II 

Calendar No. 647 

117TH CONGRESS 

2D SESSION S. 4293 

To prevent unfair and deceptive acts or practices and the dissemination 

of false information related to pharmacy benefit management services 

for prescription drugs, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

MAY 24, 2022 

Ms. CANTWELL (for herself, Mr. GRASSLEY, Mr. BOOZMAN, Mr. BRAUN, Mr. 

MORAN, Mr. TILLIS, Mr. TESTER, Mrs. HYDE-SMITH, and Mrs. CAPITO) 

introduced the following bill; which was read twice and referred to the 

Committee on Commerce, Science, and Transportation 

DECEMBER 14, 2022 

Reported by Ms. CANTWELL, with an amendment 

[Strike out all after the enacting clause and insert the part printed in italic] 

A BILL 

To prevent unfair and deceptive acts or practices and the 

dissemination of false information related to pharmacy 

benefit management services for prescription drugs, and 

for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Pharmacy Benefit 

3 Manager Transparency Act of 2022’’. 

4 SEC. 2. PROHIBITION ON UNFAIR OR DECEPTIVE PRE5 SCRIPTION DRUG PRICING PRACTICES. 

6 (a) CONDUCT PROHIBITED.—Except as provided in 

7 subsection (b), it shall be unlawful for any pharmacy ben8 efit manager (or affiliate, subsidiary, or agent of a phar9 macy benefit manager), directly or indirectly, to engage 

10 in any of the following activities related to pharmacy ben11 efit management services: 

12 (1) Charge a health plan or payer a different 

13 amount for a prescription drug’s ingredient cost or 

14 dispensing fee than the amount the pharmacy ben15 efit manager reimburses a pharmacy for the pre16 scription drug’s ingredient cost or dispensing fee 

17 where the pharmacy benefit manager retains the 

18 amount of any such difference. 

19 (2) Arbitrarily, unfairly, or deceptively, by con20 tract or any other means, reduce, rescind, or other21 wise claw back any reimbursement payment, in 

22 whole or in part, to a pharmacist or pharmacy for 

23 a prescription drug’s ingredient cost or dispensing 

24 fee. 

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1 imbursement to a pharmacy in order to offset reim2 bursement changes instructed by the Federal Gov3 ernment under any health plan funded by the Fed4 eral Government. 

5 (b) EXCEPTIONS.—A pharmacy benefit manager 

6 shall not be in violation of subsection (a) if the pharmacy 

7 benefit manager meets the following conditions: 

8 (1) The pharmacy benefit manager, affiliate, 

9 subsidiary, or agent passes along or returns 100 per10 cent of any price concession to a health plan or 

11 payer, including any rebate, discount, or other price 

12 concession. 

13 (2) The pharmacy benefit manager, affiliate, 

14 subsidiary, or agent provides full and complete dis15 closure of— 

16 (A) the cost, price, and reimbursement of 

17 the prescription drug to each health plan, 

18 payer, and pharmacy with which the pharmacy 

19 benefit manager, affiliate, subsidiary, or agent 

20 has a contract or agreement to provide phar21 macy benefit management services; 

22 (B) each fee, markup, and discount 

23 charged or imposed by the pharmacy benefit 

24 manager, affiliate, subsidiary, or agent to each 

25 health plan, payer, and pharmacy with which 


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1 the pharmacy benefit manager, affiliate, sub2 sidiary, or agent has a contract or agreement 

3 for pharmacy benefit management services; or 

4 (C) the aggregate amount of all remunera5 tion the pharmacy benefit manager receives 

6 from a prescription drug manufacturer for a 

7 prescription drug, including any rebate, dis8 count, administration fee, and any other pay9 ment or credit obtained or retained by the phar10 macy benefit manager, or affiliate, subsidiary, 

11 or agent of the pharmacy benefit manager, pur12 suant to a contract or agreement for pharmacy 

13 benefit management services to a health plan, 

14 payer, or any Federal agency (upon the request 

15 of the agency). 

16 SEC. 3. PROHIBITION ON FALSE INFORMATION. 

17 It shall be unlawful for any person to report informa18 tion related to pharmacy benefit management services to 

19 a Federal department or agency if— 

20 (1) the person knew, or reasonably should have 

21 known, the information to be false or misleading; 

22 (2) the information was required by law to be 

23 reported; and 

24 (3) the false or misleading information reported 

25 by the person would affect analysis or information 


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1 compiled by the Federal department or agency for 

2 statistical or analytical purposes with respect to the 

3 market for pharmacy benefit management services. 

4 SEC. 4. TRANSPARENCY. 

5 (a) REPORTING BY PHARMACY BENEFIT MAN6 AGERS.—Not later than 1 year after the date of enactment 

7 of this Act, and annually thereafter, each pharmacy ben8 efit manager (or affiliate, subsidiary, or agent of a phar9 macy benefit manager) shall report to the Commission the 

10 following information: 

11 (1) The aggregate amount of the difference be12 tween the amount the pharmacy benefit manager 

13 was paid by each health plan and the amount that 

14 the pharmacy benefit manager paid each pharmacy 

15 on behalf of the health plan for prescription drugs. 

16 (2) The aggregate amount of any— 

17 (A) generic effective rate fee charged to 

18 each pharmacy; 

19 (B) direct and indirect remuneration fee 

20 charged or other price concession to each phar21 macy; and 

22 (C) payment rescinded or otherwise clawed 

23 back from a reimbursement made to each phar24 macy. 


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1 (3) If, during the reporting year, the pharmacy 

2 benefit manager moved or reassigned a prescription 

3 drug to a formulary tier that has a higher cost, 

4 higher copayment, higher coinsurance, or higher de5 ductible to a consumer, or a lower reimbursement to 

6 a pharmacy, an explanation of the reason why the 

7 drug was moved or reassigned from 1 tier to an8 other, including whether the move or reassignment 

9 was determined or requested by a prescription drug 

10 manufacturer or other entity. 

11 (4) With respect to any pharmacy benefit man12 ager that owns, controls, or is affiliated with a phar13 macy, a report regarding any difference in reim14 bursement rates or practices, direct and indirect re15 muneration fees or other price concessions, and 

16 clawbacks between a pharmacy that is owned, con17 trolled, or affiliated with the pharmacy benefit man18 ager and any other pharmacy. 

19 (b) REPORT TO CONGRESS.— 

20 (1) IN GENERAL.—Not later than 1 year after 

21 the date of enactment of this Act, and annually 

22 thereafter, the Commission shall submit to the Com23 mittee on Commerce, Science, and Transportation of 

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1 merce of the House of Representatives a report that 

2 addresses, at a minimum— 

3 (A) the number actions brought by the 

4 Commission during the reporting year to en5 force this Act and the outcome of each such en6 forcement action; 

7 (B) the number of open investigations or 

8 inquiries into potential violations of this Act as 

9 of the time the report is submitted; 

10 (C) the number and nature of complaints 

11 received by the Commission relating to an alle12 gation of a violation of this Act during the re13 porting year; 

14 (D) an anonymized summary of the re15 ports filed with the Commission pursuant to 

16 subsection (a) for the reporting year; and 

17 (E) policy or legislative recommendations 

18 to strengthen any enforcement action relating 

19 to a violation of this Act, including rec20 ommendations to include additional prohibited 

21 conducted in section 2(a). 

22 (2) FORMULARY DESIGN OR PLACEMENT PRAC23 TICES.—Not later than 1 year after the date of en24 actment of this Act, the Commission shall submit to 

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1 portation of the Senate and the Committee on En2 ergy and Commerce of the House of Representatives 

3 a report that addresses the policies, practices, and 

4 role of pharmacy benefit managers (including their 

5 affiliates, subsidiaries, and agents) regarding for6 mulary design or placement, including whether— 

7 (A) pharmacy benefit managers (including 

8 their affiliates, subsidiaries, and agents) use 

9 formulary design or placement to increase their 

10 gross revenue without an accompanying in11 crease in patient access or decrease in patient 

12 cost; or 

13 (B) such policies or practices of pharmacy 

14 benefit managers regarding formulary design or 

15 placement violate section 5(a) of the Federal 

16 Trade Commission Act (45 U.S.C. 45(a)). 

17 (3) CONSTRUCTION.—Nothing in this section 

18 shall be construed as authorizing the Commission to 

19 disclose any information that is a trade secret or 

20 confidential information described in section 

21 552(b)(4) of title 5, United States Code. 

22 SEC. 5. WHISTLEBLOWER PROTECTIONS. 

23 (a) IN GENERAL.—A pharmacy benefit manager, 

24 health plan, pharmaceutical manufacturer, pharmacy, or 

25 any affiliate, subsidiary, or agent thereof shall not, directly 


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1 or indirectly, discharge, demote, suspend, diminish, or 

2 withdraw benefits from, threaten, harass, or in any other 

3 manner discriminate against or adversely impact a covered 

4 individual because— 

5 (1) the covered individual, or anyone perceived 

6 as assisting the covered individual, takes (or is sus7 pected to have taken or will take) a lawful action in 

8 providing to Congress, an agency of the Federal 

9 Government, the attorney general of a State, a State 

10 regulator with authority over the distribution or in11 surance coverage of prescription drugs, or a law en12 forcement agency relating to any act or omission 

13 that the covered individual reasonably believes to be 

14 a violation of this Act; 

15 (2) the covered individual provides information 

16 that the covered individual reasonably believes evi17 dences such a violation to— 

18 (A) a person with supervisory authority 

19 over the covered individual at the pharmacy 

20 benefit manager, health plan, pharmaceutical 

21 manufacturer, pharmacy, or any affiliate, sub22 sidiary, or agent thereof; or 

23 (B) another individual working for the 

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1 filiate, subsidiary, or agent thereof who the cov2 ered individual reasonably believes has the au3 thority to investigate, discover, or terminate the 

4 violation or to take any other action to address 

5 the violation; 

6 (3) the covered individual testifies (or it is sus7 pected that the covered individual will testify) in an 

8 investigation or judicial or administrative proceeding 

9 concerning such a violation; 

10 (4) the covered individual assists or participates 

11 (or it is expected that the covered individual will as12 sist or participate) in such an investigation or judi13 cial or administrative proceeding; or 

14 (5) the covered individual takes any other ac15 tion to assist in carrying out the purposes of this 

16 Act. 

17 (b) ENFORCEMENT.—An individual who alleges any 

18 adverse action in violation of subsection (a) may bring an 

19 action for a jury trial in the appropriate district court of 

20 the United States for the following relief: 

21 (1) Temporary relief while the case is pending. 

22 (2) Reinstatement with the same seniority sta23 tus that the individual would have had, but for the 

24 discharge or discrimination. 


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1 (3) Twice the amount of back pay otherwise 

2 owed to the individual, with interest. 

3 (4) Consequential and compensatory damages, 

4 and compensation for litigation costs, expert witness 

5 fees, and reasonable attorneys’ fees. 

6 (c) WAIVER OF RIGHTS AND REMEDIES.—The rights 

7 and remedies provided for in this section shall not be 

8 waived by any policy form or condition of employment, in9 cluding by a predispute arbitration agreement. 

10 (d) PREDISPUTE ARBITRATION AGREEMENTS.—No 

11 predispute arbitration agreement shall be valid or enforce12 able if the agreement requires arbitration of a dispute 

13 arising under this section. 

14 SEC. 6. ENFORCEMENT. 

15 (a) ENFORCEMENT BY THE COMMISSION.— 

16 (1) UNFAIR AND DECEPTIVE ACTS OR PRAC17 TICES.—A violation of this Act shall be treated as 

18 a violation of a rule defining an unfair or deceptive 

19 act or practice under section 18(a)(1)(B) of the Fed20 eral Trade Commission Act (15 U.S.C. 

21 57a(a)(1)(B)). 

22 (2) POWERS OF THE COMMISSION.— 

23 (A) IN GENERAL.—Except as provided in 

24 subparagraph (C), the Commission shall enforce 

25 this Act in the same manner, by the same 


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1 means, and with the same jurisdiction, powers, 

2 and duties as though all applicable terms and 

3 provisions of the Federal Trade Commission 

4 Act (15 U.S.C. 41 et seq.) were incorporated 

5 into and made a part of this Act. 

6 (B) PRIVILEGES AND IMMUNITIES.—Sub7 ject to paragraph (3), any person who violates 

8 this Act shall be subject to the penalties and 

9 entitled to the privileges and immunities pro10 vided in the Federal Trade Commission Act (15 

11 U.S.C. 41 et. seq.). 

12 (C) NONPROFIT ORGANIZATIONS AND IN13 SURANCE.—Notwithstanding section 4 or 6 of 

14 the Federal Trade Commission Act (15 U.S.C. 

15 44, 46), section 2 of McCarran-Ferguson Act 

16 (15 U.S.C. 1012), or any other jurisdictional 

17 limitation of the Commission, the Commission 

18 shall also enforce this Act, in the same manner 

19 provided in subparagraphs (A) and (B) of this 

20 paragraph, with respect to— 

21 (i) organizations not organized to 

22 carry on business for their own profit or 

23 that of their members; and 

24 (ii) the business of insurance, and 

25 persons engaged in such business. 


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1 (D) AUTHORITY PRESERVED.—Nothing in 

2 this section shall be construed to limit the au3 thority of the Commission under any other pro4 vision of law. 

5 (3) PENALTIES.— 

6 (A) ADDITIONAL CIVIL PENALTY.—In ad7 dition to any penalty applicable under the Fed8 eral Trade Commission Act (15 U.S.C. 41 et 

9 seq.), any person that violates this Act shall be 

10 liable for a civil penalty of not more than 

11 $1,000,000. 

12 (B) METHOD.—The penalties provided by 

13 subparagraph (A) shall be obtained in the same 

14 manner as civil penalties imposed under section 

15 18(a)(1)(B) of the Federal Trade Commission 

16 Act (15 U.S.C. 57a(a)(1)(B)). 

17 (C) MULTIPLE OFFENSES; MITIGATING

18 FACTORS.—In assessing a penalty under sub19 paragraph (A)— 

20 (i) each day of a continuing violation 

21 shall be considered a separate violation; 

22 and 

23 (ii) the court shall take into consider24 ation, among other factors— 


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1 (I) the seriousness of the viola2 tion; 

3 (II) the efforts of the person 

4 committing the violation to remedy 

5 the harm caused by the violation in a 

6 timely manner; and 

7 (III) whether the violation was 

8 intentional. 

9 (b) ENFORCEMENT BY STATES.— 

10 (1) IN GENERAL.—If the attorney general of a 

11 State has reason to believe that an interest of the 

12 residents of the State has been or is being threat13 ened or adversely affected by a practice that violates 

14 this Act, the attorney general of the State may bring 

15 a civil action on behalf of the residents of the State 

16 in an appropriate district court of the United States 

17 to obtain appropriate relief. 

18 (2) RIGHTS OF THE COMMISSION.— 

19 (A) NOTICE TO THE COMMISSION.— 

20 (i) IN GENERAL.—Except as provided 

21 in clause (iii), the attorney general of a 

22 State, before initiating a civil action under 

23 paragraph (1), shall provide written notifi24 cation to the Commission that the attorney 

25 general intends to bring such civil action. 


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1 (ii) CONTENTS.—The notification re2 quired under clause (i) shall include a copy 

3 of the complaint to be filed to initiate the 

4 civil action. 

5 (iii) EXCEPTION.—If it is not feasible 

6 for the attorney general of a State to pro7 vide the notification required under clause 

8 (i) before initiating a civil action under 

9 paragraph (1), the attorney general shall 

10 notify the Commission immediately upon 

11 instituting the civil action. 

12 (B) INTERVENTION BY THE COMMIS13 SION.—The Commission may— 

14 (i) intervene in any civil action 

15 brought by the attorney general of a State 

16 under paragraph (1); and 

17 (ii) upon intervening— 

18 (I) be heard on all matters aris19 ing in the civil action; and 

20 (II) file petitions for appeal of a 

21 decision in the civil action. 

22 (3) CONSTRUCTION.—Nothing in this sub23 section may be construed to prevent the attorney 

24 general of a State from exercising the powers con25 ferred on the attorney general by the laws of the 


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1 State to conduct investigations, to administer oaths 

2 or affirmations, or to compel the attendance of wit3 nesses or the production of documentary or other 

4 evidence. 

5 (4) VENUE; SERVICE OF PROCESS.— 

6 (A) VENUE.—Any action brought under 

7 paragraph (1) may be brought in— 

8 (i) the district court of the United 

9 States that meets applicable requirements 

10 relating to venue under section 1391 of 

11 title 28, United States Code; or 

12 (ii) another court of competent juris13 diction. 

14 (B) SERVICE OF PROCESS.—In an action 

15 brought under paragraph (1), process may be 

16 served in any district in which— 

17 (i) the defendant is an inhabitant, 

18 may be found, or transacts business; or 

19 (ii) venue is proper under section 

20 1391 of title 28, United States Code. 

21 (5) ACTIONS BY OTHER STATE OFFICIALS.— 

22 (A) IN GENERAL.—In addition to a civil 

23 action brought by an attorney general under 

24 paragraph (1), any other officer of a State who 

25 is authorized by the State to do so may bring 


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1 a civil action under paragraph (1), subject to 

2 the same requirements and limitations that 

3 apply under this subsection to civil actions 

4 brought by attorneys general. 

5 (B) SAVINGS PROVISION.—Nothing in this 

6 subsection may be construed to prohibit an au7 thorized official of a State from initiating or 

8 continuing any proceeding in a court of the 

9 State for a violation of any civil or criminal law 

10 of the State. 

11 (c) AFFIRMATIVE DEFENSE.—In an action brought 

12 under this section to enforce section 2, it shall be an af13 firmative defense, on which the defendant has the burden 

14 of persuasion by a preponderance of the evidence, that the 

15 conduct alleged to be a violation of section 2 was 

16 nonpretextual and reasonably necessary to— 

17 (1) prevent a violation of, or comply with, Fed18 eral or State law; 

19 (2) protect patient safety; or 

20 (3) protect patient access. 

21 SEC. 7. EFFECT ON STATE LAWS. 

22 Nothing in this Act shall be construed to preempt, 

23 displace, or supplant any State laws, rules, regulations, 

24 or requirements, or the enforcement thereof. 


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1 SEC. 8. DEFINITIONS. 

2 In this Act: 

3 (1) COMMISSION.—The term ‘‘Commission’’ 

4 means the Federal Trade Commission. 

5 (2) COVERED INDIVIDUAL.—The term ‘‘covered 

6 individual’’ means a current or former employee, 

7 contractor, subcontractor, service provider, or agent 

8 of a pharmacy benefit manager, health plan, phar9 maceutical manufacturer, pharmacy, or any affiliate, 

10 subsidiary, or agent thereof. 

11 (3) HEALTH PLAN.—The term ‘‘health plan’’ 

12 means any group or individual health insurance plan 

13 or coverage, including any health insurance plan or 

14 coverage sponsored or funded by the Federal Gov15 ernment or the government of any State, Territory, 

16 or subdivision thereof. 

17 (4) PHARMACY BENEFIT MANAGER.—The term 

18 ‘‘pharmacy benefit manager’’ means any entity that 

19 provides pharmacy benefit management services on 

20 behalf of a health plan, a payer, or health insurance 

21 issuer. 

22 (5) PHARMACY BENEFIT MANAGEMENT SERV23 ICES.—The term ‘‘pharmacy benefit management 

24 services’’ means, pursuant to a written agreement 

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1 vidual health insurance coverage, directly or through 

2 an intermediary, the service of— 

3 (A) negotiating terms and conditions, in4 cluding rebates and price concessions, with re5 spect to a prescription drug on behalf of the 

6 health plan, coverage, or payer; or 

7 (B) managing the prescription drug bene8 fits provided by the health plan, coverage, or 

9 payer, which may include formulary manage10 ment the processing and payment of claims for 

11 prescription drugs, the performance of drug uti12 lization review, the processing of drug prior au13 thorization requests, the adjudication of appeals 

14 or grievances related to the prescription drug 

15 benefit, contracting with network pharmacies, 

16 or the provision of related services. 

17 (6) PRESCRIPTION DRUG.—The term ‘‘prescrip18 tion drug’’ means— 

19 (A) a drug, as that term is defined in sec20 tion 201(g) of the Federal Food, Drug, and 

21 Cosmetic Act (21 U.S.C. 321(g)), that is— 

22 (i) approved by the Food and Drug 

23 Administration under section 505 of such 

24 Act (21 U.S.C. 355); and 


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1 (ii) subject to the requirements of sec2 tion 503(b)(1) of such Act (21 U.S.C. 

3 353(b)(1)); 

4 (B) a biological product as that term is de5 fined in section 351 of the Public Health Serv6 ice Act (42 U.S.C. 262(i)(1)); or 

7 (C) a product that is biosimilar to, or 

8 interchangeable with, a biologic product under 

9 section 351 of the Public Health Service Act 

10 (42 U.S.C. 262(i)). 

11 SECTION 1. SHORT TITLE. 

12 This Act may be cited as the ‘‘Pharmacy Benefit Man13 ager Transparency Act of 2022’’. 

14 SEC. 2. PROHIBITION ON UNFAIR OR DECEPTIVE PRESCRIP15 TION DRUG PRICING PRACTICES. 

16 (a) CONDUCT PROHIBITED.—Except as provided in 

17 subsection (b), it shall be unlawful for any pharmacy ben18 efit manager (or affiliate, subsidiary, or agent of a phar19 macy benefit manager), directly or indirectly, to engage in 

20 any of the following activities related to pharmacy benefit 

21 management services: 

22 (1) Charge a health plan or payer a different 

23 amount for a prescription drug’s ingredient cost or 

24 dispensing fee than the amount the pharmacy benefit 

25 manager reimburses a pharmacy for the prescription 


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1 drug’s ingredient cost or dispensing fee where the 

2 pharmacy benefit manager retains the amount of any 

3 such difference. 

4 (2) Arbitrarily, unfairly, or deceptively, by con5 tract or any other means, reduce, rescind, or other6 wise claw back any reimbursement payment, in whole 

7 or in part, to a pharmacist or pharmacy for a pre8 scription drug’s ingredient cost or dispensing fee. 

9 (3) Arbitrarily, unfairly, or deceptively, by con10 tract or any other means, increase fees or lower reim11 bursement to a pharmacy in order to offset reimburse12 ment changes instructed by the Federal Government 

13 under any health plan funded by the Federal Govern14 ment. 

15 (b) EXCEPTIONS.—A pharmacy benefit manager shall 

16 not be in violation of subsection (a) if the pharmacy benefit 

17 manager meets the following conditions: 

18 (1) The pharmacy benefit manager, affiliate, 

19 subsidiary, or agent passes along or returns 100 per20 cent of any price concession to a health plan or 

21 payer, including any rebate, discount, or other price 

22 concession. 

23 (2) The pharmacy benefit manager, affiliate, 

24 subsidiary, or agent provides full and complete disclo25 sure of— 


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1 (A) the cost, price, and reimbursement of 

2 the prescription drug to each health plan, payer, 

3 and pharmacy with which the pharmacy benefit 

4 manager, affiliate, subsidiary, or agent has a 

5 contract or agreement to provide pharmacy ben6 efit management services; 

7 (B) each fee, markup, and discount charged 

8 or imposed by the pharmacy benefit manager, af9 filiate, subsidiary, or agent to each health plan, 

10 payer, and pharmacy with which the pharmacy 

11 benefit manager, affiliate, subsidiary, or agent 

12 has a contract or agreement for pharmacy ben13 efit management services; or 

14 (C) the aggregate amount of all remunera15 tion the pharmacy benefit manager receives from 

16 a prescription drug manufacturer for a prescrip17 tion drug, including any rebate, discount, ad18 ministration fee, and any other payment or 

19 credit obtained or retained by the pharmacy ben20 efit manager, or affiliate, subsidiary, or agent of 

21 the pharmacy benefit manager, pursuant to a 

22 contract or agreement for pharmacy benefit man23 agement services to a health plan, payer, or any 

24 Federal agency (upon the request of the agency). 


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1 SEC. 3. PROHIBITION ON FALSE INFORMATION. 

2 It shall be unlawful for any person to report informa3 tion related to pharmacy benefit management services to 

4 a Federal department or agency if— 

5 (1) the person knew, or reasonably should have 

6 known, the information to be false or misleading; 

7 (2) the information was required by law to be re8 ported; and 

9 (3) the false or misleading information reported 

10 by the person would affect analysis or information 

11 compiled by the Federal department or agency for 

12 statistical or analytical purposes with respect to the 

13 market for pharmacy benefit management services. 

14 SEC. 4. TRANSPARENCY. 

15 (a) REPORTING BY PHARMACY BENEFIT MANAGERS.— 

16 Not later than 1 year after the date of enactment of this 

17 Act, and annually thereafter, each pharmacy benefit man18 ager (or affiliate, subsidiary, or agent of a pharmacy ben19 efit manager) shall report to the Commission the following 

20 information: 

21 (1) The aggregate amount of the difference be22 tween the amount the pharmacy benefit manager was 

23 paid by each health plan and the amount that the 

24 pharmacy benefit manager paid each pharmacy on 

25 behalf of the health plan for prescription drugs. 

26 (2) The aggregate amount of any— 


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1 (A) generic effective rate fee charged to each 

2 pharmacy; 

3 (B) direct and indirect remuneration fee 

4 charged or other price concession to each phar5 macy; and 

6 (C) payment rescinded or otherwise clawed 

7 back from a reimbursement made to each phar8 macy. 

9 (3) If, during the reporting year, the pharmacy 

10 benefit manager moved or reassigned a prescription 

11 drug to a formulary tier that has a higher cost, higher 

12 copayment, higher coinsurance, or higher deductible 

13 to a consumer, or a lower reimbursement to a phar14 macy, an explanation of the reason why the drug was 

15 moved or reassigned from 1 tier to another, including 

16 whether the move or reassignment was determined or 

17 requested by a prescription drug manufacturer or 

18 other entity. 

19 (4) With respect to any pharmacy benefit man20 ager that owns, controls, or is affiliated with a phar21 macy, a report regarding any difference in reimburse22 ment rates or practices, direct and indirect remunera23 tion fees or other price concessions, and clawbacks be24 tween a pharmacy that is owned, controlled, or affiliVerDate Sep 11 2014 00:57 Dec 15, 2022 Jkt 039200 PO 00000 Frm 00024 Fmt 6652 Sfmt 6203 E:\BILLS\S4293.RS S4293

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1 ated with the pharmacy benefit manager and any 

2 other pharmacy. 

3 (b) REPORT TO CONGRESS.— 

4 (1) IN GENERAL.—Not later than 1 year after 

5 the date of enactment of this Act, and annually there6 after, the Commission shall submit to the Committee 

7 on Commerce, Science, and Transportation of the 

8 Senate and the Committee on Energy and Commerce 

9 of the House of Representatives a report that address10 es, at a minimum— 

11 (A) the number actions brought by the Com12 mission during the reporting year to enforce this 

13 Act and the outcome of each such enforcement ac14 tion; 

15 (B) the number of open investigations or in16 quiries into potential violations of this Act as of 

17 the time the report is submitted; 

18 (C) the number and nature of complaints 

19 received by the Commission relating to an alle20 gation of a violation of this Act during the re21 porting year; 

22 (D) an anonymized summary of the reports 

23 filed with the Commission pursuant to subsection 

24 (a) for the reporting year; and 


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1 (E) policy or legislative recommendations to 

2 strengthen any enforcement action relating to a 

3 violation of this Act, including recommendations 

4 to include additional prohibited conducted in 

5 section 2(a). 

6 (2) FORMULARY DESIGN OR PLACEMENT PRAC7 TICES.—Not later than 1 year after the date of enact8 ment of this Act, the Commission shall submit to the 

9 Committee on Commerce, Science, and Transpor10 tation of the Senate and the Committee on Energy 

11 and Commerce of the House of Representatives a re12 port that addresses the policies, practices, and role of 

13 pharmacy benefit managers (including their affiliates, 

14 subsidiaries, and agents) regarding formulary design 

15 or placement, including whether— 

16 (A) pharmacy benefit managers (including 

17 their affiliates, subsidiaries, and agents) use for18 mulary design or placement to increase their 

19 gross revenue without an accompanying increase 

20 in patient access or decrease in patient cost; or 

21 (B) such policies or practices of pharmacy 

22 benefit managers regarding formulary design or 

23 placement violate section 5(a) of the Federal 

24 Trade Commission Act (15 U.S.C. 45(a)). 


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1 (3) CONSTRUCTION.—Nothing in this section 

2 shall be construed as authorizing the Commission to 

3 disclose any information that is a trade secret or con4 fidential information described in section 552(b)(4) of 

5 title 5, United States Code. 

6 (c) GAO STUDY.—Not later than 1 year after the date 

7 of enactment of this Act, the Comptroller General of the 

8 United States shall submit to the Committee on Finance 

9 and the Committee on Health, Education, Labor, and Pen10 sions of the Senate and to the Committee on Ways and 

11 Means and the Committee on Energy and Commerce of the 

12 House of Representatives a report that— 

13 (1) addresses, at minimum— 

14 (A) the role that pharmacy benefit man15 agers play in the pharmaceutical supply chain; 

16 (B) the state of competition among phar17 macy benefit managers, including the market 

18 share for the Nation’s 10 largest pharmacy ben19 efit managers; 

20 (C) the use of rebates and fees by pharmacy 

21 benefit managers, including data for each of the 

22 10 largest pharmacy benefit managers that re23 flects, for each drug in the formulary of each 

24 such pharmacy benefit manager— 


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1 (i) the amount of the rebate passed on 

2 to patients; 

3 (ii) the amount of the rebate passed on 

4 to payors; 

5 (iii) the amount of the rebate kept by 

6 the pharmacy benefit manager; and 

7 (iv) the role of fees charged by the 

8 pharmacy benefit manager; 

9 (D) whether pharmacy benefit managers 

10 structure their formularies in favor of high-re11 bate prescription drugs over lower-cost, lower-re12 bate alternatives; 

13 (E) the average prior authorization ap14 proval time for each of the 10 largest pharmacy 

15 benefit managers; 

16 (F) factors affecting the use of step therapy 

17 in each of the 10 largest pharmacy benefit man18 agers; and 

19 (G) the extent to which the price that phar20 macy benefit managers charge payors, such as 

21 the Medicare program under title XXVIII of the 

22 Social Security Act (42 U.S.C. 1395 et seq.), 

23 State Medicaid programs under title XIX of the 

24 Social Security Act (42 U.S.C. 1396 et seq.), the 

25 Federal Employees Health Benefits Program 


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1 under chapter 89 of title 5, United States Code, 

2 or private payors, for a drug is more than such 

3 pharmacy benefit managers pay the pharmacy 

4 for the drug; and 

5 (2) provides recommendations for legislative ac6 tion to lower the cost of prescription drugs for con7 sumers and payors, improve the efficiency of the 

8 pharmaceutical supply chain by lowering inter9 mediary costs, improve competition in pharmacy ben10 efit management, and provide transparency in phar11 macy benefit management. 

12 SEC. 5. WHISTLEBLOWER PROTECTIONS. 

13 (a) IN GENERAL.—A pharmacy benefit manager, 

14 health plan, pharmaceutical manufacturer, pharmacy, or 

15 any affiliate, subsidiary, or agent thereof shall not, directly 

16 or indirectly, discharge, demote, suspend, diminish, or 

17 withdraw benefits from, threaten, harass, or in any other 

18 manner discriminate against or adversely impact a covered 

19 individual because— 

20 (1) the covered individual, or anyone perceived 

21 as assisting the covered individual, takes (or is sus22 pected to have taken or will take) a lawful action in 

23 providing to Congress, an agency of the Federal Gov24 ernment, the attorney general of a State, a State reg25 ulator with authority over the distribution or insurVerDate Sep 11 2014 00:57 Dec 15, 2022 Jkt 039200 PO 00000 Frm 00029 Fmt 6652 Sfmt 6203 E:\BILLS\S4293.RS S4293

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1 ance coverage of prescription drugs, or a law enforce2 ment agency relating to any act or omission that the 

3 covered individual reasonably believes to be a viola4 tion of this Act; 

5 (2) the covered individual provides information 

6 that the covered individual reasonably believes evi7 dences such a violation to— 

8 (A) a person with supervisory authority 

9 over the covered individual at the pharmacy ben10 efit manager, health plan, pharmaceutical man11 ufacturer, pharmacy, or any affiliate, sub12 sidiary, or agent thereof; or 

13 (B) another individual working for the 

14 pharmacy benefit manager, health plan, phar15 maceutical manufacturer, pharmacy, or any af16 filiate, subsidiary, or agent thereof who the cov17 ered individual reasonably believes has the au18 thority to investigate, discover, or terminate the 

19 violation or to take any other action to address 

20 the violation; 

21 (3) the covered individual testifies (or it is sus22 pected that the covered individual will testify) in an 

23 investigation or judicial or administrative proceeding 

24 concerning such a violation; 


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1 (4) the covered individual assists or participates 

2 (or it is expected that the covered individual will as3 sist or participate) in such an investigation or judi4 cial or administrative proceeding; or 

5 (5) the covered individual takes any other action 

6 to assist in carrying out the purposes of this Act. 

7 (b) ENFORCEMENT.—An individual who alleges any 

8 adverse action in violation of subsection (a) may bring an 

9 action for a jury trial in the appropriate district court of 

10 the United States for the following relief: 

11 (1) Temporary relief while the case is pending. 

12 (2) Reinstatement with the same seniority status 

13 that the individual would have had, but for the dis14 charge or discrimination. 

15 (3) Twice the amount of back pay otherwise 

16 owed to the individual, with interest. 

17 (4) Consequential and compensatory damages, 

18 and compensation for litigation costs, expert witness 

19 fees, and reasonable attorneys’ fees. 

20 (c) WAIVER OF RIGHTS AND REMEDIES.—The rights 

21 and remedies provided for in this section shall not be 

22 waived by any policy form or condition of employment, in23 cluding by a predispute arbitration agreement. 

24 (d) PREDISPUTE ARBITRATION AGREEMENTS.—No 

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1 able if the agreement requires arbitration of a dispute aris2 ing under this section. 

3 SEC. 6. ENFORCEMENT. 

4 (a) ENFORCEMENT BY THE COMMISSION.— 

5 (1) UNFAIR AND DECEPTIVE ACTS OR PRAC6 TICES.—A violation of this Act shall be treated as a 

7 violation of a rule defining an unfair or deceptive act 

8 or practice under section 18(a)(1)(B) of the Federal 

9 Trade Commission Act (15 U.S.C. 57a(a)(1)(B)). 

10 (2) POWERS OF THE COMMISSION.— 

11 (A) IN GENERAL.—Except as provided in 

12 subparagraph (C), the Commission shall enforce 

13 this Act in the same manner, by the same means, 

14 and with the same jurisdiction, powers, and du15 ties as though all applicable terms and provi16 sions of the Federal Trade Commission Act (15 

17 U.S.C. 41 et seq.) were incorporated into and 

18 made a part of this Act. 

19 (B) PRIVILEGES AND IMMUNITIES.—Subject 

20 to paragraph (3), any person who violates this 

21 Act shall be subject to the penalties and entitled 

22 to the privileges and immunities provided in the 

23 Federal Trade Commission Act (15 U.S.C. 41 et. 

24 seq.). 


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1 (C) NONPROFIT ORGANIZATIONS AND INSUR2 ANCE.—Notwithstanding section 4 or 6 of the 

3 Federal Trade Commission Act (15 U.S.C. 44, 

4 46), section 2 of McCarran-Ferguson Act (15 

5 U.S.C. 1012), or any other jurisdictional limita6 tion of the Commission, the Commission shall 

7 also enforce this Act, in the same manner pro8 vided in subparagraphs (A) and (B) of this 

9 paragraph, with respect to— 

10 (i) organizations not organized to 

11 carry on business for their own profit or 

12 that of their members; and 

13 (ii) the business of insurance, and per14 sons engaged in such business. 

15 (D) AUTHORITY PRESERVED.—Nothing in 

16 this section shall be construed to limit the au17 thority of the Commission under any other pro18 vision of law. 

19 (3) PENALTIES.— 

20 (A) ADDITIONAL CIVIL PENALTY.—In addi21 tion to any penalty applicable under the Federal 

22 Trade Commission Act (15 U.S.C. 41 et seq.), 

23 any person that violates this Act shall be liable 

24 for a civil penalty of not more than $1,000,000. 


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1 (B) METHOD.—The penalties provided by 

2 subparagraph (A) shall be obtained in the same 

3 manner as civil penalties imposed under section 

4 18(a)(1)(B) of the Federal Trade Commission 

5 Act (15 U.S.C. 57a(a(1)(B). 

6 (C) MULTIPLE OFFENSES; MITIGATING FAC7 TORS.—In assessing a penalty under subpara8 graph (A)— 

9 (i) each day of a continuing violation 

10 shall be considered a separate violation; and 

11 (ii) the court shall take into consider12 ation, among other factors— 

13 (I) the seriousness of the violation; 

14 (II) the efforts of the person com15 mitting the violation to remedy the 

16 harm caused by the violation in a 

17 timely manner; and 

18 (III) whether the violation was 

19 intentional. 

20 (b) ENFORCEMENT BY STATES.— 

21 (1) IN GENERAL.—If the attorney general of a 

22 State has reason to believe that an interest of the resi23 dents of the State has been or is being threatened or 

24 adversely affected by a practice that violates this Act, 

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1 tion on behalf of the residents of the State in an ap2 propriate district court of the United States to obtain 

3 appropriate relief. 

4 (2) RIGHTS OF THE COMMISSION.— 

5 (A) NOTICE TO THE COMMISSION.— 

6 (i) IN GENERAL.—Except as provided 

7 in clause (iii), the attorney general of a 

8 State, before initiating a civil action under 

9 paragraph (1), shall provide written notifi10 cation to the Commission that the attorney 

11 general intends to bring such civil action. 

12 (ii) CONTENTS.—The notification re13 quired under clause (i) shall include a copy 

14 of the complaint to be filed to initiate the 

15 civil action. 

16 (iii) EXCEPTION.—If it is not feasible 

17 for the attorney general of a State to pro18 vide the notification required under clause 

19 (i) before initiating a civil action under 

20 paragraph (1), the attorney general shall 

21 notify the Commission immediately upon 

22 instituting the civil action. 

23 (B) INTERVENTION BY THE COMMISSION.— 

24 The Commission may— 


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1 (i) intervene in any civil action 

2 brought by the attorney general of a State 

3 under paragraph (1); and 

4 (ii) upon intervening— 

5 (I) be heard on all matters arising 

6 in the civil action; and 

7 (II) file petitions for appeal of a 

8 decision in the civil action. 

9 (3) CONSTRUCTION.—Nothing in this subsection 

10 may be construed to prevent the attorney general of 

11 a State from exercising the powers conferred on the 

12 attorney general by the laws of the State to conduct 

13 investigations, to administer oaths or affirmations, or 

14 to compel the attendance of witnesses or the produc15 tion of documentary or other evidence. 

16 (4) VENUE; SERVICE OF PROCESS.— 

17 (A) VENUE.—Any action brought under 

18 paragraph (1) may be brought in— 

19 (i) the district court of the United 

20 States that meets applicable requirements 

21 relating to venue under section 1391 of title 

22 28, United States Code; or 

23 (ii) another court of competent juris24 diction. 


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1 (B) SERVICE OF PROCESS.—In an action 

2 brought under paragraph (1), process may be 

3 served in any district in which— 

4 (i) the defendant is an inhabitant, 

5 may be found, or transacts business; or 

6 (ii) venue is proper under section 1391 

7 of title 28, United States Code. 

8 (5) ACTIONS BY OTHER STATE OFFICIALS.— 

9 (A) IN GENERAL.—If an attorney general 

10 lacks appropriate jurisdiction to bring a civil 

11 action under paragraph (1), any other officer of 

12 a State who is authorized by the State to do so 

13 may bring a civil action under paragraph (1), 

14 subject to the same requirements and limitations 

15 that apply under this subsection to civil actions 

16 brought by attorneys general. 

17 (B) CLARIFICATION OF AUTHORITY.—The 

18 authority provided by subparagraph (A) shall 

19 supplant, and not supplement, the authorities of 

20 State attorneys general under paragraph (1). 

21 (C) SAVINGS PROVISION.—Nothing in this 

22 subsection may be construed to prohibit an au23 thorized official of a State from initiating or 

24 continuing any proceeding in a court of the 


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1 State for a violation of any civil or criminal law 

2 of the State. 

3 (c) AFFIRMATIVE DEFENSE.—In an action brought 

4 under this section to enforce section 2, it shall be an affirm5 ative defense, on which the defendant has the burden of per6 suasion by a preponderance of the evidence, that the conduct 

7 alleged to be a violation of section 2 was nonpretextual and 

8 reasonably necessary to— 

9 (1) prevent a violation of, or comply with, Fed10 eral or State law; 

11 (2) protect patient safety; or 

12 (3) protect patient access. 

13 SEC. 7. EFFECT ON STATE LAWS. 

14 Nothing in this Act shall be construed to preempt, dis15 place, or supplant any State laws, rules, regulations, or re16 quirements, or the enforcement thereof. 

17 SEC. 8. DEFINITIONS. 

18 In this Act: 

19 (1) COMMISSION.—The term ‘‘Commission’’ 

20 means the Federal Trade Commission. 

21 (2) COVERED INDIVIDUAL.—The term ‘‘covered 

22 individual’’ means a current or former employee, con23 tractor, subcontractor, service provider, or agent of a 

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1 ceutical manufacturer, pharmacy, or any affiliate, 

2 subsidiary, or agent thereof. 

3 (3) HEALTH PLAN.—The term ‘‘health plan’’ 

4 means any group or individual health insurance plan 

5 or coverage, including any health insurance plan or 

6 coverage sponsored or funded by the Federal Govern7 ment or the government of any State, Territory, or 

8 subdivision thereof. 

9 (4) PHARMACY BENEFIT MANAGER.—The term 

10 ‘‘pharmacy benefit manager’’ means any entity that 

11 provides pharmacy benefit management services on 

12 behalf of a health plan, a payer, or health insurance 

13 issuer. 

14 (5) PHARMACY BENEFIT MANAGEMENT SERV15 ICES.—The term ‘‘pharmacy benefit management 

16 services’’ means, pursuant to a written agreement 

17 with a payer or health plan offering group or indi18 vidual health insurance coverage, directly or through 

19 an intermediary, the service of— 

20 (A) negotiating terms and conditions, in21 cluding rebates and price concessions, with re22 spect to a prescription drug on behalf of the 

23 health plan, coverage, or payer; or 

24 (B) managing the prescription drug benefits 

25 provided by the health plan, coverage, or payer, 


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1 which may include formulary management the 

2 processing and payment of claims for prescrip3 tion drugs, the performance of drug utilization 

4 review, the processing of drug prior authoriza5 tion requests, the adjudication of appeals or 

6 grievances related to the prescription drug ben7 efit, contracting with network pharmacies, or the 

8 provision of related services. 

9 (6) PRESCRIPTION DRUG.—The term ‘‘prescrip10 tion drug’’ means— 

11 (A) a drug, as that term is defined in sec12 tion 201(g) of the Federal Food, Drug, and Cos13 metic Act (21 U.S.C. 321(g)), that is— 

14 (i) approved by the Food and Drug 

15 Administration under section 505 of such 

16 Act (21 U.S.C. 355); and 

17 (ii) subject to the requirements of sec18 tion 503(b)(1) of such Act (21 U.S.C. 

19 353(b)(1)); 

20 (B) a biological product as that term is de21 fined in section 351 of the Public Health Service 

22 Act (42 U.S.C. 262(i)(1)); or 

23 (C) a product that is biosimilar to, or inter24 changeable with, a biologic product under section 


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1 351 of the Public Health Service Act (42 U.S.C. 

2 262(i)). 


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Calendar No. 647 

117TH CONGRESS 

2D SESSION S. 4293 

A BILL 

To prevent unfair and deceptive acts or practices 

for prescription drugs, and for other purposes. lated to pharmacy benefit management services and the dissemination of false information reDECEMBER 14, 2022 

Reported with an amendment 


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