House Bill 616

AN ACT TO CREATE THE MISSISSIPPI RARE DISEASE ADVISORY COUNCIL AT THE UNIVERSITY OF MISSISSIPPI MEDICAL CENTER; TO DECLARE CERTAIN LEGISLATIVE FINDINGS RELATING TO RARE DISEASES; TO PRESCRIBE THE MEMBERSHIP AND DUTIES OF THE COUNCIL; TO REQUIRE THE COUNCIL TO SUBMIT AN ANNUAL REPORT TO THE GOVERNOR AND LEGISLATURE; TO REQUIRE THE GOVERNOR TO APPOINT MEMBERS OF A BOARD OF DIRECTORS FOR THE GOVERNANCE OF THE COUNCIL; TO REQUIRE THE BOARD OF DIRECTORS TO EMPLOY AN EXECUTIVE DIRECTOR FOR THE COUNCIL; AND FOR RELATED PURPOSES.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MISSISSIPPI:

SECTION 1. The Legislature finds and declares that:

(a) A rare disease, sometimes called an "orphan disease," is defined as a disease that affects fewer than two hundred thousand (200,000) people.

(b) There are seven thousand (7,000) known rare diseases affecting more than twenty-five million (25,000,000) men, women and children in the United States.

(c) While the exact cause for many rare diseases remains unknown, eighty percent (80%) of rare diseases are genetic in origin and can be linked to mutations in a single gene or in multiple genes, which can be passed down from generation to generation.

(d) People with rare diseases face many challenges, including delays in obtaining a diagnosis, misdiagnosis, shortages of medical specialists who can provide treatment, and lack of access to therapies and medication used to treat rare diseases.

(e) An advisory council composed of qualified professionals and persons living with rare diseases could educate medical professionals, governmental agencies, legislators and the public about rare diseases as an important public health issue and encourage and secure funding for research for the development of new treatments for rare diseases.

SECTION 2. (1) The Mississippi Rare Disease Advisory Council is established at the University of Mississippi Medical Center for the purpose of advising the Legislature and other governmental agencies, departments, commissions and authorities on the needs of individuals living in Mississippi with a rare disease.

(2) The board of directors created under Section 4 of this act shall appoint the following members of the council, which must reflect the diversity of the state population:

(a) At least two (2) representatives from academic research institutions in the state which receive grant funding for rare disease research;

(b) At least two (2) geneticists licensed and practicing in the State of Mississippi;

(d) One (1) registered nurse or advanced practice registered nurse with experience treating rare diseases who is licensed and practicing in the state;

(e) At least two (2) physicians with experience treating rare diseases who are practicing in the state;

(f) At least two (2) hospital administrators or their designees, from hospitals in the state which provide care to persons diagnosed with a rare disease, one (1) of whom must represent a hospital in which the scope of services focuses on rare diseases of pediatric patients;

(g) At least two (2) persons having a rare disease who are eighteen (18) years of age or older;

(h) At least one (1) caregiver of a person with a rare disease;

(i) At least three (3) representatives of a rare disease patient organization that operates in this state;

(j) A pharmacist with experience with drugs used to treat rare diseases;

(k) A representative of the biotechnology industry;

(l) A representative of health plan companies; and

(m) 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.

(3) The initial meeting of the council must occur before October 1, 2024. The council shall meet on a regular basis, as determined by the board of directors, in person or via an online meeting platform.

(4) (a) Each member of the council shall serve a term of three (3) years. If a vacancy occurs on the council, the board of directors shall appoint, in a timely manner, a person to serve the remainder of the term of the vacated member.

(b) Subject to the availability of funding, members of the council may receive per diem, as authorized under Section 25-3-69, and be reimbursed for traveling expenses and mileage, as provided under Section 25-3-41.

SECTION 3. (1) The council shall perform the following duties:

(a) Convene public hearings, make inquiries and solicit comments from the general public in Mississippi to assist the council with developing a first year landscape of rare diseases in the state.

(b) Consult with experts on the board of directors, council and externally, as needed, on rare diseases to develop policy recommendations to improve access and quality of care for health insurance, education and treatment in the state.

(c) Research and make policy recommendations to the Legislature on access to insurance, specialists and other needed services for patients with rare diseases.

(d) Research and make recommendations to state agencies and insurers that provide services to persons with a rare disease on the impact of coverage, cost-sharing, tiering or other utilization management procedures on the provision of treatment and care services.

(e) Research and identify priorities relating to treatments and services provided to persons with rare diseases in Mississippi, and develop policy recommendations that include safeguards against discrimination for these populations on these and related issues.

(f) Evaluate and make recommendations to improve the state's newborn screening program.

(g) Evaluate and make recommendations to improve Medicaid coverage for approved treatment and medications for rare disease patients.

(h) Publish a list of existing, publicly accessible resources on research, diagnosis, treatment and education relating to those rare diseases in Mississippi, including publishing the information on a state webpage.

(i) Collect additional research topic areas from the public to inform future studies and reports on which the council can work for the state.

(j) Establish policies for training academic institutions, state agencies, health care professionals and others to foster a greater understanding of rare diseases in Mississippi.

(k) Identify a mechanism for sharing best practices for health care providers to ensure they are informed adequately of the most effective strategies for recognizing and treating rare diseases in Mississippi.

(2) The council shall submit an annual report on its activities to the Governor and Legislature before July 1 of each year, with the first report being due before July 1, 2025. The report must describe the activities and progress made by the council on the duties prescribed under this section and give an update on the status of funding for the council, including information on grant applications and which grants were accepted, used and have remaining balances. The report also must include recommendations on ways to address the needs of people living with rare diseases in the State of Mississippi.

SECTION 4. (1) The council will be governed by a board of directors, which shall be comprised of the executive director and the following members appointed by the Governor:

(a) The State Health Officer or the officer's designee;

(b) The Executive Director of the Division of Medicaid or the director's designee;

(d) The State Superintendent of Public Education or the superintendent's designee;

(e) One (1) representative of industry; and

(f) One (1) patient representative.

(2) The board of directors shall perform the following duties:

(a) Establish policies for swiftly appointing members of the council;

(b) Develop policies for frequency of meetings; and

(3) The initial meeting of the board of directors must occur before October 1, 2024. Subsequent meetings of the board must be held on a regular basis and in a format, as determined by the executive director.

(4) (a) Each member of the board of directors shall serve a term of three (3) years. If a vacancy occurs on the board, the remaining members of the board of directors shall appoint, in a timely manner, a person to serve the remainder of the vacated term. A vacancy on the board does not affect the power of the remaining members of the board to execute its work.

(b) Subject to the availability of funding, members of the board of directors may receive per diem, as authorized under Section 25-3-69, and be reimbursed for traveling expenses and mileage, as provided under Section 25-3-41.

SECTION 5. (1) The Mississippi Rare Disease Advisory Council will be under the direction of an executive director, who will be appointed by the board of directors. The executive director, who may not be employed by the federal or state government, shall oversee the board and lead the council.

(2) The executive director may solicit funds on behalf of the council. The council shall establish a method to securely hold and distribute funds.

SECTION 6. This act shall take effect and be in force from and after July 1, 2024.