I 

118TH CONGRESS 

1ST SESSION H. R. 6094 

To amend titles XVIII and XIX of the Social Security Act and title XXVII 

of the Public Health Service Act to refine the set of information sources 

for determining coverage of certain drugs and biologicals used in the 

treatment or management of a rare disease or condition, and for other 

purposes. 

IN THE HOUSE OF REPRESENTATIVES 

OCTOBER 26, 2023 

Ms. MATSUI (for herself, Mr. DUNN of Florida, Mr. THOMPSON of California, 

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 

refine the set of information sources for determining 

coverage of certain drugs and biologicals 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, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Providing Realistic Op3 portunity To Equal and Comparable Treatment for Rare 

4 Act’’ or the ‘‘PROTECT Rare Act’’. 

5 SEC. 2. COVERAGE OF CERTAIN DRUGS USED IN TREAT6 MENT OR MANAGEMENT OF RARE DISEASE 

7 OR CONDITION. 

8 (a) MEDICARE.— 

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

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

11 amended— 

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

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

14 or management of a disease or condition affect15 ing 200,000 or fewer individuals in the United 

16 States,’’; and 

17 (B) in subparagraph (B)(ii)— 

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

19 at the end and inserting a semicolon; 

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

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

22 (iii) by adding at the end the fol23 lowing new subclause: 

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

25 is used in the treatment or manage26 ment of a disease or condition affectVerDate Sep 11 2014 00:34 Dec 01, 2023 Jkt 049200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H6094.IH H6094

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1 ing 200,000 or fewer individuals in 

2 the United States, such use is sup3 ported by peer-reviewed medical lit4 erature, including clinical guidelines, 

5 and 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–102(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, includ22 ing clinical guidelines; and 

23 ‘‘(ii) is not reviewed unfavorably in 

24 the compendia described in subsection 


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

2 in the FDA-approved labeling.’’. 

3 (2) CONFORMING AMENDMENT.—Section 

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

5 1396r–8(d)(4)(C)) is amended by striking ‘‘com6 pendia’’ and inserting ‘‘sources’’. 

7 (3) EFFECTIVE DATE.—The amendments made 

8 by this subsection apply with respect to covered out9 patient drugs furnished on or after the date that is 

10 30 days after the date of the enactment of this Act. 

11 (c) PRIVATE HEALTH INSURANCE.— 

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

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

14 300gg–19) is amended by adding at the end the fol15 lowing new section: 

16 ‘‘SEC. 2730. EXPEDITED PROCESSES FOR REVIEW ASSOCI17 ATED WITH CERTAIN DRUGS USED IN TREAT18 MENT OR MANAGEMENT OF A RARE DISEASE 

19 OR CONDITION. 

20 ‘‘A group health plan or a health insurance issuer of21 fering group or individual health insurance coverage shall 

22 provide a mechanism for expedited formulary exception, 

23 reconsideration, and appeal of any denial of coverage for 

24 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 or peer-reviewed literature, including 

9 clinical guidelines, and that is not reviewed unfavor10 ably in the compendia described in section 

11 1927(g)(1)(B)(i)) of the Social Security Act or listed 

12 as a contraindication in the FDA-approved label13 ing.’’. 

14 (2) EFFECTIVE DATE.—The amendment made 

15 by this subsection applies with respect to plan years 

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

17 the date of the enactment of this Act. 

Æ 


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