166 
(C) by inserting after the second sentence, 
the following: ‘‘The Secretary shall establish 
standards for electronic delivery and access to 
such information by individuals, free of charge, 
in machine readable format, through an Inter-
net website and via open APIs.’’; 
(3) in subparagraph (C)— 
(A) in the first sentence, by inserting ‘‘or 
out-of-network provider’’ after ‘‘item or service 
by a participating provider’’; 
(B) in the second sentence, by striking 
‘‘through an Internet website’’ and inserting 
‘‘free of charge, in machine readable format, 
through an Internet website, and via open 
APIs, in accordance with standards established 
by the Secretary,’’; and 
(C) by adding at the end the following: 
‘‘Such information shall include specific nego-
tiated rates that allow for comparison between 
providers and across plans, and related to a pa-
tient’s specific plan, including after an enrollee 
has exceeded their deductible responsibility.’’; 
and 
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(4) in subparagraph (D) by striking ‘‘subpara-
graph (A)’’ and inserting ‘‘subparagraphs (A), (B), 
and (C)’’. 
SEC. 322. ENSURING ENROLLEE ACCESS TO COST-SHARING 
INFORMATION. 
(a) IN GENERAL.—Subpart II of part A of title 
XXVII of the Public Health Service Act (42 U.S.C. 
300gg–11 et seq.), as amended by the preceding sections, 
is further amended by adding at the end the following: 
‘‘SEC. 2729F. PROVISION OF COST-SHARING INFORMATION. 
‘‘(a) PROVIDER DISCLOSURES.—A provider that is 
in-network with respect to a group health plan or a health 
insurance issuer offering group or individual health insur-
ance coverage shall provide to an enrollee in the plan or 
coverage who submits a request for the information de-
scribed in paragraph (1) or (2), together with accurate 
and complete information about the enrollee’s coverage 
under the applicable plan or coverage— 
‘‘(1) as soon as practicable and not later than 
2 business days after the enrollee requests such in-
formation, a good faith estimate of the expected en-
rollee cost-sharing for the provision of a particular 
health care service (including any service that is rea-
sonably expected to be provided in conjunction with 
such specific service); and 
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168 
‘‘(2) as soon as practicable and not later than 
2 business days after an enrollee requests such in-
formation, the contact information for any ancillary 
providers for a scheduled health care service. 
‘‘(b) INSURER DISCLOSURES.—A group health plan 
or a health insurance issuer offering group or individual 
health insurance coverage shall provide an enrollee in the 
plan or coverage with a good faith estimate of the enroll-
ee’s cost-sharing (including deductibles, copayments, and 
coinsurance) for which the enrollee would be responsible 
for paying with respect to a specific health care service 
(including any service that is reasonably expected to be 
provided in conjunction with such specific service), as soon 
as practicable and not later than 2 business days after 
a request for such information by an enrollee. 
‘‘(c) ENFORCEMENT.— 
‘‘(1) IN GENERAL.—Subject to paragraph (2), a 
health care provider that violates a requirement 
under subsection (a) shall be subject to a civil mone-
tary penalty of not more than $10,000 for each act 
constituting such violation. 
‘‘(2) PROCEDURE.—The provisions of section 
1128A of the Social Security Act, other than sub-
sections (a) and (b) and the first sentence of sub-
section (c)(1) of such section, shall apply to civil 
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169 
money penalties under this subsection in the same 
manner as such provisions apply to a penalty or pro-
ceeding under section 1128A of the Social Security 
Act.’’. 
(b) EFFECTIVE DATE.—Section 2729G of the Public 
Health Service Act, as added by subsection (a), shall apply 
with respect to plan years beginning on or after the date 
that is 18 months after the date of enactment of this Act. 
SEC. 323. ACCESS OF INDIVIDUALS TO PROTECTED HEALTH 
INFORMATION. 
The provisions of section 164.524 of title 45, Code 
of Federal Regulations, as in effect on the day before the 
date of the enactment of this Act, shall have the force and 
effect of law. 
SEC. 324. TIMELY BILLS FOR PATIENTS. 
(a) IN GENERAL.— 
(1) AMENDMENT.—Part P of title III of the 
Public Health Service Act (42 U.S.C. 280g et seq.) 
is amended by adding at the end the following: 
‘‘SEC. 399V–7. TIMELY BILLS FOR PATIENTS. 
‘‘(a) IN GENERAL.—The Secretary shall require— 
‘‘(1) health care facilities, or in the case of 
practitioners providing services outside of such a fa-
cility, practitioners, to provide to patients a list of 
services rendered during the visit to such facility or 
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practitioner, and, in the case of a facility, the name 
of the provider for each such service, upon discharge 
or end of the visit or by postal or electronic commu-
nication as soon as practicable and not later than 5 
calendar days after discharge or date of visit; and 
‘‘(2) health care facilities and practitioners to 
furnish all adjudicated bills to the patient as soon as 
practicable, but not later than 45 calendar days 
after discharge or date of visit. 
‘‘(b) PAYMENT AFTER BILLING.—No patient may be 
required to pay a bill for health care services any earlier 
than 35 days after the postmark date of a bill for such 
services. 
‘‘(c) EFFECT OF VIOLATION.— 
‘‘(1) NOTIFICATION
AND
REFUND
REQUIRE-
MENTS.— 
‘‘(A) PROVIDER
LISTS.—If a facility or 
practitioner fails to provide a patient a list as 
required under subsection (a)(1), such facility 
or practitioner shall report such failure to the 
Secretary. 
‘‘(B) BILLING.—If a facility or practitioner 
bills a patient after the 45-calendar-day period 
described in subsection (a)(2), such facility or 
practitioner shall— 
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171 
‘‘(i) report such bill to the Secretary; 
and 
‘‘(ii) refund the patient for the full 
amount paid in response to such bill with 
interest, at a rate determined by the Sec-
retary. 
‘‘(2) CIVIL MONETARY PENALTIES.— 
‘‘(A) IN
GENERAL.—The Secretary may 
impose civil monetary penalties of up to 
$10,000 a day on any facility or practitioner 
that— 
‘‘(i) fails to provide a list required 
under subsection (a)(1) more than 10 
times, beginning on the date of such tenth 
failure; 
‘‘(ii) submits more than 10 bills out-
side of the period described in subsection 
(a)(2), beginning on the date on which 
such facility or practitioner sends the tenth 
such bill; 
‘‘(iii) fails to report to the Secretary 
any failure to provide lists as required 
under paragraph (1)(A), beginning on the 
date that is 45 calendar days after dis-
charge or visit; or 
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172 
‘‘(iv) fails to send any bill as required 
under subsection (a)(2), beginning on the 
date that is 45 calendar days after the 
date of discharge or visit, as applicable. 
‘‘(B) PROCEDURE.—The provisions of sec-
tion 1128A of the Social Security Act, other 
than subsections (a) and (b) and the first sen-
tence of subsection (c)(1) of such section, shall 
apply to civil money penalties under this sub-
section in the same manner as such provisions 
apply to a penalty or proceeding under section 
1128A of the Social Security Act. 
‘‘(3) SAFE HARBOR.—The Secretary may ex-
empt a practitioner or facility from the penalties 
under paragraph (2)(A) or extend the period of time 
specified under subsection (a)(2) for compliance with 
such subsection if a practitioner or facility— 
‘‘(A) makes a good-faith attempt to send a 
bill within 30 days but is unable to do so be-
cause of an incorrect address; or 
‘‘(B) 
experiences 
extenuating 
cir-
cumstances (as defined by the Secretary), such 
as a hurricane or cyberattack, that may reason-
ably delay delivery of a timely bill.’’. 
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(2) RULEMAKING.—Not later than 1 year after 
the date of enactment of this Act, the Secretary 
shall promulgate final regulations to define the term 
‘‘extenuating circumstance’’ for purposes of section 
399V–7(c)(3)(B) of the Public Health Service Act, 
as added by paragraph (1). 
(b) 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), as amended by the preceding sections, is fur-
ther amended by adding at the end the following: 
‘‘SEC. 2729D. TIMELY BILLS FOR PATIENTS. 
‘‘(a) IN GENERAL.—A group health plan or health 
insurance issuer offering group or individual health insur-
ance coverage shall have in place business practices with 
respect to in-network facilities and practitioners to ensure 
that claims are adjudicated in order to facilitate facility 
and practitioner compliance with the requirements under 
section 399V–7(a). 
‘‘(b) CLARIFICATION.—Nothing in subsection (a) pro-
hibits a provider and a group health plan or health insur-
ance issuer from establishing in a contract the timeline 
for submission by either party to the other party of billing 
information, adjudication, sending of remittance informa-
tion, or any other coordination required between the pro-
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174 
vider and the plan or issuer necessary for meeting the 
deadline described in section 399V–7(a)(2).’’. 
(c) EFFECTIVE DATE.—The amendments made by 
subsections (a) and (b) shall take effect 6 months after 
the date of enactment of this Act. 
SEC. 325. ADVISORY GROUP ON REDUCING BURDEN OF 
HOSPITAL ADMINISTRATIVE REQUIREMENTS. 
(a) IN GENERAL.—Not later than January 1, 2023, 
the Secretary of Health and Human Services shall convene 
an advisory group to provide, in accordance with this sec-
tion, recommendations on ways the Federal Government 
could reduce the burden of administrative requirements on 
hospitals. 
(b) RECOMMENDATIONS.—Not later than January 1, 
2024, the advisory board convened under this section 
shall— 
(1) submit to the Secretary of Health and 
Human Services recommendations described under 
subsection (a) for executive action and any rec-
ommendations for State actions for potential consid-
eration in making grants under section 2(c) to 
States; and 
(2) submit to Congress recommendations de-
scribed under subsection (a) for legislative proposals. 
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175 
(c) MEMBERSHIP.—The advisory board under this 
section shall consist of the following members: 
(1) Three representatives of companies that 
have— 
(A) geographically distributed workforces; 
(B) at least 10,000 employees; and 
(C) no more than 10 percent of such em-
ployees in any single State. 
(2) Three representatives of health insurance 
issuers and health plans, consisting of— 
(A) one representative of for-profit health 
insurance issuers and health plans with at least 
20,000,000 enrollees in the employer-sponsored 
market; 
(B) one representative of nonprofit health 
insurance issuers and health plans operating in 
at least 5 States; and 
(C) one representative of nonprofit health 
insurance issuers and health plans operating in 
a rural State (as defined by the Census Bu-
reau). 
(3) Seven public policy experts in the field of 
hospital consolidation. 
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176 
SEC. 326. DATA REPORTING TO IMPROVE THE TRANS-
PARENCY REGARDING HOW 340B HOSPITAL 
COVERED ENTITIES PROVIDE CARE FOR PA-
TIENTS. 
Section 340B of the Public Health Service Act (42 
U.S.C. 256b) is amended by adding at the end the fol-
lowing new subsection: 
‘‘(f) DATA REPORTING TO IMPROVE THE TRANS-
PARENCY REGARDING HOW HOSPITAL COVERED ENTI-
TIES PROVIDE CARE FOR PATIENTS.— 
‘‘(1) IN GENERAL.—Beginning on the date that 
is 14 months after the date of the enactment of this 
subsection, and annually thereafter, subject to sub-
paragraph (C), a covered entity described in sub-
paragraph (L) or (M) of subsection (a)(4), unless 
otherwise indicated, shall report on the following, 
with respect to the previous year, in such a manner 
and form as specified by the Secretary: 
‘‘(A) The following information: 
‘‘(i) With respect to such covered enti-
ty and with respect to each child site of 
such entity (as referenced in paragraph 
(11)), the number and percentage of indi-
viduals who are dispensed or administered 
drugs that are subject to an agreement 
under this section, organized by form of 
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177 
health insurance coverage of such individ-
uals (including at least by the Medicare 
program under title XVIII of the Social 
Security Act, the Medicaid program under 
title XIX of such Act, health insurance 
coverage offered in the individual or group 
market or a group health plan (as such 
terms are defined in section 2791), and 
uninsured). 
‘‘(ii) With respect to each such child 
site of such entity, the total costs incurred 
at each such site and the cost incurred at 
each such site for charity care as defined 
in line 23 of worksheet S–10 to the Medi-
care cost report or in any successor form. 
‘‘(B) The aggregate amount of gross reim-
bursement received by each such covered entity 
(including child sites of such entity) described 
in such subparagraph (L) or (M) for all drugs 
purchased that are subject to an agreement 
under this section and the entity’s aggregate 
acquisition cost for such drugs. 
‘‘(C) In the case of covered entity de-
scribed in subparagraph (L) of subsection 
(a)(4), at the time of application and recertifi-
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178 
cation (and at least annually thereafter), the 
contract that is the basis for eligibility under 
the requirement under clause (i) of such sub-
paragraph and any modifications to such con-
tract for purposes of review by the Secretary. 
‘‘(D) With respect to such covered entity 
and with respect to each child site of such enti-
ty, the name of all third-party vendors or other 
similar entities that the covered entity contracts 
with to provide services associated with the pro-
gram under this section. 
‘‘(2) AVAILABILITY OF INFORMATION.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
make data reported by covered entities under 
subparagraphs (A), (C), and (D) of paragraph 
(1) available on the public website of the De-
partment of Health and Human Services in an 
electronic and searchable format, which may in-
clude the 340B Office of Pharmacy Affairs In-
formation System or a successor to such sys-
tem. 
‘‘(B) 
FORMAT.—Data 
made 
available 
under subparagraph (A) shall be made available 
in a manner that shows each category of data 
reported both in the aggregate and identified by 
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179 
covered entities described in subparagraphs (L) 
and (M) of subsection (a)(4) and child sites of 
such covered entities. In carrying out this para-
graph, with respect to data reported pursuant 
to paragraph (1)(C), the Secretary shall ensure 
that any proprietary information shall be re-
dacted from contracts submitted pursuant to 
such paragraph (1)(C) before posting such 
data. 
‘‘(3) INTERIM FINAL REGULATIONS.—The Sec-
retary shall issue interim final regulations no later 
than the date that is 6 months after the date of the 
enactment of this subsection, to carry out this sub-
section and shall finalize such regulations prior to 
the end of the moratorium period to which sub-
section (a)(11) applies. 
‘‘(4) REPORTS TO CONGRESS.— 
‘‘(A) OIG REPORT.—Not later than 2 
years after the date of the enactment of this 
subsection, the Office of the Inspector General 
shall submit to Congress a final report on the 
level of charity care provided by covered entities 
described in subparagraphs (L) and (M) of sub-
section (a)(4) and separately by child sites of 
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180 
such covered entities, as reported in paragraph 
(1)(A). 
‘‘(B) GAO REPORTS.— 
‘‘(i) INITIAL REPORT.—Not later than 
1 year after the date of the enactment of 
this subsection, the Comptroller General of 
the United States shall submit to Congress 
a report— 
‘‘(I) analyzing the State and local 
government contracts intended to sat-
isfy the requirement under subsection 
(a)(4)(L)(i) for a covered entity to 
qualify as an entity described in sub-
paragraph (L) of subsection (a)(4); 
‘‘(II) assessing the amount of 
care such contracts obligate such enti-
ty to provide to low-income individuals 
ineligible for Medicare under title 
XVIII of the Social Security Act and 
Medicaid under title XIX of such Act; 
and 
‘‘(III) analyzing how these con-
tracts define low-income individuals 
and whether the Secretary reviews 
such determinations. 
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181 
‘‘(ii) 
SUBSEQUENT
REPORT.—Not 
later than 2 years after the date of the en-
actment of this subsection, the Comptroller 
General of the United States shall submit 
to Congress a final report on the informa-
tion collected under paragraph (1)(B) re-
garding the difference between the aggre-
gate gross reimbursement and aggregate 
acquisition costs received by each such cov-
ered entity (including child sites of such 
entity) for drugs subject to an agreement 
under this section.’’. 
SEC. 327. REQUIRING 340B DRUG DISCOUNT PROGRAM RE-
PORTS BY DSH HOSPITAL COVERED ENTITIES 
ON LOW-INCOME UTILIZATION RATE OF OUT-
PATIENT HOSPITAL SERVICES. 
(a) IN GENERAL.—Section 340B(d)(2) of the Public 
Health Service Act (42 U.S.C. 256b(d)(2)) is amended— 
(1) in subparagraph (B)(i), by inserting before 
the period at the end the following: ‘‘, including, 
with respect to such updates made on or after one 
year after the date of enactment of the Act, by re-
quiring covered entities described in subsection 
(a)(4)(L) to submit (and to so regularly update) in-
formation described in subparagraph (C)’’; and 
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182 
(2) by adding at the end the following new sub-
paragraph: 
‘‘(C) INFORMATION ON LOW-INCOME UTI-
LIZATION
RATE
OF
OUTPATIENT
HOSPITAL 
SERVICES.— 
‘‘(i) IN
GENERAL.—For purposes of 
subparagraph (B)(i), the information de-
scribed in this subparagraph, with respect 
to a covered entity described in subsection 
(a)(4)(L) and an update under such sub-
paragraph (B)(i), is— 
‘‘(I) the low-income outpatient 
utilization rate of such covered entity 
for the most recent fiscal year; and 
‘‘(II) the low-income outpatient 
utilization rate of off-site outpatient 
facilities, clinics, eligible off-site loca-
tions, and associated sites of such en-
tity identified as child sites of such 
entity pursuant to the identification 
system under subparagraph (B)(iv) 
for the most recent fiscal year. 
‘‘(ii) LOW-INCOME OUTPATIENT UTI-
LIZATION
RATE
DEFINED.—In this sub-
paragraph, the term ‘low-income outpatient 
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183 
utilization rate’ has the meaning given the 
term ‘low-income utilization rate’ under 
paragraph (3) of section 1923(b) of the 
Social Security Act, except that— 
‘‘(I) clauses (i) and (ii) of sub-
paragraph (A) of such paragraph 
shall be applied as if— 
‘‘(aa) each reference to ‘pa-
tient services’ were a reference to 
‘patient services furnished on an 
outpatient basis’; and 
‘‘(bb) for purposes of clause 
(i)(II) of this subparagraph, each 
reference to ‘hospital’ were a ref-
erence to ‘off-site outpatient fa-
cilities, clinics, eligible off-site lo-
cations, and associated sites of 
the hospital that are identified as 
child sites of the hospital pursu-
ant to the identification system 
under section 340B(d)(2)(B)(iv) 
of the Public Health Service Act’; 
and 
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184 
‘‘(II) clauses (i) and (ii) of sub-
paragraph (B) of such paragraph 
shall be applied as if— 
‘‘(aa) each reference to ‘in-
patient hospital services’ were a 
reference to ‘outpatient hospital 
services’; and 
‘‘(bb) for purposes of clause 
(i)(II) each reference to ‘hos-
pital’s charges’ were a reference 
to ‘charges of the off-site out-
patient facilities, clinics, eligible 
off-site locations, and associated 
sites of the hospital that are 
identified as child sites of the 
hospital pursuant to the identi-
fication system under section 
340B(d)(2)(B)(iv) of the Public 
Health Service Act’.’’. 
(b) ANNUAL REPORTS.—Not later than 1 year after 
the date of enactment of this Act, and annually thereafter, 
the Administrator of the Health Resources and Services 
Administration shall submit to Congress a report on infor-
mation submitted by covered entities for the previous year 
pursuant to the amendments made by subsection (a). 
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185 
SEC. 328. EMPLOYER BENEFITS REPORTS. 
(a) IN GENERAL.—Subject to subsection (b), for each 
plan year beginning on or after 1 year after the date of 
enactment of this Act, a group health plan and a health 
insurance issuer offering group health insurance coverage 
shall provide to each individual enrolled in such plan or 
such coverage for such plan year a notification containing 
the following: 
(1) The amount the sponsor of such group 
health plan expended with respect to such individual 
under such plan for such plan year (or, in the case 
of a health insurance issuer offering group health in-
surance coverage, the amount the employer of such 
individual contributed for such coverage for such in-
dividual for such plan year). 
(2) The amount the sponsor of such group 
health plan expended with respect to such individual 
under such plan for each previous plan year (or, in 
the case of a health insurance issuer offering group 
health insurance coverage, the amount the employer 
of such individual contributed for such coverage for 
such individual for each previous plan year), if appli-
cable. 
(b) LIMITATION.—Subsection (a) shall not apply to 
a group health plan, or a health insurance issuer offering 
group health insurance coverage, for a plan year if, for 
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186 
such plan year, the number of individuals enrolled under 
such plan or such coverage was less than 100. 
(c) PENALTY.—In the case that the Secretary of 
Health and Human Services determines that a group 
health plan or a health insurance issuer offering group 
health insurance failed to provide the notice required 
under subsection (a), the Secretary may impose a civil 
monetary penalty on the sponsor of such plan or such 
issuer, as applicable, in an amount not to exceed $100 
per individual enrolled in such plan or such coverage per 
day that such sponsor or issuer failed to provide such noti-
fication to such individual. 
(d) DEFINITIONS.—In this section, the terms ‘‘group 
health plan’’, ‘‘group health insurance coverage’’, ‘‘health 
insurance issuer’’, and ‘‘sponsor’’ have the meaning given 
such terms in section 2791 of the Public Health Service 
Act (42 U.S.C. 300gg–91). 
SEC. 329. GOVERNMENT ACCOUNTABILITY OFFICE STUDY 
ON 
PROFIT- 
AND 
REVENUE-SHARING 
IN 
HEALTH CARE. 
(a) STUDY.—Not later than 1 year after the date of 
enactment of this Act, the Comptroller General of the 
United States shall conduct a study to— 
(1) describe what is known about profit- and 
revenue-sharing relationships in the commercial 
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health care markets, including those relationships 
that— 
(A) involve one or more— 
(i) physician groups that practice 
within a hospital included in the profit- or 
revenue-sharing relationship, or refer pa-
tients to such hospital; 
(ii) laboratory, radiology, or pharmacy 
services that are delivered to privately in-
sured patients of such hospital; 
(iii) surgical services; 
(iv) hospitals or group purchasing or-
ganizations; or 
(v) rehabilitation or physical therapy 
facilities or services; and 
(B) include revenue- or profit-sharing 
whether through a joint venture, management 
or professional services agreement, or other 
form of gain-sharing contract; 
(2) describe Federal oversight of such relation-
ships, including authorities of the Department of 
Health and Human Services and the Federal Trade 
Commission to review such relationships and their 
potential to increase costs for patients, and identify 
limitations in such oversight; and 
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(3) as appropriate, make recommendations to 
improve Federal oversight of such relationships. 
(b) REPORT.—Not later than 1 year after the date 
of enactment of this Act, the Comptroller General of the 
United States shall prepare and submit a report on the 
study conducted under subsection (a) to the Committee 
on Health, Education, Labor, and Pensions of the Senate 
and the Committee on Education and Labor and Com-
mittee on Energy and Commerce of the House of Rep-
resentatives. 
Subtitle C—Prescription Drug 
Competition and Innovation 
SEC. 341. EXPEDITED DEVELOPMENT AND PRIORITY RE-
VIEW FOR GENERIC COMPLEX DRUG PROD-
UCTS. 
Subchapter A of chapter V of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 351 et seq.) is amend-
ed by adding at the end the following: 
‘‘SEC. 524B. EXPEDITED DEVELOPMENT AND PRIORITY RE-
VIEW FOR GENERIC COMPLEX DRUG PROD-
UCTS. 
‘‘(a) ESTABLISHMENT OF PROGRAM.—The Secretary 
shall establish a program to expedite the development of, 
and provide priority review under section 505(j) for, ge-
neric complex drug products. 
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189 
‘‘(b) REQUEST FOR DESIGNATION.—A sponsor of a 
generic complex drug product may request that the Sec-
retary designate such product for expedited development 
and priority review under this section. 
‘‘(c) DESIGNATION PROCESS.— 
‘‘(1) IN GENERAL.—Not later than 60 calendar 
days after the receipt of a request under subsection 
(c), the Secretary shall determine whether the prod-
uct that is the subject of the request meets the cri-
teria under subsection (e) to be considered a generic 
complex drug product. If the Secretary determines 
that the product meets the criteria, the Secretary 
shall designate the product for expedited develop-
ment and priority review. 
‘‘(2) REVIEW.—Review of a request under sub-
section (b) shall be undertaken by a team that is 
composed of experienced staff and senior managers 
of the Food and Drug Administration. 
‘‘(3) WITHDRAWAL.—The Secretary may not 
withdraw a designation granted under this section 
on the basis of the criteria under subsection (e) no 
longer applying because of the subsequent clearance 
or approval of any other product. 
‘‘(d) EXPEDITED DEVELOPMENT AND PRIORITY RE-
VIEW GUIDANCE.— 
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‘‘(1) CONTENT.—Not later than 1 year after 
the date of enactment of this Act, the Secretary 
shall issue guidance on the implementation of this 
section. Such guidance shall— 
‘‘(A) set forth the process by which a per-
son may seek a designation under subsection 
(c); 
‘‘(B) provide a template for requests under 
subsection (b); 
‘‘(C) identify the criteria the Secretary will 
use in evaluating a request for designation 
under this section; and 
‘‘(D) identify the criteria and processes the 
Secretary will use to expedite the development 
and review of products designated under this 
section. 
‘‘(2) PROCESS.—Prior to finalizing the guid-
ance under paragraph (1), the Secretary shall seek 
public comment on a draft version of that guidance. 
‘‘(e) GENERIC
COMPLEX
DRUG
PRODUCT
DE-
FINED.—In this section, the term ‘generic complex drug 
product’ means a product that represents a complex ther-
apy that consists of or includes a drug for approval under 
section 505(j) and that— 
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‘‘(1)(A) contains complex active ingredients 
(such as peptides, polymeric compounds, complex 
mixtures of active ingredients, and naturally sourced 
ingredients); 
‘‘(B) is composed of complex formulations (such 
as liposomes or colloids); 
‘‘(C) requires a complex route of delivery (such 
as locally acting drugs such as dermatological prod-
ucts and complex ophthalmological products and otic 
dosage forms that are formulated as suspensions, 
emulsions, or gels); or 
‘‘(D) involves a complex dosage form (such as 
transdermals, metered dose inhalers, or extended re-
lease injectables); 
‘‘(2) presents as a complex drug-device com-
bination product (such as auto injectors or metered 
dose inhalers); or 
‘‘(3) is a product that would benefit from early 
scientific engagement due to complexity or uncer-
tainty concerning the approval pathway under sec-
tion 505(j).’’. 
SEC. 342. PREVENTING BLOCKING OF GENERIC DRUGS. 
(a) IN GENERAL.—Section 505(j)(5)(B)(iv)(I) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(j)(5)(B)(iv)(I)) is amended— 
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(1) by striking ‘‘180 days after the date’’ and 
inserting ‘‘180 days after the earlier of the fol-
lowing: 
‘‘(aa) The date’’; and 
(2) by adding at the end the following: 
‘‘(bb) The date on which all of the fol-
lowing conditions are first met, provided 
no application submitted by any first appli-
cant is approved on or before such date: 
‘‘(AA) An application for the 
drug submitted by an applicant other 
than a first applicant has received 
tentative approval and could receive 
approval, if no first applicant were eli-
gible for 180-day exclusivity under 
this clause, and such applicant has 
not entered into an agreement that 
would prevent commercial marketing 
upon approval and has submitted a 
notification to the Secretary docu-
menting that it has not entered into 
an agreement that would prevent com-
mercial marketing. 
‘‘(BB) Thirty-three months have 
passed since the date of submission of 
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193 
an application for the drug by one 
first applicant, if there is only one 
first applicant, or, in the case of more 
than one first applicant, 33 months 
have passed since the date of submis-
sion of all such applications. 
‘‘(CC) Approval of an application 
for the drug submitted by at least one 
first applicant would not be precluded 
under clause (iii).’’. 
(b) INFORMATION.—Not later than 60 days of the 
date of enactment of this Act, the Secretary of Health and 
Human Services (referred to in this subsection as the 
‘‘Secretary’’) shall publish, as appropriate and available, 
information sufficient to allow applicants to assess wheth-
er the conditions described in subitems (AA) through (CC) 
of section 505(j)(5)(B)(iv)(I)(bb) of the Federal Food, 
Drug, and Cosmetic Act (as amended by subsection (a)) 
have been or will be satisfied for all applications where 
the exclusivity period under (iv)(I) of section 505(j)(5)(B) 
of the Federal Food, Drug, and Cosmetic Act (as so 
amended) has not expired, and shall provide updates to 
reflect the most recent information available to the Sec-
retary. 
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SEC. 343. ENSURING TIMELY ACCESS TO GENERICS. 
Section 505(q) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355(q)) is amended— 
(1) in paragraph (1)— 
(A) in subparagraph (A)(i), by inserting ‘‘, 
10.31,’’ after ‘‘10.30’’; 
(B) in subparagraph (E)— 
(i) by striking ‘‘application and’’ and 
inserting ‘‘application or’’; 
(ii) by striking ‘‘If the Secretary’’ and 
inserting the following: 
‘‘(i) IN GENERAL.—If the Secretary’’; 
and 
(iii) by striking the second sentence 
and inserting the following: 
‘‘(ii) PRIMARY
PURPOSE
OF
DELAY-
ING.— 
‘‘(I) IN
GENERAL.—In deter-
mining whether a petition was sub-
mitted with the primary purpose of 
delaying an application, the Secretary 
may consider the following factors: 
‘‘(aa) Whether the petition 
was submitted in accordance with 
paragraph (2)(B), based on when 
the petitioner knew or reasonably 
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195 
should have known the relevant 
information relied upon to form 
the basis of such petition. 
‘‘(bb) Whether the petitioner 
has submitted multiple or serial 
petitions or supplements to peti-
tions raising issues that reason-
ably could have been known to 
the petitioner at the time of sub-
mission of the earlier petition or 
petitions. 
‘‘(cc) Whether the petition 
was submitted close in time to a 
known, first date upon which an 
application 
under 
subsection 
(b)(2) or (j) of this section or 
section 351(k) of the Public 
Health Service Act could be ap-
proved. 
‘‘(dd) Whether the petition 
was submitted without relevant 
data or information in support of 
the scientific positions forming 
the basis of such petition. 
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‘‘(ee) Whether the petition 
raises the same or substantially 
similar issues as a prior petition 
to which the Secretary has re-
sponded substantively already, in-
cluding if the subsequent submis-
sion follows such response from 
the Secretary closely in time. 
‘‘(ff) Whether the petition 
requests changing the applicable 
standards that other applicants 
are required to meet, including 
requesting testing, data, or label-
ing standards that are more on-
erous or rigorous than the stand-
ards the Secretary has deter-
mined to be applicable to the list-
ed drug, reference product, or pe-
titioner’s version of the same 
drug. 
‘‘(gg) The petitioner’s record 
of submitting petitions to the 
Food and Drug Administration 
that have been determined by the 
Secretary to have been submitted 
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197 
with the primary purpose of 
delay. 
‘‘(hh) Other relevant and 
appropriate factors, which the 
Secretary shall describe in guid-
ance. 
‘‘(II) GUIDANCE.—The Secretary 
may issue or update guidance, as ap-
propriate, to describe factors the Sec-
retary considers in accordance with 
subclause (II).’’; 
(C) by adding at the end the following: 
‘‘(iii) REFERRAL
TO
THE
FEDERAL 
TRADE COMMISSION.—The Secretary shall 
establish procedures for referring to the 
Federal Trade Commission any petition or 
supplement to a petition that the Secretary 
determines was submitted with the primary 
purpose of delaying approval of an applica-
tion. Such procedures shall include notifi-
cation to the petitioner by the Secretary.’’; 
(D) by striking subparagraph (F); 
(E) by redesignating subparagraphs (G) 
through (I) as subparagraphs (F) through (H), 
respectively; and 
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198 
(F) in subparagraph (H), as so redesig-
nated, by striking ‘‘submission of this petition’’ 
and inserting ‘‘submission of this document’’; 
(2) in paragraph (2)— 
(A) by redesignating subparagraphs (A) 
through (C) as subparagraphs (C) through (E), 
respectively; 
(B) by inserting before subparagraph (C), 
as so redesignated, the following: 
‘‘(A) IN GENERAL.—A person shall submit 
a petition to the Secretary under paragraph (1) 
before filing a civil action in which the person 
seeks to set aside, delay, rescind, withdraw, or 
prevent submission, review, or approval of an 
application submitted under subsection (b)(2) 
or (j) of this section or section 351(k) of the 
Public Health Service Act. Such petition and 
any supplement to such a petition shall describe 
all information and arguments that form the 
basis of the relief requested in any civil action 
described in the previous sentence. 
‘‘(B) TIMELY SUBMISSION OF CITIZEN PE-
TITION.—A petition and any supplement to a 
petition shall be submitted within 60 days after 
the person knew, or reasonably should have 
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199 
known, the information that forms the basis of 
the request made in the petition or supple-
ment.’’; 
(C) in subparagraph (C), as so redesig-
nated— 
(i) in the heading, by striking ‘‘WITH-
IN 150 DAYS’’; 
(ii) in clause (i), by striking ‘‘during 
the 150-day period referred to in para-
graph (1)(F),’’; and 
(iii) by amending clause (ii) to read as 
follows: 
‘‘(ii) on or after the date that is 151 
days after the date of submission of the 
petition, the Secretary approves or has ap-
proved the application that is the subject 
of the petition without having made such a 
final decision.’’; 
(D) by amending subparagraph (D), as so 
redesignated, to read as follows: 
‘‘(D) DISMISSAL
OF
CERTAIN
CIVIL
AC-
TIONS.— 
‘‘(i) PETITION.—If a person files a 
civil action against the Secretary in which 
a person seeks to set aside, delay, rescind, 
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withdraw, or prevent submission, review, or 
approval of an application submitted under 
subsection (b)(2) or (j) of this section or 
section 351(k) of the Public Health Service 
Act without complying with the require-
ments of subparagraph (A), the court shall 
dismiss without prejudice the action for 
failure to exhaust administrative remedies. 
‘‘(ii) TIMELINESS.—If a person files a 
civil action against the Secretary in which 
a person seeks to set aside, delay, rescind, 
withdraw, or prevent submission, review, or 
approval of an application submitted under 
subsection (b)(2) or (j) of this section or 
section 351(k) of the Public Health Service 
Act without complying with the require-
ments of subparagraph (B), the court shall 
dismiss with prejudice the action for fail-
ure to timely file a petition. 
‘‘(iii) FINAL RESPONSE.—If a civil ac-
tion is filed against the Secretary with re-
spect to any issue raised in a petition time-
ly filed under paragraph (1) in which the 
petitioner requests that the Secretary take 
any form of action that could, if taken, set 
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201 
aside, delay, rescind, withdraw, or prevent 
submission, review, or approval of an appli-
cation submitted under subsection (b)(2) 
or (j) of this section or section 351(k) of 
the Public Health Service Act before the 
Secretary has taken final agency action on 
the petition within the meaning of sub-
paragraph (C), the court shall dismiss 
without prejudice the action for failure to 
exhaust administrative remedies.’’; and 
(E) in clause (iii) of subparagraph (E), as 
so redesignated, by striking ‘‘as defined under 
subparagraph (2)(A)’’ and inserting ‘‘within the 
meaning of subparagraph (C)’’; and 
(3) in paragraph (4)— 
(A) by striking ‘‘EXCEPTIONS’’ and all that 
follows through ‘‘This subsection does’’ and in-
serting ‘‘EXCEPTIONS.—This subsection does’’; 
(B) by striking subparagraph (B); and 
(C) by redesignating clauses (i) and (ii) as 
subparagraphs (A) and (B), respectively, and 
adjusting the margins accordingly. 
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SEC. 344. PREEMPTION OF STATE BARRIERS TO THE SUB-
STITUTION OF BIOSIMILAR PRODUCTS. 
No State, or any political subdivision thereof, may, 
under any circumstances, prohibit a pharmacy or phar-
macist from dispensing, in place of a biological reference 
product, any biosimilar that the Food and Drug Adminis-
tration has designated as an interchangeable product for 
that biological reference product. 
SEC. 345. INCREASING PHARMACEUTICAL OPTIONS TO 
TREAT AN UNMET MEDICAL NEED. 
Subsection (b) of section 506 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 356) is amended by 
adding at the end the following: 
‘‘(4) UNMET MEDICAL NEED.—For purposes of 
paragraph (1), a drug shall be deemed to address an 
unmet medical need for a disease or condition if 
fewer than 3 available drugs exist for the treatment 
of such disease or condition.’’. 
SEC. 346. PROVISIONAL APPROVAL OF NEW HUMAN DRUGS. 
(a) IN GENERAL.—Subchapter A of chapter V of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 
et seq.) is amended by adding at the end of the following: 
‘‘SEC. 524B. PROVISIONAL APPROVAL OF NEW HUMAN 
DRUGS. 
‘‘(a) PRIORITY REVIEW AND EVALUATION OF APPLI-
CATIONS.— 
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203 
‘‘(1) IN GENERAL.—The Secretary shall estab-
lish a priority review system to evaluate applications 
submitted under this pathway for provisional ap-
proval within 90 days of receipt of a completed ap-
plication. 
‘‘(2) 
REVIEW
OF
APPLICATIONS
DURING 
EPIDEMICS AND PANDEMICS.—In the case of an epi-
demic or pandemic, including with respect to 
COVID–19, the Secretary shall accept and review 
various portions of an application submitted under 
the pathway under this section for provisional ap-
proval on a rolling basis, and the review of any part 
of an application so submitted shall be completed 
not later than 3 weeks after submission. 
‘‘(3) OTHER
DESIGNATIONS.—If a drug sub-
mitted for review under the pathway under this sec-
tion is eligible for a special designation by the Sec-
retary under this Act, including as a drug for a rare 
disease or condition under section 526, all benefits 
of such other designation shall be available for use 
under provisional approval, including any tax credits 
and waiving of fees under chapter VII. 
‘‘(b) ELIGIBILITY.—A drug may be eligible for provi-
sional approval under this section if the Secretary deter-
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204 
mines that the drug is intended for the treatment, preven-
tion, or medical diagnosis of— 
‘‘(1) a serious or life-threatening disease or con-
dition for which there is a reasonable likelihood that 
premature death will occur without early medical 
intervention for an individual contracting or being 
diagnosed with such disease or condition; 
‘‘(2) a disease or condition that poses a threat 
of epidemic or pandemic; or 
‘‘(3) a disease or condition associated with mor-
bidity that has a substantial impact on day-to-day 
functioning. 
‘‘(c) STANDARD OF REVIEW FOR APPROVAL.— 
‘‘(1) REQUIREMENTS.—An application for pro-
visional approval under this section may be approved 
only if the Secretary determines that— 
‘‘(A) there is substantial evidence of safety 
for the drug, such that there is evidence con-
sisting of adequate and well-controlled inves-
tigations, including clinical investigations, by 
experts qualified by scientific training and expe-
rience to evaluate the safety of the drug in-
volved, on the basis of which it could fairly and 
responsibly be concluded that the drug will have 
the effect it purports or is represented to have 
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under the conditions of use prescribed, rec-
ommended, or suggested in the labeling or pro-
posed labeling; and 
‘‘(B) there is relevant early evidence based 
on adequate and well-controlled investigations, 
including early-stage clinical investigations, to 
establish that— 
‘‘(i) the drug provides a positive 
therapeutic outcome; and 
‘‘(ii) the outcome of the drug is con-
sistent with or greater than currently mar-
keted on-label therapies, with equal or 
fewer side effects, if there are currently 
marketed on-label therapies. 
‘‘(2) PROTOCOLS.—The Secretary shall promul-
gate rules that establish the appropriate protocols 
for a sponsor of an application for provisional ap-
proval under this section and the Commissioner to 
follow to enable rolling, real-time, mid-trial submis-
sion while preserving the integrity of the ongoing 
trial and without penalizing the sponsor for making 
use of this pathway. 
‘‘(3) REAL WORLD EVIDENCE.—The Secretary 
shall allow the use of real world evidence (as defined 
in section 505F(b)), including real world data used 
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to generate real world evidence, to support an appli-
cation for provisional approval under this section, 
and to fulfill the follow-up requirements and support 
applications for full approval as described under sec-
tion 505 or section 351 of the Public Health Service 
Act, as applicable. 
‘‘(4) USE OF SCIENTIFICALLY SUBSTANTIATED 
SURROGATES.— 
‘‘(A) IN GENERAL.—The sponsor of an ap-
plication for provisional approval under this sec-
tion may use scientifically substantiated surro-
gates to support such application. 
‘‘(B) DEFINITION.—In subparagraph (A), 
the term ‘scientifically substantiated surrogates’ 
means surrogate endpoints to predict clinical 
benefit other than such endpoints previously 
validated by the Secretary, based on— 
‘‘(i) epidemiologic, therapeutic, patho-
physiologic, or other evidence; or 
‘‘(ii) an effect on a clinical endpoint 
other than survival or irreversible mor-
bidity of interest. 
‘‘(d) TRANSPARENCY
AND PATIENT MONITORING 
REQUIREMENTS.— 
‘‘(1) REGISTRIES.— 
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‘‘(A) IN GENERAL.—The sponsor of a drug 
provisionally approved under this section shall 
require that all patients who use such drug par-
ticipate in an observational registry and consent 
to the sponsor’s collection, and submission to 
the registry, of data related to the patient’s use 
of such drug until such drug receives full ap-
proval under section 505 or section 351 of the 
Public Health Service Act, or the provisional 
approval is rescinded. 
‘‘(B) REQUIREMENTS FOR REGISTRIES.— 
An observational registry described in subpara-
graph (A) may be run by a third party, such as 
a government, for profit, or non-profit organiza-
tion, and shall track all patients who use the 
provisionally approved drug. 
‘‘(C) ACCESSIBILITY.—An observational 
registry described in subparagraph (A) shall be 
easily accessible for— 
‘‘(i) all patients who are participating 
in any registry related to a provisionally 
approved drug that allows for easy, unre-
stricted (or transparent) access for such 
patients to their patient data and related 
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208 
information regarding their usage of the 
provisionally approved drug; and 
‘‘(ii) approved researchers and med-
ical professionals who may access data 
maintained in the registry, which access 
shall be for public health research and only 
in a de-identified, aggregated manner. 
‘‘(2) 
FUNDING.—An 
observational 
registry 
under this subsection shall be maintained, as appli-
cable— 
‘‘(A) by the sponsor of the drug provision-
ally approved under this section that is the sub-
ject of the registry; 
‘‘(B) by a third party, such as a govern-
ment, for profit, or nonprofit organization; or 
‘‘(C) the Federal Government, in the case 
of any drug so approved that is intended to 
treat a disease or condition associated with an 
epidemic or pandemic. 
‘‘(3) SPONSOR REQUIREMENTS.— 
‘‘(A) IN GENERAL.—For any drug applica-
tion provisionally approved under this section, 
the Secretary shall notify the sponsor of the 
exact data such sponsor is required to submit 
to an observational registry. 
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‘‘(B) ANNUAL REVIEW OF THE REGISTRY; 
PENALTIES.—The Secretary shall conduct an 
annual review of observational registries estab-
lished under this subsection. If, at such an an-
nual review, less than 90 percent of patients are 
participating in an observational registry with 
respect to a drug approved under this section, 
the Secretary shall issue to the sponsor of such 
drug a civil monetary penalty of not more than 
$100,000. If a violation of this section is not 
corrected within the 30-day period following no-
tification, the sponsor shall, in addition to any 
penalty under this subparagraph be subject to 
a civil monetary penalty of not more than 
$10,000 for each day of the violation after such 
period until the violation is corrected. If appli-
cation patient participation in an observational 
registry is not at or above 90 percent within 6 
months of issuance of such penalty, the provi-
sional approval shall be withdrawn. 
‘‘(4) ANNUAL
REPORT
TO
CONGRESS.—The 
Secretary shall submit an annual report to Congress 
on all drugs granted provisional approval under this 
section. Such report shall include— 
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‘‘(A) the number of patients treated with 
each such drug, and the number of patients 
tracked in an observational registry with re-
spect to each such drug; 
‘‘(B) a discussion of the minimum amount 
of data required in the registries, including pa-
tient treatments and uses, length of use, side 
effects encountered, relevant biomarkers or sci-
entifically substantiated surrogates, scan re-
sults, cause of death and how long the patient 
lived, and adverse drug effects; 
‘‘(C) a list of all such drugs for which an 
application for full approval under section 505 
of this Act or section 351 of the Public Health 
Service Act, or an application for an extension 
of provisional approval under this section, has 
been submitted; and 
‘‘(D) a list of all applications denied provi-
sional approval under this section, together with 
an explanation for the decisions to deny each 
such application. 
‘‘(e) WITHDRAWAL OF PROVISIONAL APPROVAL.— 
‘‘(1) IN GENERAL.—The Secretary shall with-
draw provisional approval under this section if there 
are a significant number of patients who experience 
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211 
serious adverse effects, compared to the other cur-
rently marketed on-label therapies that are available 
for the applicable disease or condition. 
‘‘(2) EFFECT
OF
WITHDRAWAL.—If a provi-
sional approval is withdrawn under this subsection, 
the sponsor may not make the drug available to any 
new patients, but may be allowed to continue to 
make such drug available to patients who started 
taking the drug prior to the date of withdrawal, for 
as long a period as dictated by patient need, as de-
termined by the Secretary. 
‘‘(f) TRANSPARENCY.—Any scientific, medical, aca-
demic, or health care journal publishing an article explain-
ing, releasing, conveying or announcing research findings 
which were funded by the Department of Health and 
Human Services shall be prohibited from publishing such 
research unless— 
‘‘(1) such article conveying research findings is 
made publicly available on the journal’s internet 
website without a paywall or charge not later than 
3 months after the date on which such article was 
first provided to subscribers of such journal (or first 
made available for purchase); and 
‘‘(2) the article’s author or researcher or au-
thor’s institution (or, in the case of multiple authors, 
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researchers, or institutions, all such authors, re-
searchers, or institutions) received less than 30 per-
cent of funding for such research from the Depart-
ment of Health and Human Services throughout the 
period of time the research was conducted. 
‘‘(g) INFORMED CONSENT.—Prior to receiving a drug 
provisionally approved under this section, the sponsor of 
the drug shall receive from each patient, or the patient’s 
representative, informed consent, through a signed in-
formed consent form, acknowledging that such patient un-
derstands that the drug did not undergo the usual process 
for full approval of a drug by the Food and Drug Adminis-
tration, and that such patient is willing to accept the risks 
involved in taking such drug. 
‘‘(h) POSTMARKET CONTROLS AND LABELING.— 
‘‘(1) FDA 
ANNUAL
REVIEW
OF
REGISTRY 
DATA.—The Secretary shall annually review the data 
made available through the observational registries 
under subsection (d) and make a determination re-
garding whether the side effect profile of any drug 
approved under this pathway does not support the 
benefit provided, or the data shows the benefit is 
less than the benefits offered through other, fully 
approved drugs. 
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213 
‘‘(2) LABELING.—The sponsor of the provision-
ally approved drug shall ensure that all labeling and 
promotional materials for the drug bear the state-
ment ‘provisionally approved by the FDA pending a 
full demonstration of effectiveness under application 
number llllll’ (specifying the application 
number assigned by the Secretary in place of the 
blank). All promotional, educational and marketing 
materials for provisionally approved products shall 
be reviewed and approved by the Secretary before 
such materials are distributed. 
‘‘(3) 
RESCISSION
OF
PROVISIONAL
AP-
PROVAL.—If the Secretary determines that the side 
effect profile of any drug included in such observa-
tional registries does not support the benefit pro-
vided by such drug, or that the data shows that the 
benefit is less than the benefits offered through 
other, fully approved drugs, the Secretary shall re-
scind such provisional approval. 
‘‘(i) DURATION
OF PROVISIONAL APPROVAL; RE-
QUIREMENT TO BRING DRUG TO MARKET.— 
‘‘(1) DURATION; RENEWALS.—The period of 
provisional approval for a drug approved under this 
section is effective for a 2-year period. The sponsor 
may request renewal for provisional approval status 
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214 
for up to 3 subsequent 2-year periods by the Sec-
retary. Provisional approval status with respect to a 
drug shall not exceed a total of 6 years from the ini-
tial date the sponsor was awarded provisional ap-
proval status. 
‘‘(2) MARKETING REQUIREMENT.—If any drug 
that receives provisional approval status under this 
section is not brought to market within 180 days of 
the approval, such approval shall be rescinded. 
‘‘(j) LIMITATION ON LIABILITY.—With respect to any 
claim under State law alleging that a drug sold or other-
wise made available pursuant to a grant of provisional ap-
proval under this section is unsafe or ineffective, no liabil-
ity in a cause of action shall lie against a sponsor or manu-
facturer, unless the relevant conduct constitutes reckless 
or willful misconduct, gross negligence, or an intentional 
tort under any applicable State law. 
‘‘(k) APPLYING FOR FULL APPROVAL.— 
‘‘(1) IN GENERAL.—Except as provided under 
paragraph (2), the sponsor of a drug granted provi-
sional approval pursuant to this section may, at any 
point, submit an application for full approval of such 
drug under section 505 of this Act or section 351 
of the Public Health Service Act, as applicable. 
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215 
‘‘(2) EFFECT OF RECESSION ON APPROVAL AND 
AUTOMATIC APPROVAL.— 
‘‘(A) IN GENERAL.—The sponsor of a drug 
granted provisional approval pursuant to this 
section that has been rescinded under sub-
section (h)(3), may submit an application for 
full approval of such drug under section 505 of 
this Act or section 351 of the Public Health 
Service Act at any time. 
‘‘(B) AUTOMATIC
APPROVAL.—Such full 
approval may be awarded at any time for any 
drug granted provisional approval pursuant to 
this section if the sponsor of the drug estab-
lishes a 15 percent improvement in an impor-
tant endpoint, including surrogate endpoints 
not validated by the Food and Drug Adminis-
tration, compared to a standard drug. 
‘‘(3) REAL-TIME EPIDEMIC AND PANDEMIC VAC-
CINE APPROVAL.— 
‘‘(A) IN GENERAL.—In the case of a vac-
cine developed in response to an epidemic or 
pandemic, including COVID–19, the Secretary 
shall share data information regarding the ap-
proval of the vaccine with the Advisory Com-
mittee on Immunization Practices of the Cen-
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216 
ters for Disease Control and Prevention as the 
review nears completion. 
‘‘(B) EVALUATION.—Any vaccine that has 
been approved by the Secretary for an epidemic 
or pandemic-related disease, including COVID– 
19, shall be evaluated by the Advisory Com-
mittee on Immunization Practices of the Cen-
ters for Disease Control and Prevention not 
later than 1 week after the date of submission 
to the Advisory Committee by the Secretary of 
the vaccine. 
‘‘(l) PATIENT ADVOCATE GENERAL.—Not later than 
6 months after the date of enactment of the Promising 
Pathway Act, the Secretary shall establish within the Of-
fice of the Commissioner, the position of Patient Advocate 
General, who shall provide assistance to patients and their 
families who use drugs under evaluation in this pathway 
or drugs reviewed or approved under section 505 or sec-
tion 351 of the Public Health Service Act. Such assistance 
shall include providing bi-informational communication 
about maintaining patient health, delivery of proper in-
formed consent, participating in clinical investigations, 
completing required documentation in order to participate 
in the applicable programs, and providing other informa-
tion.’’. 
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(b) CONFORMING AMENDMENT.—Section 505(a) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(a)) is amended by inserting ‘‘, or there is in effect 
a provisional approval under section 524B with respect to 
such drug’’ before the period. 
(c) REIMBURSEMENT.— 
(1) 
PRIVATE
HEALTH
INSURERS.—Section 
2719A of the Public Health Service Act (42 U.S.C. 
300gg–19a) is amended by adding at the end the 
following: 
‘‘(e) TREATMENT
OF CERTAIN DRUGS.—A group 
health plan or health insurance issuer of group or indi-
vidual health insurance coverage shall not deny coverage 
of any drug provisionally approved under section 524B of 
the Federal Food, Drug, and Cosmetic Act on the basis 
of such drug being experimental. In determining coverage 
under the applicable plan or coverage, a group health plan 
or health insurance issuer shall treat a drug provisionally 
approved under such section in the same manner as such 
plan or coverage would treat a drug approved under sec-
tion 505 of the Federal Food, Drug, and Cosmetic Act 
or section 351 of this Act. Nothing in this subsection shall 
be construed to require a group health plan or health in-
surance issuer to cover any specific drug provisionally ap-
proved under such section 524B.’’. 
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218 
(2) FEDERAL HEALTH CARE PROGRAMS.—The 
requirement under subsection (e) of section 2719A 
of the Public Health Service Act (as added by para-
graph (1)) shall apply with respect to coverage de-
terminations under a Federal health care program 
(as defined in section 1128B(f) of the Social Secu-
rity Act (42 U.S.C. 1320a–7b(f))) in the same man-
ner such requirement applies under such subsection 
(e). 
(3) 
CONFORMING
AMENDMENT.—Section 
1927(k)(2)(A)(i) of the Social Security Act (42 
U.S.C. 1396r–8(k)(2)(A)(i)) is amended— 
(A) by striking ‘‘or which’’ and inserting ‘‘, 
which’’; and 
(B) by inserting ‘‘, or which is provision-
ally approved under section 524B of such Act’’ 
before the semicolon. 
SEC. 347. CONSOLIDATING EXCLUSIVITY PERIODS FOR 
DRUGS TREATING RARE DISEASES AND CON-
DITIONS. 
(a) IN GENERAL.—Subsection (a) of section 527 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360cc) is amended to read as follows: 
‘‘(a) EXCLUSIVITY.— 
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‘‘(1) IN GENERAL.—Except as provided in sub-
section (b), if the Secretary approves an application 
filed pursuant to section 505, or issues a license 
under section 351 of the Public Health Service Act, 
for a drug designated under section 526 for a rare 
disease or condition, the Secretary may not approve 
an application filed pursuant to section 505, or issue 
a license under section 351 of the Public Health 
Service Act, for the same drug for the same disease 
or condition for a person who is not the holder of 
such approved application or of such license until 
the expiration of the exclusivity period described in 
paragraph (2). 
‘‘(2) EXCLUSIVITY
PERIOD
DESCRIBED.—The 
exclusivity period described in this paragraph, with 
respect to a drug designated under section 526 for 
a rare disease or condition, is— 
‘‘(A) a single 7-year period of exclusivity 
with respect to the first designation of such 
drug under such section for that rare disease or 
condition; or 
‘‘(B) in the case of a drug that has pre-
viously received a period of exclusivity under 
paragraph (1), a single 3-year period of exclu-
sivity with respect to any subsequent designa-
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220 
tion of such drug under such section for any 
other rare disease or condition. 
‘‘(3) LIMITATION.—In the case of a drug that 
has received two periods of exclusivity pursuant to 
paragraph (1), no additional exclusivity period under 
this section is available with respect to such drug, 
regardless of whether such drug has been designated 
under section 526 for a rare disease or condition 
that is distinct from the rare disease or condition for 
which such exclusivity periods were granted.’’. 
(b) CONFORMING AMENDMENTS.— 
(1) Section 505(j)(5)(B)(iv)(II)(dd)(AA) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
360cc) is amended by striking ‘‘7-year period’’ and 
inserting ‘‘exclusivity period’’. 
(2) Section 505A(b)(1)(A)(ii) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360cc) is 
amended by striking ‘‘rather than seven years;’’ and 
inserting ‘‘, or three years and six months, rather 
than seven years or three years, respectively;’’. 
(3) Section 505A(c)(1)(A)(ii) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360cc) is 
amended by striking ‘‘rather than seven years;’’ and 
inserting ‘‘, or three years and six months, rather 
than seven years or three years, respectively;’’. 
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221 
(4) Section 505E(a) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360cc) is amended by 
striking ‘‘7-year period’’ and inserting ‘‘exclusivity 
periods’’. 
(5) Section 527(b) of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 360cc) is amended by 
striking ‘‘the 7-year period’’ and inserting ‘‘any ex-
clusivity period’’. 
(6) Section 351(m)(2)(B) of the Public Health 
Service Act (42 U.S.C. 262) is amended by striking 
‘‘rather than 7 years’’ and inserting ‘‘or 3 years and 
6 months, rather than 7 years or 3 years, respec-
tively’’. 
(7) Section 351(m)(3)(B) of the Public Health 
Service Act (42 U.S.C. 262) is amended by striking 
‘‘rather than 7 years’’ and inserting ‘‘or 3 years and 
6 months, rather than 7 years or 3 years, respec-
tively’’. 
SEC. 348. EXCLUSIVITY PERIOD FOR BRAND NAME BIO-
LOGICAL PRODUCTS. 
(a) IN GENERAL.—Section 351(k)(7)(A) of the Pub-
lic Health Service Act (42 U.S.C. 262(k)(7)(A)) is amend-
ed by striking ‘‘12 years’’ and inserting ‘‘5 years’’. 
(b) CONFORMING CHANGES.—Paragraphs (2)(A) and 
(3)(A) of section 351(m) of the Public Health Service Act 
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222 
(42 U.S.C. 262(m)) is amended by striking ‘‘12 years’’ 
each place it appears and inserting ‘‘5 years’’. 
(c) APPLICABILITY.—This Act and the amendments 
made by this Act apply only with respect to a biological 
product for which the reference product (as such term is 
used in section 351 of the Public Health Service Act (42 
U.S.C. 262)) is licensed under subsection (a) of such sec-
tion on or after the date of enactment of this Act. 
SEC. 349. REGULATION OF MANUFACTURER-SPONSORED 
COPAY CONTRIBUTIONS. 
Notwithstanding any other provision of law, the Sec-
retary of Health and Human Services may establish a 
mechanism to regulate drug manufacturers’ financial con-
tributions to patient out-of-pocket costs, such as drug co- 
pays. 
SEC. 350. ANTITRUST EXEMPTION FOR PRIVATE HEALTH 
INSURER ISSUERS TO NEGOTIATE WHOLE-
SALE ACQUISITION PRICES OF PRESCRIP-
TION DRUGS PURCHASED FROM DRUG MANU-
FACTURERS. 
(a) EXEMPTION.—It shall not be a violation of the 
antitrust laws for one or more private health insurer 
issuers or their designated agents to jointly negotiate 
wholesale acquisition prices of a prescription drug with a 
manufacturer of a prescription drug with regards to the 
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223 
reimbursement policies of the insurers of the manufactur-
er’s drugs so long as no one single wholesale acquisition 
price is jointly determined between the insurance issuers 
or their designated agents. 
(b) DEFINITIONS.—For purposes of this section: 
(1) ANTITRUST
LAWS.—The term ‘‘antitrust 
laws’’ has the meaning given it in subsection (a) of 
the 1st section of the Clayton Act (15 U.S.C. 12(a)), 
except that such term includes section 5 of the Fed-
eral Trade Commission Act (15 U.S.C. 45) to the 
extent such section 5 applies to unfair methods of 
competition. 
(2) HEALTH
INSURANCE
ISSUER.—The term 
‘‘health insurance issuer’’ means an insurance com-
pany, insurance service, or insurance organization 
(including a health maintenance organization, as de-
fined in subparagraph (C)) which is licensed to en-
gage in the business of insurance in a State and 
which is subject to State law which regulates insur-
ance (within the meaning of section 514(b)(2) of the 
Employee Retirement Income Security Act of 1974 
(29 U.S.C. 1144(b)(2))). Such term does not include 
a group health plan. 
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224 
(3) HEALTH MAINTENANCE ORGANIZATION.— 
The 
term 
‘‘health 
maintenance 
organization’’ 
means— 
(A) a Federally qualified health mainte-
nance organization (as defined in section 
300e(a) of title 42 of the United States Code), 
(B) an organization recognized under State 
law as a health maintenance organization, or 
(C) a similar organization regulated under 
State law for solvency in the same manner and 
to the same extent as such a health mainte-
nance organization. 
(4) MANUFACTURER.—The term ‘‘manufac-
turer’’ means anyone who is engaged in manufac-
turing, preparing, propagating, compounding, proc-
essing, packaging, repackaging, or labeling of a pre-
scription drug. 
(5) PRESCRIPTION DRUG.—The term ‘‘prescrip-
tion drug’’ means any human drug required by Fed-
eral law or regulation to be dispensed only by a pre-
scription, including finished dosage forms and active 
ingredients subject to section 503(b) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)). 
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(c) EFFECTIVE DATE.—This section shall take effect 
on the date of the enactment of this Act but shall not 
apply with respect to conduct that occurs before such date. 
SEC. 351. BIOLOGICAL PRODUCT INNOVATION. 
Section 351(j) of the Public Health Service Act (42 
U.S.C. 262(j)) is amended— 
(1) by striking ‘‘except that a product’’ and in-
serting ‘‘except that— 
‘‘(1) a product’’; 
(2) by striking ‘‘Act.’’ and inserting ‘‘Act; and’’; 
and 
(3) by adding at the end the following: 
‘‘(2) no requirement under such Act regarding 
an official compendium (as defined in section 201(j) 
of such Act), or other reference in such Act to an 
official compendium (as so defined), shall apply with 
respect to a biological product subject to regulation 
under this section.’’. 
SEC. 352. PROMPT APPROVAL OF DRUGS RELATED TO 
SAFETY INFORMATION. 
Section 505 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 355) is amended by adding at the end the 
following: 
‘‘(z) PROMPT APPROVAL OF DRUGS WHEN SAFETY 
INFORMATION IS ADDED TO LABELING.— 
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‘‘(1) GENERAL RULE.—A drug for which an ap-
plication has been submitted or approved under sub-
section (b)(2) or (j) shall not be considered ineligible 
for approval under this section or misbranded under 
section 502 on the basis that the labeling of the 
drug omits safety information, including contra-
indications, warnings, precautions, dosing, adminis-
tration, or other information pertaining to safety, 
when the omitted safety information is protected by 
exclusivity under clause (iii) or (iv) of subsection 
(j)(5)(F), clause (iii) or (iv) of subsection (c)(3)(E), 
or section 527(a), or by an extension of such exclu-
sivity under section 505A or 505E. 
‘‘(2) LABELING.—Notwithstanding clauses (iii) 
and (iv) of subsection (j)(5)(F), clauses (iii) and (iv) 
of subsection (c)(3)(E), or section 527, the Sec-
retary shall require that the labeling of a drug ap-
proved pursuant to an application submitted under 
subsection (b)(2) or (j) that omits safety information 
described in paragraph (1) include a statement of 
any appropriate safety information that the Sec-
retary considers necessary to assure safe use. 
‘‘(3) AVAILABILITY
AND
SCOPE
OF
EXCLU-
SIVITY.—This subsection does not affect— 
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‘‘(A) the availability or scope of exclusivity 
or an extension of exclusivity described in sub-
paragraph (A) or (B) of section 505A(o)(3); 
‘‘(B) the question of the eligibility for ap-
proval under this section of any application de-
scribed in subsection (b)(2) or (j) that omits 
any other aspect of labeling protected by exclu-
sivity under— 
‘‘(i) clause (iii) or (iv) of subsection 
(j)(5)(F); 
‘‘(ii) clause (iii) or (iv) of subsection 
(c)(3)(E); or 
‘‘(iii) section 527(a); or 
‘‘(C) except as expressly provided in para-
graphs (1) and (2), the operation of this section 
or section 527.’’. 
SEC. 353. CONGRESSIONAL REVIEW OF THE FOOD AND 
DRUG ADMINISTRATION RULEMAKING. 
(a) CONGRESSIONAL REVIEW.—Part I of title 5, 
United States Code, is amended by adding at the end the 
following: 
‘‘CHAPTER 10—CONGRESSIONAL REVIEW 
OF FOOD AND DRUG ADMINISTRATION 
RULEMAKING 
‘‘Sec. 
‘‘920. Applicability. 
‘‘921. Congressional review. 
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‘‘922. Congressional approval procedure for major rules. 
‘‘923. Congressional disapproval procedure for nonmajor rules. 
‘‘924. Definitions. 
‘‘925. Judicial review. 
‘‘926. Exemption for monetary policy. 
‘‘927. Effective date of certain rules. 
‘‘928. Regulatory cut-go requirement. 
‘‘929. Review of rules currently in effect. 
‘‘§ 920. Applicability 
‘‘This chapter applies in lieu of chapter 8 with respect 
to the Food and Drug Administration. 
‘‘§ 921. Congressional review 
‘‘(a)(1)(A) Before a rule may take effect, the Food 
and Drug Administration shall satisfy the requirements 
of section 928 and shall publish in the Federal Register 
a list of information on which the rule is based, including 
data, scientific and economic studies, and cost-benefit 
analyses, and identify how the public can access such in-
formation online, and shall submit to each House of the 
Congress and to the Comptroller General a report con-
taining— 
‘‘(i) a copy of the rule; 
‘‘(ii) a concise general statement relating to the 
rule; 
‘‘(iii) a classification of the rule as a major or 
nonmajor rule, including an explanation of the clas-
sification specifically addressing each criteria for a 
major rule contained within sections 924(2)(A), 
924(2)(B), and 924(2)(C); 
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‘‘(iv) a list of any other related regulatory ac-
tions intended to implement the same statutory pro-
vision or regulatory objective as well as the indi-
vidual and aggregate economic effects of those ac-
tions; and 
‘‘(v) the proposed effective date of the rule. 
‘‘(B) On the date of the submission of the report 
under subparagraph (A), the Food and Drug Administra-
tion shall submit to the Comptroller General and make 
available to each House of Congress— 
‘‘(i) a complete copy of the cost-benefit analysis 
of the rule, if any, including an analysis of any jobs 
added or lost, differentiating between public and pri-
vate sector jobs; 
‘‘(ii) the Food and Drug Administration’s ac-
tions pursuant to sections 603, 604, 605, 607, and 
609 of this title; 
‘‘(iii) the Food and Drug Administration’s ac-
tions pursuant to sections 202, 203, 204, and 205 
of the Unfunded Mandates Reform Act of 1995; and 
‘‘(iv) any other relevant information or require-
ments under any other Act and any relevant Execu-
tive orders. 
‘‘(C) Upon receipt of a report submitted under sub-
paragraph (A), each House shall provide copies of the re-
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port to the chairman and ranking member of each stand-
ing committee with jurisdiction under the rules of the 
House of Representatives or the Senate to report a bill 
to amend the provision of law under which the rule is 
issued. 
‘‘(2)(A) The Comptroller General shall provide a re-
port on each major rule to the committees of jurisdiction 
by the end of 15 calendar days after the submission or 
publication date. The report of the Comptroller General 
shall include an assessment of the Food and Drug Admin-
istration’s compliance with procedural steps required by 
paragraph (1)(B) and an assessment of whether the major 
rule imposes any new limits or mandates on private-sector 
activity. 
‘‘(B) The Food and Drug Administration shall co-
operate with the Comptroller General by providing infor-
mation relevant to the Comptroller General’s report under 
subparagraph (A). 
‘‘(3) A major rule relating to a report submitted 
under paragraph (1) shall take effect upon enactment of 
a joint resolution of approval described in section 922 or 
as provided for in the rule following enactment of a joint 
resolution of approval described in section 922, whichever 
is later. 
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‘‘(4) A nonmajor rule shall take effect as provided 
by section 923 after submission to Congress under para-
graph (1). 
‘‘(5) If a joint resolution of approval relating to a 
major rule is not enacted within the period provided in 
subsection (b)(2), then a joint resolution of approval relat-
ing to the same rule may not be considered under this 
chapter in the same Congress by either the House of Rep-
resentatives or the Senate. 
‘‘(b)(1) A major rule shall not take effect unless the 
Congress enacts a joint resolution of approval described 
under section 922. 
‘‘(2) If a joint resolution described in subsection (a) 
is not enacted into law by the end of 70 session days or 
legislative days, as applicable, beginning on the date on 
which the report referred to in section 921(a)(1)(A) is re-
ceived by Congress (excluding days either House of Con-
gress is adjourned for more than 3 days during a session 
of Congress), then the rule described in that resolution 
shall be deemed not to be approved and such rule shall 
not take effect. 
‘‘(c)(1) Notwithstanding any other provision of this 
section (except subject to paragraph (3)), a major rule 
may take effect for one 90-calendar-day period if the 
President makes a determination under paragraph (2) and 
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submits written notice of such determination to the Con-
gress. 
‘‘(2) Paragraph (1) applies to a determination made 
by the President by Executive order that the major rule 
should take effect because such rule is— 
‘‘(A) necessary because of an imminent threat 
to health or safety or other emergency; 
‘‘(B) necessary for the enforcement of criminal 
laws; 
‘‘(C) necessary for national security; or 
‘‘(D) issued pursuant to any statute imple-
menting an international trade agreement. 
‘‘(3) An exercise by the President of the authority 
under this subsection shall have no effect on the proce-
dures under section 922. 
‘‘(d)(1) In addition to the opportunity for review oth-
erwise provided under this chapter, in the case of any rule 
for which a report was submitted in accordance with sub-
section (a)(1)(A) during the period beginning on the date 
occurring— 
‘‘(A) in the case of the Senate, 60 session days; 
or 
‘‘(B) in the case of the House of Representa-
tives, 60 legislative days, 
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before the date the Congress is scheduled to adjourn a 
session of Congress through the date on which the same 
or succeeding Congress first convenes its next session, sec-
tions 922 and 923 shall apply to such rule in the suc-
ceeding session of Congress. 
‘‘(2)(A) In applying sections 922 and 923 for pur-
poses of such additional review, a rule described under 
paragraph (1) shall be treated as though— 
‘‘(i) such rule were published in the Federal 
Register on— 
‘‘(I) in the case of the Senate, the 15th 
session day; or 
‘‘(II) in the case of the House of Rep-
resentatives, the 15th legislative day, 
after the succeeding session of Congress first con-
venes; and 
‘‘(ii) a report on such rule were submitted to 
Congress under subsection (a)(1) on such date. 
‘‘(B) Nothing in this paragraph shall be construed 
to affect the requirement under subsection (a)(1) that a 
report shall be submitted to Congress before a rule can 
take effect. 
‘‘(3) A rule described under paragraph (1) shall take 
effect as otherwise provided by law (including other sub-
sections of this section). 
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‘‘§ 922. Congressional approval procedure for major 
rules 
‘‘(a)(1) For purposes of this section, the term ‘joint 
resolution’ means only a joint resolution addressing a re-
port classifying a rule as major pursuant to section 
921(a)(1)(A)(iii) that— 
‘‘(A) bears no preamble; 
‘‘(B) bears the following title (with blanks filled 
as appropriate): ‘Approving the rule submitted by 
lll relating to lll.’; 
‘‘(C) includes after its resolving clause only the 
following (with blanks filled as appropriate): ‘That 
Congress approves the rule submitted by lll re-
lating to lll.’; and 
‘‘(D) is introduced pursuant to paragraph (2). 
‘‘(2) After a House of Congress receives a report 
classifying a rule as major pursuant to section 
921(a)(1)(A)(iii), the majority leader of that House (or 
his or her respective designee) shall introduce (by request, 
if appropriate) a joint resolution described in paragraph 
(1)— 
‘‘(A) in the case of the House of Representa-
tives, within 3 legislative days; and 
‘‘(B) in the case of the Senate, within 3 session 
days. 
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‘‘(3) A joint resolution described in paragraph (1) 
shall not be subject to amendment at any stage of pro-
ceeding. 
‘‘(b) A joint resolution described in subsection (a) 
shall be referred in each House of Congress to the commit-
tees having jurisdiction over the provision of law under 
which the rule is issued. 
‘‘(c) In the Senate, if the committee or committees 
to which a joint resolution described in subsection (a) has 
been referred have not reported it at the end of 15 session 
days after its introduction, such committee or committees 
shall be automatically discharged from further consider-
ation of the resolution and it shall be placed on the cal-
endar. A vote on final passage of the resolution shall be 
taken on or before the close of the 15th session day after 
the resolution is reported by the committee or committees 
to which it was referred, or after such committee or com-
mittees have been discharged from further consideration 
of the resolution. 
‘‘(d)(1) In the Senate, when the committee or com-
mittees to which a joint resolution is referred have re-
ported, or when a committee or committees are discharged 
(under subsection (c)) from further consideration of a 
joint resolution described in subsection (a), it is at any 
time thereafter in order (even though a previous motion 
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to the same effect has been disagreed to) for a motion 
to proceed to the consideration of the joint resolution, and 
all points of order against the joint resolution (and against 
consideration of the joint resolution) are waived. The mo-
tion is not subject to amendment, or to a motion to post-
pone, or to a motion to proceed to the consideration of 
other business. A motion to reconsider the vote by which 
the motion is agreed to or disagreed to shall not be in 
order. If a motion to proceed to the consideration of the 
joint resolution is agreed to, the joint resolution shall re-
main the unfinished business of the Senate until disposed 
of. 
‘‘(2) In the Senate, debate on the joint resolution, 
and on all debatable motions and appeals in connection 
therewith, shall be limited to not more than 2 hours, which 
shall be divided equally between those favoring and those 
opposing the joint resolution. A motion to further limit 
debate is in order and not debatable. An amendment to, 
or a motion to postpone, or a motion to proceed to the 
consideration of other business, or a motion to recommit 
the joint resolution is not in order. 
‘‘(3) In the Senate, immediately following the conclu-
sion of the debate on a joint resolution described in sub-
section (a), and a single quorum call at the conclusion of 
the debate if requested in accordance with the rules of the 
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Senate, the vote on final passage of the joint resolution 
shall occur. 
‘‘(4) Appeals from the decisions of the Chair relating 
to the application of the rules of the Senate to the proce-
dure relating to a joint resolution described in subsection 
(a) shall be decided without debate. 
‘‘(e) In the House of Representatives, if any com-
mittee to which a joint resolution described in subsection 
(a) has been referred has not reported it to the House 
at the end of 15 legislative days after its introduction, 
such committee shall be discharged from further consider-
ation of the joint resolution, and it shall be placed on the 
appropriate calendar. On the second and fourth Thursdays 
of each month it shall be in order at any time for the 
Speaker to recognize a Member who favors passage of a 
joint resolution that has appeared on the calendar for at 
least 5 legislative days to call up that joint resolution for 
immediate consideration in the House without intervention 
of any point of order. When so called up a joint resolution 
shall be considered as read and shall be debatable for 1 
hour equally divided and controlled by the proponent and 
an opponent, and the previous question shall be considered 
as ordered to its passage without intervening motion. It 
shall not be in order to reconsider the vote on passage. 
If a vote on final passage of the joint resolution has not 
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been taken by the third Thursday on which the Speaker 
may recognize a Member under this subsection, such vote 
shall be taken on that day. 
‘‘(f)(1) If, before passing a joint resolution described 
in subsection (a), one House receives from the other a 
joint resolution having the same text, then— 
‘‘(A) the joint resolution of the other House 
shall not be referred to a committee; and 
‘‘(B) the procedure in the receiving House shall 
be the same as if no joint resolution had been re-
ceived from the other House until the vote on pas-
sage, when the joint resolution received from the 
other House shall supplant the joint resolution of 
the receiving House. 
‘‘(2) This subsection shall not apply to the House of 
Representatives if the joint resolution received from the 
Senate is a revenue measure. 
‘‘(g) If either House has not taken a vote on final 
passage of the joint resolution by the last day of the period 
described in section 921(b)(2), then such vote shall be 
taken on that day. 
‘‘(h) This section and section 923 are enacted by 
Congress— 
‘‘(1) as an exercise of the rulemaking power of 
the Senate and House of Representatives, respec-
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tively, and as such is deemed to be part of the rules 
of each House, respectively, but applicable only with 
respect to the procedure to be followed in that 
House in the case of a joint resolution described in 
subsection (a) and superseding other rules only 
where explicitly so; and 
‘‘(2) with full recognition of the Constitutional 
right of either House to change the rules (so far as 
they relate to the procedure of that House) at any 
time, in the same manner and to the same extent as 
in the case of any other rule of that House. 
‘‘§ 923. 
Congressional 
disapproval 
procedure 
for 
nonmajor rules 
‘‘(a) For purposes of this section, the term ‘joint res-
olution’ means only a joint resolution introduced in the 
period beginning on the date on which the report referred 
to in section 921(a)(1)(A) is received by Congress and 
ending 60 days thereafter (excluding days either House 
of Congress is adjourned for more than 3 days during a 
session of Congress), the matter after the resolving clause 
of which is as follows: ‘That Congress disapproves the 
nonmajor rule submitted by the lll relating to 
lll, and such rule shall have no force or effect.’ (The 
blank spaces being appropriately filled in). 
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‘‘(b) A joint resolution described in subsection (a) 
shall be referred to the committees in each House of Con-
gress with jurisdiction. 
‘‘(c) In the Senate, if the committee to which is re-
ferred a joint resolution described in subsection (a) has 
not reported such joint resolution (or an identical joint 
resolution) at the end of 15 session days after the date 
of introduction of the joint resolution, such committee may 
be discharged from further consideration of such joint res-
olution upon a petition supported in writing by 30 Mem-
bers of the Senate, and such joint resolution shall be 
placed on the calendar. 
‘‘(d)(1) In the Senate, when the committee to which 
a joint resolution is referred has reported, or when a com-
mittee is discharged (under subsection (c)) from further 
consideration of a joint resolution described in subsection 
(a), it is at any time thereafter in order (even though a 
previous motion to the same effect has been disagreed to) 
for a motion to proceed to the consideration of the joint 
resolution, and all points of order against the joint resolu-
tion (and against consideration of the joint resolution) are 
waived. The motion is not subject to amendment, or to 
a motion to postpone, or to a motion to proceed to the 
consideration of other business. A motion to reconsider the 
vote by which the motion is agreed to or disagreed to shall 
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241 
not be in order. If a motion to proceed to the consideration 
of the joint resolution is agreed to, the joint resolution 
shall remain the unfinished business of the Senate until 
disposed of. 
‘‘(2) In the Senate, debate on the joint resolution, 
and on all debatable motions and appeals in connection 
therewith, shall be limited to not more than 10 hours, 
which shall be divided equally between those favoring and 
those opposing the joint resolution. A motion to further 
limit debate is in order and not debatable. An amendment 
to, or a motion to postpone, or a motion to proceed to 
the consideration of other business, or a motion to recom-
mit the joint resolution is not in order. 
‘‘(3) In the Senate, immediately following the conclu-
sion of the debate on a joint resolution described in sub-
section (a), and a single quorum call at the conclusion of 
the debate if requested in accordance with the rules of the 
Senate, the vote on final passage of the joint resolution 
shall occur. 
‘‘(4) Appeals from the decisions of the Chair relating 
to the application of the rules of the Senate to the proce-
dure relating to a joint resolution described in subsection 
(a) shall be decided without debate. 
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‘‘(e) In the Senate, the procedure specified in sub-
section (c) or (d) shall not apply to the consideration of 
a joint resolution respecting a nonmajor rule— 
‘‘(1) after the expiration of the 60 session days 
beginning with the applicable submission or publica-
tion date; or 
‘‘(2) if the report under section 921(a)(1)(A) 
was submitted during the period referred to in sec-
tion 921(d)(1), after the expiration of the 60 session 
days beginning on the 15th session day after the 
succeeding session of Congress first convenes. 
‘‘(f) If, before the passage by one House of a joint 
resolution of that House described in subsection (a), that 
House receives from the other House a joint resolution 
described in subsection (a), then the following procedures 
shall apply: 
‘‘(1) The joint resolution of the other House 
shall not be referred to a committee. 
‘‘(2) With respect to a joint resolution described 
in subsection (a) of the House receiving the joint 
resolution— 
‘‘(A) the procedure in that House shall be 
the same as if no joint resolution had been re-
ceived from the other House; but 
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243 
‘‘(B) the vote on final passage shall be on 
the joint resolution of the other House. 
‘‘§ 924. Definitions 
‘‘For purposes of this chapter: 
‘‘(1) The term ‘major rule’ means any rule of 
the Food and Drug Administration, including an in-
terim final rule, that the Administrator of the Office 
of Information and Regulatory Affairs of the Office 
of Management and Budget finds has resulted in or 
is likely to result in— 
‘‘(A) an annual cost on the economy of 
$100,000,000 or more, adjusted annually for 
inflation; 
‘‘(B) a major increase in costs or prices for 
consumers, 
individual 
industries, 
Federal, 
State, or local government agencies, or geo-
graphic regions; or 
‘‘(C) significant adverse effects on competi-
tion, employment, investment, productivity, in-
novation, or on the ability of United States- 
based enterprises to compete with foreign-based 
enterprises in domestic and export markets. 
‘‘(2) The term ‘nonmajor rule’ means any rule 
of the Food and Drug Administration that is not a 
major rule. 
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‘‘(3) The term ‘rule’ has the meaning given 
such term in section 551, except that such term does 
not include— 
‘‘(A) any rule of particular applicability; 
‘‘(B) any rule relating to agency manage-
ment or personnel; or 
‘‘(C) any rule of agency organization, pro-
cedure, or practice that does not substantially 
affect the rights or obligations of non-agency 
parties. 
‘‘(4) The term ‘submission date or publication 
date’, except as otherwise provided in this chapter, 
means— 
‘‘(A) in the case of a major rule, the date 
on which the Congress receives the report sub-
mitted under section 921(a)(1); and 
‘‘(B) in the case of a nonmajor rule, the 
later of— 
‘‘(i) the date on which the Congress 
receives the report submitted under section 
921(a)(1); and 
‘‘(ii) the date on which the nonmajor 
rule is published in the Federal Register, if 
so published. 
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‘‘§ 925. Judicial review 
‘‘(a) No determination, finding, action, or omission 
under this chapter shall be subject to judicial review. 
‘‘(b) Notwithstanding subsection (a), a court may de-
termine whether the Food and Drug Administration has 
completed the necessary requirements under this chapter 
for a rule to take effect. 
‘‘(c) The enactment of a joint resolution of approval 
under section 922 shall not be interpreted to serve as a 
grant or modification of statutory authority by Congress 
for the promulgation of a rule, shall not extinguish or af-
fect any claim, whether substantive or procedural, against 
any alleged defect in a rule, and shall not form part of 
the record before the court in any judicial proceeding con-
cerning a rule except for purposes of determining whether 
or not the rule is in effect. 
‘‘§ 926. Exemption for monetary policy 
‘‘Nothing in this chapter shall apply to rules that con-
cern monetary policy proposed or implemented by the 
Board of Governors of the Federal Reserve System or the 
Federal Open Market Committee. 
‘‘§ 927. Effective date of certain rules 
‘‘Notwithstanding section 921, any rule other than a 
major rule which the Food and Drug Administration for 
good cause finds (and incorporates the finding and a brief 
statement of reasons therefore in the rule issued) that no-
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tice and public procedure thereon are impracticable, un-
necessary, or contrary to the public interest, shall take ef-
fect at such time as the Food and Drug Administration 
determines. 
‘‘§ 928. Regulatory cut-go requirement 
‘‘In making any new rule, the Food and Drug Admin-
istration shall identify a rule or rules that may be amend-
ed or repealed to completely offset any annual costs of 
the new rule to the United States economy. Before the 
new rule may take effect, the Food and Drug Administra-
tion shall make each such repeal or amendment. In mak-
ing such an amendment or repeal, the Food and Drug Ad-
ministration shall comply with the requirements of sub-
chapter II of chapter 5, but the Food and Drug Adminis-
tration may consolidate proceedings under subchapter II 
(of chapter 5) with proceedings on the new rule. 
‘‘§ 929. Review of rules currently in effect 
‘‘(a) ANNUAL REVIEW.—Beginning on the date that 
is 6 months after the date of enactment of this section 
and annually thereafter for the 9 years following, the Food 
and Drug Administration shall designate not less than 10 
percent of eligible rules made by the Food and Drug Ad-
ministration for review, and shall submit a report includ-
ing each such eligible rule in the same manner as a report 
under section 921(a)(1). Section 921, section 922, and 
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section 923 shall apply to each such rule, subject to sub-
section (c) of this section. No eligible rule previously des-
ignated may be designated again. 
‘‘(b) SUNSET
FOR
ELIGIBLE
RULES
NOT
EX-
TENDED.—Beginning after the date that is 10 years after 
the date of enactment of this section, if Congress has not 
enacted a joint resolution of approval for that eligible rule, 
that eligible rule shall not continue in effect. 
‘‘(c) CONSOLIDATION; SEVERABILITY.—In applying 
sections 921, 922, and 923 to eligible rules under this sec-
tion, the following shall apply: 
‘‘(1) The words ‘take effect’ shall be read as 
‘continue in effect’. 
‘‘(2) Except as provided in paragraph (3), a 
single joint resolution of approval shall apply to all 
eligible rules in a report designated for a year, and 
the matter after the resolving clause of that joint 
resolution is as follows: ‘That Congress approves the 
rules submitted by the ll for the year ll.’ (The 
blank spaces being appropriately filled in). 
‘‘(3) It shall be in order to consider any amend-
ment that provides for specific conditions on which 
the approval of a particular eligible rule included in 
the joint resolution is contingent. 
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248 
‘‘(4) A member of either House may move that 
a separate joint resolution be required for a specified 
rule. 
‘‘(d) DEFINITION.—In this section, the term ‘eligible 
rule’ means a rule that is in effect as of the date of enact-
ment of this section.’’. 
(b) BUDGETARY EFFECTS OF RULES SUBJECT TO 
SECTION 922 OF TITLE 5, UNITED STATES CODE.—Sec-
tion 257(b)(2) of the Balanced Budget and Emergency 
Deficit Control Act of 1985 is amended by adding at the 
end the following new subparagraph: 
‘‘(E) BUDGETARY
EFFECTS
OF
RULES 
SUBJECT TO SECTION 922 OF TITLE 5, UNITED 
STATES CODE.—Any rules subject to the con-
gressional approval procedure set forth in sec-
tion 922 of chapter 8 of title 5, United States 
Code, affecting budget authority, outlays, or re-
ceipts shall be assumed to be effective unless it 
is not approved in accordance with such sec-
tion.’’. 
(c) GOVERNMENT ACCOUNTABILITY OFFICE STUDY 
OF RULES.— 
(1) IN GENERAL.—The Comptroller General of 
the United States shall conduct a study to deter-
mine, as of the date of the enactment of this Act— 
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(A) how many rules (as such term is de-
fined in section 924 of title 5, United States 
Code) of the Food and Drug Administration 
were in effect; 
(B) how many major rules (as such term 
is defined in section 924 of title 5, United 
States Code) of the Food and Drug Administra-
tion were in effect; and 
(C) the total estimated economic cost im-
posed by all such rules. 
(2) REPORT.—Not later than 1 year after the 
date of the enactment of this Act, the Comptroller 
General of the United States shall submit a report 
to Congress that contains the findings of the study 
conducted under paragraph (1). 
(d) EFFECTIVE DATE.—Subsections (a) and (b), and 
the amendments made by such sections, shall take effect 
beginning on the date that is 1 year after the date of en-
actment of this Act. 
SEC. 354. GOVERNMENT ACCOUNTABILITY OFFICE STUDY 
OF RULES. 
(a) IN GENERAL.—The Comptroller General of the 
United States shall conduct a study to determine, as of 
the date of the enactment of this Act— 
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(1) how many rules (as such term is defined in 
section 804 of title 5, United States Code) were in 
effect; 
(2) how many major rules (as such term is de-
fined in section 804 of title 5, United States Code) 
were in effect; and 
(3) the total estimated economic cost imposed 
by all such rules. 
(b) REPORT.—Not later than 1 year after the date 
of the enactment of this Act, the Comptroller General of 
the United States shall submit a report to Congress that 
contains the findings of the study conducted under sub-
section (a). 
Subtitle D—Prescription Drug and 
Pharmacy 
Benefit 
Manager 
Transparency 
SEC. 361. PATENT DISCLOSURE REQUIREMENTS. 
(a) IN GENERAL.—Section 351 of the Public Health 
Service Act (42 U.S.C. 262) is amended by adding at the 
end the following: 
‘‘(o) ADDITIONAL REQUIREMENTS WITH RESPECT 
TO PATENTS.— 
‘‘(1) APPROVED APPLICATION HOLDER LISTING 
REQUIREMENTS.— 
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‘‘(A) IN GENERAL.—Beginning on the date 
of enactment of this subsection, within 30 days 
of approval of an application under subsection 
(a) or (k), the holder of such approved applica-
tion shall submit to the Secretary a list of each 
patent required to be disclosed (as described in 
paragraph (3)). 
‘‘(B) 
PREVIOUSLY
APPROVED
OR
LI-
CENSED BIOLOGICAL PRODUCTS.— 
‘‘(i) PRODUCTS
APPROVED
UNDER 
SECTION
351
OF
THE
PHSA.—Not later 
than 30 days after the date of enactment 
of the Fair Care Act of 2022, the holder 
of a biological product license that was ap-
proved under subsection (a) or (k) before 
the date of enactment of such Act shall 
submit to the Secretary a list of each pat-
ent required to be disclosed (as described 
in paragraph (3)). 
‘‘(ii) PRODUCTS
APPROVED
UNDER 
SECTION 505 OF THE FFDCA.—Not later 
than 30 days after March 23, 2021, the 
holder of an approved application for a bio-
logical product under section 505 of the 
Federal Food, Drug, and Cosmetic Act 
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252 
that is deemed to be a license for the bio-
logical product under this section on 
March 23, 2021, shall submit a list of each 
patent required to be disclosed (as de-
scribed in paragraph (3)). 
‘‘(C) UPDATES.—The holder of a biological 
product license approved under subsection (a) 
or (k) shall submit to the Secretary a list that 
includes— 
‘‘(i) any patent first required to be 
disclosed (as described in paragraph (3)) 
after the submission under subparagraph 
(A) or (B), as applicable, within 30 days of 
the earlier of— 
‘‘(I) the date of issuance of such 
patent by the United States Patent 
and Trademark Office; or 
‘‘(II) the date of approval of a 
supplemental application for the bio-
logical product; and 
‘‘(ii) any patent, or any claim with re-
spect to a patent, included on the list pur-
suant to this paragraph with respect to the 
biological product subsequently determined 
to be invalid or unenforceable, within 30 
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253 
days of a determination of patent inva-
lidity. 
‘‘(2) PUBLICATION OF INFORMATION.— 
‘‘(A) IN GENERAL.—Within 1 year of the 
date of enactment of the Fair Care Act of 
2022, the Secretary shall publish and make 
available to the public a single, easily search-
able, list that includes— 
‘‘(i) the official and proprietary name 
of each biological product licensed under 
subsection (a) or (k), and of each biological 
product application approved under section 
505 of the Federal Food, Drug, and Cos-
metic Act and deemed to be a license for 
the biological product under this section on 
March 23, 2021; 
‘‘(ii) with respect to each biological 
product described in clause (i), each patent 
submitted in accordance with paragraph 
(1); 
‘‘(iii) the date of licensure and appli-
cation number for each such biological 
product; 
‘‘(iv) the marketing status, dosage 
form, route of administration, strength, 
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and, if applicable, reference product, for 
each such biological product; 
‘‘(v) the licensure status for each such 
biological product, including whether the li-
cense at the time of listing is approved, 
withdrawn, or revoked; 
‘‘(vi) any period of any exclusivity 
under subsection (k)(7)(A) or subsection 
(k)(7)(B) of this section or section 527 of 
the Federal Food, Drug, and Cosmetic 
Act, and any extension of such period in 
accordance with subsection (m) of this sec-
tion with respect to each such biological 
product, and the date on which such exclu-
sivity expires; 
‘‘(vii) information regarding any de-
termination related to biosimilarity or 
interchangeability for each such biological 
product; and 
‘‘(viii) information regarding approved 
indications for each such biological prod-
uct, in such manner as the Secretary de-
termines appropriate. 
‘‘(B) UPDATES.—Every 30 days after the 
publication of the first list under subparagraph 
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255 
(A), the Secretary shall revise the list to in-
clude— 
‘‘(i)(I) each biological product licensed 
under subsection (a) or (k) during the 30- 
day period; and 
‘‘(II) with respect to each biological 
product described in subclause (I), the in-
formation described in clauses (i) through 
(viii) of subparagraph (A); and 
‘‘(ii) any updates to information pre-
viously published in accordance with sub-
paragraph (A). 
‘‘(3) PATENTS REQUIRED TO BE DISCLOSED.— 
In this section, a ‘patent required to be disclosed’ is 
any patent for which the holder of a biological prod-
uct license approved under subsection (a) or (k), or 
a biological product application approved under sec-
tion 505 of the Federal Food, Drug, and Cosmetic 
Act and deemed to be a license for a biological prod-
uct under this section on March 23, 2021, believes 
a claim of patent infringement could reasonably be 
asserted by the holder, or by a patent owner that 
has granted an exclusive license to the holder with 
respect to the biological product that is the subject 
of such license, if a person not licensed by the holder 
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256 
engaged in the making, using, offering to sell, sell-
ing, or importing into the United States of the bio-
logical product that is the subject of such license.’’. 
(b) 
DISCLOSURE
OF
PATENTS.—Section 
351(l)(3)(A)(i) of the Public Health Service Act (42 
U.S.C. 262(l)(3)(A)(i)) is amended by inserting ‘‘included 
in the list provided by the reference product sponsor under 
subsection (o)(1)’’ after ‘‘a list of patents’’. 
(c) RESTRICTION ON CLAIMS OF PATENT INFRINGE-
MENT.—Section 271(e) of title 35, United States Code, 
is amended by adding at the end the following: 
‘‘(7) The owner of a patent that should have 
been included in the list described in section 
351(o)(1) of the Public Health Service Act (42 
U.S.C. 262(o)(1)), including any updates required 
under subparagraph (C) of that section, but was not 
timely included in such list, may not bring an action 
under this section for infringement of the patent.’’. 
(d) REGULATIONS.—The Secretary of Health and 
Human Services may promulgate regulations to carry out 
subsection (o) of section 351 of the Public Health Service 
Act (42 U.S.C. 262), as added by subsection (a). 
(e) RULE OF CONSTRUCTION.—Nothing in this Act, 
including an amendment made by this Act, shall be con-
strued to require or allow the Secretary of Health and 
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257 
Human Services to delay the licensing of a biological prod-
uct under section 351 of the Public Health Service Act 
(42 U.S.C. 262). 
SEC. 362. REQUIREMENTS WITH RESPECT TO PRESCRIP-
TION DRUG BENEFITS. 
(a) IN GENERAL.—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. 2729A. REQUIREMENTS WITH RESPECT TO PRESCRIP-
TION DRUG BENEFITS. 
‘‘A group health plan or a health insurance issuer of-
fering group or individual health insurance coverage shall 
not, and shall ensure that any entity that provides phar-
macy benefits management services under a contract with 
any such health plan or health insurance coverage does 
not, receive from a drug manufacturer a reduction in price 
or other remuneration with respect to any prescription 
drug received by an enrollee in the plan or coverage and 
covered by the plan or coverage, unless— 
‘‘(1) any such reduction in price is reflected at 
the point of sale to the enrollee; and 
‘‘(2) any such other remuneration is a flat fee- 
based service fee that a manufacturer of prescription 
drugs pays to a pharmacy benefit manager for serv-
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258 
ices rendered to the manufacturer that relate to ar-
rangements by the pharmacy benefit manager to 
provide pharmacy benefit management services to a 
health plan or health insurance issuer, if certain 
conditions established by the Secretary are met, in-
cluding requirements that the fees are transparent 
to the health plan or health insurance issuer.’’. 
(b) EFFECTIVE DATE.—Section 2729A of the Public 
Health Service Act, as added by subsection (a), shall take 
effect on January 1, 2023. 
SEC. 363. PBM TRANSPARENCY AND ELIMINATION OF DIR 
FEES. 
(a) PROHIBITING MEDICARE PDP SPONSORS AND 
MA–PD ORGANIZATIONS FROM RETROACTIVELY REDUC-
ING PAYMENT ON CLEAN CLAIMS SUBMITTED BY PHAR-
MACIES.— 
(1) IN GENERAL.—Section 1860D–12(b)(4)(A) 
of the Social Security Act (42 U.S.C. 1395w– 
112(b)(4)(A)) is amended by adding at the end the 
following new clause: 
‘‘(iv) PROHIBITING RETROACTIVE RE-
DUCTIONS
IN
PAYMENTS
ON
CLEAN 
CLAIMS.—Each contract entered into with 
a PDP sponsor under this part with re-
spect to a prescription drug plan offered 
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259 
by such sponsor shall provide that after 
the date of receipt of a clean claim sub-
mitted by a pharmacy, the PDP sponsor 
(or an agent of the PDP sponsor) may not 
retroactively reduce payment on such claim 
directly or indirectly through aggregated 
effective rate or otherwise except in the 
case such claim is found to not be a clean 
claim (such as in the case of a claim lack-
ing required substantiating documentation) 
during the course of a routine audit as 
permitted pursuant to written agreement 
between the PDP sponsor (or such an 
agent) and such pharmacy. The previous 
sentence shall not prohibit any retroactive 
increase in payment to a pharmacy pursu-
ant to a written agreement between a PDP 
sponsor (or an agent of such sponsor) and 
such pharmacy.’’. 
(2) EFFECTIVE DATE.—The amendment made 
by subsection (a) shall apply with respect to con-
tracts entered into on or after January 1, 2023. 
(b) ELIMINATION OF DIR FEES.— 
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260 
(1) PHARMACY
BENEFITS
MANAGER
STAND-
ARDS UNDER THE MEDICARE PROGRAM FOR PRE-
SCRIPTION DRUG PLANS AND MA–PD PLANS.— 
(A) IN
GENERAL.—Section 1860D–12(b) 
of the Social Security Act (42 U.S.C. 1395w– 
112(b)) is amended by adding at the end the 
following new paragraph: 
‘‘(7) PHARMACY
BENEFITS
MANAGER
TRANS-
PARENCY
REQUIREMENTS.—Each contract entered 
into with a PDP sponsor under this part with re-
spect to a prescription drug plan offered by such 
sponsor or with an MA organization offering an 
MA–PD plan under part C shall provide that the 
sponsor or organization, respectively, may not enter 
into a contract with any pharmacy benefits manager 
(referred to in this paragraph as a ‘PBM’) to man-
age the prescription drug coverage provided under 
such plan, or to control the costs of the prescription 
drug coverage under such plan, unless the PBM ad-
heres to the following criteria when handling person-
ally identifiable utilization and claims data or other 
sensitive patient data: 
‘‘(A) The PBM may not transmit any per-
sonally identifiable utilization, protected health 
information, or claims data, with respect to a 
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261 
plan enrollee, to a pharmacy owned by a PBM 
if the plan enrollee has not voluntarily elected 
in writing or via secure electronic means to fill 
that particular prescription at the PBM-owned 
pharmacy. 
‘‘(B) The PBM may not require that a 
plan enrollee use a retail pharmacy, mail order 
pharmacy, specialty pharmacy, or other phar-
macy entity providing pharmacy services in 
which the PBM has an ownership interest or 
that has an ownership interest in the PBM, or 
provide an incentive to a plan enrollee to en-
courage the enrollee to use a retail pharmacy, 
mail order pharmacy, specialty pharmacy, or 
other pharmacy entity providing pharmacy serv-
ices in which the PBM has an ownership inter-
est or that has an ownership interest in the 
PBM, if the incentive is applicable only to such 
pharmacies.’’. 
(B) REGULAR UPDATE OF PRESCRIPTION 
DRUG PRICING STANDARD.—Paragraph (6) of 
section 1860D–12(b) of the Social Security Act 
(42 U.S.C. 1395w–112(b)) is amended to read 
as follows: 
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262 
‘‘(6) REGULAR
UPDATE
OF
PRESCRIPTION 
DRUG PRICING STANDARD.— 
‘‘(A) IN GENERAL.—If the PDP sponsor of 
a prescription drug plan (or MA organization 
offering an MA–PD plan) uses a standard for 
reimbursement (as described in subparagraph 
(B)) of pharmacies based on the cost of a drug, 
each contract entered into with such sponsor 
under this part (or organization under part C) 
with respect to the plan shall provide that the 
sponsor (or organization) shall— 
‘‘(i) update such standard not less fre-
quently than once every 7 days, beginning 
with an initial update on January 1 of 
each year, to accurately reflect the market 
price of acquiring the drug; 
‘‘(ii) disclose to applicable pharmacies 
and the contracting entities of such phar-
macies the sources used for making any 
such update immediately without require-
ment of request; 
‘‘(iii) if the source for such a standard 
for reimbursement is not publicly available, 
disclose to the applicable pharmacies and 
the respective contracting entities of such 
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263 
pharmacies all individual drug prices to be 
so updated in advance of the use of such 
prices for the reimbursement of claims; 
‘‘(iv) establish a process to appeal, in-
vestigate, and resolve disputes regarding 
individual drug prices that are less than 
the pharmacy acquisition price for such 
drug, which must be adjudicated within 7 
days of the pharmacy filing its appeal; and 
‘‘(v) provide all such pricing data in 
an .xml spreadsheet format or a com-
parable easily accessible and complete 
spreadsheet format. 
‘‘(B) 
PRESCRIPTION
DRUG
PRICING 
STANDARD
DEFINED.—For purposes of sub-
paragraph (A), a standard for reimbursement 
of a pharmacy is any methodology or formula 
for varying the pricing of a drug or drugs dur-
ing the term of the pharmacy reimbursement 
contract that is based on the cost of the drug 
involved, including drug pricing references and 
amounts that are based upon average wholesale 
price, wholesale average cost, average manufac-
turer price, average sales price, maximum al-
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lowable cost (MAC), or other costs, whether 
publicly available or not.’’. 
(C) EFFECTIVE DATE.—The amendments 
made by this section shall apply to plan years 
beginning on or after January 1, 2023. 
(2) REGULAR UPDATE OF PRESCRIPTION DRUG 
PRICING STANDARD UNDER TRICARE RETAIL PHAR-
MACY
PROGRAM.—Section 1074g(d) of title 10, 
United States Code, is amended by adding at the 
end the following new paragraph: 
‘‘(3) To the extent practicable, with respect to the 
TRICARE retail pharmacy program described in sub-
section (a)(2)(E)(ii), the Secretary shall ensure that a con-
tract entered into with a TRICARE managed care support 
contractor includes requirements described in section 
1860D–12(b)(6) of the Social Security Act (42 U.S.C. 
1395w–112(b)(6)) to ensure the provision of information 
regarding the pricing standard for prescription drugs.’’. 
(3) PRESCRIPTION
DRUG
TRANSPARENCY
IN 
THE FEDERAL EMPLOYEES HEALTH BENEFITS PRO-
GRAM.— 
(A) IN GENERAL.—Section 8902 of title 5, 
United States Code, is amended by adding at 
the end the following new subsections: 
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‘‘(p) A contract may not be made or a plan approved 
under this chapter under which a carrier has an agree-
ment with a pharmacy benefits manager (in this sub-
section referred to as a ‘PBM’) to manage prescription 
drug coverage or to control the costs of the prescription 
drug coverage unless the carrier and PBM adhere to the 
following criteria: 
‘‘(1) The PBM may not transmit any personally 
identifiable utilization, protected health information, 
or claims data with respect to an individual enrolled 
under such contract or plan to a pharmacy owned by 
the PBM if the individual has not voluntarily elected 
in writing or via secure electronic means to fill that 
particular prescription at such a pharmacy. 
‘‘(2) The PBM may not require that an indi-
vidual enrolled under such contract or plan use a re-
tail pharmacy, mail order pharmacy, specialty phar-
macy, or other pharmacy entity providing pharmacy 
services in which the PBM has an ownership interest 
or that has an ownership interest in the PBM or 
provide an incentive to a plan enrollee to encourage 
the enrollee to use a retail pharmacy, mail order 
pharmacy, specialty pharmacy, or other pharmacy 
entity providing pharmacy services in which the 
PBM has an ownership interest or that has an own-
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ership interest in the PBM, if the incentive is appli-
cable only to such pharmacies. 
‘‘(q)(1) If a contract made or plan approved under 
this chapter provides for a standard for reimbursement 
(as described in paragraph (2)) with respect to a prescrip-
tion drug plan, such contract or plan shall provide that 
the applicable carrier— 
‘‘(A) update such standard not less frequently 
than once every 7 days, beginning with an initial up-
date on January 1 of each year, to accurately reflect 
the market price of acquiring the drug; 
‘‘(B) disclose to applicable pharmacies and the 
contracting entities of such pharmacies the sources 
used for making any such update immediately with-
out requirement of request; 
‘‘(C) if the source for such a standard for reim-
bursement is not publicly available, disclose to the 
applicable pharmacies and contracting entities of 
such pharmacies all individual drug prices to be so 
updated in advance of the use of such prices for the 
reimbursement of claims; 
‘‘(D) establish a process to appeal, investigate, 
and resolve disputes regarding individual drug prices 
that are less than the pharmacy acquisition price for 
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267 
such drug, which must be adjudicated within 7 days 
of the pharmacy filing its appeal; and 
‘‘(E) provide all such pricing data in an .xml 
spreadsheet format or a comparable easily accessible 
and complete spreadsheet format. 
‘‘(2) For purposes of paragraph (1), a standard for 
reimbursement of a pharmacy is any methodology or for-
mula for varying the pricing of a drug or drugs during 
the term of the pharmacy reimbursement contract that is 
based on the cost of the drug involved, including drug pric-
ing references and amounts that are based upon average 
wholesale price, wholesale average cost, average manufac-
turer price, average sales price, maximum allowable cost, 
or other costs, whether publicly available or not.’’. 
(B) APPLICATION.—The amendment made 
by subparagraph (A) shall apply to any contract 
entered into under section 8902 of title 5, 
United States Code, on or after the date of en-
actment of this section. 
SEC. 364. HEALTH PLAN OVERSIGHT OF PHARMACY BEN-
EFIT MANAGER SERVICES. 
Subpart II of part A of title XXVII of the Public 
Health Service Act (42 U.S.C. 300gg–11 et seq.), as 
amended by the preceding sections, is further amended by 
adding at the end the following: 
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268 
‘‘SEC. 2729E. HEALTH PLAN OVERSIGHT OF PHARMACY 
BENEFIT MANAGER SERVICES. 
‘‘(a) IN GENERAL.—A group health plan or health 
insurance issuer offering group health insurance coverage 
or an entity or subsidiary providing pharmacy benefits 
management services shall not enter into a contract with 
a drug manufacturer, distributor, wholesaler, subcon-
tractor, rebate aggregator, or any associated third party 
that limits the disclosure of information to plan sponsors 
in such a manner that prevents the plan or coverage, or 
an entity or subsidiary providing pharmacy benefits man-
agement services on behalf of a plan or coverage from 
making the reports described in subsection (b). 
‘‘(b) REPORTS TO GROUP PLAN SPONSORS.— 
‘‘(1) IN
GENERAL.—Beginning with the first 
plan year that begins after the date of enactment of 
the Fair Care Act of 2022, not less frequently than 
once every 6 months, a health insurance issuer offer-
ing group health insurance coverage or an entity 
providing pharmacy benefits management services 
on behalf of a group health plan shall submit to the 
plan sponsor (as defined in section 3(16)(B) of the 
Employee Retirement Income Security Act of 1974) 
of such group health plan or health insurance cov-
erage a report in accordance with this subsection 
and make such report available to the plan sponsor 
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269 
in a machine-readable format. Each such report 
shall include, with respect to the applicable group 
health plan or health insurance coverage— 
‘‘(A) information collected from drug man-
ufacturers by such issuer or entity on the total 
amount of copayment assistance dollars paid, or 
copayment cards applied, that were funded by 
the drug manufacturer with respect to the en-
rollees in such plan or coverage; 
‘‘(B) a list of each covered drug dispensed 
during the reporting period, including, with re-
spect to each such drug during the reporting 
period— 
‘‘(i) the brand name, chemical entity, 
and National Drug Code; 
‘‘(ii) the number of enrollees for 
whom the drug was filled during the plan 
year, the total number of prescription fills 
for the drug (including original prescrip-
tions and refills), and the total number of 
dosage units of the drug dispensed across 
the plan year, including whether the dis-
pensing channel was by retail, mail order, 
or specialty pharmacy; 
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270 
‘‘(iii) the wholesale acquisition cost, 
listed as cost per days supply and cost per 
pill, or in the case of a drug in another 
form, per dose; 
‘‘(iv) the total out-of-pocket spending 
by enrollees on such drug, including en-
rollee spending through copayments, coin-
surance, and deductibles; and 
‘‘(v) for any drug for which gross 
spending of the group health plan or 
health 
insurance 
coverage 
exceeded 
$10,000 during the reporting period— 
‘‘(I) a list of all other available 
drugs in the same therapeutic cat-
egory or class, including brand name 
drugs and biological products and ge-
neric drugs or biosimilar biological 
products that are in the same thera-
peutic category or class; and 
‘‘(II) the rationale for preferred 
formulary placement of a particular 
drug or drugs in that therapeutic cat-
egory or class; 
‘‘(C) a list of each therapeutic category or 
class of drugs that were dispensed under the 
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271 
health plan or health insurance coverage during 
the reporting period, and, with respect to each 
such therapeutic category or class of drugs, 
during the reporting period— 
‘‘(i) total gross spending by the plan, 
before manufacturer rebates, fees, or other 
manufacturer remuneration; 
‘‘(ii) the number of enrollees who 
filled a prescription for a drug in that cat-
egory or class; 
‘‘(iii) if applicable to that category or 
class, a description of the formulary tiers 
and utilization mechanisms (such as prior 
authorization or step therapy) employed 
for drugs in that category or class; 
‘‘(iv) the total out-of-pocket spending 
by enrollees, including enrollee spending 
through copayments, coinsurance, and 
deductibles; and 
‘‘(v) for each therapeutic category or 
class under which 3 or more drugs are in-
cluded on the formulary of such plan or 
coverage— 
‘‘(I) the amount received, or ex-
pected to be received, from drug man-
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272 
ufacturers in rebates, fees, alternative 
discounts, or other remuneration— 
‘‘(aa) to be paid by drug 
manufacturers for claims in-
curred during the reporting pe-
riod; or 
‘‘(bb) that is related to utili-
zation of drugs, in such thera-
peutic category or class; 
‘‘(II) the total net spending, after 
deducting rebates, price concessions, 
alternative discounts or other remu-
neration from drug manufacturers, by 
the health plan or health insurance 
coverage on that category or class of 
drugs; and 
‘‘(III) the net price per course of 
treatment or 30-day supply incurred 
by the health plan or health insurance 
coverage and its enrollees, after man-
ufacturer rebates, fees, and other re-
muneration for drugs dispensed within 
such therapeutic category or class 
during the reporting period; 
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273 
‘‘(D) total gross spending on prescription 
drugs by the plan or coverage during the re-
porting period, before rebates and other manu-
facturer fees or remuneration; 
‘‘(E) total amount received, or expected to 
be received, by the health plan or health insur-
ance coverage in drug manufacturer rebates, 
fees, alternative discounts, and all other remu-
neration received from the manufacturer or any 
third party, other than the plan sponsor, re-
lated to utilization of drug or drug spending 
under that health plan or health insurance cov-
erage during the reporting period; 
‘‘(F) the total net spending on prescription 
drugs by the health plan or health insurance 
coverage during the reporting period; and 
‘‘(G) amounts paid directly or indirectly in 
rebates, fees, or any other type of remuneration 
to brokers, consultants, advisors, or any other 
individual or firm who referred the group health 
plan’s or health insurance issuer’s business to 
the pharmacy benefit manager. 
‘‘(2) PRIVACY REQUIREMENTS.—Health insur-
ance issuers offering group health insurance cov-
erage and entities providing pharmacy benefits man-
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274 
agement services on behalf of a group health plan 
shall provide information under paragraph (1) in a 
manner consistent with the privacy, security, and 
breach notification regulations promulgated under 
section 264(c) of the Health Insurance Portability 
and Accountability Act of 1996 (or successor regula-
tions), and shall restrict the use and disclosure of 
such information according to such privacy regula-
tions. 
‘‘(3) DISCLOSURE AND REDISCLOSURE.— 
‘‘(A) LIMITATION
TO
BUSINESS
ASSOCI-
ATES.—A group health plan receiving a report 
under paragraph (1) may disclose such informa-
tion only to business associates of such plan as 
defined in section 160.103 of title 45, Code of 
Federal Regulations (or successor regulations). 
‘‘(B) CLARIFICATION REGARDING PUBLIC 
DISCLOSURE
OF
INFORMATION.—Nothing in 
this section prevents a health insurance issuer 
offering group health insurance coverage or an 
entity providing pharmacy benefits management 
services on behalf of a group health plan from 
placing reasonable restrictions on the public dis-
closure of the information contained in a report 
described in paragraph (1), except that such 
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275 
issuer or entity may not restrict disclosure of 
such report to governmental agencies pursuant 
to an investigation or enforcement action. 
‘‘(C) LIMITED
FORM
OF
REPORT.—The 
Secretary shall define through rulemaking a 
limited form of the report under paragraph (1) 
required of plan sponsors who are drug manu-
facturers, drug wholesalers, or other direct par-
ticipants in the drug supply chain, in order to 
prevent anti-competitive behavior. 
‘‘(c) LIMITATIONS ON SPREAD PRICING.— 
‘‘(1) PRESCRIPTION DRUG TRANSACTIONS WITH 
PHARMACIES
INDEPENDENT
OF
THE
ISSUER
OR 
PHARMACY BENEFITS MANAGER.—If the pharmacy 
that dispenses a prescription drug to an enrollee in 
a group health plan or group or individual health in-
surance coverage is not wholly or partially owned by 
such plan, such issuer, or an entity providing phar-
macy benefit management services under such plan 
or coverage, such plan, issuer, or entity shall not 
charge the plan, issuer, or enrollee a price for such 
prescription drug that exceeds the price paid to the 
pharmacy. 
‘‘(2) 
INTRA-COMPANY
PRESCRIPTION
DRUG 
TRANSACTIONS.—If the mail order, specialty, or re-
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276 
tail pharmacy that dispenses a prescription drug to 
an enrollee in a group health plan or health insur-
ance coverage is wholly or partially owned by, and 
submits claims to, such health insurance issuer or 
an entity providing pharmacy benefit management 
services under a group health plan or group or indi-
vidual health insurance coverage, the price charged 
for such drug by such pharmacy to such group 
health plan or health insurance issuer offering group 
or individual health insurance coverage may not ex-
ceed the lesser of— 
‘‘(A) the amount paid to the pharmacy for 
acquisition of the drug; or 
‘‘(B) the median price charged to the 
group health plan or health insurance issuer 
when the same drug is dispensed to enrollees in 
the plan or coverage by other similarly situated 
pharmacies not wholly or partially owned by the 
health insurance issuer or entity providing 
pharmacy benefits management services, as de-
scribed in paragraph (1). 
‘‘(3) SUPPLEMENTARY REPORTING FOR INTRA- 
COMPANY PRESCRIPTION DRUG TRANSACTIONS.—A 
health insurance issuer of group health insurance 
coverage or an entity providing pharmacy benefits 
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277 
management services under a group health plan or 
group health insurance coverage that conducts 
transactions with a wholly or partially owned phar-
macy, as described in paragraph (2), shall submit, 
together with the report under subsection (b), a sup-
plementary report every 6 months to the plan spon-
sor that includes— 
‘‘(A) an explanation of any benefit design 
parameters that encourage enrollees in the plan 
or coverage to fill prescriptions at mail order, 
specialty, or retail pharmacies that are wholly 
or partially owned by that issuer or entity; 
‘‘(B) the percentage of total prescriptions 
charged to the plan, coverage, or enrollees in 
the plan or coverage, that were dispensed by 
mail order, specialty, or retail pharmacies that 
are wholly or partially owned by the issuer or 
entity providing pharmacy benefits management 
services; and 
‘‘(C) a list of all drugs dispensed by such 
wholly or partially owned pharmacy and 
charged to the plan or coverage, or enrollees of 
the plan or coverage, during the applicable 
quarter, and, with respect to each drug— 
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278 
‘‘(i) the amount charged per course of 
treatment or 30-day supply with respect to 
enrollees in the plan or coverage, including 
amounts charged to the plan or coverage 
and amounts charged to the enrollee; 
‘‘(ii) the median amount charged to 
the plan or coverage, per course of treat-
ment or 30-day supply, including amounts 
paid by the enrollee, when the same drug 
is dispensed by other pharmacies that are 
not wholly or partially owned by the issuer 
or entity and that are included in the 
pharmacy network of that plan or cov-
erage; 
‘‘(iii) the interquartile range of the 
costs, per course of treatment or 30-day 
supply, including amounts paid by the en-
rollee, when the same drug is dispensed by 
other pharmacies that are not wholly or 
partially owned by the issuer or entity and 
that are included in the pharmacy network 
of that plan or coverage; and 
‘‘(iv) the lowest cost per course of 
treatment or 30-day supply, for such drug, 
including amounts charged to the plan or 
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279 
issuer and enrollee, that is available from 
any pharmacy included in the network of 
the plan or coverage. 
‘‘(d) FULL REBATE PASS-THROUGH TO PLAN.— 
‘‘(1) IN GENERAL.—A pharmacy benefits man-
ager, a third-party administrator of a group health 
plan, a health insurance issuer offering group health 
insurance coverage, or an entity providing pharmacy 
benefits management services under such health 
plan or health insurance coverage shall remit 100 
percent of rebates, fees, alternative discounts, and 
all other remuneration received from a pharma-
ceutical manufacturer, distributor or any other third 
party, that are related to utilization of drugs under 
such health plan or health insurance coverage, to the 
group health plan. 
‘‘(2) FORM AND MANNER OF REMITTANCE.— 
Such rebates, fees, alternative discounts, and other 
remuneration shall be— 
‘‘(A) remitted to the group health plan in 
a timely fashion after the period for which such 
rebates, fees, or other remuneration is cal-
culated, and in no case later than 90 days after 
the end of such period; 
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280 
‘‘(B) fully disclosed and enumerated to the 
group health plan sponsor, as described in 
(b)(1); 
‘‘(C) available for audit by the plan spon-
sor, or a third party designated by a plan spon-
sor no less than once per plan year; and 
‘‘(D) returned to the issuer or entity pro-
viding 
pharmaceutical 
benefit 
management 
services by the group health plan if audits by 
such issuer or entity indicate that the amounts 
received are incorrect after such amounts have 
been paid to the group health plan. 
‘‘(3) AUDIT OF REBATE CONTRACTS.—A phar-
macy benefits manager, a third-party administrator 
of a group health plan, a health insurance issuer of-
fering group health insurance coverage, or an entity 
providing pharmacy benefits management services 
under such health plan or health insurance coverage 
shall make rebate contracts with drug manufactur-
ers available for audit by such plan sponsor or des-
ignated third party, subject to confidentiality agree-
ments to prevent re-disclosure of such contracts. 
‘‘(e) ENFORCEMENT.— 
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281 
‘‘(1) IN GENERAL.—The Secretary, in consulta-
tion with the Secretary of Labor and the Secretary 
of the Treasury, shall enforce this section. 
‘‘(2) FAILURE TO PROVIDE TIMELY INFORMA-
TION.—A health insurance issuer or an entity pro-
viding pharmacy benefit management services that 
violates subsection (a), fails to provide information 
required under subsection (b), engages in spread 
pricing as defined in subsection (c), or fails to com-
ply with the requirements of subsection (d), or a 
drug manufacturer that fails to provide information 
under subsection (b)(1)(A), in a timely manner shall 
be subject to a civil monetary penalty in the amount 
of $10,000 for each day during which such violation 
continues or such information is not disclosed or re-
ported. 
‘‘(3) FALSE INFORMATION.—A health insurance 
issuer, entity providing pharmacy benefit manage-
ment services, or drug manufacturer that knowingly 
provides false information under this section shall be 
subject to a civil money penalty in an amount not 
to exceed $100,000 for each item of false informa-
tion. Such civil money penalty shall be in addition to 
other penalties as may be prescribed by law. 
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282 
‘‘(4) PROCEDURE.—The provisions of section 
1128A of the Social Security Act, other than sub-
section (a) and (b) and the first sentence of sub-
section (c)(1) of such section shall apply to civil 
monetary penalties under this subsection in the 
same manner as such provisions apply to a penalty 
or proceeding under section 1128A of the Social Se-
curity Act. 
‘‘(5) SAFE HARBOR.—The Secretary may waive 
penalties under paragraph (2), or extend the period 
of time for compliance with a requirement of this 
section, for an entity in violation of this section that 
has made a good-faith effort to comply with this sec-
tion. 
‘‘(f) RULE OF CONSTRUCTION.—Nothing in this sec-
tion shall be construed to prohibit payments to entities 
offering pharmacy benefits management services for bona 
fide services using a fee structure not contemplated by this 
section, provided that such fees are transparent to group 
health plans and health insurance issuers. 
‘‘(g) DEFINITIONS.—In this section— 
‘‘(1) the term ‘similarly situated pharmacy’ 
means, with respect to a particular pharmacy, an-
other pharmacy that is approximately the same size 
(as measured by the number of prescription drugs 
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283 
dispensed), and that serves patients in the same geo-
graphical area, whether through physical locations or 
mail order; and 
‘‘(2) the term ‘wholesale acquisition cost’ has 
the 
meaning 
given 
such 
term 
in 
section 
1847A(c)(6)(B) of the Social Security Act.’’. 
SEC. 365. STUDY BY COMPTROLLER GENERAL OF UNITED 
STATES. 
(a) IN GENERAL.—The Comptroller General of the 
United States (referred to in this section as the ‘‘Comp-
troller General’’) shall, in consultation with appropriate 
stakeholders, conduct a study on the role of pharmacy 
benefit managers. 
(b) PERMISSIBLE EXAMINATION.—In conducting the 
study required under subsection (a), the Comptroller Gen-
eral may examine various qualitative and quantitative as-
pects of the role of pharmacy benefit managers, such as 
the following: 
(1) The role that pharmacy benefit managers 
play in the pharmaceutical supply chain. 
(2) The state of competition among pharmacy 
benefit managers, including the market share for the 
Nation’s largest pharmacy benefit managers. 
(3) The use of rebates and fees by pharmacy 
benefit managers, including— 
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284 
(A) the extent to which rebates are passed 
on to health plans and whether such rebates are 
passed on to individuals enrolled in such plans; 
(B) the extent to which rebates are kept by 
such pharmacy benefit managers; and 
(C) the role of any fees charged by such 
pharmacy benefit managers. 
(4) Whether pharmacy benefit managers struc-
ture their formularies in favor of high-rebate pre-
scription drugs over lower-cost, lower-rebate alter-
natives. 
(5) The average prior authorization approval 
time for pharmacy benefit managers. 
(6) Factors affecting the use of step therapy by 
pharmacy benefit managers. 
(c) REPORT.—Not later than 3 years after the date 
of enactment of this Act, the Comptroller General shall 
submit to the Secretary of Health and Human Services, 
the Committee on Health, Education, Labor, and Pen-
sions of the Senate, and the Committee on Energy and 
Commerce of the House of Representatives a report con-
taining the results of the study conducted under sub-
section (a), including policy recommendations. 
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285 
Subtitle E—Medicare and Medicaid 
Prescription Drug Reforms 
SEC. 371. MEDICARE PART D MODERNIZATION REDESIGN. 
(a) 
BENEFIT
STRUCTURE
REDESIGN.—Section 
1860D–2(b) of the Social Security Act (42 U.S.C. 1395w– 
102(b)) is amended— 
(1) in paragraph (2)— 
(A) in subparagraph (A), in the matter 
preceding clause (i), by inserting ‘‘for a year 
preceding 2023 and for costs above the annual 
deductible specified in paragraph (1) and up to 
the annual out-of-pocket threshold specified in 
paragraph (4)(B) for 2023 and each subsequent 
year’’ after ‘‘paragraph (3)’’; 
(B) in subparagraph (C)— 
(i) in clause (i), in the matter pre-
ceding subclause (I), by inserting ‘‘for a 
year preceding 2023,’’ after ‘‘paragraph 
(4),’’; and 
(ii) in clause (ii)(III), by striking 
‘‘and each subsequent year’’ and inserting 
‘‘, 2021, and 2022’’; and 
(C) in subparagraph (D)— 
(i) in clause (i)— 
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(I) in the matter preceding sub-
clause (I), by inserting ‘‘for a year 
preceding 2023,’’ after ‘‘paragraph 
(4),’’; and 
(II) in subclause (I)(bb), by 
striking ‘‘a year after 2018’’ and in-
serting ‘‘each of years 2018 through 
2022’’; and 
(ii) in clause (ii)(V), by striking 
‘‘2019 and each subsequent year’’ and in-
serting ‘‘each of years 2019 through 
2022’’; 
(2) in paragraph (3)(A)— 
(A) in the matter preceding clause (i), by 
inserting ‘‘for a year preceding 2023,’’ after 
‘‘and (4),’’; and 
(B) in clause (ii), by striking ‘‘for a subse-
quent year’’ and inserting ‘‘for each of years 
2007 through 2022’’; 
(3) in paragraph (4)— 
(A) in subparagraph (A)— 
(i) in clause (i)— 
(I) by redesignating subclauses 
(I) and (II) as items (aa) and (bb), 
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287 
respectively, and indenting appro-
priately; 
(II) in the matter preceding item 
(aa), as redesignated by subclause (I), 
by striking ‘‘is equal to the greater 
of—’’ and inserting ‘‘is equal to— 
‘‘(I) for a year preceding 2023, 
the greater of—’’; 
(III) by striking the period at the 
end of item (bb), as redesignated by 
subclause (I), and inserting ‘‘; and’’; 
and 
(IV) by adding at the end the fol-
lowing: 
‘‘(II) for 2023 and each suc-
ceeding year, $0.’’; and 
(ii) in clause (ii)— 
(I) by striking ‘‘clause (i)(I)’’ and 
inserting ‘‘clause (i)(I)(aa)’’; and 
(II) by adding at the end the fol-
lowing new sentence: ‘‘The Secretary 
shall continue to calculate the dollar 
amounts specified in clause (i)(I)(aa), 
including with the adjustment under 
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288 
this clause, after 2022 for purposes of 
section 1860D–14(a)(1)(D)(iii).’’; 
(B) in subparagraph (B)— 
(i) in clause (i)— 
(I) in subclause (V), by striking 
‘‘or’’ at the end; 
(II) in subclause (VI)— 
(aa) by striking ‘‘for a sub-
sequent year’’ and inserting ‘‘for 
2021 and 2022’’; and 
(bb) by striking the period 
at the end and inserting a semi-
colon; and 
(III) by adding at the end the 
following new subclauses: 
‘‘(VII) for 2023, is equal to 
$3,100; or 
‘‘(VIII) for a subsequent year, is 
equal to the amount specified in this 
subparagraph for the previous year, 
increased by the annual percentage in-
crease described in paragraph (6) for 
the year involved.’’; and 
(ii) in clause (ii), by striking ‘‘clause 
(i)(II)’’ and inserting ‘‘clause (i)’’; 
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289 
(C) in subparagraph (C)(i), by striking 
‘‘and for amounts’’ and inserting ‘‘and for a 
year preceding 2023 for amounts’’; and 
(D) in subparagraph (E), by striking ‘‘In 
applying’’ and inserting ‘‘For each of 2011 
through 2022, in applying’’. 
(b) REDUCTION IN BENEFICIARY COINSURANCE.— 
(1) IN
GENERAL.—Section 1860D–2(b)(2)(A) 
of the Social Security Act (42 U.S.C. 1395w– 
102(b)(2)(A)), as amended by subsection (a), is 
amended— 
(A) by redesignating clauses (i) and (ii) as 
subclauses (I) and (II) and moving such sub-
clauses 2 ems to the right; 
(B) by striking ‘‘25
PERCENT
COINSUR-
ANCE.—Subject to’’ and inserting ‘‘COINSUR-
ANCE.— 
‘‘(i) IN GENERAL.—Subject to’’; 
(C) in each of subclauses (I) and (II), as 
redesignated by subparagraph (A), by striking 
‘‘25 percent’’ and inserting ‘‘the applicable per-
centage (as defined in clause (ii))’’; and 
(D) by adding at the end the following new 
clause: 
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‘‘(ii) APPLICABLE
PERCENTAGE
DE-
FINED.—For purposes of clause (i), the 
term ‘applicable percentage’ means— 
‘‘(I) for a year preceding 2023, 
25 percent; and 
‘‘(II) for 2023 and each subse-
quent year, 20 percent.’’. 
(2) 
CONFORMING
AMENDMENT.—Section 
1860D–14(a)(2)(D) of the Social Security Act (42 
U.S.C. 1395w–114(a)(2)(D)) is amended by striking 
‘‘25 percent’’ and inserting ‘‘the applicable percent-
age’’. 
(c) 
DECREASING
REINSURANCE
PAYMENT 
AMOUNT.—Section 1860D–15(b) of the Social Security 
Act (42 U.S.C. 1395w–115(b)) is amended— 
(1) in paragraph (1)— 
(A) by striking ‘‘equal to 80 percent’’ and 
inserting ‘‘equal to— 
‘‘(A) for a year preceding 2023, 80 per-
cent’’; 
(B) in subparagraph (A), as added by 
paragraph (1), by striking the period at the end 
and inserting ‘‘; and’’; and 
(C) by adding at the end the following new 
subparagraph: 
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(2) by adding at the end the following new 
paragraph: 
‘‘(5) APPLICABLE
PERCENTAGE
SPECIFIED.— 
For purposes of paragraph (1)(B), the applicable 
percentage specified in this paragraph is— 
‘‘(A) with respect to applicable drugs (as 
defined in section 1860D–14B(g)(2))— 
‘‘(i) for 2023, 60 percent; 
‘‘(ii) for 2024, 40 percent; and 
‘‘(iii) for 2025 and each subsequent 
year, 20 percent; and 
‘‘(B) with respect to covered part D drugs 
that are not applicable drugs (as so defined)— 
‘‘(i) for 2023, 80 percent; 
‘‘(ii) for 2024, 60 percent; and 
‘‘(iii) for 2025 and each subsequent 
year, 40 percent.’’. 
(d) MANUFACTURER DISCOUNT PROGRAM DURING 
INITIAL AND CATASTROPHIC PHASES OF COVERAGE.— 
(1) IN GENERAL.—Part D of title XVIII of the 
Social Security Act is amended by inserting after 
section 1860D–14A (42 U.S.C. 1495w–114) the fol-
lowing new section: 
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‘‘SEC. 1860D–14B. MANUFACTURER DISCOUNT PROGRAM. 
‘‘(a) ESTABLISHMENT.—The Secretary shall estab-
lish a manufacturer discount program (in this section re-
ferred to as the ‘program’). Under the program, the Sec-
retary shall enter into agreements described in subsection 
(b) with manufacturers and provide for the performance 
of the duties described in subsection (c). The Secretary 
shall establish a model agreement for use under the pro-
gram by not later than January 1, 2022, in consultation 
with manufacturers, and allow for comment on such model 
agreement. 
‘‘(b) TERMS OF AGREEMENT.— 
‘‘(1) IN GENERAL.— 
‘‘(A) AGREEMENT.—An agreement under 
this section shall require the manufacturer to 
provide applicable beneficiaries access to dis-
counted prices for applicable drugs of the man-
ufacturer that are dispensed on or after Janu-
ary 1, 2023. 
‘‘(B) PROVISION OF DISCOUNTED PRICES 
AT THE POINT-OF-SALE.—The discounted prices 
described in subparagraph (A) shall be provided 
to the applicable beneficiary at the pharmacy or 
by the mail order service at the point-of-sale of 
an applicable drug. 
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‘‘(2) PROVISION OF APPROPRIATE DATA.—Each 
manufacturer with an agreement in effect under this 
section shall collect and have available appropriate 
data, as determined by the Secretary, to ensure that 
it can demonstrate to the Secretary compliance with 
the requirements under the program. 
‘‘(3) COMPLIANCE
WITH
REQUIREMENTS
FOR 
ADMINISTRATION
OF
PROGRAM.—Each manufac-
turer with an agreement in effect under this section 
shall comply with requirements imposed by the Sec-
retary or a third party with a contract under sub-
section (d)(3), as applicable, for purposes of admin-
istering the program, including any determination 
under subparagraph (A) of subsection (c)(1) or pro-
cedures established under such subsection (c)(1). 
‘‘(4) LENGTH OF AGREEMENT.— 
‘‘(A) IN GENERAL.—An agreement under 
this section shall be effective for an initial pe-
riod of not less than 12 months and shall be 
automatically renewed for a period of not less 
than 1 year unless terminated under subpara-
graph (B). 
‘‘(B) TERMINATION.— 
‘‘(i) BY THE SECRETARY.—The Sec-
retary may provide for termination of an 
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agreement under this section for a knowing 
and willful violation of the requirements of 
the agreement or other good cause shown. 
Such termination shall not be effective ear-
lier than 30 days after the date of notice 
to the manufacturer of such termination. 
The Secretary shall provide, upon request, 
a manufacturer with a hearing concerning 
such a termination, and such hearing shall 
take place prior to the effective date of the 
termination with sufficient time for such 
effective date to be repealed if the Sec-
retary determines appropriate. 
‘‘(ii) BY A MANUFACTURER.—A man-
ufacturer may terminate an agreement 
under this section for any reason. Any 
such termination shall be effective, with re-
spect to a plan year— 
‘‘(I) if the termination occurs be-
fore January 30 of a plan year, as of 
the day after the end of the plan year; 
and 
‘‘(II) if the termination occurs on 
or after January 30 of a plan year, as 
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of the day after the end of the suc-
ceeding plan year. 
‘‘(iii) EFFECTIVENESS
OF
TERMI-
NATION.—Any termination under this sub-
paragraph shall not affect discounts for 
applicable drugs of the manufacturer that 
are due under the agreement before the ef-
fective date of its termination. 
‘‘(iv) NOTICE TO THIRD PARTY.—The 
Secretary shall provide notice of such ter-
mination to a third party with a contract 
under subsection (d)(3) within not less 
than 30 days before the effective date of 
such termination. 
‘‘(5) EFFECTIVE
DATE
OF
AGREEMENT.—An 
agreement under this section shall take effect on a 
date determined appropriate by the Secretary, which 
may be at the start of a calendar quarter. 
‘‘(c) DUTIES DESCRIBED.—The duties described in 
this subsection are the following: 
‘‘(1) ADMINISTRATION OF PROGRAM.—Admin-
istering the program, including— 
‘‘(A) the determination of the amount of 
the discounted price of an applicable drug of a 
manufacturer; 
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‘‘(B) the establishment of procedures 
under which discounted prices are provided to 
applicable beneficiaries at pharmacies or by 
mail order service at the point-of-sale of an ap-
plicable drug; 
‘‘(C) the establishment of procedures to 
ensure that, not later than the applicable num-
ber of calendar days after the dispensing of an 
applicable drug by a pharmacy or mail order 
service, the pharmacy or mail order service is 
reimbursed for an amount equal to the dif-
ference between— 
‘‘(i) the negotiated price of the appli-
cable drug; and 
‘‘(ii) the discounted price of the appli-
cable drug; 
‘‘(D) the establishment of procedures to 
ensure that the discounted price for an applica-
ble drug under this section is applied before any 
coverage or financial assistance under other 
health benefit plans or programs that provide 
coverage or financial assistance for the pur-
chase or provision of prescription drug coverage 
on behalf of applicable beneficiaries as the Sec-
retary may specify; and 
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298 
‘‘(E) providing a reasonable dispute resolu-
tion mechanism to resolve disagreements be-
tween manufacturers, applicable beneficiaries, 
and the third party with a contract under sub-
section (d)(3). 
‘‘(2) MONITORING COMPLIANCE.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
monitor compliance by a manufacturer with the 
terms of an agreement under this section. 
‘‘(B) NOTIFICATION.—If a third party 
with a contract under subsection (d)(3) deter-
mines that the manufacturer is not in compli-
ance with such agreement, the third party shall 
notify the Secretary of such noncompliance for 
appropriate enforcement under subsection (e). 
‘‘(3) COLLECTION OF DATA FROM PRESCRIP-
TION DRUG PLANS AND MA–PD PLANS.—The Sec-
retary may collect appropriate data from prescrip-
tion drug plans and MA–PD plans in a timeframe 
that allows for discounted prices to be provided for 
applicable drugs under this section. 
‘‘(d) ADMINISTRATION.— 
‘‘(1) IN GENERAL.—Subject to paragraph (2), 
the Secretary shall provide for the implementation of 
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this section, including the performance of the duties 
described in subsection (c). 
‘‘(2) LIMITATION.—In providing for the imple-
mentation of this section, the Secretary shall not re-
ceive or distribute any funds of a manufacturer 
under the program. 
‘‘(3) CONTRACT
WITH
THIRD
PARTIES.—The 
Secretary shall enter into a contract with 1 or more 
third parties to administer the requirements estab-
lished by the Secretary in order to carry out this 
section. At a minimum, the contract with a third 
party under the preceding sentence shall require 
that the third party— 
‘‘(A) receive and transmit information be-
tween the Secretary, manufacturers, and other 
individuals or entities the Secretary determines 
appropriate; 
‘‘(B) receive, distribute, or facilitate the 
distribution of funds of manufacturers to ap-
propriate individuals or entities in order to 
meet the obligations of manufacturers under 
agreements under this section; 
‘‘(C) provide adequate and timely informa-
tion to manufacturers, consistent with the 
agreement with the manufacturer under this 
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300 
section, as necessary for the manufacturer to 
fulfill its obligations under this section; and 
‘‘(D) permit manufacturers to conduct 
periodic audits, directly or through contracts, of 
the data and information used by the third 
party to determine discounts for applicable 
drugs of the manufacturer under the program. 
‘‘(4) 
PERFORMANCE
REQUIREMENTS.—The 
Secretary shall establish performance requirements 
for a third party with a contract under paragraph 
(3) and safeguards to protect the independence and 
integrity of the activities carried out by the third 
party under the program under this section. 
‘‘(5) ADMINISTRATION.—Chapter 35 of title 44, 
United States Code, shall not apply to the program 
under this section. 
‘‘(6) FUNDING.—For purposes of carrying out 
this section, the Secretary shall provide for the 
transfer, from the Federal Supplementary Medical 
Insurance Trust Fund under section 1841 to the 
Centers for Medicare & Medicaid Services Program 
Management Account, of $4,000,000 for each of fis-
cal years 2020 through 2023, to remain available 
until expended.’’. 
‘‘(e) ENFORCEMENT.— 
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301 
‘‘(1) AUDITS.—Each manufacturer with an 
agreement in effect under this section shall be sub-
ject to periodic audit by the Secretary. 
‘‘(2) CIVIL MONEY PENALTY.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
impose a civil money penalty on a manufacturer 
that fails to provide applicable beneficiaries dis-
counts for applicable drugs of the manufacturer 
in accordance with such agreement for each 
such failure in an amount the Secretary deter-
mines is commensurate with the sum of— 
‘‘(i) the amount that the manufac-
turer would have paid with respect to such 
discounts under the agreement, which will 
then be used to pay the discounts which 
the manufacturer had failed to provide; 
and 
‘‘(ii) 25 percent of such amount. 
‘‘(B) APPLICATION.—The provisions of 
section 1128A (other than subsections (a) and 
(b)) shall apply to a civil money penalty under 
this paragraph in the same manner as such 
provisions apply to a penalty or proceeding 
under section 1128A(a). 
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302 
‘‘(f) CLARIFICATION REGARDING AVAILABILITY OF 
OTHER COVERED PART D DRUGS.—Nothing in this sec-
tion shall prevent an applicable beneficiary from pur-
chasing a covered part D drug that is not an applicable 
drug (including a generic drug or a drug that is not on 
the formulary of the prescription drug plan or MA–PD 
plan that the applicable beneficiary is enrolled in). 
‘‘(g) DEFINITIONS.—In this section: 
‘‘(1) APPLICABLE
BENEFICIARY.—The term 
‘applicable beneficiary’ means an individual who, on 
the date of dispensing a covered part D drug— 
‘‘(A) is enrolled in a prescription drug plan 
or an MA–PD plan; 
‘‘(B) is not enrolled in a qualified retiree 
prescription drug plan; and 
‘‘(C) has incurred costs for covered part D 
drugs in the year that are above the annual de-
ductible specified in section 1860D–2(b)(1) for 
such year. 
‘‘(2) APPLICABLE DRUG.—The term ‘applicable 
drug’ means, with respect to an applicable bene-
ficiary, a covered part D drug— 
‘‘(A) approved under a new drug applica-
tion under section 505(c) of the Federal Food, 
Drug, and Cosmetic Act or, in the case of a bio-
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303 
logic product, licensed under section 351 of the 
Public Health Service Act (including a product 
licensed under subsection (k) of such section 
351); and 
‘‘(B)(i) if the PDP sponsor of the prescrip-
tion drug plan or the MA organization offering 
the MA–PD plan uses a formulary, which is on 
the formulary of the prescription drug plan or 
MA–PD plan that the applicable beneficiary is 
enrolled in; 
‘‘(ii) if the PDP sponsor of the prescrip-
tion drug plan or the MA organization offering 
the MA–PD plan does not use a formulary, for 
which benefits are available under the prescrip-
tion drug plan or MA–PD plan that the appli-
cable beneficiary is enrolled in; or 
‘‘(iii) is provided through an exception or 
appeal. 
‘‘(3) APPLICABLE
NUMBER
OF
CALENDAR 
DAYS.—The term ‘applicable number of calendar 
days’ means— 
‘‘(A) with respect to claims for reimburse-
ment submitted electronically, 14 days; and 
‘‘(B) with respect to claims for reimburse-
ment submitted otherwise, 30 days. 
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‘‘(4) DISCOUNTED PRICE.— 
‘‘(A) IN GENERAL.—The term ‘discounted 
price’ means— 
‘‘(i) with respect to an applicable drug 
dispensed for an applicable beneficiary who 
has incurred costs that are below the an-
nual out-of-pocket threshold specified in 
section 1860D–2(b)(4)(B) for the year, 93 
percent of the negotiated price of the ap-
plicable drug of a manufacturer; and 
‘‘(ii) with respect to an applicable 
drug dispensed for an applicable bene-
ficiary who has incurred costs for covered 
part D drugs in the year that are equal to 
or exceed the annual out-of-pocket thresh-
old specified in section 1860D–2(b)(4)(B) 
for the year, 86 percent of the negotiated 
price of the applicable drug of a manufac-
turer. 
‘‘(B) CLARIFICATION.—Nothing in this 
section shall be construed as affecting the re-
sponsibility of an applicable beneficiary for pay-
ment of a dispensing fee for an applicable drug. 
‘‘(C) 
CLARIFICATION
FOR
CERTAIN 
CLAIMS.—With respect to the amount of the ne-
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gotiated price of an individual claim for an ap-
plicable drug with respect to an applicable bene-
ficiary, the manufacturer of the applicable drug 
shall provide— 
‘‘(i) the discounted price under clause 
(i) of subparagraph (A) only on the portion 
of the negotiated price of the applicable 
drug that falls above the deductible speci-
fied in section 1860D–2(b)(1) for the year 
and below the annual out-of-pocket thresh-
old specified in section 1860D–2(b)(4)(B) 
for the year; and 
‘‘(ii) the discounted price under clause 
(ii) of subparagraph (A) only on the por-
tion of the negotiated price of the applica-
ble drug that falls at or above such annual 
out-of-pocket threshold. 
‘‘(5) MANUFACTURER.—The term ‘manufac-
turer’ means any entity which is engaged in the pro-
duction, preparation, propagation, compounding, 
conversion, or processing of prescription drug prod-
ucts, either directly or indirectly by extraction from 
substances of natural origin, or independently by 
means of chemical synthesis, or by a combination of 
extraction and chemical synthesis. Such term does 
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not include a wholesale distributor of drugs or a re-
tail pharmacy licensed under State law. 
‘‘(6) NEGOTIATED
PRICE.—The term ‘nego-
tiated price’ has the meaning given such term in sec-
tion 1860D–2(d)(1)(B), except that such negotiated 
price shall not include any dispensing fee for the ap-
plicable drug. 
‘‘(7) QUALIFIED RETIREE PRESCRIPTION DRUG 
PLAN.—The term ‘qualified retiree prescription drug 
plan’ has the meaning given such term in section 
1860D–22(a)(2).’’. 
(2) SUNSET OF MEDICARE COVERAGE GAP DIS-
COUNT PROGRAM.—Section 1860D–14A of the So-
cial Security Act (42 U.S.C. 1395–114a) is amend-
ed— 
(A) in subsection (a), in the first sentence, 
by striking ‘‘The Secretary’’ and inserting 
‘‘Subject to subsection (h), the Secretary’’; and 
(B) by adding at the end the following new 
subsection: 
‘‘(h) SUNSET OF PROGRAM.— 
‘‘(1) IN
GENERAL.—The program shall not 
apply to applicable drugs dispensed on or after Jan-
uary 1, 2023, and, subject to paragraph (2), agree-
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307 
ments under this section shall be terminated as of 
such date. 
‘‘(2) CONTINUED APPLICATION FOR APPLICA-
BLE
DRUGS
DISPENSED
PRIOR
TO
SUNSET.—The 
provisions of this section (including all responsibil-
ities and duties) shall continue to apply after Janu-
ary 1, 2023, with respect to applicable drugs dis-
pensed prior to such date.’’. 
(3) INCLUSION OF ACTUARIAL VALUE OF MANU-
FACTURER DISCOUNTS IN BIDS.—Section 1860D–11 
of the Social Security Act (42 U.S.C. 1395w–111) 
is amended— 
(A) in subsection (b)(2)(C)(iii)— 
(i) by striking ‘‘assumptions regarding 
the reinsurance’’ and inserting ‘‘assump-
tions regarding— 
‘‘(I) the reinsurance’’; and 
(ii) by adding at the end the fol-
lowing: 
‘‘(II) for 2023 and each subse-
quent year, the manufacturer dis-
counts provided under section 1860D– 
14B subtracted from the actuarial 
value to produce such bid; and’’; and 
(B) in subsection (c)(1)(C)— 
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(i) by striking ‘‘an actuarial valuation 
of the reinsurance’’ and inserting ‘‘an ac-
tuarial valuation of— 
‘‘(i) the reinsurance’’; 
(ii) in clause (i), as added by clause 
(i) of this subparagraph, by adding ‘‘and’’ 
at the end; and 
(iii) by adding at the end the fol-
lowing: 
‘‘(ii) for 2023 and each subsequent 
year, the manufacturer discounts provided 
under section 1860D–14B;’’. 
(4) CLARIFICATION REGARDING EXCLUSION OF 
MANUFACTURER DISCOUNTS FROM TROOP.—Section 
1860D–2(b)(4) of the Social Security Act (42 
U.S.C. 1395w–102(b)(4)) is amended— 
(A) in subparagraph (C), by inserting ‘‘and 
subject to subparagraph (F)’’ after ‘‘subpara-
graph (E)’’; and 
(B) by adding at the end the following new 
subparagraph: 
‘‘(F) CLARIFICATION REGARDING EXCLU-
SION OF MANUFACTURER DISCOUNTS.—In ap-
plying subparagraph (A), incurred costs shall 
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309 
not include any manufacturer discounts pro-
vided under section 1860D–14B.’’. 
(e) DETERMINATION OF ALLOWABLE REINSURANCE 
COSTS.—Section 1860D–15(b) of the Social Security Act 
(42 U.S.C. 1395w–115(b)) is amended— 
(1) in paragraph (2)— 
(A) by striking ‘‘COSTS.—For purposes’’ 
and inserting ‘‘COSTS.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (B), for purposes’’; and 
(B) by adding at the end the following new 
subparagraph: 
‘‘(B) INCLUSION OF MANUFACTURER DIS-
COUNTS ON APPLICABLE DRUGS.—For purposes 
of applying subparagraph (A), the term ‘allow-
able reinsurance costs’ shall include the portion 
of the negotiated price (as defined in section 
1860D–14B(g)(6)) of an applicable drug (as 
defined in section 1860D–14B(g)(2)) that was 
paid by a manufacturer under the manufacturer 
discount program under section 1860D–14B.’’; 
and 
(2) in paragraph (3)— 
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(A) in the first sentence, by striking ‘‘For 
purposes’’ and inserting ‘‘Subject to paragraph 
(2)(B), for purposes’’; and 
(B) in the second sentence, by inserting 
‘‘or, in the case of an applicable drug, by a 
manufacturer’’ after ‘‘by the individual or 
under the plan’’. 
(f) UPDATING RISK ADJUSTMENT METHODOLOGIES 
TO ACCOUNT
FOR PART D MODERNIZATION REDE-
SIGN.—Section 1860D–15(c) of the Social Security Act 
(42 U.S.C. 1395w–115(c)) is amended by adding at the 
end the following new paragraph: 
‘‘(3) UPDATING
RISK
ADJUSTMENT
METH-
ODOLOGIES TO ACCOUNT FOR PART D MODERNIZA-
TION REDESIGN.—The Secretary shall update the 
risk adjustment methodologies used to adjust bid 
amounts pursuant to this subsection as appropriate 
to take into account changes in benefits under this 
part pursuant to the amendments made by section 
371 of the Fair Care Act of 2022.’’. 
(g) CONDITIONS FOR COVERAGE OF DRUGS UNDER 
THIS PART.—Section 1860D–43 of the Social Security 
Act (42 U.S.C. 1395w–153) is amended— 
(1) in subsection (a)— 
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311 
(A) in paragraph (2), by striking ‘‘and’’ at 
the end; 
(B) in paragraph (3), by striking the pe-
riod at the end and inserting a semicolon; and 
(C) by adding at the end the following new 
paragraphs: 
‘‘(4) participate in the manufacturer discount 
program under section 1860D–14B; 
‘‘(5) have entered into and have in effect an 
agreement described in subsection (b) of such sec-
tion 1860D–14B with the Secretary; and 
‘‘(6) have entered into and have in effect, under 
terms and conditions specified by the Secretary, a 
contract with a third party that the Secretary has 
entered into a contract with under subsection (d)(3) 
of such section 1860D–14B.’’; 
(2) by striking subsection (b) and inserting the 
following: 
‘‘(b) EFFECTIVE DATE.—Paragraphs (1) through (3) 
of subsection (a) shall apply to covered part D drugs dis-
pensed under this part on or after January 1, 2011, and 
before January 1, 2023, and paragraphs (4) through (6) 
of such subsection shall apply to covered part D drugs 
dispensed on or after January 1, 2023.’’; and 
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312 
(3) in subsection (c), by striking paragraph (2) 
and inserting the following: 
‘‘(2) the Secretary determines that in the period 
beginning on January 1, 2011, and ending on De-
cember 31, 2011 (with respect to paragraphs (1) 
through (3) of subsection (a)), or the period begin-
ning on January 1, 2023, and ending December 31, 
2023 (with respect to paragraphs (4) through (6) of 
such subsection), there were extenuating cir-
cumstances.’’. 
(h) CONFORMING AMENDMENTS.— 
(1) Section 1860D–2 of the Social Security Act 
(42 U.S.C. 1395w–102) is amended— 
(A) in subsection (a)(2)(A)(i)(I), by strik-
ing ‘‘, or an increase in the initial’’ and insert-
ing ‘‘or for a year preceding 2023 an increase 
in the initial’’; 
(B) in subsection (c)(1)(C)— 
(i) in the subparagraph heading, by 
striking ‘‘AT
INITIAL
COVERAGE
LIMIT’’; 
and 
(ii) by inserting ‘‘for a year preceding 
2023 or the annual out-of-pocket threshold 
specified in subsection (b)(4)(B) for the 
year for 2023 and each subsequent year’’ 
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313 
after ‘‘subsection (b)(3) for the year’’ each 
place it appears; and 
(C) in subsection (d)(1)(A), by striking ‘‘or 
an initial’’ and inserting ‘‘or for a year pre-
ceding 2023 an initial’’. 
(2) Section 1860D–4(a)(4)(B)(i) of the Social 
Security Act (42 U.S.C. 1395w–104(a)(4)(B)(i)) is 
amended by striking ‘‘the initial’’ and inserting ‘‘for 
a year preceding 2023, the initial’’. 
(3) Section 1860D–14(a) of the Social Security 
Act (42 U.S.C. 1395w–114(a)) is amended— 
(A) in paragraph (1)— 
(i) in subparagraph (C), by striking 
‘‘The continuation’’ and inserting ‘‘For a 
year preceding 2023, the continuation’’; 
(ii) in subparagraph (D)(iii), by strik-
ing ‘‘1860D–2(b)(4)(A)(i)(I)’’ and insert-
ing ‘‘1860D–2(b)(4)(A)(i)(I)(aa)’’; and 
(iii) in subparagraph (E), by striking 
‘‘The elimination’’ and inserting ‘‘For a 
year preceding 2023, the elimination’’; and 
(B) in paragraph (2)— 
(i) in subparagraph (C), by striking 
‘‘The continuation’’ and inserting ‘‘For a 
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year preceding 2023, the continuation’’; 
and 
(ii) in subparagraph (E)— 
(I) by inserting ‘‘for a year pre-
ceding 2023,’’ after ‘‘subsection (c)’’; 
and 
(II) 
by 
striking 
‘‘1860D– 
2(b)(4)(A)(i)(I)’’ 
and 
inserting 
‘‘1860D–2(b)(4)(A)(i)(I)(aa)’’. 
(4) Section 1860D–21(d)(7) of the Social Secu-
rity Act (42 U.S.C. 1395w–131(d)(7)) is amended 
by striking ‘‘section 1860D–2(b)(B)(4)(B)(i)’’ and 
inserting ‘‘section 1860D–2(b)(B)(4)(C)(i)’’. 
(5) Section 1860D–22(a)(2)(A) of the Social 
Security Act (42 U.S.C. 1395w–132(a)(2)(A)) is 
amended— 
(A) by striking ‘‘the value of any discount’’ 
and inserting the following: ‘‘the value of— 
‘‘(i) for years prior to 2023, any dis-
count’’; 
(B) in clause (i), as inserted by subpara-
graph (A) of this paragraph, by striking the pe-
riod at the end and inserting ‘‘; and’’; and 
(C) by adding at the end the following new 
clause: 
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‘‘(ii) for 2023 and each subsequent 
year, any discount provided pursuant to 
section 1860D–14B.’’. 
(6) Section 1860D–41(a)(6) of the Social Secu-
rity Act (42 U.S.C. 1395w–151(a)(6)) is amended— 
(A) by inserting ‘‘for a year before 2023’’ 
after ‘‘1860D–2(b)(3)’’; and 
(B) by inserting ‘‘for such year’’ before the 
period. 
(i) EFFECTIVE DATE.—The amendments made by 
this section shall apply to plan year 2023 and subsequent 
plan years. 
SEC. 372. MAXIMUM MONTHLY CAP ON COST-SHARING PAY-
MENTS UNDER PRESCRIPTION DRUG PLANS 
AND MA–PD PLANS. 
(a) IN GENERAL.—Section 1860D–2(b) of the Social 
Security Act (42 U.S.C. 1395w–102(b)), as amended by 
section 121, is amended— 
(1) in paragraph (2)— 
(A) in subparagraph (A), by striking ‘‘and 
(D)’’ and inserting ‘‘, (D), and (E)’’; and 
(B) by adding at the end the following new 
subparagraph: 
‘‘(E) MAXIMUM MONTHLY CAP ON COST- 
SHARING PAYMENTS.— 
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‘‘(i) IN GENERAL.—For plan years be-
ginning on or after January 1, 2023, the 
Secretary shall, through notice and com-
ment rulemaking, establish a process under 
which each PDP sponsor offering a pre-
scription drug plan and each MA organiza-
tion offering an MA–PD plan shall provide 
to any enrollee, including an enrollee who 
is a subsidy eligible individual (as defined 
in paragraph (3) of section 1860D–14(a)), 
the option to elect with respect to a plan 
year to have their monthly cost-sharing 
payments under the plan capped in accord-
ance with this subparagraph. 
‘‘(ii) DETERMINATION
OF
MAXIMUM 
MONTHLY
CAP.—For each month in the 
plan year after an enrollee in a prescrip-
tion drug plan or an MA–PD plan has 
made an election pursuant to clause (i), 
the PDP sponsor or MA organization shall 
determine a maximum monthly cap (as de-
fined in clause (iv)) for such enrollee. 
‘‘(iii) BENEFICIARY
MONTHLY
PAY-
MENTS.—With respect to an enrollee who 
has made an election pursuant to clause 
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(i), for each month described in clause (ii), 
the PDP sponsor or MA organization shall 
bill such enrollee an amount (not to exceed 
the maximum monthly cap) for the out-of- 
pocket costs of such enrollee in such 
month. 
‘‘(iv) MAXIMUM
MONTHLY
CAP
DE-
FINED.—In this subparagraph, the term 
‘maximum monthly cap’ means, with re-
spect to an enrollee— 
‘‘(I) for the first month in which 
this subparagraph applies, an amount 
determined by calculating— 
‘‘(aa) the annual out-of- 
pocket 
threshold 
specified 
in 
paragraph (4)(B) minus the in-
curred costs of the enrollee as de-
scribed in paragraph (4)(C); di-
vided by 
‘‘(bb) the number of months 
remaining in the plan year; and 
‘‘(II) for a subsequent month, an 
amount determined by calculating— 
‘‘(aa) the sum of any re-
maining out-of-pocket costs owed 
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by the enrollee from a previous 
month that have not yet been 
billed to the enrollee and any ad-
ditional costs incurred by the en-
rollee; divided by 
‘‘(bb) the number of months 
remaining in the plan year. 
‘‘(v) ADDITIONAL
REQUIREMENTS.— 
The following requirements shall apply 
with respect to the option to make an elec-
tion pursuant to clause (i) under this sub-
paragraph: 
‘‘(I) SECRETARIAL RESPONSIBIL-
ITIES.—The Secretary shall provide 
information to part D eligible individ-
uals on the option to make such elec-
tion through educational materials, in-
cluding through the notices provided 
under section 1804(a). 
‘‘(II) TIMING OF ELECTION.—An 
enrollee in a prescription drug plan or 
an MA–PD plan may make such an 
election— 
‘‘(aa) prior to the beginning 
of the plan year; or 
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319 
‘‘(bb) in any month during 
the plan year. 
‘‘(III) PDP SPONSOR
AND
MA 
ORGANIZATION
RESPONSIBILITIES.— 
Each PDP sponsor offering a pre-
scription drug plan or MA organiza-
tion offering an MA–PD plan— 
‘‘(aa) may not limit the op-
tion for an enrollee to make such 
an election to certain covered 
part D drugs; 
‘‘(bb) shall, prior to the plan 
year, notify prospective enrollees 
of the option to make such an 
election in promotional materials; 
‘‘(cc) shall include informa-
tion on such option in enrollee 
educational materials; 
‘‘(dd) shall have in place a 
mechanism to notify a pharmacy 
during the plan year when an en-
rollee incurs out-of-pocket costs 
with respect to covered part D 
drugs that make it likely the en-
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rollee may benefit from making 
such an election; 
‘‘(ee) shall provide that a 
pharmacy, after receiving a noti-
fication described in item (dd) 
with respect to an enrollee, in-
forms the enrollee of such notifi-
cation; 
‘‘(ff) shall ensure that such 
an election by an enrollee has no 
effect on the amount paid to 
pharmacies (or the timing of 
such payments) with respect to 
covered part D drugs dispensed 
to the enrollee; and 
‘‘(gg) shall have in place a 
financial reconciliation process to 
correct inaccuracies in payments 
made by an enrollee under this 
subparagraph with respect to 
covered part D drugs during the 
plan year. 
‘‘(IV) FAILURE TO PAY AMOUNT 
BILLED.—If an enrollee fails to pay 
the amount billed for a month as re-
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quired under this subparagraph, the 
election of the enrollee pursuant to 
clause (i) shall be terminated and en-
rollee shall pay the cost-sharing other-
wise applicable for any covered part D 
drugs subsequently dispensed to the 
enrollee up to the annual out-of-pock-
et threshold specified in paragraph 
(4)(B). 
‘‘(V) CLARIFICATION REGARDING 
PAST DUE AMOUNTS.—Nothing in this 
subparagraph shall be construed as 
prohibiting a PDP sponsor or an MA 
organization from billing an enrollee 
for an amount owed under this sub-
paragraph. 
‘‘(VI) TREATMENT
OF
UNSET-
TLED BALANCES.—Any unsettled bal-
ances with respect to amounts owed 
under this subparagraph shall be 
treated as plan losses and the Sec-
retary shall not be liable for any such 
balances outside of those assumed as 
losses estimated in plan bids.’’; and 
(2) in paragraph (4)— 
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(A) in subparagraph (C), by striking ‘‘and 
subject to subparagraph (F)’’ and inserting 
‘‘and subject to subparagraphs (F) and (G)’’; 
and 
(B) by adding at the end the following new 
subparagraph: 
‘‘(G) INCLUSION OF COSTS PAID UNDER 
MAXIMUM MONTHLY CAP OPTION.—In applying 
subparagraph (A), with respect to an enrollee 
who has made an election pursuant to clause (i) 
of paragraph (2)(E), costs shall be treated as 
incurred if such costs are paid by a PDP spon-
sor or an MA organization under the process 
provided under such paragraph.’’. 
(b) APPLICATION TO ALTERNATIVE PRESCRIPTION 
DRUG COVERAGE.—Section 1860D–2(c) of the Social Se-
curity Act (42 U.S.C. 1395w–102(c)) is amended by add-
ing at the end the following new paragraph: 
‘‘(4) SAME MAXIMUM MONTHLY CAP ON COST- 
SHARING.—For plan years beginning on or after 
January 1, 2023, the maximum monthly cap on 
cost-sharing payments under the process provided 
under subsection (b)(2)(E) shall apply to such cov-
erage.’’. 
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323 
SEC. 373. MEDICARE PART B REBATE BY MANUFACTURERS 
FOR DRUGS OR BIOLOGICALS WITH PRICES 
INCREASING FASTER THAN INFLATION. 
(a) IN GENERAL.—Section 1847A of the Social Secu-
rity Act (42 U.S.C. 1395w–3a) is amended by adding at 
the end the following new subsection: 
‘‘(h) REBATE BY MANUFACTURERS FOR DRUGS OR 
BIOLOGICALS WITH PRICES INCREASING FASTER THAN 
INFLATION.— 
‘‘(1) REQUIREMENTS.— 
‘‘(A) SECRETARIAL PROVISION OF INFOR-
MATION.—Not later than 6 months after the 
end of each rebate period (as defined in para-
graph (2)(A)) beginning on or after January 1, 
2023, the Secretary shall, for each rebatable 
drug (as defined in paragraph (2)(B)), report 
to each manufacturer of such rebatable drug 
the following for such rebate period: 
‘‘(i) Information on the total number 
of units of the billing and payment code 
described in subparagraph (A)(i) of para-
graph (3) with respect to such rebatable 
drug and rebate period. 
‘‘(ii) Information on the amount (if 
any) of the excess average sales price in-
crease described in subparagraph (A)(ii) of 
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324 
such paragraph for such rebatable drug 
and rebate period. 
‘‘(iii) The rebate amount specified 
under such paragraph for such rebatable 
drug and rebate period. 
‘‘(B) MANUFACTURER REBATE.— 
‘‘(i) IN GENERAL.—Subject to clause 
(ii), for each rebate period beginning on or 
after January 1, 2023, the manufacturer 
of a rebatable drug shall, for such drug, 
not later than 30 days after the date of re-
ceipt from the Secretary of the information 
and rebate amount pursuant to subpara-
graph (A) for such rebate period, provide 
to the Secretary a rebate that is equal to 
the amount specified in paragraph (3) for 
such drug for such rebate period. 
‘‘(ii) EXEMPTION FOR SHORTAGES.— 
The Secretary may reduce or waive the re-
bate under this subparagraph with respect 
to a rebatable drug that is listed on the 
drug shortage list maintained by the Food 
and Drug Administration pursuant to sec-
tion 506E of the Federal Food, Drug, and 
Cosmetic Act. 
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‘‘(C) REQUEST FOR RECONSIDERATION.— 
The Secretary shall establish procedures under 
which a manufacturer of a rebatable drug may 
request a reconsideration by the Secretary of 
the rebate amount specified under paragraph 
(3) for such rebatable drug and rebate period, 
as reported to the manufacturer pursuant to 
subparagraph (A)(iii). 
‘‘(2) REBATE PERIOD AND REBATABLE DRUG 
DEFINED.—In this subsection: 
‘‘(A) REBATE PERIOD.—The term ‘rebate 
period’ means a calendar quarter beginning on 
or after January 1, 2023. 
‘‘(B) 
REBATABLE
DRUG.—The 
term 
‘rebatable drug’ means a single source drug or 
biological (other than a biosimilar biological 
product)— 
‘‘(i) 
described 
in 
section 
1842(o)(1)(C) for which the payment 
amount is provided under this section; or 
‘‘(ii) for which payment is made sepa-
rately under section 1833(i) or section 
1833(t) and for which the payment 
amount is calculated based on the payment 
amount under this section. 
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‘‘(3) REBATE AMOUNT.— 
‘‘(A) IN GENERAL.—For purposes of para-
graph (1)(B), the amount specified in this para-
graph for a rebatable drug assigned to a billing 
and payment code for a rebate period is, subject 
to paragraph (4), the amount equal to the prod-
uct of— 
‘‘(i) subject to subparagraph (B), the 
total number of units of the billing and 
payment code for such rebatable drug fur-
nished during the rebate period; and 
‘‘(ii) the amount (if any) by which— 
‘‘(I) 
the 
amount 
determined 
under subsection (b)(4) for such 
rebatable drug during the rebate pe-
riod; exceeds 
‘‘(II) the inflation-adjusted base 
payment amount determined under 
subparagraph (C) of this paragraph 
for such rebatable drug during the re-
bate period. 
‘‘(B) EXCLUDED UNITS.—For purposes of 
subparagraph (A)(i), the total number of units 
of the billing and payment code for rebatable 
drugs furnished during a rebate period shall not 
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include units with respect to which the manu-
facturer provides a discount under the program 
under section 340B of the Public Health Serv-
ice Act or a rebate under section 1927. 
‘‘(C) DETERMINATION OF INFLATION-AD-
JUSTED PAYMENT AMOUNT.—The inflation-ad-
justed payment amount determined under this 
subparagraph for a rebatable drug for a rebate 
period is— 
‘‘(i) the amount determined under 
subsection (b)(4) for such rebatable drug 
in the payment amount benchmark quarter 
(as defined in subparagraph (D)); in-
creased by 
‘‘(ii) the percentage by which the re-
bate period CPI–U (as defined in subpara-
graph (F)) for the rebate period exceeds 
the benchmark period CPI–U (as defined 
in subparagraph (E)). 
‘‘(D) 
PAYMENT
AMOUNT
BENCHMARK 
QUARTER.—The term ‘payment amount bench-
mark quarter’ means the calendar quarter be-
ginning July 1, 2019. 
‘‘(E) BENCHMARK
PERIOD
CPI–U.—The 
term ‘benchmark period CPI–U’ means the con-
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sumer price index for all urban consumers 
(United States city average) for July 2019. 
‘‘(F) REBATE PERIOD CPI–U.—The term 
‘rebate period CPI–U’ means, with respect to a 
rebate period, the consumer price index for all 
urban consumers (United States city average) 
for the last month of the calendar quarter that 
is two calendar quarters prior to the rebate pe-
riod. 
‘‘(4) APPLICATION
TO
NEW
DRUGS.—In the 
case of a rebatable drug first approved or licensed 
by the Food and Drug Administration after July 1, 
2021, the following shall apply: 
‘‘(A) DURING INITIAL PERIOD.—For quar-
ters during the initial period in which the pay-
ment amount for such drug is determined using 
the 
methodology 
described 
in 
subsection 
(c)(4)— 
‘‘(i) clause (ii)(I) of paragraph (3)(A) 
shall be applied as if the reference to ‘the 
amount 
determined 
under 
subsection 
(b)(4),’ were a reference to ‘the wholesale 
acquisition cost applicable under subsection 
(c)(4)’; 
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‘‘(ii) clause (i) of paragraph (3)(C) 
shall be applied— 
‘‘(I) as if the reference to ‘the 
amount determined under subsection 
(b)(4),’ were a reference to ‘the whole-
sale acquisition cost applicable under 
subsection (c)(4)’; and 
‘‘(II) as if the term ‘payment 
amount benchmark quarter’ were de-
fined under paragraph (3)(D) as the 
first full calendar quarter after the 
day on which the drug was first mar-
keted; and 
‘‘(iii) clause (ii) of paragraph (3)(C) 
shall be applied as if the term ‘benchmark 
period CPI–U’ were defined under para-
graph (4)(E) as if the reference to ‘July 
2019’ under such paragraph were a ref-
erence to ‘the first month of the first full 
calendar quarter after the day on which 
the drug was first marketed’. 
‘‘(B) AFTER INITIAL PERIOD.—For quar-
ters beginning after such initial period— 
‘‘(i) clause (i) of paragraph (3)(C) 
shall be applied as if the term ‘payment 
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amount benchmark quarter’ were defined 
under paragraph (3)(D) as the first full 
calendar quarter for which the Secretary is 
able to compute an average sales price for 
the rebatable drug; and 
‘‘(ii) clause (ii) of paragraph (3)(C) 
shall be applied as if the term ‘benchmark 
period CPI–U’ were defined under para-
graph (4)(E) as if the reference to ‘July 
2019’ under such paragraph were a ref-
erence to ‘the first month of the first full 
calendar quarter for which the Secretary is 
able to compute an average sales price for 
the rebatable drug’. 
‘‘(5) REBATE DEPOSITS.—Amounts paid as re-
bates under paragraph (1)(B) shall be deposited into 
the Federal Supplementary Medical Insurance Trust 
Fund established under section 1841. 
‘‘(6) ENFORCEMENT.— 
‘‘(A) CIVIL MONEY PENALTY.— 
‘‘(i) IN
GENERAL.—The Secretary 
shall impose a civil money penalty on a 
manufacturer that fails to comply with the 
requirements under paragraph (1)(B) with 
respect to providing a rebate for a 
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rebatable drug for a rebate period for each 
such failure in an amount equal to the sum 
of— 
‘‘(I) the rebate amount specified 
pursuant to paragraph (3) for such 
drug for such rebate period; and 
‘‘(II) 25 percent of such amount. 
‘‘(ii) APPLICATION.—The provisions 
of section 1128A (other than subsections 
(a) (with respect to amounts of penalties 
or additional assessments) and (b)) shall 
apply to a civil money penalty under this 
subparagraph in the same manner as such 
provisions apply to a penalty or proceeding 
under section 1128A(a). 
‘‘(B) NO PAYMENT FOR MANUFACTURERS 
WHO FAIL TO PAY PENALTY.—If the manufac-
turer of a rebatable drug fails to pay a civil 
money penalty under subparagraph (A) with re-
spect to the failure to provide a rebate for a 
rebatable drug for a rebate period by a date 
specified by the Secretary after the imposition 
of such penalty, no payment shall be available 
under this part for such rebatable drug for cal-
endar quarters beginning on or after such date 
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until the Secretary determines the manufac-
turer has paid the penalty due under such sub-
paragraph.’’. 
(b) IMPLEMENTATION.—Section 1847A(g) of the So-
cial Security Act (42 U.S.C. 1395w–3(g)) is amended— 
(1) in paragraph (4), by striking ‘‘and’’ at the 
end; 
(2) in paragraph (5), by striking the period at 
the end and inserting ‘‘; and’’; and 
(3) by adding at the end the following new 
paragraph: 
‘‘(6) determination of the rebate amount for a 
rebatable drug under paragraph (3) of subsection 
(h), including with respect to a new drug pursuant 
to paragraph (4) of such subsection, including— 
‘‘(A) a decision by the Secretary with re-
spect to a request for reconsideration under 
paragraph (1)(C); and 
‘‘(B) the determination of— 
‘‘(i) the total number of units of the 
billing and payment code under paragraph 
(3)(A)(i); and 
‘‘(ii) the inflation-adjusted payment 
amount under paragraph (3)(C).’’. 
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pbinns on DSKJLVW7X2PROD with $$_JOB