Bill Text: CA AB2613 | 2023-2024 | Regular Session | Amended
Bill Title: Jacqueline Marie Zbur Rare Disease Advisory Council.
Spectrum: Partisan Bill (Democrat 1-0)
Status: (Introduced) 2024-05-08 - In committee: Set, first hearing. Referred to suspense file. [AB2613 Detail]
Download: California-2023-AB2613-Amended.html
|
Amended
IN
Assembly
April 25, 2024 |
CALIFORNIA LEGISLATURE—
2023–2024 REGULAR SESSION
Assembly Bill
No. 2613
| Introduced by Assembly Member Zbur |
February 14, 2024 |
An act to add and repeal Part 4.6 (commencing with Section 124965) to of Division 106 of the Health and Safety Code, relating to public health.
LEGISLATIVE COUNSEL'S DIGEST
AB 2613, as amended, Zbur.
Jacqueline Marie Zbur Rare Disease Advisory Council.
Existing law establishes the California Health and Human Services Agency, which includes the State Department of Public Health, among other state departments charged with the administration of health, social, and other human services. Under existing law, the State Department of Public Health has authority over various programs promoting public health, including genetic disease testing.
This bill would establish within the agency, until January 1, 2029, the Jacqueline Marie Zbur Rare Disease Advisory Council, composed of a minimum of 17 members, appointed as specified. The council would generally act as the advisory body on rare diseases to the Legislature and state and private entities that provide services to, or that are charged with the care of, persons with rare diseases. The council specifically would be required, among other duties, to
publish on its website a list of existing, publicly accessible resources on research, diagnosis, treatment, and education relating to rare diseases in California to foster recognition and access to treatment. The bill would require the council to report to the agency and the Legislature on the activities of the advisory council and its findings and recommendations on issues, as specified. The bill would make legislative findings and declarations in support of its provisions.
Digest Key
Vote: MAJORITY Appropriation: NO Fiscal Committee: YES Local Program: NOBill Text
The people of the State of California do enact as follows:
SECTION 1.
The Legislature finds and declares all of the following:(a) Under federal law, including the Orphan Drug Act of 1983, and its amendments, and the Rare Diseases Act of 2002, a rare disease is generally defined as a disease that affects fewer than 200,000 persons in the United States. Rare diseases are sometimes called orphan diseases. There are about 7,000 known rare diseases affecting approximately 30 million men, women, and children in the United States.
(b) The exact cause for many rare diseases remains unknown. However, 80 percent of rare diseases are genetic in origin and can be
linked to mutations in a single gene or in multiple genes. Those diseases are referred to as genetic diseases. A genetic disease can be passed down from generation to generation, explaining why certain rare diseases run in families. It is also estimated that about one-half of all rare diseases affect children.
(c) A person suffering from a rare disease in this state faces a wide range of obstacles, including, but not limited to, delays in obtaining a diagnosis, a misdiagnosis, a shortage of medical specialists familiar with and who can provide treatment for rare diseases, the prohibitive costs of treatment, and the inability to access therapies and medication that are used by physicians to treat rare diseases but that have not been approved by the United States Food and Drug Administration (FDA) for that specific purpose.
(d) In recent years, researchers have made considerable progress in developing diagnostic tools and novel treatment for, and in discovering ways to prevent, a variety of rare diseases. However, much more remains to be done in the areas of rare disease research and the search for, and development of, new therapeutics. Additionally, the equitable access to newly approved therapies, such as gene therapies, are in jeopardy due to the significant up-front costs that require novel and nontraditional approaches to coverage that do not yet exist.
(e) It is, therefore, an appropriate public policy for this state to establish an advisory body whose membership would be comprised of persons with suitable qualifications in the field of rare diseases, including persons living with rare
diseases, to educate medical professionals, government agencies, and the public about rare diseases as an important public health issue, and to encourage and fund research in the development of new treatments for rare diseases.
SEC. 2.
Part 4.6 (commencing with Section 124965) is added to Division 106 of the Health and Safety Code, to read:PART 4.6. Jacqueline Marie Zbur Rare Disease Advisory Council
124965.
(a) 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.
124965.2.
(a) (1) The Governor shall appoint the chair of the advisory council. The chair shall not hold any other position, employment, or appointment within state government.(2) On or before February 1, 2025, the Governor shall appoint the first chair of the advisory council.
(b) The minimum membership of the advisory council shall be appointed by the chair and composed of the following 17 members:
(1) Two physicians and surgeons licensed to practice in this state who have expertise in treating patients with rare diseases, at least
one of whom shall also treat children with rare diseases.
(2) One registered professional nurse licensed to practice in this state who has expertise in providing care to patients with rare diseases.
(3) One representative of the administration of a hospital located in this state and treats rare disease patients.
(4) One representative of the administration of an outpatient health care facility located in this state and treats rare disease patients.
(5) One representative of the health care coverage industry.
(6) One representative of the biopharmaceutical industry.
(7) One representative of the scientific community who is engaged in rare disease research.
(8) One rare disease geneticist or genetic counselor.
(9) 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.
(10) One medical social worker or mental health provider who works with rare disease patients.
(11) Two representatives of patient advocacy organizations that operate within this state.
(c) On or before May 1, 2025, the chair shall appoint the first members of the
advisory council as specified in subdivision (b).
(d) 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.
(e) 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 within the limits of funds made available to the advisory council for its purposes.
(f) No single rare disease population shall have more than two representatives on the advisory council.
(g) 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.
(h) 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.
124965.4.
The advisory council shall hold an initial organizational meeting within 60 days after the date of the last appointment made pursuant to subdivision (c) of Section 124965.2. At that initial organizational meeting, the advisory council shall select its vice chair from among its members, and the chair shall appoint, at their discretion, a secretary.124965.6.
(a) The advisory council shall meet periodically, but at least six times 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.
124965.8.
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) Evaluate and make recommendations to improve Medi-Cal and state-regulated private health insurance coverage of drugs and biological products for rare disease patients.
(c) Engage with the Medi-Cal Drug Use Review Board, also known as Medi-Cal DUR, and
serve as an expert advisory committee to the board, when the board makes recommendations or determinations regarding beneficiary access to drugs or biological products for rare diseases. As used in this subdivision, “beneficiary access” means developing prior authorization and reauthorization criteria for a rare disease drug, including placement on a preferred drug list or a formulary, as well as payment, cost sharing, drug utilization review, or medication therapy management.
(d) Prepare a first-year landscape survey of the needs of rare disease patients, caregivers, and providers in the state. The advisory council shall convene public hearings, make inquiries, and solicit comments from the general public in the state to assist the advisory council in fulfilling this duty.
(e) Consult with experts on rare diseases to develop policy 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.
(f) Create and maintain an internet website for the advisory council.
(g) Identify, consolidate, and publish on the advisory council’s internet website a list of existing, publicly accessible resources on research, diagnosis, treatment, and education relating to rare diseases in California to foster recognition and access to treatment.
(h) 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.
124965.10.
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.124965.12.
(a) The advisory council shall report to the California Health and Human Services Agency and the Legislature 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, as follows:(1) An interim report, submitted on or before July 1, 2026.
(2) A final report, submitted on or before December 31, 2028.
(b) The advisory council shall submit reports to the Legislature in
compliance with Section 9795 of the Government Code.
(c) The advisory council shall post the reports required by this section on its internet website required by Section 124965.8.
