reasonably attributable to the 
violation of this section; and 
(II) if such party is the subse-
quent filer (or, in the case of an 
agreement between two subsequent fil-
ers, the subsequent filer who received 
the value described in subsection 
(a)(1)), 3 times the value received by 
such subsequent filer that is reason-
ably attributable to the violation of 
this section. 
(ii) FACTORS FOR CONSIDERATION.— 
In determining such amount, the court 
shall take into account— 
(I) the nature, circumstances, ex-
tent, and gravity of the violation; 
(II) with respect to the violator, 
the degree of culpability, any history 
of violations, the ability to pay, any 
effect on the ability to continue doing 
business, profits earned by the NDA 
or BLA holder (or, in the case of an 
agreement between two subsequent fil-
ers, the subsequent filer who gave the 
value described in subsection (a)(1)),
compensation received by the subse-
quent filer (or, in the case of an 
agreement between two subsequent fil-
ers, the subsequent filer who received 
the value described in subsection 
(a)(1)), and the amount of commerce 
affected; and 
(III) other matters that justice 
requires. 
(D) INJUNCTIONS AND OTHER EQUITABLE 
RELIEF.—In a civil action under subparagraph 
(A), the United States district courts are em-
powered to grant mandatory injunctions and 
such other and further equitable relief as they 
deem appropriate. 
(4) REMEDIES
IN
ADDITION.—Remedies pro-
vided in this subsection are in addition to, and not 
in lieu of, any other remedy provided by Federal 
law. 
(5) PRESERVATION OF AUTHORITY OF COMMIS-
SION.—Nothing in this section shall be construed to 
affect any authority of the Commission under any 
other provision of law. 
(e) FEDERAL TRADE COMMISSION RULEMAKING.— 
The Commission may, in its discretion, by rule promul-
gated under section 553 of title 5, United States Code, 
exempt from this section certain agreements described in 
subsection (a) if the Commission finds such agreements 
to be in furtherance of market competition and for the 
benefit of consumers. 
(f) ANTITRUST LAWS.—Nothing in this section shall 
modify, impair, limit, or supersede the applicability of the 
antitrust laws as defined in subsection (a) of the first sec-
tion of the Clayton Act (15 U.S.C. 12(a)), and of section 
5 of the Federal Trade Commission Act (15 U.S.C. 45) 
to the extent that such section 5 applies to unfair methods 
of competition. Nothing in this section shall modify, im-
pair, limit, or supersede the right of a subsequent filer 
to assert claims or counterclaims against any person, 
under the antitrust laws or other laws relating to unfair 
competition. 
(g) DEFINITIONS.—In this section: 
(1) AGREEMENT
RESOLVING
OR
SETTLING
A 
COVERED
PATENT
INFRINGEMENT
CLAIM.—The 
term ‘‘agreement resolving or settling a covered pat-
ent infringement claim’’ means any agreement 
that— 
(A) resolves or settles a covered patent in-
fringement claim; or
(B) is contingent upon, provides for a con-
tingent condition for, or is otherwise related to 
the resolution or settlement of a covered patent 
infringement claim. 
(2) COMMISSION.—The term ‘‘Commission’’ 
means the Federal Trade Commission. 
(3) COVERED PATENT INFRINGEMENT CLAIM.— 
The term ‘‘covered patent infringement claim’’ 
means an allegation made by the NDA or BLA hold-
er to a subsequent filer (or, in the case of an agree-
ment between two subsequent filers, by one subse-
quent filer to another), whether or not included in 
a complaint filed with a court of law, that— 
(A) the submission of the application de-
scribed in subparagraph (A) or (B) of para-
graph (9), or the manufacture, use, offering for 
sale, sale, or importation into the United States 
of a covered product that is the subject of such 
an application— 
(i) in the case of an agreement be-
tween an NDA or BLA holder and a sub-
sequent filer, infringes any patent owned 
by, or exclusively licensed to, the NDA or 
BLA holder of the covered product; or
(ii) in the case of an agreement be-
tween two subsequent filers, infringes any 
patent owned by the subsequent filer; or 
(B) in the case of an agreement between 
an NDA or BLA holder and a subsequent filer, 
the covered product to be manufactured under 
such application uses a covered product as 
claimed in a published patent application. 
(4) COVERED
PRODUCT.—The term ‘‘covered 
product’’ means a drug (as defined in section 201(g) 
of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 321(g))), including a biological product (as 
defined in section 351(i) of the Public Health Serv-
ice Act (42 U.S.C. 262(i)). 
(5) NDA OR BLA HOLDER.—The term ‘‘NDA 
or BLA holder’’ means— 
(A) the holder of— 
(i) an approved new drug application 
filed under section 505(b)(1) of the Fed-
eral Food, Drug, and Cosmetic Act (21 
U.S.C. 355(b)(1)) for a covered product; 
or 
(ii) a biologics license application filed 
under section 351(a) of the Public Health
Service Act (42 U.S.C. 262(a)) with re-
spect to a biological product; 
(B) a person owning or controlling enforce-
ment of the patent on— 
(i) the list published under section 
505(j)(7) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(j)(7)) in con-
nection with the application described in 
subparagraph (A)(i); or 
(ii) any list published under section 
351 of the Public Health Service Act (42 
U.S.C. 262) comprised of patents associ-
ated with biologics license applications filed 
under section 351(a) of such Act (42 
U.S.C. 262(a)); or 
(C) the predecessors, subsidiaries, divi-
sions, groups, and affiliates controlled by, con-
trolling, or under common control with any en-
tity described in subparagraph (A) or (B) (such 
control to be presumed by direct or indirect 
share ownership of 50 percent or greater), as 
well as the licensees, licensors, successors, and 
assigns of each of the entities.
a claim of infringement could reasonably be asserted 
against any person for making, using, offering to sell, sell-
ing, or importing into the United States a biological prod-
uct that is the subject of a biosimilar biological product 
application’’ before the period at the end. 
(b) CERTIFICATION OF AGREEMENTS.—Section 1112 
of such Act (21 U.S.C. 355 note) is amended by adding 
at the end the following: 
‘‘(d) CERTIFICATION.—The Chief Executive Officer 
or the company official responsible for negotiating any 
agreement under subsection (a) or (b) that is required to 
be filed under subsection (c) shall, within 30 days of such 
filing, execute and file with the Assistant Attorney General 
and the Commission a certification as follows: ‘I declare 
that the following is true, correct, and complete to the best 
of my knowledge: The materials filed with the Federal 
Trade Commission and the Department of Justice under 
section 1112 of the Medicare Prescription Drug, Improve-
ment, and Modernization Act of 2003, with respect to the 
agreement referenced in this certification— 
‘‘ ‘(1) represent the complete, final, and exclu-
sive agreement between the parties; 
‘‘ ‘(2) include any ancillary agreements that are 
contingent upon, provide a contingent condition for,
were entered into within 30 days of, or are otherwise 
related to, the referenced agreement; and 
‘‘ ‘(3) include written descriptions of any oral 
agreements, representations, commitments, or prom-
ises between the parties that are responsive to sub-
section (a) or (b) of such section 1112 and have not 
been reduced to writing.’.’’. 
SEC. 113. FORFEITURE OF 180-DAY EXCLUSIVITY PERIOD. 
Section 505(j)(5)(D)(i)(V) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(D)(i)(V)) 
is amended by inserting ‘‘section 111 of the Strengthening 
Health Care and Lowering Prescription Drug Costs Act 
or’’ after ‘‘that the agreement has violated’’. 
SEC. 114. COMMISSION LITIGATION AUTHORITY. 
Section 16(a)(2) of the Federal Trade Commission 
Act (15 U.S.C. 56(a)(2)) is amended— 
(1) in subparagraph (D), by striking ‘‘or’’ after 
the semicolon; 
(2) in subparagraph (E), by inserting ‘‘or’’ 
after the semicolon; and 
(3) by inserting after subparagraph (E) the fol-
lowing: 
‘‘(F) under section 111(d)(3)(A) of the 
Strengthening Health Care and Lowering Pre-
scription Drug Costs Act;’’.
SEC. 115. STATUTE OF LIMITATIONS. 
(a) IN GENERAL.—Except as provided in subsection 
(b), the Commission shall commence any administrative 
proceeding or civil action to enforce section 111 of this 
Act not later than 6 years after the date on which the 
parties to the agreement file the Notice of Agreement as 
provided by section 1112(c)(2) and (d) of the Medicare 
Prescription Drug, Improvement, and Modernization Act 
of 2003 (21 U.S.C. 355 note). 
(b) CIVIL ACTION AFTER ISSUANCE OF CEASE AND 
DESIST ORDER.—If the Commission has issued a cease 
and desist order under section 5 of the Federal Trade 
Commission Act (15 U.S.C. 45) for violation of section 
111 of this Act and the proceeding for the issuance of 
such order was commenced within the period required by 
subsection (a) of this section, such subsection does not 
prohibit the commencement, after such period, of a civil 
action under section 111(d)(3)(A) against a party to such 
order or a civil action under subsection (l) of such section 
5 for violation of such order. 
Subtitle C—Creating and Restoring 
Equal 
Access 
to 
Equivalent 
Samples 
SEC. 121. ACTIONS FOR DELAYS OF GENERIC DRUGS AND 
BIOSIMILAR BIOLOGICAL PRODUCTS. 
(a) DEFINITIONS.—In this section—
(1) the term ‘‘commercially reasonable, market- 
based terms’’ means— 
(A) a nondiscriminatory price for the sale 
of the covered product at or below, but not 
greater than, the most recent wholesale acquisi-
tion cost for the drug, as defined in section 
1847A(c)(6)(B) of the Social Security Act (42 
U.S.C. 1395w–3a(c)(6)(B)); 
(B) a schedule for delivery that results in 
the transfer of the covered product to the eligi-
ble product developer consistent with the timing 
under subsection (b)(2)(A)(iv); and 
(C) no additional conditions are imposed 
on the sale of the covered product; 
(2) the term ‘‘covered product’’— 
(A) means— 
(i) any drug approved under sub-
section (c) or (j) of section 505 of the Fed-
eral Food, Drug, and Cosmetic Act (21 
U.S.C. 355) or biological product licensed 
under subsection (a) or (k) of section 351 
of the Public Health Service Act (42 
U.S.C. 262); 
(ii) any combination of a drug or bio-
logical product described in clause (i); or
(iii) when reasonably necessary to 
support approval of an application under 
section 505 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 355), or sec-
tion 351 of the Public Health Service Act 
(42 U.S.C. 262), as applicable, or other-
wise meet the requirements for approval 
under either such section, any product, in-
cluding any device, that is marketed or in-
tended for use with such a drug or biologi-
cal product; and 
(B) does not include any drug or biological 
product that appears on the drug shortage list 
in effect under section 506E of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 
356e), unless— 
(i) the drug or biological product has 
been on the drug shortage list in effect 
under such section 506E continuously for 
more than 6 months; or 
(ii) the Secretary determines that in-
clusion of the drug or biological product as 
a covered product is likely to contribute to 
alleviating or preventing a shortage.
(3) the term ‘‘device’’ has the meaning given 
the term in section 201 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321); 
(4) the term ‘‘eligible product developer’’ means 
a person that seeks to develop a product for ap-
proval pursuant to an application for approval under 
subsection (b)(2) or (j) of section 505 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355) or 
for licensing pursuant to an application under sec-
tion 351(k) of the Public Health Service Act (42 
U.S.C. 262(k)); 
(5) the term ‘‘license holder’’ means the holder 
of an application approved under subsection (c) or 
(j) of section 505 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355) or the holder of a li-
cense under subsection (a) or (k) of section 351 of 
the Public Health Service Act (42 U.S.C. 262) for 
a covered product; 
(6) the term ‘‘REMS’’ means a risk evaluation 
and mitigation strategy under section 505–1 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355–1); 
(7) the term ‘‘REMS with ETASU’’ means a 
REMS that contains elements to assure safe use
(1) IN GENERAL.—An eligible product developer 
may bring a civil action against the license holder 
for a covered product seeking relief under this sub-
section in an appropriate district court of the United 
States alleging that the license holder has declined 
to provide sufficient quantities of the covered prod-
uct to the eligible product developer on commercially 
reasonable, market-based terms. 
(2) ELEMENTS.— 
(A) IN GENERAL.—To prevail in a civil ac-
tion brought under paragraph (1), an eligible 
product developer shall prove, by a preponder-
ance of the evidence— 
(i) that— 
(I) the covered product is not 
subject to a REMS with ETASU; or 
(II) if the covered product is sub-
ject to a REMS with ETASU— 
(aa) the eligible product de-
veloper has obtained a covered 
product authorization from the 
Secretary in accordance with sub-
paragraph (B); and 
(bb) the eligible product de-
veloper has provided a copy of
the covered product authorization 
to the license holder; 
(ii) that, as of the date on which the 
civil action is filed, the product developer 
has not obtained sufficient quantities of 
the covered product on commercially rea-
sonable, market-based terms; 
(iii) that the eligible product developer 
has submitted a written request to pur-
chase sufficient quantities of the covered 
product to the license holder and such re-
quest— 
(I) was sent to a named cor-
porate officer of the license holder; 
(II) was made by certified or reg-
istered mail with return receipt re-
quested; 
(III) specified an individual as 
the point of contact for the license 
holder to direct communications re-
lated to the sale of the covered prod-
uct to the eligible product developer 
and a means for electronic and writ-
ten communications with that indi-
vidual; and
(IV) specified an address to 
which the covered product was to be 
shipped upon reaching an agreement 
to transfer the covered product; and 
(iv) that the license holder has not de-
livered to the eligible product developer 
sufficient quantities of the covered product 
on commercially reasonable, market-based 
terms— 
(I) for a covered product that is 
not subject to a REMS with ETASU, 
by the date that is 31 days after the 
date on which the license holder re-
ceived the request for the covered 
product; and 
(II) for a covered product that is 
subject to a REMS with ETASU, by 
31 days after the later of— 
(aa) the date on which the 
license holder received the re-
quest for the covered product; or 
(bb) the date on which the 
license holder received a copy of 
the covered product authorization
issued by the Secretary in ac-
cordance with subparagraph (B). 
(B) AUTHORIZATION FOR COVERED PROD-
UCT SUBJECT TO A REMS WITH ETASU.— 
(i) REQUEST.—An eligible product de-
veloper may submit to the Secretary a 
written request for the eligible product de-
veloper to be authorized to obtain suffi-
cient quantities of an individual covered 
product subject to a REMS with ETASU. 
(ii) AUTHORIZATION.—Not later than 
120 days after the date on which a request 
under clause (i) is received, the Secretary 
shall, by written notice, authorize the eligi-
ble product developer to obtain sufficient 
quantities of an individual covered product 
subject to a REMS with ETASU for pur-
poses of— 
(I) development and testing that 
does not involve human clinical trials, 
if the eligible product developer has 
agreed to comply with any conditions 
the Secretary determines necessary; or
(II) development and testing that 
involves human clinical trials, if the 
eligible product developer has— 
(aa)(AA) submitted proto-
cols, 
informed 
consent 
docu-
ments, and informational mate-
rials for testing that include pro-
tections that provide safety pro-
tections comparable to those pro-
vided by the REMS for the cov-
ered product; or 
(BB) otherwise satisfied the 
Secretary that such protections 
will be provided; and 
(bb) met any other require-
ments the Secretary may estab-
lish. 
(iii) NOTICE.—A covered product au-
thorization issued under this subparagraph 
shall state that the provision of the covered 
product by the license holder under the 
terms of the authorization will not be a 
violation of the REMS for the covered 
product.
(3) AFFIRMATIVE DEFENSE.—In a civil action 
brought under paragraph (1), it shall be an affirma-
tive defense, on which the defendant has the burden 
of persuasion by a preponderance of the evidence— 
(A) that, on the date on which the eligible 
product developer requested to purchase suffi-
cient quantities of the covered product from the 
license holder— 
(i) neither the license holder nor any 
of its agents, wholesalers, or distributors 
was engaged in the manufacturing or com-
mercial marketing of the covered product; 
and 
(ii) neither the license holder nor any 
of its agents, wholesalers, or distributors 
otherwise had access to inventory of the 
covered product to supply to the eligible 
product developer on commercially reason-
able, market-based terms; 
(B) that— 
(i) the license holder sells the covered 
product through agents, distributors, or 
wholesalers; 
(ii) the license holder has placed no 
restrictions, explicit or implicit, on its
agents, distributors, or wholesalers to sell 
covered products to eligible product devel-
opers; and 
(iii) the covered product can be pur-
chased by the eligible product developer in 
sufficient quantities on commercially rea-
sonable, market-based terms from the 
agents, distributors, or wholesalers of the 
license holder; or 
(C) that the license holder made an offer 
to the individual specified pursuant to para-
graph (2)(A)(iii)(III), by a means of commu-
nication (electronic, written, or both) specified 
pursuant to such paragraph, to sell sufficient 
quantities of the covered product to the eligible 
product developer at commercially reasonable 
market-based terms— 
(i) for a covered product that is not 
subject to a REMS with ETASU, by the 
date that is 14 days after the date on 
which the license holder received the re-
quest for the covered product, and the eli-
gible product developer did not accept such 
offer by the date that is 7 days after the 
date on which the eligible product devel-
oper received such offer from the license 
holder; or 
(ii) for a covered product that is sub-
ject to a REMS with ETASU, by the date 
that is 20 days after the date on which the 
license holder received the request for the 
covered product, and the eligible product 
developer did not accept such offer by the 
date that is 10 days after the date on 
which the eligible product developer re-
ceived such offer from the license holder. 
(4) REMEDIES.— 
(A) IN GENERAL.—If an eligible product 
developer prevails in a civil action brought 
under paragraph (1), the court shall— 
(i) order the license holder to provide 
to the eligible product developer without 
delay sufficient quantities of the covered 
product on commercially reasonable, mar-
ket-based terms; 
(ii) award to the eligible product de-
veloper reasonable attorney’s fees and costs 
of the civil action; and 
(iii) award to the eligible product de-
veloper a monetary amount sufficient to
(II) for a covered product that is 
subject to a REMS with ETASU, the 
date that is 31 days after the later 
of— 
(aa) the date on which the 
license holder received the re-
quest; or 
(bb) the date on which the 
license holder received a copy of 
the covered product authorization 
issued by the Secretary in ac-
cordance with paragraph (2)(B); 
and 
(ii) ending on the date on which the 
eligible product developer received suffi-
cient quantities of the covered product. 
(C) AVOIDANCE
OF
DELAY.—The court 
may issue an order under subparagraph (A)(i) 
before conducting further proceedings that may 
be necessary to determine whether the eligible 
product developer is entitled to an award under 
clause (ii) or (iii) of subparagraph (A), or the 
amount of any such award. 
(c) LIMITATION OF LIABILITY.—A license holder for 
a covered product shall not be liable for any claim under
Federal, State, or local law arising out of the failure of 
an eligible product developer to follow adequate safeguards 
to assure safe use of the covered product during develop-
ment or testing activities described in this section, includ-
ing transportation, handling, use, or disposal of the cov-
ered product by the eligible product developer. 
(d) NO VIOLATION OF REMS.—Section 505–1 of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355– 
1) is amended by adding at the end the following new sub-
section: 
‘‘(l) PROVISION OF SAMPLES NOT A VIOLATION OF 
STRATEGY.—The provision of samples of a covered prod-
uct to an eligible product developer (as those terms are 
defined in section 121(a) of the Strengthening Health 
Care and Lowering Prescription Drug Costs Act) shall not 
be considered a violation of the requirements of any risk 
evaluation and mitigation strategy that may be in place 
under this section for such drug.’’. 
(e) RULE OF CONSTRUCTION.— 
(1) DEFINITION.—In this subsection, the term 
‘‘antitrust laws’’— 
(A) has the meaning given the term in 
subsection (a) of the first section of the Clayton 
Act (15 U.S.C. 12); and
(B) includes section 5 of the Federal 
Trade Commission Act (15 U.S.C. 45) to the 
extent that such section applies to unfair meth-
ods of competition. 
(2) ANTITRUST LAWS.—Nothing in this section 
shall be construed to limit the operation of any pro-
vision of the antitrust laws. 
SEC. 122. REMS APPROVAL PROCESS FOR SUBSEQUENT 
FILERS. 
Section 505–1 of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 355–1), as amended by section 121, 
is further amended— 
(1) in subsection (g)(4)(B)— 
(A) in clause (i) by striking ‘‘or’’ after the 
semicolon; 
(B) in clause (ii) by striking the period at 
the end and inserting ‘‘; or’’; and 
(C) by adding at the end the following: 
‘‘(iii) accommodate different, com-
parable aspects of the elements to assure 
safe use for a drug that is the subject of 
an application under section 505(j), and 
the applicable listed drug.’’; 
(2) in subsection (i)(1), by striking subpara-
graph (C) and inserting the following:
‘‘(C)(i) Elements to assure safe use, if re-
quired under subsection (f) for the listed drug, 
which, subject to clause (ii), for a drug that is 
the subject of an application under section 
505(j) may use— 
‘‘(I) a single, shared system with the 
listed drug under subsection (f); or 
‘‘(II) a different, comparable aspect of 
the elements to assure safe use under sub-
section (f). 
‘‘(ii) The Secretary may require a drug 
that is the subject of an application under sec-
tion 505(j) and the listed drug to use a single, 
shared system under subsection (f), if the Sec-
retary determines that no different, comparable 
aspect of the elements to assure safe use could 
satisfy the requirements of subsection (f).’’; 
(3) in subsection (i), by adding at the end the 
following: 
‘‘(3) SHARED
REMS.—If the Secretary ap-
proves, in accordance with paragraph (1)(C)(i)(II), a 
different, comparable aspect of the elements to as-
sure safe use under subsection (f) for a drug that 
is the subject of an abbreviated new drug application 
under section 505(j), the Secretary may require that
such different comparable aspect of the elements to 
assure safe use can be used with respect to any 
other drug that is the subject of an application 
under section 505(j) or 505(b) that references the 
same listed drug.’’; and 
(4) by adding at the end the following: 
‘‘(m) SEPARATE REMS.—When used in this section, 
the terms ‘different, comparable aspect of the elements to 
assure safe use’ or ‘different, comparable approved risk 
evaluation and mitigation strategies’ means a risk evalua-
tion and mitigation strategy for a drug that is the subject 
of an application under section 505(j) that uses different 
methods or operational means than the strategy required 
under subsection (a) for the applicable listed drug, or 
other application under section 505(j) with the same such 
listed drug, but achieves the same level of safety as such 
strategy.’’. 
SEC. 123. RULE OF CONSTRUCTION. 
(a) IN GENERAL.—Nothing in this subtitle, the 
amendments made by this subtitle, or in section 505–1 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355–1), shall be construed as— 
(1) prohibiting a license holder from providing 
an eligible product developer access to a covered
product in the absence of an authorization under 
this subtitle; or 
(2) in any way negating the applicability of a 
REMS with ETASU, as otherwise required under 
such section 505–1, with respect to such covered 
product. 
(b) DEFINITIONS.—In this section, the terms ‘‘cov-
ered product’’, ‘‘eligible product developer’’, ‘‘license hold-
er’’, and ‘‘REMS with ETASU’’ have the meanings given 
such terms in section 121(a). 
Subtitle D—Study on Role of Fed-
eral Assistance in Drug Devel-
opment 
SEC. 131. STUDY ON ROLE OF FEDERAL ASSISTANCE IN 
DRUG DEVELOPMENT. 
(a) IN GENERAL.—Not later than 2 years after the 
date of the enactment of this Act, the Secretary of the 
Health and Human Services shall enter into a contract 
with the National Academy of Medicine to conduct a study 
on, and submit to Congress a report on, the following: 
(1) The percentage of drugs developed in the 
United States using at least some amount of Federal 
funding from any Federal source. 
(2) The average cost incurred by a drug devel-
oper to develop a drug.
(3) The average amount of revenue and profits 
made by drug developers from the sales of drugs. 
(4) The percentage of such revenue and profits 
that are reinvested into research and development of 
new drugs. 
(5) The appropriate percentage, if any, of such 
revenue and profits the Secretary, in consultation 
with the National Academy of Medicine, rec-
ommends should be returned to Federal entities for 
Federal funding used in the development of the 
drugs involved. 
(b) ENFORCEMENT.—A drug developer shall, as a 
condition of receipt of any Federal funding for the devel-
opment of drugs, comply with any request for the data 
necessary to perform the study under subsection (a). 
(c) CONFIDENTIALITY.—This section does not au-
thorize the disclosure of any trade secret, confidential 
commercial or financial information, or other matter listed 
in section 552(b) of title 5, United States Code. 
(d) DEFINITIONS.—In this section: 
(1) The term ‘‘drug’’ has the meaning given 
such term in section 201 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321). 
(2) The term ‘‘drug developer’’ means an entity 
that submitted, and received approval of, an applica-
(5) the impacts of generic drugs and biosimilar 
biological products on consumer costs. 
Subtitle F—Reports 
SEC. 151. EFFECTS OF INCREASES IN PRESCRIPTION DRUG 
PRICE. 
Not later than 1 year after the date of enactment 
of this Act, the Secretary of Health and Human Services 
shall submit a report to the Congress on the extent to 
which increases in prescription drug prices may have 
caused Medicare beneficiaries to forego recommended 
treatment, including failing to fill prescriptions. 
TITLE II—HEALTH INSURANCE 
MARKET STABILIZATION 
SEC. 201. PRESERVING STATE OPTION TO IMPLEMENT 
HEALTH CARE MARKETPLACES. 
(a) IN GENERAL.—Section 1311 of the Patient Pro-
tection and Affordable Care Act (42 U.S.C. 18031) is 
amended— 
(1) in subsection (a)— 
(A) in paragraph (4)(B), by striking 
‘‘under this subsection’’ and inserting ‘‘under 
this paragraph or paragraph (1)’’; and 
(B) by adding at the end the following new 
paragraph:
‘‘(6) ADDITIONAL PLANNING AND ESTABLISH-
MENT GRANTS.— 
‘‘(A) IN GENERAL.—There shall be appro-
priated to the Secretary, out of any moneys in 
the Treasury not otherwise appropriated, $200 
million to award grants to eligible States for 
the uses described in paragraph (3). 
‘‘(B) DURATION AND RENEWABILITY.—A 
grant awarded under subparagraph (A) shall be 
for a period of 2 years and may not be renewed. 
‘‘(C) LIMITATION.—A grant may not be 
awarded under subparagraph (A) after Decem-
ber 31, 2023. 
‘‘(D) ELIGIBLE
STATE
DEFINED.—For 
purposes of this paragraph, the term ‘eligible 
State’ means a State that, as of the date of the 
enactment of this paragraph, is not operating 
an Exchange (other than an Exchange de-
scribed in section 155.200(f) of title 45, Code 
of Federal Regulations).’’; and 
(2) in subsection (d)(5)(A)— 
(A) by striking ‘‘OPERATIONS.—In estab-
lishing an Exchange under this section’’ and in-
serting ‘‘OPERATIONS.—
‘‘(i) IN GENERAL.—In establishing an 
Exchange under this section (other than in 
establishing an Exchange pursuant to a 
grant awarded under subsection (a)(6))’’; 
and 
(B) by adding at the end the following: 
‘‘(ii) ADDITIONAL PLANNING AND ES-
TABLISHMENT
GRANTS.—In establishing 
an Exchange pursuant to a grant awarded 
under subsection (a)(6), the State shall en-
sure that such Exchange is self-sustaining 
beginning on January 1, 2025, including 
allowing the Exchange to charge assess-
ments or user fees to participating health 
insurance issuers, or to otherwise generate 
funding, to support its operations.’’. 
(b) CLARIFICATION REGARDING FAILURE TO ESTAB-
LISH EXCHANGE OR IMPLEMENT REQUIREMENTS.—Sec-
tion 1321(c) of the Patient Protection and Affordable 
Care Act (42 U.S.C. 18041(c)) is amended— 
(1) in paragraph (1), by striking ‘‘If’’ and in-
serting ‘‘Subject to paragraph (3), if’’; and 
(2) by adding at the end the following new 
paragraph:
‘‘(3) CLARIFICATION.—This subsection shall 
not apply in the case of a State that elects to apply 
the requirements described in subsection (a) and 
satisfies the requirement described in subsection (b) 
on or after January 1, 2014.’’. 
SEC. 202. PROVIDING FOR ADDITIONAL REQUIREMENTS 
WITH RESPECT TO THE NAVIGATOR PRO-
GRAM. 
(a) IN GENERAL.—Section 1311(i) of the Patient 
Protection and Affordable Care Act (42 U.S.C. 18031(i)) 
is amended— 
(1) in paragraph (2), by adding at the end the 
following new subparagraph: 
‘‘(C) SELECTION OF RECIPIENTS.—In the 
case of an Exchange established and operated 
by the Secretary within a State pursuant to sec-
tion 1321(c), in awarding grants under para-
graph (1), the Exchange shall— 
‘‘(i) select entities to receive such 
grants based on an entity’s demonstrated 
capacity to carry out each of the duties 
specified in paragraph (3); 
‘‘(ii) not take into account whether or 
not the entity has demonstrated how the 
entity will provide information to individ-
uals relating to group health plans offered 
by a group or association of employers de-
scribed in section 2510.3–5(b) of title 29, 
Code of Federal Regulations (or any suc-
cessor regulation), or short-term limited 
duration insurance (as defined by the Sec-
retary for purposes of section 2791(b)(5) 
of the Public Health Service Act); and 
‘‘(iii) ensure that, each year, the Ex-
change awards such a grant to— 
‘‘(I) at least one entity described 
in this paragraph that is a community 
and 
consumer-focused 
nonprofit 
group; and 
‘‘(II) at least one entity described 
in subparagraph (B), which may in-
clude another community and con-
sumer-focused nonprofit group in ad-
dition to any such group awarded a 
grant pursuant to subclause (I). 
In awarding such grants, an Exchange may 
consider an entity’s record with respect to 
waste, fraud, and abuse for purposes of main-
taining the integrity of such Exchange.’’. 
(2) in paragraph (3)—
(A) by amending subparagraph (C) to read 
as follows: 
‘‘(C) facilitate enrollment, including with 
respect to individuals with limited English pro-
ficiency and individuals with chronic illnesses, 
in qualified health plans, State medicaid plans 
under title XIX of the Social Security Act, and 
State child health plans under title XXI of such 
Act;’’; 
(B) in subparagraph (D), by striking 
‘‘and’’ at the end; 
(C) in subparagraph (E), by striking the 
period at the end and inserting a semicolon; 
(D) by inserting after subparagraph (E) 
the following: 
‘‘(F) conduct public education activities in 
plain language to raise awareness of the re-
quirements of and the protections provided 
under— 
‘‘(i) the essential health benefits pack-
age (as defined in section 1302(a)); and 
‘‘(ii) section 2726 of the Public 
Health Service Act (relating to parity in 
mental health and substance use disorder 
benefits); and’’;
(E) by inserting after subparagraph (F) 
(as added by subparagraph (D)) the following 
new subparagraph: 
‘‘(G) provide referrals to community-based 
organizations that address social needs related 
to health outcomes.’’; and 
(F) by adding at the end the following 
flush left sentence: 
‘‘The duties specified in the preceding sentences may 
be carried out by such a navigator at any time dur-
ing a year.’’; 
(3) in paragraph (4)(A)— 
(A) in the matter preceding clause (i), by 
striking ‘‘not’’; 
(B) in clause (i)— 
(i) by inserting ‘‘not’’ before ‘‘be’’; 
and 
(ii) by striking ‘‘; or’’ and inserting a 
semicolon; 
(C) in clause (ii)— 
(i) by inserting ‘‘not’’ before ‘‘re-
ceive’’; and 
(ii) by striking the period and insert-
ing a semicolon; and
(D) by adding at the end the following new 
clauses: 
‘‘(iii) maintain physical presence in 
the State of the Exchange so as to allow 
in-person assistance to consumers; 
‘‘(iv) receive training on how to assist 
individuals with enrolling for medical as-
sistance under State plans under the Med-
icaid program under title XIX of the Social 
Security Act or for child health assistance 
under State child health plans under title 
XXI of such Act; and 
‘‘(v) receive opioid specific education 
and training that ensures the navigator 
can best educate individuals on qualified 
health plans offered through an Exchange, 
specifically coverage under such plans for 
opioid health care treatment.’’; and 
(4) in paragraph (6)— 
(A) 
by 
striking 
‘‘FUNDING.—Grants 
under’’ and inserting ‘‘FUNDING.— 
‘‘(A) STATE EXCHANGES.—Subject to sub-
paragraph (C), grants under’’; and 
(B) by adding at the end the following new 
subparagraphs:
‘‘(B) FEDERAL
EXCHANGES.—For pur-
poses of carrying out this subsection, with re-
spect to an Exchange established and operated 
by the Secretary within a State pursuant to sec-
tion 1321(c), the Secretary shall obligate $100 
million out of amounts collected through the 
user fees on participating health insurance 
issuers pursuant to section 156.50 of title 45, 
Code of Federal Regulations (or any successor 
regulations) for fiscal year 2020 and each sub-
sequent fiscal year. Such amount for a fiscal 
year shall remain available until expended. 
‘‘(C) STATE
EXCHANGES.—For the pur-
poses of carrying out this subsection, with re-
spect to an Exchange operated by a State pur-
suant to this section, there is authorized to be 
appropriated $25 million for fiscal year 2020 
and each subsequent fiscal year. Each State re-
ceiving a grant pursuant to this subparagraph 
shall receive a grant in an amount that is not 
less than $1 million.’’. 
(b) STUDY ON EFFECTS OF FUNDING CUTS.—Not 
later than 1 year after the date of the enactment of this 
Act, the Comptroller General of the United States shall 
study the effects of funding cuts made for plan year 2019
with respect to the navigator program (as described in sec-
tion 1311(i) of the Patient Protection and Affordable Care 
Act (42 U.S.C. 18031(i))) and other education and out-
reach activities carried out with respect to Exchanges es-
tablished by the Secretary of Health and Human Services 
pursuant to section 1321(c) of such Act. Such study shall 
describe the following: 
(1) How such funding cuts negatively impacted 
the ability of entities under such program to conduct 
outreach activities and fulfill duties required under 
such section 1311(i). 
(2) The overall effect on— 
(A) the number of individuals enrolled in 
health insurance coverage offered in the indi-
vidual market for plan year 2019; and 
(B) the costs of health insurance coverage 
offered in the individual market. 
(c) PROMOTE TRANSPARENCY AND ACCOUNTABILITY 
IN
THE
ADMINISTRATION’S
EXPENDITURES
OF
EX-
CHANGE USER FEES.—For plan year 2020 and each sub-
sequent plan year, not later than the date that is 3 months 
after the end of such plan year, the Secretary of Health 
and Human Services shall submit to the appropriate com-
mittees of Congress and make available to the public an 
annual report on the expenditures by the Department of
Health and Human Services of user fees collected pursu-
ant to section 156.50 of title 45, Code of Federal Regula-
tions (or any successor regulations). Each such report for 
a plan year shall include a detailed accounting of the 
amount of such user fees collected during such plan year 
and of the amount of such expenditures used during such 
plan year for the federally facilitated Exchange operated 
pursuant to section 1321(c) of the Patient Protection and 
Affordable Care Act (42 U.S.C. 18041(c)) on outreach 
and enrollment activities, navigators, maintenance of 
Healthcare.gov, and operation of call centers. 
(d) EFFECTIVE DATE.—The amendments made by 
this section shall apply with respect to plan years begin-
ning on or after January 1, 2020. 
SEC. 203. FEDERAL EXCHANGE OUTREACH AND EDU-
CATIONAL ACTIVITIES AND ANNUAL ENROLL-
MENT TARGETS. 
(a) IN GENERAL.—Section 1321(c) of the Patient 
Protection and Affordable Care Act (42 U.S.C. 18041(c)), 
as amended by section 201(b)(2), is further amended by 
adding at the end the following new paragraphs: 
‘‘(4) OUTREACH
AND
EDUCATIONAL
ACTIVI-
TIES.— 
‘‘(A) IN GENERAL.—In the case of an Ex-
change established or operated by the Secretary
within a State pursuant to this subsection, the 
Secretary shall carry out outreach and edu-
cational activities for purposes of informing in-
dividuals about qualified health plans offered 
through the Exchange, including by informing 
such individuals of the availability of coverage 
under such plans and financial assistance for 
coverage under such plans. Such outreach and 
educational activities shall be provided in a 
manner that is culturally and linguistically ap-
propriate to the needs of the populations being 
served by the Exchange (including hard-to- 
reach populations, such as racial and sexual mi-
norities, limited English proficient populations, 
individuals residing in areas where the unem-
ployment rates exceeds the national average un-
employment rate, individuals in rural areas, vet-
erans, and young adults) and shall be provided 
to populations residing in high health disparity 
areas (as defined in subparagraph (E)) served 
by the Exchange, in addition to other popu-
lations served by the Exchange. 
‘‘(B) LIMITATION ON USE OF FUNDS.—No 
funds appropriated under this paragraph shall
be used for expenditures for promoting non- 
ACA compliant health insurance coverage. 
‘‘(C) NON-ACA COMPLIANT HEALTH INSUR-
ANCE
COVERAGE.—For purposes of subpara-
graph (B): 
‘‘(i) The term ‘non-ACA compliant 
health insurance coverage’ means health 
insurance coverage, or a group health plan, 
that is not a qualified health plan. 
‘‘(ii) Such term includes the following: 
‘‘(I) An association health plan. 
‘‘(II) Short-term limited duration 
insurance. 
‘‘(D) FUNDING.—Out of any funds in the 
Treasury not otherwise appropriated, there are 
hereby appropriated for fiscal year 2020 and 
each subsequent fiscal year, $100 million to 
carry out this paragraph. Funds appropriated 
under this subparagraph shall remain available 
until expended. 
‘‘(E) HIGH HEALTH DISPARITY AREA DE-
FINED.—For purposes of subparagraph (A), the 
term ‘high health disparity area’ means a con-
tiguous geographic area that—
‘‘(i) is located in one census tract or 
ZIP code; 
‘‘(ii) has measurable and documented 
racial, ethnic, or geographic health dispari-
ties; 
‘‘(iii) has a low-income population, as 
demonstrated by— 
‘‘(I) average income below 138 
percent of the Federal poverty line; or 
‘‘(II) a rate of participation in 
the special supplemental nutrition 
program under section 17 of the Child 
Nutrition Act of 1966 (42 U.S.C. 
1786) that is higher than the national 
average rate of participation in such 
program; 
‘‘(iv) has poor health outcomes, as 
demonstrated by— 
‘‘(I) lower life expectancy than 
the national average; or 
‘‘(II) a higher percentage of in-
stances of low birth weight than the 
national average; and
‘‘(v) is part of a Metropolitan Statis-
tical Area identified by the Office of Man-
agement and Budget. 
‘‘(5) ANNUAL
ENROLLMENT
TARGETS.—For 
plan year 2020 and each subsequent plan year, in 
the case of an Exchange established or operated by 
the Secretary within a State pursuant to this sub-
section, the Secretary shall establish annual enroll-
ment targets for such Exchange for such year.’’. 
(b) STUDY AND REPORT.—Not later than 30 days 
after the date of the enactment of this Act, the Secretary 
of Health and Human Services shall release to Congress 
all aggregated documents relating to studies and data sets 
that were created on or after January 1, 2014, and related 
to marketing and outreach with respect to qualified health 
plans offered through Exchanges under title I of the Pa-
tient Protection and Affordable Care Act. 
SEC. 204. SHORT-TERM LIMITED DURATION INSURANCE 
RULE PROHIBITION. 
(a) FINDINGS.—Congress finds the following: 
(1) On August 3, 2018, the Administration 
issued a final rule entitled ‘‘Short-Term, Limited- 
Duration Insurance’’ (83 Fed. Reg. 38212). 
(2) The final rule dramatically expands the sale 
and marketing of insurance that—
(A) may discriminate against individuals 
living with preexisting health conditions, includ-
ing children with complex medical needs and 
disabilities and their families; 
(B) lacks important financial protections 
provided by the Patient Protection and Afford-
able Care Act (Public Law 111–148), including 
the prohibition of annual and lifetime coverage 
limits and annual out-of-pocket limits, that may 
increase the cost of treatment and cause finan-
cial hardship to those requiring medical care, 
including children with complex medical needs 
and disabilities and their families; and 
(C) excludes coverage of essential health 
benefits including hospitalization, prescription 
drugs, and other lifesaving care. 
(3) The implementation and enforcement of the 
final rule weakens critical protections for up to 130 
million Americans living with preexisting health con-
ditions and may place a large financial burden on 
those who enroll in short-term limited-duration in-
surance, which jeopardizes Americans’ access to 
quality, affordable health insurance. 
(b) PROHIBITION.—The Secretary of Health and 
Human Services, the Secretary of the Treasury, and the
Secretary of Labor may not take any action to implement, 
enforce, or otherwise give effect to the rule entitled 
‘‘Short-Term, Limited Duration Insurance’’ (83 Fed. Reg. 
38212 (August 3, 2018)), and the Secretaries may not 
promulgate any substantially similar rule. 
SEC. 205. PROTECTION OF HEALTH INSURANCE COVERAGE 
IN CERTAIN EXCHANGES. 
In the case of an Exchange that the Secretary of 
Health and Human Services operates pursuant to section 
1321(c)(1) of the Patient Protection and Affordable Care 
Act (42 U.S.C. 18041(c)(1)), the Secretary may not im-
plement any process that would terminate the health in-
surance coverage of an enrollee solely because such en-
rollee did not actively enroll during the most recent open 
enrollment period. 
SEC. 206. SENSE OF CONGRESS RELATING TO THE PRAC-
TICE OF SILVER LOADING. 
It is the sense of Congress that the Secretary of 
Health and Human Services should not take any action 
to prohibit or otherwise restrict the practice commonly 
known as ‘‘silver loading’’ (as described in the rule entitled 
‘‘Patient Protection and Affordable Care Act; HHS Notice 
of Benefit and Payment Parameters for 2020’’ published 
on April 25, 2019 (84 Fed. Reg. 17533)).
SEC. 207. CONSUMER OUTREACH, EDUCATION, AND ASSIST-
ANCE. 
(a) OPEN ENROLLMENT REPORTS.—For plan year 
2020 and each subsequent year, the Secretary of Health 
and Human Services (referred to in this section as the 
‘‘Secretary’’), in coordination with the Secretary of the 
Treasury and the Secretary of Labor, shall issue biweekly 
public reports during the annual open enrollment period 
on the performance of the Federal Exchange. Each such 
report shall include a summary, including information on 
a State-by-State basis where available, of— 
(1) the number of unique website visits; 
(2) the number of individuals who create an ac-
count; 
(3) the number of calls to the call center; 
(4) the average wait time for callers contacting 
the call center; 
(5) the number of individuals who enroll in a 
qualified health plan; and 
(6) the percentage of individuals who enroll in 
a qualified health plan through each of— 
(A) the website; 
(B) the call center; 
(C) navigators; 
(D) agents and brokers; 
(E) the enrollment assistant program;