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[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 3551 Introduced in Senate (IS)]
<DOC>
119th CONGRESS
1st Session
S. 3551
To amend titles XVIII and XIX of the Social Security Act and title
XXVII of the Public Health Service Act to provide for coverage of
certain drugs used in the treatment or management of a rare disease or
condition, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
December 17, 2025
Mr. Tillis (for himself and Mr. Heinrich) introduced the following
bill; which was read twice and referred to the Committee on Finance
_______________________________________________________________________
A BILL
To amend titles XVIII and XIX of the Social Security Act and title
XXVII of the Public Health Service Act to provide for coverage of
certain drugs used in the treatment or management of a rare disease or
condition, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Providing Realistic Opportunity To
Equal and Comparable Treatment for Rare Act'' or the ``PROTECT for Rare
Act''.
SEC. 2. COVERAGE OF CERTAIN DRUGS USED IN TREATMENT OR MANAGEMENT OF A
RARE DISEASE OR CONDITION.
(a) Medicare.--
(1) Definition.--
(A) In general.--Section 1861(t)(2) of the Social
Security Act (42 U.S.C. 1395x(t)(2)) is amended--
(i) in subparagraph (A), by inserting after
``regimen'' the following: ``, or used in the
treatment or management of a disease or
condition affecting 200,000 or fewer
individuals in the United States,''; and
(ii) in subparagraph (B)(ii)--
(I) in subclause (I), by striking
``, or'' at the end and inserting a
semicolon;
(II) in subclause (II), by striking
the period at the end and inserting ``;
or''; and
(III) by adding at the end the
following new subclause:
``(III) in the case of a drug that
is used in the treatment or management
of a disease or condition affecting
200,000 or fewer individuals in the
United States, such use is supported by
peer-reviewed medical literature,
including clinical guidelines, and is
not specifically listed as not
indicated in one or more of the
compendia described in section
1927(g)(1)(B)(i), or listed as
contraindicated in the labeling
approved by the Food and Drug
Administration.''.
(B) Effective date.--The amendments made by
subparagraph (A) shall apply to items and services
furnished on or after January 1, 2027..
(2) Medically accepted uses of covered part d drugs in
treating rare conditions.--
(A) In general.--Section 1860D-2(e)(4)(A)(i) of the
Social Security Act (42 U.S.C. 1395w-104(e)(4)(A)(i))
is amended, in the matter preceding subclause (I), by
inserting ``or in the case of a covered part D drug
used in the treatment or management of a disease or
condition affecting 200,000 or fewer individuals in the
United States,'' after ``regimen,''
(B) Effective date.--The amendment made by
subparagraph (A) shall apply to plan years beginning on
or after January 1, 2027.
(b) Medicaid.--
(1) In general.--Section 1927(k)(6) of the Social Security
Act (42 U.S.C. 1396r-8(k)(6)) is amended to read as follows:
``(6) Medically accepted indication.--The term `medically
accepted indication' means any use for a covered outpatient
drug--
``(A) which is approved under the Federal Food,
Drug, and Cosmetic Act;
``(B) which is supported by one or more citations
included or approved for inclusion in any of the
compendia described in subsection (g)(1)(B)(i); or
``(C) which, in the case of a drug used to treat or
manage a disease or condition affecting 200,000 or
fewer individuals in the United States--
``(i) is a use of such drug that is
supported by peer-reviewed medical literature,
clinical guidelines, or an expert in such
disease or condition, as identified by a
medical society involved in the treatment or
management of such disease or condition; and
``(ii) is a use of such drug that is not
listed as not indicated in the compendia
described in subsection (g)(1)(B)(i), or listed
as contraindicated in the labeling approved by
the Food and Drug Administration.''.
(2) Conforming amendment.--Section 1927(d)(4)(C) of the
Social Security Act (42 U.S.C. 1396r-8(d)(4)(C)) is amended by
striking ``compendia'' and inserting ``sources''.
(3) Effective date.--The amendments made by this subsection
shall apply with respect to covered outpatient drugs furnished
on or after January 1, 2027.
(c) Private Health Insurance.--
(1) In general.--
(A) PHSA.--Part D of title XXVII of the Public
Health Service Act (42 U.S.C. 300gg-111 et seq.) is
amended by adding at the end the following new section:
``SEC. 2799A-11. EXPEDITED PROCESS FOR REVIEW ASSOCIATED WITH CERTAIN
DRUGS USED IN TREATMENT OR MANAGEMENT OF A RARE DISEASE
OR CONDITION.
``A group health plan or a health insurance issuer offering group
or individual health insurance coverage shall provide an expedited
process pursuant to section 2719 by which a participant, beneficiary,
or enrollee, or a designee or prescribing physician (or other
prescriber, as appropriate) of the participant, beneficiary, or
enrollee, may appeal any denial of coverage for a drug or biological
product--
``(1) approved under section 505 of the Federal Food, Drug,
and Cosmetic Act or licensed under section 351;
``(2) for which the use is related to treatment or
management of a disease or condition affecting 200,000 or fewer
individuals in the United States; and
``(3) the use of which is supported by--
``(A) the labeling for the drug or biological
product approved pursuant to such section 505 or 351;
or
``(B) peer-reviewed literature, including clinical
guidelines, and that is not reviewed unfavorably in the
compendia described in section 1927(g)(1)(B)(i) of the
Social Security Act and is not listed as a
contraindication in such approved labeling.''.
(B) ERISA.--
(i) In general.--Subpart B of part 7 of
subtitle B of title I of the Employee
Retirement Income Security Act of 1974 (29
U.S.C. 1185 et seq.) is amended by adding at
the end the following new section:
``SEC. 736. EXPEDITED PROCESS FOR REVIEW ASSOCIATED WITH CERTAIN DRUGS
USED IN TREATMENT OR MANAGEMENT OF A RARE DISEASE OR
CONDITION.
``A group health plan or a health insurance issuer offering group
health insurance coverage shall provide an expedited process pursuant
to section 2719 of the Public Health Service Act (42 U.S.C. 300gg-19)
by which a participant or beneficiary, or a designee or prescribing
physician (or other prescriber, as appropriate) of the participant or
beneficiary, may appeal any denial of coverage for a drug or biological
product--
``(1) approved under section 505 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355) or licensed under section 351
of the Public Health Service Act (42 U.S.C. 262);
``(2) for which the use is related to treatment or
management of a disease or condition affecting 200,000 or fewer
individuals in the United States; and
``(3) the use of which is supported by--
``(A) the labeling for the drug or biological
product approved pursuant to such section 505 or 351;
or
``(B) peer-reviewed literature, including clinical
guidelines, and that is not reviewed unfavorably in the
compendia described in section 1927(g)(1)(B)(i) of the
Social Security Act (42 U.S.C. 1396r-8(g)(1)(B)(i)) and
is not listed as a contraindication in such approved
labeling.''.
(ii) Clerical amendment.--The table of
contents in section 1 of the Employee
Retirement Income Security Act of 1974 (29
U.S.C. 1001 et seq.) is amended by inserting
after the item relating to section 725 the
following new item:
``Sec. 726. Expedited process for review associated with certain drugs
used in treatment or management of a rare
disease or condition.''.
(C) IRC.--
(i) In general.--Subchapter B of chapter
100 of the Internal Revenue Code of 1986 is
amended by adding at the end the following new
section:
``SEC. 9826. EXPEDITED PROCESS FOR REVIEW ASSOCIATED WITH CERTAIN DRUGS
USED IN TREATMENT OR MANAGEMENT OF A RARE DISEASE OR
CONDITION.
``A group health plan shall provide an expedited process pursuant
to section 2719 of the Public Health Service Act (42 U.S.C. 300gg-19)
by which a participant or beneficiary, or a designee or prescribing
physician (or other prescriber, as appropriate) of the participant or
beneficiary, may appeal any denial of coverage for a drug or biological
product--
``(1) approved under section 505 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355) or licensed under section 351
of the Public Health Service Act (42 U.S.C. 262);
``(2) for which the use is related to treatment or
management of a disease or condition affecting 200,000 or fewer
individuals in the United States; and
``(3) the use of which is supported by--
``(A) the labeling for the drug or biological
product approved pursuant to such section 505 or 351;
or
``(B) peer-reviewed literature, including clinical
guidelines, and that is not reviewed unfavorably in the
compendia described in section 1927(g)(1)(B)(i) of the
Social Security Act (42 U.S.C. 1396r-8(g)(1)(B)(i)) and
is not listed as a contraindication in such approved
labeling.''.
(ii) Clerical amendment.--The table of
sections for subchapter B of chapter 100 of the
Internal Revenue Code of 1986 is amended by
adding at the end the following new item:
``Sec. 9826. Expedited process for review associated with certain drugs
used in treatment or management of a rare
disease or condition.''.
(2) Effective date.--The amendments made by this subsection
shall apply with respect to plan years beginning on or after
January 1, 2027.
<all>
Introduced in Senate
Read twice and referred to the Committee on Finance.
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