[Congressional Record Volume 167, Number 137 (Monday, August 2, 2021)]
[Senate]
[Pages S5625-S5626]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

  SA 2225. Mr. BRAUN submitted an amendment intended to be proposed to 
amendment SA 2137 proposed by Mr. Schumer (for Ms. Sinema (for herself, 
Mr. Portman, Mr. Manchin, Mr. Cassidy, Mrs. Shaheen, Ms. Collins, Mr. 
Tester, Ms. Murkowski, Mr. Warner, and Mr. Romney)) to the bill H.R. 
3684, to authorize funds for Federal-aid highways, highway safety 
programs, and transit programs, and for other purposes; which was 
ordered to lie on the table; as follows:

        In division I, strike section 90006 and insert the 
     following:

     SEC. 90006. REQUIREMENTS FOR PRESCRIPTION DRUG BENEFITS.

       (a) Removal of Safe Harbor Protection for Rebates Involving 
     Prescription Drugs and Establishment of New Safe Harbor 
     Protections Involving Prescription Drugs.--
       (1) Removal of safe harbor protection for rebates involving 
     prescription drugs.--Section 1128B(b) of the Social Security 
     Act (42 U.S.C. 1320a-7b(b)) is amended--
       (A) in paragraph (3)(A), by striking ``a discount'' and 
     inserting ``subject to paragraph (5), a discount''; and
       (B) by adding at the end the following:
       ``(5) Removal of safe harbor protection for rebates 
     involving prescription drugs.--The safe harbor described in 
     paragraph (3)(A) shall not apply to a reduction in price or 
     other remuneration from a manufacturer of prescription drugs 
     to a sponsor of a prescription drug plan under part D of 
     title XVIII, an MA organization offering an MA-PD plan under 
     part C of such title, or a pharmacy benefit manager under 
     contract with such a sponsor or such an organization and, 
     except as provided in subparagraphs (L) and (M) of paragraph 
     (3), paragraphs (1) and (2) shall apply to any such reduction 
     in price or other remuneration.''.
       (2) Establishment of new safe harbor protections involving 
     prescription drugs .--Section 1128B(b)(3) of the Social 
     Security Act (42 U.S.C. 1320a-7b(b)(3)) is amended--
       (A) in subparagraph (J), by striking ``and'' at the end;
       (B) in subparagraph (K), by striking the period at the end 
     and inserting a semicolon; and
       (C) by adding at the end the following:
       ``(L) a reduction in price offered by a manufacturer of 
     prescription drugs to a sponsor of a prescription drug plan 
     under part D of title XVIII, an MA organization offering an 
     MA-PD plan under part C of such title, or a pharmacy benefit 
     manager under contract with such a sponsor or such an 
     organization, that is reflected at the point of sale to the 
     individual and meets such other conditions as the Secretary 
     may establish; and
       ``(M) flat fee service fees a manufacturer of prescription 
     drugs pays to a pharmacy benefit manager for services 
     rendered to the manufacturer that relate to arrangements by 
     the pharmacy benefit manager to provide pharmacy benefit 
     management services to a health plan, if certain conditions 
     established by the Secretary are met, including requirements 
     that the fees are transparent to the health plan.''.
       (3) Effective date.--The amendments made by this subsection 
     shall take effect on January 1, 2023.
       (b) Requirements for Private Insurance Plans.--
       (1) In general.--Part D of title XXVII of the Public Health 
     Service Act (42 U.S.C. 300gg-111 et seq.) is amended by 
     adding at the end the following:

     ``SEC. 2799A-11. REQUIREMENTS WITH RESPECT TO PRESCRIPTION 
                   DRUG BENEFITS.

       ``(a) In General.--A group health plan or a health 
     insurance issuer offering group or individual health 
     insurance coverage shall not, and shall ensure that any 
     entity that provides pharmacy benefits management services 
     under a contract with any such health plan or health 
     insurance coverage does not, receive from a drug manufacturer 
     a reduction in price or other remuneration with respect to 
     any prescription 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 meets such other conditions as 
     the Secretary may establish; and
       ``(2) any such other remuneration is a flat fee-based 
     service fee that a manufacturer of prescription drugs pays to 
     an entity that provides pharmacy benefits management services 
     for services rendered to the manufacturer that relate to 
     arrangements by the pharmacy benefit manager to provide 
     pharmacy benefit management services to a health plan or 
     health insurance issuer, if certain conditions established by 
     the Secretary are met, including requirements that the fees 
     are transparent to the health plan or health insurance 
     issuer.
       ``(b) Entity That Provides Pharmacy Benefits Management 
     Services.--For purposes of this section, the term `entity 
     that provides pharmacy benefits management services' means--
       ``(1) any person, business, or other 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--
       ``(A) acts as a price negotiator on behalf of the plan or 
     coverage; or
       ``(B) 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
       ``(2) any entity that is owned, affiliated, or related 
     under a common ownership structure with a person, business, 
     or entity described in paragraph (1).''.
       (2) ERISA.--
       (A) 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. 726. REQUIREMENTS WITH RESPECT TO PRESCRIPTION DRUG 
                   BENEFITS.

       ``(a) In General.--A group health plan or a health 
     insurance issuer offering group health insurance coverage 
     shall not, and shall ensure that any entity that provides 
     pharmacy benefits management services under a contract with 
     any such health plan or health insurance coverage does not, 
     receive from a drug manufacturer a reduction in price or 
     other remuneration with respect to any prescription 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 meets such other conditions as 
     the Secretary may establish; and
       ``(2) any such other remuneration is a flat fee-based 
     service fee that a manufacturer of prescription drugs pays to 
     an entity that provides pharmacy benefits management services 
     for services rendered to the manufacturer that relate to 
     arrangements by the pharmacy benefit manager to provide 
     pharmacy benefit management services to a health plan or 
     health insurance issuer, if certain conditions established by 
     the Secretary are met, including requirements that the fees 
     are transparent to the health plan or health insurance 
     issuer.
       ``(b) Entity That Provides Pharmacy Benefits Management 
     Services.--For purposes of this section, the term `entity 
     that provides pharmacy benefits management services' means--

[[Page S5626]]

       ``(1) any person, business, or other 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--
       ``(A) acts as a price negotiator on behalf of the plan or 
     coverage; or
       ``(B) 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
       ``(2) any entity that is owned, affiliated, or related 
     under a common ownership structure with a person, business, 
     or entity described in paragraph (1).''.
       (B) Clerical amendment.--The table of contents of the 
     Employee Retirement Income Security Act of 1974 is amended by 
     inserting after the item relating to section 725 the 
     following:

``Sec. 725. Requirements with respect to prescription drug benefits.''.
       (3) IRC.--
       (A) In general.--Subchapter B of chapter 100 of the 
     Internal Revenue Code of 1986 is amended by adding at the end 
     the following:

     ``SEC. 9826. REQUIREMENTS WITH RESPECT TO PRESCRIPTION DRUG 
                   BENEFITS.

       ``(a) In General.--A group health plan shall not, and shall 
     ensure that any entity that provides pharmacy benefits 
     management services under a contract with any such health 
     plan does not, receive from a drug manufacturer a reduction 
     in price or other remuneration with respect to any 
     prescription 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 meets such other conditions as 
     the Secretary may establish; and
       ``(2) any such other remuneration is a flat fee-based 
     service fee that a manufacturer of prescription drugs pays to 
     an entity that provides pharmacy benefits management services 
     for services rendered to the manufacturer that relate to 
     arrangements by the pharmacy benefit manager to provide 
     pharmacy benefit management services to a health plan, if 
     certain conditions established by the Secretary are met, 
     including requirements that the fees are transparent to the 
     health plan.
       ``(b) Entity That Provides Pharmacy Benefits Management 
     Services.--For purposes of this section, the term `entity 
     that provides pharmacy benefits management services' means--
       ``(1) any person, business, or other entity that, pursuant 
     to a written agreement with a group health plan, directly or 
     through an intermediary--
       ``(A) acts as a price negotiator on behalf of the plan; or
       ``(B) 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
       ``(2) any entity that is owned, affiliated, or related 
     under a common ownership structure with a person, business, 
     or entity described in paragraph (1).''.
       (B) Clerical amendment.--The table of sections for 
     subchapter B of chapter 100 of the Internal Revenue Code of 
     1986 is amended by adding at the end the following:

``Sec. 9816. Requirements with respect to prescription drug 
              benefits.''.
       (4) Effective date.--The amendments made by paragraphs (1), 
     (2), and (3) shall take effect on January 1, 2023.
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