STATE OF NEW YORK ________________________________________________________________________ 1287 2025-2026 Regular Sessions IN SENATE January 9, 2025 ___________ Introduced by Sens. PERSAUD, RIVERA -- read twice and ordered printed, and when printed to be committed to the Committee on Health AN ACT to amend the public health law, in relation to establishing the rare disease advisory council The People of the State of New York, represented in Senate and Assem- bly, do enact as follows: 1 Section 1. Title 2-F of the public health law is amended by adding a 2 new section 245 to read as follows: 3 § 245. Rare disease advisory council. 1. For the purposes of this 4 section, "rare disease" means any disease or condition which affects 5 less than two hundred thousand persons in the United States. 6 2. a. There shall be established within the department a rare disease 7 advisory council to identify best practices, raise awareness regarding 8 rare diseases, evaluate barriers to access to care, and to make recom- 9 mendations to the legislature and the governor. 10 b. An existing body or previously convened body, whether dissolved or 11 not, may be repurposed to meet the requirements of this section. 12 3. a. The council shall consist of at least fifteen members, including 13 the commissioner or such commissioner's designee, the superintendent of 14 financial services or such superintendent's designee, and nine members 15 to be appointed by the governor. Two members shall be appointed by the 16 speaker of the assembly, two members shall be appointed by the temporary 17 president of the senate. Membership of such council shall consist of 18 residents of the state of New York and include, but not be limited to, 19 individuals with expertise in rare diseases, including physicians, nurs- 20 es and other health care professionals with experience researching, 21 diagnosing or treating rare diseases; members of the scientific communi- 22 ty engaged in rare disease research; representatives from the health 23 insurance industry; a representative of the biopharma industry; individ- 24 uals who have a rare disease and caregivers of a person with a rare 25 disease; and representatives of rare disease patient organizations. EXPLANATION--Matter in italics (underscored) is new; matter in brackets [] is old law to be omitted. LBD02189-02-5S. 1287 2 1 b. The council shall prioritize the representation of patient and 2 caregiver voices while ensuring no single disease state is dispropor- 3 tionately represented. 4 c. The members of the rare disease advisory council shall receive no 5 compensation for their role on the council, but shall be allowed their 6 actual and necessary expenses incurred in the performance of their 7 duties as council members. 8 d. Time served on a previously convened body shall not count towards 9 the term of office for membership on the rare disease advisory council. 10 4. a. Council members shall serve up to two four year terms commencing 11 from the date of their appointment. Members may serve beyond their term 12 expiration at the pleasure of the appointing authority. 13 b. If a vacancy occurs for an unexpired term, the council, by a major- 14 ity vote, shall fill such vacancy in a timely manner and in compliance 15 with the requirements set forth in subdivisions two and three of this 16 section. 17 c. The council shall annually elect a chair from amongst its members. 18 A chair is eligible for reelection. 19 5. a. The initial meeting of the council shall occur within the first 20 one hundred eighty days after the effective date of this section. The 21 council shall meet at least once per quarter in person or via an online 22 meeting platform as determined by the chair. Such meetings shall comply 23 with article seven of the public officers law. 24 b. The council shall provide opportunities for the public to hear 25 updates and provide public comment and create and maintain a public 26 website or utilize an existing website where meeting minutes, notices of 27 upcoming meetings, and public comments can be submitted. 28 6. The council's focus shall include, but not be limited to: 29 a. identifying best practices that could improve the awareness of rare 30 diseases and referral of people with potential rare diseases to special- 31 ists; 32 b. evaluating barriers to treatment, including financial barriers on 33 access to care; 34 c. establishing best practices and protocols to include in state plan- 35 ning related to natural disasters, public health emergencies or other 36 emergency declarations to enable the continuity of care for rare disease 37 patients and ensure safeguards against discrimination for rare disease 38 patients are in place; 39 d. convening public hearings, making inquiries, and soliciting 40 comments from the general public in the state to assist the council with 41 a first-year landscape or survey of the needs of rare disease patients, 42 caregivers, and providers in the state; 43 e. providing testimony and comments on pending legislation and regu- 44 lations before the legislature and other state agencies that impact New 45 York's rare disease community; 46 f. consulting with experts on rare diseases to develop policy recom- 47 mendations to improve patient access to, and quality of, rare disease 48 specialists, affordable and comprehensive health care coverage, relevant 49 diagnostics, timely treatment, and other needed services; 50 g. advising the Medicaid drug utilization review board in their review 51 of products or medications for the treatment of rare and orphan 52 diseases, and drugs or biological products within the emerging fields of 53 personalized medicine and non-inheritable gene editing therapeutics. 54 All advisory council recommendations shall be presented in writing to 55 members of such board and explained to members of such board by repre- 56 sentatives of the advisory council during their public meetings. TheS. 1287 3 1 advisory council has no authority on any matter relating to Medicaid, 2 nor may it require such board to follow its recommendations; and 3 h. any other priorities as identified by the department or a majority 4 of the council. 5 7. a. The council, in consultation with the department shall prepare a 6 written report summarizing its findings and recommendations from the 7 council which shall include a list of existing, publicly accessible 8 resources on research, diagnosis, treatment, coverage options and educa- 9 tion relating to rare diseases. 10 b. This report shall be submitted to the governor, the speaker of the 11 assembly, the minority leader of the assembly, the temporary president 12 of the senate, the minority leader of the senate, the senate chair of 13 the committee on health, and the chair of the assembly committee on 14 health, one year following the effective date of this section and by 15 each January thirtieth thereafter and shall be posted on the depart- 16 ment's website. 17 c. Any recommendations of the council shall be posted on the depart- 18 ment's website and incorporated into any future "Prevention Agenda: New 19 York State's Health Improvement Plan". The recommendation shall also be 20 shared at a public meeting of the New York state health equity council 21 for their consideration. 22 8. The council may identify public, private, and other available fund- 23 ing sources and may accept and utilize funds from such sources to imple- 24 ment the provisions of this section, including, but not limited to, 25 state funds appropriated for rare disease research, treatment, educa- 26 tion, programming, and related activities. 27 § 2. Of the monies appropriated in chapter 53 of the laws of 2024, 28 enacting the aid to localities budget, for services and expenses related 29 to rare disease of which a portion may be transferred to state oper- 30 ations, $100,000 shall be allocated by the department of health and for 31 use by administration and support to implement this act. To implement 32 this act, the department may use this allocation for personal services. 33 § 3. This act shall take effect on the thirtieth day after it shall 34 have become a law. Effective immediately, the addition, amendment and/or 35 repeal of any rule or regulation necessary for the implementation of 36 this act on its effective date are authorized to be made and completed 37 on or before such effective date.