[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3561 Introduced in House (IH)]
<DOC>
118th CONGRESS
1st Session
H. R. 3561
To promote hospital and insurer price transparency, and for other
purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
May 22, 2023
Mrs. Rodgers of Washington (for herself and Mr. Pallone) introduced the
following bill; which was referred to the Committee on Energy and
Commerce, and in addition to the Committees on Ways and Means, and
Education and the Workforce, 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 promote hospital and insurer price transparency, 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 ``Promoting Access to Treatments and
Increasing Extremely Needed Transparency Act of 2023'' or the ``PATIENT
Act of 2023''.
TITLE I--INCREASING PRICE TRANSPARENCY TO LOWER COSTS
SEC. 101. PRICE TRANSPARENCY REQUIREMENTS.
(a) In General.--Section 2718(e) of the Public Health Service Act
(42 U.S.C. 300gg-18(e)) is amended--
(1) by striking ``Each hospital'' and inserting the
following:
``(1) In general.--Each hospital'';
(2) by inserting ``, without subscription and free of
charge, in a single machine-readable file,'' after ``a list'';
(3) by inserting ``and a list, in plain language and
without subscription and free of charge, in a consumer-friendly
format, of the hospital's standard charges for as many of the
70 Centers for Medicare & Medicaid Services-specified shoppable
services that are provided by the hospital, and as many
additional hospital-selected shoppable services (or all such
additional services, if such hospital provides fewer than 300
shoppable services) as may be necessary for a combined total of
at least 300 shoppable services'' after ``Social Security
Act''; and
(4) by adding at the end the following: ``Such lists shall
be updated not less frequently than annually. Beginning January
1, 2024, each hospital shall include in its lists of standard
charges, along with such additional information as the
Secretary may require with respect to such charges for purposes
of promoting public awareness of hospital pricing in advance of
receiving a hospital item or service, the following:
``(A) A plain language description of each item or
service included on such list, including, as
applicable, the Healthcare Common Procedure Coding
System (HCPCS) code, the Diagnosis Related Group (DRG),
the National Drug Code (NDC), or other payer identifier
used or approved by the Centers for Medicare & Medicaid
Services for such item or service.
``(B) The gross charge, expressed as a dollar
amount, for each such item or service, when provided
in, as applicable, the hospital inpatient setting and
outpatient department setting.
``(C) Any current payer-specific negotiated
charges, clearly associated with the name of the third
party payer and plan and expressed as a dollar amount,
that applies to each such item or service when provided
in, as applicable, the hospital inpatient setting and
outpatient department setting.
``(D) The de-identified maximum and minimum
negotiated charges for each such item or service.
``(E) The discounted cash price, expressed as a
dollar amount, for each such item or service when
provided in, as applicable, the hospital inpatient
setting and outpatient department setting. If the
discounted cash price is a percentage of another value
provided, the calculated value must be entered as a
dollar amount. If the discounted cash price equates to
the gross charge, the gross charge shall be re-entered
to indicate that no cash discount is available.
``(2) Deemed compliance with shoppable services requirement
for certain years.--With respect to a year before 2025, a
hospital shall be deemed to meet the requirement of paragraph
(1) that such hospital make available a list of standard
charges for shoppable services if the hospital maintains an
internet-based price estimator tool that meets the following
requirements:
``(A) The tool provides estimates for as many of
the 70 Centers for Medicare & Medicaid Services
specified shoppable services that are provided by the
hospital, and as many additional hospital-selected
shoppable services (or all such additional services, if
such hospital provides fewer than 300 shoppable
services) as may be necessary for a combined total of
at least 300 shoppable services.
``(B) The tool allows health care consumers to, at
the time they use the tool, obtain an estimate of the
amount they will be obligated to pay the hospital for
the shoppable service.
``(C) The tool is prominently displayed on the
hospital's website and easily accessible to the public,
without subscription, fee, or having to submit personal
identifying information, and searchable by service
description, billing code, and payer.
The Secretary may not deem the establishment of an internet-
based price estimator tool that meets the requirements of this
paragraph to constitute compliance with the requirement of
paragraph (1) that such hospital make available a list of
standard charges for shoppable services for 2025 or a
subsequent year.
``(3) Uniform method and format.--Not later than January 1,
2025, the Secretary shall implement a standard, uniform method
and format for hospitals to use in order to satisfy the
requirements of this subsection for disclosing directly to the
public charge and price information. Such method and format may
be similar to any template established by the Centers for
Medicare & Medicaid Services as of the date of the enactment of
this paragraph for reporting such information under this
subsection and shall meet such standards as determined
appropriate by the Secretary.
``(4) Monitoring of pricing information.--The Secretary, in
consultation with the Inspector General of the Department of
Health and Human Services, shall, through notice and comment
rulemaking, establish a process to regularly monitor the
accuracy and validity of pricing information displayed by each
hospital pursuant to paragraph (1).
``(5) Definitions.--Notwithstanding any other provision of
law, for the purpose of paragraphs (1) and (2):
``(A) De-identified maximum negotiated charge.--The
term `de-identified maximum negotiated charge' means
the highest charge that a hospital has negotiated with
all third party payers for an item or service.
``(B) De-identified minimum negotiated charge.--The
term `de-identified minimum negotiated charge' means
the lowest charge that a hospital has negotiated with
all third party payers for an item or service.
``(C) Discounted cash price.--The term `discounted
cash price' means the charge that applies to an
individual who pays cash, or cash equivalent, for a
hospital item or service. Hospitals that do not offer
self-pay discounts may display the hospital's
undiscounted gross charges as found in the hospital
chargemaster.
``(D) Gross charge.--The term `gross charge' means
the charge for an individual item or service that is
reflected on a hospital's chargemaster, absent any
discounts.
``(E) Payer-specific negotiated charge.--The term
`payer-specific negotiated charge' means the charge
that a hospital has negotiated with a third party payer
for an item or service.
``(F) Shoppable service.--The term `shoppable
service' means a service that can be scheduled by a
health care consumer in advance.
``(G) Third party payer.--The term `third party
payer' means an entity that is, by statute, contract,
or agreement, legally responsible for payment of a
claim for a health care item or service.
``(6) Enforcement.--
``(A) In general.--In the case of a hospital that
fails to comply with this subsection--
``(i) the Secretary shall notify such
hospital of such failure not later than 30 days
after the date on which the Secretary
determines such failure exists; and
``(ii) not later than 45 days after the
date of such notification, the hospital shall
complete a corrective action plan to comply
with such requirements.
``(B) Civil monetary penalty.--
``(i) In general.--In addition to any other
enforcement actions or penalties that may apply
under subsection (b)(3) or another provision of
law, a hospital that has received a
notification under subparagraph (A)(i) and
fails to satisfy the requirement under
subparagraph (A)(ii) or otherwise comply with
the requirements of this subsection by the date
that is 90 days after such notification shall
be subject to a civil monetary penalty of an
amount--
``(I) in the case the hospital
provides not more than 30 beds (as
determined under section
180.90(c)(2)(ii)(D) of title 45, Code
of Federal Regulations, as in effect on
the date of the enactment of this
paragraph), not to exceed $300 per day
that the violation is ongoing as
determined by the Secretary; and
``(II) in the case the hospital
provides more than 30 beds (as so
determined), equal to--
``(aa) subject to item
(bb), $10 per bed per day that
the violation is ongoing as
determined by the Secretary,
but for violations occurring
before January 1, 2024, not to
exceed $5,500 per each such
day; or
``(bb) in the case such
hospital has failed to satisfy
the requirement under
subparagraph (A)(ii) or
otherwise comply with the
requirements of this subsection
for any continuous 1-year
period beginning on or after
January 1, 2024, and the amount
otherwise imposed under item
(aa) for such failure for such
period would be less than
$5,000,000, an amount not less
than $5,000,000.
``(ii) Increase authority.--In applying
this subparagraph with respect to violations
occurring in 2025 or a subsequent year, the
Secretary may through notice and comment
rulemaking increase any dollar amount applied
under this subparagraph by an amount specified
by the Secretary.
``(iii) Application of certain
provisions.--The provisions of section 1128A of
the Social Security Act (other than subsections
(a) and (b) of such section) shall apply to a
civil monetary penalty imposed under clause (i)
in the same manner as such provisions apply to
a civil monetary penalty imposed under
subsection (a) of such section.''.
(b) Publication of List of Hospitals.--
(1) List of hospitals.--Beginning not later than 90 days
after the date of enactment of this Act, the Secretary of
Health and Human Services (referred to in this section as the
``Secretary'') shall establish and maintain a publicly
available list on the website of the Centers for Medicare &
Medicaid Services of each hospital with respect to which the
Secretary has conducted a review of such hospital's compliance
with the provisions of section 2718(e) of the Public Health
Service Act (42 U.S.C. 300gg-18(e)). Such list shall include,
with respect to each such hospital that was noncompliant with
such provisions, a specification as to whether such hospital--
(A) has been issued a civil monetary penalty;
(B) has received a warning notice; or
(C) has submitted a corrective action plan.
(2) Additions and updates.--In the case of a hospital not
included on the list described in paragraph (1) as of the date
of the establishment of such list and that is subject to a
review of such hospital's compliance with the provisions
described in such paragraph after such date, the Secretary
shall add such hospital to such list, along with the
specifications described in such paragraph, not later than 1
business day after such review occurs. The Secretary shall
update such specifications with respect to any hospital
included on such list--
(A) not later than 1 business day after any
subsequent review of such hospital's compliance with
such provisions; and
(B) not later than 1 business day after any
penalty, notice, or request described in paragraph (1)
is made with respect to such hospital.
(3) FOIA requests.--Any penalty, notice, or request
described in paragraph (1) shall be subject to public
disclosure, in full and without redaction, under section 552 of
title 21, United States Code, notwithstanding any exemptions or
exclusions otherwise available under such section 552.
(4) Reports to congress.--Not later than 1 year after the
date of enactment of this Act and each year thereafter, the
Secretary of Health and Human Services shall submit to
Congress, and make publicly available, a report that contains
information regarding complaints of alleged violations of law
and enforcement activities by the Secretary under the hospital
price transparency rule implementing section 2718(e) of the
Public Health Service Act (42 U.S.C. 300gg-18(e)). Such report
shall be made available to the public on the website of the
Centers for Medicare & Medicaid Services. Each such report
shall include, with respect to the year involved--
(A) the number of compliance and enforcement
inquiries opened by the Secretary pursuant to such
section;
(B) the number of notices of noncompliance issued
by the Secretary based on such inquiries;
(C) the identity of each hospital entity that
received a notice of noncompliance and the nature of
the failure giving rise to the Secretary's
determination of noncompliance;
(D) the amount of civil monetary penalty assessed
against the hospital entity;
(E) whether the hospital entity subsequently
corrected the noncompliance; and
(F) an analysis of factors contributing to
increasing health care costs.
(5) GAO report.--Not later than 1 year after the date of
enactment of this Act, the Comptroller General of the United
States shall submit to the Committee on Energy and Commerce of
the House of Representatives and the Committee on Health,
Education, Labor, and Pensions of the Senate a report on the
compliance and enforcement with the hospital price transparency
rule implementing section 2718(e) of the Public Health Service
Act (42 U.S.C. 300gg-18(e)). The report shall include
recommendations related to--
(A) improving price transparency to patients,
employers, and the public; and
(B) increased civil monetary penalty amounts to
ensure compliance.
(6) Request for information.--Not later than January 1,
2025, the Secretary of Health and Human Services shall issue a
public request for information as to the best method through
which hospitals may be required to publish quality data (such
as data required to be reported under the Medicare Hospital
Compare program) alongside data required to be reported under
section 2718(e) of the Public Health Service Act (42 U.S.C.
300gg-18(e)).
(c) Ensuring Accessibility Through Implementation.--In implementing
the amendments made by this section, the Secretary of Health and Human
Services shall through rulemaking ensure that a hospital submitting
charges and information pursuant to such amendments takes reasonable
steps (as specified by the Secretary) to ensure the accessibility of
such charges and information to individuals with limited English
proficiency. Such steps may include the hospital's provision of
interpretation services or the hospital's provision of translations of
charges and information.
SEC. 102. STRENGTHENING HEALTH INSURER TRANSPARENCY REQUIREMENTS.
(a) Transparency in Coverage.--Section 1311(e)(3)(C) of the Patient
Protection and Affordable Care Act (42 U.S.C. 18031(e)(3)(C)) is
amended--
(1) by striking ``The Exchange'' and inserting the
following:
``(i) In general.--The Exchange'';
(2) in clause (i), as inserted by paragraph (1)--
(A) by striking ``participating provider'' and
inserting ``provider'';
(B) by inserting ``shall include the information
specified in clause (ii) and'' after ``such
information'';
(C) by striking ``an Internet website'' and
inserting ``a self-service tool that meets the
requirements of clause (iii)''; and
(D) by striking ``and such other'' and all that
follows through the period and inserting ``or, at the
option such individual, through a paper or phone
disclosure (as selected by such individual and provided
at no cost to such individual) that meets such
requirements as the Secretary may specify.''; and
(3) by adding at the end the following new clauses:
``(ii) Specified information.--For purposes
of clause (i), the information specified in
this clause is, with respect to an item or
service for which benefits are available under
a health plan furnished by a health care
provider, the following:
``(I) If such provider is a
participating provider with respect to
such item or service, the in-network
rate (as defined in subparagraph (F))
for such item or service.
``(II) If such provider is not
described in subclause (I), the maximum
allowed amount for such item or
service.
``(III) The amount of cost sharing
(including deductibles, copayments, and
coinsurance) that the individual will
incur for such item or service (which,
in the case such item or service is to
be furnished by a provider described in
subclause (II), shall be calculated
using the maximum amount described in
such subclause).
``(IV) The amount the individual
has already accumulated with respect to
any deductible or out of pocket maximum
under the plan (broken down, in the
case separate deductibles or maximums
apply to separate individuals enrolled
in the plan, by such separate
deductibles or maximums, in addition to
any cumulative deductible or maximum).
``(V) In the case such plan imposes
any frequency or volume limitations
with respect to such item or service
(excluding medical necessity
determinations), the amount that such
individual has accrued towards such
limitation with respect to such item or
service.
``(VI) Any prior authorization,
concurrent review, step therapy, fail
first, or similar requirements
applicable to coverage of such item or
service under such plan.
``(iii) Self-service tool.--For purposes of
clause (i), a self-service tool established by
a health plan meets the requirements of this
clause if such tool--
``(I) is based on an internet
website;
``(II) provides for real-time
responses to requests described in such
clause;
``(III) is updated in a manner such
that information provided through such
tool is timely and accurate;
``(IV) allows such a request to be
made with respect to an item or service
furnished by--
``(aa) a specific provider
that is a participating
provider with respect to such
item or service;
``(bb) all providers that
are participating providers
with respect to such plan and
such item or service; or
``(cc) a provider that is
not described in item (bb); and
``(V) provides that such a request
may be made with respect to an item or
service through use of the billing code
for such item or service or through use
of a descriptive term for such item or
service.
The Secretary may require such tool, as a
condition of complying with subclause (V), to
link multiple billing codes to a single
descriptive term if the Secretary determines
that the billing codes to be so linked
correspond to items and services.''.
(b) Disclosure of Additional Information.--Section 1311(e)(3) of
the Patient Protection and Affordable Care Act (42 U.S.C. 18031(e)(3))
is amended by adding at the end the following new subparagraphs:
``(E) Rate and payment information.--
``(i) In general.--Not later than January
1, 2025, and every 3 months thereafter, each
health plan shall submit to the Exchange, the
Secretary, the State insurance commissioner,
and make available to the public, the rate and
payment information described in clause (ii) in
accordance with clause (iii).
``(ii) Rate and payment information
described.--For purposes of clause (i), the
rate and payment information described in this
clause is, with respect to a health plan, the
following:
``(I) With respect to each item or
service for which benefits are
available under such plan, the in-
network rate in effect as of the date
of the submission of such information
with each provider (identified by
national provider identifier) that is a
participating provider with respect to
such item or service, other than such a
rate in effect with a provider that,
during the 1-year period ending on such
date, submitted fewer than 10 claims
for such item or service to such plan.
``(II) With respect to each drug
(identified by national drug code) for
which benefits are available under such
plan, the average amount paid by such
plan (net of rebates, discounts, and
price concessions) for such drug
dispensed or administered during the
90-day period beginning 180 days before
such date of submission to each
provider that was a participating
provider with respect to such drug,
broken down by each such provider
(identified by national provider
identifier), other than such an amount
paid to a provider that, during such
period, submitted fewer than 20 claims
for such drug to such plan.
``(III) With respect to each item
or service for which benefits are
available under such plan, the amount
billed, and the amount allowed by the
plan, for each such item or service
furnished during the 90-day period
specified in subclause (II) by a
provider that was not a participating
provider with respect to such item or
service, broken down by each such
provider (identified by national
provider identifier), other than items
and services with respect to which
fewer than 20 claims for such item or
service were submitted to such plan
during such period.
``(iii) Manner of submission.--Rate and
payment information required to be submitted
and made available under this subparagraph
shall be so submitted and so made available in
3 separate machine-readable files corresponding
to the information described in each of
subclauses (I) through (III) of clause (ii)
that meet such requirements as specified by the
Secretary through rulemaking. Such requirements
shall ensure that such files are limited to an
appropriate size, are made available in a
widely-available format that allows for
information contained in such files to be
compared across health plans, and are
accessible to individuals at no cost and
without the need to establish a user account or
provider other credentials.
``(iv) User guide.--Each health plan shall
make available to the public instructions
written in plain language explaining how
individuals may search for information
described in clause (ii) in files submitted in
accordance with clause (iii).
``(F) Definitions.--In this paragraph:
``(i) Participating provider.--The term
`participating provider' has the meaning given
such term in section 2799A-1 of the Public
Health Service Act.
``(ii) In-network rate.--The term `in-
network rate' means, with respect to a health
plan and an item or service furnished by a
provider that is a participating provider with
respect to such plan and item or service, the
contracted rate in effect between such plan and
such provider for such item or service.''.
(c) Reports.--
(1) Compliance.--Not later than January 1, 2025, the
Comptroller General of the United States shall submit to
Congress a report containing--
(A) an analysis of health plan compliance with the
amendments made by this section;
(B) an analysis of enforcement of such amendments
by the Secretaries of Health and Human Services, Labor,
and the Treasury;
(C) recommendations relating to improving such
enforcement; and
(D) recommendations relating to improving public
disclosure, and public awareness, of information
required to be made available by such plans pursuant to
such amendments.
(2) Prices.--Not later than January 1, 2028, the
Comptroller General of the United States shall submit to
Congress a report containing an assessment of differences in
negotiated prices (and any trends in such prices) in the
private market between--
(A) rural and urban areas;
(B) the individual, small group, and large group
markets;
(C) consolidated and nonconsolidated health care
provider areas (as specified by the Secretary);
(D) nonprofit and for-profit hospitals;
(E) nonprofit and for-profit insurers; and
(F) insurers serving local or regional areas and
insurers serving multistate or national areas.
(d) Ensuring Accessibility Through Implementation.--In implementing
the amendments made by this section, the Secretary shall through
rulemaking ensure that any entity making available information pursuant
to such amendments takes reasonable steps (as specified by the
Secretary) to ensure the accessibility of such to individuals with
limited English proficiency. Such steps may include the entity's
provision of interpretation services or of translations of such
information.
(e) Effective Date.--
(1) In general.--The amendments made by subsection (a)
shall apply beginning January 1, 2025.
(2) Continued applicability of rules for previous years.--
Nothing in the amendments made by this section may be construed
as affecting the applicability of the rule entitled
``Transparency in Coverage'' published by the Department of the
Treasury, the Department of Labor, and the Department of Health
and Human Services on November 12, 2020 (85 Fed. Reg. 72158)
before January 1, 2025.
SEC. 103. REQUIRING A SEPARATE IDENTIFICATION NUMBER AND AN ATTESTATION
FOR EACH OFF-CAMPUS OUTPATIENT DEPARTMENT OF A PROVIDER.
Section 1833(t) of the Social Security Act (42 U.S.C. 1395l(t)) is
amended by adding at the end the following new paragraph:
``(23) Use of unique health identifiers; attestation.--
``(A) In general.--No payment may be made under
this subsection (or under an applicable payment system
pursuant to paragraph (21)) for items and services
furnished on or after January 1, 2026, by an off-campus
outpatient department of a provider (as defined in
subparagraph (C)) unless--
``(i) such department has obtained, and
such items and services are billed under, a
standard unique health identifier for health
care providers (as described in section
1173(b)) that is separate from such identifier
for such provider; and
``(ii) such provider has submitted to the
Secretary, during the 2-year period ending on
the date such items and services are so
furnished, an attestation that such department
is compliant with the requirements described in
section 413.65 of title 42, Code of Federal
Regulations (or a successor regulation).
``(B) Process for submission and review.--Not later
than 1 year after the date of enactment of this
paragraph, the Secretary shall, through notice and
comment rulemaking, establish a process for each
provider with an off-campus outpatient department of a
provider to submit an attestation pursuant to
subparagraph (A)(ii), and for the Secretary to review
each such attestation and determine, through site
visits or through remote audits (as determined
appropriate by the Secretary), whether such department
is compliant with the requirements described in such
subparagraph.
``(C) Off-campus outpatient department of a
provider defined.--For purposes of this paragraph, the
term `off-campus outpatient department of a provider'
means a department of a provider (as defined in section
413.65 of title 42, Code of Federal Regulations, or any
successor regulation) that is not located--
``(i) on the campus (as defined in such
section) of such provider; or
``(ii) within the distance (described in
such definition of campus) from a remote
location of a hospital facility (as defined in
such section).''.
SEC. 104. MANDATORY REPORTING WITH RESPECT TO CERTAIN HEALTH-RELATED
OWNERSHIP INFORMATION.
Part A of title XI of the Social Security Act (42 U.S.C. 1301 et
seq.) is amended by adding at the end the following new section:
``SEC. 1150D. MANDATORY REPORTING WITH RESPECT TO CERTAIN HEALTH-
RELATED OWNERSHIP INFORMATION.
``(a) Mandatory Reporting With Respect Certain Health-Related
Ownership Information.--
``(1) Initial report.--Not later than January 1, 2025 (or
in the case of a specified entity formed after January 1, 2025,
within 60 days of becoming a specified entity), each specified
entity (as defined in subsection (f)(5)) shall submit to the
Secretary, in a form and manner specified by the Secretary, a
report containing the following information:
``(A) Data on mergers, acquisitions, and changes in
ownership with respect to such specified entity for the
previous 1-year period.
``(B) In the case that a specified entity is, or
includes, a hospital, the additional information
described in subsection (b).
``(C) As applicable, the name, address, and
business structure of the parent company of such
specified entity (including the tax status of such
parent company), as of the date of the submission of
this report.
``(D) Any other information with respect to
ownership of a specified entity, as determined by the
Secretary.
``(2) Subsequent reports.--Not later than 1 year after
submitting the report under paragraph (1), and annually
thereafter, each specified entity shall submit to the Secretary
an updated report, including--
``(A)(i) data on mergers, acquisitions, and changes
in ownership with respect to such entities for the
previous 1-year period; and
``(ii) any other information with respect
to ownership of a specified entity, as
determined by the Secretary; and
``(B) in the case that a specified entity is, or
includes, a hospital, the additional information
described in subsection (b).
``(b) Additional Information Submitted by Certain Specified
Entities.--For purposes of paragraphs (1)(B) and (2)(B) of subsection
(a), with respect to a specified entity that is, or includes, a
hospital, the information described in this subsection is the following
information with respect to the previous 1-year period:
``(1) The business structure of the specified entity,
including the business type and the tax status of such entity.
``(2) The average debt-to-earnings ratio of the specified
entity.
``(3) The average amount of debt incurred--
``(A) by the hospital; and
``(B) by the entire specified entity.
``(4) Information with respect to real estate leases and
purchases for property used, or intended to be used, to furnish
or otherwise support the provision of health care services.
``(5) In the case of a non-profit hospital, a subsidiary of
a non-profit hospital, or a 501(c)(3) entity that shares common
ownership with a non-profit hospital, capital gains investments
(disaggregated by the type of investment) and any taxes paid on
such gains from such investments.
``(6) As applicable, information with respect to the parent
company of such specified entity.
``(c) Public Reporting.--Not later than January 1, 2027, and
annually thereafter, the Secretary shall post on a publicly available
website of the Department of Health and Human Services a report with
respect to the previous 1-year period, including--
``(1) the number of specified entities reporting for such
year, disaggregated by the business structure of each specified
entity;
``(2) the number of owners of each specified entity;
``(3) any change in ownership for each specified entity;
``(4) any change in the tax status of a specified entity;
``(5) an analysis of trends in horizontal and vertical
consolidation, disaggregated by business structure and provider
type; and
``(6) as applicable, the name, address, and business
structure of the parent company of such specified entity
(including the business type and the tax status of such parent
company).
``(d) Audits.--The Secretary shall conduct an annual audit
consisting of a random sample of specified entities to verify
compliance with the requirements of this section and the accuracy of
information submitted pursuant to this section.
``(e) Penalty for Failure To Report.--If a specified entity fails
to provide a complete report under subsection (a), or submits a report
containing false information, such entity shall be subject to a civil
monetary penalty of not more than $5,000,000 for each such report not
provided or containing false information. Such penalty shall be imposed
and collected in the same manner as civil money penalties under
subsection (a) of section 1128A are imposed and collected under that
section.
``(f) Inapplicability of Paperwork Reduction Act.--Chapter 35 of
title 44, United States Code, shall not apply to collections of
information made under this section.
``(g) Definitions.--In this section:
``(1) Health plan.--The term `health plan' has the meaning
given such term in section 1128C(c).
``(2) Hospital.--The term `hospital' has the meaning given
such term in section 1861(e).
``(3) Independent freestanding emergency department.--The
term `independent freestanding emergency department' has the
meaning given such term in section 2799A-1(a)(3)(D) of the
Public Health Service Act.
``(4) Private equity company.--The term `private equity
company' means a publicly-traded or non-publicly traded company
that collects capital investments from individuals or entities
and purchases an ownership share of a provider of services (as
defined in section 1861(u)).
``(5) Specified entity.--The term `specified entity'
means--
``(A) a hospital;
``(B) a physician-owned physician practice with
more than 25 physicians for a year;
``(C) a physician practice owned by a hospital, a
health plan, a private equity company, or a venture
capital firm;
``(D) an ambulatory surgical center meeting the
standards specified under section 1832(a)(2)(F)(i); or
``(E) an independent freestanding emergency
department.
``(6) Venture capital fund.--The term `venture capital
fund' has the meaning given such term in section 275.203(l)-1
of title 17, Code of Federal Regulations.''.
SEC. 105. INCREASING PRICE TRANSPARENCY OF CLINICAL DIAGNOSTIC
LABORATORY TESTS UNDER THE MEDICARE PROGRAM.
Section 1846 of the Social Security Act (42 U.S.C. 1395w-2) is
amended--
(1) in the header, by inserting ``and additional
requirements'' after ``sanctions''; and
(2) by adding at the end the following new subsection:
``(c) Price Transparency Requirement.--
``(1) In general.--Beginning January 1, 2025, each provider
of services or supplier that is available to furnish any
specified clinical diagnostic laboratory test under this title
shall--
``(A) make publicly available on an internet
website the information described in paragraph (2) with
respect to each such specified clinical diagnostic
laboratory test that such provider or supplier is so
available to furnish; and
``(B) ensure that such information is updated not
less frequently than annually.
``(2) Information described.--For purposes of paragraph
(1), the information described in this paragraph is, with
respect to a provider of services or supplier and a specified
clinical diagnostic laboratory test, the following:
``(A) The discounted cash price for such test (or,
if no such price exists, the gross charge for such
test).
``(B) The deidentified minimum negotiated rate in
effect between such provider or supplier and any group
health plan or group or individual health insurance
coverage for such test.
``(C) The deidentified maximum negotiated rate in
effect between such provider or supplier and any such
plan or coverage for such test.
``(3) Inclusion of ancillary services.--Any price or rate
for a specified clinical diagnostic laboratory test available
to be furnished by a provider of services or supplier made
publicly available in accordance with paragraph (1) shall
include the price or rate (as applicable) for any ancillary
item or service (such as specimen collection services) that
would normally be furnished by such provider or supplier as
part of such test, as specified by the Secretary.
``(4) Enforcement.--
``(A) In general.--In the case that the Secretary
determines that a provider of services or supplier is
not in compliance with paragraph (1)--
``(i) not later than 30 days after such
determination, the Secretary shall notify such
provider or supplier of such determination;
``(ii) not later than 90 days after such
notification is sent, such provider or supplier
shall complete a corrective action plan to
comply with such paragraph and submit such plan
to the Secretary; and
``(iii) if such provider or supplier
continues to fail to comply with such paragraph
after the date that is 90 days after such
notification is sent, the Secretary may impose
a civil monetary penalty in an amount not to
exceed $300 for each day (beginning with the
date that is 91 days after such notification
was sent) during which such failure is ongoing.
``(B) Application of certain provisions.--The
provisions of section 1128A (other than subsections (a)
and (b) of such section) shall apply to a civil
monetary penalty imposed under this paragraph in the
same manner as such provisions apply to a civil
monetary penalty imposed under subsection (a) of such
section.
``(5) Definitions.--In this subsection:
``(A) Group health plan; group health insurance
coverage; individual health insurance coverage.--The
terms `group health plan', `group health insurance
coverage', and `individual health insurance coverage'
have the meaning given such terms in section 2791 of
the Public Health Service Act.
``(B) Specified clinical diagnostic laboratory
test.--the term `specified clinical diagnostic
laboratory test' means a clinical diagnostic laboratory
test that is included on the list of shoppable services
specified by the Centers for Medicare & Medicaid
Services (as described in section 180.60 of title 42,
Code of Federal Regulations (or a successor
regulation)).''.
SEC. 106. PROMOTING TRANSPARENCY OF COMMON OWNERSHIP INTERESTS UNDER
PARTS C AND D OF THE MEDICARE PROGRAM.
(a) Medicare Advantage.--Section 1857(e) of the Social Security Act
(42 U.S.C. 1395w-27(e)) is amended by adding at the end the following
new paragraph:
``(6) Required disclosure of certain information relating
to health care provider ownership.--
``(A) In general.--For plan years beginning on or
after January 1, 2025, a contract under this section
with an MA organization shall require the organization
to report to the Secretary, not later than 1 year after
the last day of such plan year, the information
described in subparagraph (B) with respect to such plan
year.
``(B) Information described.--For purposes of
subparagraph (A), the information described in this
subparagraph is, with respect to an MA organization and
a plan year, the following:
``(i) The number of items and services
furnished during such plan year by each
specified provider (as defined in subparagraph
(C)) for which payment was made by such
organization.
``(ii) The number of items and services
furnished during such plan year by providers of
services or suppliers not described in clause
(i) for which payment was made by such
organization.
``(iii) The average per-enrollee number of
qualifying diagnoses (as defined in
subparagraph (C)) made during such plan year by
specified providers (including through chart
reviews and health risk assessments) with
respect to individuals enrolled under an MA
plan offered by such organization, broken down
by site of service of such providers, as
specified by the Secretary.
``(iv) The average per-enrollee number of
qualifying diagnoses made during such plan year
by providers of services and suppliers not
described in clause (iii) (including through
such reviews and assessments) with respect to
such individuals, broken down by site of
service of such providers.
``(v) The average risk score (as calculated
under the methodology described in subparagraph
(C)(i)) for such an individual for such plan
year who received items and services from a
specified provider during such plan year.
``(vi) The average risk score for such an
individual for such plan year who did not
receive items and services from a specified
provider during such plan year.
``(vii) The average risk score for such an
individual for such plan year who received a
health risk assessment from an assessment
entity that was a specified assessment entity
during such plan year.
``(viii) The average risk score for such an
individual for such plan year who received a
health risk assessment from an assessment
entity that was not a specified assessment
entity during such plan year.
``(ix) The number of prior authorization
requests for an item or service submitted to
such organization during such plan year, the
number of such requests that were approved, the
number of such requests that were denied, and
the number of such denied requests that were
subsequently appealed and then approved, broken
down by whether the entity proposing to furnish
such item or service was a specified provider
or not a specified provider.
``(x) The total amount of incentive-based
payments made to, and the total amount of
shared losses recoupments collected from,
specified providers during such plan year.
``(xi) The total amount of incentive-based
payments made to, and the total amount of
shared losses recoupments collected from,
providers of services and suppliers not
described in clause (x) during such plan year.
``(xii) The allowed amount, and the amount
of cost sharing imposed, with respect to each
item and service furnished during such plan
year by specified providers paid by such
organization.
``(xiii) The allowed amount, and the amount
of cost sharing imposed, with respect to each
item and service furnished during such plan
year by providers of services and suppliers not
described in clause (xii) paid by such
organization.
``(xiv) For each MA plan offered by such
organization during such plan year--
``(I) the total amount of payments
made under section 1853(a)(1) to such
organization for coverage of
individuals under such plan, and the
total amount of payments made by such
individuals to such organization for
coverage under such plan;
``(II) the total amount expended
under such plan as payment for items
and services furnished by each
specified provider during such year;
``(III) the total amount expended
under such plan as payment for items
and services furnished by providers of
services or suppliers not described in
subclause (II) during such year;
``(IV) the medical loss ratio under
such plan with respect to individuals
furnished an item or service from a
specified provider during such year;
and
``(V) the medical loss ratio under
such plan with respect to individuals
not described in subclause (IV).
``(C) Definitions.--In this paragraph:
``(i) Assessment entity.--The term
`assessment entity' means an entity with a
focus on furnishing in-home medical
assessments, as specified by the Secretary.
``(ii) Qualifying diagnosis.--The term
`qualifying diagnosis' means, with respect to
an individual, a diagnosis that is taken into
account in calculating a risk score for such
individual under the risk adjustment
methodology established by the Secretary
pursuant to section 1853(a)(3).
``(iii) Specified assessment entity.--The
term `specified assessment entity' means, with
respect to an MA organization and a plan year,
an assessment entity with respect to which such
organization (or any person with an ownership
or control interest (as defined in section
1124(a)(3)) in such organization) is a person
with an ownership or control interest (as so
defined).
``(iv) Specified provider.--The term
`specified provider' means, with respect to an
MA organization and a plan year, a provider of
services or supplier with respect to which such
organization (or any person with an ownership
or control interest (as defined in section
1124(a)(3)) in such organization) is a person
with an ownership or control interest (as so
defined).
``(D) Nonapplication of paperwork reduction act.--
Chapter 35 of title 44, United States Code, shall not
apply to information collected under this paragraph.''.
(b) Pharmacy Benefit Manager and Pharmacy Information.--Section
1860D-12(b) of the Social Security Act (42 U.S.C. 1395w-112(b)) is
amended by adding at the end the following new paragraphs:
``(9) Provision of information relating to pharmacy
ownership.--
``(A) In general.--For plan years beginning on or
after January 1, 2025, a contract entered into under
this part with a PDP sponsor shall require the sponsor
to report to the Secretary, not later than 1 year after
the last day of such plan year, the information
described in subparagraph (B) with respect to such plan
year.
``(B) Information described.--For purposes of
subparagraph (A), the information described in this
subparagraph is, for each prescription drug plan
offered by a PDP sponsor for a plan year, the
following:
``(i) The negotiated price for each covered
part D drug for which benefits are available
under such plan for each network pharmacy
(including an identification of whether each
such pharmacy is a specified pharmacy).
``(ii) The average per-drug amount of
direct and indirect remuneration paid by
specified pharmacies for such covered part D
drugs dispensed during such plan year under
such plan.
``(iii) The average per-drug amount of
direct and indirect remuneration paid by
pharmacies not described in clause (ii) for
such covered part D drugs dispensed during such
plan year under such plan.
``(C) Definitions.--In this paragraph:
``(i) Direct and indirect remuneration.--
The term `direct and indirect remuneration' has
the meaning given such term in section 423.308
of title 42, Code of Federal Regulations (or
any successor regulation).
``(ii) Network pharmacy.--The term `network
pharmacy' has the meaning given such term in
section 423.100 of title 42, Code of Federal
Regulations (or any successor regulation).
``(iii) Negotiated price.--The `negotiated
price' for a covered part D drug shall take
into account all negotiated price concessions,
such as discounts, direct or indirect
subsidies, rebates, and direct or indirect
remunerations, for such drug, and include any
dispensing fee for such drug.
``(iv) Specified pharmacy.--The term
`specified pharmacy' means, with respect to an
PDP sponsor and a plan year, a pharmacy with
respect to which such sponsor (or any person
with an ownership or control interest (as
defined in section 1124(a)(3)) in such sponsor)
is a person with an ownership or control
interest (as so defined).
``(D) Nonapplication of paperwork reduction act.--
Chapter 35 of title 44, United States Code, shall not
apply to information collected under this paragraph.
``(10) Provision of information by pharmacy benefit
managers.--
``(A) In general.--For plan years beginning on or
after January 1, 2025, a contract entered into under
this part with a PDP sponsor shall prohibit such
sponsor from entering into a contract with a specified
pharmacy benefit manager for purposes of performing any
service with respect to covered part D drugs dispensed
under any prescription drug plan offered by such
sponsor for such plan year unless such manager agrees
to report to the Secretary, not later than 1 year after
the last day of such plan year, the information
described in subparagraph (B) with respect to each
prescription drug plan for which such manager is
providing any such service during such plan year,
regardless of the sponsor of such plan.
``(B) Information described.--For purposes of
subparagraph (A), the information described in this
subparagraph is, with respect to a pharmacy benefit
manager performing services under a prescription drug
plan for a plan year, the following:
``(i) With respect to the total amount of
pharmacy and manufacturer rebates collected by
such manager (or collected on behalf of such
plan by any other entity with a contract in
effect with such manager for such collection)
for all covered part D drugs dispensed under
such plan during such plan year--
``(I) the total amount of such
rebates passed through to the PDP
sponsor of such plan; and
``(II) the total amount of such
rebates retained by such manager or
such other entities.
``(ii) The total amount paid by such
manager to pharmacies for drugs furnished under
such plan during such plan year.
``(iii) The total amount of payments made
by such sponsor to such manager as
reimbursement for such manager's payments
described in clause (ii).
``(iv) The total amount of payments made by
such sponsor to such manager as fees for
services furnished by such manager with respect
to such plan for such plan year (not including
payments described in clause (iii)).
``(v) The total amount of administrative
costs incurred by such manager for furnishing
such services under such plan for such plan
year.
``(vi) A specification as to whether such
manager is a specified pharmacy benefit manager
with respect to the PDP sponsor of such plan.
``(C) Definition.--In this paragraph, the term
`specified pharmacy benefit manager' means, with
respect to an PDP sponsor and a plan year, a pharmacy
benefit manager with respect to which such sponsor (or
any person with an ownership or control interest (as
defined in section 1124(a)(3)) in such sponsor) is a
person with an ownership or control interest (as so
defined).''.
(c) Encounter Data.--Section 1859 of the Social Security Act (42
U.S.C. 1395w-28) is amended by adding at the end the following new
subsection:
``(j) Inclusion of Certain Information in Encounter Data.--
``(1) In general.--In the case of any encounter data
submitted by a Medicare Advantage plan with respect to an item
or service furnished to an individual under such plan during a
plan year beginning on or after January 1, 2025, the Secretary
shall require that such data include--
``(A) the allowed amount for such item or service;
``(B) the amount of cost sharing (including
deductibles, copayments, and coinsurance) imposed for
such item or service;
``(C) in the case such individual was furnished,
during such plan year before such item or service was
so furnished, an at-home health risk assessment from a
specified assessment entity, an indicator that such
individual was so furnished such an assessment by such
an entity; and
``(D) in the case such individual was furnished,
during such plan year before such item or service was
so furnished, an at-home health risk assessment from an
assessment entity not described in subparagraph (C), an
indicator (distinct from the indicator described in
such subparagraph) that such individual was so
furnished such an assessment by such an entity.
``(2) Definitions.--For purposes of this subsection, the
terms `assessment entity' and `specified assessment entity'
have the meaning given such terms in section 1857(e)(6).''.
(d) MedPAC Report.--Not later than December 31, 2027, and every 2
years thereafter, the Medicare Payment Advisory Commission shall submit
to Congress a report on the effects of vertical integration in the
health care sector on the Medicare program. Such report shall include
an analysis of the effects of entities such as health care providers,
pharmacies, PDP sponsors, Medicare Advantage organizations, and
pharmacy benefit managers that were previously under separate ownership
from one another coming under common ownership.
(e) Publication.--Not later than January 1, 2027, the Secretary of
Health and Human Services shall establish a process under which
information submitted to the Secretary pursuant to the amendments made
by subsections (a) and (b) is publicly disclosed. Such process shall
ensure that any information so disclosed does not identify a specific
drug manufacturer, provider of services or supplier, pharmacy, pharmacy
benefit manager, or any price charged with respect to a particular
drug.
SEC. 107. OVERSIGHT OF PHARMACY BENEFITS MANAGER SERVICES.
(a) PHSA.--Title XXVII of the Public Health Service Act (42 U.S.C.
300gg et seq.) is amended--
(1) in part D (42 U.S.C. 300gg-111 et seq.), by adding at
the end the following new section:
``SEC. 2799A-11. OVERSIGHT OF PHARMACY BENEFITS MANAGER SERVICES.
``(a) In General.--For plan years beginning on or after January 1,
2025, a group health plan or health insurance issuer offering group
health insurance coverage or an entity or subsidiary providing pharmacy
benefits management services on behalf of such a plan or issuer shall
not enter into a contract with a drug manufacturer, distributor,
wholesaler, subcontractor, rebate aggregator, or any associated third
party that limits the disclosure of information to plan sponsors in
such a manner that prevents the plan or issuer, or an entity or
subsidiary providing pharmacy benefits management services on behalf of
a plan or issuer, from making the reports described in subsection (b).
``(b) Reports.--
``(1) In general.--For plan years beginning on or after
January 1, 2025, not less frequently than annually, a health
insurance issuer offering group health insurance coverage or an
entity providing pharmacy benefits management services on
behalf of a group health plan or an issuer providing group
health insurance coverage shall submit to the plan sponsor (as
defined in section 3(16)(B) of the Employee Retirement Income
Security Act of 1974) of such group health plan or health
insurance coverage a report in accordance with this subsection
and make such report available to the plan sponsor in a
machine-readable format. Each such report shall include, with
respect to the applicable group health plan or health insurance
coverage--
``(A) as applicable, information collected from
drug manufacturers by such issuer or entity on the
total amount of copayment assistance dollars paid, or
copayment cards applied, that were funded by the drug
manufacturer with respect to the participants and
beneficiaries in such plan or coverage;
``(B) a list of each drug covered by such plan,
issuer, or entity providing pharmacy benefits
management services that was dispensed during the
reporting period, including, with respect to each such
drug during the reporting period--
``(i) the brand name, chemical entity, and
National Drug Code;
``(ii) the number of participants and
beneficiaries for whom the drug was filled
during the plan year, the total number of
prescription fills for the drug (including
original prescriptions and refills), and the
total number of dosage units of the drug
dispensed across the plan year, including
whether the dispensing channel was by retail,
mail order, or specialty pharmacy;
``(iii) the wholesale acquisition cost,
listed as cost per days supply and cost per
pill, or in the case of a drug in another form,
per dose;
``(iv) the total out-of-pocket spending by
participants and beneficiaries on such drug,
including participant and beneficiary spending
through copayments, coinsurance, and
deductibles; and
``(v) for any drug for which gross spending
of the group health plan or health insurance
coverage exceeded $10,000 during the reporting
period--
``(I) a list of all other drugs in
the same therapeutic category or class,
including brand name drugs and
biological products and generic drugs
or biosimilar biological products that
are in the same therapeutic category or
class as such drug; and
``(II) the rationale for preferred
formulary placement of such drug in
that therapeutic category or class, if
applicable;
``(C) a list of each therapeutic category or class
of drugs that were dispensed under the health plan or
health insurance coverage during the reporting period,
and, with respect to each such therapeutic category or
class of drugs, during the reporting period--
``(i) total gross spending by the plan,
before manufacturer rebates, fees, or other
manufacturer remuneration;
``(ii) the number of participants and
beneficiaries who filled a prescription for a
drug in that category or class;
``(iii) if applicable to that category or
class, a description of the formulary tiers and
utilization mechanisms (such as prior
authorization or step therapy) employed for
drugs in that category or class;
``(iv) the total out-of-pocket spending by
participants and beneficiaries, including
participant and beneficiary spending through
copayments, coinsurance, and deductibles; and
``(v) for each therapeutic category or
class under which 3 or more drugs are included
on the formulary of such plan or coverage--
``(I) the amount received, or
expected to be received, from drug
manufacturers in rebates, fees,
alternative discounts, or other
remuneration--
``(aa) that has been paid,
or is to be paid, by drug
manufacturers for claims
incurred during the reporting
period; or
``(bb) that is related to
utilization of drugs, in such
therapeutic category or class;
``(II) the total net spending,
after deducting rebates, price
concessions, alternative discounts or
other remuneration from drug
manufacturers, by the health plan or
health insurance coverage on that
category or class of drugs; and
``(III) the net price per course of
treatment or single fill, such as a 30-
day supply or 90-day supply, incurred
by the health plan or health insurance
coverage and its participants and
beneficiaries, after manufacturer
rebates, fees, and other remuneration
for drugs dispensed within such
therapeutic category or class during
the reporting period;
``(D) total gross spending on prescription drugs by
the plan or coverage during the reporting period,
before rebates and other manufacturer fees or
remuneration;
``(E) total amount received, or expected to be
received, by the health plan or health insurance
coverage in drug manufacturer rebates, fees,
alternative discounts, and all other remuneration
received from the manufacturer or any third party,
other than the plan sponsor, related to utilization of
drug or drug spending under that health plan or health
insurance coverage during the reporting period;
``(F) the total net spending on prescription drugs
by the health plan or health insurance coverage during
the reporting period; and
``(G) amounts paid directly or indirectly in
rebates, fees, or any other type of remuneration to
brokers, consultants, advisors, or any other individual
or firm who referred the group health plan's or health
insurance issuer's business to the pharmacy benefits
manager.
``(2) Privacy requirements.--Health insurance issuers
offering group health insurance coverage and entities providing
pharmacy benefits management services on behalf of a group
health plan shall provide information under paragraph (1) in a
manner consistent with the privacy, security, and breach
notification regulations promulgated under section 264(c) of
the Health Insurance Portability and Accountability Act of
1996, and shall restrict the use and disclosure of such
information according to such privacy regulations.
``(3) Disclosure and redisclosure.--
``(A) Limitation to business associates.--A group
health plan receiving a report under paragraph (1) may
disclose such information only to business associates
of such plan as defined in section 160.103 of title 45,
Code of Federal Regulations (or successor regulations).
``(B) Clarification regarding public disclosure of
information.--Nothing in this section prevents a health
insurance issuer offering group health insurance
coverage or an entity providing pharmacy benefits
management services on behalf of a group health plan
from placing reasonable restrictions on the public
disclosure of the information contained in a report
described in paragraph (1), except that such issuer or
entity may not restrict disclosure of such report to
the Department of Health and Human Services, the
Department of Labor, the Department of the Treasury,
the Comptroller General of the United States, or
applicable State agencies.
``(C) Limited form of report.--The Secretary shall
define through rulemaking a limited form of the report
under paragraph (1) required of plan sponsors who are
drug manufacturers, drug wholesalers, or other direct
participants in the drug supply chain, in order to
prevent anti-competitive behavior.
``(4) Report to gao.--A health insurance issuer offering
group health insurance coverage or an entity providing pharmacy
benefits management services on behalf of a group health plan
shall submit to the Comptroller General of the United States
each of the first 4 reports submitted to a plan sponsor under
paragraph (1) with respect to such coverage or plan, and other
such reports as requested, in accordance with the privacy
requirements under paragraph (2), the disclosure and
redisclosure standards under paragraph (3), the standards
specified pursuant to paragraph (5), and such other information
that the Comptroller General determines necessary to carry out
the study under section 2(d) of the Pharmacy Benefits Manager
Accountability Act.
``(5) Standard format.--Not later than June 1, 2023, the
Secretary shall specify through rulemaking standards for health
insurance issuers and entities required to submit reports under
paragraph (4) to submit such reports in a standard format.
``(c) Enforcement.--
``(1) In general.--The Secretary, in consultation with the
Secretary of Labor and the Secretary of the Treasury, shall
enforce this section.
``(2) Failure to provide timely information.--A health
insurance issuer or an entity providing pharmacy benefits
management services that violates subsection (a) or fails to
provide information required under subsection (b) shall be
subject to a civil monetary penalty in the amount of $10,000
for each day during which such violation continues or such
information is not disclosed or reported.
``(3) False information.--A health insurance issuer or
entity providing pharmacy benefits management services that
knowingly provides false information under this section shall
be subject to a civil money penalty in an amount not to exceed
$100,000 for each item of false information. Such civil money
penalty shall be in addition to other penalties as may be
prescribed by law.
``(4) Procedure.--The provisions of section 1128A of the
Social Security Act, other than subsection (a) and (b) and the
first sentence of subsection (c)(1) of such section shall apply
to civil monetary penalties under this subsection in the same
manner as such provisions apply to a penalty or proceeding
under section 1128A of the Social Security Act.
``(5) Waivers.--The Secretary may waive penalties under
paragraph (2), or extend the period of time for compliance with
a requirement of this section, for an entity in violation of
this section that has made a good-faith effort to comply with
this section.
``(d) Rule of Construction.--Nothing in this section shall be
construed to permit a health insurance issuer, group health plan, or
other entity to restrict disclosure to, or otherwise limit the access
of, the Department of Health and Human Services to a report described
in subsection (b)(1) or information related to compliance with
subsection (a) by such issuer, plan, or entity.
``(e) Definition.--In this section, the term `wholesale acquisition
cost' has the meaning given such term in section 1847A(c)(6)(B) of the
Social Security Act.''; and
(2) in section 2723 (42 U.S.C. 300gg-22)--
(A) in subsection (a)--
(i) in paragraph (1), by inserting ``(other
than subsections (a) and (b) of section 2799A-
11)'' after ``part D''; and
(ii) in paragraph (2), by inserting
``(other than subsections (a) and (b) of
section 2799A-11)'' after ``part D''; and
(B) in subsection (b)--
(i) in paragraph (1), by inserting ``(other
than subsections (a) and (b) of section 2799A-
11)'' after ``part D'';
(ii) in paragraph (2)(A), by inserting
``(other than subsections (a) and (b) of
section 2799A-11)'' after ``part D''; and
(iii) in paragraph (2)(C)(ii), by inserting
``(other than subsections (a) and (b) of
section 2799A-11)'' after ``part D''.
(b) ERISA.--
(1) In general.--Subtitle B of title I of the Employee
Retirement Income Security Act of 1974 (29 U.S.C. 1021 et seq.)
is amended--
(A) in subpart B of part 7 (29 U.S.C. 1185 et
seq.), by adding at the end the following:
``SEC. 726. OVERSIGHT OF PHARMACY BENEFITS MANAGER SERVICES.
``(a) In General.--For plan years beginning on or after January 1,
2025, a group health plan (or health insurance issuer offering group
health insurance coverage in connection with such a plan) or an entity
or subsidiary providing pharmacy benefits management services on behalf
of such a plan or issuer shall not enter into a contract with a drug
manufacturer, distributor, wholesaler, subcontractor, rebate
aggregator, or any associated third party that limits the disclosure of
information to plan sponsors in such a manner that prevents the plan or
issuer, or an entity or subsidiary providing pharmacy benefits
management services on behalf of a plan or issuer, from making the
reports described in subsection (b).
``(b) Reports.--
``(1) In general.--For plan years beginning on or after
January 1, 2025, not less frequently than annually, a health
insurance issuer offering group health insurance coverage or an
entity providing pharmacy benefits management services on
behalf of a group health plan or an issuer providing group
health insurance coverage shall submit to the plan sponsor (as
defined in section 3(16)(B)) of such group health plan or group
health insurance coverage a report in accordance with this
subsection and make such report available to the plan sponsor
in a machine-readable format. Each such report shall include,
with respect to the applicable group health plan or health
insurance coverage--
``(A) as applicable, information collected from
drug manufacturers by such issuer or entity on the
total amount of copayment assistance dollars paid, or
copayment cards applied, that were funded by the drug
manufacturer with respect to the participants and
beneficiaries in such plan or coverage;
``(B) a list of each drug covered by such plan,
issuer, or entity providing pharmacy benefits
management services that was dispensed during the
reporting period, including, with respect to each such
drug during the reporting period--
``(i) the brand name, chemical entity, and
National Drug Code;
``(ii) the number of participants and
beneficiaries for whom the drug was filled
during the plan year, the total number of
prescription fills for the drug (including
original prescriptions and refills), and the
total number of dosage units of the drug
dispensed across the plan year, including
whether the dispensing channel was by retail,
mail order, or specialty pharmacy;
``(iii) the wholesale acquisition cost,
listed as cost per days supply and cost per
pill, or in the case of a drug in another form,
per dose;
``(iv) the total out-of-pocket spending by
participants and beneficiaries on such drug,
including participant and beneficiary spending
through copayments, coinsurance, and
deductibles; and
``(v) for any drug for which gross spending
of the group health plan or health insurance
coverage exceeded $10,000 during the reporting
period--
``(I) a list of all other drugs in
the same therapeutic category or class,
including brand name drugs and
biological products and generic drugs
or biosimilar biological products that
are in the same therapeutic category or
class as such drug; and
``(II) the rationale for preferred
formulary placement of such drug in
that therapeutic category or class, if
applicable;
``(C) a list of each therapeutic category or class
of drugs that were dispensed under the health plan or
health insurance coverage during the reporting period,
and, with respect to each such therapeutic category or
class of drugs, during the reporting period--
``(i) total gross spending by the plan,
before manufacturer rebates, fees, or other
manufacturer remuneration;
``(ii) the number of participants and
beneficiaries who filled a prescription for a
drug in that category or class;
``(iii) if applicable to that category or
class, a description of the formulary tiers and
utilization mechanisms (such as prior
authorization or step therapy) employed for
drugs in that category or class;
``(iv) the total out-of-pocket spending by
participants and beneficiaries, including
participant and beneficiary spending through
copayments, coinsurance, and deductibles; and
``(v) for each therapeutic category or
class under which 3 or more drugs are included
on the formulary of such plan or coverage--
``(I) the amount received, or
expected to be received, from drug
manufacturers in rebates, fees,
alternative discounts, or other
remuneration--
``(aa) that has been paid,
or is to be paid, by drug
manufacturers for claims
incurred during the reporting
period; or
``(bb) that is related to
utilization of drugs, in such
therapeutic category or class;
``(II) the total net spending,
after deducting rebates, price
concessions, alternative discounts or
other remuneration from drug
manufacturers, by the health plan or
health insurance coverage on that
category or class of drugs; and
``(III) the net price per course of
treatment or single fill, such as a 30-
day supply or 90-day supply, incurred
by the health plan or health insurance
coverage and its participants and
beneficiaries, after manufacturer
rebates, fees, and other remuneration
for drugs dispensed within such
therapeutic category or class during
the reporting period;
``(D) total gross spending on prescription drugs by
the plan or coverage during the reporting period,
before rebates and other manufacturer fees or
remuneration;
``(E) total amount received, or expected to be
received, by the health plan or health insurance
coverage in drug manufacturer rebates, fees,
alternative discounts, and all other remuneration
received from the manufacturer or any third party,
other than the plan sponsor, related to utilization of
drug or drug spending under that health plan or health
insurance coverage during the reporting period;
``(F) the total net spending on prescription drugs
by the health plan or health insurance coverage during
the reporting period; and
``(G) amounts paid directly or indirectly in
rebates, fees, or any other type of remuneration to
brokers, consultants, advisors, or any other individual
or firm who referred the group health plan's or health
insurance issuer's business to the pharmacy benefits
manager.
``(2) Privacy requirements.--Health insurance issuers
offering group health insurance coverage and entities providing
pharmacy benefits management services on behalf of a group
health plan shall provide information under paragraph (1) in a
manner consistent with the privacy, security, and breach
notification regulations promulgated under section 264(c) of
the Health Insurance Portability and Accountability Act of
1996, and shall restrict the use and disclosure of such
information according to such privacy regulations.
``(3) Disclosure and redisclosure.--
``(A) Limitation to business associates.--A group
health plan receiving a report under paragraph (1) may
disclose such information only to business associates
of such plan as defined in section 160.103 of title 45,
Code of Federal Regulations (or successor regulations).
``(B) Clarification regarding public disclosure of
information.--Nothing in this section prevents a health
insurance issuer offering group health insurance
coverage or an entity providing pharmacy benefits
management services on behalf of a group health plan
from placing reasonable restrictions on the public
disclosure of the information contained in a report
described in paragraph (1), except that such issuer or
entity may not restrict disclosure of such report to
the Department of Health and Human Services, the
Department of Labor, the Department of the Treasury,
the Comptroller General of the United States, or
applicable State agencies.
``(C) Limited form of report.--The Secretary shall
define through rulemaking a limited form of the report
under paragraph (1) required of plan sponsors who are
drug manufacturers, drug wholesalers, or other direct
participants in the drug supply chain, in order to
prevent anti-competitive behavior.
``(4) Report to gao.--A health insurance issuer offering
group health insurance coverage or an entity providing pharmacy
benefits management services on behalf of a group health plan
shall submit to the Comptroller General of the United States
each of the first 4 reports submitted to a plan sponsor under
paragraph (1) with respect to such coverage or plan, and other
such reports as requested, in accordance with the privacy
requirements under paragraph (2), the disclosure and
redisclosure standards under paragraph (3), the standards
specified pursuant to paragraph (5), and such other information
that the Comptroller General determines necessary to carry out
the study under section 2(d) of the Pharmacy Benefits Manager
Accountability Act.
``(5) Standard format.--Not later than June 1, 2023, the
Secretary shall specify through rulemaking standards for health
insurance issuers and entities required to submit reports under
paragraph (4) to submit such reports in a standard format.
``(c) Rule of Construction.--Nothing in this section shall be
construed to permit a health insurance issuer, group health plan, or
other entity to restrict disclosure to, or otherwise limit the access
of, the Department of Labor to a report described in subsection (b)(1)
or information related to compliance with subsection (a) by such
issuer, plan, or entity.
``(d) Definition.--In this section, the term `wholesale acquisition
cost' has the meaning given such term in section 1847A(c)(6)(B) of the
Social Security Act.''; and
(B) in section 502 (29 U.S.C. 1132)--
(i) in subsection (a)--
(I) in paragraph (6), by striking
``or (9)'' and inserting ``(9), or
(13)'';
(II) in paragraph (10), by striking
at the end ``or'';
(III) in paragraph (11), at the end
by striking the period and inserting
``; or''; and
(IV) by adding at the end the
following new paragraph:
``(12) by the Secretary, in consultation with the Secretary
of Health and Human Services, and the Secretary of the
Treasury, to enforce section 726.'';
(ii) in subsection (b)(3), by inserting
``and subsections (a)(12) and (c)(13)'' before
``, the Secretary is not''; and
(iii) in subsection (c), by adding at the
end the following new paragraph:
``(13) Secretarial enforcement authority relating to
oversight of pharmacy benefits manager services.--
``(A) Failure to provide timely information.--The
Secretary, in consultation with the Secretary of Health
and Human Services and the Secretary of the Treasury,
may impose a penalty against any health insurance
issuer or entity providing pharmacy benefits management
services that violates section 726(a) or fails to
provide information required under section 726(b) in
the amount of $10,000 for each day during which such
violation continues or such information is not
disclosed or reported.
``(B) False information.--The Secretary, in
consultation with the Secretary of Health and Human
Services and the Secretary of the Treasury, may impose
a penalty against a health insurance issuer or entity
providing pharmacy benefits management services that
knowingly provides false information under section 726
in an amount not to exceed $100,000 for each item of
false information. Such penalty shall be in addition to
other penalties as may be prescribed by law.
``(C) Waivers.--The Secretary may waive penalties
under subparagraph (A), or extend the period of time
for compliance with a requirement of section 726, for
an entity in violation of such section that has made a
good-faith effort to comply with such section.''.
(2) Clerical amendment.--The table of contents in section 1
of the Employee Retirement Income Security Act of 1974 (29
U.S.C. 1001 et seq.) is amended by inserting after the item
relating to section 725 the following new item:
``Sec. 726. Oversight of pharmacy benefits manager services.''.
(c) IRC.--
(1) In general.--Subchapter B of chapter 100 of the
Internal Revenue Code of 1986 is amended by adding at the end
the following:
``SEC. 9826. OVERSIGHT OF PHARMACY BENEFITS MANAGER SERVICES.
``(a) In General.--For plan years beginning on or after January 1,
2025, a group health plan or an entity or subsidiary providing pharmacy
benefits management services on behalf of such a plan shall not enter
into a contract with a drug manufacturer, distributor, wholesaler,
subcontractor, rebate aggregator, or any associated third party that
limits the disclosure of information to plan sponsors in such a manner
that prevents the plan, or an entity or subsidiary providing pharmacy
benefits management services on behalf of a plan, from making the
reports described in subsection (b).
``(b) Reports.--
``(1) In general.--For plan years beginning on or after
January 1, 2025, not less frequently than annually, an entity
providing pharmacy benefits management services on behalf of a
group health plan shall submit to the plan sponsor (as defined
in section 3(16)(B) of the Employee Retirement Income Security
Act of 1974) of such group health plan a report in accordance
with this subsection and make such report available to the plan
sponsor in a machine-readable format. Each such report shall
include, with respect to the applicable group health plan--
``(A) as applicable, information collected from
drug manufacturers by such entity on the total amount
of copayment assistance dollars paid, or copayment
cards applied, that were funded by the drug
manufacturer with respect to the participants and
beneficiaries in such plan;
``(B) a list of each drug covered by such plan or
entity providing pharmacy benefits management services
that was dispensed during the reporting period,
including, with respect to each such drug during the
reporting period--
``(i) the brand name, chemical entity, and
National Drug Code;
``(ii) the number of participants and
beneficiaries for whom the drug was filled
during the plan year, the total number of
prescription fills for the drug (including
original prescriptions and refills), and the
total number of dosage units of the drug
dispensed across the plan year, including
whether the dispensing channel was by retail,
mail order, or specialty pharmacy;
``(iii) the wholesale acquisition cost,
listed as cost per days supply and cost per
pill, or in the case of a drug in another form,
per dose;
``(iv) the total out-of-pocket spending by
participants and beneficiaries on such drug,
including participant and beneficiary spending
through copayments, coinsurance, and
deductibles; and
``(v) for any drug for which gross spending
of the group health plan exceeded $10,000
during the reporting period--
``(I) a list of all other drugs in
the same therapeutic category or class,
including brand name drugs and
biological products and generic drugs
or biosimilar biological products that
are in the same therapeutic category or
class as such drug; and
``(II) the rationale for preferred
formulary placement of such drug in
that therapeutic category or class, if
applicable;
``(C) a list of each therapeutic category or class
of drugs that were dispensed under the health plan
during the reporting period, and, with respect to each
such therapeutic category or class of drugs, during the
reporting period--
``(i) total gross spending by the plan,
before manufacturer rebates, fees, or other
manufacturer remuneration;
``(ii) the number of participants and
beneficiaries who filled a prescription for a
drug in that category or class;
``(iii) if applicable to that category or
class, a description of the formulary tiers and
utilization mechanisms (such as prior
authorization or step therapy) employed for
drugs in that category or class;
``(iv) the total out-of-pocket spending by
participants and beneficiaries, including
participant and beneficiary spending through
copayments, coinsurance, and deductibles; and
``(v) for each therapeutic category or
class under which 3 or more drugs are included
on the formulary of such plan--
``(I) the amount received, or
expected to be received, from drug
manufacturers in rebates, fees,
alternative discounts, or other
remuneration--
``(aa) that has been paid,
or is to be paid, by drug
manufacturers for claims
incurred during the reporting
period; or
``(bb) that is related to
utilization of drugs, in such
therapeutic category or class;
``(II) the total net spending,
after deducting rebates, price
concessions, alternative discounts or
other remuneration from drug
manufacturers, by the health plan on
that category or class of drugs; and
``(III) the net price per course of
treatment or single fill, such as a 30-
day supply or 90-day supply, incurred
by the health plan and its participants
and beneficiaries, after manufacturer
rebates, fees, and other remuneration
for drugs dispensed within such
therapeutic category or class during
the reporting period;
``(D) total gross spending on prescription drugs by
the plan during the reporting period, before rebates
and other manufacturer fees or remuneration;
``(E) total amount received, or expected to be
received, by the health plan in drug manufacturer
rebates, fees, alternative discounts, and all other
remuneration received from the manufacturer or any
third party, other than the plan sponsor, related to
utilization of drug or drug spending under that health
plan during the reporting period;
``(F) the total net spending on prescription drugs
by the health plan during the reporting period; and
``(G) amounts paid directly or indirectly in
rebates, fees, or any other type of remuneration to
brokers, consultants, advisors, or any other individual
or firm who referred the group health plan's business
to the pharmacy benefits manager.
``(2) Privacy requirements.--Entities providing pharmacy
benefits management services on behalf of a group health plan
shall provide information under paragraph (1) in a manner
consistent with the privacy, security, and breach notification
regulations promulgated under section 264(c) of the Health
Insurance Portability and Accountability Act of 1996, and shall
restrict the use and disclosure of such information according
to such privacy regulations.
``(3) Disclosure and redisclosure.--
``(A) Limitation to business associates.--A group
health plan receiving a report under paragraph (1) may
disclose such information only to business associates
of such plan as defined in section 160.103 of title 45,
Code of Federal Regulations (or successor regulations).
``(B) Clarification regarding public disclosure of
information.--Nothing in this section prevents an
entity providing pharmacy benefits management services
on behalf of a group health plan from placing
reasonable restrictions on the public disclosure of the
information contained in a report described in
paragraph (1), except that such entity may not restrict
disclosure of such report to the Department of Health
and Human Services, the Department of Labor, the
Department of the Treasury, the Comptroller General of
the United States, or applicable State agencies.
``(C) Limited form of report.--The Secretary shall
define through rulemaking a limited form of the report
under paragraph (1) required of plan sponsors who are
drug manufacturers, drug wholesalers, or other direct
participants in the drug supply chain, in order to
prevent anti-competitive behavior.
``(4) Report to gao.--An entity providing pharmacy benefits
management services on behalf of a group health plan shall
submit to the Comptroller General of the United States each of
the first 4 reports submitted to a plan sponsor under paragraph
(1) with respect to such plan, and other such reports as
requested, in accordance with the privacy requirements under
paragraph (2), the disclosure and redisclosure standards under
paragraph (3), the standards specified pursuant to paragraph
(5), and such other information that the Comptroller General
determines necessary to carry out the study under section 2(d)
of the Pharmacy Benefits Manager Accountability Act.
``(5) Standard format.--Not later than June 1, 2023, the
Secretary shall specify through rulemaking standards for
entities required to submit reports under paragraph (4) to
submit such reports in a standard format.
``(c) Enforcement.--
``(1) In general.--The Secretary, in consultation with the
Secretary of Labor and the Secretary of Health and Human
Services, shall enforce this section.
``(2) Failure to provide timely information.--An entity
providing pharmacy benefits management services that violates
subsection (a) or fails to provide information required under
subsection (b) shall be subject to a civil monetary penalty in
the amount of $10,000 for each day during which such violation
continues or such information is not disclosed or reported.
``(3) False information.--An entity providing pharmacy
benefits management services that knowingly provides false
information under this section shall be subject to a civil
money penalty in an amount not to exceed $100,000 for each item
of false information. Such civil money penalty shall be in
addition to other penalties as may be prescribed by law.
``(4) Procedure.--The provisions of section 1128A of the
Social Security Act, other than subsection (a) and (b) and the
first sentence of subsection (c)(1) of such section shall apply
to civil monetary penalties under this subsection in the same
manner as such provisions apply to a penalty or proceeding
under section 1128A of the Social Security Act.
``(5) Waivers.--The Secretary may waive penalties under
paragraph (2), or extend the period of time for compliance with
a requirement of this section, for an entity in violation of
this section that has made a good-faith effort to comply with
this section.
``(d) Rule of Construction.--Nothing in this section shall be
construed to permit a group health plan or other entity to restrict
disclosure to, or otherwise limit the access of, the Department of the
Treasury to a report described in subsection (b)(1) or information
related to compliance with subsection (a) by such plan or entity.
``(e) Definition.--In this section, the term `wholesale acquisition
cost' has the meaning given such term in section 1847A(c)(6)(B) of the
Social Security Act.''.
(2) Clerical amendment.--The table of sections for
subchapter B of chapter 100 of the Internal Revenue Code of
1986 is amended by adding at the end the following new item:
``Sec. 9826. Oversight of pharmacy benefits manager services.''.
(d) GAO Study.--
(1) In general.--Not later than 3 years after the date of
enactment of this Act, the Comptroller General of the United
States shall submit to Congress a report on--
(A) pharmacy networks of group health plans, health
insurance issuers, and entities providing pharmacy
benefits management services under such group health
plan or group or individual health insurance coverage,
including networks that have pharmacies that are under
common ownership (in whole or part) with group health
plans, health insurance issuers, or entities providing
pharmacy benefits management services or pharmacy
benefits administrative services under group health
plan or group or individual health insurance coverage;
(B) as it relates to pharmacy networks that include
pharmacies under common ownership described in
subparagraph (A)--
(i) whether such networks are designed to
encourage enrollees of a plan or coverage to
use such pharmacies over other network
pharmacies for specific services or drugs, and
if so, the reasons the networks give for
encouraging use of such pharmacies; and
(ii) whether such pharmacies are used by
enrollees disproportionately more in the
aggregate or for specific services or drugs
compared to other network pharmacies;
(C) whether group health plans and health insurance
issuers offering group or individual health insurance
coverage have options to elect different network
pricing arrangements in the marketplace with entities
that provide pharmacy benefits management services, the
prevalence of electing such different network pricing
arrangements;
(D) pharmacy network design parameters that
encourage enrollees in the plan or coverage to fill
prescriptions at mail order, specialty, or retail
pharmacies that are wholly or partially-owned by that
issuer or entity; and
(E) the degree to which mail order, specialty, or
retail pharmacies that dispense prescription drugs to
an enrollee in a group health plan or health insurance
coverage that are under common ownership (in whole or
part) with group health plans, health insurance
issuers, or entities providing pharmacy benefits
management services or pharmacy benefits administrative
services under group health plan or group or individual
health insurance coverage receive reimbursement that is
greater than the median price charged to the group
health plan or health insurance issuer when the same
drug is dispensed to enrollees in the plan or coverage
by other pharmacies included in the pharmacy network of
that plan, issuer, or entity that are not wholly or
partially owned by the health insurance issuer or
entity providing pharmacy benefits management services.
(2) Requirement.--The Comptroller General of the United
States shall ensure that the report under paragraph (1) does
not contain information that would allow a reader to identify a
specific plan or entity providing pharmacy benefits management
services or otherwise contain commercial or financial
information that is privileged or confidential.
(3) Definitions.--In this subsection, the terms ``group
health plan'', ``health insurance coverage'', and ``health
insurance issuer'' have the meanings given such terms in
section 2791 of the Public Health Service Act (42 U.S.C. 300gg-
91).
TITLE II--SUPPORTING PATIENTS, HEALTH CARE WORKERS, COMMUNITY HEALTH
CENTERS, AND HOSPITALS
SEC. 201. EXTENSION FOR COMMUNITY HEALTH CENTERS, THE NATIONAL HEALTH
SERVICE CORPS, AND TEACHING HEALTH CENTERS THAT OPERATE
GME PROGRAMS.
(a) Teaching Health Centers That Operate Graduate Medical Education
Programs.--Section 340H(g) of the Public Health Service Act (42 U.S.C.
256h(g)) is amended--
(1) by amending paragraph (1) to read as follows:
``(1) In general.--To carry out this section, there are
appropriated such sums as may be necessary, not to exceed--
``(A) $230,000,000, for the period of fiscal years
2011 through 2015;
``(B) $60,000,000 for each of fiscal years 2016 and
2017;
``(C) $126,500,000 for each of fiscal years 2018
through 2023;
``(D) $175,000,000 for each of fiscal years 2024
and 2025;
``(E) $225,000,000 for each of fiscal years 2026
and 2027; and
``(F) $275,000,000 for each of fiscal years 2028
and 2029.''; and
(2) by adding at the end the following:
``(3) Availability.--The amounts made available under
paragraph (1) shall remain available until expended.''.
(b) Extension for Community Health Centers.--Section 10503(b)(1)(F)
of the Patient Protection and Affordable Care Act (42 U.S.C. 254b-
2(b)(1)(F)) is amended--
(1) by striking ``and'' before ``$4,000,000,000'' and
inserting a comma; and
(2) by inserting ``, and $4,200,000,000 for each of fiscal
years 2024 and 2025'' before the semicolon.
(c) Extension for the National Health Service Corps.--Section
10503(b)(2) of the Patient Protection and Affordable Care Act (42
U.S.C. 254b-2(b)(2)) is amended--
(1) in subparagraph (G), by striking ``and'' at the end;
(2) in subparagraph (H), by striking the period at the end
and inserting ``; and''; and
(3) by adding at the end the following:
``(I) $350,000,000 for each of fiscal years 2024
and 2025.''.
(d) Application of Provisions.--Amounts appropriated pursuant to
the amendments made by this section shall be subject to the
requirements contained in Public Law 117-328 for funds for programs
authorized under sections 330 through 340 of the Public Health Service
Act.
(e) Conforming Amendment.--Paragraph (4) of section 3014(h) of
title 18, United States Code, is amended by striking ``and section
301(d) of division BB of the Consolidated Appropriations Act, 2021.''
and inserting ``section 301(d) of division BB of the Consolidated
Appropriations Act, 2021, and section 201(d) of the PATIENT Act of
2023''.
SEC. 202. EXTENSION OF SPECIAL DIABETES PROGRAMS.
(a) Extension of Special Diabetes Programs for Type I Diabetes.--
Section 330B(b)(2) of the Public Health Service Act (42 U.S.C. 254c-
2(b)(2)) is amended--
(1) in subparagraph (C), by striking ``and'' at the end;
(2) in subparagraph (D), by striking the period and
inserting ``; and''; and
(3) by adding at the end the following new subparagraph:
``(E) $170,000,000 for each of fiscal years 2024
and 2025.''.
(b) Extending Funding for Special Diabetes Programs for Indians.--
Section 330C(c)(2) of the Public Health Service Act (42 U.S.C. 254c-
3(c)(2)) is amended--
(1) in subparagraph (C), by striking ``and'' at the end;
(2) in subparagraph (D), by striking the period and
inserting ``; and''; and
(3) by adding at the end the following new subparagraph:
``(E) $170,000,000 for each of fiscal years 2024
and 2025.''.
SEC. 203. DELAYING CERTAIN DISPROPORTIONATE SHARE HOSPITAL PAYMENT
REDUCTIONS UNDER THE MEDICAID PROGRAM.
Section 1923(f)(7)(A) of the Social Security Act (42 U.S.C.1396r-
4(f)(7)(A)) is amended--
(1) in clause (i), in the matter preceding subclause (I),
by striking ``2024'' and inserting ``2026''; and
(2) in clause (ii), by striking ``2024'' and inserting
``2026''.
SEC. 204. MEDICAID IMPROVEMENT FUND.
Section 1941(b)(3)(A) of the Social Security Act (42 U.S.C. 1396w-
1(b)(3)(A)) is amended by striking ``$7,000,000,000'' and inserting
``$0''.
TITLE III--REDUCING HEALTH CARE COSTS
SEC. 301. INCREASING TRANSPARENCY IN GENERIC DRUG APPLICATIONS.
(a) In General.--Section 505(j)(3) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 355(j)(3)) is amended by adding at the end the
following:
``(H)(i) Upon request (in controlled correspondence or an analogous
process) by a person that has submitted or intends to submit an
abbreviated application under this subsection for a drug that is
required by regulation to contain one or more of the same inactive
ingredients in the same concentrations as the listed drug referred to,
or for which the Secretary determines there is a scientific
justification for an approach that is in vitro in whole or in part to
be used to demonstrate bioequivalence for a drug if such a drug
contains one or more of the same inactive ingredients in the same
concentrations as the listed drug, the Secretary shall inform the
person whether such drug is qualitatively and quantitatively the same
as the listed drug. The Secretary may also provide such information to
such a person on the Secretary's own initiative during the review of an
abbreviated application under this subsection for such drug.
``(ii) Notwithstanding section 301(j), if the Secretary determines
that such drug is not qualitatively or quantitatively the same as the
listed drug, the Secretary shall identify and disclose to the person--
``(I) the ingredient or ingredients that cause such drug
not to be qualitatively or quantitatively the same as the
listed drug; and
``(II) for any ingredient for which there is an identified
quantitative deviation, whether the quantity or proportion of
any ingredient in such drug is greater than or less than the
quantity or proportion of such ingredient in the listed drug.
``(iii) If the Secretary determines that such drug is qualitatively
and quantitatively the same as the listed drug, the Secretary shall not
change or rescind such determination after the submission of an
abbreviated application for such drug under this subsection unless--
``(I) the formulation of the listed drug has been changed
and the Secretary has determined that the prior listed drug
formulation was withdrawn for reasons of safety or
effectiveness; or
``(II) the Secretary makes a written determination that the
prior determination must be changed because an error has been
identified.
``(iv) If the Secretary makes a written determination described in
clause (iii)(II), the Secretary shall provide notice and a copy of the
written determination to the person making the request under clause
(i).
``(v) The disclosures required by this subparagraph are disclosures
authorized by law, including for purposes of section 1905 of title 18,
United States Code.''.
(b) Guidance.--
(1) In general.--Not later than one year after the date of
enactment of this Act, the Secretary of Health and Human
Services shall issue draft guidance, or update guidance,
describing how the Secretary will determine whether a drug is
qualitatively and quantitatively the same as the listed drug
(as such terms are used in section 505(j)(3)(H) of the Federal
Food, Drug, and Cosmetic Act, as added by subsection (a)),
including with respect to assessing pH adjusters.
(2) Process.--In issuing guidance under this subsection,
the Secretary of Health and Human Services shall--
(A) publish draft guidance;
(B) provide a period of at least 60 days for
comment on the draft guidance; and
(C) after considering any comments received and not
later than one year after the close of the comment
period on the draft guidance, publish final guidance.
(c) Applicability.--Section 505(j)(3)(H) of the Federal Food, Drug,
and Cosmetic Act, as added by subsection (a), applies beginning on the
date of enactment of this Act, irrespective of the date on which the
guidance required by subsection (b) is finalized.
SEC. 302. PARITY IN MEDICARE PAYMENTS FOR HOSPITAL OUTPATIENT
DEPARTMENT SERVICES FURNISHED OFF-CAMPUS.
(a) In General.--Section 1833(t)(16) of the Social Security Act (42
U.S.C. 1395l(t)(16)) is amended by adding at the end the following new
subparagraph:
``(H) Parity in fee schedule amount for certain
services furnished by an off-campus outpatient
department of a provider.--
``(i) In general.--Subject to clause (iii),
in the case of specified OPD services (as
defined in clause (iv)) that are furnished
during 2025 or a subsequent year by an off-
campus outpatient department of a provider (as
defined in clause (iv)), there shall be
substituted for the amount otherwise determined
under this subsection for such service and year
an amount equal to the payment amount that
would have been payable under the applicable
payment system under this part (other than
under this subsection) had such services been
furnished by such a department subject to such
payment system pursuant to paragraph (21)(C).
``(ii) Not budget neutral implementation.--
In making any budget neutrality adjustments
under this subsection for 2025 or a subsequent
year, the Secretary shall not take into account
the reduced expenditures that result from the
application of this subparagraph.
``(iii) Transition.--The Secretary shall
provide for a 4-year phase-in of the
application of clause (i), with clause (i)
being fully applicable for specified OPD
services beginning with 2028.
``(iv) Definitions.--For purposes of this
subparagraph:
``(I) Designated ambulatory payment
classification group.--The term
`designated ambulatory payment
classification group' means an
ambulatory payment classification group
for drug administration services.
``(II) Specified opd services
defined.--The term `specified OPD
services' means covered OPD services
included in a designated ambulatory
payment classification group.
``(III) Off-campus outpatient
department of a provider defined.--The
term `off-campus outpatient department
of a provider' means a department of a
provider (as defined in section
413.65(a)(2) of title 42, Code of
Federal Regulations) that is not
located--
``(aa) on the campus (as
such term is defined in such
section 413.65(a)(2)) of such
provider; or
``(bb) within the distance
(described in such definition
of campus) from a remote
location of a hospital facility
(as defined in such section
413.65(a)(2)).''.
(b) Implementation.--Section 1833(t)(12) of the Social Security Act
(42 U.S.C. 1395l(t)(12)) is amended--
(1) in subparagraph (D), by striking ``and'' at the end;
(2) in subparagraph (E), by striking the period at the end
and inserting ``; and''; and
(3) by adding at the end the following new subparagraph:
``(F) the determination of any payment amount under
paragraph (16)(H), including the transition under
clause (iii) of such paragraph.''.
SEC. 303. IMPROVING TRANSPARENCY AND PREVENTING THE USE OF ABUSIVE
SPREAD PRICING AND RELATED PRACTICES IN MEDICAID.
(a) Pharmacy Price Reimbursement Requirements.--
(1) In general.--Section 1927(e) of the Social Security Act
(42 U.S.C. 1396r-8(e)) is amended by adding at the end the
following:
``(6) Pharmacy price reimbursement required.--A contract
between the State and a managed care entity (or subcontractor
of a managed care entity that manages the pharmacy benefit for
such entity (in this section referred to as a `PBM'), or other
specified entity (as such terms are defined in section
1903(m)(9)(D)) that includes provisions making the managed care
entity responsible for coverage of covered outpatient drugs
dispensed to individuals enrolled with the entity, shall
require that payment for such drugs and related administrative
services (as applicable), including payments made by a PBM on
behalf of the State or entity, is based on a pass-through
pricing model under which--
``(A) any payment made by the entity or the PBM (as
applicable) for such a drug--
``(i) is limited to--
``(I) ingredient cost; and
``(II) a professional dispensing
fee that is not less than the
professional dispensing fee that the
State plan or waiver would pay if the
plan or waiver was making the payment
directly;
``(ii) is passed through in its entirety by
the entity or PBM to the pharmacy or provider
that dispenses the drug; and
``(iii) is made in a manner that is
consistent with sections 447.502, 447.512,
447.514, and 447.518 of title 42, Code of
Federal Regulations (or any successor
regulation) as if such requirements applied
directly to the entity or the PBM;
``(B) payment to the entity or the PBM (as
applicable) for administrative services performed by
the entity or PBM is limited to an administrative fee
that covers the reasonable cost of providing such
services;
``(C) the entity or the PBM (as applicable) shall
make available to the State, and the Secretary upon
request, all costs and payments related to covered
outpatient drugs and accompanying administrative
services incurred, received, or made by the entity or
the PBM, including ingredient costs, professional
dispensing fees, administrative fees, post-sale and
post-invoice fees, discounts, or related adjustments
such as direct and indirect remuneration fees, and any
and all other remuneration; and
``(D) any form of spread pricing whereby any amount
charged or claimed by the entity or the PBM (as
applicable) is in excess of the amount paid to the
pharmacies on behalf of the entity, including any post-
sale or post-invoice fees, discounts, or related
adjustments such as direct and indirect remuneration
fees or assessments (after allowing for a reasonable
administrative fee as described in subparagraph (B)) is
not allowable for purposes of claiming Federal matching
payments under this title.''.
(2) Conforming amendments.--Section 1903(m)(2)(A)(xiii) of
such Act (42 U.S.C. 1396b(m)(2)(A)(xiii)) is amended--
(A) by striking ``and (III)'' and inserting
``(III)'';
(B) by inserting before the period at the end the
following: ``, and (IV) the pharmacy benefit provided
by the entity (or pharmacy benefit manager on behalf of
the entity under a contract), the other specified
entity (as defined in paragraph (9)(D)), or by another
arrangement between the entity and the pharmacy benefit
manager, shall comply with the requirements of section
1927(e)(6)''; and
(C) by moving the left margin 2 ems to the left.
(3) Effective date.--The amendments made by this subsection
apply to contracts between States and managed care entities, or
other specified entities, that have an initial effective date
or are renewed on or after the date that is 18 months after the
date of enactment of this Act.
(b) Ensuring Accurate Payments to Pharmacies Under Medicaid.--
(1) In general.--Section 1927(f) of the Social Security Act
(42 U.S.C. 1396r-8(f)) is amended--
(A) by striking ``and'' after the semicolon at the
end of paragraph (1)(A)(i) and all that precedes it
through ``(1)'' and inserting the following:
``(1) Determining pharmacy actual acquisition costs.--The
Secretary shall conduct a survey of retail community pharmacy
drug prices to determine the national average drug acquisition
cost as follows:
``(A) Use of vendor.--The Secretary may contract
services for--
``(i) with respect to retail community
pharmacies, the determination of retail survey
prices of the national average drug acquisition
cost for covered outpatient drugs based on a
monthly survey of such pharmacies; and'';
(B) by adding at the end of paragraph (1) the
following:
``(F) Survey reporting.--A State shall require that
any retail community pharmacy in the State that
receives any payment, reimbursement, administrative
fee, discount, or rebate related to the dispensing of
covered outpatient drugs to individuals receiving
benefits under this title, regardless of whether such
payment, reimbursement, administrative fee, discount,
or rebate is received from the State or a managed care
entity directly or from a pharmacy benefit manager or
other specified entity (as defined in section
1903(m)(9)(D)) that has a contract with the State or a
managed care entity, shall respond to surveys of retail
prices conducted under this subsection.
``(G) Survey information.--Information on national
drug acquisition prices obtained under this paragraph
shall be made publicly available in a timely manner
following the collection of such information and shall
include at least the following:
``(i) The monthly response rate to the
survey including a list of pharmacies not in
compliance with subparagraph (F).
``(ii) The sampling frame and number of
pharmacies sampled monthly.
``(iii) Information on price concessions to
the pharmacy, including discounts, rebates, and
other price concessions, to the extent that
such information is available during the survey
period.
``(H) Report on specialty pharmacies.--Not later
than 1 year after the date that this subparagraph takes
effect, the Secretary shall submit to Congress a report
examining specialty drug coverage and reimbursement
under this title, including--
``(i) a description of how State Medicaid
programs define specialty drugs and specialty
pharmacies;
``(ii) the amount State Medicaid programs
pay for specialty drugs;
``(iii) how States and managed care
entities determine payment for specialty drugs;
``(iv) the settings in which specialty
drugs are dispensed to individuals receiving
benefits under this title (such as retail
community pharmacies or specialty pharmacies);
``(v) the extent to which speciality drugs
(as defined by the respective States) are
captured in the national average drug
acquisition cost survey (or through another
process);
``(vi) examples of specialty drug
dispensing fees to support the services
associated with dispensing such specialty
drugs; and
``(vii) recommendations as to whether
specialty pharmacies should be included in the
survey of retail prices to ensure national
average drug acquisition costs capture drugs
sold at specialty pharmacies, and how such
specialty pharmacies should be defined.
``(I) Enforcement.--At the discretion of the
Secretary, the Secretary may enforce non-compliance
with this paragraph by a pharmacy through the
establishment of penalties or the suspension of
payments under this title, in full or in part, until
compliance with this paragraph has been completed.'';
and
(C) in paragraph (2)--
(i) in subparagraph (A), by inserting
``(including payment rates under Medicaid
managed care plans)'' after ``under this
title''; and
(ii) in subparagraph (B), by inserting ``,
and the basis for such dispensing fees'' before
the semicolon at the end.
(2) Effective date.--The amendments made by this subsection
take effect on the first day of the first quarter that begins
on or after the date that is 18 months after the date of
enactment of this Act.
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