text:
The department shall conduct a program of grants-in-aid for the following purposes:

(a) To assist in stabilizing the health care operations of community clinics and free clinics that provide a wide range of primary health care services.

(b) To fund innovative and creative programs of such clinics designed to provide a high quality of health services at minimum cost.

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

article: 1. Clinics


kind: section

code: HSC

text:
The department shall annually receive and process grant applications submitted by eligible applicants, and shall allocate grant moneys in accordance with the policies and priorities adopted pursuant to this article. Individual grants shall be limited to a maximum of sixty thousand dollars ($60,000), including grants to nonprofit corporations comprised of more than one clinic. However, grants may be renewed on an annual basis, subject to the submission and review of an annual renewal application, that shall be considered with, and subject to the same priorities as, new applications. No applicant shall receive more than one grant in any year.

Each grant shall be subject to a contract between the department and the grantee prescribing the services to be provided by the grantee thereunder and other conditions of the grant. A contract may provide for periodic advance payments for services to be performed, but in no event shall advance payments exceed 25 percent of the grant.

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

part: 4. PRIMARY HEALTH CARE

chapter: 7. Grants in Aid for Clinics

article: 1. Clinics

path: 106. PERSONAL HEALTH CARE (INCLUDING MATERNAL, CHILD, AND ADOLESCENT) > 4. PRIMARY HEALTH CARE > 7. Grants in Aid for Clinics > 1. Clinics


text:
In developing policies and priorities pertaining to the allocation of grant funds, the department shall give primary consideration to the following factors:

(a) The applicant’s need for funds to continue its current level of operation.

(b) The applicant’s long-term prospects for financial stability.

(c) The quality of services provided.

(d) The high-risk or underserved population groups currently being served by the applicant.

All of the above factors being present, clinics primarily serving population groups determined by the director to be medically underserved shall be entitled to first consideration in the allocation of grant funds.

The department shall adopt guidelines for establishment of grant-supported activities, including criteria for evaluation of each activity and monitoring to assure compliance with grant conditions and applicable regulations of the department. The guidelines shall be developed in consultation with the Primary Care Clinics Advisory Committee and other advisory committees and persons as the department determines are appropriate.

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

article: 1. Clinics


text:
(a) (1) The State Department of Health Care Services shall select primary care clinics that are licensed under subparagraph (A) or (B) of paragraph (1) of subdivision (a) of Section 1204, or are exempt from licensure under subdivision (c) of Section 1206, to be reimbursed for delivering medical services, including preventive health care, and smoking prevention and cessation health education, to program beneficiaries.

(2) In order to be eligible to receive funds under this article a clinic shall meet all of the following conditions, at a minimum:

(A) Provide medical diagnosis and treatment.

(B) Provide medical support services of patients in all stages of illness.

(C) Provide communication of information about diagnosis, treatment, prevention, and prognosis.

(D) Provide maintenance of patients with chronic illness.

(E) Provide prevention of disability and disease through detection, education, persuasion, and preventive treatment.

(F) Meet one or both of the following conditions:

(i) Be located in an area or a facility federally designated as a health professional shortage area, medically underserved area, or medically underserved population.

(ii) Be a clinic that is able to demonstrate that at least 50 percent of the patients served are persons with incomes at or below 200 percent of the federal poverty level.

(3) Notwithstanding the requirements of paragraph (2), all clinics that received funds under this article in the 1997–98 fiscal year shall continue to be eligible to receive funds under this article.

(b) As a part of the award process for funding pursuant to this article, the department shall take into account the availability of primary care services in the various geographic areas of the state. The department shall determine which areas within the state have populations that have clear and compelling difficulty in obtaining access to primary care. The department shall consider proposals from new and existing eligible providers to extend clinic services to these populations.

(c) A primary care clinic applying for funds pursuant to this article shall demonstrate that the funds shall be used to expand medical services, including preventive health care, and smoking prevention and cessation health education, for program beneficiaries above the level of services provided in the 1988 calendar year, or in the year prior to the first year a clinic receives funds under this article if the clinic did not receive funds in the 1989 calendar year.

(d) (1) The department, in consultation with clinics funded under this article, shall develop a formula for allocation of funds available. It is the intent of the Legislature that the funds allocated pursuant to this article promote stability for those clinics participating in programs under this article as part of the state’s health care safety net and at the same time be distributed in a manner that best promotes access to health care to uninsured populations.

(2) The formula shall be based on both of the following:

(A) A hold harmless for clinics funded in the 1997–98 fiscal year to continue to reimburse them for some portion of their uncompensated care.

(B) Demonstrated unmet need by both new and existing clinics, as reflected in their levels of uncompensated care reported to the department. For purposes of this article, “uncompensated care” means clinic patient visits for persons with incomes at or below 200 percent of the federal poverty level for which there is no encounter-based third-party reimbursement which includes, but is not limited to, unpaid expanded access to primary care claims.

(3) The department shall allocate available funds, for a three-year period, as follows:

(A) Clinics that received funding in the prior fiscal year shall receive 90 percent of their prior fiscal year allocation, subject to available funds, provided that the funding award is substantiated by the clinics’ reported levels of uncompensated care.

(B) The remaining funds beyond 90 percent shall be awarded to new and existing applicants based on the clinics’ reported levels of uncompensated care as verified by the department according to subparagraph (A) of paragraph (4). The department shall seek input from stakeholders to discuss adjustments to award levels that the department deems reasonable, such as including base amounts for new applicant clinics.

(C) New applicants shall be awarded funds pursuant to this subdivision if they meet the minimum requirements for funding under this article based on the clinics’ reported levels of uncompensated care as verified by the department according to subparagraph (A) of paragraph (4). New applicants include applicants for new site expansions by existing applicants.

(4) In assessing reported levels of uncompensated care, the department shall utilize the data available from the Office of Statewide Health Planning and Development’s (OSHPD’s) completed analysis of the “Annual Report of Primary Care Clinics” for the prior fiscal year, or if more recent data is available, then the most recent data. If this data is unavailable for an existing applicant to assess reported levels of uncompensated care, the existing applicant shall receive an allocation pursuant to subparagraph (A) of paragraph (3).

(A) The department shall utilize the most recent data available from OSHPD’s completed analysis of the “Annual Report of Primary Care Clinics” for the prior fiscal year, or if more recent data is available, then the most recent data.

(B) If the funds allocated to the program are less than the prior year, the department shall allocate available funds to existing program providers only.

(5) The department shall establish a base funding level, subject to available funds, of no less than thirty-five thousand dollars ($35,000) for frontier clinics and Native American reservation-based clinics. For purposes of this article, “frontier clinics” means clinics located in a medical services study area with a population of fewer than 11 persons per square mile.

(6) The department shall develop, in consultation with clinics funded pursuant to this article, a formula for reallocation of unused funds to other participating clinics to reimburse for uncompensated care. The department shall allocate the unused funds remaining on October 30, for the prior fiscal year to other participating clinics to reimburse for uncompensated care.

(e) In applying for funds, eligible clinics shall submit a single application per clinic corporation. Applicants with multiple sites shall apply for all eligible clinics, and shall report to the department the allocation of funds among their corporate sites in the prior year. A corporation may claim reimbursement only for services provided at a program-eligible clinic site identified in the corporate entity’s application for funds, and approved for funding by the department. A corporation may increase or decrease the number of its program-eligible clinic sites on an annual basis, at the time of the annual application update for the subsequent fiscal years of any multiple-year application period.

(f) Grant allocations pursuant to this article shall be based on the formula developed by the department, notwithstanding a merger of one of more licensed primary care clinics participating in the program.

(g) A clinic that is eligible for the program in every other respect, but that provides dental services only, rather than the full range of primary care medical services, shall only be eligible to receive funds under this article on an exception basis. A dental-only provider’s application shall include a memorandum of understanding (MOU) with a primary care clinic funded under this article. The MOU shall include medical protocols for making referrals by the primary care clinic to the dental clinic and from the dental clinic to the primary care clinic, and ensure that case management services are provided and that the patient is being provided comprehensive primary care as described in subdivision (a).

(h) (1) For purposes of this article, an outpatient visit shall include diagnosis and medical treatment services, including the associated pharmacy, X-ray, and laboratory services, and prevention health and case management services that are needed as a result of the outpatient visit. For a new patient, an outpatient visit shall also include a health assessment encompassing an assessment of smoking behavior and the patient’s need for appropriate health education specific to related tobacco use and exposure.

(2) “Case management” includes, for this purpose, the management of all physician services, both primary and specialty, and arrangements for hospitalization, postdischarge care, and followup care.

(i) (1) Payment shall be on a per-visit basis at a rate that is determined by the department to be appropriate for an outpatient visit as defined in this section, and shall be not less than seventy-one dollars and fifty cents ($71.50).

(2) In developing a statewide uniform rate for an outpatient visit as defined in this article, the department shall consider existing rates of payments for comparable outpatient visits. The department shall review the outpatient visit rate on an annual basis.

(j) Not later than June 1 of each year, the department shall adopt and provide each licensed primary care clinic with a schedule for programs under this article, including the date for notification of availability of funds, the deadline for the submission of a completed application, and an anticipated contract award date for successful applicants.

(k) In administering the program created pursuant to this article, the department shall utilize the Medi-Cal program statutes and regulations pertaining to program participation standards, medical and administrative recordkeeping, the ability of the department to monitor and audit clinic records pertaining to program services rendered to program beneficiaries and take recoupments or recovery actions consistent with monitoring and audit findings, and the provider’s appeal rights. A primary care clinic applying for program participation shall certify that it will abide by these statutes and regulations and other program requirements set forth in this article.

history: (History: Amended by Stats. 2008, Ch. 179, Sec. 159. Effective January 1, 2009.)

article: 2. Primary Care

path: 106. PERSONAL HEALTH CARE (INCLUDING MATERNAL, CHILD, AND ADOLESCENT) > 4. PRIMARY HEALTH CARE > 7. Grants in Aid for Clinics > 2. Primary Care


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

history: (History: Amended by Stats. 1998, Ch. 883, Sec. 2. Effective January 1, 1999.)

article: 2. Primary Care


text:
(a) (1) Each licensed primary care clinic, as specified in subdivision (a) of Section 124900, applying for funds under this article, shall demonstrate in its application that it meets all of the following conditions, at a minimum:

(A) Provides medical diagnosis and treatment.

(B) Provides medical support services of patients in all stages of illness.

(C) Provides communication of information about diagnosis, treatment, prevention, and prognosis.

(D) Provides maintenance of patients with chronic illness.

(E) Provides prevention of disability and disease through detection, education, persuasion, and preventive treatment.

(F) Meets one or both of the following conditions:

(i) Is located in an area or a facility federally designated as a health professional shortage area, medically underserved area, or medically underserved population.

(ii) Is a clinic in which at least 50 percent of the patients served are persons with incomes at or below 200 percent of the federal poverty level.

(2) Any applicant who has applied for and received a federal or state designation for serving a health professional shortage area, medically underserved area, or population shall be deemed to meet the requirements of subdivision (a) of Section 124900.

(b) Each applicant shall also demonstrate to the satisfaction of the department that the proposed services supplement, and do not supplant, those primary care services to program beneficiaries that are funded by any county, state, or federal program.

(c) Each applicant shall demonstrate that it is an active Medi-Cal provider by being enrolled in Medi-Cal and diligently billing the Medi-Cal program for services rendered to Medi-Cal eligible patients during the past three months prior to the application due date. This subdivision shall not apply to clinics that are not currently Medi-Cal providers, and were funded participants pursuant to this article during the 1993–94 fiscal year.

(d) Each application shall be evaluated by the state department prior to funding to determine all of the following:

(1) The applicant shall provide its most recently audited financial statement to verify budget information.

(2) The applicant’s ability to deliver basic primary care to program beneficiaries.

(3) A description of the applicant’s operational quality assurance program.

(4) The applicant’s use of protocols for the most common diseases in the population served under this article.

history: (History: Amended by Stats. 2007, Ch. 188, Sec. 17. Effective August 24, 2007.)

article: 2. Primary Care


text:
(a) Commencing in the 1998–99 fiscal year, the department shall release a request for allocation of funds for a period of three succeeding fiscal years. The request for allocation shall include specifications for the clinics to submit uniform data on uncompensated patient visits.

(b) Annual funding awards for a clinic provider in the second and third fiscal years of a three-year funding period shall be contingent upon the clinic’s satisfactory performance under the program, and upon the availability of sufficient funds appropriated by the annual Budget Act.

history: (History: Added by Stats. 1998, Ch. 883, Sec. 5. Effective January 1, 1999.)

article: 2. Primary Care


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

article: 2. Primary Care


text:
(a) The department shall utilize existing contractual claims processing services in order to promote efficiency and to maximize use of funds.

(b) The department shall certify which primary care clinics are selected to participate in the program for each specific fiscal year, and how much in program funds each selected primary care clinic will be allocated each fiscal year.

(c) The department shall pay claims from selected primary care clinics up to each clinic’s annual allocation. Once a clinic has exhausted its annual allocation, the state shall stop paying its program claims.

(d) The department may adjust any selected primary care clinic’s allocation to take into account:

(1) An increase in program funds appropriated for the fiscal year.

(2) A decrease in program funds appropriated for the fiscal year.

(3) A clinic’s projected inability to fully spend its allocation within the fiscal year.

(4) Surplus funds reallocated from other selected primary care clinics.

(e) The department shall notify all affected primary care clinics in writing prior to adjusting selected primary care clinics’ allocations.

(f) Cessation of program payments under subdivision (e) or adjustment of selected primary care clinic’s allocations under subdivision (d) shall not be subject to the Medi-Cal appeals process referenced in subdivision (g) of Section 124900.

(g) A clinic’s allocation under this article shall not be reduced solely because the clinic has engaged in supplemental fundraising drives and activities, the proceeds of which have been used to defray the costs of services to the uninsured.

history: (History: Amended by Stats. 2006, Ch. 176, Sec. 4. Effective January 1, 2007.)

article: 2. Primary Care


text:
(a) For any condition detected as part of a child health and disability prevention screen for any child eligible for services under Section 104395, if the child was screened by the clinic or upon referral by a child health and disability prevention program provider, unless the child is eligible to receive care with no share of cost under the Medi-Cal program, is covered under another publicly funded program, or the services are payable under private coverage, a clinic shall, as a condition of receiving funds under this article, do all of the following:

(1) Insofar as the clinic directly provides these services for other patients, provide medically necessary followup treatment, including prescription drugs.

(2) Insofar as the clinic does not provide treatment for the condition, arrange for the treatment to be provided.

(b) (1) If any child requires treatment the clinic does not provide, the clinic shall arrange for the treatment to be provided, and the name of that provider shall be noted in the patient’s medical record.

(2) The clinic shall contact the provider or the patient or his or her guardian, or both, within 30 days after the arrangement for the provision of treatment is made, and shall determine if the provider has provided appropriate care, and shall note the results in the patient’s medical record.

(3) If the clinic is not able to determine, within 30 days after the arrangement for the provision of treatment is made, whether the needed treatment was provided, the clinic shall provide written notice to the county child health and disability prevention program director, and shall also provide a copy to the state director of the program.

history: (History: Amended by Stats. 2006, Ch. 176, Sec. 6. Effective January 1, 2007.)

article: 2. Primary Care


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

article: 2. Primary Care


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

article: 2. Primary Care


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

(a) The state has a right and duty to control the illegal use of opiate drugs.

(b) Inadequate treatment of acute and chronic pain originating from cancer or noncancerous conditions is a significant health problem.

(c) For some patients, pain management is the single most important treatment a physician can provide.

(d) A patient suffering from severe chronic intractable pain should have access to proper treatment of his or her pain.

(e) Due to the complexity of their problems, many patients suffering from severe chronic intractable pain may require referral to a physician with expertise in the treatment of severe chronic intractable pain. In some cases, severe chronic intractable pain is best treated by a team of clinicians in order to address the associated physical, psychological, social, and vocational issues.

(f) In the hands of knowledgeable, ethical, and experienced pain management practitioners, opiates administered for severe acute pain and severe chronic intractable pain can be safe.

(g) Opiates can be an accepted treatment for patients in severe chronic intractable pain who have not obtained relief from any other means of treatment.

(h) A patient suffering from severe chronic intractable pain has the option to request or reject the use of any or all modalities to relieve his or her pain.

(i) A physician treating a patient who suffers from severe chronic intractable pain may prescribe a dosage deemed medically necessary to relieve pain as long as the prescribing is in conformance with Section 2241.5 of the Business and Professions Code.

(j) A patient who suffers from severe chronic intractable pain has the option to choose opiate medication for the treatment of the severe chronic intractable pain as long as the prescribing is in conformance with Section 2241.5 of the Business and Professions Code.

(k) The patient’s physician may refuse to prescribe opiate medication for a patient who requests the treatment for severe chronic intractable pain. However, that physician shall inform the patient that there are physicians who treat severe chronic intractable pain with methods that include the use of opiates.

history: (History: Amended by Stats. 2011, Ch. 396, Sec. 2. (AB 507) Effective January 1, 2012.)

part: 4.5. PAIN PATIENT'S BILL OF RIGHTS

path: 106. PERSONAL HEALTH CARE (INCLUDING MATERNAL, CHILD, AND ADOLESCENT) > 4.5. PAIN PATIENT'S BILL OF RIGHTS


text:
Nothing in this section shall be construed to alter any of the provisions set forth in Section 2241.5 of the Business and Professions Code. This section shall be known as the Pain Patient’s Bill of Rights.

(a) A patient who suffers from severe chronic intractable pain has the option to request or reject the use of any or all modalities in order to relieve his or her pain.

(b) A patient who suffers from severe chronic intractable pain has the option to choose opiate medications to relieve that pain without first having to submit to an invasive medical procedure, which is defined as surgery, destruction of a nerve or other body tissue by manipulation, or the implantation of a drug delivery system or device, as long as the prescribing physician acts in conformance with the California Intractable Pain Treatment Act, Section 2241.5 of the Business and Professions Code.

(c) The patient’s physician may refuse to prescribe opiate medication for the patient who requests a treatment for severe chronic intractable pain. However, that physician shall inform the patient that there are physicians who treat pain and whose methods include the use of opiates.

(d) A physician who uses opiate therapy to relieve severe chronic intractable pain may prescribe a dosage deemed medically necessary to relieve the patient’s pain, as long as that prescribing is in conformance with Section 2241.5 of the Business and Professions Code.

(e) A patient may voluntarily request that his or her physician provide an identifying notice of the prescription for purposes of emergency treatment or law enforcement identification.

(f) Nothing in this section shall do either of the following:

(1) Limit any reporting or disciplinary provisions applicable to licensed physicians and surgeons who violate prescribing practices or other provisions set forth in the Medical Practice Act, Chapter 5 (commencing with Section 2000) of Division 2 of the Business and Professions Code, or the regulations adopted thereunder.

(2) Limit the applicability of any federal statute or federal regulation or any of the other statutes or regulations of this state that regulate dangerous drugs or controlled substances.

history: (History: Amended by Stats. 2011, Ch. 396, Sec. 3. (AB 507) Effective January 1, 2012.)


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

(a) Nonpharmacological therapies for pain management have been proven effective for treatment of chronic pain and their use should be promoted just as are pharmacological analgesic therapies.

(b) The United States Department of Health and Human Services’ Pain Management Best Practices Inter-Agency Task Force identified barriers to accessing nonpharmacological therapies for pain management related to health care providers that include underestimation of patients’ reported level of pain, including unconscious biases, workforce shortages, especially among behavioral and pain management specialists, lack of research on or lack of awareness of novel and effective approaches to pain care, and cost and reimbursement issues specific to the health care system. For patients, cost, time, and transportation barriers, as well as lack of coverage or lack of knowledge and awareness of nonpharmacological options have been identified.

(c) A multimodal and patient-centered approach to treating and managing acute or chronic pain has been recommended by the task force.

(d) Restorative, interventional, behavioral, complementary, and integrative health approaches have been identified as nonpharmacological therapies for pain management.

(e) The federal Food and Drug Administration has approved behavioral or instrument-based and nonpharmacological immersive therapeutics indicated to manage or treat pain.

(f) “Nonpharmacological pain management treatment” is pain management treatment without the use of medication, including behavioral therapy, instrument-based therapy, or immersive therapeutics approved by the federal Food and Drug Administration indicated for the use of managing or treating pain.

(g) Medical devices are an important option for the treatment and management of pain and prevention of opioid use disorders. With a shift in how pain is treated, there is a greater need for ensuring appropriate coverage and payment policies for effective emerging technologies.

(h) The health care system, including health care providers, health care service plans, and health insurers, should encourage the use of evidence-based nonpharmacological therapies for pain management.

history: (History: Added by Stats. 2022, Ch. 160, Sec. 1. (AB 2585) Effective January 1, 2023.)


text:
(a) Upon appropriation by the Legislature, there is established, within the California Health and Human Services Agency, the Jacqueline Marie Zbur Rare Disease Advisory Council. The council is advisory in nature and shall have no regulatory authority.

(b) Unless the context requires otherwise, for purposes of this part, the following definitions shall apply:

(1) “Advisory council” or “council” means the Jacqueline Marie Zbur Rare Disease Advisory Council.

(2) “Rare disease” has the same meaning as provided in Section 360bb of Title 21 of the United States Code, or its successor.

history: (History: Added by Stats. 2024, Ch. 726, Sec. 2. (AB 2613) Effective January 1, 2025. Repealed as of January 1, 2029, pursuant to Section 124965.14.)

path: 106. PERSONAL HEALTH CARE (INCLUDING MATERNAL, CHILD, AND ADOLESCENT) > 4.6. Jacqueline Marie Zbur Rare Disease Advisory Council


text:
(a) The Secretary of Health and Human Services shall appoint the chair of the advisory council. The chair shall not hold any other position, employment, or appointment within state government.

(b) Members of the advisory council shall be appointed by the State Public Health Officer, shall either reside in California or be employed by a California-based company or organization, and include all of the following:

(1) Two physicians and surgeons licensed to practice in this state who have experience in treating patients with rare diseases, at least one of whom shall also treat children.

(2) One registered professional nurse licensed to practice in this state who has experience in providing care to patients with rare diseases.

(3) One hospital administrator employed by a hospital that treats rare disease patients.

(4) One representative of the California health care coverage industry.

(5) One representative of the biopharmaceutical industry.

(6) One representative of the scientific community who is engaged in rare disease research.

(7) One rare disease geneticist or genetic counselor.

(8) Up to five individuals who are either a rare disease patient or a caregiver to a rare disease patient. The advisory council shall not include more than three individuals from each category.

(9) One medical social worker or mental health provider who works with rare disease patients.

(10) Up to two representatives of patient advocacy organizations that operate within this state.

(c) The advisory council may advise the California Health and Human Services Agency on additional at-large appointments to the advisory council that may be necessary to carry out its duties. At-large appointments to the advisory council may serve on an ad hoc basis.

(d) All members of the advisory council shall serve without compensation, but the members appointed pursuant to subdivision (b) may be reimbursed for travel and other miscellaneous expenses necessary to perform their duties if funds are made available to the advisory council for its purposes.

(e) Members of the advisory council appointed pursuant to subdivision (b) shall serve for the duration of this part. Any vacancy in the membership of the advisory council shall be filled in the same manner as provided for in the original appointment.

(f) Each member of the advisory council shall annually sign a conflict of interest statement disclosing any economic or other relationship with an entity that could influence the member’s decisions. At least 20 percent of the advisory council’s members shall not have a conflict of interest with respect to an insurer, pharmaceutical benefits manager, or pharmaceutical manufacturer.

part: 4.6. Jacqueline Marie Zbur Rare Disease Advisory Council


text:
(a) The advisory council shall meet periodically, but at least twice annually.

(b) The advisory council may call to its assistance, and avail itself of the services of, the employees of any state, county, or municipal department, board, bureau, commission, or agency as it may require and as may be available to it for its purposes, if those employees elect to participate.


text:
The advisory council shall perform all of the following duties:

(a) Act as the advisory body on rare diseases to the Legislature, and state departments, agencies, commissions, and authorities, and private agencies, that provide services to, or that are charged with the care of, persons with rare diseases.

(b) Consult with experts on rare diseases to develop recommendations to improve patient access to, and quality of, rare disease specialists, affordable and comprehensive health care coverage, relevant diagnostics, timely treatment, and other needed services.

(c) Create and maintain an internet web page for the advisory council.

(d) Identify, consolidate, and publish on the advisory council’s web page publicly accessible resources on research, diagnosis, treatment, and education relating to rare diseases in California to foster recognition and access to treatment.

(e) Identify areas of unmet need for research and opportunities for collaboration with stakeholders and rare disease advisory councils in other states that can inform future studies and work done by the advisory council.


text: The advisory council shall apply for, and accept, any grant of funds from the federal government, private foundations, or other sources that may be available for programs related to rare diseases. The advisory council shall not accept any funds from the employer of a currently seated council member.


text: The advisory council shall report on the activities of the advisory council and its findings and recommendations on issues relating to the quality and cost-effectiveness of, and access to, treatment and services provided to persons with rare diseases in this state on the advisory council’s web page.


text: This part shall remain in effect only until January 1, 2029, and as of that date is repealed.

history: (History: Added by Stats. 2024, Ch. 726, Sec. 2. (AB 2613) Effective January 1, 2025. Repealed as of January 1, 2029, by its own provisions. Note: Repeal affects Part 4.6, commencing with Sec. 124965.)


text:
The Legislature hereby finds and declares that:

(a) Each person in the State of California is entitled to health care commensurate with his or her health care needs, and to protection from inadequate health services not in the person’s best interests.

(b) Hereditary disorders, such as sickle cell anemia, cystic fibrosis, and hemophilia, are often costly, tragic, and sometimes deadly burdens to the health and well-being of the citizens of this state.

(c) Detection through screening of hereditary disorders can lead to the alleviation of the disability of some hereditary disorders and contribute to the further understanding and accumulation of medical knowledge about hereditary disorders that may lead to their eventual alleviation or cure.

(d) There are different severities of hereditary disorders, that some hereditary disorders have little effect on the normal functioning of individuals, and that some hereditary disorders may be wholly or partially alleviated through medical intervention and treatment.

(e) All or most persons are carriers of some deleterious recessive genes that may be transmitted through the hereditary process, and that the health of carriers of hereditary disorders is substantially unaffected by that fact.

(f) Carriers of most deleterious genes should not be stigmatized and should not be discriminated against by any person within the State of California.

(g) Specific legislation designed to alleviate the problems associated with specific hereditary disorders may tend to be inflexible in the face of rapidly expanding medical knowledge, underscoring the need for flexible approaches to coping with genetic problems.

(h) State policy regarding hereditary disorders should be made with full public knowledge, in light of expert opinion and should be constantly reviewed to consider changing medical knowledge and ensure full public protection.

(i) The extremely personal decision to bear children should remain the free choice and responsibility of the individual, and should not be restricted by the state.

(j) Participation of persons in hereditary disorders programs in the State of California should be wholly voluntary, except for initial screening for phenylketonuria (PKU) and other genetic disorders treatable through the California newborn screening program. All information obtained from persons involved in hereditary disorders programs in the state should be held strictly confidential.

(k) In order to minimize the possibility for the reoccurrence of abuse of genetic intervention in hereditary disorders programs, all programs offering screening programs for heredity disorders shall comply with the principles established in the Hereditary Disorders Act (Section 27). The Legislature finds it necessary to establish a uniform statewide policy for the screening for heredity disorder in the State of California.

chapter: 1. Genetic Prevention Services

article: 1. Hereditary Disorders Act

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


text:
(a) It is the intent of the Legislature that, unless otherwise specified, the genetic disease testing program carried out pursuant to this chapter be fully supported from fees collected for services provided by the program.

(b) (1) The department shall charge a fee to all payers for any test or activity performed pursuant to this chapter. The amount of the fee shall be established by regulation and periodically adjusted by the director in order to meet the costs of this chapter. Notwithstanding any other law, any fee charged for prenatal screening and followup services provided to a person enrolled in the Medi-Cal program, health care service plan enrollee, or person covered by a health insurance policy shall be paid in full and deposited in the Genetic Disease Testing Fund or the Birth Defects Monitoring Program Fund consistent with this section.

(2) The department shall expeditiously undertake all steps necessary to implement the fee collection process, including personnel, contracts, and data processing, to initiate the fee collection process at the earliest opportunity.

(3) Effective for services provided on and after July 1, 2002, the department shall charge a fee to the hospital of birth or, for births not occurring in a hospital, to families of the newborn for newborn screening and followup services. The hospital of birth and families of newborns born outside the hospital shall make payment in full to the Genetic Disease Testing Fund. The department shall not charge or bill Medi-Cal beneficiaries for services provided pursuant to this chapter.

(4) (A) The department shall charge a fee for prenatal screening to support the pregnancy blood sample storage, testing, and research activities of the Birth Defects Monitoring Program.

(B) The prenatal screening fee for activities of the Birth Defects Monitoring Program shall be ten dollars ($10).

(5) The department shall set guidelines for invoicing, charging, and collecting from approved researchers the amount necessary to cover all expenses associated with research application requests made pursuant to this section, data linkage, retrieval, data processing, data entry, reinventory, reporting, and shipping of blood samples or their components, and related data management.

(6) The only funds from the Genetic Disease Testing Fund that may be used for the purpose of supporting the pregnancy blood sample storage, testing, and research activities of the Birth Defects Monitoring Program are those prenatal screening fees assessed and collected prior to the creation of the Birth Defects Monitoring Program Fund specifically to support those Birth Defects Monitoring Program activities.

(7) (A) The Birth Defects Monitoring Program Fund is hereby created as a special fund in the State Treasury. Fee revenues that are collected pursuant to paragraph (4) shall be deposited into the fund and shall be available upon appropriation by the Legislature to support the pregnancy blood sample storage, testing, and research activities, including reporting, of the Birth Defects Monitoring Program.

(B) Notwithstanding Section 16305.7 of the Government Code, interest earned on funds in the Birth Defects Monitoring Program Fund shall be deposited as revenue into the fund to support the Birth Defects Monitoring Program.

(c) (1) The Legislature finds that timely implementation of changes in genetic screening programs and continuous maintenance of quality statewide services requires expeditious regulatory and administrative procedures to obtain the most cost-effective electronic data processing, hardware, software services, testing equipment, and testing and followup services.

(2) The expenditure of funds from the Genetic Disease Testing Fund for these purposes is not subject to Section 12102 of, and Chapter 2 (commencing with Section 10290) of Part 2 of Division 2 of, the Public Contract Code or to Division 25.2 (commencing with Section 38070) of this code. The department shall provide the Department of Finance with documentation that equipment and services have been obtained at the lowest cost consistent with technical requirements for a comprehensive high-quality program.

(3) The expenditure of funds from the Genetic Disease Testing Fund for implementation of the Tandem Mass Spectrometry screening for fatty acid oxidation, amino acid, and organic acid disorders, and screening for congenital adrenal hyperplasia, may be implemented through the amendment of the Genetic Disease Branch Screening Information System contracts and is not subject to Chapter 3 (commencing with Section 12100) of Part 2 of Division 2 of the Public Contract Code, Article 4 (commencing with Section 19130) of Chapter 5 of Part 2 of Division 5 of Title 2 of the Government Code, and any policy, procedure, regulation, or manual authorized by those laws.

(4) (A) The expenditure of funds from the Genetic Disease Testing Fund for the expansion of the Genetic Disease Branch Screening Information System to include cystic fibrosis, biotinidase, severe combined immunodeficiency (SCID), adrenoleukodystrophy (ALD), and any other disease that is detectable in blood samples, as specified in subdivision (d) of Section 125001, may be implemented through the amendment of the Genetic Disease Branch Screening Information System contracts and shall not be subject to Chapter 2 (commencing with Section 10290) or Chapter 3 (commencing with Section 12100) of Part 2 of Division 2 of the Public Contract Code, Article 4 (commencing with Section 19130) of Chapter 5 of Part 2 of Division 5 of Title 2 of the Government Code, or Sections 4800 to 5180, inclusive, of the State Administrative Manual as they relate to approval of information technology projects or approval of increases in the duration or costs of information technology projects.

(B) This paragraph shall apply to the design, development, and implementation of the expansion and to the maintenance and operation of the Genetic Disease Branch Screening Information System, including change requests, once the expansion is implemented.

(d) (1) (A) The department may adopt emergency regulations to implement and make specific this chapter in accordance with Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code.

(B) For the purposes of the Administrative Procedure Act, the adoption of regulations shall be deemed an emergency and necessary for the immediate preservation of the public peace, health and safety, or general welfare.

(C) Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, these emergency regulations shall not be subject to the review and approval of the Office of Administrative Law.

(D) Notwithstanding Sections 11346.1 and 11349.6 of the Government Code, the department shall submit these regulations directly to the Secretary of State for filing.

(E) The regulations shall become effective immediately upon filing by the Secretary of State.

(F) Regulations shall be subject to public hearing within 120 days of filing with the Secretary of State and shall comply with Sections 11346.8 and 11346.9 of the Government Code or shall be repealed.

(2) (A) The Office of Administrative Law shall provide for the printing and publication of these regulations in the California Code of Regulations.

(B) Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the regulations adopted pursuant to this chapter shall not be repealed by the Office of Administrative Law and shall remain in effect until revised or repealed by the department.

(3) The Legislature finds and declares that the health and safety of California newborns is in part dependent on an effective and adequately staffed genetic disease program, the cost of which shall be supported by the fees generated by the program.

history: (History: Amended by Stats. 2024, Ch. 598, Sec. 1. (SB 1099) Effective January 1, 2025.)

part: 5. HEREDITARY DISEASES/CONGENITAL DEFECTS

article: 1. Hereditary Disorders Act


text:
The director shall establish any regulations and standards for hereditary disorders programs as the director deems necessary to promote and protect the public health and safety. Standards shall include licensure of master level genetic counselors and doctoral level geneticists. Regulations adopted shall implement the principles established in this section. These principles shall include, but not be limited to, the following:

(a) The public, especially communities and groups particularly affected by programs on hereditary disorders, should be consulted before any regulations and standards are adopted by the department.

(b) The incidence, severity, and treatment costs of each hereditary disorder and its perceived burden by the affected community should be considered and, where appropriate, state and national experts in the medical, psychological, ethical, social, and economic effects or programs for the detection and management of hereditary disorders shall be consulted by the department.

(c) Information on the operation of all programs on hereditary disorders within the state, except for confidential information obtained from participants in the programs, shall be open and freely available to the public.

(d) Clinical testing procedures established for use in programs, facilities, and projects shall be accurate, provide maximum information, and the testing procedures selected shall produce results that are subject to minimum misinterpretation.

(e) No test or tests may be performed on any minor over the objection of the minor’s parents or guardian, nor may any tests be performed unless the parent or guardian is fully informed of the purposes of testing for hereditary disorders and is given reasonable opportunity to object to the testing.

(f) No testing, except initial screening for phenylketonuria (PKU) and other diseases that may be added to the newborn screening program, shall require mandatory participation, and no testing programs shall require restriction of childbearing, and participation in a testing program shall not be a prerequisite to eligibility for, or receipt of, any other service or assistance from, or to participate in, any other program, except where necessary to determine eligibility for further programs of diagnoses of or therapy for hereditary conditions.

(g) Pretest and posttest counseling services for hereditary disorders shall be available through the program or a referral source for all persons determined to be or who believe themselves to be at risk for a hereditary disorder. Genetic counseling shall be provided by a physician, a certified advanced practice nurse with a genetics specialty, or other appropriately trained licensed health care professional and shall be nondirective, shall emphasize informing the client, and shall not require restriction of childbearing.

(h) All participants in programs on hereditary disorders shall be protected from undue physical and mental harm, and except for initial screening for phenylketonuria (PKU) and other diseases that may be added to newborn screening programs, shall be informed of the nature of risks involved in participation in the programs, and those determined to be affected with genetic disease shall be informed of the nature, and where possible the cost, of available therapies or maintenance programs, and shall be informed of the possible benefits and risks associated with these therapies and programs.

(i) All testing results and personal information generated from hereditary disorders programs shall be made available to an individual over 18 years of age, or to the individual’s parent or guardian. If the individual is a minor or incompetent, all testing results that have positively determined the individual to either have, or be a carrier of, a hereditary disorder shall be given through a physician or other source of health care.

(j) All testing results and personal information from hereditary disorders programs obtained from any individual, or from specimens from any individual, shall be held confidential and be considered a confidential medical record except for information that the individual, parent, or guardian consents to be released, provided that the individual is first fully informed of the scope of the information requested to be released, of all of the risks, benefits, and purposes for the release, and of the identity of those to whom the information will be released or made available, except for data compiled without reference to the identity of any individual, and except for research purposes, provided that pursuant to Subpart A (commencing with Section 46.101) of Part 46 of Title 45 of the Code of Federal Regulations entitled “Basic HHS Policy for Protection of Human Subjects,” the research has first been reviewed and approved by an institutional review board that certifies the approval to the custodian of the information and further certifies that in its judgment the information is of such potentially substantial public health value that modification of the requirement for legally effective prior informed consent of the individual is ethically justifiable.

(k) A physician providing information to patients on expanded newborn screening shall disclose to the parent the physician’s financial interest, if any, in the laboratory to which the patient is being referred.

( l) An individual whose confidentiality has been breached as a result of any violation of the provisions of the Hereditary Disorders Act, as defined in subdivision (b) of Section 27, may recover compensatory and civil damages. Any person who negligently breaches the confidentiality of an individual tested under this article shall be subject to civil damages of not more than ten thousand dollars ($10,000), reasonable attorney’s fees, and the costs of litigation. Any person who knowingly breaches the confidentiality of an individual tested under this article shall be subject to payment of compensatory damages, and in addition, may be subject to civil damages of fifty thousand dollars ($50,000), reasonable attorney’s fees, and the costs of litigation, or imprisonment in the county jail of not more than one year. If the offense is committed under false pretenses, the person may be subject to a fine of not more than one hundred thousand dollars ($100,000), imprisonment in the county jail of not more than one year, or both. If the offense is committed with the intent to sell, transfer, or use individually identifiable health information for commercial advantage, personal gain, or malicious harm, the person may be subject to a fine of not more than two hundred fifty thousand dollars ($250,000), imprisonment in the county jail of not more than one year, or both.

(m) “Genetic counseling” as used in this section shall not include communications that occur between patients and appropriately trained and competent licensed health care professionals, such as physicians, registered nurses, and physicians assistants who are operating within the scope of their license and qualifications as defined by their licensing authority.

history: (History: Amended by Stats. 2004, Ch. 228, Sec. 6.3. Effective August 16, 2004.)

article: 1. Hereditary Disorders Act


text:
(a) A person shall not use the title of genetic counselor unless the person has applied for and obtained a license from the department.

(b) The applicant for a genetic counselor license shall meet minimum qualifications that include, but are not limited to, both of the following:

(1) Has earned a master’s degree or above from a program specializing in or having substantial course content in genetics.

(2) Has demonstrated competence by an examination administered or approved by the department.

(c) The license shall be valid for three years unless at any time during that period it is revoked or suspended. The license may be renewed prior to the expiration of the three-year period.

(d) To qualify to renew the license, a licenseholder shall have completed 45 hours of continuing education units during the three-year license renewal period. At least 30 hours of the continuing education units shall be in genetics.

(e) (1) The fee for an original license and license renewal shall be three hundred dollars ($300).

(2) (A) The department may adjust these fees to an amount not to exceed five hundred dollars ($500).

(B) The department shall solicit input from affected stakeholders before raising fees under this subdivision.

history: (History: Amended by Stats. 2025, Ch. 105, Sec. 40. (AB 144) Effective September 17, 2025.)

article: 1. Hereditary Disorders Act


text:
(a) The department shall issue a temporary genetic counselor license to a person to practice as a licensed genetic counselor who meets all of the following:

(1) The requirements for licensure set forth in subdivision (b) of Section 124981, except passing the certification examination as required by paragraph (2) of subdivision (b) of Section 124981.

(2) Either of the following requirements:

(A) The person meets the requirements to apply for and has applied for the first available certification examination offered. The department may require an applicant for a temporary genetic counselor license to provide documentation of acceptance for the examination.

(B) The person meets the requirements to apply for the certification examination and plans to apply to sit for the examination in the year following the year of the first available examination. The department shall require the applicant to provide documentation showing registration for the examination, when the documentation is received by the applicant. After the applicant takes the examination, the department shall require the applicant to provide documentation showing that the applicant took the examination.

(3) (A) The fee for a temporary license shall be three hundred dollars ($300).

(B) (i) The department may adjust this fee to an amount not to exceed five hundred dollars ($500).

(ii) The department shall solicit input from affected stakeholders before raising fees under this paragraph.

(b) A temporary genetic counselor license shall be valid for 24 months and shall not be extended or renewed.

(c) Notwithstanding subdivision (a), a temporary license issued pursuant to this section shall expire upon any of the following events, whichever occurs earlier:

(1) The issuance of a license pursuant to Section 124981.

(2) Thirty days after notification of the department that an applicant has failed the certification examination.

(3) The expiration date on the temporary license.

(d) A person holding a temporary genetic counselor license issued pursuant to this section, shall be required to work under the supervision of a licensed genetic counselor or a licensed physician and surgeon.

(e) The department may revoke the temporary license of a genetic counselor licensed pursuant to this section if the person has been convicted of a felony charge that is substantially related to the qualifications, functions, or duties of a genetic counselor. A plea of guilty or nolo contendere to a felony charge shall be deemed a conviction for the purposes of this subdivision.

history: (History: Amended by Stats. 2025, Ch. 105, Sec. 41. (AB 144) Effective September 17, 2025.)

article: 1. Hereditary Disorders Act


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

article: 1. Hereditary Disorders Act


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

article: 1. Hereditary Disorders Act


text:
(a) (1) The Birth Defects Monitoring Program, within the State Department of Public Health, shall collect and store any umbilical cord blood samples it receives from hospitals for storage and research. For purposes of ensuring financial stability, the Birth Defects Monitoring Program shall ensure that the following conditions, alone or in combination, are met:

(A) The fees paid by researchers pursuant to subdivision (c) shall be used for, and be sufficient to cover the cost of, collecting and storing blood samples, including umbilical cord blood samples.

(B) The department receives confirmation that a researcher has requested umbilical cord blood samples from the Birth Defects Monitoring Program for research or has requested umbilical cord blood samples to be included within a request for pregnancy or newborn blood samples through the program and has provided satisfactory evidence that adequate funding will be provided to the department from the fees paid by the researcher for the request.

(C) The department receives federal grant moneys to pay for initial startup costs for the collection and storage of umbilical cord blood samples.

(2) The department may limit the number of umbilical cord blood samples the program collects each year.

(b) (1) All information relating to umbilical cord blood samples collected and utilized by the department shall be confidential, and shall be used solely for the purposes of the program, or, if approved by the department, research. Access to confidential information shall be limited to authorized persons who agree, in writing, to maintain the confidentiality of that information. Notwithstanding any other provision of law, when the blood samples specified in subdivision (c), including those samples with any information identifying the person from whom the samples were obtained, are stored, processed, analyzed, or otherwise shared for research purposes with nondepartment staff, those samples may be shared by the program with department-authorized researchers for research purposes, and department representatives approved by the department, subject to the confidentiality and security requirements for confidential information established in this section and in Section 103850.

(2) The department shall maintain an accurate record of all persons who are given confidential information pursuant to this section, and any disclosure of confidential information shall be made only upon written agreement that the information will be kept confidential, used for its approved purpose, and not be further disclosed.

(3) A person who, in violation of a written agreement to maintain confidentiality, discloses information provided pursuant to this section, or who uses information provided pursuant to this section in a manner other than as approved pursuant to this section may be denied further access to confidential information maintained by the department, and shall be subject to a civil penalty not exceeding one thousand dollars ($1,000). The penalty provided in this section does not limit or otherwise restrict a remedy, provisional or otherwise, provided by law for the benefit of the department or a person covered by this section.

(c) In order to implement this section, the department shall establish fees in an amount that shall not exceed the costs of administering the program and the collection and storage of these samples, which the department shall collect from researchers who have been approved by the department and who seek to use the following types of blood samples for research:

(1) Umbilical cord blood.

(2) Pregnancy blood collected by the Genetic Disease Screening Program, and stored by the Birth Defects Monitoring Program.

(3) Newborn blood collected by the Genetic Disease Screening Program.

(d) Fees collected pursuant to subdivision (c) shall be collected by the department and deposited into the Birth Defects Monitoring Program Fund, the Genetic Disease Testing Fund, created pursuant to Section 124996, or the Cord Blood Banking Fund, which is hereby created as a special fund in the State Treasury. The amount of fees deposited into each of these funds shall be based on the program that is providing those pregnancy blood samples, and the purpose for which the blood sample was obtained. Notwithstanding any other provision of law, the moneys in the Birth Defects Monitoring Program Fund, the Genetic Disease Testing Fund, and the Cord Blood Banking Fund that are collected pursuant to subdivision (c), may be used by the department, upon appropriation by the Legislature, for the purposes specified in subdivision (e).

(e) Moneys in those funds shall be used for the costs related to reporting, data management, including data linkage and entry, and blood collection, storage, retrieval, processing, inventory, and shipping.

(f) The department shall comply with the existing requirements in the Birth Defects Monitoring Program, as set forth in Chapter 1 (commencing with Section 103825) of Part 2 of Division 102.

(g) The department, any entities approved by the department, and researchers shall maintain the confidentiality of patient information and blood samples in accordance with existing law and in the same manner as other medical record information with patient identification that they possess, and shall use the information only for the following purposes:

(1) Research to identify risk factors for children’s and women’s diseases.

(2) Research to develop and evaluate screening tests.

(3) Research to develop and evaluate prevention strategies.

(4) Research to develop and evaluate treatments.

(h) (1) For purposes of ensuring the security of a donor’s personal information, before any blood samples are released pursuant to this section for research purposes, the State Committee for the Protection of Human Subjects (CPHS) shall determine if all of the following criteria have been met:

(A) The department, contractors, researchers, or other entities approved by the department have provided a plan sufficient to protect personal information from improper use and disclosures, including sufficient administrative, physical, and technical safeguards to protect personal information from reasonable anticipated threats to the security or confidentiality of the information.

(B) The department, contractors, researchers, or other entities approved by the department have provided a sufficient plan to destroy or return all personal information as soon as it is no longer needed for the research activity, unless the program contractors, researchers, or other entities approved by the department have demonstrated an ongoing need for the personal information for the research activity and have provided a long-term plan sufficient to protect the confidentiality of that information.

(C) The department, contractors, researchers, or other entities approved by the department have provided sufficient written assurances that the personal information will not be reused or disclosed to a person or entity, or used in a manner not approved in the research protocol, except as required by law or for authorized oversight of the research activity.

(2) As part of its review and approval of the research activity for the purpose of protecting personal information held in agency databases, CPHS shall accomplish at least all of the following:

(A) Determine whether the requested personal information is needed to conduct the research.

(B) Permit access to personal information only if it is needed for the research activity.

(C) Permit access only to the minimum personal information necessary for the research activity.

(D) Require the assignment of unique subject codes that are not derived from personal information in lieu of social security numbers if the research can be conducted without social security numbers.

(E) If feasible, and if cost, time, and technical expertise permit, require the agency to conduct a portion of the data processing for the researcher to minimize the release of personal information.

(i) In addition to the fees described in subdivision (c), the department may bill a researcher for the costs associated with the department’s process of protecting personal information, including, but not limited to, the department’s costs for conducting a portion of the data processing for the researcher, removing personal information, encrypting or otherwise securing personal information, or assigning subject codes.

(j) This section does not prohibit the department from using its existing authority to enter into written agreements to enable other institutional review boards to approve research activities, projects or classes of projects for the department, provided that the data security requirements set forth in this section are satisfied.

history: (History: Amended by Stats. 2024, Ch. 598, Sec. 2. (SB 1099) Effective January 1, 2025.)

article: 1. Hereditary Disorders Act


text:
The following programs shall comply with the regulations established pursuant to the Hereditary Disorders Act, as defined in Section 27:

(a) The California Children’s Services Program under Article 5 (commencing with Section 123800) of Chapter 3 of Part 2.

(b) Prenatal testing programs for newborns under Sections 125050 to 125065, inclusive.

(c) Medical testing programs for newborns under the Maternal and Child Health Program Act, as defined in Section 27.

(d) Programs of the genetic disease unit under Section 125000.

(e) Child health and disability prevention programs under Article 6 (commencing with Section 124025) of Chapter 3 of Part 2 and Section 120475.

(f) Genetically Handicapped Persons Program under Article 1 (commencing with Section 125125) of Chapter 2.

(g) Medi-Cal Benefits Program under Article 4 (commencing with Section 14131) of Chapter 7 of Part 3 of Division 9 of the Welfare and Institutions Code.

history: (History: Amended by Stats. 2015, Ch. 303, Sec. 352. (AB 731) Effective January 1, 2016.)

article: 1. Hereditary Disorders Act


text:
(a) The Genetic Disease Testing Fund is continued in existence as a special fund in the State Treasury. The department may charge a fee for any activities carried out pursuant to the Hereditary Disorders Act, including licensing activities conducted pursuant to Section 124980. All moneys collected by the department under the act shall be deposited in the Genetic Disease Testing Fund, that is continuously appropriated to the department to carry out the purposes of the act.

(b) It is the intent of the Legislature that the program carried out pursuant to the act be fully supported from fees collected under the act.

(c) The director shall adopt regulations establishing the amount of fees for activities carried out pursuant to the act.

(d) The “Hereditary Disorders Act” or “act” referred to in this section is the act described in subdivision (b) of Section 27.

history: (History: Added by renumbering Section 125005 by Stats. 2000, Ch. 941, Sec. 4. Effective January 1, 2001.)

article: 1. Hereditary Disorders Act


text:
(a) It is the policy of the State of California to make every effort to detect, as early as possible, phenylketonuria and other preventable heritable or congenital disorders leading to intellectual disability or physical defects.

The department shall establish a genetic disease unit, that shall coordinate all programs of the department in the area of genetic disease. The unit shall promote a statewide program of information, testing, and counseling services and shall have the responsibility of designating tests and regulations to be used in executing this program.

The information, tests, and counseling for children shall be in accordance with accepted medical practices and shall be administered to each child born in California once the department has established appropriate regulations and testing methods. The information, tests, and counseling for pregnant women shall be in accordance with accepted medical practices and shall be offered to each pregnant woman in California once the department has established appropriate regulations and testing methods. These regulations shall follow the standards and principles specified in Section 124980. The department may provide laboratory testing facilities or contract with any laboratory that it deems qualified to conduct tests required under this section. However, notwithstanding former Section 125005, provision of laboratory testing facilities by the department shall be contingent upon the provision of funding therefor by specific appropriation to the Genetic Disease Testing Fund enacted by the Legislature. If moneys appropriated for purposes of this section are not authorized for expenditure to provide laboratory facilities, the department may nevertheless contract to provide laboratory testing services pursuant to this section and shall perform laboratory services, including, but not limited to, quality control, confirmatory, and emergency testing, necessary to ensure the objectives of this program.

(b) The department shall charge a fee for any tests performed pursuant to this section. The amount of the fee shall be established and periodically adjusted by the director in order to meet the costs of this section.

(c) The department shall inform all hospitals or physicians and surgeons, or both, of required regulations and tests and may alter or withdraw any of these requirements whenever sound medical practice so indicates. To the extent practicable, the department shall provide notice to hospitals and other payers in advance of an increase in the fees charged for the program.

(d) This section shall not apply if a parent or guardian of the newborn child objects to a test on the ground that the test conflicts with his or her religious beliefs or practices.

(e) The genetic disease unit is authorized to make grants or contracts or payments to vendors approved by the department for all of the following:

(1) Testing and counseling services.

(2) Demonstration projects to determine the desirability and feasibility of additional tests or new genetic services.

(3) To initiate the development of genetic services in areas of need.

(4) To purchase or provide genetic services from any sums as are appropriated for this purpose.

(f) The genetic disease unit shall evaluate and prepare recommendations on the implementation of tests for the detection of hereditary and congenital diseases, including, but not limited to, biotinidase deficiency and cystic fibrosis. The genetic disease unit shall also evaluate and prepare recommendations on the availability and effectiveness of preventative followup interventions, including the use of specialized medically necessary dietary products.

It is the intent of the Legislature that funds for the support of the evaluations and recommendations required pursuant to this subdivision, and for the activities authorized pursuant to subdivision (e), shall be provided in the annual Budget Act appropriation from the Genetic Disease Testing Fund.

(g) Health care providers that contract with a prepaid group practice health care service plan that annually has at least 20,000 births among its membership, may provide, without contracting with the department, any or all of the testing and counseling services required to be provided under this section or the regulations adopted pursuant thereto, if the services meet the quality standards and adhere to the regulations established by the department and the plan pays that portion of a fee established under this section that is directly attributable to the department’s cost of administering the testing or counseling service and to any required testing or counseling services provided by the state for plan members. The payment by the plan, as provided in this subdivision, shall be deemed to fulfill any obligation the provider or the provider’s patient may have to the department to pay a fee in connection with the testing or counseling service.

(h) The department may appoint experts in the area of genetic screening, including, but not limited to, cytogenetics, molecular biology, prenatal, specimen collection, and ultrasound to provide expert advice and opinion on the interpretation and enforcement of regulations adopted pursuant to this section. These experts shall be designated agents of the state with respect to their assignments. These experts shall receive no salary, but shall be reimbursed for expenses associated with the purposes of this section. All expenses of the experts for the purposes of this section shall be paid from the Genetic Disease Testing Fund.

history: (History: Amended by Stats. 2012, Ch. 457, Sec. 33. (SB 1381) Effective January 1, 2013.)

article: 2. Newborn Screening

path: 106. PERSONAL HEALTH CARE (INCLUDING MATERNAL, CHILD, AND ADOLESCENT) > 5. HEREDITARY DISEASES/CONGENITAL DEFECTS > 1. Genetic Prevention Services > 2. Newborn Screening


text:
(a) The department shall establish a program for the development, provision, and evaluation of genetic disease testing, and may provide laboratory testing facilities or make grants to, contract with, or make payments to, any laboratory that it deems qualified and cost effective to conduct testing or with any metabolic specialty clinic to provide necessary treatment with qualified specialists. The program shall provide genetic screening and followup services for persons who have the screening.

(b) The department shall expand statewide screening of newborns to include tandem mass spectrometry screening for fatty acid oxidation, amino acid, organic acid disorders, and congenital adrenal hyperplasia as soon as possible. The department shall provide information with respect to these disorders and available testing resources to all women receiving prenatal care and to all women admitted to a hospital for delivery. If the department is unable to provide this statewide screening by August 1, 2005, the department shall temporarily obtain these testing services through a competitive bid process from one or more public or private laboratories that meet the department’s requirements for testing, quality assurance, and reporting. If the department determines that contracting for these services is more cost effective, and meets the other requirements of this chapter, than purchasing the tandem mass spectrometry equipment themselves, the department shall contract with one or more public or private laboratories.

(c) The department shall expand statewide screening of newborns to include screening for severe combined immunodeficiency (SCID) as soon as possible. In implementing the SCID screening test, the department shall also screen for other T-cell lymphopenias that are detectable as a result of screening for SCID, insofar as it does not require additional costs or equipment beyond that needed to test for SCID.

(d) The department shall expand statewide screening of newborns to include screening for adrenoleukodystrophy (ALD) and any other disease that is detectable in blood samples as soon as practicable, but no later than two years after the disease is adopted by the federal Recommended Uniform Screening Panel (RUSP), or enrollment of the act amending this subdivision, whichever is later.

history: (History: Amended by Stats. 2016, Ch. 393, Sec. 2. (SB 1095) Effective January 1, 2017.)

article: 2. Newborn Screening


text:
(a) In order to align closely related programs and in order to facilitate research into the causes of, and treatment for, birth defects, the Birth Defects Monitoring Program provided for pursuant to Chapter 1 (commencing with Section 103825) of Part 2 of Division 102 shall become part of the Maternal, Child, and Adolescent Health program provided for in Article 1 (commencing with Section 123225) of Chapter 1 of Part 2 of Division 106.

(b) It is the intent of the Legislature that pregnancy blood samples, taken for prenatal screening, shall be stored and made available to any researcher who is approved by the department for the following purposes:

(1) Research to identify risk factors for children’s and women’s diseases.

(2) Research to develop and evaluate screening tests.

(3) Research to develop and evaluate prevention strategies.

(4) Research to develop and evaluate treatments.

(c) Before any pregnancy blood samples are released for research purposes, all of the following conditions must be met:

(1) Individual consent at the time the sample is drawn to allow confidential use of the sample for research purposes by the department or the department’s approved researchers.

(2) Protocol review for scientific merit by the department or another entity authorized by the department.

(3) Protocol review by the State Committee for the Protection of Human Subjects.

(d) Since the pregnancy blood samples described in this section will be stored by the California Birth Defects Monitoring Program or another entity authorized by the department, the storage, analysis, and sharing of pregnancy blood samples for research purposes shall be done in compliance with Section 103850, pertaining to confidentiality of information.

(e) The department shall adopt regulations specifying the protocols and conditions under which blood samples will be released for research purposes, in accordance with the procedures set forth in subdivision (d) of Section 124977.

(f) Until such time that regulations are adopted by the department pursuant to subdivision (e), the Genetic Disease Screening Program and the Birth Defects Monitoring Program shall release blood samples to only those researchers who meet the requirements of this section, including all of the following:

(1) The research project was approved by the State Committee for the Protection of Human Subjects.

(2) The research project’s protocol was approved by the State Committee for the Protection of Human Subjects, and specifically included a description of the number and type of blood samples requested from the Genetic Disease Screening Program or the Maternal, Child, and Adolescent Health Program, including the Birth Defects Monitoring Program for the project.

(3) There is written documentation that the Genetic Disease Screening Program or the Maternal, Child, and Adolescent Health Program, including the Birth Defects Monitoring Program, approved a request for the blood samples for the research project approved by the State Committee for the Protection of Human Subjects.

(4) The researcher has agreed to pay fees to the department to pay reasonable costs for processing the samples and information, including, but not limited to, costs of data management, including data linkage and entry, and costs of blood collection, storage, retrieval, inventory, and shipping.

(g) Subdivision (f) shall become inoperative on the date that the department adopts regulations specifying the protocols and conditions for release of the blood samples for research purposes.

history: (History: Amended by Stats. 2008, Ch. 680, Sec. 3. Effective January 1, 2009.)

article: 2. Newborn Screening


text:
Commencing July 1, 2026, and each July 1 thereafter, the State Department of Public Health shall generate a report that includes each of the following:

(a) The total number of any residual screening specimens stored by the California Biobank Program.

(b) The number of new residual screening specimens collected during the previous calendar year.

(c) The number of inheritable conditions identified by the original screening tests during the previous calendar year.

(d) The number of projects utilizing specimens from the California Biobank Program.

(e) The number of published research studies where biospecimens from the California Biobank Program were used or referenced and the potential public health benefits from the research.

(f) The number of specimens provided by the California Biobank Program for each research project.

(g) The number of screening tests waived for religious purposes during the previous calendar year.

(h) The number of residual screening specimens destroyed at the request of a parent or adult during the previous calendar year.

(i) The number of residual screening samples remaining to be destroyed at the request of a parent or adult during the previous calendar year.

history: (History: Added by Stats. 2024, Ch. 598, Sec. 3. (SB 1099) Effective January 1, 2025.)

article: 2.5. California Biobank Program

path: 106. PERSONAL HEALTH CARE (INCLUDING MATERNAL, CHILD, AND ADOLESCENT) > 5. HEREDITARY DISEASES/CONGENITAL DEFECTS > 1. Genetic Prevention Services > 2.5. California Biobank Program


text: Commencing July 1, 2026, and each July 1 thereafter, a report generated pursuant to this article shall be provided to the Legislature until the department has provided five annual reports and that report shall be made available to the public on the department’s internet website. The department shall continue to post the annual report to its internet website after the fifth annual report has been provided to the Legislature.

article: 2.5. California Biobank Program


text: A report submitted to the Legislature pursuant to this article shall be submitted in compliance with Section 9795 of the Government Code.

article: 2.5. California Biobank Program


text:
It is the policy of the State of California to make every effort to detect, as early as possible, sickle cell anemia, a heritable disorder that leads to physical defects.

The department shall have the responsibility of designating tests and regulations to be used in executing this policy. These tests shall be in accordance with accepted medical practices.

Testing for sickle cell anemia may be conducted at the following times:

(a) Upon first enrollment of a child at an elementary school in this state, the child may be tested.

(b) For any child not tested pursuant to subdivision (a), upon first enrollment at a junior high school or senior high school in this state, as the case may be, the child may be tested.

(c) Upon application of any person for a license to marry, the parties seeking to be married may be tested.

(d) At any other times that the department may designate.

This section shall not apply if a parent or guardian of a minor child sought to be tested or any adult sought to be tested objects to the test on the ground that the test conflicts with his or her religious beliefs or practices.

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

article: 3. Sickle Cell Anemia

path: 106. PERSONAL HEALTH CARE (INCLUDING MATERNAL, CHILD, AND ADOLESCENT) > 5. HEREDITARY DISEASES/CONGENITAL DEFECTS > 1. Genetic Prevention Services > 3. Sickle Cell Anemia


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

article: 3. Sickle Cell Anemia


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

article: 3. Sickle Cell Anemia


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

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 shall:

(a) Establish criteria for eligibility for the prenatal testing program. Eligibility shall include definition of conditions and circumstances that result in a high risk of a detectable genetic disorder or birth defect.

(b) (1) Develop an education program designed to educate physicians and surgeons and the public concerning the uses of prenatal testing and the availability of the program.

(2) (A) Include information regarding environmental health in the California Prenatal Screening Program patient educational information. This environmental health information shall include the following statement:

“We encounter chemicals and other substances in everyday life that may affect your developing fetus. Fortunately, there are steps you can take to reduce your exposure to these potentially harmful substances at home, in the workplace, and in the environment. Many Californians are unaware that a number of everyday consumer products may pose potential harm. Prospective parents should talk to their doctor and are encouraged to read more about this topic to learn about simple actions to promote a healthy pregnancy.”

(B) The department shall include in the patient educational information links to educational materials derived from peer-reviewed materials based on the best available evidence relating to environmental health and reproductive toxins.

(C) The department shall post the environmental health information described in subparagraphs (A) and (B) on its Internet Web site.

(D) The department shall send a notice to all distributors of the patient educational information informing them of the change to that information. In the notice, the department shall encourage obstetrician-gynecologists and midwives to discuss environmental health with their patients and to direct their patients to the appropriate page or pages in the patient educational information to provide their patients with additional information.

(E) In order to minimize costs, the environmental health information described in this paragraph shall be included when the patient educational information is otherwise revised and reprinted.

(F) The department may modify the language in the patient educational information after consultation with medical and scientific experts in the field of environmental health and reproductive toxins.

(c) Ensure that genetic counseling be given in conjunction with prenatal testing at the approved prenatal diagnosis centers.

(d) Designate sufficient prenatal diagnosis centers to meet the need for these services. Prenatal diagnosis centers shall have equipment and staff trained and capable of providing genetic counseling and performing prenatal diagnostic procedures and tests, including the interpretation of the results of the procedures and tests.

(e) Administer a program of subsidy grants for approved nonprofit prenatal diagnosis centers. The subsidy grants shall be awarded based on the reported number of low-income women referred to the center, the number of prenatal diagnoses performed in the previous year at that center, and the estimated size of unmet need for prenatal diagnostic procedures and tests in its service area. This subsidy shall be in addition to fees collected under other state programs.

(f) Establish any rules, regulations, and standards for prenatal diagnostic testing and the allocation of subsidies as the director deems necessary to promote and protect the public health and safety and to implement the Hereditary Disorders Act (Section 27).

(g) (1) The department shall expand prenatal screening to include all tests that meet or exceed the current standard of care as recommended by nationally recognized medical or genetic organizations, including, but not limited to, inhibin.

(2) The prenatal screening fee increase for expanding prenatal screening to include those tests described in paragraph (1) is forty dollars ($40).

(3) The department shall report to the Legislature regarding the progress of the program with regard to implementing prenatal screening for those tests described in paragraph (1) on or before July 1, 2007. The report shall include the costs of screening, followup, and treatment as compared to costs and morbidity averted by this testing under the program.

(4) (A) The expenditure of funds from the Genetic Disease Testing Fund for the expansion of the Genetic Disease Branch Screening Information System to include the expansion of prenatal screenings, pursuant to paragraph (1), may be implemented through the amendment of the Genetic Disease Branch Screening Information System contracts, and shall not be subject to Chapter 2 (commencing with Section 10290) or Chapter 3 (commencing with Section 12100) of Part 2 of Division 2 of the Public Contract Code, Article 4 (commencing with Section 19130) of Chapter 5 of Part 2 of Division 5 of Title 2 of the Government Code, or Sections 4800 to 5180, inclusive, of the State Administrative Manual as they relate to approval of information technology projects or approval of increases in the duration or costs of information technology projects. This paragraph shall apply to the design, development, and implementation of the expansion, and to the maintenance and operation of the Genetic Disease Branch Screening Information System, including change requests, once the expansion is implemented.

(B) (i) The department may adopt emergency regulations to implement and make specific the amendments to this section made during the 2006 portion of the 2005–06 Regular Session in accordance with Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code. For the purposes of the Administrative Procedure Act, the adoption of regulations shall be deemed an emergency and necessary for the immediate preservation of the public peace, health and safety, or general welfare. Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, these emergency regulations shall not be subject to the review and approval of the Office of Administrative Law. Notwithstanding Sections 11346.1 and 11349.6 of the Government Code, the department shall submit these regulations directly to the Secretary of State for filing. The regulations shall become effective immediately upon filing by the Secretary of State. Regulations shall be subject to public hearing within 120 days of filing with the Secretary of State and shall comply with Sections 11346.8 and 11346.9 of the Government Code or shall be repealed.

(ii) The Office of Administrative Law shall provide for the printing and publication of these regulations in the California Code of Regulations. Notwithstanding Chapter 3.5 (commencing with Section 11340) of Part 1 of Division 3 of Title 2 of the Government Code, the regulations adopted pursuant to this chapter shall not be repealed by the Office of Administrative Law and shall remain in effect until revised or repealed by the department.

history: (History: Amended by Stats. 2013, Ch. 667, Sec. 1. (SB 460) Effective January 1, 2014.)

article: 4. Prenatal Testing


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

article: 4. Prenatal Testing


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

article: 4. Prenatal Testing


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

history: (History: Amended by Stats. 1998, Ch. 310, Sec. 26. Effective August 19, 1998.)

article: 4. Prenatal Testing


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

article: 4. Prenatal Testing


text:
(a) As early as possible during prenatal care, a blood specimen obtained pursuant to Section 125080 shall be submitted to a clinical laboratory licensed by the department or to an approved public health laboratory for a determination of rhesus (Rh) blood type and the results shall be reported to both of the following:

(1) The physician and surgeon or other person engaged in the prenatal care of the woman or attending the woman at the time of delivery.

(2) The woman tested.

(b) (1) In addition, as early as possible during prenatal care, a blood specimen obtained pursuant to Section 125080 shall be submitted to a clinical laboratory licensed by the department or to an approved public health laboratory for a test to determine the presence of hepatitis B surface antigen and the human immunodeficiency virus (HIV), and the results shall be reported to both of the following:

(A) The physician and surgeon or other person engaged in the prenatal care of the women or attending the woman at the time of delivery who ordered the test, and who shall subsequently inform the woman tested.

(B) A positive test result shall be reported to the local health officer, with the information required and within the timeframes established by the department, pursuant to Chapter 4 (commencing with Section 2500) of Title 17 of the California Code of Regulations.

(2) In the event that other tests to determine hepatitis B infection or HIV infection become available, the department may approve additional tests.

history: (History: Amended by Stats. 2003, Ch. 749, Sec. 2. Effective January 1, 2004.)

article: 4. Prenatal Testing