[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5393 Introduced in House (IH)]
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118th CONGRESS
1st Session
H. R. 5393
To amend title XVIII of the Social Security Act to ensure fair
assessment of pharmacy performance and quality under Medicare part D,
and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
September 12, 2023
Mr. Griffith (for himself and Mr. Carter of Georgia) 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 ensure fair
assessment of pharmacy performance and quality under Medicare part D,
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. ENSURING FAIR ASSESSMENT OF PHARMACY PERFORMANCE AND QUALITY
UNDER MEDICARE PART D.
(a) Standardized Pharmacy Performance Measures.--Section 1860D-2 of
the Social Security Act (42 U.S.C. 1395w-102) is amended by adding at
the end the following new subsection:
``(f) Application of Standardized Pharmacy Performance Measures.--
``(1) Measures.--For plan years beginning on or after
January 1, 2025, a PDP sponsor offering a prescription drug
plan and an MA organization offering an MA-PD plan shall, for
purposes of incentive payments, price concessions, or any fees
or other remuneration paid or charged to a pharmacy based on
performance measures, only use measures that are--
``(A) established or adopted by the Secretary under
paragraph (2) and included on the list described in
subparagraph (B) of such paragraph; and
``(B) relevant to the performance of such pharmacy
based on the type of pharmacy (including retail, mail
order, specialty, long-term care, and home infusion or
other types of pharmacies), drugs dispensed, and
pharmacy services used to dispense and manage drugs.
``(2) Standardized pharmacy performance measures.--
``(A) Measures.--
``(i) In general .--Notwithstanding any
other provision of law, the Secretary shall
establish (or adopt pursuant to clause (iii))
standardized pharmacy performance measures to
be used by a PDP sponsor offering a
prescription drug plan and an MA organization
offering an MA-PD plan for the purpose of
determining incentive payments, price
concessions, or fees described in paragraph
(1).
``(ii) Requirements.--The measures under
clause (i) shall focus on pharmacy performance
and quality of care based on the type of
pharmacy, as determined by the Secretary. Such
measures shall be evidence-based, feasible,
appropriate and reasonable. The Secretary may
rely on data and information collected from
relevant stakeholders to make determinations
about whether a measure satisfies the
requirements of this clause.
``(iii) Adoption of measure.--In lieu of
establishing some or all of the measures under
this paragraph, the Secretary may adopt
measures and measure performance criteria that
are endorsed by 1 or more multi-stakeholder
consensus organizations (such as the Pharmacy
Quality Alliance), that has participation from
pharmacies (including retail and specialty
pharmacies not owned or affiliated with a plan,
pharmacy benefit manager, or other pharmacy),
health plans, pharmacy benefit managers, and
the Centers for Medicare & Medicaid Services.
Any measure adopted under this clause shall be
deemed to meet the requirements under clause
(ii).
``(B) Maintenance of list.--
``(i) In general.--The Secretary shall
maintain, and publish on a publicly available
internet website, a list of measures
established or adopted under this paragraph.
Such list shall initially be published no later
than June 1, 2024.
``(ii) Update.--The Secretary shall
periodically evaluate measures, measure
criteria, and how measures are applied by type
of pharmacy and update the measures on the list
under clause (i) to ensure such measures meet
the requirements under subparagraph (A)(ii).
``(3) OIG reports on pharmacy performance measures.--
``(A) OIG study.--The Office of the Inspector
General of the Department of Health and Human Services
(in this paragraph referred to as the `Inspector
General') shall conduct a study of the use of
performance measures and other quality-related
mechanisms in network pharmacy agreements and other
relevant contracting arrangements among PDP sponsors
offering a prescription drug plan, MA organizations
offering a MA-PD plan, pharmacy benefit managers acting
on behalf of such sponsors and organizations, and
network pharmacies. Such study may include audits,
reviews of relevant enforcement actions, consultation
with relevant stakeholders, and other activities
determined appropriate by the Inspector General,
consistent with other provisions of law. Such study
shall, to the extent feasible, include analysis of--
``(i) oversight and enforcement activities
undertaken with respect to current statutory
and regulatory requirements related to network
pharmacy agreements, including under sections
423.505(b)(18) and 423.505(i) of title 42 of
the Code of Federal Regulations (or any
successor regulation) and under section 1860D-
4(b)(1)(A);
``(ii) penalties or other corrective
actions imposed with respect to the
requirements described in clause (i);
``(iii) the prevalence of the application
of performance measures in network pharmacy
agreements, and the manner in which such
measures are applied, including variation based
on the type of pharmacy, the type of drug
dispensed, and the services required to manage
and dispense such drug;
``(iv) the extent to which the performance
measures and related criteria applied under
network agreements vary among similar types of
pharmacies within a single network, and the
extent to which the application of such
measures or criteria differ between
pharmacies--
``(I) affiliated with a pharmacy
benefit manager, a PDP sponsor offering
a prescription drug plan, or an MA
organization offering a MA-PD plan; and
``(II) those not affiliated with an
entity described in subclause (I);
``(v) patterns and trends in the
performance measures applied under pharmacy
network agreements, including if the measure is
being used in accordance with published measure
specifications which have been validated and
tested, if the measure is being used according
to licensing agreements with measure stewards,
and the level of attribution and attribution
criteria;
``(vi) the extent to which performance
measures result in incentive payments, fees,
price concessions, or other forms of
remuneration between pharmacies and PDP
sponsors or MA organizations (or pharmacy
benefit managers acting on their behalf),
including an analysis of which measures most
often result in incentive payments to
pharmacies (and the general amount of such
payments) and which measures most often result
in remuneration paid by pharmacies to other
entities (and the general amount of such
payments);
``(vii) variation in the type of
remuneration (as described in clause (vi)
resulting from the application of performance
measures, including between different types of
pharmacies, different types of drugs dispensed,
and affiliation status of pharmacies (as
described in clause (iv));
``(viii) when, in what manner, different
types of pharmacies receive notice of the
application of performance measures, the
measures that will be utilized, the performance
criteria that will be applied, and the data and
methodologies that will be used to evaluate
performance; and
``(ix) the extent to which the Centers for
Medicare & Medicaid Services has implemented
the pharmacy performance reporting requirements
of section 423.514(a)(5) of title 42, Code of
Federal Regulations, the extent to which PDP
sponsors or MA organizations (or pharmacy
benefit managers acting on their behalf) comply
with such provision, and the extent to which
the Centers for Medicare & Medicaid Services
has sought enforcement.
``(B) OIG reports.--
``(i) Report on initial findings.--Not
later than December 31, 2024, the Inspector
General shall submit a report to Congress
outlining, to the extent practicable, a status
update on the study under subparagraph (A),
together with initial findings with respect to
the issues included under such study. Such
report may include an analysis of barriers to
accessing any of the information required under
such study, along with recommendations for
addressing such barriers. Such report may also
include recommendations for the effective
implementation of the requirements enacted
under this subsection as well as existing
regulations, including section 423.514(a)(5) of
title 42, Code of Federal Regulations, along
with other recommendations, as determined
appropriate by the Inspector General.
``(ii) Interim report.--Not later than July
31, 2025, the Inspector General shall submit to
Congress an interim report on the study under
subparagraph (A), including additional
recommendations for the implementation of the
requirements enacted under this subsection as
well as under existing regulations, including
section 423.514(a)(5) of title 42, Code of
Federal Regulations.
``(iii) Final report.--Not later than
December 31, 2025, the Inspector General shall
submit to Congress a final report on the study
under subparagraph (A), together with
additional recommendations, as determined
appropriate by the Inspector General.
``(4) Nonapplication of paperwork reduction act.--Chapter
35 of title 44, United States Code, shall not apply to any data
collection undertaken by the Secretary under this paragraph.''.
(b) Funding.--In addition to amounts otherwise available, there is
appropriated to the Centers for Medicare & Medicaid Services Program
Management Account, out of any money in the Treasury not otherwise
appropriated, $4,000,000 for fiscal year 2025, to remain available
until expended, to carry out the amendment made by subsection (a).
SEC. 2. PROMOTING TRANSPARENCY FOR PHARMACIES UNDER MEDICARE PART D.
(a) Transparency for Pharmacies.--Section 1860D-2(f) of the Social
Security Act (42 U.S.C. 1395w-102(f)), as added by section 3, is
amended by adding at the end the following new paragraph:
``(3) Transparency for pharmacies.--
``(A) In general.--For plan years beginning on or
after January 1, 2025, a PDP sponsor offering a
prescription drug plan and an MA organization offering
an MA-PD plan, with respect to payment made by such PDP
sponsor or such MA organization to a pharmacy for a
covered part D drug dispensed by such pharmacy during a
plan year, shall promptly furnish, upon receiving a
claim for a covered Part D drug from a pharmacy, to
such pharmacy information related to such claim, such
as the Network Reimbursement ID, fees, pharmacy price
concessions, discounts, incentives, or any other forms
of remuneration that affect payment and pricing of the
claim.
``(B) Standardized format.--The PDP sponsor and the
MA organization shall furnish the information described
in subparagraph (A) in a standardized format (as
specified by the Secretary) that includes all fields
needed to price the claim for a covered part D drug
dispensed by such pharmacy.
``(C) Implementation.--The Secretary shall
implement this paragraph by program instruction or
other forms of program guidance.''.
(b) Funding.--In addition to amounts otherwise available, there is
appropriated to the Centers for Medicare & Medicaid Services Program
Management Account, out of any money in the Treasury not otherwise
appropriated, $2,000,000 for fiscal year 2025, to remain available
until expended, to carry out the amendment made by subsection (a).
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