H.R. 8324

[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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