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[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[S. 5496 Introduced in Senate (IS)]
<DOC>
119th CONGRESS
2d Session
S. 5496
To expand access to and lower the cost of health care.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
September 24, 2026
Mr. Warner introduced the following bill; which was read twice and
referred to the Committee on Finance
_______________________________________________________________________
A BILL
To expand access to and lower the cost of health care.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Health for the
Commonwealth through Affordability, Reform, and Expansion Act of 2026''
or the ``Health CARE Act of 2026''.
(b) Table of Contents.--The table of contents for this Act is as
follows:
Sec. 1. Short title; table of contents.
TITLE I--RESTORING HEALTH CARE AND LOWERING COSTS
Sec. 101. Repeal of reconciliation health provisions.
Sec. 102. Permanent extension of enhanced tax credit.
Sec. 103. Promoting consumer outreach and education.
TITLE II--PATHWAY TO UNIVERSAL COVERAGE
Sec. 201. Establishment of health plan.
Sec. 202. Availability of plan.
Sec. 203. Affordability.
Sec. 204. Participating providers.
Sec. 205. Provider payment rates.
Sec. 206. No effect on Medicare benefits or Medicare trust funds.
TITLE III--STRENGTHENING MEDICAID
Sec. 301. Increased FMAP for medical assistance to newly eligible
individuals.
Sec. 302. Supporting State Medicaid programs through economic
downturns.
TITLE IV--LOWERING DRUG COSTS
Sec. 401. Expanding Medicare drug price negotiation.
Sec. 402. Application of prescription drug inflation rebates to drugs
furnished in the commercial market.
Sec. 403. Establishing an out-of-pocket limit on expenditures for
prescription drugs under group health plans
and group and individual health insurance
coverage.
Sec. 404. Requirements with respect to cost-sharing for insulin
products.
TITLE V--ENSURING QUALITY HEALTH INSURANCE AND REMOVING BARRIERS TO
CARE
Sec. 501. Required exceptions process for medication step therapy
protocols.
Sec. 502. Establishing requirements with respect to the use of prior
authorization under Medicare Advantage
plans.
Sec. 503. Special enrollment period for provider terminations.
Sec. 504. Providing coverage for hearing care under the Medicare
program.
TITLE VI--LOWERING THE COST OF CARE
Sec. 601. Strengthening hospital price transparency.
Sec. 602. Clinical diagnostic laboratory price transparency.
Sec. 603. Imaging services price transparency.
Sec. 604. Ambulatory surgical center price transparency.
Sec. 605. Strengthening health coverage transparency requirements.
Sec. 606. Increasing group health plan access to health data.
Sec. 607. Oversight of administrative service providers.
Sec. 608. State preemption only in event of conflict.
Sec. 609. Requirement for explanation of benefits.
Sec. 610. Transparency in billing.
Sec. 611. Technical amendments.
Sec. 612. Implementation and enforcement funding.
TITLE VII--REFORMING PBMS AND PROTECTING PHARMACIES
Sec. 701. Ensuring accurate payments to pharmacies under Medicaid.
Sec. 702. Preventing the use of abusive spread pricing in Medicaid.
TITLE I--RESTORING HEALTH CARE AND LOWERING COSTS
SEC. 101. REPEAL OF RECONCILIATION HEALTH PROVISIONS.
(a) In General.--Except as provided in subsection (b), subtitle B
of title VII of the Act titled ``An Act to provide for reconciliation
pursuant to title II of H. Con. Res. 14'' (Public Law 119-21) is
repealed and any law or regulation referred to in such subtitle shall
be applied as if such subtitle and the amendments made by such subtitle
had not been enacted.
(b) Exceptions.--Subsection (a) shall not apply to the provisions
of and amendments made by sections 71202, 71306, and 71401 of such Act.
(c) Rescission.--
(1) OBBBA implementation funding.--The unobligated amounts
appropriated under the following provisions of the Act titled
``An Act to provide for reconciliation pursuant to title II of
H. Con. Res. 14'' (Public Law 119-21) are hereby rescinded:
(A) Section 71101(b).
(B) Section 71107(c).
(C) Section 71109(c).
(D) Section 71110(b).
(E) Section 71112(e).
(F) Section 71113(c).
(G) Section 71115(c).
(H) Section 71116(e).
(I) Section 71118(b).
(J) Subsections (e) and (f) of section 71119.
(K) Section 71120(c).
(L) Section 71121(b).
(2) Title xix funding.--The unobligated amounts
appropriated under section 1902(uu)(3) of the Social Security
Act (42 U.S.C. 1396a(uu)(3)), as repealed by subsection (a),
are hereby rescinded.
SEC. 102. PERMANENT EXTENSION OF ENHANCED TAX CREDIT.
(a) In General.--Subparagraph (A) of section 36B(c)(1) of the
Internal Revenue Code of 1986 is amended by striking ``but does not
exceed 400 percent''.
(b) Applicable Percentages.--
(1) In general.--Subparagraph (A) of section 36B(b)(3) of
the Internal Revenue Code of 1986 is amended to read as
follows:
``(A) Applicable percentage.--The applicable
percentage for any taxable year shall be the percentage
such that the applicable percentage for any taxpayer
whose household income is within an income tier
specified in the following table shall increase, on a
sliding scale in a linear manner, from the initial
premium percentage to the final premium percentage
specified in such table for such income tier:
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''. (2) Conforming amendments relating to affordability of
coverage.--
(A) Paragraph (1) of section 36B(c) of such Code is
amended by striking subparagraph (E).
(B) Subparagraph (C) of section 36B(c)(2) of such
Code is amended by striking clause (iv).
(C) Paragraph (4) of section 36B(c) of such Code is
amended by striking subparagraph (F).
(c) Effective Date.--The amendments made by this section shall
apply to taxable years beginning after December 31, 2026.
SEC. 103. PROMOTING CONSUMER OUTREACH AND EDUCATION.
(a) In General.--Section 1311(i) of the Patient Protection and
Affordable Care Act (42 U.S.C. 18031(i)) is amended--
(1) in paragraph (2), by adding at the end the following
new subparagraph:
``(C) Selection of recipients.--In the case of an
Exchange established and operated by the Secretary
within a State pursuant to section 1321(c), in awarding
grants under paragraph (1), the Exchange shall--
``(i) select entities to receive such
grants based on an entity's demonstrated
capacity to carry out each of the duties
specified in paragraph (3);
``(ii) not take into account whether or not
the entity has demonstrated how the entity will
provide information to individuals relating to
group health plans offered by a group or
association of employers or short-term limited
duration insurance (as defined by the Secretary
for purposes of section 2791(b)(5) of the
Public Health Service Act); and
``(iii) ensure that, each year, the
Exchange awards such a grant to--
``(I) at least one entity described
in this paragraph that is a community
and consumer-focused nonprofit group;
and
``(II) at least one entity
described in subparagraph (B), which
may include another community and
consumer-focused nonprofit group in
addition to any such group awarded a
grant pursuant to subclause (I).
In awarding such grants, an Exchange may consider an
entity's record with respect to waste, fraud, and abuse
for purposes of maintaining the integrity of such
Exchange.'';
(2) in paragraph (3)--
(A) by amending subparagraph (C) to read as
follows:
``(C) facilitate enrollment, including with respect
to individuals with limited English proficiency and
individuals with chronic illnesses, in qualified health
plans, State Medicaid plans under title XIX of the
Social Security Act, and State child health plans under
title XXI of such Act;'';
(B) in subparagraph (D), by striking ``and'' at the
end;
(C) in subparagraph (E), by striking the period at
the end and inserting ``; and'';
(D) by inserting after subparagraph (E) the
following new subparagraph:
``(F) provide referrals to community-based
organizations that address social needs related to
health outcomes.''; and
(E) by adding at the end the following flush text:
``The duties specified in the preceding sentence may be carried
out by such a navigator at any time during a year.'';
(3) in paragraph (4)(A)--
(A) in the matter preceding clause (i), by striking
``not'';
(B) in clause (i)--
(i) by inserting ``not'' before ``be''; and
(ii) by striking ``; or'' and inserting a
semicolon;
(C) in clause (ii)--
(i) by inserting ``not'' before
``receive''; and
(ii) by striking the period and inserting a
semicolon; and
(D) by adding at the end the following new clauses:
``(iii) maintain physical presence in the
State of the Exchange so as to allow in-person
assistance to consumers; and
``(iv) receive opioid specific education
and training that ensures the navigator can
best educate individuals on qualified health
plans offered through an Exchange, specifically
coverage under such plans for opioid health
care treatment.''; and
(4) in paragraph (6)--
(A) by striking ``Grants under'' and inserting the
following:
``(A) State exchanges.--Grants under''; and
(B) by adding at the end the following new
subparagraph:
``(B) Federal exchanges.--For purposes of carrying
out this subsection, with respect to an Exchange
established and operated by the Secretary within a
State pursuant to section 1321(c), the Secretary shall
obligate $100,000,000 out of amounts collected through
the user fees on participating health insurance issuers
pursuant to section 156.50 of title 45, Code of Federal
Regulations (or any successor regulations), for fiscal
year 2027 and each subsequent fiscal year. Such amount
for a fiscal year shall remain available until
expended.''.
(b) Effective Date.--The amendments made by this section shall
apply with respect to plan years beginning on or after January 1, 2027.
TITLE II--PATHWAY TO UNIVERSAL COVERAGE
SEC. 201. ESTABLISHMENT OF HEALTH PLAN.
(a) In General.--The Secretary of Health and Human Services
(referred to in this title as the ``Secretary'') shall establish a
coordinated and low-cost health plan (referred to in this title as the
``health plan'') to provide access to quality health care for
enrollees.
(b) Individual Market Availability.--The Secretary shall make the
health plan available in the individual market for plan year 2028 and
each subsequent plan year.
(c) Rulemaking.--The Secretary may promulgate such regulations as
may be necessary to carry out this title.
(d) Authorization of Appropriations.--There are authorized to be
appropriated such sums as may be necessary to carry out this title.
SEC. 202. AVAILABILITY OF PLAN.
(a) Eligibility.--An individual shall be eligible to enroll in the
health plan if such individual, for the entire period for which
enrollment is sought--
(1) is a qualified individual within the meaning of section
1312 of the Patient Protection and Affordable Care Act (42
U.S.C. 18032);
(2) is not eligible for benefits under the Medicare program
under title XVIII of the Social Security Act (42 U.S.C. 1395 et
seq.); and
(3) is not otherwise eligible for, or has been otherwise
offered, employer-sponsored health care coverage.
(b) Exchanges.--The health plan shall be made available through the
Exchanges, including the Small Business Health Options Program
Exchange.
SEC. 203. AFFORDABILITY.
The Secretary shall ensure that coverage options for the health
plan are not more costly than comparable options offered on the
Exchange in the applicable market.
SEC. 204. PARTICIPATING PROVIDERS.
(a) Requirement To Participate in Order To Be Enrolled Under
Medicare.--Beginning January 1, 2028, the Secretary may require a
health care provider enrolled under the Medicare program under section
1866(j) of the Social Security Act (42 U.S.C. 1395cc(j)) to be a
participating provider under the health plan.
(b) Requirement To Participate in Order To Participate in
Medicaid.--Beginning January 1, 2028, the Secretary may require a
health care provider under a State Medicaid plan under title XIX of the
Social Security Act (42 U.S.C. 1396 et seq.) to also be a participating
provider under the health plan.
SEC. 205. PROVIDER PAYMENT RATES.
The Secretary shall set competitive provider payment rates under
the health plan using the best information publicly available and data
otherwise accessible to the Secretary. The Secretary shall give
consideration to existing provider payment rates for commercial health
plans and provider costs to deliver care, giving special consideration
to increased costs for providers to deliver care in rural and medically
underserved areas.
SEC. 206. NO EFFECT ON MEDICARE BENEFITS OR MEDICARE TRUST FUNDS.
Nothing in this title shall--
(1) affect the benefits available under title XVIII of the
Social Security Act (42 U.S.C. 1395 et seq.); or
(2) impact the Federal Hospital Insurance Trust Fund under
section 1817 of the Social Security Act (42 U.S.C. 1395i) or
the Federal Supplementary Medical Insurance Trust Fund under
section 1841 of the Social Security Act (42 U.S.C. 1395t)
(including the Medicare Prescription Drug Account within such
Trust Fund).
TITLE III--STRENGTHENING MEDICAID
SEC. 301. INCREASED FMAP FOR MEDICAL ASSISTANCE TO NEWLY ELIGIBLE
INDIVIDUALS.
(a) In General.--Section 1905 of the Social Security Act (42 U.S.C.
1396d) is amended--
(1) in subsection (y)(1)--
(A) in subparagraph (A), by striking ``2014, 2015,
and 2016'' and inserting ``each of the first 3
consecutive 12-month periods in which the State
provides medical assistance to newly eligible
individuals'';
(B) in subparagraph (B), by striking ``2017'' and
inserting ``the fourth consecutive 12-month period in
which the State provides medical assistance to newly
eligible individuals'';
(C) in subparagraph (C), by striking ``2018'' and
inserting ``the fifth consecutive 12-month period in
which the State provides medical assistance to newly
eligible individuals'';
(D) in subparagraph (D), by striking ``2019'' and
inserting ``the sixth consecutive 12-month period in
which the State provides medical assistance to newly
eligible individuals''; and
(E) in subparagraph (E), by striking ``2020 and
each year thereafter'' and inserting ``the seventh
consecutive 12-month period in which the State provides
medical assistance to newly eligible individuals and
each such period thereafter''; and
(2) in subsection (z)(2)(B)(i)(II), by inserting ``(as in
effect on the day before the enactment of the Health CARE Act
of 2026)'' after ``subsection (y)(1)''.
(b) Retroactive Application.--The amendments made by subsection
(a)(1) shall take effect as if included in the enactment of Public Law
111-148 and shall apply to amounts expended by any State for medical
assistance for newly eligible individuals described in subclause (VIII)
of section 1902(a)(10)(A)(i) of the Social Security Act under a State
Medicaid plan (or a waiver of such plan) during the period before the
date of enactment of this Act.
SEC. 302. SUPPORTING STATE MEDICAID PROGRAMS THROUGH ECONOMIC
DOWNTURNS.
(a) In General.--Section 1905 of the Social Security Act (42 U.S.C.
1396d) is amended--
(1) in subsection (b), by striking ``and (ii)'' and
inserting ``(ii), and (ll)''; and
(2) by adding at the end the following new subsection:
``(ll) Increased FMAP During Economic Downturns.--
``(1) In general.--If a fiscal quarter that begins on or
after January 1, 2026, is an economic downturn quarter (as
defined in paragraph (2)) with respect to a State, then the
Federal medical assistance percentage determined for each State
for such quarter under subsection (b) shall be equal to the
percentage determined for the State and quarter under paragraph
(3).
``(2) Economic downturn quarter.--
``(A) In general.--
``(i) In general.--In this subsection, the
term `economic downturn quarter' means, with
respect to a State, a fiscal quarter during
which the State's unemployment rate for the
quarter exceeds the percentage determined for
the State and quarter under clause (ii).
``(ii) Threshold percentage.--The
percentage determined under this clause for a
State and fiscal quarter is the percentage
equal to the lower of--
``(I) the State unemployment rate
at the 20th percentile of the
distribution of the State's quarterly
unemployment rates for the 60-quarter
period preceding the quarter involved,
increased by 1 percentage point; and
``(II) the State's average
quarterly unemployment rate for the 12-
quarter period preceding the quarter
involved, increased by 1 percentage
point.
``(B) Unemployment data.--
``(i) In general.--Except as provided in
clause (ii), for purposes of determining
unemployment rates for a State and a quarter
under this paragraph, the Secretary shall use
data from the Local Area Unemployment
Statistics from the Bureau of Labor Statistics.
``(ii) Application to certain
territories.--In the case of the Virgin
Islands, Guam, the Northern Mariana Islands,
American Samoa, or any other jurisdiction for
which suitable data from the Local Area
Unemployment Statistics from the Bureau of
Labor Statistics are unavailable, the Secretary
shall use data from the U-3 unemployment
measure of the Bureau of Labor Statistics to
make any necessary determinations under
subparagraph (A).
``(3) Increased fmap during economic downturn quarter.--
``(A) In general.--During a fiscal quarter that is
an economic downturn quarter with respect to a State,
the Federal medical assistance percentage for the State
and quarter determined under subsection (b) shall be
equal to--
``(i) the Federal medical assistance
percentage determined for the State and quarter
under subsection (b) without regard to this
subsection; increased by
``(ii) the number of percentage points
(rounded to the nearest tenth of a percentage
point) equal to the product of--
``(I) the number of percentage
points (rounded to the nearest tenth of
a percentage point) by which the
unemployment rate for the State and
quarter exceeds the percentage
determined for the State and quarter
under paragraph (2)(A)(ii); and
``(II) 4.8.
``(B) Rules of application.--The following rules
shall apply with respect to the Federal medical
assistance percentage determined for a State and an
economic downturn quarter under this subsection:
``(i) Scope of application.--Such Federal
medical assistance percentage shall not apply
for purposes of--
``(I) disproportionate share
hospital payments described in section
1923;
``(II) payments under part D of
title IV; or
``(III) any payments under this
title that are based on a Federal
medical assistance percentage
determined for a State under subsection
(aa) (but only to the extent that such
Federal medical assistance percentage
is higher than the economic recovery
FMAP).
``(ii) Limitation.--In no case shall--
``(I) the Federal medical
assistance percentage determined for a
State and quarter pursuant to this
subsection exceed 95 percent; or
``(II) any increase to the Federal
medical assistance percentage
determined for a State and quarter
pursuant to this subsection result in
the application of a Federal medical
assistance percentage that exceeds 95
percent.
``(iii) Application to chip.--
Notwithstanding the first sentence of section
2105(b), the application of this subsection may
result in the enhanced FMAP of a State for a
fiscal year under such section exceeding 85
percent, but in no case may the application of
this subsection before application of the
second sentence of such section result in the
enhanced FMAP of the State exceeding 95
percent.
``(4) Advance payment; retrospective adjustment.--
``(A) In general.--Prior to the beginning of the
second fiscal quarter that begins after the date of
enactment of this subsection, and each subsequent
fiscal quarter, the Secretary shall, with respect to
each State--
``(i) make an initial determination, based
on the projections made for the State and
quarter under subparagraph (B), as to--
``(I) whether the application of
this subsection is expected to result
in the application of a higher Federal
medical assistance percentage for the
State and quarter than the percentage
that would otherwise apply without
regard to this subsection; and
``(II) if the application of this
subsection is expected to result in
such a higher Federal medical
assistance percentage for the State and
quarter, what such higher percentage is
expected to be; and
``(ii) if the Secretary determines under
clause (i) that the application of this
subsection is expected to result in the
application of a higher Federal medical
assistance percentage for the State and quarter
than the percentage that would otherwise apply
without regard to this subsection--
``(I) apply such higher Federal
medical assistance percentage of the
State for purposes of making payments
to the State for amounts expended
during such quarter as medical
assistance under the State plan; and
``(II) take into account such
higher Federal medical assistance
percentage of the State for purposes of
calculating the enhanced FMAP for the
State and quarter under section
2105(b).
``(B) Projection of state unemployment rates.--
Prior to the beginning of the second fiscal quarter
that begins after the date of enactment of this
subsection, and each subsequent fiscal quarter, the
Secretary, acting through the Chief Actuary of the
Centers for Medicare & Medicaid Services, shall, using
the most recently available data described in paragraph
(2)(B), make projections with respect to--
``(i) the unemployment rates for each State
for such quarter;
``(ii) the threshold percentages described
in paragraph (2)(A)(ii) for each State for such
quarter; and
``(iii) the national unemployment rate for
such quarter.
``(C) Retrospective adjustment.--As soon as
practicable after final unemployment data becomes
available for a fiscal quarter for which the Secretary
made an initial determination under this paragraph, the
Secretary shall, with respect to each State--
``(i) make a final determination with
respect to the application of this subsection
for purposes of determining the Federal medical
assistance percentage and enhanced FMAP of the
State for the quarter; and
``(ii) in accordance with section
1903(d)(2) and section 2105(e), reduce or
increase the amount payable to the State under
section 1903(a) or section 2105 for a
subsequent fiscal quarter to the extent of any
overpayment or underpayment under either such
section which the Secretary determines was made
as a result of an incorrect initial
determination under subparagraph (A)(i) with
respect to the application of this subsection
for purposes of determining the Federal medical
assistance percentage and enhanced FMAP of the
State for such prior fiscal quarter.
``(5) Retrospective application of over-the-limit fmap
increases.--
``(A) In general.--If a State has excess percentage
points with respect to an economic downturn quarter and
an applicable FMAP (as determined under subparagraph
(B)), the State may elect to apply such excess
percentage points to increase such applicable FMAP for
one or more quarters during the look-back period for
the State and economic downturn quarter in accordance
with this paragraph.
``(B) Excess percentage points.--For purposes of
this paragraph, the number of excess percentage points
for a State, economic downturn quarter, and an
applicable FMAP shall be equal to the number of
percentage points by which--
``(i) the applicable FMAP for the State and
quarter (after application of paragraph (3) but
without regard to subparagraph (B)(ii) of such
paragraph); exceeds
``(ii) 95 percent.
``(C) Effect of application of excess percentage
points.--If a State elects to apply excess percentage
points to an applicable FMAP to a quarter during a
look-back period under this paragraph, the Secretary
shall determine the additional amount of payment under
section 1903(a) to which the State would have been
entitled for such quarter if the applicable FMAP (as so
increased) had been in effect for such quarter, and
shall treat such additional amount as an underpayment
for such quarter.
``(D) Distribution of excess percentage points.--A
State that has excess percentage points with respect to
an economic downturn quarter and applicable FMAP may
elect to divide such points among more than 1 quarter
during the look-back period for such State and quarter
provided that no excess percentage point (or fraction
of an excess percentage point) is applied to the
applicable FMAP of more than 1 quarter.
``(E) Limitations.--
``(i) No increases over 100 percent.--A
State may not increase an applicable FMAP for
any quarter during a look-back period under
this paragraph if such increase would result in
the applicable FMAP for such quarter exceeding
100 percent.
``(ii) Scope of application.--Any increase
to an applicable FMAP of a State for a fiscal
quarter under this paragraph--
``(I) shall only apply with respect
to payments for amounts expended by the
State for medical assistance for
services furnished during such quarter
to which such applicable FMAP is
applicable; and
``(II) shall not apply with respect
to payments described in paragraph
(3)(B)(i).
``(F) Definitions.--In this paragraph:
``(i) Applicable fmap.--The term
`applicable FMAP' means, with respect to a
State and fiscal quarter--
``(I) the Federal medical
assistance percentage determined for
the State and quarter under subsection
(b);
``(II) the Federal medical
assistance percentage applicable under
subsection (y);
``(III) the Federal medical
assistance percentage applicable under
subsection (z)(2);
``(IV) the Federal medical
assistance percentage determined for
the State and quarter under subsection
(ff); or
``(V) the enhanced FMAP determined
for the State and quarter under section
2105(b).
``(ii) Look-back period.--The term `look-
back period' means, with respect to a State and
a fiscal quarter that is an economic downturn
quarter for the State, the period of 4 fiscal
quarters that ends with the fourth quarter
which precedes the most recent fiscal quarters
that was not an economic downturn quarter for
the State.
``(6) Requirement for all states.--This subsection shall
not apply to a State with respect to a fiscal quarter, if--
``(A) eligibility standards, methodologies, or
procedures under the State plan or a waiver of such
plan are more restrictive during such quarter than the
eligibility standards, methodologies, or procedures,
respectively, under such plan (or waiver) as in effect
on the last day of the most recent fiscal quarter that
was not an economic downturn quarter for the State;
``(B) the amount of any premium imposed by the
State pursuant to section 1916 or 1916A during such
quarter, with respect to an individual enrolled under
such plan (or waiver), exceeds the amount of such
premium as of the date described in subparagraph (A);
or
``(C) the State fails to provide that an individual
who is enrolled for benefits under such plan (or
waiver) as of the date described in subparagraph (A) or
enrolls for benefits under such plan (or waiver) during
the period beginning with such date and ending with the
day before the first day of the next quarter that is
not an economic downturn quarter for the State shall be
treated as eligible for such benefits for not less than
12 months after such date or (if later) the date that
such individual so enrolls unless the individual
requests a voluntary termination of eligibility or the
individual ceases to be a resident of the State.''.
(b) Exclusion of Economic Downturn FMAP Increases From Territorial
Caps; Special Rule for CHIP Allotments.--
(1) Exclusion from territorial caps.--Section 1108 of the
Social Security Act (42 U.S.C. 1308) is amended--
(A) in subsection (f), in the matter preceding
paragraph (1), by striking ``subsections (g) and (h)''
and inserting ``subsections (g), (h), and (j)''; and
(B) by adding at the end the following:
``(j) Exclusion From Caps of Amounts Attributable to Economic
Downturn FMAP.--Any payment made to a territory for a fiscal year in
which the Federal medical assistance percentage for the territory is
determined under section 1905(ll) shall not be taken into account for
purposes of applying payment limits under subsections (f) and (g) to
the extent that such payment exceeds the amount of the payment that
would have been made to the territory for the year if the Federal
medical assistance percentage for the territory had been determined
without regard to such section.''.
(2) CHIP allotments.--Section 2104(m) of the Social
Security Act (42 U.S.C. 1397dd(m)) is amended--
(A) in paragraph (2)(B), in the matter preceding
clause (i), by striking ``paragraphs (5), (7), and
(12)'' and inserting ``paragraphs (5), (7), (12), and
(13)''; and
(B) by adding at the end the following new
paragraph:
``(13) Special rule for adjusting allotments during fiscal
years with economic downturn quarters.--
``(A) In general.--If a fiscal quarter is
determined under section 1905(ll) to be an economic
downturn quarter with respect to a State then, as soon
as practicable after such determination, the Secretary
shall increase the allotment for the State and the
fiscal year in which such fiscal quarter occurs in
accordance with subparagraph (B).
``(B) Amount of increase.--
``(i) In general.--The amount of an
increase to the allotment of a State described
in subparagraph (A) for a fiscal year shall be
equal to the amount by which Federal payments
made to the State for the preceding fiscal year
under this title would have been increased
(without regard to whether such payments would
exceed the amount of the State's allotment for
such preceding fiscal year) if the enhanced
FMAP determined for the State for such
preceding fiscal year had been increased to the
same extent that the State's enhanced FMAP for
the fiscal year involved is expected to be
increased as a result of the application of
section 1905(ll) relative to the enhanced FMAP
that would apply to the State for the fiscal
year involved without the application of such
section.
``(ii) Inclusion of projected increases.--
In increasing the allotment of a State for a
fiscal year under this paragraph, the Secretary
may base the calculation of such increase on
projections made by the Secretary with respect
to--
``(I) the number of fiscal quarters
during such fiscal year that will be
economic downturn quarters; and
``(II) the effect that the
application of section 1905(ll) is
expected to have on the enhanced FMAP
of the State for such fiscal year.
``(C) Disregard of increased payments for purposes
of future allotments.--Any Federal payment made to a
State under this title for a fiscal year in which the
Federal medical assistance percentage for the State is
determined under section 1905(ll) shall be disregarded
when determining the allotment of the State for any
subsequent year, including for purposes of applying
this paragraph, to the extent that such payment exceeds
the amount of the payment that would have been made to
the State for the year if the Federal medical
assistance percentage for the State and year had been
determined without regard to such section.''.
TITLE IV--LOWERING DRUG COSTS
SEC. 401. EXPANDING MEDICARE DRUG PRICE NEGOTIATION.
(a) In General.--Section 1192(a) of the Social Security Act (42
U.S.C. 1320f-1(a)) is amended--
(1) in paragraph (3), by striking ``and'' at the end;
(2) in paragraph (4)--
(A) by striking ``or a subsequent year''; and
(B) by striking the period at the end and inserting
``; and''; and
(3) by adding at the end the following:
``(5) with respect to the initial price applicability year
2030, 30 negotiation-eligible drugs described in subparagraph
(A) or (B) of subsection (d)(1) with respect to such year (or,
all (if such number is less than 30) such negotiation-eligible
drugs with respect to such year);
``(6) with respect to the initial price applicability year
2031, 40 negotiation-eligible drugs described in subparagraph
(A) or (B) of subsection (d)(1) with respect to such year (or,
all (if such number is less than 40) such negotiation-eligible
drugs with respect to such year); and
``(7) with respect to the initial price applicability year
2032 or a subsequent year, 50 negotiation-eligible drugs
described in subparagraph (A) or (B) of subsection (d)(1).''.
(b) Expansion of Definition of Maximum Fair Price Eligible
Individual.--Section 1191(c)(2) of the Social Security Act (42 U.S.C.
1320f(c)(2)) is amended--
(1) in subparagraph (A), by inserting ``, or a participant,
beneficiary, or enrollee who is enrolled under a group health
plan or health insurance coverage offered in the group or
individual market (as such terms are defined in section 2791 of
the Public Health Service Act) with respect to which there is
in effect an agreement with the Secretary under section 1197
with respect to such selected drug as so furnished or
dispensed'' after ``such selected drug''; and
(2) in subparagraph (B), by inserting ``, or a participant,
beneficiary, or enrollee who is enrolled under a group health
plan or health insurance coverage offered in the group or
individual market (as such terms are defined in section 2791 of
the Public Health Service Act) with respect to which there is
in effect an agreement with the Secretary under section 1197
with respect to such selected drug as so furnished or
administered'' after ``such selected drug''.
(c) Application of Administrative Procedures to New Maximum Fair
Price Eligible Individuals.--Section 1196(a)(3) of the Social Security
Act (42 U.S.C. 1320f-5(a)(3)) is amended--
(1) in subparagraph (A), by striking ``and'' at the end;
(2) in subparagraph (B), by striking the period and
inserting ``; and''; and
(3) by adding at the end the following new subparagraph:
``(C) maximum fair price eligible individuals not
described in subparagraph (A) or (B).''.
(d) Health Insurer Agreements.--Part E of title XI of the Social
Security Act (42 U.S.C. 1320f et seq.) is amended--
(1) by redesignating sections 1197 and 1198 as sections
1198 and 1199, respectively; and
(2) by inserting after section 1196 the following new
section:
``SEC. 1197. VOLUNTARY PARTICIPATION BY OTHER HEALTH PLANS.
``(a) Agreement To Participate Under Program.--
``(1) In general.--Subject to paragraph (2), under the
program under this part the Secretary shall be treated as
having in effect an agreement with a group health plan or
health insurance issuer offering group or individual health
insurance coverage (as such terms are defined in section 2791
of the Public Health Service Act), with respect to a price
applicability period and a selected drug with respect to such
period--
``(A) in the case such selected drug furnished or
dispensed at a pharmacy or by mail order service if
coverage is provided under such plan or coverage during
such period for such selected drug as so furnished or
dispensed; and
``(B) in the case such selected drug furnished or
administered by a hospital, physician, or other
provider of services or supplier if coverage is
provided under such plan or coverage during such period
for such selected drug as so furnished or administered.
``(2) Opting out of agreement.--The Secretary shall not be
treated as having in effect an agreement under the program
under this part with a group health plan or health insurance
issuer offering group or individual health insurance coverage
with respect to a price applicability period and a selected
drug with respect to such period if such a plan or issuer
affirmatively elects, through a process specified by the
Secretary, not to participate under the program with respect to
such period and drug.
``(b) Publication of Election.--With respect to each price
applicability period and each selected drug with respect to such
period, the Secretary, the Secretary of Labor, and the Secretary of the
Treasury, as applicable, shall make public a list of each group health
plan and each health insurance issuer offering group or individual
health insurance coverage, with respect to which coverage is provided
under such plan or coverage for such drug, that has elected under
subsection (a) not to participate under the program with respect to
such period and drug.''.
(e) Application to Group Health Plans and Health Insurance
Coverage.--
(1) PHSA.--Part D of title XXVII of the Public Health
Service Act (42 U.S.C. 300gg-111 et seq.) is amended by adding
at the end the following new section:
``SEC. 2799A-12. DRUG PRICE NEGOTIATION PROGRAM AND APPLICATION OF
MAXIMUM FAIR PRICES.
``(a) In General.--In the case of a group health plan or health
insurance issuer offering group or individual health insurance coverage
that is treated under section 1197 of the Social Security Act as having
in effect an agreement with the Secretary under the Drug Price
Negotiation Program under part E of title XI of such Act, with respect
to a price applicability period (as defined in section 1191(b) of such
Act) and a selected drug (as defined in section 1192(c) of such Act)
with respect to such period for which coverage is provided under such
plan or coverage--
``(1) the provisions of such part shall apply--
``(A) in the case the drug is furnished or
dispensed at a pharmacy or by a mail order service, to
such plan or coverage, and to the participants,
beneficiaries, and enrollees enrolled under such plan
or coverage, during such period, with respect to such
selected drug, in the same manner as such provisions
apply to prescription drug plans and MA-PD plans, and
to participants, beneficiaries, and enrollees enrolled
under such prescription drug plans and MA-PD plans
during such period; and
``(B) in the case the drug is furnished or
administered by a hospital, physician, or other
provider of services or supplier, to such plan or
coverage, and to the participants, beneficiaries, and
enrollees enrolled under such plan or coverage, and to
hospitals, physicians, and other providers of services
and suppliers during such period, with respect to such
drug in the same manner as such provisions apply to the
Secretary, to participants, beneficiaries, and
enrollees entitled to benefits under part A of title
XVIII or enrolled under part B of such title, and to
hospitals, physicians, and other providers and
suppliers participating under title XVIII during such
period;
``(2) the plan or issuer shall apply any cost-sharing
responsibilities under such plan or coverage, with respect to
such selected drug, by substituting an amount not more than the
maximum fair price negotiated under such part E of title XI for
such drug in lieu of the drug price upon which the cost-sharing
would have otherwise applied, and such cost-sharing
responsibilities with respect to such selected drug may not
exceed such maximum fair price; and
``(3) the Secretary shall apply the provisions of such part
E to such plan, issuer, and coverage, such participants,
beneficiaries, and enrollees so enrolled in such plans and
coverage, and such hospitals, physicians, and other providers
and suppliers participating in such plans and coverage.
``(b) Notification Regarding Nonparticipation in Drug Price
Negotiation Program.--A group health plan or a health insurance issuer
offering group or individual health insurance coverage shall publicly
disclose, in a manner and in accordance with a process specified by the
Secretary, any election made under section 1197 of the Social Security
Act by such plan or issuer to not participate in the Drug Price
Negotiation Program under part E of title XI of such Act with respect
to a selected drug (as defined in section 1192(c) of such Act) for
which coverage is provided under such plan or coverage before the
beginning of the plan year for which such election was made.''.
(2) ERISA.--
(A) 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.) is amended by
adding at the end the following new section:
``SEC. 727. DRUG PRICE NEGOTIATION PROGRAM AND APPLICATION OF MAXIMUM
FAIR PRICES.
``(a) In General.--In the case of a group health plan or health
insurance issuer offering group health insurance coverage that is
treated under section 1197 of the Social Security Act as having in
effect an agreement with the Secretary of Health and Human Services
under the Drug Price Negotiation Program under part E of title XI of
such Act, with respect to a price applicability period (as defined in
section 1191(b) of such Act) and a selected drug (as defined in section
1192(c) of such Act) with respect to such period for which coverage is
provided under such plan or coverage--
``(1) the provisions of such part shall apply, as
applicable--
``(A) in the case the drug is furnished or
dispensed at a pharmacy or by a mail order service, to
such plan or coverage, and to the participants and
beneficiaries enrolled under such plan or coverage,
during such period, with respect to such selected drug,
in the same manner as such provisions apply to
prescription drug plans and MA-PD plans, and to
participants and beneficiaries enrolled under such
prescription drug plans and MA-PD plans during such
period; and
``(B) in the case the drug is furnished or
administered by a hospital, physician, or other
provider of services or supplier, to the group health
plan or coverage offered by an issuer, to the
participants and beneficiaries enrolled under such
plans or coverage, and to hospitals, physicians, and
other providers of services and suppliers during such
period, with respect to such drug in the same manner as
such provisions apply to the Secretary of Health and
Human Services, to participants and beneficiaries
entitled to benefits under part A of title XVIII or
enrolled under part B of such title, and to hospitals,
physicians, and other providers and suppliers
participating under title XVIII during such period;
``(2) the plan or issuer shall apply any cost-sharing
responsibilities under such plan or coverage, with respect to
such selected drug, by substituting an amount not more than the
maximum fair price negotiated under such part E of title XI for
such drug in lieu of the drug price upon which the cost-sharing
would have otherwise applied, and such cost-sharing
responsibilities with respect to such selected drug may not
exceed such maximum fair price; and
``(3) the Secretary shall apply the provisions of such part
E to such plan, issuer, and coverage, and such participants and
beneficiaries so enrolled in such plans.
``(b) Notification Regarding Nonparticipation in Drug Price
Negotiation Program.--A group health plan or a health insurance issuer
offering group health insurance coverage shall publicly disclose in a
manner and in accordance with a process specified by the Secretary any
election made under section 1197 of the Social Security Act by the plan
or issuer to not participate in the Drug Price Negotiation Program
under part E of title XI of such Act with respect to a selected drug
(as defined in section 1192(c) of such Act) for which coverage is
provided under such plan or coverage before the beginning of the plan
year for which such election was made.''.
(B) Application to retiree and certain small group
health plans.--Section 732(a) of the Employee
Retirement Income Security Act of 1974 (29 U.S.C.
1191a(a)) is amended by striking ``and 726'' and
inserting ``726, and 727''.
(C) Clerical amendment.--The table of contents in
section 1 of such Act is amended by inserting after the
item relating to section 726 the following new item:
``Sec. 727. Drug Price Negotiation Program and application of maximum
fair prices.''.
(3) IRC.--
(A) In general.--Subchapter B of chapter 100 of the
Internal Revenue Code of 1986 is amended by adding at
the end the following new section:
``SEC. 9827. DRUG PRICE NEGOTIATION PROGRAM AND APPLICATION OF MAXIMUM
FAIR PRICES.
``(a) In General.--In the case of a group health plan that is
treated under section 1197 of the Social Security Act as having in
effect an agreement with the Secretary of Health and Human Services
under the Drug Price Negotiation Program under part E of title XI of
such Act, with respect to a price applicability period (as defined in
section 1191(b) of such Act) and a selected drug (as defined in section
1192(c) of such Act) with respect to such period for which coverage is
provided under such plan--
``(1) the provisions of such part shall apply, as
applicable--
``(A) if coverage of such selected drug is provided
under such plan if the drug is furnished or dispensed
at a pharmacy or by a mail order service, to the plan,
and to the participants and beneficiaries enrolled
under such plan during such period, with respect to
such selected drug, in the same manner as such
provisions apply to prescription drug plans and MA-PD
plans, and to participants and beneficiaries enrolled
under such prescription drug plans and MA-PD plans
during such period; and
``(B) if coverage of such selected drug is provided
under such plan if the drug is furnished or
administered by a hospital, physician, or other
provider of services or supplier, to the plan, to the
participants and beneficiaries enrolled under such
plan, and to hospitals, physicians, and other providers
of services and suppliers during such period, with
respect to such drug in the same manner as such
provisions apply to the Secretary of Health and Human
Services, to participants and beneficiaries entitled to
benefits under part A of title XVIII or enrolled under
part B of such title, and to hospitals, physicians, and
other providers and suppliers participating under title
XVIII during such period;
``(2) the plan shall apply any cost-sharing
responsibilities under such plan, with respect to such selected
drug, by substituting an amount not more than the maximum fair
price negotiated under such part E of title XI for such drug in
lieu of the drug price upon which the cost-sharing would have
otherwise applied, and such cost-sharing responsibilities with
respect to such selected drug may not exceed such maximum fair
price; and
``(3) the Secretary shall apply the provisions of such part
E to such plan and such participants and beneficiaries so
enrolled in such plan.
``(b) Notification Regarding Nonparticipation in Drug Price
Negotiation Program.--A group health plan shall publicly disclose in a
manner and in accordance with a process specified by the Secretary any
election made under section 1197 of the Social Security Act by the plan
to not participate in the Drug Price Negotiation Program under part E
of title XI of such Act with respect to a selected drug (as defined in
section 1192(c) of such Act) for which coverage is provided under such
plan before the beginning of the plan year for which such election was
made.''.
(B) Application to retiree and certain small group
health plans.--Section 9831(a)(2) of the Internal
Revenue Code of 1986 is amended by inserting ``or
9827'' after ``section 9826''.
(C) 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. 9827. Drug Price Negotiation Program and application of maximum
fair prices.''.
SEC. 402. APPLICATION OF PRESCRIPTION DRUG INFLATION REBATES TO DRUGS
FURNISHED IN THE COMMERCIAL MARKET.
(a) Part B Drugs.--
(1) Application of prescription drug inflation rebates to
drugs furnished in the commercial market.--Section 1847A(i) of
the Social Security Act (42 U.S.C. 1395w-3a(i)) is amended--
(A) in paragraph (1)(A)(i), by striking ``units''
and inserting ``billing units'';
(B) in paragraph (2)(A), by striking ``for which
payment is made under this part'' and inserting ``that
would be payable under this part if such drug were
furnished to an individual enrolled under this part'';
and
(C) in paragraph (3)--
(i) in subparagraph (A)(i), by striking
``units'' and inserting ``billing units''; and
(ii) by striking subparagraph (B) and
inserting the following:
``(B) Total number of billing units.--For purposes
of subparagraph (A)(i), the total number of billing
units with respect to a part B rebatable drug is
determined as follows:
``(i) Determine the total number of units
equal to--
``(I) the total number of units, as
reported under subsection (c)(1)(B),
for each National Drug Code of such
drug during the calendar quarter that
is 2 calendar quarters prior to the
calendar quarter as described in
subparagraph (A), minus
``(II) the total number of units
with respect to each National Drug Code
of such drug for which payment was made
under a State plan under title XIX (or
waiver of such plan), as reported by
States under section 1927(b)(2)(A) for
the rebate period that is the same
calendar quarter as described in
subclause (I).
``(ii) Convert the units determined under
clause (i) to billing units for the billing and
payment code of such drug, using a methodology
similar to the methodology used under this
section, by dividing the units determined under
clause (i) for each National Drug Code of such
drug by the billing unit for the billing and
payment code of such drug.
``(iii) Compute the sum of the billing
units for each National Drug Code of such drug
in clause (ii).''.
(2) Effective date.--The amendments made by this subsection
shall apply with respect to calendar quarters beginning after
the date of the enactment of this Act.
(b) Covered Part D Drugs.--
(1) Application of prescription drug inflation rebates to
drugs furnished in the commercial market.--Section 1860D-14B of
the Social Security Act (42 U.S.C. 1395w-114b) is amended--
(A) in subsection (b)--
(i) in paragraph (1)--
(I) in subparagraph (A)(i), by
striking ``the total number of units''
and all that follows through the
semicolon and inserting the following:
``the total number of units that are
used to calculate the average
manufacturer price of such dosage form
and strength with respect to such part
D rebatable drug, as reported by the
manufacturer of such drug under section
1927 for each month, with respect to
such period;''; and
(II) by striking subparagraph (B)
and inserting the following:
``(B) Excluded units.--For purposes of subparagraph
(A)(i), the Secretary shall exclude from the total
number of units for a dosage form and strength with
respect to a part D rebatable drug, with respect to an
applicable period, the following:
``(i) Units of each dosage form and
strength of such part D rebatable drug for
which payment was made under a State plan under
title XIX (or waiver of such plan), as reported
by States under section 1927(b)(2)(A).
``(ii) Units of each dosage form and
strength of such part D rebatable drug for
which a rebate is paid under section 1847A(i).
``(iii) Beginning with plan year 2028,
units of each dosage form and strength of such
part D rebatable drug for which the
manufacturer provides a discount under the
program under section 340B of the Public Health
Service Act.''; and
(ii) in paragraph (6), by striking
``information'' and all that follows through
``rebatable covered part D drug dispensed'' and
inserting the following: ``AMP reports.--The
Secretary shall provide for a method and
process under which, in the case of a
manufacturer of a part D rebatable drug that
submits revisions to information submitted
under section 1927 by the manufacturer with
respect to such drug''; and
(B) by striking subsection (d) and inserting the
following:
``(d) Information.--For purposes of carrying out this section, the
Secretary shall use information submitted by manufacturers under
section 1927(b)(3) and information submitted by States under section
1927(b)(2)(A).''.
(2) Effective date.--The amendments made by this subsection
shall apply with respect to applicable periods (as defined in
section 1860D-14B(g)(7) of the Social Security Act (42 U.S.C.
1395w-114b(g)(7))) beginning after the date of the enactment of
this Act.
SEC. 403. ESTABLISHING AN OUT-OF-POCKET LIMIT ON EXPENDITURES FOR
PRESCRIPTION DRUGS UNDER GROUP HEALTH PLANS AND GROUP AND
INDIVIDUAL HEALTH INSURANCE COVERAGE.
(a) PHSA.--Title XXVII of the Public Health Service Act (42 U.S.C.
300gg et seq.) is amended--
(1) in section 2707, by adding at the end the following new
subsection:
``(e) Sunset.--The preceding provisions of this section shall not
apply with respect to plan years beginning on or after January 1,
2028.''; and
(2) in part D, as amended by section 401, by adding at the
end the following new section:
``SEC. 2799A-13. COMPREHENSIVE COVERAGE.
``(a) Coverage for Essential Health Benefits Package.--A health
insurance issuer that offers health insurance coverage in the
individual or small group market shall ensure that such coverage
includes the essential health benefits package required under section
1302(a) of the Patient Protection and Affordable Care Act.
``(b) Cost-Sharing Limitation.--
``(1) In general.--A group health plan and a health
insurance issuer offering group or individual health insurance
coverage shall ensure that--
``(A) any annual cost-sharing imposed under the
plan or coverage (including any such cost-sharing so
imposed with respect to prescription drugs) does not
exceed the dollar amounts specified in paragraph (2);
and
``(B) any annual cost-sharing imposed under the
plan or coverage with respect to prescription drugs
does not exceed the dollar amounts specified in
paragraph (3).
``(2) Limitation on overall out-of-pocket cost-sharing.--
For purposes of paragraph (1)(A), the dollar amounts specified
in this paragraph are the following:
``(A) With respect to self-only coverage--
``(i) for plan years beginning in 2028, the
dollar amount in effect under section
1302(c)(1) of the Patient Protection and
Affordable Care Act for such coverage for plan
years beginning in 2014, increased by an amount
equal to the product of that amount and the
premium adjustment percentage specified in
paragraph (4) of such section for the calendar
year; and
``(ii) for plan years beginning in 2029 or
a subsequent year, the dollar amount in effect
under this subparagraph for plan years
beginning in 2027, increased by an amount equal
to the product of that amount the premium
adjustment percentage specified in paragraph
(4) for the calendar year.
``(B) With respect to coverage other than self-only
coverage, for plan years beginning in 2028 or a
subsequent year, twice the amount in effect under
subparagraph (A) for such plan year.
If the amount of any increase under subparagraph (A) is not a
multiple of $50, such increase shall be rounded to the next
lowest multiple of $50.
``(3) Limitation on prescription drug out-of-pocket cost-
sharing.--For purposes of paragraph (1)(B), the dollar amounts
specified in this paragraph are the following:
``(A) With respect to self-only coverage--
``(i) for plan years beginning in 2028,
$2,000; and
``(ii) for plan years beginning in 2029 or
a subsequent year, the dollar amount in effect
under this subparagraph for plan years
beginning in 2028, increased by an amount equal
to the product of that amount and the premium
adjustment percentage under paragraph (4) for
the calendar year.
``(B) With respect to coverage other than self-only
coverage, for plan years beginning in 2028 or a
subsequent year, twice the amount in effect under
subparagraph (A) for such plan year.
If the amount of any increase under subparagraph (A) is not a
multiple of $50, such increase shall be rounded to the next
lowest multiple of $50.
``(4) Premium adjustment percentage.--For purposes of
paragraphs (2)(A)(ii) and (3)(A)(ii), the premium adjustment
percentage for any calendar year is the percentage (if any) by
which the average per capita premium for health insurance
coverage in the United States for the preceding calendar year
(as estimated by the Secretary no later than October 1 of such
preceding calendar year) exceeds such average per capita
premium for 2026 (as determined by the Secretary).
``(5) Cost-sharing.--In this section:
``(A) In general.--The term `cost-sharing'
includes--
``(i) deductibles, coinsurance, copayments,
or similar charges; and
``(ii) any other expenditure required of an
insured individual which is a qualified medical
expense (within the meaning of section
223(d)(2) of the Internal Revenue Code of 1986)
with respect to essential health benefits
covered under the plan or coverage.
``(B) Exceptions.--Such term does not include
premiums, balance billing amounts for non-network
providers, or spending for non-covered services.
``(6) Implementation.--The Secretary may implement the
provisions of this subsection by subregulatory guidance,
interim final rule, or otherwise.
``(c) Child-Only Plans.--If a health insurance issuer offers health
insurance coverage in any level of coverage specified under section
1302(d) of the Patient Protection and Affordable Care Act, the issuer
shall also offer such coverage in that level as a plan in which the
only enrollees are individuals who, as of the beginning of a plan year,
have not attained the age of 21.
``(d) Dental Only.--This section shall not apply to a plan
described in section 1311(d)(2)(B)(ii) of the Patient Protection and
Affordable Care Act.''.
(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 401, is further
amended by adding at the end the following new section:
``SEC. 728. COMPREHENSIVE COVERAGE.
``(a) Coverage for Essential Health Benefits Package.--A health
insurance issuer that offers health insurance coverage in the small
group market shall ensure that such coverage includes the essential
health benefits package required under section 1302(a) of the Patient
Protection and Affordable Care Act.
``(b) Cost-Sharing Limitation.--
``(1) In general.--A group health plan and a health
insurance issuer offering group health insurance coverage shall
ensure that--
``(A) any annual cost-sharing imposed under the
plan or coverage (including any such cost-sharing so
imposed with respect to prescription drugs) does not
exceed the dollar amounts specified in paragraph (2);
and
``(B) any annual cost-sharing imposed under the
plan or coverage with respect to prescription drugs
does not exceed the dollar amounts specified in
paragraph (3).
``(2) Limitation on overall out-of-pocket cost-sharing.--
For purposes of paragraph (1)(A), the dollar amounts specified
in this paragraph are the following:
``(A) With respect to self-only coverage--
``(i) for plan years beginning in 2028, the
dollar amount in effect under section
1302(c)(1) of the Patient Protection and
Affordable Care Act for such coverage for plan
years beginning in 2014, increased by an amount
equal to the product of that amount and the
premium adjustment percentage specified in
paragraph (4) of such section for the calendar
year; and
``(ii) for plan years beginning in 2029 or
a subsequent year, the dollar amount in effect
under this subparagraph for plan years
beginning in 2028, increased by an amount equal
to the product of that amount the premium
adjustment percentage specified in paragraph
(4) for the calendar year.
``(B) With respect to coverage other than self-only
coverage, for plan years beginning in 2028 or a
subsequent year, twice the amount in effect under
subparagraph (A) for such plan year.
If the amount of any increase under subparagraph (A) is not a
multiple of $50, such increase shall be rounded to the next
lowest multiple of $50.
``(3) Limitation on prescription drug out-of-pocket cost-
sharing.--For purposes of paragraph (1)(B), the dollar amounts
specified in this paragraph are the following:
``(A) With respect to self-only coverage--
``(i) for plan years beginning in 2028,
$2,000; and
``(ii) for plan years beginning in 2029 or
a subsequent year, the dollar amount in effect
under this subparagraph for plan years
beginning in 2028, increased by an amount equal
to the product of that amount and the premium
adjustment percentage under paragraph (4) for
the calendar year.
``(B) With respect to coverage other than self-only
coverage, for plan years beginning in 2028 or a
subsequent year, twice the amount in effect under
subparagraph (A) for such plan year.
If the amount of any increase under subparagraph (A) is not a
multiple of $50, such increase shall be rounded to the next
lowest multiple of $50.
``(4) Premium adjustment percentage.--For purposes of
paragraphs (2)(A)(ii) and (3)(A)(ii), the premium adjustment
percentage for any calendar year is the percentage (if any) by
which the average per capita premium for health insurance
coverage in the United States for the preceding calendar year
(as estimated by the Secretary no later than October 1 of such
preceding calendar year) exceeds such average per capita
premium for 2027 (as determined by the Secretary).
``(5) Cost-sharing.--In this section:
``(A) In general.--The term `cost-sharing'
includes--
``(i) deductibles, coinsurance, copayments,
or similar charges; and
``(ii) any other expenditure required of an
insured individual which is a qualified medical
expense (within the meaning of section
223(d)(2) of the Internal Revenue Code of 1986)
with respect to essential health benefits
covered under the plan or coverage.
``(B) Exceptions.--Such term does not include
premiums, balance billing amounts for non-network
providers, or spending for non-covered services.
``(6) Implementation.--The Secretary may implement the
provisions of this subsection by subregulatory guidance,
interim final rule, or otherwise.
``(c) Child-Only Plans.--If a health insurance issuer offers health
insurance coverage in any level of coverage specified under section
1302(d) of the Patient Protection and Affordable Care Act, the issuer
shall also offer such coverage in that level as a plan in which the
only enrollees are individuals who, as of the beginning of a plan year,
have not attained the age of 21.
``(d) Dental Only.--This section shall not apply to a plan
described in section 1311(d)(2)(B)(ii) of the Patient Protection and
Affordable Care Act.''.
(2) Clerical amendment.--The table of contents in section 1
of such Act, as amended by section 401, is further amended by
inserting after the item relating to section 727 the following
new item:
``Sec. 728. Comprehensive coverage.''.
(c) IRC.--
(1) In general.--Subchapter B of chapter 100 of the
Internal Revenue Code of 1986, as amended by section 401, is
further amended by adding at the end the following new section:
``SEC. 9828. COMPREHENSIVE COVERAGE.
``(a) Cost-Sharing Limitation.--
``(1) In general.--A group health plan shall ensure that--
``(A) any annual cost-sharing imposed under the
plan (including any such cost-sharing so imposed with
respect to prescription drugs) does not exceed the
dollar amounts specified in paragraph (2); and
``(B) any annual cost-sharing imposed under the
plan with respect to prescription drugs does not exceed
the dollar amounts specified in paragraph (3).
``(2) Limitation on overall out-of-pocket cost-sharing.--
For purposes of paragraph (1)(A), the dollar amounts specified
in this paragraph are the following:
``(A) With respect to self-only coverage--
``(i) for plan years beginning in 2028, the
dollar amount in effect under section
1302(c)(1) of the Patient Protection and
Affordable Care Act for such coverage for plan
years beginning in 2014, increased by an amount
equal to the product of that amount and the
premium adjustment percentage specified in
paragraph (4) of such section for the calendar
year; and
``(ii) for plan years beginning in 2029 or
a subsequent year, the dollar amount in effect
under this subparagraph for plan years
beginning in 2028, increased by an amount equal
to the product of that amount the premium
adjustment percentage specified in paragraph
(4) for the calendar year.
``(B) With respect to coverage other than self-only
coverage, for plan years beginning in 2028 or a
subsequent year, twice the amount in effect under
subparagraph (A) for such plan year.
If the amount of any increase under subparagraph (A) is not a
multiple of $50, such increase shall be rounded to the next
lowest multiple of $50.
``(3) Limitation on prescription drug out-of-pocket cost-
sharing.--For purposes of paragraph (1)(B), the dollar amounts
specified in this paragraph are the following:
``(A) With respect to self-only coverage--
``(i) for plan years beginning in 2028,
$2,000; and
``(ii) for plan years beginning in 2029 or
a subsequent year, the dollar amount in effect
under this subparagraph for plan years
beginning in 2028, increased by an amount equal
to the product of that amount and the premium
adjustment percentage under paragraph (4) for
the calendar year.
``(B) With respect to coverage other than self-only
coverage, for plan years beginning in 2028 or a
subsequent year, twice the amount in effect under
subparagraph (A) for such plan year.
If the amount of any increase under subparagraph (A) is not a
multiple of $50, such increase shall be rounded to the next
lowest multiple of $50.
``(4) Premium adjustment percentage.--For purposes of
paragraphs (2)(A)(ii) and (3)(A)(ii), the premium adjustment
percentage for any calendar year is the percentage (if any) by
which the average per capita premium for health insurance
coverage in the United States for the preceding calendar year
(as estimated by the Secretary no later than October 1 of such
preceding calendar year) exceeds such average per capita
premium for 2026 (as determined by the Secretary).
``(5) Cost-sharing.--In this section:
``(A) In general.--The term `cost-sharing'
includes--
``(i) deductibles, coinsurance, copayments,
or similar charges; and
``(ii) any other expenditure required of an
insured individual which is a qualified medical
expense (within the meaning of section
223(d)(2) of the Internal Revenue Code of 1986)
with respect to essential health benefits
covered under the plan.
``(B) Exceptions.--Such term does not include
premiums, balance billing amounts for non-network
providers, or spending for non-covered services.
``(6) Implementation.--The Secretary may implement the
provisions of this subsection by subregulatory guidance,
interim final rule, or otherwise.
``(b) Dental Only.--This section shall not apply to a plan
described in section 1311(d)(2)(B)(ii) of the Patient Protection and
Affordable Care Act.''.
(2) Clerical amendment.--The table of sections for
subchapter B of chapter 100 of the Internal Revenue Code of
1986, as amended by section 401, is further amended by adding
at the end the following new item:
``Sec. 9828. Comprehensive coverage.''.
(d) Conforming Amendments.--The Patient Protection and Affordable
Care Act (Public Law 111-148) is amended--
(1) in section 1302--
(A) in subsection (a)(2), by inserting ``with
respect to plan years beginning before January 1,
2027,'' before ``limits cost-sharing''; and
(B) in subsection (e)(1)(B)(i)--
(i) by inserting ``(or, with respect to
plan years beginning on or after January 1,
2028, in effect under section 2799A-13(b)(1)(A)
of the Public Health Service Act)'' after
``subsection (c)(1)''; and
(ii) by inserting ``and except, with
respect to plan years beginning on or after
January 1, 2028, in the case of an individual
who has incurred cost-sharing expenses with
respect to prescription drugs in an amount
equal to the annual limitation in effect under
section 2799A-13(b)(1)(B) of such Act, for
benefits consisting of prescription drugs''
after ``section 2713''; and
(2) in section 1402(c)(1)(A), by inserting ``(or, with
respect to plan years beginning on or after January 1, 2028,
the applicable out-of-pocket limit under section 2799A-
13(b)(1)(A) of the Public Health Service Act)'' after ``section
1302(c)(1)''.
(e) Effective Date.--The amendments made by this section shall
apply with respect to plan years beginning on or after January 1, 2028.
SEC. 404. REQUIREMENTS WITH RESPECT TO COST-SHARING FOR INSULIN
PRODUCTS.
(a) PHSA.--Part D of title XXVII of the Public Health Service Act
(42 U.S.C. 300gg-111 et seq.), as amended by section 403, is further
amended by adding at the end the following new section:
``SEC. 2799A-14. REQUIREMENTS WITH RESPECT TO COST-SHARING FOR CERTAIN
INSULIN PRODUCTS.
``(a) In General.--For plan years beginning on or after January 1,
2028, a group health plan or health insurance issuer offering group or
individual health insurance coverage shall provide coverage of selected
insulin products, and with respect to such products, shall not--
``(1) apply any deductible; or
``(2) impose any cost-sharing in excess of the lesser of,
per 30-day supply--
``(A) $35; or
``(B) the amount equal to 25 percent of the
negotiated price of the selected insulin product net of
all price concessions received by or on behalf of the
plan or coverage, including price concessions received
by or on behalf of third-party entities providing
services to the plan or coverage, such as pharmacy
benefit management services.
``(b) Definitions.--In this section:
``(1) Selected insulin products.--The term `selected
insulin products' means at least one of each dosage form (such
as vial, pump, or inhaler dosage forms) of each different type
(such as rapid-acting, short-acting, intermediate-acting, long-
acting, ultra long-acting, and premixed) of insulin (as defined
below), when available, as selected by the group health plan or
health insurance issuer.
``(2) Insulin defined.--The term `insulin' means insulin
that is licensed under subsection (a) or (k) of section 351 and
continues to be marketed under such section.
``(c) Out-of-Network Providers.--Nothing in this section requires a
plan or issuer that has a network of providers to provide benefits for
selected insulin products described in this section that are delivered
by an out-of-network provider, or precludes a plan or issuer that has a
network of providers from imposing higher cost-sharing than the levels
specified in subsection (a) for selected insulin products described in
this section that are delivered by an out-of-network provider.
``(d) Rule of Construction.--Subsection (a) shall not be construed
to require coverage of, or prevent a group health plan or health
insurance coverage from imposing cost-sharing other than the levels
specified in subsection (a) on, insulin products that are not selected
insulin products, to the extent that such coverage is not otherwise
required and such cost-sharing is otherwise permitted under Federal and
applicable State law.
``(e) Application of Cost-Sharing Towards Deductibles and Out-of-
Pocket Maximums.--Any cost-sharing payments made pursuant to subsection
(a)(2) shall be counted toward any deductible or out-of-pocket maximum
that applies under the plan or coverage.''.
(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 403, is further
amended by adding at the end the following new section:
``SEC. 729. REQUIREMENTS WITH RESPECT TO COST-SHARING FOR CERTAIN
INSULIN PRODUCTS.
``(a) In General.--For plan years beginning on or after January 1,
2028, a group health plan or health insurance issuer offering group
health insurance coverage shall provide coverage of selected insulin
products, and with respect to such products, shall not--
``(1) apply any deductible; or
``(2) impose any cost-sharing in excess of the lesser of,
per 30-day supply--
``(A) $35; or
``(B) the amount equal to 25 percent of the
negotiated price of the selected insulin product net of
all price concessions received by or on behalf of the
plan or coverage, including price concessions received
by or on behalf of third-party entities providing
services to the plan or coverage, such as pharmacy
benefit management services.
``(b) Definitions.--In this section:
``(1) Selected insulin products.--The term `selected
insulin products' means at least one of each dosage form (such
as vial, pump, or inhaler dosage forms) of each different type
(such as rapid-acting, short-acting, intermediate-acting, long-
acting, ultra long-acting, and premixed) of insulin (as defined
below), when available, as selected by the group health plan or
health insurance issuer.
``(2) Insulin defined.--The term `insulin' means insulin
that is licensed under subsection (a) or (k) of section 351 of
the Public Health Service Act (42 U.S.C. 262) and continues to
be marketed under such section.
``(c) Out-of-Network Providers.--Nothing in this section requires a
plan or issuer that has a network of providers to provide benefits for
selected insulin products described in this section that are delivered
by an out-of-network provider, or precludes a plan or issuer that has a
network of providers from imposing higher cost-sharing than the levels
specified in subsection (a) for selected insulin products described in
this section that are delivered by an out-of-network provider.
``(d) Rule of Construction.--Subsection (a) shall not be construed
to require coverage of, or prevent a group health plan or health
insurance coverage from imposing cost-sharing other than the levels
specified in subsection (a) on, insulin products that are not selected
insulin products, to the extent that such coverage is not otherwise
required and such cost-sharing is otherwise permitted under Federal and
applicable State law.
``(e) Application of Cost-Sharing Towards Deductibles and Out-of-
Pocket Maximums.--Any cost-sharing payments made pursuant to subsection
(a)(2) shall be counted toward any deductible or out-of-pocket maximum
that applies under the plan or coverage.''.
(2) Clerical amendment.--The table of contents in section 1
of such Act is amended by inserting after the item relating to
section 728 (as inserted by section 403) the following new
item:
``Sec. 729. Requirements with respect to cost-sharing for certain
insulin products.''.
(c) IRC.--
(1) In general.--Subchapter B of chapter 100 of the
Internal Revenue Code of 1986, as amended by section 403, is
further amended by adding at the end the following new section:
``SEC. 9829. REQUIREMENTS WITH RESPECT TO COST-SHARING FOR CERTAIN
INSULIN PRODUCTS.
``(a) In General.--For plan years beginning on or after January 1,
2028, a group health plan shall provide coverage of selected insulin
products, and with respect to such products, shall not--
``(1) apply any deductible; or
``(2) impose any cost-sharing in excess of the lesser of,
per 30-day supply--
``(A) $35; or
``(B) the amount equal to 25 percent of the
negotiated price of the selected insulin product net of
all price concessions received by or on behalf of the
plan, including price concessions received by or on
behalf of third-party entities providing services to
the plan, such as pharmacy benefit management services.
``(b) Definitions.--In this section:
``(1) Selected insulin products.--The term `selected
insulin products' means at least one of each dosage form (such
as vial, pump, or inhaler dosage forms) of each different type
(such as rapid-acting, short-acting, intermediate-acting, long-
acting, ultra long-acting, and premixed) of insulin (as defined
below), when available, as selected by the group health plan.
``(2) Insulin defined.--The term `insulin' means insulin
that is licensed under subsection (a) or (k) of section 351 of
the Public Health Service Act (42 U.S.C. 262) and continues to
be marketed under such section.
``(c) Out-of-Network Providers.--Nothing in this section requires a
plan that has a network of providers to provide benefits for selected
insulin products described in this section that are delivered by an
out-of-network provider, or precludes a plan that has a network of
providers from imposing higher cost-sharing than the levels specified
in subsection (a) for selected insulin products described in this
section that are delivered by an out-of-network provider.
``(d) Rule of Construction.--Subsection (a) shall not be construed
to require coverage of, or prevent a group health plan from imposing
cost-sharing other than the levels specified in subsection (a) on,
insulin products that are not selected insulin products, to the extent
that such coverage is not otherwise required and such cost-sharing is
otherwise permitted under Federal and applicable State law.
``(e) Application of Cost-Sharing Towards Deductibles and Out-of-
Pocket Maximums.--Any cost-sharing payments made pursuant to subsection
(a)(2) shall be counted toward any deductible or out-of-pocket maximum
that applies under the plan.''.
(2) Clerical amendment.--The table of sections for
subchapter B of chapter 100 of the Internal Revenue Code of
1986, as amended by section 403, is further amended by adding
at the end the following new item:
``Sec. 9829. Requirements with respect to cost-sharing for certain
insulin products.''.
(d) No Effect on Other Cost-Sharing.--Section 1302(d)(2) of the
Patient Protection and Affordable Care Act (42 U.S.C. 18022(d)(2)) is
amended by adding at the end the following new subparagraph:
``(D) Special rule relating to insulin coverage.--
The exemption of coverage of selected insulin products
(as defined in section 2799A-14(b) of the Public Health
Service Act) from the application of any deductible
pursuant to section 2799A-14(a)(1) of such Act, section
729(a)(1) of the Employee Retirement Income Security
Act of 1974, or section 9829(a)(1) of the Internal
Revenue Code of 1986 shall not be considered when
determining the actuarial value of a qualified health
plan under this subsection.''.
(e) Coverage of Certain Insulin Products Under Catastrophic
Plans.--Section 1302(e) of the Patient Protection and Affordable Care
Act (42 U.S.C. 18022(e)) is amended by adding at the end the following
new paragraph:
``(4) Coverage of certain insulin products.--
``(A) In general.--Notwithstanding paragraph
(1)(B)(i), a health plan described in paragraph (1)
shall provide coverage of selected insulin products, in
accordance with section 2799A-14 of the Public Health
Service Act, for a plan year before an enrolled
individual has incurred cost-sharing expenses in an
amount equal to the annual limitation in effect under
subsection (c)(1) for the plan year.
``(B) Terminology.--For purposes of subparagraph
(A)--
``(i) the term `selected insulin products'
has the meaning given such term in section
2799A-14(b) of the Public Health Service Act;
and
``(ii) the requirements of section 2799A-14
of such Act shall be applied by deeming each
reference in such section to `individual health
insurance coverage' to be a reference to a plan
described in paragraph (1).''.
TITLE V--ENSURING QUALITY HEALTH INSURANCE AND REMOVING BARRIERS TO
CARE
SEC. 501. REQUIRED EXCEPTIONS PROCESS FOR MEDICATION STEP THERAPY
PROTOCOLS.
(a) Required Exceptions Process for Medication Step Therapy
Protocols.--The Employee Retirement Income Security Act of 1974 is
amended by inserting after section 713 of such Act (29 U.S.C. 1185b)
the following new section:
``SEC. 713A. REQUIRED EXCEPTIONS PROCESS FOR MEDICATION STEP THERAPY
PROTOCOLS.
``(a) In General.--In the case of a group health plan or health
insurance issuer offering coverage offered in connection with such a
plan that provides coverage of a prescription drug pursuant to a
medication step therapy protocol, the plan or issuer shall--
``(1) implement a clear, prompt, and transparent process
for a participant or beneficiary (or the prescribing health
care provider (referred to in this section as the `prescriber')
on behalf of the participant or beneficiary) to request an
exception to such medication step therapy protocol, pursuant to
subsection (b); and
``(2) where the participant or beneficiary or prescriber's
request for an exception to the medication step therapy
protocols satisfies the criteria and requirements of subsection
(b), cover the requested drug in accordance with the terms
established by the plan or coverage for patient cost-sharing
rates or amounts at the beginning of the plan year.
``(b) Circumstances for Exception Approval.--The circumstances
requiring an exception to a medication step therapy protocol, pursuant
to a request under subsection (a), are any of the following:
``(1) Any treatments otherwise required under the protocol,
or treatments in the same pharmacological class or having the
same mechanism of action, including treatments provided prior
to the effective date of the participant's or beneficiary's
coverage under the plan or coverage, have been ineffective in
the treatment of the disease or condition of the participant or
beneficiary, when prescribed consistent with clinical
indications, clinical guidelines, or other peer-reviewed
evidence, based on the prescribing health care professional's
judgement or relevant information provided by the participant
or beneficiary (including the medical records of the
participant or beneficiary).
``(2) Delay of effective treatment would lead to severe or
irreversible consequences, or worsen disease progression or a
comorbidity and the treatment otherwise required under the
protocol is reasonably expected by the prescriber to be
ineffective based upon the documented physical or mental
characteristics of the participant or beneficiary and the known
characteristics of such treatment.
``(3) Any treatments otherwise required under the protocol
are contraindicated for the participant or beneficiary or have
caused, or are likely to cause, based on clinical, peer-
reviewed evidence, an adverse reaction or other physical or
mental harm to the participant or beneficiary.
``(4) Any treatment otherwise required under the protocol
has prevented, will prevent, or is likely to prevent a
participant or beneficiary from achieving or maintaining
reasonable and safe functional ability in performing
occupational responsibilities or activities of daily living (as
defined in section 441.505 of title 42, Code of Federal
Regulations (or successor regulations)).
``(5) The participant or beneficiary is stable for his or
her disease or condition on the prescription drug or drugs
selected by the prescriber and has previously received approval
for coverage of the relevant drug or drugs for the disease or
condition by any public or private health plan.
``(6) Other circumstances, as determined by the Secretary.
``(c) Requirement of a Clear Process.--
``(1) In general.--The process required by subsection (a)
shall--
``(A) provide the prescriber or participant or
beneficiary an opportunity to present such prescriber's
clinical rationale and relevant medical information for
the group health plan or health insurance issuer to
evaluate such request for exception;
``(B) develop and use a standard form and
instructions for the request of an exception under
subsection (b), available in paper and electronic
forms, and allow for submission of such form by paper
and electronic means;
``(C) provide both paper and electronic means for
the submission of requests for additional information;
``(D) clearly set forth all required information
and the specific criteria that will be used to
determine whether an exception is warranted, which may
require disclosure of--
``(i) the medical history or other health
records of the participant or beneficiary
demonstrating that the participant or
beneficiary seeking an exception--
``(I) has tried other drugs
included in the drug therapy class
without success; or
``(II) has taken the requested drug
for a clinically appropriate amount of
time to establish stability, in
relation to the condition being treated
and prescription guidelines given by
the prescribing physician; or
``(ii) other clinical information that may
be relevant to conducting the exception review;
``(E) not require the submission of any information
or supporting documentation beyond what is strictly
necessary (as determined by the Secretary) to determine
whether a circumstance listed in subsection (b) exists;
``(F) clearly outline conditions under which an
exception request warrants expedited resolution from
the group health plan or health insurance issuer,
pursuant to subsection (d)(2); and
``(G) allow a representative of a participant or
beneficiary, which may include a designated third-party
advocate, to act on behalf of the participant or
beneficiary.
``(2) Availability of process information.--The group
health plan or health insurance issuer shall make information
regarding the process required under subsection (a) readily
available in the relevant plan materials, including the summary
of benefits and, if available, on the website of the group
health plan or health insurance issuer. Such information shall
include--
``(A) the requirements for requesting an exception
to a medication step therapy protocol pursuant to this
section; and
``(B) any forms, supporting information, and
contact information, as appropriate.
``(d) Timing for Determination of Exception.--The process required
under subsection (a)(1) shall provide for the disposition of requests
received under such paragraph in accordance with the following:
``(1) Subject to paragraph (2), not later than 72 hours
after receiving an initial exception request, the plan or
issuer shall respond to the participant or beneficiary and, if
applicable, the requesting prescriber with either a
determination of exception eligibility or a request for
additional required information strictly necessary to make a
determination of whether the conditions specified in subsection
(b) are met. The plan or issuer shall respond to the
participant or beneficiary and, if applicable, the requesting
prescriber, with a determination of exception eligibility no
later than 72 hours after receipt of the additional required
information.
``(2) In the case of a request under circumstances in which
the applicable medication step therapy protocol may seriously
jeopardize the life or health of the participant or
beneficiary, may jeopardize the ability of the participant or
beneficiary to regain maximum function, or may subject the
participant or beneficiary to severe pain that cannot be
adequately managed without the treatment that is the subject of
the request, the plan or issuer shall conduct a review of the
request and respond to the participant or beneficiary and, if
applicable, the requesting prescriber, with either a
determination of exception eligibility or a request for
additional required information strictly necessary to make a
determination of whether the conditions specified in subsection
(b) are met, in accordance with the following:
``(A) If the plan or issuer can make a
determination of exception eligibility without
additional information, such determination shall be
made on an expedited basis, and no later than 24 hours
after receipt of such request.
``(B) If the plan or issuer requires additional
information before making a determination of exception
eligibility, the plan or issuer shall respond to the
participant or beneficiary and, if applicable, the
requesting prescriber, with a request for such
information within 24 hours of the request for a
determination, and shall respond with a determination
of exception eligibility as quickly as the condition or
disease requires, and no later than 24 hours after
receipt of the additional required information.
``(e) Duration of a Grant.--If an exception to a medication step
therapy protocol is granted under this section to a participant or
beneficiary, coverage for the requested drug shall remain in effect
with respect to such participant or beneficiary for not less than 1
year.
``(f) Medication Step Therapy Protocol.--In this section, the term
`medication step therapy protocol' means a drug therapy utilization
management protocol or program under which a group health plan or
health insurance issuer offering group health insurance coverage of
prescription drugs requires a participant or beneficiary to try an
alternative preferred prescription drug or drugs before the plan or
health insurance issuer approves coverage for the non-preferred drug
therapy prescribed.
``(g) Clarification.--This section shall apply with respect to any
group health plan or health insurance coverage offered in connection
with such a plan that provides coverage of a prescription drug pursuant
to a policy that meets the definition of the term `medication step
therapy protocol' in subsection (f), regardless of whether such policy
is described by such group health plan or health insurance coverage as
a step therapy protocol.
``(h) Reporting.--
``(1) Reporting to the secretary.--Not later than 3 years
after the date of enactment of the Health CARE Act of 2026, and
not later than October 1 of each year thereafter, each group
health plan and health insurance issuer offering group health
insurance coverage shall report to the Secretary, in such
manner as the Secretary shall require, the following:
``(A) The number of step therapy exception requests
received for each exception circumstance described in
paragraphs (1) through (6) of subsection (b), and the
numbers of such requests for each such circumstance
that were--
``(i) approved;
``(ii) denied, and the reasons for the
denials;
``(iii) initially denied and appealed; and
``(iv) initially denied and then
subsequently reversed by internal appeals or
external reviews.
``(B) The number of times a plan or issuer
requested additional information in response to a step
therapy exception request, by exception circumstance
described in paragraphs (1) through (6) of subsection
(b).
``(C) The number of exception requests submitted by
participants or beneficiaries, and the number of
exception requests submitted by prescribers, by medical
specialty.
``(D) The medical conditions for which participants
and beneficiaries were granted exceptions due to the
likelihood that switching from a prescription drug will
likely cause an adverse reaction by, or physical or
mental harm to, the participant or beneficiary, as
described in subsection (b)(3).
``(E) The entities responsible for providing
pharmacy benefit management services for the group
health plan or health insurance coverage.
``(2) Information.--A group health plan or health insurance
issuer offering group health insurance coverage shall not enter
into a contract with a third-party administrator or an entity
providing pharmacy benefit management services on behalf of the
plan or coverage that prevents the plan or issuer from
obtaining from the third-party administrator or the entity
providing pharmacy benefit management services any information
needed for the plan or issuer to comply with the reporting
requirements under paragraph (1).
``(3) Reports to congress.--Not later than 3 years after
the date of enactment of the Health CARE Act of 2026, and not
later than October 1 of each year thereafter, the Secretary
shall submit to Congress, and make publicly available, a report
that contains a summary and analysis of the information
reported under paragraph (1), including an analysis of, with
respect to requests for exceptions under this section,
approvals, and denials, including the reasons for denials;
appeals and external reviews; and trends, if any, in exception
requests by medical specialty or medical condition.''.
(b) 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 713
the following new item:
``Sec. 713A. Required exceptions process for medication step therapy
protocols.''.
(c) Effective Date.--
(1) In general.--The amendment made by subsection (a)
applies with respect to plan years beginning with the first
plan year that begins at least 6 months after the date of the
enactment of this Act.
(2) Regulations.--Not later than 6 months after the date of
the enactment of this Act, the Secretary of Labor shall issue
final regulations, through notice and comment rulemaking, to
implement the provisions of section 713A of the Employee
Retirement Income Security Act of 1974, as added by subsection
(a).
SEC. 502. ESTABLISHING REQUIREMENTS WITH RESPECT TO THE USE OF PRIOR
AUTHORIZATION UNDER MEDICARE ADVANTAGE PLANS.
(a) In General.--Section 1852 of the Social Security Act (42 U.S.C.
1395w-22) is amended by adding at the end the following new subsection:
``(o) Prior Authorization Requirements.--
``(1) In general.--In the case of a Medicare Advantage plan
that imposes any prior authorization requirement with respect
to any applicable item or service (as defined in paragraph (5))
during a plan year, such plan shall--
``(A) beginning with plan years beginning on or
after January 1, 2029--
``(i) establish the electronic prior
authorization program described in paragraph
(2); and
``(ii) meet the enrollee protection
standards specified pursuant to paragraph (4);
and
``(B) beginning with plan years beginning on or
after January 1, 2028, meet the transparency
requirements specified in paragraph (3).
``(2) Electronic prior authorization program.--
``(A) In general.--For purposes of paragraph
(1)(A), the electronic prior authorization program
described in this paragraph is a program that provides
for the secure electronic transmission of--
``(i) a prior authorization request from a
provider or supplier to a Medicare Advantage
plan with respect to an applicable item or
service to be furnished to an individual and a
response, in accordance with this paragraph,
from such plan to such provider or supplier;
and
``(ii) any supporting documentation
relating to such request or response.
``(B) Electronic transmission.--
``(i) Exclusions.--For purposes of this
paragraph, a facsimile, a proprietary payer
portal that does not meet standards specified
by the Secretary, or an electronic form shall
not be treated as an electronic transmission
described in subparagraph (A).
``(ii) Standards.--An electronic
transmission described in subparagraph (A)
shall comply with applicable technical
standards and other requirements to promote the
standardization and streamlining of electronic
transactions adopted by the Secretary.
``(3) Transparency requirements.--
``(A) In general.--For purposes of paragraph
(1)(B), the transparency requirements specified in this
paragraph are, with respect to a Medicare Advantage
plan, the following:
``(i) The plan, annually and in a manner
specified by the Secretary, shall submit to the
Secretary the following information:
``(I) A list of all applicable
items and services that were subject to
a prior authorization requirement under
the plan during the previous plan year.
``(II) The percentage and number of
specified requests (as defined in
subparagraph (F)) approved during the
previous plan year by the plan in an
initial determination and the
percentage and number of specified
requests denied during such plan year
by such plan in an initial
determination (both in the aggregate
and categorized by each item and
service).
``(III) The percentage and number
of specified requests that were denied
during the previous plan year by the
plan in an initial determination and
that were subsequently appealed.
``(IV) The number of appeals of
specified requests resolved during the
preceding plan year, and the percentage
and number of such resolved appeals
that resulted in approval of the
furnishing of the item or service that
was the subject of such request,
categorized by each applicable item and
service and categorized by each level
of appeal (including judicial review).
``(V) The percentage and number of
specified requests that were denied,
and the percentage and number of
specified requests that were approved,
by the plan during the previous plan
year through the utilization of
decision support technology, artificial
intelligence technology, machine-
learning technology, clinical decision-
making technology, or any other
technology specified by the Secretary.
``(VI) The average and the median
amount of time (in hours) that elapsed
during the previous plan year between
the submission of a specified request
to the plan and a determination by the
plan with respect to such request for
each such item and service, excluding
any such requests that were not
submitted with the medical or other
documentation required to be submitted
by the plan.
``(VII) The percentage and number
of specified requests that were
excluded from the calculation described
in subclause (VI) based on the plan's
determination that such requests were
not submitted with the medical or other
documentation required to be submitted
by the plan.
``(VIII) Information on each
occurrence during the previous plan
year in which, during a surgical or
medical procedure involving the
furnishing of an applicable item or
service with respect to which such plan
had approved a prior authorization
request, the provider or supplier
furnishing such item or service
determined that a different or
additional item or service was
medically necessary, including a
specification of whether such plan
subsequently approved the furnishing of
such different or additional item or
service.
``(IX) A disclosure and description
of any technology described in
subclause (V) that the plan utilized
during the previous plan year in making
determinations with respect to
specified requests.
``(X) The number of grievances (as
described in subsection (f)) received
by such plan during the previous plan
year that were related to a prior
authorization requirement.
``(XI) Such other information as
the Secretary determines appropriate.
``(ii) The plan shall provide--
``(I) to each provider or supplier
who seeks to enter into a contract with
such plan to furnish applicable items
and services under such plan, the list
described in clause (i)(I) and any
policies or procedures used by the plan
for making determinations with respect
to prior authorization requests;
``(II) to each such provider and
supplier that enters into such a
contract, access to the criteria used
by the plan for making such
determinations and an itemization of
the medical or other documentation
required to be submitted by a provider
or supplier with respect to such a
request; and
``(III) to an enrollee of the plan,
upon request, access to the criteria
used by the plan for making
determinations with respect to prior
authorization requests for an item or
service.
``(B) Option for plan to provide certain additional
information.--As part of the information described in
subparagraph (A)(i) provided to the Secretary during a
plan year, a Medicare Advantage plan may elect to
include information regarding the percentage and number
of specified requests made with respect to an
individual and an item or service that were denied by
the plan during the preceding plan year in an initial
determination based on such requests failing to
demonstrate that such individuals met the clinical
criteria established by such plan to receive such items
or services.
``(C) Regulations.--The Secretary shall, through
notice and comment rulemaking, establish requirements
for Medicare Advantage plans regarding the provision
of--
``(i) access to criteria described in
subparagraph (A)(ii)(II) to providers of
services and suppliers in accordance with such
subparagraph; and
``(ii) access to such criteria to enrollees
in accordance with subparagraph (A)(ii)(III).
``(D) Publication of information.--The Secretary
shall publish information described in subparagraph
(A)(i) and subparagraph (B) on a public website of the
Centers for Medicare & Medicaid Services. Such
information shall be so published on an individual plan
level and may in addition be aggregated in such manner
as determined appropriate by the Secretary.
``(E) Medpac report.--Not later than 3 years after
the date information is first submitted under
subparagraph (A)(i), the Medicare Payment Advisory
Commission shall submit to Congress a report on such
information that includes a descriptive analysis of the
use of prior authorization. As appropriate, the
Commission should report on statistics including the
frequency of appeals and overturned decisions. The
Commission shall provide recommendations, as
appropriate, on any improvement that should be made to
the electronic prior authorization programs of Medicare
Advantage plans.
``(F) Specified request defined.--For purposes of
this paragraph, the term `specified request' means a
prior authorization request made with respect to an
applicable item or service.
``(4) Enrollee protection standards.--For purposes of
paragraph (1)(A)(ii), with respect to the use of prior
authorization by Medicare Advantage plans for applicable items
and services, the enrollee protection standards specified in
this paragraph are--
``(A) the adoption of transparent prior
authorization programs developed in consultation with
enrollees and with providers and suppliers with
contracts in effect with such plans for furnishing such
items and services under such plans;
``(B) allowing for the waiver or modification of
prior authorization requirements based on the
performance of such providers and suppliers in
demonstrating compliance with such requirements, such
as adherence to evidence-based medical guidelines and
other quality criteria; and
``(C) conducting annual reviews of such items and
services for which prior authorization requirements are
imposed under such plans through a process that takes
into account input from enrollees and from providers
and suppliers with such contracts in effect and is
based on consideration of prior authorization data from
previous plan years and analyses of current coverage
criteria.
``(5) Applicable item or service defined.--For purposes of
this subsection, the term `applicable item or service' means,
with respect to a Medicare Advantage plan, any item or service
for which benefits are available under such plan, other than a
covered part D drug.
``(6) Reports to congress.--
``(A) GAO.--Not later than January 1, 2033, the
Comptroller General of the United States shall submit
to Congress a report containing an evaluation of the
implementation of the requirements of this subsection
and an analysis of issues in implementing such
requirements faced by Medicare Advantage plans.
``(B) HHS.--
``(i) The secretary.--Not later than the
end of the fifth plan year beginning after the
date of the enactment of this subsection, and
biennially thereafter through the date that is
10 years after such date of enactment, the
Secretary shall submit to Congress a report
containing a description of the information
submitted under paragraph (3)(A)(i) during--
``(I) in the case of the first such
report, the fourth plan year beginning
after the date of the enactment of this
subsection; and
``(II) in the case of a subsequent
report, the 2 plan years preceding the
year of the submission of such report.
``(ii) CMS.--Not later than January 1,
2029, the Centers for Medicare & Medicaid
Services and the Office of the National
Coordinator for Health Information Technology
shall submit to Congress and publish on the
internet website of the Centers for Medicare &
Medicaid Services a report that--
``(I) defines the term `real-time
decision' and details how the
definition for such term may be updated
based on any technological advances;
``(II) using the data submitted to
the Secretary under paragraph
(3)(A)(i), details a process for real-
time decisions for routinely approved
items and services for purposes of the
electronic prior authorization program
described in paragraph (2); and
``(III) includes an analysis of--
``(aa) items and services
that are routinely approved;
``(bb) items and services
identified in item (aa) that
could be eligible for real-time
decisions;
``(cc) whether establishing
real-time decisions for such
items and services could--
``(AA) improve
enrollee access to
benefits under this
part;
``(BB) produce
operational
efficiencies for
providers and suppliers
and Medicare Advantage
plans; and
``(CC) reduce
health disparities for
Medicare Advantage
enrollees in rural and
low-income communities;
and
``(dd) how determinations
of routinely approved items and
services made solely through
automation and artificial
intelligence by Medicare
Advantage plans impact patient
access, including disparities
in access for rural and low-
income beneficiaries.''.
(b) Providing the Secretary Authority To Enforce Timely Responses
for All Prior Authorization Requests Submitted Under Part C.--Section
1852(g) of the Social Security Act (42 U.S.C. 1395w-22(g)) is amended--
(1) in paragraph (1)(A), by inserting ``and in accordance
with any timeframe established by the Secretary under paragraph
(6)'' after ``paragraph (3)'';
(2) in paragraph (3)(B)(iii), by inserting ``(with respect
to prior authorization requests submitted on or after the first
day of the third plan year beginning after the date of the
enactment of the Health CARE Act of 2026, any timeframe
established by the Secretary under paragraph (6))'' after ``72
hours''; and
(3) by adding at the end the following new paragraph:
``(6) Timeframe for response to prior authorization
requests.--Subject to paragraph (3), the Secretary may
establish, for purposes of an organization determination made
with respect to a prior authorization request for an item or
service to be furnished to an individual, timeframes, such as
24 hours, for the organization to notify the enrollee (and the
physician involved, as appropriate) of such determination for--
``(A) a request for expedited determination
described in paragraph (3)(A);
``(B) a real time decision for routinely approved
items and services; and
``(C) any other prior authorization request.''.
SEC. 503. SPECIAL ENROLLMENT PERIOD FOR PROVIDER TERMINATIONS.
Section 1851(e)(4) of the Social Security Act (42 U.S.C. 1395w-
21(e)(4)) is amended--
(1) by redesignating subparagraph (D) as subparagraph (E);
and
(2) by inserting after subparagraph (C) the following new
subparagraph:
``(D) the individual demonstrates or the Secretary
or organization determines that the individual is
assigned to, currently receiving care from, or has
received care in the previous 3 months from, a provider
of services or supplier that is terminated from the
provider network of the plan;''.
SEC. 504. PROVIDING COVERAGE FOR HEARING CARE UNDER THE MEDICARE
PROGRAM.
(a) Provision of Audiology Services by Qualified Audiologists and
Qualified Hearing Aid Professionals.--
(1) In general.--Section 1861(ll) of the Social Security
Act (42 U.S.C. 1395x(ll)) is amended--
(A) in paragraph (3)--
(i) by inserting ``(and, beginning January
1, 2028, such aural rehabilitation and
treatment services)'' after ``assessment
services'';
(ii) by inserting ``, and, beginning on
January 1, 2028, such hearing assessment
services furnished by a qualified hearing aid
professional,'' after ``by a qualified
audiologist''; and
(iii) by striking ``the audiologist'' and
inserting ``the audiologist or qualified
hearing aid professional''; and
(B) in paragraph (4), by adding at the end the
following new subparagraph:
``(C) The term `qualified hearing aid professional' means,
with respect to hearing assessment services described in
paragraph (3), an individual who--
``(i) is licensed or registered as a hearing aid
dispenser, hearing aid specialist, hearing instrument
dispenser, or related professional by the State in
which the individual furnishes such services; and
``(ii) meets such other requirements as the
Secretary determines appropriate (including
requirements relating to educational certifications or
accreditations), taking into account any additional
requirements for hearing aid specialists, hearing aid
dispensers, and hearing instrument dispensers
established by Medicare Advantage organizations under
part C, State plans (or waivers of such plans) under
title XIX, and the group health plans and health
insurance issuers (as such terms are defined in section
2791 of the Public Health Service Act).''.
(2) Payment for qualified hearing aid professionals.--
Section 1833(a)(1) of the Social Security Act (42 U.S.C.
1395l(a)(1)) is amended--
(A) by striking ``and'' before ``(HH)''; and
(B) by inserting before the semicolon at the end
the following: ``and (II) with respect to hearing
assessment services (as described in paragraph (3) of
section 1861(ll)) furnished by a qualified hearing aid
professional (as defined in paragraph (4)(C) of such
section), the amounts paid shall be equal to 80 percent
of the lesser of the actual charge for such services or
85 percent of the amount for such services determined
under the payment basis determined under section
1848''.
(b) Coverage of Hearing Aids.--
(1) Inclusion of hearing aids as prosthetic devices.--
Section 1861(s)(8) of the Social Security Act (42 U.S.C.
1395x(s)(8)) is amended by inserting ``, and including hearing
aids (as described in section 1834(h)(7)) furnished on or after
January 1, 2028, to individuals diagnosed with moderately
severe, severe, or profound hearing loss'' before the semicolon
at the end.
(2) Payment limitations for hearing aids.--Section 1834(h)
of the Social Security Act (42 U.S.C. 1395m(h)) is amended by
adding at the end the following new paragraphs:
``(6) Payment only on an assignment-related basis.--Payment
for hearing aids for which payment may be made under this part
may be made only on an assignment-related basis. The provisions
of section 1842(b)(18)(B) shall apply to hearing aids in the
same manner as they apply to services furnished by a
practitioner described in subsection (b)(18)(C).
``(7) Limitations for hearing aids.--Payment may be made
under this part with respect to an individual, with respect to
hearing aids furnished on or after January 1, 2028--
``(A) not more than once per ear during a 5-year
period;
``(B) only for types of such hearing aids that are
determined appropriate by the Secretary; and
``(C) only if furnished pursuant to a written order
of a physician, qualified audiologist (as defined in
section 1861(ll)(4)), qualified hearing aid
professional (as so defined), physician assistant,
nurse practitioner, or clinical nurse specialist.''.
(3) Application of competitive acquisition.--
(A) In general.--Section 1834(h)(1)(H) of the
Social Security Act (42 U.S.C. 1395m(h)(1)(H)) is
amended--
(i) in the header, by inserting ``and
hearing aids'' after ``orthotics'';
(ii) in the matter preceding clause (i), by
inserting ``, or of hearing aids described in
paragraph (2)(E) of such section,'' after
``2011,''; and
(iii) in clause (i), by inserting ``or such
hearing aids'' after ``such orthotics''.
(B) Conforming amendment.--
(i) In general.--Section 1847(a)(2) of the
Social Security Act (42 U.S.C. 1395w-3(a)(2))
is amended by adding at the end the following
new subparagraph:
``(E) Hearing aids.--Hearing aids described in
section 1861(s)(8) for which payment would otherwise be
made under section 1834(h).''.
(ii) Exemption of certain items from
competitive acquisition.--Section 1847(a)(7) of
the Social Security Act (42 U.S.C. 1395w-
3(a)(7)) is amended by adding at the end the
following new subparagraph:
``(C) Certain hearing aids.--Those items and
services described in paragraph (2)(E) if furnished by
a physician or other practitioner (as defined by the
Secretary) to the physician's or practitioner's own
patients as part of the physician's or practitioner's
professional service.''.
(4) Inclusion of qualified audiologists and qualified
hearing aid professionals as certain practitioners to receive
payment on an assignment-related basis.--Section 1842(b)(18)(C)
of the Social Security Act (42 U.S.C. 1395u(b)(18)(C)), is
amended by adding at the end the following new clauses:
``(ix) Beginning on January 1, 2028, a
qualified audiologist (as defined in section
1861(ll)(4)(B)).
``(x) A qualified hearing aid professional
(as defined in section 1861(ll)(4)(C)).''.
(c) Exclusion Modification.--Section 1862(a)(7) of the Social
Security Act (42 U.S.C. 1395y(a)(7)) is amended by inserting ``(except
such hearing aids or examinations therefor as described in and
otherwise allowed under section 1861(s)(8))'' after ``hearing aids or
examinations therefor''.
(d) Inclusion as Excepted Medical Treatment.--Section 1821(b)(5)(A)
of the Social Security Act (42 U.S.C. 1395i-5(b)(5)(A)) is amended--
(1) in clause (ii), by striking ``or'';
(2) in clause (iii), by striking the period and inserting
``, or''; and
(3) by adding at the end the following new clause:
``(iv) consisting of audiology services
described in subsection (ll)(3) of section
1861, or hearing aids described in subsection
(s)(8) of such section, that are payable under
part B as a result of the amendments made by
the Health CARE Act of 2026.''.
(e) Rural Health Clinics and Federally Qualified Health Centers.--
(1) Clarifying coverage of audiology services as
physicians' services.--Section 1861(aa)(1)(A) of the Social
Security Act (42 U.S.C. 1395x(aa)(1)(A)) is amended by
inserting ``(including audiology services (as defined in
subsection (ll)(3)))'' after ``physicians' services''.
(2) Inclusion of qualified audiologists and qualified
hearing aid professionals as rhc and fqhc practitioners.--
Section 1861(aa)(1)(B) of the Social Security Act (42 U.S.C.
1395x(aa)(1)(B)) is amended by inserting ``or by a qualified
audiologist or a qualified hearing aid professional (as such
terms are defined in subsection (ll)),'' after ``(as defined in
subsection (hh)(1)),''.
(3) Temporary payment rates for certain services under the
rhc air and fqhc pps.--
(A) AIR.--Section 1833 of the Social Security Act
(42 U.S.C. 1395l) is amended--
(i) in subsection (a)(3)(A), by inserting
``(which shall, in the case of audiology
services (as defined in section 1861(ll)(3)),
in lieu of any limits on reasonable charges
otherwise applicable, be based on the rates
payable for such services under the payment
basis determined under section 1848 until such
time as the Secretary determines sufficient
data has been collected to otherwise apply such
limits (or January 1, 2034, if no such
determination has been made as of such date))''
after ``may prescribe in regulations''; and
(ii) by adding at the end the following new
subsection:
``(ee) Disregard of Costs Attributable to Certain Services From
Calculation of RHC AIR.--Payments for rural health clinic services
other than audiology services (as defined in section 1861(ll)(3)) under
the methodology for all-inclusive rates (established by the Secretary)
under subsection (a)(3) shall not take into account the costs of such
services while rates for such services are based on rates payable for
such services under the payment basis established under section
1848.''.
(B) PPS.--Section 1834(o) of the Social Security
Act (42 U.S.C. 1395m(o)) is amended by adding at the
end the following new paragraph:
``(6) Temporary payment rates based on pfs for certain
services.--The Secretary shall, in establishing payment rates
for audiology services (as defined in section 1861(ll)(3)) that
are Federally qualified health center services under the
prospective payment system established under this subsection,
in lieu of the rates otherwise applicable under such system,
base such rates on rates payable for such services under the
payment basis established under section 1848 until such time as
the Secretary determines sufficient data has been collected to
otherwise establish rates for such services under such system
(or January 1, 2034, if no such determination has been made as
of such date). Payments for Federally qualified health center
services other than such audiology services under such system
shall not take into account the costs of such services while
rates for such services are based on rates payable for such
services under the payment basis established under section
1848.''.
(f) Implementation.--
(1) In general.--In addition to amounts otherwise
available, there is appropriated to the Secretary of Health and
Human Services for fiscal year 2027, out of any money in the
Treasury not otherwise appropriated, $370,000,000, to remain
available until expended, for purposes of implementing the
amendments made by this section during the period beginning on
January 1, 2027, and ending on September 30, 2036.
(2) Program instruction.--The Secretary of Health and Human
Services shall implement the provisions of, and the amendments
made by, this section for 2027 and 2028 by program instruction.
TITLE VI--LOWERING THE COST OF CARE
SEC. 601. STRENGTHENING HOSPITAL PRICE TRANSPARENCY.
Title XXVII of the Public Health Service Act is amended by
inserting after section 2718 (42 U.S.C. 300gg-18) the following:
``SEC. 2718A. PROVIDER PRICE TRANSPARENCY.
``(a) Definitions.--In this section:
``(1) Applicable imaging service provider.--The term
`applicable imaging provider' means a provider of services or
supplier who furnishes any imaging services to patients,
including an independent diagnostic testing facility, an
outpatient diagnostic facility, and any other imaging center
designated by the Secretary, except that such term does not
include an imaging service provider with respect to which
standard charges for specified imaging service provider
services furnished by such service provider are made available
by a hospital pursuant to subsection (b) or specified
ambulatory surgical center pursuant to subsection (e).
``(2) Applicable laboratory.--The term `applicable
laboratory' means a `laboratory' as such term is defined in
section 493.2, 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 for specified
clinical diagnostic laboratory tests furnished by such
laboratory are made available by a hospital pursuant to
subsection (b) or specified ambulatory surgical center pursuant
to subsection (e).
``(3) Discounted cash price.--
``(A) In general.--The term `discounted cash price'
means the minimum charge expressed as a dollar amount,
subject to subparagraph (B), that the applicable
service provider subject to this section accepts from
an individual who pays cash, or cash equivalent, for a
furnished item or service, without regard to health
insurance coverage, as payment in full.
``(B) Exclusions.--For purposes of subparagraph
(A), the minimum charge described in such subparagraph,
with respect to a furnished item or service, as
applicable, shall be calculated without taking into
account any financial assistance, including assistance
attributable to charity care (in the case of a
hospital, as such term is used for purposes of hospital
cost reporting under title XVIII of the Social Security
Act), or third-party assistance for such item or
service.
``(4) Extraordinary collection actions.--The term
`extraordinary collection action' has the meaning given such
term for purposes of section 501(r) of the Internal Revenue
Code of 1986.
``(5) Gross charge.--The term `gross charge' means the
charge for an individual item or service that is reflected on a
hospital's chargemaster or similar list of prices facilitated
by any other provider, as defined by the Secretary, absent any
discounts.
``(6) Hospital.--The term `hospital' means an institution
in any State in which State or applicable local law provides
for the licensing of hospitals, that is licensed as a hospital
pursuant to such law or is approved, by the agency of such
State or locality responsible for licensing hospitals, as
meeting the standards established for such licensing. For
purposes of this paragraph, the term `State' includes each of
the several States, the District of Columbia, Puerto Rico, the
Virgin Islands, Guam, American Samoa, and the Northern Mariana
Islands.
``(7) 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.
``(8) Shoppable service.--The term `shoppable service'
means a service that can be scheduled by a healthcare consumer
in advance. Such services are routinely provided in non-urgent
situations that do not require immediate action or attention to
the patient, thus allowing patients to price shop and schedule
a service at a time that is convenient for them.
``(9) Specified ambulatory surgical center.--The term
`specified ambulatory surgical center' means any distinct
entity that operates exclusively for the purpose of providing
surgical services to patients not requiring hospitalization and
in which the expected duration of services would not exceed 24
hours following an admission, except that such term does not
include a surgical center with respect to which standard
charges for specified ambulatory surgical center services
furnished by such surgical center are made available by a
hospital pursuant to subsection (b).
``(10) Specified clinical diagnostic laboratory test.--The
term `specified clinical diagnostic laboratory test' means any
clinical diagnostic laboratory test or service that is provided
by the applicable laboratory, excluding advanced diagnostic
laboratory tests (as defined in section 1834A(d)(5) of the
Social Security Act).
``(11) Specified imaging service.--The term `specified
imaging service' has the meaning given to the term `radiology
and certain other imaging services' for purposes of section
411.351 of title 42, Code of Federal Regulations (or successor
regulations).
``(12) 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) Hospital Price Transparency.--
``(1) In general.--Beginning January 1 of the year that
begins on or after the date that is 1 year after the date of
enactment of the Health CARE Act of 2026, each hospital shall,
in accordance with a method and format established by the
Secretary under paragraph (3), on a quarterly basis (if there
have been any changes to the standard charges described in
subparagraph (2)) compile and make publicly available on an
internet website (without subscription and free of charge)--
``(A) all of the hospital's standard charges for
each item and service furnished by such hospital in a
machine-readable format (or a successor technology
specified by the Secretary);
``(B) all of the hospital's standard charges in a
consumer-friendly format (as specified by the
Secretary), that includes--
``(i) 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
through the January 1 described in this
subparagraph, after which the hospital shall
include all shoppable services that the
hospital furnishes; and
``(ii) 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
``(C) the name and business address for each person
or entity that, with respect to the hospital--
``(i) has an ownership or investment
interest;
``(ii) has a controlling interest;
``(iii) is a management services
organization; or
``(iv) is a significant equity investor.
``(2) Standard charges defined.--For purposes of paragraph
(1), the term `standard charges' means the following:
``(A) A plain language description of each item and
service, accompanied by any applicable billing codes,
including modifiers, using commonly recognized billing
code sets, including--
``(i) the Diagnosis Related Group;
``(ii) the Healthcare Common Procedure
Coding System code;
``(iii) the National Drug Code; and
``(iv) other applicable identifiers as
determined by the Secretary (or successor code
sets).
``(B) The gross charge, expressed as a dollar
amount, for each such item or service, when provided
in, as applicable, the inpatient setting and outpatient
department setting.
``(C) The discounted cash price.
``(D) The payer-specific negotiated charges,
expressed as a dollar amount and clearly associated
with the name of the applicable third-party payer and
name of each plan, that apply to each such item or
service when provided in, as applicable, the inpatient
setting and outpatient department setting. If the
charges are based on an algorithm, percentage of
another amount, or other formula or criteria, the
hospital shall also disclose such algorithm,
percentage, formula, or criteria as set forth in its
contract and any other information necessary to
determine the negotiated charge as a dollar amount.
``(E) The de-identified maximum and minimum
negotiated charges for each such item or service,
expressed as a non-zero dollar amount.
``(F) The amount of any facility fee, as defined by
the Secretary, or add-on charges that will be part of
the final payment amount, in addition to any
information that might help the patient understand when
a facility fee or add-on charge may apply and how to
avoid such charges.
``(G) 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 for an item or service,
except information that is duplicative of any other
reporting requirement under this subsection. In the
case of standard charges 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.
``(3) Uniform method and format.--The Secretary shall
establish a standard, uniform method and format for hospitals
to use in compiling and making public information described in
paragraph (1). Such method and format shall--
``(A) include a machine-readable format (or
successor technology specified by the Secretary)
containing the information described in paragraph (2)
for all items and services furnished by each hospital;
``(B) meet such standards as determined appropriate
by the Secretary in order to ensure the accessibility
and usability of such charges; and
``(C) be updated as determined appropriate by the
Secretary, in consultation with stakeholders.
``(4) No deemed compliance.--Hospitals may offer a price
estimator tool, but the availability of such a price estimator
tool shall not be considered to deem compliance with or
otherwise vitiate the requirements of paragraph (1)(B) or any
other requirements of this subsection.
``(5) Monitoring compliance.--The Secretary shall, 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 year.
``(6) Attestation.--A senior official from each hospital
(the Chief Executive Officer, Chief Financial Officer, or an
official of equivalent seniority) shall attest to the accuracy
and completeness of the disclosures, and any other attestations
as required by the Secretary, made in accordance with the
hospital price transparency requirements based on criteria
established by the Secretary.
``(7) Enforcement.--
``(A) In general.--In the case of a hospital that
fails to comply with the requirements of this
subsection, not later than 30 days after the date on
which the Secretary determines such failure exists, the
Secretary shall notify such hospital of such
determination, which shall include a request for a
corrective action plan if applicable 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, a hospital that
has received a request for a corrective action
plan under subparagraph (A) and fails to comply
with the requirements of this subsection by the
date that is 90 days after such request is made
shall be subject to a civil monetary penalty of
an amount specified by the Secretary for each
day (beginning on the day the hospital was
first out of compliance, as determined by the
Secretary) 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 hospitals
that fail to comply in 2028 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 limitation on the
increase of any penalty applied under
clause (iii) pursuant to the amounts
specified in subclause (II) of such
clause.
``(iii) Persistent noncompliance.--
``(I) In general.--In the case of a
hospital that the Secretary has
determined to be noncompliant with the
provisions of this subsection two or
more times during a 1-year period (as
determined by the Secretary), 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, an amount that is not
less than $5,000,000 and not
more than $10,000,000.
``(iv) Provision of technical assistance.--
The Secretary may, to the extent practicable,
provide technical assistance relating to
compliance with the provisions of this section
to hospitals requesting such assistance.
``(v) Application of certain provisions.--
The provisions of section 1128A of the Social
Security Act (other than subsections (a) and
(b) of such section) shall apply to a civil
monetary penalty imposed under this
subparagraph in the same manner as such
provisions apply to a civil monetary penalty
imposed under subsection (a) of such section.
``(C) No authority to waive or reduce penalty.--The
Secretary shall not grant or extend any waiver, delay,
tolling, or other mitigation of a civil monetary
penalty for failing to comply with the requirements of
this subsection except where the Secretary determines
that imposing the maximum civil monetary penalty,
including penalties for persistent noncompliance, will
disrupt hospital operations in a manner that impacts
patient care. The Secretary may request documentation
in such form and manner as the Secretary may require in
order to evaluate impact on hospital operations.
``(D) Prohibition on extraordinary collection.--In
addition to civil monetary penalties applicable under
subparagraph (B) and any other enforcement actions or
penalties that may apply under any other provision of
law, for a hospital that has received a request for a
corrective action plan under subparagraph (A) and fails
to comply with the requirements of this subsection by
the date that is 90 days after such request, that
hospital or any other person or entity collecting on
behalf of the hospital shall--
``(i) not take any extraordinary collection
actions against any patient or patient
guarantor for debt incurred by any patient on
the date or dates of service when the hospital
was not in compliance with the requirements of
this subsection;
``(ii) cease any extraordinary collection
actions that have begun against any patient or
patient guarantor for debt incurred by any
patient on the date or dates of service when
the hospital was not in compliance with the
requirements of this subsection; and
``(iii) not take any extraordinary
collection actions against any patient or
patient guarantor for debt incurred by any
patient on the date or dates of service when
the hospital was not in compliance with the
requirements of this subsection after the
hospital comes back into compliance with the
requirements of this subsection.
``(8) Rulemaking.--
``(A) In general.--The Secretary shall implement
this subsection through notice and comment rulemaking
in accordance with section 553 of title 5, United
States Code.
``(B) Ownership information.--In promulgating
regulations under this paragraph, the Secretary shall
define the individuals and organizations that must be
disclosed under paragraph (1)(C) in a manner that
harmonizes disclosure requirements with requirements
established under section 1124 of the Social Security
Act and prioritizes the disclosure of individuals and
organizations whose ownership or management
relationship with a hospital impacts operational,
financial, or clinical decision making for such
hospital.''.
SEC. 602. CLINICAL DIAGNOSTIC LABORATORY PRICE TRANSPARENCY.
Section 2718A of the Public Health Service Act, as added by section
601, is amended by adding at the end the following:
``(c) Clinical Diagnostic Laboratory Price Transparency.--
``(1) In general.--Beginning January 1 of the year that
begins on or after the date that is 1 year after the date of
enactment of the Health CARE Act of 2026, an applicable
laboratory shall, on a quarterly basis (if there have been any
changes to the standard charges described in paragraph (2))
compile and make publicly available on an internet website
(without subscription and free of charge)--
``(A) the standard charges described in paragraph
(2) with respect to each specified clinical diagnostic
laboratory test that such laboratory so furnishes; and
``(B) the name and business address for each person
or entity that, with respect to the laboratory--
``(i) has an ownership or investment
interest;
``(ii) has a controlling interest;
``(iii) is a management services
organization; or
``(iv) is a significant equity investor.
``(2) Standard charges defined.--For purposes of paragraph
(1), the term `standard charges' means, with respect to an
applicable laboratory and a specified clinical diagnostic
laboratory test, the following:
``(A) A plain language description of each item or
service, accompanied by any applicable billing codes
(including modifiers that materially change the price
for insurers or providers, and that materially change
out-of-pocket costs for consumers) using commonly
recognized billing code sets, including--
``(i) the Healthcare Common Procedure
Coding System code;
``(ii) the National Drug Code; or
``(iii) other applicable identifier as
determined by the Secretary (or successor code
sets).
``(B) The gross charge expressed as a dollar
amount, for each such test.
``(C) The discounted cash price.
``(D) The payer-specific negotiated charges,
expressed as a dollar amount and clearly associated
with the name of the applicable third-party payer and
name of each plan, that apply to each such test. If the
charges are based on an algorithm, percentage of
another amount, or other formula or criteria, the
applicable laboratory also shall disclose such
algorithm, percentage, formula, or criteria as set
forth in its contract and any other information
necessary to determine the negotiated charge as a
dollar amount.
``(E) The de-identified maximum and minimum
negotiated charges for each such item or service,
expressed as a non-zero dollar amount.
``(F) 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 for an item or service,
except information that is duplicative of any other
reporting requirement under this section. In the case
of standard charges 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.
``(3) Uniform method and format.--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 shall--
``(A) include a machine-readable format (or a
successor technology specified by the Secretary)
containing the information described in paragraph (2)
for all specified clinical diagnostic laboratory tests
furnished by each laboratory and the ownership
information described in paragraph (1)(B);
``(B) meet such standards as determined appropriate
by the Secretary in order to ensure the accessibility
and usability of such information; and
``(C) be updated as determined appropriate by the
Secretary, in consultation with stakeholders.
``(4) Monitoring compliance.--The Secretary shall, 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 applicable laboratory's compliance with this subsection is
reviewed not less frequently than once every year.
``(5) Inclusion of ancillary services.--Any charge for a
specified clinical diagnostic laboratory test furnished by an
applicable laboratory made publicly available in accordance
with paragraph (1) shall include the charge for any ancillary
item or service (such as specimen collection services, specimen
transport, centrifugation, aliquoting, labeling, requisition
processing, and standard result reporting services) that would
customarily and routinely be furnished by such laboratory as
part of such test, as specified by the Secretary.
``(6) Attestation.--A senior official from each clinical
diagnostic laboratory (the Chief Executive Officer, Chief
Financial Officer, or an official of equivalent seniority)
shall attest to the accuracy and completeness of the
disclosures, and any other attestations as required by the
Secretary, made in accordance with the clinical laboratory
price transparency requirements based on criteria established
by the Secretary.
``(7) Enforcement.--
``(A) In general.--In the case of an applicable
laboratory that fails to comply with the requirements
of this subsection--
``(i) the Secretary shall notify such
laboratory 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, such
laboratory 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.--An applicable laboratory
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 applicable laboratory 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 day (beginning with the day
on which the Secretary first determined that
such laboratory was not complying with such
requirements) during which such failure is
ongoing (not to exceed $300 per day).
``(ii) Increase authority.--In applying
this subparagraph with respect to an applicable
laboratory that fails to comply with the
requirements of this subsection in 2028 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 applicable laboratory under
clause (i).
``(iii) Application of certain
provisions.--The provisions of section 1128A of
the Social Security Act (other than subsections
(a) and (b) of such section) shall apply to a
civil monetary penalty imposed under this
subparagraph in the same manner as such
provisions apply to a civil monetary penalty
imposed under subsection (a) of such section.
``(iv) No authority to waive or reduce
penalty.--The Secretary shall not grant or
extend any waiver, delay, tolling, or other
mitigation of a civil monetary penalty for
failing to comply with the requirements of this
subsection except where the Secretary
determines that imposing the maximum civil
monetary penalty will disrupt applicable
laboratory operations in a manner that impacts
patient care. The Secretary may request
documentation in such form and manner as the
Secretary may require in order to evaluate
impact on applicable laboratory operations.
``(8) 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.
``(9) Rulemaking.--
``(A) In general.--The Secretary shall implement
this subsection through notice and comment rulemaking
in accordance with section 553 of title 5, United
States Code.
``(B) Ownership information.--In promulgating
regulations under this paragraph, the Secretary shall
define the individuals and organizations that must be
disclosed under paragraph (1)(B) in a manner that
harmonizes disclosure requirements with requirements
established under section 1124 of the Social Security
Act and prioritizes the disclosure of individuals and
organizations whose ownership or management
relationship with a laboratory impacts operational,
financial, or clinical decision making for such
laboratory.''.
SEC. 603. IMAGING SERVICES PRICE TRANSPARENCY.
Section 2718A of the Public Health Service Act, as amended by
section 602, is further amended by adding at the end the following:
``(d) Imaging Services Price Transparency.--
``(1) In general.--Beginning January 1 of the year that
begins on or after the date that is 1 year after the date of
enactment of the Health CARE Act of 2026, each applicable
imaging service provider shall, on a quarterly basis (if there
have been any changes to the standard charges described in
paragraph (2)) compile and make publicly available on an
internet website (without subscription and free of charge)--
``(A) the standard charges described in paragraph
(2) with respect to each such specified imaging service
provided by such provider; and
``(B) the name and business address for each person
or entity that, with respect to the imaging services
provider--
``(i) has an ownership or investment
interest;
``(ii) has a controlling interest;
``(iii) is a management services
organization; or
``(iv) is a significant equity investor.
``(2) Standard charges defined.--For purposes of paragraph
(1), the term `standard charges', with respect to an applicable
imaging service provider and a specified imaging service, means
the following:
``(A) A plain language description of each item or
service, accompanied by any applicable billing codes
(including modifiers that materially change the price
for insurers or providers, and that materially change
out-of-pocket costs for consumers) using commonly
recognized billing code sets, including--
``(i) the Healthcare Common Procedure
Coding System code;
``(ii) the National Drug Code; or
``(iii) other applicable identifier as
determined by the Secretary (or successor code
sets).
``(B) The gross charge expressed as a dollar
amount, for each such item or service.
``(C) The discounted cash price.
``(D) The payer-specific negotiated charges,
expressed as a dollar amount and clearly associated
with the name of the applicable third-party payer and
name of each plan, that apply to each such service. If
the charges are based on an algorithm, percentage of
another amount, or other formula or criteria, the
provider or supplier also shall disclose such
algorithm, percentage, formula, or criteria as set
forth in its contract and any other information
necessary to determine the negotiated charge as a
dollar amount.
``(E) The de-identified maximum and minimum
negotiated charges for each such item or service,
expressed as a non-zero dollar amount.
``(F) 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 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.
``(3) Uniform method and format.--The Secretary shall
establish a standard, uniform method and format for applicable
imaging service providers to use in making public information
described in paragraph (1). Any such method and format shall--
``(A) include a machine-readable format (as
specified by the Secretary) containing the information
described in paragraph (2) for all specified imaging
services furnished by each applicable imaging service
provider and ownership information described in
paragraph (1)(B);
``(B) meet such standards as determined appropriate
by the Secretary in order to ensure the accessibility
and usability of such information; and
``(C) be updated as determined appropriate by the
Secretary, in consultation with stakeholders.
``(4) Monitoring compliance.--The Secretary shall, in
consultation with the Inspector General of the Department of
Health and Human Services, establish a process to monitor
compliance with this subsection.
``(5) Attestation.--A senior official from each specified
imaging service provider (the Chief Executive Officer, Chief
Financial Officer, or an official of equivalent seniority)
shall attest to the accuracy and completeness of the
disclosures, and any other attestations as required by the
Secretary, made in accordance with the imaging service provider
price transparency requirements based on criteria established
by the Secretary.
``(6) Enforcement.--
``(A) In general.--In the case of a specified
imaging service provider that fails to comply with the
requirements of this subsection--
``(i) the Secretary shall notify such
imaging service provider 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, such
imaging service provider 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.--A specified imaging
service provider 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 a
specified imaging service provider 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 day (beginning with the day
on which the Secretary first determined that
such imaging service provider was not complying
with such requirements) during which such
failure is ongoing (not to exceed $300 per
day).
``(ii) Increase authority.--In applying
this subparagraph with respect to a specified
imaging service provider that fails to comply
with the requirements of this subsection in
2028 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 a specified imaging
service provider under clause (i).
``(iii) Application of certain
provisions.--The provisions of section 1128A of
the Social Security Act (other than subsections
(a) and (b) of such section) shall apply to a
civil monetary penalty imposed under this
subparagraph in the same manner as such
provisions apply to a civil monetary penalty
imposed under subsection (a) of such section.
``(iv) No authority to waive or reduce
penalty.--The Secretary shall not grant or
extend any waiver, delay, tolling, or other
mitigation of a civil monetary penalty for
failing to comply with the requirements of this
subsection except where the Secretary
determines that imposing the maximum civil
monetary penalty will disrupt specified imaging
service provider operations in a manner that
impacts patient care. The Secretary may request
documentation in such form and manner as the
Secretary may require in order to evaluate
impact on specified imaging service provider
operations.
``(7) 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.
``(8) Rulemaking.--
``(A) In general.--The Secretary shall implement
this subsection through notice and comment rulemaking
in accordance with section 553 of title 5, United
States Code.
``(B) Ownership information.--In promulgating
regulations under this paragraph, the Secretary shall
define the individuals and organizations that must be
disclosed under paragraph (1)(B) in a manner that
harmonizes disclosure requirements with requirements
established under section 1124 of the Social Security
Act and prioritizes the disclosure of individuals and
organizations whose ownership or management
relationship with an imaging service provider impacts
operational, financial, or clinical decision making for
such imaging service provider.''.
SEC. 604. AMBULATORY SURGICAL CENTER PRICE TRANSPARENCY.
Section 2718A of the Public Health Service Act, as amended by
section 603, is further amended by adding at the end the following:
``(e) Ambulatory Surgical Center Price Transparency.--
``(1) In general.--Beginning January 1 of the year that
begins on or after the date that is 1 year after the date of
enactment of the Health CARE Act of 2026, each specified
ambulatory surgical center shall, on a quarterly basis (if
there have been any changes to the standard charges described
in paragraph (2)), compile and make publicly available on an
internet website (without subscription and free of charge)--
``(A) the standard charges described in paragraph
(2) with respect to each specified service furnished by
such surgical center; and
``(B) the name and business address for each person
or entity that, with respect to the ambulatory surgical
center--
``(i) has an ownership or investment
interest;
``(ii) has a controlling interest;
``(iii) is a management services
organization; or
``(iv) is a significant equity investor.
``(2) Standard charges defined.--For purposes of paragraph
(1), the term `standard charges' with respect to standard
charges and prices made public by a specified ambulatory
surgical center means the following:
``(A) A plain language description of each item or
service, accompanied by any applicable billing codes
(including modifiers that materially change the price
for insurers or providers, and that materially change
out-of-pocket costs for consumers) using commonly
recognized billing code sets, including--
``(i) the Healthcare Common Procedure
Coding System code;
``(ii) the National Drug Code; or
``(iii) other applicable identifier as
determined by the Secretary (or successor code
sets).
``(B) The gross charge, expressed as a dollar
amount, for each such item or service.
``(C) The discounted cash price.
``(D) The payer-specific negotiated charges,
expressed as a dollar amount and clearly associated
with the name of the applicable third party payer and
name of each plan, that apply to each such item or
service. If the charges are based on an algorithm,
percentage of another amount, or other formula or
criteria, the ambulatory surgical center also shall
disclose such algorithm, percentage, formula, or
criteria as set forth in its contract and any other
information necessary to determine the negotiated
charge as a dollar amount.
``(E) The de-identified maximum and minimum
negotiated charges for each such item or service,
expressed as a non-zero dollar amount.
``(F) 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. In the case of standard charges 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.
``(3) Uniform method and format.--The Secretary shall
establish a standard, uniform method and format for specified
ambulatory surgical centers to use in compiling and making
public information pursuant to paragraph (1). Such method and
format shall--
``(A) include a machine-readable format (or a
successor technology specified by the Secretary)
containing the information described in paragraph (2)
for all specified services furnished by each ambulatory
surgical center and for the ownership information
described in paragraph (1)(B);
``(B) meet such standards as determined appropriate
by the Secretary in order to ensure the accessibility
and usability of such charges; and
``(C) be updated as determined appropriate by the
Secretary, in consultation with stakeholders.
``(4) Monitoring compliance.--The Secretary shall, 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 ambulatory surgical center's compliance with
this subsection is reviewed not less frequently than once every
year.
``(5) Attestation.--A senior official from each specified
ambulatory surgical center (the Chief Executive Officer, Chief
Financial Officer, or an official of equivalent seniority)
shall attest to the accuracy and completeness of the
disclosures, and any other attestations as required by the
Secretary, made in accordance with the ambulatory center price
transparency requirements based on criteria established by the
Secretary.
``(6) Enforcement.--
``(A) In general.--In the case of a specified
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, such
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.--A specified 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 a
specified 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 day (beginning with the day
on which the Secretary first determined that
such ambulatory surgical center was not
complying with such requirements) during which
such failure is ongoing (not to exceed $300 per
day).
``(ii) Increase authority.--In applying
this subparagraph with respect to a specified
ambulatory surgical center that fails to comply
with the requirements of this subsection in
2028 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 a specified ambulatory
surgical center under clause (i).
``(iii) Application of certain
provisions.--The provisions of section 1128A of
the Social Security Act (other than subsections
(a) and (b) of such section) shall apply to a
civil monetary penalty imposed under this
subparagraph in the same manner as such
provisions apply to a civil monetary penalty
imposed under subsection (a) of such section.
``(iv) No authority to waive or reduce
penalty.--The Secretary shall not grant or
extend any waiver, delay, tolling, or other
mitigation of a civil monetary penalty for
failing to comply with the requirements of this
subsection except where the Secretary
determines that imposing the maximum civil
monetary penalty will disrupt specified
ambulatory surgical center operations in a
manner that impacts patient care. The Secretary
may request documentation in such form and
manner as the Secretary may require in order to
evaluate impact on specified ambulatory
surgical center operations.
``(7) 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 ambulatory surgical centers requesting such
assistance.
``(8) Rulemaking.--
``(A) In general.--The Secretary shall implement
this subsection through notice and comment rulemaking
in accordance with section 553 of title 5, United
States Code.
``(B) Ownership information.--In promulgating
regulations under this paragraph, the Secretary shall
define the individuals and organizations that must be
disclosed under paragraph (1)(B) in a manner that
harmonizes disclosure requirements with requirements
established under section 1124 of the Social Security
Act and prioritizes the disclosure of individuals and
organizations whose ownership or management
relationship with an ambulatory surgical center impacts
operational, financial, or clinical decision making for
such ambulatory surgical center.
``(f) Continued Applicability of State Law.--The provisions of this
section shall not supersede any provision of State law that
establishes, implements, or continues in effect any requirement or
prohibition related to health care price transparency, except to the
extent that such requirement or prohibition prevents the application of
a requirement or prohibition of this section.''.
SEC. 605. STRENGTHENING HEALTH COVERAGE TRANSPARENCY REQUIREMENTS.
(a) Transparency in Coverage.--Section 2715A of the Public Health
Service Act (42 U.S.C. 300gg-15a) is amended--
(1) by striking ``A Group health'' and inserting the
following:
``(a) In General.--A group health''; and
(2) by adding at the end the following:
``(b) Additional Transparency Requirements.--
``(1) Specified information required.--
``(A) In general.--A group health plan or health
insurance issuer offering coverage in the individual or
group market shall provide to each participant,
beneficiary, or enrollee, at the time of enrollment in
the plan or coverage, the information described in
subparagraph (B).
``(B) Information required.--For purposes of
subparagraph (A), the information specified in this
subparagraph is, with respect to benefits available
under the plan or coverage for an item or service
furnished by a health care provider, the following (or
other information as determined appropriate by the
Secretary):
``(i) If such provider is an in-network
provider with respect to such item or service,
the in-network rate (as defined in paragraph
(5)) for such item or service.
``(ii) If such provider is not described in
clause (i), the out-of-network allowed amount
(as such term is defined for purposes of
section 147.210(a)(2)(xvii) of title 45, Code
of Federal Regulations) for such item or
service that the plan or coverage will pay
without regard to the amount in clause (iii).
``(iii) The amount of cost-sharing
liability (including deductibles, copayments,
and coinsurance) that the individual will incur
for such item or service based on the
information available to the plan or coverage
at the time the request is made (which, in the
case such item or service is to be furnished by
a provider described in clause (ii), shall be
calculated using the maximum amount described
in such clause).
``(iv) The accumulated amounts with respect
to any deductible or out-of-pocket maximum
under the plan or coverage reflected in the
plan's or coverage's records at the time the
request is made (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).
``(v) In the case such plan or coverage
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
reflected in the plan's or coverage's records
at the time the request is made.
``(vi) Information about any utilization
management requirements, such as prior
authorization, concurrent review, step therapy,
fail first, or similar requirements applicable
to coverage of such item or service under such
plan or coverage, including information
regarding utilization management practices and
determinations, including aggregate information
related to approval and denial rates,
associated timelines, and appeals, as
determined appropriate by the Secretary.
``(C) Self-service tool.--For purposes of
subparagraph (A), a self-service tool established by a
health plan meets the requirements of this subparagraph
if such tool--
``(i) is based on an internet website;
``(ii) provides for real-time responses to
requests described in such subparagraph;
``(iii) is updated in a manner such that
the information is accurate based on the
information available to the plan or coverage
at the time the request is made;
``(iv) allows such a request to be made for
information with respect to an item or service
furnished by--
``(I) a specific provider that is
an in-network provider with respect to
such item or service; or
``(II) all providers that are in-
network providers with respect to such
plan or coverage and such item or
service;
``(v) provides that such a request may be
made for information with respect to an item or
service through use of--
``(I) the billing code for such
item or service; or
``(II) through use of a descriptive
term for such item or service; and
``(vi) is made available in plain language,
without subscription or other fee.
``(D) Nonduplication.--A group health plan or
health insurance issuers shall be deemed to be in
compliance with this paragraph if such plan or issuer
has a tool in place under section 2799A-4.
``(2) Rate and payment information.--
``(A) In general.--Beginning January 1 of the year
that begins on or after the date that is 1 year after
the date of enactment of the Health CARE Act of 2026,
and every quarter thereafter (if there have been any
changes to the rate and payment information described
in subparagraphs (B) and (C), each group health plan or
health insurance issuer offering coverage in the group
or individual market shall make available to the
public, the rate and payment information described in
subparagraph (B) in accordance with subparagraph (C)).
``(B) Rate and payment information described.--For
purposes of subparagraph (A), the rate and payment
information described in this subparagraph is, with
respect to a plan or coverage, the following:
``(i) With respect to each item or service
for which benefits are available under such
plan or coverage, excluding those included in
clause (ii), identified by CPT, HCPCS, DRG, or
other applicable nationally recognized
identifier, including any applicable code
modifiers, and accompanied by a plain language
description of the item or service, the in-
network rate (expressed as a dollar amount or
percentage of charges, unless otherwise
specified by the Secretary), including the
individual and total amounts for any bundled
rates, in effect as of the date of the
submission of such information with each
provider (identified by national provider
identifier) that is an in-network provider with
respect to such item or service, other than
such a rate in effect with a provider that an
issuer has determined based on factors
determined by the Secretary (such as medical
specialty) that it is unlikely that the
provider would be reimbursed for the item or
service.
``(ii) With respect to each drug and
biologic (identified by National Drug Code, J-
code, or other commonly recognized billing code
used for drugs) for which benefits are
available under such plan or coverage, the in-
network rate (expressed as a dollar amount or
percentage of charges, unless otherwise
specified by the Secretary) in effect as of the
first day of the quarter in which such
information is made public with each pharmacy
or other prescription drug dispenser that is an
in-network pharmacy or other prescription drug
dispenser with respect to such drug.
``(iii) With respect to each item or
service for which benefits are available under
such plan or coverage (expressed as a dollar
amount), identified by CPT, DRG, HCPCS, or
other applicable nationally recognized
identifier, including any applicable code
modifiers, and accompanied by a brief
description of the item or service, the amount
billed or charged by the provider, and the
amount allowed by the plan or coverage, for
each such item or service furnished during a
representative lookback window established by
the Secretary by each provider that was an out-
of-network provider with respect to such item
or service, broken down by each such provider
(identified by national provider identifier),
other than items and services with respect to
which not fewer than 11 claims for such item or
service were submitted to such plan during such
period.
``(C) Manner of submission.--Rate and payment
information required to be submitted and made available
under this paragraph shall be so submitted and so made
available as follows:
``(i) Information shall be contained in at
least 3 separate machine-readable files
corresponding to the information described in
each of clauses (i) through (iii) of
subparagraph (B) that meet such requirements as
specified by the Secretary through rulemaking,
in consultation with the Secretaries of Labor
and the Treasury, to apply comparable
requirements to group health plans and health
insurance coverage and to entities providing
benefit management or other third-party
administration services on a contractual basis
with a group health plan or coverage.
``(ii) Requirements specified by the
Secretary through rulemaking (or subregulatory
guidance) shall ensure the following:
``(I) Such files are made available
in a widely available format that
allows for information contained in
such files to be compared across plans
and coverage and are freely accessible
to individuals at no cost and without
the need to establish a user account or
provide other credentials.
``(II) Each such file includes each
of the following data elements:
``(aa) A numerical
identifier for the group health
plan or health insurance issuer
(such as a Health Insurance
Oversight System identifier).
``(bb) A plain-language
description of the item or
service (including, for drugs,
the proprietary and
nonproprietary name assigned).
``(cc) The billing code,
including any applicable
modifiers, associated with such
item or service, including the
Healthcare Common Procedure
Coding System code, diagnosis-
related group, national drug
code, or other commonly
recognized code set.
``(dd) The place of service
code.
``(ee) The National
Provider Identifier and
provider Tax Identification
Number.
``(iii) The rate and payment information
disclosed under clauses (i) through (iii) of
subparagraph (B) shall be separately delineated
for each item or service, regardless of whether
such item or service is reimbursed as a part of
a bundle, episode, or other grouping of items
and services.
``(iv) An officer or executive of competent
authority shall attest to the accuracy and
completeness of information submitted and made
available under this subparagraph. In the case
of a plan or coverage that relies on a third-
party administrator or other service provider
to compile the information submitted and made
available under this subparagraph, such plan or
coverage may satisfy the requirement under this
clause by obtaining such an attestation from
the third-party administrator or other service
provider. Such attestation shall be subject to
enforcement under paragraph (6).
``(3) Ownership information.--Beginning January 1 of the
year that begins on or after the date that is 1 year after the
date of enactment of the Health CARE Act of 2026, and every
quarter thereafter (if there have been any changes in the
required information), each group health plan or health
insurance issuer offering coverage in the individual or group
market shall submit to the Secretary, the applicable State
authority, and make available to the public, the name and
business address of each person or entity that, with respect to
such plan or coverage--
``(A) has an ownership or investment interest;
``(B) has a controlling interest;
``(C) is a management services organization; or
``(D) is a significant equity investor.
``(4) Enforcement.--
``(A) In general.--Each year, the Secretary shall
audit the machine-readable files required by paragraph
(2)(B) posted by not fewer than 50 group health plans
or health insurance issuers for compliance with format
and accessibility standards.
``(B) Notification and request for corrective
action.--In the case of a group health plan or health
insurance issuer that fails to comply with the
requirements of this paragraph, not later than 30 days
after the date on which the Secretary determines such
failure exists, the Secretary shall submit to such plan
or issuer a notification of such determination, which
shall include a request for a corrective action plan to
comply with such requirements.
``(C) Civil monetary penalty.--A plan or issuer
that has received a request for a corrective action
plan under subparagraph (B) and fails to comply with
the requirements of this paragraph by the date that is
30 days after such request is made shall be subject to
a civil monetary penalty of an amount specified by the
Secretary for each day (beginning with the day on which
such health plan or health insurance issuer was failing
to comply with such paragraph) during which such
failure was ongoing. Such amount shall not exceed $300
per participant, beneficiary, or covered individual per
day or $10,000,000, whichever is lesser.
``(5) Definitions.--In this subsection:
``(A) In-network provider.--The term `in-network
provider' has the meaning given such term in section
54.9815-2715A1(a)(2)(xii) of title 26, Code of Federal
Regulations.
``(B) In-network rate.--The term `in-network rate'
means, with respect to a health plan and an item or
service furnished by a provider that is a participating
provider with respect to such plan and item or service,
the contracted rate in effect between such plan and
such provider for such item or service. If the rate is
based on an algorithm, percentage of another amount, or
other formula or criteria, the health plan also shall
disclose such algorithm, percentage, formula, or
criteria as set forth in its contract and any other
terms, schedules, exhibits, data, or other information
referenced in any such contract as shall be required to
determine and disclose the negotiated rate.
``(6) Rulemaking.--
``(A) In general.--The Secretary shall implement
this subsection through notice and comment rulemaking
in accordance with section 553 of title 5, United
States Code. The Secretary may implement the manner of
submission of data described in paragraph (2)(C)
through subregulatory guidance.
``(B) Regulations.--Regulations promulgated
pursuant to this subsection shall provide the
following:
``(i) The Secretary shall annually audit
the machine-readable files required by
paragraph (2)(B) posted by not fewer than 50
group health plans or health insurance issuers
for compliance with format and accessibility
standards.
``(ii) The Secretary of Labor shall
annually audit the machine-readable files
required by paragraph (2)(B) posted by not
fewer than 250 group health plans or service
providers furnishing third-party administrator
services to a group health plan for compliance
with format and accessibility standards.
``(iii) The Secretary of Health and Human
Services, in conjunction with the Secretary of
Labor and the Secretary of the Treasury, shall
annually issue a report to Congress that
includes findings, conclusions, and enforcement
actions taken based on audits of the machine-
readable files. Such report shall be provided
no later than July 1 following the calendar
year during which the audits were completed.
The Secretary of Health and Human Services
shall make such report to Congress accessible
to the public.''.
(b) Effective Date.--
(1) In general.--The amendments made by subsections (a) and
(b) shall apply beginning January 1 of the year that begins on
or after the date that is 1 year after the date of enactment of
the Health CARE Act of 2026.
(2) Continued applicability of rules for previous years.--
Nothing in the amendments made by this section may be construed
as affecting the applicability of the rule entitled
``Transparency in Coverage'' published by the Department of the
Treasury, the Department of Labor, and the Department of Health
and Human Services on November 12, 2020 (85 Fed. Reg. 72158),
or amendments made to such rule that are applicable before the
date of enactment of the Health CARE Act of 2026.
SEC. 606. INCREASING GROUP HEALTH PLAN ACCESS TO HEALTH DATA.
(a) Group Health Plan Access to Information.--
(1) In general.--Section 2799A-9 of the Public Health
Service Act (42 U.S.C. 300gg-119) is amended by adding at the
end the following:
``(1) Group health plan access to information.--
``(A) In general.--No contract or arrangement for
services, and no extension or renewal of such contract
or arrangement, between a group health plan that is
offered by a specified large employer or that is a
specified large plan (as such terms are defined in
subparagraph (F)) and a health care provider (which for
purposes of this subparagraph, includes a health care
facility), network or association of providers, service
provider offering access to a network of providers,
third-party administrator, health insurance issuer
offering group or individual health insurance coverage,
or pharmacy benefit manager, or any entity acting as an
intermediary between the group health plan and the
health care provider, network association of providers,
service provider offering access to a network or
association of providers (including a licensed health
insurance issuer or third-party administrator), or
pharmacy benefit manager (collectively referred to in
this subsection as `Covered Service Providers'), is
reasonable within the meaning of this subsection unless
such contract or arrangement--
``(i) allows the responsible plan fiduciary
(as that term is defined in section
408(b)(2)(B)(ii)(I)(ee)) access to all claims
and encounter information or data, and any
documentation supporting claim payments,
including, but not limited to, medical records
and policy documents, or information or data
described in subsection (a)(1)(B) to--
``(I) comply with applicable law;
and
``(II) determine the accuracy or
reasonableness of claims payment; and
``(ii) does not--
``(I) unreasonably limit or delay
access, as determined by the Secretary
but in any event not longer than 15
days, after a request for access by a
plan fiduciary to such information or
data;
``(II) limit the volume of claims
and encounter information or data that
the group health plan, the plan
sponsor, the plan administrator, or a
business associate of such plan may
access during an audit or pursuant to
any request for such information or
data;
``(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 group
health plan, the plan sponsor, or the
plan administrator of such plan to
select an auditor or define audit scope
or frequency;
``(VI) otherwise limit or unduly
delay the group health plan, the plan
sponsor, the plan administrator, or a
business associate of such plan from
accessing claims and encounter
information or data;
``(VII) limit the disclosure of
fees charged to the group health plan
related to plan administration and
claims processing, including
renegotiation fees, access fees,
repricing fees, or enhanced review
fees;
``(VIII) limit the right of the
group health plan, the plan sponsor, or
the plan administrator to request
action on any suspect claim payments;
``(IX) limit public disclosure of
de-identified or aggregate information;
``(X) limit the disclosure of, with
respect to a provider that files claims
under such plan, whether a Covered
Service Provider--
``(aa) has an ownership or
investment interest;
``(bb) has a controlling
interest;
``(cc) is a management
services organization; or
``(dd) is a significant
equity investor; or
``(XI) limit the disclosure of the
name and address of each person or
entity that, with respect to the health
plan service provider--
``(aa) has an ownership or
investment interest;
``(bb) has a controlling
interest; or
``(cc) is a significant
equity investor.
``(B) Manner of providing information or data.--
``(i) In general.--A Covered Service
Provider shall provide information or data
under this subsection in a manner consistent
with the privacy regulations promulgated under
section 13402(a) of the Health Information
Technology for Economic and Clinical Health Act
(42 U.S.C. 17932(a)) and consistent with the
privacy regulations promulgated under the
Health Insurance Portability and Accountability
Act of 1996 in part 160 and subparts A and E of
part 164 of title 45, Code of Federal
Regulations (or successor regulations)
(referred to in this paragraph as the `HIPAA
privacy regulations') and shall restrict the
use and disclosure of such information
according to such privacy regulations and such
HIPAA privacy regulations. A Covered Service
Provider shall not be required to disclose
information or data under this subsection that
could reasonably identify a participant or
beneficiary through individually identifiable
health information (as such term is defined
under HIPAA privacy regulations).
``(ii) Additional requirements.--In
carrying out this subsection, a Covered Service
Provider shall comply with section 164.504(f)
of title 45, Code of Federal Regulations (or a
successor regulation).
``(iii) Rule of construction.--
``(I) In general.--Nothing in this
subsection shall be construed to modify
the requirements for the creation,
receipt, maintenance, or transmission
of protected health information under
the HIPAA privacy regulations.
``(II) Civil rights laws.--Nothing
in this subsection shall be construed
to affect the application of any
Federal or State privacy or civil
rights law, including the HIPAA privacy
regulations, the Genetic Information
Nondiscrimination Act of 2008 (Public
Law 110-233) (including the amendments
made by such Act), the Americans with
Disabilities Act of 1990 (42 U.S.C.
12101 et seq.), section 504 of the
Rehabilitation Act of 1973 (29 U.S.C.
794), section 1557 of the Patient
Protection and Affordable Care Act (42
U.S.C. 18116), title VI of the Civil
Rights Act of 1964 (42 U.S.C. 2000d),
and title VII of the Civil Rights Act
of 1964 (42 U.S.C. 2000e).
``(iv) Written notice.--Each plan year, a
Covered Service Provider shall provide to each
participant or beneficiary written notice
informing the participant or beneficiary of the
requirement that Covered Service Providers
respond to requests to submit information or
data under paragraph (1), as applicable, which
may include incorporating such notification in
plan documents provided to the participant or
beneficiary, or providing individual
notification.
``(v) Clarification regarding public
disclosure of information.--Nothing in this
subsection shall prevent a Covered Service
Provider from placing reasonable restrictions
on the public disclosure of the information or
data described in paragraph (1), except that
such Provider may not restrict disclosure of
such report to the Department of Health and
Human Services, the Department of Labor, or the
Department of the Treasury.
``(vi) Limitation.--This paragraph shall
not be construed to abridge or limit the
disclosure requirements under this subsection
or to impose additional privacy or security
requirements on Covered Service Providers or
plan sponsors.
``(C) Limitation on disclosure.--A group health
plan receiving information or data under this
subsection may disclose such information only in a
manner that is consistent with HIPAA and the privacy
and security regulations promulgated thereunder,
regardless of their direct or indirect applicability to
the plan or any entities that could be or are business
associates. A group health plan (and any business
associate or other entity acting on behalf of such
plan) may use such information or data only for
purposes of plan administration and may not sell,
license, or otherwise commercially exploit such
information or data or provide such information or data
to any third party that may take such action.
``(D) Requirements of information.--Information
made available under this subsection shall conform to
the following standards:
``(i) All claims from a healthcare provider
shall be made to the group health plan in
accordance with transaction standards adopted
by regulation under HIPAA, as follows:
``(I) Institutional, professional,
and dental claims shall be in ASC X12N
837D format or any subsequent standard
as established by the Secretary.
``(II) Pharmacy claims shall be in
the National Council for Prescription
Drug Programs (NCPDP) format or any
subsequent standard as established by
the Secretary.
``(III) The files shall be
unmodified copies of the files sent
from the provider, or, upon request,
delivered in a machine readable format.
In the event that paper claims are sent
by the provider, they shall be
converted to the appropriate standard
electronic format. Files shall be
accessible to the plan at no cost to
the group health plan.
``(ii) All claim payment (or EFT,
electronic funds transfer) and electronic
remittance advice (ERA) notices sent by a
Covered Service Provider shall be made
available to the group health plan as ASC X12N
835 files (or any other format as identified by
the Secretary) in accordance with standards
adopted by regulation under HIPAA. The files
shall be unmodified copies of the files sent by
the Covered Service Provider to the healthcare
provider. Files shall be accessible at no cost
to the group health plan.
``(iii) The contractual terms containing
payment calculations and formulas, pricing
methodologies, and other information used to
determine the dollar value of reimbursement, in
a format as specified by the Secretary.
``(iv) All non-claim costs shall be
itemized and made available to the group health
plan as requested through a web-based portal,
through an application program interface (API),
through a downloadable Comma-Separated Value
(CSV) file, and, as appropriate, through other
downloadable machine-readable file types.
``(E) Implementation.--The Secretary shall
implement this subsection through notice and comment
rulemaking in accordance with section 553 of title 5,
United States Code.
``(F) Definitions.--
``(i) In general.--The provisions of
sections 408 and 410 of the Employee Retirement
Income Security Act of 1974 shall apply with
respect to terms used under this subsection.
``(ii) Specified large employer.--In this
subsection, the term `specified large employer'
means, in connection with a group health plan
(including group health insurance coverage
offered in connection with such a plan)
established or maintained by a single employer,
with respect to a calendar year or a plan year,
as applicable, an employer who employed an
average of at least 50 employees on business
days during the preceding calendar year or plan
year and who employs at least 1 employee on the
first day of the calendar year or plan year.
``(iii) Specified large plan.--In this
subsection, the term `specified large plan'
means a group health plan (including group
health insurance coverage offered in connection
with such a plan) established or maintained by
a plan sponsor described in clause (ii) or
(iii) of section 3(16)(B) of the Employee
Retirement Income Security Act of 1974 that had
an average of at least 50 participants on
business days during the preceding calendar
year or plan year, as applicable.''.
(2) Civil enforcement.--
(A) Civil enforcement.--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)(A) In the case of an agreement between a group
health plan (as defined in section 733(a)), the plan sponsor of
such plan (as defined in section 3(16)(B)), or the plan
administrator of such plan (as defined in section 3(16)(A)) and
a health care provider (which, for purposes of this paragraph,
includes a health care facility), network or association of
providers, service provider offering access to a network or
association of providers, third-party administrator, or
pharmacy benefit manager, that violates the provisions of
section 724(b), the Secretary may assess a civil penalty
against such provider, network or association, service provider
offering access to a network or association of providers,
third-party administrator, pharmacy benefit manager, or other
service provider in the amount of up to $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) Nothing in subparagraph (A) shall be construed to
permit the Secretary to regulate health care providers acting
in their capacity as medical organizations furnishing items and
services to patients.''.
(B) Existing provisions void.--Section 410 of such
Act (29 U.S.C. 1110) is amended by adding at the end
the following:
``(c) Any provision in an agreement or instrument shall be void as
against public policy if such provision--
``(1) unduly delays or limits a group health plan (as
defined in section 733(a)), the plan sponsor of such plan (as
defined in section 3(16)(B)), or the plan administrator of such
plan (as defined in section 3(16)(A)) from accessing the claims
and encounter information or data described in section
724(b)(1)(B); or
``(2) violates the requirements of section 408(b)(2)(C).''.
(C) Technical amendments.--Section 408(b)(2)(B) of
such Act (29 U.S.C. 1108(b)(2)) is amended--
(i) in clause (i), by striking ``this
clause'' and inserting ``this paragraph''; and
(ii) by adding at the end the following:
``(xi) A contract or arrangement shall not
be reasonable under this subparagraph if it
fails to comply with section 724(b).''.
(b) Updated Attestation for Price and Quality Information.--Section
2799A-9(a)(4) of the Public Health Service Act (42 U.S.C. 300gg-
119(a)(4)) is amended to read as follows:
``(4) Attestation.--
``(A) In general.--Subject to subparagraph (C), 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 group health plan, the plan sponsor, the
plan administrator, or the business associate
of such plan, or the issuer, as applicable, 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 group
health plan, the plan sponsor, the plan
administrator, a business associate of such
plan, or the issuer from auditing, reviewing,
or otherwise accessing such information.
``(B) Limitation on submission.--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 health insurance 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, the plan sponsor, or the plan
administrator 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 group health plan, the plan sponsor, or the
plan administrator 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), including the name of the third-party
administrator or other service provider.''.
(c) 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. 607. OVERSIGHT OF ADMINISTRATIVE SERVICE PROVIDERS.
(a) PHSA Amendment.--Part D of title XXVII of the Public Health
Service Act (42 U.S.C. 300gg-111 et seq.), as amended by section 404,
is amended by adding at the end the following:
``SEC. 2799A-15. OVERSIGHT OF ADMINISTRATIVE SERVICE PROVIDERS.
``(a) In General.--For plan years beginning on or after January 1
of the year that begins on or after the date that is 1 year after the
date of enactment of the Health CARE Act of 2026, no agreement between
a group health plan that is offered by a specified large employer or
that is a specified large plan (as such terms are defined in section
2799A-11(f)) or a health insurance issuer offering individual or group
health coverage (that makes an election subject to subsection (b)(5))
and a health insurance issuer that is operating as a third-party
administrator, a health care provider, network or association of
providers, third-party administrator, service provider offering access
to a network of providers, pharmacy benefit managers, or any other
third party (each referred to in this section as a `health plan service
provider') is permissible if such agreement limits (or delays beyond
the applicable reporting period described in subsection (b)(1)) the
disclosure of information to such group health plans and health
insurance issuers in a manner that prevents any health plan service
provider from providing the information described in subsection (b).
``(b) Required Disclosures.--
``(1) Contents and frequency.--With respect to plan years
beginning on or after the date that is 1 year after the date of
enactment of this section, not less frequently than quarterly,
a health plan service provider shall provide to the group
health or the health insurance issuer offering individual or
group health insurance coverage the following information at no
cost to the plan or issuer:
``(A) The information described in section 2799A-
9(a)(1)(B) (42 U.S.C. 300gg-119(a)(1)(B)).
``(B) Any contractual and subcontractual
calculation methodologies, pricing or fee schedules, or
other formulae used to determine reimbursement amounts
to providers and subcontractors, including
methodologies, schedules, fee structures, and any
applied adjustments or modifiers, with such information
provided in a manner sufficiently detailed to enable
the group health plan or issuer to accurately assess,
verify, and ensure compliance with the terms of any
contractual and subcontractual agreement governing the
reimbursement amounts.
``(C) The total amount received or expected to be
received by the health plan service provider or its
subcontractors in provider or supplier rebates, fees,
alternative discounts, and all other remuneration
including amounts held in escrow or variance accounts
that has been paid or is to be paid for claims incurred
and administrative services including data sales or
network payments.
``(D) The total amount paid or expected to be paid
by the health plan service provider to its
subcontractors in rebates, fees, contractual
arrangements, and all other remuneration for
administrative and other services.
``(E) All payment data, calculation methodologies,
and reconciliation information related to alternative
compensation arrangements, including accountable care
organizations, value-based programs, shared savings
programs, incentive compensation, bundled payments,
capitation arrangements, performance payments, and any
other reimbursement or payment models, where the group
health plan paid fees, incurred obligations, or made
payments in connection with the group health plan or
issuer related to such arrangements.
``(F) Whether, with respect to a provider that
files claims under such plan or coverage, the health
plan service provider--
``(i) has an ownership or investment
interest;
``(ii) has a controlling interest;
``(iii) is a management services
organization; or
``(iv) is a significant equity investor.
``(G) The name and business address for each person
or entity that, with respect to the health plan service
provider--
``(i) has an ownership or investment
interest;
``(ii) has a controlling interest; or
``(iii) is a significant equity investor.
``(2) Manner of providing information or data.--
``(A) In general.--A health plan service provider
shall provide information or data under paragraph (1)
in a manner consistent with the privacy regulations
promulgated under section 13402(a) of the Health
Information Technology for Economic and Clinical Health
Act (42 U.S.C. 17932(a)) and consistent with the
privacy regulations promulgated under the Health
Insurance Portability and Accountability Act of 1996 in
part 160 and subparts A and E of part 164 of title 45,
Code of Federal Regulations (or successor regulations)
(referred to in this paragraph as the `HIPAA privacy
regulations') and shall restrict the use and disclosure
of such information according to such privacy
regulations and such HIPAA privacy regulations.
``(B) Additional requirements.--In carrying out
this subsection, a health plan service provider shall
comply with section 164.504(f) of title 45, Code of
Federal Regulations (or a successor regulation).
``(C) Rule of construction.--
``(i) In general.--Nothing in this
subsection shall be construed to modify the
requirements for the creation, receipt,
maintenance, or transmission of protected
health information under the HIPAA privacy
regulations.
``(ii) Civil rights laws.--Nothing in this
subsection shall be construed to affect the
application of any Federal or State privacy or
civil rights law, including the HIPAA privacy
regulations, the Genetic Information
Nondiscrimination Act of 2008 (Public Law 110-
233) (including the amendments made by such
Act), the Americans with Disabilities Act of
1990 (42 U.S.C. 12101 et seq.), section 504 of
the Rehabilitation Act of 1973 (29 U.S.C. 794),
section 1557 of the Patient Protection and
Affordable Care Act (42 U.S.C. 18116), title VI
of the Civil Rights Act of 1964 (42 U.S.C.
2000d), and title VII of the Civil Rights Act
of 1964 (42 U.S.C. 2000e).
``(D) Written notice.--Each plan year, a health
plan service provider shall provide to each participant
or beneficiary written notice informing the participant
or beneficiary of the requirement for health plan
service providers to submit information or data under
paragraph (1), as applicable, which may include
incorporating such notification in plan documents
provided to the participant or beneficiary, or
providing individual notification.
``(E) Clarification regarding public disclosure of
information.--Nothing in this subsection shall prevent
a health plan service provider from placing reasonable
restrictions on the public disclosure of the
information or data described in paragraph (1), except
that such provider may not restrict disclosures under
subsection (b)(1) to the Department of Health and Human
Services, the Department of Labor, or the Department of
the Treasury.
``(F) Limitation.--This paragraph shall not be
construed to abridge or limit the disclosure
requirements under this subsection or to impose
additional privacy or security requirements on health
plan service providers or plan sponsors.
``(3) Disclosure and redisclosure.--
``(A) In general.--A group health plan or health
insurance issuer offering individual or group coverage
receiving information under paragraph (1) may disclose
such information only--
``(i) to the entity from which the
information 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
``(ii) as permitted by the HIPAA Privacy
Rule (45 CFR part 160 and subparts A and E of
part 164).
``(B) Availability of information.--To the extent
the information required by this subsection is made
available to the health insurance issuer offering group
health insurance coverage, the health insurance issuer
shall make such information available, at the same
time, in the same format, and at no cost, to the group
health plan.
``(C) Limitation on use of information.--A group
health plan or health insurance issuer (and any
business associate or other entity acting on behalf of
such plan) may use information or data under this
paragraph only for purposes of plan administration and
may not sell, license, or otherwise commercially
exploit such information or data or provide such
information or data to any third party that may take
such action.
``(D) Rule of construction.--Nothing in this
section shall be construed to prevent a group health
plan, a health insurance issuer, or a health plan
service provider providing services with respect to
such a plan, from placing reasonable restrictions on
the public disclosure of the information described in
paragraph (1), except that such plan or entity may not
restrict disclosure of such information 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.
``(E) Failure to provide.--The obligation to
provide information pursuant to this subsection shall
exist notwithstanding the presence of any formal data-
sharing agreement between the parties. Failure to
provide the required information as specified shall
constitute a violation of this Act and the Secretary
shall initiate enforcement action under section 2723(b)
(42 U.S.C. 300gg-22(b)) within 90 days of becoming
aware of a violation of this section, except that
nothing in this section shall be construed to limit the
Secretary's existing authority under this Act.
``(4) Data format standards.--All data and information
provided pursuant to this subsection shall comply with the
following standards:
``(A) All claims from a healthcare provider shall
be made to the group health plan in accordance with
standards adopted under HIPAA as described in subpart K
of part 162 of title 45, Code of Federal Regulations,
as follows:
``(i) Institutional, professional, and
dental claims and adjustments to these claims
shall be provided to the group health plan or
health insurance issuer in the ASC X12N 837
format.
``(ii) Prescription drug claims shall be in
the National Council for Prescription Drug
Programs (NCPDP) format.
``(iii) The files shall be unmodified
copies of the files sent from the provider. In
the event that paper claims are sent by the
provider, they shall be converted to the
appropriate standard electronic format. Such
data shall be provided at no cost to the group
health plan.
``(B) All claim payment (or EFT, electronic funds
transfer) and electronic remittance advice (ERA)
information sent by a health plan service provider
shall be provided to the group health plan or health
insurance issuer in the ASC X12N 835 format, in
accordance with standards and operating rules adopted
under HIPAA at subpart P of part 162 of title 45, Code
of Federal Regulations, unmodified from the form in
which it was transmitted to the healthcare provider.
Such information shall be provided at no cost to the
group health plan.
``(C) The Secretary may modify the standards set
forth in this paragraph as necessary to align with any
changes adopted by the Secretary pursuant to the
authority provided under section 1173 of the Social
Security Act (42 U.S.C. 1320d-2).
``(5) Opt-in for health insurance coverage.--In the case of
a health insurance issuer offering coverage in the individual
or group market, such issuer may, on an annual basis, for plan
years beginning on or after the effective date of this section,
elect to require a health plan service provider to submit to
such issuer a report that includes all of the information
described in paragraph (1).
``(c) Prohibited Contractual Provisions.--Any provision in an
agreement that unduly delays or limits a group health plan or issuer's
access to information described in this section or that restricts the
format or timing of the provision of such information in a manner that
is inconsistent with the requirements of this section shall be
prohibited and, if a group health plan or issuer enters into such
agreement, shall be deemed void as against public policy.
``(d) Regulations.--The Secretary shall implement this section
through notice and comment rulemaking in accordance with section 553 of
title 5, United States Code.''.
(b) Penalty.--Section 2723(b) of the Public Health Service Act (42
U.S.C. 300gg-22(b)) is amended by adding at the end the following:
``(4) Enforcement authority relating to health plan service
providers.--Notwithstanding any provisions to the contrary, the
Secretary may assess a penalty against a health plan service
provider, as defined in section 2799A-15(a), of $100,000 per
day for each violation of such section, pursuant to
substantially similar processes and procedures as those set
forth in section 2723(b)(2)(D) through (G).''.
(c) ERISA Amendments.--
(1) In general.--Section 502(c) of the Employee Retirement
Income Security Act of 1974 (29 U.S.C. 1132(c)) is amended by
adding at the end the following new paragraph:
``(14) The Secretary may assess a civil penalty against any
person of $100,000 per day for each violation by any person of
section 2799A-15 of the Public Health Service Act.''.
(2) Technical amendment.--Paragraph (6) of section 502(a)
of the Employee Retirement Income Security Act of 1974 (29
U.S.C. 1132(a)) is amended by striking ``or (9)'' and inserting
``(9), (13), or (14)''.
SEC. 608. STATE PREEMPTION ONLY IN EVENT OF CONFLICT.
The provisions of section 2718A of the Public Health Service Act
(as added and amended by this Act) shall not be construed to supersede
any provision of State law which establishes, implements, or continues
in effect any requirement or prohibition related to health care price
transparency, including for hospitals, clinical diagnostic
laboratories, provider of specified imaging services, and ambulatory
surgical centers (as such terms are defined in section 2718A(a) of the
Public Health Service Act), except to the extent that such requirement
or prohibition prevents the application of a requirement or prohibition
of such sections (or such amendments). Nothing in this section shall be
construed to affect group health plans established under the Employee
Retirement Income Security Act of 1974, or alter the application of
section 514 of such Act (29 U.S.C. 1144).
SEC. 609. REQUIREMENT FOR EXPLANATION OF BENEFITS.
(a) Advanced Explanation of Benefits.--Section 2799A-1(f) of the
Public Health Service Act (42 U.S.C. 300gg-111(f)) is amended--
(1) in paragraph (1)--
(A) by striking subparagraph (C) and inserting the
following:
``(C) A good faith estimate of the amount the plan
or coverage is responsible for paying for items and
services included in the estimate described in
subparagraph (B), including a plain language
description of each item or service and all applicable
billing codes for each item or service, including
modifiers, using standard and commonly recognized
billing code sets that are clearly identified.''; and
(B) by adding at the end the following:
``(I) A notification that the recipient may be held
harmless, in certain circumstances, if the information
in the advanced explanation of benefits does not match
the amount the recipient is billed.''; and
(2) by adding at the end the following:
``(3) Hold harmless.--
``(A) In general.--For plan years beginning on or
after the date that is 1 year after the date on which
the Secretary implements this section, a participant,
beneficiary, or enrollee shall be held harmless for any
amount that is substantially in excess (as defined by
the Secretary in a manner consistent with the process
described in section 2799B-7) of the estimate generated
by the advanced explanation of benefits.
``(B) No patient responsibility for excess
charges.--A group health plan or a health insurance
issuer in the group or individual market shall not hold
a participant, beneficiary, or enrollee responsible for
excess charges described in this paragraph if such
excess is the result of coverage or payment
determinations that differ from projections made in the
advanced explanation of benefits at the time such
explanation was generated.
``(C) Substantial excess.--A participant,
beneficiary, or enrollee shall not be held harmless for
excess amounts if such amounts reflect the cost of
medically necessary items or services furnished based
on unforeseen circumstances that could not have
reasonably been anticipated by the provider or facility
at the time the good faith estimate was generated or by
the plan or issuer at the time the advanced explanation
of benefits was generated.''.
(b) Good Faith Estimates.--Section 2799B-6 of the Public Health
Service Act (42 U.S.C. 300gg-136) is amended--
(1) by striking ``Each health care'' and inserting the
following:
``(a) In General.--Each health care''; and
(2) by adding at the end the following:
``(b) Hold Harmless.--
``(1) In general.--For plan years beginning on or after the
date that is 1 year after the date on which the Secretary
implements section 2799A-1(f), if an individual enrolled in a
group health plan or health insurance coverage (and seeks to
have a claim for an item or service submitted to such plan or
coverage) is responsible for any amount that is substantially
in excess (as defined by the Secretary in a manner consistent
the process described in section 2799B-7) of the estimate
generated in the advanced explanation of benefits described in
section 2799A-1(f) because the final charges for items and
services were substantially in excess of the good faith
estimate provided to the plan or coverage under this section, a
provider shall not bill the patient for amounts substantially
in excess of the advanced explanation of benefits.
``(2) Substantial excess.--An individual seeking to have a
claim for an item or service covered by a group health plan or
health insurance coverage shall not be held harmless for excess
amounts if such amounts reflect the cost of medically necessary
items or services furnished based on unforeseen circumstances
that could not have reasonably been anticipated by the provider
or facility at the time the good faith estimate was generated
or by the plan or issuer at the time the advanced explanation
of benefits was generated.''.
(c) Explanation of Benefits.--Section 2799A-1 of the Public Health
Service Act (42 U.S.C. 300gg-111) is amended by adding at the end the
following:
``(g) Explanation of Benefits.--
``(1) In general.--For plan years beginning on January 1 of
the year that begins on or after the date that is 1 year after
the date of enactment of the Health CARE Act of 2026, each
group health plan, or a health insurance issuer offering group
or individual health insurance coverage shall, within 45 days
of receiving the information necessary to decide a claim for
payment (as defined by the Secretary) for an item or service
under the plan or coverage for which liability under the plan
or coverage has been determined, provide to the participant,
beneficiary, or enrollee (through mail or electronic means, as
requested by the participant, beneficiary, or enrollee) a
notification (in clear and understandable language and
utilizing substantially the same format as the advanced
explanation of benefits required by subsection (f) to enable
comparison when an advanced explanation of benefits is
provided) including the following:
``(A) Whether or not the provider or facility is a
participating provider or a participating facility with
respect to the plan or coverage with respect to the
furnishing of such item or service.
``(B) An itemized explanation of benefits that
includes the following:
``(i) A plain language description of each
item or service.
``(ii) All applicable billing codes for
each item or service, including modifiers,
using standard and commonly recognized billing
code sets that are clearly identified.
``(iii) The amount the plan or coverage is
responsible for paying for each item or
service.
``(iv) The amount of any cost-sharing for
which the participant, beneficiary, or enrollee
is responsible for each item or service (as of
the date of such notification).
``(v) The amount that the participant,
beneficiary, or enrollee has incurred toward
meeting the limit of the financial
responsibility (including with respect to
deductibles and out-of-pocket maximums) under
the plan or coverage (as of the date of such
notification).
``(vi) The type of site of each item or
service, including office, facility, or
emergency room.
``(vii) If applicable, a description of any
discrepancies that exist between the services
outlined in a patient's advanced explanation of
benefits and the explanation of benefits.
``(viii) The amount of any facility fee or
other patient charges that were added to the
final payment amount, together with a plain
language explanation of the fee, if applicable.
``(C) If the provider or facility is a
participating provider or facility with respect to the
plan or coverage with respect to the furnishing of such
item or service, the contracted rate under such plan or
coverage for such item or service.
``(D) The charges submitted by the provider or
facility for each item or service.
``(E) Information pertaining to plan type, as
defined the Secretary.
``(2) Format.--If applicable, the notification described in
paragraph (1) may be provided in conjunction with, or as part
of, a notice of a claim determination or other communication
required by section 2719(a) (42 U.S.C. 300gg-19(a)), or
regulations thereunder.
``(h) Regulations.--The Secretary shall implement this section
through notice and comment rulemaking in accordance with section 553 of
title 5, United States Code.''.
SEC. 610. TRANSPARENCY IN BILLING.
(a) In General.--Part E of title XXVII of the Public Health Service
Act (42 U.S.C. 300gg-131 et seq.) is amended by adding at the end the
following:
``SEC. 2799B-10. PATIENT ACCESS TO COMPLETE BILLING INFORMATION.
``(a) Requirements.--
``(1) Notice of right of access to itemized bills; in
general.--A health care provider or health care facility that
requests payment from an individual for providing a health care
item or service to the patient shall include with such request
a written notice of the individual's right to request an
itemized bill as part of the individual's designated record set
under section 164.524 of title 45, Code of Federal Regulations
(or a successor regulation).
``(2) Required information.--A notice under paragraph (1)
shall provide--
``(A) a phone number and internet website where an
individual can make a request for access to their
itemized bill;
``(B) information about the availability of
language-assistance services for individuals with
limited English proficiency (LEP); and
``(C) information about the health care provider's
or health care facility's charity care policies and
instructions on how to apply for charity care.
``(3) Collections actions.--
``(A) In general.--A health care provider or health
care facility shall not bill or take any collections
actions against an individual--
``(i) for any provided health care item or
service unless the health care provider or
health care facility has complied with
paragraph (1) or section 13405(e)(4) of the
HITECH Act; or
``(ii) with respect to any items or
services for which the amount appearing on an
itemized bill described above in paragraph (1)
exceeds the amount disclosed pursuant to
Federal health care price transparency
regulations, including part 180 of title 45,
Code of Federal Regulations, or provided in a
good faith estimate that complies with section
2799B-6 of this Act and section 149.610 of
title 45, Code of Federal Regulations, or
another good faith estimate provided by a
health care entity covered under this section
but not otherwise covered under such section
2799B-6, unless the provider or facility
documents that the additional items or services
were medically necessary due to unforeseen
complications or a patient-initiated change,
and could not reasonably have been anticipated.
``(B) Provider requirement.--If a provider fails to
provide a documentation as required under subparagraph
(A)(ii) in the case of items or services, the good
faith estimate described in such subparagraph with
respect to such items or services shall be binding.
``(b) Failure To Comply.--
``(1) Penalties.--The Secretary shall impose penalties on
any health care provider or health care facility that fails to
comply with the requirements of this section in an amount not
to exceed $10,000 for each instance of failure to comply.
``(2) Presumption in favor of individual.--If a health care
provider or health care facility fails to comply with the
requirements of this section, the presumption shall be that
charges were substantially in excess of the good faith
estimate, as set forth in section 2799B-6, for the purpose of
any patient-provider dispute, including in accordance with
section 2799B-7 and regulations promulgated thereunder.
``(c) Regulations.--The Secretary shall implement this section
through notice and comment rulemaking in accordance with section 553 of
title 5, United States Code.''.
(b) Standards for Accessing Itemized Bills.--Section 13405(e) of
the HITECH Act (42 U.S.C. 17935(e)) is amended--
(1) in paragraph (2), by striking ``and'' at the end;
(2) in paragraph (3), by striking the period and inserting
``; and''; and
(3) by adding at the end, the following:
``(4) if the individual makes a request only for an
itemized copy of a bill for services provided, the covered
entity or business associate shall--
``(A) make such protected health information
available within 30 days of such request;
``(B) not impose any fee for providing such
individual a copy of their information; and
``(C) include in such itemized bill, a plain
language description of each distinct health care item
or service, all applicable billing codes for each
distinct item or service, including modifiers, using
standard and commonly recognized billing code sets, the
price and billed amount, if different, of each distinct
item or service.''.
SEC. 611. TECHNICAL AMENDMENTS.
(a) ERISA.--Section 715(a)(1) of the Employee Retirement Income
Security Act of 1974 (29 U.S.C. 1185d(a)(1)) is amended by inserting
``and parts D and E of title XXVII of the Public Health Service Act (as
amended by title VI the Health CARE Act of 2026)'' after ``Affordable
Care Act)''.
(b) Internal Revenue Code.--Section 9815(a)(1) of the Internal
Revenue Code of 1986 is amended by inserting ``and parts D and E of
title XXVII of the Public Health Service Act (as amended by title VI of
the Health CARE Act of 2026)'' after ``Affordable Care Act)''.
SEC. 612. IMPLEMENTATION AND ENFORCEMENT FUNDING.
(a) Appropriation for Secretary of Labor.--There are authorized to
be appropriated, such sums as may be necessary for fiscal year 2027,
and each subsequent fiscal year, to enable the Secretary of Labor to
carry out this Act and the amendments made by this Act, including
enforcement activities.
(b) Appropriation for the Secretary of Health and Human Services.--
There are authorized to be appropriated, such sums as may be necessary
for fiscal year 2027, and each subsequent fiscal year, to enable the
Secretary of Health and Human Services to carry out the amendments made
by this Act, including implementation and enforcement activities.
TITLE VII--REFORMING PBMS AND PROTECTING PHARMACIES
SEC. 701. ENSURING ACCURATE PAYMENTS TO PHARMACIES UNDER MEDICAID.
(a) In General.--Section 1927(f) of the Social Security Act (42
U.S.C. 1396r-8(f)) is amended--
(1) in paragraph (1)(A)--
(A) by redesignating clause (ii) as clause (iii);
and
(B) by striking ``and'' after the semicolon at the
end of clause (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 and applicable non-retail pharmacy drug prices to
determine national average drug acquisition cost benchmarks (as
such term is defined by the Secretary) 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 that
represent a nationwide average of consumer
purchase prices for such drugs, net of all
discounts, rebates, and other price concessions
(to the extent any information with respect to
such discounts, rebates, and other price
concessions is available) based on a monthly
survey of such pharmacies;
``(ii) with respect to applicable non-
retail pharmacies--
``(I) the determination of survey
prices, separate from the survey prices
described in clause (i), of the non-
retail national average drug
acquisition cost for covered outpatient
drugs that represent a nationwide
average of consumer purchase prices for
such drugs, net of all discounts,
rebates, and other price concessions
(to the extent any information with
respect to such discounts, rebates, and
other price concessions is available)
based on a monthly survey of such
pharmacies; and
``(II) at the discretion of the
Secretary, for each type of applicable
non-retail pharmacy, the determination
of survey prices, separate from the
survey prices described in clause (i)
or subclause (I) of this clause, of the
national average drug acquisition cost
for such type of pharmacy for covered
outpatient drugs that represent a
nationwide average of consumer purchase
prices for such drugs, net of all
discounts, rebates, and other price
concessions (to the extent any
information with respect to such
discounts, rebates, and other price
concessions is available) based on a
monthly survey of such pharmacies;
and'';
(2) in subparagraph (B) of paragraph (1), by striking
``subparagraph (A)(ii)'' and inserting ``subparagraph
(A)(iii)'';
(3) in subparagraph (D) of paragraph (1), by striking
clauses (ii) and (iii) and inserting the following:
``(ii) The vendor must update the Secretary
no less often than monthly on the survey prices
for covered outpatient drugs.
``(iii) The vendor must differentiate, in
collecting and reporting survey data, for all
cost information collected, whether a pharmacy
is a retail community pharmacy or an applicable
non-retail pharmacy, including whether such
pharmacy is an affiliate (as defined in
subsection (k)(13)), and, in the case of an
applicable non-retail pharmacy, which type of
applicable non-retail pharmacy it is using the
relevant pharmacy type indicators included in
the guidance required by subsection (d)(2) of
section 701 of the Health CARE Act of 2026.'';
(4) by adding at the end of paragraph (1) the following:
``(F) Survey reporting.--In order to meet the
requirement of section 1902(a)(54), a State shall
require that any retail community pharmacy or
applicable non-retail pharmacy in the State that
receives any payment, reimbursement, administrative
fee, discount, rebate, or other price concession
related to the dispensing of covered outpatient drugs
to individuals receiving benefits under this title,
regardless of whether such payment, reimbursement,
administrative fee, discount, rebate, or other price
concession is received from the State or a managed care
entity or other specified entity (as such terms are
defined in section 1903(m)(9)(D)) directly or from a
pharmacy benefit manager or another entity that has a
contract with the State or a managed care entity or
other specified entity (as so defined), shall respond
to surveys conducted under this paragraph.
``(G) Survey information.--Information on national
drug acquisition prices obtained under this paragraph
shall be made publicly available in a form and manner
to be determined by the Secretary 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 methodology and number
of pharmacies sampled monthly.
``(iii) Information on price concessions to
pharmacies, including discounts, rebates, and
other price concessions, to the extent that
such information may be publicly released and
has been collected by the Secretary as part of
the survey.
``(H) Penalties.--
``(i) In general.--Subject to clauses (ii),
(iii), and (iv), the Secretary shall enforce
the provisions of this paragraph with respect
to a pharmacy through the establishment of
civil money penalties applicable to a retail
community pharmacy or an applicable non-retail
pharmacy.
``(ii) Basis for penalties.--The Secretary
shall impose a civil money penalty established
under this subparagraph on a retail community
pharmacy or applicable non-retail pharmacy if--
``(I) the retail pharmacy or
applicable non-retail pharmacy refuses
or otherwise fails to respond to a
request for information about prices in
connection with a survey under this
subsection;
``(II) knowingly provides false
information in response to such a
survey; or
``(III) otherwise fails to comply
with the requirements established under
this paragraph.
``(iii) Parameters for penalties.--
``(I) In general.--A civil money
penalty established under this
subparagraph may be assessed with
respect to each violation, and with
respect to each non-compliant retail
community pharmacy (including a
pharmacy that is part of a chain) or
non-compliant applicable non-retail
pharmacy (including a pharmacy that is
part of a chain), in an amount not to
exceed $100,000 for each such
violation.
``(II) Considerations.--In
determining the amount of a civil money
penalty imposed under this
subparagraph, the Secretary may
consider the size, business structure,
and type of pharmacy involved, as well
as the type of violation and other
relevant factors, as determined
appropriate by the Secretary.
``(iv) Rule of application.--The provisions
of section 1128A (other than subsections (a)
and (b)) shall apply to a civil money penalty
under this subparagraph in the same manner as
such provisions apply to a civil money penalty
or proceeding under section 1128A(a).
``(I) Limitation on use of applicable non-retail
pharmacy pricing information.--No State shall use
pricing information reported by applicable non-retail
pharmacies under subparagraph (A)(ii) to develop or
inform payment methodologies for retail community
pharmacies.'';
(5) in paragraph (2)--
(A) in subparagraph (A), by inserting ``, including
payment rates and methodologies for determining
ingredient cost reimbursement under managed care
entities or other specified entities (as such terms are
defined in section 1903(m)(9)(D)),'' after ``under this
title''; and
(B) in subparagraph (B), by inserting ``and the
basis for such dispensing fees'' before the semicolon;
(6) by redesignating paragraph (4) as paragraph (5);
(7) by inserting after paragraph (3) the following new
paragraph:
``(4) Oversight.--
``(A) In general.--The Inspector General of the
Department of Health and Human Services shall conduct
periodic studies of the survey data reported under this
subsection, as appropriate, including with respect to
substantial variations in acquisition costs or other
applicable costs, as well as with respect to how
internal transfer prices and related party transactions
may influence the costs reported by pharmacies that are
affiliates (as defined in subsection (k)(13)) or are
owned by, controlled by, or related under a common
ownership structure with a wholesaler, distributor, or
other entity that acquires covered outpatient drugs
relative to costs reported by pharmacies not affiliated
with such entities. The Inspector General shall provide
periodic updates to Congress on the results of such
studies, as appropriate, in a manner that does not
disclose trade secrets or other proprietary
information.
``(B) Appropriation.--There is appropriated to the
Inspector General of the Department of Health and Human
Services, out of any money in the Treasury not
otherwise appropriated, $5,000,000 for fiscal year
2027, to remain available until expended, to carry out
this paragraph.''; and
(8) in paragraph (5), as so redesignated--
(A) by inserting ``, and $9,000,000 for fiscal year
2027 and each fiscal year thereafter,'' after ``2010'';
and
(B) by inserting ``Funds appropriated under this
paragraph for fiscal year 2027 and any subsequent
fiscal year shall remain available until expended.''
after the period.
(b) Definitions.--Section 1927(k) of the Social Security Act (42
U.S.C. 1396r-8(k)) is amended--
(1) in the matter preceding paragraph (1), by striking ``In
the section'' and inserting ``In this section''; and
(2) by adding at the end the following new paragraphs:
``(12) Applicable non-retail pharmacy.--The term
`applicable non-retail pharmacy' means a pharmacy that is
licensed as a pharmacy by the State and that is not a retail
community pharmacy, including a pharmacy that dispenses
prescription medications to patients primarily through mail and
specialty pharmacies. Such term does not include nursing home
pharmacies, long-term care facility pharmacies, hospital
pharmacies, clinics, charitable or not-for-profit pharmacies,
government pharmacies, or low dispensing pharmacies (as defined
by the Secretary).
``(13) Affiliate.--The term `affiliate' means any entity
that is owned by, controlled by, or related under a common
ownership structure with a pharmacy benefit manager or a
managed care entity or other specified entity (as such terms
are defined in section 1903(m)(9)(D)).''.
(c) Effective Date.--
(1) In general.--Subject to paragraph (2), the amendments
made by this section shall take effect on the first day of the
first quarter that begins on or after the date that is 6 months
after the date of enactment of this Act.
(2) Delayed application to applicable non-retail
pharmacies.--The pharmacy survey requirements established by
the amendments to section 1927(f) of the Social Security Act
(42 U.S.C. 1396r-8(f)) made by this section shall apply to
retail community pharmacies beginning on the effective date
described in paragraph (1), but shall not apply to applicable
non-retail pharmacies until 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.
(d) Identification of Applicable Non-Retail Pharmacies.--
(1) In general.--Not later than January 1, 2028, the
Secretary of Health and Human Services shall, in consultation
with stakeholders as appropriate, publish guidance specifying
pharmacies that meet the definition of applicable non-retail
pharmacies (as such term is defined in subsection (k)(12) of
section 1927 of the Social Security Act (42 U.S.C. 1396r-8), as
added by subsection (b)), and that will be subject to the
survey requirements under subsection (f)(1) of such section, as
amended by subsection (a).
(2) Inclusion of pharmacy type indicators.--The guidance
published under paragraph (1) shall include pharmacy type
indicators to distinguish between different types of applicable
non-retail pharmacies, such as pharmacies that dispense
prescriptions primarily through the mail and pharmacies that
dispense prescriptions that require special handling or
distribution. An applicable non-retail pharmacy may be
identified through multiple pharmacy type indicators.
(e) Implementation.--
(1) In general.--Notwithstanding any other provision of
law, the Secretary of Health and Human Services may implement
the amendments made by this section by program instruction or
otherwise.
(2) Nonapplication of administrative procedure act.--
Implementation of the amendments made by this section shall be
exempt from the requirements of section 553 of title 5, United
States Code.
(f) Nonapplication of Paperwork Reduction Act.--Chapter 35 of title
44, United States Code, shall not apply to any data collection
undertaken by the Secretary of Health and Human Services under section
1927(f) of the Social Security Act (42 U.S.C. 1396r-8(f)), as amended
by this section.
SEC. 702. PREVENTING THE USE OF ABUSIVE SPREAD PRICING IN MEDICAID.
(a) In General.--Section 1927 of the Social Security Act (42 U.S.C.
1396r-8) is amended--
(1) in subsection (e), by adding at the end the following
new paragraph:
``(6) Transparent prescription drug pass-through pricing
required.--
``(A) In general.--A contract between the State and
a pharmacy benefit manager (referred to in this
paragraph as a `PBM'), or a contract between the State
and a managed care entity or other specified entity (as
such terms are defined in section 1903(m)(9)(D) and
collectively referred to in this paragraph as the
`entity') that includes provisions making the entity
responsible for coverage of covered outpatient drugs
dispensed to individuals enrolled with the entity,
shall require that payment for such drugs and related
administrative services (as applicable), including
payments made by a PBM on behalf of the State or
entity, is based on a transparent prescription drug
pass-through pricing model under which--
``(i) any payment made by the 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
would pay if the State were
making the payment directly in
accordance with the State plan;
``(II) is passed through in its
entirety (except as reduced under
Federal or State laws and regulations
in response to instances of waste,
fraud, or abuse) by the entity or PBM
to the pharmacy or provider that
dispenses the drug; and
``(III) is made in a manner that is
consistent with sections 447.502,
447.512, 447.514, and 447.518 of title
42, Code of Federal Regulations (or any
successor regulation) as if such
requirements applied directly to the
entity or the PBM, except that any
payment by the entity or the PBM for
the ingredient cost of such drug
purchased by a covered entity (as
defined in subsection (a)(5)(B)) may
exceed the actual acquisition cost (as
defined in 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 the
ingredient cost of such drug
does not exceed the maximum
payment that would have been
made by the entity or the PBM
for the ingredient cost of such
drug if such drug had not been
purchased by such covered
entity; and
``(cc) such covered entity
reports to the Secretary (in a
form and manner specified by
the Secretary), on an annual
basis and with respect to
payments for the ingredient
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 entity or the PBM (as
applicable) for administrative services
performed by the entity or PBM is limited to an
administrative fee that reflects the fair
market value (as defined by the Secretary) of
such services;
``(iii) the entity or the PBM (as
applicable) makes available to the State, and
the Secretary upon request in a form and manner
specified by the Secretary, all costs and
payments related to covered outpatient drugs
and accompanying administrative services (as
described in clause (ii)) incurred, received,
or made by the entity or the PBM, broken down
(as specified by the Secretary), to the extent
such costs and payments are attributable to an
individual covered outpatient drug, by each
such drug, including any ingredient costs,
professional dispensing fees, administrative
fees (as described in clause (ii)), post-sale
and post-invoice fees, discounts, or related
adjustments such as direct and indirect
remuneration fees, and any and all other
remuneration, as defined by the Secretary; and
``(iv) any form of spread pricing whereby
any amount charged or claimed by the entity or
the PBM (as applicable) that exceeds the amount
paid to the pharmacies or providers on behalf
of the State or entity, including any post-sale
or post-invoice fees, discounts, or related
adjustments such as direct and indirect
remuneration fees or assessments, as defined by
the Secretary (after allowing for an
administrative fee as described in clause
(ii)), is not allowable for purposes of
claiming Federal matching payments under this
title.
``(B) Publication of information.--The Secretary
shall publish, not less frequently than on an annual
basis and in a manner that does not disclose the
identity of a particular covered entity or
organization, information received by the Secretary
pursuant to subparagraph (A)(iii)(III) that is broken
out by State and by each of the following categories of
covered entity within each such State:
``(i) Covered entities described in
subparagraph (A) of section 340B(a)(4) of the
Public Health Service Act.
``(ii) Covered entities described in
subparagraphs (B) through (K) of such section.
``(iii) Covered entities described in
subparagraph (L) of such section.
``(iv) Covered entities described in
subparagraph (M) of such section.
``(v) Covered entities described in
subparagraph (N) of such section.
``(vi) Covered entities described in
subparagraph (O) of such section.''; and
(2) in subsection (k), as amended by section 701(b), by
adding at the end the following new paragraph:
``(14) Pharmacy benefit manager.--The term `pharmacy
benefit manager' means any person or entity that, either
directly or through an intermediary, acts as a price negotiator
or group purchaser on behalf of a State, managed care entity
(as defined in section 1903(m)(9)(D)), or other specified
entity (as so defined), or manages the prescription drug
benefits provided by a State, managed care entity, or other
specified entity, including the processing and payment of
claims for prescription drugs, the performance of drug
utilization review, the processing of drug prior authorization
requests, the managing of appeals or grievances related to the
prescription drug benefits, contracting with pharmacies,
controlling the cost of covered outpatient drugs, or the
provision of services related thereto. Such term includes any
person or entity that acts as a price negotiator (with regard
to payment amounts to pharmacies and providers for a covered
outpatient drug or the net cost of the drug) or group purchaser
on behalf of a State, managed care entity, or other specified
entity or that carries out 1 or more of the other activities
described in the preceding sentence, irrespective of whether
such person or entity calls itself a pharmacy benefit
manager.''.
(b) Conforming Amendments.--Section 1903(m) of such Act (42 U.S.C.
1396b(m)) is amended--
(1) in paragraph (2)(A)(xiii)--
(A) by striking ``and (III)'' and inserting
``(III)'';
(B) by inserting before the period at the end the
following: ``, and (IV) if the contract includes
provisions making the entity responsible for coverage
of covered outpatient drugs, the entity shall comply
with the requirements of section 1927(e)(6)''; and
(C) by moving the margin 2 ems to the left; and
(2) 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 the State for payment
for services provided by an other specified entity (as defined
in paragraph (9)(D)(iii)) unless such services are provided in
accordance with a contract between the State and such entity
which satisfies the requirements of paragraph (2)(A)(xiii).''.
(c) Effective Date.--The amendments made by this section shall
apply to contracts between States and managed care entities, other
specified entities, or pharmacy benefit managers that have an effective
date beginning on or after the date that is 18 months after the date of
enactment of this Act.
(d) Implementation.--
(1) In general.--Notwithstanding any other provision of
law, the Secretary of Health and Human Services may implement
the amendments made by this section by program instruction or
otherwise.
(2) Nonapplication of administrative procedure act.--
Implementation of the amendments made by this section shall be
exempt from the requirements of section 553 of title 5, United
States Code.
(e) Nonapplication of Paperwork Reduction Act.--Chapter 35 of title
44, United States Code, shall not apply to any data collection
undertaken by the Secretary of Health and Human Services under section
1927(e) of the Social Security Act (42 U.S.C. 1396r-8(e)), as amended
by this section.
<all>