text:
(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.

history: (History: Amended by Stats. 2007, Ch. 550, Sec. 3. Effective January 1, 2008.)

article: 4. Prenatal Testing


kind: section

code: HSC

text: 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.

history: (History: Added by Stats. 2003, Ch. 749, Sec. 4. Effective January 1, 2004.)

chapter: 1. Genetic Prevention Services

article: 4. Prenatal Testing

path: 106. PERSONAL HEALTH CARE (INCLUDING MATERNAL, CHILD, AND ADOLESCENT) > 5. HEREDITARY DISEASES/CONGENITAL DEFECTS > 1. Genetic Prevention Services > 4. Prenatal Testing


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

history: (History: Added by Stats. 1995, Ch. 415, Sec. 8. Effective January 1, 1996.)

division: 106. PERSONAL HEALTH CARE (INCLUDING MATERNAL, CHILD, AND ADOLESCENT)

part: 5. HEREDITARY DISEASES/CONGENITAL DEFECTS

article: 4. Prenatal Testing


text:
(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.

article: 4. Prenatal Testing


text:
(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.

article: 4. Prenatal Testing


text:
(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.

history: (History: Amended by Stats. 2007, Ch. 550, Sec. 4. Effective January 1, 2008.)

article: 4. Prenatal Testing


text: 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.

article: 4. Prenatal Testing


text:
(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.

history: (History: Amended by Stats. 2007, Ch. 483, Sec. 33. Effective January 1, 2008.)

article: 4. Prenatal Testing


text:
(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.

history: (History: Amended by Stats. 2006, Ch. 483, Sec. 3. Effective January 1, 2007.)

article: 4. Prenatal Testing


text:
(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.

history: (History: Amended by Stats. 2006, Ch. 483, Sec. 4. Effective January 1, 2007.)

article: 4. Prenatal Testing


text:
(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.

history: (History: Amended by Stats. 2006, Ch. 483, Sec. 5. Effective January 1, 2007.)

article: 4. Prenatal Testing


text: This article shall be known and may be cited as the Holden-Moscone-Garamendi Genetically Handicapped Persons Program.

history: (History: Amended by Stats. 2015, Ch. 303, Sec. 353. (AB 731) Effective January 1, 2016.)

chapter: 2. Genetic Disease Services

path: 106. PERSONAL HEALTH CARE (INCLUDING MATERNAL, CHILD, AND ADOLESCENT) > 5. HEREDITARY DISEASES/CONGENITAL DEFECTS > 2. Genetic Disease Services > 1. Genetically Handicapped Persons Program


text:
(a) The Director of Health Care 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.

(b) 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.

(c) The medical and social support services may be obtained through physicians and surgeons Genetically Handicapped Persons 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.

(d) The director shall adopt regulations that are necessary for the implementation of this article.

history: (History: Amended by Stats. 2015, Ch. 303, Sec. 354. (AB 731) Effective January 1, 2016.)

article: 1. Genetically Handicapped Persons Program


text: 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.


text:
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.


text: 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).


text: 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.


text:
(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.

history: (History: Added by Stats. 2009, 4th Ex. Sess., Ch. 5, Sec. 14. Effective July 28, 2009.)


text:
(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.

history: (History: Added by Stats. 2009, 4th Ex. Sess., Ch. 5, Sec. 15. Effective July 28, 2009.)


text: 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 the Genetically Handicapped Persons Program shall be made by the department.

history: (History: Amended by Stats. 2015, Ch. 303, Sec. 355. (AB 731) Effective January 1, 2016.)


text:
(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.

history: (History: Added by Stats. 2009, 4th Ex. Sess., Ch. 5, Sec. 17. Effective July 28, 2009.)


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


text: 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 125166 shall then be applied to the remaining cost of genetically handicapped persons’ services.

history: (History: Amended by Stats. 2015, Ch. 303, Sec. 356. (AB 731) Effective January 1, 2016.)


text: 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.


text:
(a) (1) By July 1, 2016, or a subsequent date determined by the department, Genetically Handicapped Persons Program (GHPP) requests for authorization of services, excluding requests for authorization of services submitted by dental providers enrolled in the Medi-Cal Dental program, shall be submitted in an electronic format determined by the department and shall be submitted via the department’s Internet Web site or other electronic means designated by the department. The department may implement this requirement in phases.

(2) The department shall designate an alternate format for submitting requests for authorization of services when the department’s Internet Web site or other electronic means designated in paragraph (1) are unavailable due to a system disruption.

(b) Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the department may, without taking regulatory action, implement, interpret, or make specific this section and any applicable waivers and state plan amendments by means of all-county letters, plan letters, plan or provider bulletins, or similar instructions. Thereafter, the department shall adopt regulations by July 1, 2017, 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. The department shall consult with interested parties and appropriate stakeholders in implementing this section.

history: (History: Added by Stats. 2014, Ch. 849, Sec. 2. (SB 1457) Effective January 1, 2015.)


text: Notwithstanding any other law, the department is considered to be the purchaser, but not the dispenser or distributor, of blood factor products under the Genetically Handicapped Persons Program. The department may receive manufacturers’ discounts, rebates, or refunds based on the quantities purchased under the Genetically Handicapped Persons 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.

history: (History: Amended by Stats. 2015, Ch. 303, Sec. 357. (AB 731) Effective January 1, 2016.)


text:
(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 Persons 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 state law, to obtain discounts, rebates, or refunds from the manufacturers based upon the large quantities purchased under the program. This subdivision does not 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 is 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 Title 2 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 (Division 10 (commencing with Section 7920.000) 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 does 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 Title 2 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. This subdivision shall not 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.

history: (History: Amended by Stats. 2021, Ch. 615, Sec. 284. (AB 474) Effective January 1, 2022. Operative January 1, 2023, pursuant to Sec. 463 of Stats. 2021, Ch. 615.)


text:
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.

path: 106. PERSONAL HEALTH CARE (INCLUDING MATERNAL, CHILD, AND ADOLESCENT) > 5. HEREDITARY DISEASES/CONGENITAL DEFECTS > 2. Genetic Disease Services > 2. Long-Term Care for Degenerative Genetic Disease


text:
The department and the State Department of Social Services shall, after consultation with the Genetically Handicapped Persons Program of the department and 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 State Department of Health Care 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.

history: (History: Amended by Stats. 2012, Ch. 23, Sec. 38. (AB 1467) Effective June 27, 2012.)

article: 2. Long-Term Care for Degenerative Genetic Disease


text: 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.

history: (History: Added by Stats. 1995, Ch. 415, Sec. 8. Effective January 1, 1996.)


text:
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. 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.

history: (History: Amended by Stats. 2012, Ch. 23, Sec. 39. (AB 1467) Effective June 27, 2012.)


text: 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.


text:
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.

path: 106. PERSONAL HEALTH CARE (INCLUDING MATERNAL, CHILD, AND ADOLESCENT) > 5. HEREDITARY DISEASES/CONGENITAL DEFECTS > 2. Genetic Disease Services > 3. Huntington’s Disease Research and Workshop Grants


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

article: 3. Huntington’s Disease Research and Workshop Grants


text:
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.


text: 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.


text:
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).


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


text:
(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).

history: (History: Added by renumbering Section 412 (as amended by Stats. 1995, Ch. 551) by Stats. 1996, Ch. 1023, Sec. 134. Effective September 29, 1996.)

article: 4. Alzheimer’s Disease

path: 106. PERSONAL HEALTH CARE (INCLUDING MATERNAL, CHILD, AND ADOLESCENT) > 5. HEREDITARY DISEASES/CONGENITAL DEFECTS > 2. Genetic Disease Services > 4. Alzheimer’s Disease


text:
(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.

article: 4. Alzheimer’s Disease


text:
From funds appropriated to the department in the Budget Act of 2016 for these purposes, the department shall allocate funds to the diagnostic and treatment centers for Alzheimer’s disease established pursuant to Section 125280 to be used for all of the following purposes:

(a) To determine the standard of care in early and accurate diagnosis drawing on peer-reviewed evidence, best practices, Medicare and Medicaid policy and reimbursement, and experience working with patients seeking services at a center.

(b) To conduct targeted outreach to health professionals through medical school instruction, hospital grant rounds, continuing education, community education, and free online resources.

(c) To provide low-cost, accessible detection and diagnosis tools that the center shall make available via open source portals of the postsecondary higher educational institution that established the center. Furthermore, the department shall post these tools on its Internet Web site to serve as a resource for the state.

(d) To endorse and disseminate low-cost, accessible detection and diagnosis tools for broad use by health professionals practicing in a variety of settings.

(e) To address unique health disparities that exist within diverse populations, with special focus and attention on reaching African Americans, Latinos, and women.

(f) To evaluate the educational effectiveness and measure the impact of these efforts, including pretests and posttests for health professionals, metrics, and documented practice change.

history: (History: Added by Stats. 2016, Ch. 30, Sec. 8. (SB 833) Effective June 27, 2016.)

article: 4. Alzheimer’s Disease


text: 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.

history: (History: Added by Stats. 2000, Ch. 93, Sec. 35. Effective July 7, 2000.)

article: 4. Alzheimer’s Disease


text: This article shall be known, and may be cited, as the Standards of Service for Providers of Blood Clotting Products for Home Use Act.

history: (History: Added by Stats. 2012, Ch. 75, Sec. 1. (AB 389) Effective January 1, 2013.)

path: 106. PERSONAL HEALTH CARE (INCLUDING MATERNAL, CHILD, AND ADOLESCENT) > 5. HEREDITARY DISEASES/CONGENITAL DEFECTS > 2. Genetic Disease Services > 5. Standards of Service for Providers of Blood Clotting Products for Home Use Act


text:
The Legislature hereby finds and declares all of the following:

(a) Hemophilia is a rare, hereditary, bleeding disorder affecting at least 4,000 persons in California and is a chronic, lifelong, and incurable, but treatable, disease.

(b) Von Willebrand disease is a human bleeding disorder caused by a hereditary deficiency or abnormality of the von Willebrand factor in human blood, which is a protein that helps clot blood. Von Willebrand disease is a chronic, lifelong, incurable, but treatable, disease affecting at least 360,000 Californians.

(c) Until the 1970s, people with severe hemophilia suffered from uncontrollable internal bleeding, crippling orthopedic deformities, and a shortened lifespan. More recently, the production of highly purified blood clotting factors has provided people with hemophilia and other bleeding disorders the opportunity to lead normal lives, free of pain and crippling arthritis.

(d) The preferred method of treatment of hemophilia today is intravenous injection, or infusion, of prescription blood clotting products several times per week, along with case management and specialized medical care at a federally designated regional hemophilia treatment center.

(e) Pharmacies and other entities specializing in the delivery of blood clotting products and related equipment, supplies, and services for home use form a growing enterprise in California.

(f) Timely access to federally designated regional hemophilia centers and appropriate products and services in the home, including infusion of blood clotting products and related equipment, and supplies and services for persons with hemophilia and other bleeding disorders, reduces mortality and bleeding-related hospitalizations according to the federal Centers for Disease Control and Prevention and the Medical and Scientific Advisory Council of the National Hemophilia Foundation.

(g) Eligible persons with hemophilia or other bleeding disorders may receive treatment through the Genetically Handicapped Persons Program, the California Children’s Services Program, and the Medi-Cal program.

(h) For the benefit of persons with hemophilia or other bleeding disorders, the purposes of this article are to do the following:

(1) Establish standards of service for entities that deliver blood clotting products and related equipment, supplies, and services for home use.

(2) Promote access to a full range of essential, cost-effective, lifesaving, blood clotting products and related equipment, supplies, and high-quality services for home use for persons with hemophilia and other bleeding disorders.

article: 5. Standards of Service for Providers of Blood Clotting Products for Home Use Act


text:
Unless the context otherwise requires, the following definitions shall apply for purposes of this article:

(a) “Assay” means the amount of a particular constituent of a mixture or of the biological or pharmacological potency of a drug.

(b) “Ancillary infusion equipment and supplies” means the equipment and supplies required to infuse a blood clotting product into a human vein, including, but not limited to, syringes, needles, sterile gauze, field pads, gloves, alcohol swabs, numbing creams, tourniquets, medical tape, sharps or equivalent biohazard waste containers, and cold compression packs.

(c) “Bleeding disorder” means a medical condition characterized by a deficiency or absence of one or more essential blood clotting proteins in the human blood, often called “factors,” including all forms of hemophilia and other bleeding disorders that, without treatment, result in uncontrollable bleeding or abnormal blood clotting.

(d) “Blood clotting product” means an intravenously administered medicine manufactured from human plasma or recombinant biotechnology techniques, approved for distribution by the federal Food and Drug Administration, that is used for the treatment and prevention of symptoms associated with bleeding disorders. Blood clotting products include, but are not limited to, factor VII, factor VIIa, factor VIII, and factor IX products, von Willebrand factor products, bypass products for patients with inhibitors, and activated prothrombin complex concentrates.

(e) “Emergency” means care as defined in Section 1317.1.

(f) “Hemophilia” means a human bleeding disorder caused by a hereditary deficiency of the factor I, II, V, VIII, IX, XI, XII, or XIII blood clotting protein in human blood.

(g) “Hemophilia treatment center” means a facility for the treatment of bleeding disorders, including, but not limited to, hemophilia, that receives funding specifically for the treatment of patients with bleeding disorders from federal government sources, including, but not limited to, the federal Centers for Disease Control and Prevention and the federal Health Resources and Services Administration (HRSA) of the United States Department of Health and Human Services.

(h) “Home use” means infusion or other use of a blood clotting product in a place other than a state-recognized hemophilia treatment center or other clinical setting. Places where home use occurs include, without limitation, a home or other nonclinical setting.

(i) “Patient” means a person needing a blood clotting product for home use.

(j) (1) “Provider of blood clotting products for home use” means all the following pharmacies, except as described in Section 125286.35, that dispense blood clotting factors for home use:

(A) Hospital pharmacies.

(B) Health system pharmacies.

(C) Pharmacies affiliated with hemophilia treatment centers.

(D) Specialty home care pharmacies.

(E) Retail pharmacies.

(2) The providers described in this subdivision shall include a health care service plan and all its affiliated providers if the health care service plan exclusively contracts with a single medical group in a specified geographic area to provide professional services to its enrollees.

history: (History: Amended by Stats. 2013, Ch. 76, Sec. 129. (AB 383) Effective January 1, 2014.)


text:
Each provider of blood clotting products for home use shall meet all of the following requirements:

(a) Have sufficient knowledge and understanding of bleeding disorders to accurately follow the instructions of the prescribing physician and ensure high-quality service for the patient and the medical and psychosocial management thereof, including, but not limited to, home therapy.

(b) Have access to a provider with sufficient clinical experience providing services to persons with bleeding disorders that enables the provider to know when patients have an appropriate supply of clotting factor on hand and about proper storage and refrigeration of clotting factors.

(c) Maintain 24-hour on-call service seven days a week for every day of the year, adequately screen telephone calls for emergencies, acknowledge all telephone calls within one hour or less, and have access to knowledgeable pharmacy staffing on call 24 hours a day, to initiate emergency requests for clotting factors.

(d) Have the ability to obtain all brands of blood clotting products approved by the federal Food and Drug Administration in multiple assay ranges (low, medium, and high, as applicable) and vial sizes, including products manufactured from human plasma and those manufactured with recombinant biotechnology techniques, provided manufacturer supply exists and payer authorization is obtained.

(e) Supply all necessary ancillary infusion equipment and supplies with each prescription, as needed.

(f) Store and ship, or otherwise deliver, all blood clotting products in conformity with all state and federally mandated standards, including, but not limited to, the standards set forth in the product’s approved package insert (PI).

(g) Upon receiving approved authorization for a nonemergency prescription, provided manufacturer supply exists, ship the prescribed blood clotting products and ancillary infusion equipment and supplies to the patient within two business days or less for established and new patients.

(h) Upon receiving approved authorization to dispense a prescription for an emergency situation, provided manufacturer supply exists, deliver prescribed blood products, ancillary infusion equipment and supplies, and medications to the patient within 12 hours for patients living within 100 miles of a major metropolitan airport, and within one day for patients living more than 100 miles from a major metropolitan airport.

(i) Provide patients who have ordered their products with a designated contact telephone number for reporting problems with a delivery and respond to these calls within a reasonable time period.

(j) Provide patients with notification of Class 1 and Class 2 recalls and withdrawals of blood clotting products and ancillary infusion equipment within 24 hours of the provider of blood clotting products for home use receiving notification and participate in the National Patient Notification System for blood clotting product recalls.

(k) Provide language interpretive services over the telephone or in person, as needed by the patient.

(l) Have a detailed plan for meeting the requirements of this article in the event of a natural or manmade disaster or other disruption of normal business operations.

(m) Provide appropriate and necessary recordkeeping and documentation as required by state and federal law and retain copies of the patient’s prescriptions.

(n) Comply with the privacy and confidentiality requirements of the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA).


text: The California State Board of Pharmacy shall administer and enforce this article.


text: Nothing in this article shall apply to either hospital pharmacies or health system pharmacies that dispense blood clotting products due only to emergency, urgent care, or inpatient encounters, or if an inpatient is discharged with a supply of blood clotting products for home use.


text:
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).

history: (History: Added November 2, 2004, by initiative Proposition 71, Sec. 5. Note: Prop. 71 is titled the California Stem Cell Research and Cures Act.)

path: 106. PERSONAL HEALTH CARE (INCLUDING MATERNAL, CHILD, AND ADOLESCENT) > 5. HEREDITARY DISEASES/CONGENITAL DEFECTS > 3. California Stem Cell Research and Cures Bond Act > 1. California Stem Cell Research and Cures Act


text:
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.

history: (History: Added November 2, 2004, by initiative Proposition 71, Sec. 5.)

chapter: 3. California Stem Cell Research and Cures Bond Act

article: 1. California Stem Cell Research and Cures Act


text:
ICOC Membership; Appointments; Terms of Office

(a) ICOC Membership

The ICOC shall have 35 members, appointed as follows:

(1) The Chancellors of the University of California at San Francisco, Davis, San Diego, Los Angeles, Irvine, and Riverside shall each appoint an executive officer from his or her campus. In addition, the Chancellor of the University of California at San Francisco (UCSF) shall also appoint a faculty member, physician/scientist, researcher, or executive officer from the UCSF Fresno/Clovis campus to promote geographic diversity and access.

(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 seven campuses of the University of California described in paragraph (1), that has demonstrated success and leadership in stem cell research, other vital research opportunities, therapy development, or therapy delivery, 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.

(iv) For purposes of this category, the Governor may appoint an executive officer from the California State University system who has an advanced degree in biological 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, other vital research opportunities, therapy development, or therapy delivery 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) annually.

(C) A California life science commercial entity that is not actively engaged in researching or developing therapies or therapy delivery with pluripotent or progenitor stem cells or genetic medical treatments that has a background in implementing or developing experimental medical therapies, including conducting human clinical trials, and that has not been awarded, or applied for, funding by the institute at the time of appointment. A board member of that entity who generally meets the same qualifications may be appointed in lieu of an executive officer.

(D) Only one member shall be appointed from a single university, institution, or entity for the purposes of paragraph (2). 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 three members, one from each of the following disease advocacy groups: spinal cord injury; Alzheimer’s disease; and mental health conditions.

(B) The Lieutenant Governor shall appoint three members, one from each of the following disease advocacy groups: type II diabetes; multiple sclerosis or amyotrophic lateral sclerosis; and mental health conditions.

(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 or mental health conditions 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) The Treasurer and Controller shall each appoint a nurse with experience in clinical trial management or stem cell or genetic therapy delivery.

(7) 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 or other vital research opportunity in therapy development or therapy delivery 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 this act, 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 (7) of subdivision (a).

(c) ICOC Member Terms of Office

(1) The members appointed pursuant to paragraphs (1), (3), (4), (5), and (6) 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, unless earlier removed pursuant to paragraph (5).

(2) If a vacancy occurs within a term, the appointing authority shall appoint a replacement member within 90 days to serve the remainder of the term.

(3) When a term expires, the appointing authority shall appoint a member within 90 days. ICOC members shall continue to serve until their replacements are appointed.

(4) Notwithstanding paragraph (1), the appointing authority may replace a member, other than the chairperson or vice chairperson, who has served, as of the effective date of the act adding this paragraph, at least half of the member’s current term, by appointing a new member, who shall be eligible to serve a full term. These appointments shall be made within 90 days of the effective date of the initiative adding this paragraph.

(5) The ICOC may, by a vote of 60 percent of a quorum, recommend the removal of a member by the member’s appointing authority, or in the case of the chairperson and the vice chairperson, the nominating authority or nominating authorities, if more than one constitutional officer nominated the chairperson or vice chairperson. The appointing authority or nominating authority or authorities in the case of the chairperson and vice chairperson, shall have the authority to remove the member, chairperson, or vice chairperson, respectively, upon receipt of the ICOC’s recommendation. If more than one constitutional officer nominated the chairperson or vice chairperson, each of them must agree in order to remove the chairperson or vice chairperson.

history: (History: Amended November 3, 2020, by initiative Proposition 14, Sec. 9. Effective December 16, 2020. Note: This section was added on Nov. 2, 2004, by initiative Prop. 71.)


text:
Majority Vote of Quorum

Actions of the ICOC may be taken only by a majority vote of a quorum of the ICOC.


text:
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 or patient advocacy 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 four 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, including, but not limited to, applications and progress reports.

(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 Chapter 2.1 (commencing with Section 10500) 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 Chapter 2.1 (commencing with Section 10500) 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 an 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 family suffers or in which the member has an interest as a representative of a disease advocacy organization.

(C) The adoption of standards, including, but not limited to, strategic plans, concept plans, and research budgets, 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 royalty revenues received through the intellectual property agreements established pursuant to this subdivision shall be deposited into an interest-bearing account in the General Fund, and to the extent permitted by law, the amount so deposited and interest thereon shall be appropriated for the purpose of offsetting the costs of providing treatments and cures arising from institute-funded research to California patients who have insufficient means to purchase such treatment or cure, including the reimbursement of patient-qualified costs for research participants.

(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.

(A) (i) A grantee that licenses an invention or technology that arises from a research program funded by CIRM, regardless of the number of grants awarded to that research program, 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. For awards made on or after November 5, 2020, 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 2020, 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 ClRM 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). The amendments made to this subdivision are not intended to affect the institute’s authority to modify the provisions set forth in this subdivision pursuant to this paragraph, including, but not limited to, any modifications that occurred prior to the effective date of the initiative amending this subdivision.

(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.

(l) Additional Accountability Requirements

To assure strict accountability and transparency, including rigorous conflict of interest rules, ethical research and treatment standards, and independent financial audits, every four years the ICOC shall update, at its discretion, the standards relating to conflict of interest rules, ethical research and treatment, and independent financial audits, to be generally aligned with standards adopted by the National Academy of Sciences to the extent that those standards are consistent with constitutional and statutory requirements applicable to the institute.

history: (History: Amended November 3, 2020, by initiative Proposition 14, Sec. 10. Effective on December 16, 2020. Note: This section was added on Nov. 2, 2004, by initiative Prop. 71.)