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[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 1332 Introduced in House (IH)]

<DOC>

116th CONGRESS
  1st Session
                                H. R. 1332

To address the high costs of health care services, prescription drugs, 
   and health insurance coverage in the United States, and for other 
                               purposes.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                           February 25, 2019

Mr. Westerman introduced the following bill; which was referred to the 
Committee on Energy and Commerce, and in addition to the Committees on 
  Ways and Means, the Judiciary, Oversight and Reform, Education and 
Labor, Rules, the Budget, Armed Services, and House Administration, 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 address the high costs of health care services, prescription drugs, 
   and health insurance coverage in the United States, 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 ``Fair Care Act of 
2019''.
    (b) Table of Contents.--The table of contents for this Act is as 
follows:

Sec. 1. Short title; table of contents.
            TITLE I--PRIVATE-SECTOR HEALTH INSURANCE REFORMS

           Subtitle A--Commercial Health Insurance Provisions

Sec. 101. Invisible high risk pool reinsurance program; tax on exchange 
                            plans.
Sec. 102. Change in permissible age variation in health insurance 
                            premium rates.
Sec. 103. Employer health insurance mandate repeal.
Sec. 104. Employer benefits reports.
Sec. 105. Waivers for State innovation.
Sec. 106. State-operated Exchanges flexibility for open enrollment 
                            periods.
Sec. 107. Enrollment periods.
Sec. 108. Short-term limited duration insurance.
Sec. 109. Promoting health plans that cover individuals in more than 
                            one State.
Sec. 110. Restoring the application of antitrust laws to the business 
                            of health insurance.
Sec. 111. Health plans created under PPACA or offered through Exchanges 
                            to be only health plans Federal Government 
                            may make available to President, Vice 
                            President, Members of Congress, and Federal 
                            employees.
Sec. 112. Cost-sharing reductions.
Sec. 113. Health savings accounts.
Sec. 114. Adding copper plans to Exchanges.
Sec. 115. Eliminating FEHBP eligibility for annuitants.
                  Subtitle B--Association Health Plans

Sec. 121. Rules governing association health plans.
Sec. 122. Clarification of treatment of single employer arrangements.
Sec. 123. Enforcement provisions relating to association health plans.
Sec. 124. Cooperation between Federal and State authorities.
Sec. 125. Effective date and transitional and other rules.
                   Subtitle C--Tax-Related Provisions

Sec. 131. Premium assistance adjustment to reflect age.
Sec. 132. Repeal of annual fee on health insurance providers.
Sec. 133. Repeal of medical device excise tax.
Sec. 134. Inclusion in income of certain costs of employer-provided 
                            coverage under health plans.
Sec. 135. Inclusion of certain over-the-counter medical products as 
                            qualified medical expenses.
Sec. 136. Repeal of limitation on health flexible spending 
                            arrangements.
Sec. 137. Medicare part D tax deduction.
Sec. 138. Repeal of net investment income tax.
Sec. 139. Basis for purposes of determining gain or loss.
Sec. 140. Deduction for qualified charity care.
Sec. 141. Limitation on liability for volunteer health care 
                            professionals.
                TITLE II--MEDICARE AND MEDICAID REFORMS

               Subtitle A--Medicare and Medicaid Reforms

Sec. 201. Flexible block grant option for States.
Sec. 202. Medicaid eligibility determinations.
Sec. 203. Lowering safe harbor threshold with respect to State taxes on 
                            health care providers.
Sec. 204. Income limitations for refundable credits for coverage under 
                            a qualified health plan.
                          Subtitle B--Medicare

Sec. 221. Off-campus provider-based department medicare site neutral 
                            payment.
Sec. 222. Elimination of Medicare eligibility for certain individuals.
Sec. 223. Medicare coverage of bad debt.
                 Subtitle C--Medical Malpractice Reform

Sec. 231. Encouraging speedy resolution of claims.
Sec. 232. Compensating patient injury.
Sec. 233. Maximizing patient recovery.
Sec. 234. Authorization of payment of future damages to claimants in 
                            health care lawsuits.
Sec. 235. Product liability for health care providers.
Sec. 236. Definitions.
Sec. 237. Effect on other laws.
Sec. 238. Rules of construction.
Sec. 239. Effective date.
Sec. 240. Limitation on expert witness testimony.
Sec. 241. Communications following unanticipated outcome.
Sec. 242. Expert witness qualifications.
Sec. 243. Affidavit of merit.
Sec. 244. Notice of intent to commence lawsuit.
                TITLE III--PRESCRIPTION DRUG COMPETITION

Subtitle A--Eliminating Delays of Generic Drugs and Biosimilar Products

Sec. 301. Actions for delays of generic drugs and biosimilar biological 
                            products.
Sec. 302. REMS approval process for subsequent filers.
     Subtitle B--Increasing Access to Drugs and Biosimilar Products

Sec. 311. Expedited development and priority review for generic complex 
                            drug products.
Sec. 312. Increasing pharmaceutical options to treat an unmet medical 
                            need.
Sec. 313. Preemption of State barriers to the substitution of 
                            biosimilar products.
     Subtitle C--Limiting Exclusivity Periods Delaying Competition

Sec. 321. Limiting exclusivity periods for drugs treating rare diseases 
                            and conditions.
Sec. 322. Limiting exclusivity for biosimilar products.
         Subtitle D--Congressional Review of Agency Rulemaking

Sec. 331. Congressional review of the Food and Drug Administration 
                            rulemaking.
Sec. 332. Government Accountability Office study of rules.
           Subtitle E--Medicare Prescription Drug Competition

Sec. 341. Medicare drug coverage.
Sec. 342. PBM transparency and elimination of DIR fees.
Sec. 343. Sunset of limit on maximum rebate amount for single source 
                            drugs and innovator multiple source drugs.
Sec. 344. Regulation of manufacturer-sponsored copay contributions.
Sec. 345. Data reporting to improve the transparency regarding how 340B 
                            hospital covered entities provide care for 
                            patients.
Sec. 346. Requiring 340B drug discount program reports by DSH hospital 
                            covered entities on low-income utilization 
                            rate of outpatient hospital services.
                     TITLE IV--PROVIDER COMPETITION

Sec. 401. Hospital consolidation.
Sec. 402. Price transparency.
Sec. 403. Repealing shared savings incentives from Medicare shared 
                            savings program.
Sec. 404. Repeal of health care reform provisions limiting Medicare 
                            exception to the prohibition on certain 
                            physician referrals for hospitals.
Sec. 405. Advisory group on reducing burden of hospital administrative 
                            requirements.
Sec. 406. Authority of Federal Trade Commission over certain tax-exempt 
                            organizations.
                      TITLE V--DIGITAL HEALTH CARE

Sec. 501. Access of individuals to protected health information.
Sec. 502. Expansion of coverage of telehealth services.
Sec. 503. STARK and AKS exemptions.
Sec. 504. STARK technical penalty.

            TITLE I--PRIVATE-SECTOR HEALTH INSURANCE REFORMS

           Subtitle A--Commercial Health Insurance Provisions

SEC. 101. INVISIBLE HIGH RISK POOL REINSURANCE PROGRAM; TAX ON EXCHANGE 
              PLANS.

    (a) Establishment.--Not later than January 1, 2021, the Secretary 
of Health and Human Services shall establish the Invisible High Risk 
Pool Reinsurance Program (in this section referred to as the ``IHRPR 
program'').
    (b) State Grants.--Under the IHRPR program, the Secretary shall, 
from amounts appropriated under subsection (f) for a fiscal year, award 
grants to States for such fiscal year, in amounts determined in 
accordance with the allocation methodology specified under subsection 
(d). Such grants shall be used for the purpose of establishing or 
maintaining a qualifying invisible high risk pool for the State.
    (c) Federal Default.--
            (1) In general.--In the case of a State that does not, by a 
        date and in a manner specified by the Secretary, choose to be 
        awarded a grant under subsection (b) for a fiscal year to 
        operate a qualifying invisible high risk pool for the State, 
        the Secretary shall, from amounts appropriated under subsection 
        (f) for such fiscal year, use the allocation determined for the 
        State under subsection (d) for participation of such State in 
        the Federal default qualifying invisible high risk pool 
        described in paragraph (2).
            (2) Federal default qualifying invisible high risk pool.--
        The Federal default qualifying high risk pool is, with respect 
        to each State that chooses not to be awarded a grant under 
        subsection (b) with respect to a fiscal year for which funds 
        are appropriated under subsection (f), an invisible high risk 
        pool under which health insurance issuers participating in the 
        Exchange of such a State, with respect to designated 
        individuals who are enrolled in health insurance coverage and 
        are expected to experience higher than average health costs as 
        determined by the insurer, cede risk to the pool, without 
        affecting the premium paid by the designated individuals or 
        their terms of coverage. With respect to such pool--
                    (A) high-risk individuals designated for cession to 
                the pool shall be designated by the ceding issuer;
                    (B) the premium amount the ceding issuer shall pay 
                to the reinsurance pool shall be 90 percent of the 
                premium paid to the issuer for the coverage;
                    (C) the ceding issuer shall retain the same risk 
                under the ceded policies as under any other policy of 
                the issuer with respect to the first $10,000 of 
                benefits for each ceded policy involved and will not 
                retain any risk under ceded policies after such first 
                $10,000 of benefits; and
                    (D) after a ceding issuer, with respect to a ceded 
                policy, no longer retains risk under such policy 
                pursuant to subparagraph (C), the negotiated rate under 
                such policy for items and services shall be payable at 
                the reimbursement rate under the Medicare program under 
                title XVIII of the Social Security Act for such items 
                and services, or in the case of items and services for 
                which payment is available under the policy but not the 
                Medicare program, at a rate determined by the 
                Secretary.
    (d) Allocation Methodology.--Not later than June 30, 2020, the 
Secretary shall specify an allocation methodology for determining the 
amount of funds appropriated under subsection (f) for a fiscal year to 
be allocated for each State for purposes of subsections (b) and (c). 
Such methodology shall be based on the number of residents of each 
State and the general health status of such residents.
    (e) Qualifying Invisible High Risk Pool.--For purposes of this 
section, the term ``qualifying invisible high risk pool'' means, with 
respect to a State, a method of designation under which health 
insurance issuers identify individuals who experience higher than 
average health costs as determined by the State and are enrolled in 
health insurance coverage offered in the individual market, and cede 
the risk of spending more than $10,000 on health care services for a 
single individual to the pool without affecting the premium paid by the 
designated individuals or their terms of coverage. With respect to such 
pool, the State, or an entity operating the pool on behalf of the 
State, shall establish--
            (1) the premium amount the ceding issuer shall pay to the 
        reinsurance pool;
            (2) the applicable attachment points or coinsurance 
        percentages if the ceding issuer retains any portion of the 
        risk under ceded policies, except that the provisions of 
        subparagraphs (C) and (D) of subsection (c)(2) shall apply to 
        such high risk pool in the same manner as such clauses apply to 
        the Federal default high risk pool; and
            (3) the mechanism by which high-risk individuals are 
        designated for cession to the pool, which may include a list of 
        designated high-cost health conditions.
    (f) Appropriations.--There is appropriated to the Secretary of 
Health and Human Services $200,000,000,000 to carry out this section 
for the period of fiscal year 2020 through fiscal year 2029.
    (g) Tax on Health Insurance Plans Sold on Exchanges.--
            (1) In general.--Chapter 34 of the Internal Revenue Code of 
        1986 is amended by adding at the end the following new 
        subchapter:

   ``Subchapter C--Additional Tax on Health Insurance Plans Sold by 
                  Insurers Offering Plans on Exchanges

``Sec. 4401. Additional tax on health insurance plans sold by insurers 
                            offering plans on exchanges.

``SEC. 4401. ADDITIONAL TAX ON HEALTH INSURANCE PLANS SOLD BY INSURERS 
              OFFERING PLANS ON EXCHANGES.

    ``(a) Imposition of Tax.--There is imposed a tax of $4 for each 
policy month of each health insurance policy sold by insurers offering 
plans through an Exchange established under the Patient Protection and 
Affordable Care Act.
    ``(b) Liability.--The tax imposed by subsection (a) shall be paid 
by the plan sponsor.''.
            (2) Conforming amendment.--The table of subchapters for 
        chapter 34 of the Internal Revenue Code of 1986 is amended by 
        adding at the end the following item:

   ``subchapter c--additional tax on health insurance plans sold by 
                insurers offering plans on exchanges''.

            (3) Effective date.--The amendments made by this subsection 
        shall apply with respect to months beginning after the date of 
        enactment of this Act.

SEC. 102. CHANGE IN PERMISSIBLE AGE VARIATION IN HEALTH INSURANCE 
              PREMIUM RATES.

    Section 2701(a)(1)(A)(iii) of the Public Health Service Act (42 
U.S.C. 300gg(a)(1)(A)(iii)) is amended by inserting after ``(consistent 
with section 2707(c))'' the following: ``or, for plan years beginning 
on or after January 1, 2020, as the Secretary may implement through 
interim final regulation, 5 to 1 for adults (consistent with section 
2707(c))''.

SEC. 103. EMPLOYER HEALTH INSURANCE MANDATE REPEAL.

    (a) In General.--Chapter 43 of the Internal Revenue Code of 1986 is 
amended by striking section 4980H.
    (b) Repeal of Related Reporting Requirements.--Subpart D of part 
III of subchapter A of chapter 61 of such Code is amended by striking 
section 6056.
    (c) Conforming Amendments.--
            (1) Section 6724(d)(1)(B) of such Code is amended by 
        inserting ``or'' at the end of clause (xxiii), by striking 
        ``or'' at the end of clause (xxiv), and by striking clause 
        (xxv).
            (2) Section 6724(d)(2) of such Code is amended by inserting 
        ``or'' at the end of subparagraph (GG) and by striking 
        subparagraph (HH).
            (3) The table of sections for chapter 43 of such Code is 
        amended by striking the item relating to section 4980H.
            (4) The table of sections for subpart D of part III of 
        subchapter A of chapter 61 of such Code is amended by striking 
        the item relating to section 6056.
            (5) Section 1513 of the Patient Protection and Affordable 
        Care Act is amended by striking subsection (c).
    (d) Effective Date.--
            (1) In general.--Except as otherwise provided in this 
        subsection, the amendments made by this section shall apply to 
        months and other periods beginning after December 31, 2020.
            (2) Repeal of study and report.--The amendment made by 
        subsection (c)(5) shall take effect on the date of the 
        enactment of this Act.

SEC. 104. EMPLOYER BENEFITS REPORTS.

    (a) In General.--Subject to subsection (b), for each plan year 
beginning on or after January 1, 2021, a group health plan and a health 
insurance issuer offering group health insurance coverage shall provide 
to each individual enrolled in such plan or such coverage for such plan 
year a notification containing the following:
            (1) The amount the sponsor of such group health plan 
        expended with respect to such individual under such plan for 
        such plan year (or, in the case of a health insurance issuer 
        offering group health insurance coverage, the amount the 
        employer of such individual contributed for such coverage for 
        such individual for such plan year).
            (2) The amount the sponsor of such group health plan 
        expended with respect to such individual under such plan for 
        each previous plan year (or, in the case of a health insurance 
        issuer offering group health insurance coverage, the amount the 
        employer of such individual contributed for such coverage for 
        such individual for each previous plan year), if applicable.
    (b) Limitation.--Subsection (a) shall not apply to a group health 
plan, or a health insurance issuer offering group health insurance 
coverage, for a plan year if, for such plan year, the number of 
individuals enrolled under such plan or such coverage was less than 
100.
    (c) Penalty.--In the case that the Secretary of Health and Human 
Services determines that a group health plan or a health insurance 
issuer offering group health insurance failed to provide the notice 
required under subsection (a), the Secretary may impose a civil 
monetary penalty on the sponsor of such plan or such issuer, as 
applicable, in an amount not to exceed $100 per individual enrolled in 
such plan or such coverage per day that such sponsor or issuer failed 
to provide such notification to such individual.
    (d) Definitions.--In this section, the terms ``group health plan'', 
``group health insurance coverage'', ``health insurance issuer'', and 
``sponsor'' have the meaning given such terms in section 2791 of the 
Public Health Service Act (42 U.S.C. 300gg-91).

SEC. 105. WAIVERS FOR STATE INNOVATION.

    (a) Streamlining the State Application Process.--Section 1332 of 
the Patient Protection and Affordable Care Act (42 U.S.C. 18052) is 
amended--
            (1) in subsection (a)(1)(C), by striking ``the law'' and 
        inserting ``a law or has in effect a certification''; and
            (2) in subsection (b)(2)--
                    (A) in the paragraph heading, by inserting ``or 
                certify'' after ``law'';
                    (B) in subparagraph (A)--
                            (i) by striking ``A law'' and inserting the 
                        following:
                            ``(i) Laws.--A law''; and
                            (ii) by adding at the end the following:
                            ``(ii) Certifications.--A certification 
                        described in this paragraph is a document, 
                        signed by the Governor of the State, that 
                        certifies that such Governor has the authority 
                        under existing Federal and State law to take 
                        action under this section, including 
                        implementation of the State plan under 
                        subsection (a)(1)(B).''; and
                    (C) in subparagraph (B)--
                            (i) in the subparagraph heading, by 
                        striking ``of opt out''; and
                            (ii) by striking ``may repeal a law'' and 
                        all that follows through the period at the end 
                        and inserting the following: ``may terminate 
                        the authority provided under the waiver with 
                        respect to the State by--
                            ``(i) repealing a law described in 
                        subparagraph (A)(i); or
                            ``(ii) terminating a certification 
                        described in subparagraph (A)(ii), through a 
                        certification for such termination signed by 
                        the Governor of the State.''.
    (b) Providing Expedited Approval of State Waivers.--Section 1332(d) 
of the Patient Protection and Affordable Care Act (42 U.S.C. 18052(d)) 
is amended--
            (1) in paragraph (1) by striking ``180'' and inserting 
        ``90''; and
            (2) by adding at the end the following:
            ``(3) Expedited determination.--
                    ``(A) In general.--With respect to any application 
                under subsection (a)(1) submitted on or after the date 
                of this paragraph or any such application submitted 
                prior to such date of enactment and under review by the 
                Secretary on such date of enactment, the Secretary 
                shall make a determination on such application, using 
                the criteria for approval otherwise applicable under 
                this section, not later than 45 days after the receipt 
                of such application, and shall allow the public notice 
                and comment at the State and Federal levels described 
                under subsection (a)(4) to occur concurrently if such 
                State application--
                            ``(i) is submitted in response to an urgent 
                        situation, with respect to areas in the State 
                        that the Secretary determines are at risk for 
                        excessive premium increases or having no health 
                        plans offered in the applicable health 
                        insurance market for the current or following 
                        plan year; or
                            ``(ii) is for a waiver that is the same or 
                        substantially similar to a waiver that the 
                        Secretary already has approved for another 
                        State.
                    ``(B) Approval.--
                            ``(i) Urgent situations.--
                                    ``(I) Provisional approval.--A 
                                waiver approved under the expedited 
                                determination process under 
                                subparagraph (A)(i) shall be in effect 
                                for a period of 3 years, unless the 
                                State requests a shorter duration.
                                    ``(II) Full approval.--Subject to 
                                the requirements for approval otherwise 
                                applicable under this section, not 
                                later than 1 year before the expiration 
                                of a provisional waiver period 
                                described in subclause (I) with respect 
                                to an application described in 
                                subparagraph (A)(i), the Secretary 
                                shall make a determination on whether 
                                to extend the approval of such waiver 
                                for the full term of the waiver 
                                requested by the State, for a total 
                                approval period not to exceed 6 years. 
                                The Secretary may request additional 
                                information as the Secretary determines 
                                appropriate to make such determination.
                            ``(ii) Approval of same or similar 
                        applications.--An approval of a waiver under 
                        subparagraph (A)(ii) shall be subject to the 
                        terms of subsection (e).
                    ``(C) GAO study.--Not later than 5 years after the 
                date of enactment of this paragraph, the Comptroller 
                General of the United States shall conduct a review of 
                all waivers approved pursuant to an application under 
                subparagraph (A)(ii) to evaluate whether such waivers 
                met the requirements of subsection (b)(1) and whether 
                the applications should have qualified for such 
                expedited process.''.
    (c) Providing Certainty for State-Based Reforms.--Section 1332(e) 
of the Patient Protection and Affordable Care Act (42 U.S.C. 18052(e)) 
is amended by striking ``No waiver'' and all that follows through the 
period at the end and inserting the following: ``A waiver under this 
section--
            ``(1) shall be in effect for a period of 6 years unless the 
        State requests a shorter duration;
            ``(2) may be renewed, subject to the State meeting the 
        criteria for approval otherwise applicable under this section, 
        for unlimited additional 6-year periods upon application by the 
        State; and
            ``(3) may not be suspended or terminated, in whole or in 
        part, by the Secretary at any time before the date of 
        expiration of the waiver period (including any renewal period 
        under paragraph (2)), unless the Secretary determines that the 
        State materially failed to comply with the terms and conditions 
        of the waiver.''.
    (d) Ensuring Patient Access to More Flexible Health Plans.--Section 
1332(b)(1)(B) of the Patient Protection and Affordable Care Act (42 
U.S.C. 18052(b)(1)(B)) is amended by striking ``at least as 
affordable'' and inserting ``of comparable affordability, including for 
low-income individuals, individuals with serious health needs, and 
other vulnerable populations,''.
    (e) Applicability.--The amendments made by this Act to section 1332 
of the Patient Protection and Affordable Care Act (42 U.S.C. 18052)--
            (1) with respect to applications for waivers under such 
        section 1332 submitted after the date of enactment of this Act 
        and applications for such waivers submitted prior to such date 
        of enactment and under review by the Secretary on the date of 
        enactment, shall take effect on the date of enactment of this 
        Act; and
            (2) with respect to applications for waivers approved under 
        such section 1332 before the date of enactment of this Act, 
        shall not require reconsideration of whether such applications 
        meet the requirements of such section 1332, except that, at the 
        request of a State, the Secretary shall recalculate the amount 
        of funding provided under subsection (a)(3) of such section.

SEC. 106. STATE-OPERATED EXCHANGES FLEXIBILITY FOR OPEN ENROLLMENT 
              PERIODS.

    Section 1311(c) of the Patient Protection and Affordable Care Act 
(42 U.S.C. 18031(c)) is amended--
            (1) in paragraph (6), by striking ``The Secretary'' and 
        inserting ``Subject to paragraph (7), the Secretary''; and
            (2) by adding at the end the following new paragraph:
            ``(7) Flexibility for enrollment periods.--
                    ``(A) State-operated exchanges open enrollment 
                periods.--In the case of an Exchange operated by a 
                State, beginning with plan year 2021, the Exchange may 
                provide for open enrollment periods (after the initial 
                enrollment period) every 12, 24, or 36 months, as 
                determined by the State.''.

SEC. 107. ENROLLMENT PERIODS.

    (a) Exchanges.--Paragraph (7) of section 1311(c) of the Patient 
Protection and Affordable Care Act (42 U.S.C. 18031(c)), as added by 
section 106, is amended by adding at the end the following new 
subparagraph:
                    ``(B) Enrollments other than during initial, open, 
                and special enrollment periods.--Beginning with plan 
                year 2021, an Exchange may provide for enrollments 
                during period in addition to open enrollment periods 
                described in subparagraph (A) or paragraph (6) and 
                special enrollment periods described in paragraph 
                (6).''.
    (b) Health Plans.--Subpart I of part A of title XXVII of the Public 
Health Service Act is amended by adding at the end the following new 
section:

``SEC. 2710. ENROLLMENT OUTSIDE OF INITIAL, OPEN, AND SPECIAL 
              ENROLLMENT PERIOD.

    ``Beginning with plan year 2021, a group health plan and a health 
insurance issuer offering group or individual health insurance coverage 
may provide for enrollment in such plan or coverage during periods in 
addition to initial, open, or special enrollment periods. In the case 
that an individual enrolls in such plan or coverage during a period 
pursuant to the previous sentence, the plan or issuer may charge the 
individual a one-time enrollment fee.''.

SEC. 108. SHORT-TERM LIMITED DURATION INSURANCE.

    (a) Definition.--Section 2791(b) of the Public Health Service Act 
(42 U.S.C. 300gg-91(b)) is amended by adding at the end the following:
            ``(6) Short-term limited duration insurance.--The term 
        `short-term limited duration insurance' means health insurance 
        coverage provided pursuant to a contract with a health 
        insurance issuer that has an expiration date specified in the 
        contract (not taking into account any extensions that may be 
        elected by the policyholder with or without the issuer's 
        consent) that is less than 12 months after the original 
        effective date of the contract.''.
    (b) Guaranteed Renewability.--Section 2703 of the Public Health 
Service Act (42 U.S.C. 300gg-2) is amended--
            (1) in subsection (a), by inserting ``or offers short-term 
        limited duration insurance'' after ``group market''; and
            (2) by adding at the end the following:
    ``(f) Application to Short-Term Limited Duration Insurance.--
            ``(1) In general.--In applying this section in the case of 
        short-term limited duration insurance--
                    ``(A) a reference to `health insurance coverage' 
                with respect to such coverage offered in the individual 
                market shall be deemed to include short-term limited 
                duration insurance; and
                    ``(B) a reference to `health insurance issuer' with 
                respect to health insurance coverage offered in the 
                individual market shall be deemed to include an issuer 
                of short-term limited duration insurance.
            ``(2) Special rule for short-term limited duration 
        insurance.--In the case of short-term limited duration 
        insurance, at the time of application for enrollment in such 
        insurance coverage, an issuer of such insurance may offer 
        renewability of such coverage, and an individual may decline 
        renewability of such coverage in accordance with this section, 
        and the contract between such individual and the health 
        insurance issuer shall specify whether the individual opted for 
        renewability or no renewability.''.
    (c) Applicability.--The amendments made by subsections (a) and (b) 
shall apply with respect to contracts for short-term limited duration 
insurance that take effect on or after January 1, 2020.

SEC. 109. PROMOTING HEALTH PLANS THAT COVER INDIVIDUALS IN MORE THAN 
              ONE STATE.

    There are appropriated, out of amounts in the Treasury not 
otherwise appropriated, $10,000,000 to be made available by December 
31, 2020, to the Center for Medicare & Medicaid Innovation to fund new 
research or pilot programs dedicated to pursuing viable methods of 
enrolling individuals in health insurance programs that cross State 
lines.

SEC. 110. RESTORING THE APPLICATION OF ANTITRUST LAWS TO THE BUSINESS 
              OF HEALTH INSURANCE.

    (a) Amendment to McCarran-Ferguson Act.--Section 3 of the Act of 
March 9, 1945 (15 U.S.C. 1013), commonly known as the McCarran-Ferguson 
Act, is amended by adding at the end the following:
    ``(c)(1) Nothing contained in this Act shall modify, impair, or 
supersede the operation of any of the antitrust laws with respect to 
the business of health insurance (including the business of dental 
insurance and limited-scope dental benefits).
    ``(2) Paragraph (1) shall not apply with respect to making a 
contract, or engaging in a combination or conspiracy--
            ``(A) to collect, compile, or disseminate historical loss 
        data;
            ``(B) to determine a loss development factor applicable to 
        historical loss data;
            ``(C) to perform actuarial services if such contract, 
        combination, or conspiracy does not involve a restraint of 
        trade; or
            ``(D) to develop or disseminate a standard insurance policy 
        form (including a standard addendum to an insurance policy form 
        and standard terminology in an insurance policy form) if such 
        contract, combination, or conspiracy is not to adhere to such 
        standard form or require adherence to such standard form.
    ``(3) For purposes of this subsection--
            ``(A) the term `antitrust laws' has the meaning given it in 
        subsection (a) of the first section of the Clayton Act (15 
        U.S.C. 12), except that such term includes section 5 of the 
        Federal Trade Commission Act (15 U.S.C. 45) to the extent that 
        such section 5 applies to unfair methods of competition;
            ``(B) the term `business of health insurance (including the 
        business of dental insurance and limited-scope dental 
        benefits)' does not include--
                    ``(i) the business of life insurance (including 
                annuities); or
                    ``(ii) the business of property or casualty 
                insurance, including but not limited to--
                            ``(I) any insurance or benefits defined as 
                        `excepted benefits' under paragraph (1), 
                        subparagraph (B) or (C) of paragraph (2), or 
                        paragraph (3) of section 9832(c) of the 
                        Internal Revenue Code of 1986 (26 U.S.C. 
                        9832(c)) whether offered separately or in 
                        combination with insurance or benefits 
                        described in paragraph (2)(A) of such section; 
                        and
                            ``(II) any other line of insurance that is 
                        classified as property or casualty insurance 
                        under State law;
            ``(C) the term `historical loss data' means information 
        respecting claims paid, or reserves held for claims reported, 
        by any person engaged in the business of insurance; and
            ``(D) the term `loss development factor' means an 
        adjustment to be made to reserves held for losses incurred for 
        claims reported by any person engaged in the business of 
        insurance, for the purpose of bringing such reserves to an 
        ultimate paid basis.''.
    (b) Related Provision.--For purposes of section 5 of the Federal 
Trade Commission Act (15 U.S.C. 45) to the extent such section applies 
to unfair methods of competition, section 3(c) of the McCarran-Ferguson 
Act shall apply with respect to the business of health insurance 
without regard to whether such business is carried on for profit, 
notwithstanding the definition of ``Corporation'' contained in section 
4 of the Federal Trade Commission Act.

SEC. 111. HEALTH PLANS CREATED UNDER PPACA OR OFFERED THROUGH EXCHANGES 
              TO BE ONLY HEALTH PLANS FEDERAL GOVERNMENT MAY MAKE 
              AVAILABLE TO PRESIDENT, VICE PRESIDENT, MEMBERS OF 
              CONGRESS, AND FEDERAL EMPLOYEES.

    Section 1312(d)(3)(D) of the Patient Protection and Affordable Care 
Act (42 U.S.C. 18032(d)(3)(D)) is amended--
            (1) in the subparagraph heading, by striking ``Members of 
        congress'' and inserting ``President, vice president, members 
        of congress, and federal employees'';
            (2) in clause (i), in the matter preceding subclause (I)--
                    (A) by striking ``Members of Congress and 
                congressional staff'' and inserting ``the President, 
                Vice President, Members of Congress, and Federal 
                employees''; and
                    (B) by striking ``a Member of Congress or 
                congressional staff'' and inserting ``the President, 
                the Vice President, a Member of Congress, or a Federal 
                employee''; and
            (3) in clause (ii), by amending subclause (II) to read as 
        follows:
                                    ``(II) Federal employee.--The term 
                                `Federal employee' means--
                                            ``(aa) an `employee', as 
                                        such term is defined in section 
                                        2105 of title 5, United States 
                                        Code; and
                                            ``(bb) includes an 
                                        individual to whom subsection 
                                        (c) or (f) of such section 2105 
                                        pertains (whether or not such 
                                        individual satisfies item 
                                        (aa)).''.

SEC. 112. COST-SHARING REDUCTIONS.

    (a) Cost-sharing Reduction Payments.--Section 1402 of the Patient 
Protection and Affordable Care Act (42 U.S.C. 18071) is amended by 
adding at the end the following new subsection:
    ``(g) Funding.--
            ``(1) Appropriations.--There is appropriated, from any 
        money in the Treasury not otherwise appropriated, such sums as 
        may be necessary to, subject to paragraph (2), provide health 
        benefits coverage through payment to issuers (under this 
        section or through advance payment by the Secretary of the 
        Treasury under section 1412(c)(3)) of the amounts computed 
        under this section for each of plan years 2019 through 2022.
            ``(2) Adjustments.--Notwithstanding any other provision of 
        law, payments and other actions for adjustments to obligations 
        incurred prior to December 31, 2020, may be made through 
        December 31, 2021.
            ``(3) Limitation.--Amounts appropriated under paragraph (1) 
        for each of plan years 2019 through 2022 are subject to the 
        requirements and limitations under sections 506 and 507 of 
        division H of Public Law 115-31 in the same manner and to the 
        same extent as if such amounts for each such year were 
        appropriated under such division.''.
    (b) Election.--In the case of an election under this subsection by 
a State and a certification by the Secretary of Health and Human 
Services that such election will not result in an increase in Federal 
expenditures, in lieu of the amounts that would be paid to health 
insurance issuers in such State under section 1402 of the Patient 
Protection and Affordable Care Act, the Secretary may pay to such State 
an amount equal to such amounts. Prior to such payment, such State 
shall make such assurances as the Secretary deems necessary to ensure 
that such State shall redistribute such payments to health savings 
accounts of individuals--
            (1) enrolled in qualified health plans (as defined in 
        section 36B of the Internal Revenue Code of 1986) offered by 
        such issuers, and
            (2) whose income is less than 250 percent of the Federal 
        poverty line.

SEC. 113. HEALTH SAVINGS ACCOUNTS.

    (a) No High Deductible Health Plans Required for Health Savings 
Account Contributions.--
            (1) In general.--Section 223 of the Internal Revenue Code 
        of 1986 is amended by inserting ``or qualified health plan'' 
        after ``high deductible health plan'' each place such term 
        appears.
            (2) Qualified health plan defined.--Section 223(c) of such 
        Code is amended to read as follows:
    ``(c) Eligible Individual.--For purposes of this section--
            ``(1) In general.--The term `eligible individual' means, 
        with respect to any month, any individual if such individual is 
        covered under a qualified health plan as of the 1st day of such 
        month.
            ``(2) Qualified health plan.--The term `qualified health 
        plan' has the meaning given such term in section 36B.''.
    (b) Premiums for Plans as Qualified Medical Expenses; Treatment of 
Abortions.--
            (1) In general.--Section 223(d)(2)(B) of such Code is 
        amended to read as follows:
                    ``(B) Abortions.--
                            ``(i) Payments for health insurance with 
                        abortion coverage.--The term `qualified medical 
                        expense' shall not include amounts paid for 
                        insurance that includes coverage for abortions.
                            ``(ii) Payments for abortions.--The term 
                        `qualified medical expense' shall not include 
                        amounts paid for an abortion.
                            ``(iii) Exception.--Clauses (i) and (ii) 
                        shall not apply to an abortion, or to coverage 
                        for an abortion--
                                    ``(I) if the pregnancy is the 
                                result of an act of rape or incest, or
                                    ``(II) in the case where a woman 
                                suffers from a physical disorder, 
                                physical injury, or physical illness 
                                that would, as certified by a 
                                physician, place the woman in danger of 
                                death unless an abortion is performed, 
                                including a life-endangering physical 
                                condition caused by or arising from the 
                                pregnancy itself.''.
            (2) Conforming amendment.--Subsection 223(d)(2) is amended 
        by striking subparagraph (C).

SEC. 114. ADDING COPPER PLANS TO EXCHANGES.

    (a) In General.--Section 1302 of the Patient Protection and 
Affordable Care Act (42 U.S.C. 18022) is amended--
            (1) in subsection (a)(3), by inserting ``copper,'' after 
        ``either the'';
            (2) in subsection (c), by adding at the end the following 
        new paragraph:
            ``(5) Special rule for copper plans.--A health plan in the 
        copper level of coverage (as described in subsection (d)(1)(E)) 
        shall be deemed to meet the requirements of this subsection.'';
            (3) in subsection (d)--
                    (A) in paragraph (1), by adding at the end the 
                following new subparagraph:
                    ``(E) Copper level.--A plan in the copper level 
                shall provide a level of coverage that is designed to 
                provide benefits that are actuarially equivalent to 50 
                percent of the full actuarial value of the benefits 
                provided under the plan.''; and
                    (B) in paragraph (4)--
                            (i) by inserting ``copper,'' after ``any 
                        reference to a''; and
                            (ii) by inserting ``copper,'' after 
                        ``providing a''; and
            (4) in subsection (e)(1), by inserting ``copper,'' after 
        ``not providing a''.
    (b) Effective Date.--The amendments made by this section shall 
apply with respect to plan years beginning on or after January 1, 2020.

SEC. 115. ELIMINATING FEHBP ELIGIBILITY FOR ANNUITANTS.

    Section 8905(b) of title 5, United States Code, is amended--
            (1) in the matter preceding paragraph (1), by striking 
        ``An'' and inserting ``Consistent with the last sentence of 
        this subsection, an''; and
            (2) by adding at the end the following: ``. An individual 
        who is entitled to benefits under part A of title XVIII of the 
        Social Security Act (42 U.S.C. 1395c et seq.) by reason of 
        section 226 or 226A of such Act (42 U.S.C. 426, 426-1), or 
        otherwise eligible to enroll under such part pursuant to 
        section 1818 or 1818A of such Act (42 U.S.C. 1395i-2, 1395i-
        2a), and who first becomes an annuitant after the date of 
        enactment of this sentence may not continue enrollment in any 
        health benefits plan under this chapter.''.

                  Subtitle B--Association Health Plans

SEC. 121. RULES GOVERNING ASSOCIATION HEALTH PLANS.

    (a) In General.--Subtitle B of title I of the Employee Retirement 
Income Security Act of 1974 is amended by adding after part 7 the 
following new part:

           ``PART 8--RULES GOVERNING ASSOCIATION HEALTH PLANS

``SEC. 801. ASSOCIATION HEALTH PLANS.

    ``(a) In General.--For purposes of this part, the term `association 
health plan' means a group health plan whose sponsor is (or is deemed 
under this part to be) described in subsection (b).
    ``(b) Sponsorship.--The sponsor of a group health plan is described 
in this subsection if such sponsor--
            ``(1) is organized and maintained in good faith, with a 
        constitution and bylaws specifically stating its purpose and 
        providing for periodic meetings on at least an annual basis, as 
        a bona fide trade association, a bona fide industry association 
        (including a rural electric cooperative association or a rural 
        telephone cooperative association), a bona fide professional 
        association, or a bona fide chamber of commerce (or similar 
        bona fide business association, including a corporation or 
        similar organization that operates on a cooperative basis 
        (within the meaning of section 1381 of the Internal Revenue 
        Code of 1986)), for substantial purposes other than that of 
        obtaining or providing medical care;
            ``(2) is established as a permanent entity which receives 
        the active support of its members and requires for membership 
        payment on a periodic basis of dues or payments necessary to 
        maintain eligibility for membership in the sponsor; and
            ``(3) does not condition membership, such dues or payments, 
        or coverage under the plan on the basis of health status-
        related factors with respect to the employees of its members 
        (or affiliated members), or the dependents of such employees, 
        and does not condition such dues or payments on the basis of 
        group health plan participation.
Any sponsor consisting of an association of entities which meet the 
requirements of paragraphs (1), (2), and (3) shall be deemed to be a 
sponsor described in this subsection.

``SEC. 802. CERTIFICATION OF ASSOCIATION HEALTH PLANS.

    ``(a) In General.--The applicable authority shall prescribe by 
regulation a procedure under which, subject to subsection (b), the 
applicable authority shall certify association health plans which apply 
for certification as meeting the requirements of this part.
    ``(b) Standards.--Under the procedure prescribed pursuant to 
subsection (a), in the case of an association health plan that provides 
at least one benefit option which does not consist of health insurance 
coverage, the applicable authority shall certify such plan as meeting 
the requirements of this part only if the applicable authority is 
satisfied that the applicable requirements of this part are met (or, 
upon the date on which the plan is to commence operations, will be met) 
with respect to the plan.
    ``(c) Requirements Applicable to Certified Plans.--An association 
health plan with respect to which certification under this part is in 
effect shall meet the applicable requirements of this part, effective 
on the date of certification (or, if later, on the date on which the 
plan is to commence operations).
    ``(d) Requirements for Continued Certification.--The applicable 
authority may provide by regulation for continued certification of 
association health plans under this part.
    ``(e) Class Certification for Fully Insured Plans.--The applicable 
authority shall establish a class certification procedure for 
association health plans under which all benefits consist of health 
insurance coverage. Under such procedure, the applicable authority 
shall provide for the granting of certification under this part to the 
plans in each class of such association health plans upon appropriate 
filing under such procedure in connection with plans in such class and 
payment of the prescribed fee under section 807(a).
    ``(f) Certification of Self-Insured Association Health Plans.--An 
association health plan which offers one or more benefit options which 
do not consist of health insurance coverage may be certified under this 
part only if such plan consists of any of the following:
            ``(1) A plan which offered such coverage on the date of the 
        enactment of this section.
            ``(2) A plan under which the sponsor does not restrict 
        membership to one or more trades and businesses or industries 
        and whose eligible participating employers represent a broad 
        cross-section of trades and businesses or industries.
            ``(3) A plan whose eligible participating employers 
        represent one or more trades or businesses, or one or more 
        industries, consisting of any of the following: agriculture; 
        equipment and automobile dealerships; barbering and 
        cosmetology; certified public accounting practices; child care; 
        construction; dance, theatrical and orchestra productions; 
        disinfecting and pest control; financial services; fishing; 
        food service establishments; hospitals; labor organizations; 
        logging; manufacturing (metals); mining; medical and dental 
        practices; medical laboratories; professional consulting 
        services; sanitary services; transportation (local and 
        freight); warehousing; wholesaling/distributing; or any other 
        trade or business or industry which has been indicated as 
        having average or above-average risk or health claims 
        experience by reason of State rate filings, denials of 
        coverage, proposed premium rate levels, or other means 
        demonstrated by such plan in accordance with regulations.

``SEC. 803. REQUIREMENTS RELATING TO SPONSORS AND BOARDS OF TRUSTEES.

    ``(a) Sponsor.--The requirements of this subsection are met with 
respect to an association health plan if the sponsor has met (or is 
deemed under this part to have met) the requirements of section 801(b) 
for a continuous period of not less than 3 years ending with the date 
of the application for certification under this part.
    ``(b) Board of Trustees.--The requirements of this subsection are 
met with respect to an association health plan if the following 
requirements are met:
            ``(1) Fiscal control.--The plan is operated, pursuant to a 
        trust agreement, by a board of trustees which has complete 
        fiscal control over the plan and which is responsible for all 
        operations of the plan.
            ``(2) Rules of operation and financial controls.--The board 
        of trustees has in effect rules of operation and financial 
        controls, based on a 3-year plan of operation, adequate to 
        carry out the terms of the plan and to meet all requirements of 
        this title applicable to the plan.
            ``(3) Rules governing relationship to participating 
        employers and to contractors.--
                    ``(A) Board membership.--
                            ``(i) In general.--Except as provided in 
                        clauses (ii) and (iii), the members of the 
                        board of trustees are individuals selected from 
                        individuals who are the owners, officers, 
                        directors, or employees of the participating 
                        employers or who are partners in the 
                        participating employers and actively 
                        participate in the business.
                            ``(ii) Limitation.--
                                    ``(I) General rule.--Except as 
                                provided in subclauses (II) and (III), 
                                no such member is an owner, officer, 
                                director, or employee of, or partner 
                                in, a contract administrator or other 
                                service provider to the plan.
                                    ``(II) Limited exception for 
                                providers of services solely on behalf 
                                of the sponsor.--Officers or employees 
                                of a sponsor which is a service 
                                provider (other than a contract 
                                administrator) to the plan may be 
                                members of the board if they constitute 
                                not more than 25 percent of the 
                                membership of the board and they do not 
                                provide services to the plan other than 
                                on behalf of the sponsor.
                                    ``(III) Treatment of providers of 
                                medical care.--In the case of a sponsor 
                                which is an association whose 
                                membership consists primarily of 
                                providers of medical care, subclause 
                                (I) shall not apply in the case of any 
                                service provider described in subclause 
                                (I) who is a provider of medical care 
                                under the plan.
                            ``(iii) Certain plans excluded.--Clause (i) 
                        shall not apply to an association health plan 
                        which is in existence on the date of the 
                        enactment of this section.
                    ``(B) Sole authority.--The board has sole authority 
                under the plan to approve applications for 
                participation in the plan and to contract with a 
                service provider to administer the day-to-day affairs 
                of the plan.
    ``(c) Treatment of Franchise Networks.--In the case of a group 
health plan which is established and maintained by a franchiser for a 
franchise network consisting of its franchisees--
            ``(1) the requirements of subsection (a) and section 801(a) 
        shall be deemed met if such requirements would otherwise be met 
        if the franchiser were deemed to be the sponsor referred to in 
        section 801(b), such network were deemed to be an association 
        described in section 801(b), and each franchisee were deemed to 
        be a member (of the association and the sponsor) referred to in 
        section 801(b); and
            ``(2) the requirements of section 804(a)(1) shall be deemed 
        met.
The Secretary may by regulation define for purposes of this subsection 
the terms `franchiser', `franchise network', and `franchisee'.

``SEC. 804. PARTICIPATION AND COVERAGE REQUIREMENTS.

    ``(a) Covered Employers and Individuals.--The requirements of this 
subsection are met with respect to an association health plan if, under 
the terms of the plan--
            ``(1) each participating employer must be--
                    ``(A) a member of the sponsor,
                    ``(B) the sponsor, or
                    ``(C) an affiliated member of the sponsor with 
                respect to which the requirements of subsection (b) are 
                met,
        except that, in the case of a sponsor which is a professional 
        association or other individual-based association, if at least 
        one of the officers, directors, or employees of an employer, or 
        at least one of the individuals who are partners in an employer 
        and who actively participates in the business, is a member or 
        such an affiliated member of the sponsor, participating 
        employers may also include such employer; and
            ``(2) all individuals commencing coverage under the plan 
        after certification under this part must be--
                    ``(A) active or retired owners (including self-
                employed individuals), officers, directors, or 
                employees of, or partners in, participating employers; 
                or
                    ``(B) the beneficiaries of individuals described in 
                subparagraph (A).
    ``(b) Coverage of Previously Uninsured Employees.--In the case of 
an association health plan in existence on the date of the enactment of 
this section, an affiliated member of the sponsor of the plan may be 
offered coverage under the plan as a participating employer only if--
            ``(1) the affiliated member was an affiliated member on the 
        date of certification under this part; or
            ``(2) during the 12-month period preceding the date of the 
        offering of such coverage, the affiliated member has not 
        maintained or contributed to a group health plan with respect 
        to any of its employees who would otherwise be eligible to 
        participate in such association health plan.
    ``(c) Individual Market Unaffected.--The requirements of this 
subsection are met with respect to an association health plan if, under 
the terms of the plan, no participating employer may provide health 
insurance coverage in the individual market for any employee not 
covered under the plan which is similar to the coverage 
contemporaneously provided to employees of the employer under the plan, 
if such exclusion of the employee from coverage under the plan is based 
on a health status-related factor with respect to the employee and such 
employee would, but for such exclusion on such basis, be eligible for 
coverage under the plan.
    ``(d) Prohibition of Discrimination Against Employers and Employees 
Eligible To Participate.--The requirements of this subsection are met 
with respect to an association health plan if--
            ``(1) under the terms of the plan, all employers meeting 
        the preceding requirements of this section are eligible to 
        qualify as participating employers for all geographically 
        available coverage options, unless, in the case of any such 
        employer, participation or contribution requirements of the 
        type referred to in section 2711 of the Public Health Service 
        Act are not met;
            ``(2) upon request, any employer eligible to participate is 
        furnished information regarding all coverage options available 
        under the plan; and
            ``(3) the applicable requirements of sections 701, 702, and 
        703 are met with respect to the plan.

``SEC. 805. OTHER REQUIREMENTS RELATING TO PLAN DOCUMENTS, CONTRIBUTION 
              RATES, AND BENEFIT OPTIONS.

    ``(a) In General.--The requirements of this section are met with 
respect to an association health plan if the following requirements are 
met:
            ``(1) Contents of governing instruments.--The instruments 
        governing the plan include a written instrument, meeting the 
        requirements of an instrument required under section 402(a)(1), 
        which--
                    ``(A) provides that the board of trustees serves as 
                the named fiduciary required for plans under section 
                402(a)(1) and serves in the capacity of a plan 
                administrator (referred to in section 3(16)(A));
                    ``(B) provides that the sponsor of the plan is to 
                serve as plan sponsor (referred to in section 
                3(16)(B)); and
                    ``(C) incorporates the requirements of section 806.
            ``(2) Contribution rates must be nondiscriminatory.--
                    ``(A) The contribution rates for any participating 
                small employer do not vary on the basis of any health 
                status-related factor in relation to employees of such 
                employer or their beneficiaries and do not vary on the 
                basis of the type of business or industry in which such 
                employer is engaged.
                    ``(B) Nothing in this title or any other provision 
                of law shall be construed to preclude an association 
                health plan, or a health insurance issuer offering 
                health insurance coverage in connection with an 
                association health plan, from--
                            ``(i) setting contribution rates based on 
                        the claims experience of the plan; or
                            ``(ii) varying contribution rates for small 
                        employers in a State to the extent that such 
                        rates could vary using the same methodology 
                        employed in such State for regulating premium 
                        rates in the small group market with respect to 
                        health insurance coverage offered in connection 
                        with bona fide associations (within the meaning 
                        of section 2791(d)(3) of the Public Health 
                        Service Act),
                subject to the requirements of section 702(b) relating 
                to contribution rates.
            ``(3) Floor for number of covered individuals with respect 
        to certain plans.--If any benefit option under the plan does 
        not consist of health insurance coverage, the plan has as of 
        the beginning of the plan year not fewer than 1,000 
        participants and beneficiaries.
            ``(4) Marketing requirements.--
                    ``(A) In general.--If a benefit option which 
                consists of health insurance coverage is offered under 
                the plan, State-licensed insurance agents shall be used 
                to distribute to small employers coverage which does 
                not consist of health insurance coverage in a manner 
                comparable to the manner in which such agents are used 
                to distribute health insurance coverage.
                    ``(B) State-licensed insurance agents.--For 
                purposes of subparagraph (A), the term `State-licensed 
                insurance agents' means one or more agents who are 
                licensed in a State and are subject to the laws of such 
                State relating to licensure, qualification, testing, 
                examination, and continuing education of persons 
                authorized to offer, sell, or solicit health insurance 
                coverage in such State.
            ``(5) Regulatory requirements.--Such other requirements as 
        the applicable authority determines are necessary to carry out 
        the purposes of this part, which shall be prescribed by the 
        applicable authority by regulation.
    ``(b) Ability of Association Health Plans To Design Benefit 
Options.--Subject to section 514(d), nothing in this part or any 
provision of State law (as defined in section 514(c)(1)) shall be 
construed to preclude an association health plan, or a health insurance 
issuer offering health insurance coverage in connection with an 
association health plan, from exercising its sole discretion in 
selecting the specific items and services consisting of medical care to 
be included as benefits under such plan or coverage, except (subject to 
section 514) in the case of (1) any law to the extent that it is not 
preempted under section 731(a)(1) with respect to matters governed by 
section 711, 712, or 713, or (2) any law of the State with which filing 
and approval of a policy type offered by the plan was initially 
obtained to the extent that such law prohibits an exclusion of a 
specific disease from such coverage.

``SEC. 806. MAINTENANCE OF RESERVES AND PROVISIONS FOR SOLVENCY FOR 
              PLANS PROVIDING HEALTH BENEFITS IN ADDITION TO HEALTH 
              INSURANCE COVERAGE.

    ``(a) In General.--The requirements of this section are met with 
respect to an association health plan if--
            ``(1) the benefits under the plan consist solely of health 
        insurance coverage; or
            ``(2) if the plan provides any additional benefit options 
        which do not consist of health insurance coverage, the plan--
                    ``(A) establishes and maintains reserves with 
                respect to such additional benefit options, in amounts 
                recommended by the qualified actuary, consisting of--
                            ``(i) a reserve sufficient for unearned 
                        contributions;
                            ``(ii) a reserve sufficient for benefit 
                        liabilities which have been incurred, which 
                        have not been satisfied, and for which risk of 
                        loss has not yet been transferred, and for 
                        expected administrative costs with respect to 
                        such benefit liabilities;
                            ``(iii) a reserve sufficient for any other 
                        obligations of the plan; and
                            ``(iv) a reserve sufficient for a margin of 
                        error and other fluctuations, taking into 
                        account the specific circumstances of the plan; 
                        and
                    ``(B) establishes and maintains aggregate and 
                specific excess/stop loss insurance and solvency 
                indemnification, with respect to such additional 
                benefit options for which risk of loss has not yet been 
                transferred, as follows:
                            ``(i) The plan shall secure aggregate 
                        excess/stop loss insurance for the plan with an 
                        attachment point which is not greater than 125 
                        percent of expected gross annual claims. The 
                        applicable authority may by regulation provide 
                        for upward adjustments in the amount of such 
                        percentage in specified circumstances in which 
                        the plan specifically provides for and 
                        maintains reserves in excess of the amounts 
                        required under subparagraph (A).
                            ``(ii) The plan shall secure specific 
                        excess/stop loss insurance for the plan with an 
                        attachment point which is at least equal to an 
                        amount recommended by the plan's qualified 
                        actuary. The applicable authority may by 
                        regulation provide for adjustments in the 
                        amount of such insurance in specified 
                        circumstances in which the plan specifically 
                        provides for and maintains reserves in excess 
                        of the amounts required under subparagraph (A).
                            ``(iii) The plan shall secure 
                        indemnification insurance for any claims which 
                        the plan is unable to satisfy by reason of a 
                        plan termination.
Any person issuing to a plan insurance described in clause (i), (ii), 
or (iii) of subparagraph (B) shall notify the Secretary of any failure 
of premium payment meriting cancellation of the policy prior to 
undertaking such a cancellation. Any regulations prescribed by the 
applicable authority pursuant to clause (i) or (ii) of subparagraph (B) 
may allow for such adjustments in the required levels of excess/stop 
loss insurance as the qualified actuary may recommend, taking into 
account the specific circumstances of the plan.
    ``(b) Minimum Surplus in Addition to Claims Reserves.--In the case 
of any association health plan described in subsection (a)(2), the 
requirements of this subsection are met if the plan establishes and 
maintains surplus in an amount at least equal to--
            ``(1) $500,000, or
            ``(2) such greater amount (but not greater than $2,000,000) 
        as may be set forth in regulations prescribed by the applicable 
        authority, considering the level of aggregate and specific 
        excess/stop loss insurance provided with respect to such plan 
        and other factors related to solvency risk, such as the plan's 
        projected levels of participation or claims, the nature of the 
        plan's liabilities, and the types of assets available to assure 
        that such liabilities are met.
    ``(c) Additional Requirements.--In the case of any association 
health plan described in subsection (a)(2), the applicable authority 
may provide such additional requirements relating to reserves, excess/
stop loss insurance, and indemnification insurance as the applicable 
authority considers appropriate. Such requirements may be provided by 
regulation with respect to any such plan or any class of such plans.
    ``(d) Adjustments for Excess/Stop Loss Insurance.--The applicable 
authority may provide for adjustments to the levels of reserves 
otherwise required under subsections (a) and (b) with respect to any 
plan or class of plans to take into account excess/stop loss insurance 
provided with respect to such plan or plans.
    ``(e) Alternative Means of Compliance.--The applicable authority 
may permit an association health plan described in subsection (a)(2) to 
substitute, for all or part of the requirements of this section (except 
subsection (a)(2)(B)(iii)), such security, guarantee, hold-harmless 
arrangement, or other financial arrangement as the applicable authority 
determines to be adequate to enable the plan to fully meet all its 
financial obligations on a timely basis and is otherwise no less 
protective of the interests of participants and beneficiaries than the 
requirements for which it is substituted. The applicable authority may 
take into account, for purposes of this subsection, evidence provided 
by the plan or sponsor which demonstrates an assumption of liability 
with respect to the plan. Such evidence may be in the form of a 
contract of indemnification, lien, bonding, insurance, letter of 
credit, recourse under applicable terms of the plan in the form of 
assessments of participating employers, security, or other financial 
arrangement.
    ``(f) Measures To Ensure Continued Payment of Benefits by Certain 
Plans in Distress.--
            ``(1) Payments by certain plans to association health plan 
        fund.--
                    ``(A) In general.--In the case of an association 
                health plan described in subsection (a)(2), the 
                requirements of this subsection are met if the plan 
                makes payments into the Association Health Plan Fund 
                under this subparagraph when they are due. Such 
                payments shall consist of annual payments in the amount 
                of $5,000, and, in addition to such annual payments, 
                such supplemental payments as the Secretary may 
                determine to be necessary under paragraph (2). Payments 
                under this paragraph are payable to the Fund at the 
                time determined by the Secretary. Initial payments are 
                due in advance of certification under this part. 
                Payments shall continue to accrue until a plan's assets 
                are distributed pursuant to a termination procedure.
                    ``(B) Penalties for failure to make payments.--If 
                any payment is not made by a plan when it is due, a 
                late payment charge of not more than 100 percent of the 
                payment which was not timely paid shall be payable by 
                the plan to the Fund.
                    ``(C) Continued duty of the secretary.--The 
                Secretary shall not cease to carry out the provisions 
                of paragraph (2) on account of the failure of a plan to 
                pay any payment when due.
            ``(2) Payments by secretary to continue excess/stop loss 
        insurance coverage and indemnification insurance coverage for 
        certain plans.--In any case in which the applicable authority 
        determines that there is, or that there is reason to believe 
        that there will be: (A) A failure to take necessary corrective 
        actions under section 809(a) with respect to an association 
        health plan described in subsection (a)(2); or (B) a 
        termination of such a plan under section 809(b) or 810(b)(8) 
        (and, if the applicable authority is not the Secretary, 
        certifies such determination to the Secretary), the Secretary 
        shall determine the amounts necessary to make payments to an 
        insurer (designated by the Secretary) to maintain in force 
        excess/stop loss insurance coverage or indemnification 
        insurance coverage for such plan, if the Secretary determines 
        that there is a reasonable expectation that, without such 
        payments, claims would not be satisfied by reason of 
        termination of such coverage. The Secretary shall, to the 
        extent provided in advance in appropriation Acts, pay such 
        amounts so determined to the insurer designated by the 
        Secretary.
            ``(3) Association health plan fund.--
                    ``(A) In general.--There is established on the 
                books of the Treasury a fund to be known as the 
                `Association Health Plan Fund'. The Fund shall be 
                available for making payments pursuant to paragraph 
                (2). The Fund shall be credited with payments received 
                pursuant to paragraph (1)(A), penalties received 
                pursuant to paragraph (1)(B); and earnings on 
                investments of amounts of the Fund under subparagraph 
                (B).
                    ``(B) Investment.--Whenever the Secretary 
                determines that the moneys of the fund are in excess of 
                current needs, the Secretary may request the investment 
                of such amounts as the Secretary determines advisable 
                by the Secretary of the Treasury in obligations issued 
                or guaranteed by the United States.
    ``(g) Excess/Stop Loss Insurance.--For purposes of this section--
            ``(1) Aggregate excess/stop loss insurance.--The term 
        `aggregate excess/stop loss insurance' means, in connection 
        with an association health plan, a contract--
                    ``(A) under which an insurer (meeting such minimum 
                standards as the applicable authority may prescribe by 
                regulation) provides for payment to the plan with 
                respect to aggregate claims under the plan in excess of 
                an amount or amounts specified in such contract;
                    ``(B) which is guaranteed renewable; and
                    ``(C) which allows for payment of premiums by any 
                third party on behalf of the insured plan.
            ``(2) Specific excess/stop loss insurance.--The term 
        `specific excess/stop loss insurance' means, in connection with 
        an association health plan, a contract--
                    ``(A) under which an insurer (meeting such minimum 
                standards as the applicable authority may prescribe by 
                regulation) provides for payment to the plan with 
                respect to claims under the plan in connection with a 
                covered individual in excess of an amount or amounts 
                specified in such contract in connection with such 
                covered individual;
                    ``(B) which is guaranteed renewable; and
                    ``(C) which allows for payment of premiums by any 
                third party on behalf of the insured plan.
    ``(h) Indemnification Insurance.--For purposes of this section, the 
term `indemnification insurance' means, in connection with an 
association health plan, a contract--
            ``(1) under which an insurer (meeting such minimum 
        standards as the applicable authority may prescribe by 
        regulation) provides for payment to the plan with respect to 
        claims under the plan which the plan is unable to satisfy by 
        reason of a termination pursuant to section 809(b) (relating to 
        mandatory termination);
            ``(2) which is guaranteed renewable and noncancellable for 
        any reason (except as the applicable authority may prescribe by 
        regulation); and
            ``(3) which allows for payment of premiums by any third 
        party on behalf of the insured plan.
    ``(i) Reserves.--For purposes of this section, the term `reserves' 
means, in connection with an association health plan, plan assets which 
meet the fiduciary standards under part 4 and such additional 
requirements regarding liquidity as the applicable authority may 
prescribe by regulation.
    ``(j) Solvency Standards Working Group.--
            ``(1) In general.--Within 90 days after the date of the 
        enactment of this section, the applicable authority shall 
        establish a Solvency Standards Working Group. In prescribing 
        the initial regulations under this section, the applicable 
        authority shall take into account the recommendations of such 
        Working Group.
            ``(2) Membership.--The Working Group shall consist of not 
        more than 15 members appointed by the applicable authority. The 
        applicable authority shall include among persons invited to 
        membership on the Working Group at least one of each of the 
        following:
                    ``(A) A representative of the National Association 
                of Insurance Commissioners.
                    ``(B) A representative of the American Academy of 
                Actuaries.
                    ``(C) A representative of the State governments, or 
                their interests.
                    ``(D) A representative of existing self-insured 
                arrangements, or their interests.
                    ``(E) A representative of associations of the type 
                referred to in section 801(b)(1), or their interests.
                    ``(F) A representative of multiemployer plans that 
                are group health plans, or their interests.

``SEC. 807. REQUIREMENTS FOR APPLICATION AND RELATED REQUIREMENTS.

    ``(a) Filing Fee.--Under the procedure prescribed pursuant to 
section 802(a), an association health plan shall pay to the applicable 
authority at the time of filing an application for certification under 
this part a filing fee in the amount of $5,000, which shall be 
available in the case of the Secretary, to the extent provided in 
appropriation Acts, for the sole purpose of administering the 
certification procedures applicable with respect to association health 
plans.
    ``(b) Information To Be Included in Application for 
Certification.--An application for certification under this part meets 
the requirements of this section only if it includes, in a manner and 
form which shall be prescribed by the applicable authority by 
regulation, at least the following information:
            ``(1) Identifying information.--The names and addresses 
        of--
                    ``(A) the sponsor; and
                    ``(B) the members of the board of trustees of the 
                plan.
            ``(2) States in which plan intends to do business.--The 
        States in which participants and beneficiaries under the plan 
        are to be located and the number of them expected to be located 
        in each such State.
            ``(3) Bonding requirements.--Evidence provided by the board 
        of trustees that the bonding requirements of section 412 will 
        be met as of the date of the application or (if later) 
        commencement of operations.
            ``(4) Plan documents.--A copy of the documents governing 
        the plan (including any bylaws and trust agreements), the 
        summary plan description, and other material describing the 
        benefits that will be provided to participants and 
        beneficiaries under the plan.
            ``(5) Agreements with service providers.--A copy of any 
        agreements between the plan and contract administrators and 
        other service providers.
            ``(6) Funding report.--In the case of association health 
        plans providing benefits options in addition to health 
        insurance coverage, a report setting forth information with 
        respect to such additional benefit options determined as of a 
        date within the 120-day period ending with the date of the 
        application, including the following:
                    ``(A) Reserves.--A statement, certified by the 
                board of trustees of the plan, and a statement of 
                actuarial opinion, signed by a qualified actuary, that 
                all applicable requirements of section 806 are or will 
                be met in accordance with regulations which the 
                applicable authority shall prescribe.
                    ``(B) Adequacy of contribution rates.--A statement 
                of actuarial opinion, signed by a qualified actuary, 
                which sets forth a description of the extent to which 
                contribution rates are adequate to provide for the 
                payment of all obligations and the maintenance of 
                required reserves under the plan for the 12-month 
                period beginning with such date within such 120-day 
                period, taking into account the expected coverage and 
                experience of the plan. If the contribution rates are 
                not fully adequate, the statement of actuarial opinion 
                shall indicate the extent to which the rates are 
                inadequate and the changes needed to ensure adequacy.
                    ``(C) Current and projected value of assets and 
                liabilities.--A statement of actuarial opinion signed 
                by a qualified actuary, which sets forth the current 
                value of the assets and liabilities accumulated under 
                the plan and a projection of the assets, liabilities, 
                income, and expenses of the plan for the 12-month 
                period referred to in subparagraph (B). The income 
                statement shall identify separately the plan's 
                administrative expenses and claims.
                    ``(D) Costs of coverage to be charged and other 
                expenses.--A statement of the costs of coverage to be 
                charged, including an itemization of amounts for 
                administration, reserves, and other expenses associated 
                with the operation of the plan.
                    ``(E) Other information.--Any other information as 
                may be determined by the applicable authority, by 
                regulation, as necessary to carry out the purposes of 
                this part.
    ``(c) Filing Notice of Certification With States.--A certification 
granted under this part to an association health plan shall not be 
effective unless written notice of such certification is filed with the 
applicable State authority of each State in which at least 25 percent 
of the participants and beneficiaries under the plan are located. For 
purposes of this subsection, an individual shall be considered to be 
located in the State in which a known address of such individual is 
located or in which such individual is employed.
    ``(d) Notice of Material Changes.--In the case of any association 
health plan certified under this part, descriptions of material changes 
in any information which was required to be submitted with the 
application for the certification under this part shall be filed in 
such form and manner as shall be prescribed by the applicable authority 
by regulation. The applicable authority may require by regulation prior 
notice of material changes with respect to specified matters which 
might serve as the basis for suspension or revocation of the 
certification.
    ``(e) Reporting Requirements for Certain Association Health 
Plans.--An association health plan certified under this part which 
provides benefit options in addition to health insurance coverage for 
such plan year shall meet the requirements of section 103 by filing an 
annual report under such section which shall include information 
described in subsection (b)(6) with respect to the plan year and, 
notwithstanding section 104(a)(1)(A), shall be filed with the 
applicable authority not later than 90 days after the close of the plan 
year (or on such later date as may be prescribed by the applicable 
authority). The applicable authority may require by regulation such 
interim reports as it considers appropriate.
    ``(f) Engagement of Qualified Actuary.--The board of trustees of 
each association health plan which provides benefits options in 
addition to health insurance coverage and which is applying for 
certification under this part or is certified under this part shall 
engage, on behalf of all participants and beneficiaries, a qualified 
actuary who shall be responsible for the preparation of the materials 
comprising information necessary to be submitted by a qualified actuary 
under this part. The qualified actuary shall utilize such assumptions 
and techniques as are necessary to enable such actuary to form an 
opinion as to whether the contents of the matters reported under this 
part--
            ``(1) are in the aggregate reasonably related to the 
        experience of the plan and to reasonable expectations; and
            ``(2) represent such actuary's best estimate of anticipated 
        experience under the plan.
The opinion by the qualified actuary shall be made with respect to, and 
shall be made a part of, the annual report.

``SEC. 808. NOTICE REQUIREMENTS FOR VOLUNTARY TERMINATION.

    ``Except as provided in section 809(b), an association health plan 
which is or has been certified under this part may terminate (upon or 
at any time after cessation of accruals in benefit liabilities) only if 
the board of trustees, not less than 60 days before the proposed 
termination date--
            ``(1) provides to the participants and beneficiaries a 
        written notice of intent to terminate stating that such 
        termination is intended and the proposed termination date;
            ``(2) develops a plan for winding up the affairs of the 
        plan in connection with such termination in a manner which will 
        result in timely payment of all benefits for which the plan is 
        obligated; and
            ``(3) submits such plan in writing to the applicable 
        authority.
Actions required under this section shall be taken in such form and 
manner as may be prescribed by the applicable authority by regulation.

``SEC. 809. CORRECTIVE ACTIONS AND MANDATORY TERMINATION.

    ``(a) Actions To Avoid Depletion of Reserves.--An association 
health plan which is certified under this part and which provides 
benefits other than health insurance coverage shall continue to meet 
the requirements of section 806, irrespective of whether such 
certification continues in effect. The board of trustees of such plan 
shall determine quarterly whether the requirements of section 806 are 
met. In any case in which the board determines that there is reason to 
believe that there is or will be a failure to meet such requirements, 
or the applicable authority makes such a determination and so notifies 
the board, the board shall immediately notify the qualified actuary 
engaged by the plan, and such actuary shall, not later than the end of 
the next following month, make such recommendations to the board for 
corrective action as the actuary determines necessary to ensure 
compliance with section 806. Not later than 30 days after receiving 
from the actuary recommendations for corrective actions, the board 
shall notify the applicable authority (in such form and manner as the 
applicable authority may prescribe by regulation) of such 
recommendations of the actuary for corrective action, together with a 
description of the actions (if any) that the board has taken or plans 
to take in response to such recommendations. The board shall thereafter 
report to the applicable authority, in such form and frequency as the 
applicable authority may specify to the board, regarding corrective 
action taken by the board until the requirements of section 806 are 
met.
    ``(b) Mandatory Termination.--In any case in which--
            ``(1) the applicable authority has been notified under 
        subsection (a) (or by an issuer of excess/stop loss insurance 
        or indemnity insurance pursuant to section 806(a)) of a failure 
        of an association health plan which is or has been certified 
        under this part and is described in section 806(a)(2) to meet 
        the requirements of section 806 and has not been notified by 
        the board of trustees of the plan that corrective action has 
        restored compliance with such requirements; and
            ``(2) the applicable authority determines that there is a 
        reasonable expectation that the plan will continue to fail to 
        meet the requirements of section 806,
the board of trustees of the plan shall, at the direction of the 
applicable authority, terminate the plan and, in the course of the 
termination, take such actions as the applicable authority may require, 
including satisfying any claims referred to in section 
806(a)(2)(B)(iii) and recovering for the plan any liability under 
subsection (a)(2)(B)(iii) or (e) of section 806, as necessary to ensure 
that the affairs of the plan will be, to the maximum extent possible, 
wound up in a manner which will result in timely provision of all 
benefits for which the plan is obligated.

``SEC. 810. TRUSTEESHIP BY THE SECRETARY OF INSOLVENT ASSOCIATION 
              HEALTH PLANS PROVIDING HEALTH BENEFITS IN ADDITION TO 
              HEALTH INSURANCE COVERAGE.

    ``(a) Appointment of Secretary as Trustee for Insolvent Plans.--
Whenever the Secretary determines that an association health plan which 
is or has been certified under this part and which is described in 
section 806(a)(2) will be unable to provide benefits when due or is 
otherwise in a financially hazardous condition, as shall be defined by 
the Secretary by regulation, the Secretary shall, upon notice to the 
plan, apply to the appropriate United States district court for 
appointment of the Secretary as trustee to administer the plan for the 
duration of the insolvency. The plan may appear as a party and other 
interested persons may intervene in the proceedings at the discretion 
of the court. The court shall appoint such Secretary trustee if the 
court determines that the trusteeship is necessary to protect the 
interests of the participants and beneficiaries or providers of medical 
care or to avoid any unreasonable deterioration of the financial 
condition of the plan. The trusteeship of such Secretary shall continue 
until the conditions described in the first sentence of this subsection 
are remedied or the plan is terminated.
    ``(b) Powers as Trustee.--The Secretary, upon appointment as 
trustee under subsection (a), shall have the power--
            ``(1) to do any act authorized by the plan, this title, or 
        other applicable provisions of law to be done by the plan 
        administrator or any trustee of the plan;
            ``(2) to require the transfer of all (or any part) of the 
        assets and records of the plan to the Secretary as trustee;
            ``(3) to invest any assets of the plan which the Secretary 
        holds in accordance with the provisions of the plan, 
        regulations prescribed by the Secretary, and applicable 
        provisions of law;
            ``(4) to require the sponsor, the plan administrator, any 
        participating employer, and any employee organization 
        representing plan participants to furnish any information with 
        respect to the plan which the Secretary as trustee may 
        reasonably need in order to administer the plan;
            ``(5) to collect for the plan any amounts due the plan and 
        to recover reasonable expenses of the trusteeship;
            ``(6) to commence, prosecute, or defend on behalf of the 
        plan any suit or proceeding involving the plan;
            ``(7) to issue, publish, or file such notices, statements, 
        and reports as may be required by the Secretary by regulation 
        or required by any order of the court;
            ``(8) to terminate the plan (or provide for its termination 
        in accordance with section 809(b)) and liquidate the plan 
        assets, to restore the plan to the responsibility of the 
        sponsor, or to continue the trusteeship;
            ``(9) to provide for the enrollment of plan participants 
        and beneficiaries under appropriate coverage options; and
            ``(10) to do such other acts as may be necessary to comply 
        with this title or any order of the court and to protect the 
        interests of plan participants and beneficiaries and providers 
        of medical care.
    ``(c) Notice of Appointment.--As soon as practicable after the 
Secretary's appointment as trustee, the Secretary shall give notice of 
such appointment to--
            ``(1) the sponsor and plan administrator;
            ``(2) each participant;
            ``(3) each participating employer; and
            ``(4) if applicable, each employee organization which, for 
        purposes of collective bargaining, represents plan 
        participants.
    ``(d) Additional Duties.--Except to the extent inconsistent with 
the provisions of this title, or as may be otherwise ordered by the 
court, the Secretary, upon appointment as trustee under this section, 
shall be subject to the same duties as those of a trustee under section 
704 of title 11, United States Code, and shall have the duties of a 
fiduciary for purposes of this title.
    ``(e) Other Proceedings.--An application by the Secretary under 
this subsection may be filed notwithstanding the pendency in the same 
or any other court of any bankruptcy, mortgage foreclosure, or equity 
receivership proceeding, or any proceeding to reorganize, conserve, or 
liquidate such plan or its property, or any proceeding to enforce a 
lien against property of the plan.
    ``(f) Jurisdiction of Court.--
            ``(1) In general.--Upon the filing of an application for 
        the appointment as trustee or the issuance of a decree under 
        this section, the court to which the application is made shall 
        have exclusive jurisdiction of the plan involved and its 
        property wherever located with the powers, to the extent 
        consistent with the purposes of this section, of a court of the 
        United States having jurisdiction over cases under chapter 11 
        of title 11, United States Code. Pending an adjudication under 
        this section such court shall stay, and upon appointment by it 
        of the Secretary as trustee, such court shall continue the stay 
        of, any pending mortgage foreclosure, equity receivership, or 
        other proceeding to reorganize, conserve, or liquidate the 
        plan, the sponsor, or property of such plan or sponsor, and any 
        other suit against any receiver, conservator, or trustee of the 
        plan, the sponsor, or property of the plan or sponsor. Pending 
        such adjudication and upon the appointment by it of the 
        Secretary as trustee, the court may stay any proceeding to 
        enforce a lien against property of the plan or the sponsor or 
        any other suit against the plan or the sponsor.
            ``(2) Venue.--An action under this section may be brought 
        in the judicial district where the sponsor or the plan 
        administrator resides or does business or where any asset of 
        the plan is situated. A district court in which such action is 
        brought may issue process with respect to such action in any 
        other judicial district.
    ``(g) Personnel.--In accordance with regulations which shall be 
prescribed by the Secretary, the Secretary shall appoint, retain, and 
compensate accountants, actuaries, and other professional service 
personnel as may be necessary in connection with the Secretary's 
service as trustee under this section.

``SEC. 811. STATE ASSESSMENT AUTHORITY.

    ``(a) In General.--Notwithstanding section 514, a State may impose 
by law a contribution tax on an association health plan described in 
section 806(a)(2), if the plan commenced operations in such State after 
the date of the enactment of this section.
    ``(b) Contribution Tax.--For purposes of this section, the term 
`contribution tax' imposed by a State on an association health plan 
means any tax imposed by such State if--
            ``(1) such tax is computed by applying a rate to the amount 
        of premiums or contributions, with respect to individuals 
        covered under the plan who are residents of such State, which 
        are received by the plan from participating employers located 
        in such State or from such individuals;
            ``(2) the rate of such tax does not exceed the rate of any 
        tax imposed by such State on premiums or contributions received 
        by insurers or health maintenance organizations for health 
        insurance coverage offered in such State in connection with a 
        group health plan;
            ``(3) such tax is otherwise nondiscriminatory; and
            ``(4) the amount of any such tax assessed on the plan is 
        reduced by the amount of any tax or assessment otherwise 
        imposed by the State on premiums, contributions, or both 
        received by insurers or health maintenance organizations for 
        health insurance coverage, aggregate excess/stop loss insurance 
        (as defined in section 806(g)(1)), specific excess/stop loss 
        insurance (as defined in section 806(g)(2)), other insurance 
        related to the provision of medical care under the plan, or any 
        combination thereof provided by such insurers or health 
        maintenance organizations in such State in connection with such 
        plan.

``SEC. 812. DEFINITIONS AND RULES OF CONSTRUCTION.

    ``(a) Definitions.--For purposes of this part--
            ``(1) Group health plan.--The term `group health plan' has 
        the meaning provided in section 733(a)(1) (after applying 
        subsection (b) of this section).
            ``(2) Medical care.--The term `medical care' has the 
        meaning provided in section 733(a)(2).
            ``(3) Health insurance coverage.--The term `health 
        insurance coverage' has the meaning provided in section 
        733(b)(1).
            ``(4) Health insurance issuer.--The term `health insurance 
        issuer' has the meaning provided in section 733(b)(2).
            ``(5) Applicable authority.--The term `applicable 
        authority' means the Secretary, except that, in connection with 
        any exercise of the Secretary's authority regarding which the 
        Secretary is required under section 506(d) to consult with a 
        State, such term means the Secretary, in consultation with such 
        State.
            ``(6) Health status-related factor.--The term `health 
        status-related factor' has the meaning provided in section 
        733(d)(2).
            ``(7) Individual market.--
                    ``(A) In general.--The term `individual market' 
                means the market for health insurance coverage offered 
                to individuals other than in connection with a group 
                health plan.
                    ``(B) Treatment of very small groups.--
                            ``(i) In general.--Subject to clause (ii), 
                        such term includes coverage offered in 
                        connection with a group health plan that has 
                        fewer than 2 participants as current employees 
                        or participants described in section 732(d)(3) 
                        on the first day of the plan year.
                            ``(ii) State exception.--Clause (i) shall 
                        not apply in the case of health insurance 
                        coverage offered in a State if such State 
                        regulates the coverage described in such clause 
                        in the same manner and to the same extent as 
                        coverage in the small group market (as defined 
                        in section 2791(e)(5) of the Public Health 
                        Service Act) is regulated by such State.
            ``(8) Participating employer.--The term `participating 
        employer' means, in connection with an association health plan, 
        any employer, if any individual who is an employee of such 
        employer, a partner in such employer, or a self-employed 
        individual who is such employer (or any dependent, as defined 
        under the terms of the plan, of such individual) is or was 
        covered under such plan in connection with the status of such 
        individual as such an employee, partner, or self-employed 
        individual in relation to the plan.
            ``(9) Applicable state authority.--The term `applicable 
        State authority' means, with respect to a health insurance 
        issuer in a State, the State insurance commissioner or official 
        or officials designated by the State to enforce the 
        requirements of title XXVII of the Public Health Service Act 
        for the State involved with respect to such issuer.
            ``(10) Qualified actuary.--The term `qualified actuary' 
        means an individual who is a member of the American Academy of 
        Actuaries.
            ``(11) Affiliated member.--The term `affiliated member' 
        means, in connection with a sponsor--
                    ``(A) a person who is otherwise eligible to be a 
                member of the sponsor but who elects an affiliated 
                status with the sponsor,
                    ``(B) in the case of a sponsor with members which 
                consist of associations, a person who is a member of 
                any such association and elects an affiliated status 
                with the sponsor, or
                    ``(C) in the case of an association health plan in 
                existence on the date of the enactment of this section, 
                a person eligible to be a member of the sponsor or one 
                of its member associations.
            ``(12) Large employer.--The term `large employer' means, in 
        connection with a group health plan with respect to a plan 
        year, an employer who employed an average of at least 51 
        employees on business days during the preceding calendar year 
        and who employs at least 2 employees on the first day of the 
        plan year.
            ``(13) Small employer.--The term `small employer' means, in 
        connection with a group health plan with respect to a plan 
        year, an employer who is not a large employer.
    ``(b) Rules of Construction.--
            ``(1) Employers and employees.--For purposes of determining 
        whether a plan, fund, or program is an employee welfare benefit 
        plan which is an association health plan, and for purposes of 
        applying this title in connection with such plan, fund, or 
        program so determined to be such an employee welfare benefit 
        plan--
                    ``(A) in the case of a partnership, the term 
                `employer' (as defined in section 3(5)) includes the 
                partnership in relation to the partners, and the term 
                `employee' (as defined in section 3(6)) includes any 
                partner in relation to the partnership; and
                    ``(B) in the case of a self-employed individual, 
                the term `employer' (as defined in section 3(5)) and 
                the term `employee' (as defined in section 3(6)) shall 
                include such individual.
            ``(2) Plans, funds, and programs treated as employee 
        welfare benefit plans.--In the case of any plan, fund, or 
        program which was established or is maintained for the purpose 
        of providing medical care (through the purchase of insurance or 
        otherwise) for employees (or their dependents) covered 
        thereunder and which demonstrates to the Secretary that all 
        requirements for certification under this part would be met 
        with respect to such plan, fund, or program if such plan, fund, 
        or program were a group health plan, such plan, fund, or 
        program shall be treated for purposes of this title as an 
        employee welfare benefit plan on and after the date of such 
        demonstration.''.
    (b) Conforming Amendments to Preemption Rules.--
            (1) Section 514(b)(6) of such Act (29 U.S.C. 1144(b)(6)) is 
        amended by adding at the end the following new subparagraph:
    ``(E) The preceding subparagraphs of this paragraph do not apply 
with respect to any State law in the case of an association health plan 
which is certified under part 8.''.
            (2) Section 514 of such Act (29 U.S.C. 1144) is amended--
                    (A) in subsection (b)(4), by striking ``Subsection 
                (a)'' and inserting ``Subsections (a) and (f)'';
                    (B) in subsection (b)(5), by striking ``subsection 
                (a)'' in subparagraph (A) and inserting ``subsection 
                (a) of this section and subsections (a)(2)(B) and (b) 
                of section 805'', and by striking ``subsection (a)'' in 
                subparagraph (B) and inserting ``subsection (a) of this 
                section or subsection (a)(2)(B) or (b) of section 
                805''; and
                    (C) by adding at the end the following new 
                subsection:
    ``(f)(1) Except as provided in subsection (b)(4), the provisions of 
this title shall supersede any and all State laws insofar as they may 
now or hereafter preclude, or have the effect of precluding, a health 
insurance issuer from offering health insurance coverage in connection 
with an association health plan which is certified under part 8.
    ``(2) Except as provided in paragraphs (4) and (5) of subsection 
(b) of this section--
            ``(A) In any case in which health insurance coverage of any 
        policy type is offered under an association health plan 
        certified under part 8 to a participating employer operating in 
        such State, the provisions of this title shall supersede any 
        and all laws of such State insofar as they may preclude a 
        health insurance issuer from offering health insurance coverage 
        of the same policy type to other employers operating in the 
        State which are eligible for coverage under such association 
        health plan, whether or not such other employers are 
        participating employers in such plan.
            ``(B) In any case in which health insurance coverage of any 
        policy type is offered in a State under an association health 
        plan certified under part 8 and the filing, with the applicable 
        State authority (as defined in section 812(a)(9)), of the 
        policy form in connection with such policy type is approved by 
        such State authority, the provisions of this title shall 
        supersede any and all laws of any other State in which health 
        insurance coverage of such type is offered, insofar as they may 
        preclude, upon the filing in the same form and manner of such 
        policy form with the applicable State authority in such other 
        State, the approval of the filing in such other State.
    ``(3) Nothing in subsection (b)(6)(E) or the preceding provisions 
of this subsection shall be construed, with respect to health insurance 
issuers or health insurance coverage, to supersede or impair the law of 
any State--
            ``(A) providing solvency standards or similar standards 
        regarding the adequacy of insurer capital, surplus, reserves, 
        or contributions, or
            ``(B) relating to prompt payment of claims.
    ``(4) For additional provisions relating to association health 
plans, see subsections (a)(2)(B) and (b) of section 805.
    ``(5) For purposes of this subsection, the term `association health 
plan' has the meaning provided in section 801(a), and the terms `health 
insurance coverage', `participating employer', and `health insurance 
issuer' have the meanings provided such terms in section 812, 
respectively.''.
            (3) Section 514(b)(6)(A) of such Act (29 U.S.C. 
        1144(b)(6)(A)) is amended--
                    (A) in clause (i)(II), by striking ``and'' at the 
                end;
                    (B) in clause (ii), by inserting ``and which does 
                not provide medical care (within the meaning of section 
                733(a)(2)),'' after ``arrangement,'', and by striking 
                ``title.'' and inserting ``title, and''; and
                    (C) by adding at the end the following new clause:
            ``(iii) subject to subparagraph (E), in the case of any 
        other employee welfare benefit plan which is a multiple 
        employer welfare arrangement and which provides medical care 
        (within the meaning of section 733(a)(2)), any law of any State 
        which regulates insurance may apply.''.
            (4) Section 514(d) of such Act (29 U.S.C. 1144(d)) is 
        amended--
                    (A) by striking ``Nothing'' and inserting ``(1) 
                Except as provided in paragraph (2), nothing''; and
                    (B) by adding at the end the following new 
                paragraph:
    ``(2) Nothing in any other provision of law enacted on or after the 
date of the enactment of this paragraph shall be construed to alter, 
amend, modify, invalidate, impair, or supersede any provision of this 
title, except by specific cross-reference to the affected section.''.
    (c) Plan Sponsor.--Section 3(16)(B) of such Act (29 U.S.C. 
102(16)(B)) is amended by adding at the end the following new sentence: 
``Such term also includes a person serving as the sponsor of an 
association health plan under part 8.''.
    (d) Disclosure of Solvency Protections Related to Self-Insured and 
Fully Insured Options Under Association Health Plans.--Section 102(b) 
of such Act (29 U.S.C. 102(b)) is amended by adding at the end the 
following: ``An association health plan shall include in its summary 
plan description, in connection with each benefit option, a description 
of the form of solvency or guarantee fund protection secured pursuant 
to this Act or applicable State law, if any.''.
    (e) Savings Clause.--Section 731(c) of such Act is amended by 
inserting ``or part 8'' after ``this part''.
    (f) Report to the Congress Regarding Certification of Self-Insured 
Association Health Plans.--Not later than January 1, 2022, the 
Secretary of Labor shall report to the Committee on Education and Labor 
of the House of Representatives and the Committee on Health, Education, 
Labor, and Pensions of the Senate the effect association health plans 
have had, if any, on reducing the number of uninsured individuals.
    (g) Clerical Amendment.--The table of contents in section 1 of the 
Employee Retirement Income Security Act of 1974 is amended by inserting 
after the item relating to section 734 the following new items:

           ``Part 8. Rules Governing Association Health Plans

``801. Association health plans.
``802. Certification of association health plans.
``803. Requirements relating to sponsors and boards of trustees.
``804. Participation and coverage requirements.
``805. Other requirements relating to plan documents, contribution 
                            rates, and benefit options.
``806. Maintenance of reserves and provisions for solvency for plans 
                            providing health benefits in addition to 
                            health insurance coverage.
``807. Requirements for application and related requirements.
``808. Notice requirements for voluntary termination.
``809. Corrective actions and mandatory termination.
``810. Trusteeship by the Secretary of insolvent association health 
                            plans providing health benefits in addition 
                            to health insurance coverage.
``811. State assessment authority.
``812. Definitions and rules of construction.''.

SEC. 122. CLARIFICATION OF TREATMENT OF SINGLE EMPLOYER ARRANGEMENTS.

    Section 3(40)(B) of the Employee Retirement Income Security Act of 
1974 (29 U.S.C. 1002(40)(B)) is amended--
            (1) in clause (i), by inserting after ``control group,'' 
        the following: ``except that, in any case in which the benefit 
        referred to in subparagraph (A) consists of medical care (as 
        defined in section 812(a)(2)), two or more trades or 
        businesses, whether or not incorporated, shall be deemed a 
        single employer for any plan year of such plan, or any fiscal 
        year of such other arrangement, if such trades or businesses 
        are within the same control group during such year or at any 
        time during the preceding 1-year period,'';
            (2) in clause (iii), by striking ``(iii) the 
        determination'' and inserting the following:
            ``(iii)(I) in any case in which the benefit referred to in 
        subparagraph (A) consists of medical care (as defined in 
        section 812(a)(2)), the determination of whether a trade or 
        business is under `common control' with another trade or 
        business shall be determined under regulations of the Secretary 
        applying principles consistent and coextensive with the 
        principles applied in determining whether employees of two or 
        more trades or businesses are treated as employed by a single 
        employer under section 4001(b), except that, for purposes of 
        this paragraph, an interest of greater than 25 percent may not 
        be required as the minimum interest necessary for common 
        control, or
            ``(II) in any other case, the determination'';
            (3) by redesignating clauses (iv) and (v) as clauses (v) 
        and (vi), respectively; and
            (4) by inserting after clause (iii) the following new 
        clause:
            ``(iv) in any case in which the benefit referred to in 
        subparagraph (A) consists of medical care (as defined in 
        section 812(a)(2)), in determining, after the application of 
        clause (i), whether benefits are provided to employees of two 
        or more employers, the arrangement shall be treated as having 
        only one participating employer if, after the application of 
        clause (i), the number of individuals who are employees and 
        former employees of any one participating employer and who are 
        covered under the arrangement is greater than 75 percent of the 
        aggregate number of all individuals who are employees or former 
        employees of participating employers and who are covered under 
        the arrangement,''.

SEC. 123. ENFORCEMENT PROVISIONS RELATING TO ASSOCIATION HEALTH PLANS.

    (a) Criminal Penalties for Certain Willful Misrepresentations.--
Section 501 of the Employee Retirement Income Security Act of 1974 (29 
U.S.C. 1131) is amended by adding at the end the following new 
subsection:
    ``(c) Any person who willfully falsely represents, to any employee, 
any employee's beneficiary, any employer, the Secretary, or any State, 
a plan or other arrangement established or maintained for the purpose 
of offering or providing any benefit described in section 3(1) to 
employees or their beneficiaries as--
            ``(1) being an association health plan which has been 
        certified under part 8;
            ``(2) having been established or maintained under or 
        pursuant to one or more collective bargaining agreements which 
        are reached pursuant to collective bargaining described in 
        section 8(d) of the National Labor Relations Act (29 U.S.C. 
        158(d)) or paragraph Fourth of section 2 of the Railway Labor 
        Act (45 U.S.C. 152, paragraph Fourth) or which are reached 
        pursuant to labor-management negotiations under similar 
        provisions of State public employee relations laws; or
            ``(3) being a plan or arrangement described in section 
        3(40)(A)(i),
shall, upon conviction, be imprisoned not more than 5 years, be fined 
under title 18, United States Code, or both.''.
    (b) Cease Activities Orders.--Section 502 of the Employee 
Retirement Income Security Act of 1974 (29 U.S.C. 1132) is amended by 
adding at the end the following new subsection:
    ``(n) Association Health Plan Cease and Desist Orders.--
            ``(1) In general.--Subject to paragraph (2), upon 
        application by the Secretary showing the operation, promotion, 
        or marketing of an association health plan (or similar 
        arrangement providing benefits consisting of medical care (as 
        defined in section 733(a)(2))) that--
                    ``(A) is not certified under part 8, is subject 
                under section 514(b)(6) to the insurance laws of any 
                State in which the plan or arrangement offers or 
                provides benefits, and is not licensed, registered, or 
                otherwise approved under the insurance laws of such 
                State; or
                    ``(B) is an association health plan certified under 
                part 8 and is not operating in accordance with the 
                requirements under part 8 for such certification,
        a district court of the United States shall enter an order 
        requiring that the plan or arrangement cease activities.
            ``(2) Exception.--Paragraph (1) shall not apply in the case 
        of an association health plan or other arrangement if the plan 
        or arrangement shows that--
                    ``(A) all benefits under it referred to in 
                paragraph (1) consist of health insurance coverage; and
                    ``(B) with respect to each State in which the plan 
                or arrangement offers or provides benefits, the plan or 
                arrangement is operating in accordance with applicable 
                State laws that are not superseded under section 514.
            ``(3) Additional equitable relief.--The court may grant 
        such additional equitable relief, including any relief 
        available under this title, as it deems necessary to protect 
        the interests of the public and of persons having claims for 
        benefits against the plan.''.
    (c) Responsibility for Claims Procedure.--Section 503 of the 
Employee Retirement Income Security Act of 1974 (29 U.S.C. 1133) is 
amended by inserting ``(a) In General.--'' before ``In accordance'', 
and by adding at the end the following new subsection:
    ``(b) Association Health Plans.--The terms of each association 
health plan which is or has been certified under part 8 shall require 
the board of trustees or the named fiduciary (as applicable) to ensure 
that the requirements of this section are met in connection with claims 
filed under the plan.''.

SEC. 124. COOPERATION BETWEEN FEDERAL AND STATE AUTHORITIES.

    Section 506 of the Employee Retirement Income Security Act of 1974 
(29 U.S.C. 1136) is amended by adding at the end the following new 
subsection:
    ``(d) Consultation With States With Respect to Association Health 
Plans.--
            ``(1) Agreements with states.--The Secretary shall consult 
        with the State recognized under paragraph (2) with respect to 
        an association health plan regarding the exercise of--
                    ``(A) the Secretary's authority under sections 502 
                and 504 to enforce the requirements for certification 
                under part 8; and
                    ``(B) the Secretary's authority to certify 
                association health plans under part 8 in accordance 
                with regulations of the Secretary applicable to 
                certification under part 8.
            ``(2) Recognition of primary domicile state.--In carrying 
        out paragraph (1), the Secretary shall ensure that only one 
        State will be recognized, with respect to any particular 
        association health plan, as the State with which consultation 
        is required. In carrying out this paragraph--
                    ``(A) in the case of a plan which provides health 
                insurance coverage (as defined in section 812(a)(3)), 
                such State shall be the State with which filing and 
                approval of a policy type offered by the plan was 
                initially obtained, and
                    ``(B) in any other case, the Secretary shall take 
                into account the places of residence of the 
                participants and beneficiaries under the plan and the 
                State in which the trust is maintained.''.

SEC. 125. EFFECTIVE DATE AND TRANSITIONAL AND OTHER RULES.

    (a) Effective Date.--The amendments made by this Act shall take 
effect 1 year after the date of the enactment of this Act. The 
Secretary of Labor shall first issue all regulations necessary to carry 
out the amendments made by this Act within 1 year after the date of the 
enactment of this Act.
    (b) Treatment of Certain Existing Health Benefits Programs.--
            (1) In general.--In any case in which, as of the date of 
        the enactment of this Act, an arrangement is maintained in a 
        State for the purpose of providing benefits consisting of 
        medical care for the employees and beneficiaries of its 
        participating employers, at least 200 participating employers 
        make contributions to such arrangement, such arrangement has 
        been in existence for at least 10 years, and such arrangement 
        is licensed under the laws of one or more States to provide 
        such benefits to its participating employers, upon the filing 
        with the applicable authority (as defined in section 812(a)(5) 
        of the Employee Retirement Income Security Act of 1974 (as 
        amended by this subtitle)) by the arrangement of an application 
        for certification of the arrangement under part 8 of subtitle B 
        of title I of such Act--
                    (A) such arrangement shall be deemed to be a group 
                health plan for purposes of title I of such Act;
                    (B) the requirements of sections 801(a) and 803(a) 
                of the Employee Retirement Income Security Act of 1974 
                shall be deemed met with respect to such arrangement;
                    (C) the requirements of section 803(b) of such Act 
                shall be deemed met, if the arrangement is operated by 
                a board of directors which--
                            (i) is elected by the participating 
                        employers, with each employer having one vote; 
                        and
                            (ii) has complete fiscal control over the 
                        arrangement and which is responsible for all 
                        operations of the arrangement;
                    (D) the requirements of section 804(a) of such Act 
                shall be deemed met with respect to such arrangement; 
                and
                    (E) the arrangement may be certified by any 
                applicable authority with respect to its operations in 
                any State only if it operates in such State on the date 
                of certification.
        The provisions of this subsection shall cease to apply with 
        respect to any such arrangement at such time after the date of 
        the enactment of this Act as the applicable requirements of 
        this subsection are not met with respect to such arrangement.
            (2) Definitions.--For purposes of this subsection, the 
        terms ``group health plan'', ``medical care'', and 
        ``participating employer'' shall have the meanings provided in 
        section 812 of the Employee Retirement Income Security Act of 
        1974, except that the reference in paragraph (7) of such 
        section to an ``association health plan'' shall be deemed a 
        reference to an arrangement referred to in this subsection.
    (c) Coordination With Existing Law.--Nothing in this Act shall 
require plans to become certified under section 802 of the Employee 
Retirement Income Security Act of 1974, as amended by this Act, or 
require plans that are not certified under such section to comply with 
the requirements under part 8 of such Act, except to the extent 
provided in section 809 of such Act.

                   Subtitle C--Tax-Related Provisions

SEC. 131. PREMIUM ASSISTANCE ADJUSTMENT TO REFLECT AGE.

    (a) Modification of Applicable Percentage.--Section 36B(b)(3)(A) of 
the Internal Revenue Code of 1986 is amended to read as follows:
                    ``(A) Applicable percentage.--
                            ``(i) In general.--The applicable 
                        percentage for any taxable year shall be the 
                        percentage such that the applicable percentage 
                        for any taxpayer whose household income is 
                        within an income tier specified in the 
                        following table shall increase, on a sliding 
                        scale in a linear manner, from the initial 
                        percentage to the final percentage specified in 
                        such table for such income tier with respect to 
                        a taxpayer of the age involved:

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  ``In the case of              Up to Age 29                         Age 30-39                          Age 40-49                         Age 50-59                        Over Age 59
  household income  ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------
  (expressed as a
   percent of the
   poverty line)
     within the          Initial %          Final %          Initial %         Final %         Initial %         Final %         Initial %         Final %         Initial %         Final %
 following  income
       tier:
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Up to 100%           0...............  0...............  0...............  0..............  0..............  0..............  0..............  0..............  0..............  0
100%-133%            2...............  2...............  2...............  2..............  2..............  2..............  2..............  2..............  2..............  2
133%-150%            3...............  4...............  3...............  4..............  3..............  4..............  3..............  4..............  3..............  4
150%-200%            4...............  4.3.............  4...............  5.3............  4..............  6.3............  4..............  7.3............  4..............  8.3
200%-250%            4.3.............  4.3.............  5.3.............  5.9............  6.3............  8.05...........  7.3............  9..............  8.3............  10
250%-300%            4.3.............  4.3.............  5.9.............  5.9............  8.05...........  8.35...........  9..............  10.5...........  10.............  11.5
300%-400%            4.3.............  4.3.............  5.9.............  5.9............  8.35...........  8.35...........  10.5...........  10.5...........  11.5...........  11.5
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

                            ``(ii) Age determinations.--
                                    ``(I) In general.--For purposes of 
                                clause (i), the age of the taxpayer 
                                taken into account under clause (i) 
                                with respect to any taxable year is the 
                                age attained by such taxpayer before 
                                the close of such taxable year.
                                    ``(II) Joint returns.--In the case 
                                of a joint return, the age of the older 
                                spouse shall be taken into account 
                                under clause (i).
                            ``(iii) Indexing.--In the case of any 
                        taxable year beginning after calendar year 
                        2021, the initial and final percentages 
                        contained in clause (i) shall be adjusted to 
                        reflect--
                                    ``(I) the excess (if any) of the 
                                rate of premium growth for the period 
                                beginning with calendar year 2013 and 
                                ending with calendar year 2020, over 
                                the rate of income growth for such 
                                period, and
                                    ``(II) in addition to any 
                                adjustment under subclause (I), the 
                                excess (if any) of the rate of premium 
                                growth for calendar year 2020, over the 
                                rate of growth in the consumer price 
                                index for calendar year 2020.
                            ``(iv) Failsafe.--Clause (iii)(II) shall 
                        apply only if the aggregate amount of premium 
                        tax credits under this section and cost-sharing 
                        reductions under section 1402 of the Patient 
                        Protection and Affordable Care Act for calendar 
                        year 2018 exceeds an amount equal to 0.504 
                        percent of the gross domestic product for such 
                        calendar year.''.
    (b) Effective Date.--The amendment made by this section shall apply 
to taxable years beginning after December 31, 2020.

SEC. 132. REPEAL OF ANNUAL FEE ON HEALTH INSURANCE PROVIDERS.

    (a) In General.--The Patient Protection and Affordable Care Act is 
amended by striking section 9010.
    (b) Effective Date.--The amendments made by this section shall 
apply with respect to calendar years beginning after December 31, 2019.

SEC. 133. REPEAL OF MEDICAL DEVICE EXCISE TAX.

    (a) In General.--Chapter 32 of the Internal Revenue Code of 1986 is 
amended by striking subchapter E.
    (b) Conforming Amendments.--
            (1) Subsection (a) of section 4221 of such Code is amended 
        by striking the last sentence.
            (2) Paragraph (2) of section 6416(b) of such Code is 
        amended by striking the last sentence.
    (c) Clerical Amendment.--The table of subchapters for chapter 32 of 
such Code is amended by striking the item relating to subchapter E.
    (d) Effective Date.--The amendments made by this section shall 
apply to sales after December 31, 2017.

SEC. 134. INCLUSION IN INCOME OF CERTAIN COSTS OF EMPLOYER-PROVIDED 
              COVERAGE UNDER HEALTH PLANS.

    (a) In General.--Section 106 of the Internal Revenue Code of 1986 
is amended by adding at the end the following new subsection:
    ``(h) Limitation.--
            ``(1) In general.--Subsection (a) shall not apply to the 
        extent that employer-provided coverage under health plans for 
        an employee for a taxable year exceeds--
                    ``(A) $10,200 for self-only coverage, and
                    ``(B) $27,500 for all other coverage.
            ``(2) In general.--In the case of any calendar year after 
        2021, the dollar amounts in paragraph (1) shall each be 
        increased by an amount equal to--
                    ``(A) such dollar amount, multiplied by--
                    ``(B) the cost-of-living adjustment determined 
                under section 1(f)(3) for such calendar year, 
                determined
                            ``(i) by substituting `calendar year 2020' 
                        for `calendar year 2016' in subparagraph 
                        (A)(ii) thereof, and
                            ``(ii) by substituting for the C-CPI-U 
                        referred to in section 1(f)(3)(A) the amount 
                        that such CPI would have been if the annual 
                        percentage increase in CPI with respect to each 
                        year after 2020 and before 2031 had been one 
                        percentage point greater.
            ``(3) Terms related to cpi.--
                    ``(A) Annual percentage increase.--For purposes of 
                subparagraph (B)(ii)(II), the term `annual percentage 
                increase' means the percentage (if any) by which C-CPI-
                U for any year exceeds the C-CPI-U for the prior year.
                    ``(B) Other terms.--Terms used in this paragraph 
                which are also used in section 1(f)(3) shall have the 
                same meanings as when used in such section.''.
    (b) Repeal of Employer-Sponsored Health Coverage Excise Tax.--The 
Internal Revenue Code of 1986 is amended by striking section 4980I.
    (c) Effective Date.--The amendments made by this section shall 
apply with respect to taxable years beginning after December 31, 2020.

SEC. 135. INCLUSION OF CERTAIN OVER-THE-COUNTER MEDICAL PRODUCTS AS 
              QUALIFIED MEDICAL EXPENSES.

    (a) HSAS.--Section 223(d)(2) of the Internal Revenue Code of 1986 
is amended--
            (1) by striking the last sentence of subparagraph (A) and 
        inserting the following: ``For purposes of this subparagraph, 
        amounts paid for menstrual care products shall be treated as 
        paid for medical care.'', and
            (2) by adding at the end the following new subparagraph:
                    ``(D) Menstrual care product.--For purposes of this 
                paragraph, the term `menstrual care product' means a 
                tampon, pad, liner, cup, sponge, or similar product 
                used by women with respect to menstruation or other 
                genital-tract secretions.''.
    (b) Archer MSAS.--Section 220(d)(2)(A) of such Code is amended by 
striking the last sentence and inserting the following: ``For purposes 
of this subparagraph, amounts paid for menstrual care products (as 
defined in section 223(d)(2)(D)) shall be treated as paid for medical 
care.''.
    (c) Health Flexible Spending Arrangements and Health Reimbursement 
Arrangements.--Section 106 of such Code is amended by striking 
subsection (f) and inserting the following new subsection:
    ``(f) Reimbursements for Menstrual Care Products.--For purposes of 
this section and section 105, expenses incurred for menstrual care 
products (as defined in section 223(d)(2)(D)) shall be treated as 
incurred for medical care.''.
    (d) Effective Dates.--
            (1) Distributions from health savings accounts.--The 
        amendments made by subsections (a) and (b) shall apply to 
        amounts paid after December 31, 2020.
            (2) Reimbursements.--The amendment made by subsection (c) 
        shall apply to expenses incurred after December 31, 2020.

SEC. 136. REPEAL OF LIMITATION ON HEALTH FLEXIBLE SPENDING 
              ARRANGEMENTS.

    (a) In General.--Section 125 of the Internal Revenue Code of 1986 
is amended by striking subsection (i).
    (b) Effective Date.--The amendment made by this section shall apply 
to taxable years beginning after December 31, 2018.

SEC. 137. MEDICARE PART D TAX DEDUCTION.

    (a) In General.--Section 139A of the Internal Revenue Code of 1986 
is amended by adding at the end the following: ``This section shall not 
be taken into account for purposes of determining whether any deduction 
is allowable with respect to any cost taken into account in determining 
such payment.''.
    (b) Effective Date.--The amendment made by this section shall apply 
to taxable years beginning after December 31, 2018.

SEC. 138. REPEAL OF NET INVESTMENT INCOME TAX.

    (a) In General.--Subtitle A of the Internal Revenue Code of 1986 is 
amended by striking chapter 2A.
    (b) Effective Date.--The amendment made by this section shall apply 
to taxable years beginning after December 31, 2019.

SEC. 139. BASIS FOR PURPOSES OF DETERMINING GAIN OR LOSS.

    Nothing in the Internal Revenue Code of 1986 shall be construed to 
prevent the Secretary of the Treasury (or any designee of the 
Secretary) from providing that the basis for determining gain or loss 
(whether on the basis of cost or otherwise) is adjusted on the basis of 
inflation.

SEC. 140. DEDUCTION FOR QUALIFIED CHARITY CARE.

    (a) In General.--Part VI of subchapter B of chapter 1 of the 
Internal Revenue Code of 1986 is amended by adding at the end the 
following new section:

``SEC. 199B. QUALIFIED CHARITY CARE.

    ``(a) In General.--There shall be allowed as a deduction for the 
taxable year an amount equal to--
            ``(1) in the case of a direct primary care physician, an 
        amount equal to the sum of--
                    ``(A) the fee (as published on a publicly available 
                website of such physician) for physicians' services 
                that are qualified charity care furnished by such 
                taxpayer during such year, and
                    ``(B) for each visit by a patient to such physician 
                during which qualified charity care is furnished, half 
                of so much of the lowest subscription fee of such 
                physician that is attributable to a month, and
            ``(2) in the case of any other individual, the unreimbursed 
        Medicare-based value of qualified charity care furnished by 
        such taxpayer during such year.
    ``(b) Definitions.--For purposes of this section:
            ``(1) Unreimbursed medicare-based value.--The term 
        `unreimbursed Medicare-based value' means, with respect to 
        physicians' services, the amount payable for such services 
        under the physician fee schedule established under section 1848 
        of the Social Security Act.
            ``(2) Qualified charity care.--The term `qualified charity 
        care' means physicians' services that are furnished--
                    ``(A) without expectation of reimbursement, and
                    ``(B) to an individual enrolled--
                            ``(i) under a State plan under title XIX of 
                        the Social Security Act (or a waiver of such 
                        plan), or
                            ``(ii) under a State child health plan 
                        under title XXI of the Social Security Act (or 
                        a waiver of such plan).
            ``(3) Direct primary care physician.--The term `direct 
        primary care physician' means a physician (as defined in 
        section 1861(r) of the Social Security Act) who provides 
        primary care--
                    ``(A) to individuals who have paid a periodic 
                subscription fee, and
                    ``(B) in exchange for a fee that is published on a 
                publicly available website of such physician.
            ``(4) Physicians' services.--The term `physicians' 
        services' has the meaning given such term by section 1861(q) of 
        the Social Security Act.
    ``(c) Limitation.--The amount allowed as a deduction under 
subsection (a) for a taxable year shall not exceed the gross receipts 
attributable to physicians' services furnished by the taxpayer during 
the taxable year.''.
    (b) Clerical Amendment.--The table of sections for part VI of 
subchapter B of chapter 1 of the Internal Revenue Code of 1986 is 
amended by adding at the end the following new item:

``Sec. 199B. Qualified charity care.''.

SEC. 141. LIMITATION ON LIABILITY FOR VOLUNTEER HEALTH CARE 
              PROFESSIONALS.

    (a) In General.--Title II of the Public Health Service Act (42 
U.S.C. 202 et seq.) is amended by inserting after section 224 the 
following:

``SEC. 224A. LIMITATION ON LIABILITY FOR VOLUNTEER HEALTH CARE 
              PROFESSIONALS.

    ``(a) Limitation on Liability.--A physician shall not be liable 
under Federal or State law in any civil action for any harm caused by 
an act or omission of such physician, or attending medical personnel 
supporting such physician, if such act or omission--
            ``(1) occurs in the course of furnishing qualified charity 
        care (as such term is defined in section 199B of the Internal 
        Revenue Code of 1986); and
            ``(2) was not grossly negligent.
    ``(b) Preemption.--This section preempts the laws of a State or any 
political subdivision of a State to the extent that such laws are 
inconsistent with this section, unless such laws provide greater 
protection from liability for a defendant.
    ``(c) Definitions.--In this section:
            ``(1) Physician.--The term `physician' has the meaning 
        given such term by section 1861(r) of the Social Security Act.
            ``(2) Attending medical personnel.--The term `attending 
        medical personnel' means an individual who is licensed to 
        directly support a physician in furnishing medical services.''.
    (b) Effective Date.--The amendments made by this section shall 
apply to any claim filed to the extent that it is with respect to acts 
or omissions occurring after the date of the enactment of this Act.

                TITLE II--MEDICARE AND MEDICAID REFORMS

                               Subtitle A

SEC. 201. FLEXIBLE BLOCK GRANT OPTION FOR STATES.

    Title XIX of the Social Security Act is amended--
            (1) in section 1903 (42 U.S.C. 1396b)--
                    (A) in subsection (a), in the matter before 
                paragraph (1), by inserting ``and section 1903A(a)'' 
                after ``except as otherwise provided in this section''; 
                and
                    (B) in subsection (d)(1), by striking ``to which'' 
                and inserting ``to which, subject to section 
                1903A(a),''; and
            (2) by inserting after such section 1903 the following new 
        section:

``SEC. 1903A. FLEXIBLE BLOCK GRANT OPTION FOR STATES.

    ``(a) In General.--In the case of a State that elects the option of 
applying this section for a 10-fiscal-year period (beginning no earlier 
than fiscal year 2020 and, at the State option, for any succeeding 10-
fiscal-year period) and that has a plan approved by the Secretary under 
subsection (b) to carry out the option for such period--
            ``(1) the State shall receive, instead of amounts otherwise 
        payable to the State under this title for medical assistance 
        for block grant individuals within the applicable block grant 
        category (as defined in subsection (f)) for the State during 
        the period in which the election is in effect, the amount 
        specified in subsection (d);
            ``(2) the payment under this section may only be used 
        consistent with the State plan under subsection (b) for block 
        grant health care assistance (as defined in subsection (g)); 
        and
            ``(3) with respect to block grant individuals within the 
        applicable block grant category for the State for which block 
        grant health care assistance is made available under this 
        section, such assistance shall be instead of medical assistance 
        otherwise provided to the individual under this title.
    ``(b) State Plan for Administering Block Grant Option.--
            ``(1) In general.--No payment shall be made under this 
        section to a State pursuant to an election for a 10-fiscal-year 
        period under subsection (a) unless the State has a plan, 
        approved under paragraph (2), for such period that specifies--
                    ``(A) the applicable block grant category with 
                respect to which the State will apply the option under 
                this section for such period;
                    ``(B) the conditions for eligibility of block grant 
                individuals within such applicable block grant category 
                for block grant health care assistance under the 
                option, which shall be instead of other conditions for 
                eligibility under this title, except that in the case 
                of a State that has elected the applicable block grant 
                category described in--
                            ``(i) paragraph (1) of subsection (f), the 
                        plan must provide for eligibility for pregnant 
                        women and children required to be provided 
                        medical assistance under subsections 
                        (a)(10)(A)(i) and (e)(4) of section 1902; or
                            ``(ii) paragraph (2) of subsection (f), the 
                        plan must provide for eligibility for pregnant 
                        women required to be provided medical 
                        assistance under subsection (a)(10)(A)(i); and
                    ``(C) the types of items and services, the amount, 
                duration, and scope of such services, the cost-sharing 
                with respect to such services, and the method for 
                delivery of block grant health care assistance under 
                this section, which shall be instead of the such types, 
                amount, duration, and scope, cost-sharing, and methods 
                of delivery for medical assistance otherwise required 
                under this title, except that the plan must provide for 
                assistance for--
                            ``(i) hospital care;
                            ``(ii) surgical care and treatment;
                            ``(iii) medical care and treatment;
                            ``(iv) obstetrical and prenatal care and 
                        treatment;
                            ``(v) prescribed drugs, medicines, and 
                        prosthetic devices;
                            ``(vi) other medical supplies and services; 
                        and
                            ``(vii) health care for children under 18 
                        years of age.
            ``(2) Review and approval.--A plan described in paragraph 
        (1) shall be deemed approved by the Secretary unless the 
        Secretary determines, within 30 days after the date of the 
        Secretary's receipt of the plan, that the plan is incomplete or 
        actuarially unsound and, with respect to such plan and its 
        implementation under this section, the requirements of 
        paragraphs (1), (10)(B), (17), and (23) of section 1902(a) 
        shall not apply.
    ``(c) Amount of Block Grant Funds.--
            ``(1) For initial fiscal year.--The block grant amount 
        under this subsection for a State for the initial fiscal year 
        in the first 10-fiscal-year period is equal to an amount 
        determined by the Secretary to equal the per capita spending on 
        the population covered by the State plan established in 
        subsection (b) of section 1903A.
            ``(2) For any subsequent fiscal year.--The block grant 
        amount under this section for a State for each succeeding 
        fiscal year (in any 10-fiscal-year period) is equal to the 
        block grant amount under paragraph (1) (or this paragraph) for 
        the State for the previous fiscal year increased by the annual 
        increase in the consumer price index for all urban consumers 
        (all items; U.S. city average) for the fiscal year involved.
            ``(3) Availability of rollover funds.--The block grant 
        amount under this subsection for a State for a fiscal year 
        shall remain available to the State for expenditures under this 
        section for the succeeding fiscal year but only if an election 
        is in effect under this section for the State in such 
        succeeding fiscal year.
    ``(d) Federal Payment and State Responsibility.--The Secretary 
shall pay to each State with an election in effect under this section 
for a fiscal year, from its block grant amount under subsection (c) 
available for such fiscal year, an amount for each quarter of such 
fiscal year equal to the enhanced FMAP described in the first sentence 
of section 2105(b) of the total amount expended under the State plan 
under this section during such quarter, and the State is responsible 
for the balance of funds to carry out such plan.
    ``(e) Block Grant Individual Defined.--In this section, the term 
`block grant individual' means, with respect to a State for a 10-
fiscal-year period, an individual who is within an applicable block 
grant category for the State and such period.
    ``(f) Applicable Block Grant Category Defined.--In this section, 
the term `applicable block grant category' means with respect to a 
State for a 10-fiscal-year period, either of the following as specified 
by the State for such period in its plan under subsection (b)(1)(A):
            ``(1) Elderly, blind, disabled.--Both of the following 
        categories:
                    ``(A) Elderly.--Individuals who are 65 years of age 
                or older.
                    ``(B) Blind and disabled.--Individuals (not 
                described in the previous subparagraph) who are 
                eligible for medical assistance under this title on the 
                basis of being blind or disabled.
            ``(2) Elderly, blind, disabled, and others.--All of the 
        following categories:
                    ``(A) Elderly.--Individuals who are 65 years of age 
                or older.
                    ``(B) Blind and disabled.--Individuals (not 
                described in the previous subparagraph) who are 
                eligible for medical assistance under this title on the 
                basis of being blind or disabled.
                    ``(C) Children.--Individuals (not described in a 
                previous subparagraph) who are children under 19 years 
                of age.
                    ``(D) Expansion enrollees.--Individuals (not 
                described in a previous subparagraph) for whom the 
                amounts expended for medical assistance are subject to 
                an increase or change in the Federal medical assistance 
                percentage under subsection (y) or (z)(2), 
                respectively, of section 1905.
                    ``(E) Other nonelderly, nondisabled, non-expansion 
                adults.--Individuals who are not described in any of 
                the previous subparagraphs and whose income does not 
                exceed 60 percent of the poverty line (as defined in 
                section 2110(c)(5)) applicable to a family of the size 
                involved.
    ``(g) Block Grant Health Care Assistance.--In this section, the 
term `block grant health care assistance' means assistance for health-
care-related items and medical services for block grant individuals 
within the applicable block grant category for the State and 10-fiscal-
year period involved who are low-income individuals (as defined by the 
State).
    ``(h) Auditing.--As a condition of receiving funds under this 
section, a State shall contract with an independent entity to conduct 
audits of its expenditures made with respect to activities funded under 
this section for each fiscal year for which the State elects to apply 
this section to ensure that such funds are used consistent with this 
section and shall make such audits available to the Secretary upon the 
request of the Secretary.''.

SEC. 202. MEDICAID ELIGIBILITY DETERMINATIONS.

    (a) State Flexibility To Use Contractors To Make Eligibility 
Determinations on Behalf of State.--Section 1902(a)(5) of the Social 
Security Act (42 U.S.C. 1396a(a)(5)) is amended by inserting before the 
semicolon at the end the following: ``, but such determinations of 
eligibility may be made, at the option of a State, under a contract 
with another State or local agency or a contractor so long as the 
contract does not provide incentives for the agency or contractor to 
delay eligibility determinations or to deny eligibility for individuals 
otherwise eligible for medical assistance''.
    (b) Frequency of Eligibility Redeterminations.--Section 1902(e)(14) 
of the Social Security Act (42 U.S.C. 1396a(e)(14)) is amended by 
adding at the end the following:
                    ``(L) Frequency of eligibility redeterminations.--
                Beginning on October 1, 2019, and notwithstanding 
                subparagraph (H), in the case of an individual whose 
                eligibility for medical assistance under the State plan 
                under this title (or a waiver of such plan) is 
                determined based on the application of modified 
                adjusted gross income under subparagraph (A) and who is 
                so eligible on the basis of clause (i)(VIII), (ii)(XX), 
                or (ii)(XXIII) of subsection (a)(10)(A), at the option 
                of the State, the State plan may provide that the 
                individual's eligibility shall be redetermined every 6 
                months (or such shorter number of months as the State 
                may elect).''.

SEC. 203. LOWERING SAFE HARBOR THRESHOLD WITH RESPECT TO STATE TAXES ON 
              HEALTH CARE PROVIDERS.

     Section 1903(w)(4)(C)(ii) of the Social Security Act (42 U.S.C. 
1396b(w)(4)(C)(ii)) is amended--
            (1) by striking ``of fiscal years beginning'' and inserting 
        ``of fiscal years--
                    ``(I) beginning''; and
            (2) by striking ``it appears.'' and inserting the 
        following: ``it appears;
                    ``(II) beginning on or after January 1, 2020, and 
                before January 1, 2030, `4 percent' shall be 
                substituted for `6 percent' each place it appears;
                    ``(III) beginning on or after January 1, 2030, and 
                before January 1, 2035, `3 percent' shall be 
                substituted for `6 percent' each place it appears;
                    ``(IV) beginning on or after January 1, 2035, and 
                before January 1, 2040, `2 percent' shall be 
                substituted for `6 percent' each place it appears;
                    ``(V) beginning on or after January 1, 2040, and 
                before January 1, 2045, `1 percent' shall be 
                substituted for `6 percent' each place it appears; and
                    ``(VI) beginning on or after January 1, 2045, `0 
                percent' shall be substituted for `6 percent' each 
                place it appears.''.

SEC. 204. INCOME LIMITATIONS FOR REFUNDABLE CREDITS FOR COVERAGE UNDER 
              A QUALIFIED HEALTH PLAN.

    (a) In General.--Subparagraphs (A) and (B) of section 36B(c)(1) of 
the Internal Revenue Code of 1986 are amended by inserting after ``100 
percent'' each place such term appears the following: ``(60 percent in 
the case of an individual enrolled through an Exchange utilized by a 
State that makes the election described in section 1903A of the Social 
Security Act)''.
    (b) Effective Date.--The amendments made by this section shall 
apply with respect to taxable years beginning after the date of the 
enactment of this Act.

                          Subtitle B--Medicare

SEC. 221. OFF-CAMPUS PROVIDER-BASED DEPARTMENT MEDICARE SITE NEUTRAL 
              PAYMENT.

    (a) In General.--Section 1834 of the Social Security Act (42 U.S.C. 
1395m) is amended by adding at the end the following new subsection:
    ``(x) Off-Campus Provider-Based Department Site Neutral Payment.--
            ``(1) In general.--With respect to items and services 
        furnished in an off-campus provider-based department, payment 
        under this section for such items and services shall be the 
        amount determined under the fee schedule under section 1848 for 
        such items and services furnished if furnished in a physician 
        office setting.
            ``(2) Off-campus provider-based department.--For purposes 
        of this subsection, the term `off-campus provider-based 
        department' has such meaning as specified by the Secretary.''.
    (b) Effective Date.--The amendment made by subsection (a) shall 
apply with respect to items and services furnished on or after January 
1, 2021.

SEC. 222. ELIMINATION OF MEDICARE ELIGIBILITY FOR CERTAIN INDIVIDUALS.

    (a) Enrollment Prohibition.--
            (1) Part b.--Section 1836 of the Social Security Act (42 
        U.S.C. 1395o) is amended by striking the period at the end and 
        inserting ``, except that an individual who attains age 65 on 
        or after January 1, 2030, and is an individual who, upon 
        attaining such age, has earned $10,000,000 or more in lifetime 
        wages, shall not be eligible to so enroll.''.
            (2) Part d.--Section 1860D-1(a)(3)(A) of such Act (42 
        U.S.C. 1395w-101(a)(3)(A)) is amended by striking the period at 
        the end and inserting ``, excluding an individual who, upon 
        attaining age 65, has earned $10,000,000 or more in lifetime 
        wages.''.
    (b) Medigap.--Section 1882 of the Social Security Act (42 U.S.C. 
1395ss) is amended by adding at the end the following new subsection:
    ``(aa) Additional Limitation on Newly Eligible Beneficiaries.--
            ``(1) In general.--Notwithstanding any other provision of 
        this section, on or after January 1, 2030, a medicare 
        supplemental policy may not be sold or issued to a targeted 
        newly eligible Medicare beneficiary.
            ``(2) Targeted newly eligible medicare beneficiary.--For 
        purposes of this subsection, the term `targeted newly eligible 
        Medicare beneficiary' means an individual who, upon attaining 
        the age of 65, has earned $10,000,000 or more in lifetime 
        wages.''.

SEC. 223. MEDICARE COVERAGE OF BAD DEBT.

    Section 1861(v)(1) of the Social Security Act (42 U.S.C. 
1395(v)(1)) is amended--
            (1) in subparagraph (T)--
                    (A) in clause (iv), by striking ``and'' at the end;
                    (B) in clause (v)--
                            (i) by striking ``during fiscal year'' and 
                        inserting ``during fiscal years'';
                            (ii) by striking ``or a subsequent fiscal 
                        year'' and inserting ``through 2020''; and
                            (iii) by striking the period at the end and 
                        inserting ``, and''; and
                    (C) by adding at the end the following new clause:
            ``(vi) for cost reporting periods beginning during fiscal 
        year 2021 or a subsequent fiscal year, by the percent 
        applicable for cost reporting periods beginning during the 
        previous fiscal year, increased (through fiscal year 2024) by 
        10 percentage points.'';
            (2) in subparagraph (V)--
                    (A) in clause (i)--
                            (i) in subclause (III), by striking ``and'' 
                        at the end;
                            (ii) in subclause (IV)--
                                    (I) by striking ``during fiscal 
                                year'' and inserting ``during fiscal 
                                years 2015 through 2020''; and
                                    (II) by striking the period at the 
                                end and inserting ``; and''; and
                            (iii) by adding at the end the following 
                        new subclause:
                    ``(V) for cost reporting periods beginning during 
                fiscal year 2021 or a subsequent fiscal year, the 
                percent applicable for cost reporting periods beginning 
                during the previous fiscal year, increased (through 
                fiscal year 2024) by 10 percentage points.''; and
                    (B) in clause (ii)--
                            (i) in subclause (III), by striking ``and'' 
                        at the end; and
                            (ii) in subclause (IV)--
                                    (I) by striking ``a subsequent 
                                fiscal year'' and inserting ``fiscal 
                                years 2015 through 2020'';
                                    (II) by striking the period at the 
                                end and inserting ``; and''; and
                                    (III) by adding at the end the 
                                following new subclause:
                    ``(V) for cost reporting periods beginning during 
                fiscal year 2021 or a subsequent fiscal year, shall be 
                reduced by the percent applicable for cost reporting 
                periods beginning during the previous fiscal year, 
                increased (through fiscal year 2024) by 10 percentage 
                points.''; and
            (3) in subparagraph (W)(i)--
                    (A) in subclause (II), by striking ``and'' at the 
                end;
                    (B) in subclause (III)--
                            (i) by striking ``during a subsequent 
                        fiscal year'' and inserting ``during fiscal 
                        years 2015 through 2020''; and
                            (ii) by striking the period at the end and 
                        inserting ``; and''; and
                    (C) by adding at the end the following new 
                subclause:
            ``(IV) for cost reporting periods beginning during fiscal 
        year 2021 or a subsequent fiscal year, by the percent 
        applicable for cost reporting periods beginning during the 
        previous fiscal year, increased (through fiscal year 2024) by 
        10 percentage points.''.

                 Subtitle C--Medical Malpractice Reform

SEC. 231. ENCOURAGING SPEEDY RESOLUTION OF CLAIMS.

    (a) Statute of Limitations.--
            (1) In general.--Except as provided in paragraph (2), the 
        time for the commencement of a health care lawsuit shall be, 
        whichever occurs first of the following:
                    (A) Three years after the date of the occurrence of 
                the breach or tort.
                    (B) Three years after the date the medical or 
                health care treatment that is the subject of the claim 
                is completed.
                    (C) One year after the claimant discovers, or 
                through the use of reasonable diligence should have 
                discovered, the injury.
            (2) Tolling.--In no event shall the time for commencement 
        of a health care lawsuit exceed 3 years after the date of the 
        occurrence of the breach or tort or 3 years after the date the 
        medical or health care treatment that is the subject of the 
        claim is completed (whichever occurs first) unless tolled for 
        any of the following--
                    (A) upon proof of fraud;
                    (B) intentional concealment; or
                    (C) the presence of a foreign body, which has no 
                therapeutic or diagnostic purpose or effect, in the 
                person of the injured person.
            (3) Actions by a minor.--Actions by a minor shall be 
        commenced within 3 years after the date of the occurrence of 
        the breach or tort or 3 years after the date of the medical or 
        health care treatment that is the subject of the claim is 
        completed (whichever occurs first) except that actions by a 
        minor under the full age of 6 years shall be commenced within 3 
        years after the date of the occurrence of the breach or tort, 3 
        years after the date of the medical or health care treatment 
        that is the subject of the claim is completed, or 1 year after 
        the injury is discovered, or through the use of reasonable 
        diligence should have been discovered, or prior to the minor's 
        8th birthday, whichever provides a longer period. Such time 
        limitation shall be tolled for minors for any period during 
        which a parent or guardian and a health care provider have 
        committed fraud or collusion in the failure to bring an action 
        on behalf of the injured minor.
    (b) State Flexibility.--No provision of subsection (a) shall be 
construed to preempt any State law (whether effective before, on, or 
after the date of the enactment of this Act) that--
            (1) specifies a time period of less than 3 years after the 
        date of injury or less than 1 year after the claimant 
        discovers, or through the use of reasonable diligence should 
        have discovered, the injury, for the filing of a health care 
        lawsuit;
            (2) that specifies a different time period for the filing 
        of lawsuits by a minor;
            (3) that triggers the time period based on the date of the 
        alleged negligence; or
            (4) establishes a statute of repose for the filing of a 
        health care lawsuit.

SEC. 232. COMPENSATING PATIENT INJURY.

    (a) Unlimited Amount of Damages for Actual Economic Losses in 
Health Care Lawsuits.--In any health care lawsuit, nothing in this Act 
shall limit a claimant's recovery of the full amount of the available 
economic damages, notwithstanding the limitation in subsection (b).
    (b) Additional Noneconomic Damages.--In any health care lawsuit, 
the amount of noneconomic damages, if available, shall not exceed 
$250,000, regardless of the number of parties against whom the action 
is brought or the number of separate claims or actions brought with 
respect to the same injury.
    (c) No Discount of Award for Noneconomic Damages.--For purposes of 
applying the limitation in subsection (b), future noneconomic damages 
shall not be discounted to present value. The jury shall not be 
informed about the maximum award for noneconomic damages. An award for 
noneconomic damages in excess of $250,000 shall be reduced either 
before the entry of judgment, or by amendment of the judgment after 
entry of judgment, and such reduction shall be made before accounting 
for any other reduction in damages required by law. If separate awards 
are rendered for past and future noneconomic damages and the combined 
awards exceed $250,000, the future noneconomic damages shall be reduced 
first.
    (d) Fair Share Rule.--In any health care lawsuit, each party shall 
be liable for that party's several share of any damages only and not 
for the share of any other person. Each party shall be liable only for 
the amount of damages allocated to such party in direct proportion to 
such party's percentage of responsibility. Whenever a judgment of 
liability is rendered as to any party, a separate judgment shall be 
rendered against each such party for the amount allocated to such 
party. For purposes of this section, the trier of fact shall determine 
the proportion of responsibility of each party for the claimant's harm.
    (e) State Flexibility.--No provision of this section shall be 
construed to preempt any State law (whether effective before, on, or 
after the date of the enactment of this Act) that specifies a 
particular monetary amount of economic or noneconomic damages (or the 
total amount of damages) that may be awarded in a health care lawsuit, 
regardless of whether such monetary amount is greater or lesser than is 
provided for under this section.

SEC. 233. MAXIMIZING PATIENT RECOVERY.

    (a) Court Supervision of Share of Damages Actually Paid to 
Claimants.--In any health care lawsuit, the court shall supervise the 
arrangements for payment of damages to protect against conflicts of 
interest that may have the effect of reducing the amount of damages 
awarded that are actually paid to claimants. In particular, in any 
health care lawsuit in which the attorney for a party claims a 
financial stake in the outcome by virtue of a contingent fee, the court 
shall have the power to restrict the payment of a claimant's damage 
recovery to such attorney, and to redirect such damages to the claimant 
based upon the interests of justice and principles of equity. In no 
event shall the total of all contingent fees for representing all 
claimants in a health care lawsuit exceed the following limits:
            (1) Forty percent of the first $50,000 recovered by the 
        claimant(s).
            (2) Thirty-three and one-third percent of the next $50,000 
        recovered by the claimant(s).
            (3) Twenty-five percent of the next $500,000 recovered by 
        the claimant(s).
            (4) Fifteen percent of any amount by which the recovery by 
        the claimant(s) is in excess of $600,000.
    (b) Applicability.--The limitations in this section shall apply 
whether the recovery is by judgment, settlement, mediation, 
arbitration, or any other form of alternative dispute resolution. In a 
health care lawsuit involving a minor or incompetent person, a court 
retains the authority to authorize or approve a fee that is less than 
the maximum permitted under this section. The requirement for court 
supervision in the first two sentences of subsection (a) applies only 
in civil actions.
    (c) State Flexibility.--No provision of this section shall be 
construed to preempt any State law (whether effective before, on, or 
after the date of the enactment of this Act) that specifies a lesser 
percentage or lesser total value of damages which may be claimed by an 
attorney representing a claimant in a health care lawsuit.

SEC. 234. AUTHORIZATION OF PAYMENT OF FUTURE DAMAGES TO CLAIMANTS IN 
              HEALTH CARE LAWSUITS.

    (a) In General.--In any health care lawsuit, if an award of future 
damages, without reduction to present value, equaling or exceeding 
$50,000 is made against a party with sufficient insurance or other 
assets to fund a periodic payment of such a judgment, the court shall, 
at the request of any party, enter a judgment ordering that the future 
damages be paid by periodic payments, in accordance with the Uniform 
Periodic Payment of Judgments Act promulgated by the National 
Conference of Commissioners on Uniform State Laws.
    (b) Applicability.--This section applies to all actions which have 
not been first set for trial or retrial before the effective date of 
this Act.
    (c) State Flexibility.--No provision of this section shall be 
construed to preempt any State law (whether effective before, on, or 
after the date of the enactment of this Act) that specifies periodic 
payments for future damages at any amount other than $50,000 or that 
mandates such payments absent the request of either party.

SEC. 235. PRODUCT LIABILITY FOR HEALTH CARE PROVIDERS.

    A health care provider who prescribes, or who dispenses pursuant to 
a prescription, a medical product approved, licensed, or cleared by the 
Food and Drug Administration shall not be named as a party to a product 
liability lawsuit involving such product and shall not be liable to a 
claimant in a class action lawsuit against the manufacturer, 
distributor, or seller of such product.

SEC. 236. DEFINITIONS.

    In this Act:
            (1) Alternative dispute resolution system; adr.--The term 
        ``alternative dispute resolution system'' or ``ADR'' means a 
        system that provides for the resolution of health care lawsuits 
        in a manner other than through a civil action brought in a 
        State or Federal court.
            (2) Claimant.--The term ``claimant'' means any person who 
        brings a health care lawsuit, including a person who asserts or 
        claims a right to legal or equitable contribution, indemnity, 
        or subrogation, arising out of a health care liability claim or 
        action, and any person on whose behalf such a claim is asserted 
        or such an action is brought, whether deceased, incompetent, or 
        a minor.
            (3) Collateral source benefits.--The term ``collateral 
        source benefits'' means any amount paid or reasonably likely to 
        be paid in the future to or on behalf of the claimant, or any 
        service, product, or other benefit provided or reasonably 
        likely to be provided in the future to or on behalf of the 
        claimant, as a result of the injury or wrongful death, pursuant 
        to--
                    (A) any State or Federal health, sickness, income-
                disability, accident, or workers' compensation law;
                    (B) any health, sickness, income-disability, or 
                accident insurance that provides health benefits or 
                income-disability coverage;
                    (C) any contract or agreement of any group, 
                organization, partnership, or corporation to provide, 
                pay for, or reimburse the cost of medical, hospital, 
                dental, or income-disability benefits; and
                    (D) any other publicly or privately funded program.
            (4) Contingent fee.--The term ``contingent fee'' includes 
        all compensation to any person or persons which is payable only 
        if a recovery is effected on behalf of one or more claimants.
            (5) Economic damages.--The term ``economic damages'' means 
        objectively verifiable monetary losses incurred as a result of 
        the provision or use of (or failure to provide or use) health 
        care services or medical products, such as past and future 
        medical expenses, loss of past and future earnings, cost of 
        obtaining domestic services, loss of employment, and loss of 
        business or employment opportunities, unless otherwise defined 
        under applicable State law. In no circumstances shall damages 
        for health care services or medical products exceed the amount 
        actually paid or incurred by or on behalf of the claimant.
            (6) Future damages.--The term ``future damages'' means any 
        damages that are incurred after the date of judgment, 
        settlement, or other resolution (including mediation, or any 
        other form of alternative dispute resolution).
            (7) Health care lawsuit.--The term ``health care lawsuit'' 
        means any health care liability claim concerning the provision 
        of goods or services for which coverage was provided in whole 
        or in part via a Federal program, subsidy or tax benefit, or 
        any health care liability action concerning the provision of 
        goods or services for which coverage was provided in whole or 
        in part via a Federal program, subsidy or tax benefit, brought 
        in a State or Federal court or pursuant to an alternative 
        dispute resolution system, against a health care provider 
        regardless of the theory of liability on which the claim is 
        based, or the number of claimants, plaintiffs, defendants, or 
        other parties, or the number of claims or causes of action, in 
        which the claimant alleges a health care liability claim. Such 
        term does not include a claim or action which is based on 
        criminal liability; which seeks civil fines or penalties paid 
        to Federal, State, or local government; or which is grounded in 
        antitrust.
            (8) Health care liability action.--The term ``health care 
        liability action'' means a civil action brought in a State or 
        Federal court or pursuant to an alternative dispute resolution 
        system, against a health care provider regardless of the theory 
        of liability on which the claim is based, or the number of 
        plaintiffs, defendants, or other parties, or the number of 
        causes of action, in which the claimant alleges a health care 
        liability claim.
            (9) Health care liability claim.--The term ``health care 
        liability claim'' means a demand by any person, whether or not 
        pursuant to ADR, against a health care provider, including, but 
        not limited to, third-party claims, cross-claims, counter-
        claims, or contribution claims, which are based upon the 
        provision or use of (or the failure to provide or use) health 
        care services or medical products, regardless of the theory of 
        liability on which the claim is based, or the number of 
        plaintiffs, defendants, or other parties, or the number of 
        causes of action.
            (10) Health care provider.--The term ``health care 
        provider'' means any person or entity required by State or 
        Federal laws or regulations to be licensed, registered, or 
        certified to provide health care services, and being either so 
        licensed, registered, or certified, or exempted from such 
        requirement by other statute or regulation, as well as any 
        other individual or entity defined as a health care provider, 
        health care professional, or health care institution under 
        State law.
            (11) Health care services.--The term ``health care 
        services'' means the provision of any goods or services 
        (including safety, professional, or administrative services 
        directly related to health care) by a health care provider, or 
        by any individual working under the supervision of a health 
        care provider, that relates to the diagnosis, prevention, or 
        treatment of any human disease or impairment, or the assessment 
        or care of the health of human beings.
            (12) Medical product.--The term ``medical product'' means a 
        drug, device, or biological product intended for humans, and 
        the terms ``drug'', ``device'', and ``biological product'' have 
        the meanings given such terms in sections 201(g)(1) and 201(h) 
        of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 321(g)(1) 
        and (h)) and section 351(a) of the Public Health Service Act 
        (42 U.S.C. 262(a)), respectively, including any component or 
        raw material used therein, but excluding health care services.
            (13) Noneconomic damages.--The term ``noneconomic damages'' 
        means damages for physical and emotional pain, suffering, 
        inconvenience, physical impairment, mental anguish, 
        disfigurement, loss of enjoyment of life, loss of society and 
        companionship, loss of consortium (other than loss of domestic 
        service), hedonic damages, injury to reputation, and all other 
        nonpecuniary losses of any kind or nature incurred as a result 
        of the provision or use of (or failure to provide or use) 
        health care services or medical products, unless otherwise 
        defined under applicable State law.
            (14) Recovery.--The term ``recovery'' means the net sum 
        recovered after deducting any disbursements or costs incurred 
        in connection with prosecution or settlement of the claim, 
        including all costs paid or advanced by any person. Costs of 
        health care incurred by the plaintiff and the attorneys' office 
        overhead costs or charges for legal services are not deductible 
        disbursements or costs for such purpose.
            (15) Representative.--The term ``representative'' means a 
        legal guardian, attorney, person designated to make decisions 
        on behalf of a patient under a medical power of attorney, or 
        any person recognized in law or custom as a patient's agent.
            (16) State.--The term ``State'' means each of the several 
        States, the District of Columbia, the Commonwealth of Puerto 
        Rico, the Virgin Islands, Guam, American Samoa, the Northern 
        Mariana Islands, the Trust Territory of the Pacific Islands, 
        and any other territory or possession of the United States, or 
        any political subdivision thereof.

SEC. 237. EFFECT ON OTHER LAWS.

    (a) Vaccine Injury.--
            (1) To the extent that title XXI of the Public Health 
        Service Act establishes a Federal rule of law applicable to a 
        civil action brought for a vaccine-related injury or death--
                    (A) this Act does not affect the application of the 
                rule of law to such an action; and
                    (B) any rule of law prescribed by this subtitle in 
                conflict with a rule of law of such title XXI shall not 
                apply to such action.
            (2) If there is an aspect of a civil action brought for a 
        vaccine-related injury or death to which a Federal rule of law 
        under title XXI of the Public Health Service Act does not 
        apply, then this subtitle or otherwise applicable law (as 
        determined under this subtitle) will apply to such aspect of 
        such action.
    (b) Other Federal Law.--Except as provided in this section, nothing 
in this subtitle shall be deemed to affect any defense available to a 
defendant in a health care lawsuit or action under any other provision 
of Federal law.

SEC. 238. RULES OF CONSTRUCTION.

    (a) Health Care Lawsuits.--Unless otherwise specified in this 
subtitle, the provisions governing health care lawsuits set forth in 
this subtitle preempt, subject to subsections (b) and (c), State law to 
the extent that State law prevents the application of any provisions of 
law established by or under this subtitle. The provisions governing 
health care lawsuits set forth in this subtitle supersede chapter 171 
of title 28, United States Code, to the extent that such chapter--
            (1) provides for a greater amount of damages or contingent 
        fees, a longer period in which a health care lawsuit may be 
        commenced, or a reduced applicability or scope of periodic 
        payment of future damages, than provided in this subtitle; or
            (2) prohibits the introduction of evidence regarding 
        collateral source benefits, or mandates or permits subrogation 
        or a lien on collateral source benefits.
    (b) Protection of States' Rights and Other Laws.--Any issue that is 
not governed by any provision of law established by or under this 
subtitle (including State standards of negligence) shall be governed by 
otherwise applicable State or Federal law.
    (c) State Flexibility.--No provision of this subtitle shall be 
construed to preempt any defense available to a party in a health care 
lawsuit under any other provision of State or Federal law.

SEC. 239. EFFECTIVE DATE.

    This subtitle shall apply to any health care lawsuit brought in a 
Federal or State court, or subject to an alternative dispute resolution 
system, that is initiated on or after the date of the enactment of this 
subtitle, except that any health care lawsuit arising from an injury 
occurring prior to the date of the enactment of this subtitle shall be 
governed by the applicable statute of limitations provisions in effect 
at the time the cause of action accrued.

SEC. 240. LIMITATION ON EXPERT WITNESS TESTIMONY.

    (a) In General.--No person in a health care profession requiring 
licensure under the laws of a State shall be competent to testify in 
any court of law to establish the following facts--
            (1) the recognized standard of acceptable professional 
        practice and the specialty thereof, if any, that the defendant 
        practices, which shall be the type of acceptable professional 
        practice recognized in the defendant's community or in a 
        community similar to the defendant's community that was in 
        place at the time the alleged injury or wrongful action 
        occurred;
            (2) that the defendant acted with less than or failed to 
        act with ordinary and reasonable care in accordance with the 
        recognized standard; and
            (3) that as a proximate result of the defendant's negligent 
        act or omission, the claimant suffered injuries which would not 
        otherwise have occurred,
unless the person was licensed to practice, in the State or a 
contiguous bordering State, a profession or specialty which would make 
the person's expert testimony relevant to the issues in the case and 
had practiced this profession or specialty in one of these States 
during the year preceding the date that the alleged injury or wrongful 
act occurred.
    (b) Applicability.--The requirements set forth in subsection (a) 
shall also apply to expert witnesses testifying for the defendant as 
rebuttal witnesses.
    (c) Waiver Authority.--The court may waive the requirements in this 
subsection if it determines that the appropriate witnesses otherwise 
would not be available.

SEC. 241. COMMUNICATIONS FOLLOWING UNANTICIPATED OUTCOME.

    (a) Provider Communications.--In any health care liability action, 
any and all statements, affirmations, gestures, or conduct expressing 
apology, fault, sympathy, commiseration, condolence, compassion, or a 
general sense of benevolence which are made by a health care provider 
or an employee of a health care provider to the patient, a relative of 
the patient, or a representative of the patient and which relate to the 
discomfort, pain, suffering, injury, or death of the patient as the 
result of the unanticipated outcome of medical care shall be 
inadmissible for any purpose as evidence of an admission of liability 
or as evidence of an admission against interest.
    (b) State Flexibility.--No provision of this section shall be 
construed to preempt any State law (whether effective before, on, or 
after the date of the enactment of this Act) that makes additional 
communications inadmissible as evidence of an admission of liability or 
as evidence of an admission against interest.

SEC. 242. EXPERT WITNESS QUALIFICATIONS.

    (a) In General.--In any health care lawsuit, an individual shall 
not give expert testimony on the appropriate standard of practice or 
care involved unless the individual is licensed as a health 
professional in one or more States and the individual meets the 
following criteria:
            (1) If the party against whom or on whose behalf the 
        testimony is to be offered is or claims to be a specialist, the 
        expert witness shall specialize at the time of the occurrence 
        that is the basis for the lawsuit in the same specialty or 
        claimed specialty as the party against whom or on whose behalf 
        the testimony is to be offered. If the party against whom or on 
        whose behalf the testimony is to be offered is or claims to be 
        a specialist who is board certified, the expert witness shall 
        be a specialist who is board certified in that specialty or 
        claimed specialty.
            (2) During the 1-year period immediately preceding the 
        occurrence of the action that gave rise to the lawsuit, the 
        expert witness shall have devoted a majority of the 
        individual's professional time to one or more of the following:
                    (A) The active clinical practice of the same health 
                profession as the defendant and, if the defendant is or 
                claims to be a specialist, in the same specialty or 
                claimed specialty.
                    (B) The instruction of students in an accredited 
                health professional school or accredited residency or 
                clinical research program in the same health profession 
                as the defendant and, if the defendant is or claims to 
                be a specialist, in an accredited health professional 
                school or accredited residency or clinical research 
                program in the same specialty or claimed specialty.
            (3) If the defendant is a general practitioner, the expert 
        witness shall have devoted a majority of the witness's 
        professional time in the 1-year period preceding the occurrence 
        of the action giving rise to the lawsuit to one or more of the 
        following:
                    (A) Active clinical practice as a general 
                practitioner.
                    (B) Instruction of students in an accredited health 
                professional school or accredited residency or clinical 
                research program in the same health profession as the 
                defendant.
    (b) Lawsuits Against Entities.--If the defendant in a health care 
lawsuit is an entity that employs a person against whom or on whose 
behalf the testimony is offered, the provisions of subsection (a) apply 
as if the person were the party or defendant against whom or on whose 
behalf the testimony is offered.
    (c) Power of Court.--Nothing in this subsection shall limit the 
power of the trial court in a health care lawsuit to disqualify an 
expert witness on grounds other than the qualifications set forth under 
this subsection.
    (d) Limitation.--An expert witness in a health care lawsuit shall 
not be permitted to testify if the fee of the witness is in any way 
contingent on the outcome of the lawsuit.
    (e) State Flexibility.--No provision of this section shall be 
construed to preempt any State law (whether effective before, on, or 
after the date of the enactment of this Act) that places additional 
qualification requirements upon any individual testifying as an expert 
witness.

SEC. 243. AFFIDAVIT OF MERIT.

    (a) Required Filing.--Subject to subsection (b), the plaintiff in a 
health care lawsuit alleging negligence or, if the plaintiff is 
represented by an attorney, the plaintiff's attorney shall file 
simultaneously with the health care lawsuit an affidavit of merit 
signed by a health professional who meets the requirements for an 
expert witness under section 242 of this Act. The affidavit of merit 
shall certify that the health professional has reviewed the notice and 
all medical records supplied to him or her by the plaintiff's attorney 
concerning the allegations contained in the notice and shall contain a 
statement of each of the following:
            (1) The applicable standard of practice or care.
            (2) The health professional's opinion that the applicable 
        standard of practice or care was breached by the health 
        professional or health facility receiving the notice.
            (3) The actions that should have been taken or omitted by 
        the health professional or health facility in order to have 
        complied with the applicable standard of practice or care.
            (4) The manner in which the breach of the standard of 
        practice or care was the proximate cause of the injury alleged 
        in the notice.
            (5) A listing of the medical records reviewed.
    (b) Filing Extension.--Upon motion of a party for good cause shown, 
the court in which the complaint is filed may grant the plaintiff or, 
if the plaintiff is represented by an attorney, the plaintiff's 
attorney an additional 28 days in which to file the affidavit required 
under subsection (a).
    (c) State Flexibility.--No provision of this section shall be 
construed to preempt any State law (whether effective before, on, or 
after the date of the enactment of this Act) that establishes 
additional requirements for the filing of an affidavit of merit or 
similar pre-litigation documentation.

SEC. 244. NOTICE OF INTENT TO COMMENCE LAWSUIT.

    (a) Advance Notice.--A person shall not commence a health care 
lawsuit against a health care provider unless the person has given the 
health care provider 90 days written notice before the action is 
commenced.
    (b) Exceptions.--A health care lawsuit against a health care 
provider filed within 6 months of the statute of limitations expiring 
as to any claimant, or within 1 year of the statute of repose expiring 
as to any claimant, shall be exempt from compliance with this section.
    (c) State Flexibility.--No provision of this section shall be 
construed to preempt any State law (whether effective before, on, or 
after the date of the enactment of this Act) that establishes a 
different time period for the filing of written notice.

                TITLE III--PRESCRIPTION DRUG COMPETITION

Subtitle A--Eliminating Delays of Generic Drugs and Biosimilar Products

SEC. 301. ACTIONS FOR DELAYS OF GENERIC DRUGS AND BIOSIMILAR BIOLOGICAL 
              PRODUCTS.

    (a) Definitions.--In this section--
            (1) the term ``covered product''--
                    (A) means--
                            (i) any drug approved under subsection (b) 
                        or (j) of section 505 of the Federal Food, 
                        Drug, and Cosmetic Act (21 U.S.C. 355) or 
                        biological product licensed under subsection 
                        (a) or (k) of section 351 of the Public Health 
                        Service Act (42 U.S.C. 262);
                            (ii) any combination of a drug or 
                        biological product described in clause (i); or
                            (iii) when reasonably necessary to 
                        demonstrate sameness, biosimilarity, or 
                        interchangeability for purposes of section 505 
                        of the Federal Food, Drug, and Cosmetic Act (21 
                        U.S.C. 355), or section 351 of the Public 
                        Health Service Act (42 U.S.C. 262), as 
                        applicable, any product, including any device, 
                        that is marketed or intended for use with such 
                        drug or biological product; and
                    (B) does not include any drug or biological product 
                that the Secretary has determined to be currently in 
                shortage and that appears on the drug shortage list in 
                effect under section 506E of the Federal Food, Drug, 
                and Cosmetic Act (21 U.S.C. 356e), unless the shortage 
                will not be promptly resolved--
                            (i) as demonstrated by the fact that the 
                        drug or biological product has been in shortage 
                        for more than 6 months; or
                            (ii) as otherwise determined by the 
                        Secretary;
            (2) the term ``device'' has the meaning given the term in 
        section 201 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 321);
            (3) the term ``eligible product developer'' means a person 
        that seeks to develop a product for approval pursuant to an 
        application for approval under subsection (b)(2) or (j) of 
        section 505 of the Federal Food, Drug, and Cosmetic Act (21 
        U.S.C. 355) or for licensing pursuant to an application under 
        section 351(k) of the Public Health Service Act (42 U.S.C. 
        262(k));
            (4) the term ``license holder'' means the holder of an 
        application approved under subsection (c) or (j) of section 505 
        of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) or 
        the holder of a license under subsection (a) or (k) of section 
        351 of the Public Health Service Act (42 U.S.C. 262) for a 
        covered product;
            (5) the term ``REMS'' means a risk evaluation and 
        mitigation strategy under section 505-1 of the Federal Food, 
        Drug, and Cosmetic Act (21 U.S.C. 355-1);
            (6) the term ``REMS with ETASU'' means a REMS that contains 
        elements to assure safe use under section 505-1 of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 355-1);
            (7) the term ``Secretary'' means the Secretary of Health 
        and Human Services;
            (8) the term ``single, shared system of elements to assure 
        safe use'' means a single, shared system of elements to assure 
        safe use under section 505-1 of the Federal Food, Drug, and 
        Cosmetic Act (21 U.S.C. 355-1); and
            (9) the term ``sufficient quantities'' means an amount of a 
        covered product that allows the eligible product developer to--
                    (A) conduct testing to support an application--
                            (i) for approval under subsection (b)(2) or 
                        (j) of section 505 of the Federal Food, Drug, 
                        and Cosmetic Act (21 U.S.C. 355); or
                            (ii) for licensing under section 351(k) of 
                        the Public Health Service Act (42 U.S.C. 
                        262(k)); and
                    (B) fulfill any regulatory requirements relating to 
                such an application for approval or licensing.
    (b) Civil Action for Failure To Provide Sufficient Quantities of a 
Covered Product.--
            (1) In general.--An eligible product developer may bring a 
        civil action against the license holder for a covered product 
        seeking relief under this subsection in an appropriate district 
        court of the United States alleging that the license holder has 
        declined to provide sufficient quantities of the covered 
        product to the eligible product developer on commercially 
        reasonable, market-based terms.
            (2) Elements.--
                    (A) In general.--To prevail in a civil action 
                brought under paragraph (1), an eligible product 
                developer shall prove, by a preponderance of the 
                evidence--
                            (i) that--
                                    (I) the covered product is not 
                                subject to a REMS with ETASU; or
                                    (II) if the covered product is 
                                subject to a REMS with ETASU--
                                            (aa) the eligible product 
                                        developer has obtained a 
                                        covered product authorization 
                                        from the Secretary in 
                                        accordance with subparagraph 
                                        (B); and
                                            (bb) the eligible product 
                                        developer has provided a copy 
                                        of the covered product 
                                        authorization to the license 
                                        holder;
                            (ii) that, as of the date on which the 
                        civil action is filed, the product developer 
                        has not obtained sufficient quantities of the 
                        covered product on commercially reasonable, 
                        market-based terms;
                            (iii) that the eligible product developer 
                        has requested to purchase sufficient quantities 
                        of the covered product from the license holder; 
                        and
                            (iv) that the license holder has not 
                        delivered to the eligible product developer 
                        sufficient quantities of the covered product on 
                        commercially reasonable, market-based terms--
                                    (I) for a covered product that is 
                                not subject to a REMS with ETASU, by 
                                the date that is 31 days after the date 
                                on which the license holder received 
                                the request for the covered product; 
                                and
                                    (II) for a covered product that is 
                                subject to a REMS with ETASU, by 31 
                                days after the later of--
                                            (aa) the date on which the 
                                        license holder received the 
                                        request for the covered 
                                        product; or
                                            (bb) the date on which the 
                                        license holder received a copy 
                                        of the covered product 
                                        authorization issued by the 
                                        Secretary in accordance with 
                                        subparagraph (B).
                    (B) Authorization for covered product subject to a 
                rems with etasu.--
                            (i) Request.--An eligible product developer 
                        may submit to the Secretary a written request 
                        for the eligible product developer to be 
                        authorized to obtain sufficient quantities of 
                        an individual covered product subject to a REMS 
                        with ETASU.
                            (ii) Authorization.--Not later than 90 days 
                        after the date on which a request under clause 
                        (i) is received, the Secretary shall, by 
                        written notice, authorize the eligible product 
                        developer to obtain sufficient quantities of an 
                        individual covered product subject to a REMS 
                        with ETASU for purposes of--
                                    (I) development and testing that 
                                does not involve human clinical trials, 
                                if the eligible product developer has 
                                agreed to comply with any conditions 
                                the Secretary determines necessary; or
                                    (II) development and testing that 
                                involves human clinical trials, if the 
                                eligible product developer has--
                                            (aa)(AA) submitted 
                                        protocols, informed consent 
                                        documents, and informational 
                                        materials for testing that 
                                        include protections that 
                                        provide safety protections 
                                        comparable to those provided by 
                                        the REMS for the covered 
                                        product; or
                                            (BB) otherwise satisfied 
                                        the Secretary that such 
                                        protections will be provided; 
                                        and
                                            (bb) met any other 
                                        requirements the Secretary may 
                                        establish.
                            (iii) Notice.--A covered product 
                        authorization issued under this subparagraph 
                        shall state that the provision of the covered 
                        product by the license holder under the terms 
                        of the authorization will not be a violation of 
                        the REMS for the covered product.
            (3) Affirmative defense.--In a civil action brought under 
        paragraph (1), it shall be an affirmative defense, on which the 
        defendant has the burden of persuasion by a preponderance of 
        the evidence--
                    (A) that, on the date on which the eligible product 
                developer requested to purchase sufficient quantities 
                of the covered product from the license holder--
                            (i) neither the license holder nor any of 
                        its agents, wholesalers, or distributors was 
                        engaged in the manufacturing or commercial 
                        marketing of the covered product; and
                            (ii) neither the license holder nor any of 
                        its agents, wholesalers, or distributors 
                        otherwise had access to inventory of the 
                        covered product to supply to the eligible 
                        product developer on commercially reasonable, 
                        market-based terms; or
                    (B) that--
                            (i) the license holder sells the covered 
                        product through agents, distributors, or 
                        wholesalers;
                            (ii) the license holder has placed no 
                        restrictions, explicit or implicit, on its 
                        agents, distributors, or wholesalers to sell 
                        covered products to eligible product 
                        developers; and
                            (iii) the covered product can be purchased 
                        by the eligible product developer in sufficient 
                        quantities on commercially reasonable, market-
                        based terms from the agents, distributors, or 
                        wholesalers of the license holder.
            (4) Remedies.--
                    (A) In general.--If an eligible product developer 
                prevails in a civil action brought under paragraph (1), 
                the court shall--
                            (i) order the license holder to provide to 
                        the eligible product developer without delay 
                        sufficient quantities of the covered product on 
                        commercially reasonable, market-based terms;
                            (ii) award to the eligible product 
                        developer reasonable attorney fees and costs of 
                        the civil action; and
                            (iii) award to the eligible product 
                        developer a monetary amount sufficient to deter 
                        the license holder from failing to provide 
                        other eligible product developers with 
                        sufficient quantities of a covered product on 
                        commercially reasonable, market-based terms, if 
                        the court finds, by a preponderance of the 
                        evidence--
                                    (I) that the license holder delayed 
                                providing sufficient quantities of the 
                                covered product to the eligible product 
                                developer without a legitimate business 
                                justification; or
                                    (II) that the license holder failed 
                                to comply with an order issued under 
                                clause (i).
                    (B) Maximum monetary amount.--A monetary amount 
                awarded under subparagraph (A)(iii) shall not be 
                greater than the revenue that the license holder earned 
                on the covered product during the period--
                            (i) beginning on--
                                    (I) for a covered product that is 
                                not subject to a REMS with ETASU, the 
                                date that is 31 days after the date on 
                                which the license holder received the 
                                request; or
                                    (II) for a covered product that is 
                                subject to a REMS with ETASU, the date 
                                that is 31 days after the later of--
                                            (aa) the date on which the 
                                        license holder received the 
                                        request; or
                                            (bb) the date on which the 
                                        license holder received a copy 
                                        of the covered product 
                                        authorization issued by the 
                                        Secretary in accordance with 
                                        paragraph (2)(B); and
                            (ii) ending on the date on which the 
                        eligible product developer received sufficient 
                        quantities of the covered product.
                    (C) Avoidance of delay.--The court may issue an 
                order under subparagraph (A)(i) before conducting 
                further proceedings that may be necessary to determine 
                whether the eligible product developer is entitled to 
                an award under clause (ii) or (iii) of subparagraph 
                (A), or the amount of any such award.
    (c) Limitation of Liability.--A license holder for a covered 
product shall not be liable for any claim arising out of the failure of 
an eligible product developer to follow adequate safeguards to assure 
safe use of the covered product during development or testing 
activities described in this section, including transportation, 
handling, use, or disposal of the covered product by the eligible 
product developer.
    (d) Rule of Construction.--
            (1) Definition.--In this subsection, the term ``antitrust 
        laws''--
                    (A) has the meaning given the term in subsection 
                (a) of the first section of the Clayton Act (15 U.S.C. 
                12); and
                    (B) includes section 5 of the Federal Trade 
                Commission Act (15 U.S.C. 45) to the extent that such 
                section applies to unfair methods of competition.
            (2) Antitrust laws.--Nothing in this section shall be 
        construed to limit the operation of any provision of the 
        antitrust laws.

SEC. 302. REMS APPROVAL PROCESS FOR SUBSEQUENT FILERS.

    Section 505-1 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 355-1) is amended--
            (1) in subsection (g)(4)(B)--
                    (A) in clause (i) by striking ``or'' after the 
                semicolon;
                    (B) in clause (ii) by striking the period at the 
                end and inserting ``; or''; and
                    (C) by adding at the end the following:
                            ``(iii) accommodate different approved risk 
                        evaluation and mitigation strategies for a 
                        reference drug product and a drug that is the 
                        subject of an abbreviated new drug 
                        application.''; and
            (2) in subsection (i)(1), by striking subparagraph (B) and 
        inserting the following:
                    ``(B) Elements to assure safe use, if required 
                under subsection (f) for the listed drug in accordance 
                with the following:
                            ``(i) Subject to clause (ii), a drug that 
                        is the subject of an abbreviated new drug 
                        application may use--
                                    ``(I) a single, shared system with 
                                the listed drug under subsection (f); 
                                or
                                    ``(II) a different, comparable 
                                aspect of the elements to assure safe 
                                use under subsection (f).
                            ``(ii) The Secretary may require a drug 
                        that is the subject of an abbreviated new drug 
                        application and the listed drug to use a 
                        single, shared system under subsection (f), if 
                        the Secretary determines that no different, 
                        comparable aspect of the elements to assure 
                        safe use could satisfy the requirements of 
                        subsection (f).''.

     Subtitle B--Increasing Access to Drugs and Biosimilar Products

SEC. 311. EXPEDITED DEVELOPMENT AND PRIORITY REVIEW FOR GENERIC COMPLEX 
              DRUG PRODUCTS.

    Subchapter A of chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by adding at the end the 
following:

``SEC. 524B. EXPEDITED DEVELOPMENT AND PRIORITY REVIEW FOR GENERIC 
              COMPLEX DRUG PRODUCTS.

    ``(a) Establishment of Program.--The Secretary shall establish a 
program to expedite the development of, and provide priority review 
under section 505(j) for, generic complex drug products.
    ``(b) Request for Designation.--A sponsor of a generic complex drug 
product may request that the Secretary designate such product for 
expedited development and priority review under this section.
    ``(c) Designation Process.--
            ``(1) In general.--Not later than 60 calendar days after 
        the receipt of a request under subsection (c), the Secretary 
        shall determine whether the product that is the subject of the 
        request meets the criteria under subsection (e) to be 
        considered a generic complex drug product. If the Secretary 
        determines that the product meets the criteria, the Secretary 
        shall designate the product for expedited development and 
        priority review.
            ``(2) Review.--Review of a request under subsection (b) 
        shall be undertaken by a team that is composed of experienced 
        staff and senior managers of the Food and Drug Administration.
            ``(3) Withdrawal.--The Secretary may not withdraw a 
        designation granted under this section on the basis of the 
        criteria under subsection (e) no longer applying because of the 
        subsequent clearance or approval of any other product.
    ``(d) Expedited Development and Priority Review Guidance.--
            ``(1) Content.--Not later than December 31, 2021, the 
        Secretary shall issue guidance on the implementation of this 
        section. Such guidance shall--
                    ``(A) set forth the process by which a person may 
                seek a designation under subsection (c);
                    ``(B) provide a template for requests under 
                subsection (b);
                    ``(C) identify the criteria the Secretary will use 
                in evaluating a request for designation under this 
                section; and
                    ``(D) identify the criteria and processes the 
                Secretary will use to expedite the development and 
                review of products designated under this section.
            ``(2) Process.--Prior to finalizing the guidance under 
        paragraph (1), the Secretary shall seek public comment on a 
        draft version of that guidance.
    ``(e) Generic Complex Drug Product Defined.--In this section, the 
term `generic complex drug product' means a product that represents a 
complex therapy that consists of or includes a drug for approval under 
section 505(j) and that--
            ``(1)(A) contains complex active ingredients (such as 
        peptides, polymeric compounds, complex mixtures of active 
        ingredients, and naturally sourced ingredients);
            ``(B) is composed of complex formulations (such as 
        liposomes or colloids);
            ``(C) requires a complex route of delivery (such as locally 
        acting drugs such as dermatological products and complex 
        ophthalmological products and otic dosage forms that are 
        formulated as suspensions, emulsions, or gels); or
            ``(D) involves a complex dosage form (such as transdermals, 
        metered dose inhalers, or extended release injectables);
            ``(2) presents as a complex drug-device combination product 
        (such as auto injectors or metered dose inhalers); or
            ``(3) is a product that would benefit from early scientific 
        engagement due to complexity or uncertainty concerning the 
        approval pathway under section 505(j).''.

SEC. 312. INCREASING PHARMACEUTICAL OPTIONS TO TREAT AN UNMET MEDICAL 
              NEED.

    Subsection (b) of section 506 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 356) is amended by adding at the end the 
following:
            ``(4) Unmet medical need.--For purposes of paragraph (1), a 
        drug shall be deemed to address an unmet medical need for a 
        disease or condition if fewer than 3 available drugs exist for 
        the treatment of such disease or condition.''.

SEC. 313. PREEMPTION OF STATE BARRIERS TO THE SUBSTITUTION OF 
              BIOSIMILAR PRODUCTS.

    No State, or any political subdivision thereof, may, under any 
circumstances, prohibit a pharmacy or pharmacist from dispensing, in 
place of a biological reference product, any biosimilar that the Food 
and Drug Administration has designated as an interchangeable product 
for that biological reference product.

     Subtitle C--Limiting Exclusivity Periods Delaying Competition

SEC. 321. LIMITING EXCLUSIVITY PERIODS FOR DRUGS TREATING RARE DISEASES 
              AND CONDITIONS.

    (a) In General.--Subsection (a) of section 527 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360cc) is amended to read as follows:
    ``(a) Exclusivity.--
            ``(1) In general.--Except as provided in subsection (b), if 
        the Secretary approves an application filed pursuant to section 
        505, or issues a license under section 351 of the Public Health 
        Service Act, for a drug designated under section 526 for a rare 
        disease or condition, the Secretary may not approve an 
        application filed pursuant to section 505, or issue a license 
        under section 351 of the Public Health Service Act, for the 
        same drug for the same disease or condition for a person who is 
        not the holder of such approved application or of such license 
        until the expiration of the exclusivity period described in 
        paragraph (2).
            ``(2) Exclusivity period described.--The exclusivity period 
        described in this paragraph, with respect to a drug designated 
        under section 526 for a rare disease or condition, is--
                    ``(A) a single 7-year period of exclusivity with 
                respect to the first designation of such drug under 
                such section for that rare disease or condition; or
                    ``(B) in the case of a drug that has previously 
                received a period of exclusivity under paragraph (1), a 
                single 3-year period of exclusivity with respect to any 
                subsequent designation of such drug under such section 
                for any other rare disease or condition.
            ``(3) Limitation.--In the case of a drug that has received 
        two periods of exclusivity pursuant to paragraph (1), no 
        additional exclusivity period under this section is available 
        with respect to such drug, regardless of whether such drug has 
        been designated under section 526 for a rare disease or 
        condition that is distinct from the rare disease or condition 
        for which such exclusivity periods were granted.''.
    (b) Conforming Amendments.--
            (1) Section 505(j)(5)(B)(iv)(II)(dd)(AA) of the Federal 
        Food, Drug, and Cosmetic Act (21 U.S.C. 360cc) is amended by 
        striking ``7-year period'' and inserting ``exclusivity 
        period''.
            (2) Section 505A(b)(1)(A)(ii) of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 360cc) is amended by striking 
        ``rather than seven years;'' and inserting ``, or three years 
        and six months, rather than seven years or three years, 
        respectively;''.
            (3) Section 505A(c)(1)(A)(ii) of the Federal Food, Drug, 
        and Cosmetic Act (21 U.S.C. 360cc) is amended by striking 
        ``rather than seven years;'' and inserting ``, or three years 
        and six months, rather than seven years or three years, 
        respectively;''.
            (4) Section 505E(a) of the Federal Food, Drug, and Cosmetic 
        Act (21 U.S.C. 360cc) is amended by striking ``7-year period'' 
        and inserting ``exclusivity periods''.
            (5) Section 527(b) of the Federal Food, Drug, and Cosmetic 
        Act (21 U.S.C. 360cc) is amended by striking ``the 7-year 
        period'' and inserting ``any exclusivity period''.
            (6) Section 351(m)(2)(B) of the Public Health Service Act 
        (42 U.S.C. 262) is amended by striking ``rather than 7 years'' 
        and inserting ``or 3 years and 6 months, rather than 7 years or 
        3 years, respectively''.
            (7) Section 351(m)(3)(B) of the Public Health Service Act 
        (42 U.S.C. 262) is amended by striking ``rather than 7 years'' 
        and inserting ``or 3 years and 6 months, rather than 7 years or 
        3 years, respectively''.

SEC. 322. LIMITING EXCLUSIVITY FOR BIOSIMILAR PRODUCTS.

    Paragraph (7) of section 351(k) of the Public Health Service Act 
(42 U.S.C. 262(k)) is amended in subparagraph (A), by striking ``12'' 
and inserting ``5''.

         Subtitle D--Congressional Review of Agency Rulemaking

SEC. 331. CONGRESSIONAL REVIEW OF THE FOOD AND DRUG ADMINISTRATION 
              RULEMAKING.

    (a) Congressional Review.--Part I of title 5, United States Code, 
is amended by adding at the end the following:

  ``CHAPTER 10--CONGRESSIONAL REVIEW OF FOOD AND DRUG ADMINISTRATION 
                               RULEMAKING

``Sec.
``920. Applicability.
``921. Congressional review.
``922. Congressional approval procedure for major rules.
``923. Congressional disapproval procedure for nonmajor rules.
``924. Definitions.
``925. Judicial review.
``926. Exemption for monetary policy.
``927. Effective date of certain rules.
``928. Regulatory cut-go requirement.
``929. Review of rules currently in effect.
``Sec. 920. Applicability
    ``This chapter applies in lieu of chapter 8 with respect to the 
Food and Drug Administration.
``Sec. 921. Congressional review
    ``(a)(1)(A) Before a rule may take effect, the Food and Drug 
Administration shall satisfy the requirements of section 928 and shall 
publish in the Federal Register a list of information on which the rule 
is based, including data, scientific and economic studies, and cost-
benefit analyses, and identify how the public can access such 
information online, and shall submit to each House of the Congress and 
to the Comptroller General a report containing--
            ``(i) a copy of the rule;
            ``(ii) a concise general statement relating to the rule;
            ``(iii) a classification of the rule as a major or nonmajor 
        rule, including an explanation of the classification 
        specifically addressing each criteria for a major rule 
        contained within sections 924(2)(A), 924(2)(B), and 924(2)(C);
            ``(iv) a list of any other related regulatory actions 
        intended to implement the same statutory provision or 
        regulatory objective as well as the individual and aggregate 
        economic effects of those actions; and
            ``(v) the proposed effective date of the rule.
    ``(B) On the date of the submission of the report under 
subparagraph (A), the Food and Drug Administration shall submit to the 
Comptroller General and make available to each House of Congress--
            ``(i) a complete copy of the cost-benefit analysis of the 
        rule, if any, including an analysis of any jobs added or lost, 
        differentiating between public and private sector jobs;
            ``(ii) the Food and Drug Administration's actions pursuant 
        to sections 603, 604, 605, 607, and 609 of this title;
            ``(iii) the Food and Drug Administration's actions pursuant 
        to sections 202, 203, 204, and 205 of the Unfunded Mandates 
        Reform Act of 1995; and
            ``(iv) any other relevant information or requirements under 
        any other Act and any relevant Executive orders.
    ``(C) Upon receipt of a report submitted under subparagraph (A), 
each House shall provide copies of the report to the chairman and 
ranking member of each standing committee with jurisdiction under the 
rules of the House of Representatives or the Senate to report a bill to 
amend the provision of law under which the rule is issued.
    ``(2)(A) The Comptroller General shall provide a report on each 
major rule to the committees of jurisdiction by the end of 15 calendar 
days after the submission or publication date. The report of the 
Comptroller General shall include an assessment of the Food and Drug 
Administration's compliance with procedural steps required by paragraph 
(1)(B) and an assessment of whether the major rule imposes any new 
limits or mandates on private-sector activity.
    ``(B) The Food and Drug Administration shall cooperate with the 
Comptroller General by providing information relevant to the 
Comptroller General's report under subparagraph (A).
    ``(3) A major rule relating to a report submitted under paragraph 
(1) shall take effect upon enactment of a joint resolution of approval 
described in section 922 or as provided for in the rule following 
enactment of a joint resolution of approval described in section 922, 
whichever is later.
    ``(4) A nonmajor rule shall take effect as provided by section 923 
after submission to Congress under paragraph (1).
    ``(5) If a joint resolution of approval relating to a major rule is 
not enacted within the period provided in subsection (b)(2), then a 
joint resolution of approval relating to the same rule may not be 
considered under this chapter in the same Congress by either the House 
of Representatives or the Senate.
    ``(b)(1) A major rule shall not take effect unless the Congress 
enacts a joint resolution of approval described under section 922.
    ``(2) If a joint resolution described in subsection (a) is not 
enacted into law by the end of 70 session days or legislative days, as 
applicable, beginning on the date on which the report referred to in 
section 921(a)(1)(A) is received by Congress (excluding days either 
House of Congress is adjourned for more than 3 days during a session of 
Congress), then the rule described in that resolution shall be deemed 
not to be approved and such rule shall not take effect.
    ``(c)(1) Notwithstanding any other provision of this section 
(except subject to paragraph (3)), a major rule may take effect for one 
90-calendar-day period if the President makes a determination under 
paragraph (2) and submits written notice of such determination to the 
Congress.
    ``(2) Paragraph (1) applies to a determination made by the 
President by Executive order that the major rule should take effect 
because such rule is--
            ``(A) necessary because of an imminent threat to health or 
        safety or other emergency;
            ``(B) necessary for the enforcement of criminal laws;
            ``(C) necessary for national security; or
            ``(D) issued pursuant to any statute implementing an 
        international trade agreement.
    ``(3) An exercise by the President of the authority under this 
subsection shall have no effect on the procedures under section 922.
    ``(d)(1) In addition to the opportunity for review otherwise 
provided under this chapter, in the case of any rule for which a report 
was submitted in accordance with subsection (a)(1)(A) during the period 
beginning on the date occurring--
            ``(A) in the case of the Senate, 60 session days; or
            ``(B) in the case of the House of Representatives, 60 
        legislative days,
before the date the Congress is scheduled to adjourn a session of 
Congress through the date on which the same or succeeding Congress 
first convenes its next session, sections 922 and 923 shall apply to 
such rule in the succeeding session of Congress.
    ``(2)(A) In applying sections 922 and 923 for purposes of such 
additional review, a rule described under paragraph (1) shall be 
treated as though--
            ``(i) such rule were published in the Federal Register on--
                    ``(I) in the case of the Senate, the 15th session 
                day; or
                    ``(II) in the case of the House of Representatives, 
                the 15th legislative day,
        after the succeeding session of Congress first convenes; and
            ``(ii) a report on such rule were submitted to Congress 
        under subsection (a)(1) on such date.
    ``(B) Nothing in this paragraph shall be construed to affect the 
requirement under subsection (a)(1) that a report shall be submitted to 
Congress before a rule can take effect.
    ``(3) A rule described under paragraph (1) shall take effect as 
otherwise provided by law (including other subsections of this 
section).
``Sec. 922. Congressional approval procedure for major rules
    ``(a)(1) For purposes of this section, the term `joint resolution' 
means only a joint resolution addressing a report classifying a rule as 
major pursuant to section 921(a)(1)(A)(iii) that--
            ``(A) bears no preamble;
            ``(B) bears the following title (with blanks filled as 
        appropriate): `Approving the rule submitted by ___ relating to 
        ___.';
            ``(C) includes after its resolving clause only the 
        following (with blanks filled as appropriate): `That Congress 
        approves the rule submitted by ___ relating to ___.'; and
            ``(D) is introduced pursuant to paragraph (2).
    ``(2) After a House of Congress receives a report classifying a 
rule as major pursuant to section 921(a)(1)(A)(iii), the majority 
leader of that House (or his or her respective designee) shall 
introduce (by request, if appropriate) a joint resolution described in 
paragraph (1)--
            ``(A) in the case of the House of Representatives, within 3 
        legislative days; and
            ``(B) in the case of the Senate, within 3 session days.
    ``(3) A joint resolution described in paragraph (1) shall not be 
subject to amendment at any stage of proceeding.
    ``(b) A joint resolution described in subsection (a) shall be 
referred in each House of Congress to the committees having 
jurisdiction over the provision of law under which the rule is issued.
    ``(c) In the Senate, if the committee or committees to which a 
joint resolution described in subsection (a) has been referred have not 
reported it at the end of 15 session days after its introduction, such 
committee or committees shall be automatically discharged from further 
consideration of the resolution and it shall be placed on the calendar. 
A vote on final passage of the resolution shall be taken on or before 
the close of the 15th session day after the resolution is reported by 
the committee or committees to which it was referred, or after such 
committee or committees have been discharged from further consideration 
of the resolution.
    ``(d)(1) In the Senate, when the committee or committees to which a 
joint resolution is referred have reported, or when a committee or 
committees are discharged (under subsection (c)) from further 
consideration of a joint resolution described in subsection (a), it is 
at any time thereafter in order (even though a previous motion to the 
same effect has been disagreed to) for a motion to proceed to the 
consideration of the joint resolution, and all points of order against 
the joint resolution (and against consideration of the joint 
resolution) are waived. The motion is not subject to amendment, or to a 
motion to postpone, or to a motion to proceed to the consideration of 
other business. A motion to reconsider the vote by which the motion is 
agreed to or disagreed to shall not be in order. If a motion to proceed 
to the consideration of the joint resolution is agreed to, the joint 
resolution shall remain the unfinished business of the Senate until 
disposed of.
    ``(2) In the Senate, debate on the joint resolution, and on all 
debatable motions and appeals in connection therewith, shall be limited 
to not more than 2 hours, which shall be divided equally between those 
favoring and those opposing the joint resolution. A motion to further 
limit debate is in order and not debatable. An amendment to, or a 
motion to postpone, or a motion to proceed to the consideration of 
other business, or a motion to recommit the joint resolution is not in 
order.
    ``(3) In the Senate, immediately following the conclusion of the 
debate on a joint resolution described in subsection (a), and a single 
quorum call at the conclusion of the debate if requested in accordance 
with the rules of the Senate, the vote on final passage of the joint 
resolution shall occur.
    ``(4) Appeals from the decisions of the Chair relating to the 
application of the rules of the Senate to the procedure relating to a 
joint resolution described in subsection (a) shall be decided without 
debate.
    ``(e) In the House of Representatives, if any committee to which a 
joint resolution described in subsection (a) has been referred has not 
reported it to the House at the end of 15 legislative days after its 
introduction, such committee shall be discharged from further 
consideration of the joint resolution, and it shall be placed on the 
appropriate calendar. On the second and fourth Thursdays of each month 
it shall be in order at any time for the Speaker to recognize a Member 
who favors passage of a joint resolution that has appeared on the 
calendar for at least 5 legislative days to call up that joint 
resolution for immediate consideration in the House without 
intervention of any point of order. When so called up a joint 
resolution shall be considered as read and shall be debatable for 1 
hour equally divided and controlled by the proponent and an opponent, 
and the previous question shall be considered as ordered to its passage 
without intervening motion. It shall not be in order to reconsider the 
vote on passage. If a vote on final passage of the joint resolution has 
not been taken by the third Thursday on which the Speaker may recognize 
a Member under this subsection, such vote shall be taken on that day.
    ``(f)(1) If, before passing a joint resolution described in 
subsection (a), one House receives from the other a joint resolution 
having the same text, then--
            ``(A) the joint resolution of the other House shall not be 
        referred to a committee; and
            ``(B) the procedure in the receiving House shall be the 
        same as if no joint resolution had been received from the other 
        House until the vote on passage, when the joint resolution 
        received from the other House shall supplant the joint 
        resolution of the receiving House.
    ``(2) This subsection shall not apply to the House of 
Representatives if the joint resolution received from the Senate is a 
revenue measure.
    ``(g) If either House has not taken a vote on final passage of the 
joint resolution by the last day of the period described in section 
921(b)(2), then such vote shall be taken on that day.
    ``(h) This section and section 923 are enacted by Congress--
            ``(1) as an exercise of the rulemaking power of the Senate 
        and House of Representatives, respectively, and as such is 
        deemed to be part of the rules of each House, respectively, but 
        applicable only with respect to the procedure to be followed in 
        that House in the case of a joint resolution described in 
        subsection (a) and superseding other rules only where 
        explicitly so; and
            ``(2) with full recognition of the Constitutional right of 
        either House to change the rules (so far as they relate to the 
        procedure of that House) at any time, in the same manner and to 
        the same extent as in the case of any other rule of that House.
``Sec. 923. Congressional disapproval procedure for nonmajor rules
    ``(a) For purposes of this section, the term `joint resolution' 
means only a joint resolution introduced in the period beginning on the 
date on which the report referred to in section 921(a)(1)(A) is 
received by Congress and ending 60 days thereafter (excluding days 
either House of Congress is adjourned for more than 3 days during a 
session of Congress), the matter after the resolving clause of which is 
as follows: `That Congress disapproves the nonmajor rule submitted by 
the ___ relating to ___, and such rule shall have no force or effect.' 
(The blank spaces being appropriately filled in).
    ``(b) A joint resolution described in subsection (a) shall be 
referred to the committees in each House of Congress with jurisdiction.
    ``(c) In the Senate, if the committee to which is referred a joint 
resolution described in subsection (a) has not reported such joint 
resolution (or an identical joint resolution) at the end of 15 session 
days after the date of introduction of the joint resolution, such 
committee may be discharged from further consideration of such joint 
resolution upon a petition supported in writing by 30 Members of the 
Senate, and such joint resolution shall be placed on the calendar.
    ``(d)(1) In the Senate, when the committee to which a joint 
resolution is referred has reported, or when a committee is discharged 
(under subsection (c)) from further consideration of a joint resolution 
described in subsection (a), it is at any time thereafter in order 
(even though a previous motion to the same effect has been disagreed 
to) for a motion to proceed to the consideration of the joint 
resolution, and all points of order against the joint resolution (and 
against consideration of the joint resolution) are waived. The motion 
is not subject to amendment, or to a motion to postpone, or to a motion 
to proceed to the consideration of other business. A motion to 
reconsider the vote by which the motion is agreed to or disagreed to 
shall not be in order. If a motion to proceed to the consideration of 
the joint resolution is agreed to, the joint resolution shall remain 
the unfinished business of the Senate until disposed of.
    ``(2) In the Senate, debate on the joint resolution, and on all 
debatable motions and appeals in connection therewith, shall be limited 
to not more than 10 hours, which shall be divided equally between those 
favoring and those opposing the joint resolution. A motion to further 
limit debate is in order and not debatable. An amendment to, or a 
motion to postpone, or a motion to proceed to the consideration of 
other business, or a motion to recommit the joint resolution is not in 
order.
    ``(3) In the Senate, immediately following the conclusion of the 
debate on a joint resolution described in subsection (a), and a single 
quorum call at the conclusion of the debate if requested in accordance 
with the rules of the Senate, the vote on final passage of the joint 
resolution shall occur.
    ``(4) Appeals from the decisions of the Chair relating to the 
application of the rules of the Senate to the procedure relating to a 
joint resolution described in subsection (a) shall be decided without 
debate.
    ``(e) In the Senate, the procedure specified in subsection (c) or 
(d) shall not apply to the consideration of a joint resolution 
respecting a nonmajor rule--
            ``(1) after the expiration of the 60 session days beginning 
        with the applicable submission or publication date; or
            ``(2) if the report under section 921(a)(1)(A) was 
        submitted during the period referred to in section 921(d)(1), 
        after the expiration of the 60 session days beginning on the 
        15th session day after the succeeding session of Congress first 
        convenes.
    ``(f) If, before the passage by one House of a joint resolution of 
that House described in subsection (a), that House receives from the 
other House a joint resolution described in subsection (a), then the 
following procedures shall apply:
            ``(1) The joint resolution of the other House shall not be 
        referred to a committee.
            ``(2) With respect to a joint resolution described in 
        subsection (a) of the House receiving the joint resolution--
                    ``(A) the procedure in that House shall be the same 
                as if no joint resolution had been received from the 
                other House; but
                    ``(B) the vote on final passage shall be on the 
                joint resolution of the other House.
``Sec. 924. Definitions
    ``For purposes of this chapter:
            ``(1) The term `major rule' means any rule of the Food and 
        Drug Administration, including an interim final rule, that the 
        Administrator of the Office of Information and Regulatory 
        Affairs of the Office of Management and Budget finds has 
        resulted in or is likely to result in--
                    ``(A) an annual cost on the economy of $100,000,000 
                or more, adjusted annually for inflation;
                    ``(B) a major increase in costs or prices for 
                consumers, individual industries, Federal, State, or 
                local government agencies, or geographic regions; or
                    ``(C) significant adverse effects on competition, 
                employment, investment, productivity, innovation, or on 
                the ability of United States-based enterprises to 
                compete with foreign-based enterprises in domestic and 
                export markets.
            ``(2) The term `nonmajor rule' means any rule of the Food 
        and Drug Administration that is not a major rule.
            ``(3) The term `rule' has the meaning given such term in 
        section 551, except that such term does not include--
                    ``(A) any rule of particular applicability;
                    ``(B) any rule relating to agency management or 
                personnel; or
                    ``(C) any rule of agency organization, procedure, 
                or practice that does not substantially affect the 
                rights or obligations of non-agency parties.
            ``(4) The term `submission date or publication date', 
        except as otherwise provided in this chapter, means--
                    ``(A) in the case of a major rule, the date on 
                which the Congress receives the report submitted under 
                section 921(a)(1); and
                    ``(B) in the case of a nonmajor rule, the later 
                of--
                            ``(i) the date on which the Congress 
                        receives the report submitted under section 
                        921(a)(1); and
                            ``(ii) the date on which the nonmajor rule 
                        is published in the Federal Register, if so 
                        published.
``Sec. 925. Judicial review
    ``(a) No determination, finding, action, or omission under this 
chapter shall be subject to judicial review.
    ``(b) Notwithstanding subsection (a), a court may determine whether 
the Food and Drug Administration has completed the necessary 
requirements under this chapter for a rule to take effect.
    ``(c) The enactment of a joint resolution of approval under section 
922 shall not be interpreted to serve as a grant or modification of 
statutory authority by Congress for the promulgation of a rule, shall 
not extinguish or affect any claim, whether substantive or procedural, 
against any alleged defect in a rule, and shall not form part of the 
record before the court in any judicial proceeding concerning a rule 
except for purposes of determining whether or not the rule is in 
effect.
``Sec. 926. Exemption for monetary policy
    ``Nothing in this chapter shall apply to rules that concern 
monetary policy proposed or implemented by the Board of Governors of 
the Federal Reserve System or the Federal Open Market Committee.
``Sec. 927. Effective date of certain rules
    ``Notwithstanding section 921, any rule other than a major rule 
which the Food and Drug Administration for good cause finds (and 
incorporates the finding and a brief statement of reasons therefore in 
the rule issued) that notice and public procedure thereon are 
impracticable, unnecessary, or contrary to the public interest, shall 
take effect at such time as the Food and Drug Administration 
determines.
``Sec. 928. Regulatory cut-go requirement
    ``In making any new rule, the Food and Drug Administration shall 
identify a rule or rules that may be amended or repealed to completely 
offset any annual costs of the new rule to the United States economy. 
Before the new rule may take effect, the Food and Drug Administration 
shall make each such repeal or amendment. In making such an amendment 
or repeal, the Food and Drug Administration shall comply with the 
requirements of subchapter II of chapter 5, but the Food and Drug 
Administration may consolidate proceedings under subchapter with 
proceedings on the new rule.
``Sec. 929. Review of rules currently in effect
    ``(a) Annual Review.--Beginning on the date that is 6 months after 
the date of enactment of this section and annually thereafter for the 9 
years following, the Food and Drug Administration shall designate not 
less than 10 percent of eligible rules made by the Food and Drug 
Administration for review, and shall submit a report including each 
such eligible rule in the same manner as a report under section 
921(a)(1). Section 921, section 922, and section 923 shall apply to 
each such rule, subject to subsection (c) of this section. No eligible 
rule previously designated may be designated again.
    ``(b) Sunset for Eligible Rules Not Extended.--Beginning after the 
date that is 10 years after the date of enactment of this section, if 
Congress has not enacted a joint resolution of approval for that 
eligible rule, that eligible rule shall not continue in effect.
    ``(c) Consolidation; Severability.--In applying sections 921, 922, 
and 923 to eligible rules under this section, the following shall 
apply:
            ``(1) The words `take effect' shall be read as `continue in 
        effect'.
            ``(2) Except as provided in paragraph (3), a single joint 
        resolution of approval shall apply to all eligible rules in a 
        report designated for a year, and the matter after the 
        resolving clause of that joint resolution is as follows: `That 
        Congress approves the rules submitted by the __ for the year 
        __.' (The blank spaces being appropriately filled in).
            ``(3) It shall be in order to consider any amendment that 
        provides for specific conditions on which the approval of a 
        particular eligible rule included in the joint resolution is 
        contingent.
            ``(4) A member of either House may move that a separate 
        joint resolution be required for a specified rule.
    ``(d) Definition.--In this section, the term `eligible rule' means 
a rule that is in effect as of the date of enactment of this 
section.''.
    (b) Budgetary Effects of Rules Subject to Section 922 of Title 5, 
United States Code.--Section 257(b)(2) of the Balanced Budget and 
Emergency Deficit Control Act of 1985 is amended by adding at the end 
the following new subparagraph:
                    ``(E) Budgetary effects of rules subject to section 
                922 of title 5, united states code.--Any rules subject 
                to the congressional approval procedure set forth in 
                section 922 of chapter 8 of title 5, United States 
                Code, affecting budget authority, outlays, or receipts 
                shall be assumed to be effective unless it is not 
                approved in accordance with such section.''.
    (c) Government Accountability Office Study of Rules.--
            (1) In general.--The Comptroller General of the United 
        States shall conduct a study to determine, as of the date of 
        the enactment of this Act--
                    (A) how many rules (as such term is defined in 
                section 924 of title 5, United States Code) of the Food 
                and Drug Administration were in effect;
                    (B) how many major rules (as such term is defined 
                in section 924 of title 5, United States Code) of the 
                Food and Drug Administration were in effect; and
                    (C) the total estimated economic cost imposed by 
                all such rules.
            (2) Report.--Not later than 1 year after the date of the 
        enactment of this Act, the Comptroller General of the United 
        States shall submit a report to Congress that contains the 
        findings of the study conducted under paragraph (1).
    (d) Effective Date.--Subsections (a) and (b), and the amendments 
made by such sections, shall take effect beginning on the date that is 
1 year after the date of enactment of this Act.

SEC. 332. GOVERNMENT ACCOUNTABILITY OFFICE STUDY OF RULES.

    (a) In General.--The Comptroller General of the United States shall 
conduct a study to determine, as of the date of the enactment of this 
Act--
            (1) how many rules (as such term is defined in section 804 
        of title 5, United States Code) were in effect;
            (2) how many major rules (as such term is defined in 
        section 804 of title 5, United States Code) were in effect; and
            (3) the total estimated economic cost imposed by all such 
        rules.
    (b) Report.--Not later than 1 year after the date of the enactment 
of this Act, the Comptroller General of the United States shall submit 
a report to Congress that contains the findings of the study conducted 
under subsection (a).

           Subtitle E--Medicare Prescription Drug Competition

SEC. 341. MEDICARE DRUG COVERAGE.

    Notwithstanding any other provision of law, the Secretary of Health 
and Human Services may alter the reimbursement mechanism for 
prescription drugs provided through the Medicare Part B program by 
reimbursing at a rate that, based on ASP+6% in the year of 
implementation of this Act, grows at CPI.

SEC. 342. PBM TRANSPARENCY AND ELIMINATION OF DIR FEES.

    (a) Prohibiting Medicare PDP Sponsors and MA-PD Organizations From 
Retroactively Reducing Payment on Clean Claims Submitted by 
Pharmacies.--
            (1) In general.--Section 1860D-12(b)(4)(A) of the Social 
        Security Act (42 U.S.C. 1395w-112(b)(4)(A)) is amended by 
        adding at the end the following new clause:
                            ``(iv) Prohibiting retroactive reductions 
                        in payments on clean claims.--Each contract 
                        entered into with a PDP sponsor under this part 
                        with respect to a prescription drug plan 
                        offered by such sponsor shall provide that 
                        after the date of receipt of a clean claim 
                        submitted by a pharmacy, the PDP sponsor (or an 
                        agent of the PDP sponsor) may not retroactively 
                        reduce payment on such claim directly or 
                        indirectly through aggregated effective rate or 
                        otherwise except in the case such claim is 
                        found to not be a clean claim (such as in the 
                        case of a claim lacking required substantiating 
                        documentation) during the course of a routine 
                        audit as permitted pursuant to written 
                        agreement between the PDP sponsor (or such an 
                        agent) and such pharmacy. The previous sentence 
                        shall not prohibit any retroactive increase in 
                        payment to a pharmacy pursuant to a written 
                        agreement between a PDP sponsor (or an agent of 
                        such sponsor) and such pharmacy.''.
            (2) Effective date.--The amendment made by subsection (a) 
        shall apply with respect to contracts entered into on or after 
        January 1, 2021.
    (b) Elimination of DIR Fees.--
            (1) Pharmacy benefits manager standards under the medicare 
        program for prescription drug plans and ma-pd plans.--
                    (A) In general.--Section 1860D-12(b) of the Social 
                Security Act (42 U.S.C. 1395w-112(b)) is amended by 
                adding at the end the following new paragraph:
            ``(7) Pharmacy benefits manager transparency 
        requirements.--Each contract entered into with a PDP sponsor 
        under this part with respect to a prescription drug plan 
        offered by such sponsor or with an MA organization offering an 
        MA-PD plan under part C shall provide that the sponsor or 
        organization, respectively, may not enter into a contract with 
        any pharmacy benefits manager (referred to in this paragraph as 
        a `PBM') to manage the prescription drug coverage provided 
        under such plan, or to control the costs of the prescription 
        drug coverage under such plan, unless the PBM adheres to the 
        following criteria when handling personally identifiable 
        utilization and claims data or other sensitive patient data:
                    ``(A) The PBM may not transmit any personally 
                identifiable utilization, protected health information, 
                or claims data, with respect to a plan enrollee, to a 
                pharmacy owned by a PBM if the plan enrollee has not 
                voluntarily elected in writing or via secure electronic 
                means to fill that particular prescription at the PBM-
                owned pharmacy.
                    ``(B) The PBM may not require that a plan enrollee 
                use a retail pharmacy, mail order pharmacy, specialty 
                pharmacy, or other pharmacy entity providing pharmacy 
                services in which the PBM has an ownership interest or 
                that has an ownership interest in the PBM, or provide 
                an incentive to a plan enrollee to encourage the 
                enrollee to use a retail pharmacy, mail order pharmacy, 
                specialty pharmacy, or other pharmacy entity providing 
                pharmacy services in which the PBM has an ownership 
                interest or that has an ownership interest in the PBM, 
                if the incentive is applicable only to such 
                pharmacies.''.
                    (B) Regular update of prescription drug pricing 
                standard.--Paragraph (6) of section 1860D-12(b) of the 
                Social Security Act (42 U.S.C. 1395w-112(b)) is amended 
                to read as follows:
            ``(6) Regular update of prescription drug pricing 
        standard.--
                    ``(A) In general.--If the PDP sponsor of a 
                prescription drug plan (or MA organization offering an 
                MA-PD plan) uses a standard for reimbursement (as 
                described in subparagraph (B)) of pharmacies based on 
                the cost of a drug, each contract entered into with 
                such sponsor under this part (or organization under 
                part C) with respect to the plan shall provide that the 
                sponsor (or organization) shall--
                            ``(i) update such standard not less 
                        frequently than once every 7 days, beginning 
                        with an initial update on January 1 of each 
                        year, to accurately reflect the market price of 
                        acquiring the drug;
                            ``(ii) disclose to applicable pharmacies 
                        and the contracting entities of such pharmacies 
                        the sources used for making any such update 
                        immediately without requirement of request;
                            ``(iii) if the source for such a standard 
                        for reimbursement is not publicly available, 
                        disclose to the applicable pharmacies and the 
                        respective contracting entities of such 
                        pharmacies all individual drug prices to be so 
                        updated in advance of the use of such prices 
                        for the reimbursement of claims;
                            ``(iv) establish a process to appeal, 
                        investigate, and resolve disputes regarding 
                        individual drug prices that are less than the 
                        pharmacy acquisition price for such drug, which 
                        must be adjudicated within 7 days of the 
                        pharmacy filing its appeal; and
                            ``(v) provide all such pricing data in an 
                        .xml spreadsheet format or a comparable easily 
                        accessible and complete spreadsheet format.
                    ``(B) Prescription drug pricing standard defined.--
                For purposes of subparagraph (A), a standard for 
                reimbursement of a pharmacy is any methodology or 
                formula for varying the pricing of a drug or drugs 
                during the term of the pharmacy reimbursement contract 
                that is based on the cost of the drug involved, 
                including drug pricing references and amounts that are 
                based upon average wholesale price, wholesale average 
                cost, average manufacturer price, average sales price, 
                maximum allowable cost (MAC), or other costs, whether 
                publicly available or not.''.
                    (C) Effective date.--The amendments made by this 
                section shall apply to plan years beginning on or after 
                January 1, 2020.
            (2) Regular update of prescription drug pricing standard 
        under tricare retail pharmacy program.--Section 1074g(d) of 
        title 10, United States Code, is amended by adding at the end 
        the following new paragraph:
    ``(3) To the extent practicable, with respect to the TRICARE retail 
pharmacy program described in subsection (a)(2)(E)(ii), the Secretary 
shall ensure that a contract entered into with a TRICARE managed care 
support contractor includes requirements described in section 1860D-
12(b)(6) of the Social Security Act (42 U.S.C. 1395w-112(b)(6)) to 
ensure the provision of information regarding the pricing standard for 
prescription drugs.''.
            (3) Prescription drug transparency in the federal employees 
        health benefits program.--
                    (A) In general.--Section 8902 of title 5, United 
                States Code, is amended by adding at the end the 
                following new subsections:
    ``(p) A contract may not be made or a plan approved under this 
chapter under which a carrier has an agreement with a pharmacy benefits 
manager (in this subsection referred to as a `PBM') to manage 
prescription drug coverage or to control the costs of the prescription 
drug coverage unless the carrier and PBM adhere to the following 
criteria:
            ``(1) The PBM may not transmit any personally identifiable 
        utilization, protected health information, or claims data with 
        respect to an individual enrolled under such contract or plan 
        to a pharmacy owned by the PBM if the individual has not 
        voluntarily elected in writing or via secure electronic means 
        to fill that particular prescription at such a pharmacy.
            ``(2) The PBM may not require that an individual enrolled 
        under such contract or plan use a retail pharmacy, mail order 
        pharmacy, specialty pharmacy, or other pharmacy entity 
        providing pharmacy services in which the PBM has an ownership 
        interest or that has an ownership interest in the PBM or 
        provide an incentive to a plan enrollee to encourage the 
        enrollee to use a retail pharmacy, mail order pharmacy, 
        specialty pharmacy, or other pharmacy entity providing pharmacy 
        services in which the PBM has an ownership interest or that has 
        an ownership interest in the PBM, if the incentive is 
        applicable only to such pharmacies.
    ``(q)(1) If a contract made or plan approved under this chapter 
provides for a standard for reimbursement (as described in paragraph 
(2)) with respect to a prescription drug plan, such contract or plan 
shall provide that the applicable carrier--
            ``(A) update such standard not less frequently than once 
        every 7 days, beginning with an initial update on January 1 of 
        each year, to accurately reflect the market price of acquiring 
        the drug;
            ``(B) disclose to applicable pharmacies and the contracting 
        entities of such pharmacies the sources used for making any 
        such update immediately without requirement of request;
            ``(C) if the source for such a standard for reimbursement 
        is not publicly available, disclose to the applicable 
        pharmacies and contracting entities of such pharmacies all 
        individual drug prices to be so updated in advance of the use 
        of such prices for the reimbursement of claims;
            ``(D) establish a process to appeal, investigate, and 
        resolve disputes regarding individual drug prices that are less 
        than the pharmacy acquisition price for such drug, which must 
        be adjudicated within 7 days of the pharmacy filing its appeal; 
        and
            ``(E) provide all such pricing data in an .xml spreadsheet 
        format or a comparable easily accessible and complete 
        spreadsheet format.
    ``(2) For purposes of paragraph (1), a standard for reimbursement 
of a pharmacy is any methodology or formula for varying the pricing of 
a drug or drugs during the term of the pharmacy reimbursement contract 
that is based on the cost of the drug involved, including drug pricing 
references and amounts that are based upon average wholesale price, 
wholesale average cost, average manufacturer price, average sales 
price, maximum allowable cost, or other costs, whether publicly 
available or not.''.
                    (B) Application.--The amendment made by 
                subparagraph (A) shall apply to any contract entered 
                into under section 8902 of title 5, United States Code, 
                on or after the date of enactment of this section.

SEC. 343. SUNSET OF LIMIT ON MAXIMUM REBATE AMOUNT FOR SINGLE SOURCE 
              DRUGS AND INNOVATOR MULTIPLE SOURCE DRUGS.

    Section 1927(c)(2)(D) of the Social Security Act (42 U.S.C. 1396r-
8(c)(2)(D)) is amended by inserting after ``December 31, 2009,'' the 
following: ``and before December 31, 2024,''.

SEC. 344. REGULATION OF MANUFACTURER-SPONSORED COPAY CONTRIBUTIONS.

    Notwithstanding any other provision of law, the Secretary of Health 
and Human Services may establish a mechanism prohibiting drug 
manufacturers from contributing financially to patient copays, and 
establish a system of penalizing such behavior.

SEC. 345. DATA REPORTING TO IMPROVE THE TRANSPARENCY REGARDING HOW 340B 
              HOSPITAL COVERED ENTITIES PROVIDE CARE FOR PATIENTS.

    Section 340B of the Public Health Service Act (42 U.S.C. 256b) is 
amended by adding at the end the following new subsection:
    ``(f) Data Reporting To Improve the Transparency Regarding How 
Hospital Covered Entities Provide Care for Patients.--
            ``(1) In general.--Beginning on the date that is 14 months 
        after the date of the enactment of this subsection, and 
        annually thereafter, subject to subparagraph (C), a covered 
        entity described in subparagraph (L) or (M) of subsection 
        (a)(4), unless otherwise indicated, shall report on the 
        following, with respect to the previous year, in such a manner 
        and form as specified by the Secretary:
                    ``(A) The following information:
                            ``(i) With respect to such covered entity 
                        and with respect to each child site of such 
                        entity (as referenced in paragraph (11)), the 
                        number and percentage of individuals who are 
                        dispensed or administered drugs that are 
                        subject to an agreement under this section, 
                        organized by form of health insurance coverage 
                        of such individuals (including at least by the 
                        Medicare program under title XVIII of the 
                        Social Security Act, the Medicaid program under 
                        title XIX of such Act, health insurance 
                        coverage offered in the individual or group 
                        market or a group health plan (as such terms 
                        are defined in section 2791), and uninsured).
                            ``(ii) With respect to each such child site 
                        of such entity, the total costs incurred at 
                        each such site and the cost incurred at each 
                        such site for charity care as defined in line 
                        23 of worksheet S-10 to the Medicare cost 
                        report or in any successor form.
                    ``(B) The aggregate amount of gross reimbursement 
                received by each such covered entity (including child 
                sites of such entity) described in such subparagraph 
                (L) or (M) for all drugs purchased that are subject to 
                an agreement under this section and the entity's 
                aggregate acquisition cost for such drugs.
                    ``(C) In the case of covered entity described in 
                subparagraph (L) of subsection (a)(4), at the time of 
                application and recertification (and at least annually 
                thereafter), the contract that is the basis for 
                eligibility under the requirement under clause (i) of 
                such subparagraph and any modifications to such 
                contract for purposes of review by the Secretary.
                    ``(D) With respect to such covered entity and with 
                respect to each child site of such entity, the name of 
                all third-party vendors or other similar entities that 
                the covered entity contracts with to provide services 
                associated with the program under this section.
            ``(2) Availability of information.--
                    ``(A) In general.--The Secretary shall make data 
                reported by covered entities under subparagraphs (A), 
                (C), and (D) of paragraph (1) available on the public 
                website of the Department of Health and Human Services 
                in an electronic and searchable format, which may 
                include the 340B Office of Pharmacy Affairs Information 
                System or a successor to such system.
                    ``(B) Format.--Data made available under 
                subparagraph (A) shall be made available in a manner 
                that shows each category of data reported both in the 
                aggregate and identified by covered entities described 
                in subparagraphs (L) and (M) of subsection (a)(4) and 
                child sites of such covered entities. In carrying out 
                this paragraph, with respect to data reported pursuant 
                to paragraph (1)(C), the Secretary shall ensure that 
                any proprietary information shall be redacted from 
                contracts submitted pursuant to such paragraph (1)(C) 
                before posting such data.
            ``(3) Interim final regulations.--The Secretary shall issue 
        interim final regulations no later than the date that is 6 
        months after the date of the enactment of this subsection, to 
        carry out this subsection and shall finalize such regulations 
        prior to the end of the moratorium period to which subsection 
        (a)(11) applies.
            ``(4) Reports to congress.--
                    ``(A) OIG report.--Not later than 2 years after the 
                date of the enactment of this subsection, the Office of 
                the Inspector General shall submit to Congress a final 
                report on the level of charity care provided by covered 
                entities described in subparagraphs (L) and (M) of 
                subsection (a)(4) and separately by child sites of such 
                covered entities, as reported in paragraph (1)(A).
                    ``(B) GAO reports.--
                            ``(i) Initial report.--Not later than 1 
                        year after the date of the enactment of this 
                        subsection, the Comptroller General of the 
                        United States shall submit to Congress a 
                        report--
                                    ``(I) analyzing the State and local 
                                government contracts intended to 
                                satisfy the requirement under 
                                subsection (a)(4)(L)(i) for a covered 
                                entity to qualify as an entity 
                                described in subparagraph (L) of 
                                subsection (a)(4);
                                    ``(II) assessing the amount of care 
                                such contracts obligate such entity to 
                                provide to low-income individuals 
                                ineligible for Medicare under title 
                                XVIII of the Social Security Act and 
                                Medicaid under title XIX of such Act; 
                                and
                                    ``(III) analyzing how these 
                                contracts define low-income individuals 
                                and whether the Secretary reviews such 
                                determinations.
                            ``(ii) Subsequent report.--Not later than 2 
                        years after the date of the enactment of this 
                        subsection, the Comptroller General of the 
                        United States shall submit to Congress a final 
                        report on the information collected under 
                        paragraph (1)(B) regarding the difference 
                        between the aggregate gross reimbursement and 
                        aggregate acquisition costs received by each 
                        such covered entity (including child sites of 
                        such entity) for drugs subject to an agreement 
                        under this section.''.

SEC. 346. REQUIRING 340B DRUG DISCOUNT PROGRAM REPORTS BY DSH HOSPITAL 
              COVERED ENTITIES ON LOW-INCOME UTILIZATION RATE OF 
              OUTPATIENT HOSPITAL SERVICES.

    (a) In General.--Section 340B(d)(2) of the Public Health Service 
Act (42 U.S.C. 256b(d)(2)) is amended--
            (1) in subparagraph (B)(i), by inserting before the period 
        at the end the following: ``, including, with respect to such 
        updates made on or after January 1, 2020, by requiring covered 
        entities described in subsection (a)(4)(L) to submit (and to so 
        regularly update) information described in subparagraph (C)''; 
        and
            (2) by adding at the end the following new subparagraph:
                    ``(C) Information on low-income utilization rate of 
                outpatient hospital services.--
                            ``(i) In general.--For purposes of 
                        subparagraph (B)(i), the information described 
                        in this subparagraph, with respect to a covered 
                        entity described in subsection (a)(4)(L) and an 
                        update under such subparagraph (B)(i), is--
                                    ``(I) the low-income outpatient 
                                utilization rate of such covered entity 
                                for the most recent fiscal year; and
                                    ``(II) the low-income outpatient 
                                utilization rate of off-site outpatient 
                                facilities, clinics, eligible off-site 
                                locations, and associated sites of such 
                                entity identified as child sites of 
                                such entity pursuant to the 
                                identification system under 
                                subparagraph (B)(iv) for the most 
                                recent fiscal year.
                            ``(ii) Low-income outpatient utilization 
                        rate defined.--In this subparagraph, the term 
                        `low-income outpatient utilization rate' has 
                        the meaning given the term `low-income 
                        utilization rate' under paragraph (3) of 
                        section 1923(b) of the Social Security Act, 
                        except that--
                                    ``(I) clauses (i) and (ii) of 
                                subparagraph (A) of such paragraph 
                                shall be applied as if--
                                            ``(aa) each reference to 
                                        `patient services' were a 
                                        reference to `patient services 
                                        furnished on an outpatient 
                                        basis'; and
                                            ``(bb) for purposes of 
                                        clause (i)(II) of this 
                                        subparagraph, each reference to 
                                        `hospital' were a reference to 
                                        `off-site outpatient 
                                        facilities, clinics, eligible 
                                        off-site locations, and 
                                        associated sites of the 
                                        hospital that are identified as 
                                        child sites of the hospital 
                                        pursuant to the identification 
                                        system under section 
                                        340B(d)(2)(B)(iv) of the Public 
                                        Health Service Act'; and
                                    ``(II) clauses (i) and (ii) of 
                                subparagraph (B) of such paragraph 
                                shall be applied as if--
                                            ``(aa) each reference to 
                                        `inpatient hospital services' 
                                        were a reference to `outpatient 
                                        hospital services'; and
                                            ``(bb) for purposes of 
                                        clause (i)(II) each reference 
                                        to `hospital's charges' were a 
                                        reference to `charges of the 
                                        off-site outpatient facilities, 
                                        clinics, eligible off-site 
                                        locations, and associated sites 
                                        of the hospital that are 
                                        identified as child sites of 
                                        the hospital pursuant to the 
                                        identification system under 
                                        section 340B(d)(2)(B)(iv) of 
                                        the Public Health Service 
                                        Act'.''.
    (b) Annual Reports.--Not later than January 1, 2021, and annually 
thereafter, the Administrator of the Health Resources and Services 
Administration shall submit to Congress a report on information 
submitted by covered entities for the previous year pursuant to the 
amendments made by subsection (a).

                     TITLE IV--PROVIDER COMPETITION

SEC. 401. HOSPITAL CONSOLIDATION.

    (a) Authorization of Appropriations.--There is authorized to be 
appropriated $160,000,000 to the Federal Trade Commission to hire staff 
to investigate, as consistent with the Sherman Antitrust Act and other 
relevant Federal laws, anti-competitive mergers and practices under 
such laws to the extent such mergers and practices relate to providers 
of inpatient and outpatient health care services, as defined by the 
Secretary of Health and Human Services.
    (b) Medicare Rates Applied to Certain HHI Hospitals.--
            (1) In general.--Section 1866(a) of the Social Security Act 
        (42 U.S.C. 1395cc(a)) is amended--
                    (A) in paragraph (1)--
                            (i) in subparagraph (X), by striking 
                        ``and'' at the end;
                            (ii) in subparagraph (Y), by striking the 
                        period at the end and inserting ``; and''; and
                            (iii) by inserting after subparagraph (Y) 
                        the following new subparagraph:
                    ``(Z) subject to paragraph (4), in the case of a 
                hospital in an urban area and with respect to which 
                there is a Herfindahl-Hirschman Index (HHI) of greater 
                than 4,000 and in the case of a hospital in a rural 
                area and with respect to which there is Herfindahl-
                Hirschman Index (HHI) of greater than 5,000, to apply 
                the reimbursement rate with respect to individuals 
                (regardless of whether such an individual is entitled 
                to or eligible for benefits under this title, but 
                excluding individuals eligible for medical assistance 
                under a State plan under title XIX) furnished items and 
                services at such hospital that would be billable under 
                this title for such items and services if furnished by 
                such hospital to an individual entitled to or enrolled 
                for benefits under this title.''; and
                    (B) by adding at the end the following new 
                paragraph:
            ``(4)(A) The requirement under paragraph (1)(Z) shall not 
        apply in the case of a hospital in a hospital referral region 
        if the HRR market share of such hospital (as determined under 
        subparagraph (B)) is less than 0.15.
            ``(B) For purposes of subparagraph (A), the HRR market 
        share of a hospital in a hospital referral region is equal to--
                    ``(i) the total revenue of the hospital, divided by
                    ``(ii) the total revenue of all hospital in the 
                hospital referral region.''.
            (2) Effective date.--The amendments made by this subsection 
        shall apply with respect to items and services furnished on or 
        after January 1, 2021.
    (c) Grants for Hospital Infrastructure Improvement.--
            (1) In general.--The Secretary of Health and Human Services 
        shall carry out a grant program under which the Secretary shall 
        provide grants to eligible States, in accordance with this 
        subsection.
            (2) Uses.--An eligible State receiving a grant under this 
        subsection may use such grant to improve the State hospital 
        infrastructure and to supplement any other funds provided for a 
        purpose authorized under a State or local hospital grant 
        programs under State law.
            (3) Eligibility.--
                    (A) In general.--An eligible State may receive not 
                more than one grant under this subsection with respect 
                to each qualifying criterion described in subparagraph 
                (B) that is met by the State.
                    (B) Eligible state.--For purposes of this 
                subsection, the term ``eligible State'' means a State 
                that meets any one or more of the following qualifying 
                criteria:
                            (i) The State does not have in effect any 
                        State certificate of need law that requires a 
                        health care provider to provide to a regulatory 
                        body a certification that the community needs 
                        the services provided by the health care 
                        provider.
                            (ii) The State has in effect State scope of 
                        practice laws that--
                                    (I) allow advanced practice 
                                providers (such as nurse practitioners, 
                                advanced practice registered nurses, 
                                clinical nurse specialists, and 
                                physician assistants) to evaluate 
                                patients; diagnose, order, and 
                                interpret diagnostic tests; and 
                                initiate and manage treatments; or
                                    (II) provide that the only 
                                justification for limiting the scope of 
                                practice of a health care provider is 
                                safety to the public.
                            (iii) The State does not have in effect any 
                        State laws that require managed care plans to 
                        accept into the network of such plan any 
                        qualified provider who is willing to accept the 
                        terms and conditions of the managed care plan.
            (4) Funding.--There is authorized to be appropriated to 
        carry out this subsection $1,000,000,000 for each of the fiscal 
        years 2019 through 2028. Funds appropriated under this 
        paragraph shall remain available until expended.

SEC. 402. PRICE TRANSPARENCY.

    Section 1866 of the Social Security Act (42 U.S.C. 1395cc), as 
amended by section 401, is further amended--
            (1) in subsection (a)(1)--
                    (A) in subparagraph (Y), by striking ``and'' at the 
                end;
                    (B) in subparagraph (Z), by striking the period at 
                the end and inserting ``; and''; and
                    (C) by inserting after subparagraph (Z) the 
                following new subparagraph:
            ``(AA) in the case of a hospital, to comply with the 
        requirement under subsection (l).''; and
            (2) by adding at the end the following new subsection:
    ``(l) Requirement Relating to Publishing Certain Hospital Prices.--
            ``(1) In general.--For purposes of subsection (a)(1)(AA), 
        the requirement described in this subsection is, with respect 
        to a hospital and year (beginning with 2021), for the hospital 
        to publicly post, through the system established under 
        paragraph (3), for each service included in the list published 
        under paragraph (2) for such year, the volume-weighted average 
        price charged by the hospital to--
                    ``(A) individuals enrolled during such year in 
                group health plans or health insurance coverage offered 
                in the individual or group market (as such terms are 
                defined in section 2791 of the Public Health Service 
                Act); and
                    ``(B) individuals who are not enrolled in any 
                health insurance coverage or health benefits plan and 
                individuals who are enrolled in such coverage or plan 
                but such coverage or plan does not provide benefits for 
                the service.
            ``(2) Services.--For purposes of subsection (a)(1)(AA) and 
        this subsection, the Secretary shall, for 2021 and each 
        subsequent year, publish a list of the 100 services that are 
        the most highly utilized in a hospital-based setting.
            ``(3) Standardized digital reporting system.--Not later 
        than January 1, 2021, the Secretary shall establish a 
        standardized digital system for purposes of paragraph (1).''.

SEC. 403. REPEALING SHARED SAVINGS INCENTIVES FROM MEDICARE SHARED 
              SAVINGS PROGRAM.

    (a) In General.--Section 1899 of the Social Security Act (42 U.S.C. 
1395jjj) is amended--
            (1) in subsection (a)(1)--
                    (A) by striking subparagraph (B); and
                    (B) by striking ``such program--
                    ``(A) groups of providers'' and inserting ``such 
                program, groups of providers'';
            (2) in subsection (b)(2)--
                    (A) in subparagraph (C), by striking ``that would 
                allow the organization to receive and distribute 
                payments for shared savings under subsection (d)(2) to 
                participating providers of services and suppliers''; 
                and
                    (B) in subparagraph (E)--
                            (i) by striking ``the implementation'' and 
                        inserting ``and the implementation''; and
                            (ii) by striking ``, and the determination 
                        of payments for shared savings under subsection 
                        (d)(2)'';
            (3) in subsection (d)--
                    (A) in paragraph (1)--
                            (i) in subparagraph (A), by striking 
                        ``except'' and all that follows through 
                        ``subparagraph (B)(i).''; and
                            (ii) by striking subparagraph (B); and
                    (B) by striking paragraph (2); and
            (4) in subsection (g), by striking paragraph (4) and 
        redesignating paragraphs (5) and (6) as paragraphs (4) and (5), 
        respectively.
    (b) Effective Date.--The amendments made by subsection (a) shall 
take effect on January 1, 2021.

SEC. 404. REPEAL OF HEALTH CARE REFORM PROVISIONS LIMITING MEDICARE 
              EXCEPTION TO THE PROHIBITION ON CERTAIN PHYSICIAN 
              REFERRALS FOR HOSPITALS.

    Sections 6001 and 10601 of the Patient Protection and Affordable 
Care Act (Public Law 111-148; 124 Stat. 684, 1005) and section 1106 of 
the Health Care and Education Reconciliation Act of 2010 (Public Law 
111-152; 124 Stat. 1049) are repealed and the provisions of law amended 
by such sections are restored as if such sections had never been 
enacted.

SEC. 405. ADVISORY GROUP ON REDUCING BURDEN OF HOSPITAL ADMINISTRATIVE 
              REQUIREMENTS.

    (a) In General.--Not later than January 1, 2021, the Secretary of 
Health and Human Services shall convene an advisory group to provide, 
in accordance with this section, recommendations on ways the Federal 
Government could reduce the burden of administrative requirements on 
hospitals.
    (b) Recommendations.--Not later than January 1, 2022, the advisory 
board convened under this section shall--
            (1) submit to the Secretary of Health and Human Services 
        recommendations described under subsection (a) for executive 
        action and any recommendations for State actions for potential 
        consideration in making grants under section 2(c) to States; 
        and
            (2) submit to Congress recommendations described under 
        subsection (a) for legislative proposals.
    (c) Membership.--The advisory board under this section shall 
consist of the following members:
            (1) Three representatives of companies that have--
                    (A) geographically distributed workforces;
                    (B) at least 10,000 employees; and
                    (C) no more than 10 percent of such employees in 
                any single State.
            (2) Three representatives of health insurance issuers and 
        health plans, consisting of--
                    (A) one representative of for-profit health 
                insurance issuers and health plans with at least 
                20,000,000 enrollees in the employer-sponsored market;
                    (B) one representative of non-profit health 
                insurance issuers and health plans operating in at 
                least 5 States; and
                    (C) one representative of non-profit health 
                insurance issuers and health plans operating in a rural 
                State (as defined by the Census Bureau).
            (3) Seven public policy experts in the field of hospital 
        consolidation.

SEC. 406. AUTHORITY OF FEDERAL TRADE COMMISSION OVER CERTAIN TAX-EXEMPT 
              ORGANIZATIONS.

    Section 4 of the Federal Trade Commission Act (15 U.S.C. 44) is 
amended, in the undesignated paragraph relating to the definition of 
the term ``Corporation''--
            (1) by striking ``, and any'' and inserting ``, any''; and
            (2) by inserting before the period at the end the 
        following: ``, and any organization described in section 
        501(c)(3) of the Internal Revenue Code of 1986 that is exempt 
        from taxation under section 501(a) of such Code''.

                      TITLE V--DIGITAL HEALTH CARE

SEC. 501. ACCESS OF INDIVIDUALS TO PROTECTED HEALTH INFORMATION.

    The provisions of section 164.524 of title 45, Code of Federal 
Regulations, as in effect on the day before the date of the enactment 
of this Act, shall have the force and effect of law.

SEC. 502. EXPANSION OF COVERAGE OF TELEHEALTH SERVICES.

    (a) Covered Services.--Section 1834(m)(4)(F)(i) of the Social 
Security Act (42 U.S.C. 1395m(m)(4)(F)(i)) is amended--
            (1) by striking ``and office'' and inserting ``office''; 
        and
            (2) by inserting: ``respiratory services, audiology 
        services (as defined in section 1861(ll)), outpatient therapy 
        services (including physical therapy, occupational therapy, and 
        speech-language pathology services)'' after ``the 
        Secretary)),''.
    (b) Providers.--Subsection (m) of section 1834 of such Act (42 
U.S.C. 1395m) is amended--
            (1) in paragraph (1), by striking ``or a practitioner 
        (described in section 1842(b)(18)(C))'' and inserting ``, a 
        practitioner (described in section 1842(b)(18)(C)), or an 
        applicable professional (as defined in paragraph (4)(G))'';
            (2) by striking ``physician or practitioner'' each time it 
        appears in such subsection and inserting ``physician, 
        practitioner, or applicable professional'';
            (3) in paragraph (3)(A)--
                    (A) in the heading, by striking ``Physician and 
                practitioner'' and inserting ``Physician, practitioner, 
                and applicable professional''; and
                    (B) by striking ``physicians or practitioners'' and 
                inserting ``physicians, practitioners, or applicable 
                professionals''; and
            (4) in paragraph (4), by adding at the end the following 
        new subparagraph:
                    ``(G) Applicable professional.--The term 
                `applicable professional' means, with respect to 
                services furnished on or after the date that is 6 
                months after the date of the enactment of this 
                subparagraph, a certified diabetes educator or 
                licensed--
                            ``(i) respiratory therapist;
                            ``(ii) audiologist;
                            ``(iii) occupational therapist;
                            ``(iv) physical therapist; or
                            ``(v) speech language pathologist.''.
    (c) Home-Based Monitoring Services for Congestive Heart Failure and 
Chronic Obstructive Pulmonary Disease.--
            (1) Coverage of remote patient monitoring services for 
        certain chronic health conditions.--
                    (A) In general.--Section 1861(s)(2) of the Social 
                Security Act (42 U.S.C. 1395x(s)(2)) is amended--
                            (i) in subparagraph (GG), by striking 
                        ``and'' at the end;
                            (ii) in subparagraph (HH), by inserting 
                        ``and'' at the end; and
                            (iii) by inserting after subparagraph (HH) 
                        the following new subparagraph:
                    ``(II) applicable remote patient monitoring 
                services (as defined in paragraph (1)(A) of subsection 
                (iii));''.
            (2) Services described.--Section 1861 of the Social 
        Security Act (42 U.S.C. 1395x) is amended by adding at the end 
        the following new subsection:
    ``(kkk) Remote Patient Monitoring Services for Chronic Health 
Conditions.--
            ``(1)(A) The term `applicable remote patient monitoring 
        services' means remote patient monitoring services (as defined 
        in subparagraph (B)) furnished to provide for the monitoring, 
        evaluation, and management of an individual with a covered 
        chronic condition (as defined in paragraph (2)), insofar as 
        such services are for the management of such chronic condition.
            ``(B) The term `remote patient monitoring services' means 
        services furnished through remote patient monitoring technology 
        (as defined in subparagraph (C)).
            ``(C) The term `remote patient monitoring technology' means 
        a coordinated system that uses one or more home-based or mobile 
        monitoring devices that automatically transmit vital sign data 
        or information on activities of daily living and may include 
        responses to assessment questions collected on the devices 
        wirelessly or through a telecommunications connection to a 
        server that complies with the Federal regulations (concerning 
        the privacy of individually identifiable health information) 
        promulgated under section 264(c) of the Health Insurance 
        Portability and Accountability Act of 1996, as part of an 
        established plan of care for that patient that includes the 
        review and interpretation of that data by a health care 
        professional.
            ``(2) For purposes of paragraph (1), the term `covered 
        chronic health condition' means applicable conditions (as 
        defined in and applied under section 1886(q)(5)) when under 
        chronic care management (identified as of July 1, 2015, by 
        HCPCS code 99490 (and as subsequently modified by the 
        Secretary)).
            ``(3)(A) Payment may be made under this part for applicable 
        remote patient monitoring services provided to an individual 
        during a period of up to 90 days and such additional period as 
        provided for under subparagraph (B).
            ``(B) The 90-day period described in subparagraph (A), with 
        respect to an individual, may be renewed by the physician who 
        provides chronic care management to such individual if the 
        individual continues to qualify for such management.''.
            (3) Payment under the physician fee schedule.--Section 1848 
        of the Social Security Act (42 U.S.C. 1395w-4) is amended--
                    (A) in subsection (c)--
                            (i) in paragraph (2)(B)--
                                    (I) in clause (ii)(II), by striking 
                                ``and (v)'' and inserting ``(v), and 
                                (vii)''; and
                                    (II) by adding at the end the 
                                following new clause:
                            ``(vii) Budgetary treatment of certain 
                        services.--The additional expenditures 
                        attributable to services described in section 
                        1861(s)(2)(II) shall not be taken into account 
                        in applying clause (ii)(II).''; and
                            (ii) by adding at the end the following new 
                        paragraph:
            ``(7) Treatment of applicable remote patient monitoring 
        services.--
                    ``(A) In determining relative value units for 
                applicable remote patient monitoring services (as 
                defined in section 1861(iii)(1)(A)), the Secretary, in 
                consultation with appropriate physician groups, 
                practitioner groups, and supplier groups, shall take 
                into consideration--
                            ``(i) physician or practitioner resources, 
                        including physician or practitioner time and 
                        the level of intensity of services provided, 
                        based on--
                                    ``(I) the frequency of evaluation 
                                necessary to manage the individual 
                                being furnished the services;
                                    ``(II) the complexity of the 
                                evaluation, including the information 
                                that must be obtained, reviewed, and 
                                analyzed; and
                                    ``(III) the number of possible 
                                diagnoses and the number of management 
                                options that must be considered;
                            ``(ii) practice expense costs associated 
                        with such services, including the direct costs 
                        associated with installation and information 
                        transmission, costs of remote patient 
                        monitoring technology (including equipment and 
                        software), device delivery costs, and resource 
                        costs necessary for patient monitoring and 
                        followup (but not including costs of any 
                        related item or non-physician service otherwise 
                        reimbursed under this title); and
                            ``(iii) malpractice expense resources.
                    ``(B) Using the relative value units determined in 
                subparagraph (A), the Secretary shall provide for 
                separate payment for such services and shall not adjust 
                the relative value units assigned to other services 
                that might otherwise have been determined to include 
                such separately paid remote patient monitoring 
                services.''; and
                    (B) in subsection (j)(3), by inserting ``(2)(II),'' 
                after ``health risk assessment),''.

SEC. 503. STARK AND AKS EXEMPTIONS.

    Notwithstanding any other provision of law, the Secretary of Health 
and Human Services may exempt value-based arrangements, alternative 
payment models, and technologies (as defined by the Secretary) from any 
provision of section 1128B or 1877 of the Social Security Act for 
purposes of maintaining, analyzing, or transferring electronic health 
records.

SEC. 504. STARK TECHNICAL PENALTY.

    Notwithstanding any other provision of law, the Secretary of Health 
and Human Services may institute a civil monetary penalty for 
technical, nonegregious violations of section 1877 of the Social 
Security Act in lieu of any penalty otherwise applicable for such 
violations under such section.
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