| Chapter 266 |
| 2025 -- S 0474 AS AMENDED Enacted 06/27/2025 |
| A N A C T |
| RELATING TO HEALTH AND SAFETY -- RARE DISEASE ADVISORY COUNCIL |
Introduced By: Senators Lawson, Lauria, Tikoian, Murray, Sosnowski, Britto, DiMario, Valverde, and Ujifusa |
| Date Introduced: February 26, 2025 |
| It is enacted by the General Assembly as follows: |
| SECTION 1. Title 23 of the General Laws entitled "HEALTH AND SAFETY" is hereby |
| amended by adding thereto the following chapter: |
| CHAPTER 87.1 |
| RARE DISEASE ADVISORY COUNCIL |
| 23-87.1-1. Short title. |
| This chapter shall be known and may be cited as the "Rare Disease Advisory Council." |
| 23-87.1-2. Establishment. |
| (a) There is established in the department of health the rare disease advisory council. |
| (b) The purpose of the council is to provide guidance and recommendations to educate the |
| public, legislature, as well as other government agencies, on the needs of individuals with rare |
| diseases living in Rhode Island. |
| (c) The council shall conduct the following activities to benefit those impacted by rare |
| diseases in Rhode Island. The duties of the council shall include: |
| (1) Convene public hearings, make inquiries, and solicit comments from the general public |
| in Rhode Island to assist the council with a first-year landscape or survey of the needs of rare |
| disease patients, caregivers, and providers in the state. |
| (2) Provide testimony and comments on pending legislation and regulations before the |
| legislature and other state agencies that impact Rhode Island's rare disease community. |
| (3) 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. |
| (4) Research and make recommendations to state agencies and insurers that provide |
| services to persons with a rare disease on the impact of prior authorization, cost-sharing, tiering, or |
| other utilization management procedures on the provision of treatment and care for patients. |
| (5) Establish best practices and protocols to include in-state planning related to natural |
| disasters, public health emergencies, or other emergency declarations to enable continuity of care |
| for rare disease patients and ensure safeguards against discrimination for rare disease patients are |
| in place. |
| (6) Evaluate and make recommendations to implement improvements to newborn infant |
| screening programs. |
| (7) Evaluate and make recommendations to improve Medicaid coverage of drugs for rare |
| disease patients, including engagement with the drug utilization review board, to improve coverage |
| of diagnostics, and facilitate access to necessary healthcare providers with expertise in the treatment |
| of rare diseases. |
| (8) Publish a list of existing, publicly accessible resources on research, diagnosis, |
| treatment, and education relating to the rare diseases on the council's website. For purposes of this |
| chapter, "rare disease" or "orphan disease" means a disease that affects fewer than two hundred |
| thousand (200,000) people in the United States. |
| (9) Identify areas of unmet need for research and opportunities for collaboration across |
| stakeholders that can inform future studies and reports by the council. |
| (10) Identify and distribute educational resources for health carehealthcare providers to |
| foster recognition and optimize treatment of rare diseases. |
| (11) Research and identify best practices to reduce health disparities and achieve health |
| equity in the research, diagnosis and treatment of rare diseases. |
| (12) Research and identify best practices to ensure continuity of care for rare disease |
| patients transitioning from child/youth services to adult care. |
| 23-87.1-3. Membership of council. |
| (a) All members of the council shall be full-time residents of Rhode Island and membership |
| shall include a diverse set of stakeholders. |
| (b) The governor shall appoint all members and shall designate a chair of the council within |
| thirty (30) days of enactment. The chair shall not hold any position within the government of Rhode |
| Island and shall serve for a term of three (3) years. |
| (c) The governor shall appoint the following members: |
| (1) One representative from academic research institutions in the state that receives any |
| grant funding for rare disease research; |
| (2) One representative from the Rhode Island department of health's office of minority |
| health; |
| (3) One representative from the Rhode Island Medicaid agency; |
| (4) One representative from the Rhode Island department of business regulation insurance |
| division; |
| (5) One registered nurse or advanced practice registered nurse licensed and practicing in |
| Rhode Island with experience treating rare diseases; |
| (6) One physician practicing in Rhode Island with experience treating rare diseases; |
| (7) One hospital administrator, or designee, from a hospital in Rhode Island that provides |
| care to persons diagnosed with a rare disease; |
| (8) At least two (2) patients who have a rare disease; |
| (9) At least one caregiver of a person with a rare disease; |
| (10) One representative of a rare disease patient organization that operates in Rhode Island; |
| (11) A pharmacist with experience dispensing drugs used to treat rare diseases; |
| (12) A representative of the biopharma industry; |
| (13) A representative of a health plan company; and |
| (14) A member of the scientific community who is engaged in rare disease research, |
| including, but not limited to, a medical researcher with experience conducting research on rare |
| diseases. |
| 23-87.1-4. Terms and vacancies for council members. |
| (a) Term of members. Council members shall serve no longer than three (3) years, except |
| that, to facilitate a staggered rotation of members to retain continuity and knowledge transfer, |
| during the initial five (5) years after the establishment of the council, members may serve up to a |
| four-(4)year (4) term. |
| (b) Vacancy. If a vacancy occurs, the vacancy shall be filled in a like manner as required |
| pursuant to this section. |
| 23-87.1-5. Reporting requirements. |
| (a) The council shall submit a report to the governor, the speaker of the house and the |
| president of the senate, and the chairs of the house and senate health and finance committees within |
| one year of enactment of the council and annually thereafter. Prior to submission, a draft of the |
| annual report shall be made available for public comment and discussed at an open public meeting. |
| (b) Annual reports shall: |
| (1) Describe the activities and progress of the council under this section; and |
| (2) Provide recommendations to the governor and legislature on ways to address the needs |
| of people living with rare diseases in the state. |
| 23-87.1-6. Meeting requirements. |
| (a) Frequency. |
| (1) The initial meeting of the council shall occur within the first ninety (90) days after |
| enactment. |
| (2) During the first twelve (12) months after the initial meeting, the council shall meet each |
| month. |
| (3) Thereafter, the council shall meet once per quarter in person or via online meeting |
| platform as determined by the chair. |
| (b) Notice. |
| (1) The council shall, in compliance with chapter 46 of title 42 ("open meetings"): |
| (i) Provide opportunities for the public to hear updates and provide input into their work; |
| and |
| (ii) Create and maintain a public website where meeting minutes, notices of upcoming |
| meetings, and public comments can be submitted. |
| SECTION 2. This act shall take effect upon passage." |
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| LC002079 |
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