[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8261 Introduced in House (IH)]
<DOC>
118th CONGRESS
2d Session
H. R. 8261
To amend title XVIII of the Social Security Act to extend certain
flexibilities and payment adjustments under the Medicare program, and
for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
May 7, 2024
Mr. Schweikert (for himself and Mr. Thompson of California) introduced
the following bill; which was referred to the Committee on Ways and
Means, and in addition to the Committee on Energy and Commerce, 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 extend certain
flexibilities and payment adjustments under the Medicare program, 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 ``Preserving Telehealth, Hospital, and
Ambulance Access Act''.
TITLE I--PRESERVING PATIENTS' ACCESS TO CARE IN THE HOME
SEC. 101. EXTENSION OF CERTAIN TELEHEALTH FLEXIBILITIES.
(a) Removing Geographic Requirements and Expanding Originating
Sites for Telehealth Services.--Section 1834(m) of the Social Security
Act (42 U.S.C. 1395m) is amended--
(1) in paragraph (2)(B)(iii), by striking ``ending December
31, 2024'' and inserting ``ending December 31, 2026''; and
(2) in paragraph (4)(C)(iii), by striking ``ending on
December 31, 2024'' and inserting ``ending on December 31,
2026''.
(b) Expanding Practitioners Eligible to Furnish Telehealth
Services.--Section 1834(m)(4)(E) of the Social Security Act (42 U.S.C.
1395m(m)(4)(E)) is amended by striking ``ending on December 31, 2024''
and inserting ``ending on December 31, 2026''.
(c) Extending Telehealth Services for Federally Qualified Health
Centers and Rural Health Clinics.--Section 1834(m)(8)(A) of the Social
Security Act (42 U.S.C. 1395m(m)(8)(A)) is amended by striking ``ending
on December 31, 2024'' and inserting ``ending on December 31, 2026''.
(d) Delaying the In-Person Requirements Under Medicare for Mental
Health Services Furnished Through Telehealth and Telecommunications
Technology.--
(1) Delay in requirements for mental health services
furnished through telehealth.--Section 1834(m)(7)(B)(i) of the
Social Security Act (42 U.S.C. 1395m(m)(7)(B)(i)) is amended,
in the matter preceding subclause (I), by striking ``on or
after'' and all that follows through ``described in section
1135(g)(1)(B))'' and inserting ``on or after January 1, 2027''.
(2) Mental health visits furnished by rural health
clinics.--Section 1834(y)(2) of the Social Security Act (42
U.S.C. 1395m(y)(2)) is amended by striking ``January 1, 2025''
and all that follows through the period at the end and
inserting ``January 1, 2027.''.
(3) Mental health visits furnished by federally qualified
health centers.--Section 1834(o)(4)(B) of the Social Security
Act (42 U.S.C. 1395m(o)(4)(B)) is amended by striking ``January
1, 2025'' and all that follows through the period at the end
and inserting ``January 1, 2027.''.
(e) Allowing for the Furnishing of Audio-Only Telehealth
Services.--Section 1834(m)(9) of the Social Security Act (42 U.S.C.
1395m(m)(9)) is amended by striking ``ending on December 31, 2024'' and
inserting ``ending on December 31, 2026''.
(f) Extending Use of Telehealth To Conduct Face-to-Face Encounter
Prior to Recertification of Eligibility for Hospice Care.--Section
1814(a)(7)(D)(i)(II) of the Social Security Act (42 U.S.C.
1395f(a)(7)(D)(i)(II)) is amended--
(1) by striking ``ending on December 31, 2024'' and
inserting ``ending on December 31, 2026''; and
(2) by inserting ``, except that this subclause shall not
apply in the case of such an encounter with an individual
occurring on or after January 1, 2025, if such individual is
located in an area that is subject to a moratorium on the
enrollment of hospice programs under this title pursuant to
section 1866(j)(7), if such individual is receiving hospice
care from a provider that is subject to enhanced oversight
under this title pursuant to section 1866(j)(3), or if such
encounter is performed by a hospice physician or nurse
practitioner who is not enrolled under section 1866(j) and is
not an opt-out physician or practitioner (as defined in section
1802(b)(6)(D))'' before the semicolon.
(g) Program Instruction Authority.--The Secretary of Health and
Human Services may implement the amendments made by this section
through program instruction or otherwise.
SEC. 102. GUIDANCE ON FURNISHING SERVICES VIA TELEHEALTH TO INDIVIDUALS
WITH LIMITED ENGLISH PROFICIENCY.
(a) In General.--Not later than 1 year after the date of the
enactment of this section, the Secretary of Health and Human Services,
in consultation with 1 or more entities from each of the categories
described in paragraphs (1) through (7) of subsection (b), shall issue
and disseminate, or update and revise as applicable, guidance for the
entities described in such subsection on the following:
(1) Best practices on facilitating and integrating use of
interpreters during a telemedicine appointment.
(2) Best practices on providing accessible instructions on
how to access telecommunications systems (as such term is used
for purposes of section 1834(m) of the Social Security Act (42
U.S.C. 1395m(m)) for individuals with limited English
proficiency.
(3) Best practices on improving access to digital patient
portals for individuals with limited English proficiency.
(4) Best practices on integrating the use of video
platforms that enable multi-person video calls furnished via a
telecommunications system for purposes of providing
interpretation during a telemedicine appointment for an
individual with limited English proficiency.
(5) Best practices for providing patient materials,
communications, and instructions in multiple languages,
including text message appointment reminders and prescription
information.
(b) Entities Described.--For purposes of subsection (a), an entity
described in this subsection is an entity in 1 or more of the following
categories:
(1) Health information technology service providers,
including--
(A) electronic medical record companies;
(B) remote patient monitoring companies; and
(C) telehealth or mobile health vendors and
companies.
(2) Health care providers, including--
(A) physicians; and
(B) hospitals.
(3) Health insurers.
(4) Language service companies.
(5) Interpreter or translator professional associations.
(6) Health and language services quality certification
organizations.
(7) Patient and consumer advocates, including such
advocates that work with individuals with limited English
proficiency.
SEC. 103. ESTABLISHMENT OF MODIFIER FOR RECERTIFICATIONS OF HOSPICE
CARE ELIGIBILITY CONDUCTED THROUGH TELEHEALTH.
Section 1814(a)(7)(D)(i)(II) of the Social Security Act (42 U.S.C.
1395f(a)(7)(D)(i)(II)), as amended by section 101(f), is further
amended by inserting ``, provided that, in the case of such an
encounter occurring on or after the date that is 2 years after the date
of the enactment of the `Preserving Telehealth, Hospital, and Ambulance
Access Act', such physician or nurse practitioner includes in any claim
for such encounter one or more modifiers or codes specified by the
Secretary to indicate that such encounter was furnished through
telehealth'' after ``as determined appropriate by the Secretary''.
SEC. 104. EXTENDING ACUTE HOSPITAL CARE AT HOME WAIVER FLEXIBILITIES.
Section 1866G of the Social Security Act (42 U.S.C. 1395cc-7) is
amended--
(1) in subsection (a)(1), by striking ``2024'' and
inserting ``2029''; and
(2) in subsection (b)--
(A) in the header, by striking ``Study and Report''
and inserting ``Studies and Reports'';
(B) in paragraph (1)--
(i) in the matter preceding subparagraph
(A), by striking ``The Secretary'' and
inserting ``Not later than September 30, 2024,
and again not later than September 30, 2028,
the Secretary'';
(ii) in clause (vi), by striking ``and'' at
the end;
(iii) in clause (vii), by striking the
period and inserting ``; and''; and
(iv) by adding at the end the following new
clause:
``(viii) in the case of the second study
conducted under this paragraph, the quality of
care, outcomes, costs, quantity and intensity
of services, and other relevant metrics between
individuals who entered into the Acute Hospital
Care at Home initiative directly from an
emergency department compared with individuals
who entered into the Acute Hospital Care at
Home initiative directly from an existing
inpatient stay in a hospital.''; and
(C) in paragraph (2)--
(i) in the header, by striking ``Report''
and inserting ``Reports''; and
(ii) by inserting ``and again not later
than September 30, 2028,'' after ``2024,''; and
(iii) by striking ``on the study conducted
under paragraph (1).'' and inserting the
following: ``on--
``(A) with respect to the first report submitted
under this paragraph, the first study conducted under
paragraph (1); and
``(B) with respect to the second report submitted
under this paragraph, the second study conducted under
paragraph (1).''.
SEC. 105. REPORT ON WEARABLE MEDICAL DEVICES.
Not later than 18 months after the date of the enactment of this
Act, the Comptroller General of the United States shall conduct a
technology assessment of, and submit to Congress a report on, the
capabilities and limitations of wearable medical devices used to
support clinical decision-making. Such report shall include a
description of--
(1) the potential for such devices to accurately prescribe
treatments;
(2) an examination of the benefits and challenges of
artificial intelligence to augment such capabilities; and
(3) policy options to enhance the benefits and mitigate
potential challenges of developing or using such devices.
SEC. 106. ENHANCING CERTAIN PROGRAM INTEGRITY REQUIREMENTS FOR DME
UNDER MEDICARE.
(a) Durable Medical Equipment.--Section 1834(a) of the Social
Security Act (42 U.S.C. 1395m(a)) is amended by adding at the end the
following new paragraph:
``(23) Master list inclusion and claim review for certain
items.--
``(A) Master list inclusion.--Beginning January 1,
2026, for purposes of the Master List described in
section 414.234(b) of title 42, Code of Federal
Regulations (or any successor regulation), an item for
which payment may be made under this subsection shall
be treated as having aberrant billing patterns (as such
term is used for purposes of such section) if the
Secretary determines that, without explanatory
contributing factors (such as furnishing emergent care
services), a substantial number of written orders for
such items under this subsection are from an ordering
physician or applicable practitioner with whom the
individual involved does not have a prior relationship,
as determined on the basis of prior payment experience.
``(B) Claim review.--With respect to items
furnished on or after January 1, 2026 that are included
on the Master List pursuant to subparagraph (A), if
such an item is not subject to a determination of
coverage in advance pursuant to paragraph (15)(C), the
Secretary may conduct prepayment review of claims for
payment for such item.''.
(b) Report on Identifying Clinical Diagnostic Laboratory Tests at
High Risk for Fraud and Effective Mitigation Measures.--Not later than
January 1, 2026, the Inspector General of the Department of Health and
Human Services shall submit to Congress a report assessing fraudulent
claims for clinical diagnostic laboratory tests for which payment may
be made under section 1834A of the Social Security Act (42 U.S.C.
1395m-1) and effective tools for reducing such fraudulent claims. The
report shall include--
(1) which, if any, clinical diagnostic laboratory tests are
identified as being at high risk of fraudulent claims, and an
analysis of the factors that contribute to such risk;
(2) with respect to a clinical diagnostic laboratory test
identified under subparagraph (A) as being at high risk of
fraudulent claims--
(A) the amount payable under such section 1834A
with respect to such test;
(B) the number of such tests furnished to
individuals enrolled under part B of title XVIII of the
Social Security Act (42 U.S.C. 1395j et seq.);
(C) whether an order for such a test was more
likely to come from a provider with whom the individual
involved did not have a prior relationship, as
determined on the basis of prior payment experience;
and
(D) the frequency with which a claim for payment
under such section 1834A included the payment modifier
identified by code 59 or 91; and
(3) suggested strategies for reducing the number of
fraudulent claims made with respect to tests so identified as
being at high risk, including--
(A) an analysis of whether the Centers for Medicare
& Medicaid Services can detect aberrant billing
patterns with respect to such tests in a timely manner;
(B) any strategies for identifying and monitoring
the providers who are outliers with respect to the
number of such tests that such providers order; and
(C) targeted education efforts to mitigate improper
billing for such tests.
TITLE II--SUSTAINING ACCESS TO HOSPITAL AND EMERGENCY SERVICES
SEC. 201. EXTENSION OF INCREASED INPATIENT HOSPITAL PAYMENT ADJUSTMENT
FOR CERTAIN LOW-VOLUME HOSPITALS.
(a) In General.--Section 1886(d)(12) of the Social Security Act (42
U.S.C. 1395ww(d)(12)) is amended--
(1) in subparagraph (B), by striking ``during the portion
of fiscal year 2025 beginning on January 1, 2025, and ending on
September 30, 2025, and'';
(2) in subparagraph (C)(i)--
(A) in the matter preceding subclause (I)--
(i) by striking ``or portion of a fiscal
year''; and
(ii) by striking ``2024 and the portion of
fiscal year 2025 beginning on October 1, 2024,
and ending on December 31, 2024'' and inserting
``2025'';
(B) in subclause (III), by striking ``2024 and the
portion of fiscal year 2025 beginning on October 1,
2024, and ending on December 31, 2024'' and inserting
``2025''; and
(C) in subclause (IV), by striking ``the portion of
fiscal year 2025 beginning on January 1, 2025, and
ending on September 30, 2025, and''; and
(3) in subparagraph (D)--
(A) in the matter preceding clause (i), by striking
``2024 or during the portion of fiscal year 2025
beginning on October 1, 2024, and ending on December
31, 2024'' and inserting ``2025''; and
(B) in clause (ii), by striking `` 2024 and the
portion of fiscal year 2025 beginning on October 1,
2024, and ending on December 31, 2024'' and inserting
``2025''.
(b) Implementation.--Notwithstanding any other provision of law,
the Secretary of Health and Human Services may implement the provisions
of, including the amendments made by, this section by program
instruction or otherwise.
SEC. 202. EXTENSION OF THE MEDICARE-DEPENDENT HOSPITAL PROGRAM.
(a) In General.--Section 1886(d)(5)(G) of the Social Security Act
(42 U.S.C. 1395ww(d)(5)(G)) is amended--
(1) in clause (i), by striking ``January 1, 2025'' and
inserting ``October 1, 2025''; and
(2) in clause (ii)(II), by striking ``January 1, 2025'' and
inserting ``October 1, 2025''.
(b) Conforming Amendments.--
(1) Extension of target amount.--Section 1886(b)(3)(D) of
the Social Security Act (42 U.S.C. 1395ww(b)(3)(D)) is
amended--
(A) in the matter preceding clause (i), by striking
``January 1, 2025'' and inserting ``October 1, 2025'';
and
(B) in clause (iv), by striking ``2024 and the
portion of fiscal year 2025 beginning on October 1,
2024, and ending on December 31, 2024'' and inserting
``2025''.
(2) Permitting hospitals to decline reclassification.--
Section 13501(e)(2) of the Omnibus Budget Reconciliation Act of
1993 (42 U.S.C. 1395ww note) is amended by striking ``2024, or
the portion of fiscal year 2025 beginning on October 1, 2024,
and ending on December 31, 2024'' and inserting ``2025''.
SEC. 203. EXTENSION OF ADD-ON PAYMENTS FOR AMBULANCE SERVICES.
(a) In General.--Section 1834(l) of the Social Security Act (42
U.S.C. 1395m(l)) is amended--
(1) in paragraph (12)(A), by striking ``January 1, 2025''
and inserting ``October 1, 2025''; and
(2) in paragraph (13), by striking ``January 1, 2025'' in
each place it appears and inserting ``October 1, 2025'' in each
such place.
(b) Program Instruction Authority.--Notwithstanding any other
provision of law, the Secretary of Health and Human Services may
implement the provisions of, including amendments made by, this section
through program instruction or otherwise.
TITLE III--OFFSETS
SEC. 301. REVISING PHASE-IN OF MEDICARE CLINICAL LABORATORY TEST
PAYMENT CHANGES.
(a) Revised Phase-In of Reductions From Private Payor Rate
Implementation.--Section 1834A(b)(3) of the Social Security Act (42
U.S.C. 1395m-1(b)(3)) is amended--
(1) in subparagraph (A), by striking ``2027'' and inserting
``2028''; and
(2) in subparagraph (B)--
(A) in clause (ii), by striking ``2024'' and
inserting ``2025''; and
(B) in clause (iii), by striking ``2025 through
2027'' and inserting ``2026 through 2028''.
(b) Revised Reporting Period for Reporting of Private Sector
Payment Rates for Establishment of Medicare Payment Rates.--Section
1834A(a)(1)(B) of the Social Security Act (42 U.S.C. 1395m-1(a)(1)(B))
is amended--
(1) in clause (i), by striking ``2024'' and inserting
``2025''; and
(2) in clause (ii), by striking ``2025'' each place it
appears and inserting ``2026''.
(c) Implementation.--The Secretary of Health and Human Services may
implement the amendments made by this section by program instruction or
otherwise.
SEC. 302. ARRANGEMENTS WITH PHARMACY BENEFIT MANAGERS WITH RESPECT TO
PRESCRIPTION DRUG PLANS AND MA-PD PLANS.
(a) In General.--
(1) Prescription drug plans.--Section 1860D-12 of the
Social Security Act (42 U.S.C. 1395w-112) is amended by adding
at the end the following new subsection:
``(h) Requirements Relating to Pharmacy Benefit Managers.--For plan
years beginning on or after January 1, 2027:
``(1) Agreements with pharmacy benefit managers.--Each
contract entered into with a PDP sponsor under this part with
respect to a prescription drug plan offered by such sponsor
shall provide that any pharmacy benefit manager acting on
behalf of such sponsor has a written agreement with the PDP
sponsor under which the pharmacy benefit manager, and any
affiliates of such pharmacy benefit manager, as applicable,
agree to meet the following requirements:
``(A) No income other than bona fide service
fees.--
``(i) In general.--The pharmacy benefit
manager and any affiliate of such pharmacy
benefit manager shall not derive any
remuneration with respect to any services
provided on behalf of any entity or individual,
in connection with the utilization of covered
part D drugs, from any such entity or
individual other than bona fide service fees,
subject to clauses (ii) and (iii).
``(ii) Incentive payments.--For the
purposes of this subsection, an incentive
payment paid by a PDP sponsor to a pharmacy
benefit manager that is performing services on
behalf of such sponsor shall be deemed a `bona
fide service fee'(even if such payment does not
otherwise meet the definition of such term
under paragraph (7)(B)) if such payment is a
flat dollar amount, is consistent with fair
market value (as specified by the Secretary),
is related to services actually performed by
the pharmacy benefit manager or affiliate of
such pharmacy benefit manager, on behalf of the
entity making such payment, in connection with
the utilization of covered part D drugs, and
meets additional requirements, if any, as
determined appropriate by the Secretary.
``(iii) Clarification on rebates and
discounts used to lower costs for covered part
d drugs.--Rebates, discounts, and other price
concessions received by a pharmacy benefit
manager or an affiliate of a pharmacy benefit
manager from manufacturers, even if such price
concessions are calculated as a percentage of a
drug's price, shall not be considered a
violation of the requirements of clause (i) if
they are fully passed through to a PDP sponsor
and are compliant with all regulatory and
subregulatory requirements related to direct
and indirect remuneration for manufacturer
rebates under this part, including in cases
where a PDP sponsor is acting as a pharmacy
benefit manager on behalf of a prescription
drug plan offered by such PDP sponsor.
``(iv) Evaluation of remuneration
arrangements.--Components of subsets of
remuneration arrangements (such as fees or
other forms of compensation paid to or retained
by the pharmacy benefit manager or affiliate of
such pharmacy benefit manager), as determined
appropriate by the Secretary, between pharmacy
benefit managers or affiliates of such pharmacy
benefit managers, as applicable, and other
entities involved in the dispensing or
utilization of covered part D drugs (including
PDP sponsors, manufacturers, pharmacies, and
other entities as determined appropriate by the
Secretary) shall be subject to review by the
Secretary, in consultation with the Office of
the Inspector General of the Department of
Health and Human Services, as determined
appropriate by the Secretary. The Secretary, in
consultation with the Office of the Inspector
General, shall review whether remuneration
under such arrangements is consistent with fair
market value (as specified by the Secretary)
through reviews and assessments of such
remuneration, as determined appropriate.
``(v) Disgorgement.--The pharmacy benefit
manager shall disgorge any remuneration paid to
such pharmacy benefit manager or an affiliate
of such pharmacy benefit manager in violation
of this subparagraph to the PDP sponsor.
``(vi) Additional requirements.--The
pharmacy benefit manager shall--
``(I) enter into a written
agreement with any affiliate of such
pharmacy benefit manager, under which
the affiliate shall identify and
disgorge any remuneration described in
clause (v) to the pharmacy benefit
manager; and
``(II) attest, subject to any
requirements determined appropriate by
the Secretary, that the pharmacy
benefit manager has entered into a
written agreement described in
subclause (I) with any relevant
affiliate of the pharmacy benefit
manager.
``(B) Transparency regarding guarantees and cost
performance evaluations.--The pharmacy benefit manager
shall--
``(i) define, interpret, and apply, in a
fully transparent and consistent manner for
purposes of calculating or otherwise evaluating
pharmacy benefit manager performance against
pricing guarantees or similar cost performance
measurements related to rebates, discounts,
price concessions, or net costs, terms such
as--
``(I) `generic drug', in a manner
consistent with the definition of the
term under section 423.4 of title 42,
Code of Federal Regulations, or a
successor regulation;
``(II) `brand name drug', in a
manner consistent with the definition
of the term under section 423.4 of
title 42, Code of Federal Regulations,
or a successor regulation;
``(III) `specialty drug';
``(IV) `rebate'; and
``(V) `discount';
``(ii) identify any drugs, claims, or price
concessions excluded from any pricing guarantee
or other cost performance calculation or
evaluation in a clear and consistent manner;
and
``(iii) where a pricing guarantee or other
cost performance measure is based on a pricing
benchmark other than the wholesale acquisition
cost (as defined in section 1847A(c)(6)(B)) of
a drug, calculate and provide a wholesale
acquisition cost-based equivalent to the
pricing guarantee or other cost performance
measure in the written agreement.
``(C) Provision of information.--
``(i) In general.--Not later than July 1 of
each year, beginning in 2027, the pharmacy
benefit manager shall submit to the PDP
sponsor, and to the Secretary, a report, in
accordance with this subparagraph, and shall
make such report available to such sponsor at
no cost to such sponsor in a format specified
by the Secretary under paragraph (5). Each such
report shall include, with respect to such PDP
sponsor and each plan offered by such sponsor,
the following information with respect to the
previous plan year:
``(I) A list of all drugs covered
by the plan that were dispensed
including, with respect to each such
drug--
``(aa) the brand name,
generic or non-proprietary
name, and National Drug Code;
``(bb) the number of plan
enrollees for whom the drug was
dispensed, the total number of
prescription claims for the
drug (including original
prescriptions and refills,
counted as separate claims),
and the total number of dosage
units of the drug dispensed;
``(cc) the number of
prescription claims described
in item (bb) by each type of
dispensing channel through
which the drug was dispensed,
including retail, mail order,
specialty pharmacy, long term
care pharmacy, home infusion
pharmacy, or other types of
pharmacies or providers;
``(dd) the average
wholesale acquisition cost,
listed as cost per day's
supply, cost per dosage unit,
and cost per typical course of
treatment (as applicable);
``(ee) the average
wholesale price for the drug,
listed as cost per day's
supply, cost per dosage unit,
and cost per typical course of
treatment (as applicable);
``(ff) the total out-of-
pocket spending by plan
enrollees on such drug after
application of any benefits
under the plan, including plan
enrollee spending through
copayments, coinsurance, and
deductibles;
``(gg) total rebates paid
by the manufacturer on the drug
as reported under the Detailed
DIR Report (or any successor
report) submitted by such
sponsor to the Centers for
Medicare & Medicaid Services;
``(hh) all other direct or
indirect remuneration on the
drug as reported under the
Detailed DIR Report (or any
successor report) submitted by
such sponsor to the Centers for
Medicare & Medicaid Services;
``(ii) the average pharmacy
reimbursement amount paid by
the plan for the drug in the
aggregate and disaggregated by
dispensing channel identified
in item (cc);
``(jj) the average National
Average Drug Acquisition Cost
(NADAC); and
``(kk) total manufacturer-
derived revenue, inclusive of
bona fide service fees,
attributable to the drug and
retained by the pharmacy
benefit manager and any
affiliate of such pharmacy
benefit manager.
``(II) In the case of a pharmacy
benefit manager that has an affiliate
that is a retail, mail order, or
specialty pharmacy, with respect to
drugs covered by such plan that were
dispensed, the following information:
``(aa) The percentage of
total prescriptions that were
dispensed by pharmacies that
are an affiliate of the
pharmacy benefit manager for
each drug.
``(bb) The interquartile
range of the total combined
costs paid by the plan and plan
enrollees, per dosage unit, per
course of treatment, per 30-day
supply, and per 90-day supply
for each drug dispensed by
pharmacies that are not an
affiliate of the pharmacy
benefit manager and that are
included in the pharmacy
network of such plan.
``(cc) The interquartile
range of the total combined
costs paid by the plan and plan
enrollees, per dosage unit, per
course of treatment, per 30-day
supply, and per 90-day supply
for each drug dispensed by
pharmacies that are an
affiliate of the pharmacy
benefit manager and that are
included in the pharmacy
network of such plan.
``(dd) The lowest total
combined cost paid by the plan
and plan enrollees, per dosage
unit, per course of treatment,
per 30-day supply, and per 90-
day supply, for each drug that
is available from any pharmacy
included in the pharmacy
network of such plan.
``(ee) The difference
between the average acquisition
cost of the affiliate, such as
a pharmacy or other entity that
acquires prescription drugs,
that initially acquires the
drug and the amount reported
under subclause (I)(jj) for
each drug.
``(ff) A list inclusive of
the brand name, generic or non-
proprietary name, and National
Drug Code of covered part D
drugs subject to an agreement
with a covered entity under
section 340B of the Public
Health Service Act for which
the pharmacy benefit manager or
an affiliate of the pharmacy
benefit manager had a contract
or other arrangement with such
a covered entity in the service
area of such plan.
``(III) Where a drug approved under
section 505(c) of the Federal Food,
Drug, and Cosmetic Act (referred to in
this subclause as the `listed drug') is
covered by the plan, the following
information:
``(aa) A list of currently
marketed generic drugs approved
under section 505(j) of the
Federal Food, Drug, and
Cosmetic Act pursuant to an
application that references
such listed drug that are not
covered by the plan, are
covered on the same formulary
tier or a formulary tier
typically associated with
higher cost-sharing than the
listed drug, or are subject to
utilization management that the
listed drug is not subject to.
``(bb) The estimated
average beneficiary cost-
sharing under the plan for a
30-day supply of the listed
drug.
``(cc) Where a generic drug
listed under item (aa) is on a
formulary tier typically
associated with higher cost-
sharing than the listed drug,
the estimated average cost-
sharing that a beneficiary
would have paid for a 30-day
supply of each of the generic
drugs described in item (aa),
had the plan provided coverage
for such drugs on the same
formulary tier as the listed
drug.
``(dd) A written
justification for providing
more favorable coverage of the
listed drug than the generic
drugs described in item (aa).
``(ee) The number of
currently marketed generic
drugs approved under section
505(j) of the Federal Food,
Drug, and Cosmetic Act pursuant
to an application that
references such listed drug.
``(IV) Where a reference product
(as defined in section 351(i) of the
Public Health Service Act) is covered
by the plan, the following information:
``(aa) A list of currently
marketed biosimilar biological
products licensed under section
351(k) of the Public Health
Service Act pursuant to an
application that refers to such
reference product that are not
covered by the plan, are
covered on the same formulary
tier or a formulary tier
typically associated with
higher cost-sharing than the
reference product, or are
subject to utilization
management that the reference
product is not subject to.
``(bb) The estimated
average beneficiary cost-
sharing under the plan for a
30-day supply of the reference
product.
``(cc) Where a biosimilar
biological product listed under
item (aa) is on a formulary
tier typically associated with
higher cost-sharing than the
listed drug, the estimated
average cost-sharing that a
beneficiary would have paid for
a 30-day supply of each of the
biosimilar biological products
described in item (aa), had the
plan provided coverage for such
products on the same formulary
tier as the reference product.
``(dd) A written
justification for providing
more favorable coverage of the
reference product than the
biosimilar biological product
described in item (aa).
``(ee) The number of
currently marketed biosimilar
biological products licensed
under section 351(k) of the
Public Health Service Act,
pursuant to an application that
refers to such reference
product.
``(V) Total gross spending on
covered part D drugs by the plan, not
net of rebates, fees, discounts, or
other direct or indirect remuneration.
``(VI) The total amount retained by
the pharmacy benefit manager or an
affiliate of such pharmacy benefit
manager in revenue related to
utilization of covered part D drugs
under that plan, inclusive of bona fide
service fees.
``(VII) The total spending on
covered part D drugs net of rebates,
fees, discounts, or other direct and
indirect remuneration by the plan.
``(VIII) An explanation of any
benefit design parameters under such
plan that encourage plan enrollees to
fill prescriptions at pharmacies that
are an affiliate of such pharmacy
benefit manager, such as mail and
specialty home delivery programs, and
retail and mail auto-refill programs.
``(IX) The following information:
``(aa) A list of all
brokers, consultants, advisors,
and auditors that receive
compensation from the pharmacy
benefit manager or an affiliate
of such pharmacy benefit
manager for referrals,
consulting, auditing, or other
services offered to PDP
sponsors related to pharmacy
benefit management services.
``(bb) The amount of
compensation provided by such
pharmacy benefit manager or
affiliate to each such broker,
consultant, advisor, and
auditor.
``(cc) The methodology for
calculating the amount of
compensation provided by such
pharmacy benefit manager or
affiliate, for each such
broker, consultant, advisor,
and auditor.
``(X) A list of all affiliates of
the pharmacy benefit manager.
``(XI) A summary document submitted
in a standardized template developed by
the Secretary that includes such
information described in subclauses (I)
through (X).
``(ii) Written explanation of contracts or
agreements with drug manufacturers.--
``(I) In general.--The pharmacy
benefit manager shall, not later than
30 days after the finalization of any
contract or agreement between such
pharmacy benefit manager or an
affiliate of such pharmacy benefit
manager and a drug manufacturer (or
subsidiary, agent, or entity affiliated
with such drug manufacturer) that makes
rebates, discounts, payments, or other
financial incentives related to one or
more covered part D drugs or other
prescription drugs, as applicable, of
the manufacturer directly or indirectly
contingent upon coverage, formulary
placement, or utilization management
conditions on any other covered part D
drugs or other prescription drugs, as
applicable, submit to the PDP sponsor a
written explanation of such contract or
agreement.
``(II) Requirements.--A written
explanation under subclause (I) shall--
``(aa) include the
manufacturer subject to the
contract or agreement, all
covered part D drugs and other
prescription drugs, as
applicable, subject to the
contract or agreement and the
manufacturers of such drugs,
and a high-level description of
the terms of such contract or
agreement and how such terms
apply to such drugs; and
``(bb) be certified by the
Chief Executive Officer, Chief
Financial Officer, or General
Counsel of such pharmacy
benefit manager, or affiliate
of such pharmacy benefit
manager, as applicable, or an
individual delegated with the
authority to sign on behalf of
one of these officers, who
reports directly to the
officer.
``(III) Definition of other
prescription drugs.--For purposes of
this clause, the term `other
prescription drugs' means prescription
drugs covered as supplemental benefits
under this part or prescription drugs
paid outside of this part.
``(D) Audit rights.--
``(i) In general.--Not less than once a
year, at the request of the PDP sponsor, the
pharmacy benefit manager shall allow for an
audit of the pharmacy benefit manager to ensure
compliance with all terms and conditions under
the written agreement and the accuracy of
information reported under subparagraph (C).
``(ii) Auditor.--The PDP sponsor shall have
the right to select an auditor. The pharmacy
benefit manager shall not impose any
limitations on the selection of such auditor.
``(iii) Provision of information.--The
pharmacy benefit manager shall make available
to such auditor all records, data, contracts,
and other information necessary to confirm the
accuracy of information provided under
subparagraph (C), subject to reasonable
restrictions on how such information must be
reported to prevent redisclosure of such
information.
``(iv) Timing.--The pharmacy benefit
manager must provide information under clause
(iii) and other information, data, and records
relevant to the audit to such auditor within 6
months of the initiation of the audit and
respond to requests for additional information
from such auditor within 30 days after the
request for additional information.
``(v) Information from affiliates.--The
pharmacy benefit manager shall be responsible
for providing to such auditor information
required to be reported under subparagraph (C)
that is owned or held by an affiliate of such
pharmacy benefit manager.
``(2) Enforcement.--
``(A) In general.--Each PDP sponsor shall--
``(i) disgorge to the Secretary any amounts
disgorged to the PDP sponsor by a pharmacy
benefit manager under paragraph (1)(A)(v);
``(ii) require, in a written agreement with
any pharmacy benefit manager acting on behalf
of such sponsor or affiliate of such pharmacy
benefit manager, that such pharmacy benefit
manager or affiliate reimburse the PDP sponsor
for any civil money penalty imposed on the PDP
sponsor as a result of the failure of the
pharmacy benefit manager or affiliate to meet
the requirements of paragraph (1) that are
applicable to the pharmacy benefit manager or
affiliate under the agreement; and
``(iii) require, in a written agreement
with any such pharmacy benefit manager acting
on behalf of such sponsor or affiliate of such
pharmacy benefit manager, that such pharmacy
benefit manager or affiliate be subject to
punitive remedies for breach of contract for
failure to comply with the requirements
applicable under paragraph (1).
``(B) Reporting of alleged violations.--The
Secretary shall make available and maintain a mechanism
for manufacturers, PDP sponsors, pharmacies, and other
entities that have contractual relationships with
pharmacy benefit managers or affiliates of such
pharmacy benefit managers to report, on a confidential
basis, alleged violations of paragraph (1)(A) or
subparagraph (C).
``(C) Anti-retaliation and anti-coercion.--
Consistent with applicable Federal or State law, a PDP
sponsor shall not--
``(i) retaliate against an individual or
entity for reporting an alleged violation under
subparagraph (B); or
``(ii) coerce, intimidate, threaten, or
interfere with the ability of an individual or
entity to report any such alleged violations.
``(3) Certification of compliance.--
``(A) In general.--Each PDP sponsor shall furnish
to the Secretary (in a time and manner specified by the
Secretary) an annual certification of compliance with
this subsection, as well as such information as the
Secretary determines necessary to carry out this
subsection.
``(B) Implementation.--Notwithstanding any other
provision of law, the Secretary may implement this
paragraph by program instruction or otherwise.
``(4) Rule of construction.--Nothing in this subsection
shall be construed as prohibiting payments related to
reimbursement for ingredient costs to any entity that acquires
prescription drugs, such as a pharmacy or wholesaler.
``(5) Standard formats.--
``(A) In general.--Not later than June 1, 2026, the
Secretary shall specify standard, machine-readable
formats for pharmacy benefit managers to submit annual
reports required under paragraph (1)(C)(i).
``(B) Implementation.--Notwithstanding any other
provision of law, the Secretary may implement this
paragraph by program instruction or otherwise.
``(6) Confidentiality.--
``(A) In general.--Information disclosed by a
pharmacy benefit manager, an affiliate of a pharmacy
benefit manager, a PDP sponsor, or a pharmacy under
this subsection that is not otherwise publicly
available or available for purchase shall not be
disclosed by the Secretary or a PDP sponsor receiving
the information, except that the Secretary may disclose
the information for the following purposes:
``(i) As the Secretary determines necessary
to carry out this part.
``(ii) To permit the Comptroller General to
review the information provided.
``(iii) To permit the Director of the
Congressional Budget Office to review the
information provided.
``(iv) To permit the Executive Director of
the Medicare Payment Advisory Commission to
review the information provided.
``(v) To the Attorney General for the
purposes of conducting oversight and
enforcement under this title.
``(vi) To the Inspector General of the
Department of Health and Human Services in
accordance with its authorities under the
Inspector General Act of 1978 (section 406 of
title 5, United States Code), and other
applicable statutes.
``(B) Restriction on use of information.--The
Secretary, the Comptroller General, the Director of the
Congressional Budget Office, and the Executive Director
of the Medicare Payment Advisory Commission shall not
report on or disclose information disclosed pursuant to
subparagraph (A) to the public in a manner that would
identify--
``(i) a specific pharmacy benefit manager,
affiliate, pharmacy, manufacturer, wholesaler,
PDP sponsor, or plan; or
``(ii) contract prices, rebates, discounts,
or other remuneration for specific drugs in a
manner that may allow the identification of
specific contracting parties or of such
specific drugs.
``(7) Definitions.--For purposes of this subsection:
``(A) Affiliate.--The term `affiliate' means any
entity that is owned by, controlled by, or related
under a common ownership structure with a pharmacy
benefit manager or PDP sponsor, or that acts as a
contractor or agent to such pharmacy benefit manager or
PDP sponsor, insofar as such contractor or agent
performs any of the functions described under
subparagraph (C).
``(B) Bona fide service fee.--The term `bona fide
service fee' means a fee that is reflective of the fair
market value (as specified by the Secretary) for a bona
fide, itemized service actually performed on behalf of
an entity, that the entity would otherwise perform (or
contract for) in the absence of the service arrangement
and that is not passed on in whole or in part to a
client or customer, whether or not the entity takes
title to the drug. Such fee must be a flat dollar
amount and shall not be directly or indirectly based
on, or contingent upon--
``(i) drug price, such as wholesale
acquisition cost or drug benchmark price (such
as average wholesale price);
``(ii) the amount of discounts, rebates,
fees, or other direct or indirect remuneration
with respect to covered part D drugs dispensed
to enrollees in a prescription drug plan,
except as permitted pursuant to paragraph
(1)(A)(ii);
``(iii) coverage or formulary placement
decisions or the volume or value of any
referrals or business generated between the
parties to the arrangement; or
``(iv) any other amounts or methodologies
prohibited by the Secretary.
``(C) Pharmacy benefit manager.--The term `pharmacy
benefit manager' means any person or entity that,
either directly or through an intermediary, acts as a
price negotiator or group purchaser on behalf of a PDP
sponsor or prescription drug plan, or manages the
prescription drug benefits provided by such sponsor or
plan, including the processing and payment of claims
for prescription drugs, the performance of drug
utilization review, the processing of drug prior
authorization requests, the adjudication of appeals or
grievances related to the prescription drug benefit,
contracting with network pharmacies, controlling the
cost of covered part D drugs, or the provision of
related services. Such term includes any person or
entity that carries out one or more of the activities
described in the preceding sentence, irrespective of
whether such person or entity calls itself a `pharmacy
benefit manager'.''.
(2) MA-PD plans.--Section 1857(f)(3) of the Social Security
Act (42 U.S.C. 1395w-27(f)(3)) is amended by adding at the end
the following new subparagraph:
``(F) Requirements relating to pharmacy benefit
managers.--For plan years beginning on or after January
1, 2027, section 1860D-12(h).''.
(3) Nonapplication of paperwork reduction act.--Chapter 35
of title 44, United States Code, shall not apply to the
implementation of this subsection.
(4) Funding.--
(A) Secretary.--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, $113,000,000 for fiscal year 2025, to
remain available until expended, to carry out this
subsection.
(B) OIG.--In addition to amounts otherwise
available, there is appropriated to the Inspector
General of the Department of Health and Human Services,
out of any money in the Treasury not otherwise
appropriated, $20,000,000 for fiscal year 2025, to
remain available until expended, to carry out this
subsection.
(b) GAO Study and Report on Certain Reporting Requirements.--
(1) Study.--The Comptroller General of the United States
(in this subsection referred to as the ``Comptroller General'')
shall conduct a study on Federal and State reporting
requirements for health plans and pharmacy benefit managers
related to the transparency of prescription drug costs and
prices. Such study shall include an analysis of the following:
(A) Federal statutory and regulatory reporting
requirements for health plans and pharmacy benefit
managers related to prescription drug costs and prices.
(B) Selected States' statutory and regulatory
reporting requirements for health plans and pharmacy
benefit managers related to prescription drug costs and
prices.
(C) The extent to which the statutory and
regulatory reporting requirements identified in
subparagraphs (A) and (B) overlap and conflict.
(D) The resources required by health plans and
pharmacy benefit managers to comply with the reporting
requirements described in subparagraphs (A) and (B).
(E) Other items determined appropriate by the
Comptroller General.
(2) Report.--Not later than 2 years after the date on which
information is first required to be reported under section
1860D-12(h)(1)(C) of the Social Security Act, as added by
subsection (a)(1), the Comptroller General shall submit to
Congress a report containing the results of the study conducted
under paragraph (1), together with recommendations for
legislation and administrative actions that would streamline
and reduce the burden associated with the reporting
requirements for health plans and pharmacy benefit managers
described in paragraph (1).
(c) MedPAC Reports on Agreements With Pharmacy Benefit Managers
With Respect to Prescription Drug Plans and MA-PD Plans.--The Medicare
Payment Advisory Commission shall submit to Congress the following
reports:
(1) Not later than March 31, 2028, a report regarding
agreements with pharmacy benefit managers with respect to
prescription drug plans and MA-PD plans. Such report shall
include--
(A) a description of trends and patterns, including
relevant averages, totals, and other figures for each
of the types of information submitted;
(B) an analysis of any differences in agreements
and their effects on plan enrollee out-of-pocket
spending and average pharmacy reimbursement, and any
other impacts; and
(C) any recommendations the Commission determines
appropriate.
(2) Not later than March 31, 2030, a report describing any
changes with respect to the information described in paragraph
(1) over time, together with any recommendations the Commission
determines appropriate.
SEC. 303. EXTENDING THE ADJUSTMENT TO THE CALCULATION OF HOSPICE CAP
AMOUNTS UNDER THE MEDICARE PROGRAM.
Section 1814(i)(2)(B) of the Social Security Act (42 U.S.C.
1395f(i)(2)(B)) is amended--
(1) in clause (ii), by striking ``2033'' and inserting
``2034''; and
(2) in clause (iii), by striking ``2033'' and inserting
``2034''.
<all>