Rare diseases; establish Rare Disease Task Force and establish insurance coverage integrity for rare disease therapies.

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To: Public Health and
Welfare
MISSISSIPPI LEGISLATURE REGULAR SESSION 2026

By: Senator(s) McMahan

SENATE BILL NO. 2529

AN ACT TO STATE LEGISLATIVE FINDINGS CONCERNING RARE 1
DISEASES; TO PROVIDE THE PURPOSE OF THIS ACT; TO DEFINE TERMS; TO 2
ESTABLISH THE RARE DISEASE TASK FORCE; TO PROVIDE FOR THE 3
MEMBERSHIP OF THE TASK FORCE; TO PROVIDE THE POWERS AND DUTIES OF 4
THE TASK FORCE; TO PROVIDE FOR MEETINGS OF THE TASK FORCE; TO 5
PROVIDE FOR COORDINATION AND OVERSIGHT OF THE TASK FORCE; TO 6
ESTABLISH REPORTING REQUIREMENTS; TO PROVIDE THAT THE MISSISSIPPI 7
INSURANCE DEPARTMENT SHALL PROVIDE STAFF AND CLERICAL SUPPORT TO 8
THE TASK FORCE; TO GRANT THE MISSISSIPPI INSURANCE DEPARTMENT 9
RULEMAKING AUTHORITY; TO ESTABLISH INSURANCE COVERAGE INTEGRITY 10
FOR RARE DISEASE THERAPIES; AND FOR RELATED PURPOSES. 11
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MISSISSIPPI: 12
SECTION 1. The Legislature finds that rare diseases 13
collectively affect a substantial number of residents of the State 14
of Mississippi and frequently result in delayed diagnosis, limited 15
treatment options, fragmented care delivery and significant 16
financial burdens for patients and their families. The 17
Legislature further finds that certain insurance coverage 18
practices, including the use of alternative funding programs, may 19
improperly limit or delay access to medically necessary therapies 20
for individuals living with rare diseases. 21
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The purpose of Sections 1 through 8 of this act is to 22
establish a coordinated, expert-driven Rare Disease Task Force to 23
identify gaps in care, evaluate funding and insurance coverage 24
practices, advise policymakers on evidence-based solutions and 25
ensure fair, timely and equitable access to rare disease therapies 26
in the State of Mississippi. 27
SECTION 2. For the purposes of this act, the following terms 28
shall have the meanings ascribed herein unless the context clearly 29
requires otherwise: 30
(a) "Rare disease" means a disease or condition 31
affecting a small percentage of the population, including 32
conditions designated under 21 USC § 360bb as rare or recognized 33
as rare by nationally recognized medical authorities. 34
(b) "Council" means the Mississippi Rare Disease 35
Advisory Council. 36
(c) "Task force" means the Rare Disease Task Force 37
established in this act. 38
(d) "Alternative funding program" means any program or 39
arrangement that relies on manufacturer assistance, charitable 40
contributions, or other third-party financial aid in lieu of 41
direct insurance coverage for a prescribed therapy. 42
SECTION 3. (1) There is hereby created the Rare Disease 43
Task Force within the Mississippi Rare Disease Advisory Council. 44
(2) The task force shall serve as a coordinated, 45
expert-driven advisory body to provide guidance and 46
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recommendations regarding health challenges, treatment access, 47
insurance coverage practices, and funding considerations related 48
to rare diseases in the State of Mississippi. 49
SECTION 4. (1) The task force shall be composed of no more 50
than seven (7) members representing a broad range of professional 51
expertise and lived experience, which may include: 52
(a) Licensed clinicians with experience diagnosing or 53
treating rare diseases; 54
(b) Medical or scientific researchers specializing in 55
rare diseases; 56
(c) Individuals diagnosed with a rare disease; 57
(d) Family members or caregivers of individuals with 58
rare diseases; 59
(e) Representatives of rare disease patient advocacy 60
organizations; and 61
(f) Policymakers with expertise in public health, 62
insurance regulation or health finance. 63
(2) Within thirty (30) days of the effective date of this 64
act, members of the task force shall be appointed in coordination 65
with the Mississippi Rare Disease Advisory Council. Three (3) 66
members shall be appointed by the Governor, one (1) member shall 67
be appointed by the Lieutenant Governor, one (1) member shall be 68
appointed by the Speaker of the House of Representatives, and one 69
(1) member, employed in the insurance sector at the time of 70
appointment, shall be appointed by the Mississippi Rare Disease 71
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Advisory Council. The Chairman of the Mississippi Rare Disease 72
Advisory Council shall be the seventh member of the Rare Disease 73
Task Force and shall serve as the chairman of the task force. 74
(3) (a) Any legislative member of the study committee shall 75
be entitled to per diem and reimbursement of expenses in 76
accordance with Section 25-3-41, Mississippi Code of 1972. 77
(b) Nonlegislative members shall serve without 78
compensation but may be reimbursed for necessary travel expenses 79
from any available funds designated for such purposes. 80
SECTION 5. (1) The task force shall have the authority and 81
responsibility to: 82
(a) Identify gaps in care, coverage limitations, 83
workforce shortages and systemic barriers affecting individuals 84
with rare diseases in the State of Mississippi; 85
(b) Advise the Governor, Legislature and relevant state 86
agencies on evidence-based policy, regulatory and funding 87
recommendations to improve the quality, coordination and 88
accessibility of rare disease care; 89
(c) Review and evaluate alternative funding programs 90
and insurance coverage practices impacting access to rare disease 91
therapies and assess their fiscal, clinical and equity 92
implications; and 93
(d) Ensure that the perspectives and experiences of 94
patients and caregivers are meaningfully represented and 95
considered in all Task Force deliberations and recommendations. 96
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(2) The task force shall meet within forty-five (45) days of 97
the effective date of this act at a meeting to be called by the 98
appointed chair of the task force. At its first meeting, the 99
committee shall establish rules for transacting business and 100
keeping records. The committee shall thereafter meet as 101
necessary. 102
SECTION 6. (1) The Mississippi Insurance Department shall 103
consult with the Mississippi Rare Disease Advisory Council and the 104
Task Force to monitor emerging coverage barriers related to rare 105
disease therapies. 106
(2) The council may accept and review written complaints 107
from patients, providers or advocacy organizations regarding 108
alternative funding practices and shall refer substantiated 109
complaints to the Mississippi Insurance Department for 110
investigation. 111
SECTION 7. (1) No later than December 1 of each year, the 112
task force, in collaboration with the Mississippi Insurance 113
Department, shall submit a written report to the Governor, the 114
Lieutenant Governor, the Speaker of the House of Representatives, 115
and the relevant legislative committees, including the Public 116
Health and Welfare Committee of the Mississippi Senate, the Public 117
Health and Human Services Committee of the Mississippi House of 118
Representatives and the Insurance Committees. 119
(2) The report shall include: 120
(i) A summary of task force activities and findings; 121
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(ii) Trends in rare disease therapy access and 122
insurance coverage; 123
(iii) The prevalence and impact of alternative funding 124
programs in Mississippi; and 125
(iv) Recommendations for legislative, regulatory or 126
administrative action. 127
SECTION 8. (1) The Mississippi Insurance Department shall 128
provide necessary staff and administrative support to the 129
committee, as well as prepare annual written reports. 130
SECTION 9. (1) A health insurer, health benefit plan or 131
pharmacy benefit manager regulated by the Mississippi Department 132
of Insurance shall not: 133
(a) Exclude, remove, or reclassify a rare disease 134
therapy that would otherwise be covered under a plan's formulary 135
or benefit design for the purpose or effect of obtaining, 136
directing, or relying upon financial assistance from a 137
manufacturer, charitable organization, or other third party; 138
(b) Designate a rare disease therapy as "nonessential," 139
"noncovered," or any similar classification intended to avoid the 140
obligation to cover or reimburse for the therapy; or 141
(c) Condition, delay, or deny coverage of a prescribed 142
rare disease therapy based on the availability or potential 143
availability of third-party financial assistance. 144
(2) A rebuttable presumption of violation shall exist if a 145
health insurer or pharmacy benefit manager removes a prescribed 146
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ST: Rare diseases; establish Rare Disease Task
Force and establish insurance coverage integrity
for rare disease therapies.
rare disease therapy from coverage and directs or refers an 147
enrollee to an alternative funding program as a means of obtaining 148
that therapy. 149
(3) The presumption may be rebutted only by clear and 150
convincing evidence, submitted to the Mississippi Department of 151
Insurance, that the exclusion or reclassification was made solely 152
for legitimate clinical reasons and not for the purpose or effect 153
of shifting payment responsibility. 154
(4) Any violation of this section shall constitute an unfair 155
or deceptive act or practice in the business of insurance under 156
Mississippi law and shall be subject to all existing enforcement 157
powers, remedies, and penalties of the Department of Insurance, 158
including the authority to order reimbursement for out-of-pocket 159
costs or delays in treatment. 160
(5) The Mississippi Insurance Department may adopt rules and 161
regulations and require plan filings necessary to implement this 162
section, including documentation demonstrating compliance with 163
formulary inclusion standards and reporting of any 164
reclassification or exclusion of previously covered rare disease 165
therapies. 166
SECTION 10. This act shall take effect and be in force from 167
and after January 1, 2027, and Section 9 of this act shall apply 168
to all health benefit plans and pharmacy benefit managers 169
regulated by the Mississippi Department of Insurance that are 170
issued, renewed or amended on or after that date. 171