,,ib ,union ,calendar ,no4 #agj #aafth ,,congress #ast ,session ,h4 ,r4 #bbif ,report ,no4 #aaf-bae ,,in ,,the ,,house ,,of ,,representatives ,april #ab1 #bjai ,ms4 ,schakowsky 7for herself and ,mr4 ,rooney of ,florida7 introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce ,september #bd1 #bjai;,additional sponsors3 ,mr4 ,doggett1 ,mr4 ,sarbanes1 ,ms4 ,underwood1 ,mr4 ,griffith1 ,mr4 ,suozzi1 ,mr4 ,pocan1 and ,mr4 ,carter of ,georgia ,september #bd1 #bjai ,reported with amendments1 committed to the ,committee of the ,whole ,house on the ,state of the ,union1 and ordered to be printed ,strike out all after the enacting clause and insert the part printed in italic ,for text of introduced bill1 see copy of bill as introduced on ,april #ab1 #bjai ,a ,,bill ,to require reporting regarding certain drug price increases1 and for other purposes4 #a4 ,short title2 table of contents 7a7 ,short title ,this ,act may be cited as the ,more ,efficient ,tools to ,realize ,information for ,consumers ,act or the ,,metric ,act4 7b7 ,table of contents ,the table of contents for this ,act is as follows3 ,sec4 #a4 ,short title2 table of contents4 ,sec4 #b4 ,reporting on explanation for drug price increases4 ,sec4 #c4 ,public disclosure of drug discounts4 ,sec4 #d4 ,study of pharmaceutical supply chain intermediaries and merger activity4 ,sec4 #e4 ,requiring certain manufacturers to report drug pricing information with respect to drugs under the ,medicare program4 ,sec4 #f4 ,making prescription drug marketing sample information reported by manufacturers available to certain individuals and entities4 ,sec4 #g4 ,requiring prescription drug plan sponsors to include real-time benefit information as part of such sponsor's electronic prescription program under the ,medicare program4 ,sec4 #h4 ,sense of ,congress regarding the need to expand commercially available drug pricing comparison platforms4 ,sec4 #i4 ,technical corrections4 #b4 ,reporting on explanation for drug price increases 7a7 ,in general ,title ,,iii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #bda et seq47 is amended by adding at the end the following3 ,w ,drug ,price ,reporting2 ,drug ,value ,fund #cii,,oo4 ,reporting on explanation for drug price increases 7a7 ,definitions ,in this section3 7#a7 ,manufacturer ,the term manufacturer means the person-- 7,a7 that holds the application for a drug approved under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or licensed under section #cea of this ,act2 or 7,b7 who is responsible for setting the wholesale acquisition cost for the drug4 7#b7 ,qualifying drug ,the term qualifying drug means any drug that is approved under subsection 7c7 or 7j7 of section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or licensed under subsection 7a7 or 7k7 of section #cea of this ,act-- 7,a7 that has a wholesale acquisition cost of #ajj or more1 adjusted for inflation occurring after the date of enactment of the ,more ,efficient ,tools to ,realize ,information for ,consumers ,act1 for a month's supply or a typical course of treatment that lasts less than a month1 and is-- 7i7 subject to section #ejc7;b77#a7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 7ii7 administered or otherwise dispensed to treat a disease or condition affecting more than #bjj1jjj persons in the ,united ,states2 and 7iii7 not a vaccine2 and 7,b7 for which1 during the previous calendar year1 at least #a dollar of the total amount of sales were for individuals enrolled under the ,medicare program under title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq47 or under a ,state ,medicaid plan under title ,,xix of such ,act 7#db ,u4,s4,c4 #acif et seq47 or under a waiver of such plan4 7#c7 ,wholesale acquisition cost ,the term wholesale acquisition cost has the meaning given that term in section #ahdg;,a7c77#f77;,b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7c77#f77;,b774 7b7 ,report 7#a7 ,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-- 7,a7 #aj percent or more within a single calendar year beginning on or after ,january #a1 #bjai2 or 7,b7 #be percent or more within three consecutive calendar years for which the first such calendar year begins on or after ,january #a1 #bjai4 7#b7 ,report deadline ,each report described in paragraph 7#a7 shall be submitted to the ,secretary-- 7,a7 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 #a1 #bjai1 and ending on the day that is #fj days after the date of the enactment of the ,more ,efficient ,tools to ,realize ,information for ,consumers ,act1 not later than #ij days after such date of enactment2 and 7,b7 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 7,a71 not later than #cj days prior to the planned effective date of such price increase for such qualifying drug4 7c7 ,contents ,a report under subsection 7b71 consistent with the standard for disclosures described in section #bac4c7;d7 of title #ab1 ,code of ,federal ,regulations 7as in effect on the date of enactment of the ,more ,efficient ,tools to ,realize ,information for ,consumers ,act71 shall1 at a minimum1 include-- 7#a7 with respect to the qualifying drug-- 7,a7 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 7b77#a77;,a7 or 7b77#a77;,b71 and the effective date of such price increase2 7,b7 an explanation for1 and description of1 each price increase for such drug that will occur during the calendar year period described in subsection 7b77#a77;,a7 or the three consecutive calendar year period described in subsection 7b77#a77;,b71 as applicable2 7,c7 if known and different from the manufacturer of the qualifying drug1 the identity of-- 7i7 the sponsor or sponsors of any investigational new drug applications under section #eje7;i7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act for clinical investigations with respect to such drug1 for which the full reports are submitted as part of the application-- 7,i7 for approval of the drug under section #eje of such ,act2 or 7,,ii7 for licensure of the drug under section #cea of this ,act2 and 7ii7 the sponsor of an application for the drug approved under such section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or licensed under section #cea of this ,act2 7,d7 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 #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or the issuance of the license for the drug under section #cea of this ,act1 or since the manufacturer acquired such approved application or license1 if applicable2 7,e7 the current wholesale acquisition cost of the drug2 7,f7 the total expenditures of the manufacturer on-- 7i7 materials and manufacturing for such drug2 and 7ii7 acquiring patents and licensing for such drug2 7,g7 the percentage of total expenditures of the manufacturer on research and development for such drug that was derived from ,federal funds2 7,h7 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 #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or licensure under section #cea of this ,act1 as applicable2 7,i7 the total expenditures of the manufacturer on pursuing new or expanded indications or dosage changes for such drug under section #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or section #cea of this ,act2 7,j7 the total expenditures of the manufacturer on carrying out postmarket requirements related to such drug1 including under section #eje7o77#c7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act2 7,k7 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 #eje of the ,federal ,food1 ,drug1 and ,cosmetic ,act or the issuance of the license for the drug under section #cea1 or since the manufacturer acquired such approved application or license2 and 7,l7 the total costs associated with marketing and advertising for the qualifying drug2 7#b7 with respect to the manufacturer-- 7,a7 the total revenue and the net profit of the manufacturer for each of the #a-year period described in subsection 7b77#a77;,a7 or the #c-year period described in subsection 7b77#a77;,b71 as applicable2 7,b7 all stock-based performance metrics used by the manufacturer to determine executive compensation for each of the #a-year period described in subsection 7b77#a77;,a7 or the #c-year period described in subsection 7b77#a77;,b71 as applicable2 and 7,c7 any additional information the manufacturer chooses to provide related to drug pricing decisions1 such as total expenditures on-- 7i7 drug research and development2 or 7ii7 clinical trials1 including on drugs that failed to receive approval by the ,food and ,drug ,administration2 and 7#c7 such other related information as the ,secretary considers appropriate and as specified by the ,secretary through notice-and-comment rulemaking4 7d7 ,information provided ,the manufacturer of a qualifying drug that is required to submit a report under subsection 7b71 shall ensure that such report and any explanation for1 and description of1 each price increase described in subsection 7c77#a77;,b7 shall be truthful1 not misleading1 and accurate4 7e7 ,civil monetary penalty ,any manufacturer of a qualifying drug that fails to submit a report for the drug as required by this section1 following notification by the ,secretary to the manufacturer that the manufacturer is not in compliance with this section1 shall be subject to a civil monetary penalty of #ge1jjj for each day on which the violation continues4 7f7 ,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 #ge1jjj for each item of false information4 7g7 ,public posting 7#a7 ,in general ,subject to paragraph 7#c71 the ,secretary shall post each report submitted under subsection 7b7 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 effect4 7#b7 ,format ,in developing the format in which reports will be publicly posted under paragraph 7#a71 the ,secretary shall consult with stakeholders1 including beneficiary groups1 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-- 7,a7 user-friendly to the public2 and 7,b7 written in plain language that consumers can readily understand4 7#c7 ,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 secrets1 commercial information1 and other information covered under such laws4 #cii,,oo-#a4 ,annual report to ,congress 7a7 ,in ,general ,subject to subsection 7b71 the ,secretary shall submit to ,congress1 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 understand1 an annual report-- 7#a7 summarizing the information reported pursuant to section #cii,,oo2 7#b7 including copies of the reports and supporting detailed economic analyses submitted pursuant to such section2 7#c7 detailing the costs and expenditures incurred by the ,department of ,health and ,human ,services in carrying out section #cii,,oo2 and 7#d7 explaining how the ,department of ,health and ,human ,services is improving consumer and provider information about drug value and drug price transparency4 7b7 ,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 secrets1 commercial information1 and other information covered under such laws4 4 7b7 ,effective date ,the amendment made by subsection 7a7 takes effect on the date of enactment of this ,act4 #c4 ,public disclosure of drug discounts ,section #aaej;,a of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;b-#bc7 is amended-- 7#a7 in subsection 7c71 in the matter preceding paragraph 7#a71 by inserting 7other than as permitted under subsection 7e77 after disclosed by the ,secretary2 and 7#b7 by adding at the end the following new subsection3 7e7 ,public availability of certain information 7#a7 ,in general ,in order to allow the comparison of ,p,b,ms' ability to negotiate rebates1 discounts1 direct and indirect remuneration fees1 administrative fees1 and price concessions and the amount of such rebates1 discounts1 direct and indirect remuneration fees1 administrative fees1 and price concessions that are passed through to plan sponsors1 beginning ,january #a1 #bjbj1 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 7as described in paragraph 7#a7 of subsection 7b77 and information provided to the ,secretary under paragraphs 7#b7 and 7#c7 of such subsection that1 as determined by the ,secretary1 is with respect to each ,,pbm4 7#b7 ,availability of data ,in carrying out paragraph 7#a71 the ,secretary shall ensure the following3 7,a7 ,confidentiality ,the information described in such paragraph is displayed in a manner that prevents the disclosure of information1 with respect to an individual drug or an individual plan1 on rebates1 discounts1 direct and indirect remuneration fees1 administrative fees1 and price concessions4 7,b7 ,class of drug ,the information described in such paragraph is made available by class of drug1 using an existing classification system1 but only if the class contains such number of drugs1 as specified by the ,secretary 7but not fewer than three drugs71 to ensure confidentiality of proprietary information or other information that is prevented to be disclosed under subparagraph 7,a74 4 #d4 ,study of pharmaceutical supply chain intermediaries and merger activity 7a7 ,initial report ,not later than #a year after the date of enactment of this ,act1 the ,commission shall submit to the appropriate committees of ,congress a report that-- 7#a7 addresses at minimum-- 7,a7 whether pharmacy benefit managers-- 7i7 charge payers a higher price than the reimbursement rate at which the pharmacy benefit managers reimburse competing pharmacies2 7ii7 steer patients for anticompetitive purposes to any pharmacies1 including retail1 mail-order1 or any other type of pharmacy1 in which the pharmacy benefit manager has an ownership interest2 7iii7 audit or review proprietary data1 including acquisition costs1 patient information1 or dispensing information1 of competing pharmacies that can be used for anticompetitive purposes2 or 7iv7 use formulary designs to increase the market share of higher cost prescription drugs and depress the market share of lower cost prescription drugs 7each net of rebates and discounts72 7,b7 how companies and payers assess the benefits1 costs1 and risks of contracting with intermediaries1 including pharmacy services administrative organizations1 and whether more information about the roles of intermediaries should be available to consumers and payers2 and 7,c7 whether there are any specific legal or regulatory obstacles the ,commission currently faces in ensuring a competitive and transparent marketplace in the pharmaceutical supply chain1 including the pharmacy benefit manager marketplace and pharmacy services administrative organizations2 and 7#b7 provides-- 7,a7 observations or conclusions drawn from the ,november #bjag roundtable entitled ,understanding ,competition in ,prescription ,drug ,markets3 ,entry and ,supply ,chain ,dynamics1 and any similar efforts2 7,b7 specific actions the ,commission intends to take as a result of the ,november #bjag roundtable1 and any similar efforts1 including a detailed description of relevant forthcoming actions1 additional research or roundtable discussions1 consumer education efforts1 or enforcement actions2 and 7,c7 policy or legislative recommendations to-- 7i7 improve transparency and competition in the pharmaceutical supply chain2 7ii7 prevent and deter anticompetitive behavior in the pharmaceutical supply chain2 and 7iii7 best ensure that consumers benefit from any cost savings or efficiencies that may result from mergers and consolidations4 7b7 ,interim report ,not later than #ahj days after the date of enactment of this ,act1 the ,commission shall submit to the appropriate committees of ,congress an interim report on the progress of the report required by subsection 7a71 along with preliminary findings and conclusions based on information collected to that date4 7c7 ,definitions ,in this section3 7#a7 ,appropriate committees of congress ,the term appropriate committees of ,congress means-- 7,a7 the ,committee on ,energy and ,commerce of the ,house of ,representatives2 7,b7 the ,committee on the ,judiciary of the ,senate2 and 7,c7 the ,committee on the ,judiciary of the ,house of ,representatives4 7#b7 ,commission ,the term ,commission means the ,federal ,trade ,commission4 #e4 ,requiring certain manufacturers to report drug pricing information with respect to drugs under the ,medicare program 7a7 ,in general ,section #ahdg;,a of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a7 is amended-- 7#a7 in subsection 7b7-- 7,a7 in paragraph 7#b77;,a71 by inserting or subsection 7f77#b71 as applicable before the period at the end2 7,b7 in paragraph 7#c71 in the matter preceding subparagraph 7,a71 by inserting or subsection 7f77#b71 as applicable1 before determined by2 and 7,c7 in paragraph 7#f77;,a71 in the matter preceding clause 7i71 by inserting or subsection 7f77#b71 as applicable1 before determined by2 and 7#b7 in subsection 7f7-- 7,a7 by striking ,for requirements and inserting the following3 7#a7 ,in general ,for requirements 2 and 7,b7 by adding at the end the following new paragraph3 7#b7 ,manufacturers without a rebate agreement under title ,,xix 7,a7 ,in general ,if the manufacturer of a drug or biological described in subparagraph 7,c71 7,e71 or 7,g7 of section #ahdb7o77#a7 or in section #ahha7;b77#ad77;,b7 that is payable under this part has not entered into and does not have in effect a rebate agreement described in subsection 7b7 of section #aibg1 for calendar quarters beginning on or after ,january #a1 #bjbj1 such manufacturer shall report to the ,secretary the information described in subsection 7b77#c77;,a77iii7 of such section #aibg with respect to such drug or biological in a time and manner specified by the ,secretary4 ,for purposes of applying this paragraph1 a drug or biological described in the previous sentence includes items1 services1 supplies1 and products that are payable under this part as a drug or biological4 7,b7 ,audit ,information reported under subparagraph 7,a7 is subject to audit by the ,inspector ,general of the ,department of ,health and ,human ,services4 7,c7 ,verification ,the ,secretary may survey wholesalers and manufacturers that directly distribute drugs described in subparagraph 7,a71 when necessary1 to verify manufacturer prices and manufacturer's average sales prices 7including wholesale acquisition cost7 if required to make payment reported under subparagraph 7,a74 ,the ,secretary may impose a civil monetary penalty in an amount not to exceed #ajj1jjj on a wholesaler1 manufacturer1 or direct seller1 if the wholesaler1 manufacturer1 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 information4 ,the provisions of section #aabh;,a 7other than subsections 7a7 7with respect to amounts of penalties or additional assessments7 and 7b77 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 #aabh;,a7a74 7,d7 ,confidentiality ,notwithstanding any other provision of law1 information disclosed by manufacturers or wholesalers under this paragraph 7other than the wholesale acquisition cost for purposes of carrying out this section7 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 wholesaler1 except-- 7i7 as the ,secretary determines to be necessary to carry out this section 7including the determination and implementation of the payment amount71 or to carry out section #ahdg;,b2 7ii7 to permit the ,comptroller ,general of the ,united ,states to review the information provided2 and 7iii7 to permit the ,director of the ,congressional ,budget ,office to review the information provided4 4 7b7 ,enforcement ,section #ahdg;,a of such ,act 7#db ,u4,s4,c4 #aciew-#c;a7 is further amended-- 7#a7 in subsection 7d77#d7-- 7,a7 in subparagraph 7,a71 by striking ,in general and inserting ,misrepresentation2 7,b7 in subparagraph 7,b71 by striking subparagraph 7,b7 and inserting subparagraph 7,a71 7,b71 or 7,c72 7,c7 by redesignating subparagraph 7,b7 as subparagraph 7,d72 and 7,d7 by inserting after subparagraph 7,a7 the following new subparagraphs3 7,b7 ,failure to provide timely information ,if the ,secretary determines that a manufacturer described in subsection 7f77#b7 has failed to report on information described in section #aibg7;b77#c77;,a77iii7 with respect to a drug or biological in accordance with such subsection1 the ,secretary shall apply a civil money penalty in an amount of #aj1jjj for each day the manufacturer has failed to report such information and such amount shall be paid to the ,treasury4 7,c7 ,false information ,any manufacturer required to submit information under subsection 7f77#b7 that knowingly provides false information is subject to a civil money penalty in an amount not to exceed #ajj1jjj for each item of false information4 ,such civil money penalties are in addition to other penalties as may be prescribed by law4 2 and 7#b7 in subsection 7c77#f77;,a71 by striking the period at the end and inserting 1 except that1 for purposes of subsection 7f77#b71 the ,secretary may1 if the ,secretary determines appropriate1 exclude repackagers of a drug or biological from such term44 7c7 ,manufacturers with a rebate agreement 7#a7 ,in general ,section #aibg7;b77#c77;,a7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#c77;,a77 is amended by adding at the end the following new sentence3 ,for purposes of applying clause 7iii71 a drug or biological described in the flush matter following such clause includes items1 services1 supplies1 and products that are payable under this part as a drug or biological44 7#b7 ,technical amendment ,section #aibg7;b77#c77;,a77iii7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acifr-#h7;b77#c77;,a77iii77 is amended by striking section #ahha7;b77#ac77;,a77ii7 and inserting section #ahha7;b77#ad77;,b74 7d7 ,report ,not later than ,january #a1 #bjba1 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 #ahdg;,a of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#c;a74 ,such report shall include any recommendations on how to improve the accuracy of such information4 #f4 ,making prescription drug marketing sample information reported by manufacturers available to certain individuals and entities 7a7 ,in general ,section #aabh;,h of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;a-#g;i7 is amended-- 7#a7 by redesignating subsection 7b7 as subsection 7e72 and 7#b7 by inserting after subsection 7a7 the following new subsections3 7b7 ,data sharing agreements 7#a7 ,in general ,the ,secretary shall enter into agreements with the specified data sharing individuals and entities described in paragraph 7#b7 under which-- 7,a7 upon request of such an individual or entity1 as applicable1 the ,secretary makes available to such individual or entity the information submitted under subsection 7a7 by manufacturers and authorized distributors of record2 and 7,b7 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 facility4 7#b7 ,specified data sharing individuals and entities ,for purposes of paragraph 7#a71 the specified data sharing individuals and entities described in this paragraph are the following3 7,a7 ,oversight agencies ,health oversight agencies 7as defined in section #afd4eja of title #de1 ,code of ,federal ,regulations71 including the ,centers for ,medicare ,medicaid ,services1 the ,office of the ,inspector ,general of the ,department of ,health and ,human ,services1 the ,government ,accountability ,office1 the ,congressional ,budget ,office1 the ,medicare ,payment ,advisory ,commission1 and the ,medicaid and ,,chip ,payment and ,access ,commission4 7,b7 ,researchers ,individuals who conduct scientific research 7as defined in section #afd4eja of title #de1 ,code of ,federal ,regulations7 in relevant areas as determined by the ,secretary4 7,c7 ,payers ,private and public health care payers1 including group health plans1 health insurance coverage offered by health insurance issuers1 ,federal health programs1 and ,state health programs4 7#c7 ,exemption from ,freedom of ,information ,act ,except as described in paragraph 7#a71 the ,secretary may not be compelled to disclose the information submitted under subsection 7a7 to any individual or entity4 ,for purposes of section #eeb of title #e1 ,united ,states ,code 7commonly referred to as the ,freedom of ,information ,act71 this paragraph shall be considered a statute described in subsection 7b77#c77;,b7 of such section4 7c7 ,penalties 7#a7 ,data sharing agreements ,subject to paragraph 7#c71 any specified data sharing individual or entity described in subsection 7b77#b7 that violates the terms of a data sharing agreement the individual or entity has with the ,secretary under subsection 7b77#a7 shall be subject to a civil money penalty of not less than #a1jjj1 but not more than #aj1jjj1 for each such violation4 ,such penalty shall be imposed and collected in the same manner as civil money penalties under subsection 7a7 of section #aabh;,a are imposed and collected under that section4 7#b7 ,failure to report ,subject to paragraph 7#c71 any manufacturer or authorized distributor of record of an applicable drug under subsection 7a7 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 #a1jjj1 but not more than #aj1jjj1 for each such failure4 ,such penalty shall be imposed and collected in the same manner as civil money penalties under subsection 7a7 of section #aabh;,a are imposed and collected under that section4 7#c7 ,limitation ,the total amount of civil money penalties imposed under paragraph 7#a7 or 7#b7 with respect to a year and an individual or entity described in subparagraph 7,a7 or a manufacturer or distributor described in subparagraph 7,b71 respectively1 shall not exceed #aej1jjj4 7d7 ,drug sample distribution information 7#a7 ,in general ,not later than ,january #a of each year 7beginning with #bjba71 the ,secretary shall maintain a list containing information related to the distribution of samples of applicable drugs4 ,such list shall provide the following information with respect to the preceding year3 7,a7 ,the name of the manufacturer or authorized distributor of record of an applicable drug for which samples were requested or distributed under this section4 7,b7 ,the quantity and class of drug samples requested4 7,c7 ,the quantity and class of drug samples distributed4 7#b7 ,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 ,administration4 4 7b7 ,,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 #aabh;,h of the ,social ,security ,act4 7c7 ,prohibition on distribution of samples of opioids ,section #ejc7;d7 of the ,federal ,food1 ,drug1 and ,cosmetic ,act 7#ba ,u4,s4,c4 #cec7;d77 is amended-- 7#a7 by moving the margin of paragraph 7#d7 #b ems to the left2 and 7#b7 by adding at the end the following3 7#e7 ,no person may distribute a drug sample of a drug that is-- 7,a7 an applicable drug 7as defined in section #aabh;,h7d7 of the ,social ,security ,act72 7,b7 a controlled substance 7as defined in section #ajb of the ,controlled ,substances ,act7 for which the findings required under section #bjb7;b77#b7 of such ,act have been made2 and 7,c7 approved under section #eje for use in the management or treatment of pain 7other than for the management or treatment of a substance use disorder74 4 7d7 ,med,p,a,c report ,not later than #c years after the date of the enactment of this ,act1 the ,medicare ,payment ,advisory ,commission shall conduct a study on the impact of drug samples on provider prescribing practices and health care costs and may1 as the ,commission deems appropriate1 make recommendations on such study4 #g4 ,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 #ahfj;,d-#d7;e77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #aciew-#ajd7;e77#b77 is amended-- 7#a7 in subparagraph 7,d71 by striking ,to the extent and inserting ,except as provided in subparagraph 7,f71 to the extent2 and 7#b7 by adding at the end the following new subparagraph3 7,f7 ,real-time benefit information 7i7 ,in general ,not later than ,january #a1 #bjba1 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 professionals4 ,with respect to a covered part ,d drug1 such tools shall be capable of transmitting such information specific to an individual enrolled in a prescription drug plan4 ,such information shall include the following3 7,i7 ,a list of any clinically-appropriate alternatives to such drug included in the formulary of such plan4 7,,ii7 ,cost-sharing information for such drug and such alternatives1 including a description of any variance in cost sharing based on the pharmacy dispensing such drug or such alternatives4 7,,iii7 ,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 included4 7ii7 ,electronic transmission ,the provisions of subclauses 7,i7 and 7,,ii7 of clause 7ii7 of subparagraph 7,e7 shall apply to an electronic transmission described in clause 7i7 in the same manner as such provisions apply with respect to an electronic transmission described in clause 7i7 of such subparagraph4 7iii7 ,special rule for #bjba ,the program shall be deemed to be in compliance with clause 7i7 for #bjba if the program complies with the provisions of section #dbc4afj7;b77#g7 of title #db1 ,code of ,federal ,regulations 7or a successor regulation71 for such year4 7iv7 ,rule of construction ,nothing in this subparagraph shall be construed as to allow a real time benefits tool to steer an individual1 without the consent of the individual1 to a particular pharmacy or pharmacy setting over their preferred pharmacy setting nor prohibit the designation of a preferred pharmacy under such tool4 4 #h4 ,sense of ,congress regarding the need to expand commercially available drug pricing comparison platforms ,it is the sense of ,congress that-- 7#a7 commercially available drug pricing comparison platforms can1 at no cost1 help patients find the lowest price for their medications at their local pharmacy2 7#b7 such platforms should be integrated1 to the maximum extent possible1 in the health care delivery ecosystem2 and 7#c7 pharmacy benefit managers should work to disclose generic and brand name drug prices to such platforms to ensure that-- 7,a7 patients can benefit from the lowest possible price available to them2 and 7,b7 overall drug prices can be reduced as more educated purchasing decisions are made based on price transparency4 #i4 ,technical corrections 7a7 ,in general ,section #cjbb7;b7 of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;jj-#eb7;b77 is amended by adding at the end the following new paragraph3 7#d7 ,application of authorities under ,inspector ,general ,act of #aigh ,in carrying out this subsection1 the ,inspector ,general shall have the same authorities as provided under section #f of the ,inspector ,general ,act of #aigh 7#e ,u4,s4,c4 ,app474 4 7b7 ,effective date ,the amendment made by subsection 7a7 shall take effect as if included in the enactment of the #bast ,century ,cures ,act 7,public ,law #aad-bee74 ,amend the title so as to read3 ,a bill to require reporting for certain drug price information1 and for other purposes44 ,september #bd1 #bjai ,reported with amendments1 committed to the ,committee of the ,whole ,house on the ,state of the ,union1 and ordered to be printed