More Efficient Tools to Realize Information for Consumers Act

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] VerDate Sep 11 2014 21:16 Sep 24, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6652 E:\BILLS\H2296.RH H2296 pamtmann on DSKBC07HB2PROD with BILLS 2 •HR 2296 RH A BILL To require reporting regarding certain drug price increases, and for other purposes. VerDate Sep 11 2014 21:16 Sep 24, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6652 E:\BILLS\H2296.RH H2296 pamtmann on DSKBC07HB2PROD with BILLS 3 •HR 2296 RH Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE; TABLE OF CONTENTS. 3 (a) SHORT TITLE.—This Act may be cited as the 4 ‘‘More Efficient Tools to Realize Information for Consumers 5 Act’’ or the ‘‘METRIC Act’’. 6 (b) TABLE OF CONTENTS.—The table of contents for 7 this Act is as follows: 8 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 activ- ity. 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 in- formation as part of such sponsor’s electronic prescription pro- gram under the Medicare program. Sec. 8. Sense of Congress regarding the need to expand commercially available drug pricing comparison platforms. Sec. 9. Technical corrections. SEC. 2. REPORTING ON EXPLANATION FOR DRUG PRICE IN- 9 CREASES. 10 (a) IN GENERAL.—Title III of the Public Health Serv- 11 ice Act (42 U.S.C. 241 et seq.) is amended by adding at 12 the end the following: 13 ‘‘PART W—DRUG PRICE REPORTING; DRUG VALUE 14 FUND 15 ‘‘SEC. 399OO. REPORTING ON EXPLANATION FOR DRUG 16 PRICE INCREASES. 17 ‘‘(a) DEFINITIONS.—In this section: 18 VerDate Sep 11 2014 21:16 Sep 24, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6203 E:\BILLS\H2296.RH H2296 pamtmann on DSKBC07HB2PROD with BILLS 4 •HR 2296 RH ‘‘(1) MANUFACTURER.—The term ‘manufacturer’ 1 means the person— 2 ‘‘(A) that holds the application for a drug 3 approved under section 505 of the Federal Food, 4 Drug, and Cosmetic Act or licensed under section 5 351 of this Act; or 6 ‘‘(B) who is responsible for setting the 7 wholesale acquisition cost for the drug. 8 ‘‘(2) QUALIFYING DRUG.—The term ‘qualifying 9 drug’ means any drug that is approved under sub- 10 section (c) or (j) of section 505 of the Federal Food, 11 Drug, and Cosmetic Act or licensed under subsection 12 (a) or (k) of section 351 of this Act— 13 ‘‘(A) that has a wholesale acquisition cost of 14 $100 or more, adjusted for inflation occurring 15 after the date of enactment of the More Efficient 16 Tools to Realize Information for Consumers Act, 17 for a month’s supply or a typical course of treat- 18 ment that lasts less than a month, and is— 19 ‘‘(i) subject to section 503(b)(1) of the 20 Federal Food, Drug, and Cosmetic Act; 21 ‘‘(ii) administered or otherwise dis- 22 pensed to treat a disease or condition affect- 23 ing more than 200,000 persons in the 24 United States; and 25 VerDate Sep 11 2014 21:16 Sep 24, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6203 E:\BILLS\H2296.RH H2296 pamtmann on DSKBC07HB2PROD with BILLS 5 •HR 2296 RH ‘‘(iii) not a vaccine; and 1 ‘‘(B) for which, during the previous cal- 2 endar year, at least 1 dollar of the total amount 3 of sales were for individuals enrolled under the 4 Medicare program under title XVIII of the So- 5 cial Security Act (42 U.S.C. 1395 et seq.) or 6 under a State Medicaid plan under title XIX of 7 such Act (42 U.S.C. 1396 et seq.) or under a 8 waiver of such plan. 9 ‘‘(3) WHOLESALE ACQUISITION COST.—The term 10 ‘wholesale acquisition cost’ has the meaning given 11 that term in section 1847A(c)(6)(B) of the Social Se- 12 curity Act (42 U.S.C. 1395w–3a(c)(6)(B)). 13 ‘‘(b) REPORT.— 14 ‘‘(1) REPORT REQUIRED.—The manufacturer of 15 a qualifying drug shall submit a report to the Sec- 16 retary for each increase in the price of a qualifying 17 drug that results in an increase in the wholesale ac- 18 quisition cost of that drug that is equal to— 19 ‘‘(A) 10 percent or more within a single cal- 20 endar year beginning on or after January 1, 21 2019; or 22 ‘‘(B) 25 percent or more within three con- 23 secutive calendar years for which the first such 24 VerDate Sep 11 2014 21:16 Sep 24, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6203 E:\BILLS\H2296.RH H2296 pamtmann on DSKBC07HB2PROD with BILLS 6 •HR 2296 RH calendar year begins on or after January 1, 1 2019. 2 ‘‘(2) REPORT DEADLINE.—Each report described 3 in paragraph (1) shall be submitted to the Sec- 4 retary— 5 ‘‘(A) in the case of a report with respect to 6 an increase in the price of a qualifying drug 7 that occurs during the period beginning on Jan- 8 uary 1, 2019, and ending on the day that is 60 9 days after the date of the enactment of the More 10 Efficient Tools to Realize Information for Con- 11 sumers Act, not later than 90 days after such 12 date of enactment; and 13 ‘‘(B) in the case of a report with respect to 14 an increase in the price of a qualifying drug 15 that occurs after the period described in subpara- 16 graph (A), not later than 30 days prior to the 17 planned effective date of such price increase for 18 such qualifying drug. 19 ‘‘(c) CONTENTS.—A report under subsection (b), con- 20 sistent with the standard for disclosures described in section 21 213.3(d) of title 12, Code of Federal Regulations (as in effect 22 on the date of enactment of the More Efficient Tools to Real- 23 ize Information for Consumers Act), shall, at a minimum, 24 include— 25 VerDate Sep 11 2014 21:16 Sep 24, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6203 E:\BILLS\H2296.RH H2296 pamtmann on DSKBC07HB2PROD with BILLS 7 •HR 2296 RH ‘‘(1) with respect to the qualifying drug— 1 ‘‘(A) the percentage by which the manufac- 2 turer will raise the wholesale acquisition cost of 3 the drug within the calendar year or three con- 4 secutive calendar years as described in subsection 5 (b)(1)(A) or (b)(1)(B), and the effective date of 6 such price increase; 7 ‘‘(B) an explanation for, and description of, 8 each price increase for such drug that will occur 9 during the calendar year period described in 10 subsection (b)(1)(A) or the three consecutive cal- 11 endar year period described in subsection 12 (b)(1)(B), as applicable; 13 ‘‘(C) if known and different from the manu- 14 facturer of the qualifying drug, the identity of— 15 ‘‘(i) the sponsor or sponsors of any in- 16 vestigational new drug applications under 17 section 505(i) of the Federal Food, Drug, 18 and Cosmetic Act for clinical investigations 19 with respect to such drug, for which the full 20 reports are submitted as part of the appli- 21 cation— 22 ‘‘(I) for approval of the drug 23 under section 505 of such Act; or 24 VerDate Sep 11 2014 21:16 Sep 24, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6203 E:\BILLS\H2296.RH H2296 pamtmann on DSKBC07HB2PROD with BILLS 8 •HR 2296 RH ‘‘(II) for licensure of the drug 1 under section 351 of this Act; and 2 ‘‘(ii) the sponsor of an application for 3 the drug approved under such section 505 of 4 the Federal Food, Drug, and Cosmetic Act 5 or licensed under section 351 of this Act; 6 ‘‘(D) a description of the history of the 7 manufacturer’s price increases for the drug since 8 the approval of the application for the drug 9 under section 505 of the Federal Food, Drug, 10 and Cosmetic Act or the issuance of the license 11 for the drug under section 351 of this Act, or 12 since the manufacturer acquired such approved 13 application or license, if applicable; 14 ‘‘(E) the current wholesale acquisition cost 15 of the drug; 16 ‘‘(F) the total expenditures of the manufac- 17 turer on— 18 ‘‘(i) materials and manufacturing for 19 such drug; and 20 ‘‘(ii) acquiring patents and licensing 21 for such drug; 22 ‘‘(G) the percentage of total expenditures of 23 the manufacturer on research and development 24 VerDate Sep 11 2014 21:16 Sep 24, 2019 Jkt 089200 PO 00000 Frm 00008 Fmt 6652 Sfmt 6203 E:\BILLS\H2296.RH H2296 pamtmann on DSKBC07HB2PROD with BILLS 9 •HR 2296 RH for such drug that was derived from Federal 1 funds; 2 ‘‘(H) the total expenditures of the manufac- 3 turer on research and development for such drug 4 that is necessary to demonstrate that it meets 5 applicable statutory standards for approval 6 under section 505 of the Federal Food, Drug, 7 and Cosmetic Act or licensure under section 351 8 of this Act, as applicable; 9 ‘‘(I) the total expenditures of the manufac- 10 turer on pursuing new or expanded indications 11 or dosage changes for such drug under section 12 505 of the Federal Food, Drug, and Cosmetic Act 13 or section 351 of this Act; 14 ‘‘(J) the total expenditures of the manufac- 15 turer on carrying out postmarket requirements 16 related to such drug, including under section 17 505(o)(3) of the Federal Food, Drug, and Cos- 18 metic Act; 19 ‘‘(K) the total revenue and the net profit 20 generated from the qualifying drug for each cal- 21 endar year since the approval of the application 22 for the drug under section 505 of the Federal 23 Food, Drug, and Cosmetic Act or the issuance of 24 the license for the drug under section 351, or 25 VerDate Sep 11 2014 21:16 Sep 24, 2019 Jkt 089200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6203 E:\BILLS\H2296.RH H2296 pamtmann on DSKBC07HB2PROD with BILLS 10 •HR 2296 RH since the manufacturer acquired such approved 1 application or license; and 2 ‘‘(L) the total costs associated with mar- 3 keting and advertising for the qualifying drug; 4 ‘‘(2) with respect to the manufacturer— 5 ‘‘(A) the total revenue and the net profit of 6 the manufacturer for each of the 1-year period 7 described in subsection (b)(1)(A) or the 3-year 8 period described in subsection (b)(1)(B), as ap- 9 plicable; 10 ‘‘(B) all stock-based performance metrics 11 used by the manufacturer to determine executive 12 compensation for each of the 1-year period de- 13 scribed in subsection (b)(1)(A) or the 3-year pe- 14 riod described in subsection (b)(1)(B), as appli- 15 cable; and 16 ‘‘(C) any additional information the manu- 17 facturer chooses to provide related to drug pric- 18 ing decisions, such as total expenditures on— 19 ‘‘(i) drug research and development; or 20 ‘‘(ii) clinical trials, including on drugs 21 that failed to receive approval by the Food 22 and Drug Administration; and 23 VerDate Sep 11 2014 21:16 Sep 24, 2019 Jkt 089200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6203 E:\BILLS\H2296.RH H2296 pamtmann on DSKBC07HB2PROD with BILLS 11 •HR 2296 RH ‘‘(3) such other related information as the Sec- 1 retary considers appropriate and as specified by the 2 Secretary through notice-and-comment rulemaking. 3 ‘‘(d) INFORMATION PROVIDED.—The manufacturer of 4 a qualifying drug that is required to submit a report under 5 subsection (b), shall ensure that such report and any expla- 6 nation for, and description of, each price increase described 7 in subsection (c)(1)(B) shall be truthful, not misleading, 8 and accurate. 9 ‘‘(e) CIVIL MONETARY PENALTY.—Any manufacturer 10 of a qualifying drug that fails to submit a report for the 11 drug as required by this section, following notification by 12 the Secretary to the manufacturer that the manufacturer 13 is not in compliance with this section, shall be subject to 14 a civil monetary penalty of $75,000 for each day on which 15 the violation continues. 16 ‘‘(f) FALSE INFORMATION.—Any manufacturer that 17 submits a report for a drug as required by this section that 18 knowingly provides false information in such report is sub- 19 ject to a civil monetary penalty in an amount not to exceed 20 $75,000 for each item of false information. 21 ‘‘(g) PUBLIC POSTING.— 22 ‘‘(1) IN GENERAL.—Subject to paragraph (3), the 23 Secretary shall post each report submitted under sub- 24 section (b) on the public website of the Department of 25 VerDate Sep 11 2014 21:16 Sep 24, 2019 Jkt 089200 PO 00000 Frm 00011 Fmt 6652 Sfmt 6203 E:\BILLS\H2296.RH H2296 pamtmann on DSKBC07HB2PROD with BILLS 12 •HR 2296 RH Health and Human Services the day the price in- 1 crease of a qualifying drug is scheduled to go into ef- 2 fect. 3 ‘‘(2) FORMAT.—In developing the format in 4 which reports will be publicly posted under para- 5 graph (1), the Secretary shall consult with stake- 6 holders, including beneficiary groups, and shall seek 7 feedback from consumer advocates and readability ex- 8 perts on the format and presentation of the content of 9 such reports to ensure that such reports are— 10 ‘‘(A) user-friendly to the public; and 11 ‘‘(B) written in plain language that con- 12 sumers can readily understand. 13 ‘‘(3) PROTECTED INFORMATION.—Nothing in 14 this section shall be construed to authorize the public 15 disclosure of information submitted by a manufac- 16 turer that is prohibited from disclosure by applicable 17 laws concerning the protection of trade secrets, com- 18 mercial information, and other information covered 19 under such laws. 20 ‘‘SEC. 399OO–1. ANNUAL REPORT TO CONGRESS. 21 ‘‘(a) IN GENERAL.—Subject to subsection (b), the Sec- 22 retary shall submit to Congress, and post on the public 23 website of the Department of Health and Human Services 24 in a way that is user-friendly to the public and written 25 VerDate Sep 11 2014 21:16 Sep 24, 2019 Jkt 089200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6203 E:\BILLS\H2296.RH H2296 pamtmann on DSKBC07HB2PROD with BILLS 13 •HR 2296 RH in plain language that consumers can readily understand, 1 an annual report— 2 ‘‘(1) summarizing the information reported pur- 3 suant to section 399OO; 4 ‘‘(2) including copies of the reports and sup- 5 porting detailed economic analyses submitted pursu- 6 ant t [Text truncated for display. Full text available on Congress.gov.]