Rare Disease Council’s Drug Industry Seat Can Come From Any State

The text as introduced · 1,263 words

89R392 MPF-F

By: Miles
S.B. No. 1140

A BILL TO BE ENTITLED

AN ACT

relating to establishment of the Texas Rare Disease Advisory

Council.

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

SECTION 1. Subtitle E, Title 2, Health and Safety Code, is

amended by adding Chapter 101A to read as follows:

CHAPTER 101A. TEXAS RARE DISEASE ADVISORY COUNCIL

Sec. 101A.001. DEFINITIONS. In this chapter:

(1) "Advisory council" means the Texas Rare Disease

Advisory Council established under this chapter.

(2) "Institution of higher education" means an

institution of higher education or a private or independent

institution of higher education, as those terms are defined by

Section 61.003, Education Code.

Sec. 101A.002. ESTABLISHMENT OF ADVISORY COUNCIL. (a) The

Texas Rare Disease Advisory Council is established to advise the

legislature, the governor, state agencies, and private entities

that provide services or care to individuals with rare diseases in

this state on the needs of those individuals.

(b) The department shall designate an institution of higher

education in this state on agreement of the institution to provide

administrative support to the advisory council in discharging

duties under this chapter.

Sec. 101A.003. ADVISORY COUNCIL MEMBERS. (a) The advisory

council is composed of:

(1) one representative of the institution of higher

education providing administrative support under Section 101A.002,

appointed by the president of the institution;

(2) one representative of the department, appointed by

the commissioner;

(3) one representative of the commission whose duties

involve the medical assistance program under Chapter 32, Human

Resources Code, appointed by the executive commissioner;

(4) one representative of the Texas Department of

Insurance, appointed by the commissioner of insurance; and

(5) the following members, appointed by majority vote

of the members of the advisory council described by Subdivisions

(1)-(4):

(A) one geneticist licensed and practicing in

this state;

(B) one registered nurse or advanced practice

registered nurse licensed and practicing in this state with

experience treating rare diseases;

(C) one physician licensed and practicing in this

state with experience treating rare diseases;

(D) one hospital administrator, or the hospital

administrator's designee, of a hospital in this state that provides

care to persons diagnosed with a rare disease;

(E) at least two persons with a rare disease;

(F) at least one caregiver of a person with a rare

disease;

(G) one representative of a rare disease patient

organization that operates in this state;

(H) one pharmacist with experience dispensing

drugs used to treat rare diseases;

(I) one representative of the biopharmaceutical

industry;

(J) one representative of a health insurance

company; and

(K) one member of the scientific community who is

engaged in rare disease research, including a medical researcher

with experience conducting research on rare diseases.

(a-1) Notwithstanding Subsection (a) and not later than

December 1, 2025, the initial members of the advisory council shall

be appointed as follows:

(1) the appropriate appointing authority shall

appoint the members described by Subsections (a)(1)-(4); and

(2) the initial presiding officer of the advisory

council appointed under Section 101A.004(b-1) shall appoint the

members described by Subsection (a)(5).

(a-2) This subsection and Subsection (a-1) expire September

1, 2031.

(b) Except as otherwise provided by Subsection (c), an

individual must be a resident of this state to be eligible for

appointment as a member of the advisory council.

(c) The representative of the biopharmaceutical industry

appointed under Subsection (a)(5)(I) may be a resident of any

state.

(d) If a vacancy occurs on the advisory council, the

appropriate appointing authority shall, in a timely manner and in

compliance with the requirements of this section, appoint a

successor to serve for the remainder of the unexpired term.

(e) The advisory council shall conduct the member

appointment process in a transparent manner to provide interested

individuals an opportunity to apply for membership on the advisory

council.

Sec. 101A.004. PRESIDING OFFICER. (a) Members of the

advisory council shall select from among the advisory council's

members a presiding officer.

(b) A person who holds an elected or appointed state

governmental position or a state employee may not be appointed as

the presiding officer of the advisory council.

(b-1) Notwithstanding Subsection (a) or Section 101A.005(b)

and not later than October 1, 2025, the governor, or the governor's

designee, shall appoint an initial presiding officer of the

advisory council. This subsection expires September 1, 2031.

Sec. 101A.005. TERMS. (a) Members of the advisory council

serve staggered three-year terms, with the terms of one-third of

the members, or as near to one-third as possible, expiring each

year.

(a-1) Notwithstanding Subsection (a), an initial advisory

council member appointed under Section 101A.003(a-1) may serve a

two-year, three-year, or four-year term. This subsection expires

September 1, 2031.

(b) The presiding officer of the advisory council serves a

two-year term.

(b-1) Notwithstanding Subsection (b), the initial presiding

officer of the advisory council appointed under Section

101A.004(b-1) serves a three-year term. This subsection expires

September 1, 2031.

Sec. 101A.006. DUTIES. The advisory council shall:

(1) consult with experts on rare diseases to develop

policy recommendations for improving patient access to:

(A) rare disease specialists;

(B) affordable and comprehensive health care

coverage;

(C) relevant diagnostic procedures for rare

diseases;

(D) timely and quality treatment for rare

diseases; and

(E) other needed services, as determined by the

advisory council;

(2) make recommendations to state agencies and

insurers that provide services to persons with a rare disease on the

impact on treatment provision for the person of prior authorization

requirements, cost-sharing requirements, benefits tiering, or

other utilization management procedures;

(3) make recommendations to improve coverage under the

state Medicaid program of drugs for rare disease patients,

including engagement with the Drug Utilization Review Board, to

improve health benefit plan coverage of diagnostic procedures, and

to facilitate access to necessary health care providers with

expertise in the treatment of rare diseases;

(4) identify best practices to reduce health

disparities and achieve health equity in the research, diagnosis,

and treatment of rare diseases in this state; and

(5) identify best practices to ensure continuity of

care for rare disease patients transitioning from pediatric to

adult care.

Sec. 101A.007. BIENNIAL REPORT. (a) Not later than

September 1 of each even-numbered year, the advisory council shall

prepare and submit a report to the governor, department, and

standing committees of the senate and house of representatives with

primary jurisdiction over health care and appropriations a report

on the advisory council's activities, funding, and legislative

recommendations.

(b) Before finalizing and submitting the report under

Subsection (a), a draft of the report must be made available for

public comment and discussion at a meeting open to the public.

Sec. 101A.008. FUNDING. The advisory council may solicit

and accept gifts, grants, and donations from any source to

establish and operate the advisory council.

Sec. 101A.009. ADVISORY COUNCIL MEETINGS. (a) The

advisory council shall meet at least once each quarter.

(b) A meeting conducted under this section may be in person

or by video conference call, as determined by the presiding

officer.

(c) Not later than January 1, 2026, the advisory council

shall hold an initial meeting. During the 2026 calendar year, the

advisory council shall meet at least once per month. This

subsection expires September 1, 2027.

Sec. 101A.010. PUBLIC OUTREACH. The advisory council

shall:

(1) provide opportunities to inform the public about

the advisory council's work and for the public to provide comments

on that work; and

(2) create and maintain a public Internet website to:

(A) provide public access to meeting minutes;

(B) provide notice of upcoming advisory council

meetings; and

(C) allow for the submission of public comments.

SECTION 2. This Act takes effect September 1, 2025.