II 119THCONGRESS 1 STSESSION S. 526 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 FEBRUARY11, 2025 Mr. G RASSLEY(for himself, Ms. CANTWELL, Ms. ERNST, Mr. WELCH, Mrs. C APITO, Mrs. SHAHEEN, Mr. MARSHALL, Mr. HEINRICH, Mr. MORAN, Mrs. H YDE-SMITH, Mr. TILLIS, and Mr. ROUNDS) introduced the fol- lowing bill; which was read twice and referred to the Committee on Com- merce, Science, and Transportation 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. Be it enacted by the Senate and House of Representa-1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘Pharmacy Benefit 4 Manager Transparency Act of 2025’’. 5 VerDate Sep 11 2014 20:11 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S526.IS S526 ssavage on LAPJG3WLY3PROD with BILLS 2 •S 526 IS SEC. 2. PROHIBITION ON UNFAIR OR DECEPTIVE PRE-1 SCRIPTION DRUG PRICING PRACTICES. 2 (a) C ONDUCTPROHIBITED.—Except as provided in 3 subsection (b), it shall be unlawful for any pharmacy ben-4 efit manager (or affiliate, subsidiary, or agent of a phar-5 macy benefit manager), directly or indirectly, to engage 6 in any of the following activities related to pharmacy ben-7 efit management services: 8 (1) Charge a health plan or payer a different 9 amount for a prescription drug’s ingredient cost or 10 dispensing fee than the amount the pharmacy ben-11 efit manager reimburses a pharmacy for the pre-12 scription drug’s ingredient cost or dispensing fee 13 where the pharmacy benefit manager retains the 14 amount of any such difference. 15 (2) Arbitrarily, unfairly, or deceptively, by con-16 tract or any other means, reduce, rescind, or other-17 wise claw back any reimbursement payment, in 18 whole or in part, to a pharmacist or pharmacy for 19 a prescription drug’s ingredient cost or dispensing 20 fee, unless— 21 (A) the original claim was submitted 22 fraudulently; 23 (B) the original claim payment was incon-24 sistent with the reimbursement terms in the 25 contract; or 26 VerDate Sep 11 2014 20:11 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S526.IS S526 ssavage on LAPJG3WLY3PROD with BILLS 3 •S 526 IS (C) the pharmacist services were not ren-1 dered by the pharmacy or pharmacist. 2 (3) Arbitrarily, unfairly, or deceptively, by con-3 tract or any other means, increase fees or lower re-4 imbursement to a pharmacy in order to offset reim-5 bursement changes instructed by the Federal Gov-6 ernment under any health plan funded by the Fed-7 eral Government. 8 (b) E XCEPTIONS.—A pharmacy benefit manager 9 shall not be in violation of paragraph (1) or (3) of sub-10 section (a) if the pharmacy benefit manager meets the fol-11 lowing conditions: 12 (1) The pharmacy benefit manager, affiliate, 13 subsidiary, or agent passes along or returns 100 per-14 cent of any price concession to a health plan or 15 payer, including any rebate, discount, or other price 16 concession. 17 (2) The pharmacy benefit manager, affiliate, 18 subsidiary, or agent provides full and complete dis-19 closure of— 20 (A) the cost, price, and reimbursement of 21 a prescription drug to each health plan, payer, 22 and pharmacy with which the pharmacy benefit 23 manager, affiliate, subsidiary, or agent has a 24 VerDate Sep 11 2014 20:11 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S526.IS S526 ssavage on LAPJG3WLY3PROD with BILLS 4 •S 526 IS contract or agreement to provide pharmacy ben-1 efit management services; 2 (B) each fee, markup, and discount 3 charged or imposed by the pharmacy benefit 4 manager, affiliate, subsidiary, or agent to each 5 health plan, payer, and pharmacy with which 6 the pharmacy benefit manager, affiliate, sub-7 sidiary, or agent has a contract or agreement 8 for pharmacy benefit management services; or 9 (C) the aggregate amount of all remunera-10 tion the pharmacy benefit manager receives 11 from a prescription drug manufacturer for a 12 prescription drug, including any rebate, dis-13 count, administration fee, and any other pay-14 ment or credit obtained or retained by the phar-15 macy benefit manager, or affiliate, subsidiary, 16 or agent of the pharmacy benefit manager, pur-17 suant to a contract or agreement for pharmacy 18 benefit management services to a health plan, 19 payer, or any Federal agency (upon the request 20 of the agency). 21 SEC. 3. PROHIBITION ON FALSE INFORMATION. 22 It shall be unlawful for any person to report informa-23 tion related to pharmacy benefit management services to 24 a Federal department or agency if— 25 VerDate Sep 11 2014 20:11 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S526.IS S526 ssavage on LAPJG3WLY3PROD with BILLS 5 •S 526 IS (1) the person knew, or reasonably should have 1 known, the information to be false or misleading; 2 (2) the information was required by law to be 3 reported; and 4 (3) the false or misleading information reported 5 by the person would affect analysis or information 6 compiled by the Federal department or agency for 7 statistical or analytical purposes with respect to the 8 market for pharmacy benefit management services. 9 SEC. 4. TRANSPARENCY. 10 (a) R EPORTING BY PHARMACYBENEFITMAN-11 AGERS.—Subject to subsection (d), not later than 1 year 12 after the date of enactment of this Act, and annually 13 thereafter, each pharmacy benefit manager (or affiliate, 14 subsidiary, or agent of a pharmacy benefit manager) shall 15 report to the Commission and the Secretary of Health and 16 Human Services the following information: 17 (1) The aggregate amount of the difference be-18 tween the amount the pharmacy benefit manager 19 was paid by each health plan and the amount that 20 the pharmacy benefit manager paid each pharmacy 21 on behalf of the health plan for prescription drugs. 22 (2) The aggregate amount of any— 23 (A) generic effective rate fee charged to 24 each pharmacy; 25 VerDate Sep 11 2014 20:11 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S526.IS S526 ssavage on LAPJG3WLY3PROD with BILLS 6 •S 526 IS (B) direct and indirect remuneration fee 1 charged or other price concession to each phar-2 macy; and 3 (C) payment rescinded or otherwise clawed 4 back from a reimbursement made to each phar-5 macy. 6 (3) If, during the reporting year, the pharmacy 7 benefit manager moved or reassigned a prescription 8 drug to a formulary tier that has a higher cost, 9 higher copayment, higher coinsurance, or higher de-10 ductible to a consumer, or a lower reimbursement to 11 a pharmacy, an explanation of the reason why the 12 drug was moved or reassigned from 1 tier to an-13 other, including whether the move or reassignment 14 was determined or requested by a prescription drug 15 manufacturer or other entity. 16 (4) With respect to any pharmacy benefit man-17 ager that owns, controls, or is affiliated with a phar-18 macy, a report regarding any difference in reim-19 bursement rates or practices, direct and indirect re-20 muneration fees or other price concessions, and 21 clawbacks between a pharmacy that is owned, con-22 trolled, or affiliated with the pharmacy benefit man-23 ager and any other pharmacy. 24 (b) R EPORT TOCONGRESS.— 25 VerDate Sep 11 2014 20:11 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S526.IS S526 ssavage on LAPJG3WLY3PROD with BILLS 7 •S 526 IS (1) IN GENERAL.—Not later than 1 year after 1 the date of enactment of this Act, and annually 2 thereafter, the Commission shall submit to the Com-3 mittee on Commerce, Science, and Transportation of 4 the Senate and the Committee on Energy and Com-5 merce of the House of Representatives a report that 6 addresses, at a minimum— 7 (A) the number actions brought by the 8 Commission during the reporting year to en-9 force this Act and the outcome of each such en-10 forcement action; 11 (B) the number of open investigations or 12 inquiries into potential violations of this Act as 13 of the time the report is submitted; 14 (C) the number and nature of complaints 15 received by the Commission relating to an alle-16 gation of a violation of this Act during the re-17 porting year; 18 (D) an anonymized summary of the re-19 ports filed with the Commission pursuant to 20 subsection (a) for the reporting year; 21 (E) an analysis of the requirements of this 22 Act and whether the implementation of such re-23 quirements leads to mergers (including hori-24 zontal mergers or vertical mergers) amongst 25 VerDate Sep 11 2014 20:11 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\S526.IS S526 ssavage on LAPJG3WLY3PROD with BILLS 8 •S 526 IS any pharmacy benefit managers, or any phar-1 macy benefit manager that owns, controls, or is 2 affiliated with a pharmacy, or any pharmacy 3 benefit manager that owns, controls, or is affili-4 ated with a health plan, and the effect of such 5 merger (including the likelihood of a substantial 6 decrease in competition or the potential for a 7 monopoly); and 8 (F) policy or legislative recommendations 9 to strengthen any enforcement action relating 10 to a violation of this Act, including rec-11 ommendations to include additional prohibited 12 conduct in section 2(a), and recommendations 13 to encourage more competition and decrease the 14 likelihood of a monopoly in the pharmaceutical 15 supply chain. 16 (2) F ORMULARY DESIGN OR PLACEMENT PRAC -17 TICES.—Not later than 1 year after the date of en-18 actment of this Act, the Commission shall submit to 19 the Committee on Commerce, Science, and Trans-20 portation of the Senate, the Committee on Finance 21 of the Senate, the Committee on Health, Education, 22 Labor, and Pensions of the Senate, the Committee 23 on Ways and Means of the House of Representa-24 tives, and the Committee on Energy and Commerce 25 VerDate Sep 11 2014 20:11 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6201 E:\BILLS\S526.IS S526 ssavage on LAPJG3WLY3PROD with BILLS 9 •S 526 IS of the House of Representatives a report that ad-1 dresses the policies, practices, and role of pharmacy 2 benefit managers (including their affiliates, subsidi-3 aries, and agents) regarding formulary design or 4 placement, including— 5 (A) whether pharmacy benefit managers 6 (including their affiliates, subsidiaries, and 7 agents) use formulary design or placement to 8 increase their gross revenue without an accom-9 panying increase in patient access or decrease 10 in patient cost; or 11 (B) recommendations to Congress for leg-12 islative action addressing such policies, prac-13 tices, and role of pharmacy benefit managers 14 (including their affiliates, subsidiaries, and 15 agents). 16 (3) C ONSTRUCTION.—Nothing in this section 17 shall be construed as authorizing the Commission to 18 disclose any information that is a trade secret or 19 confidential information described in section 20 552(b)(4) of title 5, United States Code, except as 21 necessary to enforce this Act. 22 (4) C ONFIDENTIALITY.—The Commission may 23 disclose the information in a form which does not 24 disclose the identity of a specific pharmacy benefit 25 VerDate Sep 11 2014 20:11 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S526.IS S526 ssavage on LAPJG3WLY3PROD with BILLS 10 •S 526 IS manager, pharmacy, or health plan for the following 1 purposes: 2 (A) To permit the Comptroller General of 3 the United States to review the information 4 provided to carry out this Act. 5 (B) To permit the Director of the Congres-6 sional Budget Office to review the information 7 provided. 8 (c) GAO S TUDY.—Not later than 1 year after the 9 date of enactment of this Act, the Comptroller General 10 of the United States shall submit to the Committee on 11 Commerce, Science, and Transportation, the Committee 12 on Finance, and the Committee on Health, Education, 13 Labor, and Pensions of the Senate and to the Committee 14 on Ways and Means and the Committee on Energy and 15 Commerce of the House of Representatives a report 16 that— 17 (1) addresses, at minimum— 18 (A) the role that pharmacy benefit man-19 agers play in the pharmaceutical supply chain; 20 (B) the state of competition among phar-21 macy benefit managers, including the market 22 share for the Nation’s 10 largest pharmacy 23 benefit managers; 24 VerDate Sep 11 2014 20:11 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S526.IS S526 ssavage on LAPJG3WLY3PROD with BILLS 11 •S 526 IS (C) the use of rebates and fees by phar-1 macy benefit managers, including data for each 2 of the 10 largest pharmacy benefit managers 3 that reflects, for each drug in the formulary of 4 each such pharmacy benefit manager— 5 (i) the amount of the rebate passed on 6 to patients; 7 (ii) the amount of the rebate passed 8 on to payors; 9 (iii) the amount of the rebate kept by 10 the pharmacy benefit manager; and 11 (iv) the role of fees charged by the 12 pharmacy benefit manager; 13 (D) whether pharmacy benefit managers 14 structure their formularies in favor of high-re-15 bate prescription drugs over lower-cost, lower- 16 rebate alternatives; 17 (E) the average prior authorization ap-18 proval time for each of the 10 largest pharmacy 19 benefit managers; 20 (F) factors affecting the use of step ther-21 apy in each of the 10 largest pharmacy benefit 22 managers; 23 (G) the extent to which the price that 24 pharmacy benefit managers charge payors, such 25 VerDate Sep 11 2014 20:11 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6201 E:\BILLS\S526.IS S526 ssavage on LAPJG3WLY3PROD with BILLS 12 •S 526 IS as the Medicare program under title XXVIII of 1 the Social Security Act (42 U.S.C. 1395 et 2 seq.), State Medicaid programs under title XIX 3 of the Social Security Act (42 U.S.C. 1396 et 4 seq.), the Federal Employees Health Benefits 5 Program under chapter 89 of title 5, United 6 States Code, or private payors, for a drug is 7 more than such pharmacy benefit managers pay 8 the pharmacy for the drug; and 9 (H) the competitive impact of pharmacy 10 benefit managers’ business practices, including 11 the impact that such business practices have on 12 the cost of health plan premiums or prescrip-13 tion drugs for consumers; and 14 (2) provides recommendations for legislative ac-15 tion to lower the cost of prescription drugs for con-16 sumers and payors, improve the efficiency of the 17 pharmaceutical supply chain by lowering inter-18 mediary costs, improve competition in pharmacy 19 benefit management, and provide transparency in 20 pharmacy benefit management. 21 (d) P RIVACYREQUIREMENTS.—Any entity shall pro-22 vide information under subsection (a) in a manner con-23 sistent with the privacy, security, and breach notification 24 regulations promulgated under section 264(c) of the 25 VerDate Sep 11 2014 20:11 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\S526.IS S526 ssavage on LAPJG3WLY3PROD with BILLS 13 •S 526 IS Health Insurance Portability and Accountability Act of 1 1996 (42 U.S.C. 1320d–2 note) (or any successor regula-2 tion), and shall restrict the use and disclosure of such in-3 formation according to such regulations. 4 SEC. 5. WHISTLEBLOWER PROTECTIONS. 5 (a) I NGENERAL.—A pharmacy benefit manager, 6 health plan, pharmaceutical manufacturer, pharmacy, or 7 any affiliate, subsidiary, or agent thereof shall not, directly 8 or indirectly, discharge, demote, suspend, diminish, or 9 withdraw benefits from, threaten, harass, or in any other 10 manner discriminate against or adversely impact a covered 11 individual because— 12 (1) the covered individual, or anyone perceived 13 as assisting the covered individual, takes (or is sus-14 pected to have taken or will take) a lawful action in 15 providing to Congress, an agency of the Federal 16 Government, the attorney general of a State, a State 17 regulator with authority over the distribution or in-18 surance coverage of prescription drugs, or a law en-19 forcement agency relating to any act or omission 20 that the covered individual reasonably believes to be 21 a violation of this Act; 22 (2) the covered individual provides information 23 that the covered individual reasonably believes evi-24 dences such a violation to— 25 VerDate Sep 11 2014 20:11 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00013 Fmt 6652 Sfmt 6201 E:\BILLS\S526.IS S526 ssavage on LAPJG3WLY3PROD with BILLS 14 •S 526 IS (A) a person with supervisory authority 1 over the covered individual at the pharmacy 2 benefit manager, health plan, pharmaceutical 3 manufacturer, pharmacy, or any affiliate, sub-4 sidiary, or agent thereof; or 5 (B) another individual working for the 6 pharmacy benefit manager, health plan, phar-7 maceutical manufacturer, pharmacy, or any af-8 filiate, subsidiary, or agent thereof who the cov-9 ered individual reasonably believes has the au-10 thority to investigate, discover, or terminate the 11 violation or to take any other action to address 12 the violation; 13 (3) the covered individual testifies (or it is sus-14 pected that the covered individual will testify) in an 15 investigation or judicial or administrative proceeding 16 concerning such a violation; or 17 (4) the covered individual assists or participates 18 (or it is expected that the covered individual will as-19 sist or participate) in such an investigation or judi-20 cial or administrative proceeding. 21 (b) E NFORCEMENT.—An individual who alleges any 22 adverse action in violation of subsection (a) may bring an 23 action for a jury trial in the appropriate district court of 24 the United States for the following relief: 25 VerDate Sep 11 2014 20:11 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\S526.IS S526 ssavage on LAPJG3WLY3PROD with BILLS 15 •S 526 IS (1) Temporary relief while the case is pending. 1 (2) Reinstatement with the same seniority sta-2 tus that the individual would have had, but for the 3 discharge or discrimination. 4 (3) Twice the amount of back pay otherwise 5 owed to the individual, with interest. 6 (4) Consequential and compensatory damages, 7 and compensation for litigation costs, expert witness 8 fees, and reasonable attorneys’ fees. 9 (c) W AIVER OFRIGHTS ANDREMEDIES.—The rights 10 and remedies provided for in this section shall not be 11 waived by any policy form or condition of employment, in-12 cluding by a predispute arbitration agreement. 13 (d) P REDISPUTEARBITRATIONAGREEMENTS.—No 14 predispute arbitration agreement shall be valid or enforce-15 able if the agreement requires arbitration of a dispute 16 arising under this section. 17 SEC. 6. ENFORCEMENT. 18 (a) E NFORCEMENT BY THE COMMISSION.— 19 (1) U NFAIR AND DECEPTIVE ACTS OR PRAC -20 TICES.—A violation of this Act shall be treated as 21 a violation of a rule defining an unfair or deceptive 22 act or practice under section 18(a)(1)(B) of the Fed-23 eral Trade Commission Act (15 U.S.C. 24 57a(a)(1)(B)). 25 VerDate Sep 11 2014 20:11 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00015 Fmt 6652 Sfmt 6201 E:\BILLS\S526.IS S526 ssavage on LAPJG3WLY3PROD with BILLS 16 •S 526 IS (2) POWERS OF THE COMMISSION .— 1 (A) I N GENERAL.—Except as provided in 2 subparagraph (C), the Commission shall enforce 3 this Act in the same manner, by the same 4 means, and with the same jurisdiction, powers, 5 and duties as though all applicable terms and 6 provisions of the Federal Trade Commission 7 Act (15 U.S.C. 41 et seq.) were incorporated 8 into and made a part of this Act. 9 (B) P RIVILEGES AND IMMUNITIES .—Sub-10 ject to paragraph (3), any person who violates 11 this Act shall be subject to the penalties and 12 entitled to the privileges and immunities pro-13 vided in the Federal Trade Commission Act (15 14 U.S.C. 41 et seq.). 15 (C) N ONPROFIT ORGANIZATIONS AND IN -16 SURANCE.—Notwithstanding section 4 or 6 of 17 the Federal Trade Commission Act (15 U.S.C. 18 44, 46), section 2 of McCarran-Ferguson Act 19 (15 U.S.C. 1012), or any other jurisdictional 20 limitation of the Commission, the Commission 21 shall also enforce this Act, in the same manner 22 provided in subparagraphs (A) and (B) of this 23 paragraph, with respect to— 24 VerDate Sep 11 2014 20:11 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00016 Fmt 6652 Sfmt 6201 E:\BILLS\S526.IS S526 ssavage on LAPJG3WLY3PROD with BILLS 17 •S 526 IS (i) organizations not organized to 1 carry on business for their own profit or 2 that of their members; and 3 (ii) the business of insurance, and 4 persons engaged in such business. 5 (D) A UTHORITY PRESERVED .—Nothing in 6 this section shall be construed to limit the au-7 thority of the Commission under any other pro-8 vision of law. 9 (3) P ENALTIES.— 10 (A) A DDITIONAL CIVIL PENALTY .—In ad-11 dition to any penalty applicable under the Fed-12 eral Trade Commission Act (15 U.S.C. 41 et 13 seq.), any person that violates this Act shall be 14 liable for a civil penalty of not more than 15 $1,000,000. 16 (B) M ETHOD.—The penalties provided by 17 subparagraph (A) shall be obtained in the same 18 manner as civil penalties imposed under section 19 18(a)(1)(B) of the Federal Trade Commission 20 Act (15 U.S.C. 57a(a(1)(B). 21 (C) M ULTIPLE OFFENSES ; MITIGATING 22 FACTORS.—In assessing a penalty under sub-23 paragraph (A)— 24 VerDate Sep 11 2014 20:11 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00017 Fmt 6652 Sfmt 6201 E:\BILLS\S526.IS S526 ssavage on LAPJG3WLY3PROD with BILLS 18 •S 526 IS (i) each day of a continuing violation 1 shall be considered a separate violation; 2 and 3 (ii) the court shall take into consider-4 ation, among other factors— 5 (I) the seriousness of the viola-6 tion; 7 (II) the efforts of the person 8 committing the violation to remedy 9 the harm caused by the violation in a 10 timely manner; and 11 (III) whether the violation was 12 intentional. 13 (b) E NFORCEMENT BY STATES.— 14 (1) I N GENERAL.—If the attorney general of a 15 State has reason to believe that an interest of the 16 residents of the State has been or is being threat-17 ened or adversely affected by a practice that violates 18 this Act, the attorney general of the State may bring 19 a civil action on behalf of the residents of the State 20 in an appropriate district court of the United States 21 to obtain appropriate relief. 22 (2) R IGHTS OF THE COMMISSION .— 23 (A) N OTICE TO THE COMMISSION .— 24 VerDate Sep 11 2014 20:11 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00018 Fmt 6652 Sfmt 6201 E:\BILLS\S526.IS S526 ssavage on LAPJG3WLY3PROD with BILLS 19 •S 526 IS (i) IN GENERAL.—Except as provided 1 in clause (iii), the attorney general of a 2 State, before initiating a civil action under 3 paragraph (1), shall provide written notifi-4 cation to the Commission that the attorney 5 general intends to bring such civil action. 6 (ii) C ONTENTS.—The notification re-7 quired under clause (i) shall include a copy 8 of the complaint to be filed to initiate the 9 civil action. 10 (iii) E XCEPTION.—If it is not feasible 11 for the attorney general of a State to pro-12 vide the notification required under clause 13 (i) before initiating a civil action under 14 paragraph (1), the attorney general shall 15 notify the Commission immediately upon 16 instituting the civil action. 17 (B) I NTERVENTION BY THE COMMIS -18 SION.—The Commission may— 19 (i) intervene in any civil action 20 brought by the attorney general of a State 21 under paragraph (1); and 22 (ii) upon intervening— 23 (I) be heard on all matters aris-24 ing in the civil action; and 25 VerDate Sep 11 2014 20:11 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00019 Fmt 6652 Sfmt 6201 E:\BILLS\S526.IS S526 ssavage on LAPJG3WLY3PROD with BILLS 20 •S 526 IS (II) file petitions for appeal of a 1 decision in the civil action. 2 (3) C ONSTRUCTION.— 3 (A) P OWERS CONFERRED ON THE ATTOR -4 NEY GENERAL OF A STATE .—Nothing in this 5 subsection may be construed to prevent the at-6 torney general of a State from exercising the 7 powers conferred on the attorney general by the 8 laws of the State to conduct investigations, to 9 administer oaths or affirmations, or to compel 10 the attendance of witnesses or the production of 11 documentary or other evidence. 12 (B) ERISA.—No civil action brought pur-13 suant to this subsection shall conflict with the 14 Employee Retirement Income Security Act of 15 1974 (29 U.S.C. 1001 et seq.). 16 (4) V ENUE; SERVICE OF PROCESS.— 17 (A) V ENUE.—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 22 title 28, United States Code; or 23 (ii) another court of competent juris-24 diction. 25 VerDate Sep 11 2014 20:11 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00020 Fmt 6652 Sfmt 6201 E:\BILLS\S526.IS S526 ssavage on LAPJG3WLY3PROD with BILLS 21 •S 526 IS (B) SERVICE OF PROCESS.—In an action 1 brought under paragraph (1), process may be 2 served in any district in which— 3 (i) the defendant is an inhabitant, 4 may be found, or transacts business; or 5 (ii) venue is proper under section 6 1391 of title 28, United States Code. 7 (5) A CTIONS BY OTHER STATE OFFICIALS .— 8 (A) I N GENERAL.—If an attorney general 9 lacks appropriate jurisdiction to bring a civil ac-10 tion under paragraph (1), any other officer of 11 a State who is authorized by the State to do so 12 may bring a civil action under paragraph (1), 13 subject to the same requirements and limita-14 tions that apply under this subsection to civil 15 actions brought by attorneys general. 16 (B) C LARIFICATION OF AUTHORITY .—The 17 authority provided by subparagraph (A) shall 18 supplant, and not supplement, the authorities of 19 State attorneys general under paragraph (1). 20 (C) S AVINGS PROVISION.—Nothing in this 21 subsection may be construed to prohibit an au-22 thorized official of a State from initiating or 23 continuing any proceeding in a court of the 24 VerDate Sep 11 2014 20:11 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00021 Fmt 6652 Sfmt 6201 E:\BILLS\S526.IS S526 ssavage on LAPJG3WLY3PROD with BILLS 22 •S 526 IS State for a violation of any civil or criminal law 1 of the State. 2 (c) A FFIRMATIVEDEFENSE.— 3 (1) I N GENERAL.—In an action brought under 4 this section to enforce section 2, it shall be an af-5 firmative defense, on which the defendant has the 6 burden of persuasion by a preponderance of the evi-7 dence, that the conduct alleged to be a violation of 8 section 2 was nonpretextual and reasonably nec-9 essary to— 10 (A) prevent a violation of, or comply with, 11 Federal or State law; 12 (B) protect patient safety; or 13 (C) protect patient access. 14 (2) C LARIFICATION.—Nothing in this sub-15 section shall be construed to prohibit a defendant 16 from raising any other affirmative defense available. 17 SEC. 7. PROTECTION OF PERSONAL HEALTH INFORMA-18 TION. 19 In making any disclosure or report required by this 20 Act, a pharmacy benefit manager (including their affili-21 ates, subsidiaries, and agents) shall not include any infor-22 mation that would identify a patient or a provider that 23 issued a prescription. 24 VerDate Sep 11 2014 20:11 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00022 Fmt 6652 Sfmt 6201 E:\BILLS\S526.IS S526 ssavage on LAPJG3WLY3PROD with BILLS 23 •S 526 IS SEC. 8. EFFECT ON STATE LAWS. 1 Nothing in this Act shall be construed to preempt, 2 displace, or supplant any State laws, rules, regulations, 3 or requirements, or the enforcement thereof. 4 SEC. 9. DEFINITIONS. 5 In this Act: 6 (1) C OMMISSION.—The term ‘‘Commission’’ 7 means the Federal Trade Commission. 8 (2) C OVERED INDIVIDUAL.—The term ‘‘covered 9 individual’’ means a current or former employee, 10 contractor, subcontractor, service provider, or agent 11 of a pharmacy benefit manager, health plan, phar-12 maceutical manufacturer, pharmacy, or any affiliate, 13 subsidiary, or agent thereof. 14 (3) H EALTH PLAN.—The term ‘‘health plan’’ 15 means any group or individual health insurance plan 16 or coverage, including any health insurance plan or 17 coverage sponsored or funded by the Federal Gov-18 ernment or the government of any State, Territory, 19 or subdivision thereof. 20 (4) P HARMACY BENEFIT MANAGER .—The term 21 ‘‘pharmacy benefit manager’’ means any entity that 22 provides pharmacy benefit management services on 23 behalf of a health plan, a payer, or health insurance 24 issuer. 25 VerDate Sep 11 2014 20:11 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00023 Fmt 6652 Sfmt 6201 E:\BILLS\S526.IS S526 ssavage on LAPJG3WLY3PROD with BILLS 24 •S 526 IS (5) PHARMACY BENEFIT MANAGEMENT SERV -1 ICES.—The term ‘‘pharmacy benefit management 2 services’’ means, pursuant to a written agreement 3 with a payer or health plan offering group or indi-4 vidual health insurance coverage, directly or through 5 an intermediary, the service of— 6 (A) negotiating terms and conditions, in-7 cluding rebates and price concessions, with re-8 spect to a prescription drug on behalf of the 9 health plan, coverage, or payer; or 10 (B) managing the prescription drug bene-11 fits provided by the health plan, coverage, or 12 payer, which may include formulary manage-13 ment the processing and payment of claims for 14 prescription drugs, the performance of drug uti-15 lization review, the processing of drug prior au-16 thorization requests, the adjudication of appeals 17 or grievances related to the prescription drug 18 benefit, contracting with network pharmacies, 19 or the provision of related services. 20 (6) P RESCRIPTION DRUG.—The term ‘‘prescrip-21 tion drug’’ means— 22 (A) a drug, as that term is defined in sec-23 tion 201(g) of the Federal Food, Drug, and 24 Cosmetic Act (21 U.S.C. 321(g)), that is— 25 VerDate Sep 11 2014 20:11 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00024 Fmt 6652 Sfmt 6201 E:\BILLS\S526.IS S526 ssavage on LAPJG3WLY3PROD with BILLS 25 •S 526 IS (i) approved by the Food and Drug 1 Administration under section 505 of such 2 Act (21 U.S.C. 355); and 3 (ii) subject to the requirements of sec-4 tion 503(b)(1) of such Act (21 U.S.C. 5 353(b)(1)); 6 (B) a biological product as that term is de-7 fined in section 351 of the Public Health Serv-8 ice Act (42 U.S.C. 262(i)(1)); or 9 (C) a product that is biosimilar to, or 10 interchangeable with, a biologic product under 11 section 351 of the Public Health Service Act 12 (42 U.S.C. 262(i)). 13 Æ VerDate Sep 11 2014 20:11 Mar 08, 2025 Jkt 059200 PO 00000 Frm 00025 Fmt 6652 Sfmt 6301 E:\BILLS\S526.IS S526 ssavage on LAPJG3WLY3PROD with BILLS