[Congressional Bills 119th Congress]
[From the U.S. Government Publishing Office]
[H.R. 8324 Introduced in House (IH)]
<DOC>
119th CONGRESS
2d Session
H. R. 8324
To amend the Internal Revenue Code of 1986 to increase the limitations
on contributions to health savings accounts, to amend the Public Health
Service Act to provide for hospital and insurer price transparency, and
for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
April 16, 2026
Mr. Burlison (for himself and Mr. Barrett) introduced the following
bill; which was referred to the Committee on Energy and Commerce, and
in addition to the Committees on Ways and Means, Education and
Workforce, the Judiciary, Armed Services, Veterans' Affairs, and
Foreign Affairs, for a period to be subsequently determined by the
Speaker, in each case for consideration of such provisions as fall
within the jurisdiction of the committee concerned
_______________________________________________________________________
A BILL
To amend the Internal Revenue Code of 1986 to increase the limitations
on contributions to health savings accounts, to amend the Public Health
Service Act to provide for hospital and insurer price transparency, and
for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE; TABLE OF CONTENTS.
(a) Short Title.--This Act may be cited as the ``Great American
Healthcare Plan''.
(b) Table of Contents.--The table of contents for this Act is as
follows:
Sec. 1. Short title; table of contents.
TITLE I--HEALTH SAVINGS ACCOUNTS
Sec. 101. Short title.
Sec. 102. Increase in contribution limitations.
Sec. 103. Freedom from mandate.
Sec. 104. Amounts paid for health insurance or direct primary care
service arrangement.
Sec. 105. Special rule for certain medical expenses incurred before
establishment of account.
Sec. 106. Administrative error correction before due date of return.
Sec. 107. Allowing HSA rollover to child or parent of account holder.
Sec. 108. Coverage for amounts paid for healthy food, vitamins, dietary
supplements, and sports and fitness
expenses.
Sec. 109. Equivalent bankruptcy protections for health savings accounts
as retirement funds.
Sec. 110. Satisfaction of employer mandate through health savings
account contributions.
Sec. 111. Rollovers from health care FSAs and HRAs permitted.
Sec. 112. Qualified general contributions to health savings accounts.
Sec. 113. Charitable contributions to health savings accounts.
Sec. 114. Amounts paid for health care sharing ministry.
TITLE II--HEALTH MARKETPLACE FOR ALL
Sec. 201. Short title.
Sec. 202. Health marketplace pools deemed an ``employer'' for purposes
of offering group health plans or group
health insurance coverage.
Sec. 203. Conforming amendments.
TITLE III--STRENGTHENING HOSPITAL AND INSURER PRICE TRANSPARENCY
Sec. 301. Short title.
Sec. 302. Strengthening hospital price transparency requirements.
Sec. 303. Increasing price transparency of clinical diagnostic
laboratory tests.
Sec. 304. Imaging transparency.
Sec. 305. Ambulatory surgical center price transparency requirements.
Sec. 306. Strengthening health coverage transparency requirements.
Sec. 307. Increasing group health plan access to health data.
Sec. 308. Oversight of administrative service providers.
Sec. 309. State preemption only in event of conflict.
Sec. 310. Requirement for explanation of benefits.
Sec. 311. Provision of itemized bills.
TITLE IV--PROTECTING PATIENT ACCESS TO CANCER AND COMPLEX THERAPIES
Sec. 401. Short title.
Sec. 402. Rebate by manufacturers for selected drugs and biological
products subject to maximum fair price
negotiation.
TITLE V--EXPANDED-ACCESS PRESCRIPTION DRUGS
Sec. 501. Expanded-access prescription drugs.
Sec. 502. Government sponsored programs.
TITLE I--HEALTH SAVINGS ACCOUNTS
SEC. 101. SHORT TITLE.
This title may be cited as the ``Health Savings Accounts For All
Act of 2026''.
SEC. 102. INCREASE IN CONTRIBUTION LIMITATIONS.
(a) In General.--Subsection (b) of section 223 of the Internal
Revenue Code of 1986 is amended--
(1) in paragraph (1), by striking ``the sum of'' and all
that follows through the period and inserting ``an amount equal
to the applicable dollar amount under paragraph (1)(B) of
section 402(g) (as adjusted pursuant to paragraph (4) of such
section) with respect to such taxable year.'',
(2) by striking paragraphs (2), (3), (5), (7), and (8),
(3) by inserting after paragraph (1) the following:
``(2) Additional contributions for individuals 50 or
older.--In the case of an individual who has attained age 50
before the close of the taxable year, the amount of the
limitation under paragraph (1) shall be increased by an amount
equal to the applicable dollar amount under subparagraph (B)(i)
of section 414(v)(2) (as adjusted pursuant to subparagraph (C)
of such section).'',
(4) in paragraph (4), by striking the flush matter
following subparagraph (C), and
(5) by redesignating paragraphs (4) and (6) as paragraphs
(3) and (4), respectively.
(b) Conforming Amendments.--
(1) Subparagraph (A) of section 223(d)(1) of the Internal
Revenue Code of 1986 is amended by striking ``the sum of--''
and all that follows through the period and inserting ``the
amount determined under subsection (b)(1).''.
(2) Subsection (g)(1) of section 223 of such Code is
amended--
(A) by striking ``(b)(2), (c)(2)(A), and'' and
inserting ``(c)(2)(A) and,'',
(B) by amending subparagraph (B) to read as
follows:
``(B) the cost-of-living adjustment determined
under section 1(f)(3) for the calendar year in which
such taxable year begins determined by substituting
`calendar year 2003' for `calendar year 2016' in
subparagraph (A)(ii) thereof.'', and
(C) by striking ``(b)(2), (c)(1)(E)(ii)(II),'' and
inserting ``(c)(1)(E)(ii)(II)''.
(3) Section 26(b)(2)(S) of such Code is amended by striking
``, 223(b)(8)(B)(i)(II),''.
(4) Section 408(d)(9)(C)(i)(I) of such Code is amended by
striking ``computed on the basis of the type of coverage under
the high deductible health plan covering the individual''.
(c) Effective Date.--The amendments made by this section shall
apply to taxable years beginning after the date of the enactment of
this Act.
SEC. 103. FREEDOM FROM MANDATE.
(a) In General.--Section 223 of the Internal Revenue Code of 1986,
as amended by section 102, is further amended by striking subsections
(c) and (g) and by redesignating subsections (d), (e), (f), and (h) as
subsections (c), (d), (e), and (f), respectively.
(b) Conforming Amendments.--
(1) Subsection (a) of section 223 of the Internal Revenue
Code of 1986 is amended to read as follows:
``(a) Deduction Allowed.--In the case of an individual, there shall
be allowed as a deduction for the taxable year an amount equal to the
aggregate amount paid in cash during such taxable year by or on behalf
of such individual to a health savings account of such individual.''.
(2) Subsection (c)(1)(A) of section 223 of such Code, as
amended by section 102 and redesignated by subsection (a), is
further amended by striking ``subsection (f)(4)'' and inserting
``subsection (e)(4)''.
(3) Subparagraph (U) of section 26(b)(2) of such Code, as
amended by section 102, is further amended by striking
``section 223(f)(4)'' and inserting ``section 223(e)(4)''.
(4) Sections 35(g)(3), 220(f)(5)(A), 848(e)(1)(B)(v),
4973(a)(5), and 6051(a)(12) of such Code are each amended by
striking ``section 223(d)'' each place it appears and inserting
``section 223(c)''.
(5) Section 106(d)(1) of such Code is amended--
(A) by striking ``who is an eligible individual (as
defined in section 223(c)(1))'', and
(B) by striking ``section 223(d)'' and inserting
``section 223(c)''.
(6) Section 106(e) of such Code is amended--
(A) by striking paragraphs (3) and (4) and by
redesignating paragraph (5) as paragraph (4),
(B) by inserting after paragraph (2) the following
new paragraph:
``(3) Treatment as rollover contribution.--A qualified HSA
distribution shall be treated as a rollover contribution
described in section 223(e)(5).'', and
(C) by striking ``to any eligible individual
covered under a high deductible health plan of the
employer'' in paragraph (4)(B)(ii) (as so redesignated)
and inserting ``to any employee with respect to whom a
health savings account has been established''.
(7) Section 408(d)(9)(A) of such Code is amended by
striking ``who is an eligible individual (as defined in section
223(c)) and''.
(8) Section 877A(g)(6) of such Code is amended by striking
``223(f)(4)'' and inserting ``223(e)(4)''.
(9) Section 4973(g) of such Code is amended--
(A) by striking ``section 223(d)'' and inserting
``section 223(c)'',
(B) in paragraph (1), by striking ``or 223(f)(5)''
and inserting ``or 223(e)(5)'',
(C) in paragraph (2)(A), by striking ``section
223(f)(2)'' and inserting ``section 223(e)(2)'', and
(D) in the flush matter at the end, by striking
``section 223(f)(3)'' and inserting ``section
223(e)(3)''.
(10) Section 4975 of such Code is amended--
(A) in subsection (c)(6)--
(i) by striking ``section 223(d)'' and
inserting ``section 223(c)'', and
(ii) by striking ``section 223(e)(2)'' and
inserting ``section 223(d)(2)'', and
(B) in subsection (e)(1)(E), by striking ``section
223(d)'' and inserting ``section 223(c)''.
(11) Subsection (b) of section 4980G of such Code is
amended to read as follows:
``(b) Rules and Requirements.--
``(1) In general.--An employer meets the requirements of
this subsection for any calendar year if the employer makes
available comparable contributions to the health savings
accounts of all comparable participating employees for each
coverage period during such calendar year.
``(2) Comparable contributions.--
``(A) In general.--For purposes of paragraph (1),
the term `comparable contributions' means
contributions--
``(i) which are the same amount, or
``(ii) if the employees are covered by a
health plan, which are the same percentage of
the annual deductible limit under the plan
covering the employees.
``(B) Part-year employees.--In the case of an
employee who is employed by the employer for only a
portion of the calendar year, a contribution to the
health savings account of such employee shall be
treated as comparable if it is an amount which bears
the same ratio to the comparable amount (determined
without regard to this subparagraph) as such portion
bears to the entire calendar year.
``(3) Comparable participating employees.--For purposes of
paragraph (1), the term `comparable participating employees'
means all employees who are covered (if at all) under the same
health plan of the employer and have the same category of
coverage. For purposes of the preceding sentence, the
categories of coverage are self-only and family coverage.
``(4) Part-time employees.--
``(A) In general.--Paragraph (3) shall be applied
separately with respect to part-time employees and
other employees.
``(B) Part-time employee.--For purposes of
subparagraph (A), the term `part-time employee' means
any employee who is customarily employed for fewer than
30 hours per week.''.
(12) Section 4980G(d) of such Code is amended by striking
``section 4980E'' and inserting ``this section''.
(13) Section 6693(a)(2)(C) of such Code is amended by
striking ``section 223(h)'' and inserting ``section 223(f)''.
(c) Effective Date.--The amendments made by this section shall
apply to taxable years beginning after the date of the enactment of
this Act.
SEC. 104. AMOUNTS PAID FOR HEALTH INSURANCE OR DIRECT PRIMARY CARE
SERVICE ARRANGEMENT.
(a) In General.--Paragraph (2) of section 223(c) of the Internal
Revenue Code of 1986, as redesignated by section 103, is amended--
(1) in subparagraph (A), by inserting ``or pursuant to an
arrangement under which an individual is provided coverage
restricted to primary care services in exchange for a fixed
periodic fee or payment for primary care services'' after
``menstrual care products'',
(2) by striking subparagraphs (B) and (C), and
(3) by redesignating subparagraph (D) as subparagraph (B).
(b) Conforming Amendment.--Paragraph (2) of section 223(c) of the
Internal Revenue Code of 1986, as amended by the preceding sections of
this Act, is further amended by striking ``and any dependent (as
defined in section 152, determined without regard to subsections
(b)(1), (b)(2), and (d)(1)(B) thereof) of such individual'' and
inserting ``any dependent (as defined in section 152, determined
without regard to subsections (b)(1), (b)(2), and (d)(1)(B) thereof) of
such individual, and any child (as defined in section 152(f)(1)) of
such individual who has not attained the age of 27 before the end of
such individual's taxable year''.
(c) Technical Amendments.--
(1) Section 220(d)(2)(A) of the Internal Revenue Code of
1986 is amended by striking ``section 223(d)(2)(D)'' and
inserting ``section 223(c)(2)(B)''.
(2) Subsection (f) of section 106 of the Internal Revenue
Code of 1986 is amended by striking ``section 223(d)(2)(D)''
and inserting ``section 223(c)(2)(B)''.
(d) Effective Dates.--
(1) In general.--The amendments made by subsections (a) and
(b) shall apply with respect to amounts paid after the date of
the enactment of this Act in taxable years beginning after such
date.
(2) Technical amendments.--The amendments made by
subsection (c) shall apply with respect to taxable years
beginning after the date of enactment of this Act.
SEC. 105. SPECIAL RULE FOR CERTAIN MEDICAL EXPENSES INCURRED BEFORE
ESTABLISHMENT OF ACCOUNT.
(a) In General.--Paragraph (2) of section 223(c) of the Internal
Revenue Code of 1986, as amended and redesignated by the preceding
sections of this Act, is further amended by adding at the end the
following new subparagraph:
``(C) Certain medical expenses incurred before
establishment of account treated as qualified.--An
expense shall not fail to be treated as a qualified
medical expense solely because such expense was
incurred before the establishment of the health savings
account if such expense was incurred--
``(i) during either--
``(I) the taxable year in which the
health savings account was established,
or
``(II) the preceding taxable year,
in the case of a health savings account
established after the taxable year in
which such expense was incurred but
before the time prescribed by law for
filing the return for such taxable year
(not including extensions thereof), and
``(ii) for medical care which (but for the
fact that it was incurred before the
establishment of the account) otherwise meets
the requirements of the preceding
subparagraphs.''.
(b) Effective Date.--The amendment made by this section shall apply
to taxable years beginning after the date of the enactment of this Act.
SEC. 106. ADMINISTRATIVE ERROR CORRECTION BEFORE DUE DATE OF RETURN.
(a) In General.--Paragraph (4) of section 223(e) of the Internal
Revenue Code of 1986, as amended and redesignated by the preceding
sections of this Act, is amended by adding at the end the following new
subparagraph:
``(D) Exception for administrative errors corrected
before due date of return.--Subparagraph (A) shall not
apply if any payment or distribution is made to correct
an administrative, clerical, or payroll contribution
error and if--
``(i) such distribution is received by the
individual on or before the last day prescribed
by law (including extensions of time) for
filing such individual's return for such
taxable year, and
``(ii) such distribution is accompanied by
the amount of net income attributable to such
contribution.
Any net income described in clause (ii) shall be
included in the gross income of the individual for the
taxable year in which it is received.''.
(b) Effective Date.--The amendment made by this section shall take
effect on the date of the enactment of this Act.
SEC. 107. ALLOWING HSA ROLLOVER TO CHILD OR PARENT OF ACCOUNT HOLDER.
(a) In General.--Paragraph (8)(A) of section 223(e) of the Internal
Revenue Code of 1986, as redesignated by the preceding sections of this
Act, is amended--
(1) by inserting ``, child, parent, or grandparent'' after
``surviving spouse'',
(2) by inserting ``, child, parent, or grandparent, as the
case may be,'' after ``the spouse'',
(3) by inserting ``, child, parent, or grandparent'' after
``spouse'' in the heading thereof, and
(4) by adding at the end the following: ``In the case of a
child who acquires such beneficiary's interest and with respect
to whom a deduction under section 151 is allowable to another
taxpayer for a taxable year beginning in the calendar year in
which such individual's taxable year begins, such health
savings account shall be treated as a health savings account of
such child.''.
(b) Effective Date.--The amendments made by this section shall
apply to taxable years beginning after the date of the enactment of
this Act.
SEC. 108. COVERAGE FOR AMOUNTS PAID FOR HEALTHY FOOD, VITAMINS, DIETARY
SUPPLEMENTS, AND SPORTS AND FITNESS EXPENSES.
(a) In General.--Paragraph (2) of section 223(c) of the Internal
Revenue Code of 1986, as amended by the preceding provisions of this
Act, is amended--
(1) in subparagraph (A), by adding at the end the following
new sentence: ``For purposes of this subparagraph, amounts paid
for qualified wellness expenses shall be treated as paid for
medical care, but only to the extent that such amounts paid
with respect to each individual described in the first sentence
of this subparagraph do not exceed $100 per month in the case
of a health savings account the balance of which does not
exceed $5,000; $150 per month in the case of a health savings
account the balance of which exceeds $5,000 but does not exceed
$10,000; and $200 per month in the case of a health savings
account the balance of which exceeds $10,000.'', and
(2) by adding at the end the following:
``(D) Qualified wellness expenses.--
``(i) In general.--For purposes of this
paragraph, the term `qualified wellness
expenses' means amounts paid for healthy food,
vitamins, dietary supplements (as defined in
section 201(ff) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321(ff))), or qualified
sports and fitness expenses.
``(ii) Healthy food.--The term `healthy
food' means any individual food which meets the
criteria of section 101.65(d)(3)(i) of title
21, Code of Federal Regulations (or any
successor regulations).
``(iii) Qualified sports and fitness
expenses.--
``(I) In general.--The term
`qualified sports and fitness expenses'
means amounts paid exclusively for the
sole purpose of participating in a
physical activity, including--
``(aa) for membership at a
fitness facility,
``(bb) for participation or
instruction in physical
exercise or physical activity,
or
``(cc) for equipment used
in a program (including a self-
directed program) of physical
exercise or physical activity,
including a wearable fitness
tracker.
``(II) Fitness facility.--For
purposes of subclause (I)(aa), the term
`fitness facility' means a facility--
``(aa) which provides
instruction in a program of
physical exercise, offers
facilities for the
preservation, maintenance,
encouragement, or development
of physical fitness, or serves
as the site of such a program
of a State or local government
or an organization described in
section 501(c)(3) and exempt
from tax under section 501(a),
``(bb) which is not a
private club owned and operated
by its members,
``(cc) which does not offer
golf, hunting, sailing, or
riding facilities,
``(dd) the health or
fitness component of which is
not incidental to its overall
function and purpose, and
``(ee) which is fully
compliant with the State of
jurisdiction and Federal anti-
discrimination laws.
``(III) Treatment of exercise
videos, etc.--Videos, books, and
similar materials shall be treated as
described in subclause (I)(bb) if the
content of such materials constitutes
instruction in a program of physical
exercise or physical activity.
``(IV) Limitations related to
sports and fitness equipment.--Amounts
paid for equipment described in
subclause (I)(cc) shall be treated as
qualified sports and fitness expenses
only--
``(aa) if such equipment is
utilized exclusively for
participation in fitness,
exercise, sport, or other
physical activity, and
``(bb) in the case of
amounts paid for apparel or
footwear, if such apparel or
footwear is of a type that is
necessary for, and is not used
for any purpose other than, a
specific physical activity.''.
(b) Effective Date.--The amendments made by this section shall
apply to taxable years beginning after the date of the enactment of
this Act.
SEC. 109. EQUIVALENT BANKRUPTCY PROTECTIONS FOR HEALTH SAVINGS ACCOUNTS
AS RETIREMENT FUNDS.
(a) In General.--Section 522 of title 11, United States Code, is
amended by adding at the end the following new subsection:
``(r) Treatment of Health Savings Accounts.--For purposes of this
section, any health savings account (as described in section 223 of the
Internal Revenue Code of 1986) shall be treated in the same manner as
an individual retirement account described in section 408 of such
Code.''.
(b) Effective Date.--The amendment made by this section shall apply
to cases commencing under title 11, United States Code, after the date
of the enactment of this Act.
SEC. 110. SATISFACTION OF EMPLOYER MANDATE THROUGH HEALTH SAVINGS
ACCOUNT CONTRIBUTIONS.
(a) In General.--Section 4980H of the Internal Revenue Code of 1986
is amended by adding at the end the following new subsection:
``(e) Contributions to Health Savings Accounts.--
``(1) In general.--An offer to make a contribution of $450
per month to an employee's health savings account shall be
treated for purposes of this section as an offer to enroll in
minimum essential coverage under an eligible employer-sponsored
plan for such month.
``(2) Treatment as affordable coverage.--Any employee
offered a contribution described in paragraph (1) by any
employer for any month shall not be treated as described in
subsection (b)(1)(B) with respect to such employer for such
month.''.
(b) Application of Exclusion for Employer Contributions to Health
Savings Accounts.--Section 106(d) of such Code is amended--
(1) by redesignating paragraphs (2) and (3) as paragraphs
(3) and (4), respectively, and
(2) by inserting after paragraph (1) the following new
paragraph:
``(2) Limitation.--In the case of an employee whose
employer makes a contribution of at least $450 per month to
such employee's health savings account, paragraph (1) shall
apply to such a contribution only if such employee is enrolled
in health care coverage for such month.''.
(c) Effective Date.--The amendments made by this section shall
apply to months beginning in taxable years beginning after the date of
the enactment of this Act.
SEC. 111. ROLLOVERS FROM HEALTH CARE FSAS AND HRAS PERMITTED.
(a) In General.--Section 106 of the Internal Revenue Code of 1986
is amended by adding at the end the following new subsection:
``(h) FSA and HRA Rollovers to Health Savings Accounts.--
``(1) In general.--A plan shall not fail to be treated as a
health flexible spending arrangement or health reimbursement
arrangement under this section or section 105 merely because
such plan provides for a qualified HSA rollover distribution.
``(2) Qualified hsa rollover distribution.--For purposes of
this subsection, the term `qualified HSA rollover distribution'
means any portion of a beneficiary's unused balance of a health
flexible spending arrangement or health reimbursement
arrangement at the end of any plan year (or such other times as
the Secretary may provide) which is transferred in a direct
trustee-to-trustee transfer to a health savings account of such
beneficiary.
``(3) Treatment as hsa rollover contribution.--For purposes
of this title, a qualified HSA rollover distribution shall be
treated as a contribution described in section 223(e)(5).''.
(b) Effective Date.--The amendment made by this section shall apply
to taxable years beginning after the date of the enactment of this Act.
SEC. 112. QUALIFIED GENERAL CONTRIBUTIONS TO HEALTH SAVINGS ACCOUNTS.
(a) In General.--Section 223 of the Internal Revenue Code of 1986,
as amended by the preceding provisions of this Act, is amended--
(1) in subsection (c)(1)(A), by inserting ``or a qualified
general contribution,'' after ``section 220(f)(5),'', and
(2) in subsection (e)--
(A) in paragraph (3)(B), by inserting ``, or a
qualified general contribution'' after ``section
220(f)(5)'', and
(B) by adding at the end the following new
paragraph:
``(9) Qualified general contribution.--For purposes of this
section--
``(A) In general.--The term `qualified general
contribution' means any contribution which--
``(i) is made by the Secretary pursuant to
a general funding contribution,
``(ii) is made to the health savings
account of an account beneficiary in the
qualified class of account beneficiaries
specified in the general funding contribution,
and
``(iii) is in an amount which is equal to
the ratio of--
``(I) the amount of such general
funding contribution, to
``(II) the number of account
beneficiaries in such qualified class.
``(B) General funding contribution.--The term
`general funding contribution' means a contribution
which--
``(i) is made by--
``(I) an entity described in
section 170(c)(1) (other than a
possession of the United States or a
political subdivision thereof) or an
Indian tribal government, or
``(II) an organization described in
section 501(c)(3) and exempt from tax
under section 501(a), and
``(ii) which specifies a qualified class of
account beneficiaries to whom such contribution
is to be distributed.
``(C) Qualified class.--
``(i) In general.--The term `qualified
class' means any of the following:
``(I) All account beneficiaries.
``(II) All account beneficiaries
who reside in one or more States or
other qualified geographic areas
specified by the terms of the general
funding contribution.
``(ii) Qualified geographic area.--The term
`qualified geographic area' means any
geographic area in which not less than 5,000
account beneficiaries reside and which is
designated by the Secretary as a qualified
geographic area under this clause.''.
(b) Exclusion From Gross Income.--
(1) In general.--Part III of subchapter B of chapter 1 of
such Code is amended by inserting before section 140 the
following new section:
``SEC. 139M. QUALIFIED GENERAL CONTRIBUTIONS TO HEALTH SAVINGS
ACCOUNTS.
``(a) In General.--Gross income of an account beneficiary shall not
include any qualified general contribution to a health savings account
of the account beneficiary.
``(b) Definitions.--Any term used in this section which is used in
section 223 shall have the meaning given such term under section
223.''.
(2) Clerical amendment.--The table of sections for part III
of subchapter B of chapter 1 of such Code is amended by
inserting before the item relating to section 140 the following
new item:
``Sec. 139M. Qualified general contributions to health savings
accounts.''.
(c) Effective Date.--The amendments made by this section shall
apply to taxable years beginning after the date of the enactment of
this Act.
SEC. 113. CHARITABLE CONTRIBUTIONS TO HEALTH SAVINGS ACCOUNTS.
(a) In General.--Section 223(c)(1) of the Internal Revenue Code of
1986, as amended by the preceding provisions of this Act, is amended by
adding at the end the following new subparagraph:
``(F) The trustee provides the account beneficiary
with a URL (or other similar shareable link) which
allows any organization described in section 501(c)(3)
and exempt from tax under section 501(a) to make
contributions to the account on the account
beneficiary's behalf. Any such contribution shall be
taken into account as a charitable contribution for
purposes of section 170 to the extent that the
aggregate amount of such contributions from each such
organization for any taxable year does not exceed
$5,000.''.
(b) Effective Date.--The amendment made by this section shall apply
to taxable years beginning after the date of the enactment of this Act.
SEC. 114. AMOUNTS PAID FOR HEALTH CARE SHARING MINISTRY.
(a) In General.--Section 223(c)(2)(A) of the Internal Revenue Code
of 1986, as amended by the preceding provisions of this Act, is amended
by adding at the end the following new sentence: ``For purposes of this
subparagraph, amounts paid by a member of a health care sharing
ministry (as defined in section 5000A(d)(2)(B)(ii) without regard to
subclause (IV) thereof) for the sharing of medical expenses among
members, or administrative fees of such ministry, shall be treated as
paid for medical care.''.
(b) Effective Date.--The amendment made by this section shall apply
to taxable years beginning after the date of the enactment of this Act.
TITLE II--HEALTH MARKETPLACE FOR ALL
SEC. 201. SHORT TITLE.
This title may be cited as the ``Health Marketplace for All Act of
2026''.
SEC. 202. HEALTH MARKETPLACE POOLS DEEMED AN ``EMPLOYER'' FOR PURPOSES
OF OFFERING GROUP HEALTH PLANS OR GROUP HEALTH INSURANCE
COVERAGE.
(a) Definition of Employer.--Section 3(5) of the Employee
Retirement Income Security Act of 1974 (29 U.S.C. 1002(5)) is amended
by adding at the end the following: ``Such term shall be deemed to
include, for purposes of offering a group health plan (as defined in
section 733(a)(1)) or group health insurance coverage (as defined in
section 733(b)(4)) (which, notwithstanding any other provision of law,
may include such a plan or coverage covering prescription or
nonprescription drugs as the only benefit offered by the plan or
coverage in accordance with section 736(b)(5)(B)), any entity that
meets the requirements under section 736(b).''.
(b) Group Health Plans and Group Health Insurance Coverage.--Part 7
of subtitle B of title I of the Employee Retirement Income Security Act
of 1974 (29 U.S.C. 1181 et seq.) is amended by adding at the end the
following:
``SEC. 736. HEALTH MARKETPLACE POOLS DEEMED AN `EMPLOYER' FOR PURPOSES
OF OFFERING GROUP HEALTH PLANS OR GROUP HEALTH INSURANCE
COVERAGE.
``(a) In General.--An entity (referred to in this section as a
`health marketplace pool') that meets the requirements under subsection
(b) shall be deemed an employer under section 3(5) for purposes of
offering a group health plan or group health insurance coverage (which,
notwithstanding any other provision of law, may include such a plan or
coverage covering prescription or nonprescription drugs as the only
benefit offered by the plan or coverage in accordance with subsection
(b)(5)(B)).
``(b) Requirements for Health Marketplace Pools.--The requirements
under this subsection are each of the following:
``(1) Organization.--The health marketplace pool shall--
``(A) be formed and maintained in good faith for a
purpose that includes the formation of a risk pool in
order to offer group health insurance coverage or a
group health plan to its members; and
``(B) not condition membership in the health
marketplace pool on any health status-related factor
relating to an individual (including an employee of an
employer or a dependent of an employee).
``(2) Offering group health plans and group health
insurance coverage.--
``(A) Different groups.--
``(i) In general.--The health marketplace
pool, which may be in conjunction with a health
insurance issuer that offers group health
insurance coverage through the health
marketplace pool, shall make available a group
health plan or group health insurance coverage
to all members of the health marketplace pool
(and, in the case of members that are
employers, employees of the employers) at rates
that--
``(I) are established by the health
marketplace pool, or a health insurance
issuer contracting with such health
marketplace pool, on a policy or
product specific basis; and
``(II) subject to sections 701 and
702, may vary for individuals covered
through the health marketplace pool.
``(ii) Permissible coverage for
dependents.--Such group health plan or group
health insurance coverage may be made available
under clause (i) to any dependents of members
of the health marketplace pool or dependents of
employees of employers that are such members.
``(B) Nondiscrimination in coverage offered.--
``(i) In general.--Subject to clause (ii),
the health marketplace pool may not offer
coverage under a group health plan or group
health insurance coverage to a member of the
health marketplace pool unless the same
coverage is offered to all such members of the
health marketplace pool.
``(ii) Construction.--Nothing in this
subsection shall be construed as requiring a
health insurance issuer or group health plan to
provide coverage outside the service area of
the issuer or plan, or preventing a health
insurance issuer or group health plan from
underwriting or from excluding or limiting the
coverage on any individual, subject to the
requirements under sections 701 and 702.
``(C) Assumption of risk.--The health marketplace
pool may provide--
``(i) group health insurance coverage
through a contract with a health insurance
issuer; or
``(ii) a group health plan through self-
insurance.
``(3) Geographic areas.--Nothing in this subsection shall
be construed as preventing the establishment and operation of
more than 1 health marketplace pool in a geographic area or as
limiting the number of health marketplace pools that may
operate in any area.
``(4) Provision of administrative services to purchasers.--
The health marketplace pool may provide administrative services
for members. Such services may include accounting, billing, and
enrollment information.
``(5) Drug coverage.--The group health plan or group health
insurance coverage offered by the health marketplace pool may
offer--
``(A) drug coverage, including coverage of over-
the-counter drugs, in combination with other benefits
covered by the group health plan or group health
insurance coverage; or
``(B) notwithstanding any other provision of law,
drug coverage, including coverage of over-the-counter
drugs, as the only benefit covered by the group health
plan or group health insurance coverage.
``(6) Members.--
``(A) In general.--With respect to an individual
who is a member of the health marketplace pool--
``(i) the individual may enroll for
coverage under the group health plan or group
health insurance coverage offered by the health
marketplace pool (including, if applicable,
enrollment for coverage for a dependent of such
individual); or
``(ii) the employer of the individual may
enroll the individual for coverage under the
group health plan or group health insurance
coverage offered by the health marketplace pool
(including, if applicable, enrollment for
coverage for a dependent of such individual).
``(B) Eligibility.--An individual shall be eligible
to be a member of the health marketplace pool if such
individual is--
``(i) a member of an entity that
establishes or joins the health marketplace
pool (or a dependent of such a member, as
applicable);
``(ii) an employee of a member of an entity
described in clause (i) (or a dependent of such
an employee, as applicable); or
``(iii) an employee of an entity (or a
dependent of such an employee, as applicable)
controlled by a member of an entity described
in clause (i).
``(C) Rules for enrollment.--Nothing in this
paragraph shall preclude the health marketplace pool
from establishing rules of enrollment and reenrollment
of members. Such rules shall be applied consistently to
all members within the health marketplace pool and
shall not be based in any manner on health status-
related factors in accordance with sections 701 and
702.
``(c) Determination of Employer and Joint Employer Status.--
Participating in or facilitating a group health plan or group health
insurance coverage under this section shall not be construed as
establishing under any Federal or State law--
``(1) an employer relationship for any purpose other than
offering the group health plan or group health insurance
coverage; or
``(2) a joint employer relationship for any purpose.
``(d) Definition.--In this section, the term `dependent', as
applied to a group health plan or group health insurance coverage
offered in a State, shall have the meaning applied to such term with
respect to such plan or coverage under the State law applying to such
plan or coverage. Such term may include the spouse and children of the
individual involved in accordance with such State law.''.
SEC. 203. CONFORMING AMENDMENTS.
Section 3 of the Employee Retirement Income Security Act of 1974
(29 U.S.C. 1002) is amended--
(1) in paragraph (6), by inserting before the period ``,
except (with respect to an entity meeting the requirements
under section 736(b)) such term includes any member of such
entity'';
(2) in paragraph (21)--
(A) in subparagraph (A), by striking ``subparagraph
(B)'' and inserting ``subparagraphs (B) and (C)''; and
(B) by adding at the end the following:
``(C) With respect to a person that is a member of an entity
(referred to in section 736 and this subparagraph as a `health
marketplace pool') that meets the requirements of section 736(b) and
offers a group health plan (as defined in section 733(a)(1)) or group
health insurance coverage (as defined in section 733(b)(4)) (which,
notwithstanding any other provision of law, may include such a plan or
coverage covering prescription or nonprescription drugs as the only
benefit offered by the plan or coverage), membership in the health
marketplace pool shall not by itself cause the person to be a fiduciary
with respect to the group health plan or group health insurance
coverage.''; and
(3) in paragraph (40)(A)--
(A) in clause (ii), by striking ``, or'' and
inserting ``,'';
(B) in clause (iii), by striking the period and
inserting ``, or''; and
(C) by adding at the end the following:
``(iv) as a group health plan (as defined in section
733(a)(1)), or group health insurance coverage (as defined in
section 733(b)(4)), offered by an entity meeting the
requirements under section 736(b) (which, notwithstanding any
other provision of law, may include such an entity offering
such a plan or coverage covering prescription or
nonprescription drugs as the only benefit offered by the plan
or coverage).''.
TITLE III--STRENGTHENING HOSPITAL AND INSURER PRICE TRANSPARENCY
SEC. 301. SHORT TITLE.
This title may be cited as the ``Patients Deserve Price Tags Act''.
SEC. 302. STRENGTHENING HOSPITAL PRICE TRANSPARENCY REQUIREMENTS.
(a) In General.--Section 2718(e) of the Public Health Service Act
(42 U.S.C. 300gg-18(e)) is amended to read as follows:
``(e) Standard Hospital Charges.--
``(1) In general.--
``(A) Disclosure of standard charges.--Each
hospital shall, in accordance with a method and format
established by the Secretary under subparagraph (C), on
a monthly basis compile and make public (without
subscription and free of charge)--
``(i) all of the hospital's standard
charges (including the information described in
subparagraph (B)) for each item and service
furnished by such hospital; and
``(ii) hospital standard charge
information, including the information
described in subparagraph (B), 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 December 31,
2027, after which the hospital's prices
shall include all shoppable services;
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.
``(B) Standard charges described.--For purposes of
subparagraph (A), standard charges means:
``(i) A plain language description of each
item or service, accompanied by any applicable
billing codes, including modifiers, using
commonly recognized billing code sets,
including the Current Procedural Terminology
code, the Healthcare Common Procedure Coding
System code, the diagnosis-related group, the
National Drug Code, and other nationally
recognized identifier.
``(ii) 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.
``(iii) The discounted cash price expressed
as a dollar amount, for each such item or
service when provided in, as applicable, the
inpatient setting and outpatient department
setting (or, in the case no discounted cash
price is available for an item or service, the
minimum cash price accepted by the hospital
from self-pay individuals for such item or
service, expressed as a dollar amount, as well
as, with respect to prices made public pursuant
to subparagraph (A)(ii), a link to a consumer-
friendly document that clearly explains the
hospital's charity care policy). The hospital
shall accept the discounted cash price as
payment in full from any patient that chooses
to pay in cash without regard to the patient's
coverage.
``(iv) 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 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 charge.
``(v) The de-identified maximum and minimum
negotiated charges for each such item or
service, expressed as a non-zero dollar amount.
``(vi) Any other additional information the
Secretary may require for the purpose of
improving the accuracy of, or enabling
consumers to easily understand and compare,
standard charges and prices for an item or
service, except information that is duplicative
of any other reporting requirement under this
subsection. In the case of standard charges and
prices for an item or service included as part
of a bundled, per diem, episodic, or other
similar arrangement, the information described
in this subparagraph shall be made available as
determined appropriate by the Secretary.
``(C) Uniform method and format.--Not later than
January 1, 2027, the Secretary shall establish a
standard, uniform method and format for hospitals to
use in compiling and making public standard charges
pursuant to subparagraph (A)(i) and a standard, uniform
method and format for such hospitals to use in
compiling and making public prices pursuant to
subparagraph (A)(ii). Such methods and formats shall--
``(i) in the case of such method and format
for making public standard charges pursuant to
subparagraph (A)(i), ensure that such charges
are made available in a machine-readable
spreadsheet format;
``(ii) meet such standards as determined
appropriate by the Secretary in order to ensure
the accessibility and usability of such charges
and prices; and
``(iii) be updated as determined
appropriate by the Secretary, in consultation
with stakeholders.
``(2) No deemed compliance.--The availability of a price
estimator tool shall not be considered to deem compliance with
or otherwise vitiate the requirements of paragraph (1)(A)(ii)
or any other requirements of this section. Furthermore, the use
of an estimator tool shall not be used for purposes of
compliance with any provisions in this section.
``(3) 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.
``(4) 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 made in accordance with the
hospital price transparency requirements set forth in this
regulation. Such attestation shall be deemed to be material to
payment from the Federal Government to the hospital.
``(5) 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 submit to such hospital a notification
of such determination, which shall include a request
for a corrective action plan to comply with such
requirements.
``(B) Civil monetary penalty.--
``(i) In general.--In addition to any other
enforcement actions or penalties that may apply
under another provision of law, 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 45 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 the
Secretary first determined that such hospital
was not complying with such requirements)
during which such failure was ongoing. Such
amount shall not exceed--
``(I) in the case of a hospital
with 30 or fewer beds, $300 per day;
``(II) in the case of a hospital
with more than 30 beds but fewer than
101 beds, $12.50 per bed per day (or,
in the case of such a hospital that has
been noncompliant with such
requirements for a 1-year period or
longer, beginning with the first day
following such 1-year period, $15 per
bed per day);
``(III) in the case of a hospital
with more than 100 beds but fewer than
301 beds, $17.50 per bed per day (or,
in the case of such a hospital that has
been noncompliant with such
requirements for a 1-year period or
longer, beginning with the first day
following such 1-year period, $20 per
bed per day);
``(IV) in the case of a hospital
with more than 300 beds but fewer than
501 beds, $20 per bed per day (or, in
the case of such a hospital that has
been noncompliant with such
requirements for a 1-year period or
longer, beginning with the first day
following such 1-year period, $25 per
bed per day); and
``(V) in the case of a hospital
with more than 500 beds, $25 per bed
per day (or, in the case of such a
hospital that has been noncompliant
with such requirements for a 1-year
period or longer, beginning with the
first day following such 1-year period,
$35 per bed per day).
``(ii) Increase authority.--In applying
this subparagraph with respect to violations
occurring in 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 knowingly and
willfully noncompliant with the
provisions of this subsection two or
more times during a 1-year period, the
Secretary may increase any penalty
otherwise applicable under this
subparagraph by the amount specified in
subclause (II) with respect to such
hospital and may require such hospital
to complete such additional corrective
actions plans as the Secretary may
specify.
``(II) Specified amount.--For
purposes of subclause (I), the amount
specified in this subclause is, with
respect to a hospital--
``(aa) with more than 30
beds but fewer than 101 beds,
an amount that is not less than
$500,000 and not more than
$1,000,000;
``(bb) with more than 100
beds but fewer than 301 beds,
an amount that is greater than
$1,000,000 and not more than
$2,000,000;
``(cc) with more than 300
beds but fewer than 501 beds,
an amount that is greater than
$2,000,000 and not more than
$4,000,000; and
``(dd) with more than 500
beds, 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 (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 waiver.--The Secretary shall not grant or
extend any waiver, delay, tolling, or other mitigation
of a civil monetary penalty for violation of this
subsection.
``(6) Definitions.--For purposes of this subsection:
``(A) Discounted cash price.--The term `discounted
cash price' means the minimum charge, exclusive of any
hospital or third-party payer assistance, that the
hospital accepts from an individual who pays cash, or
cash equivalent, for a hospital-furnished item or
service, without regard to patient coverage, as payment
in full.
``(B) Gross charge.--The term `gross charge' means
the charge for an individual item or service that is
reflected on a hospital's chargemaster, absent any
discounts.
``(C) Hospital.--The term `hospital' means a
hospital (as defined in section 1861(e) of the Social
Security Act), a critical access hospital (as defined
in section 1861(mmm)(1) of the Social Security Act), or
a rural emergency hospital (as defined in section
1861(kkk) of the Social Security Act), together with
any parent, subsidiary, or other affiliated provider or
supplier of health care items and services without
regard to whether such parent, subsidiary, or other
affiliated provider or supplier operates under separate
licensure, certification, or designation.
``(D) Payer-specific negotiated charge.--The term
`payer-specific negotiated charge' means the charge
that a hospital has negotiated with a third party payer
for an item or service.
``(E) Shoppable service.--The term `shoppable
service' means a service that can be scheduled by a
health care consumer in advance and includes all
ancillary items and services customarily furnished as
part of such service.
``(F) Third party payer.--The term `third party
payer' means an entity that is, by statute, contract,
or agreement, legally responsible for payment of a
claim for a health care item or service.
``(7) Rulemaking.--The Secretary shall implement this
subsection through notice and comment rulemaking in accordance
with section 553 of title 5, United States Code.''.
(b) Effective Date.--
(1) In general.--The amendment made by subsection (a) shall
apply beginning January 1, 2027.
(2) Continued applicability of rules for previous years.--
Nothing in the amendment made by this section may be construed
as affecting the applicability of the regulations codified at
part 180 of title 45, Code of Federal Regulations, before
January 1, 2026.
(c) Continued Applicability of State Law.--The provisions of this
Act 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 Act.
SEC. 303. INCREASING PRICE TRANSPARENCY OF CLINICAL DIAGNOSTIC
LABORATORY TESTS.
Section 2718 of the Public Health Service Act (42 U.S.C. 300gg-18)
is amended by adding at the end the following:
``(f) Clinical Diagnostic Laboratory Price Transparency.--
``(1) In general.--Beginning July 1, 2028, an applicable
laboratory shall--
``(A) make publicly available on an internet
website the information described in paragraph (2) with
respect to each such specified clinical diagnostic
laboratory test that such laboratory so furnishes; and
``(B) ensure that such information is updated not
less frequently than monthly, if there have been any
changes to such information.
``(2) Information described.--For purposes of paragraph
(1), the information described in this paragraph is, with
respect to an applicable laboratory and a specified clinical
diagnostic laboratory test, the following:
``(A) A plain language description of each item or
service, accompanied by any applicable billing codes,
including modifiers, using commonly recognized billing
code sets, including the Current Procedural Terminology
code, the Healthcare Common Procedure Coding System
code, the diagnosis-related group, the National Drug
Code, and other nationally recognized identifier.
``(B) The gross charge expressed as a dollar
amount, for each such item or service.
``(C) The discounted cash price expressed as a
dollar amount, for each such item or service (or, in
the case no discounted cash price is available for an
item or service, the minimum cash price accepted by the
laboratory from self-pay individuals for such item or
service when provided in such settings for the previous
three years, expressed as a dollar amount, as well as,
with respect to prices made public pursuant to
subparagraph (A)(ii), a link to a consumer-friendly
document that clearly explains the laboratory's charity
care policy). The laboratory shall accept the
discounted or minimum cash price as payment in full
from any patient that chooses to pay in cash without
regard to the patient's coverage.
``(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
clinical diagnostic laboratory 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 charge.
``(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 and prices for an item or
service included as part of a bundled, per diem,
episodic, or other similar arrangement, the information
described in this subparagraph shall be made available
as determined appropriate by the Secretary.
``(3) Uniform method and format.--Not later than January 1,
2028, 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 spreadsheet format
containing the information described in paragraph (2)
for all items and services furnished by each
laboratory;
``(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) Inclusion of ancillary services.--Any price or rate
for a specified clinical diagnostic laboratory test available
to be furnished by an applicable laboratory made publicly
available in accordance with paragraph (1) shall include the
price or rate for any ancillary item or service (including
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.
``(5) Enforcement.--
``(A) In general.--In the case that the Secretary
determines that an applicable laboratory is not in
compliance with paragraph (1)--
``(i) not later than 30 days after such
determination, the Secretary shall notify such
laboratory of such determination; and
``(ii) if such laboratory continues to fail
to comply with such paragraph after the date
that is 90 days after such notification is
sent, the Secretary may impose a civil monetary
penalty in an amount not to exceed $300 for
each day (beginning with the day on which the
Secretary first determined that such laboratory
was failing to comply with such paragraph)
during which such failure is ongoing.
``(B) Increase authority.--In applying this
paragraph with respect to violations occurring in 2029
or a subsequent year, the Secretary may through notice
and comment rulemaking increase the per day limitation
on civil monetary penalties under subparagraph (A)(ii).
``(C) Application of certain provisions.--The
provisions of section 1128A of the Social Security Act
(other than subsections (a) and (b) of such section)
shall apply to a civil monetary penalty imposed under
this paragraph in the same manner as such provisions
apply to a civil monetary penalty imposed under
subsection (a) of such section.
``(6) Provision of technical assistance.--The Secretary
shall, to the extent practicable, provide technical assistance
relating to compliance with the provisions of this subsection
to applicable laboratories requesting such assistance.
``(7) Definitions.--In this subsection:
``(A) Applicable laboratory.--The term `applicable
laboratory' 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 and prices for specified
clinical diagnostic laboratory tests furnished by such
laboratory are made available by a hospital pursuant to
subsection (e) of this section.
``(B) Discounted cash price.--The term `discounted
cash price' means the charge that applies to an
individual who pays cash, or cash equivalent, for an
item or service.
``(C) Gross charge.--The term `gross charge' means
the charge for an individual item or service that is
reflected on an applicable laboratory's chargemaster,
absent any discounts.
``(D) Payer-specific negotiated charge.--The term
`payer-specific negotiated charge' means the charge
that an applicable laboratory has negotiated with a
third party payer for an item or service.
``(E) Specified clinical diagnostic laboratory
test.--The term `specified clinical diagnostic
laboratory test' means a clinical diagnostic laboratory
test that is included on the list of shoppable services
specified by the Centers for Medicare & Medicaid
Services (as described in subsection (e) of this
section), other than such a test that is only available
to be furnished by a single provider of services or
supplier.
``(F) Third party payer.--The term `third party
payer' means an entity that is, by statute, contract,
or agreement, legally responsible for payment of a
claim for a health care item or service.
``(8) Rulemaking.--The Secretary shall implement this
subsection through notice and comment rulemaking in accordance
with section 553 of title 5, United States Code.''.
SEC. 304. IMAGING TRANSPARENCY.
Section 2718 of the Public Health Service Act (42 U.S.C. 300gg-18),
as amended by section 303, is further amended by adding at the end the
following:
``(g) Imaging Services Price Transparency.--
``(1) In general.--Beginning July 1, 2028, each provider of
services or supplier that furnishes a specified imaging
service, other than such a provider or supplier with respect to
which standard charges and prices for such services furnished
by such provider or supplier are made available by a hospital
pursuant to subsection (e), shall--
``(A) make publicly available (in accordance with
paragraph (3)) on an internet website the information
described in paragraph (2) with respect to each such
service that such provider of services or supplier
furnishes; and
``(B) ensure that such information is updated not
less frequently than annually.
``(2) Information described.--For purposes of paragraph
(1), the information described in this paragraph is, with
respect to a provider of services or supplier and a specified
imaging service, the following:
``(A) A plain language description of each item or
service, accompanied by any applicable billing codes,
including modifiers, using commonly recognized billing
code sets, including the Current Procedural Terminology
code, the Healthcare Common Procedure Coding System
code, the diagnosis-related group, the National Drug
Code, and other nationally recognized identifiers.
``(B) The gross charge expressed as a dollar
amount, for each such item or service.
``(C) The discounted cash price expressed as a
dollar amount, for each such item or service (or, in
the case no discounted cash price is available for an
item or service, the minimum cash price accepted by the
provider of services or supplier from self-pay
individuals for such item or service when provided in
such settings for the previous three years, expressed
as a dollar amount, as well as, with respect to prices
made public pursuant to subparagraph (A)(ii), a link to
a consumer-friendly document that clearly explains the
provider of services or supplier's charity care
policy). The provider of services or supplier shall
accept the discounted or minimum cash price as payment
in full from any patient that chooses to pay in cash
without regard to the patient's coverage.
``(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
provider or supplier 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 charge.
``(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 and prices for an item or
service included as part of a bundled, per diem,
episodic, or other similar arrangement, the information
described in this subparagraph shall be made available
as determined appropriate by the Secretary.
``(3) Uniform method and format.--Not later than January 1,
2028, the Secretary shall establish a standard, uniform method
and format for providers of services and suppliers to use in
making public information described in paragraph (2). Any such
method and format shall--
``(A) include a machine-readable spreadsheet format
containing the information described in paragraph (2)
for all items and services furnished by each provider
of services and supplier described in paragraph (1);
``(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, through
notice and comment rulemaking and in consultation with the
Inspector General of the Department of Health and Human
Services, establish a process to monitor compliance with this
subsection.
``(5) Enforcement.--
``(A) In general.--In the case that the Secretary
determines that a provider of services or supplier is
not in compliance with paragraph (1)--
``(i) not later than 30 days after such
determination, the Secretary shall notify such
provider or supplier of such determination;
``(ii) upon request of the Secretary, such
provider or supplier shall submit to the
Secretary, not later than 45 days after the
date of such request, a corrective action plan
to comply with such paragraph; and
``(iii) if such provider or supplier
continues to fail to comply with such paragraph
after the date that is 90 days after such
notification is sent (or, in the case of such a
provider or supplier that has submitted a
corrective action plan described in clause (ii)
in response to a request so described, after
the date that is 90 days after such
submission), the Secretary may impose a civil
monetary penalty in an amount not to exceed
$300 for each day (beginning with the day on
which the Secretary first determined that such
provider or supplier was failing to comply with
such paragraph) during which such failure to
comply or failure to submit is ongoing.
``(B) Increase authority.--In applying this
paragraph with respect to violations occurring in 2028
or a subsequent year, the Secretary may through notice
and comment rulemaking increase the amount of the civil
monetary penalty under subparagraph (A)(iii).
``(C) Application of certain provisions.--The
provisions of section 1128A of the Social Security Act
(other than subsections (a) and (b) of such section)
shall apply to a civil monetary penalty imposed under
this paragraph in the same manner as such provisions
apply to a civil monetary penalty imposed under
subsection (a) of such section.
``(D) 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 violation of this subsection.
``(E) Provision of technical assistance.--The
Secretary shall, to the extent practicable, provide
technical assistance relating to compliance with the
provisions of this subsection to providers of services
and suppliers requesting such assistance.
``(F) Clarification of nonapplicability of other
enforcement provisions.--Notwithstanding any other
provision of this title, this paragraph shall be the
sole means of enforcing the provisions of this
subsection.
``(6) Specified imaging service defined.--The term
`specified imaging service' means an imaging service that is a
Centers for Medicare & Medicaid Services-specified shoppable
service (as described in subsection (e)).
``(7) Rulemaking.--The Secretary shall implement this
subsection through notice and comment rulemaking in accordance
with section 553 of title 5, United States Code.''.
SEC. 305. AMBULATORY SURGICAL CENTER PRICE TRANSPARENCY REQUIREMENTS.
Section 2718 of the Public Health Service Act (42 U.S.C. 300gg-18),
as amended by section 304, is further amended by adding at the end the
following:
``(h) Ambulatory Surgery Center Transparency.--
``(1) In general.--Beginning July 1, 2028, each specified
ambulatory surgical center shall comply with the price
transparency requirement described in paragraph (2).
``(2) Requirement described.--
``(A) In general.--A specified ambulatory surgical
center, in accordance with a method and format
established by the Secretary under subparagraph (C),
shall compile and make public (without subscription and
free of charge), for each year--
``(i) one or more lists, in a machine-
readable format specified by the Secretary, of
the ambulatory surgical center's standard
charges (including the information described in
subparagraph (B)) for each item and service
furnished by such surgical center;
``(ii) information in a consumer-friendly
format (as specified by the Secretary) on the
ambulatory surgical center's prices (including
the information described in subparagraph (B))
for as many of the Centers for Medicare &
Medicaid Services-specified shoppable services
included on the list described in subsection
(e) that are furnished by such surgical center,
and as many additional ambulatory surgical
center-selected shoppable services (or all such
additional services, if such surgical center
furnishes fewer than 300 shoppable services) as
may be necessary for a combined total of at
least 300 shoppable services; and
``(iii) with respect to each Centers for
Medicare & Medicaid Services-specified
shoppable service (as described in clause (ii))
that is not furnished by the ambulatory
surgical center, an indication that such
service is not so furnished.
``(B) Information described.--For purposes of
subparagraph (A), the information described in this
subparagraph is, with respect to standard charges and
prices made public by a specified ambulatory surgical
center, the following:
``(i) A description of each item or
service, accompanied by the Healthcare Common
Procedure Coding System code, the national drug
code, or other identifier used or approved by
the Centers for Medicare & Medicaid Services.
``(ii) The gross charge, expressed as a
dollar amount, for each such item or service.
``(iii) The discounted cash price,
expressed as a dollar amount, for each such
item or service (or, in the case no discounted
cash price is available for an item or service,
the minimum cash price accepted by the
specified ambulatory surgical center from self-
pay individuals for such item or service when
provided in such settings for the previous
three years, expressed as a dollar amount, as
well as, with respect to prices made public
pursuant to subparagraph (A)(ii), a link to a
consumer-friendly document that clearly
explains the provider of services or supplier's
charity care policy). The specified ambulatory
surgical center shall accept the discounted
cash price as payment in full from any patient
that chooses to pay in cash without regard to
the patient's coverage.
``(iv) 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 ambulatory surgical center
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 charge.
``(v) The de-identified maximum and minimum
negotiated charges for each such item or
service, expressed as a non-zero dollar amount.
``(vi) Any other additional information the
Secretary may require for the purpose of
improving the accuracy of, or enabling
consumers to easily understand and compare,
standard charges and prices for an item or
service, except information that is duplicative
of any other reporting requirement under this
subsection.
``(C) Uniform method and format.--Not later than
January 1, 2028, the Secretary shall establish a
standard, uniform method and format for specified
ambulatory surgical centers to use in making public
standard charges pursuant to subparagraph (A)(i) and a
standard, uniform method and format for such centers to
use in making public prices pursuant to subparagraph
(A)(ii). Any such method and format shall--
``(i) in the case of such charges made
public by an ambulatory surgical center, ensure
that such charges are made available in a
machine-readable format;
``(ii) meet such standards as determined
appropriate by the Secretary in order to ensure
the accessibility and usability of such charges
and prices; and
``(iii) be updated as determined
appropriate by the Secretary, in consultation
with stakeholders.
``(3) No deemed compliance.--The availability of a price
estimator tool shall not be considered to deem compliance with
or otherwise vitiate the requirements of this subsection (aa).
Furthermore, the use of an estimator tool shall not be used for
purposes of compliance with any provisions in this subsection.
``(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) 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, the
ambulatory surgical center shall submit to the
Secretary, not later than 45 days after the
date of such request, a corrective action plan
to comply with such requirements.
``(B) Civil monetary penalty.--
``(i) In general.--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 an
ambulatory surgical center that has submitted a
corrective action plan described in
subparagraph (A)(ii) in response to a request
so described, by the date that is 90 days after
such submission) shall be subject to a civil
monetary penalty of an amount specified by the
Secretary for each day (beginning with the day
on which the Secretary first determined that
such hospital 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 violations
occurring 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
violation of this subsection.
``(6) Provision of technical assistance.--The Secretary
shall, to the extent practicable, provide technical assistance
relating to compliance with the provisions of this subsection
to specified ambulatory surgical centers requesting such
assistance.
``(7) Definitions.--For purposes of this section:
``(A) Discounted cash price.--The term `discounted
cash price' means the charge that applies to an
individual who pays cash, or cash equivalent, for a
item or service furnished by an ambulatory surgical
center.
``(B) Gross charge.--The term `gross charge' means
the charge for an individual item or service that is
reflected on a specified surgical center's
chargemaster, absent any discounts.
``(C) Group health plan; group health insurance
coverage; individual health insurance coverage.--The
terms `group health plan', `group health insurance
coverage', and `individual health insurance coverage'
have the meaning given such terms in section 2791 of
the Public Health Service Act.
``(D) Payer-specific negotiated charge.--The term
`payer-specific negotiated charge' means the charge
that a specified surgical center has negotiated with a
third party payer for an item or service.
``(E) Shoppable service.--The term `shoppable
service' means a service that can be scheduled by a
health care consumer in advance and includes all
ancillary items and services customarily furnished as
part of such service.
``(F) Specified ambulatory surgical center.--The
term `specified ambulatory surgical center' means an
ambulatory surgical center with respect to which a
hospital (or any person with an ownership or control
interest (as defined in section 1124(a)(3) of the
Social Security Act) in a hospital) is a person with an
ownership or control interest (as so defined).
``(G) Third party payer.--The term `third party
payer' means an entity that is, by statute, contract,
or agreement, legally responsible for payment of a
claim for a health care item or service.
``(8) Rulemaking.--The Secretary shall implement this
subsection through notice and comment rulemaking in accordance
with section 553 of title 5, United States Code.''.
SEC. 306. STRENGTHENING HEALTH COVERAGE TRANSPARENCY REQUIREMENTS.
(a) Transparency in Coverage.--Section 1311(e)(3)(C) of the Patient
Protection and Affordable Care Act (42 U.S.C. 18031(e)(3)(C)) is
amended--
(1) by striking ``The Exchange'' and inserting the
following:
``(i) In general.--The Exchange'';
(2) in clause (i), as inserted by paragraph (1)--
(A) by striking ``participating provider'' and
inserting ``provider'';
(B) by inserting ``shall include the information
specified in clause (ii) and'' after ``such
information'';
(C) by striking ``an Internet website'' and
inserting ``a self-service tool that meets the
requirements of clause (iii)''; and
(D) by striking ``and such other'' and all that
follows through the period and inserting ``or, at the
option such individual, through a paper or phone
disclosure (as selected by such individual and provided
at no cost to such individual) that meets such
requirements as the Secretary may specify.''; and
(3) by adding at the end the following new clauses:
``(ii) Specified information.--For purposes
of clause (i), the information specified in
this clause is, with respect to benefits
available under a health plan for an item or
service furnished by a health care provider,
the following:
``(I) If such provider is a
participating provider with respect to
such item or service, the in-network
rate (as defined in subparagraph (F))
for such item or service.
``(II) If such provider is not
described in subclause (I), the maximum
allowed dollar amount for such item or
service.
``(III) The amount of cost sharing
(including deductibles, copayments, and
coinsurance) that the individual will
incur for such item or service (which,
in the case such item or service is to
be furnished by a provider described in
subclause (II), shall be calculated
using the maximum amount described in
such subclause).
``(IV) The amount the individual
has already accumulated with respect to
any deductible or out-of-pocket maximum
under the plan (broken down, in the
case separate deductibles or maximums
apply to separate individuals enrolled
in the plan, by such separate
deductibles or maximums, in addition to
any cumulative deductible or maximum).
``(V) In the case such plan imposes
any frequency or volume limitations
with respect to such item or service
(excluding medical necessity
determinations), the amount that such
individual has accrued towards such
limitation with respect to such item or
service.
``(VI) Any prior authorization,
concurrent review, step therapy, fail
first, or similar requirements
applicable to coverage of such item or
service under such plan.
``(iii) Self-service tool.--For purposes of
clause (i), a self-service tool established by
a health plan meets the requirements of this
clause if such tool--
``(I) is based on an internet
website;
``(II) provides for real-time
responses to requests described in such
clause;
``(III) is updated in a manner such
that information provided through such
tool is timely and accurate;
``(IV) allows such a request to be
made with respect to an item or service
furnished by--
``(aa) a specific provider
that is a participating
provider with respect to such
item or service;
``(bb) all providers that
are participating providers
with respect to such plan and
such item or service; or
``(cc) a provider that is
not described in item (bb);
``(V) provides that such a request
may be made with respect to an item or
service through use of--
``(aa) the billing code for
such item or service; or
``(bb) through use of a
descriptive term for such item
or service to produce a list of
billing code options from which
the individual selects to
indicate the subject matter
items or services; and
``(VI) holds a member harmless for
the amount of any difference in excess
of the amount of the individual's
responsibility generated by the self-
service tool and the amount ultimately
billed or charged to the individual.''.
(b) Disclosure of Additional Information.--Section 1311(e)(3) of
the Patient Protection and Affordable Care Act (42 U.S.C. 18031(e)(3))
is amended by adding at the end the following new subparagraphs:
``(E) Rate and payment information.--
``(i) In general.--Not later than January
1, 2028, and every month thereafter, each
health plan shall submit to the Exchange, the
Secretary, the State insurance commissioner,
and make available to the public, the rate and
payment information described in clause (ii) in
accordance with clause (iii).
``(ii) Rate and payment information
described.--For purposes of clause (i), the
rate and payment information described in this
clause is, with respect to a health plan, the
following:
``(I) With respect to each item or
service for which benefits are
available under such plan (expressed as
a dollar amount), including
prescription drugs, identified by CPT,
HCPCS, DRG, NDC, or other applicable
nationally recognized identifier,
including any applicable code
modifiers, and accompanied by a brief
description of the item or service, the
in-network rate in effect as of the
date of the submission of such
information with each provider
(identified by national provider
identifier) that is a participating
provider with respect to such item or
service, other than such a rate in
effect with a provider--
``(aa) that has submitted
no claims; and
``(bb) expects to receive
no claims in the then
applicable calendar year for
such item or service to such
plan.
``(II) With respect to each drug
(identified by National Drug Code, J-
code, or other commonly recognized
billing code used for drugs) for which
benefits are available under such plan:
``(aa) The in-network rate
(expressed as a dollar amount),
including the individual and
total amounts for any bundled
rates, in effect as of the
first day of the month in which
such information is made public
with each provider that is a
participating provider with
respect to such drug.
``(bb) The historical net
price paid by such plan (net of
rebates, discounts, and price
concessions) (expressed as a
dollar amount) for such drug
dispensed or administered
during the 90-day period
beginning 180 days before such
date of submission to each
provider that was a
participating provider with
respect to such drug, broken
down by each such provider
(identified by national
provider identifier), other
than such an amount paid to a
provider that has submitted no
claims for such drug to such
plan.
``(III) With respect to each item
or service for which benefits are
available under such plan (expressed as
a dollar amount), identified by CPT,
DRG, HCPCS, NDC, 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, for each such item or service
furnished during the 90-day period
beginning 180 days before such date of
submission by each provider that was
not a participating provider with
respect to such item or service, broken
down by each such provider (identified
by national provider identifier), other
than items and services with respect to
which no claims for such item or
service were submitted to such plan
during such period.
``(iii) Manner of submission.--Rate and
payment information required to be submitted
and made available under this subparagraph
shall be so submitted and so made available as
follows:
``(I) Information shall be
contained in 3 separate machine-
readable files corresponding to the
information described in each of
subclauses (I) through (III) of clause
(ii) that meet such requirements as
specified by the Secretary through
rulemaking, in consultation with the
Secretaries of Labor and the Treasury
to apply comparable requirements to
group health plans and to entities
providing benefit management or other
third-party administration services on
a contractual basis with a group health
plan.
``(II) Requirements specified by
the Secretary through rulemaking shall
ensure that:
``(aa) Such files are
limited to an appropriate size,
are made available in a widely
available format that allows
for information contained in
such files to be compared
across health plans, and are
accessible to individuals at no
cost and without the need to
establish a user account or
provider other credentials.
``(bb) The rates, amounts,
and prices to be disclosed
include contractual terms
containing calculation
formulae, pricing
methodologies, and other
information necessary to
determine the dollar value of
reimbursement.
``(cc) Each such file
includes each of the following
data elements:
``(AA) A numerical
identifier for the
group health plan and/
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 or
provider Tax
Identification Number.
``(III) The rate and payment
information disclosed under subclauses
(I) through (III) of clause (ii) 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. Such
attestation shall be subject to
enforcement under subparagraph (H) and,
where applicable, shall be deemed
material to payments from the Federal
Government received by the group health
plan or health insurance issuer.
``(V) Regulations promulgated
pursuant to this section shall provide
that:
``(aa) The Secretary shall
audit the three machine-
readable files required by
subparagraph (E)(ii) posted by
no fewer than 20 group health
plans or health insurance
issuers.
``(bb) The Secretary of
Labor shall audit the three
machine-readable files required
by subparagraph (E)(ii) posted
by no fewer than 200 group
health plans or service
providers furnishing third-
party administrator services to
a group health plan.
``(cc) Findings,
conclusions, and enforcement
actions taken based on audits
of the machine-readable files
shall be reported annually to
Congress no later than July 1
of the calendar year during
which the files were audited.
Such report to Congress shall
be accessible to the public.
``(iv) User guide.--Each health plan shall
make available to the public instructions
written in plain language explaining how
individuals may search for information
described in clause (ii) in files submitted in
accordance with clause (iii).
``(F) Definitions.--In this paragraph:
``(i) Participating provider.--The term
`participating provider' has the meaning given
such term in section 2799A-1 of the Public
Health Service Act.
``(ii) In-network rate.--The term `in-
network rate' means, with respect to a health
plan and an item or service furnished by a
provider that is a participating provider with
respect to such plan and item or service, the
contracted rate in effect between such plan and
such provider for such item or service. 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.
``(G) Applicability to accountable care
organizations.--An applicable ACO participating in the
Medicare Shared Savings Program, as defined in Section
1899 of the Social Security Act (42 U.S.C. 1395jjj),
shall be subject to the requirements of this paragraph
as if such applicable ACO is a group health plan or
health insurance issuer.
``(H) Enforcement.--
``(i) In general.--Each year, the Secretary
shall audit the three machine-readable files
required by subparagraph (E)(ii) posted by no
fewer than 20 group health plans or health
insurance issuers.
``(ii) Notification and request for
corrective action.--In the case of a health
plan 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 submit to such health plan a notification
of such determination, which shall include a
request for a corrective action plan to comply
with such requirements.
``(iii) Civil monetary penalty.--A health
plan that has received a request for a
corrective action plan under clause (ii) 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 with
the day on which the Secretary first determined
that such laboratory was failing to comply with
such paragraph) during which such failure was
ongoing. Such amount shall not exceed $300 per
member per day or $10,000,000, whichever is
lesser.
``(I) Rulemaking.--The Secretary shall implement
subparagraphs (E) through (H) through notice and
comment rulemaking in accordance with section 553 of
title 5, United States Code.''.
(c) Effective Date.--
(1) In general.--The amendments made by subsections (a) and
(b) shall apply beginning January 1, 2027.
(2) Continued applicability of rules for previous years.--
Nothing in the amendments made by this section may be construed
as affecting the applicability of the rule entitled
``Transparency in Coverage'' published by the Department of the
Treasury, the Department of Labor, and the Department of Health
and Human Services on November 12, 2020 (85 Fed. Reg. 72158)
before January 1, 2027.
SEC. 307. INCREASING GROUP HEALTH PLAN ACCESS TO HEALTH DATA.
(a) Group Health Plan Access to Information.--
(1) In general.--Paragraph (2) of section 408(b) of the
Employee Retirement Income Security Act of 1974 (29 U.S.C.
1108(b)) is amended by adding at the end the following new
subparagraphs:
``(C) No contract or arrangement for services, and
no extension or renewal of such contract or
arrangement, between a group health plan (as that term
is defined in section 733(a) of this title) and party
in interest, including 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, or third-party administrator (collectively
referred to as `Covered Service Providers'), is
reasonable within the meaning of this paragraph unless
such contract or arrangement--
``(i) allows the responsible plan fiduciary
(as that term is defined in subparagraph
(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 section 724(a)(1)(B) to--
``(I) enable such entity to comply
with the terms of the plan and any
applicable law; and
``(II) determine the accuracy or
reasonableness of 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, 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, or third-party
administrator;
``(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 in a daily batch;
``(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;
or
``(IX) limit public disclosure of
de-identified or aggregate information.
``(D)(i) Covered Service Providers shall provide
information or data under this paragraph in a manner
consistent with the privacy and security regulations
promulgated under the Health Insurance Portability and
Accountability Act (referred to in this subparagraph as
`HIPAA').
``(ii) A group health plan that receives a
disclosure from a party in interest pursuant to
subparagraph (B) or (C) shall comply with the privacy
and security regulations promulgated under HIPAA.
``(iii) Nothing in this subparagraph shall be
construed to modify the requirements for the creation,
receipt, maintenance, or transmission of protected
health information under the HIPAA privacy regulation
(as defined in section 1180(b)(3) of the Social
Security Act) as they apply directly or indirectly to
an entity pursuant to this paragraph.
``(iv) This subparagraph shall not be read to
abridge or limit the disclosure requirements under this
paragraph or to impose additional privacy or security
requirements on Covered Service Providers or plan
sponsors.
``(E) A group health plan receiving information or
data under this paragraph may disclose such information
only in a manner that is consistent with the Health
Insurance Portability and Accountability Act (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.
``(F) Information made available under this section
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
837 format or any subsequent standard.
``(II) Pharmacy claims shall be in
the National Council for Prescription
Drug Programs (NCPDP) format or any
subsequent standard.
``(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.
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 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
calculation formulae, pricing methodologies,
and other information used to determine the
dollar value of reimbursement.
``(iv) All non-claim costs shall be
itemized and made available to the group health
plan in real time through a web-based portal,
through an API, and through a downloadable CSV
file.
``(G) The Secretary shall implement subparagraphs
(C) through (F) through notice and comment rulemaking
in accordance with section 553 of title 5, United
States Code.''.
(2) 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) 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, or third-party administrator, that
violates the provisions of section 724, the Secretary may
assess a civil penalty against such provider, network or
association, service provider offering access to a network or
association of providers, third-party administrator, or other
service provider in the amount of $10,000 for each day during
which such violation continues. Such penalty shall be in
addition to other penalties as may be prescribed by law.''.
(3) 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(a)(1)(B); or
``(2) violates the requirements of section 408(b)(2)(C).''.
(4) Technical amendment.--Clause (i) of section
408(b)(2)(B) of such Act is amended by striking ``this clause''
and inserting ``this paragraph''.
(b) Updated Attestation for Price and Quality Information.--Section
724(a)(3) of the Employee Retirement Income Security Act of 1974 (29
U.S.C. 1185m(a)(3)) is amended to read as follows:
``(3) 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 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.--Subject to clause
(ii), a group health plan or issuer offering group
health insurance coverage may not enter into an
agreement with a third-party administrator or other
service provider to submit the attestation required
under subparagraph (A).
``(C) Exception.--In the case of a group health
plan or issuer offering group health insurance coverage
that is unable to obtain the information or data needed
to submit the attestation required under subparagraph
(A), such plan or issuer may submit a written statement
in lieu of such attestation that includes--
``(i) an explanation of why such plan or
issuer was unsuccessful in obtaining such
information or data, including whether such
plan, 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. 308. OVERSIGHT OF ADMINISTRATIVE SERVICE PROVIDERS.
(a) ERISA Amendments.--
(1) In general.--Subpart B of part 7 of subtitle B of the
Employee Retirement Income Security Act of 1974 (29 U.S.C. 1021
et seq.) is amended by adding at the end the following:
``SEC. 727. OVERSIGHT OF ADMINISTRATIVE SERVICE PROVIDERS.
``(a) In General.--For plan years beginning on or after the date
that is 2 years after the date of enactment of this section, no
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)), the
plan administrator of such plan (as defined in section 3(16)(A)), or a
business associate of such plan (as defined in section 160.103 of title
45, Code of Federal Regulations), (or health insurance issuer offering
group health insurance coverage in connection with such a plan), and a
health care provider, network or association of providers, third-party
administrator, service provider offering access to a network of
providers, or any other third party (each referred to 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 group health plans in such a manner
that prevents such plan, issuer, or entity 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 2 years after the date
of enactment of this section, not less frequently than
quarterly, a health plan service provider shall provide to the
group health plan or health insurance issuer the following
information at no cost to the group health plan or health
insurance issuer:
``(A) The information described in section
724(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 health insurance 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 or to
subcontractors in rebates, fees, contractual
arrangements, and all other remuneration that has been
paid or is expected to be paid for administrative and
other services.
``(E) All payment data 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 or health insurance issuer paid fees, incurred
obligations, or made payments in connection with the
group health plan related to such arrangements.
``(2) Privacy requirements.--
``(A) In general.--Health plan service providers
shall provide the information or data under paragraph
(1) consistent with the privacy, security, and breach
notification regulations at parts 160 and 164 of title
45, Code of Federal Regulations, promulgated under
subtitle F of the Health Insurance Portability and
Accountability Act of 1996, subtitle D of the Health
Information Technology for Clinical Health Act of 2009,
and section 1180 of the Social Security Act, and shall
restrict the use and disclosure of such information
according to such privacy, security, and breach
notification regulations. An entity that receives a
disclosure from a party in interest pursuant to
subparagraph (B) or (C) shall comply with the privacy
and security regulations promulgated under HIPAA.
``(B) Restrictions.--A group health plan shall
comply with section 164.504(f) of title 45, Code of
Federal Regulations (or a successor regulation), and a
plan sponsor shall act in accordance with the terms of
the agreement described in such section.
``(C) Rule of construction.--Nothing in this
section shall be construed to modify the requirements
for the creation, receipt, maintenance, or transmission
of protected health information under the HIPAA privacy
regulations (45 CFR parts 160 and 164, subparts A and
E).
``(3) Disclosure and redisclosure.--
``(A) In general.--A group health plan 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 or to the group health
plan'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 parts 160 and 164, subparts A and
E).
``(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 in connection with a group health
plan, 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) 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 502
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 the 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
transactions standards adopted under HIPAA, as follows:
``(i) Institutional, professional, and
dental claims and adjustments to these claims
shall be in ASC X12N 837 format, as transmitted
by the provider, or, in the case of paper
claims, converted to the ASC X12N 837
electronic format.
``(ii) Prescription drug claims shall be in
the National Council for Prescription Drug
Programs (NCPDP) format, as transmitted by the
provider, or in the case of paper claims,
converted to the NCPDP electronic format.
``(iii) 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 transaction standards adopted under
HIPAA, 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 or health insurance issuer.
``(C) The Secretary may modify the standards set
forth in this paragraph as necessary to align with any
changes adopted by the Secretary of Health and Human
Services pursuant to the authority provided under
section 1173 of the Social Security Act (42 U.S.C.
1320d-2).
``(c) Prohibited Contractual Provisions.--Any provision in an
agreement between a group health plan, the plan sponsor, the plan
administrator, or a business associate of such plan or a health
insurance issuer and a health plan service provider that unduly delays
or limits a group health plan's or health insurance 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 health insurance issuer enters into such
agreement, shall be deemed void as against public policy.
``(d) Penalties for Non-Compliance.--Any failure by a health plan
service provider to comply with the requirements of this section shall
result in the imposition of a civil penalty of $100,000 for each day
the violation continues, in addition to any other penalties prescribed
by law.
``(e) Regulations.--The Secretary shall implement this section
through notice and comment rulemaking in accordance with section 553 of
title 5, United States Code.''.
(2) Penalty.--
(A) In general.--Section 502(a) of the Employee
Retirement Income Security Act of 1974 (29 U.S.C.
1132(a)) 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 727.''.
(B) 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 it with the phrase ``(9), (13), or
(14)''.
(b) PHSA Amendments.--
(1) In general.--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:
``SEC. 2799A-12. OVERSIGHT OF ADMINISTRATIVE SERVICE PROVIDERS.
``(a) In General.--For plan years beginning on or after the date
that is 1 year after the date of enactment of this section, no
agreement between a group health plan that is a self-funded, non-
Federal plan, as defined in section 2791(d)(8)(C) (42 U.S.C. 300gg-
91(d)(8)(C)), and a health care provider, network or association of
providers, third-party administrator, service provider offering access
to a network of providers, 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 group
health plans in such a manner that prevents such plan, issuer, or
entity 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 plan that is a self-funded, non-Federal governmental
plan the following information at no cost to the plan:
``(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 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 or to
subcontractors in rebates, fees, contractual
arrangements, and all other remuneration that has been
paid or is expected to be paid for administrative and
other services.
``(E) All payment data 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 related to
such arrangements.
``(2) Privacy requirements.--
``(A) In general.--Health plan service providers
shall provide the information or data under paragraph
(1) consistent with the privacy, security, and breach
notification regulations at parts 160 and 164 of title
45, Code of Federal Regulations, promulgated under
subtitle F of the Health Insurance Portability and
Accountability Act of 1996, subtitle D of the Health
Information Technology for Clinical Health Act of 2009,
and section 1180 of the Social Security Act, and shall
restrict the use and disclosure of such information
according to such privacy, security, and breach
notification regulations. An entity that receives a
disclosure from a party in interest pursuant to
subparagraph (B) or (C) shall comply with the privacy
and security regulations promulgated under HIPAA.
``(B) Restrictions.--A group health plan that is a
self-funded, non-Federal governmental plan shall comply
with section 164.504(f) of title 45, Code of Federal
Regulations (or a successor regulation), and a plan
sponsor shall act in accordance with the terms of the
agreement described in such section.
``(C) Rule of construction.--Nothing in this
section shall be construed to modify the requirements
for the creation, receipt, maintenance, or transmission
of protected health information under the HIPAA privacy
regulations (45 CFR parts 160 and 164, subparts A and
E).
``(3) Disclosure and redisclosure.--
``(A) In general.--A group health plan that is a
self-funded, non-Federal governmental plan 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 parts 160 and 164, subparts A and
E).
``(B) Rule of construction.--Nothing in this
section shall be construed to prevent a group health
plan that is a self-funded, non-Federal governmental
plan, 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.
``(C) 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 at section 162.1101 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 that
is a self-funded, non-Federal governmental plan
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 adopted under HIPAA at
section 162.1602 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).
``(c) Prohibited Contractual Provisions.--Any provision in an
agreement that unduly delays or limits a group health plan that is a
self-funded, non-Federal governmental plan'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 self-funded,
non-Federal governmental plan 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.''.
(2) 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-12(a) (42 U.S.C. 300gg-
121(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) (42 U.S.C. 300gg-121(b)(2)(D) through (G)).''.
SEC. 309. STATE PREEMPTION ONLY IN EVENT OF CONFLICT.
The provisions of sections 302 through 305 (including the
amendments made by such sections) shall not supersede any provision of
State law which establishes, implements, or continues in effect any
requirement or prohibition related to health care price transparency,
including hospital, clinical diagnostic laboratory tests, imaging
services, and ambulatory surgical center, except to the extent that
such requirement or prohibition prevents the application of a
requirement or prohibition of such sections (or amendment). 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. 310. REQUIREMENT FOR EXPLANATION OF BENEFITS.
(a) PHSA Amendments.--
(1) Emergency services.--Section 2799A-1(f)(1)(C) of the
Public Health Service Act (42 U.S.C. 300gg-111(f)(1)(C)) is
amended to read as follows:
``(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.''.
(2) 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 or after
January 1, 2027, each group health plan, or a health insurance
issuer offering group or individual health insurance coverage
shall, within 45 days of receiving any request for payment for
an item or service under the plan, 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) 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 site of each item or service.
``(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.''.
(b) IRC Amendments.--
(1) Emergency services.--Section 9816(f)(1)(C) of the
Internal Revenue Code of 1986 is amended to read as follows:
``(C) A good faith estimate of the amount the plan
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.''.
(2) Explanation of benefits.--Section 9816 of the Internal
Revenue Code of 1986 is amended by adding at the end the
following:
``(g) Explanation of Benefits.--
``(1) In general.--For plan years beginning on or after
January 1, 2027, each group health plan shall, within 45 days
of receiving any request for payment for an item or service
under the plan, provide to the participant or beneficiary
(through mail or electronic means, as requested by the
participant or beneficiary) 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) including the following:
``(A) Whether or not the provider or facility is a
participating provider or a participating facility with
respect to the plan 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 is responsible
for paying for each item or service.
``(iv) The amount of any cost-sharing for
which the participant or beneficiary is
responsible for each item or service (as of the
date of such notification).
``(v) The amount that the participant or
beneficiary has incurred toward meeting the
limit of the financial responsibility
(including with respect to deductibles and out-
of-pocket maximums) under the plan (as of the
date of such notification).
``(vi) The site of each item or service.
``(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 503 of the Employee Retirement Income
Security Act of 1974 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.''.
(c) ERISA Amendments.--
(1) Emergency services.--Section 716(f)(1)(C) of the
Employee Retirement Income Security Act of 1974 (29 U.S.C.
1185e(f)(1)(C)) is amended to read as follows:
``(C) A good faith estimate of the amount the
health plan 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.''.
(2) Explanation of benefits.--Section 716 of the Employee
Retirement Income Security Act of 1974 (29 U.S.C. 1185e) is
amended by adding at the end the following:
``(g) Explanation of Benefits.--
``(1) In general.--For plan years beginning on or after
January 1, 2027, each group health plan or health insurance
issuer offering group health insurance coverage shall, within
45 days of receiving any request for payment for an item or
service under the plan, provide to the participant or
beneficiary (through mail or electronic means, as requested by
the participant or beneficiary) 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) 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 or beneficiary is
responsible for each item or service (as of the
date of such notification).
``(v) The amount that the participant or
beneficiary 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 site of each item or service.
``(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 503 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. 311. PROVISION OF ITEMIZED BILLS.
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. PROVIDER REQUIREMENTS FOR ITEMIZED BILLS.
``(a) Requirements.--
``(1) Itemized bill and other information required.--
``(A) In general.--A health care provider or health
care facility that requests payment from an individual
after providing a health care item or service to the
patient shall include with such request a written,
itemized bill of the cost of each reasonably expected
item or service the health care provider or health care
facility provided to the individual, including
telehealth visits or visits by other electronic means.
The health care provider or health care facility shall
provide the itemized bill not later than 30 days after
the health care provider or health care facility
received a final payment on the provided service or
supply from a third party.
``(B) Required information.--For each item or
service provided by the health care provider or
facility or for which the health care provider or
facility is billing the individual, the itemized bill
must include--
``(i) a plain language description of each
distinct health care item or service;
``(ii) all applicable billing codes for
each distinct health care item or service,
including modifiers, using standard and
commonly recognized billing code sets that are
clearly identified;
``(iii) the price and billed amount, if
different, of each distinct health care item or
service or if the provider or facility is
offering binding, all-in prices for bundled
items and services, the total binding price for
bundled items and services and billed amount;
``(iv) any payments made to the health care
provider or health care facility by or on
behalf of the individual (including payments by
any health plan or insurance) for any health
care item or service covered in the itemized
bill;
``(v) information about the availability of
language-assistance services for individuals
with limited English proficiency (LEP);
``(vi) the identification of an office or
individual at the health care provider or
health care facility, including phone number
and email address, that shall be able to
discuss the specific details of the itemized
statement and be authorized to make appropriate
changes thereto; and
``(vii) information about the health care
provider's or health care facility's charity
care policies and instructions on how to apply
for charity care.
``(2) Collections actions.--
``(A) In general.--A health care provider or health
care facility shall not 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
``(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) Burden of proof.--The burden of proof under
subparagraph (A)(ii) shall rest with the provider, and
absent the documentation described in such
subparagraph, the good faith estimate 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.''.
TITLE IV--PROTECTING PATIENT ACCESS TO CANCER AND COMPLEX THERAPIES
SEC. 401. SHORT TITLE.
This title may be cited as the ``Protecting Patient Access to
Cancer and Complex Therapies Act''.
SEC. 402. REBATE BY MANUFACTURERS FOR SELECTED DRUGS AND BIOLOGICAL
PRODUCTS SUBJECT TO MAXIMUM FAIR PRICE NEGOTIATION.
(a) Maintaining Payments Under Part B Based on ASP+6.--Section
1847A(b)(1)(B) of the Social Security Act (42 U.S.C. 1395w-3a(b)(1)(B))
is amended by striking ``or in the case of such a drug or biological
product that is a selected drug'' and all that follows through the
semicolon and inserting a semicolon.
(b) Rebate by Manufacturers for Selected Drugs and Biological
Products Subject to Maximum Fair Price Negotiation.--
(1) In general.--Section 1847A of the Social Security Act
(42 U.S.C. 1395w-3a) is amended--
(A) by redesignating subsection (j) as subsection
(k); and
(B) by inserting after subsection (i) the following
new subsection:
``(j) Rebate by Manufacturers for Selected Drugs and Biological
Products Subject to Maximum Fair Price Negotiation.--
``(1) Requirements.--
``(A) Secretarial provision of information.--Not
later than 6 months after the end of each calendar
quarter beginning on or after the first day of the
initial price applicability period (as defined in
section 1191(b)(2)), the Secretary shall, for each
selected drug (as defined in section 1192(c)) of each
manufacturer with an agreement under section 1193 for
which a maximum fair price is in effect and for which
payment may be made under this part, report to each
manufacturer of such selected drug the following for
such calendar quarter during such price applicability
period:
``(i) Information on the total number of
units of the billing and payment code for such
selected drug furnished under this part during
such calendar quarter.
``(ii) Information on the sum of--
``(I) the amount (if any) by
which--
``(aa) the ASP+6 payment
amount (as defined in paragraph
(5)) for such drug and calendar
quarter, less the ASP+6
coinsurance amount for such
drug and calendar quarter;
exceeds
``(bb) the MFP+6 payment
amount (as so defined) for such
drug and calendar quarter, less
the MFP+6 coinsurance amount
for such drug and calendar
quarter; and
``(II) the amount (if any) by
which--
``(aa) the ASP+6
coinsurance amount (as defined
in paragraph (5)) for such drug
and calendar quarter; exceeds
``(bb) the MFP+6
coinsurance amount (as so
defined) for such drug and
calendar quarter.
``(iii) The rebate amount specified under
subparagraph (B) for such drug and calendar
quarter.
``(B) Manufacturer requirement.--For each calendar
quarter beginning on or after the first day of the
initial price applicability period (as defined in
section 1191(b)(2)), the manufacturer of a selected
drug shall, for such drug, not later than 30 days after
the date of receipt from the Secretary of the
information described in subparagraph (A) for such
calendar quarter, provide to the Secretary a rebate
that is equal to the amount specified in subparagraph
(A)(ii) multiplied by the number of units specified in
subparagraph (A)(i) for such drug for such calendar
quarter. The rebate required under this subparagraph
shall be in addition to any other rebates required
under this title or title XIX, including the payments
required under subsections (h) and (i).
``(2) Calculation of beneficiary coinsurance based on
mfp+6.--
``(A) In general.--Subject to subparagraph (B), in
the case of a selected drug with respect to which a
rebate is paid under this subsection--
``(i) the amount of any coinsurance
applicable under this part to an individual to
whom such drug is furnished during a calendar
quarter shall be equal to the MFP+6 coinsurance
amount; and
``(ii) the amount of such coinsurance for
such calendar quarter shall be applied as a
percent, as determined by the Secretary, to the
payment amount that would otherwise apply under
subsection (b)(1)(B).
``(B) Clarification regarding application of
inflation rebate.--If a rebate is required under
subsection (i) with respect to a selected drug for a
calendar quarter, the lesser of the amount of
coinsurance computed under subparagraph (A) or the
coinsurance computed under subsection (i)(5) shall
apply for such drug and calendar quarter.
``(3) Rebate deposits.--Amounts paid as rebates under
paragraph (1)(B) shall be deposited into the Federal
Supplementary Medical Insurance Trust Fund established under
section 1841.
``(4) Civil money penalty.--The civil money penalty
established under paragraph (7) of subsection (i) shall apply
to the failure to comply with this subsection in the same
manner as such penalty applies to failures to comply with the
requirements under paragraph (1)(B) of subsection (i).
``(5) Definitions.--In this subsection, with respect to a
selected drug for a calendar quarter during a price
applicability period:
``(A) ASP+6 coinsurance amount.--The `ASP+6
coinsurance amount' is equal to 20 percent of the ASP+6
payment amount.
``(B) ASP+6 payment amount.--The `ASP+6 payment
amount' is equal to 106 percent of the amount
determined under paragraph (4) of subsection (b) for
such drug during such calendar quarter.
``(C) MFP+6 coinsurance amount.--The `MFP+6
coinsurance amount' is equal to 20 percent of the MFP+6
payment amount.
``(D) MFP+6 payment amount.--The `MFP+6 payment
amount' is equal to 106 percent of the maximum fair
price (as defined in section 1191(c)(2)) applicable for
such drug during such calendar quarter.
``(6) Clarification.--Nothing in part E of title XI or this
subsection shall be construed to require a manufacturer to
provide selected drugs at maximum fair prices other than
through the rebate required under this subsection.''.
(2) Amounts payable; cost-sharing.--Section 1833(a)(1) of
the Social Security Act (42 U.S.C. 1395l(a)(1)) is amended--
(A) in subparagraph (G), by striking ``subsection
(i)(9)'' and inserting ``paragraphs (9) and (10) of
subsection (i)'';
(B) in subparagraph (S), by striking ``subparagraph
(EE)'' and inserting ``subparagraphs (EE) and (II)'';
(C) by striking ``and (HH)'' and inserting
``(HH)''; and
(D) by inserting before the semicolon at the end
the following: ``, and (II) with respect to a selected
drug (as defined in section 1192(c)) that is subject to
a rebate under section 1847A(j), the amounts paid shall
be equal to the percent of the payment amount otherwise
determined under section 1847A(b)(1)(B) that equals the
difference between (i) 100 percent, and (ii) the
percent applied under section 1847A(j)(2)(A)(ii)''.
(3) ASC conforming amendments.--Section 1833(i) of the
Social Security Act (42 U.S.C. 1395l(i)) is amended by adding
at the end the following new paragraph:
``(11) In the case of a selected drug (as defined in
section 1192(c)), subject to a rebate under section 1847A(j)
for which payment under this subsection is not packaged into a
payment for a service furnished on or after the initial price
applicability year for the selected drug under the revised
payment system under this subsection, in lieu of calculation of
coinsurance and the amount of payment otherwise applicable
under this subsection, the provisions of section 1847(j)(2) and
paragraph (1)(II) of subsection (a), shall, as determined
appropriate by the Secretary, apply under this subsection in
the same manner as such provisions of section 1847A(j)(2) and
subsection (a) apply under such section and subsection.''.
(4) OPPS conforming amendment.--Section 1833(t)(8) of the
Social Security Act (42 U.S.C. 1395l(t)(8)) is amended by
adding at the end the following new subparagraph:
``(G) Selected drugs subject to rebate.--In the
case of a selected drug (as defined in section
1192(c)), subject to a rebate under section 1847A(j)
for which payment under this subsection is not packaged
into a payment for a covered OPD service (or group of
services) furnished on or after the initial price
applicability year for the selected drug, and the
payment for such drug is the same as the amount for a
calendar quarter under section 1847A(b)(1)(B), under
the system under this subsection, in lieu of the
calculation of the copayment amount and the amount
otherwise applicable under this subsection (other than
the application of the limitation described in
subparagraph (C)), the provisions of section
1847A(j)(2) and paragraph (1)(II) of subsection (a),
shall, as determined by the Secretary apply under this
section in the same manner as such provisions of
section 1847A(j)(2) and subsection (a) apply under such
section and subsection.''.
(5) Exclusion of selected drug mfp rebates from asp
calculation.--Section 1847A(c)(3) of the Social Security Act
(42 U.S.C. 1395w-3a(c)(3)) is amended by striking ``subsection
(i)'' and inserting ``subsection (i), subsection (j)''.
(6) Coordination with medicaid rebate information
disclosures.--Section 1927(b)(3)(D)(i) of the Social Security
Act (42 U.S.C. 1396r-8(b)(3)(D)(i)) is amended by striking
``and the rebate'' and inserting ``and the rebates''.
(7) Provision of rebates.--Section 1193(a) of the Social
Security Act (42 U.S.C. 1320f-2(a)) is amended--
(A) in paragraph (1), by striking subparagraph (B)
and inserting the following:
``(B) by paying rebates in accordance with section
1847A(j);'';
(B) in paragraph (2), by striking subparagraph (B)
and inserting the following:
``(B) by paying rebates in accordance with section
1847A(j);''; and
(C) in paragraph (3), by striking subparagraph (B)
and inserting the following:
``(B) by paying rebates in accordance with section
1847A(j);''.
(c) Conforming Amendments.--
(1) Section 1847A(i)(5) of the Social Security Act (42
U.S.C. 1395w-3a(i)(5)) is amended, in the matter preceding
subparagraph (A)--
(A) by striking ``In the case'' and inserting
``Subsection to subsection (j)(2)(B), in the case'';
and
(B) by striking ``(or, in the case of a part B
rebatable drug that is a selected drug (as defined in
section 1192(c)), the payment amount described in
subsection (b)(1)(B) for such drug)''; and
(2) Section 1833(a)(1)(EE) of the Social Security Act (42
U.S.C. 1395l(a)(1)(EE)) is amended--
(A) by striking ``(or, in the case of a part B
rebatable drug that is a selected drug (as defined in
section 1192(c) for which, the payment amount described
in section 1847A(b)(1)(B)) for such drug for such
quarter''; and
(B) by striking ``or section 1847A(b)(1)(B), as
applicable,''.
TITLE V--EXPANDED-ACCESS PRESCRIPTION DRUGS
SEC. 501. EXPANDED-ACCESS PRESCRIPTION DRUGS.
(a) In General.--Section 503(b) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 353(b)) is amended by adding at the end the
following:
``(6) Expanded-access Prescription Drugs.--
``(A) Establishment of list.--The Secretary shall establish
and maintain a list of expanded-access prescription drugs.
``(B) Designation.--The Secretary shall designate such
expanded-access prescription drugs based on safety data,
evidence of low risk, and suitability for assessment in a
pharmacy or similar setting (such as certain antibiotics for
minor infections, antivirals, hormonal therapies, and
maintenance drugs for chronic conditions).
``(C) Dispensing and administering.--Notwithstanding
paragraph (1), an expanded-access prescription drug may be
dispensed and administered by a covered individual after
conducting an appropriate patient assessment consistent with
protocols to be issued by the Secretary.
``(D) Rulemaking.--Not later than 120 days after the date
of enactment of this paragraph, the Secretary shall issue such
regulations through notice-and-comment rulemaking as may be
necessary to carry out this paragraph, including--
``(i) to establish and maintain the list under
subparagraph (A); and
``(ii) to issue protocols under subparagraph (C).
``(E) Preemption.--
``(i) In general.--Except as provided in clause
(ii), no State or political subdivision of a State may
establish, enforce, or continue in effect with respect
to an expanded-access prescription drug any provision
of law or legal requirement, including with respect to
licensure of a covered individual, that is different
from, or is in conflict with, any requirement
applicable under this paragraph.
``(ii) State opt-out authority.--The prohibition in
clause (i) shall not apply in the case of a State
(excluding a political subdivision thereof) that has in
effect a law explicitly prohibiting or limiting the
prescribing or dispensing of an expanded-access
prescription drug by a covered individual.
``(F) Covered individual defined.--In this paragraph, the
term `covered individual' means an individual who is licensed
under applicable State law as--
``(i) a pharmacist;
``(ii) an advanced practice registered nurse;
``(iii) an advanced practice provider;
``(iv) a physician assistant; or
``(v) such other health care professional, as may
be specified by the Secretary.''.
(b) Congressional Report.--Not later than 2 years after the date of
enactment of this Act, the Secretary of Health and Human Services shall
submit to Congress a report on the implementation of, and State opt-
outs under, paragraph (6) of section 503(b) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 353(b)) (as added by subsection (a)).
SEC. 502. GOVERNMENT SPONSORED PROGRAMS.
(a) Requirement.--The President shall take such steps as are
necessary to ensure that each Government sponsored program includes
coverage for expanded-access prescription drugs administered by covered
individuals to beneficiaries of the program.
(b) Preemption.--A covered individual may administer expanded-
access prescription drugs pursuant to subsection (a) regardless of a
provision of law or legal requirement in the State of the covered
individual regarding the licensure or scope-of-practice of the
individual.
(c) Definitions.--In this section:
(1) The term ``covered individual'' has the meaning given
that term in section 503(b)(6) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 353(b)(6)), as added by section 501 of
this Act.
(2) The term ``expanded-access prescription drugs'' means
drugs covered under such section 503(b)(6).
(3) The term ``Government sponsored program'' means any
coverage described in section 5000A(f)(1)(A) of the Internal
Revenue Code of 1986.
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