final decisions on research standards and grant awards in California. (d) Ensure the completion of an annual financial audit of the institute's operations. (e) Issue public reports on the activities of the institute. (f) Establish policies regarding intellectual property rights arising from research funded by the institute. (g) Establish rules and guidelines for the operation of the ICOC and its working groups. (h) Perform all other acts necessary or appropriate in the exercise of its power, authority, and jurisdiction over the institute. (i) Select members of the working groups. (j) Adopt, amend, and rescind rules and regulations to carry out the purposes and provisions of this chapter, and to govern the procedures of the ICOC. Except as provided in subdivision (k), these rules and regulations shall be adopted in accordance with the Administrative Procedure Act (Government Code, Title 2, Division 3, Part 1, Chapter 4.5, Sections 11371 et seq.). (k) Notwithstanding the Administrative Procedure Act (APA), and in order to facilitate the immediate commencement of research covered by this chapter, the ICOC may adopt interim regulations without compliance with the procedures set forth in the APA. The interim regulations shall remain in effect for 270 days unless earlier superseded by regulations adopted pursuant to the APA. (l) Request the issuance of bonds from the California Stem Cell Research and Cures Finance Committee and loans from the Pooled Money Investment Board. (m) May annually modify its funding and finance programs to optimize the institute's ability to achieve the objective that its activities be revenue-positive for the State of California during its first five years of operation without jeopardizing the progress of its core medical and scientific research program. (n) Notwithstanding Section 11005 of the Government Code, accept additional revenue and real and personal property, including, but not limited to, gifts, royalties, interest, and appropriations that may be used to supplement annual research grant funding and the operations of the institute. (o) Under the guidance of the ICOC, the institute shall create a succession plan addressing changes in leadership of both the institute and the ICOC designed to minimize disruption and adverse impacts to the activities of the institute. A copy of the succession plan shall be transmitted to the Governor, Controller, and the Legislature within 30 days of its completion. The succession plan should include, but is not limited to: (1) An assessment of leadership needs before beginning a search. (2) An outline of succession procedures. (3) Strategies to ensure successful knowledge transfer.


125290.45. ICOC Operations (a) Legal Actions and Liability (1) The institute may sue and be sued. (2) Based upon ICOC standards, institute grantees shall indemnify or insure and hold the institute harmless against any and all losses, claims, damages, expenses, or liabilities, including attorneys' fees, arising from research conducted by the grantee pursuant to the grant, and/or, in the alternative, grantees shall name the institute as an additional insured and submit proof of such insurance. (3) Given the scientific, medical, and technical nature of the issues facing the ICOC, and notwithstanding Section 11042 of the Government Code, the institute is authorized to retain outside counsel when the ICOC determines that the institute requires specialized services not provided by the Attorney General's office. (4) The institute may enter into any contracts or obligations which are authorized or permitted by law. (b) Personnel (1) The ICOC shall from time to time determine the total number of authorized employees for the institute, excluding members of the working groups who shall not be considered institute employees. The ICOC shall select a chairperson, vice chairperson, and president who shall exercise all of the powers delegated to them by the ICOC. The following functions apply to the chairperson, vice chairperson, and president: (A) The chairperson's primary responsibilities are to manage the ICOC agenda and workflow including all evaluations and approvals of scientific and medical working group grants, loans, facilities, and standards evaluations, and to supervise all annual reports and public accountability requirements; to manage and optimize the institute's bond financing plans and funding cashflow plan; to interface with the California Legislature, the United States Congress, the California health care system, and the California public; to optimize all financial leverage opportunities for the institute; and to lead negotiations for intellectual property agreements, policies, and contract terms. The chairperson shall also serve as a member of the Scientific and Medical Accountability Standards Working Group and the Scientific and Medical Research Facilities Working Group and as an ex officio member of the Scientific and Medical Research Funding Working Group. The vice chairperson's primary responsibilities are to support the chairperson in all duties and to carry out those duties in the chairperson's absence. (B) The president's primary responsibilities are to serve as the chief executive of the institute; to recruit the highest scientific and medical talent in the United States to serve the institute on its working groups; to serve the institute on its working groups; to direct ICOC staff and participate in the process of supporting all working group requirements to develop recommendations on grants, loans, facilities, and standards as well as to direct and support the ICOC process of evaluating and acting on those recommendations, the implementation of all decisions on these and general matters of the ICOC; to hire, direct, and manage the staff of the institute; to develop the budgets and cost control programs of the institute; to manage compliance with all rules and regulations of the ICOC, including the performance of all grant recipients; and to manage and execute all intellectual property agreements and any other contracts pertaining to the institute or research it funds. (2) Each member of the ICOC except, the chairperson, vice chairperson, and president, shall receive a per diem of one hundred dollars ($100) per day (adjusted annually for cost of living) for each day actually spent in the discharge of the member's duties, plus reasonable and necessary travel and other expenses incurred in the performance of the member's duties. (3) The ICOC shall establish daily consulting rates and expense reimbursement standards for the members of all of its working groups. (4) Notwithstanding Section 19825 of the Government Code, the ICOC shall set compensation for the chairperson, vice chairperson, and president and other officers, and for the scientific, medical, technical, and administrative staff of the institute within the range of compensation levels for executive officers and scientific, medical, technical, and administrative staff of medical schools within the University of California system and the nonprofit academic and research institutions described in paragraph (2) of subdivision (a) of Section 125290.20.

125290.50. Scientific and Medical Working Groups--General (a) The institute shall have, and there is hereby established, three separate scientific and medical working groups as follows: (1) Scientific and Medical Research Funding Working Group. (2) Scientific and Medical Accountability Standards Working Group. (3) Scientific and Medical Research Facilities Working Group. (b) Working Group Members Appointments of scientific and medical working group members shall be made by a majority vote of a quorum of the ICOC, within 30 days of the election and appointment of the initial ICOC members. The working group members' terms shall be six years except that, after the first six-year terms, the members' terms will be staggered so that one-third of the members shall be elected for a term that expires two years later, one-third of the members shall be elected for a term that expires four years later, and one-third of the members shall be elected for a term that expires six years later. Subsequent terms are for six years. Working group members may serve a maximum of two consecutive terms. (c) Working Group Meetings Each scientific and medical working group shall hold at least four meetings per year, one of which shall be designated as its annual meeting. (d) Working Group Recommendations to the ICOC Recommendations of each of the working groups may be forwarded to the ICOC only by a vote of a majority of a quorum of the members of each working group. If 35 percent of the members of any working group join together in a minority position, a minority report may be submitted to the ICOC. The ICOC shall consider the recommendations of the working groups in making its decisions on applications for research and facility grants and loan awards and in adopting regulatory standards. Each working group shall recommend to ICOC rules, procedures, and practices for that working group. (e) Conflict of Interest (1) The ICOC shall adopt conflict of interest rules, based on standards applicable to members of scientific review committees of the National Institutes of Health, to govern the participation of non-ICOC working group members. (2) The ICOC shall appoint an ethics officer from among the staff of the institute. (3) Because the working groups are purely advisory and have no final decisionmaking authority, members of the working groups shall not be considered public officials, employees, or consultants for purposes of the Political Reform Act (Title 9 (commencing with Section 81000) of the Government Code), Sections 1090 and 19990 of the Government Code, and Sections 10516 and 10517 of the Public Contract Code. (f) Working Group Records All records of the working groups submitted as part of the working groups' recommendations to the ICOC for approval shall be subject to the Public Records Act. Except as provided in this subdivision, the working groups shall not be subject to the provisions of Article 9 (commencing with Section 11120) of Chapter 1 of Part 1 of Division 3 of Title 2 of the Government Code, or Article 1 (commencing with Section 6250) of Chapter 3.5 of Division 7 of Title 1 of the Government Code.

125290.55. Scientific and Medical Accountability Standards Working Group (a) Membership The Scientific and Medical Accountability Standards Working Group shall have 19 members as follows: (1) Five ICOC members from the 10 groups that focus on disease-specific areas described in paragraphs (3), (4), and (5) of subdivision (a) of Section 125290.20. (2) Nine scientists and clinicians nationally recognized in the field of pluripotent and progenitor cell research. (3) Four medical ethicists. (4) The Chairperson of the ICOC. (b) Functions The Scientific and Medical Accountability Standards Working Group shall have the following functions: (1) To recommend to the ICOC scientific, medical, and ethical standards. (2) To recommend to the ICOC standards for all medical, socioeconomic, and financial aspects of clinical trials and therapy delivery to patients, including, among others, standards for safe and ethical procedures for obtaining materials and cells for research and clinical efforts for the appropriate treatment of human subjects in medical research consistent with paragraph (2) of subdivision (b) of Section 125290.35, and to ensure compliance with patient privacy laws. (3) To recommend to the ICOC modification of the standards described in paragraphs (1) and (2) as needed. (4) To make recommendations to the ICOC on the oversight of funded research to ensure compliance with the standards described in paragraphs (1) and (2). (5) To advise the ICOC, the Scientific and Medical Research Funding Working Group, and the Scientific and Medical Research Facilities Working Group, on an ongoing basis, on relevant ethical and regulatory issues.


125290.60. Scientific and Medical Research Funding Working Group (a) Membership The Scientific and Medical Research Funding Working Group shall have at least 23 members as follows: (1) Seven ICOC members from the 10 disease advocacy group members described in paragraphs (3), (4), and (5) of subdivision (a) of Section 125290.20. (2) At least 15 scientists nationally recognized in the field of stem cell research. (3) The Chairperson of the ICOC. (b) Functions The Scientific and Medical Research Funding Working Group shall perform the following functions: (1) Recommend to the ICOC interim and final criteria, standards, and requirements for considering funding applications and for awarding research grants and loans. (2) Recommend to the ICOC standards for the scientific and medical oversight of awards. (3) Recommend to the ICOC any modifications of the criteria, standards, and requirements described in paragraphs (1) and (2) above as needed. (4) Review grant and loan applications based on the criteria, requirements, and standards adopted by the ICOC and make recommendations to the ICOC for the award of research, therapy development, and clinical trial grants and loans. (5) Conduct peer group progress oversight reviews of grantees to ensure compliance with the terms of the award, and report to the ICOC any recommendations for subsequent action. (6) Recommend to the ICOC standards for the evaluation of grantees to ensure that they comply with all applicable requirements. Such standards shall mandate periodic reporting by grantees and shall authorize the Scientific and Medical Research Funding Working Group to audit a grantee and forward any recommendations for action to the ICOC. (7) Recommend its first grant awards within 60 days of the issuance of the interim standards. (c) Recommendations for Awards Award recommendations shall be based upon a competitive evaluation as follows: A peer review panel shall consist of both scientists and patient advocates. There shall be 15 scientists on a peer review panel. Only the scientist members of the Scientific and Medical Research Funding Working Group shall score grant and loan award applications for scientific merit. Such scoring shall be based on scientific merit in three separate classifications--research, therapy development, and clinical trials, on criteria including the following: (1) A demonstrated record of achievement in the areas of pluripotent stem cell and progenitor cell biology and medicine, unless the research is determined to be a vital research opportunity. (2) The quality of the research proposal, the potential for achieving significant research, or clinical results, the timetable for realizing such significant results, the importance of the research objectives, and the innovativeness of the proposed research. (3) In order to ensure that institute funding does not duplicate or supplant existing funding, a high priority shall be placed on funding pluripotent stem cell and progenitor cell research that cannot, or is unlikely to, receive timely or sufficient federal funding, unencumbered by limitations that would impede the research. In this regard, other research categories funded by the National Institutes of Health shall not be funded by the institute. (4) Notwithstanding paragraph (3), other scientific and medical research and technologies and/or any stem cell research proposal not actually funded by the institute under paragraph (3) may be funded by the institute if at least two-thirds of a quorum of the members of the Scientific and Medical Research Funding Working Group recommend to the ICOC that such a research proposal is a vital research opportunity.

125290.65. Scientific and Medical Facilities Working Group (a) Membership The Scientific and Medical Research Facilities Working Group shall have 11 members as follows: (1) Six members of the Scientific and Medical Research Funding Working Group. (2) Four real estate specialists. To be eligible to serve on the Scientific and Medical Research Facilities Working Group, a real estate specialist shall be a resident of California, shall be prohibited from receiving compensation from any construction or development entity providing specialized services for medical research facilities, and shall not provide real estate facilities brokerage services for any applicant for, or any funding by the Scientific and Medical Research Facilities Working Group and shall not receive compensation from any recipient of institute funding grants. (3) The Chairperson of the ICOC. (b) Functions The Scientific and Medical Research Facilities Working Group shall perform the following functions: (1) Make recommendations to the ICOC on interim and final criteria, requirements, and standards for applications for, and the awarding of, grants and loans for buildings, building leases, and capital equipment; those standards and requirements shall include, among others: (A) Facility milestones and timetables for achieving such milestones. (B) Priority for applications that provide for facilities that will be available for research no more than two years after the grant award. (C) The requirement that all funded facilities and equipment be located solely within California. (D) The requirement that grantees comply with reimbursable building cost standards, competitive building leasing standards, capital equipment cost standards, and reimbursement standards and terms recommended by the Scientific and Medical Facilities Funding Working Group, and adopted by the ICOC. (E) The requirement that grantees shall pay all workers employed on construction or modification of the facility funded by facilities grants or loans of the institute, the general prevailing rate of per diem wages for work of a similar character in the locality in which work on the facility is performed, and not less than the general prevailing rate of per diem wages for holiday and overtime work fixed as provided in Chapter 1 (commencing with Section 1720) of Part 7 of Division 2 of the Labor Code. (F) The requirement that grantees be not-for-profit entities. (G) The requirement that awards be made on a competitive basis, with the following minimum requirements: (i) That the grantee secure matching funds from sources other than the institute equal to at least 20 percent of the award. Applications of equivalent merit, as determined by the Scientific and Medical Research Funding Working Group, considering research opportunities to be conducted in the proposed research facility, shall receive priority to the extent that they provide higher matching fund amounts. The Scientific and Medical Research Facilities Working Group may recommend waiving the matching fund requirement in extraordinary cases of high merit or urgency. (ii) That capital equipment costs and capital equipment loans be allocated when equipment costs can be recovered in part by the grantee from other users of the equipment. (2) Make recommendations to the ICOC on oversight procedures to ensure grantees' compliance with the terms of an award.


125290.70. Appropriation and Allocation of Funding (a) Moneys in the California Stem Cell Research and Cures Fund shall be allocated as follows: (1) (A) No less than 97 percent of the proceeds of the bonds authorized pursuant to Section 125291.30, after allocation of bond proceeds to purposes described in paragraphs (4) and (5) of subdivision (a) of Section 125291.20, shall be used for grants and grant oversight as provided in this chapter. (B) Not less than 90 percent of the amount used for grants shall be used for research grants, with no more than the following amounts as stipulated below to be committed during the first 10 years of grant making by the institute, with each year's commitments to be advanced over a period of one to seven years, except that any such funds that are not committed may be carried over to one or more following years. The maximum amount of research funding to be allocated annually as follows: Year 1, 5.6 percent; Year 2, 9.4 percent; Year 3, 9.4 percent; Year 4, 11.3 percent; Year 5, 11.3 percent; Year 6, 11.3 percent; Year 7, 11.3 percent; Year 8, 11.3 percent; Year 9, 11.3 percent; and Year 10, 7.5 percent. (C) Not more than 3 percent of the proceeds of bonds authorized by Section 125291.30 may be used by the institute for research and research facilities implementation costs, including the development, administration, and oversight of the grant making process and the operations of the working groups. (2) Not more than 3 percent of the proceeds of the bonds authorized pursuant to Section 125291.30 shall be used for the costs of general administration of the institute. (3) In any single year any new research funding to any single grantee for any program year is limited to no more than 2 percent of the total bond authorization under this chapter. This limitation shall be considered separately for each new proposal without aggregating any prior year approvals that may fund research activities. This requirement shall be determinative, unless 65 percent of a quorum of the ICOC approves a higher limit for that grantee. (4) Recognizing the priority of immediately building facilities that ensure the independence of the scientific and medical research of the institute, up to 10 percent of the proceeds of the bonds authorized pursuant to Section 125291.30, net of costs described in paragraphs (2), (4), and (5) of subdivision (a) of Section 125291.20 shall be allocated for grants to build scientific and medical research facilities of nonprofit entities which are intended to be constructed in the first five years. (5) The institute shall limit indirect costs to 25 percent of a research award, excluding amounts included in a facilities award, except that the indirect cost limitation may be increased by that amount by which the grantee provides matching funds in excess of 20 percent of the grant amount. (b) To enable the institute to commence operating during the first six months following the adoption of the measure adding this chapter, there is hereby appropriated from the General Fund as a temporary start-up loan to the institute three million dollars ($3,000,000) for initial administrative and implementation costs. All loans to the institute pursuant to this appropriation shall be repaid to the General Fund within 12 months of each loan draw from the proceeds of bonds sold pursuant to Section 125291.30. (c) The institute's funding schedule is designed to create a positive tax revenue stream for the State of California during the institute's first five calendar years of operations, without drawing funds from the General Fund for principal and interest payments for those first five calendar years.


125290.71. Under the guidance of the ICOC, the institute shall, by January 31, 2012, create a transition plan addressing the expiration of current bond funding. A copy of the transition plan shall be transmitted to the Governor, the Controller, and the Legislature within 30 days of its completion.


125290.80. The intellectual property standards that the ICOC develops shall include: (a) A requirement that each grantee or the exclusive licensee of the grantee submit a plan to CIRM to afford access to any drug that is, in whole or in part, the result of research funded by CIRM to Californians who have no other means to purchase the drug. The access plan must be consistent with industry standards at the time of commercialization in California, accounting for the size of the market for the drug, and the resources of the grantee or exclusive licensee. (b) A requirement that the grantee or exclusive licensee either submit the plan required by subdivision (a), seek an extension from CIRM, or notify CIRM of its intention to seek a waiver, within 10 business days following final approval of the drug by the federal Food and Drug Administration. If the grantee seeks an extension, the plan must be submitted within 30 business days following final approval of the drug by the federal Food and Drug Administration. The plan shall be subject to the approval of CIRM, after a public hearing and opportunity for public comment. (c) A process by which the ICOC may waive the requirement in subdivision (a) if the ICOC determines, after a public hearing, that in the absence of the waiver, development and broad delivery of the drug will be unreasonably hindered or that the waiver will provide significant benefits that equal or exceed the benefits that would otherwise flow to the state pursuant to subdivision (a). The process shall include the requirement that a request for a waiver shall be posted on CIRM's Internet Web site for a minimum of 10 business days in advance of the public hearing and that CIRM shall notify the Legislature if the ICOC grants a waiver request, including the reasons that justified the waiver request. (d) Procedures to protect from public disclosure proprietary information submitted by grantees and exclusive licensees to CIRM pursuant to this section.


Article 2. California Stem Cell Research And Cures Bond Act Of 2004

Ca Codes (hsc:125291.10-125291.85) Health And Safety Code Section 125291.10-125291.85



125291.10. This article shall be known, and may be cited, as the California Stem Cell Research and Cures Bond Act of 2004.


125291.15. As used in this article, the following terms have the following meaning: (a) "Act" means the California Stem Cell Research and Cures Bond Act constituting Chapter 3 (commencing with Section 125290.10) of Part 5 of Division 106. (b) "Board" or "institute" means the California Institute for Regenerative Medicine designated in accordance with subdivision (b) of Section 125291.40. (c) "Committee" means the California Stem Cell Research and Cures Finance Committee created pursuant to subdivision (a) of Section 125291.40. (d) "Fund" means the California Stem Cell Research and Cures Fund created pursuant to Section 125291.25. (e) "Interim debt" means any interim loans pursuant to subdivision (b) of Section 125290.70, and Sections 125291.60 and 125291.65, bond anticipation notes or commercial paper notes issued to make deposits into the fund and which will be paid from the proceeds of bonds issued pursuant to this article.

125291.20. (a) Notwithstanding Section 13340 of the Government Code or any other provision of law, moneys in the fund are appropriated without regard to fiscal years to the institute for the purpose of (1) making grants or loans to fund research and construct facilities for research, all as described in and pursuant to the act, (2) paying general administrative costs of the institute (not to exceed 3 percent of the net proceeds of each sale of bonds), (3) paying the annual administration costs of the interim debt or bonds after December 31 of the fifth full calendar year after this article takes effect, (4) paying the costs of issuing interim debt, paying the annual administration costs of the interim debt until and including December 31 of the fifth full calendar year after this article takes effect, and paying interest on interim debt, if such interim debt is incurred or issued on or prior to December 31 of the fifth full calendar year after this article takes effect, and (5) paying the costs of issuing bonds, paying the annual administration costs of the bonds until and including December 31 of the fifth full calendar year after this article takes effect, and paying interest on bonds that accrues on or prior to December 31 of the fifth full calendar year after this article takes effect (except that such limitation does not apply to premium and accrued interest as provided in Section 125291.70). In addition, moneys in the fund or other proceeds of the sale of bonds authorized by this article may be used to pay principal of or redemption premium on any interim debt issued prior to the issuance of bonds authorized by this article. Moneys deposited in the fund from the proceeds of interim debt may be used to pay general administrative costs of the institute without regard to the 3 percent limit set forth in (2) above, so long as such 3 percent limit is satisfied for each issue of bonds. (b) Repayment of principal and interest on any loans made by the institute pursuant to this article shall be deposited in the fund and used to make additional grants and loans for the purposes of this act or for paying continuing costs of the annual administration of outstanding bonds.

125291.25. The proceeds of interim debt and bonds issued and sold pursuant to this article shall be deposited in the State Treasury to the credit of the California Stem Cell Research and Cures Fund, which is hereby created in the State Treasury, except to the extent that proceeds of the issuance of bonds are used directly to repay interim debt.


125291.30. Bonds in the total amount of three billion dollars ($3,000,000,000), not including the amount of any refunding bonds issued in accordance with Section 125291.75, or as much thereof as is necessary, may be issued and sold to provide a fund to be used for carrying out the purposes expressed in this article and to be used and sold for carrying out the purposes of Section 125291.20 and to reimburse the General Obligation Bond Expense Revolving Fund pursuant to Section 16724.5 of the Government Code. The bonds, when sold, shall be and shall constitute a valid and binding obligation of the State of California, and the full faith and credit of the State of California is hereby pledged for the punctual payment of both the principal of, and interest on, the bonds as the principal and interest become due and payable.


125291.35. The bonds authorized by this article shall be prepared, executed, issued, sold, paid, and redeemed as provided in the State General Obligation Bond Law (Chapter 4 (commencing with Section 16720) of Part 3 of Division 4 of Title 2 of the Government Code), and all of the provisions of that law except Section 16727 apply to the bonds and to this article and are hereby incorporated in this article as though set forth in full in this article.


125291.40. (a) Solely for the purpose of authorizing the issuance and sale, pursuant to the State General Obligation Bond Law, of the bonds and interim debt authorized by this article, the California Stem Cell Research and Cures Finance Committee is hereby created. For purposes of this article, the California Stem Cell Research and Cures Finance Committee is "the committee" as that term is used in the State General Obligation Bond Law. The committee consists of the Treasurer, the Controller, the Director of Finance, the Chairperson of the California Institute for Regenerative Medicine, and two other members of the Independent Citizens Oversight Committee (as created by the act) chosen by the Chairperson of the California Institute for Regenerative Medicine, or their designated representatives. The Treasurer shall serve as chairperson of the committee. A majority of the committee may act for the committee. (b) For purposes of the State General Obligation Bond Law, the California Institute for Regenerative Medicine is designated the "board."


125291.45. (a) The committee shall determine whether or not it is necessary or desirable to issue bonds authorized pursuant to this article in order to carry out the actions specified in this article and, if so, the amount of bonds to be issued and sold. Successive issues of bonds may be authorized and sold to carry out those actions progressively, and it is not necessary that all of the bonds authorized to be issued be sold at any one time. The bonds may bear interest which is includable in gross income for federal income tax purposes if the committee determines that such treatment is necessary in order to provide funds for the purposes of the act. (b) The total amount of the bonds authorized by Section 125291.30 which may be issued in any calendar year, commencing in 2005, shall not exceed three hundred fifty million dollars ($350,000,000). If less than this amount of bonds is issued in any year, the remaining permitted amount may be carried over to one or more subsequent years. (c) An interest-only floating rate bond structure will be implemented for interim debt and bonds until at least December 31 of the fifth full calendar year after this article takes effect, with all interest to be paid from proceeds from the sale of interim debt or bonds, to minimize debt service payable from the General Fund during the initial period of basic research and therapy development, if the committee determines, with the advice of the Treasurer, that this structure will result in the lowest achievable borrowing costs for the state during that five-year period considering the objective of avoiding any bond debt service payments, by the General Fund, during that period. Upon such initial determination, the committee may delegate, by resolution, to the Treasurer such authority in connection with issuance of bonds as it may determine, including, but not limited to, the authority to implement and continue this bond financing structure (including during any time following the initial five-year period) and to determine that an alternate financing plan would result in significant lower borrowing costs for the state consistent with the objectives related to the General Fund and to implement such alternate financing plan.


125291.50. There shall be collected each year and in the same manner and at the same time as other state revenue is collected, in addition to the ordinary revenues of the state, a sum in an amount required to pay the principal of, and interest on, the bonds maturing each year. It is the duty of all officers charged by law with any duty in regard to the collection of the revenue to do and perform each and every act that is necessary to collect that additional sum.


125291.55. Notwithstanding Section 13340 of the Government Code, there is hereby appropriated from the General Fund in the State Treasury, for the purposes of this article, an amount that will equal the total of the following: (a) The sum annually necessary to pay the principal of, and interest on, bonds issued and sold pursuant to this article, as the principal and interest become due and payable. (b) The sum necessary to carry out Section 125291.60 appropriated without regard to fiscal years.


125291.60. The Director of Finance may authorize the withdrawal from the General Fund of an amount or amounts, not to exceed the amount of the unsold bonds that have been authorized by the committee, to be sold for the purpose of carrying out this article. Any amount withdrawn shall be deposited in the fund. Any money made available under this section shall be returned to the General Fund, plus an amount equal to the interest that the money would have earned in the Pooled Money Investment Account, from money received from the sale of bonds for the purpose of carrying out this article.


125291.65. The institute may request the Pooled Money Investment Board to make a loan from the Pooled Money Investment Account in accordance with Section 16312 of the Government Code for the purposes of carrying out this article. The amount of the request shall not exceed the amount of the unsold bonds that the committee, by resolution, has authorized to be sold for the purpose of carrying out this article. The institute shall execute any documents required by the Pooled Money Investment Board to obtain and repay the loan. Any amounts loaned shall be deposited in the fund to be allocated by the institute in accordance with this article.


125291.70. All money deposited in the fund that is derived from premium and accrued interest on bonds sold shall be reserved in the fund and shall be available for transfer to the General Fund as a credit to expenditures for bond interest.


125291.75. The bonds may be refunded in accordance with Article 6 (commencing with Section 16780) of Chapter 4 of Part 3 of Division 4 of Title 2 of the Government Code, which is a part of the State General Obligation Bond Law. Approval by the voters of the state for the issuance of the bonds described in this article includes the approval of the issuance of any bonds issued to refund any bonds originally issued under this article or any previously issued refunding bonds.

125291.80. Notwithstanding any provision of this article or the State General Obligation Bond Law, if the Treasurer sells bonds pursuant to this article that include a bond counsel opinion to the effect that the interest on the bonds is excluded from gross income for federal tax purposes, subject to designated conditions, the Treasurer may maintain separate accounts for the investment of bond proceeds and the investment earnings on those proceeds. The Treasurer may use or direct the use of those proceeds or earnings to pay any rebate, penalty, or other payment required under federal law or to take any other action with respect to the investment and use of bond proceeds required or desirable under federal law to maintain the tax-exempt status of those bonds and to obtain any other advantage under federal law on behalf of the funds of this state.


125291.85. Inasmuch as the proceeds from the sale of bonds authorized by this article are not "proceeds of taxes" as that term is used in Article XIII B of the California Constitution, the disbursement of these proceeds is not subject to the limitations imposed by that article.


Article 3. Definitions

Ca Codes (hsc:125292.10) Health And Safety Code Section 125292.10



125292.10. As used in this chapter and in Article XXXV of the California Constitution, the following terms have the following meanings: (a) "Act" means the California Stem Cell Research and Cures Bond Act constituting Chapter 3 (commencing with Section 125290.10) of Part 5 of Division 106 of the Health and Safety Code. (b) "Adult stem cell" means an undifferentiated cell found in a differentiated tissue in an adult organism that can renew itself and may, with certain limitations, differentiate to yield all the specialized cell types of the tissue from which it originated. (c) "Capitalized interest" means interest funded by bond proceeds. (d) "Committee" means the California Stem Cell Research and Cures Finance Committee created pursuant to subdivision (a) of Section 125291.40. (e) "Constitutional officers" means the Governor, Lieutenant Governor, Treasurer, and Controller of California. (f) "Facilities" means buildings, building leases, or capital equipment. (g) "Floating-rate bonds" means bonds which do not bear a fixed rate of interest until their final maturity date, including commercial paper notes. (h) "Fund" means the California Stem Cell Research and Disease Cures Fund created pursuant to Section 125291.25. (i) "Grant" means a grant, loan, or guarantee. (j) "Grantee" means a recipient of a grant from the institute. All University of California grantee institutions shall be considered as separate and individual grantee institutions. (k) "Human reproductive cloning" means the practice of creating or attempting to create a human being by transferring the nucleus from a human cell into an egg cell from which the nucleus has been removed for the purpose of implanting the resulting product in a uterus to initiate a pregnancy. (l) "Indirect costs" mean the recipient's costs in the administration, accounting, general overhead, and general support costs for implementing a grant or loan of the institute. NIH definitions of indirect costs will be utilized as one of the bases by the Scientific and Medical Research Standards Working Group to create a guideline for recipients on this definition, with modifications to reflect guidance by the ICOC and this act. (m) "Institute" means the California Institute for Regenerative Medicine. (n) "Interim standards" means temporary standards that perform the same function as "emergency regulations" under the Administrative Procedure Act (Government Code, Title 2, Division 3, Part 1, Chapter 4.5, Sections 11371 et seq.) except that in order to provide greater opportunity for public comment on the permanent regulations, remain in force for 270 days rather than 180 days. (o) "Life science commercial entity" means a firm or organization, headquartered in California, whose business model includes biomedical or biotechnology product development and commercialization. (p) "Medical ethicist" means an individual with advanced training in ethics who holds a Ph.D., MA, or equivalent training and who spends or has spent substantial time (1) researching and writing on ethical issues related to medicine, and (2) administering ethical safeguards during the clinical trial process, particularly through service on institutional review boards. (q) "Pluripotent cells" means cells that are capable of self-renewal, and have broad potential to differentiate into multiple adult cell types. Pluripotent stem cells may be derived from somatic cell nuclear transfer or from surplus products of in vitro fertilization treatments when such products are donated under appropriate informed consent procedures. These excess cells from in vitro fertilization treatments would otherwise be intended to be discarded if not utilized for medical research. (r) "Progenitor cells" means multipotent or precursor cells that are partially differentiated but retain the ability to divide and give rise to differentiated cells. (s) "Quorum" means at least 65 percent of the members who are eligible to vote. (t) "Research donor" means a human who donates biological materials for research purposes after full disclosure and consent. (u) "Research funding" includes interdisciplinary scientific and medical funding for basic research, therapy development, and the development of pharmacologies and treatments through clinical trials. When a facility's grant or loan has not been provided to house all elements of the research, therapy development, and/or clinical trials, research funding shall include an allowance for a market lease rate of reimbursement for the facility. In all cases, operating costs of the facility, including, but not limited to, library and communication services, utilities, maintenance, janitorial, and security, shall be included as direct research funding costs. Legal costs of the institute incurred in order to negotiate standards with federal and state governments and research institutions; to implement standards or regulations; to resolve disputes; and/or to carry out all other actions necessary to defend and/or advance the institute's mission shall be considered direct research funding costs. (v) "Research participant" means a human enrolled with full disclosure and consent, and participating in clinical trials. (w) "Revenue positive" means all state tax revenues generated directly and indirectly by the research and facilities of the institute are greater than the debt service on the state bonds actually paid by the General Fund in the same year. (x) "Stem cells" mean nonspecialized cells that have the capacity to divide in culture and to differentiate into more mature cells with specialized functions. (y) "Vital research opportunity" means scientific and medical research and technologies and/or any stem cell research not actually funded by the institute under subparagraph (C) of paragraph (1) of subdivision (c) of Section 125290.60 which provides a substantially superior research opportunity vital to advance medical science as determined by at least a two-thirds vote of a quorum of the members of the Scientific and Medical Research Funding Working Group and recommended as such by that working group to the ICOC. Human reproductive cloning shall not be a vital research opportunity.


Part 5.5. Use Of Human Cells

Chapter 1. Embryo Registry

Ca Codes (hsc:125300-125320) Health And Safety Code Section 125300-125320



125300. The policy of the State of California shall be that research involving the derivation and use of human embryonic stem cells, human embryonic germ cells, and human adult stem cells, including somatic cell nuclear transplantation, shall be reviewed by a stem cell research oversight committee.


125305. (a) The department shall establish and maintain an anonymous registry of embryos that are available for research. The purpose of this registry is to provide researchers with access to embryos that are available for research purposes. (b) The department may contract with the University of California, private organizations, or public entities to establish and administer the registry. (c) This section shall be implemented only to the extent that funds for the purpose of establishing and administering the registry are received by the department from private or other nonstate sources.

125315. (a) A physician and surgeon or other health care provider delivering fertility treatment shall provide his or her patient with timely, relevant, and appropriate information to allow the individual to make an informed and voluntary choice regarding the disposition of any human embryos remaining following the fertility treatment. The failure to provide to a patient this information constitutes unprofessional conduct within the meaning of Chapter 5 (commencing with Section 2000) of Division 2 of the Business and Professions Code. (b) Any individual to whom information is provided pursuant to subdivision (a) shall be presented with the option of storing any unused embryos, donating them to another individual, discarding the embryos, or donating the remaining embryos for research. When providing fertility treatment, a physician and surgeon or other health care provider shall provide a form to the male and female partner, or the individual without a partner, as applicable, that sets forth advanced written directives regarding the disposition of embryos. This form shall indicate the time limit on storage of the embryos at the clinic or storage facility and shall provide, at a minimum, the following choices for disposition of the embryos based on the following circumstances: (1) In the event of the death of either the male or female partner, the embryos shall be disposed of by one of the following actions: (A) Made available to the living partner. (B) Donation for research purposes. (C) Thawed with no further action taken. (D) Donation to another couple or individual. (E) Other disposition that is clearly stated. (2) In the event of the death of both partners or the death of a patient without a partner, the embryos shall be disposed of by one of the following actions: (A) Donation for research purposes. (B) Thawed with no further action taken. (C) Donation to another couple or individual. (D) Other disposition that is clearly stated. (3) In the event of separation or divorce of the partners, the embryos shall be disposed of by one of the following actions: (A) Made available to the female partner. (B) Made available to the male partner. (C) Donation for research purposes. (D) Thawed with no further action taken. (E) Donation to another couple or individual. (F) Other disposition that is clearly stated. (4) In the event of the partners' decision or a patient's decision who is without a partner, to abandon the embryos by request or a failure to pay storage fees, the embryos shall be disposed of by one of the following actions: (A) Donation for research purposes. (B) Thawed with no further action taken. (C) Donation to another couple or individual. (D) Other disposition that is clearly stated. (c) A physician and surgeon or other health care provider delivering fertility treatment shall obtain written consent from any individual who elects to donate embryos remaining after fertility treatments for research. For any individual considering donating the embryos for research, to obtain informed consent, the health care provider shall convey all of the following to the individual: (1) A statement that the early human embryos will be used to derive human pluripotent stem cells for research and that the cells may be used, at some future time, for human transplantation research. (2) A statement that all identifiers associated with the embryos will be removed prior to the derivation of human pluripotent stem cells. (3) A statement that donors will not receive any information about subsequent testing on the embryo or the derived human pluripotent cells. (4) A statement that derived cells or cell lines, with all identifiers removed, may be kept for many years. (5) Disclosure of the possibility that the donated material may have commercial potential, and a statement that the donor will not receive financial or any other benefits from any future commercial development. (6) A statement that the human pluripotent stem cell research is not intended to provide direct medical benefit to the donor. (7) A statement that early human embryos donated will not be transferred to a woman's uterus, will not survive the human pluripotent stem cell derivation process, and will be handled respectfully, as is appropriate for all human tissue used in research.


125320. (a) A person may not knowingly, for valuable consideration, purchase or sell embryonic or cadaveric fetal tissue for research purposes pursuant to this chapter. (b) For purposes of this section, "valuable consideration" does not include reasonable payment for the removal, processing, disposal, preservation, quality control, storage, transplantation, or implantation of a part. (c) Embryonic or cadaveric fetal tissue may be donated for research purposes pursuant to this chapter.


Chapter 1.5. Oocyte Retrieval For Fertility Treatment

Ca Codes (hsc:125325-125325.15) Health And Safety Code Section 125325-125325.15



125325. (a) The person or entity posting an advertisement seeking oocyte donation associated with the delivery of fertility treatment that includes assisted oocyte production and a financial payment or compensation of any kind, shall include the following notice in a clear and conspicuous manner: "Egg donation involves a screening process. Not all potential egg donors are selected. Not all selected egg donors receive the monetary amounts or compensation advertised. As with any medical procedure, there may be risks associated with human egg donation. Before an egg donor agrees to begin the egg donation process, and signs a legally binding contract, she is required to receive specific information on the known risks of egg donation. Consultation with your doctor prior to entering into a donor contract is advised." (b) A summary pertaining to oocyte donation procedures, shall be provided, as required pursuant to Section 125335, to all potential egg donors before signing a legally binding contract to become an egg donor, or beginning any egg donation procedures, as part of compliance with the informed consent requirements. (c) Persons or entities that certify compliance with the American Society for Reproductive Medicine (ASRM) guidelines by registering with ASRM are exempt from the notice requirements set forth in subdivision (a). Use of the exemption when the guidelines are violated shall constitute false advertising. (d) Donors recruited through the advertisement shall undergo the same disclosure, counseling, and informed consent process, as required pursuant to Section 125335, as donors recruited by those exempt from subdivision (a).

125325.15. The following definitions shall apply to this chapter: (a) "Assisted oocyte production" or "AOP" means surgical extraction of oocytes following pharmaceutically induced manipulation of oocyte production through the use of ovarian stimulation for the purposes of fertility treatment. (b) "Oocyte" means a female egg or egg cell of a human female.


Chapter 2. Procuring Of Oocytes For Research

Ca Codes (hsc:125330-125355) Health And Safety Code Section 125330-125355



125330. The following definitions shall apply to this chapter: (a) "Assisted oocyte production" or "AOP" means surgical extraction of oocytes following pharmaceutically induced manipulation of oocyte production through the use of ovarian stimulation. (b) "Oocyte" means a female egg or egg cell of a human female. (c) "Subject" means any person undergoing AOP or any alternative method of ovarian retrieval for research or for the development of medical therapies, including those who would not meet the definition of "subject" under 45 C.F.R. 46.102. (d) "Alternate method of oocyte retrieval" means a method of oocyte retrieval that does not involve the pharmaceutically induced manipulation of oocyte production. (e) "Institutional review board" means a body established in accordance with federal regulations, including Part 46 (commencing with Section 46.101) of Subchapter A of Subtitle A of Title 45 of the Code of Federal Regulations.

125335. (a) Prior to obtaining informed consent from a subject for AOP or any alternative method of ovarian retrieval on a subject for the purpose of procuring oocytes for research or the development of medical therapies, a physician and surgeon shall provide to the subject a standardized medically accurate written summary of health and consumer issues associated with AOP and any alternative methods of oocyte retrieval. The failure to provide to a subject this standardized medically accurate written summary constitutes unprofessional conduct within the meaning of Chapter 5 (commencing with Section 2000) of Division 2 of the Business and Professions Code. (b) The summary shall include, but not be limited to, medically accurate disclosures concerning the potential risks of AOP or any alternative method of oocyte retrieval, including the risks associated with the surgical procedure and with using the drugs, medications, and hormones prescribed for ovarian stimulation during the AOP process or any alternative method of oocyte retrieval. (c) For purposes of subdivision (a), "written summary of health and consumer issues" means the guide published and updated by the American Society for Reproductive Medicine entitled, "Assisted Reproductive Technology: A Guide for Patients" or an alternative written medically accurate document prepared by a recognized authority on oocyte retrieval for medical research that also meets the criteria included in this section. This alternative document may be one that has been approved and recommended by the State Department of Public Health pursuant to Section 125118 and shall include all of the following: (1) The document shall adhere to simplified reading standards, including, but not limited to, those generally accepted and required for government publications. The document shall be written in layperson's language and shall be made available in languages spoken by subjects in the study if their proficiency is largely in a language other than English. All information in the document shall be conveyed to the subject orally in easy to understand and nontechnical terms. (2) The document shall include additional resources for, or list additional sources of, medical information on health and safety issues surrounding oocyte retrieval.

125340. (a) Prior to providing AOP or any alternative method of ovarian retrieval to a subject for the purposes of medical research or development of medical therapies, a physician and surgeon shall obtain written and oral informed consent for the procedure from the subject. Informed consent for the purposes of this chapter shall comply with the informed consent requirements of the Protection of Human Subjects in Medical Experimentation Act (Chapter 1.3 (commencing with Section 24170) of Division 20). (b) The failure to obtain written informed consent from the subject constitutes unprofessional conduct within the meaning of Chapter 5 (commencing with Section 2000) of Division 2 of the Business and Professions Code. Nothing in this section shall be construed to relieve the physician and surgeon from other existing duties under the law, including, but not limited to, the duty to obtain a subject's informed consent after fully explaining the proposed procedure. The requirement that a physician and surgeon provide the standardized written summary pursuant to Section 125335 is in addition to, and does not supplant, other existing legal requirements regarding informed consent, including, but not limited to, compliance with the Protection of Human Subjects in Medical Experimentation Act (Chapter 1.3 (commencing with Section 24170) of Division 20. (c) This chapter shall not affect the suitability or availability of oocytes procured for research before January 1, 2007, if the oocytes were donated pursuant to protocols or standards that are generally recognized and accepted by national or international scientific bodies. (d) Any written document required pursuant to this section shall adhere to simplified reading standards, including, but not limited to, those generally accepted and required for government publications, and in layperson's language. The document shall be made available in languages spoken by subjects in the study if their proficiency is largely in a language other than English. All information in the written informed consent document shall also be conveyed to the subject orally in easy to understand and nontechnical terms.


125341. An institutional review board (IRB) that reviews and approves medical and scientific research shall require all of the following of any research program or project that comes under its review that involves AOP or any alternative method of oocyte retrieval: (a) That it include a written summary as required under Section 125335 that would include information on health risks and potential adverse consequences of the procedure and describe the manner in which the subject will receive and review this written summary. (b) That it obtain informed consent in compliance with the Protection of Human Subjects in Medical Experimentation Act (Chapter 1.3 (commencing with Section 24170) of Division 20), including informed consent for information obtained pursuant to Section 125342. (c) That it provide the subject with an objective and accurate statement about the existing state of the research for which the subject is providing oocytes. (d) That it perform psychological and physical screening, in accordance with the appropriate standard of care, for all subjects prior to the oocyte retrieval procedure. (e) That it ensure that after conducting AOP or any alternative method of oocyte retrieval on a subject, the subject be given a postprocedure medical examination at a time within the standard of care to determine if the subject has experienced an adverse health effect that is a result of the procedure. The subject shall be informed that she has the right to a second opinion if she has any medical concerns. (f) That it ensure that the subject has access to and coverage for medically appropriate medical care that is required as a direct result of the procedure for research purposes. The research program or project shall ensure that payment or coverage of resulting medical expenses be provided at no cost to the subject and that a summary of the arrangements the procuring entity has made for coverage or payment for medical care related to AOP or any alternative method of oocyte retrieval is provided to the subject prior to the procedure. (g) That it provide a summary informing the subject that oocytes may not be sold or transferred for valuable consideration except as set forth in Section 125350. (h) That it provide disclosure if the physician and surgeon and his or her immediate family members have any professional interest in the outcome of the research or of the oocyte retrieval procedure and, if so, that it provide disclosure that he or she carries the interest of both the subject and the success of the research.


125342. (a) A research program or project that involves AOP or any alternative method of oocyte retrieval shall ensure that a written record is established and maintained to include, but not be limited to, all of the following components: (1) The demographics of subjects, including, but not limited to, their age, race, primary language, ethnicity, income bracket, education level, and the first three digits of the ZIP Code of current residence. (2) Information regarding every oocyte that has been donated or used. This record should be sufficient to determine the provenance and disposition of those materials. (3) A record of all adverse health outcomes, including, but not limited to, incidences and degrees of severity, resulting from the AOP or any alternative method of oocyte retrieval. (b) (1) The information included in the written record pursuant to subdivision (a) shall not disclose personally identifiable information about subjects, and shall be confidential and is deemed protected by subject privacy provisions of law. This information shall be reported to the State Department of Public Health, which shall aggregate the data and make it publicly available, as set forth in paragraph (2), in a manner that does not reveal personally identifiable information about the subjects. (2) The department shall provide public access to information which it is required to release pursuant to the California Public Records Act (Chapter 3.5 (commencing with Section 6250) of Division 7 of Title 1 of the Government Code). The department shall disseminate the information to the general public via governmental and other Web sites in a manner that is understandable to the average person. The information shall be made available to the public when the biennial review pursuant to Section 125119.5 is provided to the Legislature.


125343. Any employee who works in the unit conducting stem cell research using human oocytes, persons who report to, or are supervised by, the principal investigator or key personnel of the project, or both, along with the principal investigator and the key personnel of the project, and the immediate family members of any of the above persons are prohibited from being a subject in the research.

125344. The physician and surgeon performing the AOP or any alternative method of oocyte retrieval shall not have a financial interest in the outcome of the research.


125345. Pursuant to guidelines adopted by the Research Council and Institute of Medicine of the National Academies, researchers shall offer subjects an opportunity to document their preferences regarding future uses of their donated materials. The consent process shall fully explore whether subjects have objections to any specific forms of research to ensure that their wishes are honored.


125346. Any procedures for procuring oocytes in this state for research or the development of medical therapies shall meet all of the standards for subjects included in this chapter. All oocytes procured outside of this state for research taking place in this state shall meet these same standards. All egg extractions for research shall be approved by an institutional review board pursuant to Section 125341.


125350. No human oocyte or embryo shall be acquired, sold, offered for sale, received, or otherwise transferred for valuable consideration for the purposes of medical research or development of medical therapies. For purposes of this section, "valuable consideration" does not include reasonable payment for the removal, processing, disposal, preservation, quality control, and storage of oocytes or embryos.


125355. No payment in excess of the amount of reimbursement of direct expenses incurred as a result of the procedure shall be made to any subject to encourage her to produce human oocytes for the purposes of medical research.


Part 6. Hospitals (reserved)

Part 7. Chronic Disease Services

Chapter 1. Kidney Diseases-chronic Uremia

Ca Codes (hsc:125500-125545) Health And Safety Code Section 125500-125545



125500. (a) Up to four regional dialysis centers with up to two in the northern and up to two in the southern part of the state, shall be established for the treatment of persons suffering from chronic uremia. Each center shall be located in a metropolitan area and shall have an affiliation with a large hospital or medical school, but shall not be necessarily a physical part of the institution. These institutions, however, shall be able to provide a full range of medical, surgical and rehabilitation services. The department shall only act as a granting agency for state funds that are appropriated for the establishment and the continuation of the four centers. The department, upon the advice of the review committee that is provided for by Section 125515, may contract with any hospital or medical care institution for the administration and operation of one of the regional dialysis centers. It is not the intent of this section that any new hospital or medical school be established. (b) Any moneys appropriated by Chapter 1416 of the Statutes of 1972 may be used either in existing dialysis and kidney transplantation programs for children or to establish new programs for such purposes. Any new or existing dialysis center funded pursuant to this subdivision shall provide for children the same center dialysis, home dialysis, and outpatient clinic services as are provided under Section 125530. Any new center funded pursuant to this subdivision shall be designated as a pediatric renal failure center. Funds granted for aid to children under this subdivision shall be based upon need as determined by the Renal Dialysis Review Committee established pursuant to Section 125515 and an evaluation by the department of a county's ability to fund their one-fourth share of a child's care under the Crippled Children's Services Program. The funds shall only cover costs not recoverable from direct or third party payments. A pediatric renal failure center may use funds provided under this subdivision for payment of costs for kidney transplantation services at any hospital that is authorized to perform these services by the department. For purposes of this subdivision, a child is any person 18 years of age or under.


125505. The dialysis centers shall be designed primarily to provide lifesaving dialysis services to approximately 30 patients in each center. Funds shall be provided for developing home dialysis treatment services for approximately 20 patients in each center and the necessary specialized personnel and equipment to operate each center. Funds for construction of the centers shall also be provided. The centers shall develop and utilize newer methods of dialysis designed to make the process more efficient and economical and shall take into account other applications of the procedure such as home dialysis. Centers may seek the active participation and consultation from industry in order to streamline equipment and procedures for greater efficiency.


125510. The dialysis centers shall also serve to provide training for medical and nursing personnel who will carry out dialysis services in other communities in the state. The dialysis centers may also work in close cooperation with other medical specialists who are seeking ways to develop successful means of kidney transplantation. Dialysis services are necessary as an adjunct to this type of medical investigation.


125515. The director shall appoint a review committee, upon nomination of the represented party, not to exceed nine members, at least four of whom shall be physicians, including at least one physician specializing in kidney transplantation and at least two physicians specializing in pediatric nephrology, one member to represent the University of California, one to represent a private organization or organizations concerned with kidney disease in California, one to represent the department, and two members to represent the lay public. The chairman of the committee shall be appointed by the Governor. This committee shall establish standards for the expenditure of state funds that are provided for the establishment and support of regional dialysis and transplantation centers to assure the availability of specialized personnel, resources, and equipment necessary to enable the centers to function and care for patients with severe uremia. The director shall choose from a list provided by the review committee the institutions that qualify under the standards established to receive grants of state funds to establish and continue a regional dialysis center. The review committee shall also examine periodically the performance of established regional dialysis centers and recommend continuation grants to the director. The members of the review committee shall serve for a two-year period and may be reappointed. Not more than half the membership of the committee shall be changed during any one year. The committee shall serve without compensation, but shall receive their necessary travel expenses.


125520. The dialysis centers may also receive and make use of any outside source of funds that may become available from federal, voluntary, philanthropic, or other sources in order to augment state funds.

125525. No resident of this state shall be denied treatment in any of the regional dialysis centers because of his or her place of residence, so long as he or she is able to transport himself to the center.

125530. The funds that are provided by the state shall only be expended for the construction and equipment of the regional dialysis centers; equipment for and development of, home dialysis services; training of personnel and other expenses incident to the activation of the regional centers; services of dialysis and directly associated procedures; and treatment of complications that may result from dialysis. These funds shall not be utilized to pay for general medical care services that should come from private, local, other state or federal sources.

125535. The department succeeds to and is vested with the duties, purposes, responsibilities, and jurisdiction heretofore exercised by the Department of Benefit Payments with respect to the payment of grants to and audit responsibility for regional dialysis centers under this chapter and for home dialysis training centers under Chapter 2 (commencing with Section 125550).


125540. The department shall have possession and control of all records, papers, equipment, and supplies held for the benefit or use of the Director of Benefit Payments in the performance of his or her duties, powers, purposes, responsibilities, and jurisdiction that are vested in the department by Section 125535.

125545. All officers and employees of the Director of Benefit Payments who, on July 1, 1978, are serving in the state civil service, other than as temporary employees, and engaged in the performance of a function vested in the department by Section 125535 shall be transferred to the department. The status, positions, and rights of those persons shall not be affected by the transfer and shall be retained by them as officers and employees of the department pursuant to the State Civil Service Act, except as to positions exempt from civil service.


Chapter 2. Home Dialysis Training Center

Ca Codes (hsc:125550-125555) Health And Safety Code Section 125550-125555



125550. Up to three home dialysis training centers shall be established for the purpose of training persons suffering from chronic uremia for home dialysis. Each center shall have an affiliation with a large hospital or medical school, but shall utilize the most economical facilities for treatment. These institutions, however, shall be able to provide a full range of home dialysis training services. The department and the review committee established pursuant to Section 125515 shall exercise over the home dialysis training centers the same powers they exercise, pursuant to Chapter 1 (commencing with Section 125500), over regional dialysis centers.


125555. Each center shall contain approximately four dialysis bed units. The department shall grant to each center fifty thousand dollars ($50,000) during the first year, twenty-five thousand dollars ($25,000) during the second year, and twelve thousand five hundred dollars ($12,500) during the third year. The department shall grant to each center not to exceed five thousand dollars ($5,000) in the first year for the purchasing or leasing of equipment and not to exceed two thousand five hundred dollars ($2,500) in the first year for construction or remodeling of the physical facility.


Part 8. Adult Health (reserved)

Chapter 1. California Osteoporosis Prevention And Education Act

Ca Codes (hsc:125700-125710) Health And Safety Code Section 125700-125710



125700. This chapter shall be known and may be cited as the "California Osteoporosis Prevention and Education Act."


125701. It is the intent of the Legislature to promote public awareness of the causes of and options for the prevention of osteoporosis, to educate the public regarding the prevention and management of osteoporosis, and to improve management of osteoporosis, and thereby to minimize the impact of this debilitating disease.


125702. There is hereby created within the department the California Osteoporosis Prevention and Education Program. The target population for this program shall be persons of age 50 years or older.

125703. The department shall, in consultation with the California Department of Aging, do all of the following in the establishment of the program: (a) Promote public awareness concerning the causes and nature of, the personal risk factors for, the value of prevention of, and the options for management of osteoporosis. (b) Work with other state and local agencies to promote osteoporosis educational and training programs for physicians and other health professionals. (c) Convene an advisory panel of individuals with knowledge and expertise in osteoporosis research, women's health, healthy aging, prevention strategies, educational programs, and consumer needs to guide program development.

125704. In consultation with the advisory panel convened pursuant to subdivision (c) of Section 125703, the department shall develop effective protocols for the prevention of falls and fractures and establish these protocols in community practice to improve the prevention and management of osteoporosis.


125710. The director shall seek private sector financial support, grants, and other appropriate moneys to support the California Osteoporosis Prevention and Education Program.


Part 9. Other (reserved)


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