Access to Rare Indications Act of 2020

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- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Access to Rare Indica- 4 tions Act of 2020’’. 5 VerDate Sep 11 2014 04:54 Oct 27, 2020 Jkt 019200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\H8467.IH H8467 pbinns on DSKJLVW7X2PROD with BILLS 2 •HR 8467 IH SEC. 2. COVERAGE OF CERTAIN DRUGS USED IN TREAT- 1 MENT OR MANAGEMENT OF RARE DISEASE 2 OR CONDITION. 3 (a) MEDICARE.— 4 (1) IN GENERAL.—Section 1861(t)(2) of the 5 Social Security Act (42 U.S.C. 1395x(t)(2)) is 6 amended— 7 (A) in subparagraph (A), by inserting after 8 ‘‘regimen’’ the following: ‘‘, or in the treatment 9 or management of a disease or condition affect- 10 ing 200,000 or fewer individuals in the United 11 States,’’; and 12 (B) in subparagraph (B)(ii)— 13 (i) in subclause (I), by striking ‘‘, or’’ 14 at the end and inserting a semicolon; 15 (ii) in subclause (II), by striking the 16 period at the end and inserting ‘‘; or’’; and 17 (iii) by adding at the end the fol- 18 lowing new subclause: 19 ‘‘(III) in the case that the drug is used in the 20 treatment or management of a disease or condition 21 affecting 200,000 or fewer individuals in the United 22 States, such use is supported by peer-reviewed lit- 23 erature, clinical guidelines, or expert opinion within 24 the National Institutes of Health Rare Diseases 25 VerDate Sep 11 2014 04:54 Oct 27, 2020 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\H8467.IH H8467 pbinns on DSKJLVW7X2PROD with BILLS 3 •HR 8467 IH Clinical Research Network consortia or its partici- 1 pating clinical centers.’’. 2 (2) PROHIBITION OF COVERAGE EXCLUSIONS 3 FOR FORMULARIES UNDER MEDICARE PART D.—Sec- 4 tion 1860D–4(b)(3) of the Social Security Act (42 5 U.S.C. 1395w–104(b)(3)) is amended by adding at 6 the end the following new subparagraph: 7 ‘‘(I) PROHIBITION OF CERTAIN COVERAGE 8 EXCLUSIONS.— 9 ‘‘(i) IN GENERAL.—If the PDP spon- 10 sor of a prescription drug plan uses a for- 11 mulary, such sponsor may not impose a 12 limitation or exclusion of benefits with re- 13 spect to coverage of a rare disease covered 14 part D drug (as defined in clause (ii)) in- 15 cluded in such formulary. 16 ‘‘(ii) RARE DISEASE COVERED PART D 17 DRUG.—For purposes of this subpara- 18 graph, the term ‘rare disease covered part 19 D drug’ means a covered part D drug— 20 ‘‘(I) used in the treatment or 21 management of a disease or condition 22 affecting 200,000 or fewer individuals 23 in the United States; and 24 VerDate Sep 11 2014 04:54 Oct 27, 2020 Jkt 019200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\H8467.IH H8467 pbinns on DSKJLVW7X2PROD with BILLS 4 •HR 8467 IH ‘‘(II) the use of which is sup- 1 ported by peer-reviewed literature, 2 clinical guidelines, or expert opinion 3 within the National Institutes of 4 Health Rare Diseases Clinical Re- 5 search Network consortia or its par- 6 ticipating clinical centers.’’. 7 (3) EFFECTIVE DATE.—The amendments made 8 by this subsection apply with respect to items and 9 services furnished on or after the date that is 30 10 days after the date of the enactment of this Act. 11 (b) MEDICAID.— 12 (1) IN GENERAL.—Section 1927(k)(6) of the 13 Social Security Act (42 U.S.C. 1396r–8(k)(6)) is 14 amended— 15 (A) by striking ‘‘, or’’ and inserting a 16 comma; and 17 (B) by inserting before the period the fol- 18 lowing: ‘‘, or the use of which is related to the 19 treatment or management of a disease or condi- 20 tion affecting 200,000 or fewer individuals in 21 the United States and is supported by peer-re- 22 viewed literature, clinical guidelines, or expert 23 opinion within the National Institutes of Health 24 VerDate Sep 11 2014 04:54 Oct 27, 2020 Jkt 019200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\H8467.IH H8467 pbinns on DSKJLVW7X2PROD with BILLS 5 •HR 8467 IH Rare Diseases Clinical Research Network con- 1 sortia or its participating clinical centers’’. 2 (2) PROHIBITION OF COVERAGE EXCLUSIONS 3 FOR FORMULARIES.—Section 1927(d)(4) of the So- 4 cial Security Act (42 U.S.C. 1396r–8(d)(4)) is 5 amended— 6 (A) in subparagraph (C), by striking ‘‘A 7 covered outpatient drug’’ and inserting ‘‘Sub- 8 ject to subparagraph (E), a covered outpatient 9 drug’’; 10 (B) by redesignating subparagraph (E) as 11 subparagraph (F); and 12 (C) by inserting after subparagraph (D) 13 the following new subparagraph: 14 ‘‘(E) Notwithstanding subparagraph (C), 15 the State may not impose a limitation or exclu- 16 sion of benefits with respect to coverage of a 17 covered outpatient drug that is— 18 ‘‘(i) used in the treatment or manage- 19 ment of a disease or condition affecting 20 200,000 or fewer individuals in the United 21 States; and 22 ‘‘(ii) the use of which is supported by 23 peer-reviewed literature, clinical guidelines, 24 or expert opinion within the National Insti- 25 VerDate Sep 11 2014 04:54 Oct 27, 2020 Jkt 019200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\H8467.IH H8467 pbinns on DSKJLVW7X2PROD with BILLS 6 •HR 8467 IH tutes of Health Rare Diseases Clinical Re- 1 search Network consortia or its partici- 2 pating clinical centers.’’. 3 (3) EFFECTIVE DATE.—The amendments made 4 by this subsection apply with respect to covered out- 5 patient drugs furnished on or after the date that is 6 30 days after the date of the enactment of this Act. 7 (c) PRIVATE HEALTH INSURANCE.— 8 (1) IN GENERAL.—Subpart II of part A of title 9 XXVII of the Public Health Service Act (42 U.S.C. 10 300gg–11 et seq.) is amended by adding at the end 11 the following new section: 12 ‘‘SEC. 2730. COVERAGE OF CERTAIN DRUGS USED IN TREAT- 13 MENT OR MANAGEMENT OF RARE DISEASE 14 OR CONDITION. 15 ‘‘(a) IN GENERAL.—A group health plan or a health 16 insurance issuer offering group or individual health insur- 17 ance coverage shall provide coverage for a drug— 18 ‘‘(1) approved by the Food and Drug Adminis- 19 tration; 20 ‘‘(2) used in the treatment or management of 21 a disease or condition affecting 200,000 or fewer in- 22 dividuals in the United States; and 23 ‘‘(3) the use of which is supported by peer-re- 24 viewed literature, clinical guidelines, or expert opin- 25 VerDate Sep 11 2014 04:54 Oct 27, 2020 Jkt 019200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\H8467.IH H8467 pbinns on DSKJLVW7X2PROD with BILLS 7 •HR 8467 IH ion within the National Institutes of Health Rare 1 Diseases Clinical Research Network consortia or its 2 participating clinical centers. 3 ‘‘(b) PROHIBITION OF CERTAIN COVERAGE EXCLU- 4 SIONS.—A group health plan or a health insurance issuer 5 offering group or individual health insurance coverage 6 may not impose a limitation or exclusion of benefits with 7 respect to coverage of a drug described in subsection (a) 8 other than a limitation or exclusion of benefits with re- 9 spect to a use of such drug identified as contraindicated 10 by the Food and Drug Administration.’’. 11 (2) EFFECTIVE DATE.—The amendment made 12 by this subsection applies with respect to plan years 13 beginning on or after the date that is 30 days after 14 the date of the enactment of this Act. 15 Æ VerDate Sep 11 2014 04:54 Oct 27, 2020 Jkt 019200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6301 E:\BILLS\H8467.IH H8467 pbinns on DSKJLVW7X2PROD with BILLS