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 condition, 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 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 2020’’. 


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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 that the drug is used in the 

21 treatment or management of a disease or condition 

22 affecting 200,000 or fewer individuals in the United 

23 States, such use is supported by peer-reviewed lit24 erature, clinical guidelines, or expert opinion within 

25 the National Institutes of Health Rare Diseases 


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1 Clinical Research Network consortia or its partici2 pating clinical centers.’’. 

3 (2) PROHIBITION OF COVERAGE EXCLUSIONS

4 FOR FORMULARIES UNDER MEDICARE PART D.—Sec5 tion 1860D–4(b)(3) of the Social Security Act (42 

6 U.S.C. 1395w–104(b)(3)) is amended by adding at 

7 the end the following new subparagraph: 

8 ‘‘(I) PROHIBITION OF CERTAIN COVERAGE

9 EXCLUSIONS.— 

10 ‘‘(i) IN GENERAL.—If the PDP spon11 sor of a prescription drug plan uses a for12 mulary, such sponsor may not impose a 

13 limitation or exclusion of benefits with re14 spect to coverage of a rare disease covered 

15 part D drug (as defined in clause (ii)) in16 cluded in such formulary. 

17 ‘‘(ii) RARE DISEASE COVERED PART D

18 DRUG.—For purposes of this subpara19 graph, the term ‘rare disease covered part 

20 D drug’ means a covered part D drug— 

21 ‘‘(I) used in the treatment or 

22 management of a disease or condition 

23 affecting 200,000 or fewer individuals 

24 in the United States; and 


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1 ‘‘(II) the use of which is sup2 ported by peer-reviewed literature, 

3 clinical guidelines, or expert opinion 

4 within the National Institutes of 

5 Health Rare Diseases Clinical Re6 search Network consortia or its par7 ticipating clinical centers.’’. 

8 (3) EFFECTIVE DATE.—The amendments made 

9 by this subsection apply with respect to items and 

10 services furnished on or after the date that is 30 

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

12 (b) MEDICAID.— 

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

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

15 amended— 

16 (A) by striking ‘‘, or’’ and inserting a 

17 comma; and 

18 (B) by inserting before the period the fol19 lowing: ‘‘, or the use of which is related to the 

20 treatment or management of a disease or condi21 tion affecting 200,000 or fewer individuals in 

22 the United States and is supported by peer-re23 viewed literature, clinical guidelines, or expert 

24 opinion within the National Institutes of Health 


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1 Rare Diseases Clinical Research Network con2 sortia or its participating clinical centers’’. 

3 (2) PROHIBITION OF COVERAGE EXCLUSIONS

4 FOR FORMULARIES.—Section 1927(d)(4) of the So5 cial Security Act (42 U.S.C. 1396r–8(d)(4)) is 

6 amended— 

7 (A) in subparagraph (C), by striking ‘‘A 

8 covered outpatient drug’’ and inserting ‘‘Sub9 ject to subparagraph (E), a covered outpatient 

10 drug’’; 

11 (B) by redesignating subparagraph (E) as 

12 subparagraph (F); and 

13 (C) by inserting after subparagraph (D) 

14 the following new subparagraph: 

15 ‘‘(E) Notwithstanding subparagraph (C), 

16 the State may not impose a limitation or exclu17 sion of benefits with respect to coverage of a 

18 covered outpatient drug that is— 

19 ‘‘(i) used in the treatment or manage20 ment of a disease or condition affecting 

21 200,000 or fewer individuals in the United 

22 States; and 

23 ‘‘(ii) the use of which is supported by 

24 peer-reviewed literature, clinical guidelines, 

25 or expert opinion within the National InstiVerDate Sep 11 2014 04:54 Oct 27, 2020 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H8467.IH H8467

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1 tutes of Health Rare Diseases Clinical Re2 search Network consortia or its partici3 pating clinical centers.’’. 

4 (3) EFFECTIVE DATE.—The amendments made 

5 by this subsection apply with respect to covered out6 patient drugs furnished on or after the date that is 

7 30 days after the date of the enactment of this Act. 

8 (c) PRIVATE HEALTH INSURANCE.— 

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

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

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

12 the following new section: 

13 ‘‘SEC. 2730. COVERAGE OF CERTAIN DRUGS USED IN TREAT14 MENT OR MANAGEMENT OF RARE DISEASE 

15 OR CONDITION. 

16 ‘‘(a) IN GENERAL.—A group health plan or a health 

17 insurance issuer offering group or individual health insur18 ance coverage shall provide coverage for a drug— 

19 ‘‘(1) approved by the Food and Drug Adminis20 tration; 

21 ‘‘(2) used in the treatment or management of 

22 a disease or condition affecting 200,000 or fewer in23 dividuals in the United States; and 

24 ‘‘(3) the use of which is supported by peer-re25 viewed literature, clinical guidelines, or expert opinVerDate Sep 11 2014 04:54 Oct 27, 2020 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H8467.IH H8467

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1 ion within the National Institutes of Health Rare 

2 Diseases Clinical Research Network consortia or its 

3 participating clinical centers. 

4 ‘‘(b) PROHIBITION OF CERTAIN COVERAGE EXCLU5 SIONS.—A group health plan or a health insurance issuer 

6 offering group or individual health insurance coverage 

7 may not impose a limitation or exclusion of benefits with 

8 respect to coverage of a drug described in subsection (a) 

9 other than a limitation or exclusion of benefits with re10 spect to a use of such drug identified as contraindicated 

11 by the Food and Drug Administration.’’. 

12 (2) EFFECTIVE DATE.—The amendment made 

13 by this subsection applies with respect to plan years 

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

15 the date of the enactment of this Act. 

Æ 


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