[Congressional Bills 118th Congress]
[From the U.S. Government Publishing Office]
[H.R. 3285 Introduced in House (IH)]

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118th CONGRESS
  1st Session
                                H. R. 3285

 To establish patient protections with respect to highly rebated drugs.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 15, 2023

 Mr. Griffith introduced the following bill; which was referred to the 
Committee on Energy and Commerce, and in addition to the Committees on 
  Education and the Workforce, and Ways and Means, 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 establish patient protections with respect to highly rebated drugs.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Fairness for Patient Medications 
Act''.

SEC. 2. REQUIREMENTS WITH RESPECT TO COST-SHARING FOR HIGHLY REBATED 
              DRUGS.

    (a) PHSA.--Part D of title XXVII of the Public Health Service Act 
(42 U.S.C. 300gg-111 et seq.) is amended by adding at the end the 
following:

``SEC. 2799A-11. REQUIREMENTS WITH RESPECT TO COST-SHARING FOR HIGHLY 
              REBATED DRUGS.

    ``(a) In General.--No later than April 1, 2024, and annually 
thereafter, the Secretary shall certify (or recertify, if applicable) 
as a `highly rebated drug' any drug identified in reports submitted 
under sections 2799A-10, 725 of the Employee Retirement Income Security 
Act, and 9825 of the Internal Revenue Code of 1986 for which total 
rebates, reductions in price, and other forms of remuneration in the 
previous year aggregated across all commercial markets exceeded 50 
percent of total annual spending on such drug in such year.
    ``(b) Deductible and Cost-Sharing Limitations for Certified 
Drugs.--For plan years that begin on or after January 1, 2025, a group 
health plan or a health insurance issuer offering group or individual 
health insurance coverage (or entity that provides pharmacy benefits 
management services on behalf of such a plan or issuer) that provides 
coverage of any highly rebated drug shall not impose cost-sharing in 
excess of, per 30-day supply, the quotient of the annual net price paid 
by such group health plan or health insurance issuer (or entity that 
provides pharmacy benefits management services on behalf of such a plan 
or issuer), in the most recent calendar year for which a final net 
price has been calculated by such plan or coverage (or entity that 
provides pharmacy benefit management services on behalf of such plan or 
issuer), per 30-day supply of such specific highly rebated drug, 
divided by 12.
    ``(c) Highly Rebated Drug Previously Subject to Formulary 
Exclusion.--Beginning on January 1, 2025, in the case of a specific 
highly rebated drug covered by a group health plan or health insurance 
issuer offering group or individual health insurance coverage (or 
entity that provides pharmacy benefits management services on behalf of 
such plan or issuer) that provides coverage of a specific highly 
rebated drug that was not covered in the previous year, such group 
health plan or health insurance issuer shall not receive from a drug 
manufacturer a reduction in price or other remuneration with respect to 
such specific highly rebated drug received by an enrollee in the plan 
or coverage and covered by the plan or coverage, unless--
            ``(1) any such reduction in price is reflected at the point 
        of sale to the enrollee; and
            ``(2) any such other remuneration is a flat fee-based 
        service fee not contingent on total volume of sales that a 
        manufacturer of prescription drugs pays to an entity that 
        provides pharmacy benefits management services.
    ``(d) Definitions.--In this section:
            ``(1) Entity that provides pharmacy benefits management 
        services.--The term `entity that provides pharmacy benefits 
        management services' means--
                    ``(A) any entity that, pursuant to a written 
                agreement with a group health plan or a health 
                insurance issuer offering group or individual health 
                insurance coverage, directly or through an 
                intermediary--
                            ``(i) acts as a price negotiator on behalf 
                        of the plan or coverage; or
                            ``(ii) manages the prescription drug 
                        benefits provided by the plan or coverage, 
                        which may include the processing and payment of 
                        claims for prescription drugs, the performance 
                        of drug utilization review, the processing of 
                        drug prior authorization requests, the 
                        adjudication of appeals or grievances related 
                        to the prescription drug benefit, contracting 
                        with network pharmacies, controlling the cost 
                        of covered prescription drugs, or the provision 
                        of related services; or
                    ``(B) any entity that is owned, affiliated, or 
                related under a common ownership structure with an 
                entity described in subparagraph (A).
            ``(2) Net price.--The term `net price', with respect to a 
        prescription drug, means the final price paid by a group health 
        plan or health insurance issuer offering group or individual 
        health insurance coverage (or entity that provides pharmacy 
        benefits management services on behalf of such a plan or 
        issuer) after applying any rebates and other remuneration under 
        the plan or coverage from drug manufacturers during the plan 
        year.
    ``(e) Specification.--A health insurance plan will not fail to be 
treated as an HDHP for complying with the cost-sharing cap in this 
section.''.
    (b) ERISA.--
            (1) In general.--Subpart B of part 7 of subtitle B of title 
        I of the Employee Retirement Income Security Act of 1974 (29 
        U.S.C. 1185 et seq.) is amended by adding at the end the 
        following:

``SEC. 725. REQUIREMENTS WITH RESPECT TO COST-SHARING FOR HIGHLY 
              REBATED DRUGS.

    ``(a) In General.--No later than April 1, 2024, and annually 
thereafter, the Secretary shall certify (or recertify, if applicable) 
as a `highly rebated drug' any drug identified in reports submitted 
under sections 725, 2799A-10 of the Public Health Service Act, and 9825 
of the Internal Revenue Code of 1986 for which total rebates, 
reductions in price, and other forms of remuneration in the previous 
year aggregated across all commercial markets exceeded 50 percent of 
total annual spending on such drug in such year.
    ``(b) Deductible and Cost-Sharing Limitations for Certified 
Drugs.--For plan years that begin on or after January 1, 2025, a group 
health plan or a health insurance issuer offering group health 
insurance coverage (or entity that provides pharmacy benefits 
management services on behalf of such a plan or issuer) that provides 
coverage of any highly rebated drug shall not impose cost-sharing in 
excess of, per 30-day supply, the quotient of the annual net price paid 
by such group health plan or health insurance issuer (or entity that 
provides pharmacy benefits management services on behalf of such a plan 
or issuer), in the most recent calendar year for which a final net 
price has been calculated by such plan or coverage (or entity that 
provides pharmacy benefit management services on behalf of such plan or 
issuer), per 30-day supply of such specific highly rebated drug, 
divided by 12.
    ``(c) Highly Rebated Drug Previously Subject to Formulary 
Exclusion.--Beginning on January 1, 2025, in the case of a specific 
highly rebated drug covered by a group health plan or health insurance 
issuer offering group health insurance coverage (or entity that 
provides pharmacy benefits management services on behalf of such plan 
or issuer) that provides coverage of a specific highly rebated drug 
that was not covered in the previous year, such group health plan or 
health insurance issuer shall not receive from a drug manufacturer a 
reduction in price or other remuneration with respect to such specific 
highly rebated drug received by an enrollee in the plan or coverage and 
covered by the plan or coverage, unless--
            ``(1) any such reduction in price is reflected at the point 
        of sale to the enrollee; and
            ``(2) any such other remuneration is a flat fee-based 
        service fee not contingent on total volume of sales that a 
        manufacturer of prescription drugs pays to an entity that 
        provides pharmacy benefits management services.
    ``(d) Definitions.--In this section:
            ``(1) Entity that provides pharmacy benefits management 
        services.--The term `entity that provides pharmacy benefits 
        management services' means--
                    ``(A) any entity that, pursuant to a written 
                agreement with a group health plan or a health 
                insurance issuer offering group health insurance 
                coverage, directly or through an intermediary--
                            ``(i) acts as a price negotiator on behalf 
                        of the plan or coverage; or
                            ``(ii) manages the prescription drug 
                        benefits provided by the plan or coverage, 
                        which may include the processing and payment of 
                        claims for prescription drugs, the performance 
                        of drug utilization review, the processing of 
                        drug prior authorization requests, the 
                        adjudication of appeals or grievances related 
                        to the prescription drug benefit, contracting 
                        with network pharmacies, controlling the cost 
                        of covered prescription drugs, or the provision 
                        of related services; or
                    ``(B) any entity that is owned, affiliated, or 
                related under a common ownership structure with an 
                entity described in subparagraph (A).
            ``(2) Net price.--The term `net price', with respect to a 
        prescription drug, means the final price paid by a group health 
        plan or health insurance issuer offering group health insurance 
        coverage (or entity that provides pharmacy benefits management 
        services on behalf of such a plan or issuer) after applying any 
        rebates and other remuneration under the plan or coverage from 
        drug manufacturers during the plan year.
    ``(e) Specification.--A health insurance plan will not fail to be 
treated as an HDHP for complying with the cost-sharing cap in this 
section.''.
            (2) Clerical amenmdnet.--The table of contents in section 1 
        of the Employee Retirement Income Security Act of 1974 (29 
        U.S.C. 1001 et seq.) is amended by inserting after the item 
        related to section 725 the following:

``Sec. 725. Requirements with respect to cost-sharing for highly 
                            rebated drugs.''.
    (c) IRC.--
            (1) In general.--Subchapter B of chapter 100 of the 
        Internal Revenue Code of 1986 is amended by adding at the end 
        the following new section:

``SEC. 9826. REQUIREMENTS WITH RESPECT TO COST-SHARING FOR HIGHLY 
              REBATED DRUGS.

    ``(a) In General.--No later than April 1, 2024, and annually 
thereafter, the Secretary shall certify (or recertify, if applicable) 
as a `highly rebated drug' any drug identified in reports submitted 
under sections 9825, 2799A-10 of the Public Health Service Act, and 725 
of the Employee Retirement Income Security Act for which total rebates, 
reductions in price, and other forms of remuneration in the previous 
year aggregated across all commercial markets exceeded 50 percent of 
total annual spending on such drug in such year.
    ``(b) Deductible and Cost-Sharing Limitations for Certified 
Drugs.--For plan years that begin on or after January 1, 2025, a group 
health plan (or entity that provides pharmacy benefits management 
services on behalf of such a plan) that provides coverage of any highly 
rebated drug shall not impose cost-sharing in excess of, per 30-day 
supply, the quotient of the annual net price paid by such group health 
plan (or entity that provides pharmacy benefits management services on 
behalf of such a plan), in the most recent calendar year for which a 
final net price has been calculated by such plan (or entity that 
provides pharmacy benefit management services on behalf of such plan), 
per 30-day supply of such specific highly rebated drug, divided by 12.
    ``(c) Highly Rebated Drug Previously Subject to Formulary 
Exclusion.--Beginning on January 1, 2025, in the case of a specific 
highly rebated drug covered by a group health plan (or entity that 
provides pharmacy benefits management services on behalf of such plan) 
that provides coverage of a specific highly rebated drug that was not 
covered in the previous year, such group health plan shall not receive 
from a drug manufacturer a reduction in price or other remuneration 
with respect to such specific highly rebated drug received by an 
enrollee in the plan and covered by the plan, unless--
            ``(1) any such reduction in price is reflected at the point 
        of sale to the enrollee; and
            ``(2) any such other remuneration is a flat fee-based 
        service fee not contingent on total volume of sales that a 
        manufacturer of prescription drugs pays to an entity that 
        provides pharmacy benefits management services.
    ``(d) Definitions.--In this section:
            ``(1) Entity that provides pharmacy benefits management 
        services.--The term `entity that provides pharmacy benefits 
        management services' means--
                    ``(A) any entity that, pursuant to a written 
                agreement with a group health plan, directly or through 
                an intermediary--
                            ``(i) acts as a price negotiator on behalf 
                        of the plan; or
                            ``(ii) manages the prescription drug 
                        benefits provided by the plan, which may 
                        include the processing and payment of claims 
                        for prescription drugs, the performance of drug 
                        utilization review, the processing of drug 
                        prior authorization requests, the adjudication 
                        of appeals or grievances related to the 
                        prescription drug benefit, contracting with 
                        network pharmacies, controlling the cost of 
                        covered prescription drugs, or the provision of 
                        related services; or
                    ``(B) any entity that is owned, affiliated, or 
                related under a common ownership structure with an 
                entity described in subparagraph (A).
            ``(2) Net price.--The term `net price', with respect to a 
        prescription drug, means the final price paid by a group health 
        plan (or entity that provides pharmacy benefits management 
        services on behalf of such a plan) after applying any rebates 
        and other remuneration under the plan from drug manufacturers 
        during the plan year.
    ``(e) Specification.--A health insurance plan will not fail to be 
treated as an HDHP for complying with the cost-sharing cap in this 
section.''.
            (2) Clerical amendment.--The table of sections for 
        subchapter B of chapter 100 of such Code is amended by adding 
        at the end the following new item:

``Sec. 9826. Requirements with respect to cost-sharing for highly 
                            rebated drugs.''.
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