[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4317 Introduced in House (IH)]
<DOC>
119th CONGRESS
1st Session
H. R. 4317
To assure pharmacy access and choice for Medicare beneficiaries, and
for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
July 10, 2025
Mr. Carter of Georgia (for himself, Mrs. Dingell, Mr. Murphy, Ms. Ross,
Mr. Arrington, Mrs. Harshbarger, Mr. Vicente Gonzalez of Texas, Mr.
Allen, Mr. Krishnamoorthi, Mr. Rose, Mr. Tran, and Ms. Malliotakis)
introduced the following bill; which was referred to the Committee on
Energy and Commerce, and in addition to the Committees on Education and
Workforce, and 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 assure pharmacy access and choice for Medicare beneficiaries, 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 ``Pharmacy Benefit Manager Reform Act
of 2025'' or the ``PBM Reform Act of 2025''.
SEC. 2. ASSURING PHARMACY ACCESS AND CHOICE FOR MEDICARE BENEFICIARIES.
(a) In General.--Section 1860D-4(b)(1) of the Social Security Act
(42 U.S.C. 1395w-104(b)(1)) is amended by striking subparagraph (A) and
inserting the following:
``(A) In general.--
``(i) Participation of any willing
pharmacy.--A PDP sponsor offering a
prescription drug plan shall permit any
pharmacy that meets the standard contract terms
and conditions under such plan to participate
as a network pharmacy of such plan.
``(ii) Contract terms and conditions.--
``(I) In general.--Notwithstanding
any other provision of law, for plan
years beginning on or after January 1,
2029, in accordance with clause (i),
contract terms and conditions offered
by such PDP sponsor shall be reasonable
and relevant according to standards
established by the Secretary under
subclause (II).
``(II) Standards.--Not later than
the first Monday in April of 2028, the
Secretary shall establish standards for
reasonable and relevant contract terms
and conditions for purposes of this
clause.
``(III) Request for information.--
Not later than April 1, 2027, for
purposes of establishing the standards
under subclause (II), the Secretary
shall issue a request for information
to seek input on trends in prescription
drug plan and network pharmacy contract
terms and conditions, current
prescription drug plan and network
pharmacy contracting practices, whether
pharmacy reimbursement and dispensing
fees paid by PDP sponsors to network
pharmacies sufficiently cover the
ingredient and operational costs of
such pharmacies, the use and
application of pharmacy quality
measures by PDP sponsors for network
pharmacies, PDP sponsor restrictions or
limitations on the dispensing of
covered part D drugs by network
pharmacies (or any subsets of such
pharmacies), PDP sponsor auditing
practices for network pharmacies, areas
in current regulations or program
guidance related to contracting between
prescription drug plans and network
pharmacies requiring clarification or
additional specificity, factors for
consideration in determining the
reasonableness and relevance of
contract terms and conditions between
prescription drug plans and network
pharmacies, and other issues as
determined appropriate by the
Secretary.''.
(b) Essential Retail Pharmacies.--Section 1860D-42 of the Social
Security Act (42 U.S.C. 1395w-152) is amended by adding at the end the
following new subsection:
``(e) Essential Retail Pharmacies.--
``(1) In general.--With respect to plan years beginning on
or after January 1, 2028, the Secretary shall publish reports,
at least once every 2 years until 2034, and periodically
thereafter, that provide information, to the extent feasible,
on--
``(A) trends in ingredient cost reimbursement,
dispensing fees, incentive payments and other fees paid
by PDP sponsors offering prescription drug plans and MA
organizations offering MA-PD plans under this part to
essential retail pharmacies (as defined in paragraph
(2)) with respect to the dispensing of covered part D
drugs, including a comparison of such trends between
essential retail pharmacies and pharmacies that are not
essential retail pharmacies;
``(B) trends in amounts paid to PDP sponsors
offering prescription drug plans and MA organizations
offering MA-PD plans under this part by essential
retail pharmacies with respect to the dispensing of
covered part D drugs, including a comparison of such
trends between essential retail pharmacies and
pharmacies that are not essential retail pharmacies;
``(C) trends in essential retail pharmacy
participation in pharmacy networks and preferred
pharmacy networks for prescription drug plans offered
by PDP sponsors and MA-PD plans offered by MA
organizations under this part, including a comparison
of such trends between essential retail pharmacies and
pharmacies that are not essential retail pharmacies;
``(D) trends in the number of essential retail
pharmacies, including variation in such trends by
geographic region or other factors;
``(E) a comparison of cost-sharing for covered part
D drugs dispensed by essential retail pharmacies that
are network pharmacies for prescription drug plans
offered by PDP sponsors and MA-PD plans offered by MA
organizations under this part and cost-sharing for
covered part D drugs dispensed by other network
pharmacies for such plans located in similar geographic
areas that are not essential retail pharmacies;
``(F) a comparison of the volume of covered part D
drugs dispensed by essential retail pharmacies that are
network pharmacies for prescription drug plans offered
by PDP sponsors and MA-PD plans offered by MA
organizations under this part and such volume of
dispensing by network pharmacies for such plans located
in similar geographic areas that are not essential
retail pharmacies, including information on any
patterns or trends in such comparison specific to
certain types of covered part D drugs, such as generic
drugs or drugs specified as specialty drugs by a PDP
sponsor under a prescription drug plan or an MA
organization under an MA-PD plan; and
``(G) a comparison of the information described in
subparagraphs (A) through (F) between essential retail
pharmacies that are network pharmacies for prescription
drug plans offered by PDP sponsors under this part and
essential retail pharmacies that are network pharmacies
for MA-PD plans offered by MA organizations under this
part.
``(2) Definition of essential retail pharmacy.--In this
subsection, the term `essential retail pharmacy' means, with
respect to a plan year, a retail pharmacy that--
``(A) is not a pharmacy that is an affiliate as
defined in paragraph (4); and
``(B) is located in--
``(i) a medically underserved area (as
designated pursuant to section 330(b)(3)(A) of
the Public Health Service Act);
``(ii) a rural area in which there is no
other retail pharmacy within 10 miles, as
determined by the Secretary;
``(iii) a suburban area in which there is
no other retail pharmacy within 2 miles, as
determined by the Secretary; or
``(iv) an urban area in which there is no
other retail pharmacy within 1 mile, as
determined by the Secretary.
``(3) List of essential retail pharmacies.--
``(A) Publication of list of essential retail
pharmacies.--For each plan year (beginning with plan
year 2028), the Secretary shall publish, on a publicly
available internet website of the Centers for Medicare
& Medicaid Services, a list of pharmacies that meet the
criteria described in subparagraphs (A) and (B) of
paragraph (2) to be considered an essential retail
pharmacy.
``(B) Required submissions from pdp sponsors.--For
each plan year (beginning with plan year 2028), each
PDP sponsor offering a prescription drug plan and each
MA organization offering an MA-PD plan shall submit to
the Secretary, for the purposes of determining retail
pharmacies that meet the criterion specified in
subparagraph (A) of paragraph (2), a list of retail
pharmacies that are affiliates of such sponsor or
organization, or are affiliates of a pharmacy benefit
manager acting on behalf of such sponsor or
organization, at a time, and in a form and manner,
specified by the Secretary.
``(C) Reporting by pdp sponsors and ma
organizations.--For each plan year beginning with plan
year 2027, each PDP sponsor offering a prescription
drug plan and each MA organization offering an MA-PD
plan under this part shall submit to the Secretary
information on incentive payments and other fees paid
by such sponsor or organization to pharmacies, insofar
as any such payments or fees are not otherwise
reported, at a time, and in a form and manner,
specified by the Secretary.
``(D) Implementation.--Notwithstanding any other
provision of law, the Secretary may implement this
paragraph by program instruction or otherwise.
``(E) Nonapplication of paperwork reduction act.--
Chapter 35 of title 44, United States Code, shall not
apply to the implementation of this paragraph.
``(4) Definition of affiliate; pharmacy benefit manager.--
In this subsection, the terms `affiliate' and `pharmacy benefit
manager' have the meaning given those terms in section 1860D-
12(h)(7).''.
(c) Enforcement.--
(1) 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.--
``(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 to the Secretary an
allegation of a violation by a PDP
sponsor offering a prescription drug
plan of the standards for reasonable
and relevant contract terms and
conditions under subparagraph (A)(ii),
or of subclause (VIII) of this clause.
``(II) Frequency of submission.--
``(aa) In general.--Except
as provided in item (bb), the
allegation submission process
under this clause shall allow
pharmacies to submit any
allegations of violations
described in subclause (I) not
more frequently than once per
plan year per contract between
a pharmacy and a PDP sponsor.
``(bb) Allegations relating
to contract modifications.--In
the case where a contract
between a pharmacy and a PDP
sponsor is modified 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 modifications
with respect to such contract
and plan year.
``(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 a
standardized template for pharmacies to
use for the submission of allegations
described in subclause (I). 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.
``(VII) Rule of construction.--
Nothing in this clause shall be