I 
117TH CONGRESS 
1ST SESSION H. R. 6160 
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 condi-
tion, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
DECEMBER 7, 2021 
Ms. MATSUI (for herself, Mr. THOMPSON of California, Mr. MULLIN, and Mr. 
KELLY of Pennsylvania) introduced the following bill; which was referred 
to the Committee on Energy and Commerce, and in addition to the Com-
mittee on Ways and Means, for a period to be subsequently determined 
by the Speaker, in each case for consideration of such provisions as fall 
within the jurisdiction of the committee concerned 
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 treat-
ment or management of a rare disease or condition, 
and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Access to Rare Indica-
tions Act of 2021’’. 
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SEC. 2. COVERAGE OF CERTAIN DRUGS USED IN TREAT-
MENT OR MANAGEMENT OF RARE DISEASE 
OR CONDITION. 
(a) MEDICARE.— 
(1) IN
GENERAL.—Section 1861(t)(2) of the 
Social Security Act (42 U.S.C. 1395x(t)(2)) is 
amended— 
(A) in subparagraph (A), by inserting after 
‘‘regimen’’ the following: ‘‘, or in the treatment 
or management of a disease or condition affect-
ing 200,000 or fewer individuals in the United 
States,’’; and 
(B) 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 fol-
lowing new subclause: 
‘‘(III) in the case of a drug that 
is used in the treatment or manage-
ment of a disease or condition affect-
ing 200,000 or fewer individuals in 
the United States, such use is sup-
ported by peer-reviewed medical lit-
erature, clinical guidelines, or an ex-
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pert in such disease or condition as 
identified by a medical society in-
volved in the treatment or manage-
ment of such disease or condition, and 
is not reviewed unfavorably in the 
compendia 
described 
in 
section 
1927(g)(1)(B)(i), or listed as a con-
traindication in the FDA-approved la-
beling.’’. 
(2) MEDICALLY ACCEPTED USES OF COVERED 
PART D DRUGS IN TREATING RARE CONDITIONS.— 
Section 1860D–2(e)(4)(A) of the Social Security Act 
(42 U.S.C. 1395w–104(e)(4)(A)) is amended— 
(A) in clause (i)(II), by striking ‘‘and’’; 
(B) by redesignating clause (ii) as clause 
(iii); and 
(C) by inserting after clause (i)(II) the fol-
lowing new clause: 
‘‘(ii) 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, 
in section 1861(t)(2)(B); and’’. 
(3) EFFECTIVE DATE.—The amendments made 
by this subsection apply with respect to items and 
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‘‘(ii) is not reviewed unfavorably in 
the compendia described in subsection 
(g)(1)(B)(i), or listed as a contraindication 
in the FDA-approved labeling.’’. 
(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 ‘‘com-
pendia’’ and inserting ‘‘sources’’. 
(3) EFFECTIVE DATE.—The amendments made 
by this subsection apply with respect to covered out-
patient drugs furnished on or after the date that is 
30 days after the date of the enactment of this Act. 
(c) PRIVATE HEALTH INSURANCE.— 
(1) IN GENERAL.—Subpart II of part A of title 
XXVII of the Public Health Service Act (42 U.S.C. 
300gg–11 et seq.) is amended by adding at the end 
the following new section: 
‘‘SEC. 2730. IN GENERAL COVERAGE OF CERTAIN DRUGS 
USED IN TREATMENT OR MANAGEMENT OF A 
RARE DISEASE OR CONDITION. 
‘‘A group health plan or a health insurance issuer of-
fering group or individual health insurance coverage shall 
provide a mechanism for expedited formulary exception, 
reconsideration, and appeal of any denial of coverage for 
a drug or biological— 
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‘‘(1) approved by the Food and Drug Adminis-
tration; 
‘‘(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 the FDA- 
approved label, peer-reviewed 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 condi-
tion, and that is not reviewed unfavorably in the 
compendia described in section 1927(g)(1)(B)(i) of 
the Social Security Act or listed as a contraindica-
tion in the FDA-approved labeling.’’. 
(2) EFFECTIVE DATE.—The amendment made 
by this subsection applies with respect to plan years 
beginning on or after the date that is 30 days after 
the date of the enactment of this Act. 
Æ 
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