[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 7716 Introduced in House (IH)]
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118th CONGRESS
2d Session
H. R. 7716
To amend title XVIII of the Social Security Act to provide for
enforcement of standards for reasonable and relevant contract terms and
conditions and essential retail pharmacy protections under the Medicare
program.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
March 19, 2024
Mr. Gallego 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 title XVIII of the Social Security Act to provide for
enforcement of standards for reasonable and relevant contract terms and
conditions and essential retail pharmacy protections under the Medicare
program.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. PROVIDING FOR ENFORCEMENT OF STANDARDS FOR REASONABLE AND
RELEVANT CONTRACT TERMS AND CONDITIONS AND ESSENTIAL
RETAIL PHARMACY PROTECTIONS UNDER THE MEDICARE PROGRAM.
(a) In General.--Section 1860D-4(b)(1) of the Social Security Act
(42 U.S.C. 1395w-104(b)(1)) is amended by adding at the end the
following new subparagraph:
``(F) Enforcement of standards for reasonable and
relevant contract terms and conditions and essential
retail pharmacy protections.--
``(i) Allegation submission process.--
``(I) In general.--Not later than
January 1, 2028, the Secretary shall
establish a process through which a
pharmacy may submit an allegation of a
violation by a PDP sponsor offering a
prescription drug plan of--
``(aa) the standards for
reasonable and relevant
contract terms and conditions
under subparagraph (A)(ii); or
``(bb) the requirements for
total reimbursement for
essential retail pharmacies
that are independent community
pharmacies under subparagraph
(C)(v)(II).
``(II) Frequency of submission.--
``(aa) Violations of
reasonable and relevant
contract terms and
conditions.--
``(AA) In
general.--Except as
provided in subitem
(BB), the allegation
submission process
under this clause shall
allow pharmacies to
submit any allegations
of violations described
in item (aa) of
subclause (I) not more
frequently than once
per plan year per
contract between a
pharmacy and a PDP
sponsor.
``(BB) Allegations
relating to contract
changes.--In the case
where a contract is
amended or otherwise
updated following the
submission of
allegations by a
pharmacy with respect
to such contract and
plan year, the
allegation submission
process under this
clause shall allow such
pharmacy to submit an
additional allegation
related to those
changes with respect to
such contract and plan
year.
``(CC)
Submissions.--Submission
s of any allegations
under this item shall
be separate from any
submissions under item
(bb) and may include
multiple allegations of
such violations.
``(bb) Violations of
essential retail pharmacy
protections.--
``(AA) In
general.--The
allegation submission
process under this
clause shall allow
essential retail
pharmacies that are
independent community
pharmacies to submit
any allegations of
violations described in
item (bb) of subclause
(I) once per calendar
quarter.
``(BB)
Submissions.--Submission
s of any allegations
under this item shall
be separate from any
submissions under item
(aa) and may include
multiple allegations of
such violations.
``(III) Access to relevant
documents and materials.--A PDP sponsor
subject to an allegation under this
clause--
``(aa) shall provide
documents or materials, as
specified by the Secretary,
including contract offers made
by such sponsor to such
pharmacy or correspondence
related to such offers, to the
Secretary at a time and in a
form and manner specified by
the Secretary; and
``(bb) shall not prohibit
or otherwise limit the ability
of a pharmacy to submit such
documents or materials to the
Secretary for the purpose of
submitting an allegation or
providing evidence for such an
allegation under this clause.
``(IV) Standardized template.--The
Secretary shall establish separate
standardized templates for pharmacies
to use for the submission of
allegations described in items (aa) and
(bb) of subclause (I). Each such
template shall require that the
submission include a certification by
the pharmacy that the information
included is accurate, complete, and
true to the best of the knowledge,
information, and belief of such
pharmacy.
``(V) Preventing frivolous
allegations.--In the case where the
Secretary determines that a pharmacy
has submitted frivolous allegations
under this clause on a routine basis,
the Secretary may temporarily prohibit
such pharmacy from using the allegation
submission process under this clause,
as determined appropriate by the
Secretary.
``(VI) Exemption from freedom of
information act.--Allegations submitted
under this clause shall be exempt from
disclosure under section 552 of title
5, United States Code.
``(ii) Investigation.--The Secretary shall
investigate, as determined appropriate by the
Secretary, allegations submitted pursuant to
clause (i).
``(iii) Enforcement.--
``(I) Reasonable and relevant
contract terms and conditions.--In the
case where the Secretary determines
that a PDP sponsor offering a
prescription drug plan has violated the
standards for reasonable and relevant
contract terms and conditions under
subparagraph (A)(ii), the Secretary
shall use existing authorities under
sections 1857(g) and 1860D-12(b)(3)(E)
to impose civil monetary penalties or
take other enforcement actions.
``(II) Essential retail pharmacy
protections.--In the case where the
Secretary determines that a PDP sponsor
offering a prescription drug plan has
violated the requirements for total
reimbursement for essential retail
pharmacies that are independent
community pharmacies under subparagraph
(C)(v)(II), the Secretary shall--
``(aa) if the amount of
total reimbursement paid by the
sponsor to an essential retail
pharmacy that is an independent
community pharmacy for a
covered part D drug was less
than the amount of total
reimbursement required to be
paid to the pharmacy under
subparagraph (C)(v)(II) for
such drug, require the PDP
sponsor to pay to the pharmacy
an amount equal to the
difference between such
amounts; and
``(bb) use existing
authorities under section
1857(g) and 1860D-12(b)(3)(E)
to impose civil monetary
penalties or take other
enforcement actions.
``(III) Application of civil
monetary penalties.--The provisions of
section 1128A (other than subsections
(a) and (b)) shall apply to a civil
monetary penalty under this clause in
the same manner as such provisions
apply to a penalty or proceeding under
section 1128A(a).
``(iv) Definitions.--In this subparagraph,
the terms `essential retail pharmacy',
`independent community pharmacy', and `total
reimbursement' have the meaning given those
terms in subparagraph (C)(v).''.
(b) Conforming Amendment.--Section 1857(g)(1) of the Social
Security Act (42 U.S.C. 1395w-27(g)(1)) is amended--
(1) in subparagraph (J), by striking ``or'' after the
semicolon;
(2) by redesignating subparagraph (K) as subparagraph (L);
(3) by inserting after subparagraph (J), the following new
subparagraph:
``(K) fails to comply with--
``(i) the standards for reasonable and
relevant contract terms and conditions under
subparagraph (A)(ii) of section 1860D-4(b)(1);
or
``(ii) the requirements for total
reimbursement for essential retail pharmacies
that are independent community pharmacies under
subparagraph (C)(v)(II) of such section; or'';
(4) in subparagraph (L), as redesignated by subparagraph
(B), by striking ``through (J)'' and inserting ``through (K)'';
and
(5) in the flush matter following subparagraph (L), as so
redesignated, by striking ``subparagraphs (A) through (K)'' and
inserting ``subparagraphs (A) through (L)''.
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