(a) Short title.—This Act may be cited as the “Fair Care Act of 2022”.

(b) Table of contents.—The table of contents for this Act is as follows:

Sec. 1. Short title; table of contents.

(a) In general.—Section 223 of the Internal Revenue Code of 1986 is amended to read as follows:

(b) Employer contributions to health savings accounts.—

(1) IN GENERAL.—Section 106(d) is amended to read as follows:

“(d) Contributions to health savings accounts.—

“(1) IN GENERAL.—In the case of an employee who is an eligible individual, amounts contributed by such employee’s employer to any health savings account of such employee shall be treated as employer-provided coverage for medical expenses under an accident or health plan to the extent—

“(A) such amounts do not exceed twice the limitation in effect under section 223(b)(2) (determined without regard to this subsection) which is applicable to such employee for such taxable year,

“(B) such amounts are contributed to an account which is integrated with an integration eligible health plan,

“(C) such employer does not offer such employee coverage under any other accident or health plan,

“(D) such employer offers such amounts only to members of a qualified class of employees and offers such amounts to all members of any such qualified class,

“(E) such employer offers employees an opportunity to elect not to receive such amounts at least once per year and upon termination from employment, and

“(F) such employee is not covered under any health insurance offered by an employer of such employee’s spouse.

“(2) INTEGRATION ELIGIBLE HEALTH PLAN.—For purposes of this subsection, the term ‘integration eligible health plan’ means—

“(A) any bronze, silver, or gold plan offered through an Exchange established under the Patient Protection and Affordable Care Act,

“(B) entitlement to benefits under part A of title XVIII of the Social Security Act and enrollment under part B of such title, including enrollment under a Medicare Advantage plan under part C of such title,

“(C) in the case of any individual who has not attained age 30 or is determined by the Secretary (after consultation with the Secretary of Health and Human Services) to have a hardship, coverage under a catastrophic plan, and

“(D) in the case of any student, coverage under a health plan which is conditioned on maintaining status as being such a student.

“(3) INTEGRATION OF PLANS AND ACCOUNTS.—For purposes of this subsection, an account shall be treated as integrated with an integration eligible health plan (and such plan shall be treated as integrated with such account) for any month if—

“(A) the employee is the account beneficiary of such account and such employee is covered under an integration eligible health plan for such month,

“(B) the employer verifies that the employee is so covered by requiring the submission of documentation to such employer, and

“(C) the employer makes contributions to such account for such month which are not less than the excess (if any) of—

“(i) the adjusted monthly premiums for the applicable second lowest cost silver plan with respect to the taxpayer, over

“(ii) ¹⁄12 of 9.5 percent of the taxpayer’s household income (within the meaning of section 36B).

“(4) QUALIFIED CLASS.—For purposes of this subsection—

“(A) IN GENERAL.—The term ‘qualified class’ means only the following: All employees; Full-time employees; Part-time employees; Seasonal employees; Employees covered under a collective bargaining agreement; Employees in a waiting period; Foreign employees who work abroad; Employees working in the same geographic location (same insurance rating area, State, or multi-State region); Salaried workers; Non-Salaried workers (such as hourly workers); Temporary employees of staffing firms.

“(B) RULES RELATED TO CLASS SIZE.—

“(i) MINIMUM CLASS SIZE.—A class shall not be treated as a qualified class unless in consisting of at least the following number of employees:

“(I) In the case of an employer with fewer than 100 employees, the lesser of 10 employees or all employees of the employer.

“(II) In the case of an employer with at least 100 and not more than 200 employees, 10 percent of the number of such employees (if not a whole number, rounded down to the next lowest whole number).

“(III) In the case of an employer with more than 200 employees, 20 employees.

“(ii) COMBINATION OF CLASSES.—Two or more qualified classes described in subparagraph (A) may be combined if each such class separately would not satisfy the requirement of clause (i).

“(C) PERMITTED VARIATION WITHIN QUALIFIED CLASSES.—An employer shall not fail to meet the requirements of paragraph (1)(D) solely because the amounts offered to members of a qualified class vary on the basis of—

“(i) number of dependents,

“(ii) age, if such variation based on age does not exceed a ratio of 3:1, and

“(iii) chronic health condition, if such variation based on chronic health condition does not exceed a ratio of 1.2:1.

“(5) COORDINATION WITH ACA PROVISIONS.—In the case of an integration eligible health plan which is integrated with a health savings account—

“(A) such plan shall be treated as an eligible employer-sponsored plan described in section 5000A(f)(1)(B),

“(B) if an individual receives contributions to such account which are excludible from the gross income of such individual under this section during any taxable year, no credit shall be allowed under section 36B with respect to such individual for such taxable year, and

“(C) for purposes of section 36B(c)(2)(C)(i)(II), the employee’s required contribution with respect to such plan shall be treated as being equal to the excess (if any) of—

“(i) the adjusted monthly premiums for the applicable second lowest cost silver plan with respect to the taxpayer, over

“(ii) the contributions made the employer to such health savings account which are excludible from the gross income of the employee under this section.

“(6) NO CONSTRUCTIVE RECEIPT.—No amount shall be included in the gross income of any employee solely because the employee may choose between the contributions referred to in paragraph (1) and employer contributions to another health plan of the employer.

“(7) SPECIAL RULE FOR DEDUCTION OF EMPLOYER CONTRIBUTIONS.—Any employer contribution to a health savings account, if otherwise allowable as a deduction under this chapter, shall be allowed only for the taxable year in which paid.

“(8) EMPLOYER HEALTH SAVINGS ACCOUNT CONTRIBUTIONS REQUIRED TO BE SHOWN ON RETURN.—Every individual required to file a return under section 6012 for the taxable year shall include on such return the aggregate amount contributed by employers to the health savings accounts of such individual or such individual’s spouse for such taxable year.

“(9) HEALTH SAVINGS ACCOUNT CONTRIBUTIONS NOT PART OF COBRA COVERAGE.—Paragraph (1) shall not apply for purposes of section 4980B.

“(10) DEFINITIONS.—Terms used in this subsection which are also used in section 223 shall have the same respective meanings as when used in such section.

“(11) REGULATIONS.—The Secretaries of Treasury, Labor, and Health and Human Services shall each issue such regulations or other guidance as may be necessary or appropriate to carry out the purposes of this subsection, including regulations or other guidance to—

“(A) prevent employers from offering plans integrated with health savings accounts selectively to sicker workers, and

“(B) establish a safe harbor that helps employers determine whether contributions to health savings accounts with respect to which there is an integrated health plan comply with affordability requirements under the Patient Protection and Affordable Care Act and the amendments made by such Act.

“(12) CROSS REFERENCE.—For penalty on failure by employer to make comparable contributions to the health savings accounts of comparable employees, see section 4980G.”.

(2) NONAPPLICATION OF ERISA.—Contributions by an employer to a health savings account (as defined in section 223 of the Internal Revenue Code of 1986), and an integration eligible health plan which is integrated with such account (within the meaning of such section), shall not be treated as a plan for purposes of the Employee Retirement Income Security Act of 1974 if—

(A) receipt of such contributions by the employee is voluntary,

(B) the employer does not select or endorse the integration eligible health plan which is integrated with such account,

(C) no premiums, other than premiums for the integration eligible health plan which is integrated with such account, are paid from the account,

(D) the employer receives no consideration (money or other benefit) in connection with the employee selecting or renewing a plan, and

(E) each participant is notified annually that such contributions and such plan are not subject to the requirements of such Act.

(c) Termination of certain other health care related tax benefits.—

(1) EXCLUSION LIMITED TO SELF-FUNDED MAJOR MEDICAL PLAN OF EMPLOYERS.—Section 105(b) of such Code is amended by striking “paid,” and inserting “paid under a self-funded major medical plan of the employer”.

(2) EXCLUSION NOT APPLICABLE TO HEALTH REIMBURSEMENT ARRANGEMENTS.—Section 105(h) of such Code is amended to read as follows:

“(h) Exclusion not applicable to health reimbursement arrangements.—Subsection (b) shall not apply to health reimbursement arrangements.”.

(3) REPEAL OF EXCLUSIONS FROM INCOME FOR ARCHER MSAS AND FSAS.—Section 106 of such Code is amended by striking subsections (b), (e), and (g).

(4) TERMINATION OF DEDUCTION FOR CONTRIBUTIONS TO ARCHER MSAS.—Section 220(a) of such Code is amended by adding at the end the following: “No amount shall be allowed as a deduction under the preceding sentence for any taxable year beginning after one year after the date of the enactment of this sentence.”.

(d) Bankruptcy protections.—Section 522 of title 11, United States Code, is amended by adding at the end the following new subsection:

“(r) For purposes of this section, any health savings account (as described in section 223 of the Internal Revenue Code of 1986) shall be treated in the same manner as an individual retirement account described in section 408 of such Code.”.

(e) Rollover of FSA, Archer MSA, HRA to health savings account.—Notwithstanding any other provision of law, if the remaining balance in a health flexible spending arrangement, Archer MSA, or health reimbursement arrangement is transferred to a health savings account before the end of any taxable year ending on or before one year after the date of the enactment of this Act, such transfer shall be treated as a rollover to the health savings account under section 223(f)(5) of the Internal Revenue Code of 1986 and the distribution from the health flexible spending arrangement, Archer MSA, or health reimbursement arrangement shall not be includible in gross income.

(f) Effective dates.—

(1) IN GENERAL.—The amendments made by subsections (a) and (b) shall apply to taxable years beginning after the date of the enactment of this Act.

(2) TERMINATION OF CERTAIN OTHER HEALTH CARE RELATED TAX BENEFITS.—The amendments made by subsection (c) shall apply to taxable years beginning after the date which is 1 year after the date of the enactment of this Act.

(3) BANKRUPTCY PROTECTIONS.—The amendment made by subsection (d) shall apply to cases commencing under title 11, United States Code, after the date of the enactment of this Act.

(a) In general.—Section 36B is amended by redesignating subsection (h) as subsection (i) and by inserting after subsection (g) the following new subsection:

“(h) Excess credit may be deposited into a health savings account.—

“(1) IN GENERAL.—If the amount described in subparagraph (B) of subsection (b)(2) exceeds the amount described in subparagraph (A) of such subsection with respect to any coverage month and an election under paragraph (2) is in effect with respect to the applicable taxpayer, the Secretary shall deposit such excess into a health savings account of such taxpayer.

“(2) ELECTION TO DEPOSIT EXCESS CREDIT INTO A HEALTH SAVINGS ACCOUNT.—A taxpayer may elect (at such time and in such manner as the Secretary may provide) to have the Secretary deposit the excess described in paragraph (1) into a health savings account of the taxpayer. Any such election shall only be treated as being in effect if the taxpayer provides the Secretary with such information as the Secretary may require to allow the Secretary to make such deposit.

“(3) COORDINATION WITH HEALTH SAVINGS ACCOUNT RULES.—Any amount deposited in a health savings account by the Secretary under this subsection shall—

“(A) be includible in the gross income of the applicable taxpayer, and

“(B) be taken into account as an amount paid to such account for purposes of this section.

“(4) TREATMENT OF DEPOSITS.—For purposes of section 1324 of title 31, United States Code, any deposit made under this subsection shall be treated as a credit allowed under this section.”.

(b) Effective date.—The amendments made by this section shall apply to taxable years beginning after the date of the enactment of this Act.

The rule published by the Internal Revenue Service, the Employee Benefits Security Administration, and the Health and Human Services Department relating to “Health Reimbursement Arrangements and Other Account-Based Group Health Plans” (June 20, 2019) shall have the force and effect of law. Health Reimbursement Arrangements as described in this rule are subject to all sections in this title.

(a) Alternative waiver for State innovation.—Section 1332 of the Patient Protection and Affordable Care Act (42 U.S.C. 18052) is amended by adding at the end the following new subsection:

“(f) Alternative waiver for State innovation.—

“(1) IN GENERAL.—Notwithstanding any preceding provision of this section, a State may apply to the Secretary for the waiver of any requirement of subsection (a)(2) with respect to health insurance coverage within that State for plan years beginning on or after January 1, 2023, if instead of complying with section 1402 the State provides for the distribution of funding received under paragraph (2) to health savings accounts of qualifying individuals with respect to such State. Such application shall be filed at such time and in such manner as the Secretary may require, and shall include such information as the Secretary may require (including a 10-year budget plan for such plan that is budget neutral for the Federal Government).

“(2) PASS-THROUGH FUNDING.—With respect to a State waiver under paragraph (1), under which, due to the structure of such waiver, individuals in the State would not qualify for cost-sharing reductions under section 1402 for which they would otherwise be eligible, the Secretary shall provide for an alternative means by which an amount is transferred to the State equal to the aggregate amount of such reductions that would have been paid on behalf of the participants in the Exchanges established under this title—

“(A) had the State not received such waiver;

“(B) had references to ‘eligible insureds’ under section 1402 referred to ‘qualifying insureds (as defined in section 1332(f))’;

“(C) had, after application of clause (ii), in the case of a qualifying insured enrolled in the bronze level of coverage—

“(i) the percentages specified in subclauses (I), (II), and (III) of section 1402(c)(1)(B) were references to 84 percent, 77 percent, and 63 percent, respectively; and

“(ii) the references in subparagraphs (A), (B), and (C) of section 1402(c)(2) to 94 percent, 87 percent, and 73 percent, respectively, were references to 84 percent, 77 percent, and 63 percent, respectively; and

“(D) had, after application of clause (ii), in the case of a qualifying insured enrolled in the copper level of coverage—

“(i) the percentages specified in subclauses (I), (II), and (III) of section 1402(c)(1)(B) were references to 74 percent, 67 percent, and 53 percent, respectively; and

“(ii) the references in subparagraphs (A), (B), and (C) of section 1402(c)(2) to 94 percent, 87 percent, and 73 percent, respectively, were references to 74 percent, 67 percent, and 53 percent, respectively.

The amount transferred pursuant to the previous sentence shall be determined annually by the Secretary, taking into consideration the experience of other States with respect to participation in an Exchange and reductions provided under such provisions to residents of the other States, and shall be paid to the State for purposes of implementing such waiver.

“(3) WAIVER CONSIDERATION AND TRANSPARENCY.—The provisions of paragraph (4) of subsection (a) shall apply to an application for a waiver under paragraph (1) in the same manner as such provisions apply with respect to an application for a waiver under subsection (a)(1), except that, for purposes of this paragraph, the provisions of subsection (a)(4)(B)(ii) shall not apply.

“(4) DETERMINATIONS; TERM OF WAIVER.—The provisions of subsections (d) and (e) shall apply with respect to a determination with respect to an application under paragraph (1), and with respect to the term of a waiver under such paragraph, in the same manner as such provisions apply with respect to a determination with respect to an application under subsection (a)(1), and with respect to the term of a waiver under such subsection.

“(5) DEFINITIONS.—For purposes of this subsection:

“(A) HEALTH SAVINGS ACCOUNT.—The term ‘health savings account’ has the meaning given such term in section 223 of the Internal Revenue Code of 1986.

“(B) QUALIFYING INSURED.—The term ‘qualifying insured’ means, with respect to a State and a year, an individual—

“(i) who is enrolled in a health savings account;

“(ii) who is enrolled for such year in a silver, bronze, or copper level coverage offered through an Exchange; and

“(iii) whose household income is not more than 250 percent of the Federal poverty line for a family of the size involved.”.

(b) Additional amendments.—Section 1402 of the Patient Protection and Affordable Care Act (42 U.S.C. 18071) is amended by striking “not less than 100 percent but” and “exceeds 100 percent but” and “more than 100 percent but” each place such phrases appear.

(c) Conforming amendments.—Section 1332 of the Patient Protection and Affordable Care Act (42 U.S.C. 18052), as amended by subsection (a), is further amended in subsection (a)(4)—

(1) in subparagraph (A) by striking the period and inserting “, except in the case of a waiver described in subsection (f).”; and

(2) in subparagraph (B)(ii) by inserting after “an application” the following: “(except in the case of a waiver described in subsection (f))”.

(d) Appropriation for cost-Sharing 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.—Out of any funds in the Treasury not otherwise appropriated, there is 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 2023 through 2027.

“(2) ADJUSTMENTS.—Notwithstanding any other provision of law, payments and other actions for adjustments to obligations incurred prior to December 31, 2023, may be made through December 31, 2023.

“(3) LIMITATION.—Amounts appropriated under paragraph (1) for each of plan years 2023 through 2027 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.”.

(a) In general.—Section 223(c)(1) of the Internal Revenue Code of 1986 is amended by adding at the end the following new subparagraph:

“(D) TREATMENT OF DIRECT PRIMARY CARE SERVICE ARRANGEMENTS.—

“(i) IN GENERAL.—A direct primary care service arrangement shall not be treated as a health plan for purposes of subparagraph (A)(ii).

“(ii) DIRECT PRIMARY CARE SERVICE ARRANGEMENT.—For purposes of this paragraph—

“(I) IN GENERAL.—The term ‘direct primary care service arrangement’ means, with respect to any individual, an arrangement under which such individual is provided medical care (as defined in section 213(d)) consisting solely of primary care services provided by primary care practitioners (as defined in section 1833(x)(2)(A) of the Social Security Act, determined without regard to clause (ii) thereof), if the sole compensation for such care is a fixed periodic fee.

“(II) LIMITATION.—With respect to any individual for any month, such term shall not include any arrangement if the aggregate fees for all direct primary care service arrangements (determined without regard to this subclause) with respect to such individual for such month exceed $150 (twice such dollar amount in the case of an individual with any direct primary care service arrangement (as so determined) that covers more than one individual).

“(iii) CERTAIN SERVICES SPECIFICALLY EXCLUDED FROM TREATMENT AS PRIMARY CARE SERVICES.—For purposes of this paragraph, the term ‘primary care services’ shall not include—

“(I) procedures that require the use of general anesthesia, and

“(II) laboratory services not typically administered in an ambulatory primary care setting.

The Secretary, after consultation with the Secretary of Health and Human Services, shall issue regulations or other guidance regarding the application of this clause.”.

(b) Direct primary care service arrangement fees treated as medical expenses.—Section 223(d)(2)(C) is amended by striking “or” at the end of clause (iii), by striking the period at the end of clause (iv) and inserting “, or”, and by adding at the end the following new clause:

“(v) any direct primary care service arrangement.”.

(c) Inflation adjustment.—Section 223(g)(1) of such Code is amended—

(1) by inserting “, (c)(1)(D)(ii)(II),” after “(b)(2),” each place such term appears, and

(2) in subparagraph (B), by inserting “and (iii)” after “clause (ii)” in clause (i), by striking “and” at the end of clause (i), by striking the period at the end of clause (ii) and inserting “, and”, and by inserting after clause (ii) the following new clause:

“(iii) in the case of the dollar amount in subsection (c)(1)(D)(ii)(II) for taxable years beginning in calendar years after 2020, calendar year 2019.”.

(d) Reporting of direct primary care service arrangement fees on W–2.—Section 6051(a) of such Code is amended by striking “and” at the end of paragraph (16), by striking the period at the end of paragraph (17) and inserting “, and”, and by inserting after paragraph (17) the following new paragraph:

“(18) in the case of a direct primary care service arrangement (as defined in section 223(c)(1)(D)(ii)) which is provided in connection with employment, the aggregate fees for such arrangement for such employee.”.

(e) Effective date.—The amendments made by this section shall apply to months beginning after December 31, 2022, in taxable years ending after such date.

(a) In general.—In the case of an applicable taxable year, contributions to any health savings account of the taxpayer during such taxable year shall be treated as a qualified retirement savings contribution for purposes of section 25B of the Internal Revenue Code of 1986.

(b) Applicable taxable year.—For purposes of this section, the term “applicable taxable year” means any taxable year elected by the taxpayer (at such time and in such manner as the Secretary of the Treasury may provide) which begins after during the 3-year period beginning 1 year after the date of the enactment of this Act. A taxpayer may not elect not more than 1 applicable taxable year under this subsection.

(a) In general.—The Administrator shall establish a grant program to provide assistance to eligible entities to carry out the activities described in subsection (c).

(b) Application.—An eligible entity shall submit an application to the Administrator in such time and in such manner as the Administrator may require, providing that such application requires a demonstration of the existence of a relationship with, or the ability to establish a relationship with, an employer, employee, self-employed individual, or consumer eligible to enroll in a health savings account.

(c) Use of funds.—An eligible entity receiving a grant under this section shall use such funds to—

(1) distribute fair and impartial information to consumers about health savings accounts, including the availability of such accounts and how such accounts may be utilized;

(2) conduct activities to raise public awareness of health savings accounts;

(3) facilitate enrollment in health savings accounts; and

(4) refer individuals enrolled in a health savings account to the appropriate official, organization, or State agency for the purpose of addressing a complaint, grievance, or other question with respect to such health savings account.

(d) Amount.—The Administrator may distribute up to $5,000,000 annually to be divided among grant recipients under this section.

(e) Report.—Not later than one year after the date on which the last of the grant periods awarded under this section ends, the Administrator shall submit a report to the Congress on the effectiveness of the grants provided under this section.

(f) Definitions.—In this section:

(1) ADMINISTRATOR.—The term “Administrator” means the Administrator of the Centers for Medicare & Medicaid Services.

(2) CONSUMER.—The term “consumer” means an individual enrolled in, or seeking to enroll in, a health savings account.

(3) ELIGIBLE ENTITY.—The term “eligible entity” includes the following:

(A) A State.

(B) Trade.

(C) Industry.

(D) Professional associations.

(E) Commercial fishing industry organizations.

(F) Ranching and farming organizations.

(G) Community and consumer-focused nonprofit groups.

(H) Chambers of commerce.

(I) Unions.

(J) Small business development centers (as defined in section 21 of the Small Business Act (15 U.S.C. 648)).

(K) Other entities capable of carrying out the activities described under subsection (b).

(4) HEALTH SAVINGS ACCOUNT.—The term “health savings account” has the meaning given such term in section 223 of the Internal Revenue Code of 1986.

(5) STATE.—The term “State” means each of the several States, the District of Columbia, each territory and possession of the United States, and each federally recognized Indian Tribe.

Notwithstanding any other provision of law, a corporation incorporated after December 31, 2022, may not receive tax benefits for offering employees health insurance. The previous sentence shall not apply to health savings account contributions offered by such a corporation.

(a) In general.—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)).”.

(b) Conversion to health savings accounts.—Each plan offered under chapter 89 of title 5, United States Code, shall be converted into a health savings account deposit and funded at the level of the second-least expensive silver plan available through the Exchange where the applicable individual resides.

(a) In general.—Subtitle C of title I of the Health Insurance Portability and Accountability Act of 1996 (Public Law 104–191) is amended by adding at the end the following:

(b) Conforming amendment.—The table of contents under section 1(b) of the Health Insurance Portability and Accountability Act of 1996 (Public Law 104–191) is amended by inserting after the item relating to section 195 the following:

“Sec. 196. Guaranteed availability of coverage.
“Sec. 197. Fair health insurance premiums.
“Sec. 198. Prohibiting discrimination against individual participants and beneficiaries based on health status.
“Sec. 199. Prohibition of preexisting condition exclusions or other discrimination based on health status.
“Sec. 199A. Extension of dependent coverage.
“Sec. 199B. Annual limitation on cost-sharing.
“Sec. 199C. Enforcement of certain health insurance requirements.”.

(c) ERISA and IRC Enforcement.—

(1) ERISA.—Subpart B of part 7 of title I of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1185 et seq.) is amended by adding at the end the following new section:

(2) IRC.—Subchapter B of chapter 100 of subtitle K of title 26 of the Internal Revenue Code of 1986 is amended by adding at the end the following new section:

(d) Effective date.—The amendments made by this section shall take effect on the date on which the Supreme Court of the United States issues a decision striking down the Patient Protection and Affordable Care Act (Public Law 111–148) in its entirety.

(a) Definition of employer.—Section 3(5) of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1002(5)) is amended by striking the period and inserting “(which, with respect to a group health plan, shall be determined in accordance with criteria that includes the criteria under section 735).”.

(b) Group health plans.—Part 7 of subtitle B of title I of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1181 et seq.) is amended by adding at the end the following:

(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, 2023.

(a) Establishment.—Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services shall establish the Invisible Guaranteed Coverage Pool Reinsurance Program (in this section referred to as the “IGCPR program”).

(b) State grants.—Under the IGCPR 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 Guaranteed Coverage 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 Guaranteed Coverage 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 Guaranteed Coverage Pool described in paragraph (2).

(2) FEDERAL DEFAULT QUALIFYING INVISIBLE GUARANTEED COVERAGE 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 Guaranteed Coverage 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 six months after the establishment of the IGCPR program, 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 Guaranteed Coverage Pool.—For purposes of this section, the term “qualifying Invisible Guaranteed Coverage 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 the first 10 years after the establishment of the IGCPR program.

(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:

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

(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:

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

(h) Report.—The Secretary of Health and Human Services, in collaboration with the Comptroller General of the United States, shall submit to Congress, not later than 5 years after the date of enactment of this Act, and again 5 years thereafter, a report on the status of reinsurance pool funding, along with any recommendations with respect to future allocations or funding methods for such pool.

(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, 2023.

(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.

(a) In general.—Section 36B(c)(2) of the Internal Revenue Code of 1986 is amended—

(1) in subparagraph (B)(i), by inserting “or section 5000A(f)(1)(B)”, and

(2) by striking subparagraph (C).

(b) Effective date.—The amendments made by this section shall apply to taxable years beginning after the date of the enactment of this Act.

(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 2023, 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 2023’ for ‘calendar year 2018’ 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 2023 and before 2033 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) Effective date.—The amendments made by this section shall apply with respect to taxable years beginning after December 31, 2023.

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, 2023, as the Secretary may implement through interim final regulation, 5 to 1 for adults (consistent with section 2707(c))”.

(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:

“(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 2023, 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 2023, 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 2023, over the rate of growth in the consumer price index for calendar year 2023.

“(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 the preceding calendar year exceeds an amount equal to 0.504 percent of the gross domestic product for such calendar year.”.

(b) Expansion of eligibility.—Section 36B of the Internal Revenue Code of 1986 is amended—

(1) in subsection (c)(1)(A), by striking “400” and inserting “600”; and

(2) in subsection (f)(2)(B)(i), by striking “400” each place such reference appears and inserting “600” in each such place.

(c) Effective date.—The amendment made by this section shall apply to taxable years beginning after December 31, 2023.

Notwithstanding any other provision of law, the Secretary of the Treasury shall calculate the credit allowable under section 36B of the Internal Revenue Code of 1986 based on the taxpayer’s prior year tax return and the Secretary of Health and Human Services shall provide for open enrollment periods that end on April 15.

(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 will have out-of-pocket limits that are 30 percent higher than bronze plans.”; 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, 2023.

Notwithstanding any other provision of law, refundable credits for coverage under a qualified health plan and cost-sharing reductions may be used to purchase bronze and copper plans.

(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.

(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 2023, an Exchange may provide for enrollments during periods 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:

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 years of 1 year after the date of enactment of this Act, the Exchange may provide for open enrollment periods (after the initial enrollment period) every 12, 24, or 36 months, as determined by the State.”.

There are appropriated, out of amounts in the Treasury not otherwise appropriated, $10,000,000 to be made available by no later than 1 year after the date of enactment of this Act, 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.

(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 Advantage 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 located in a county whose population density is above the median population density for all counties in the United States with respect to which there is a Herfindahl-Hirschman Index (HHI) of greater than 4,000, to apply the average 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 enrolled under part C.”; 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—

“(i) the HRR market share of such hospital (as determined under subparagraph (B)) is less than 0.15; or

“(ii) the hospital is located in a rural area (as defined in section 1886(d)(2)(D)).

“(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, 2023.

(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 program 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.

(iv) The State does not have in effect any Certificate of Public Advantage laws that clearly articulate the State’s intent to displace competition in favor of regulation or that violate State or Federal antitrust laws.

(v) The State does not have in effect any network adequacy laws regulating a health plan’s ability to deliver benefits by providing reasonable access to a sufficient number of in-network primary care and specialty physicians, as well as all health care services included under the terms of an insuree’s contract with a health insurer.

(4) FUNDING.—There is authorized to be appropriated to carry out this subsection $1,000,000,000 for each of the fiscal years 2022 through 2031. Funds appropriated under this paragraph shall remain available until expended.

(d) Critical access hospital reimbursement rates.—

(1) PART A.—Section 1814(l)(1) of the Social Security Act (42 U.S.C. 1395f(l)(1)) is amended by inserting “(or, for 2023, 102, plus 1 percentage point for each subsequent year through 2031, and 110 for each subsequent year thereafter)” after “101”.

(2) PART B.—Section 1834(g)(1) of such Act (42 U.S.C. 1395m(g)(1)) is amended by inserting “(or, for 2023, 102, plus 1 percentage point for each subsequent year through 2031, and 110 for each subsequent year thereafter)” after “101”.

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”.

(a) Exemption.—It shall not be a violation of the antitrust laws for one or more private health insurer issuers or their designated agents to jointly negotiate prices of particular hospital services with a hospital provider with regards to the reimbursement policies of the insurers for those services.

(b) Definitions.—For purposes of this section:

(1) ANTITRUST LAWS.—The term “antitrust laws” has the meaning given it in subsection (a) of the 1st section of the Clayton Act (15 U.S.C. 12(a)), except that such term includes section 5 of the Federal Trade Commission Act (15 U.S.C. 45) to the extent such section 5 applies to unfair methods of competition.

(2) HEALTH INSURANCE ISSUER.—The term “health insurance issuer” means an insurance company, insurance service, or insurance organization (including a health maintenance organization, as defined in subparagraph (C)) which is licensed to engage in the business of insurance in a State and which is subject to State law which regulates insurance (within the meaning of section 514(b)(2) of the Employee Retirement Income Security Act of 1974 (29 U.S.C. 1144(b)(2))). Such term does not include a group health plan.

(3) HEALTH MAINTENANCE ORGANIZATION.—The term “health maintenance organization” means—

(A) a Federally qualified health maintenance organization (as defined in section 300e(a) of title 42 of the United States Code),

(B) an organization recognized under State law as a health maintenance organization, or

(C) a similar organization regulated under State law for solvency in the same manner and to the same extent as such a health maintenance organization.

(c) Effective date.—This section shall take effect on the date of the enactment of this Act but shall not apply with respect to conduct that occurs before such date.

(a) In general.—Section 2729B of the Public Health Service Act, as added by section 301, is amended by adding at the end the following:

“(b) Protecting Health Plans Network Design Flexibility.—

“(1) IN GENERAL.—A group health plan or a health insurance issuer offering group or individual health insurance coverage shall not enter into an agreement with a provider, network or association of providers, or other service provider offering access to a network of service providers if such agreement, directly or indirectly—

“(A) restricts the group health plan or health insurance issuer from—

“(i) directing or steering enrollees to other health care providers; or

“(ii) offering incentives to encourage enrollees to utilize specific health care providers;

“(B) requires the group health plan or health insurance issuer to enter into any additional contract with an affiliate of the provider, such as an affiliate of the provider, as a condition of entering into a contract with such provider;

“(C) requires the group health plan or health insurance issuer to agree to payment rates or other terms for any affiliate not party to the contract of the provider involved; or

“(D) restricts other group health plans or health insurance issuers not party to the contract from paying a lower rate for items or services than the contracting plan or issuer pays for such items or services.

“(2) ADDITIONAL REQUIREMENT FOR SELF-INSURED PLANS.—A self-insured group health plan shall not enter into an agreement with a provider, network or association of providers, third-party administrator, or other service provider offering access to a network of providers if such agreement directly or indirectly requires the group health plan to certify, attest, or otherwise confirm in writing that the group health plan is bound by restrictive contracting terms between the service provider and a third-party administrator that the group health plan is not party to, without a disclosure that such terms exist.

“(3) EXCEPTION FOR CERTAIN GROUP MODEL ISSUERS.—Paragraph (1)(A) shall not apply to a group health plan or health insurance issuer offering group or individual health insurance coverage with respect to—

“(A) a health maintenance organization (as defined in section 2791(b)(3)), if such health maintenance organization operates primarily through exclusive contracts with multi-specialty physician groups, nor to any arrangement between such a health maintenance organization and its affiliates; or

“(B) a value-based network arrangement, such as an exclusive provider network, accountable care organization, center of excellence, a provider sponsored health insurance issuer that operates primarily through aligned multi-specialty physician group practices or integrated health systems, or such other similar network arrangements as determined by the Secretary through rulemaking.

“(4) ATTESTATION.—A group health plan or health insurance issuer offering group or individual health insurance coverage shall annually submit to, as applicable, the applicable authority described in section 2723 or the Secretary of Labor, an attestation that such plan or issuer is in compliance with the requirements of this subsection.

“(c) Maintenance of existing HIPAA, GINA, and ADA protections.—Nothing in this section shall modify, reduce, or eliminate the existing privacy protections and standards provided by reason of State and Federal law, including the requirements of parts 160 and 164 of title 45, Code of Federal Regulations (or any successor regulations).

“(d) Regulations.—The Secretary, not later than 1 year after the date of enactment of the Fair Care Act of 2022, shall promulgate regulations to carry out this section.

“(e) Rule of construction.—Nothing in this section shall be construed to limit network design or cost or quality initiatives by a group health plan or health insurance issuer, including accountable care organizations, exclusive provider organizations, networks that tier providers by cost or quality or steer enrollees to centers of excellence, or other pay-for-performance programs.

“(f) Clarification with respect to antitrust laws.—Compliance with this section does not constitute compliance with the antitrust laws, as defined in subsection (a) of the first section of the Clayton Act (15 U.S.C. 12(a)).”.

(b) Effective date.—Section 2729B of the Public Health Service Act (as added by section 301 and amended by subsection (a)) shall apply with respect to any contract entered into on or after the date that is 18 months after the date of enactment of this Act. With respect to an applicable contract that is in effect on the date of enactment of this Act, such section 2729B shall apply on the earlier of the date of renewal of such contract or 3 years after such date of enactment.

(a) In general.—Section 1899(b)(1) of the Social Security Act (42 U.S.C. 1395jjj(b)(1)) is amended by striking subparagraphs (C) through (E).

(b) Effective date.—The amendment made by subsection (a) shall take effect on January 1, 2023.

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.

(a) In general.—A group health plan and a health insurance issuer offering group or individual health insurance coverage (as such terms are defined in section 2791 of the Public Health Service Act (42 U.S.C. 300gg–91)) may elect, with respect to a plan year, to provide a set payment amount to an enrollee under such plan or coverage for certain shoppable procedures (as defined in subsection (b)) in accordance with the provisions of this section in lieu of otherwise providing coverage for such a procedure under such plan or coverage, but only if the enrollee so agrees to such set payment amount.

(b) Definition.—For purposes of this section, the term “shoppable procedure” means a procedure specified by the Secretary of Health and Human Services (in this section referred to as the “Secretary”) with respect to which individuals may be expected to compare prices for such procedure of health care providers and facilities, including primary and preventive services, prenatal care and childbirth, common surgeries that can be scheduled, and other similar services.

(c) Set payment rules.—A set payment described in subsection (a) under a group health plan or group or individual health insurance coverage offered by a health insurance issuer shall—

(1) be disclosed prior to beginning of each plan year such payment is in effect and shall not vary during such plan year;

(2) be the same amount with respect to the same shoppable procedure furnished in a geographic area (as defined by the Secretary);

(3) not be less than the median negotiated rate for all group health plans and health insurance coverage offered in such area for such procedure;

(4) be made available to an enrolled under such plan or such coverage regardless of the provider or facility furnishing the shoppable procedure;

(5) represent the entirety of the payment obligation of such plan or such issuer with respect to such procedure; and

(6) may be retained by such enrollee to the extent that the amount of such payment exceeds the amount charged by such provider or facility for such procedure.

(d) Provision of price information.—Each health care provider and facility that may furnish a shoppable procedure during a year shall post in a public area a notice containing the prices that will be charged by such provider of facility with respect to each such procedure to individuals making payment for such services pursuant to a set payment amount described in subsection (a).

(e) EHB waiver authority.—The Secretary may waive such provisions of section 1302(b) of the Patient Protection and Affordable Care Act (42 U.S.C. 18022(b)) with respect to a group health plan, health insurance issuer offering group or individual health insurance coverage, and a plan year as the Secretary determines necessary to allow for the provision of set payment amounts described in subsection (a).

(a) Hospitals.—Section 2718(e) of the Public Health Service Act (42 U.S.C. 300gg–18(e)) is amended—

(1) by striking “Each hospital” and inserting the following:

“(1) IN GENERAL.—Each hospital”;

(2) by inserting “, in a machine-readable format, via open application program interfaces (APIs)” after “a list”;

(3) by inserting “, along with such additional information as the Secretary may require with respect to such charges for purposes of promoting public awareness of hospital pricing in advance of receiving a hospital item or service” before the period; and

(4) by adding at the end the following:

“(2) DEFINITION OF STANDARD CHARGES.—Notwithstanding any other provision of law, for purposes of paragraph (1), the term ‘standard charges’ means the rates hospitals, including providers or entities that contract with or practice at a hospital, charge for all items and services at a minimum, chargemaster rates, rates that hospitals negotiate with third party payers across all plans, including those related to a patient’s specific plan, discounted cash prices, and other rates determined by the Secretary.

“(3) ENFORCEMENT.—In addition to any other enforcement actions or penalties that may apply under subsection (b)(3) or another provision of law, a hospital that fails to provide the information required by this subsection and has not completed a corrective action plan to comply with the requirements of such subsection shall be subject to a civil monetary penalty of an amount not to exceed $300 per day that the violation is ongoing as determined by the Secretary. Such penalty shall be imposed and collected in the same manner as civil money penalties under subsection (a) of section 1128A of the Social Security Act are imposed and collected.”.

(b) Transparency in coverage.—Section 1311(e)(3) of the Patient Protection and Affordable Care Act (42 U.S.C. 18031(e)(3)) is amended—

(1) in subparagraph (A)—

(A) in clause (vii), by inserting before the period the following: “, including, for all items and services covered under the plan, aggregate information on specific payments the plan has made to out-of-network health care providers on behalf of plan enrollees”;

(B) by designating clause (ix) as clause (x); and

(C) by inserting after clause (viii), the following:

“(ix) Information on the specific negotiated payment rates between the plan and health care providers for all items and services covered under the plan.”;

(2) in subparagraph (B)—

(A) in the heading, by striking “use” and inserting “delivery methods and use”;

(B) by inserting “, as applicable,” after “English proficiency”; and

(C) by inserting after the second sentence, the following: “The Secretary shall establish standards for electronic delivery and access to such information by individuals, free of charge, in machine readable format, through an Internet website and via open APIs.”;

(3) in subparagraph (C)—

(A) in the first sentence, by inserting “or out-of-network provider” after “item or service by a participating provider”;

(B) in the second sentence, by striking “through an Internet website” and inserting “free of charge, in machine readable format, through an Internet website, and via open APIs, in accordance with standards established by the Secretary,”; and

(C) by adding at the end the following: “Such information shall include specific negotiated rates that allow for comparison between providers and across plans, and related to a patient’s specific plan, including after an enrollee has exceeded their deductible responsibility.”; and

(4) in subparagraph (D) by striking “subparagraph (A)” and inserting “subparagraphs (A), (B), and (C)”.

(a) In general.—Subpart II of part A of title XXVII of the Public Health Service Act (42 U.S.C. 300gg–11 et seq.), as amended by the preceding sections, is further amended by adding at the end the following:

(b) Effective date.—Section 2729G of the Public Health Service Act, as added by subsection (a), shall apply with respect to plan years beginning on or after the date that is 18 months after the date of enactment of this Act.

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.

(a) In general.—

(1) AMENDMENT.—Part P of title III of the Public Health Service Act (42 U.S.C. 280g et seq.) is amended by adding at the end the following:

(2) RULEMAKING.—Not later than 1 year after the date of enactment of this Act, the Secretary shall promulgate final regulations to define the term “extenuating circumstance” for purposes of section 399V–7(c)(3)(B) of the Public Health Service Act, as added by paragraph (1).

(b) Group health plan and health insurance issuer requirements.—Subpart II of part A of title XXVII of the Public Health Service Act (42 U.S.C. 300gg–11), as amended by the preceding sections, is further amended by adding at the end the following:

(c) Effective date.—The amendments made by subsections (a) and (b) shall take effect 6 months after the date of enactment of this Act.

(a) In general.—Not later than January 1, 2023, 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, 2024, 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 nonprofit health insurance issuers and health plans operating in at least 5 States; and

(C) one representative of nonprofit 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.

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.”.

(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 one year after the date of enactment of the Act, 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 1 year after the date of enactment of this Act, 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).

(a) In general.—Subject to subsection (b), for each plan year beginning on or after 1 year after the date of enactment of this Act, 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).

(a) Study.—Not later than 1 year after the date of enactment of this Act, the Comptroller General of the United States shall conduct a study to—

(1) describe what is known about profit- and revenue-sharing relationships in the commercial health care markets, including those relationships that—

(A) involve one or more—

(i) physician groups that practice within a hospital included in the profit- or revenue-sharing relationship, or refer patients to such hospital;

(ii) laboratory, radiology, or pharmacy services that are delivered to privately insured patients of such hospital;

(iii) surgical services;

(iv) hospitals or group purchasing organizations; or

(v) rehabilitation or physical therapy facilities or services; and

(B) include revenue- or profit-sharing whether through a joint venture, management or professional services agreement, or other form of gain-sharing contract;

(2) describe Federal oversight of such relationships, including authorities of the Department of Health and Human Services and the Federal Trade Commission to review such relationships and their potential to increase costs for patients, and identify limitations in such oversight; and

(3) as appropriate, make recommendations to improve Federal oversight of such relationships.

(b) Report.—Not later than 1 year after the date of enactment of this Act, the Comptroller General of the United States shall prepare and submit a report on the study conducted under subsection (a) to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Education and Labor and Committee on Energy and Commerce of the House of Representatives.

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:

Section 505(q) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(q)) is amended—

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.

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.”.

Notwithstanding any other provision of law, the Secretary of Health and Human Services may establish a mechanism to regulate drug manufacturers’ financial contributions to patient out-of-pocket costs, such as drug co-pays.

Section 351(j) of the Public Health Service Act (42 U.S.C. 262(j)) is amended—

Section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) is amended by adding at the end the following:

“(z) Prompt Approval of Drugs When safety information Is Added to Labeling.—

“(1) GENERAL RULE.—A drug for which an application has been submitted or approved under subsection (b)(2) or (j) shall not be considered ineligible for approval under this section or misbranded under section 502 on the basis that the labeling of the drug omits safety information, including contraindications, warnings, precautions, dosing, administration, or other information pertaining to safety, when the omitted safety information is protected by exclusivity under clause (iii) or (iv) of subsection (j)(5)(F), clause (iii) or (iv) of subsection (c)(3)(E), or section 527(a), or by an extension of such exclusivity under section 505A or 505E.