IB 

Union Calendar No. 170 

116TH CONGRESS 

1ST SESSION H. R. 2296 

[Report No. 116–215] 

To require reporting regarding certain drug price increases, and for other 

purposes. 

IN THE HOUSE OF REPRESENTATIVES 

APRIL 12, 2019 

Ms. SCHAKOWSKY (for herself and Mr. ROONEY of Florida) introduced the 

following bill; which was referred to the Committee on Energy and Commerce 

SEPTEMBER 24, 2019 

Additional sponsors: Mr. DOGGETT, Mr. SARBANES, Ms. UNDERWOOD, Mr. 

GRIFFITH, Mr. SUOZZI, Mr. POCAN, and Mr. CARTER of Georgia 

SEPTEMBER 24, 2019 

Reported with amendments, committed to the Committee of the Whole House 

on the State of the Union, and ordered to be printed 

[Strike out all after the enacting clause and insert the part printed in italic] 

[For text of introduced bill, see copy of bill as introduced on April 12, 2019] 


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A BILL 

To require reporting regarding certain drug price increases, 

and for other purposes. 


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

3 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 

4 (a) SHORT TITLE.—This Act may be cited as the 

5 ‘‘More Efficient Tools to Realize Information for Consumers 

6 Act’’ or the ‘‘METRIC Act’’. 

7 (b) TABLE OF CONTENTS.—The table of contents for 

8 this Act is as follows: 

Sec. 1. Short title; table of contents. 

Sec. 2. Reporting on explanation for drug price increases. 

Sec. 3. Public disclosure of drug discounts. 

Sec. 4. Study of pharmaceutical supply chain intermediaries and merger activity. 

Sec. 5. Requiring certain manufacturers to report drug pricing information with 

respect to drugs under the Medicare program. 

Sec. 6. Making prescription drug marketing sample information reported by 

manufacturers available to certain individuals and entities. 

Sec. 7. Requiring prescription drug plan sponsors to include real-time benefit information as part of such sponsor’s electronic prescription program under the Medicare program. 

Sec. 8. Sense of Congress regarding the need to expand commercially available 

drug pricing comparison platforms. 

Sec. 9. Technical corrections. 

9 SEC. 2. REPORTING ON EXPLANATION FOR DRUG PRICE IN10 CREASES. 

11 (a) IN GENERAL.—Title III of the Public Health Serv12 ice Act (42 U.S.C. 241 et seq.) is amended by adding at 

13 the end the following: 

14 ‘‘PART W—DRUG PRICE REPORTING; DRUG VALUE 

15 FUND 

16 ‘‘SEC. 399OO. REPORTING ON EXPLANATION FOR DRUG 

17 PRICE INCREASES. 

18 ‘‘(a) DEFINITIONS.—In this section: 


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1 ‘‘(1) MANUFACTURER.—The term ‘manufacturer’ 

2 means the person— 

3 ‘‘(A) that holds the application for a drug 

4 approved under section 505 of the Federal Food, 

5 Drug, and Cosmetic Act or licensed under section 

6 351 of this Act; or 

7 ‘‘(B) who is responsible for setting the 

8 wholesale acquisition cost for the drug. 

9 ‘‘(2) QUALIFYING DRUG.—The term ‘qualifying 

10 drug’ means any drug that is approved under sub11 section (c) or (j) of section 505 of the Federal Food, 

12 Drug, and Cosmetic Act or licensed under subsection 

13 (a) or (k) of section 351 of this Act— 

14 ‘‘(A) that has a wholesale acquisition cost of 

15 $100 or more, adjusted for inflation occurring 

16 after the date of enactment of the More Efficient 

17 Tools to Realize Information for Consumers Act, 

18 for a month’s supply or a typical course of treat19 ment that lasts less than a month, and is— 

20 ‘‘(i) subject to section 503(b)(1) of the 

21 Federal Food, Drug, and Cosmetic Act; 

22 ‘‘(ii) administered or otherwise dis23 pensed to treat a disease or condition affect24 ing more than 200,000 persons in the 

25 United States; and 


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1 ‘‘(iii) not a vaccine; and 

2 ‘‘(B) for which, during the previous cal3 endar year, at least 1 dollar of the total amount 

4 of sales were for individuals enrolled under the 

5 Medicare program under title XVIII of the So6 cial Security Act (42 U.S.C. 1395 et seq.) or 

7 under a State Medicaid plan under title XIX of 

8 such Act (42 U.S.C. 1396 et seq.) or under a 

9 waiver of such plan. 

10 ‘‘(3) WHOLESALE ACQUISITION COST.—The term 

11 ‘wholesale acquisition cost’ has the meaning given 

12 that term in section 1847A(c)(6)(B) of the Social Se13 curity Act (42 U.S.C. 1395w–3a(c)(6)(B)). 

14 ‘‘(b) REPORT.— 

15 ‘‘(1) REPORT REQUIRED.—The manufacturer of 

16 a qualifying drug shall submit a report to the Sec17 retary for each increase in the price of a qualifying 

18 drug that results in an increase in the wholesale ac19 quisition cost of that drug that is equal to— 

20 ‘‘(A) 10 percent or more within a single cal21 endar year beginning on or after January 1, 

22 2019; or 

23 ‘‘(B) 25 percent or more within three con24 secutive calendar years for which the first such 


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1 calendar year begins on or after January 1, 

2 2019. 

3 ‘‘(2) REPORT DEADLINE.—Each report described 

4 in paragraph (1) shall be submitted to the Sec5 retary— 

6 ‘‘(A) in the case of a report with respect to 

7 an increase in the price of a qualifying drug 

8 that occurs during the period beginning on Jan9 uary 1, 2019, and ending on the day that is 60 

10 days after the date of the enactment of the More 

11 Efficient Tools to Realize Information for Con12 sumers Act, not later than 90 days after such 

13 date of enactment; and 

14 ‘‘(B) in the case of a report with respect to 

15 an increase in the price of a qualifying drug 

16 that occurs after the period described in subpara17 graph (A), not later than 30 days prior to the 

18 planned effective date of such price increase for 

19 such qualifying drug. 

20 ‘‘(c) CONTENTS.—A report under subsection (b), con21 sistent with the standard for disclosures described in section 

22 213.3(d) of title 12, Code of Federal Regulations (as in effect 

23 on the date of enactment of the More Efficient Tools to Real24 ize Information for Consumers Act), shall, at a minimum, 

25 include— 


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1 ‘‘(1) with respect to the qualifying drug— 

2 ‘‘(A) the percentage by which the manufac3 turer will raise the wholesale acquisition cost of 

4 the drug within the calendar year or three con5 secutive calendar years as described in subsection 

6 (b)(1)(A) or (b)(1)(B), and the effective date of 

7 such price increase; 

8 ‘‘(B) an explanation for, and description of, 

9 each price increase for such drug that will occur 

10 during the calendar year period described in 

11 subsection (b)(1)(A) or the three consecutive cal12 endar year period described in subsection 

13 (b)(1)(B), as applicable; 

14 ‘‘(C) if known and different from the manu15 facturer of the qualifying drug, the identity of— 

16 ‘‘(i) the sponsor or sponsors of any in17 vestigational new drug applications under 

18 section 505(i) of the Federal Food, Drug, 

19 and Cosmetic Act for clinical investigations 

20 with respect to such drug, for which the full 

21 reports are submitted as part of the appli22 cation— 

23 ‘‘(I) for approval of the drug 

24 under section 505 of such Act; or 


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1 ‘‘(II) for licensure of the drug 

2 under section 351 of this Act; and 

3 ‘‘(ii) the sponsor of an application for 

4 the drug approved under such section 505 of 

5 the Federal Food, Drug, and Cosmetic Act 

6 or licensed under section 351 of this Act; 

7 ‘‘(D) a description of the history of the 

8 manufacturer’s price increases for the drug since 

9 the approval of the application for the drug 

10 under section 505 of the Federal Food, Drug, 

11 and Cosmetic Act or the issuance of the license 

12 for the drug under section 351 of this Act, or 

13 since the manufacturer acquired such approved 

14 application or license, if applicable; 

15 ‘‘(E) the current wholesale acquisition cost 

16 of the drug; 

17 ‘‘(F) the total expenditures of the manufac18 turer on— 

19 ‘‘(i) materials and manufacturing for 

20 such drug; and 

21 ‘‘(ii) acquiring patents and licensing 

22 for such drug; 

23 ‘‘(G) the percentage of total expenditures of 

24 the manufacturer on research and development 


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1 for such drug that was derived from Federal 

2 funds; 

3 ‘‘(H) the total expenditures of the manufac4 turer on research and development for such drug 

5 that is necessary to demonstrate that it meets 

6 applicable statutory standards for approval 

7 under section 505 of the Federal Food, Drug, 

8 and Cosmetic Act or licensure under section 351 

9 of this Act, as applicable; 

10 ‘‘(I) the total expenditures of the manufac11 turer on pursuing new or expanded indications 

12 or dosage changes for such drug under section 

13 505 of the Federal Food, Drug, and Cosmetic Act 

14 or section 351 of this Act; 

15 ‘‘(J) the total expenditures of the manufac16 turer on carrying out postmarket requirements 

17 related to such drug, including under section 

18 505(o)(3) of the Federal Food, Drug, and Cos19 metic Act; 

20 ‘‘(K) the total revenue and the net profit 

21 generated from the qualifying drug for each cal22 endar year since the approval of the application 

23 for the drug under section 505 of the Federal 

24 Food, Drug, and Cosmetic Act or the issuance of 

25 the license for the drug under section 351, or 


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1 since the manufacturer acquired such approved 

2 application or license; and 

3 ‘‘(L) the total costs associated with mar4 keting and advertising for the qualifying drug; 

5 ‘‘(2) with respect to the manufacturer— 

6 ‘‘(A) the total revenue and the net profit of 

7 the manufacturer for each of the 1-year period 

8 described in subsection (b)(1)(A) or the 3-year 

9 period described in subsection (b)(1)(B), as ap10 plicable; 

11 ‘‘(B) all stock-based performance metrics 

12 used by the manufacturer to determine executive 

13 compensation for each of the 1-year period de14 scribed in subsection (b)(1)(A) or the 3-year pe15 riod described in subsection (b)(1)(B), as appli16 cable; and 

17 ‘‘(C) any additional information the manu18 facturer chooses to provide related to drug pric19 ing decisions, such as total expenditures on— 

20 ‘‘(i) drug research and development; or 

21 ‘‘(ii) clinical trials, including on drugs 

22 that failed to receive approval by the Food 

23 and Drug Administration; and 


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1 ‘‘(3) such other related information as the Sec2 retary considers appropriate and as specified by the 

3 Secretary through notice-and-comment rulemaking. 

4 ‘‘(d) INFORMATION PROVIDED.—The manufacturer of 

5 a qualifying drug that is required to submit a report under 

6 subsection (b), shall ensure that such report and any expla7 nation for, and description of, each price increase described 

8 in subsection (c)(1)(B) shall be truthful, not misleading, 

9 and accurate. 

10 ‘‘(e) CIVIL MONETARY PENALTY.—Any manufacturer 

11 of a qualifying drug that fails to submit a report for the 

12 drug as required by this section, following notification by 

13 the Secretary to the manufacturer that the manufacturer 

14 is not in compliance with this section, shall be subject to 

15 a civil monetary penalty of $75,000 for each day on which 

16 the violation continues. 

17 ‘‘(f) FALSE INFORMATION.—Any manufacturer that 

18 submits a report for a drug as required by this section that 

19 knowingly provides false information in such report is sub20 ject to a civil monetary penalty in an amount not to exceed 

21 $75,000 for each item of false information. 

22 ‘‘(g) PUBLIC POSTING.— 

23 ‘‘(1) IN GENERAL.—Subject to paragraph (3), the 

24 Secretary shall post each report submitted under sub25 section (b) on the public website of the Department of 


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1 Health and Human Services the day the price in2 crease of a qualifying drug is scheduled to go into ef3 fect. 

4 ‘‘(2) FORMAT.—In developing the format in 

5 which reports will be publicly posted under para6 graph (1), the Secretary shall consult with stake7 holders, including beneficiary groups, and shall seek 

8 feedback from consumer advocates and readability ex9 perts on the format and presentation of the content of 

10 such reports to ensure that such reports are— 

11 ‘‘(A) user-friendly to the public; and 

12 ‘‘(B) written in plain language that con13 sumers can readily understand. 

14 ‘‘(3) PROTECTED INFORMATION.—Nothing in 

15 this section shall be construed to authorize the public 

16 disclosure of information submitted by a manufac17 turer that is prohibited from disclosure by applicable 

18 laws concerning the protection of trade secrets, com19 mercial information, and other information covered 

20 under such laws. 

21 ‘‘SEC. 399OO–1. ANNUAL REPORT TO CONGRESS. 

22 ‘‘(a) IN GENERAL.—Subject to subsection (b), the Sec23 retary shall submit to Congress, and post on the public 

24 website of the Department of Health and Human Services 

25 in a way that is user-friendly to the public and written 


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1 in plain language that consumers can readily understand, 

2 an annual report— 

3 ‘‘(1) summarizing the information reported pur4 suant to section 399OO; 

5 ‘‘(2) including copies of the reports and sup6 porting detailed economic analyses submitted pursu7 ant to such section; 

8 ‘‘(3) detailing the costs and expenditures in9 curred by the Department of Health and Human 

10 Services in carrying out section 399OO; and 

11 ‘‘(4) explaining how the Department of Health 

12 and Human Services is improving consumer and pro13 vider information about drug value and drug price 

14 transparency. 

15 ‘‘(b) PROTECTED INFORMATION.—Nothing in this sec16 tion shall be construed to authorize the public disclosure of 

17 information submitted by a manufacturer that is prohibited 

18 from disclosure by applicable laws concerning the protection 

19 of trade secrets, commercial information, and other infor20 mation covered under such laws.’’. 

21 (b) EFFECTIVE DATE.—The amendment made by sub22 section (a) takes effect on the date of enactment of this Act. 

23 SEC. 3. PUBLIC DISCLOSURE OF DRUG DISCOUNTS. 

24 Section 1150A of the Social Security Act (42 U.S.C. 

25 1320b–23) is amended— 


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1 (1) in subsection (c), in the matter preceding 

2 paragraph (1), by inserting ‘‘(other than as permitted 

3 under subsection (e))’’ after ‘‘disclosed by the Sec4 retary’’; and 

5 (2) by adding at the end the following new sub6 section: 

7 ‘‘(e) PUBLIC AVAILABILITY OF CERTAIN INFORMA8 TION.— 

9 ‘‘(1) IN GENERAL.—In order to allow the com10 parison of PBMs’ ability to negotiate rebates, dis11 counts, direct and indirect remuneration fees, admin12 istrative fees, and price concessions and the amount 

13 of such rebates, discounts, direct and indirect remu14 neration fees, administrative fees, and price conces15 sions that are passed through to plan sponsors, begin16 ning January 1, 2020, the Secretary shall make 

17 available on the Internet website of the Department of 

18 Health and Human Services the information with re19 spect to the second preceding calendar year provided 

20 to the Secretary on generic dispensing rates (as de21 scribed in paragraph (1) of subsection (b)) and infor22 mation provided to the Secretary under paragraphs 

23 (2) and (3) of such subsection that, as determined by 

24 the Secretary, is with respect to each PBM. 


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1 ‘‘(2) AVAILABILITY OF DATA.—In carrying out 

2 paragraph (1), the Secretary shall ensure the fol3 lowing: 

4 ‘‘(A) CONFIDENTIALITY.—The information 

5 described in such paragraph is displayed in a 

6 manner that prevents the disclosure of informa7 tion, with respect to an individual drug or an 

8 individual plan, on rebates, discounts, direct and 

9 indirect remuneration fees, administrative fees, 

10 and price concessions. 

11 ‘‘(B) CLASS OF DRUG.—The information 

12 described in such paragraph is made available 

13 by class of drug, using an existing classification 

14 system, but only if the class contains such num15 ber of drugs, as specified by the Secretary (but 

16 not fewer than three drugs), to ensure confiden17 tiality of proprietary information or other infor18 mation that is prevented to be disclosed under 

19 subparagraph (A).’’. 

20 SEC. 4. STUDY OF PHARMACEUTICAL SUPPLY CHAIN INTER21 MEDIARIES AND MERGER ACTIVITY. 

22 (a) INITIAL REPORT.—Not later than 1 year after the 

23 date of enactment of this Act, the Commission shall submit 

24 to the appropriate committees of Congress a report that— 

25 (1) addresses at minimum— 


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1 (A) whether pharmacy benefit managers— 

2 (i) charge payers a higher price than 

3 the reimbursement rate at which the phar4 macy benefit managers reimburse competing 

5 pharmacies; 

6 (ii) steer patients for anticompetitive 

7 purposes to any pharmacies, including re8 tail, mail-order, or any other type of phar9 macy, in which the pharmacy benefit man10 ager has an ownership interest; 

11 (iii) audit or review proprietary data, 

12 including acquisition costs, patient infor13 mation, or dispensing information, of com14 peting pharmacies that can be used for 

15 anticompetitive purposes; or 

16 (iv) use formulary designs to increase 

17 the market share of higher cost prescription 

18 drugs and depress the market share of lower 

19 cost prescription drugs (each net of rebates 

20 and discounts); 

21 (B) how companies and payers assess the 

22 benefits, costs, and risks of contracting with 

23 intermediaries, including pharmacy services ad24 ministrative organizations, and whether more 

25 information about the roles of intermediaries 


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1 should be available to consumers and payers; 

2 and 

3 (C) whether there are any specific legal or 

4 regulatory obstacles the Commission currently 

5 faces in ensuring a competitive and transparent 

6 marketplace in the pharmaceutical supply chain, 

7 including the pharmacy benefit manager market8 place and pharmacy services administrative or9 ganizations; and 

10 (2) provides— 

11 (A) observations or conclusions drawn from 

12 the November 2017 roundtable entitled ‘‘Under13 standing Competition in Prescription Drug Mar14 kets: Entry and Supply Chain Dynamics’’, and 

15 any similar efforts; 

16 (B) specific actions the Commission intends 

17 to take as a result of the November 2017 round18 table, and any similar efforts, including a de19 tailed description of relevant forthcoming ac20 tions, additional research or roundtable discus21 sions, consumer education efforts, or enforcement 

22 actions; and 

23 (C) policy or legislative recommendations 

24 to— 


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1 (i) improve transparency and competi2 tion in the pharmaceutical supply chain; 

3 (ii) prevent and deter anticompetitive 

4 behavior in the pharmaceutical supply 

5 chain; and 

6 (iii) best ensure that consumers benefit 

7 from any cost savings or efficiencies that 

8 may result from mergers and consolida9 tions. 

10 (b) INTERIM REPORT.—Not later than 180 days after 

11 the date of enactment of this Act, the Commission shall sub12 mit to the appropriate committees of Congress an interim 

13 report on the progress of the report required by subsection 

14 (a), along with preliminary findings and conclusions based 

15 on information collected to that date. 

16 (c) DEFINITIONS.—In this section: 

17 (1) APPROPRIATE COMMITTEES OF CONGRESS.— 

18 The term ‘‘appropriate committees of Congress’’ 

19 means— 

20 (A) the Committee on Energy and Com21 merce of the House of Representatives; 

22 (B) the Committee on the Judiciary of the 

23 Senate; and 

24 (C) the Committee on the Judiciary of the 

25 House of Representatives. 


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

2 means the Federal Trade Commission. 

3 SEC. 5. REQUIRING CERTAIN MANUFACTURERS TO REPORT 

4 DRUG PRICING INFORMATION WITH RESPECT 

5 TO DRUGS UNDER THE MEDICARE PROGRAM. 

6 (a) IN GENERAL.—Section 1847A of the Social Secu7 rity Act (42 U.S.C. 1395w–3a) is amended— 

8 (1) in subsection (b)— 

9 (A) in paragraph (2)(A), by inserting ‘‘or 

10 subsection (f)(2), as applicable’’ before the period 

11 at the end; 

12 (B) in paragraph (3), in the matter pre13 ceding subparagraph (A), by inserting ‘‘or sub14 section (f)(2), as applicable,’’ before ‘‘determined 

15 by’’; and 

16 (C) in paragraph (6)(A), in the matter pre17 ceding clause (i), by inserting ‘‘or subsection 

18 (f)(2), as applicable,’’ before ‘‘determined by’’; 

19 and 

20 (2) in subsection (f)— 

21 (A) by striking ‘‘For requirements’’ and in22 serting the following: 

23 ‘‘(1) IN GENERAL.—For requirements’’; and 

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

25 paragraph: 


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1 ‘‘(2) MANUFACTURERS WITHOUT A REBATE

2 AGREEMENT UNDER TITLE XIX.— 

3 ‘‘(A) IN GENERAL.—If the manufacturer of 

4 a drug or biological described in subparagraph 

5 (C), (E), or (G) of section 1842(o)(1) or in sec6 tion 1881(b)(14)(B) that is payable under this 

7 part has not entered into and does not have in 

8 effect a rebate agreement described in subsection 

9 (b) of section 1927, for calendar quarters begin10 ning on or after January 1, 2020, such manu11 facturer shall report to the Secretary the infor12 mation described in subsection (b)(3)(A)(iii) of 

13 such section 1927 with respect to such drug or 

14 biological in a time and manner specified by the 

15 Secretary. For purposes of applying this para16 graph, a drug or biological described in the pre17 vious sentence includes items, services, supplies, 

18 and products that are payable under this part as 

19 a drug or biological. 

20 ‘‘(B) AUDIT.—Information reported under 

21 subparagraph (A) is subject to audit by the In22 spector General of the Department of Health and 

23 Human Services. 

24 ‘‘(C) VERIFICATION.—The Secretary may 

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1 rectly distribute drugs described in subparagraph 

2 (A), when necessary, to verify manufacturer 

3 prices and manufacturer’s average sales prices 

4 (including wholesale acquisition cost) if required 

5 to make payment reported under subparagraph 

6 (A). The Secretary may impose a civil monetary 

7 penalty in an amount not to exceed $100,000 on 

8 a wholesaler, manufacturer, or direct seller, if the 

9 wholesaler, manufacturer, or direct seller of such 

10 a drug refuses a request for information about 

11 charges or prices by the Secretary in connection 

12 with a survey under this subparagraph or know13 ingly provides false information. The provisions 

14 of section 1128A (other than subsections (a) 

15 (with respect to amounts of penalties or addi16 tional assessments) and (b)) shall apply to a 

17 civil money penalty under this subparagraph in 

18 the same manner as such provisions apply to a 

19 penalty or proceeding under section 1128A(a). 

20 ‘‘(D) CONFIDENTIALITY.—Notwithstanding 

21 any other provision of law, information disclosed 

22 by manufacturers or wholesalers under this 

23 paragraph (other than the wholesale acquisition 

24 cost for purposes of carrying out this section) is 

25 confidential and shall not be disclosed by the 


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1 Secretary in a form which discloses the identity 

2 of a specific manufacturer or wholesaler or prices 

3 charged for drugs by such manufacturer or 

4 wholesaler, except— 

5 ‘‘(i) as the Secretary determines to be 

6 necessary to carry out this section (includ7 ing the determination and implementation 

8 of the payment amount), or to carry out 

9 section 1847B; 

10 ‘‘(ii) to permit the Comptroller General 

11 of the United States to review the informa12 tion provided; and 

13 ‘‘(iii) to permit the Director of the 

14 Congressional Budget Office to review the 

15 information provided.’’. 

16 (b) ENFORCEMENT.—Section 1847A of such Act (42 

17 U.S.C. 1395w–3a) is further amended— 

18 (1) in subsection (d)(4)— 

19 (A) in subparagraph (A), by striking ‘‘IN

20 GENERAL’’ and inserting ‘‘MISREPRESENTA21 TION’’; 

22 (B) in subparagraph (B), by striking ‘‘sub23 paragraph (B)’’ and inserting ‘‘subparagraph 

24 (A), (B), or (C)’’; 


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1 (C) by redesignating subparagraph (B) as 

2 subparagraph (D); and 

3 (D) by inserting after subparagraph (A) the 

4 following new subparagraphs: 

5 ‘‘(B) FAILURE TO PROVIDE TIMELY INFOR6 MATION.—If the Secretary determines that a 

7 manufacturer described in subsection (f)(2) has 

8 failed to report on information described in sec9 tion 1927(b)(3)(A)(iii) with respect to a drug or 

10 biological in accordance with such subsection, the 

11 Secretary shall apply a civil money penalty in 

12 an amount of $10,000 for each day the manufac13 turer has failed to report such information and 

14 such amount shall be paid to the Treasury. 

15 ‘‘(C) FALSE INFORMATION.—Any manufac16 turer required to submit information under sub17 section (f)(2) that knowingly provides false infor18 mation is subject to a civil money penalty in an 

19 amount not to exceed $100,000 for each item of 

20 false information. Such civil money penalties are 

21 in addition to other penalties as may be pre22 scribed by law.’’; and 

23 (2) in subsection (c)(6)(A), by striking the period 

24 at the end and inserting ‘‘, except that, for purposes 

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1 retary determines appropriate, exclude repackagers of 

2 a drug or biological from such term.’’. 

3 (c) MANUFACTURERS WITH A REBATE AGREEMENT.— 

4 (1) IN GENERAL.—Section 1927(b)(3)(A) of the 

5 Social Security Act (42 U.S.C. 1396r-8(b)(3)(A)) is 

6 amended by adding at the end the following new sen7 tence: ‘‘For purposes of applying clause (iii), a drug 

8 or biological described in the flush matter following 

9 such clause includes items, services, supplies, and 

10 products that are payable under this part as a drug 

11 or biological.’’. 

12 (2) TECHNICAL AMENDMENT.—Section 

13 1927(b)(3)(A)(iii) of the Social Security Act (42 

14 U.S.C. 1396r-8(b)(3)(A)(iii)) is amended by striking 

15 ‘‘section 1881(b)(13)(A)(ii)’’ and inserting ‘‘section 

16 1881(b)(14)(B)’’. 

17 (d) REPORT.—Not later than January 1, 2021, the In18 spector General of the Department of Health and Human 

19 Services shall assess and submit to Congress a report on 

20 the accuracy of average sales price information submitted 

21 by manufacturers under section 1847A of the Social Secu22 rity Act (42 U.S.C. 1395w–3a). Such report shall include 

23 any recommendations on how to improve the accuracy of 

24 such information. 


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1 SEC. 6. MAKING PRESCRIPTION DRUG MARKETING SAMPLE 

2 INFORMATION REPORTED BY MANUFACTUR3 ERS AVAILABLE TO CERTAIN INDIVIDUALS 

4 AND ENTITIES. 

5 (a) IN GENERAL.—Section 1128H of the Social Secu6 rity Act (42 U.S.C. 1320a–7i) is amended— 

7 (1) by redesignating subsection (b) as subsection 

8 (e); and 

9 (2) by inserting after subsection (a) the following 

10 new subsections: 

11 ‘‘(b) DATA SHARING AGREEMENTS.— 

12 ‘‘(1) IN GENERAL.—The Secretary shall enter 

13 into agreements with the specified data sharing indi14 viduals and entities described in paragraph (2) under 

15 which— 

16 ‘‘(A) upon request of such an individual or 

17 entity, as applicable, the Secretary makes avail18 able to such individual or entity the information 

19 submitted under subsection (a) by manufacturers 

20 and authorized distributors of record; and 

21 ‘‘(B) such individual or entity agrees to not 

22 disclose publicly or to another individual or en23 tity any information that identifies a particular 

24 practitioner or health care facility. 

25 ‘‘(2) SPECIFIED DATA SHARING INDIVIDUALS

26 AND ENTITIES.—For purposes of paragraph (1), the 


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1 specified data sharing individuals and entities de2 scribed in this paragraph are the following: 

3 ‘‘(A) OVERSIGHT AGENCIES.—Health over4 sight agencies (as defined in section 164.501 of 

5 title 45, Code of Federal Regulations), including 

6 the Centers for Medicare & Medicaid Services, 

7 the Office of the Inspector General of the Depart8 ment of Health and Human Services, the Gov9 ernment Accountability Office, the Congressional 

10 Budget Office, the Medicare Payment Advisory 

11 Commission, and the Medicaid and CHIP Pay12 ment and Access Commission. 

13 ‘‘(B) RESEARCHERS.—Individuals who con14 duct scientific research (as defined in section 

15 164.501 of title 45, Code of Federal Regulations) 

16 in relevant areas as determined by the Secretary. 

17 ‘‘(C) PAYERS.—Private and public health 

18 care payers, including group health plans, health 

19 insurance coverage offered by health insurance 

20 issuers, Federal health programs, and State 

21 health programs. 

22 ‘‘(3) EXEMPTION FROM FREEDOM OF INFORMA23 TION ACT.—Except as described in paragraph (1), the 

24 Secretary may not be compelled to disclose the infor25 mation submitted under subsection (a) to any indiVerDate Sep 11 2014 21:16 Sep 24, 2019 Jkt 089200 PO 00000 Frm 00026 Fmt 6652 Sfmt 6203 E:\BILLS\H2296.RH H2296

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1 vidual or entity. For purposes of section 552 of title 

2 5, United States Code (commonly referred to as the 

3 Freedom of Information Act), this paragraph shall be 

4 considered a statute described in subsection (b)(3)(B) 

5 of such section. 

6 ‘‘(c) PENALTIES.— 

7 ‘‘(1) DATA SHARING AGREEMENTS.—Subject to 

8 paragraph (3), any specified data sharing individual 

9 or entity described in subsection (b)(2) that violates 

10 the terms of a data sharing agreement the individual 

11 or entity has with the Secretary under subsection 

12 (b)(1) shall be subject to a civil money penalty of not 

13 less than $1,000, but not more than $10,000, for each 

14 such violation. Such penalty shall be imposed and 

15 collected in the same manner as civil money penalties 

16 under subsection (a) of section 1128A are imposed 

17 and collected under that section. 

18 ‘‘(2) FAILURE TO REPORT.—Subject to para19 graph (3), any manufacturer or authorized dis20 tributor of record of an applicable drug under sub21 section (a) that fails to submit information required 

22 under such subsection in a timely manner in accord23 ance with rules or regulations promulgated to carry 

24 out such subsection shall be subject to a civil money 

25 penalty of not less than $1,000, but not more than 


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1 $10,000, for each such failure. Such penalty shall be 

2 imposed and collected in the same manner as civil 

3 money penalties under subsection (a) of section 1128A 

4 are imposed and collected under that section. 

5 ‘‘(3) LIMITATION.—The total amount of civil 

6 money penalties imposed under paragraph (1) or (2) 

7 with respect to a year and an individual or entity de8 scribed in subparagraph (A) or a manufacturer or 

9 distributor described in subparagraph (B), respec10 tively, shall not exceed $150,000. 

11 ‘‘(d) DRUG SAMPLE DISTRIBUTION INFORMATION.— 

12 ‘‘(1) IN GENERAL.—Not later than January 1 of 

13 each year (beginning with 2021), the Secretary shall 

14 maintain a list containing information related to the 

15 distribution of samples of applicable drugs. Such list 

16 shall provide the following information with respect 

17 to the preceding year: 

18 ‘‘(A) The name of the manufacturer or au19 thorized distributor of record of an applicable 

20 drug for which samples were requested or distrib21 uted under this section. 

22 ‘‘(B) The quantity and class of drug sam23 ples requested. 

24 ‘‘(C) The quantity and class of drug sam25 ples distributed. 


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1 ‘‘(2) PUBLIC AVAILABILITY.—The Secretary shall 

2 make the information in such list available to the 

3 public on the Internet Web site of the Food and Drug 

4 Administration.’’. 

5 (b) FDA MAINTENANCE OF INFORMATION.—The Food 

6 and Drug Administration shall maintain information 

7 available to affected reporting companies to ensure their 

8 ability to fully comply with the requirements of section 

9 1128H of the Social Security Act. 

10 (c) PROHIBITION ON DISTRIBUTION OF SAMPLES OF

11 OPIOIDS.—Section 503(d) of the Federal Food, Drug, and 

12 Cosmetic Act (21 U.S.C. 353(d)) is amended— 

13 (1) by moving the margin of paragraph (4) 2 

14 ems to the left; and 

15 (2) by adding at the end the following: 

16 ‘‘(5) No person may distribute a drug sample of a drug 

17 that is— 

18 ‘‘(A) an applicable drug (as defined in section 

19 1128H(d) of the Social Security Act); 

20 ‘‘(B) a controlled substance (as defined in section 

21 102 of the Controlled Substances Act) for which the 

22 findings required under section 202(b)(2) of such Act 

23 have been made; and 

24 ‘‘(C) approved under section 505 for use in the 

25 management or treatment of pain (other than for the 


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1 management or treatment of a substance use dis2 order).’’. 

3 (d) MEDPAC REPORT.—Not later than 3 years after 

4 the date of the enactment of this Act, the Medicare Payment 

5 Advisory Commission shall conduct a study on the impact 

6 of drug samples on provider prescribing practices and 

7 health care costs and may, as the Commission deems appro8 priate, make recommendations on such study. 

9 SEC. 7. REQUIRING PRESCRIPTION DRUG PLAN SPONSORS 

10 TO INCLUDE REAL-TIME BENEFIT INFORMA11 TION AS PART OF SUCH SPONSOR’S ELEC12 TRONIC PRESCRIPTION PROGRAM UNDER 

13 THE MEDICARE PROGRAM. 

14 Section 1860D–4(e)(2) of the Social Security Act (42 

15 U.S.C. 1395w–104(e)(2)) is amended— 

16 (1) in subparagraph (D), by striking ‘‘To the ex17 tent’’ and inserting ‘‘Except as provided in subpara18 graph (F), to the extent’’; and 

19 (2) by adding at the end the following new sub20 paragraph: 

21 ‘‘(F) REAL-TIME BENEFIT INFORMATION.— 

22 ‘‘(i) IN GENERAL.—Not later than Jan23 uary 1, 2021, the program shall implement 

24 real-time benefit tools that are capable of 

25 integrating with a prescribing health care 


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1 professional’s electronic prescribing or elec2 tronic health record system for the trans3 mission of formulary and benefit informa4 tion in real time to prescribing health care 

5 professionals. With respect to a covered part 

6 D drug, such tools shall be capable of trans7 mitting such information specific to an in8 dividual enrolled in a prescription drug 

9 plan. Such information shall include the 

10 following: 

11 ‘‘(I) A list of any clinically-ap12 propriate alternatives to such drug in13 cluded in the formulary of such plan. 

14 ‘‘(II) Cost-sharing information for 

15 such drug and such alternatives, in16 cluding a description of any variance 

17 in cost sharing based on the pharmacy 

18 dispensing such drug or such alter19 natives. 

20 ‘‘(III) Information relating to 

21 whether such drug is included in the 

22 formulary of such plan and any prior 

23 authorization or other utilization man24 agement requirements applicable to 


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1 such drug and such alternatives so in2 cluded. 

3 ‘‘(ii) ELECTRONIC TRANSMISSION.— 

4 The provisions of subclauses (I) and (II) of 

5 clause (ii) of subparagraph (E) shall apply 

6 to an electronic transmission described in 

7 clause (i) in the same manner as such pro8 visions apply with respect to an electronic 

9 transmission described in clause (i) of such 

10 subparagraph. 

11 ‘‘(iii) SPECIAL RULE FOR 2021.—The 

12 program shall be deemed to be in compli13 ance with clause (i) for 2021 if the program 

14 complies with the provisions of section 

15 423.160(b)(7) of title 42, Code of Federal 

16 Regulations (or a successor regulation), for 

17 such year. 

18 ‘‘(iv) RULE OF CONSTRUCTION.—Noth19 ing in this subparagraph shall be construed 

20 as to allow a real time benefits tool to steer 

21 an individual, without the consent of the in22 dividual, to a particular pharmacy or 

23 pharmacy setting over their preferred phar24 macy setting nor prohibit the designation of 

25 a preferred pharmacy under such tool.’’. 


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1 SEC. 8. SENSE OF CONGRESS REGARDING THE NEED TO EX2 PAND COMMERCIALLY AVAILABLE DRUG 

3 PRICING COMPARISON PLATFORMS. 

4 It is the sense of Congress that— 

5 (1) commercially available drug pricing com6 parison platforms can, at no cost, help patients find 

7 the lowest price for their medications at their local 

8 pharmacy; 

9 (2) such platforms should be integrated, to the 

10 maximum extent possible, in the health care delivery 

11 ecosystem; and 

12 (3) pharmacy benefit managers should work to 

13 disclose generic and brand name drug prices to such 

14 platforms to ensure that— 

15 (A) patients can benefit from the lowest pos16 sible price available to them; and 

17 (B) overall drug prices can be reduced as 

18 more educated purchasing decisions are made 

19 based on price transparency. 

20 SEC. 9. TECHNICAL CORRECTIONS. 

21 (a) IN GENERAL.—Section 3022(b) of the Public 

22 Health Service Act (42 U.S.C. 300jj–52(b)) is amended by 

23 adding at the end the following new paragraph: 

24 ‘‘(4) APPLICATION OF AUTHORITIES UNDER IN25 SPECTOR GENERAL ACT OF 1978.—In carrying out 

26 this subsection, the Inspector General shall have the 


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1 same authorities as provided under section 6 of the 

2 Inspector General Act of 1978 (5 U.S.C. App.).’’. 

3 (b) EFFECTIVE DATE.—The amendment made by sub4 section (a) shall take effect as if included in the enactment 

5 of the 21st Century Cures Act (Public Law 114–255). 

Amend the title so as to read: ‘‘A bill to require reporting for certain drug price information, and for other 

purposes.’’. 


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Union Calendar No. 170 

116TH CONGRESS 

1ST SESSION H. R. 2296 

[Report No. 116–215] 

A BILL 

To require reporting regarding certain drug price 

increases, and for other purposes. 

SEPTEMBER 24, 2019 

Reported with amendments, committed to the Committee 

dered to be printed of the Whole House on the State of the Union, and orVerDate Sep 11 2014 21:16 Sep 24, 2019 Jkt 089200 PO 00000 Frm 00036 Fmt 6651 Sfmt 6651 E:\BILLS\H2296.RH H2296

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