Title: Access to Rare Indications Act of 2020
Policy area: Health

Summary:
Access to Rare Indications Act of 2020
This bill prohibits coverage exclusions or limitations under the Medicare prescription drug benefit, Medicaid, or private health insurance of certain drugs that are used to treat rare diseases or conditions (i.e., diseases or conditions that affect 200,000 or fewer individuals and that are supported by the National Institutes of Health Rare Diseases Clinical Research Network).

[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8467 Introduced in House (IH)]

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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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Access to Rare Indications Act of 
2020''.

SEC. 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:

``SEC. 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.
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