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[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 2296 Reported in House (RH)]

<DOC>

                                                 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]

_______________________________________________________________________

                                 A BILL

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

 

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

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``More Efficient 
Tools to Realize Information for Consumers Act'' or the ``METRIC Act''.
    (b) Table of Contents.--The table of contents for 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.

SEC. 2. REPORTING ON EXPLANATION FOR DRUG PRICE INCREASES.

    (a) In General.--Title III of the Public Health Service Act (42 
U.S.C. 241 et seq.) is amended by adding at the end the following:

            ``PART W--DRUG PRICE REPORTING; DRUG VALUE FUND

``SEC. 399OO. REPORTING ON EXPLANATION FOR DRUG PRICE INCREASES.

    ``(a) Definitions.--In this section:
            ``(1) Manufacturer.--The term `manufacturer' means the 
        person--
                    ``(A) that holds the application for a drug 
                approved under section 505 of the Federal Food, Drug, 
                and Cosmetic Act or licensed under section 351 of this 
                Act; or
                    ``(B) who is responsible for setting the wholesale 
                acquisition cost for the drug.
            ``(2) Qualifying drug.--The term `qualifying drug' means 
        any drug that is approved under subsection (c) or (j) of 
        section 505 of the Federal Food, Drug, and Cosmetic Act or 
        licensed under subsection (a) or (k) of section 351 of this 
        Act--
                    ``(A) that has a wholesale acquisition cost of $100 
                or more, adjusted for inflation occurring after the 
                date of enactment of the More Efficient Tools to 
                Realize Information for Consumers Act, for a month's 
                supply or a typical course of treatment that lasts less 
                than a month, and is--
                            ``(i) subject to section 503(b)(1) of the 
                        Federal Food, Drug, and Cosmetic Act;
                            ``(ii) administered or otherwise dispensed 
                        to treat a disease or condition affecting more 
                        than 200,000 persons in the United States; and
                            ``(iii) not a vaccine; and
                    ``(B) for which, during the previous calendar year, 
                at least 1 dollar of the total amount of sales were for 
                individuals enrolled under the Medicare program under 
                title XVIII of the Social Security Act (42 U.S.C. 1395 
                et seq.) or under a State Medicaid plan under title XIX 
                of such Act (42 U.S.C. 1396 et seq.) or under a waiver 
                of such plan.
            ``(3) Wholesale acquisition cost.--The term `wholesale 
        acquisition cost' has the meaning given that term in section 
        1847A(c)(6)(B) of the Social Security Act (42 U.S.C. 1395w-
        3a(c)(6)(B)).
    ``(b) Report.--
            ``(1) Report required.--The manufacturer of a qualifying 
        drug shall submit a report to the Secretary for each increase 
        in the price of a qualifying drug that results in an increase 
        in the wholesale acquisition cost of that drug that is equal 
        to--
                    ``(A) 10 percent or more within a single calendar 
                year beginning on or after January 1, 2019; or
                    ``(B) 25 percent or more within three consecutive 
                calendar years for which the first such calendar year 
                begins on or after January 1, 2019.
            ``(2) Report deadline.--Each report described in paragraph 
        (1) shall be submitted to the Secretary--
                    ``(A) in the case of a report with respect to an 
                increase in the price of a qualifying drug that occurs 
                during the period beginning on January 1, 2019, and 
                ending on the day that is 60 days after the date of the 
                enactment of the More Efficient Tools to Realize 
                Information for Consumers Act, not later than 90 days 
                after such date of enactment; and
                    ``(B) in the case of a report with respect to an 
                increase in the price of a qualifying drug that occurs 
                after the period described in subparagraph (A), not 
                later than 30 days prior to the planned effective date 
                of such price increase for such qualifying drug.
    ``(c) Contents.--A report under subsection (b), consistent with the 
standard for disclosures described in section 213.3(d) of title 12, 
Code of Federal Regulations (as in effect on the date of enactment of 
the More Efficient Tools to Realize Information for Consumers Act), 
shall, at a minimum, include--
            ``(1) with respect to the qualifying drug--
                    ``(A) the percentage by which the manufacturer will 
                raise the wholesale acquisition cost of the drug within 
                the calendar year or three consecutive calendar years 
                as described in subsection (b)(1)(A) or (b)(1)(B), and 
                the effective date of such price increase;
                    ``(B) an explanation for, and description of, each 
                price increase for such drug that will occur during the 
                calendar year period described in subsection (b)(1)(A) 
                or the three consecutive calendar year period described 
                in subsection (b)(1)(B), as applicable;
                    ``(C) if known and different from the manufacturer 
                of the qualifying drug, the identity of--
                            ``(i) the sponsor or sponsors of any 
                        investigational new drug applications under 
                        section 505(i) of the Federal Food, Drug, and 
                        Cosmetic Act for clinical investigations with 
                        respect to such drug, for which the full 
                        reports are submitted as part of the 
                        application--
                                    ``(I) for approval of the drug 
                                under section 505 of such Act; or
                                    ``(II) for licensure of the drug 
                                under section 351 of this Act; and
                            ``(ii) the sponsor of an application for 
                        the drug approved under such section 505 of the 
                        Federal Food, Drug, and Cosmetic Act or 
                        licensed under section 351 of this Act;
                    ``(D) a description of the history of the 
                manufacturer's price increases for the drug since the 
                approval of the application for the drug under section 
                505 of the Federal Food, Drug, and Cosmetic Act or the 
                issuance of the license for the drug under section 351 
                of this Act, or since the manufacturer acquired such 
                approved application or license, if applicable;
                    ``(E) the current wholesale acquisition cost of the 
                drug;
                    ``(F) the total expenditures of the manufacturer 
                on--
                            ``(i) materials and manufacturing for such 
                        drug; and
                            ``(ii) acquiring patents and licensing for 
                        such drug;
                    ``(G) the percentage of total expenditures of the 
                manufacturer on research and development for such drug 
                that was derived from Federal funds;
                    ``(H) the total expenditures of the manufacturer on 
                research and development for such drug that is 
                necessary to demonstrate that it meets applicable 
                statutory standards for approval under section 505 of 
                the Federal Food, Drug, and Cosmetic Act or licensure 
                under section 351 of this Act, as applicable;
                    ``(I) the total expenditures of the manufacturer on 
                pursuing new or expanded indications or dosage changes 
                for such drug under section 505 of the Federal Food, 
                Drug, and Cosmetic Act or section 351 of this Act;
                    ``(J) the total expenditures of the manufacturer on 
                carrying out postmarket requirements related to such 
                drug, including under section 505(o)(3) of the Federal 
                Food, Drug, and Cosmetic Act;
                    ``(K) the total revenue and the net profit 
                generated from the qualifying drug for each calendar 
                year since the approval of the application for the drug 
                under section 505 of the Federal Food, Drug, and 
                Cosmetic Act or the issuance of the license for the 
                drug under section 351, or since the manufacturer 
                acquired such approved application or license; and
                    ``(L) the total costs associated with marketing and 
                advertising for the qualifying drug;
            ``(2) with respect to the manufacturer--
                    ``(A) the total revenue and the net profit of the 
                manufacturer for each of the 1-year period described in 
                subsection (b)(1)(A) or the 3-year period described in 
                subsection (b)(1)(B), as applicable;
                    ``(B) all stock-based performance metrics used by 
                the manufacturer to determine executive compensation 
                for each of the 1-year period described in subsection 
                (b)(1)(A) or the 3-year period described in subsection 
                (b)(1)(B), as applicable; and
                    ``(C) any additional information the manufacturer 
                chooses to provide related to drug pricing decisions, 
                such as total expenditures on--
                            ``(i) drug research and development; or
                            ``(ii) clinical trials, including on drugs 
                        that failed to receive approval by the Food and 
                        Drug Administration; and
            ``(3) such other related information as the Secretary 
        considers appropriate and as specified by the Secretary through 
        notice-and-comment rulemaking.
    ``(d) Information Provided.--The manufacturer of a qualifying drug 
that is required to submit a report under subsection (b), shall ensure 
that such report and any explanation for, and description of, each 
price increase described in subsection (c)(1)(B) shall be truthful, not 
misleading, and accurate.
    ``(e) Civil Monetary Penalty.--Any manufacturer of a qualifying 
drug that fails to submit a report for the drug as required by this 
section, following notification by the Secretary to the manufacturer 
that the manufacturer is not in compliance with this section, shall be 
subject to a civil monetary penalty of $75,000 for each day on which 
the violation continues.
    ``(f) False Information.--Any manufacturer that submits a report 
for a drug as required by this section that knowingly provides false 
information in such report is subject to a civil monetary penalty in an 
amount not to exceed $75,000 for each item of false information.
    ``(g) Public Posting.--
            ``(1) In general.--Subject to paragraph (3), the Secretary 
        shall post each report submitted under subsection (b) on the 
        public website of the Department of Health and Human Services 
        the day the price increase of a qualifying drug is scheduled to 
        go into effect.
            ``(2) Format.--In developing the format in which reports 
        will be publicly posted under paragraph (1), the Secretary 
        shall consult with stakeholders, including beneficiary groups, 
        and shall seek feedback from consumer advocates and readability 
        experts on the format and presentation of the content of such 
        reports to ensure that such reports are--
                    ``(A) user-friendly to the public; and
                    ``(B) written in plain language that consumers can 
                readily understand.
            ``(3) Protected information.--Nothing in this section shall 
        be construed to authorize the public disclosure of information 
        submitted by a manufacturer that is prohibited from disclosure 
        by applicable laws concerning the protection of trade secrets, 
        commercial information, and other information covered under 
        such laws.

``SEC. 399OO-1. ANNUAL REPORT TO CONGRESS.

    ``(a) In General.--Subject to subsection (b), the Secretary shall 
submit to Congress, and post on the public website of the Department of 
Health and Human Services in a way that is user-friendly to the public 
and written in plain language that consumers can readily understand, an 
annual report--
            ``(1) summarizing the information reported pursuant to 
        section 399OO;
            ``(2) including copies of the reports and supporting 
        detailed economic analyses submitted pursuant to such section;
            ``(3) detailing the costs and expenditures incurred by the 
        Department of Health and Human Services in carrying out section 
        399OO; and
            ``(4) explaining how the Department of Health and Human 
        Services is improving consumer and provider information about 
        drug value and drug price transparency.
    ``(b) Protected Information.--Nothing in this section shall be 
construed to authorize the public disclosure of information submitted 
by a manufacturer that is prohibited from disclosure by applicable laws 
concerning the protection of trade secrets, commercial information, and 
other information covered under such laws.''.
    (b) Effective Date.--The amendment made by subsection (a) takes 
effect on the date of enactment of this Act.

SEC. 3. PUBLIC DISCLOSURE OF DRUG DISCOUNTS.

    Section 1150A of the Social Security Act (42 U.S.C. 1320b-23) is 
amended--
            (1) in subsection (c), in the matter preceding paragraph 
        (1), by inserting ``(other than as permitted under subsection 
        (e))'' after ``disclosed by the Secretary''; and
            (2) by adding at the end the following new subsection:
    ``(e) Public Availability of Certain Information.--
            ``(1) In general.--In order to allow the comparison of 
        PBMs' ability to negotiate rebates, discounts, direct and 
        indirect remuneration fees, administrative fees, and price 
        concessions and the amount of such rebates, discounts, direct 
        and indirect remuneration fees, administrative fees, and price 
        concessions that are passed through to plan sponsors, beginning 
        January 1, 2020, the Secretary shall make available on the 
        Internet website of the Department of Health and Human Services 
        the information with respect to the second preceding calendar 
        year provided to the Secretary on generic dispensing rates (as 
        described in paragraph (1) of subsection (b)) and information 
        provided to the Secretary under paragraphs (2) and (3) of such 
        subsection that, as determined by the Secretary, is with 
        respect to each PBM.
            ``(2) Availability of data.--In carrying out paragraph (1), 
        the Secretary shall ensure the following:
                    ``(A) Confidentiality.--The information described 
                in such paragraph is displayed in a manner that 
                prevents the disclosure of information, with respect to 
                an individual drug or an individual plan, on rebates, 
                discounts, direct and indirect remuneration fees, 
                administrative fees, and price concessions.
                    ``(B) Class of drug.--The information described in 
                such paragraph is made available by class of drug, 
                using an existing classification system, but only if 
                the class contains such number of drugs, as specified 
                by the Secretary (but not fewer than three drugs), to 
                ensure confidentiality of proprietary information or 
                other information that is prevented to be disclosed 
                under subparagraph (A).''.

SEC. 4. STUDY OF PHARMACEUTICAL SUPPLY CHAIN INTERMEDIARIES AND MERGER 
              ACTIVITY.

    (a) Initial Report.--Not later than 1 year after the date of 
enactment of this Act, the Commission shall submit to the appropriate 
committees of Congress a report that--
            (1) addresses at minimum--
                    (A) whether pharmacy benefit managers--
                            (i) charge payers a higher price than the 
                        reimbursement rate at which the pharmacy 
                        benefit managers reimburse competing 
                        pharmacies;
                            (ii) steer patients for anticompetitive 
                        purposes to any pharmacies, including retail, 
                        mail-order, or any other type of pharmacy, in 
                        which the pharmacy benefit manager has an 
                        ownership interest;
                            (iii) audit or review proprietary data, 
                        including acquisition costs, patient 
                        information, or dispensing information, of 
                        competing pharmacies that can be used for 
                        anticompetitive purposes; or
                            (iv) use formulary designs to increase the 
                        market share of higher cost prescription drugs 
                        and depress the market share of lower cost 
                        prescription drugs (each net of rebates and 
                        discounts);
                    (B) how companies and payers assess the benefits, 
                costs, and risks of contracting with intermediaries, 
                including pharmacy services administrative 
                organizations, and whether more information about the 
                roles of intermediaries should be available to 
                consumers and payers; and
                    (C) whether there are any specific legal or 
                regulatory obstacles the Commission currently faces in 
                ensuring a competitive and transparent marketplace in 
                the pharmaceutical supply chain, including the pharmacy 
                benefit manager marketplace and pharmacy services 
                administrative organizations; and
            (2) provides--
                    (A) observations or conclusions drawn from the 
                November 2017 roundtable entitled ``Understanding 
                Competition in Prescription Drug Markets: Entry and 
                Supply Chain Dynamics'', and any similar efforts;
                    (B) specific actions the Commission intends to take 
                as a result of the November 2017 roundtable, and any 
                similar efforts, including a detailed description of 
                relevant forthcoming actions, additional research or 
                roundtable discussions, consumer education efforts, or 
                enforcement actions; and
                    (C) policy or legislative recommendations to--
                            (i) improve transparency and competition in 
                        the pharmaceutical supply chain;
                            (ii) prevent and deter anticompetitive 
                        behavior in the pharmaceutical supply chain; 
                        and
                            (iii) best ensure that consumers benefit 
                        from any cost savings or efficiencies that may 
                        result from mergers and consolidations.
    (b) Interim Report.--Not later than 180 days after the date of 
enactment of this Act, the Commission shall submit to the appropriate 
committees of Congress an interim report on the progress of the report 
required by subsection (a), along with preliminary findings and 
conclusions based on information collected to that date.
    (c) Definitions.--In this section:
            (1) Appropriate committees of congress.--The term 
        ``appropriate committees of Congress'' means--
                    (A) the Committee on Energy and Commerce of the 
                House of Representatives;
                    (B) the Committee on the Judiciary of the Senate; 
                and
                    (C) the Committee on the Judiciary of the House of 
                Representatives.
            (2) Commission.--The term ``Commission'' means the Federal 
        Trade Commission.

SEC. 5. REQUIRING CERTAIN MANUFACTURERS TO REPORT DRUG PRICING 
              INFORMATION WITH RESPECT TO DRUGS UNDER THE MEDICARE 
              PROGRAM.

    (a) In General.--Section 1847A of the Social Security Act (42 
U.S.C. 1395w-3a) is amended--
            (1) in subsection (b)--
                    (A) in paragraph (2)(A), by inserting ``or 
                subsection (f)(2), as applicable'' before the period at 
                the end;
                    (B) in paragraph (3), in the matter preceding 
                subparagraph (A), by inserting ``or subsection (f)(2), 
                as applicable,'' before ``determined by''; and
                    (C) in paragraph (6)(A), in the matter preceding 
                clause (i), by inserting ``or subsection (f)(2), as 
                applicable,'' before ``determined by''; and
            (2) in subsection (f)--
                    (A) by striking ``For requirements'' and inserting 
                the following:
            ``(1) In general.--For requirements''; and
                    (B) by adding at the end the following new 
                paragraph:
            ``(2) Manufacturers without a rebate agreement under title 
        xix.--
                    ``(A) In general.--If the manufacturer of a drug or 
                biological described in subparagraph (C), (E), or (G) 
                of section 1842(o)(1) or in section 1881(b)(14)(B) that 
                is payable under this part has not entered into and 
                does not have in effect a rebate agreement described in 
                subsection (b) of section 1927, for calendar quarters 
                beginning on or after January 1, 2020, such 
                manufacturer shall report to the Secretary the 
                information described in subsection (b)(3)(A)(iii) of 
                such section 1927 with respect to such drug or 
                biological in a time and manner specified by the 
                Secretary. For purposes of applying this paragraph, a 
                drug or biological described in the previous sentence 
                includes items, services, supplies, and products that 
                are payable under this part as a drug or biological.
                    ``(B) Audit.--Information reported under 
                subparagraph (A) is subject to audit by the Inspector 
                General of the Department of Health and Human Services.
                    ``(C) Verification.--The Secretary may survey 
                wholesalers and manufacturers that directly distribute 
                drugs described in subparagraph (A), when necessary, to 
                verify manufacturer prices and manufacturer's average 
                sales prices (including wholesale acquisition cost) if 
                required to make payment reported under subparagraph 
                (A). The Secretary may impose a civil monetary penalty 
                in an amount not to exceed $100,000 on a wholesaler, 
                manufacturer, or direct seller, if the wholesaler, 
                manufacturer, or direct seller of such a drug refuses a 
                request for information about charges or prices by the 
                Secretary in connection with a survey under this 
                subparagraph or knowingly provides false information. 
                The provisions of section 1128A (other than subsections 
                (a) (with respect to amounts of penalties or additional 
                assessments) and (b)) shall apply to a civil money 
                penalty under this subparagraph in the same manner as 
                such provisions apply to a penalty or proceeding under 
                section 1128A(a).
                    ``(D) Confidentiality.--Notwithstanding any other 
                provision of law, information disclosed by 
                manufacturers or wholesalers under this paragraph 
                (other than the wholesale acquisition cost for purposes 
                of carrying out this section) is confidential and shall 
                not be disclosed by the Secretary in a form which 
                discloses the identity of a specific manufacturer or 
                wholesaler or prices charged for drugs by such 
                manufacturer or wholesaler, except--
                            ``(i) as the Secretary determines to be 
                        necessary to carry out this section (including 
                        the determination and implementation of the 
                        payment amount), or to carry out section 1847B;
                            ``(ii) to permit the Comptroller General of 
                        the United States to review the information 
                        provided; and
                            ``(iii) to permit the Director of the 
                        Congressional Budget Office to review the 
                        information provided.''.
    (b) Enforcement.--Section 1847A of such Act (42 U.S.C. 1395w-3a) is 
further amended--
            (1) in subsection (d)(4)--
                    (A) in subparagraph (A), by striking ``In general'' 
                and inserting ``Misrepresentation'';
                    (B) in subparagraph (B), by striking ``subparagraph 
                (B)'' and inserting ``subparagraph (A), (B), or (C)'';
                    (C) by redesignating subparagraph (B) as 
                subparagraph (D); and
                    (D) by inserting after subparagraph (A) the 
                following new subparagraphs:
                    ``(B) Failure to provide timely information.--If 
                the Secretary determines that a manufacturer described 
                in subsection (f)(2) has failed to report on 
                information described in section 1927(b)(3)(A)(iii) 
                with respect to a drug or biological in accordance with 
                such subsection, the Secretary shall apply a civil 
                money penalty in an amount of $10,000 for each day the 
                manufacturer has failed to report such information and 
                such amount shall be paid to the Treasury.
                    ``(C) False information.--Any manufacturer required 
                to submit information under subsection (f)(2) that 
                knowingly provides false information is subject to a 
                civil money penalty in an amount not to exceed $100,000 
                for each item of false information. Such civil money 
                penalties are in addition to other penalties as may be 
                prescribed by law.''; and
            (2) in subsection (c)(6)(A), by striking the period at the 
        end and inserting ``, except that, for purposes of subsection 
        (f)(2), the Secretary may, if the Secretary determines 
        appropriate, exclude repackagers of a drug or biological from 
        such term.''.
    (c) Manufacturers With a Rebate Agreement.--
            (1) In general.--Section 1927(b)(3)(A) of the Social 
        Security Act (42 U.S.C. 1396r-8(b)(3)(A)) is amended by adding 
        at the end the following new sentence: ``For purposes of 
        applying clause (iii), a drug or biological described in the 
        flush matter following such clause includes items, services, 
        supplies, and products that are payable under this part as a 
        drug or biological.''.
            (2) Technical amendment.--Section 1927(b)(3)(A)(iii) of the 
        Social Security Act (42 U.S.C. 1396r-8(b)(3)(A)(iii)) is 
        amended by striking ``section 1881(b)(13)(A)(ii)'' and 
        inserting ``section 1881(b)(14)(B)''.
    (d) Report.--Not later than January 1, 2021, the Inspector General 
of the Department of Health and Human Services shall assess and submit 
to Congress a report on the accuracy of average sales price information 
submitted by manufacturers under section 1847A of the Social Security 
Act (42 U.S.C. 1395w-3a). Such report shall include any recommendations 
on how to improve the accuracy of such information.

SEC. 6. MAKING PRESCRIPTION DRUG MARKETING SAMPLE INFORMATION REPORTED 
              BY MANUFACTURERS AVAILABLE TO CERTAIN INDIVIDUALS AND 
              ENTITIES.

    (a) In General.--Section 1128H of the Social Security Act (42 
U.S.C. 1320a-7i) is amended--
            (1) by redesignating subsection (b) as subsection (e); and
            (2) by inserting after subsection (a) the following new 
        subsections:
    ``(b) Data Sharing Agreements.--
            ``(1) In general.--The Secretary shall enter into 
        agreements with the specified data sharing individuals and 
        entities described in paragraph (2) under which--
                    ``(A) upon request of such an individual or entity, 
                as applicable, the Secretary makes available to such 
                individual or entity the information submitted under 
                subsection (a) by manufacturers and authorized 
                distributors of record; and
                    ``(B) such individual or entity agrees to not 
                disclose publicly or to another individual or entity 
                any information that identifies a particular 
                practitioner or health care facility.
            ``(2) Specified data sharing individuals and entities.--For 
        purposes of paragraph (1), the specified data sharing 
        individuals and entities described in this paragraph are the 
        following:
                    ``(A) Oversight agencies.--Health oversight 
                agencies (as defined in section 164.501 of title 45, 
                Code of Federal Regulations), including the Centers for 
                Medicare & Medicaid Services, the Office of the 
                Inspector General of the Department of Health and Human 
                Services, the Government Accountability Office, the 
                Congressional Budget Office, the Medicare Payment 
                Advisory Commission, and the Medicaid and CHIP Payment 
                and Access Commission.
                    ``(B) Researchers.--Individuals who conduct 
                scientific research (as defined in section 164.501 of 
                title 45, Code of Federal Regulations) in relevant 
                areas as determined by the Secretary.
                    ``(C) Payers.--Private and public health care 
                payers, including group health plans, health insurance 
                coverage offered by health insurance issuers, Federal 
                health programs, and State health programs.
            ``(3) Exemption from freedom of information act.--Except as 
        described in paragraph (1), the Secretary may not be compelled 
        to disclose the information submitted under subsection (a) to 
        any individual or entity. For purposes of section 552 of title 
        5, United States Code (commonly referred to as the Freedom of 
        Information Act), this paragraph shall be considered a statute 
        described in subsection (b)(3)(B) of such section.
    ``(c) Penalties.--
            ``(1) Data sharing agreements.--Subject to paragraph (3), 
        any specified data sharing individual or entity described in 
        subsection (b)(2) that violates the terms of a data sharing 
        agreement the individual or entity has with the Secretary under 
        subsection (b)(1) shall be subject to a civil money penalty of 
        not less than $1,000, but not more than $10,000, for each such 
        violation. Such penalty shall be imposed and collected in the 
        same manner as civil money penalties under subsection (a) of 
        section 1128A are imposed and collected under that section.
            ``(2) Failure to report.--Subject to paragraph (3), any 
        manufacturer or authorized distributor of record of an 
        applicable drug under subsection (a) that fails to submit 
        information required under such subsection in a timely manner 
        in accordance with rules or regulations promulgated to carry 
        out such subsection shall be subject to a civil money penalty 
        of not less than $1,000, but not more than $10,000, for each 
        such failure. Such penalty shall be imposed and collected in 
        the same manner as civil money penalties under subsection (a) 
        of section 1128A are imposed and collected under that section.
            ``(3) Limitation.--The total amount of civil money 
        penalties imposed under paragraph (1) or (2) with respect to a 
        year and an individual or entity described in subparagraph (A) 
        or a manufacturer or distributor described in subparagraph (B), 
        respectively, shall not exceed $150,000.
    ``(d) Drug Sample Distribution Information.--
            ``(1) In general.--Not later than January 1 of each year 
        (beginning with 2021), the Secretary shall maintain a list 
        containing information related to the distribution of samples 
        of applicable drugs. Such list shall provide the following 
        information with respect to the preceding year:
                    ``(A) The name of the manufacturer or authorized 
                distributor of record of an applicable drug for which 
                samples were requested or distributed under this 
                section.
                    ``(B) The quantity and class of drug samples 
                requested.
                    ``(C) The quantity and class of drug samples 
                distributed.
            ``(2) Public availability.--The Secretary shall make the 
        information in such list available to the public on the 
        Internet Web site of the Food and Drug Administration.''.
    (b) FDA Maintenance of Information.--The Food and Drug 
Administration shall maintain information available to affected 
reporting companies to ensure their ability to fully comply with the 
requirements of section 1128H of the Social Security Act.
    (c) Prohibition on Distribution of Samples of Opioids.--Section 
503(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(d)) 
is amended--
            (1) by moving the margin of paragraph (4) 2 ems to the 
        left; and
            (2) by adding at the end the following:
    ``(5) No person may distribute a drug sample of a drug that is--
            ``(A) an applicable drug (as defined in section 1128H(d) of 
        the Social Security Act);
            ``(B) a controlled substance (as defined in section 102 of 
        the Controlled Substances Act) for which the findings required 
        under section 202(b)(2) of such Act have been made; and
            ``(C) approved under section 505 for use in the management 
        or treatment of pain (other than for the management or 
        treatment of a substance use disorder).''.
    (d) MedPAC Report.--Not later than 3 years after the date of the 
enactment of this Act, the Medicare Payment Advisory Commission shall 
conduct a study on the impact of drug samples on provider prescribing 
practices and health care costs and may, as the Commission deems 
appropriate, make recommendations on such study.

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.

    Section 1860D-4(e)(2) of the Social Security Act (42 U.S.C. 1395w-
104(e)(2)) is amended--
            (1) in subparagraph (D), by striking ``To the extent'' and 
        inserting ``Except as provided in subparagraph (F), to the 
        extent''; and
            (2) by adding at the end the following new subparagraph:
                    ``(F) Real-time benefit information.--
                            ``(i) In general.--Not later than January 
                        1, 2021, the program shall implement real-time 
                        benefit tools that are capable of integrating 
                        with a prescribing health care professional's 
                        electronic prescribing or electronic health 
                        record system for the transmission of formulary 
                        and benefit information in real time to 
                        prescribing health care professionals. With 
                        respect to a covered part D drug, such tools 
                        shall be capable of transmitting such 
                        information specific to an individual enrolled 
                        in a prescription drug plan. Such information 
                        shall include the following:
                                    ``(I) A list of any clinically-
                                appropriate alternatives to such drug 
                                included in the formulary of such plan.
                                    ``(II) Cost-sharing information for 
                                such drug and such alternatives, 
                                including a description of any variance 
                                in cost sharing based on the pharmacy 
                                dispensing such drug or such 
                                alternatives.
                                    ``(III) Information relating to 
                                whether such drug is included in the 
                                formulary of such plan and any prior 
                                authorization or other utilization 
                                management requirements applicable to 
                                such drug and such alternatives so 
                                included.
                            ``(ii) Electronic transmission.--The 
                        provisions of subclauses (I) and (II) of clause 
                        (ii) of subparagraph (E) shall apply to an 
                        electronic transmission described in clause (i) 
                        in the same manner as such provisions apply 
                        with respect to an electronic transmission 
                        described in clause (i) of such subparagraph.
                            ``(iii) Special rule for 2021.--The program 
                        shall be deemed to be in compliance with clause 
                        (i) for 2021 if the program complies with the 
                        provisions of section 423.160(b)(7) of title 
                        42, Code of Federal Regulations (or a successor 
                        regulation), for such year.
                            ``(iv) Rule of construction.--Nothing in 
                        this subparagraph shall be construed as to 
                        allow a real time benefits tool to steer an 
                        individual, without the consent of the 
                        individual, to a particular pharmacy or 
                        pharmacy setting over their preferred pharmacy 
                        setting nor prohibit the designation of a 
                        preferred pharmacy under such tool.''.

SEC. 8. SENSE OF CONGRESS REGARDING THE NEED TO EXPAND COMMERCIALLY 
              AVAILABLE DRUG PRICING COMPARISON PLATFORMS.

    It is the sense of Congress that--
            (1) commercially available drug pricing comparison 
        platforms can, at no cost, help patients find the lowest price 
        for their medications at their local pharmacy;
            (2) such platforms should be integrated, to the maximum 
        extent possible, in the health care delivery ecosystem; and
            (3) pharmacy benefit managers should work to disclose 
        generic and brand name drug prices to such platforms to ensure 
        that--
                    (A) patients can benefit from the lowest possible 
                price available to them; and
                    (B) overall drug prices can be reduced as more 
                educated purchasing decisions are made based on price 
                transparency.

SEC. 9. TECHNICAL CORRECTIONS.

    (a) In General.--Section 3022(b) of the Public Health Service Act 
(42 U.S.C. 300jj-52(b)) is amended by adding at the end the following 
new paragraph:
            ``(4) Application of authorities under inspector general 
        act of 1978.--In carrying out this subsection, the Inspector 
        General shall have the same authorities as provided under 
        section 6 of the Inspector General Act of 1978 (5 U.S.C. 
        App.).''.
    (b) Effective Date.--The amendment made by subsection (a) shall 
take effect as if included in the enactment 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.''.
                                                 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 of the Whole House 
          on the State of the Union, and ordered to be printed
```