Part 4.6Jacqueline Marie Zbur Rare Disease Advisory Council

Section § 124965

Explanation

This section creates the Jacqueline Marie Zbur Rare Disease Advisory Council within the California Health and Human Services Agency. The council offers advice but does not have the power to make or enforce rules. The law also clarifies that within this section, 'advisory council' refers to the Jacqueline Marie Zbur Rare Disease Advisory Council and 'rare disease' is defined using the U.S. Code.

(a)CA Health and Safety Code § 124965(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)CA Health and Safety Code § 124965(b) Unless the context requires otherwise, for purposes of this part, the following definitions shall apply:
(1)CA Health and Safety Code § 124965(b)(1) “Advisory council” or “council” means the Jacqueline Marie Zbur Rare Disease Advisory Council.
(2)CA Health and Safety Code § 124965(b)(2) “Rare disease” has the same meaning as provided in Section 360bb of Title 21 of the United States Code, or its successor.
Jacqueline Marie Zbur Rare Disease Advisory Council California Health and Human Services rare disease definition advisory council role legislative appropriation council establishment regulatory authority disease advisory U.S. Code Section 360bb health advisory bodies council definitions state advisory council health services agency California legislation
(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 Repealed as of January 1, 2029, pursuant to Section 124965.14.)

Section § 124965.10

Explanation

This law section mandates that the advisory council tasked with rare diseases should seek and accept grants from federal or private sources to support their programs. However, the council is prohibited from accepting funds from any organization that employs a current council member to avoid conflicts of interest.

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.
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(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.)

Section § 124965.12

Explanation

This law section mandates that the advisory council must share updates, findings, and suggestions about the quality, affordability, and access to treatment and services for people with rare diseases in California. These updates are to be posted on the advisory council's website.

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.
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(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.)

Section § 124965.14

Explanation

This section of the law is temporary and will no longer be effective after January 1, 2029. On that date, it will officially be removed from the books.

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

Section § 124965.2

Explanation

This section outlines the composition and functioning of an advisory council related to rare diseases in California. The council's chair is appointed by the Secretary of Health and Human Services and cannot hold any other state government position. Members are appointed by the State Public Health Officer and must live in or work with a California-based organization. They include various healthcare professionals, industry representatives, scientists, and rare disease patients or caregivers.

The council can suggest additional members as needed and serve without pay, though expenses may be reimbursed if funds are available. Members serve for the duration specified and vacancies are filled in the original manner. Every year, members must disclose potential conflicts of interest, ensuring that at least 20% of council members remain unbiased concerning insurers, pharmaceutical benefits managers, or manufacturers.

(a)CA Health and Safety Code § 124965.2(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)CA Health and Safety Code § 124965.2(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)CA Health and Safety Code § 124965.2(b)(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)CA Health and Safety Code § 124965.2(b)(2) One registered professional nurse licensed to practice in this state who has experience in providing care to patients with rare diseases.
(3)CA Health and Safety Code § 124965.2(b)(3) One hospital administrator employed by a hospital that treats rare disease patients.
(4)CA Health and Safety Code § 124965.2(b)(4) One representative of the California health care coverage industry.
(5)CA Health and Safety Code § 124965.2(b)(5) One representative of the biopharmaceutical industry.
(6)CA Health and Safety Code § 124965.2(b)(6) One representative of the scientific community who is engaged in rare disease research.
(7)CA Health and Safety Code § 124965.2(b)(7) One rare disease geneticist or genetic counselor.
(8)CA Health and Safety Code § 124965.2(b)(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)CA Health and Safety Code § 124965.2(b)(9) One medical social worker or mental health provider who works with rare disease patients.
(10)CA Health and Safety Code § 124965.2(b)(10) Up to two representatives of patient advocacy organizations that operate within this state.
(c)CA Health and Safety Code § 124965.2(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)CA Health and Safety Code § 124965.2(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)CA Health and Safety Code § 124965.2(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)CA Health and Safety Code § 124965.2(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.
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(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.)

Section § 124965.6

Explanation

This section requires the advisory council to meet at least twice a year. The council can also request help from employees of various state, county, or municipal agencies if those employees choose to participate.

(a)CA Health and Safety Code § 124965.6(a) The advisory council shall meet periodically, but at least twice annually.
(b)CA Health and Safety Code § 124965.6(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.
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(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.)

Section § 124965.8

Explanation

The advisory council on rare diseases in California is responsible for offering guidance on rare diseases to government bodies and private agencies involved in patient care. They work with experts to suggest improvements in patient access to specialized care, comprehensive health coverage, diagnostics, and timely treatment for rare diseases.

They must also create a website to share resources on rare disease research, diagnosis, treatment, and education. Additionally, the council identifies unmet research needs and seeks collaboration opportunities with other states to enhance their work and future studies.

The advisory council shall perform all of the following duties:
(a)CA Health and Safety Code § 124965.8(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)CA Health and Safety Code § 124965.8(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)CA Health and Safety Code § 124965.8(c) Create and maintain an internet web page for the advisory council.
(d)CA Health and Safety Code § 124965.8(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)CA Health and Safety Code § 124965.8(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.
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(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.)