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[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6094 Introduced in House (IH)]

<DOC>

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.

    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 ``Providing Realistic Opportunity To 
Equal and Comparable Treatment for Rare Act'' or the ``PROTECT Rare 
Act''.

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 of a drug that 
                                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 medical literature, 
                                including clinical guidelines, and is 
                                not reviewed unfavorably in the 
                                compendia described in section 
                                1927(g)(1)(B)(i), or listed as a 
                                contraindication in the FDA-approved 
                                labeling.''.
            (2) Medically accepted uses of covered part d drugs in 
        treating rare conditions.--Section 1860D-2(e)(4)(A) of the 
        Social Security Act (42 U.S.C. 1395w-102(e)(4)(A)) is amended--
                    (A) in clause (i)(II), by striking ``and'';
                    (B) by redesignating clause (ii) as clause (iii); 
                and
                    (C) by inserting after clause (i)(II) the following 
                new clause:
                            ``(ii) in the case of a covered part D drug 
                        used in the treatment or management of a 
                        disease or condition affecting 200,000 or fewer 
                        individuals in the United States, in section 
                        1861(t)(2)(B); and''.
            (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 to read as follows:
            ``(6) Medically accepted indication.--The term `medically 
        accepted indication' means any use for a covered drug--
                    ``(A) which is approved under the Federal Food, 
                Drug, and Cosmetic Act;
                    ``(B) which is supported by one or more citations 
                included or approved for inclusion in any of the 
                compendia described in subsection (g)(1)(B)(i); or
                    ``(C) in the case of a drug used to treat or manage 
                a disease or condition affecting 200,000 or fewer 
                individuals in the United States--
                            ``(i) the use of such drug is supported by 
                        peer-reviewed medical literature, including 
                        clinical guidelines; and
                            ``(ii) is not reviewed unfavorably in the 
                        compendia described in subsection (g)(1)(B)(i), 
                        or listed as a contraindication in the FDA-
                        approved labeling.''.
            (2) Conforming amendment.--Section 1927(d)(4)(C) of the 
        Social Security Act (42 U.S.C. 1396r-8(d)(4)(C)) is amended by 
        striking ``compendia'' and inserting ``sources''.
            (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-19) is amended by 
        adding at the end the following new section:

``SEC. 2730. EXPEDITED PROCESSES FOR REVIEW ASSOCIATED WITH CERTAIN 
              DRUGS USED IN TREATMENT OR MANAGEMENT OF A RARE DISEASE 
              OR CONDITION.

    ``A group health plan or a health insurance issuer offering group 
or individual health insurance coverage shall provide a mechanism for 
expedited formulary exception, reconsideration, and appeal of any 
denial of coverage for a drug or biological--
            ``(1) approved by the Food and Drug Administration;
            ``(2) for which the use is related to 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 the FDA-approved 
        label or peer-reviewed literature, including clinical 
        guidelines, and that is not reviewed unfavorably in the 
        compendia described in section 1927(g)(1)(B)(i)) of the Social 
        Security Act or listed as a contraindication in the FDA-
        approved labeling.''.
            (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.
                                 <all>
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