I 
118TH CONGRESS 
1ST SESSION H. R. 5385 
To amend title XVIII of the Social Security Act to establish pharmacy 
benefit manager reporting requirements with respect to prescription drug 
plans and MA–PD plans under Medicare part D. 
IN THE HOUSE OF REPRESENTATIVES 
SEPTEMBER 12, 2023 
Mr. LANDSMAN (for himself and Mrs. HARSHBARGER) introduced the fol-
lowing bill; which was referred to the Committee on Energy and Com-
merce, and in addition to the Committee on Ways and Means, for a pe-
riod to be subsequently determined by the Speaker, in each case for con-
sideration of such provisions as fall within the jurisdiction of the com-
mittee concerned 
A BILL 
To amend title XVIII of the Social Security Act to establish 
pharmacy benefit manager reporting requirements with 
respect to prescription drug plans and MA–PD plans 
under Medicare part D. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Medicare PBM Ac-
countability Act’’. 
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SEC. 2. PHARMACY BENEFIT MANAGER REPORTING RE-
QUIREMENTS WITH RESPECT TO PRESCRIP-
TION DRUG PLANS AND MA–PD PLANS. 
(a) IN GENERAL.— 
(1) 
PRESCRIPTION
DRUG
PLANS.—Section 
1860D–12 of the Social Security Act (42 U.S.C. 
1395w–112) is amended by adding at the end the 
following new subsection: 
‘‘(h) PHARMACY BENEFIT MANAGER REPORTING 
REQUIREMENTS.—For plan years beginning on or after 
January 1, 2026: 
‘‘(1) AGREEMENTS WITH PHARMACY BENEFIT 
MANAGERS.—Each contract entered into with a 
PDP sponsor under this part with respect to a pre-
scription drug plan offered by such sponsor shall 
provide that any pharmacy benefit manager acting 
on behalf of such sponsor has a written agreement 
with the PDP sponsor under which the pharmacy 
benefit manager agrees to meet the following re-
quirements: 
‘‘(A) TRANSPARENCY REGARDING GUARAN-
TEES
AND
COST
PERFORMANCE
EVALUA-
TIONS.—The pharmacy benefit manager shall— 
‘‘(i) define, interpret, and apply terms 
(such as generic drug, brand name drug 
(consistent with the definition of those 
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terms under section 423.4 of title 42, Code 
of Federal Regulations, or a successor reg-
ulation), specialty drug, rebate, and dis-
count) in a fully transparent and con-
sistent manner for purposes of calculating 
or otherwise evaluating pharmacy benefit 
manager performance against pricing guar-
antees or similar cost performance meas-
urements related to rebates, discounts, 
price concessions, or net costs; 
‘‘(ii) identify any drugs, claims, or 
price concessions excluded from any pric-
ing guarantee or other cost performance 
calculation or evaluation in a clear and 
consistent manner; and 
‘‘(iii) where a pricing guarantee or 
other cost performance measure is based 
on a pricing benchmark other than the 
wholesale acquisition cost (as defined in 
section 1847A(c)(6)(B)) of a drug, cal-
culate and provide a wholesale acquisition 
cost-based equivalent to the pricing guar-
antee or other cost performance measure 
in the contract. 
‘‘(B) PROVISION OF INFORMATION.— 
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‘‘(i) IN
GENERAL.—Not later than 
July 1 of each year, the pharmacy benefit 
manager shall submit to the PDP sponsor, 
and to the Secretary upon request, a re-
port, in accordance with this subpara-
graph, and shall make such report avail-
able to the sponsor at no cost to such 
sponsor in a machine-readable format and, 
as the Secretary may determine, other for-
mats. Each such report shall include, with 
respect to such PDP sponsor and each 
plan offered by such sponsor, the following 
information with respect to the previous 
plan year: 
‘‘(I) A list of all drugs covered by 
the plan that were dispensed includ-
ing, with respect to each such drug— 
‘‘(aa) the brand name, ge-
neric or non-proprietary name, 
and National Drug Code; 
‘‘(bb) the number of plan 
enrollees for whom the drug was 
dispensed, the total number of 
prescription claims for the drug 
(including original prescriptions 
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and refills, counted as separate 
claims), and the total number of 
dosage units of the drug dis-
pensed; 
‘‘(cc) the number of claims 
described in item (bb) that were 
dispensed using each type of dis-
pensing channel, including retail, 
mail order, specialty pharmacy, 
or other types of pharmacies or 
providers as defined by the phar-
macy benefit manager; 
‘‘(dd) the average wholesale 
acquisition cost, listed as cost per 
day’s supply, cost per dosage 
unit, and cost per typical course 
of treatment (as applicable); 
‘‘(ee) the average wholesale 
price for the drug, listed as cost 
per day’s supply, cost per dosage 
unit, and cost per typical course 
of treatment (as applicable); 
‘‘(ff) the total out-of-pocket 
spending by plan enrollees on 
such drug after application of 
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any benefits under the plan, in-
cluding plan enrollee spending 
through copayments, coinsurance, 
and deductibles; 
‘‘(gg) total rebates paid by 
the manufacturer on the drug as 
reported under the Detailed DIR 
Report (or any successor report) 
submitted by such sponsor to the 
Centers for Medicare & Medicaid 
Services; 
‘‘(hh) all other direct or in-
direct remuneration on the drug 
as reported under the Detailed 
DIR Report (or any successor re-
port) submitted by such sponsor 
to the Centers for Medicare & 
Medicaid Services; 
‘‘(ii) the average pharmacy 
reimbursement amount charged 
to the plan for the drug by dis-
pensing channel identified in item 
(cc); 
‘‘(jj) the average National 
Average Drug Acquisition Cost 
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and per 90-day supply for each 
drug dispensed by pharmacies 
that are not with an affiliate of 
the pharmacy benefit manager 
and that are included in the 
pharmacy network of such plan. 
‘‘(cc) 
The 
interquartile 
range of the total combined costs 
paid by the plan and plan enroll-
ees, per dosage unit, per course 
of treatment, per 30-day supply, 
and per 90-day supply for each 
drug dispensed by pharmacies 
that are an affiliate of the phar-
macy benefit manager that are 
included in the pharmacy net-
work of such plan. 
‘‘(dd) The lowest total com-
bined cost paid by the plan and 
plan enrollees, per dosage unit, 
per course of treatment, per 30- 
day supply, and per 90-day sup-
ply, for each drug that is avail-
able from any pharmacy included 
in the network of the plan. 
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‘‘(ee) The difference between 
the average acquisition cost of 
the affiliate that initially acquires 
the drug and the amount re-
ported under subclause (I)(jj) for 
each drug. 
‘‘(ff) A list of prescription 
drugs for which the pharmacy 
benefit manager or an affiliate of 
the pharmacy benefit manager 
had a contract or other arrange-
ment with a covered entity under 
section 
340B 
of 
the 
Public 
Health Service Act in the service 
area of such plan. 
‘‘(III) Where a drug approved 
under section 505(c) of the Federal 
Food, Drug, and Cosmetic Act (re-
ferred to in this subclause as the ‘list-
ed drug’) is covered by the plan, the 
following information: 
‘‘(aa) A list of currently 
marketed generic drugs approved 
under section 505(j) of the Fed-
eral Food, Drug, and Cosmetic 
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Act pursuant to an application 
that references such listed drug 
that are not covered by the plan, 
are covered on a formulary tier 
typically associated with higher 
cost-sharing than the listed drug, 
or are subject to utilization man-
agement that the listed drug is 
not subject to. 
‘‘(bb) The estimated average 
beneficiary 
cost-sharing 
under 
the plan for a 30-day supply of 
the listed drug. 
‘‘(cc) The estimated average 
cost-sharing that a beneficiary 
would have paid for a 30-day 
supply of each of the generic 
drugs described in item (aa), had 
the plan provided coverage for 
such drugs on the same for-
mulary tier as the listed drug. 
‘‘(dd) A written justification 
for providing more favorable cov-
erage of the listed drug than the 
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generic drugs described in item 
(aa). 
‘‘(IV) Where a reference product 
(as defined in section 351(i) of the 
Public Health Service Act) is covered 
by the plan, the following information: 
‘‘(aa) A list of currently 
marketed 
biosimilar 
biological 
products licensed under section 
351(k) of the Public Health 
Service Act pursuant to an appli-
cation that refers to such ref-
erence product that are not cov-
ered by the plan, are covered on 
a formulary tier typically associ-
ated with higher cost-sharing 
than the reference product, or 
are subject to utilization manage-
ment that the reference product 
is not subject to. 
‘‘(bb) The estimated average 
beneficiary 
cost-sharing 
under 
the plan for a 30-day supply of 
the reference product. 
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‘‘(cc) The estimated average 
cost-sharing that a beneficiary 
would have paid for a 30-day 
supply of each of the biosimilar 
biological products described in 
item (aa), had the plan provided 
coverage for such products on the 
same formulary tier as the ref-
erence product. 
‘‘(dd) A written justification 
for providing more favorable cov-
erage of the reference product 
than the biosimilar biological 
product described in item (aa). 
‘‘(V) Total gross spending on 
prescription drugs by the plan, not 
net of rebates, fees, discounts, or 
other direct or indirect remuneration. 
‘‘(VI) The total amount retained 
by the pharmacy benefit manager or 
an affiliate of such pharmacy benefit 
manager in revenue related to utiliza-
tion of prescription drugs under that 
plan, inclusive of bona fide service 
fees. 
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‘‘(VII) The total spending on 
prescription drugs net of rebates, fees, 
discounts, or other direct and indirect 
remuneration by the plan. 
‘‘(VIII) An explanation of any 
benefit design parameters under such 
plan that encourage plan enrollees to 
fill prescriptions at pharmacies that 
are an affiliate of such pharmacy ben-
efit manager, such as mail and spe-
cialty home delivery programs, and re-
tail and mail auto-refill programs. 
‘‘(IX) A list of all brokers, con-
sultants, advisors, and auditors that 
receive compensation from the phar-
macy benefit manager or an affiliate 
of such pharmacy benefit manager for 
referrals, 
consulting, 
auditing, 
or 
other services offered to PDP spon-
sors related to pharmacy benefit man-
agement services. 
‘‘(X) A list of all pharmacies, 
wholesalers, distributors, private label-
ers, providers, group purchasing orga-
nizations, health plans, or any other 
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entity that is an affiliate of the phar-
macy benefit manager. 
‘‘(XI) A summary document sub-
mitted in a standardized template de-
veloped by the Secretary that includes 
such information described in sub-
clauses (I) through (X). 
‘‘(ii) STANDARD FORMATS.—Not later 
than June 1, 2025, the Secretary shall 
specify standard formats for pharmacy 
benefit managers to submit annual reports 
required under clause (i). 
‘‘(iii) CONFIDENTIALITY.— 
‘‘(I) IN
GENERAL.—Information 
disclosed by a pharmacy benefit man-
ager or PDP sponsor under this sub-
section that is not otherwise publicly 
available shall not be disclosed by the 
Secretary or a PDP sponsor receiving 
the information, except that the Sec-
retary may disclose the information 
for the following purposes: 
‘‘(aa) As the Secretary de-
termines to be necessary to carry 
out this part. 
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‘‘(bb) To permit the Comp-
troller General to review the in-
formation provided. 
‘‘(cc) To permit the Director 
of the Congressional Budget Of-
fice to review the information 
provided. 
‘‘(dd) To permit the Execu-
tive Director of the Medicare 
Payment Advisory Commission to 
review the information provided. 
‘‘(ee) To the Attorney Gen-
eral for the purposes of con-
ducting oversight and enforce-
ment under this title. 
‘‘(II) RESTRICTION
ON
USE
OF 
INFORMATION.—The Secretary, the 
Comptroller General, the Director of 
the Congressional Budget Office, and 
the Executive Director of the Medi-
care Payment Advisory Commission 
shall not report on or disclose infor-
mation disclosed pursuant to sub-
clause (I) to the public in a manner 
that would identify a specific phar-
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macy benefit manager, affiliate, PDP 
sponsor, or plan, or prices charged for 
specific drugs. 
‘‘(C) AUDIT RIGHTS.— 
‘‘(i) IN GENERAL.—Not less than once 
a year, at the request of the PDP sponsor, 
the pharmacy benefit manager shall allow 
for an audit of the pharmacy benefit man-
ager to ensure compliance with all terms 
and conditions under the contract and the 
accuracy of information reported under 
subparagraph (B). 
‘‘(ii) AUDITOR.—The PDP sponsor 
shall have the right to select an auditor. 
The pharmacy benefit manager shall not 
impose any limitations on the selection of 
such auditor. 
‘‘(iii) PROVISION OF INFORMATION.— 
The pharmacy benefit manager shall make 
available to such auditor all records, data, 
contracts, and other information necessary 
to confirm the accuracy of information 
provided under subparagraph (B), subject 
to reasonable restrictions on how such in-
formation must be reported (as determined 
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by the Secretary) to prevent redisclosure of 
such information. 
‘‘(iv) TIMING.—The pharmacy benefit 
manager must provide information under 
clause (iii) and other information, data, 
and records relevant to the audit to such 
auditor within 6 months of the initiation of 
the audit and respond to requests for addi-
tional information from such auditor with-
in 30 days after the request for additional 
information. 
‘‘(v) INFORMATION
FROM
AFFILI-
ATES.—The pharmacy benefit manager 
shall be responsible for providing to such 
auditor information required to be reported 
under subparagraph (B) that is owned or 
held by an affiliate of such pharmacy ben-
efit manager. 
‘‘(D) ENFORCEMENT.—The pharmacy ben-
efit manager shall— 
‘‘(i) reimburse the PDP sponsor for 
any civil money penalty imposed on the 
PDP sponsor as a result of the failure of 
the pharmacy benefit manager to meet the 
requirements of this paragraph that are 
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applicable to the pharmacy benefit man-
ager under the agreement; and 
‘‘(ii) be subject to punitive remedies 
for breach of contract for failure to comply 
with the requirements applicable under this 
paragraph. 
‘‘(2) CERTIFICATION
OF
COMPLIANCE.—Each 
PDP sponsor shall furnish to the Secretary (in a 
time and manner specified by the Secretary) an an-
nual certification of compliance with this subsection, 
as well as such information as the Secretary deter-
mines necessary to carry out this subsection. 
‘‘(3) DEFINITIONS.—For purposes of this sub-
section: 
‘‘(A) AFFILIATE.—The term ‘affiliate’ 
means any entity that is owned by, controlled 
by, or related under a common ownership struc-
ture with a pharmacy benefit manager (includ-
ing an entity owned or controlled by the PDP 
sponsor) or that acts as a contractor or agent 
to such pharmacy benefit manager, insofar as 
such contractor or agent performs any of the 
functions described under subparagraph (B). 
‘‘(B) PHARMACY BENEFIT MANAGER.—The 
term ‘pharmacy benefit manager’ means any 
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person or entity that, either directly or through 
an intermediary, acts as a price negotiator or 
group purchaser on behalf of a PDP sponsor or 
prescription drug plan, or manages the pre-
scription drug benefits provided by such spon-
sor or plan, including the processing and pay-
ment of claims for prescription drugs, the per-
formance of drug utilization review, the proc-
essing of drug prior authorization requests, the 
adjudication of appeals or grievances related to 
the prescription drug benefit, contracting with 
network pharmacies, controlling the cost of cov-
ered part D drugs, or the provision of services 
related thereto. Such term includes any person 
or entity that carries out one or more of the ac-
tivities described in the preceding sentence, ir-
respective of whether such person or entity calls 
itself a ‘pharmacy benefit manager’.’’. 
(2) MA–PD PLANS.—Section 1857(f)(3) of the 
Social Security Act (42 U.S.C. 1395w–27(f)(3)) is 
amended by adding at the end the following new 
subparagraph: 
‘‘(F) PHARMACY BENEFIT MANAGER RE-
PORTING REQUIREMENTS.—For plan years be-
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the reporting requirements described in clauses 
(i) and (ii). 
(E) Other items determined appropriate by 
the Comptroller General. 
(2) REPORT.—Not later than 2 years after en-
actment, the Comptroller General shall submit to 
Congress a report containing the results of the study 
conducted under paragraph (1), together with rec-
ommendations for legislation and administrative ac-
tions that would streamline and reduce the burden 
associated with the reporting requirements for 
health plans and pharmacy benefit managers de-
scribed in paragraph (1). 
Æ 
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