[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5378 Engrossed in House (EH)]
<DOC>
118th CONGRESS
1st Session
H. R. 5378
_______________________________________________________________________
AN ACT
To promote price transparency in the health care sector, 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 ``Lower Costs, More Transparency
Act''.
SEC. 2. TABLE OF CONTENTS.
The table of contents of this Act is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents.
TITLE I--IMPROVING HEALTH CARE TRANSPARENCY
Sec. 101. Hospital price transparency.
Sec. 102. Clinical diagnostic laboratory test price transparency.
Sec. 103. Imaging price transparency.
Sec. 104. Ambulatory surgical center price transparency.
Sec. 105. Health coverage price transparency.
Sec. 106. Pharmacy benefits price transparency.
Sec. 107. Reports on health care transparency tools and data.
Sec. 108. Report on integration in Medicare.
Sec. 109. Advisory Committee.
Sec. 110. Report on impact of Medicare regulations on provider and
payer consolidation.
Sec. 111. Implementation funding.
TITLE II--REDUCING HEALTH CARE COSTS FOR PATIENTS
Sec. 201. Increasing transparency in generic drug applications.
Sec. 202. Improving transparency and preventing the use of abusive
spread pricing and related practices in
Medicaid.
Sec. 203. Parity in Medicare payments for hospital outpatient
department services furnished off-campus.
Sec. 204. Requiring a separate identification number and an attestation
for each off-campus outpatient department
of a provider.
TITLE III--SUPPORTING PATIENTS, HEALTH CARE WORKERS, COMMUNITY HEALTH
CENTERS, AND HOSPITALS
Sec. 301. Extension for community health centers, the national health
service corps, and teaching health centers
that operate GME programs.
Sec. 302. Extension of special diabetes programs.
Sec. 303. Delaying certain disproportionate share payment cuts.
Sec. 304. Medicaid improvement fund.
TITLE IV--INCREASING ACCESS TO QUALITY HEALTH DATA AND LOWERING HIDDEN
FEES
Sec. 401. Increasing Plan Fiduciaries' Access to Health Data.
Sec. 402. Hidden Fees Disclosure Requirements.
Sec. 403. Prescription drug price information requirement.
Sec. 404. Implementation funding.
TITLE I--IMPROVING HEALTH CARE TRANSPARENCY
SEC. 101. HOSPITAL PRICE TRANSPARENCY.
(a) Medicare.--Part E of title XVIII of the Social Security Act (42
U.S.C. 1395x et seq.) is amended by adding at the end the following new
section:
``SEC. 1899C. HOSPITAL PRICE TRANSPARENCY.
``(a) Transparency Requirement.--
``(1) In general.--Beginning January 1, 2026, each
specified hospital that receives payment under this title for
furnishing items and services shall comply with the price
transparency requirement described in paragraph (2).
``(2) Requirement described.--
``(A) In general.--For purposes of paragraph (1),
the price transparency requirement described in this
paragraph is, with respect to a specified hospital,
that such hospital, in accordance with a method and
format established by the Secretary under subparagraph
(C), compile and make public (without subscription and
free of charge) for each year--
``(i) all of the hospital's standard
charges (including the information described in
subparagraph (B)) for each item and service
furnished by such hospital;
``(ii) information in a consumer-friendly
format (as specified by the Secretary)--
``(I) on the hospital's prices
(including the information described in
subparagraph (B)) for as many of the
Centers for Medicare & Medicaid
Services-specified shoppable services
that are furnished by the hospital, and
as many additional hospital-selected
shoppable services (or all such
additional services, if such hospital
furnishes fewer than 300 shoppable
services) as may be necessary for a
combined total of at least 300
shoppable services; and
``(II) that includes, with respect
to each Centers for Medicare & Medicaid
Services-specified shoppable service
that is not furnished by the hospital,
an indication that such service is not
so furnished; and
``(iii) an attestation that all information
made public pursuant to this subparagraph is
complete and accurate.
``(B) Information described.--For purposes of
subparagraph (A), the information described in this
subparagraph is, with respect to standard charges and
prices, as applicable, made public by a specified
hospital, the following:
``(i) A plain language description of each
item or service, accompanied by, as applicable,
the Healthcare Common Procedure Coding System
code, the diagnosis-related group, the national
drug code, or other identifier used or approved
by the Centers for Medicare & Medicaid
Services.
``(ii) The gross charge, as applicable,
expressed as a dollar amount, for each such
item or service, when provided in, as
applicable, the inpatient setting and
outpatient department setting.
``(iii) The discounted cash price, as
applicable, expressed as a dollar amount, for
each such item or service when provided in, as
applicable, the inpatient setting and
outpatient department setting (or, in the case
no discounted cash price is available for an
item or service, the median cash price charged
by the hospital to self-pay individuals for
such item or service when provided in such
settings for the previous three years,
expressed as a dollar amount, as well as, with
respect to prices made public pursuant to
subparagraph (A)(ii), a link to a consumer-
friendly document that clearly explains the
hospital's charity care policy that includes,
if applicable, any sliding scale payment
structure employed for determining charges for
a self-pay individual).
``(iv) The payer-specific negotiated
charges, as applicable, clearly associated with
the name of the third party payer and plan and
expressed as a dollar amount, that apply to
each such item or service when provided in, as
applicable, the inpatient setting and
outpatient department setting.
``(v) The de-identified maximum and minimum
negotiated charges, as applicable, for each
such item or service.
``(vi) Any other additional information the
Secretary may require for the purpose of
improving the accuracy of, or enabling
consumers to easily understand and compare,
standard charges and prices for an item or
service, except information that is duplicative
of any other reporting requirement under this
subsection.
In the case of standard charges and prices for an item
or service included as part of a bundled, per diem,
episodic, or other similar arrangement, the information
described in this subparagraph shall be made available
as determined appropriate by the Secretary.
``(C) Uniform method and format.--Not later than
January 1, 2026, the Secretary shall establish a
standard, uniform method and format for specified
hospitals to use in compiling and making public
standard charges pursuant to subparagraph (A)(i) and a
standard, uniform method and format for such hospitals
to use in compiling and making public prices pursuant
to subparagraph (A)(ii). Such methods and formats--
``(i) shall, in the case of such method and
format for making public standard charges
pursuant to subparagraph (A)(i), ensure that
such charges are made available in a machine-
readable format (or a successor technology
specified by the Secretary);
``(ii) may be similar to any template made
available by the Centers for Medicare &
Medicaid Services as of the date of the
enactment of this subparagraph;
``(iii) shall meet such standards as
determined appropriate by the Secretary in
order to ensure the accessibility and usability
of such charges and prices; and
``(iv) shall be updated as determined
appropriate by the Secretary, in consultation
with stakeholders.
``(3) Monitoring compliance.--The Secretary shall, through
notice and comment rulemaking and in consultation with the
Inspector General of the Department of Health and Human
Services, establish a process to monitor compliance with this
subsection. Such process shall ensure that each specified
hospital's compliance with this subsection is reviewed not less
frequently than once every 3 years.
``(4) Enforcement.--
``(A) In general.--In the case of a specified
hospital that fails to comply with the requirements of
this subsection--
``(i) not later than 30 days after the date
on which the Secretary determines such failure
exists, the Secretary shall submit to such
hospital a notification of such determination
(which may include, as determined appropriate
by the Secretary, a request for a corrective
action plan to comply with such requirements);
and
``(ii) in the case of a hospital that does
not receive a request for a corrective action
plan as part of a notification submitted by the
Secretary under clause (i)--
``(I) the Secretary shall, not
later than 45 days after such
notification is sent, determine whether
such hospital is in compliance with
such requirements; and
``(II) if the Secretary determines
under subclause (I) that such hospital
is not in compliance with such
requirements, the Secretary shall
either--
``(aa) submit to such
hospital a request for a
corrective action plan to
comply with such requirements;
or
``(bb) if the Secretary
determines that such hospital
has not taken meaningful
actions to come into compliance
since such notification was
sent, impose a civil monetary
penalty in accordance with
subparagraph (B).
``(B) Civil monetary penalty.--
``(i) In general.--Subject to clause (vii),
in addition to any other enforcement actions or
penalties that may apply under another
provision of law, a specified hospital that has
received a request for a corrective action plan
under clause (i) or (ii) of subparagraph (A)
and fails to comply with the requirements of
this subsection by the date that is 45 days
after such request is made, and a specified
hospital with respect to which the Secretary
has made a determination described in clause
(ii)(II)(bb) of such subparagraph, shall be
subject to a civil monetary penalty of an
amount specified by the Secretary for each day
(beginning with the day on which the Secretary
first determined that such hospital was not
complying with such requirements) during which
such failure was ongoing. Such amount shall not
exceed--
``(I) in the case of a specified
hospital with 30 or fewer beds, $300
per day (or, in the case of such a
hospital that has been noncompliant
with such requirements for a 1-year
period or longer, beginning with the
first day following such 1-year period,
$400 per day);
``(II) in the case of a specified
hospital with more than 30 beds but
fewer than 101 beds, $12.50 per bed per
day (or, in the case of such a hospital
that has been noncompliant with such
requirements for a 1-year period or
longer, beginning with the first day
following such 1-year period, $15 per
bed per day);
``(III) in the case of a specified
hospital with more than 100 beds but
fewer than 201 beds, $17.50 per bed per
day (or, in the case of such a hospital
that has been noncompliant with such
requirements for a 1-year period or
longer, beginning with the first day
following such 1-year period, $20 per
bed per day);
``(IV) in the case of a specified
hospital with more than 200 beds but
fewer than 501 beds, $20 per bed per
day (or, in the case of such a hospital
that has been noncompliant with such
requirements for a 1-year period or
longer, beginning with the first day
following such 1-year period, $25 per
bed per day); and
``(V) in the case of a specified
hospital with more than 500 beds, $25
per bed per day (or, in the case of
such a hospital that has been
noncompliant with such requirements for
a 1-year period or longer, beginning
with the first day following such 1-
year period, $35 per bed per day).
``(ii) Increase authority.--In applying
this subparagraph with respect to violations
occurring in 2027 or a subsequent year, the
Secretary may through notice and comment
rulemaking increase--
``(I) the limitation on the per day
amount of any penalty applicable to a
specified hospital under clause (i)(I);
``(II) the limitations on the per
bed per day amount of any penalty
applicable under any of subclauses (II)
through (V) of clause (i); and
``(III) the amounts specified in
clause (iii)(II).
``(iii) Persistent noncompliance.--
``(I) In general.--In the case of a
specified hospital (other than a
specified hospital with 30 or fewer
beds) that the Secretary has determined
to be knowingly and willfully
noncompliant with the provisions of
this subsection two or more times
during a 1-year period, the Secretary
may increase any penalty otherwise
applicable under this subparagraph by
the amount specified in subclause (II)
with respect to such hospital and may
require such hospital to complete such
additional corrective actions plans as
the Secretary may specify.
``(II) Specified amount.--For
purposes of subclause (I), the amount
specified in this subclause is, with
respect to a specified hospital--
``(aa) with more than 30
beds but fewer than 101 beds,
an amount that is not less than
$500,000 and not more than
$1,000,000;
``(bb) with more than 100
beds but fewer than 301 beds,
an amount that is greater than
$1,000,000 and not more than
$2,000,000;
``(cc) with more than 300
beds but fewer than 501 beds,
an amount that is greater than
$2,000,000 and not more than
$4,000,000; and
``(dd) with more than 500
beds, and amount that is not
less than $5,000,000 and not
more than $10,000,000.
``(iv) Authority to waive or reduce
penalty.--
``(I) In general.--Subject to
subclause (II), the Secretary may waive
any penalty, or reduce any penalty by
not more than 75 percent, otherwise
applicable under this subparagraph with
respect to a specified hospital located
in a rural or underserved area if the
Secretary certifies that imposition of
such penalty would result in an
immediate threat to access to care for
individuals in the service area of such
hospital.
``(II) Limitation on application.--
The Secretary may not elect to waive a
penalty under subclause (I) with
respect to a specified hospital more
than once in a 6-year period and may
not elect to reduce such a penalty with
respect to such a hospital more than
once in such a period. Nothing in the
preceding sentence shall be construed
as prohibiting the Secretary from both
waiving and reducing a penalty with
respect to a specified hospital during
a 6-year period.
``(v) Provision of technical assistance.--
The Secretary shall, to the extent practicable,
provide technical assistance relating to
compliance with the provisions of this
subsection to specified hospitals requesting
such assistance.
``(vi) 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 subparagraph in the same manner as such
provisions apply to a civil monetary penalty
imposed under subsection (a) of such section.
``(vii) Nonduplication of certain
penalties.--The Secretary may not subject a
specified hospital to a civil monetary penalty
under this subparagraph with respect to
noncompliance with the provisions of this
section for a period if the Secretary has
imposed a civil monetary penalty on such
hospital under section 2718(f) of the Public
Health Service Act for failure to comply with
the provisions of such section for such period.
``(C) Publication of hospital price transparency
information.--Beginning on January 1, 2026, the
Secretary shall make publicly available on the public
website of the Centers for Medicare & Medicaid Services
information with respect to compliance with the
requirements of this subsection and enforcement
activities undertaken by the Secretary under this
subsection. Such information shall be updated in real
time and include--
``(i) the number of reviews of compliance
with this subsection undertaken by the
Secretary;
``(ii) the number of notifications
described in subparagraph (A)(i) sent by the
Secretary;
``(iii) the identity of each specified
hospital that was sent such a notification and
a description of the nature of such hospital's
noncompliance with this subsection;
``(iv) the amount of any civil monetary
penalty imposed on such hospital under
subparagraph (B);
``(v) whether such hospital subsequently
came into compliance with this subsection;
``(vi) any waivers or reductions of
penalties made pursuant to a certification by
the Secretary under subparagraph (B)(iv),
including--
``(I) the name of any specified
hospital that received such a waiver or
reduction;
``(II) the dollar amount of each
such penalty so waived or reduced; and
``(III) the rationale for the
granting of each such waiver or
reduction; and
``(vii) any other information as determined
by the Secretary.
``(b) 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.
``(c) Definitions.--For purposes of this section:
``(1) Discounted cash price.--The term `discounted cash
price' means the charge that applies to an individual who pays
cash, or cash equivalent, for an item or service.
``(2) Federal health care program.--The term `Federal
health care program' has the meaning given such term in section
1128B.
``(3) Gross charge.--The term `gross charge' means the
charge for an individual item or service that is reflected on a
specified hospital's or provider of service's or supplier's, as
applicable, chargemaster, absent any discounts.
``(4) 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.
``(5) Payer-specific negotiated charge.--The term `payer-
specific negotiated charge' means the charge that a specified
hospital or provider of services or supplier, as applicable,
has negotiated with a third party payer for an item or service.
``(6) Shoppable service.--The term `shoppable service'
means a service that can be scheduled by a health care consumer
in advance and includes all ancillary items and services
customarily furnished as part of such service.
``(7) Specified hospital.--The term `specified hospital'
means a hospital (as defined in section 1861(e)), a critical
access hospital (as defined in section 1861(mmm)(1)), or a
rural emergency hospital (as defined in section 1861(kkk)).
``(8) 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.''.
(b) PHSA.--
(1) In general.--Section 2718 of the Public Health Service
Act (42 U.S.C. 300gg-18) is amended by adding at the end the
following new subsection:
``(f) Hospital Transparency Requirement.--
``(1) In general.--Beginning January 1, 2026, each hospital
shall comply with the price transparency requirement described
in paragraph (2).
``(2) Requirement described.--
``(A) In general.--For purposes of paragraph (1),
the price transparency requirement described in this
paragraph is, with respect to a hospital, that such
hospital, in accordance with a method and format
established by the Secretary under subparagraph (C),
compile and make public (without subscription and free
of charge) for each year--
``(i) all of the hospital's standard
charges (including the information described in
subparagraph (B)) for each item and service
furnished by such hospital;
``(ii) information in a consumer-friendly
format (as specified by the Secretary)--
``(I) on the hospital's prices
(including the information described in
subparagraph (B)) for as many of the
Centers for Medicare & Medicaid
Services-specified shoppable services
that are furnished by the hospital, and
as many additional hospital-selected
shoppable services (or all such
additional services, if such hospital
furnishes fewer than 300 shoppable
services) as may be necessary for a
combined total of at least 300
shoppable services; and
``(II) that includes, with respect
to each Centers for Medicare & Medicaid
Services-specified shoppable service
that is not furnished by the hospital,
an indication that such service is not
so furnished; and
``(iii) an attestation that all information
made public pursuant to this subparagraph is
complete and accurate.
``(B) Information described.--For purposes of
subparagraph (A), the information described in this
subparagraph is, with respect to standard charges and
prices, as applicable, made public by a hospital, the
following:
``(i) A plain language description of each
item or service, accompanied by, as applicable,
the Healthcare Common Procedure Coding System
code, the diagnosis-related group, the national
drug code, current procedure terminology codes,
or other identifier used or approved by the
Centers for Medicare & Medicaid Services.
``(ii) The gross charge, as applicable,
expressed as a dollar amount, for each such
item or service, when provided in, as
applicable, the inpatient setting and
outpatient department setting.
``(iii) The discounted cash price, as
applicable, expressed as a dollar amount, for
each such item or service when provided in, as
applicable, the inpatient setting and
outpatient department setting (or, in the case
no discounted cash price is available for an
item or service, the median cash price charged
by the hospital to self-pay individuals for
such item or service when provided in such
settings for the previous three years,
expressed as a dollar amount, as well as, with
respect to prices made public pursuant to
subparagraph (A)(ii), a link to a consumer-
friendly document that clearly explains the
hospital's charity care policy that includes,
if applicable, any sliding scale payment
structure employed for determining charges for
a self-pay individual).
``(iv) The payer-specific negotiated
charges, as applicable, clearly associated with
the name of the third party payer and plan and
expressed as a dollar amount, that apply to
each such item or service when provided in, as
applicable, the inpatient setting and
outpatient department setting.
``(v) The de-identified maximum and minimum
negotiated charges, as applicable, for each
such item or service.
``(vi) Any other additional information the
Secretary may require for the purpose of
improving the accuracy of, or enabling
consumers to easily understand and compare,
standard charges and prices for an item or
service, except information that is duplicative
of any other reporting requirement under this
subsection.
In the case of standard charges and prices for an item
or service included as part of a bundled, per diem,
episodic, or other similar arrangement, the information
described in this subparagraph shall be made available
as determined appropriate by the Secretary.
``(C) Uniform method and format.--Not later than
January 1, 2026, the Secretary shall establish a
standard, uniform method and format for hospitals to
use in compiling and making public standard charges
pursuant to subparagraph (A)(i) and a standard, uniform
method and format for such hospitals to use in
compiling and making public prices pursuant to
subparagraph (A)(ii). Such methods and formats--
``(i) shall, in the case of such method and
format for making public standard charges
pursuant to subparagraph (A)(i), ensure that
such charges are made available in a machine-
readable format (or a successor technology
specified by the Secretary);
``(ii) may be similar to any template made
available by the Centers for Medicare &
Medicaid Services as of the date of the
enactment of this subparagraph;
``(iii) shall meet such standards as
determined appropriate by the Secretary in
order to ensure the accessibility and usability
of such charges and prices; and
``(iv) shall be updated as determined
appropriate by the Secretary, in consultation
with stakeholders.
``(3) Monitoring compliance.--The Secretary shall, through
notice and comment rulemaking and in consultation with the
Inspector General of the Department of Health and Human
Services, establish a process to monitor compliance with this
subsection. Such process shall ensure that each hospital's
compliance with this subsection is reviewed not less frequently
than once every 3 years.
``(4) Enforcement.--
``(A) In general.--In the case of a hospital that
fails to comply with the requirements of this
subsection--
``(i) not later than 30 days after the date
on which the Secretary determines such failure
exists, the Secretary shall submit to such
hospital a notification of such determination
(which may include, as determined appropriate
by the Secretary, a request for a corrective
action plan to comply with such requirements);
and
``(ii) in the case of a hospital that does
not receive a request for a corrective action
plan as part of a notification submitted by the
Secretary under clause (i)--
``(I) the Secretary shall, not
later than 45 days after such
notification is sent, determine whether
such hospital is in compliance with
such requirements; and
``(II) if the Secretary determines
under subclause (I) that such hospital
is not in compliance with such
requirements, the Secretary shall
either--
``(aa) submit to such
hospital a request for a
corrective action plan to
comply with such requirements;
or
``(bb) if the Secretary
determines that such hospital
has not taken meaningful
actions to come into compliance
since such notification was
sent, impose a civil monetary
penalty in accordance with
subparagraph (B).
``(B) Civil monetary penalty.--
``(i) In general.--In addition to any other
enforcement actions or penalties that may apply
under another provision of law, a hospital that
has received a request for a corrective action
plan under clause (i) or (ii) of subparagraph
(A) and fails to comply with the requirements
of this subsection by the date that is 45 days
after such request is made, and a hospital with
respect to which the Secretary has made a
determination described in clause (ii)(II)(bb)
of such subparagraph, shall be subject to a
civil monetary penalty of an amount specified
by the Secretary for each day (beginning with
the day on which the Secretary first determined
that such hospital was not complying with such
requirements) during which such failure was
ongoing. Such amount shall not exceed--
``(I) in the case of a hospital
with 30 or fewer beds, $300 per day
(or, in the case of such a hospital
that has been noncompliant with such
requirements for a 1-year period or
longer, beginning with the first day
following such 1-year period, $400 per
bed per day);
``(II) in the case of a hospital
with more than 30 beds but fewer than
101 beds, $12.50 per bed per day (or,
in the case of such a hospital that has
been noncompliant with such
requirements for a 1-year period or
longer, beginning with the first day
following such 1-year period, $15 per
bed per day);
``(III) in the case of a hospital
with more than 100 beds but fewer than
201 beds, $17.50 per bed per day (or,
in the case of such a hospital that has
been noncompliant with such
requirements for a 1-year period or
longer, beginning with the first day
following such 1-year period, $20 per
bed per day);
``(IV) in the case of a hospital
with more than 200 beds but fewer than
501 beds, $20 per bed per day (or, in
the case of such a hospital that has
been noncompliant with such
requirements for a 1-year period or
longer, beginning with the first day
following such 1-year period, $25 per
bed per day); and
``(V) in the case of a hospital
with more than 500 beds, $25 per bed
per day (or, in the case of such a
hospital that has been noncompliant
with such requirements for a 1-year
period or longer, beginning with the
first day following such 1-year period,
$35 per bed per day).
``(ii) Increase authority.--In applying
this subparagraph with respect to violations
occurring in 2027 or a subsequent year, the
Secretary may through notice and comment
rulemaking increase--
``(I) the limitation on the per day
amount of any penalty applicable to a
hospital under clause (i)(I);
``(II) the limitations on the per
bed per day amount of any penalty
applicable under any of subclauses (II)
through (V) of clause (i); and
``(III) the amounts specified in
clause (iii)(II).
``(iii) Persistent noncompliance.--
``(I) In general.--In the case of a
hospital (other than a hospital with 30
or fewer beds) that the Secretary has
determined to be knowingly and
willfully noncompliant with the
provisions of this subsection two or
more times during a 1-year period, the
Secretary may increase any penalty
otherwise applicable under this
subparagraph by the amount specified in
subclause (II) with respect to such
hospital and may require such hospital
to complete such additional corrective
actions plans as the Secretary may
specify.
``(II) Specified amount.--For
purposes of subclause (I), the amount
specified in this subclause is, with
respect to a hospital--
``(aa) with more than 30
beds but fewer than 101 beds,
an amount that is not less than
$500,000 and not more than
$1,000,000;
``(bb) with more than 100
beds but fewer than 301 beds,
an amount that is greater than
$1,000,000 and not more than
$2,000,000;
``(cc) with more than 300
beds but fewer than 501 beds,
an amount that is greater than
$2,000,000 and not more than
$4,000,000; and
``(dd) with more than 500
beds, and amount that is not
less than $5,000,000 and not
more than $10,000,000.
``(iv) Authority to waive or reduce
penalty.--
``(I) In general.--Subject to
subclause (II), the Secretary may waive
any penalty, or reduce any penalty by
not more than 75 percent, otherwise
applicable under this subparagraph with
respect to a hospital located in a
rural or underserved area if the
Secretary certifies that imposition of
such penalty would result in an
immediate threat to access to care for
individuals in the service area of such
hospital.
``(II) Limitation on application.--
The Secretary may not elect to waive a
penalty under subclause (I) with
respect to a hospital more than once in
a 6-year period and may not elect to
reduce such a penalty with respect to
such a hospital more than once in such
a period. Nothing in the preceding
sentence shall be construed as
prohibiting the Secretary from both
waiving and reducing a penalty with
respect to a hospital during a 6-year
period.
``(v) Provision of technical assistance.--
The Secretary shall, to the extent practicable,
provide technical assistance relating to
compliance with the provisions of this section
to hospitals requesting such assistance.
``(vi) 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 subparagraph in the same manner as such
provisions apply to a civil monetary penalty
imposed under subsection (a) of such section.
``(vii) Nonduplication of penalties.--The
Secretary may not subject a hospital to a civil
monetary penalty under this subparagraph with
respect to noncompliance with the provisions of
this subsection for a period if the Secretary
has imposed a civil monetary penalty on such
hospital under section 1899C of the Social
Security Act for failure to comply with the
provisions of such section for such period.
``(C) Publication of hospital price transparency
information.--Beginning on January 1, 2026, the
Secretary shall make publicly available on the public
website of the Centers for Medicare & Medicaid Services
information with respect to compliance with the
requirements of this subsection and enforcement
activities undertaken by the Secretary under this
subsection. Such information shall be updated in real
time and include--
``(i) the number of reviews of compliance
with this subsection undertaken by the
Secretary;
``(ii) the number of notifications
described in subparagraph (A)(i) sent by the
Secretary;
``(iii) the identity of each hospital that
was sent such a notification and a description
of the nature of such hospital's noncompliance
with this subsection;
``(iv) the amount of any civil monetary
penalty imposed on such hospital under
subparagraph (B);
``(v) whether such hospital subsequently
came into compliance with this subsection;
``(vi) any waivers or reductions of
penalties made pursuant to a certification by
the Secretary under subparagraph (B)(iv),
including--
``(I) the name of any hospital that
received such a waiver or reduction;
``(II) the dollar amount of each
such penalty so waived or reduced; and
``(III) the rationale for the
granting of each such waiver or
reduction; and
``(vii) any other information as determined
by the Secretary.
``(5) 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.
``(6) Definitions.--For purposes of this subsection:
``(A) 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-furnished item or service.
``(B) Federal health care program.--The term
`Federal health care program' has the meaning given
such term in section 1128B of the Social Security Act.
``(C) 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.
``(D) 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.
``(E) Shoppable service.--The term `shoppable
service' means a service that can be scheduled by a
health care consumer in advance and includes all
ancillary items and services customarily furnished as
part of such service.
``(F) 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.''.
(2) Conforming amendments.--Section 2718 of the Public
Health Service Act (42 U.S.C. 300gg-18) is amended--
(A) in subsection (b)(3), by inserting ``(other
than the provisions of subsection (f))'' after ``this
section''; and
(B) in subsection (e), by adding at the end the
following new sentence: ``The preceding provisions of
this subsection shall not apply beginning on January 1,
2026.''.
(3) Effective date.--The amendments made by this subsection
shall apply beginning January 1, 2026.
(c) 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. CLINICAL DIAGNOSTIC LABORATORY TEST PRICE TRANSPARENCY.
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, 2026, any
applicable laboratory that receives payment under this title
for furnishing 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 laboratory so furnishes; 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 an applicable laboratory 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 payer-specific
negotiated charge between such laboratory and any third
party payer for such test.
``(C) The deidentified maximum payer-specific
negotiated charge between such laboratory and any third
party payer for such test.
``(3) Uniform method and format.--Not later than January 1,
2026, the Secretary shall establish a standard, uniform method
and format for applicable laboratories to use in compiling and
making public information pursuant to paragraph (1). Such
method and format--
``(A) may be similar to any template made available
by the Centers for Medicare & Medicaid Services (as
described in section 1899C(a)(2)(C)(ii));
``(B) shall meet such standards as determined
appropriate by the Secretary in order to ensure the
accessibility and usability of such information; and
``(C) shall be updated as determined appropriate by
the Secretary, in consultation with stakeholders.
``(4) Inclusion of ancillary services.--Any price or rate
for a specified clinical diagnostic laboratory test available
to be furnished by an applicable laboratory 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 laboratory as part of such test, as specified
by the Secretary.
``(5) Enforcement.--
``(A) In general.--In the case that the Secretary
determines that an applicable laboratory is not in
compliance with paragraph (1)--
``(i) not later than 30 days after such
determination, the Secretary shall notify such
laboratory of such determination; and
``(ii) if such laboratory 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 (beginning with the day on which the
Secretary first determined that such laboratory
was failing to comply with such paragraph)
during which such failure is ongoing.
``(B) Increase authority.--In applying this
paragraph with respect to violations occurring in 2027
or a subsequent year, the Secretary may through notice
and comment rulemaking increase the per day limitation
on civil monetary penalties under subparagraph (A)(ii).
``(C) 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.
``(6) Provision of technical assistance.--The Secretary
shall, to the extent practicable, provide technical assistance
relating to compliance with the provisions of this subsection
to applicable laboratories requesting such assistance.
``(7) Definitions.--In this subsection:
``(A) Applicable laboratory.--The term `applicable
laboratory' has the meaning given such term in section
414.502, of title 42, Code of Federal Regulations (or a
successor regulation), except that such term does not
include a laboratory with respect to which standard
charges and prices for specified clinical diagnostic
laboratory tests furnished by such laboratory are made
available by a hospital pursuant to section 1899C or
section 2718(f) of the Public Health Service Act.
``(B) Discounted cash price.--The term `discounted
cash price' means the charge that applies to an
individual who pays cash, or cash equivalent, for an
item or service.
``(C) Gross charge.--The term `gross charge' means
the charge for an individual item or service that is
reflected on an applicable laboratory's chargemaster,
absent any discounts.
``(D) Payer-specific negotiated charge.--The term
`payer-specific negotiated charge' means the charge
that an applicable laboratory has negotiated with a
third party payer for an item or service.
``(E) 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
1899C(a)(2)(A)(ii)(I)), other than such a test that is
only available to be furnished by a single provider of
services or supplier.
``(F) 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.''.
SEC. 103. IMAGING PRICE TRANSPARENCY.
Section 1899C of the Social Security Act, as added by section 101,
is amended--
(1) by redesignating subsection (b) as subsection (c);
(2) by inserting after subsection (a) the following new
subsection:
``(b) Imaging Services Price Transparency.--
``(1) In general.--Beginning January 1, 2028, each provider
of services and supplier that receives payment under this title
for furnishing a specified imaging service, other than such a
provider or supplier with respect to which standard charges and
prices for such services furnished by such provider or supplier
are made available by a hospital pursuant to section 1899C or
section 2718(f) of the Public Health Service Act, shall--
``(A) make publicly available (in accordance with
paragraph (3)) on an internet website the information
described in paragraph (2) with respect to each such
service that such provider of services or supplier
furnishes; 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
imaging service, the following:
``(A) The discounted cash price for such service
(or, if no such price exists, the gross charge for such
service).
``(B) If required by the Secretary, the
deidentified minimum payer-specific negotiated charge
for such service and the deidentified maximum payer-
specific negotiated charge for such service.
``(3) Uniform method and format.--Not later than January 1,
2028, the Secretary shall establish a standard, uniform method
and format for providers of services and suppliers to use in
making public information described in paragraph (2). Any such
method and format--
``(A) may be similar to any template made available
by the Centers for Medicare & Medicaid Services (as
described in section 1899C(a)(2)(C)(ii));
``(B) shall meet such standards as determined
appropriate by the Secretary in order to ensure the
accessibility and usability of such information; and
``(C) shall be updated as determined appropriate by
the Secretary, in consultation with stakeholders.
``(4) Monitoring compliance.--The Secretary shall, through
notice and comment rulemaking and in consultation with the
Inspector General of the Department of Health and Human
Services, establish a process to monitor compliance with this
subsection.
``(5) 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) upon request of the Secretary, such
provider or supplier shall submit to the
Secretary, not later than 45 days after the
date of such request, a corrective action plan
to comply with such paragraph; 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 (or, in the case of such a
provider or supplier that has submitted a
corrective action plan described in clause (ii)
in response to a request so described, after
the date that is 90 days after such
submission), the Secretary may impose a civil
monetary penalty in an amount not to exceed
$300 for each day (beginning with the day on
which the Secretary first determined that such
provider or supplier was failing to comply with
such paragraph) during which such failure to
comply or failure to submit is ongoing.
``(B) Increase authority.--In applying this
paragraph with respect to violations occurring in 2029
or a subsequent year, the Secretary may through notice
and comment rulemaking increase the amount of the civil
monetary penalty under subparagraph (A)(iii).
``(C) 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.
``(D) Authority to waive or reduce penalty.--
``(i) In general.--Subject to clause (ii),
the Secretary may waive or reduce any penalty
otherwise applicable with respect to a provider
of services or supplier under this subparagraph
if the Secretary certifies that imposition of
such penalty would result in an immediate
threat to access to care for individuals in the
service area of such provider or supplier.
``(ii) Limitation.--The Secretary may not
elect to waive or reduce a penalty under clause
(i) with respect to a specific provider of
services or supplier more than 3 times.
``(E) Provision of technical assistance.--The
Secretary shall, to the extent practicable, provide
technical assistance relating to compliance with the
provisions of this subsection to providers of services
and suppliers requesting such assistance.
``(F) Clarification of nonapplicability of other
enforcement provisions.--Notwithstanding any other
provision of this title, this paragraph shall be the
sole means of enforcing the provisions of this
subsection.''; and
(3) in subsection (c), as so redesignated by paragraph
(1)--
(A) by redesignating paragraph (8) as paragraph
(9); and
(B) by inserting after paragraph (7) the following
new paragraph:
``(8) Specified imaging service.--the term `specified
imaging service' means an imaging service that is a Centers for
Medicare & Medicaid Services-specified shoppable service (as
described in subsection (a)(2)(A)(ii)(I)).''.
SEC. 104. AMBULATORY SURGICAL CENTER PRICE TRANSPARENCY.
Section 1834 of the Social Security Act (42 U.S.C. 1395m) is
amended by adding at the end the following new subsection:
``(aa) Ambulatory Surgical Center Price Transparency.--
``(1) In general.--Beginning January 1, 2026, each
ambulatory surgical center that receives payment under this
title for furnishing items and services shall comply with the
price transparency requirement described in paragraph (2).
``(2) Requirement described.--
``(A) In general.--For purposes of paragraph (1),
the price transparency requirement described in this
subsection is, with respect to an ambulatory surgical
center, that such surgical center in accordance with a
method and format established by the Secretary under
subparagraph (C), compile and make public (without
subscription and free of charge), for each year--
``(i) all of the ambulatory surgical
center's standard charges (including the
information described in subparagraph (B)) for
each item and service furnished by such
surgical center;
``(ii) information on the ambulatory
surgical center's prices (including the
information described in subparagraph (B)) for
as many of the Centers for Medicare & Medicaid
Services-specified shoppable services that are
furnished by such surgical center, and as many
additional ambulatory surgical center-selected
shoppable services (or all such additional
services, if such surgical center furnishes
fewer than 300 shoppable services) as may be
necessary for a combined total of at least 300
shoppable services; and
``(iii) with respect to each Centers for
Medicare & Medicaid Services-specified
shoppable service that is not furnished by the
ambulatory surgical center, an indication that
such service is not so furnished.
``(B) Information described.--For purposes of
subparagraph (A), the information described in this
subparagraph is, with respect to standard charges and
prices (as applicable) made public by an ambulatory
surgical center, the following:
``(i) A plain language description of each
item or service, accompanied by, as applicable,
the Healthcare Common Procedure Coding System
code, the diagnosis-related group, the national
drug code, or other identifier used or approved
by the Centers for Medicare & Medicaid
Services.
``(ii) The gross charge, as applicable,
expressed as a dollar amount, for each such
item or service.
``(iii) The discounted cash price, as
applicable, expressed as a dollar amount, for
each such item or service (or, in the case no
discounted cash price is available for an item
or service, the median cash price charged to
self-pay individuals for such item or service
for the previous three years, expressed as a
dollar amount).
``(iv) The 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.
``(v) The de-identified maximum and minimum
negotiated charges, as applicable, for each
such item or service.
``(vi) Any other additional information the
Secretary may require for the purpose of
improving the accuracy of, or enabling
consumers to easily understand and compare,
standard charges and prices for an item or
service, except information that is duplicative
of any other reporting requirement under this
subsection.
``(C) Uniform method and format.--Not later than
January 1, 2026, the Secretary shall establish a
standard, uniform method and format for ambulatory
surgical centers to use in making public standard
charges and a standard, uniform method and format for
such centers to use in making public prices pursuant to
subparagraph (A). Any such method and format--
``(i) shall, in the case of such charges
made public by an ambulatory surgical center,
ensure that such charges are made available in
a machine-readable format (or successor
technology);
``(ii) may be similar to any template made
available by the Centers for Medicare &
Medicaid Services as of the date of the
enactment of this paragraph;
``(iii) shall meet such standards as
determined appropriate by the Secretary in
order to ensure the accessibility and usability
of such charges and prices; and
``(iv) shall be updated as determined
appropriate by the Secretary, in consultation
with stakeholders.
``(3) Monitoring compliance.--The Secretary shall, through
notice and comment rulemaking and in consultation with the
Inspector General of the Department of Health and Human
Services, establish a process to monitor compliance with this
subsection. Such process shall ensure that each ambulatory
surgical center's compliance with this subsection is reviewed
not less frequently than once every 3 years.
``(4) Enforcement.--
``(A) In general.--In the case of an ambulatory
surgical center that fails to comply with the
requirements of this subsection--
``(i) the Secretary shall notify such
ambulatory surgical center of such failure not
later than 30 days after the date on which the
Secretary determines such failure exists; and
``(ii) upon request of the Secretary, the
ambulatory surgical center shall submit to the
Secretary, not later than 45 days after the
date of such request, 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 another provision of law, an ambulatory
surgical center that has received a
notification under subparagraph (A)(i) and
fails to comply with the requirements of this
subsection by the date that is 90 days after
such notification (or, in the case of an
ambulatory surgical center that has submitted a
corrective action plan described in
subparagraph (A)(ii) in response to a request
so described, by the date that is 90 days after
such submission) shall be subject to a civil
monetary penalty of an amount specified by the
Secretary for each subsequent day during which
such failure is ongoing (not to exceed $300 per
day).
``(ii) Increase authority.--In applying
this subparagraph with respect to violations
occurring in 2027 or a subsequent year, the
Secretary may through notice and comment
rulemaking increase the limitation on the per
day amount of any penalty applicable to an
ambulatory surgical center under clause (i).
``(iii) 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 subparagraph in the
same manner as such provisions apply to a civil
monetary penalty imposed under subsection (a)
of such section.
``(iv) Authority to waive or reduce
penalty.--
``(I) In general.--Subject to
subclause (II), the Secretary may waive
any penalty, or reduce any penalty by
not more than 75 percent, otherwise
applicable under this subparagraph with
respect to an ambulatory surgical
center located in a rural or
underserved area if the Secretary
certifies that imposition of such
penalty would result in an immediate
threat to access to care for
individuals in the service area of such
surgical center.
``(II) Limitation on application.--
The Secretary may not elect to waive a
penalty under subclause (I) with
respect to an ambulatory surgical
center more than once in a 6-year
period and may not elect to reduce such
a penalty with respect to such a
surgical center more than once in such
a period. Nothing in the preceding
sentence shall be construed as
prohibiting the Secretary from both
waiving and reducing a penalty with
respect to an ambulatory surgical
center during a 6-year period.
``(5) Definitions.--For purposes of this section:
``(A) Discounted cash price.--The term `discounted
cash price' means the charge that applies to an
individual who pays cash, or cash equivalent, for a
item or service furnished by an ambulatory surgical
center.
``(B) Federal health care program.--The term
`Federal health care program' has the meaning given
such term in section 1128B.
``(C) Gross charge.--The term `gross charge' means
the charge for an individual item or service that is
reflected on an ambulatory surgical center's
chargemaster, absent any discounts.
``(D) 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.
``(E) Payer-specific negotiated charge.--The term
`payer-specific negotiated charge' means the charge
that an ambulatory surgical center 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 and includes all
ancillary items and services customarily furnished as
part of such service.
``(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.''.
SEC. 105. HEALTH COVERAGE PRICE TRANSPARENCY.
(a) Price Transparency Requirements.--
(1) IRC.--
(A) In general.--Section 9819 of the Internal
Revenue Code of 1986 is amended to read as follows:
``SEC. 9819. TRANSPARENCY IN COVERAGE.
``(a) Cost-sharing Transparency.--
``(1) In general.--For plan years beginning on or after
January 1, 2026, a group health plan shall permit a participant
or beneficiary to learn the amount of cost-sharing (including
deductibles, copayments, and coinsurance) under the participant
or beneficiary's plan that the participant or beneficiary would
be responsible for paying with respect to the furnishing of a
specific item or service by a provider in a timely manner upon
the request of the participant or beneficiary. At a minimum,
such information shall include the information specified in
paragraph (2) and shall be made available to such participant
or beneficiary through a self-service tool that meets the
requirements of paragraph (3) or, at the option of such
participant or beneficiary, through a paper disclosure or phone
or other electronic disclosure (as selected by such participant
or beneficiary and provided at no cost to such participant or
beneficiary) that meets such requirements as the Secretary may
specify.
``(2) Specified information.--For purposes of paragraph
(1), the information specified in this paragraph is, with
respect to an item or service for which benefits are available
under a group health plan furnished by a health care provider
to a participant or beneficiary of such plan, the following:
``(A) If such provider is a participating provider
with respect to such item or service, the in-network
rate (as defined in subsection (c)) for such item or
service.
``(B) If such provider is not a participating
provider with respect to such item or service, the
maximum allowed amount or other dollar amount that such
plan or coverage will recognize as payment for such
item or service, along with a notice that such
participant or beneficiary may be liable for additional
charges.
``(C) The estimated amount of cost sharing
(including deductibles, copayments, and coinsurance)
that the participant or beneficiary will incur for such
item or service (which, in the case such item or
service is to be furnished by a provider described in
subparagraph (B), shall be calculated using the maximum
allowed amount or other dollar amount described in such
subparagraph).
``(D) The amount the participant or beneficiary 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 participants and beneficiaries enrolled in the
plan, by such separate deductibles or maximums, in
addition to any cumulative deductible or maximum).
``(E) 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 participant or beneficiary has
accrued towards such limitation with respect to such
item or service.
``(F) Any prior authorization, concurrent review,
step therapy, fail first, or similar requirements
applicable to coverage of such item or service under
such plan.
``(G) Any shared savings (such as any credit,
payment, or other benefit provided by such plan)
available to the participant or beneficiary with
respect to such item or service furnished by such
provider known at the time such request is made.
``(3) Self-service tool.--For purposes of paragraph (1), a
self-service tool established by a group health plan meets the
requirements of this paragraph if such tool--
``(A) is based on an Internet website (or successor
technology specified by the Secretary);
``(B) provides for real-time responses to requests
described in paragraph (1);
``(C) is updated in a manner such that information
provided through such tool is timely and accurate at
the time such request is made;
``(D) allows such a request to be made with respect
to an item or service furnished by--
``(i) a specific provider that is a
participating provider with respect to such
item or service; or
``(ii) all providers that are participating
providers with respect to such item or service;
``(E) 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; and
``(F) meets any other requirement determined
appropriate by the Secretary to ensure the
accessibility and usability of information provided
through such tool.
The Secretary may require such tool, as a condition of
complying with subparagraph (E), to link multiple billing codes
to a single descriptive term if the Secretary determines that
the billing codes to be so linked correspond to similar items
and services.
``(b) Rate and Payment Information.--
``(1) In general.--For plan years beginning on or after
January 1, 2026, each group health plan (other than a
grandfathered health plan (as defined in section 1251(e) of the
Patient Protection and Affordable Care Act)) shall, for each
month, not later than the tenth day of such month, make
available to the public the rate and payment information
described in paragraph (2) in accordance with paragraph (3).
``(2) Rate and payment information described.--For purposes
of paragraph (1), the rate and payment information described in
this paragraph is, with respect to a group health plan, the
following:
``(A) With respect to each item or service (other
than a drug) for which benefits are available under
such plan, the in-network rate (expressed as a dollar
amount) in effect as of the date on which such
information is made public with each provider that is a
participating provider with respect to such item or
service.
``(B) With respect to each drug (identified by
national drug code) for which benefits are available
under such plan--
``(i) the in-network rate (expressed as a
dollar amount) in effect as of the first day of
the month in which such information is made
public with each provider that is a
participating provider with respect to such
drug; and
``(ii) 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 publication to
each provider that was a participating provider
with respect to such drug, broken down by each
such provider, other than such an amount paid
to a provider that, during such period,
submitted fewer than 20 claims for such drug to
such plan.
``(C) 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 subparagraph (B) by a provider that
was not a participating provider with respect to such
item or service, broken down by each such provider.
``(3) Manner of publication.--Rate and payment information
required to be made available under this subsection shall be so
made available in dollar amounts through separate machine-
readable files (and any successor technology, such as
application program interface technology, determined
appropriate by the Secretary) corresponding to the information
described in each of subparagraphs (A) through (C) of paragraph
(2) that meet such requirements as specified by the Secretary
through subregulatory guidance. Such requirements shall ensure
that such files are limited to an appropriate size, do not
include disclosure of unnecessary duplicative information
contained in other files made available under this subsection,
are made available in a widely available format through a
publicly available website that allows for information
contained in such files to be compared across group health
plans and group or individual health insurance coverage, and
are accessible to individuals at no cost and without the need
to establish a user account or provide other credentials.
``(4) User instructions.--Each group health plan shall make
available to the public instructions written in plain language
explaining how individuals may search for information described
in paragraph (2) in files submitted in accordance with
paragraph (3). The Secretary shall develop and publish through
subregulatory guidance a template that such a plan may use in
developing instructions for purposes of the preceding sentence.
``(5) Summary.--For each plan year beginning on or after
January 1, 2026, each group health plan shall make public a
data file, in a manner that ensures that such file may be
easily downloaded and read by standard spreadsheet software and
that meets such requirements as established by the Secretary,
containing a summary of all rate and payment information made
public by such plan with respect to such plan during such plan
year. Such file shall include the following:
``(A) The mean, median, and interquartile range of
the in-network rate, and the amount allowed for an item
or service when not furnished by a participating
provider, in effect as of the first day of such plan
year for each item or service (identified by payer
identifier approved or used by the Centers for Medicare
& Medicaid Services) for which benefits are available
under the plan, broken down by the type of provider
furnishing the item or service and by the geographic
area in which such item or service is furnished.
``(B) Trends in payment rates for such items and
services over such plan year, including an
identification of instances in which such rates have
increased, decreased, or remained the same.
``(C) The name of such plan, a description of the
type of network of participating providers used by such
plan, and a description of whether such plan is self-
insured or fully-insured.
``(D) For each item or service which is paid as
part of a bundled rate--
``(i) a description of the formulae,
pricing methodologies, or other information
used to calculate the payment rate for such
bundle; and
``(ii) a list of the items and services
included in such bundle.
``(E) The percentage of items and services that are
paid for on a fee-for-service basis and the percentage
of items and services that are paid for as part of a
bundled rate, capitated payment rate, or other
alternative payment model.
``(6) Attestation.--Each group health plan shall post,
along with rate and payment information made public by such
plan, an attestation that such information is complete and
accurate.
``(c) Accessibility.--A group health plan shall take reasonable
steps (as specified by the Secretary) to ensure that information
provided in response to a request described in subsection (a), and rate
and payment information made public under subsection (b), is provided
in plain, easily understandable language and that interpretation,
translations, and assistive services are provided to those with limited
English proficiency and those with disabilities.
``(d) Definitions.--In this section:
``(1) Participating provider.--The term `participating
provider' means, with respect to an item or service and a group
health plan, a physician or other health care provider who is
acting within the scope of practice of that provider's license
or certification under applicable State law and who has a
contractual relationship with the plan, respectively, for
furnishing such item or service under the plan, and includes
facilities, respectively.
``(2) Provider.--The term `provider' includes a health care
facility.
``(3) In-network rate.--The term `in-network rate' means,
with respect to a group 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
(reflected as a dollar amount) in effect between such plan and
such provider for such item or service, regardless of whether
such rate is calculated based on a set amount, a fee schedule,
or an amount derived from another amount, or a formula, or
other method.''.
(B) Clerical amendment.--The item relating to
section 9819 of the table of sections for subchapter B
of chapter 100 of the Internal Revenue Code of 1986 is
amended to read as follows:
``Sec. 9819. Transparency in coverage.''.
(2) PHSA.--Section 2799A-4 of the Public Health Service Act
(42 U.S.C. 300gg-114) is amended to read as follows:
``SEC. 2799A-4. TRANSPARENCY IN COVERAGE.
``(a) Cost-sharing Transparency.--
``(1) In general.--For plan years beginning on or after
January 1, 2026, a group health plan and a health insurance
issuer offering group or individual health insurance coverage
shall permit an individual enrolled under such plan or coverage
to learn the amount of cost-sharing (including deductibles,
copayments, and coinsurance) under the individual's plan or
coverage that the individual would be responsible for paying
with respect to the furnishing of a specific item or service by
a provider in a timely manner upon the request of the
individual. At a minimum, such information shall include the
information specified in paragraph (2) and shall be made
available to such individual through a self-service tool that
meets the requirements of paragraph (3) or, at the option of
such individual, through a paper disclosure or phone or other
electronic disclosure (as selected by such individual and
provided at no cost to such individual) that meets such
requirements as the Secretary may specify.
``(2) Specified information.--For purposes of paragraph
(1), the information specified in this paragraph is, with
respect to an item or service for which benefits are available
under a group health plan or group or individual health
insurance coverage furnished by a health care provider to an
individual enrolled under such plan or coverage, the following:
``(A) If such provider is a participating provider
with respect to such item or service, the in-network
rate (as defined in subsection (c)) for such item or
service.
``(B) If such provider is not a participating
provider with respect to such item or service, the
maximum allowed amount or other dollar amount that such
plan or coverage will recognize as payment for such
item or service, along with a notice that such
individual may be liable for additional charges.
``(C) The estimated 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 subparagraph (B),
shall be calculated using the maximum allowed amount or
other dollar amount described in such subparagraph).
``(D) The amount the individual has already
accumulated with respect to any deductible or out of
pocket maximum under the plan or coverage (broken down,
in the case separate deductibles or maximums apply to
separate individuals enrolled in the plan or coverage,
by such separate deductibles or maximums, in addition
to any cumulative deductible or maximum).
``(E) 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.
``(F) Any prior authorization, concurrent review,
step therapy, fail first, or similar requirements
applicable to coverage of such item or service under
such plan or coverage.
``(G) Any shared savings (such as any credit,
payment, or other benefit provided by such plan or
issuer) available to the individual with respect to
such item or service furnished by such provider known
at the time such request is made.
``(3) Self-service tool.--For purposes of paragraph (1), a
self-service tool established by a group health plan or health
insurance issuer offering group or individual health insurance
coverage meets the requirements of this paragraph if such
tool--
``(A) is based on an internet website (or successor
technology specified by the Secretary);
``(B) provides for real-time responses to requests
described in paragraph (1);
``(C) is updated in a manner such that information
provided through such tool is timely and accurate at
the time such request is made;
``(D) allows such a request to be made with respect
to an item or service furnished by--
``(i) a specific provider that is a
participating provider with respect to such
item or service; or
``(ii) all providers that are participating
providers with respect to such item or service;
``(E) 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; and
``(F) meets any other requirement determined
appropriate by the Secretary to ensure the
accessibility and usability of information provided
through such tool.
The Secretary may require such tool, as a condition of
complying with subparagraph (E), to link multiple billing codes
to a single descriptive term if the Secretary determines that
the billing codes to be so linked correspond to similar items
and services.
``(b) Rate and Payment Information.--
``(1) In general.--For plan years beginning on or after
January 1, 2026, each group health plan and health insurance
issuer offering group or individual health insurance coverage
(other than a grandfathered health plan (as defined in section
1251(e) of the Patient Protection and Affordable Care Act))
shall, for each month, not later than the tenth day of such
month, make available to the public the rate and payment
information described in paragraph (2) in accordance with
paragraph (3).
``(2) Rate and payment information described.--For purposes
of paragraph (1), the rate and payment information described in
this paragraph is, with respect to a group health plan or group
or individual health insurance coverage, the following:
``(A) With respect to each item or service (other
than a drug) for which benefits are available under
such plan or coverage, the in-network rate (expressed
as a dollar amount) in effect as of the date on which
such information is made public with each provider that
is a participating provider with respect to such item
or service.
``(B) With respect to each drug (identified by
national drug code) for which benefits are available
under such plan or coverage--
``(i) the in-network rate (expressed as a
dollar amount) in effect as of the first day of
the month in which such information is made
public with each provider that is a
participating provider with respect to such
drug; and
``(ii) 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 publication to
each provider that was a participating provider
with respect to such drug, broken down by each
such provider, other than such an amount paid
to a provider that, during such period,
submitted fewer than 20 claims for such drug to
such plan or coverage.
``(C) With respect to each item or service for
which benefits are available under such plan or
coverage, the amount billed, and the amount allowed by
the plan, for each such item or service furnished
during the 90-day period specified in subparagraph (B)
by a provider that was not a participating provider
with respect to such item or service, broken down by
each such provider.
``(3) Manner of publication.--Rate and payment information
required to be made available under this subsection shall be so
made available in dollar amounts through separate machine-
readable files (and any successor technology, such as
application program interface technology, determined
appropriate by the Secretary) corresponding to the information
described in each of subparagraphs (A) through (C) of paragraph
(2) that meet such requirements as specified by the Secretary
through subregulatory guidance. Such requirements shall ensure
that such files are limited to an appropriate size, do not
include disclosure of unnecessary duplicative information
contained in other files made available under this subsection,
are made available in a widely-available format through a
publicly-available website that allows for information
contained in such files to be compared across group health
plans and group or individual health insurance coverage, and
are accessible to individuals at no cost and without the need
to establish a user account or provide other credentials.
``(4) User instructions.--Each group health plan and health
insurance issuer offering group or individual health insurance
coverage shall make available to the public instructions
written in plain language explaining how individuals may search
for information described in paragraph (2) in files submitted
in accordance with paragraph (3). The Secretary shall develop
and publish through subregulatory guidance a template that such
a plan may use in developing instructions for purposes of the
preceding sentence.
``(5) Summary.--For each plan year beginning on or after
January 1, 2026, each group health plan and health insurance
issuer offering group or individual health insurance coverage
shall make public a data file, in a manner that ensures that
such file may be easily downloaded and read by standard
spreadsheet software and that meets such requirements as
established by the Secretary, containing a summary of all rate
and payment information made public by such plan or issuer with
respect to such plan or coverage during such plan year. Such
file shall include the following:
``(A) The mean, median, and interquartile range of
the in-network rate, and the amount allowed for an item
or service when not furnished by a participating
provider, in effect as of the first day of such plan
year for each item or service (identified by payer
identifier approved or used by the Centers for Medicare
& Medicaid Services) for which benefits are available
under the plan or coverage, broken down by the type of
provider furnishing the item or service and by the
geographic area in which such item or service is
furnished.
``(B) Trends in payment rates for such items and
services over such plan year, including an
identification of instances in which such rates have
increased, decreased, or remained the same.
``(C) The name of such plan, a description of the
type of network of participating providers used by such
plan or coverage, and, in the case of a group health
plan, a description of whether such plan is self-
insured or fully-insured.
``(D) For each item or service which is paid as
part of a bundled rate--
``(i) a description of the formulae,
pricing methodologies, or other information
used to calculate the payment rate for such
bundle; and
``(ii) a list of the items and services
included in such bundle.
``(E) The percentage of items and services that are
paid for on a fee-for-service basis and the percentage
of items and services that are paid for as part of a
bundled rate, capitated payment rate, or other
alternative payment model.
``(6) Attestation.--Each group health plan and health
insurance issuer offering group or individual health insurance
coverage shall post, along with rate and payment information
made public by such plan or issuer, an attestation that such
information is complete and accurate.
``(c) Accessibility.--A group health plan and a health insurance
issuer offering group or individual health insurance coverage shall
take reasonable steps (as specified by the Secretary) to ensure that
information provided in response to a request described in subsection
(a), and rate and payment information made public under subsection (b),
is provided in plain, easily understandable language and that
interpretation, translations, and assistive services are provided to
those with limited English proficiency and those with disabilities.
``(d) Definitions.--In this section:
``(1) Participating provider.--The term `participating
provider' means, with respect to an item or service and a group
health plan or health insurance issuer offering group or
individual health insurance coverage, a physician or other
health care provider who is acting within the scope of practice
of that provider's license or certification under applicable
State law and who has a contractual relationship with the plan
or issuer, respectively, for furnishing such item or service
under the plan or coverage, and includes facilities,
respectively.
``(2) Provider.--The term `provider' includes a health care
facility.
``(3) In-network rate.--The term `in-network rate' means,
with respect to a group health plan or group or individual
health insurance coverage and an item or service furnished by a
provider that is a participating provider with respect to such
plan or coverage and item or service, the contracted rate
(reflected as a dollar amount) in effect between such plan or
coverage and such provider for such item or service, regardless
of whether such rate is calculated based on a set amount, a fee
schedule, or an amount derived from another amount, or a
formula, or other method.''.
(3) ERISA.--
(A) In general.--Section 719 of the Employee
Retirement Income Security Act of 1974 (29 U.S.C.
1185h) is amended to read as follows:
``SEC. 719. TRANSPARENCY IN COVERAGE.
``(a) Cost-Sharing Transparency.--
``(1) In general.--For plan years beginning on or after
January 1, 2026, a group health plan and a health insurance
issuer offering group health insurance coverage shall permit a
participant or beneficiary to learn the amount of cost-sharing
(including deductibles, copayments, and coinsurance) under the
participant or beneficiary's plan or coverage that the
participant or beneficiary would be responsible for paying with
respect to the furnishing of a specific item or service by a
provider in a timely manner upon the request of the participant
or beneficiary. At a minimum, such information shall include
the information specified in paragraph (2) and shall be made
available to such participant or beneficiary through a self-
service tool that meets the requirements of paragraph (3) or,
at the option of such participant or beneficiary, through a
paper disclosure or phone or other electronic disclosure (as
selected by such participant or beneficiary and provided at no
cost to such participant or beneficiary) that meets such
requirements as the Secretary may specify.
``(2) Specified information.--For purposes of paragraph
(1), the information specified in this paragraph is, with
respect to an item or service for which benefits are available
under a group health plan or group health insurance coverage
furnished by a health care provider to a participant or
beneficiary of such plan or coverage, the following:
``(A) If such provider is a participating provider
with respect to such item or service, the in-network
rate (as defined in subsection (c)) for such item or
service.
``(B) If such provider is not a participating
provider with respect to such item or service, the
maximum allowed amount or other dollar amount that such
plan or coverage will recognize as payment for such
item or service, along with a notice that such
participant or beneficiary may be liable for additional
charges.
``(C) The estimated amount of cost-sharing
(including deductibles, copayments, and coinsurance)
that the participant or beneficiary will incur for such
item or service (which, in the case such item or
service is to be furnished by a provider described in
subparagraph (B), shall be calculated using the maximum
allowed amount or other dollar amount described in such
subparagraph).
``(D) The amount the participant or beneficiary has
already accumulated with respect to any deductible or
out of pocket maximum under the plan or coverage
(broken down, in the case separate deductibles or
maximums apply to separate participants and
beneficiaries enrolled in the plan or coverage, by such
separate deductibles or maximums, in addition to any
cumulative deductible or maximum).
``(E) 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 participant or beneficiary has
accrued towards such limitation with respect to such
item or service.
``(F) Any prior authorization, concurrent review,
step therapy, fail first, or similar requirements
applicable to coverage of such item or service under
such plan or coverage.
``(G) Any shared savings (such as any credit,
payment, or other benefit provided by such plan or
issuer) available to the participant or beneficiary
with respect to such item or service furnished by such
provider known at the time such request is made.
``(3) Self-service tool.--For purposes of paragraph (1), a
self-service tool established by a group health plan or health
insurance issuer offering group health insurance coverage meets
the requirements of this paragraph if such tool--
``(A) is based on an internet website (or successor
technology specified by the Secretary);
``(B) provides for real-time responses to requests
described in paragraph (1);
``(C) is updated in a manner such that information
provided through such tool is timely and accurate at
the time such request is made;
``(D) allows such a request to be made with respect
to an item or service furnished by--
``(i) a specific provider that is a
participating provider with respect to such
item or service; or
``(ii) all providers that are participating
providers with respect to such item or service;
``(E) 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; and
``(F) meets any other requirement determined
appropriate by the Secretary to ensure the
accessibility and usability of information provided
through such tool.
The Secretary may require such tool, as a condition of
complying with subparagraph (E), to link multiple billing codes
to a single descriptive term if the Secretary determines that
the billing codes to be so linked correspond to similar items
and services.
``(b) Rate and Payment Information.--
``(1) In general.--For plan years beginning on or after
January 1, 2026, each group health plan and health insurance
issuer offering group health insurance coverage (other than a
grandfathered health plan (as defined in section 1251(e) of the
Patient Protection and Affordable Care Act)) shall, for each
month, not later than the tenth day of such month, make
available to the public the rate and payment information
described in paragraph (2) in accordance with paragraph (3).
``(2) Rate and payment information described.--For purposes
of paragraph (1), the rate and payment information described in
this paragraph is, with respect to a group health plan or group
health insurance coverage, the following:
``(A) With respect to each item or service (other
than a drug) for which benefits are available under
such plan or coverage, the in-network rate (expressed
as a dollar amount) in effect as of the date on which
such information is made public with each provider that
is a participating provider with respect to such item
or service.
``(B) With respect to each drug (identified by
national drug code) for which benefits are available
under such plan or coverage--
``(i) the in-network rate (expressed as a
dollar amount) in effect as of the first day of
the month in which such information is made
public with each provider that is a
participating provider with respect to such
drug; and
``(ii) 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 publication to
each provider that was a participating provider
with respect to such drug, broken down by each
such provider, other than such an amount paid
to a provider that, during such period,
submitted fewer than 20 claims for such drug to
such plan or coverage.
``(C) With respect to each item or service for
which benefits are available under such plan or
coverage, the amount billed, and the amount allowed by
the plan, for each such item or service furnished
during the 90-day period specified in subparagraph (B)
by a provider that was not a participating provider
with respect to such item or service, broken down by
each such provider.
``(3) Manner of publication.--Rate and payment information
required to be made available under this subsection shall be so
made available in dollar amounts through separate machine-
readable files (and any successor technology, such as
application program interface technology, determined
appropriate by the Secretary) corresponding to the information
described in each of subparagraphs (A) through (C) of paragraph
(2) that meet such requirements as specified by the Secretary
through subregulatory guidance. Such requirements shall ensure
that such files are limited to an appropriate size, do not
include disclosure of unnecessary duplicative information
contained in other files made available under this subsection,
are made available in a widely available format through a
publicly available website that allows for information
contained in such files to be compared across group health
plans and group or individual health insurance coverage, and
are accessible to individuals at no cost and without the need
to establish a user account or provide other credentials.
``(4) User instructions.--Each group health plan and health
insurance issuer offering group health insurance coverage shall
make available to the public instructions written in plain
language explaining how individuals may search for information
described in paragraph (2) in files submitted in accordance
with paragraph (3). The Secretary shall develop and publish
through subregulatory guidance a template that such a plan may
use in developing instructions for purposes of the preceding
sentence.
``(5) Summary.--For each plan year beginning on or after
January 1, 2026, each group health plan and health insurance
issuer offering group health insurance coverage shall make
public a data file, in a manner that ensures that such file may
be easily downloaded and read by standard spreadsheet software
and that meets such requirements as established by the
Secretary, containing a summary of all rate and payment
information made public by such plan or issuer with respect to
such plan or coverage during such plan year. Such file shall
include the following:
``(A) The mean, median, and interquartile range of
the in-network rate, and the amount allowed for an item
or service when not furnished by a participating
provider, in effect as of the first day of such plan
year for each item or service (identified by payer
identifier approved or used by the Centers for Medicare
& Medicaid Services) for which benefits are available
under the plan or coverage, broken down by the type of
provider furnishing the item or service and by the
geographic area in which such item or service is
furnished.
``(B) Trends in payment rates for such items and
services over such plan year, including an
identification of instances in which such rates have
increased, decreased, or remained the same.
``(C) The name of such plan, a description of the
type of network of participating providers used by such
plan or coverage, and, in the case of a group health
plan, a description of whether such plan is self-
insured or fully-insured.
``(D) For each item or service which is paid as
part of a bundled rate--
``(i) a description of the formulae,
pricing methodologies, or other information
used to calculate the payment rate for such
bundle; and
``(ii) a list of the items and services
included in such bundle.
``(E) The percentage of items and services that are
paid for on a fee-for-service basis and the percentage
of items and services that are paid for as part of a
bundled rate, capitated payment rate, or other
alternative payment model.
``(6) Attestation.--Each group health plan and health
insurance issuer offering group health insurance coverage shall
post, along with rate and payment information made public by
such plan or issuer, an attestation that such information is
complete and accurate.
``(c) Accessibility.--A group health plan and a health insurance
issuer offering group health insurance coverage shall take reasonable
steps (as specified by the Secretary) to ensure that information
provided in response to a request described in subsection (a), and rate
and payment information made public under subsection (b), is provided
in plain, easily understandable language and that interpretation,
translations, and assistive services are provided to those with limited
English proficiency and those with disabilities.
``(d) Definitions.--In this section:
``(1) Participating provider.--The term `participating
provider' means, with respect to an item or service and a group
health plan or health insurance issuer offering group or
individual health insurance coverage, a physician or other
health care provider who is acting within the scope of practice
of that provider's license or certification under applicable
State law and who has a contractual relationship with the plan
or issuer, respectively, for furnishing such item or service
under the plan or coverage, and includes facilities,
respectively.
``(2) Provider.--The term `provider' includes a health care
facility.
``(3) In-network rate.--The term `in-network rate' means,
with respect to a group health plan or group health insurance
coverage and an item or service furnished by a provider that is
a participating provider with respect to such plan or coverage
and item or service, the contracted rate (reflected as a dollar
amount) in effect between such plan or coverage and such
provider for such item or service, regardless of whether such
rate is calculated based on a set amount, a fee schedule, or an
amount derived from another amount, or a formula, or other
method.''.
(B) Clerical amendment.--The table of contents in
section 1 of the Employee Retirement Income Security
Act of 1974 is amended by striking the item relating to
section 719 and inserting the following new item:
``Sec. 719. Transparency in coverage.''.
(b) Application Programming Interface Report.--Not later than
January 1, 2025, and annually thereafter, the Secretary of Health and
Human Services shall, in consultation with the Office of the National
Coordinator for Health Information Technology, Department of Labor, the
Department of the Treasury, and stakeholders, submit to the House
Committees on Education and the Workforce, Energy and Commerce, and
Ways and Means, and the Senate Committees on Finance and Health,
Education, Labor, and Pensions a report on the use of standards-based
application programming interfaces (in this subsection referred to as
``APIs'') to facilitate access to health care price transparency
information and the interoperability of other medical information. Such
report shall include an evaluation of the capacity of the Department of
Health and Human Services, the Department of Labor, and the Department
of the Treasury to regulate and implement standards related to APIs and
recommendations for improving such capacity. Such report shall include
the following:
(1) A description of current use, and proposed use, of APIs
under Federal rules to facilitate interoperability, including
information related to capacity constraints within the
agencies, barriers to adoption, privacy and security,
administrative burdens and efficiencies, care coordination, and
levels of compliance.
(2) A description of the feasibility of agency
participation in the development of APIs to enable application
access to price transparency data under the amendments made by
subsection (a).
(3) A specification of the timeline for which such data
standards can be required to make such data accessible via an
API.
(4) An analysis of the benefits and challenges of
implementing standards-based APIs for price transparency data,
including the ability for consumers to access rate and payment
information and the amount of cost-sharing (including
deductibles, copayments, and coinsurance) under the consumer's
plan through third-party internet-based tools and applications.
(5) An analysis of the impact that APIs which provide real-
time access to pricing and cost-sharing information may have in
increasing the amount of services shoppable for individuals,
such as by standardizing more health care spend via episode
bundles.
(6) An analysis of which health care items and services may
be useful under API, such as those for which prices change with
the greatest frequency.
(7) An analysis of the cost of API standards implementation
on issuers, employers, and other private-sector entities.
(8) An analysis of the ability of State regulators to
enforce API standards and the costs to the Federal Government
and States to regulate and enforce API standards.
(9) An analysis of the interaction with API standards and
Federal health information privacy standards.
(c) Provider Tool Report.--
(1) In general.--Not later than 1 year after the date of
the enactment of this Act, The Secretary of Health and Human
Services, acting through the Administrator of the Centers for
Medicare & Medicaid Services, shall, in consultation with
stakeholders, conduct a study and submit to the House
Committees on Education and the Workforce, Energy and Commerce,
and Ways and Means, and the Senate Committees on Finance and
Health, Education, Labor, and Pensions a report on the
usefulness and feasibility of the establishment of a provider
tool by a group health plan, or a health insurance issuer
offering group and individual health insurance coverage, in
facilitating the provision of information made available
pursuant to the amendments made by subsection (a). Such report
shall include the following:
(A) A description of the feasibility of
establishing a requirement for the various types of
plans and coverage to offer such a provider tool,
including any challenges to establishing a provider
tool using the same technology platform as the self-
service tool described in such amendments.
(B) An evaluation on the usefulness of a provider
tool to aid patient-decision making and how such tool
would coordinate with other information available to a
patient and their provider under other Federal
requirements in place or under consideration.
(C) An evaluation of whether the information
provided by such tool would be duplicative of the
advanced explanation of benefits required under Federal
law or any other existing requirement.
(D) A description of the usability and expected
utilization of such tool among providers, including
among different provider types.
(E) An analysis of the impact of a provider tool in
value-based care arrangements.
(F) An analysis on the potential impact of the
provider tool on--
(i) patients' out-of-pocket spending;
(ii) plan design, including impacts on
cost-sharing requirements;
(iii) care coordination and quality;
(iv) plan premiums;
(v) overall health care spending and
utilization; and
(vi) health care access in rural areas.
(G) An analysis of the feasibility of a provider
tool to include additional functionality to facilitate
and improve the administration of the requirements on
providers to submit notifications to such plan or
coverage under section 2799B-6 of the Public Health
Service Act and the requirements on such plan or
coverage to provide an advanced explanation of benefits
to individuals under section 2799A-1(f) of such Act.
(H) An analysis of which health care items and
services, would be most useful for patients utilizing a
provider tool.
(I) An analysis of rulemaking required to ensure
such a tool complies with federal health information
privacy standards.
(J) An analysis of the burden and cost of the
creation of a provider tool by plans and coverage on
providers, issuers, employers, and other private-sector
entities.
(K) An analysis of the ability of state regulators
to enforce provider tool standards and the costs to the
Department and states to regulate and enforce provider
tool standards.
(2) Definition.--The term ``provider tool'' means a tool
designed to facilitate the provision of information made
available pursuant to the amendments made by subsection (a) and
established by a group health plan or a health insurance issuer
offering group and individual health insurance coverage that
allows providers to access the information such plan or
coverage must provide through the self-service tool described
in such amendments to an individual with whom the provider is
actively treating at the time of such request, upon the request
of the provider, and with the consent of such individual.
(d) Reports.--
(1) Compliance.--Not later than January 1, 2027, the
Comptroller General of the United States shall submit to
Congress a report containing--
(A) an analysis of 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 group health plans and
health insurance issuers pursuant to such amendments.
(2) Prices.--Not later than January 1, 2028, and biennially
thereafter, the Secretaries of Health and Human Services,
Labor, and the Treasury shall jointly 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 of Health
and Human Services);
(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.
(e) Quality Report.--Not later than 1 year after the date of
enactment of this subsection, the Secretaries of Health and Human
Services, Labor, and the Treasury shall jointly submit to Congress a
report on the feasibility of including data relating to the quality of
health care items and services with the price transparency information
required to be made available under the amendments made by subsection
(a). Such report shall include recommendations for legislative and
regulatory actions to identify appropriate metrics for assessing and
comparing quality of care.
(f) Continued Applicability of Rules for Previous Years.--Nothing
in the amendments made by subsection (a) 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), for any plan year beginning before January 1,
2026.
SEC. 106. PHARMACY BENEFITS PRICE TRANSPARENCY.
(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 the date
that is 2 years after the date of enactment of this section, a group
health plan or a 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 other third party
that limits (or delays beyond the applicable reporting period described
in subsection (b)(1)) the disclosure of information to group health
plans in such a manner that prevents such plan, issuer, or entity from
making the reports described in subsection (b).
``(b) Reports.--
``(1) In general.--With respect to plan years beginning on
or after the date that is 2 years after the date of enactment
of this section, not less frequently than every 6 months (or at
the request of a group health plan, not less frequently than
quarterly, but under the same conditions, terms, and cost of
the semiannual report under this subsection), a group health
plan or health insurance issuer offering group health insurance
coverage, or an entity providing pharmacy benefits management
services on behalf of such a plan or issuer, shall submit to
the group health plan a report in accordance with this section.
Each such report shall be made available to such group health
plan in a machine-readable format and shall include the
information described in paragraph (2).
``(2) Information described.--For purposes of paragraph
(1), the information described in this paragraph is, with
respect to drugs covered by a group health plan or health
insurance issuer offering group health insurance coverage
during each reporting period--
``(A) in the case of such a plan offered by a
specified large employer (or such coverage offered in
connection with such a plan offered by a specified
large employer)--
``(i) a list of drugs for which a claim was
filed and, with respect to each such drug on
such list--
``(I) the brand name, chemical
entity, and National Drug Code;
``(II) the type of dispensing
channel used to furnish such drug,
including retail, mail order, or
specialty pharmacy;
``(III) with respect to each drug
dispensed under each type of dispensing
channel (including retail, mail order,
or specialty pharmacy)--
``(aa) whether such drug is
a brand name drug or a generic
drug, and--
``(AA) in the case
of a brand name drug,
the wholesale
acquisition cost,
listed as cost per days
supply and cost per
dosage unit, on the
date such drug was
dispensed; and
``(BB) in the case
of a generic drug, the
average wholesale
price, listed as cost
per days supply and
cost per dosage unit,
on the date such drug
was dispensed; and
``(bb) the total number
of--
``(AA) prescription
claims (including
original prescriptions
and refills);
``(BB)
participants,
beneficiaries, and
enrollees for whom a
claim for such drug was
filed;
``(CC) dosage units
per fill of such drug;
and
``(DD) days supply
of such drug per fill;
``(IV) the net price per course of
treatment or single fill, such as a 30-
day supply or 90-day supply to the plan
or coverage after manufacturer rebates,
fees, and other remuneration or
adjustments;
``(V) the total amount of out-of-
pocket spending by participants,
beneficiaries, and enrollees on such
drug, including spending through
copayments, coinsurance, and
deductibles;
``(VI) the total net spending by
the plan or coverage during the
reporting period;
``(VII) the total amount received,
or expected to be received, by the plan
or coverage from any entity in drug
manufacturer rebates, fees, alternative
discounts, and all other remuneration
received from an entity or any third
party (including group purchasing
organizations) other than the plan
sponsor;
``(VIII) the total amount received,
or expected to be received by the plan
or issuer, 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; and
``(bb) that is related to
utilization rebates for such
drug; and
``(IX) to the extent feasible,
information on the total amount of
remuneration, including copayment
assistance dollars paid, copayment
cards applied, or other discounts
provided by each drug manufacturer (or
entity administering copay assistance
on behalf of such drug manufacturer) to
the participants, beneficiaries, and
enrollees enrolled in such plan or
coverage for such drug;
``(ii) for each category or class of drugs
for which a claim was filed, a breakdown of the
total gross spending on drugs in such category
or class before rebates, price concessions,
alternative discounts, or other remuneration
from drug manufacturers, and the net spending
after such rebates, price concessions,
alternative discounts, or other remuneration
from drug manufacturers, including--
``(I) the number of participants,
beneficiaries, and enrollees who filled
a prescription for a drug in such
category or class, including the
National Drug Code for each such drug;
``(II) if applicable, a description
of the formulary tiers and utilization
mechanisms (such as prior authorization
or step therapy) employed for drugs in
that category or class; and
``(III) the total out-of-pocket
spending under the plan or coverage by
participants, beneficiaries, and
enrollees, including spending through
copayments, coinsurance, and
deductibles;
``(iii) in the case of a drug for which
gross spending by such plan, coverage, or
entity exceeded $10,000 during the reporting
period--
``(I) a list of all other drugs in
the same therapeutic category or class;
and
``(II) the rationale for the
formulary placement of such drug in
that therapeutic category or class, if
applicable; and
``(iv) in the case such plan or coverage
(or an entity providing pharmacy benefits
management services on behalf of such plan or
coverage) has an affiliated pharmacy or
pharmacy under common ownership--
``(I) the percentage of total
prescriptions dispensed by such
pharmacies to individuals enrolled in
such plan or coverage;
``(II) a list of all drugs
dispensed by such pharmacies to
individuals enrolled in such plan or
coverage, and, with respect to each
drug dispensed--
``(aa) the amount charged,
per dosage unit, per 30-day
supply, or per 90-day supply
(as applicable) to the plan or
issuer, and to participants,
beneficiaries, and enrollees
enrolled in such plan or
coverage;
``(bb) the median amount
charged to such plan or issuer,
and the interquartile range of
the costs, per dosage unit, per
30-day supply, and per 90-day
supply, including amounts paid
by the participants,
beneficiaries, and enrollees,
when the same drug is dispensed
by other pharmacies that are
not affiliated with or under
common ownership with the
entity and that are included in
the pharmacy network of such
plan or coverage;
``(cc) the lowest cost per
dosage unit, per 30-day supply
and per 90-day supply, for each
such drug, including amounts
charged to the plan and
participants, beneficiaries,
and enrollees, that is
available from any pharmacy
included in the network of such
plan or coverage; and
``(dd) the net acquisition
cost per dosage unit, per 30-
day supply, and per 90-day
supply, if such drug is subject
to a maximum price discount;
``(B) in the case of a plan or coverage not
described in subparagraph (A)--
``(i) the total net spending by the plan or
coverage for all drugs covered by such plan or
coverage during such reporting period;
``(ii) the total amount received, or
expected to be received, by the plan or
coverage from any entity in drug manufacturer
rebates, fees, alternative discounts, and all
other remuneration received from an entity or
any third party (including group purchasing
organizations) other than the plan sponsor for
all such drugs; and
``(iii) to the extent feasible, information
on the total amount of remuneration, including
copayment assistance dollars paid, copayment
cards applied, or other discounts provided by
each drug manufacturer (or entity administering
copay assistance on behalf of such drug
manufacturer) to the participants,
beneficiaries, and enrollees enrolled in such
plan or coverage for such drugs;
``(C) amounts paid directly or indirectly in
rebates, fees, or any other type of compensation (as
defined in section 408(b)(2)(B)(ii)(dd)(AA) of the
Employee Retirement Income Security Act) to brokers,
consultants, advisors, or any other individual or firm,
for the referral of the group health plan's or health
insurance issuer's business to an entity providing
pharmacy benefits management services, including the
identity of the recipient of such amounts;
``(D) an explanation of any benefit design
parameters that encourage or require participants,
beneficiaries, and enrollees in such plan or coverage
to fill prescriptions at mail order, specialty, or
retail pharmacies that are affiliated with or under
common ownership with the entity providing pharmacy
benefit management services under such plan or
coverage, including mandatory mail and specialty home
delivery programs, retail and mail auto-refill
programs, and cost-sharing assistance incentives
directly or indirectly funded by such entity; and
``(E) total gross spending on all drugs during the
reporting period.
``(3) Privacy requirements.--
``(A) In general.--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 13402(a) of the Health
Information Technology for Clinical Health Act and
consistent with the HIPAA privacy regulations (as
defined in section 1180(b)(3) of the Social Security
Act) and shall restrict the use and disclosure of such
information according to such privacy, security, and
breach notification regulations and such HIPAA privacy
regulations.
``(B) Additional requirements.--
``(i) In general.--An entity providing
pharmacy benefits management services on behalf
of a group health plan or health insurance
issuer offering group health insurance coverage
that submits a report under paragraph (1) shall
ensure that such report contains only summary
health information, as defined in section
164.504(a) of title 45, Code of Federal
Regulations (or successor regulations).
``(ii) Restrictions.--A group health plan
shall comply with section 164.504(f) of title
45, Code of Federal Regulations (or a successor
regulation) and a plan sponsor shall act in
accordance with the terms of the agreement
described in such section.
``(C) Rule of construction.--Nothing in this
section shall be construed to modify the requirements
for the creation, receipt, maintenance, or transmission
of protected health information under the HIPAA privacy
regulations (as defined in section 1180(b)(3) of the
Social Security Act).
``(4) Disclosure and redisclosure.--
``(A) Limitation to business associates.--A group
health plan receiving a report under paragraph (1) may
disclose such information only to the entity from which
the report was received or to that entity's business
associates as defined in section 160.103 of title 45,
Code of Federal Regulations (or successor regulations)
or as permitted by the HIPAA Privacy Rule (45 CFR parts
160 and 164, subparts A and E).
``(B) Clarification regarding public disclosure of
information.--Nothing in this section shall prevent a
group health plan or health insurance issuer offering
group health insurance coverage, or an entity providing
pharmacy benefits management services on behalf of such
a plan or coverage, from placing reasonable
restrictions on the public disclosure of the
information contained in a report described in
paragraph (1), except that such plan, 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, or the
Comptroller General of the United States.
``(C) Limited form of report.--The Secretary shall
define through rulemaking a limited form of the report
under paragraph (1) required with respect to group
health plans where the plan sponsors of such plans are
drug manufacturers, drug wholesalers, or other direct
participants in the drug supply chain, in order to
prevent anti-competitive behavior.
``(5) Report to gao.--A group health plan or health
insurance issuer offering group health insurance coverage, or
an entity providing pharmacy benefits management services on
behalf of such plan or coverage, shall submit to the
Comptroller General of the United States each of the first 4
reports submitted to a group health plan under paragraph (1)
and other such reports as requested, in accordance with the
privacy requirements under paragraph (3), the disclosure and
redisclosure standards under paragraph (4), the standards
specified pursuant to paragraph (6), and such other information
that the Comptroller General determines necessary to carry out
the study under section 106(d) of the Lower Costs, More
Transparency Act.
``(6) Standard format.--Not later than 1 year after the
date of enactment of this section, the Secretary shall specify
through rulemaking standards for group health plans, health
insurance issuers offering group health insurance coverage, and
entities providing pharmacy benefits management services on
behalf of such plans or coverage, required to submit reports
under paragraph (1) to submit such reports in a standard
format.
``(c) Enforcement.--
``(1) In general.--The Secretary shall enforce this
section.
``(2) Failure to provide information.--A health insurance
issuer or an entity providing pharmacy benefits management
services on behalf of such plan or coverage that violates sub-
section (a) or fails to provide the 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 an
entity providing pharmacy benefits management services on
behalf of such a plan or coverage 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 subsections (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 such section.
``(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
the requirements in this section.
``(d) Rule of Construction.--Nothing in this section shall be
construed to permit a group health plan, health insurance issuer, or
entity providing pharmacy benefits management services on behalf of
such plan or coverage, 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) or (b) by entities subject to such subsection.
``(e) Definitions.--In this section:
``(1) Specified large employer.--The term `specified large
employer' means, in connection with a group health plan with
respect to a calendar year and a plan year, an employer who
employed an average of at least 50 employees on business days
during the preceding calendar year and who employs at least 1
employee on the first day of the plan year.
``(2) Wholesale acquisition cost.--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 BENEFIT MANAGER SERVICES.
``(a) In General.--For plan years beginning on or after the date
that is 2 years after the date of enactment of this section, a group
health plan or a 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 other third party
that limits (or delays beyond the applicable reporting period described
in subsection (b)(1)) the disclosure of information to group health
plans in such a manner that prevents such plan, issuer, or entity from
making the reports described in subsection (b).
``(b) Reports.--
``(1) In general.--With respect to plan years beginning on
or after the date that is 2 years after the date of enactment
of this section, not less frequently than every 6 months (or at
the request of a group health plan, not less frequently than
quarterly, but under the same conditions, terms, and cost of
the semiannual report under this subsection), a group health
plan or health insurance issuer offering group health insurance
coverage, or an entity providing pharmacy benefits management
services on behalf of such a plan or issuer, shall submit to
the group health plan a report in accordance with this section.
Each such report shall be made available to such group health
plan in a machine-readable format and shall include the
information described in paragraph (2).
``(2) Information described.--For purposes of paragraph
(1), the information described in this paragraph is, with
respect to drugs covered by a group health plan or health
insurance issuer offering group health insurance coverage
during each reporting period--
``(A) in the case of such a plan offered by a
specified large employer (or such coverage offered in
connection with such a plan offered by a specified
large employer)--
``(i) a list of drugs for which a claim was
filed and, with respect to each such drug on
such list--
``(I) the brand name, chemical
entity, and National Drug Code;
``(II) the type of dispensing
channel used to furnish such drug,
including retail, mail order, or
specialty pharmacy;
``(III) with respect to each drug
dispensed under each type of dispensing
channel (including retail, mail order,
or specialty pharmacy)--
``(aa) whether such drug is
a brand name drug or a generic
drug, and--
``(AA) in the case
of a brand name drug,
the wholesale
acquisition cost,
listed as cost per days
supply and cost per
dosage unit, on the
date such drug was
dispensed; and
``(BB) in the case
of a generic drug, the
average wholesale
price, listed as cost
per days supply and
cost per dosage unit,
on the date such drug
was dispensed; and
``(bb) the total number
of--
``(AA) prescription
claims (including
original prescriptions
and refills);
``(BB) participants
and beneficiaries for
whom a claim for such
drug was filed;
``(CC) dosage units
per fill of such drug;
and
``(DD) days supply
of such drug per fill;
``(IV) the net price per course of
treatment or single fill, such as a 30-
day supply or 90-day supply to the plan
or coverage after manufacturer rebates,
fees, and other remuneration or
adjustments;
``(V) the total amount of out-of-
pocket spending by participants,
beneficiaries, and enrollees on such
drug, including spending through
copayments, coinsurance, and
deductibles;
``(VI) the total net spending by
the plan or coverage during the
reporting period;
``(VII) the total amount received,
or expected to be received, by the plan
or coverage from any entity in drug
manufacturer rebates, fees, alternative
discounts, and all other remuneration
received from an entity or any third
party (including group purchasing
organizations) other than the plan
sponsor;
``(VIII) the total amount received,
or expected to be received by the plan
or issuer, 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; and
``(bb) that is related to
utilization rebates for such
drug; and
``(IX) to the extent feasible,
information on the total amount of
remuneration, including copayment
assistance dollars paid, copayment
cards applied, or other discounts
provided by each drug manufacturer (or
entity administering copay assistance
on behalf of such drug manufacturer) to
the participants, beneficiaries, and
enrollees enrolled in such plan or
coverage for such drug;
``(ii) for each category or class of drugs
for which a claim was filed, a breakdown of the
total gross spending on drugs in such category
or class before rebates, price concessions,
alternative discounts, or other remuneration
from drug manufacturers, and the net spending
after such rebates, price concessions,
alternative discounts, or other remuneration
from drug manufacturers, including--
``(I) the number of participants,
beneficiaries, and enrollees who filled
a prescription for a drug in such
category or class, including the
National Drug Code for each such drug;
``(II) if applicable, a description
of the formulary tiers and utilization
mechanisms (such as prior authorization
or step therapy) employed for drugs in
that category or class; and
``(III) the total out-of-pocket
spending under the plan or coverage by
participants, beneficiaries, and
enrollees, including spending through
copayments, coinsurance, and
deductibles;
``(iii) in the case of a drug for which
gross spending by such plan, coverage, or
entity exceeded $10,000 during the reporting
period--
``(I) a list of all other drugs in
the same therapeutic category or class;
and
``(II) the rationale for the
formulary placement of such drug in
that therapeutic category or class, if
applicable; and
``(iv) in the case such plan or coverage
(or an entity providing pharmacy benefits
management services on behalf of such plan or
coverage) has an affiliated pharmacy or
pharmacy under common ownership--
``(I) the percentage of total
prescriptions dispensed by such
pharmacies to individuals enrolled in
such plan or coverage;
``(II) a list of all drugs
dispensed by such pharmacies to
individuals enrolled in such plan or
coverage, and, with respect to each
drug dispensed--
``(aa) the amount charged,
per dosage unit, per 30-day
supply, or per 90-day supply
(as applicable) to the plan or
issuer, and to participants,
beneficiaries, and enrollees
enrolled in such plan or
coverage;
``(bb) the median amount
charged to such plan or issuer,
and the interquartile range of
the costs, per dosage unit, per
30-day supply, and per 90-day
supply, including amounts paid
by the participants,
beneficiaries, and enrollees,
when the same drug is dispensed
by other pharmacies that are
not affiliated with or under
common ownership with the
entity and that are included in
the pharmacy network of such
plan or coverage;
``(cc) the lowest cost per
dosage unit, per 30-day supply
and per 90-day supply, for each
such drug, including amounts
charged to the plan and
participants, beneficiaries,
and enrollees, that is
available from any pharmacy
included in the network of such
plan or coverage; and
``(dd) the net acquisition
cost per dosage unit, per 30-
day supply, and per 90-day
supply, if such drug is subject
to a maximum price discount;
``(B) in the case of a plan or coverage not
described in subparagraph (A)--
``(i) the total net spending by the plan or
coverage for all drugs covered by such plan or
coverage during such reporting period;
``(ii) the total amount received, or
expected to be received, by the plan or
coverage from any entity in drug manufacturer
rebates, fees, alternative discounts, and all
other remuneration received from an entity or
any third party (including group purchasing
organizations) other than the plan sponsor for
all such drugs; and
``(iii) to the extent feasible, information
on the total amount of remuneration, including
copayment assistance dollars paid, copayment
cards applied, or other discounts provided by
each drug manufacturer (or entity administering
copay assistance on behalf of such drug
manufacturer) to the participants,
beneficiaries, and enrollees enrolled in such
plan or coverage for such drugs;
``(C) amounts paid directly or indirectly in
rebates, fees, or any other type of compensation (as
defined in section 408(b)(2)(B)(ii)(dd)(AA)) to
brokers, consultants, advisors, or any other individual
or firm, for the referral of the group health plan's or
health insurance issuer's business to an entity
providing pharmacy benefits management services,
including the identity of the recipient of such
amounts;
``(D) an explanation of any benefit design
parameters that encourage or require participants,
beneficiaries, and enrollees in such plan or coverage
to fill prescriptions at mail order, specialty, or
retail pharmacies that are affiliated with or under
common ownership with the entity providing pharmacy
benefit management services under such plan or
coverage, including mandatory mail and specialty home
delivery programs, retail and mail auto-refill
programs, and cost-sharing assistance incentives
directly or indirectly funded by such entity; and
``(E) total gross spending on all drugs during the
reporting period.
``(3) Privacy requirements.--
``(A) In general.--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 13402(a) of the Health
Information Technology for Clinical Health Act and
consistent with the HIPAA privacy regulations (as
defined in section 1180(b)(3) of the Social Security
Act) and shall restrict the use and disclosure of such
information according to such privacy, security, and
breach notification regulations and such HIPAA privacy
regulations.
``(B) Additional requirements.--
``(i) In general.--An entity providing
pharmacy benefits management services on behalf
of a group health plan or health insurance
issuer offering group health insurance coverage
that submits a report under paragraph (1) shall
ensure that such report contains only summary
health information, as defined in section
164.504(a) of title 45, Code of Federal
Regulations (or successor regulations).
``(ii) Restrictions.--A group health plan
shall comply with section 164.504(f) of title
45, Code of Federal Regulations (or a successor
regulation) and a plan sponsor shall act in
accordance with the terms of the agreement
described in such section.
``(C) Rule of construction.--Nothing in this
section shall be construed to modify the requirements
for the creation, receipt, maintenance, or transmission
of protected health information under the HIPAA privacy
regulations (as defined in section 1180(b)(3) of the
Social Security Act).
``(4) Disclosure and redisclosure.--
``(A) Limitation to business associates.--A group
health plan receiving a report under paragraph (1) may
disclose such information only to the entity from which
the report was received or to that entity's business
associates as defined in section 160.103 of title 45,
Code of Federal Regulations (or successor regulations)
or as permitted by the HIPAA Privacy Rule (45 CFR parts
160 and 164, subparts A and E).
``(B) Clarification regarding public disclosure of
information.--Nothing in this section shall prevent a
group health plan or health insurance issuer offering
group health insurance coverage, or an entity providing
pharmacy benefits management services on behalf of such
a plan or coverage, from placing reasonable
restrictions on the public disclosure of the
information contained in a report described in
paragraph (1), except that such plan, 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, or the
Comptroller General of the United States.
``(C) Limited form of report.--The Secretary shall
define through rulemaking a limited form of the report
under paragraph (1) required with respect to group
health plans where the plan sponsors of such plans are
drug manufacturers, drug wholesalers, or other direct
participants in the drug supply chain, in order to
prevent anti-competitive behavior.
``(5) Report to gao.--A group health plan or health
insurance issuer offering group health insurance coverage, or
an entity providing pharmacy benefits management services on
behalf of such plan or coverage, shall submit to the
Comptroller General of the United States each of the first 4
reports submitted to a group health plan under paragraph (1)
and other such reports as requested, in accordance with the
privacy requirements under paragraph (3), the disclosure and
redisclosure standards under paragraph (4), the standards
specified pursuant to paragraph (6), and such other information
that the Comptroller General determines necessary to carry out
the study under section 106(d) of the Lower Costs, More
Transparency Act.
``(6) Standard format.--Not later than 1 year after the
date of enactment of this section, the Secretary shall specify
through rulemaking standards for group health plans, health
insurance issuers offering group health insurance coverage, and
entities providing pharmacy benefits management services on
behalf of such plans or coverage, required to submit reports
under paragraph (1) to submit such reports in a standard
format.
``(c) Rule of Construction.--Nothing in this section shall be
construed to permit a group health plan, health insurance issuer, or
entity providing pharmacy benefits management services on behalf of
such plan or coverage, to restrict disclosure to, or otherwise limit
the access of, the Secretary of Labor to a report described in
subsection (b)(1) or information related to compliance with subsection
(a) or (b) by entities subject to such subsection.
``(d) Definitions.--In this section:
``(1) Specified large employer.--The term `specified large
employer' means, in connection with a group health plan with
respect to a calendar year and a plan year, an employer who
employed an average of at least 50 employees on business days
during the preceding calendar year and who employs at least 1
employee on the first day of the plan year.
``(2) Wholesale acquisition cost.--The term `wholesale
acquisition cost' has the meaning given such term in section
1847A(c)(6)(B) of the Social Security Act.''.
(B) in section 502 (29 U.S.C. 1132)--
(i) in subsection (b)(3), by striking
``under subsection (c)(9))'' and inserting
``under paragraphs (9) and (13) of subsection
(c))''; and
(ii) 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 information.--The
Secretary 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 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 BENEFIT MANAGER SERVICES.
``(a) In General.--For plan years beginning on or after the date
that is 2 years after the date of enactment of this section, 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 other third party that limits
(or delays beyond the applicable reporting period described in
subsection (b)(1)) the disclosure of information to group health plans
in such a manner that prevents such plan or entity from making the
reports described in subsection (b).
``(b) Reports.--
``(1) In general.--With respect to plan years beginning on
or after the date that is 2 years after the date of enactment
of this section, not less frequently than every 6 months (or at
the request of a group health plan, not less frequently than
quarterly, but under the same conditions, terms, and cost of
the semiannual report under this subsection), a group health
plan, or an entity providing pharmacy benefits management
services on behalf of such a plan, shall submit to the group
health plan a report in accordance with this section. Each such
report shall be made available to such group health plan in a
machine-readable format and shall include the information
described in paragraph (2).
``(2) Information described.--For purposes of paragraph
(1), the information described in this paragraph is, with
respect to drugs covered by a group health plan during each
reporting period--
``(A) in the case of such a plan offered by a
specified large employer--
``(i) a list of drugs for which a claim was
filed and, with respect to each such drug on
such list--
``(I) the brand name, chemical
entity, and National Drug Code;
``(II) the type of dispensing
channel used to furnish such drug,
including retail, mail order, or
specialty pharmacy;
``(III) with respect to each drug
dispensed under each type of dispensing
channel (including retail, mail order,
or specialty pharmacy)--
``(aa) whether such drug is
a brand name drug or a generic
drug, and--
``(AA) in the case
of a brand name drug,
the wholesale
acquisition cost,
listed as cost per days
supply and cost per
dosage unit, on the
date such drug was
dispensed; and
``(BB) in the case
of a generic drug, the
average wholesale
price, listed as cost
per days supply and
cost per dosage unit,
on the date such drug
was dispensed; and
``(bb) the total number
of--
``(AA) prescription
claims (including
original prescriptions
and refills);
``(BB)
participants,
beneficiaries, and
enrollees for whom a
claim for such drug was
filed;
``(CC) dosage units
per fill of such drug;
and
``(DD) days supply
of such drug per fill;
``(IV) the net price per course of
treatment or single fill, such as a 30-
day supply or 90-day supply to the plan
after manufacturer rebates, fees, and
other remuneration or adjustments;
``(V) the total amount of out-of-
pocket spending by participants,
beneficiaries, and enrollees on such
drug, including spending through
copayments, coinsurance, and
deductibles;
``(VI) the total net spending by
the plan during the reporting period;
``(VII) the total amount received,
or expected to be received, by the plan
from any entity in drug manufacturer
rebates, fees, alternative discounts,
and all other remuneration received
from an entity or any third party
(including group purchasing
organizations) other than the plan
sponsor;
``(VIII) the total amount received,
or expected to be received by the plan,
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; and
``(bb) that is related to
utilization rebates for such
drug; and
``(IX) to the extent feasible,
information on the total amount of
remuneration, including copayment
assistance dollars paid, copayment
cards applied, or other discounts
provided by each drug manufacturer (or
entity administering copay assistance
on behalf of such drug manufacturer) to
the participants, beneficiaries, and
enrollees enrolled in such plan for
such drug;
``(ii) for each category or class of drugs
for which a claim was filed, a breakdown of the
total gross spending on drugs in such category
or class before rebates, price concessions,
alternative discounts, or other remuneration
from drug manufacturers, and the net spending
after such rebates, price concessions,
alternative discounts, or other remuneration
from drug manufacturers, including--
``(I) the number of participants,
beneficiaries, and enrollees who filled
a prescription for a drug in such
category or class, including the
National Drug Code for each such drug;
``(II) if applicable, a description
of the formulary tiers and utilization
mechanisms (such as prior authorization
or step therapy) employed for drugs in
that category or class;
``(III) the total out-of-pocket
spending under the plan by
participants, beneficiaries, and
enrollees, including spending through
copayments, coinsurance, and
deductibles; and
``(iii) in the case of a drug for which
gross spending by such plan or entity exceeded
$10,000 during the reporting period--
``(I) a list of all other drugs in
the same therapeutic category or class;
and
``(II) the rationale for the
formulary placement of such drug in
that therapeutic category or class, if
applicable; and
``(iv) in the case such plan (or an entity
providing pharmacy benefits management services
on behalf of such plan) that has an affiliated
pharmacy or pharmacy under common ownership--
``(I) the percentage of total
prescriptions dispensed by such
pharmacies to individuals enrolled in
such plan;
``(II) a list of all drugs
dispensed by such pharmacies to
individuals enrolled in such plan, and,
with respect to each drug dispensed--
``(aa) the amount charged,
per dosage unit, per 30-day
supply, or per 90-day supply
(as applicable) to the plan,
and to participants,
beneficiaries, and enrollees
enrolled in such plan;
``(bb) the median amount
charged to such plan, and the
interquartile range of the
costs, per dosage unit, per 30-
day supply, and per 90-day
supply, including amounts paid
by the participants,
beneficiaries, and enrollees,
when the same drug is dispensed
by other pharmacies that are
not affiliated with or under
common ownership with the
entity and that are included in
the pharmacy network of such
plan;
``(cc) the lowest cost per
dosage unit, per 30-day supply
and per 90-day supply, for each
such drug, including amounts
charged to the plan and
participants, beneficiaries,
and enrollees, that is
available from any pharmacy
included in the network of such
plan; and
``(dd) the net acquisition
cost per dosage unit, per 30-
day supply, and per 90-day
supply, if such drug is subject
to a maximum price discount;
``(B) in the case of a plan not described in
subparagraph (A)--
``(i) the total net spending by the plan
for all drugs covered by such plan during such
reporting period;
``(ii) the total amount received, or
expected to be received, by the plan from any
entity in drug manufacturer rebates, fees,
alternative discounts, and all other
remuneration received from an entity or any
third party (including group purchasing
organizations) other than the plan sponsor for
all such drugs; and
``(iii) to the extent feasible, information
on the total amount of remuneration, including
copayment assistance dollars paid, copayment
cards applied, or other discounts provided by
each drug manufacturer (or entity administering
copay assistance on behalf of such drug
manufacturer) to the participants,
beneficiaries, and enrollees enrolled in such
plan for such drugs;
``(C) amounts paid directly or indirectly in
rebates, fees, or any other type of compensation (as
defined in section 408(b)(2)(B)(ii)(dd)(AA) of the
Employee Retirement Income Security Act) to brokers,
consultants, advisors, or any other individual or firm,
for the referral of the group health plan's business to
an entity providing pharmacy benefits management
services, including the identity of the recipient of
such amounts;
``(D) an explanation of any benefit design
parameters that encourage or require participants,
beneficiaries, and enrollees in such plan to fill
prescriptions at mail order, specialty, or retail
pharmacies that are affiliated with or under common
ownership with the entity providing pharmacy benefit
management services under such plan, including
mandatory mail and specialty home delivery programs,
retail and mail auto-refill programs, and cost-sharing
assistance incentives directly or indirectly funded by
such entity; and
``(E) total gross spending on all drugs during the
reporting period.
``(3) Privacy requirements.--
``(A) In general.--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 13402(a) of the Health Information Technology
for Clinical Health Act and consistent with the HIPAA
privacy regulations (as defined in section 1180(b)(3)
of the Social Security Act) and shall restrict the use
and disclosure of such information according to such
privacy, security, and breach notification regulations
and such HIPAA privacy regulations.
``(B) Additional requirements.--
``(i) In general.--An entity providing
pharmacy benefits management services on behalf
of a group health plan that submits a report
under paragraph (1) shall ensure that such
report contains only summary health
information, as defined in section 164.504(a)
of title 45, Code of Federal Regulations (or
successor regulations).
``(ii) Restrictions.--A group health plan
shall comply with section 164.504(f) of title
45, Code of Federal Regulations (or a successor
regulation) and a plan sponsor shall act in
accordance with the terms of the agreement
described in such section.
``(C) Rule of construction.--Nothing in this
section shall be construed to modify the requirements
for the creation, receipt, maintenance, or transmission
of protected health information under the HIPAA privacy
regulations (as defined in section 1180(b)(3) of the
Social Security Act).
``(4) Disclosure and redisclosure.--
``(A) Limitation to business associates.--A group
health plan receiving a report under paragraph (1) may
disclose such information only to the entity from which
the report was received or to that entity's business
associates as defined in section 160.103 of title 45,
Code of Federal Regulations (or successor regulations)
or as permitted by the HIPAA Privacy Rule (45 CFR parts
160 and 164, subparts A and E).
``(B) Clarification regarding public disclosure of
information.--Nothing in this section shall prevent a
group health plan or health insurance issuer offering
group health insurance coverage, or an entity providing
pharmacy benefits management services on behalf of such
a plan or coverage, from placing reasonable
restrictions on the public disclosure of the
information contained in a report described in
paragraph (1), except that such plan, 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, or the
Comptroller General of the United States.
``(C) Limited form of report.--The Secretary shall
define through rulemaking a limited form of the report
under paragraph (1) required with respect to group
health plans where the plan sponsors of such plans are
drug manufacturers, drug wholesalers, or other direct
participants in the drug supply chain, in order to
prevent anti-competitive behavior.
``(5) Report to gao.--A group health plan, or an entity
providing pharmacy benefits management services on behalf of
such plan, shall submit to the Comptroller General of the
United States each of the first 4 reports submitted to a group
health plan under paragraph (1) and other such reports as
requested, in accordance with the privacy requirements under
paragraph (3), the disclosure and redisclosure standards under
paragraph (4), the standards specified pursuant to paragraph
(6), and such other information that the Comptroller General
determines necessary to carry out the study under section
106(d) of the Lower Costs, More Transparency Act.
``(6) Standard format.--Not later than 1 year after the
date of enactment of this section, the Secretary shall specify
through rulemaking standards for group health plans, and
entities providing pharmacy benefits management services on
behalf of such plans, required to submit reports under
paragraph (1) to submit such reports in a standard format.
``(c) Rule of Construction.--Nothing in this section shall be
construed to permit a group health plan or entity providing pharmacy
benefits management services on behalf of such plan, to restrict
disclosure to, or otherwise limit the access of, the Secretary of
Health and Human Services to a report described in subsection (b)(1) or
information related to compliance with subsections (a) or (b) by
entities subject to such subsection.
``(d) Definitions.--In this section:
``(1) Specified large employer.--The term `specified large
employer' means, in connection with a group health plan with
respect to a calendar year and a plan year, an employer who
employed an average of at least 50 employees on business days
during the preceding calendar year and who employs at least 1
employee on the first day of the plan year.
``(2) Wholesale acquisition cost.--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 Reports.--
(1) Report on pharmacy network design.--
(A) 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--
(i) pharmacy networks that have contracted
with group health plans, health insurance
issuers offering group health insurance
coverage, or entities providing pharmacy
benefits management services on behalf of such
plans or issuers, including networks with
pharmacies that are under common ownership (in
whole or part) with such plans, issuers, or
entities (including entities that provide
pharmacy benefits administrative services on
behalf of such plans or issuers);
(ii) pharmacy network design parameters
that encourage individuals enrolled in such
plans or coverage to fill prescriptions at mail
order, specialty, or retail pharmacies that are
wholly or partially owned by a plan, issuer, or
entity;
(iii) whether such plans and issuers have
options to elect different network pricing
arrangements in the marketplace with entities
that provide pharmacy benefits management
services and the prevalence of electing such
different network pricing arrangements;
(iv) with respect to pharmacy networks that
include pharmacies under common ownership
described in clause (i)--
(I) whether such networks are
designed to encourage individuals
enrolled in a group health plan or
health insurance 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;
(v) the degree to which mail order,
specialty, or retail pharmacies that dispense
prescription drugs to an enrollee in a plan or
coverage that are under common ownership (in
whole or part) with plans, issuers, or entities
providing pharmacy benefits management services
or pharmacy benefits administrative services on
behalf of such plan or coverage receive
reimbursement that is greater than the median
price charged to the plan or 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 plan or issuer, or entity providing
pharmacy benefits management services on behalf
of such plan or issuer.
(B) Requirement.--The Comptroller General of the
United States shall ensure that the report under
subparagraph (A) does not contain information that
would identify a specific group health plan or health
insurance issuer (or an entity providing pharmacy
benefits management services on behalf of such plan or
issuer), or otherwise contain commercial or financial
information that is privileged or confidential.
(C) Definitions.--In this paragraph, 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).
(2) Report on copay assistance programs.--Not later than 18
months after the date of the enactment of this Act, the
Comptroller General of the United States shall submit to
Congress a report on what is known about the role of copay
assistance programs and the impact of such programs on
commercial health insurance, stop loss, and drug prices. Such
report shall include to the extent feasible--
(A) a description of copay assistance programs,
including--
(i) the types of programs available and the
methods of providing copay assistance through
such programs, including cash discounts, copay
cards, or drugs provided to an individual at no
cost;
(ii) how such programs are funded;
(iii) the types of entities that own,
operate, or otherwise conduct such programs,
the types of information such entities collect,
and the direct and indirect contractual
relationships between the entities in the drug
supply chain that interact with such programs,
such as a drug manufacturer, pharmacy,
wholesaler, switch, rebate aggregator, pharmacy
benefit manager, and other entities in the drug
supply chain;
(iv) the effect of such programs on patient
out-of-pocket spending, including for stop-loss
insurance, and drug utilization, including drug
adherence; and
(v) patient eligibility criteria for such
programs; and
(B) an analysis of--
(i) the sources of funding for such
programs; and
(ii) the effects of such programs on
Federal health care programs and the
individuals enrolled in such Federal health
care programs.
SEC. 107. REPORTS ON HEALTH CARE TRANSPARENCY TOOLS AND DATA.
(a) Initial Report.--Not later than December 31, 2024, the
Comptroller General of the United States shall submit to the Committees
(as defined in subsection (d)) an initial report that--
(1) identifies and describes health care transparency tools
and Federal health care reporting requirements (as described in
subsection (d)) that are in effect as of the date of the
submission of such initial report, including the frequency of
reports with respect to each such requirement and whether any
such requirements are duplicative;
(2) reviews how such reporting requirements are enforced;
(3) analyzes whether the public availability of health care
transparency tools, and the publication of data pursuant to
such reporting requirements, has--
(A) been utilized and valued by consumers,
including reasons for such utilization (or lack
thereof); and
(B) assisted health insurance plan sponsors and
fiduciaries improve benefits, lower health care costs
for plan participants, and meet fiduciary requirements;
(4) includes recommendations to the Committees, the
Secretary of Health and Human Services, the Secretary of Labor,
and the Secretary of the Treasury to--
(A) improve the efficiency, accuracy, and usability
of health care transparency tools;
(B) streamline Federal health care reporting
requirements to eliminate duplicative requirements and
reduce the burden on entities required to submit
reports pursuant to such provisions;
(C) improve the accuracy and efficiency of such
reports while maintaining the integrity and usability
of the data provided by such reports;
(D) address any gaps in data provided by such
reports; and
(E) ensure that the data and information reported
is comparable and usable to consumers, including
patients, plan sponsors, and policy makers.
(b) Final Report.--Not later than December 31, 2028, the
Comptroller General of the United States shall submit to the Committees
a report that includes--
(1) the information provided in the initial report, along
with any updates to such information; and
(2) any new information with respect to health care
transparency tools that have been released following the
submission of such initial report, or new reporting
requirements in effect as of the date of the submission of the
final report.
(c) Report on Expanding Price Transparency Requirements.--Not later
than December 31, 2025, the Comptroller General of the United States,
in consultation with the Secretary of Health and Human Services, health
care provider groups, and patient advocacy groups, shall submit to the
Committees a report that includes recommendations to expand price
transparency reporting requirements to additional care settings, with
an emphasis on settings where shoppable services (as defined in
subsection (d)) are furnished.
(d) Definitions.--In this section:
(1) Committees.--The term ``Committees'' means the
Committee on Ways and Means, the Committee on Energy and
Commerce, and the Committee on Education and the Workforce of
the House of Representatives, and the Committee on Finance and
the Committee on Health, Education, Labor, and Pensions of the
Senate.
(2) Federal health care reporting requirements.--The term
``Federal health care reporting requirements'' includes
regulatory and statutory requirements with respect to the
reporting and publication of health care price, cost access,
and quality data, including requirements established by the
Consolidated Appropriations Act of 2021 (Public Law 116-260),
this Act, and other reporting and publication requirements with
respect to transparency in health care as identified by the
Comptroller General of the United States.
(3) Shoppable service.--The term ``shoppable service''
means a service that can be scheduled by a health care consumer
in advance and includes all ancillary items and services
customarily furnished as part of such service.
SEC. 108. REPORT ON INTEGRATION IN MEDICARE.
(a) Required MA and PDP Reporting.--
(1) MA plans.--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 year 2025 and for every
third plan year thereafter, each applicable MA
organization offering an MA plan under this part during
such plan year shall submit to the Secretary, at a time
and in a manner specified by the Secretary--
``(i) the taxpayer identification number
for each health care provider that was a
specified health care provider with respect to
such organization during such year;
``(ii) the total amount of incentive-based
payments made to, and the total amount of
shared losses recoupments collected from, such
specified health care providers during such
plan year; and
``(iii) 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 (ii) during such plan year.
``(B) Definitions.--For purposes of this paragraph:
``(i) Applicable ma organization.--The term
`applicable MA organization' means, with
respect to a plan year, an MA organization with
at least 25,000 individuals enrolled under
Medicare Advantage plans offered by such
organization during such plan year.
``(ii) Specified health care provider.--The
term `specified health care provider' means,
with respect to an applicable 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).''.
(2) Prescription drug plans.--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 paragraph:
``(9) Provision of information relating to pharmacy
ownership.--
``(A) In general.--For plan year 2025 and for every
third plan year thereafter, each PDP sponsor offering a
prescription drug plan under this part during such plan
year shall submit to the Secretary, at a time and in a
manner specified by the Secretary, the taxpayer
identification number and National Provider Identifier
for each pharmacy that was a specified pharmacy with
respect to such sponsor during such year.
``(B) Definition.--For purposes of this paragraph,
the term `specified pharmacy' means, with respect to an
PDP sponsor offering a prescription drug plan and a
plan year, a pharmacy with respect to which--
``(i) 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); or
``(ii) a pharmacy benefit manager offering
services under such plan (or any person with an
ownership or control interest (as so defined)
in such sponsor) is a person with an ownership
or control interest (as so defined).''.
(b) MedPAC Reports.--Part E of title XVIII of the Social Security
Act (42 U.S.C. 1395x et seq.), as amended by section 101, is further
amended by adding at the end the following new section:
``SEC. 1899D. REPORTS ON VERTICAL INTEGRATION UNDER MEDICARE.
``(a) In General.--Not later than June 15, 2029, and every 3 years
thereafter, the Medicare Payment Advisory Commission shall submit to
Congress a report on the state of vertical integration in the health
care sector during the applicable year with respect to entities
participating in the Medicare program, including health care providers,
pharmacies, prescription drug plan sponsors, Medicare Advantage
organizations, and pharmacy benefit managers. Such report shall
include--
``(1) with respect to Medicare Advantage organizations, the
evaluation described in subsection (b);
``(2) with respect to prescription drug plans, pharmacy
benefit managers, and pharmacies, the comparisons and
evaluations described in subsection (c);
``(3) with respect to Medicare Advantage plans under which
benefits are available for physician-administered drugs, the
information described in subsection (d);
``(4) the identifications described in subsection (e); and
``(5) an analysis of the impact of such integration on
health care access, price, quality, and outcomes.
``(b) Medicare Advantage Organizations.--For purposes of subsection
(a)(1), the evaluation described in this subsection is, with respect to
Medicare Advantage organizations and an applicable year, an evaluation,
taking into account patient acuity and the types of areas serviced by
such organization, of--
``(1) the average number of qualifying diagnoses made
during such year with respect to enrollees of a Medicare
Advantage plan offered by such organization who, during such
year, received a health risk assessment from a specified health
care provider;
``(2) the average risk score for such enrollees who
received such an assessment during such year;
``(3) any relationship between such risk scores for such
enrollees receiving such an assessment from such a provider
during such year and incentive payments made to such providers;
``(4) the average risk score for enrollees of such plan who
received any item or service from a specified health care
provider during such year;
``(5) any relationship between the risk scores of enrollees
under such plan and whether the enrollees have received any
item or service from a specified provider; and
``(6) any relationship between the risk scores of enrollees
under such plan that have received any item or service from a
specified provider and incentive payments made under the plan
to specified providers.
``(c) Prescription Drug Plans.--For purposes of subsection (a)(2),
the comparisons and evaluations described in this subsection are, with
respect to prescription drug plans and an applicable year, the
following:
``(1) For each covered part D drug for which benefits are
available under such a plan, a comparison of the average
negotiated rate in effect with specified pharmacies with such
rates in effect for in-network pharmacies that are not
specified pharmacies.
``(2) Comparisons of the following:
``(A) The total amount paid by pharmacy benefit
managers to specified pharmacies for covered part D
drugs and the total amount so paid to pharmacies that
are not specified pharmacies for such drugs.
``(B) The total amount paid by such sponsors to
specified pharmacy benefit managers as reimbursement
for covered part D drugs and the total amount so paid
to pharmacy benefit managers that are not specified
pharmacy benefit managers as such reimbursement.
``(C) Fees paid under by plan to specified pharmacy
benefit managers compared to such fees paid to pharmacy
benefit managers that are not specified pharmacy
benefit managers.
``(3) An evaluation of the total amount of direct and
indirect remuneration for covered part D drugs passed through
to prescription drug plan sponsors and the total amount
retained by pharmacy benefit managers (including entities under
contract with such a manager).
``(4) To the extent that the available data permits, an
evaluation of fees charged by rebate aggregators that are
affiliated with plan sponsors.
``(d) Physician-administered Drugs.--For purposes of subsection
(a)(3), the information described in this subsection is, with respect
to physician-administered drugs for which benefits are available under
a Medicare Advantage plan during an applicable year, the following:
``(1) With respect to each such plan, an identification of
each drug for which benefits were available under such plan
only when administered by a health care provider that acquired
such drug from an affiliated pharmacy.
``(2) An evaluation of the difference between the total
number of drugs administered by a health care provider that
were acquired from affiliated pharmacies compared to the number
of such drugs so administered that were acquired from
pharmacies other than affiliated pharmacies, and an evaluation
of the difference in payments for such drugs so administered
when acquired from a specified pharmacy and when acquired from
a pharmacy that is not a specified pharmacy.
``(3) An evaluation of the dollar value of all such drugs
that were not so administered because of a delay attributable
to an affiliated pharmacy compared to the dollar value of all
such drugs that were not so administered because of a delay
attributable to pharmacy that is not an affiliated pharmacy.
``(4) The number of enrollees administered such a drug that
was acquired from an affiliated pharmacy.
``(5) The number of enrollees furnished such a drug that
was acquired from a pharmacy that is not an affiliated
pharmacy.
``(e) Identifications.--For purposes of subsection (a)(4), the
identifications described in this subsection are, with respect to an
applicable year, identifications of each health care entity
participating under the Medicare program with respect to which another
health care entity so participating is a person with an ownership or
control interest (as defined in section 1124(a)(3)).
``(f) Definitions.--In this section:
``(1) Affiliated pharmacy.--The term `affiliated pharmacy'
means, with respect to a Medicare Advantage plan offered by a
Medicare Advantage organization, a pharmacy 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).
``(2) Applicable year.--The term `applicable year' means,
with respect to a report submitted under subsection (a), the
first calendar year beginning at least 4 years prior to the
date of the submission of such report.
``(3) Covered part d drug.--The term `covered part D drug'
has the meaning given such term in section 1860D-2(e).
``(4) 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).
``(5) Qualifying diagnosis.--The term `qualifying
diagnosis' means, with respect to an enrollee of a Medicare
Advantage plan, a diagnosis that is taken into account in
calculating a risk score for such enrollee under the risk
adjustment methodology established by the Secretary pursuant to
section 1853(a)(3).
``(6) Risk score.--The term `risk score' means, with
respect to an enrollee of a Medicare Advantage plan, the score
calculated for such individual using the methodology described
in paragraph (5).
``(7) Physician-administered drug.--The term `physician-
administered drug' means a drug furnished to an individual
that, had such individual been enrolled under part B and not
enrolled under part C, would have been payable under section
1842(o).
``(8) Specified health care provider.--The term `specified
health care provider' means, with respect to a Medicare
Advantage plan offered by a Medicare Advantage organization, a
health care provider 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).
``(9) Specified pharmacy.--The term `specified pharmacy'
means, with respect to a prescription drug plan offered by a
prescription drug plan sponsor, a pharmacy with respect to
which--
``(A) 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); or
``(B) a pharmacy benefit manager offering services
under such plan (or any person with an ownership or
control interest (as so defined) in such sponsor) is a
person with an ownership or control interest (as so
defined).
``(10) Specified pharmacy benefit manager.--The term
`specified pharmacy benefit manager' means, with respect to a
prescription drug plan offered by a prescription drug plan
sponsor, 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).''.
SEC. 109. ADVISORY COMMITTEE.
(a) In General.--Not later than January 1, 2025, the Secretary of
Labor, the Secretary of Health and Human Services, and the Secretary of
the Treasury shall jointly convene an advisory committee (in this
section referred to as the ``committee'') consisting of 9 members to
advise the Secretaries on how to improve the usefulness, accessibility,
and usability of information made available in accordance the
amendments made by sections 105 and 106, and by section 204 of division
BB of the Consolidated Appropriation Act, 2021 (Public Law 116-260),
streamline the reporting of such information, and ensure that--
(1) such information is accurate, accessible, and is
delivered in a form and manner consistent with the requirements
of such section;
(2) the form and manner in which such information is
delivered is routinely updated in accordance with widely-used
practices in order to ensure accessibility; and
(3) such information is available for audit (including by
making recommendations relating to how Federal and State actors
may conduct such audits).
(b) Membership.--The Secretaries shall jointly appoint members
representing end-users of the information described in subsection (a).
Vacancies on the committee shall be filled by appointment consistent
with this subsection not later than 3 months after the vacancy arises.
(c) Termination.--The committee shall terminate on January 1, 2028.
(d) Nonapplicaiton of FACA.--The Federal Advisory Committee Act (5
U.S.C. App.) shall not apply to the committee.
SEC. 110. REPORT ON IMPACT OF MEDICARE REGULATIONS ON PROVIDER AND
PAYER CONSOLIDATION.
(a) Annual Report on the Impact of Certain Medicare Regulations on
Provider and Payer Consolidation; Public Comment on Provider and Payer
Consolidation for Certain Proposed Rules.--
(1) Annual report.--Not later than December 30, 2026, and
annually thereafter, the Secretary of Health and Human Services
(in this section referred to as the ``Secretary'') shall submit
to Congress a report on the impact in the aggregate on provider
and payer consolidation with respect to regulations for parts
A, B, C, and D of title XVIII of the Social Security Act (42
U.S.C. 1395 et seq.) implemented in the calendar year
immediately prior to such report. Such report shall include
regulations that--
(A) implement a change to an applicable payment
system, a rate schedule, or another payment system
under part A, B, C, or D of such title; or
(B) result in a significant rule effecting provider
or payer consolidation.
(2) Public comment on impact to provider and payer
consolidation.--Beginning for 2025, as part of any notice and
comment rulemaking process that will result in a significant
rule effecting provider or payer consolidation with respect to
a proposed rule for parts A, B, C, and D of title XVIII of the
Social Security Act (42 U.S.C. 1395j et seq.), the Secretary
shall seek public comment on the projected impact of such
proposed rule on provider and payer consolidation in the
aggregate.
(3) Definitions.--In this section:
(A) Provider and payer consolidation.--The term
``provider and payer consolidation'' includes the
vertical or horizontal integration among providers of
services (as defined in subsection (u) of section 1861
of the Social Security Act (42 U.S.C. 1395x)),
suppliers (as defined in subsection (d) of such
section), accountable care organizations under section
1899 of the Social Security Act (42 U.S.C. 1395jjj),
Medicare Advantage organizations, PDP sponsors,
pharmacy benefit managers, pharmacies, and integrated
delivery systems.
(B) Applicable payment system.--The term
``applicable payment system'' includes--
(i) with respect to outpatient hospital
services, the prospective payment system for
covered OPD services established under section
1833(t) of such Act (42 U.S.C. 1395(l)); and
(ii) with respect to physicians' services,
the physician fee schedules established under
section 1848 of such Act (42 U.S.C. 1395w-4).
(b) Consideration of Effects on Provider and Payer Consolidation
With Respect to CMI Models.--
(1) In general.--Section 1115A(b)(4)(A) of the Social
Security Act (42 U.S.C. 1315a(b)(4)(A)) is amended--
(A) in clause (i), by striking at the end ``and'';
(B) in clause (ii), by striking the period at the
end and inserting ``; and''; and
(C) by adding at the end the following new clause:
``(iii) the extent to which, and how, the
model has effected and could effect provider
and payer consolidation, which includes the
vertical or horizontal integration among
providers of services (as defined in subsection
(u) of section 1861), suppliers (as defined in
subsection (d) of such section), and
accountable care organizations under section
1899.''.
(2) Effective date.--The amendments made by paragraph (1)
shall apply with respect to models tested on or after January
1, 2025.
SEC. 111. IMPLEMENTATION FUNDING.
(a) In General.--For the purposes described in subsection (b),
there are appropriated, in addition to amounts otherwise available, out
of amounts in the Treasury not otherwise appropriated, to the Secretary
of Health and Human Services and the Secretary of the Treasury,
$65,000,000 for fiscal year 2024, to remain available through fiscal
year 2029.
(b) Permitted Purposes.--The purposes described in this subsection
are the following purposes, insofar as such purposes are to carry out
the provisions of, including the amendments made by, this title:
(1) Preparing, drafting, and issuing proposed and final
regulations or interim regulations.
(2) Preparing, drafting, and issuing guidance and public
information.
(3) Preparing, drafting, and publishing reports.
(4) Enforcement of such provisions.
(5) Reporting, collection, and analysis of data.
(6) Other administrative duties necessary for
implementation of such provisions.
(c) Transparency of Implementation Funds.--Each Secretary described
in subsection (a) shall annually submit, no later than September 1st of
each year, to the Committees on Energy and Commerce, on Ways and Means,
on Education and Workforce, and on Appropriations of the House of
Representatives and on the Committees on Health, Education, Labor, and
Pensions and on Appropriations of the Senate a report on funds expended
pursuant to funds appropriated under this section.
TITLE II--REDUCING HEALTH CARE COSTS FOR PATIENTS
SEC. 201. 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, the amount of such deviation.
``(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. 202. IMPROVING TRANSPARENCY AND PREVENTING THE USE OF ABUSIVE
SPREAD PRICING AND RELATED PRACTICES IN MEDICAID.
(a) Spread Pricing.--
(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) In general.--A contract between the State and
a pharmacy benefit manager (in this paragraph referred
to as a `PBM'), or a contract between the State and a
designated entity (as defined in subparagraph (C)) that
includes provisions making the designated entity
responsible for the administration of medical
assistance consisting of covered outpatient drugs for
individuals enrolled with the designated 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
designated entity, is based on a pharmacy price
reimbursement model under which--
``(i) any payment made by the designated
entity or the PBM (as applicable) for such a
drug--
``(I) is limited to--
``(aa) ingredient cost; and
``(bb) 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 designated entity or
PBM to the pharmacy or provider that
dispenses the drug and is not
retroactively denied or reduced except
as permitted or required under Federal
or State law or regulation; 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
designated entity or the PBM, except
that any payment by the designated
entity or the PBM for the ingredient
cost of such a drug purchased by a
covered entity (as defined in
subsection (a)(5)(B)) may exceed the
actual acquisition cost (as defined in
section 447.502 of title 42, Code of
Federal Regulations (or any successor
regulation)) for such drug if--
``(aa) such drug was
subject to an agreement under
section 340B of the Public
Health Service Act;
``(bb) such payment for
such cost of such drug does not
exceed the maximum payment that
would have been made by the
designated entity or the PBM
for the ingredient cost of such
drug had such drug not been
purchased by such a covered
entity; and
``(cc) such covered entity
reports to the Secretary, on an
annual basis (in a form and
manner specified by the
Secretary) and with respect to
payments for such costs of such
drugs so purchased by such
covered entity that are in
excess of the actual
acquisition costs for such
drugs, the aggregate amount of
such excess;
``(ii) payment to the designated entity or
the PBM (as applicable) for administrative
services performed by the designated entity or
PBM is limited to an administrative fee that
reflects the fair market value of providing
such services;
``(iii) the designated entity or the PBM
(as applicable) makes 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 designated
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
``(iv) any form of spread pricing whereby
any amount charged or claimed by the designated
entity or the PBM (as applicable) is in excess
of the amount paid to the pharmacies by the
designated entity or the PBM, 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 fair market administrative fee
as described in clause (ii)), is not allowable
for purposes of claiming Federal matching
payments under this title.
``(B) Making certain information available.--The
Secretary shall publish, not less frequently than on an
annual basis, information received by the Secretary
pursuant to subparagraph (A)(i)(III)(cc). Such
information shall be so published in an electronic and
searchable format, such as through the 340B Office of
Pharmacy Affairs Information System (or a successor
system).
``(C) Definitions.--In this paragraph:
``(i) Designated entity.--The term
`designated entity' means a managed care entity
or other specified entity.
``(ii) Managed care entity; other specified
entity.--The terms `managed care entity' and
`other specified entity' have the meaning given
such terms in section 1903(m)(9)(D).''.
(2) Conforming amendments.--Section 1903(m) of such Act (42
U.S.C. 1396b(m)) is amended--
(A) in paragraph (2)(A)(xiii)--
(i) by striking ``and (III)'' and inserting
``(III)'';
(ii) by inserting before the period at the
end the following: ``, and (IV) with respect to
covered outpatient drugs and related
administrative services (as applicable)
provided by the entity (or by a pharmacy
benefit manager on behalf of the entity under a
contract or other arrangement with the entity),
that payment for such drugs and related
administrative services is based on a pharmacy
price reimbursement model described in section
1927(e)(6)(A)''; and
(iii) by moving the margin 2 ems to the
left; and
(B) by adding at the end the following new
paragraph:
``(10) No payment shall be made under this title to a State with
respect to expenditures incurred by it for payment for services
provided by an other specified entity (as defined in paragraph (9)(D))
unless the contract between the State and the entity for the provision
of such services provides, with respect to covered outpatient drugs and
related administrative services (as applicable) provided by the entity
(or by a pharmacy benefit manager on behalf of the entity under a
contract or other arrangement with the entity), that payment for such
drugs and related administrative services is based on a pharmacy price
reimbursement model described in section 1927(e)(6)(A).''.
(3) Effective date.--The amendments made by this subsection
apply to contracts between States and pharmacy benefit managers
and designated entities (as defined in section 1927(e)(6) of
the Social Security Act, as added by paragraph (1)) that have
an effective date beginning 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 designated
entity (as defined in subsection (e)(6)(C)) directly or
from a pharmacy benefit manager that has a contract
with the State or a designated 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 may be publicly released and
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 designated entities
(as defined in subsection (e)(6)(C)) 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 specialty 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 (acting through the Inspector
General and in collaboration with the Administrator of
the Centers for Medicare & Medicaid Services) may
enforce non-compliance with this paragraph by a
pharmacy through the establishment of penalties until
compliance with this paragraph has been completed.'';
and
(C) in paragraph (2)--
(i) in subparagraph (A), by inserting
``(including payment rates under managed care
organization as defined in section
1932(a)(1)(B)(i) and PIHPs and PAHPs as defined
in section 1903(m)(9)(D)(iii)(I) and (II),
respectively)'' 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
shall 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.
SEC. 203. 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 (v)) that are furnished
during 2025 or a subsequent year by an off-
campus outpatient department of a provider (as
defined in clause (iv)) (or, in the case of an
off-campus outpatient department of a provider
that is a hospital described in section
1886(d)(1)(B)(v), or is located in a rural area
or a health professional shortage area, such
services that are furnished during 2026 or a
subsequent year), 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 (or in the case of
an off-campus outpatient department of a
provider that is a hospital described in
section 1886(d)(1)(B)(v), or is located in a
rural area or a health professional shortage
area, beginning with 2029).
``(iv) Off-campus department of a
provider.--For purposes of this subparagraph,
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--
``(I) on the campus (as such term
is 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).
``(v) Other 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) Health professional shortage
area.--The term `health professional
shortage area' has the meaning given
such term in section 332(a)(1)(A) of
the Public Health Service Act.
``(III) Rural area.--The term
`rural area' has the meaning given such
term in section 1886(d)(2)(D).
``(IV) Specified opd services.--The
term `specified OPD services' means
covered OPD services assigned to a
designated ambulatory payment
classification group.''.
(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. 204. REQUIRING A SEPARATE IDENTIFICATION NUMBER AND AN ATTESTATION
FOR EACH OFF-CAMPUS OUTPATIENT DEPARTMENT OF A PROVIDER.
(a) In General.--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, remote audits, or other means (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).''.
(b) HHS OIG Analysis.--Not later than January 1, 2030, the
Inspector General of the Department of Health and Human Services shall
submit to Congress--
(1) an analysis of the process established by the Secretary
of Health and Human Services to conduct the reviews and
determinations described in section 1833(t)(23)(B) of the
Social Security Act, as added by subsection (a) of this
section; and
(2) recommendations based on such analysis, as the
Inspector General determines appropriate.
TITLE III--SUPPORTING PATIENTS, HEALTH CARE WORKERS, COMMUNITY HEALTH
CENTERS, AND HOSPITALS
SEC. 301. 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.--
(1) Addition to capped amounts for fiscal years 2024 and
2025.--Paragraph (2) of section 340H(b) of the Public Health
Service Act (42 U.S.C. 256h(b)) is amended by adding at the end
the following:
``(C) Addition.--Notwithstanding any provision of
this section, for each of fiscal years 2024 and 2025,
the Secretary may use any amounts made available in any
fiscal year to carry out this section (including
amounts recouped under subsection (f)) to make payments
described in paragraphs (1)(A) and (1)(B), in addition
to the total amount of funds appropriated under
subsection (g).''.
(2) Reconciliation.--Section 340H(f) of the Public Health
Service Act (42 U.S.C. 256h(f)) is amended--
(A) by striking ``The Secretary shall determine''
and inserting the following:
``(1) Determination.--The Secretary shall determine''; and
(B) by adding at the end the following:
``(2) Annual report to congress.--For each fiscal year, the
Secretary 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
specifying--
``(A) the total amount of funds recouped under
paragraph (1);
``(B) the rationale for the funds being recouped;
and
``(C) in the case of the reports for each of fiscal
years 2024 and 2025, the total amount of funds recouped
under paragraph (1) that were used pursuant to
subsection (b)(2)(C) to adjust total payment amounts
above the total amounts appropriated under subsection
(g).''.
(3) Funding.--Section 340H(g) of the Public Health Service
Act (42 U.S.C. 256h(g)) is amended--
(A) 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) $16,635,616 for the period beginning on
October 1, 2023, and ending on November 17, 2023;
``(E) $21,834,247 for the period beginning on
November 18, 2023, and ending on January 19, 2024;
``(F) $136,530,137 for the period beginning on
January 20, 2024, and ending on September 30, 2024;
``(G) $175,000,000 for fiscal year 2025;
``(H) $225,000,000 for each of fiscal years 2026
and 2027; and
``(I) $300,000,000 for each of fiscal years 2028,
2029, and 2030.''; and
(B) 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 ``$690,410,959''; and
(2) by inserting ``, $3,183,561,644 for the period
beginning on January 20, 2024, and ending on September 30,
2024, $4,400,000,000 for fiscal year 2025, and $1,109,000,000
for the period beginning October 1, 2025, and ending December
31, 2025'' before the semicolon at the end.
(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 (H), by striking ``and'' at the end;
(2) in subparagraph (I), by striking the period at the end
and inserting ``; and''; and
(3) by adding at the end the following:
``(J) $255,726,028 for the period beginning on
January 20, 2024, and ending on September 30, 2024,
$350,000,000 for fiscal year 2025, and $88,219,178 for
the period beginning October 1, 2025, and ending
December 31, 2025.''.
(d) Government Accountability Office Report.--
(1) In general.--Not later than one 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 assessing
the effectiveness of the National Health Service Corps at
attracting health care professionals to HPSAs, including by--
(A) assessing the metrics used by the Health
Resources and Services Administration in evaluating the
program;
(B) comparing the retention rates of NHSC
participants in the HPSAs where they completed their
period of obligated service to the retention rate of
non-NHSC participants in the corresponding HPSAs;
(C) comparing the retention rates of NHSC
participants in the HPSAs where they completed their
period of obligated service to the retention rates of
NHSC participants in HPSAs other than those where they
completed their period of obligated service;
(D) identifying factors that influence a NHSC
participant's decision to practice in a HPSA other than
the HPSA where they completed their period of obligated
service;
(E) identifying factors other than participation in
the National Health Service Corps Scholarship and Loan
Repayment Programs that attract health care
professionals to a HPSA;
(F) assessing the impact the National Health
Service Corps has on wages for health care
professionals in a HPSA; and
(G) comparing the distribution of NHSC participants
across HPSAs, including a comparison of rural versus
non-rural HPSAs.
(2) Definition.--In this section:
(A) The term ``HPSA'' means a health professional
shortage area designated under section 332 of the
Public Health Service Act (42 U.S.C. 254e).
(B) The term ``NHSC participant'' means a National
Health Service Corps member participating in the
National Health Service Corps Scholarship or Loan
Repayment Program.
(e) 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.
(f) Conforming Amendment.--Paragraph (4) of section 3014(h) of
title 18, United States Code, is amended by striking ``and section
2321(d) of the Continuing Appropriations Act, 2024 and Other Extensions
Act'' and inserting ``section 2321(d) of the Continuing Appropriations
Act, 2024 and Other Extensions Act, and section 301(e) of the Lower
Costs, More Transparency Act''.
SEC. 302. 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 (D), by striking ``and'' at the end;
(2) in subparagraph (E), by striking the period at the end
and inserting a semicolon; and
(3) by adding at the end the following:
``(F) $124,383,562 for the period beginning on
January 20, 2024, and ending on September 30, 2024, to
remain available until expended;
``(G) $170,000,000 for fiscal year 2025, to remain
available until expended; and
``(H) $42,849,315 for the period beginning October
1, 2025, and ending December 31, 2025, to remain
available until expended.''.
(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 (D), by striking ``and'' at the end;
(2) in subparagraph (E), by striking the period at the end
and inserting a semicolon; and
(3) by adding at the end the following:
``(F) $124,383,562 for the period beginning on
January 20, 2024, and ending on September 30, 2024, to
remain available until expended;
``(G) $170,000,000 for fiscal year 2025, to remain
available until expended; and
``(H) $42,849,315 for the period beginning October
1, 2025, and ending December 31, 2025, to remain
available until expended.''.
SEC. 303. DELAYING CERTAIN DISPROPORTIONATE SHARE PAYMENT CUTS.
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)--
(A) by striking ``For the period beginning January
20, 2024, and ending September 30, 2024, and for each
of fiscal years 2025'' and inserting ``For each of
fiscal years 2026''; and
(B) by striking ``or period'' each place such term
appears; and
(2) in clause (ii), by striking ``for the period beginning
January 20, 2024, and ending September 30, 2024, and for each
of fiscal years 2025'' and inserting ``for each of fiscal years
2026''.
SEC. 304. 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 `` $6,357,117,810'' and inserting
``$0''.
TITLE IV--INCREASING ACCESS TO QUALITY HEALTH DATA AND LOWERING HIDDEN
FEES
SEC. 401. INCREASING PLAN FIDUCIARIES' ACCESS TO HEALTH DATA.
(a) Plan Fiduciary Access to Information.--
(1) In general.--Paragraph (2) of section 408(b) of the
Employee Retirement Income Security Act of 1974 (29 U.S.C.
1108(b)) is amended by adding at the end the following new
subparagraph:
``(C) No contract or arrangement for services between a
group health plan and any other entity, including a health care
provider (including a health care facility), network or
association of providers, service provider offering access to a
network of providers, third-party administrator, or pharmacy
benefit manager, is reasonable within the meaning of this
paragraph unless such contract or arrangement--
``(i) allows the responsible plan fiduciary (as
defined in subparagraph (B)(ii)(I)(ee)) to audit or
review all de-identified claims and encounter
information or data described in section 724(a)(1)(B)
to--
``(I) ensure that such entity complies with
the terms of the plan and any applicable law;
and
``(II) determine the reasonableness of
compensation received by such entity; and
``(ii) does not--
``(I) unreasonably limit the number of
audits permitted during a given period of time;
``(II) limit the number of de-identified
claims and encounter information or data that
the responsible plan fiduciary may access
during an audit;
``(III) limit the disclosure of pricing
terms for value-based payment arrangements or
capitated payment arrangements, including--
``(aa) payment calculations and
formulas;
``(bb) quality measures;
``(cc) contract terms;
``(dd) payment amounts;
``(ee) measurement periods for all
incentives; and
``(ff) other payment methodologies
used by an entity, including a health
care provider (including a health care
facility), network or association of
providers, service provider offering
access to a network of providers,
third-party administrator, or pharmacy
benefit manager;
``(IV) limit the disclosure of overpayments
and overpayment recovery terms;
``(V) limit the right of the responsible
plan fiduciary to select an auditor;
``(VI) otherwise limit or unduly delay by
greater than 60 calendar days after the date of
request the responsible plan fiduciary from
auditing all de-identified claims and encounter
information or data; or
``(VII) permit the entity to charge a fee
beyond the reasonable direct costs to provide
the required information and otherwise comply
and assist with an audit request.''.
(2) Civil enforcement.--
(A) In general.--Subsection (c) of section 502 of
such Act (29 U.S.C. 1132) is amended by adding at the
end the following new paragraph:
``(13) In the case of an agreement between a group health plan and
a health care provider (including a health care facility), network or
association of providers, service provider offering access to a network
of providers, third-party administrator, or pharmacy benefit manager,
that violates the provisions of section 724, the Secretary may assess a
civil penalty against such provider, network or association, service
provider offering access to a network of providers, third-party
administrator, pharmacy benefit manager, or other service provider in
the amount of $10,000 for each day during which such violation
continues. Such penalty shall be in addition to other penalties as may
be prescribed by law.''.
(B) Conforming amendment.--Paragraph (6) of section
502(a) of such Act is amended by striking ``or (9)''
and inserting ``(9), or (13)''.
(3) Existing provisions void.--Section 410 of such Act is
amended by adding at the end the following new subsection:
``(c) Any provision in an agreement or instrument shall be void as
against public policy if such provision--
``(1) unduly delays or limits a plan fiduciary from
accessing the de-identified claims and encounter information or
data described in section 724(a)(1)(B); or
``(2) violates the requirements of section 408(b)(2)(C).''.
(b) Updated Attestation for Price and Quality Information.--Section
724(a)(3) of the Employee Retirement Income Security Act (29 U.S.C.
1185m(a)(3)) is amended to read as follows:
``(3) Attestation.--
``(A) In general.--Subject to subparagraph (C), the
plan fiduciary of a group health plan or health
insurance issuer offering group health insurance
coverage shall annually submit to the Secretary an
attestation that such plan or issuer of such coverage
is in compliance with the requirements of this
subsection. Such attestation shall also include a
statement verifying that--
``(i) the information or data described
under subparagraphs (A) and (B) of paragraph
(1) is available upon request and provided to
the plan fiduciary, the plan administrator, or
the issuer in a timely manner; and
``(ii) there are no terms in the agreement
under such paragraph (1) that directly or
indirectly restrict or unduly delay a plan
fiduciary, the plan administrator, or the
issuer from auditing, reviewing, or otherwise
accessing such information, except as permitted
under section 408(b)(2)(C).
``(B) Limitation on submission.--Subject to clause
(ii), a group health plan or issuer offering group
health insurance coverage may not enter into an
agreement with a third-party administrator or other
service provider to submit the attestation required
under subparagraph (A).
``(C) Exception.--In the case of a group health
plan or issuer offering group health insurance coverage
that is unable to obtain the information or data needed
to submit the attestation required under subparagraph
(A), such plan or issuer may submit a written statement
in lieu of such attestation that includes--
``(i) an explanation of why such plan or
issuer was unsuccessful in obtaining such
information or data, including whether such
plan or issuer was limited or prevented from
auditing, reviewing, or otherwise accessing
such information or data;
``(ii) a description of the efforts made by
the plan fiduciary to remove any gag clause
provisions from the agreement under paragraph
(1); and
``(iii) a description of any response by
the third-party administrator or other service
provider with respect to efforts to comply with
the attestation requirement under subparagraph
(A).''.
(c) Report on Plan Assets.--Not later than 1 year after the date of
enactment of this Act, the Secretary of Labor shall submit to the
Committee on Education and the Workforce of the House of
Representatives and the Committee on Health, Education, Labor, and
Pensions of the Senate a report on the status of de-identified claims
and encounter information or data described in section 724(a)(1)(B) of
the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1185m),
including information on the following:
(1) Whether changes to regulations or guidance would permit
such information or data to be deemed a group health plan asset
(as defined under section 3(42) of such Act).
(2) Whether restrictions on the ability of a plan fiduciary
to access such information or data violates a requirement of
current law.
(3) The existing regulatory authority of the Secretary to
clarify whether such information or data is the property of a
group health plan, rather than a service provider.
(4) Legislative recommendations to establish that such
information or data related to a plan belongs to a group health
plan and is handled in the best interests of plan participants
and beneficiaries.
(d) Effective Date.--The amendments made by subsections (a) and (b)
shall apply with respect to a plan beginning with the first plan year
that begins on or after the date that is 1 year after the date of
enactment of this Act.
SEC. 402. HIDDEN FEES DISCLOSURE REQUIREMENTS.
(a) Clarification of the Application of Fee Disclosure Requirements
to Covered Service Providers.--
(1) Services.--Clause (ii)(I)(bb) of section 408(b)(2)(B)
of the Employee Retirement Income Security Act of 1974 (29
U.S.C. 1108(b)(2)(B)) is amended--
(A) in subitem (AA) by striking ``Brokerage
services,'' and inserting ``Services (including
brokerage services),''; and
(B) in subitem (BB)--
(i) by striking ``Consulting,'' and
inserting ``Other services,''; and
(ii) by inserting ``any of the following:''
before ``plan design''.
(2) Disclosures.--Clause (iii)(III) of section 408(b)(2)(B)
of the Employee Retirement Income Security Act of 1974 (29
U.S.C. 1108(b)(2)(B)) is amended by striking ``, either in the
aggregate or by service,'' and inserting ``by service''.
(b) Strengthening Disclosure Requirements With Respect to Pharmacy
Benefit Managers and Third Party Administrators for Group Health
Plans.--
(1) Certain arrangements for pharmacy benefit manager
services considered as indirect.--
(A) In general.--Clause (i) of section 408(b)(2)(B)
of the Employee Retirement Income Security Act of 1974
(29 U.S.C. 1108(b)(2)(B)) is amended--
(i) by striking ``requirements of this
clause'' and inserting ``requirements of this
subparagraph''; and
(ii) by adding at the end the following:
``For purposes of applying section 406(a)(1)(C)
with respect to a transaction described under
this subparagraph, a contract or arrangement
for services between a covered plan and a
health insurance issuer providing health
insurance coverage in connection with the
covered plan in which the health insurance
issuer contracts, in connection with such plan,
with a service provider for pharmacy benefit
management services shall be considered to
constitute an indirect furnishing of goods,
services, or facilities between the plan and
the service provider acting as the party in
interest.''.
(B) Health insurance issuer and health insurance
coverage defined.--Clause (ii)(I)(aa) of section
408(b)(2)(B) of such Act (29 U.S.C. 1108(b)(2)(B)) is
amended by inserting before the period at the end ``and
the terms `health insurance coverage' and `health
insurance issuer' have the meanings given such terms in
section 733(b)''.
(C) Technical amendment.--Clause (ii)(I)(aa) of
section 408(b)(2)(B) of the Employee Retirement Income
Security Act of 1974 (29 U.S.C. 1108(b)(2)(B)) is
further amended by inserting ``in'' after ``defined''.
(2) Specific disclosure requirements with respect to
pharmacy benefit management services.--
(A) In general.--Clause (iii) of section
408(b)(2)(B) of such Act (29 U.S.C. 1108(b)(2)(B)) is
amended by adding at the end the following:
``(VII) With respect to a contract or arrangement
with the covered plan in connection with the provision
of pharmacy benefit management services, as part of the
description required under subclauses (III) and (IV)--
``(aa) all compensation described in clause
(ii)(I)(dd)(AA), including fees, rebates,
alternative discounts, co-payment offsets, and
other remuneration expected to be received by
the covered service provider, an affiliate, or
a subcontractor from a pharmaceutical
manufacturer, distributor, rebate aggregator,
accumulator, and maximizer, group purchasing
organization, or any other third party;
``(bb) the amount and form of any rebates,
discounts, or price concessions, including the
amount expected to be passed through to the
plan sponsor or the participants and
beneficiaries under the covered plan;
``(cc) all compensation expected to be
received by the covered service provider, an
affiliate, or a subcontractor as a result of
paying a lower amount for the drug than the
amount charged as a copayment, coinsurance
amount, or deductible;
``(dd) all compensation expected to be
received by the covered service provider, an
affiliate, or a subcontractor as a result of
paying pharmacies less than what is charged the
health plan, plan sponsor, or participants and
beneficiaries under the covered plan; and
``(ee) all compensation expected to be
received by the covered service provider, an
affiliate, or a subcontractor from drug
manufacturers and any other third party in
exchange for--
``(AA) administering, invoicing,
allocating, or collecting rebates
related to the covered plan;
``(BB) providing business services
and activities, including providing
access to drug utilization data;
``(CC) keeping a percentage of the
list price of a drug; or
``(DD) any other reason related to
the role of a covered service provider
as a conduit between the drug
manufacturers or any other third party
and the covered plan.''.
(B) Annual disclosure.--Clause (v) of section
408(b)(2)(B) of such Act (29 U.S.C. 1108(b)(2)(B)) is
amended by adding at the end the following:
``(III) A covered service provider, with respect to
a contract or arrangement with the covered plan in
connection with providing pharmacy benefit management
services, shall disclose, on an annual basis not later
than 60 days after the beginning of the current plan
year, to a responsible plan fiduciary, in writing, the
following with respect to the twelve months preceding
the current plan year:
``(aa) All direct compensation described in
subclause (III) of clause (iii) and indirect
compensation described in subclause (IV) of
clause (iii) received by the covered service
provider (including such compensation described
in subclause (VII) of clause (iii)).
``(bb) The total gross spending by the
covered plan on drugs (excluding rebates,
discounts, or other price concessions).
``(cc) The total net spending by the
covered plan on drugs.
``(dd) The total gross spending at all
pharmacies wholly or partially owned by the
covered service provider or any entity
affiliated with the covered service provider,
including mail-order, specialty and retail
pharmacies, with a breakdown by individual
pharmacy location.
``(ee) The aggregate amount of clawback
from such pharmacies, including mail-order,
specialty, and retail pharmacies.
``(AA) categorical explanations
(grouped by the reason for clawback,
such as contractual true-up provisions,
overpayments, or non-covered medication
dispensed, and including information on
the amount in each category that was
passed through to the covered plan and
to participants and beneficiaries of
the covered plan); or
``(BB) individual explanations for
such clawbacks.
``(ff) Total aggregate amounts of fees
collected by the covered service provider, an
affiliate, or a subcontractor in connection
with the provision of pharmacy benefit
management services to the covered plan.
``(gg) Any other information specified by
the Secretary through regulations or guidance
that may be necessary for a responsible plan
fiduciary to consider the merits of the
contract or arrangement with the covered
service provider and any conflicts of interest
that may exist.''.
(C) Pharmacy benefit management services defined.--
Clause (ii)(I) of section 408(b)(2)(B) of such Act (29
U.S.C. 1108(b)(2)(B)) is amended by adding at the end
the following:
``(gg) The term `pharmacy benefit
management services' includes any services
provided by a covered service provider to a
covered plan with respect to the administration
of prescription drug benefits under the covered
plan, including--
``(AA) processing and payment of
claims;
``(BB) design of pharmacy networks;
``(CC) negotiation, aggregation,
and distribution of rebates, discounts,
and other price concessions;
``(DD) formulary design and
maintenance;
``(EE) operation of pharmacies
(whether retail, mail order, specialty
drug, or otherwise);
``(FF) recordkeeping;
``(GG) utilization review;
``(HH) adjudication of claims; and
``(II) any other services specified
by the Secretary through guidance or
rulemaking.''.
(D) Clawback defined.--Clause (ii)(I) of section
408(b)(2)(B) of such Act (29 U.S.C. 1108(b)(2)(B)), as
amended by subparagraph (C), is amended by adding at
the end the following:
``(hh) The term `clawback' means amounts
collected by a provider of pharmacy benefit
management services from a pharmacy for
copayments collected from a participant or
beneficiary in excess of the contracted
rate.''.
(3) Specific disclosure requirements with respect to third
party administration services for group health plans.--
(A) In general.--Clause (iii) of section
408(b)(2)(B) of such Act (29 U.S.C. 1108(b)(2)(B)), as
amended by paragraph (2)(A), is further amended by
adding at the end the following:
``(VIII) With respect to a contract or arrangement
with the covered plan in connection with the provision
of third party administration services for group health
plans, as part of the description required under
subclauses (III) and (IV)--
``(aa) the amount and form of any rebates,
discounts, savings fees, refunds, or amounts
received from providers and facilities,
including the amounts that will be retained by
the covered service provider as a fee;
``(bb) the amount and form of fees expected
to be received from other service providers in
relation to the covered plan, including the
amounts that will be retained by the covered
service provider as a fee; and
``(cc) the amount and form of expected
recoveries by the covered service provider,
including the amounts that will be retained by
the covered service provider as a fee
(disaggregated by category), as a result of--
``(AA) overpayments;
``(BB) erroneous payments;
``(CC) uncashed checks or
incomplete payments;
``(DD) billing errors;
``(EE) subrogation;
``(FF) fraud; or
``(GG) any other reason on behalf
of the covered plan.''.
(B) Annual disclosure.--Clause (v) of section
408(b)(2)(B) of such Act (29 U.S.C. 1108(b)(2)(B)), as
amended by paragraph (2)(B), is amended by adding at
the end the following:
``(IV) A covered service provider, with respect to
a contract or arrangement with the covered plan in
connection with providing third party administration
services for group health plans, shall disclose, on an
annual basis not later than 60 days after the beginning
of the current plan year, to a responsible plan
fiduciary, in writing, the following with respect to
the twelve months preceding the current plan year:
``(aa) All direct compensation described in
subclause (III) of clause (iii).
``(bb) All indirect compensation described
in subclause (IV) of clause (iii) received by
the covered service provider, an affiliate, or
a subcontractor (including such compensation
described in subclause (VIII) of clause (iii)).
``(cc) The aggregate amount for which the
covered service provider, an affiliate, or a
subcontractor received indirect compensation
and the estimated amount of cost-sharing
incurred by plan participants and beneficiaries
as a result.
``(dd) The total gross spending by the
covered plan on all costs and fees arising
under or paid under the administrative services
agreement with the covered service provider
(not including any amounts described in items
(aa) through (cc) of clause (iii)(VIII)).
``(ee) The total net spending by the
covered plan on all costs and fees arising
under or paid under the administrative services
agreement with the covered service provider.
``(ff) The aggregate fees collected by the
covered service provider, an affiliate, or a
subcontractor.
``(gg) Any other information specified by
the Secretary through regulations or guidance
that may be necessary for a responsible plan
fiduciary to consider the merits of the
contract or arrangement with the covered
service provider and any conflicts of interest
that may exist.''.
(C) Third party administration services for group
health plans defined.--Clause (ii)(I) of section
408(b)(2)(B) of such Act (29 U.S.C. 1108(b)(2)(B)), as
amended by paragraph (2)(C), is amended by adding at
the end the following:
``(ii) The term `third party administration
services for group health plans' includes any
services provided by a covered service
provider, an affiliate, or a subcontractor to a
covered plan with respect to the administration
of health benefits under the covered plan,
including--
``(AA) the processing, repricing,
and payment of claims;
``(BB) design, creation, and
maintenance of provider networks;
``(CC) negotiation of discounts off
gross rates;
``(DD) benefit and plan design;
``(EE) negotiation of payment
rates;
``(FF) recordkeeping;
``(GG) utilization review;
``(HH) adjudication of claims;
``(II) regulatory compliance; and
``(JJ) any other services set forth
in an administrative services agreement
or similar agreement or specified by
the Secretary through rulemaking.''.
(4) Rule of construction.--Nothing in the amendments made
by this section shall be construed to imply that a practice in
relation to which a covered service provider is required to
provide information as a result of such amendments is
permissible under Federal law.
(5) Effective date.--No contract or arrangement entered
into prior to January 1, 2025, shall be subject to the
requirements of subsection (b).
(c) Privacy Requirements.--Section 408(b)(2) of the Employee
Retirement Income Security Act of 1974 (29 U.S.C. 1108(b)(2)), as
amended by section 401, is further amended by adding at the end the
following:
``(D) Privacy requirements.--Covered service providers
shall provide information under subparagraph (B) in a manner
consistent with the privacy, security, and breach notification
regulations promulgated under section 13402(a) of the Health
Information Technology for Clinical Health Act (42 U.S.C.
17932(a)), and consistent with the HIPAA privacy regulations
(as defined in section 1180(b)(3) of the Social Security Act)
and shall restrict the use and disclosure of such information
according to such privacy, security, and breach notification
regulations and such HIPAA privacy regulations.
``(E) Disclosure and redisclosure.--
``(i) Limitation to business associates.--A
responsible plan fiduciary receiving information
disclosed under subparagraph (B) may disclose such
information only to the entity from which the
information was received, the group health plan for
which the information pertains, or to that entity's
business associates as defined in section 160.103 of
title 45, Code of Federal Regulations (or successor
regulations) or as permitted by the HIPAA Privacy Rule
(45 CFR parts 160 and 164, subparts A and E).
``(ii) Clarification regarding public disclosure of
information.--Nothing in this section shall prevent a
group health plan or health insurance issuer offering
group health insurance coverage, or a covered service
provider, from placing reasonable restrictions on the
public disclosure of the information described in this
subparagraph, except that such plan, issuer, or entity
may not restrict disclosure of such information to the
Department of Labor.
``(F) Additional privacy requirements.--
``(i) In general.--Covered service providers shall
ensure that information provided under subparagraph (B)
contains only summary health information, as defined in
section 164.504(a) of title 45, Code of Federal
Regulations (or successor regulations).
``(ii) Restrictions.--A group health plan must
comply with section 164.504(f) of title 45, Code of
Federal Regulations and a responsible plan
administrator who is a plan sponsor must act in
accordance with the terms of the agreement described in
such section.
``(G) Rule of construction.--Nothing in this section shall
be construed to modify the requirements for the creation,
receipt, maintenance, or transmission of protected health
information under the HIPAA privacy regulations (as defined in
section 1180(b)(3) of the Social Security Act).''.
(d) Implementation.--Not later than 1 year after the date of
enactment of this Act, the Secretary of Labor shall issue notice and
comment rulemaking as necessary to implement the provisions of this
section. The Secretary shall ensure that such rulemaking--
(1) accounts for the varied compensation practices of
covered service providers (as defined under section
408(b)(2)(B); and
(2) establishes standards for the disclosure of expected
compensation by such covered service providers.
SEC. 403. PRESCRIPTION DRUG PRICE INFORMATION REQUIREMENT.
(a) PHSA.--
(1) In general.--Part D of title XXVII of the Public Health
Service Act, as amended by section 106, is further amended by
adding at the end the following new section:
``SEC. 2799A-12. INFORMATION ON PRESCRIPTION DRUGS.
``(a) In General.--A group health plan or a health insurance issuer
offering group or individual health insurance coverage shall--
``(1) not restrict, directly or indirectly, any pharmacy
that dispenses a prescription drug to an enrollee in the plan
or coverage from informing (or penalize such pharmacy for
informing) an enrollee of any differential between the
enrollee's out-of-pocket cost under the plan or coverage with
respect to acquisition of the drug and the amount an individual
would pay for acquisition of the drug without using any group
health plan or health insurance coverage; and
``(2) ensure that any entity that provides pharmacy
benefits management services under a contract with any such
health plan or health insurance coverage does not, with respect
to such plan or coverage, restrict, directly or indirectly, a
pharmacy that dispenses a prescription drug from informing (or
penalize such pharmacy for informing) an enrollee of any
differential between the enrollee's out-of-pocket cost under
such plan or coverage with respect to acquisition of the drug
and the amount an individual would pay for acquisition of the
drug without using any group health plan or health insurance
coverage.
``(b) Definition.--For purposes of this section, the term `out-of-
pocket cost', with respect to acquisition of a drug, means the amount
to be paid by the enrollee under the plan or coverage, including any
cost-sharing (including any deductible, copayment, or coinsurance) and,
as determined by the Secretary, any other expenditure.''.
(2) Conforming amendment.--Section 2729 of the Public
Health Service Act (42 U.S.C. 300gg-29) is amended by adding at
the end the following new subsection:
``(c) Sunset.--The preceding provisions of this section shall not
apply beginning on the date of the enactment of this subsection.''.
(b) ERISA.--
(1) In general.--Subpart B of part 7 of Subtitle B of title
I of the Employee Retirement Income Security Act of 1974 (29
U.S.C. 1185 et seq.), as amended by section 106, is further
amended by adding at the end the following new section:
``SEC. 727. INFORMATION ON PRESCRIPTION DRUGS.
``(a) In General.--A group health plan or a health insurance issuer
offering group health insurance coverage shall--
``(1) not restrict, directly or indirectly, any pharmacy
that dispenses a prescription drug to a participant or
beneficiary in the plan or coverage from informing (or penalize
such pharmacy for informing) a participant or beneficiary of
any differential between the participant's or beneficiary's
out-of-pocket cost under the plan or coverage with respect to
acquisition of the drug and the amount an individual would pay
for acquisition of the drug without using any group health plan
or health insurance coverage; and
``(2) ensure that any entity that provides pharmacy
benefits management services under a contract with any such
health plan or health insurance coverage does not, with respect
to such plan or coverage, restrict, directly or indirectly, a
pharmacy that dispenses a prescription drug from informing (or
penalize such pharmacy for informing) a participant or
beneficiary of any differential between the participant's or
beneficiary's out-of-pocket cost under such plan or coverage
with respect to acquisition of the drug and the amount an
individual would pay for acquisition of the drug without using
any group health plan or health insurance coverage.
``(b) Definition.--For purposes of this section, the term `out-of-
pocket cost', with respect to acquisition of a drug, means the amount
to be paid by the participant or beneficiary under the plan or
coverage, including any cost-sharing (including any deductible,
copayment, or coinsurance) and, as determined by the Secretary, any
other expenditure.''.
(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.), as amended by section 106, is further
amended by inserting after the item relating to section 726 the
following new item:
``Sec. 727. Information on prescription drugs.''.
(c) IRC.--
(1) In general.--Subchapter B of chapter 100 of the
Internal Revenue Code of 1986, as amended by section 106, is
further amended by adding at the end the following:
``SEC. 9827. INFORMATION ON PRESCRIPTION DRUGS.
``(a) In General.--A group health plan shall--
``(1) not restrict, directly or indirectly, any pharmacy
that dispenses a prescription drug to a participant or
beneficiary in the plan from informing (or penalize such
pharmacy for informing) a participant or beneficiary of any
differential between the participant's or beneficiary's out-of-
pocket cost under the plan with respect to acquisition of the
drug and the amount an individual would pay for acquisition of
the drug without using any group health plan or health
insurance coverage; and
``(2) ensure that any entity that provides pharmacy
benefits management services under a contract with any such
plan does not, with respect to such plan or coverage, restrict,
directly or indirectly, a pharmacy that dispenses a
prescription drug from informing (or penalize such pharmacy for
informing) a participant or beneficiary of any differential
between the participant's or beneficiary's out-of-pocket cost
under the plan with respect to acquisition of the drug and the
amount an individual would pay for acquisition of the drug
without using any group health plan or health insurance
coverage.
``(b) Definition.--For purposes of this section, the term `out-of-
pocket cost', with respect to acquisition of a drug, means the amount
to be paid by the participant or beneficiary under the plan, including
any cost-sharing (including any deductible, copayment, or coinsurance)
and, as determined by the Secretary, any other expenditure.''.
(2) Clerical amendment.--The table of sections for
subchapter B of chapter 100 of the Internal Revenue Code of
1986, as amended by section 106, is further amended by adding
at the end the following new item:
``Sec. 9827. Information on prescription drugs.''.
SEC. 404. IMPLEMENTATION FUNDING.
(a) In General.--For the purposes described in subsection (b), and
in addition to amounts otherwise available for such purposes there are
appropriated, out of amounts in the Treasury not otherwise
appropriated, to the Secretary of Labor $35,000,000, for fiscal year
2024, to remain available through fiscal year 2029.
(b) Permitted Purposes.--The purposes described in this subsection
are limited to the following purposes, insofar as such purposes are to
carry out the provisions of, including the amendments made by, title I
and IV:
(1) Preparing, drafting, and issuing proposed and final
regulations or interim regulations.
(2) Preparing, drafting, and issuing guidance and public
information.
(3) Preparing, drafting, and publishing reports.
(4) Enforcement of such provisions.
(5) Reporting, collection, and analysis of data.
(6) Other administrative duties necessary for
implementation of such provisions.
(c) Transparency of Implementation Funds.--The Secretary of Labor
shall annually submit, no later than September 1st of each year, to the
Committees on Education and Workforce and on Appropriations of the
House of Representatives and the Committees on Health, Education,
Labor, and Pensions and on Appropriations of the Senate a report on
funds expended pursuant to funds appropriated under this section.
Passed the House of Representatives December 11, 2023.
Attest:
Clerk.
118th CONGRESS
1st Session
H. R. 5378
_______________________________________________________________________
AN ACT
To promote price transparency in the health care sector, and for other
purposes.