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 condition, 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 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 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 treatment or management of a rare disease or condition, 

and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Access to Rare Indica5 tions Act of 2021’’. 


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1 SEC. 2. COVERAGE OF CERTAIN DRUGS USED IN TREAT2 MENT OR MANAGEMENT OF RARE DISEASE 

3 OR CONDITION. 

4 (a) MEDICARE.— 

5 (1) IN GENERAL.—Section 1861(t)(2) of the 

6 Social Security Act (42 U.S.C. 1395x(t)(2)) is 

7 amended— 

8 (A) in subparagraph (A), by inserting after 

9 ‘‘regimen’’ the following: ‘‘, or in the treatment 

10 or management of a disease or condition affect11 ing 200,000 or fewer individuals in the United 

12 States,’’; and 

13 (B) in subparagraph (B)(ii)— 

14 (i) in subclause (I), by striking ‘‘, or’’ 

15 at the end and inserting a semicolon; 

16 (ii) in subclause (II), by striking the 

17 period at the end and inserting ‘‘; or’’; and 

18 (iii) by adding at the end the fol19 lowing new subclause: 

20 ‘‘(III) in the case of a drug that 

21 is used in the treatment or manage22 ment of a disease or condition affect23 ing 200,000 or fewer individuals in 

24 the United States, such use is sup25 ported by peer-reviewed medical lit26 erature, clinical guidelines, or an exVerDate Sep 11 2014 00:37 Dec 17, 2021 Jkt 029200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H6160.IH H6160

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1 pert in such disease or condition as 

2 identified by a medical society in3 volved in the treatment or manage4 ment of such disease or condition, and 

5 is not reviewed unfavorably in the 

6 compendia described in section 

7 1927(g)(1)(B)(i), or listed as a con8 traindication in the FDA-approved la9 beling.’’. 

10 (2) MEDICALLY ACCEPTED USES OF COVERED

11 PART D DRUGS IN TREATING RARE CONDITIONS.— 

12 Section 1860D–2(e)(4)(A) of the Social Security Act 

13 (42 U.S.C. 1395w–104(e)(4)(A)) is amended— 

14 (A) in clause (i)(II), by striking ‘‘and’’; 

15 (B) by redesignating clause (ii) as clause 

16 (iii); and 

17 (C) by inserting after clause (i)(II) the fol18 lowing new clause: 

19 ‘‘(ii) in the case of a covered part D 

20 drug used in the treatment or management 

21 of a disease or condition affecting 200,000 

22 or fewer individuals in the United States, 

23 in section 1861(t)(2)(B); and’’. 

24 (3) EFFECTIVE DATE.—The amendments made 

25 by this subsection apply with respect to items and 


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1 services furnished on or after the date that is 30 

2 days after the date of the enactment of this Act. 

3 (b) MEDICAID.— 

4 (1) IN GENERAL.—Section 1927(k)(6) of the 

5 Social Security Act (42 U.S.C. 1396r–8(k)(6)) is 

6 amended to read as follows: 

7 ‘‘(6) MEDICALLY ACCEPTED INDICATION.—The 

8 term ‘medically accepted indication’ means any use 

9 for a covered drug— 

10 ‘‘(A) which is approved under the Federal 

11 Food, Drug, and Cosmetic Act; 

12 ‘‘(B) which is supported by one or more ci13 tations included or approved for inclusion in 

14 any of the compendia described in subsection 

15 (g)(1)(B)(i); or 

16 ‘‘(C) in the case of a drug used to treat or 

17 manage a disease or condition affecting 

18 200,000 or fewer individuals in the United 

19 States— 

20 ‘‘(i) the use of such drug is supported 

21 by peer-reviewed medical literature, clinical 

22 guidelines, or an expert in such disease or 

23 condition as identified by a medical society 

24 involved in the treatment or management 

25 of such disease or condition; and 


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1 ‘‘(ii) is not reviewed unfavorably in 

2 the compendia described in subsection 

3 (g)(1)(B)(i), or listed as a contraindication 

4 in the FDA-approved labeling.’’. 

5 (2) CONFORMING AMENDMENT.—Section 

6 1927(d)(4)(C) of the Social Security Act (42 U.S.C. 

7 1396r–8(d)(4)(C)) is amended by striking ‘‘com8 pendia’’ and inserting ‘‘sources’’. 

9 (3) EFFECTIVE DATE.—The amendments made 

10 by this subsection apply with respect to covered out11 patient drugs furnished on or after the date that is 

12 30 days after the date of the enactment of this Act. 

13 (c) PRIVATE HEALTH INSURANCE.— 

14 (1) IN GENERAL.—Subpart II of part A of title 

15 XXVII of the Public Health Service Act (42 U.S.C. 

16 300gg–11 et seq.) is amended by adding at the end 

17 the following new section: 

18 ‘‘SEC. 2730. IN GENERAL COVERAGE OF CERTAIN DRUGS 

19 USED IN TREATMENT OR MANAGEMENT OF A 

20 RARE DISEASE OR CONDITION. 

21 ‘‘A group health plan or a health insurance issuer of22 fering group or individual health insurance coverage shall 

23 provide a mechanism for expedited formulary exception, 

24 reconsideration, and appeal of any denial of coverage for 

25 a drug or biological— 


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1 ‘‘(1) approved by the Food and Drug Adminis2 tration; 

3 ‘‘(2) for which the use is related to treatment 

4 or management of a disease or condition affecting 

5 200,000 or fewer individuals in the United States; 

6 and 

7 ‘‘(3) the use of which is supported by the FDA8 approved label, peer-reviewed literature, clinical 

9 guidelines, or an expert in such disease or condition 

10 as identified by a medical society involved in the 

11 treatment or management of such disease or condi12 tion, and that is not reviewed unfavorably in the 

13 compendia described in section 1927(g)(1)(B)(i) of 

14 the Social Security Act or listed as a contraindica15 tion in the FDA-approved labeling.’’. 

16 (2) EFFECTIVE DATE.—The amendment made 

17 by this subsection applies with respect to plan years 

18 beginning on or after the date that is 30 days after 

19 the date of the enactment of this Act. 

Æ 


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