130 
‘‘(9) PROVISION OF DRUG CLAIMS DATA; MECH-
ANISM TO REFUND DUPLICATED AMOUNTS.—A con-
tract under this part shall require a PDP sponsor to 
furnish to the clearinghouse in a machine-readable 
format, claims level data for covered outpatient 
drugs dispensed to individuals enrolled in a prescrip-
tion drug plan offered by such sponsor under this 
part that includes, with respect to each dispense of 
such drug, the data elements described in section 
340B(a)(5)(J)(iii) of the Public Health Service Act. 
Such contract shall require a PDP sponsor to fur-
nish such data to the clearinghouse within 5 days 
following the date the claim for such drug is paid by 
the PDP sponsor.’’. 
(4) MA–PDS.—Section 1857(f)(3) of the Social 
Security Act (42 U.S.C. 1395w–27(f)(3)) is amend-
ed by adding at the end the following: 
‘‘(E) PROVISION OF DRUG CLAIMS DATA; 
MECHANISM
TO
REFUND
DUPLICATED 
AMOUNTS.—Section 1860D–12(b)(9).’’. 
SEC. 17. LIMITATION ON ADMINISTRATOR SERVICE FEES 
AND CONTRACT PHARMACY FEES. 
Section 340B of the Public Health Service Act (42 
U.S.C. 256b) is amended by adding at the end the fol-
lowing: 
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‘‘(f) REQUIREMENTS
FOR
TPA AND
CONTRACT 
PHARMACY REMUNERATION.— 
‘‘(1) THIRD-PARTY ADMINISTRATOR FEES.—A 
third-party administrator furnishing 340B program- 
related services on behalf of a covered entity de-
scribed in subsection (a)(4), including reviewing or 
processing claims or other information to identify 
covered outpatient drugs dispensed to individuals 
who are patients of the covered entity (as defined in 
subsection (b)(3)) may receive remuneration from 
such covered entity for the performance of such 
services only if— 
‘‘(A) such remuneration is a flat dollar 
amount not directly or indirectly based on any 
price of, or discount or other remuneration pro-
vided with respect to, a covered outpatient 
drug, paid for each unit of service furnished to 
the covered entity, regardless of whether a pre-
scription was dispensed to an individual who is 
a patient of the covered entity; 
‘‘(B) the amount of such remuneration is 
consistent with fair market value in an arm’s- 
length transaction for the bona fide, itemized 
340B-related services actually performed on be-
half of the covered entity; and 
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‘‘(C) such remuneration complies with ap-
plicable State and Federal law, including sec-
tion 1128B(b) of the Social Security Act. 
‘‘(2) CONTRACT PHARMACY FEES.—A contract 
pharmacy that has entered into a written agreement 
with a covered entity pursuant to and satisfies the 
applicable requirements in subsection (a)(5)(F) may 
receive remuneration from such covered entity for 
the performance of services associated with dis-
pensing covered outpatient drugs subject to an 
agreement under this section to individuals who are 
patients of the covered entity (as defined in sub-
section (b)(3)) only if— 
‘‘(A) such remuneration is a flat dollar 
amount not directly or indirectly based on any 
price of, or discount or other remuneration pro-
vided with respect to, a covered outpatient 
drug, paid for each dispense of such a drug to 
a patient of the covered entity; 
‘‘(B) the amount of remuneration for each 
dispense does not exceed 125 percent of the av-
erage per-prescription dispensing fee paid to 
such pharmacy by all third-party payors, based 
on data from the most recent full calendar year 
for which such data is available; 
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‘‘(C) the amount of such remuneration is 
consistent with fair market value in an arm’s- 
length transaction for the bona fide, itemized 
340B-related services actually performed on be-
half of the covered entity; and 
‘‘(D) such remuneration complies with ap-
plicable State and Federal law, including sec-
tion 1128B(b) of the Social Security Act. 
For purposes of subparagraph (B), if a covered enti-
ty has entered into an agreement for contract phar-
macy services pursuant to subsection (a)(5)(F) that 
permits the contract pharmacy service provider to 
dispense covered outpatient drugs on behalf of the 
covered entity at more than one pharmacy location, 
the average dispensing fee shall be calculated across 
all pharmacy locations subject to such agreement. 
‘‘(3) AUDITABLE RECORDS.—A covered entity 
shall retain copies of written agreements with third- 
party administrators or contract pharmacies de-
scribed in this subsection for a period of time speci-
fied by the Secretary and shall make copies of such 
agreements available to the Secretary or their des-
ignee upon request. 
‘‘(4) CIVIL
MONETARY
PENALTY.—A third- 
party administrator or contract pharmacy described 
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in this subsection that fails to comply with the appli-
cable requirements specified in this subsection shall 
be required to pay a civil monetary penalty equal to 
10 times the amount such third-party administrator 
or contract pharmacy received for the performance 
of relevant services described in this subsection. The 
provisions of section 1128A of the Social Security 
Act (other than subsections (a) and (b)) shall apply 
to a civil monetary penalty under this paragraph in 
the same manner as such provisions apply to a pen-
alty or proceeding under section 1128A(a). The Of-
fice of Inspector General of the Department of 
Health and Human Services shall carry out the pro-
visions related to the imposition of civil monetary 
penalties under this paragraph.’’. 
SEC. 18. CLARIFICATION. 
Section 340B of the Public Health Service Act (42 
U.S.C. 256b) is further amended by adding at the end 
the following: 
‘‘(g) CLARIFICATION.—The provisions of this section 
supersede any provision or requirement of State or local 
law insofar as that State or local law may establish, imple-
ment, or continue in effect a standard or requirement that 
differs from or relates in any way to the provisions of this 
section or, except for any State regulations issued to carry 
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out subsection (a)(5)(A)(iii), relates in any way to the 
drug discount program under this section or covered out-
patient drugs subject to an agreement under this section, 
including the distribution of such drugs. Except for any 
State regulations issued to carry out subsection 
(a)(5)(A)(iii), no provision or requirement of State or local 
law shall grant additional rights or impose additional obli-
gations related to the 340B program.’’. 
SEC. 19. ENSURING THE EQUITABLE TREATMENT OF 340B 
COVERED ENTITIES AND PHARMACIES PAR-
TICIPATING IN THE 340B DRUG DISCOUNT 
PROGRAM. 
(a) GROUP HEALTH PLAN AND HEALTH INSURANCE 
ISSUER REQUIREMENTS.—Subpart II of part A of title 
XXVII of the Public Health Service Act (42 U.S.C. 
300gg–11 et seq.) is amended by adding at the end the 
following: 
‘‘SEC. 2730. REQUIREMENTS RELATING TO THE 340B DRUG 
DISCOUNT PROGRAM. 
‘‘(a) IN GENERAL.—A group health plan, a health 
insurance issuer offering group or individual health insur-
ance coverage, or a pharmacy benefit manager acting on 
behalf of such plan or issuer, may not discriminate against 
a covered entity (as defined in subsection (e)(1)), a con-
tract pharmacy (as defined in subsection (e)(2)), or a par-
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ticipant, beneficiary, or enrollee of such plan or coverage 
by imposing requirements, exclusions, reimbursement 
terms, or other conditions on such entity or pharmacy that 
differ from those applied to entities or pharmacies that 
are not covered entities or contract pharmacies on the 
basis that the entity or pharmacy is a covered entity or 
contract pharmacy or that the entity or pharmacy dis-
penses 340B drugs, by taking any action prohibited under 
subsection (b). 
‘‘(b) SPECIFIED PROHIBITED ACTIONS.—A group 
health plan, a health insurance issuer offering group or 
individual health insurance coverage, or a pharmacy ben-
efit manager acting on behalf of such plan or issuer, may 
not discriminate against a covered entity, a contract phar-
macy, or a participant, beneficiary, or enrollee of such 
plan or coverage by doing any of the following: 
‘‘(1) Reimbursing a covered entity or contract 
pharmacy for a quantity of a 340B drug (as defined 
in subsection (e)) in an amount less than such plan, 
issuer, or pharmacy benefit manager (as applicable) 
would pay to any other similarly situated (as speci-
fied by the Secretary) entity or pharmacy that is not 
a covered entity or a contract pharmacy for such 
quantity of such drug on the basis that the entity 
or pharmacy is a covered entity or contract phar-
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macy or that the entity or pharmacy dispenses 340B 
drugs. 
‘‘(2) Imposing any terms or conditions on cov-
ered entities or contract pharmacies with respect to 
any of the following that differ from such terms or 
conditions applied to other similarly situated entities 
or pharmacies that are not covered entities or con-
tract pharmacies on the basis that the entity or 
pharmacy is a covered entity or contract pharmacy 
or that the entity or pharmacy dispenses 340B 
drugs: 
‘‘(A) Fees, chargebacks, clawbacks, adjust-
ments, or other assessments. 
‘‘(B) Professional dispensing fees. 
‘‘(C) Restrictions or requirements regard-
ing participation in standard or preferred phar-
macy networks. 
‘‘(D) Requirements relating to the fre-
quency or scope of audits or to inventory man-
agement systems using generally accepted ac-
counting principles. 
‘‘(E) Any other restrictions, conditions, 
practices, or policies that interfere with the 
ability of a covered entity or contract pharmacy 
to use the discounts provided under section 
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340B in accordance with applicable require-
ments under such section. 
‘‘(3) Interfering with an individual’s choice to 
receive a 340B drug from a covered entity or con-
tract pharmacy, whether in person or via direct de-
livery, mail, or other form of shipment, as permitted 
under section 340B. 
‘‘(4) Interfering with, limiting, or prohibiting 
actions by a covered entity or contract pharmacy to 
identify, either directly or through a third party, 
claims for 340B drugs, including by submission of 
claims data or use of claims modifiers or indicators. 
‘‘(5) Refusing to contract with a covered entity 
or contract pharmacy for reasons other than those 
that apply equally to entities or pharmacies that are 
not covered entities or contract pharmacies, or on 
the basis that— 
‘‘(A) the entity or pharmacy is a covered 
entity or a contract pharmacy; or 
‘‘(B) the entity or pharmacy is described in 
any of subparagraphs (A) through (O) of sec-
tion 340B(a)(4). 
‘‘(6) With respect to a group health plan or 
health insurance issuer for health insurance cov-
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erage, denying coverage of a drug on the basis that 
such drug is a 340B drug. 
‘‘(c) PROHIBITED ACTIONS IN DEROGATION OF SEC-
TION 340B AFFORDABILITY ASSISTANCE PROVISIONS.— 
A group health plan, a health insurance issuer offering 
group or individual health insurance coverage, or a phar-
macy benefit manager acting on behalf of such plan or 
issuer shall not prohibit or restrict, in contracts with phar-
macies in their network that are contract pharmacies or 
entity pharmacies, or in any other manner, any reduction 
in or subsidy for the out-of-pocket amount for a 340B 
drug charged to an individual (including a participant, 
beneficiary, or enrollee of such plan or coverage) that is 
required or authorized by subparagraphs (G) or (H) of 
section 340B(a)(5). Any general prohibition or restriction 
on reducing or subsidizing the out-of-pocket amount for 
a drug charged to an individual that lacks an express ex-
emption for any reductions in or subsidies for the out-of- 
pocket amount for a 340B drug that are required or au-
thorized by subparagraphs (G) or (H) of section 
340B(a)(5) is a violation of this subsection. Any contrac-
tual provision that violates this subsection in any manner 
shall be void and unenforceable. 
‘‘(d) ENFORCEMENT MECHANISM
FOR PHARMACY 
BENEFIT MANAGERS.—The Secretary shall impose a civil 
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monetary penalty on any pharmacy benefit manager that 
violates the requirements of this section. Such penalty 
shall not exceed $5,000 per violation per day. The Sec-
retary shall issue proposed regulations to implement this 
subsection not later than 60 days after the date of the 
enactment of this subsection and shall finalize such regu-
lations not later than 180 days after such date of enact-
ment. 
‘‘(e) DEFINITIONS.—For purposes of this section: 
‘‘(1) 340B
DRUG.—The term ‘340B drug’ 
means a drug that is— 
‘‘(A) a covered outpatient drug (as defined 
for purposes of section 340B); and 
‘‘(B) purchased under an agreement in ef-
fect under such section. 
‘‘(2) CONTRACT
PHARMACY.—The term ‘con-
tract pharmacy’ has the meaning given such term in 
section 340B(a)(5)(F). 
‘‘(3) COVERED ENTITY.—The term ‘covered en-
tity’ has the meaning given such term in section 
340B(a)(4). 
‘‘(4) ENTITY
PHARMACY.—The term ‘entity 
pharmacy’ has the meaning given such term in sec-
tion 340B(a)(5)(F).’’. 
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