I 
116TH CONGRESS 
2D SESSION 
H. R. 8467 
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 
SEPTEMBER 30, 2020 
Mr. THOMPSON of California (for himself and Mr. KELLY of Pennsylvania) 
introduced the following bill; which was referred to the Committee on En-
ergy and Commerce, and in addition to the Committee 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 jurisdic-
tion 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 2020’’. 
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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 that the drug 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 lit-
erature, clinical guidelines, or expert opinion within 
the National Institutes of Health Rare Diseases 
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Clinical Research Network consortia or its partici-
pating clinical centers.’’. 
(2) PROHIBITION
OF
COVERAGE
EXCLUSIONS 
FOR FORMULARIES UNDER MEDICARE PART D.—Sec-
tion 1860D–4(b)(3) of the Social Security Act (42 
U.S.C. 1395w–104(b)(3)) is amended by adding at 
the end the following new subparagraph: 
‘‘(I) PROHIBITION OF CERTAIN COVERAGE 
EXCLUSIONS.— 
‘‘(i) IN GENERAL.—If the PDP spon-
sor of a prescription drug plan uses a for-
mulary, such sponsor may not impose a 
limitation or exclusion of benefits with re-
spect to coverage of a rare disease covered 
part D drug (as defined in clause (ii)) in-
cluded in such formulary. 
‘‘(ii) RARE DISEASE COVERED PART D 
DRUG.—For purposes of this subpara-
graph, the term ‘rare disease covered part 
D drug’ means a covered part D drug— 
‘‘(I) used in the treatment or 
management of a disease or condition 
affecting 200,000 or fewer individuals 
in the United States; and 
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‘‘(II) the use of which is sup-
ported by peer-reviewed literature, 
clinical guidelines, or expert opinion 
within the National Institutes of 
Health Rare Diseases Clinical Re-
search Network consortia or its par-
ticipating clinical centers.’’. 
(3) EFFECTIVE DATE.—The amendments made 
by this subsection apply with respect to items and 
services furnished on or after the date that is 30 
days after the date of the enactment of this Act. 
(b) MEDICAID.— 
(1) IN GENERAL.—Section 1927(k)(6) of the 
Social Security Act (42 U.S.C. 1396r–8(k)(6)) is 
amended— 
(A) by striking ‘‘, or’’ and inserting a 
comma; and 
(B) by inserting before the period the fol-
lowing: ‘‘, or the use of which is related to the 
treatment or management of a disease or condi-
tion affecting 200,000 or fewer individuals in 
the United States and is supported by peer-re-
viewed literature, clinical guidelines, or expert 
opinion within the National Institutes of Health 
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