[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[S. 2052 Introduced in Senate (IS)]
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118th CONGRESS
1st Session
S. 2052
To amend title XVIII of the Social Security Act to enforce any willing
pharmacy requirements and establish safeguards to ensure patient access
to pharmacies in Medicare part D, and for other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
June 20, 2023
Mr. Tester (for himself, Mrs. Capito, Mr. Brown, and Mr. Lankford)
introduced the following bill; which was read twice and referred to the
Committee on Finance
_______________________________________________________________________
A BILL
To amend title XVIII of the Social Security Act to enforce any willing
pharmacy requirements and establish safeguards to ensure patient access
to pharmacies in 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. SHORT TITLE.
This Act may be cited as the ``Protect Patient Access to Pharmacies
Act''.
SEC. 2. ESTABLISHING SAFEGUARDS TO ENSURE FAIR MARKET COMPETITION FOR
PHARMACIES IN MEDICARE PART D.
Section 1860D-4(b)(1)(C) of the Social Security Act (42 U.S.C.
1395w-104(b)(1)(C)) is amended by adding at the end the following new
clauses:
``(v) Enforcing any willing provider
requirements to support patient choice of
pharmacy.--Not later than September 30, 2024,
the Secretary shall require that total payment
(including dispensing fees) by a PDP sponsor
offering a prescription drug plan or MA
organization offering an MA-PD plan for each
covered part D drug dispensed to an enrollee by
a network pharmacy (including specialty
pharmacies (as defined under section 1860D-
2(d)(4)(E))), net of any and all price
concessions, discounts, fees of any type,
incentive payments, or any other form of
remuneration, ensures that at a minimum, such
payment covers such pharmacy's costs to acquire
and to dispense each covered part D drug so
that such pharmacy may have the option to
participate as a network provider, which shall
include the ability to acquire and dispense
covered part D drugs and provide pharmacy
services necessary for dispensing such drugs.
In carrying out this clause, the Secretary
shall--
``(I) utilize pharmacy acquisition
cost data on each type of pharmacy for
each covered part D drug (excluding
drugs purchased under section 340B of
the Public Health Service Act) and cost
to dispense data from each type of
pharmacy (including pharmacies not
otherwise owned, controlled, or
affiliated with any other pharmacy,
plan, or pharmacy benefit manager);
``(II) establish payment parameters
for each covered part D drug that
considers how the drug is dispensed and
what pharmacy services are provided by
each type of pharmacy to support drug
management with the individual for whom
the drug is dispensed; and
``(III) establish an appeal process
in which the pharmacy may appeal
payment, in writing and with supporting
documentation, to the Medicare
Pharmaceutical and Technology Ombudsman
within 60 days following notification
of the payment or any adjustment of
such payment of such a drug, if a
network pharmacy believes that the
amount a PDP offering a prescription
drug plan or an MA organization
offering an MA-PD plan has paid for
such drug is below the pharmacy's
lowest actual acquisition and
dispensing costs of such drug.
``(vi) Utilization of pharmacy acquisition
cost data.--With respect to the requirement
under clause (v)(I) for the Secretary to
utilize pharmacy acquisition cost data--
``(I) the Secretary shall utilize
pharmacy acquisition cost data
described in section 1927(f), relating
to a survey of retail prices; and
``(II) for each covered part D drug
not included in the survey described in
section 1927(f), the Secretary shall
amend the survey or establish a
survey.''.
SEC. 3. ENSURING FAIR ASSESSMENT OF PHARMACY PERFORMANCE AND QUALITY.
Section 1860D-2(d) of the Social Security Act (42 U.S.C. 1395w-
102(d)) is amended--
(1) in paragraph (1)(B), by striking ``For purposes'' and
inserting ``Subject to paragraph (4), for purposes''; and
(2) by adding at the end the following new paragraph:
``(4) Application of pharmacy performance measures.--
``(A) Evaluation of pharmacy performance
measures.--Not later than 6 months after the date of
enactment of this Act, and annually thereafter, the
Secretary shall complete an evaluation of the
performance measures used by PDP sponsors offering
prescription drug plans and MA organizations offering
MA-PD plans to assess pharmacy price concessions or any
other fees based on performance, as established in
network pharmacy agreements. Each such evaluation shall
(to the extent practicable) include at least 5 years of
retrospective information to examine the following:
``(i) How measures are being applied to
pharmacies, including whether such measures are
applied based on the type of pharmacy
(including specialty pharmacy), drugs
dispensed, and pharmacy services used to
dispense and manage drugs.
``(ii) Whether, with respect to each such
measure, such measure results in anything of
value including any fees, pharmacy price
concessions, discounts, or incentives,
transferred to or received from a pharmacy by a
PDP sponsor offering a prescription drug plan
or MA organization offering an MA-PD plan after
the point-of-sale of a drug, broken down by
type of pharmacy and the drug dispensed.
``(iii) The extent to which each measure is
applied across prescription drug plans offered
by a PDP sponsor and MA-PD plans offered by an
MA organization and if such application is
uniform.
``(iv) How measures are applied and if they
are uniformly applied to all in-network types
of pharmacies or only certain pharmacies within
a network.
``(v) How and when pharmacies are provided
notice of measures, as well as methods and
actual data calculations used to evaluate
performance, and evaluation outcomes by type of
pharmacy.
``(vi) How pharmacy performance is
evaluated using such measures and the extent to
which the goals or targets are--
``(I) achievable at scale;
``(II) structured to improve
patient outcomes; and
``(III) reasonable in the context
of industry data regarding baseline
patient behavior, such as improved
patient outcomes and measure
performance.
``(B) Application of standardized pharmacy
performance measures.--For plan years beginning on or
after January 1, 2025, a PDP sponsor offering a
prescription drug plan or an MA organization offering
an MA-PD plan that makes incentive payments to a
pharmacy, or receives price concessions or any other
remuneration paid by a pharmacy, based on measures of
the performance or quality of work of the pharmacy,
shall, for the purposes of such incentive payments and
price concessions or fees with respect to covered part
D drugs dispensed by such pharmacy, only use measures--
``(i) on the most recently updated list
maintained by the Secretary under subparagraph
(C), as listed under clause (ii) of such
subparagraph; and
``(ii) that are relevant to the performance
of such pharmacy based on the type of pharmacy,
drugs dispensed, and pharmacy services used to
dispense and manage drugs.
``(C) Standardized pharmacy performance measures.--
``(i) In general.--Notwithstanding any
other provision of law, the Secretary shall,
taking into account evaluations under
subparagraph (A), establish or adopt from one
or more multi-stakeholder, neutral, consensus-
based measure development organizations
representing all types of pharmacies (including
pharmacies not otherwise owned, controlled, or
affiliated with any other pharmacy, plan, or
pharmacy benefit manager) standardized pharmacy
quality measures and performance criteria, such
as cut points, or any type of payment to be
used by a PDP sponsor offering a prescription
drug plan and an MA organization offering an
MA-PD plan for the purposes of determining
incentive payments and price concessions or
fees described in subparagraph (B). Such
measures shall be evidence-based, feasible,
appropriate, and achievable based on industry
data, and focus on pharmacy performance and
quality of care, as determined by the
Secretary, that the pharmacy can impact based
on covered part D drugs the pharmacy dispenses
and manages.
``(ii) Maintenance of list.--The Secretary
shall maintain a single list of measures
established or adopted under this subparagraph.
Such measures shall be evaluated and such list
updated on an ongoing basis through stakeholder
consensus organizations representing all types
of pharmacies as referenced in clause (i) to
ensure the measures on such list are evidence-
based, feasible, appropriate, and achievable.
Such list shall be published on a public
website not later than January 1, 2024, and
updated thereafter as appropriate as determined
by the Secretary.
``(D) Transparency to pharmacy.--For plan years
beginning on or after January 1, 2025, the Secretary
shall establish a uniform process under which a PDP
sponsor offering a prescription drug plan and an MA
organization offering an MA-PD plan shall promptly
disclose, upon receiving a claim for a covered part D
drug from a pharmacy, to such pharmacy all pricing
components related to such claim, including the Network
Reimbursement ID used to price the claim, any service
fees and other fees, pharmacy price concessions,
discounts, incentives or anything else of value to or
from the pharmacy.
``(E) Specialty pharmacy.--For purposes of this
subparagraph and section 1860D-4(b)(1)(C), not later
than December 31, 2024, the Secretary shall define the
term `specialty pharmacy' in consultation with all
relevant stakeholders.
``(F) Definitions.--For purposes of this
subparagraph:
``(i) Affiliated.--The term `affiliated'
means, with respect to a pharmacy, a PDP
sponsor offering a prescription drug plan, or
an MA organization offering an MA-PD plan, that
the pharmacy, PDP sponsor, or MA organization--
``(I) is directly or indirectly
through one or more intermediaries
wholly or partially owned by,
controlled by, or is under common
ownership of such pharmacy, PDP
sponsor, or MA organization; or
``(II) has a financial interest in
such pharmacy, PDP sponsor, or MA
organization.
``(ii) Type of pharmacy.--The term `type of
pharmacy' means any type of pharmacy licensed
by a State, including a retail pharmacy,
specialty pharmacy, and any other type of
pharmacy specified by the Secretary.''.
SEC. 4. ENCOURAGING USE OF PHARMACY PERFORMANCE MEASURES THROUGH
QUALITY RATINGS.
Section 1853(o)(4)(A) of the Social Security Act (42 U.S.C. 1395w-
23(o)(4)(A)) is amended--
(1) by striking ``determination.--The quality'' and
inserting determination.--
``(i) In general.--Subject to clause (ii),
the quality''; and
(2) by adding at the end the following new clause:
``(ii) Encouraging use of pharmacy
performance measures.--
``(I) In general.--In the case of a
plan described in subclause (II), with
respect to the determination of quality
ratings on or after January 1, 2024,
the Secretary shall provide for an
increase in the quality rating
otherwise determined under clause (i)
in a manner determined appropriate by
the Secretary.
``(II) Plan described.--For
purposes of subclause (I), a plan
described in this subclause is a
prescription drug plan offered by a PDP
sponsor or an MA-PD plan offered by an
MA organization that makes incentive
payments to a pharmacy, or receives
price concessions or any other
remuneration paid by a pharmacy, based
on measures of the performance or
quality of work of the pharmacy.''.
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