I 116th CONGRESS 2d Session H. R. 8467 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. Short title This Act may be cited as the Access to Rare Indications Act of 2020 . 2. Coverage of certain drugs used in treatment 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 affecting 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 following 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 literature, clinical guidelines, or expert opinion within the National Institutes of Health Rare Diseases Clinical Research Network consortia or its participating clinical centers. . (2) Prohibition of coverage exclusions for formularies under Medicare part D Section 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 sponsor of a prescription drug plan uses a formulary, such sponsor may not impose a limitation or exclusion of benefits with respect to coverage of a rare disease covered part D drug (as defined in clause (ii)) included in such formulary. (ii) Rare disease covered part D drug For purposes of this subparagraph, 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 (II) the use of which is supported by peer-reviewed literature, clinical guidelines, or expert opinion within the National Institutes of Health Rare Diseases Clinical Research Network consortia or its participating 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 following: , or the use of which is related to the treatment or management of a disease or condition affecting 200,000 or fewer individuals in the United States and is supported by peer-reviewed literature, clinical guidelines, or expert opinion within the National Institutes of Health Rare Diseases Clinical Research Network consortia or its participating clinical centers . (2) Prohibition of coverage exclusions for formularies Section 1927(d)(4) of the Social Security Act ( 42 U.S.C. 1396r–8(d)(4) ) is amended— (A) in subparagraph (C), by striking A covered outpatient drug and inserting Subject to subparagraph (E), a covered outpatient drug ; (B) by redesignating subparagraph (E) as subparagraph (F); and (C) by inserting after subparagraph (D) the following new subparagraph: (E) Notwithstanding subparagraph (C), the State may not impose a limitation or exclusion of benefits with respect to coverage of a covered outpatient drug that is— (i) used in the treatment or management of a disease or condition affecting 200,000 or fewer individuals in the United States; and (ii) the use of which is supported by peer-reviewed literature, clinical guidelines, or expert opinion within the National Institutes of Health Rare Diseases Clinical Research Network consortia or its participating clinical centers. . (3) Effective date The amendments made by this subsection apply with respect to covered outpatient drugs furnished on or after the date that is 30 days after the date of the enactment of this Act. (c) Private health insurance (1) In general Subpart II of part A of title XXVII of the Public Health Service Act ( 42 U.S.C. 300gg–11 et seq.) is amended by adding at the end the following new section: 2730. Coverage of certain drugs used in treatment or management of rare disease or condition (a) In general A group health plan or a health insurance issuer offering group or individual health insurance coverage shall provide coverage for a drug— (1) approved by the Food and Drug Administration; (2) used in the treatment or management of a disease or condition affecting 200,000 or fewer individuals in the United States; and (3) the use of which is supported by peer-reviewed literature, clinical guidelines, or expert opinion within the National Institutes of Health Rare Diseases Clinical Research Network consortia or its participating clinical centers. (b) Prohibition of certain coverage exclusions A group health plan or a health insurance issuer offering group or individual health insurance coverage may not impose a limitation or exclusion of benefits with respect to coverage of a drug described in subsection (a) other than a limitation or exclusion of benefits with respect to a use of such drug identified as contraindicated by the Food and Drug Administration. . (2) Effective date The amendment made by this subsection applies with respect to plan years beginning on or after the date that is 30 days after the date of the enactment of this Act.