777 
had the plan provided coverage 
for such products on the same 
formulary tier as the reference 
product. 
‘‘(dd) A written justification 
for providing more favorable cov-
erage of the reference product 
than the biosimilar biological 
products described in item (aa). 
‘‘(ee) The number of cur-
rently marketed biosimilar bio-
logical products licensed under 
section 351(k) of the Public 
Health Service Act, pursuant to 
an application that refers to such 
reference product. 
‘‘(V) Total gross spending on 
covered part D 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 covered part D drugs under 
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kjohnson on DSK7ZCZBW3PROD with $$_JOB
778 
that plan, inclusive of bona fide serv-
ice fees. 
‘‘(VII) The total spending on cov-
ered part D 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) The following information: 
‘‘(aa) A list of all brokers, 
consultants, advisors, and audi-
tors that receive compensation 
from the pharmacy benefit man-
ager or an affiliate of such phar-
macy benefit manager for refer-
rals, 
consulting, 
auditing, 
or 
other services offered to PDP 
sponsors related to pharmacy 
benefit management services. 
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‘‘(bb) The amount of com-
pensation provided by such phar-
macy benefit manager or affiliate 
to each such broker, consultant, 
advisor, and auditor. 
‘‘(cc) The methodology for 
calculating the amount of com-
pensation provided by such phar-
macy benefit manager or affil-
iate, for each such broker, con-
sultant, advisor, and auditor. 
‘‘(X) A list of all affiliates of the 
pharmacy 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) WRITTEN EXPLANATION OF CON-
TRACTS OR AGREEMENTS WITH MANUFAC-
TURERS.— 
‘‘(I) IN
GENERAL.—The phar-
macy benefit manager shall, not later 
than 30 days after the finalization of 
any contract or agreement between 
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such pharmacy benefit manager or an 
affiliate of such pharmacy benefit 
manager and a manufacturer (or sub-
sidiary, agent, or entity affiliated with 
such manufacturer) that makes re-
bates, discounts, payments, or other 
financial incentives related to one or 
more covered part D drugs or other 
prescription drugs, as applicable, of 
the manufacturer directly or indirectly 
contingent upon coverage, formulary 
placement, or utilization management 
conditions on any other covered part 
D drugs or other prescription drugs, 
as applicable, submit to the PDP 
sponsor a written explanation of such 
contract or agreement. 
‘‘(II) REQUIREMENTS.—A writ-
ten explanation under subclause (I) 
shall— 
‘‘(aa) include the manufac-
turer subject to the contract or 
agreement, all covered part D 
drugs 
and 
other 
prescription 
drugs, as applicable, subject to 
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781 
the contract or agreement and 
the manufacturers of such drugs, 
and a high-level description of 
the terms of such contract or 
agreement and how such terms 
apply to such drugs; and 
‘‘(bb) be certified by the 
Chief Executive Officer, Chief Fi-
nancial Officer, or General Coun-
sel of such pharmacy benefit 
manager, or affiliate of such 
pharmacy benefit manager, as 
applicable, or an individual dele-
gated with the authority to sign 
on behalf of one of these officers, 
who reports directly to the offi-
cer. 
‘‘(III) DEFINITION
OF
OTHER 
PRESCRIPTION DRUGS.—For purposes 
of this clause, the term ‘other pre-
scription drugs’ means prescription 
drugs covered as supplemental bene-
fits under this part or prescription 
drugs paid outside of this part. 
‘‘(D) AUDIT RIGHTS.— 
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‘‘(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 written agree-
ment described in this paragraph and the 
accuracy of information reported under 
subparagraph (C). 
‘‘(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 re-
ported under subparagraph (C), subject to 
reasonable restrictions on how such infor-
mation must be reported to prevent re-
disclosure of such information. 
‘‘(iv) TIMING.—The pharmacy benefit 
manager must provide information under 
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