IIB 

116TH CONGRESS 

1ST SESSION H. R. 987 

IN THE SENATE OF THE UNITED STATES 

MAY 20, 2019 

Received; read twice and referred to the Committee on Health, Education, 

Labor, and Pensions 

AN ACT 

To amend the Patient Protection and Affordable Care Act 

to provide for Federal Exchange outreach and educational activities. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 


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1 SECTION 1. SHORT TITLE. 

2 This Act may be cited as the ‘‘Strengthening Health 

3 Care and Lowering Prescription Drug Costs Act’’. 

4 SEC. 2. TABLE OF CONTENTS. 

5 The table of contents of this Act is as follows: 

Sec. 1. Short title. 

Sec. 2. Table of contents. 

TITLE I—LOWERING PRESCRIPTION DRUG COSTS 

Subtitle A—Bringing Low-Cost Options and Competition While Keeping 

Incentives for New Generics 

Sec. 101. Change conditions of first generic exclusivity to spur access and competition. 

Subtitle B—Protecting Consumer Access to Generic Drugs 

Sec. 111. Unlawful agreements. 

Sec. 112. Notice and certification of agreements. 

Sec. 113. Forfeiture of 180-day exclusivity period. 

Sec. 114. Commission litigation authority. 

Sec. 115. Statute of limitations. 

Subtitle C—Creating and Restoring Equal Access to Equivalent Samples 

Sec. 121. Actions for delays of generic drugs and biosimilar biological products. 

Sec. 122. REMS approval process for subsequent filers. 

Sec. 123. Rule of construction. 

Subtitle D—Study on Role of Federal Assistance in Drug Development 

Sec. 131. Study on role of Federal assistance in drug development. 

Subtitle E—Pharmacy School Outreach 

Sec. 141. Pharmacy school outreach. 

Subtitle F—Reports 

Sec. 151. Effects of increases in prescription drug price. 

TITLE II—HEALTH INSURANCE MARKET STABILIZATION 

Sec. 201. Preserving State option to implement health care marketplaces. 

Sec. 202. Providing for additional requirements with respect to the navigator 

program. 

Sec. 203. Federal Exchange outreach and educational activities and annual enrollment targets. 

Sec. 204. Short-term limited duration insurance rule prohibition. 

Sec. 205. Protection of health insurance coverage in certain Exchanges. 

Sec. 206. Sense of Congress relating to the practice of silver loading. 

Sec. 207. Consumer outreach, education, and assistance. 


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Sec. 208. GAO report. 

Sec. 209. Report on the effects of website maintenance during open enrollment. 

TITLE III—BUDGETARY EFFECTS 

Sec. 301. Determination of budgetary effects. 

1 TITLE I—LOWERING 

2 PRESCRIPTION DRUG COSTS 

3 Subtitle A—Bringing Low-Cost Op4 tions and Competition While 

5 Keeping Incentives for New 

6 Generics 

7 SEC. 101. CHANGE CONDITIONS OF FIRST GENERIC EXCLU8 SIVITY TO SPUR ACCESS AND COMPETITION. 

9 Section 505(j)(5)(B)(iv) of the Federal Food, Drug, 

10 and Cosmetic Act (21 U.S.C. 355(j)(5)(B)(iv)) is amend11 ed— 

12 (1) in subclause (I), by striking ‘‘180 days 

13 after’’ and all that follows through the period at the 

14 end and inserting the following: ‘‘180 days after the 

15 earlier of— 

16 ‘‘(aa) the date of the first com17 mercial marketing of the drug (includ18 ing the commercial marketing of the 

19 listed drug) by any first applicant; or 

20 ‘‘(bb) the applicable date speci21 fied in subclause (III).’’; and 

22 (2) by adding at the end the following new sub23 clause: 


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1 ‘‘(III) APPLICABLE DATE.—The appli2 cable date specified in this subclause, with 

3 respect to an application for a drug de4 scribed in subclause (I), is the date on 

5 which each of the following conditions is 

6 first met: 

7 ‘‘(aa) The approval of such an 

8 application could be made effective, 

9 but for the eligibility of a first appli10 cant for 180-day exclusivity under 

11 this clause. 

12 ‘‘(bb) At least 30 months have 

13 passed since the date of submission of 

14 an application for the drug by at least 

15 one first applicant. 

16 ‘‘(cc) Approval of an application 

17 for the drug submitted by at least one 

18 first applicant is not precluded under 

19 clause (iii). 

20 ‘‘(dd) No application for the drug 

21 submitted by any first applicant is ap22 proved at the time the conditions 

23 under items (aa), (bb), and (cc) are 

24 all met, regardless of whether such an 


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1 application is subsequently ap2 proved.’’. 

3 Subtitle B—Protecting Consumer 

4 Access to Generic Drugs 

5 SEC. 111. UNLAWFUL AGREEMENTS. 

6 (a) AGREEMENTS PROHIBITED.—Subject to sub7 sections (b) and (c), it shall be unlawful for an NDA or 

8 BLA holder and a subsequent filer (or for two subsequent 

9 filers) to enter into, or carry out, an agreement resolving 

10 or settling a covered patent infringement claim on a final 

11 or interim basis if under such agreement— 

12 (1) a subsequent filer directly or indirectly re13 ceives from such holder (or in the case of such an 

14 agreement between two subsequent filers, the other 

15 subsequent filer) anything of value, including a li16 cense; and 

17 (2) the subsequent filer agrees to limit or fore18 go research on, or development, manufacturing, 

19 marketing, or sales, for any period of time, of the 

20 covered product that is the subject of the application 

21 described in subparagraph (A) or (B) of subsection 

22 (g)(8). 

23 (b) EXCLUSION.—It shall not be unlawful under sub24 section (a) if a party to an agreement described in such 

25 subsection demonstrates by clear and convincing evidence 


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1 that the value described in subsection (a)(1) is compensa2 tion solely for other goods or services that the subsequent 

3 filer has promised to provide. 

4 (c) LIMITATION.—Nothing in this section shall pro5 hibit an agreement resolving or settling a covered patent 

6 infringement claim in which the consideration granted by 

7 the NDA or BLA holder to the subsequent filer (or from 

8 one subsequent filer to another) as part of the resolution 

9 or settlement includes only one or more of the following: 

10 (1) The right to market the covered product 

11 that is the subject of the application described in 

12 subparagraph (A) or (B) of subsection (g)(8) in the 

13 United States before the expiration of— 

14 (A) any patent that is the basis of the cov15 ered patent infringement claim; or 

16 (B) any patent right or other statutory ex17 clusivity that would prevent the marketing of 

18 such covered product. 

19 (2) A payment for reasonable litigation ex20 penses not to exceed $7.5 million in the aggregate. 

21 (3) A covenant not to sue on any claim that 

22 such covered product infringes a patent. 

23 (d) ENFORCEMENT BY FEDERAL TRADE COMMIS24 SION.— 


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1 (1) GENERAL APPLICATION.—The requirements 

2 of this section apply, according to their terms, to an 

3 NDA or BLA holder or subsequent filer that is— 

4 (A) a person, partnership, or corporation 

5 over which the Commission has authority pur6 suant to section 5(a)(2) of the Federal Trade 

7 Commission Act (15 U.S.C. 45(a)(2)); or 

8 (B) a person, partnership, or corporation 

9 over which the Commission would have author10 ity pursuant to such section but for the fact 

11 that such person, partnership, or corporation is 

12 not organized to carry on business for its own 

13 profit or that of its members. 

14 (2) UNFAIR OR DECEPTIVE ACTS OR PRACTICES

15 ENFORCEMENT AUTHORITY.— 

16 (A) IN GENERAL.—A violation of this sec17 tion shall be treated as an unfair or deceptive 

18 act or practice in violation of section 5(a)(1) of 

19 the Federal Trade Commission Act (15 U.S.C. 

20 45(a)(1)). 

21 (B) POWERS OF COMMISSION.—Except as 

22 provided in subparagraph (C) and paragraphs 

23 (1)(B) and (3)— 

24 (i) the Commission shall enforce this 

25 section in the same manner, by the same 


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1 means, and with the same jurisdiction, 

2 powers, and duties as though all applicable 

3 terms and provisions of the Federal Trade 

4 Commission Act (15 U.S.C. 41 et seq.) 

5 were incorporated into and made a part of 

6 this section; and 

7 (ii) any NDA or BLA holder or subse8 quent filer that violates this section shall 

9 be subject to the penalties and entitled to 

10 the privileges and immunities provided in 

11 the Federal Trade Commission Act. 

12 (C) JUDICIAL REVIEW.—In the case of a 

13 cease and desist order issued by the Commis14 sion under section 5 of the Federal Trade Com15 mission Act (15 U.S.C. 45) for violation of this 

16 section, a party to such order may obtain judi17 cial review of such order as provided in such 

18 section 5, except that— 

19 (i) such review may only be obtained 

20 in— 

21 (I) the United States Court of 

22 Appeals for the District of Columbia 

23 Circuit; 

24 (II) the United States Court of 

25 Appeals for the circuit in which the 


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1 ultimate parent entity, as defined in 

2 section 801.1(a)(3) of title 16, Code 

3 of Federal Regulations, or any suc4 cessor thereto, of the NDA or BLA 

5 holder (if any such holder is a party 

6 to such order) is incorporated as of 

7 the date that the application described 

8 in subparagraph (A) or (B) of sub9 section (g)(8) or an approved applica10 tion that is deemed to be a license for 

11 a biological product under section 

12 351(k) of the Public Health Service 

13 Act (42 U.S.C. 262(k)) pursuant to 

14 section 7002(e)(4) of the Biologics 

15 Price Competition and Innovation Act 

16 of 2009 (Public Law 111–148; 124 

17 Stat. 817) is submitted to the Com18 missioner of Food and Drugs; or 

19 (III) the United States Court of 

20 Appeals for the circuit in which the 

21 ultimate parent entity, as so defined, 

22 of any subsequent filer that is a party 

23 to such order is incorporated as of the 

24 date that the application described in 

25 subparagraph (A) or (B) of subsection 


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1 (g)(8) is submitted to the Commis2 sioner of Food and Drugs; and 

3 (ii) the petition for review shall be 

4 filed in the court not later than 30 days 

5 after such order is served on the party 

6 seeking review. 

7 (3) ADDITIONAL ENFORCEMENT AUTHORITY.— 

8 (A) CIVIL PENALTY.—The Commission 

9 may commence a civil action to recover a civil 

10 penalty in a district court of the United States 

11 against any NDA or BLA holder or subsequent 

12 filer that violates this section. 

13 (B) SPECIAL RULE FOR RECOVERY OF

14 PENALTY IF CEASE AND DESIST ORDER

15 ISSUED.— 

16 (i) IN GENERAL.—If the Commission 

17 has issued a cease and desist order in a 

18 proceeding under section 5 of the Federal 

19 Trade Commission Act (15 U.S.C. 45) for 

20 violation of this section— 

21 (I) the Commission may com22 mence a civil action under subpara23 graph (A) to recover a civil penalty 

24 against any party to such order at 

25 any time before the expiration of the 


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1 1-year period beginning on the date 

2 on which such order becomes final 

3 under section 5(g) of such Act (15 

4 U.S.C. 45(g)); and 

5 (II) in such civil action, the find6 ings of the Commission as to the ma7 terial facts in such proceeding shall be 

8 conclusive, unless— 

9 (aa) the terms of such order 

10 expressly provide that the Com11 mission’s findings shall not be 

12 conclusive; or 

13 (bb) such order became final 

14 by reason of section 5(g)(1) of 

15 such Act (15 U.S.C. 45(g)(1)), in 

16 which case such findings shall be 

17 conclusive if supported by evi18 dence. 

19 (ii) RELATIONSHIP TO PENALTY FOR

20 VIOLATION OF AN ORDER.—The penalty 

21 provided in clause (i) for violation of this 

22 section is separate from and in addition to 

23 any penalty that may be incurred for viola24 tion of an order of the Commission under 


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1 section 5(l) of the Federal Trade Commis2 sion Act (15 U.S.C. 45(l)). 

3 (C) AMOUNT OF PENALTY.— 

4 (i) IN GENERAL.—The amount of a 

5 civil penalty imposed in a civil action under 

6 subparagraph (A) on a party to an agree7 ment described in subsection (a) shall be 

8 sufficient to deter violations of this section, 

9 but in no event greater than— 

10 (I) if such party is the NDA or 

11 BLA holder (or, in the case of an 

12 agreement between two subsequent fil13 ers, the subsequent filer who gave the 

14 value described in subsection (a)(1)), 

15 the greater of— 

16 (aa) three times the value 

17 received by such NDA or BLA 

18 holder (or by such subsequent 

19 filer) that is reasonably attrib20 utable to the violation of this sec21 tion; or 

22 (bb) three times the value 

23 given to the subsequent filer (or 

24 to the other subsequent filer) 


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1 reasonably attributable to the 

2 violation of this section; and 

3 (II) if such party is the subse4 quent filer (or, in the case of an 

5 agreement between two subsequent fil6 ers, the subsequent filer who received 

7 the value described in subsection 

8 (a)(1)), 3 times the value received by 

9 such subsequent filer that is reason10 ably attributable to the violation of 

11 this section. 

12 (ii) FACTORS FOR CONSIDERATION.— 

13 In determining such amount, the court 

14 shall take into account— 

15 (I) the nature, circumstances, ex16 tent, and gravity of the violation; 

17 (II) with respect to the violator, 

18 the degree of culpability, any history 

19 of violations, the ability to pay, any 

20 effect on the ability to continue doing 

21 business, profits earned by the NDA 

22 or BLA holder (or, in the case of an 

23 agreement between two subsequent fil24 ers, the subsequent filer who gave the 

25 value described in subsection (a)(1)), 


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1 compensation received by the subse2 quent filer (or, in the case of an 

3 agreement between two subsequent fil4 ers, the subsequent filer who received 

5 the value described in subsection 

6 (a)(1)), and the amount of commerce 

7 affected; and 

8 (III) other matters that justice 

9 requires. 

10 (D) INJUNCTIONS AND OTHER EQUITABLE

11 RELIEF.—In a civil action under subparagraph 

12 (A), the United States district courts are em13 powered to grant mandatory injunctions and 

14 such other and further equitable relief as they 

15 deem appropriate. 

16 (4) REMEDIES IN ADDITION.—Remedies pro17 vided in this subsection are in addition to, and not 

18 in lieu of, any other remedy provided by Federal 

19 law. 

20 (5) PRESERVATION OF AUTHORITY OF COMMIS21 SION.—Nothing in this section shall be construed to 

22 affect any authority of the Commission under any 

23 other provision of law. 

24 (e) FEDERAL TRADE COMMISSION RULEMAKING.— 

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1 gated under section 553 of title 5, United States Code, 

2 exempt from this section certain agreements described in 

3 subsection (a) if the Commission finds such agreements 

4 to be in furtherance of market competition and for the 

5 benefit of consumers. 

6 (f) ANTITRUST LAWS.—Nothing in this section shall 

7 modify, impair, limit, or supersede the applicability of the 

8 antitrust laws as defined in subsection (a) of the first sec9 tion of the Clayton Act (15 U.S.C. 12(a)), and of section 

10 5 of the Federal Trade Commission Act (15 U.S.C. 45) 

11 to the extent that such section 5 applies to unfair methods 

12 of competition. Nothing in this section shall modify, im13 pair, limit, or supersede the right of a subsequent filer 

14 to assert claims or counterclaims against any person, 

15 under the antitrust laws or other laws relating to unfair 

16 competition. 

17 (g) DEFINITIONS.—In this section: 

18 (1) AGREEMENT RESOLVING OR SETTLING A

19 COVERED PATENT INFRINGEMENT CLAIM.—The 

20 term ‘‘agreement resolving or settling a covered pat21 ent infringement claim’’ means any agreement 

22 that— 

23 (A) resolves or settles a covered patent in24 fringement claim; or 


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1 (B) is contingent upon, provides for a con2 tingent condition for, or is otherwise related to 

3 the resolution or settlement of a covered patent 

4 infringement claim. 

5 (2) COMMISSION.—The term ‘‘Commission’’ 

6 means the Federal Trade Commission. 

7 (3) COVERED PATENT INFRINGEMENT CLAIM.— 

8 The term ‘‘covered patent infringement claim’’ 

9 means an allegation made by the NDA or BLA hold10 er to a subsequent filer (or, in the case of an agree11 ment between two subsequent filers, by one subse12 quent filer to another), whether or not included in 

13 a complaint filed with a court of law, that— 

14 (A) the submission of the application de15 scribed in subparagraph (A) or (B) of para16 graph (9), or the manufacture, use, offering for 

17 sale, sale, or importation into the United States 

18 of a covered product that is the subject of such 

19 an application— 

20 (i) in the case of an agreement be21 tween an NDA or BLA holder and a sub22 sequent filer, infringes any patent owned 

23 by, or exclusively licensed to, the NDA or 

24 BLA holder of the covered product; or 


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1 (ii) in the case of an agreement be2 tween two subsequent filers, infringes any 

3 patent owned by the subsequent filer; or 

4 (B) in the case of an agreement between 

5 an NDA or BLA holder and a subsequent filer, 

6 the covered product to be manufactured under 

7 such application uses a covered product as 

8 claimed in a published patent application. 

9 (4) COVERED PRODUCT.—The term ‘‘covered 

10 product’’ means a drug (as defined in section 201(g) 

11 of the Federal Food, Drug, and Cosmetic Act (21 

12 U.S.C. 321(g))), including a biological product (as 

13 defined in section 351(i) of the Public Health Serv14 ice Act (42 U.S.C. 262(i)). 

15 (5) NDA OR BLA HOLDER.—The term ‘‘NDA 

16 or BLA holder’’ means— 

17 (A) the holder of— 

18 (i) an approved new drug application 

19 filed under section 505(b)(1) of the Fed20 eral Food, Drug, and Cosmetic Act (21 

21 U.S.C. 355(b)(1)) for a covered product; 

22 or 

23 (ii) a biologics license application filed 

24 under section 351(a) of the Public Health 


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1 Service Act (42 U.S.C. 262(a)) with re2 spect to a biological product; 

3 (B) a person owning or controlling enforce4 ment of the patent on— 

5 (i) the list published under section 

6 505(j)(7) of the Federal Food, Drug, and 

7 Cosmetic Act (21 U.S.C. 355(j)(7)) in con8 nection with the application described in 

9 subparagraph (A)(i); or 

10 (ii) any list published under section 

11 351 of the Public Health Service Act (42 

12 U.S.C. 262) comprised of patents associ13 ated with biologics license applications filed 

14 under section 351(a) of such Act (42 

15 U.S.C. 262(a)); or 

16 (C) the predecessors, subsidiaries, divi17 sions, groups, and affiliates controlled by, con18 trolling, or under common control with any en19 tity described in subparagraph (A) or (B) (such 

20 control to be presumed by direct or indirect 

21 share ownership of 50 percent or greater), as 

22 well as the licensees, licensors, successors, and 

23 assigns of each of the entities. 


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1 (6) PATENT.—The term ‘‘patent’’ means a pat2 ent issued by the United States Patent and Trade3 mark Office. 

4 (7) STATUTORY EXCLUSIVITY.—The term 

5 ‘‘statutory exclusivity’’ means those prohibitions on 

6 the submission or approval of drug applications 

7 under clauses (ii) through (iv) of section 

8 505(c)(3)(E) (5- and 3-year exclusivity), clauses (ii) 

9 through (iv) of section 505(j)(5)(F) (5-year and 3- 

10 year exclusivity), section 505(j)(5)(B)(iv) (180-day 

11 exclusivity), section 527 (orphan drug exclusivity), 

12 section 505A (pediatric exclusivity), or section 505E 

13 (qualified infectious disease product exclusivity) of 

14 the Federal Food, Drug, and Cosmetic Act (21 

15 U.S.C. 355(c)(3)(E), 355(j)(5)(B)(iv), 355(j)(5)(F), 

16 360cc, 355a, 355f), or prohibitions on the submis17 sion or licensing of biologics license applications 

18 under section 351(k)(6) (interchangeable biological 

19 product exclusivity) or section 351(k)(7) (biological 

20 product reference product exclusivity) of the Public 

21 Health Service Act (42 U.S.C. 262(k)(6), (7)). 

22 (8) SUBSEQUENT FILER.—The term ‘‘subse23 quent filer’’ means— 

24 (A) in the case of a drug, a party that 

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1 cation submitted pursuant to section 505(j) of 

2 the Federal Food, Drug, and Cosmetic Act (21 

3 U.S.C. 355(j)) or a new drug application sub4 mitted pursuant to section 505(b)(2) of the 

5 Federal Food, Drug, and Cosmetic Act 

6 (21U.S.C. 355(b)(2)) and filed under section 

7 505(b)(1) of such Act (21 U.S.C. 355(b)(1)) or 

8 has the exclusive rights to distribute the cov9 ered product that is the subject of such applica10 tion; or 

11 (B) in the case of a biological product, a 

12 party that owns or controls an application filed 

13 with the Food and Drug Administration under 

14 section 351(k) of the Public Health Service Act 

15 (42 U.S.C. 262(k)) or has the exclusive rights 

16 to distribute the biological product that is the 

17 subject of such application. 

18 (h) EFFECTIVE DATE.—This section applies with re19 spect to agreements described in subsection (a) entered 

20 into on or after the date of the enactment of this Act. 

21 SEC. 112. NOTICE AND CERTIFICATION OF AGREEMENTS. 

22 (a) NOTICE OF ALL AGREEMENTS.—Section 1111(7) 

23 of the Medicare Prescription Drug, Improvement, and 

24 Modernization Act of 2003 (21 U.S.C. 355 note) is 

25 amended by inserting ‘‘or the owner of a patent for which 


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1 a claim of infringement could reasonably be asserted 

2 against any person for making, using, offering to sell, sell3 ing, or importing into the United States a biological prod4 uct that is the subject of a biosimilar biological product 

5 application’’ before the period at the end. 

6 (b) CERTIFICATION OF AGREEMENTS.—Section 1112 

7 of such Act (21 U.S.C. 355 note) is amended by adding 

8 at the end the following: 

9 ‘‘(d) CERTIFICATION.—The Chief Executive Officer 

10 or the company official responsible for negotiating any 

11 agreement under subsection (a) or (b) that is required to 

12 be filed under subsection (c) shall, within 30 days of such 

13 filing, execute and file with the Assistant Attorney General 

14 and the Commission a certification as follows: ‘I declare 

15 that the following is true, correct, and complete to the best 

16 of my knowledge: The materials filed with the Federal 

17 Trade Commission and the Department of Justice under 

18 section 1112 of the Medicare Prescription Drug, Improve19 ment, and Modernization Act of 2003, with respect to the 

20 agreement referenced in this certification— 

21 ‘‘ ‘(1) represent the complete, final, and exclu22 sive agreement between the parties; 

23 ‘‘ ‘(2) include any ancillary agreements that are 

24 contingent upon, provide a contingent condition for, 


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1 were entered into within 30 days of, or are otherwise 

2 related to, the referenced agreement; and 

3 ‘‘ ‘(3) include written descriptions of any oral 

4 agreements, representations, commitments, or prom5 ises between the parties that are responsive to sub6 section (a) or (b) of such section 1112 and have not 

7 been reduced to writing.’.’’. 

8 SEC. 113. FORFEITURE OF 180-DAY EXCLUSIVITY PERIOD. 

9 Section 505(j)(5)(D)(i)(V) of the Federal Food, 

10 Drug, and Cosmetic Act (21 U.S.C. 355(j)(5)(D)(i)(V)) 

11 is amended by inserting ‘‘section 111 of the Strengthening 

12 Health Care and Lowering Prescription Drug Costs Act 

13 or’’ after ‘‘that the agreement has violated’’. 

14 SEC. 114. COMMISSION LITIGATION AUTHORITY. 

15 Section 16(a)(2) of the Federal Trade Commission 

16 Act (15 U.S.C. 56(a)(2)) is amended— 

17 (1) in subparagraph (D), by striking ‘‘or’’ after 

18 the semicolon; 

19 (2) in subparagraph (E), by inserting ‘‘or’’ 

20 after the semicolon; and 

21 (3) by inserting after subparagraph (E) the fol22 lowing: 

23 ‘‘(F) under section 111(d)(3)(A) of the 

24 Strengthening Health Care and Lowering Pre25 scription Drug Costs Act;’’. 


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1 SEC. 115. STATUTE OF LIMITATIONS. 

2 (a) IN GENERAL.—Except as provided in subsection 

3 (b), the Commission shall commence any administrative 

4 proceeding or civil action to enforce section 111 of this 

5 Act not later than 6 years after the date on which the 

6 parties to the agreement file the Notice of Agreement as 

7 provided by section 1112(c)(2) and (d) of the Medicare 

8 Prescription Drug, Improvement, and Modernization Act 

9 of 2003 (21 U.S.C. 355 note). 

10 (b) CIVIL ACTION AFTER ISSUANCE OF CEASE AND

11 DESIST ORDER.—If the Commission has issued a cease 

12 and desist order under section 5 of the Federal Trade 

13 Commission Act (15 U.S.C. 45) for violation of section 

14 111 of this Act and the proceeding for the issuance of 

15 such order was commenced within the period required by 

16 subsection (a) of this section, such subsection does not 

17 prohibit the commencement, after such period, of a civil 

18 action under section 111(d)(3)(A) against a party to such 

19 order or a civil action under subsection (l) of such section 

20 5 for violation of such order. 

21 Subtitle C—Creating and Restoring 

22 Equal Access to Equivalent 

23 Samples 

24 SEC. 121. ACTIONS FOR DELAYS OF GENERIC DRUGS AND 

25 BIOSIMILAR BIOLOGICAL PRODUCTS. 

26 (a) DEFINITIONS.—In this section— 


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1 (1) the term ‘‘commercially reasonable, market2 based terms’’ means— 

3 (A) a nondiscriminatory price for the sale 

4 of the covered product at or below, but not 

5 greater than, the most recent wholesale acquisi6 tion cost for the drug, as defined in section 

7 1847A(c)(6)(B) of the Social Security Act (42 

8 U.S.C. 1395w–3a(c)(6)(B)); 

9 (B) a schedule for delivery that results in 

10 the transfer of the covered product to the eligi11 ble product developer consistent with the timing 

12 under subsection (b)(2)(A)(iv); and 

13 (C) no additional conditions are imposed 

14 on the sale of the covered product; 

15 (2) the term ‘‘covered product’’— 

16 (A) means— 

17 (i) any drug approved under sub18 section (c) or (j) of section 505 of the Fed19 eral Food, Drug, and Cosmetic Act (21 

20 U.S.C. 355) or biological product licensed 

21 under subsection (a) or (k) of section 351 

22 of the Public Health Service Act (42 

23 U.S.C. 262); 

24 (ii) any combination of a drug or bio25 logical product described in clause (i); or 


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1 (iii) when reasonably necessary to 

2 support approval of an application under 

3 section 505 of the Federal Food, Drug, 

4 and Cosmetic Act (21 U.S.C. 355), or sec5 tion 351 of the Public Health Service Act 

6 (42 U.S.C. 262), as applicable, or other7 wise meet the requirements for approval 

8 under either such section, any product, in9 cluding any device, that is marketed or in10 tended for use with such a drug or biologi11 cal product; and 

12 (B) does not include any drug or biological 

13 product that appears on the drug shortage list 

14 in effect under section 506E of the Federal 

15 Food, Drug, and Cosmetic Act (21 U.S.C. 

16 356e), unless— 

17 (i) the drug or biological product has 

18 been on the drug shortage list in effect 

19 under such section 506E continuously for 

20 more than 6 months; or 

21 (ii) the Secretary determines that in22 clusion of the drug or biological product as 

23 a covered product is likely to contribute to 

24 alleviating or preventing a shortage. 


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1 (3) the term ‘‘device’’ has the meaning given 

2 the term in section 201 of the Federal Food, Drug, 

3 and Cosmetic Act (21 U.S.C. 321); 

4 (4) the term ‘‘eligible product developer’’ means 

5 a person that seeks to develop a product for ap6 proval pursuant to an application for approval under 

7 subsection (b)(2) or (j) of section 505 of the Federal 

8 Food, Drug, and Cosmetic Act (21 U.S.C. 355) or 

9 for licensing pursuant to an application under sec10 tion 351(k) of the Public Health Service Act (42 

11 U.S.C. 262(k)); 

12 (5) the term ‘‘license holder’’ means the holder 

13 of an application approved under subsection (c) or 

14 (j) of section 505 of the Federal Food, Drug, and 

15 Cosmetic Act (21 U.S.C. 355) or the holder of a li16 cense under subsection (a) or (k) of section 351 of 

17 the Public Health Service Act (42 U.S.C. 262) for 

18 a covered product; 

19 (6) the term ‘‘REMS’’ means a risk evaluation 

20 and mitigation strategy under section 505–1 of the 

21 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

22 355–1); 

23 (7) the term ‘‘REMS with ETASU’’ means a 

24 REMS that contains elements to assure safe use 


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1 under section 505–1(f) of the Federal Food, Drug, 

2 and Cosmetic Act (21 U.S.C. 355–1(f)); 

3 (8) the term ‘‘Secretary’’ means the Secretary 

4 of Health and Human Services; 

5 (9) the term ‘‘single, shared system of elements 

6 to assure safe use’’ means a single, shared system 

7 of elements to assure safe use under section 505– 

8 1(f) of the Federal Food, Drug, and Cosmetic Act 

9 (21 U.S.C. 355–1(f)); and 

10 (10) the term ‘‘sufficient quantities’’ means an 

11 amount of a covered product that the eligible prod12 uct developer determines allows it to— 

13 (A) conduct testing to support an applica14 tion under— 

15 (i) subsection (b)(2) or (j) of section 

16 505 of the Federal Food, Drug, and Cos17 metic Act (21 U.S.C. 355); or 

18 (ii) section 351(k) of the Public 

19 Health Service Act (42 U.S.C. 262(k)); 

20 and 

21 (B) fulfill any regulatory requirements re22 lating to approval of such an application. 

23 (b) CIVIL ACTION FOR FAILURE TO PROVIDE SUFFI24 CIENT QUANTITIES OF A COVERED PRODUCT.— 


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1 (1) IN GENERAL.—An eligible product developer 

2 may bring a civil action against the license holder 

3 for a covered product seeking relief under this sub4 section in an appropriate district court of the United 

5 States alleging that the license holder has declined 

6 to provide sufficient quantities of the covered prod7 uct to the eligible product developer on commercially 

8 reasonable, market-based terms. 

9 (2) ELEMENTS.— 

10 (A) IN GENERAL.—To prevail in a civil ac11 tion brought under paragraph (1), an eligible 

12 product developer shall prove, by a preponder13 ance of the evidence— 

14 (i) that— 

15 (I) the covered product is not 

16 subject to a REMS with ETASU; or 

17 (II) if the covered product is sub18 ject to a REMS with ETASU— 

19 (aa) the eligible product de20 veloper has obtained a covered 

21 product authorization from the 

22 Secretary in accordance with sub23 paragraph (B); and 

24 (bb) the eligible product de25 veloper has provided a copy of 


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1 the covered product authorization 

2 to the license holder; 

3 (ii) that, as of the date on which the 

4 civil action is filed, the product developer 

5 has not obtained sufficient quantities of 

6 the covered product on commercially rea7 sonable, market-based terms; 

8 (iii) that the eligible product developer 

9 has submitted a written request to pur10 chase sufficient quantities of the covered 

11 product to the license holder and such re12 quest— 

13 (I) was sent to a named cor14 porate officer of the license holder; 

15 (II) was made by certified or reg16 istered mail with return receipt re17 quested; 

18 (III) specified an individual as 

19 the point of contact for the license 

20 holder to direct communications re21 lated to the sale of the covered prod22 uct to the eligible product developer 

23 and a means for electronic and writ24 ten communications with that indi25 vidual; and 


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1 (IV) specified an address to 

2 which the covered product was to be 

3 shipped upon reaching an agreement 

4 to transfer the covered product; and 

5 (iv) that the license holder has not de6 livered to the eligible product developer 

7 sufficient quantities of the covered product 

8 on commercially reasonable, market-based 

9 terms— 

10 (I) for a covered product that is 

11 not subject to a REMS with ETASU, 

12 by the date that is 31 days after the 

13 date on which the license holder re14 ceived the request for the covered 

15 product; and 

16 (II) for a covered product that is 

17 subject to a REMS with ETASU, by 

18 31 days after the later of— 

19 (aa) the date on which the 

20 license holder received the re21 quest for the covered product; or 

22 (bb) the date on which the 

23 license holder received a copy of 

24 the covered product authorization 


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1 issued by the Secretary in ac2 cordance with subparagraph (B). 

3 (B) AUTHORIZATION FOR COVERED PROD4 UCT SUBJECT TO A REMS WITH ETASU.— 

5 (i) REQUEST.—An eligible product de6 veloper may submit to the Secretary a 

7 written request for the eligible product de8 veloper to be authorized to obtain suffi9 cient quantities of an individual covered 

10 product subject to a REMS with ETASU. 

11 (ii) AUTHORIZATION.—Not later than 

12 120 days after the date on which a request 

13 under clause (i) is received, the Secretary 

14 shall, by written notice, authorize the eligi15 ble product developer to obtain sufficient 

16 quantities of an individual covered product 

17 subject to a REMS with ETASU for pur18 poses of— 

19 (I) development and testing that 

20 does not involve human clinical trials, 

21 if the eligible product developer has 

22 agreed to comply with any conditions 

23 the Secretary determines necessary; or 


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1 (II) development and testing that 

2 involves human clinical trials, if the 

3 eligible product developer has— 

4 (aa)(AA) submitted proto5 cols, informed consent docu6 ments, and informational mate7 rials for testing that include pro8 tections that provide safety pro9 tections comparable to those pro10 vided by the REMS for the cov11 ered product; or 

12 (BB) otherwise satisfied the 

13 Secretary that such protections 

14 will be provided; and 

15 (bb) met any other require16 ments the Secretary may estab17 lish. 

18 (iii) NOTICE.—A covered product au19 thorization issued under this subparagraph 

20 shall state that the provision of the covered 

21 product by the license holder under the 

22 terms of the authorization will not be a 

23 violation of the REMS for the covered 

24 product. 


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1 (3) AFFIRMATIVE DEFENSE.—In a civil action 

2 brought under paragraph (1), it shall be an affirma3 tive defense, on which the defendant has the burden 

4 of persuasion by a preponderance of the evidence— 

5 (A) that, on the date on which the eligible 

6 product developer requested to purchase suffi7 cient quantities of the covered product from the 

8 license holder— 

9 (i) neither the license holder nor any 

10 of its agents, wholesalers, or distributors 

11 was engaged in the manufacturing or com12 mercial marketing of the covered product; 

13 and 

14 (ii) neither the license holder nor any 

15 of its agents, wholesalers, or distributors 

16 otherwise had access to inventory of the 

17 covered product to supply to the eligible 

18 product developer on commercially reason19 able, market-based terms; 

20 (B) that— 

21 (i) the license holder sells the covered 

22 product through agents, distributors, or 

23 wholesalers; 

24 (ii) the license holder has placed no 

25 restrictions, explicit or implicit, on its 


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1 agents, distributors, or wholesalers to sell 

2 covered products to eligible product devel3 opers; and 

4 (iii) the covered product can be pur5 chased by the eligible product developer in 

6 sufficient quantities on commercially rea7 sonable, market-based terms from the 

8 agents, distributors, or wholesalers of the 

9 license holder; or 

10 (C) that the license holder made an offer 

11 to the individual specified pursuant to para12 graph (2)(A)(iii)(III), by a means of commu13 nication (electronic, written, or both) specified 

14 pursuant to such paragraph, to sell sufficient 

15 quantities of the covered product to the eligible 

16 product developer at commercially reasonable 

17 market-based terms— 

18 (i) for a covered product that is not 

19 subject to a REMS with ETASU, by the 

20 date that is 14 days after the date on 

21 which the license holder received the re22 quest for the covered product, and the eli23 gible product developer did not accept such 

24 offer by the date that is 7 days after the 

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1 oper received such offer from the license 

2 holder; or 

3 (ii) for a covered product that is sub4 ject to a REMS with ETASU, by the date 

5 that is 20 days after the date on which the 

6 license holder received the request for the 

7 covered product, and the eligible product 

8 developer did not accept such offer by the 

9 date that is 10 days after the date on 

10 which the eligible product developer re11 ceived such offer from the license holder. 

12 (4) REMEDIES.— 

13 (A) IN GENERAL.—If an eligible product 

14 developer prevails in a civil action brought 

15 under paragraph (1), the court shall— 

16 (i) order the license holder to provide 

17 to the eligible product developer without 

18 delay sufficient quantities of the covered 

19 product on commercially reasonable, mar20 ket-based terms; 

21 (ii) award to the eligible product de22 veloper reasonable attorney’s fees and costs 

23 of the civil action; and 

24 (iii) award to the eligible product de25 veloper a monetary amount sufficient to 


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1 deter the license holder from failing to pro2 vide eligible product developers with suffi3 cient quantities of a covered product on 

4 commercially reasonable, market-based 

5 terms, if the court finds, by a preponder6 ance of the evidence— 

7 (I) that the license holder delayed 

8 providing sufficient quantities of the 

9 covered product to the eligible product 

10 developer without a legitimate busi11 ness justification; or 

12 (II) that the license holder failed 

13 to comply with an order issued under 

14 clause (i). 

15 (B) MAXIMUM MONETARY AMOUNT.—A 

16 monetary amount awarded under subparagraph 

17 (A)(iii) shall not be greater than the revenue 

18 that the license holder earned on the covered 

19 product during the period— 

20 (i) beginning on— 

21 (I) for a covered product that is 

22 not subject to a REMS with ETASU, 

23 the date that is 31 days after the date 

24 on which the license holder received 

25 the request; or 


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1 (II) for a covered product that is 

2 subject to a REMS with ETASU, the 

3 date that is 31 days after the later 

4 of— 

5 (aa) the date on which the 

6 license holder received the re7 quest; or 

8 (bb) the date on which the 

9 license holder received a copy of 

10 the covered product authorization 

11 issued by the Secretary in ac12 cordance with paragraph (2)(B); 

13 and 

14 (ii) ending on the date on which the 

15 eligible product developer received suffi16 cient quantities of the covered product. 

17 (C) AVOIDANCE OF DELAY.—The court 

18 may issue an order under subparagraph (A)(i) 

19 before conducting further proceedings that may 

20 be necessary to determine whether the eligible 

21 product developer is entitled to an award under 

22 clause (ii) or (iii) of subparagraph (A), or the 

23 amount of any such award. 

24 (c) LIMITATION OF LIABILITY.—A license holder for 

25 a covered product shall not be liable for any claim under 


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1 Federal, State, or local law arising out of the failure of 

2 an eligible product developer to follow adequate safeguards 

3 to assure safe use of the covered product during develop4 ment or testing activities described in this section, includ5 ing transportation, handling, use, or disposal of the cov6 ered product by the eligible product developer. 

7 (d) NO VIOLATION OF REMS.—Section 505–1 of the 

8 Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355– 

9 1) is amended by adding at the end the following new sub10 section: 

11 ‘‘(l) PROVISION OF SAMPLES NOT A VIOLATION OF

12 STRATEGY.—The provision of samples of a covered prod13 uct to an eligible product developer (as those terms are 

14 defined in section 121(a) of the Strengthening Health 

15 Care and Lowering Prescription Drug Costs Act) shall not 

16 be considered a violation of the requirements of any risk 

17 evaluation and mitigation strategy that may be in place 

18 under this section for such drug.’’. 

19 (e) RULE OF CONSTRUCTION.— 

20 (1) DEFINITION.—In this subsection, the term 

21 ‘‘antitrust laws’’— 

22 (A) has the meaning given the term in 

23 subsection (a) of the first section of the Clayton 

24 Act (15 U.S.C. 12); and 


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1 (B) includes section 5 of the Federal 

2 Trade Commission Act (15 U.S.C. 45) to the 

3 extent that such section applies to unfair meth4 ods of competition. 

5 (2) ANTITRUST LAWS.—Nothing in this section 

6 shall be construed to limit the operation of any pro7 vision of the antitrust laws. 

8 SEC. 122. REMS APPROVAL PROCESS FOR SUBSEQUENT 

9 FILERS. 

10 Section 505–1 of the Federal Food, Drug, and Cos11 metic Act (21 U.S.C. 355–1), as amended by section 121, 

12 is further amended— 

13 (1) in subsection (g)(4)(B)— 

14 (A) in clause (i) by striking ‘‘or’’ after the 

15 semicolon; 

16 (B) in clause (ii) by striking the period at 

17 the end and inserting ‘‘; or’’; and 

18 (C) by adding at the end the following: 

19 ‘‘(iii) accommodate different, com20 parable aspects of the elements to assure 

21 safe use for a drug that is the subject of 

22 an application under section 505(j), and 

23 the applicable listed drug.’’; 

24 (2) in subsection (i)(1), by striking subpara25 graph (C) and inserting the following: 


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1 ‘‘(C)(i) Elements to assure safe use, if re2 quired under subsection (f) for the listed drug, 

3 which, subject to clause (ii), for a drug that is 

4 the subject of an application under section 

5 505(j) may use— 

6 ‘‘(I) a single, shared system with the 

7 listed drug under subsection (f); or 

8 ‘‘(II) a different, comparable aspect of 

9 the elements to assure safe use under sub10 section (f). 

11 ‘‘(ii) The Secretary may require a drug 

12 that is the subject of an application under sec13 tion 505(j) and the listed drug to use a single, 

14 shared system under subsection (f), if the Sec15 retary determines that no different, comparable 

16 aspect of the elements to assure safe use could 

17 satisfy the requirements of subsection (f).’’; 

18 (3) in subsection (i), by adding at the end the 

19 following: 

20 ‘‘(3) SHARED REMS.—If the Secretary ap21 proves, in accordance with paragraph (1)(C)(i)(II), a 

22 different, comparable aspect of the elements to as23 sure safe use under subsection (f) for a drug that 

24 is the subject of an abbreviated new drug application 

25 under section 505(j), the Secretary may require that 


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1 such different comparable aspect of the elements to 

2 assure safe use can be used with respect to any 

3 other drug that is the subject of an application 

4 under section 505(j) or 505(b) that references the 

5 same listed drug.’’; and 

6 (4) by adding at the end the following: 

7 ‘‘(m) SEPARATE REMS.—When used in this section, 

8 the terms ‘different, comparable aspect of the elements to 

9 assure safe use’ or ‘different, comparable approved risk 

10 evaluation and mitigation strategies’ means a risk evalua11 tion and mitigation strategy for a drug that is the subject 

12 of an application under section 505(j) that uses different 

13 methods or operational means than the strategy required 

14 under subsection (a) for the applicable listed drug, or 

15 other application under section 505(j) with the same such 

16 listed drug, but achieves the same level of safety as such 

17 strategy.’’. 

18 SEC. 123. RULE OF CONSTRUCTION. 

19 (a) IN GENERAL.—Nothing in this subtitle, the 

20 amendments made by this subtitle, or in section 505–1 

21 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 

22 355–1), shall be construed as— 

23 (1) prohibiting a license holder from providing 

24 an eligible product developer access to a covered 


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1 product in the absence of an authorization under 

2 this subtitle; or 

3 (2) in any way negating the applicability of a 

4 REMS with ETASU, as otherwise required under 

5 such section 505–1, with respect to such covered 

6 product. 

7 (b) DEFINITIONS.—In this section, the terms ‘‘cov8 ered product’’, ‘‘eligible product developer’’, ‘‘license hold9 er’’, and ‘‘REMS with ETASU’’ have the meanings given 

10 such terms in section 121(a). 

11 Subtitle D—Study on Role of Fed12 eral Assistance in Drug Devel13 opment 

14 SEC. 131. STUDY ON ROLE OF FEDERAL ASSISTANCE IN 

15 DRUG DEVELOPMENT. 

16 (a) IN GENERAL.—Not later than 2 years after the 

17 date of the enactment of this Act, the Secretary of the 

18 Health and Human Services shall enter into a contract 

19 with the National Academy of Medicine to conduct a study 

20 on, and submit to Congress a report on, the following: 

21 (1) The percentage of drugs developed in the 

22 United States using at least some amount of Federal 

23 funding from any Federal source. 

24 (2) The average cost incurred by a drug devel25 oper to develop a drug. 


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1 (3) The average amount of revenue and profits 

2 made by drug developers from the sales of drugs. 

3 (4) The percentage of such revenue and profits 

4 that are reinvested into research and development of 

5 new drugs. 

6 (5) The appropriate percentage, if any, of such 

7 revenue and profits the Secretary, in consultation 

8 with the National Academy of Medicine, rec9 ommends should be returned to Federal entities for 

10 Federal funding used in the development of the 

11 drugs involved. 

12 (b) ENFORCEMENT.—A drug developer shall, as a 

13 condition of receipt of any Federal funding for the devel14 opment of drugs, comply with any request for the data 

15 necessary to perform the study under subsection (a). 

16 (c) CONFIDENTIALITY.—This section does not au17 thorize the disclosure of any trade secret, confidential 

18 commercial or financial information, or other matter listed 

19 in section 552(b) of title 5, United States Code. 

20 (d) DEFINITIONS.—In this section: 

21 (1) The term ‘‘drug’’ has the meaning given 

22 such term in section 201 of the Federal Food, Drug, 

23 and Cosmetic Act (21 U.S.C. 321). 

24 (2) The term ‘‘drug developer’’ means an entity 

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1 tion under section 505 of the Federal Food, Drug, 

2 and Cosmetic Act (21 U.S.C. 355) or section 351 of 

3 the Public Health Service Act (42 U.S.C. 262). 

4 Subtitle E—Pharmacy School 

5 Outreach 

6 SEC. 141. PHARMACY SCHOOL OUTREACH. 

7 The Secretary of Health and Human Services and the 

8 Secretary of Education shall make every effort necessary 

9 to ensure appropriate outreach to institutions of higher 

10 education to ensure that students and faculty at schools 

11 of pharmacy are provided with materials regarding generic 

12 drugs and biosimilar biological products, including mate13 rials on— 

14 (1) how generic drugs and biosimilar biological 

15 products are equivalent or similar to brand-name 

16 drugs; 

17 (2) the approval process at the Food and Drug 

18 Administration for generic drugs and biosimilar bio19 logical products; 

20 (3) how to make consumers aware of the avail21 ability of generic drugs and biosimilar biological 

22 products; 

23 (4) requirements for substituting generic drugs 

24 and biosimliar biological products in place of cor25 responding drugs products; and 


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1 (5) the impacts of generic drugs and biosimilar 

2 biological products on consumer costs. 

3 Subtitle F—Reports 

4 SEC. 151. EFFECTS OF INCREASES IN PRESCRIPTION DRUG 

5 PRICE. 

6 Not later than 1 year after the date of enactment 

7 of this Act, the Secretary of Health and Human Services 

8 shall submit a report to the Congress on the extent to 

9 which increases in prescription drug prices may have 

10 caused Medicare beneficiaries to forego recommended 

11 treatment, including failing to fill prescriptions. 

12 TITLE II—HEALTH INSURANCE 

13 MARKET STABILIZATION 

14 SEC. 201. PRESERVING STATE OPTION TO IMPLEMENT 

15 HEALTH CARE MARKETPLACES. 

16 (a) IN GENERAL.—Section 1311 of the Patient Pro17 tection and Affordable Care Act (42 U.S.C. 18031) is 

18 amended— 

19 (1) in subsection (a)— 

20 (A) in paragraph (4)(B), by striking 

21 ‘‘under this subsection’’ and inserting ‘‘under 

22 this paragraph or paragraph (1)’’; and 

23 (B) by adding at the end the following new 

24 paragraph: 


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1 ‘‘(6) ADDITIONAL PLANNING AND ESTABLISH2 MENT GRANTS.— 

3 ‘‘(A) IN GENERAL.—There shall be appro4 priated to the Secretary, out of any moneys in 

5 the Treasury not otherwise appropriated, $200 

6 million to award grants to eligible States for 

7 the uses described in paragraph (3). 

8 ‘‘(B) DURATION AND RENEWABILITY.—A 

9 grant awarded under subparagraph (A) shall be 

10 for a period of 2 years and may not be renewed. 

11 ‘‘(C) LIMITATION.—A grant may not be 

12 awarded under subparagraph (A) after Decem13 ber 31, 2023. 

14 ‘‘(D) ELIGIBLE STATE DEFINED.—For 

15 purposes of this paragraph, the term ‘eligible 

16 State’ means a State that, as of the date of the 

17 enactment of this paragraph, is not operating 

18 an Exchange (other than an Exchange de19 scribed in section 155.200(f) of title 45, Code 

20 of Federal Regulations).’’; and 

21 (2) in subsection (d)(5)(A)— 

22 (A) by striking ‘‘OPERATIONS.—In estab23 lishing an Exchange under this section’’ and in24 serting ‘‘OPERATIONS.— 


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1 ‘‘(i) IN GENERAL.—In establishing an 

2 Exchange under this section (other than in 

3 establishing an Exchange pursuant to a 

4 grant awarded under subsection (a)(6))’’; 

5 and 

6 (B) by adding at the end the following: 

7 ‘‘(ii) ADDITIONAL PLANNING AND ES8 TABLISHMENT GRANTS.—In establishing 

9 an Exchange pursuant to a grant awarded 

10 under subsection (a)(6), the State shall en11 sure that such Exchange is self-sustaining 

12 beginning on January 1, 2025, including 

13 allowing the Exchange to charge assess14 ments or user fees to participating health 

15 insurance issuers, or to otherwise generate 

16 funding, to support its operations.’’. 

17 (b) CLARIFICATION REGARDING FAILURE TO ESTAB18 LISH EXCHANGE OR IMPLEMENT REQUIREMENTS.—Sec19 tion 1321(c) of the Patient Protection and Affordable 

20 Care Act (42 U.S.C. 18041(c)) is amended— 

21 (1) in paragraph (1), by striking ‘‘If’’ and in22 serting ‘‘Subject to paragraph (3), if’’; and 

23 (2) by adding at the end the following new 

24 paragraph: 


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1 ‘‘(3) CLARIFICATION.—This subsection shall 

2 not apply in the case of a State that elects to apply 

3 the requirements described in subsection (a) and 

4 satisfies the requirement described in subsection (b) 

5 on or after January 1, 2014.’’. 

6 SEC. 202. PROVIDING FOR ADDITIONAL REQUIREMENTS 

7 WITH RESPECT TO THE NAVIGATOR PRO8 GRAM. 

9 (a) IN GENERAL.—Section 1311(i) of the Patient 

10 Protection and Affordable Care Act (42 U.S.C. 18031(i)) 

11 is amended— 

12 (1) in paragraph (2), by adding at the end the 

13 following new subparagraph: 

14 ‘‘(C) SELECTION OF RECIPIENTS.—In the 

15 case of an Exchange established and operated 

16 by the Secretary within a State pursuant to sec17 tion 1321(c), in awarding grants under para18 graph (1), the Exchange shall— 

19 ‘‘(i) select entities to receive such 

20 grants based on an entity’s demonstrated 

21 capacity to carry out each of the duties 

22 specified in paragraph (3); 

23 ‘‘(ii) not take into account whether or 

24 not the entity has demonstrated how the 

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1 uals relating to group health plans offered 

2 by a group or association of employers de3 scribed in section 2510.3–5(b) of title 29, 

4 Code of Federal Regulations (or any suc5 cessor regulation), or short-term limited 

6 duration insurance (as defined by the Sec7 retary for purposes of section 2791(b)(5) 

8 of the Public Health Service Act); and 

9 ‘‘(iii) ensure that, each year, the Ex10 change awards such a grant to— 

11 ‘‘(I) at least one entity described 

12 in this paragraph that is a community 

13 and consumer-focused nonprofit 

14 group; and 

15 ‘‘(II) at least one entity described 

16 in subparagraph (B), which may in17 clude another community and con18 sumer-focused nonprofit group in ad19 dition to any such group awarded a 

20 grant pursuant to subclause (I). 

21 In awarding such grants, an Exchange may 

22 consider an entity’s record with respect to 

23 waste, fraud, and abuse for purposes of main24 taining the integrity of such Exchange.’’. 

25 (2) in paragraph (3)— 


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1 (A) by amending subparagraph (C) to read 

2 as follows: 

3 ‘‘(C) facilitate enrollment, including with 

4 respect to individuals with limited English pro5 ficiency and individuals with chronic illnesses, 

6 in qualified health plans, State medicaid plans 

7 under title XIX of the Social Security Act, and 

8 State child health plans under title XXI of such 

9 Act;’’; 

10 (B) in subparagraph (D), by striking 

11 ‘‘and’’ at the end; 

12 (C) in subparagraph (E), by striking the 

13 period at the end and inserting a semicolon; 

14 (D) by inserting after subparagraph (E) 

15 the following: 

16 ‘‘(F) conduct public education activities in 

17 plain language to raise awareness of the re18 quirements of and the protections provided 

19 under— 

20 ‘‘(i) the essential health benefits pack21 age (as defined in section 1302(a)); and 

22 ‘‘(ii) section 2726 of the Public 

23 Health Service Act (relating to parity in 

24 mental health and substance use disorder 

25 benefits); and’’; 


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1 (E) by inserting after subparagraph (F) 

2 (as added by subparagraph (D)) the following 

3 new subparagraph: 

4 ‘‘(G) provide referrals to community-based 

5 organizations that address social needs related 

6 to health outcomes.’’; and 

7 (F) by adding at the end the following 

8 flush left sentence: 

9 ‘‘The duties specified in the preceding sentences may 

10 be carried out by such a navigator at any time dur11 ing a year.’’; 

12 (3) in paragraph (4)(A)— 

13 (A) in the matter preceding clause (i), by 

14 striking ‘‘not’’; 

15 (B) in clause (i)— 

16 (i) by inserting ‘‘not’’ before ‘‘be’’; 

17 and 

18 (ii) by striking ‘‘; or’’ and inserting a 

19 semicolon; 

20 (C) in clause (ii)— 

21 (i) by inserting ‘‘not’’ before ‘‘re22 ceive’’; and 

23 (ii) by striking the period and insert24 ing a semicolon; and 


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1 (D) by adding at the end the following new 

2 clauses: 

3 ‘‘(iii) maintain physical presence in 

4 the State of the Exchange so as to allow 

5 in-person assistance to consumers; 

6 ‘‘(iv) receive training on how to assist 

7 individuals with enrolling for medical as8 sistance under State plans under the Med9 icaid program under title XIX of the Social 

10 Security Act or for child health assistance 

11 under State child health plans under title 

12 XXI of such Act; and 

13 ‘‘(v) receive opioid specific education 

14 and training that ensures the navigator 

15 can best educate individuals on qualified 

16 health plans offered through an Exchange, 

17 specifically coverage under such plans for 

18 opioid health care treatment.’’; and 

19 (4) in paragraph (6)— 

20 (A) by striking ‘‘FUNDING.—Grants 

21 under’’ and inserting ‘‘FUNDING.— 

22 ‘‘(A) STATE EXCHANGES.—Subject to sub23 paragraph (C), grants under’’; and 

24 (B) by adding at the end the following new 

25 subparagraphs: 


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1 ‘‘(B) FEDERAL EXCHANGES.—For pur2 poses of carrying out this subsection, with re3 spect to an Exchange established and operated 

4 by the Secretary within a State pursuant to sec5 tion 1321(c), the Secretary shall obligate $100 

6 million out of amounts collected through the 

7 user fees on participating health insurance 

8 issuers pursuant to section 156.50 of title 45, 

9 Code of Federal Regulations (or any successor 

10 regulations) for fiscal year 2020 and each sub11 sequent fiscal year. Such amount for a fiscal 

12 year shall remain available until expended. 

13 ‘‘(C) STATE EXCHANGES.—For the pur14 poses of carrying out this subsection, with re15 spect to an Exchange operated by a State pur16 suant to this section, there is authorized to be 

17 appropriated $25 million for fiscal year 2020 

18 and each subsequent fiscal year. Each State re19 ceiving a grant pursuant to this subparagraph 

20 shall receive a grant in an amount that is not 

21 less than $1 million.’’. 

22 (b) STUDY ON EFFECTS OF FUNDING CUTS.—Not 

23 later than 1 year after the date of the enactment of this 

24 Act, the Comptroller General of the United States shall 

25 study the effects of funding cuts made for plan year 2019 


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1 with respect to the navigator program (as described in sec2 tion 1311(i) of the Patient Protection and Affordable Care 

3 Act (42 U.S.C. 18031(i))) and other education and out4 reach activities carried out with respect to Exchanges es5 tablished by the Secretary of Health and Human Services 

6 pursuant to section 1321(c) of such Act. Such study shall 

7 describe the following: 

8 (1) How such funding cuts negatively impacted 

9 the ability of entities under such program to conduct 

10 outreach activities and fulfill duties required under 

11 such section 1311(i). 

12 (2) The overall effect on— 

13 (A) the number of individuals enrolled in 

14 health insurance coverage offered in the indi15 vidual market for plan year 2019; and 

16 (B) the costs of health insurance coverage 

17 offered in the individual market. 

18 (c) PROMOTE TRANSPARENCY AND ACCOUNTABILITY

19 IN THE ADMINISTRATION’S EXPENDITURES OF EX20 CHANGE USER FEES.—For plan year 2020 and each sub21 sequent plan year, not later than the date that is 3 months 

22 after the end of such plan year, the Secretary of Health 

23 and Human Services shall submit to the appropriate com24 mittees of Congress and make available to the public an 

25 annual report on the expenditures by the Department of 


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1 Health and Human Services of user fees collected pursu2 ant to section 156.50 of title 45, Code of Federal Regula3 tions (or any successor regulations). Each such report for 

4 a plan year shall include a detailed accounting of the 

5 amount of such user fees collected during such plan year 

6 and of the amount of such expenditures used during such 

7 plan year for the federally facilitated Exchange operated 

8 pursuant to section 1321(c) of the Patient Protection and 

9 Affordable Care Act (42 U.S.C. 18041(c)) on outreach 

10 and enrollment activities, navigators, maintenance of 

11 Healthcare.gov, and operation of call centers. 

12 (d) EFFECTIVE DATE.—The amendments made by 

13 this section shall apply with respect to plan years begin14 ning on or after January 1, 2020. 

15 SEC. 203. FEDERAL EXCHANGE OUTREACH AND EDU16 CATIONAL ACTIVITIES AND ANNUAL ENROLL17 MENT TARGETS. 

18 (a) IN GENERAL.—Section 1321(c) of the Patient 

19 Protection and Affordable Care Act (42 U.S.C. 18041(c)), 

20 as amended by section 201(b)(2), is further amended by 

21 adding at the end the following new paragraphs: 

22 ‘‘(4) OUTREACH AND EDUCATIONAL ACTIVI23 TIES.— 

24 ‘‘(A) IN GENERAL.—In the case of an Ex25 change established or operated by the Secretary 


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1 within a State pursuant to this subsection, the 

2 Secretary shall carry out outreach and edu3 cational activities for purposes of informing in4 dividuals about qualified health plans offered 

5 through the Exchange, including by informing 

6 such individuals of the availability of coverage 

7 under such plans and financial assistance for 

8 coverage under such plans. Such outreach and 

9 educational activities shall be provided in a 

10 manner that is culturally and linguistically ap11 propriate to the needs of the populations being 

12 served by the Exchange (including hard-to13 reach populations, such as racial and sexual mi14 norities, limited English proficient populations, 

15 individuals residing in areas where the unem16 ployment rates exceeds the national average un17 employment rate, individuals in rural areas, vet18 erans, and young adults) and shall be provided 

19 to populations residing in high health disparity 

20 areas (as defined in subparagraph (E)) served 

21 by the Exchange, in addition to other popu22 lations served by the Exchange. 

23 ‘‘(B) LIMITATION ON USE OF FUNDS.—No 

24 funds appropriated under this paragraph shall 


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1 be used for expenditures for promoting non2 ACA compliant health insurance coverage. 

3 ‘‘(C) NON-ACA COMPLIANT HEALTH INSUR4 ANCE COVERAGE.—For purposes of subpara5 graph (B): 

6 ‘‘(i) The term ‘non-ACA compliant 

7 health insurance coverage’ means health 

8 insurance coverage, or a group health plan, 

9 that is not a qualified health plan. 

10 ‘‘(ii) Such term includes the following: 

11 ‘‘(I) An association health plan. 

12 ‘‘(II) Short-term limited duration 

13 insurance. 

14 ‘‘(D) FUNDING.—Out of any funds in the 

15 Treasury not otherwise appropriated, there are 

16 hereby appropriated for fiscal year 2020 and 

17 each subsequent fiscal year, $100 million to 

18 carry out this paragraph. Funds appropriated 

19 under this subparagraph shall remain available 

20 until expended. 

21 ‘‘(E) HIGH HEALTH DISPARITY AREA DE22 FINED.—For purposes of subparagraph (A), the 

23 term ‘high health disparity area’ means a con24 tiguous geographic area that— 


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1 ‘‘(i) is located in one census tract or 

2 ZIP code; 

3 ‘‘(ii) has measurable and documented 

4 racial, ethnic, or geographic health dispari5 ties; 

6 ‘‘(iii) has a low-income population, as 

7 demonstrated by— 

8 ‘‘(I) average income below 138 

9 percent of the Federal poverty line; or 

10 ‘‘(II) a rate of participation in 

11 the special supplemental nutrition 

12 program under section 17 of the Child 

13 Nutrition Act of 1966 (42 U.S.C. 

14 1786) that is higher than the national 

15 average rate of participation in such 

16 program; 

17 ‘‘(iv) has poor health outcomes, as 

18 demonstrated by— 

19 ‘‘(I) lower life expectancy than 

20 the national average; or 

21 ‘‘(II) a higher percentage of in22 stances of low birth weight than the 

23 national average; and 


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1 ‘‘(v) is part of a Metropolitan Statis2 tical Area identified by the Office of Man3 agement and Budget. 

4 ‘‘(5) ANNUAL ENROLLMENT TARGETS.—For 

5 plan year 2020 and each subsequent plan year, in 

6 the case of an Exchange established or operated by 

7 the Secretary within a State pursuant to this sub8 section, the Secretary shall establish annual enroll9 ment targets for such Exchange for such year.’’. 

10 (b) STUDY AND REPORT.—Not later than 30 days 

11 after the date of the enactment of this Act, the Secretary 

12 of Health and Human Services shall release to Congress 

13 all aggregated documents relating to studies and data sets 

14 that were created on or after January 1, 2014, and related 

15 to marketing and outreach with respect to qualified health 

16 plans offered through Exchanges under title I of the Pa17 tient Protection and Affordable Care Act. 

18 SEC. 204. SHORT-TERM LIMITED DURATION INSURANCE 

19 RULE PROHIBITION. 

20 (a) FINDINGS.—Congress finds the following: 

21 (1) On August 3, 2018, the Administration 

22 issued a final rule entitled ‘‘Short-Term, Limited23 Duration Insurance’’ (83 Fed. Reg. 38212). 

24 (2) The final rule dramatically expands the sale 

25 and marketing of insurance that— 


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1 (A) may discriminate against individuals 

2 living with preexisting health conditions, includ3 ing children with complex medical needs and 

4 disabilities and their families; 

5 (B) lacks important financial protections 

6 provided by the Patient Protection and Afford7 able Care Act (Public Law 111–148), including 

8 the prohibition of annual and lifetime coverage 

9 limits and annual out-of-pocket limits, that may 

10 increase the cost of treatment and cause finan11 cial hardship to those requiring medical care, 

12 including children with complex medical needs 

13 and disabilities and their families; and 

14 (C) excludes coverage of essential health 

15 benefits including hospitalization, prescription 

16 drugs, and other lifesaving care. 

17 (3) The implementation and enforcement of the 

18 final rule weakens critical protections for up to 130 

19 million Americans living with preexisting health con20 ditions and may place a large financial burden on 

21 those who enroll in short-term limited-duration in22 surance, which jeopardizes Americans’ access to 

23 quality, affordable health insurance. 

24 (b) PROHIBITION.—The Secretary of Health and 

25 Human Services, the Secretary of the Treasury, and the 


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1 Secretary of Labor may not take any action to implement, 

2 enforce, or otherwise give effect to the rule entitled 

3 ‘‘Short-Term, Limited Duration Insurance’’ (83 Fed. Reg. 

4 38212 (August 3, 2018)), and the Secretaries may not 

5 promulgate any substantially similar rule. 

6 SEC. 205. PROTECTION OF HEALTH INSURANCE COVERAGE 

7 IN CERTAIN EXCHANGES. 

8 In the case of an Exchange that the Secretary of 

9 Health and Human Services operates pursuant to section 

10 1321(c)(1) of the Patient Protection and Affordable Care 

11 Act (42 U.S.C. 18041(c)(1)), the Secretary may not im12 plement any process that would terminate the health in13 surance coverage of an enrollee solely because such en14 rollee did not actively enroll during the most recent open 

15 enrollment period. 

16 SEC. 206. SENSE OF CONGRESS RELATING TO THE PRAC17 TICE OF SILVER LOADING. 

18 It is the sense of Congress that the Secretary of 

19 Health and Human Services should not take any action 

20 to prohibit or otherwise restrict the practice commonly 

21 known as ‘‘silver loading’’ (as described in the rule entitled 

22 ‘‘Patient Protection and Affordable Care Act; HHS Notice 

23 of Benefit and Payment Parameters for 2020’’ published 

24 on April 25, 2019 (84 Fed. Reg. 17533)). 


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1 SEC. 207. CONSUMER OUTREACH, EDUCATION, AND ASSIST2 ANCE. 

3 (a) OPEN ENROLLMENT REPORTS.—For plan year 

4 2020 and each subsequent year, the Secretary of Health 

5 and Human Services (referred to in this section as the 

6 ‘‘Secretary’’), in coordination with the Secretary of the 

7 Treasury and the Secretary of Labor, shall issue biweekly 

8 public reports during the annual open enrollment period 

9 on the performance of the Federal Exchange. Each such 

10 report shall include a summary, including information on 

11 a State-by-State basis where available, of— 

12 (1) the number of unique website visits; 

13 (2) the number of individuals who create an ac14 count; 

15 (3) the number of calls to the call center; 

16 (4) the average wait time for callers contacting 

17 the call center; 

18 (5) the number of individuals who enroll in a 

19 qualified health plan; and 

20 (6) the percentage of individuals who enroll in 

21 a qualified health plan through each of— 

22 (A) the website; 

23 (B) the call center; 

24 (C) navigators; 

25 (D) agents and brokers; 

26 (E) the enrollment assistant program; 


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1 (F) directly from issuers or web brokers; 

2 and 

3 (G) other means. 

4 (b) OPEN ENROLLMENT AFTER ACTION REPORT.— 

5 For plan year 2020 and each subsequent year, the Sec6 retary, in coordination with the Secretary of the Treasury 

7 and the Secretary of Labor, shall publish an after action 

8 report not later than 3 months after the completion of the 

9 annual open enrollment period regarding the performance 

10 of the Federal Exchange for the applicable plan year. 

11 Each such report shall include a summary, including in12 formation on a State-by-State basis where available, of— 

13 (1) the open enrollment data reported under 

14 subsection (a) for the entirety of the enrollment pe15 riod; and 

16 (2) activities related to patient navigators de17 scribed in section 1311(i) of the Patient Protection 

18 and Affordable Care Act (42 U.S.C. 18031(i)), in19 cluding— 

20 (A) the performance objectives established 

21 by the Secretary for such patient navigators; 

22 (B) the number of consumers enrolled by 

23 such a patient navigator; 

24 (C) an assessment of how such patient 

25 navigators have met established performance 


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1 metrics, including a detailed list of all patient 

2 navigators, funding received by patient naviga3 tors, and whether established performance ob4 jectives of patient navigators were met; and 

5 (D) with respect to the performance objec6 tives described in subparagraph (A)— 

7 (i) whether such objectives assess the 

8 full scope of patient navigator responsibil9 ities, including general education, plan se10 lection, and determination of eligibility for 

11 tax credits, cost-sharing reductions, or 

12 other coverage; 

13 (ii) how the Secretary worked with pa14 tient navigators to establish such objec15 tives; and 

16 (iii) how the Secretary adjusted such 

17 objectives for case complexity and other 

18 contextual factors. 

19 (c) REPORT ON ADVERTISING AND CONSUMER OUT20 REACH.—Not later than 3 months after the completion of 

21 the annual open enrollment period for the 2020 plan year, 

22 the Secretary shall issue a report on advertising and out23 reach to consumers for the open enrollment period for the 

24 2020 plan year. Such report shall include a description 

25 of— 


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1 (1) the division of spending on individual adver2 tising platforms, including television and radio ad3 vertisements and digital media, to raise consumer 

4 awareness of open enrollment; 

5 (2) the division of spending on individual out6 reach platforms, including email and text messages, 

7 to raise consumer awareness of open enrollment; and 

8 (3) whether the Secretary conducted targeted 

9 outreach to specific demographic groups and geo10 graphic areas. 

11 SEC. 208. GAO REPORT. 

12 Not later than 1 year after the date of the enactment 

13 of this Act, the Comptroller General of the United States 

14 shall submit to Congress a study that analyzes the costs 

15 and benefits of the establishment of State-administered 

16 health insurance plans to be offered in the insurance mar17 ket of such States that choose to administer and offer such 

18 a plan. 

19 SEC. 209. REPORT ON THE EFFECTS OF WEBSITE MAINTE20 NANCE DURING OPEN ENROLLMENT. 

21 Not later than 1 year after the date of the enactment 

22 of this Act, the Comptroller General of the United States 

23 shall submit to Congress a report examining whether the 

24 Department of Health and Human Services has been con25 ducting maintenance on the website commonly referred to 


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1 as ‘‘Healthcare.gov’’ during annual open enrollment peri2 ods (as described in section 1311(c)(6)(B) of the Patient 

3 Protection and Affordable Care Act (42 U.S.C. 

4 18031(c)(6)(B)) in such a manner so as to minimize any 

5 disruption to the use of such website resulting from such 

6 maintenance. 

7 TITLE III—BUDGETARY EFFECTS 

8 SEC. 301. DETERMINATION OF BUDGETARY EFFECTS. 

9 The budgetary effects of this Act, for the purpose of 

10 complying with the Statutory Pay-As-You-Go Act of 2010, 

11 shall be determined by reference to the latest statement 

12 titled ‘‘Budgetary Effects of PAYGO Legislation’’ for this 

13 Act, submitted for printing in the Congressional Record 

14 by the Chairman of the House Budget Committee, pro15 vided that such statement has been submitted prior to the 

16 vote on passage. 

Passed the House of Representatives May 16, 2019. 

Attest: CHERYL L. JOHNSON, 

Clerk. 


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