Us Congress 2025 2025-2026 Regular Session

Us Congress Senate Bill SB526 Introduced / Bill

Filed 03/11/2025

                    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
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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
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(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
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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
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(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
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(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
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(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
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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
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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
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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
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(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
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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
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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
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(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
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(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
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(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
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(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
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(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
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(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
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(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
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(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
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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
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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
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(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
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(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 
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