[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>