,i #aafth ,,congress #b;d ,session ,h4 ,r4 #hifg ,,in ,,the ,,house ,,of ,,representatives ,december #ae1 #bjbj,mr4 ,beyer introduced the following bill2 which was referred to the ,committee on ,energy and ,commerce1 and in addition to the ,committees on ,ways and ,means1 ,oversight and ,reform1 ,armed ,services1 and ,education and ,labor1 for a period to be subsequently determined by the ,speaker1 in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned ,a ,,bill ,to require the ,secretary of ,health and ,human ,services to award a contract to an eligible nonprofit entity to establish and maintain a health care claims database for purposes of lowering ,americans' health care costs1 and for other purposes4 #a4 ,short title ,this ,act may be cited as the ,federal ,all-,payer ,claims ,database ,act of #bjbj4 #b4 ,establishment and maintenance of health care claims database to lower health care costs 7a7 ,in general ,not later than the date that is #ahj days after the date of the enactment of this ,act1 the ,secretary of ,health and ,human ,services 7referred to in this section as the ,secretary71 acting through the ,administrator of the ,centers for ,medicare ,medicaid ,services and in consultation with the ,secretary of ,labor1 shall award a contract in accordance with subsection 7b7 to an eligible nonprofit entity described in such subsection for purposes of carrying out the requirements of such entity under this section4 7b7 ,contract with eligible nonprofit entity 7#a7 ,competitive procedures ,the ,secretary shall award the contract described in subsection 7a7 to an eligible nonprofit entity described in paragraph 7#b7 using full and open competition procedures pursuant to chapter #cc of title #da1 ,united ,states ,code4 7#b7 ,eligible nonprofit entity ,an eligible nonprofit entity described in this paragraph is a nonprofit entity that-- 7,a7 is governed by a board that includes-- 7i7 representatives of the academic research community2 and 7ii7 individuals with expertise in employer-sponsored insurance1 research using health care claims data1 and actuarial analysis2 and 7,b7 conducts its business in an open and transparent manner that provides the opportunity for public comment on its activities4 7#c7 ,considerations ,in awarding a contract to an eligible nonprofit entity under this section1 the ,secretary shall consider the experience of each eligible nonprofit entity in-- 7,a7 collecting and aggregating health care claims data1 ensuring quality assurance and security of such claims data1 and securing such claims data2 7,b7 supporting academic research on health care costs1 spending1 and utilization for and by privately insured patients2 7,c7 working with large health insurance issuers1 group health plans1 and third-party administrators of group health plans to assemble a health care claims database2 7,d7 effectively collaborating with and engaging stakeholders to develop reports2 7,e7 meeting budgets and timelines1 including with respect to developing reports2 and 7,f7 facilitating the creation of1 or supporting1 ,state all-payer claims databases4 7#d7 ,period of contract 7,a7 ,in general ,a contract awarded under this section shall be for a period of #e years and may be renewed1 subject to the full and open competition procedures described in paragraph 7#a74 7,b7 ,transition of contract ,in the case that a contract is not renewed for a subsequent #e-year period under subparagraph 7,a7 after the use of the full and open competition procedures described in paragraph 7#a71 the ,secretary shall require the entity whose contract is expiring to transfer all data maintained by the health care claims database described in paragraph 7#e77;,a7 to the entity to whom the ,secretary has awarded a contract for the subsequent #e-year period4 ,the entity whose contract is expiring may not disclose such data to any other entity or keep such data after the expiration of such contract4 7#e7 ,requirements of contract ,each contract awarded under this section shall require the entity awarded such contract to carry out each of the following3 7,a7 ,establish and maintain a health care claims database in accordance with the requirements of the ,,hipaa privacy regulation4 7,b7 ,ensure that such health care claims database makes available data submitted under subsection 7d7 in accordance with the requirements of subsection 7c74 7,c7 ,in the case that the contract is not renewed after the end of the #e-year period of the contract1 carry out the transfer of data required pursuant to paragraph 7#d77;,b7 in accordance with a schedule and process determined by the ,secretary4 7,d7 ,comply with the ,,hipaa privacy regulation in the same manner and to the same extent as such regulation applies to a covered entity 7as defined pursuant to such regulation74 7,e7 ,strictly limit staff access to such health care claims database to staff with appropriate training1 clearance1 and background checks1 and require such staff to undergo regular privacy and security training4 7,f7 ,maintain effective security standards for transferring data from such health care claims database and making such data available to all individuals and entities who are authorized users pursuant to subsection 7c77#b74 7,g7 ,adhere to best security practices with respect to the management and use of such data for health services research1 in accordance with applicable ,federal privacy law4 7,h7 ,report on the security methods of the entity to-- 7i7 the ,secretary2 7ii7 the ,committee on ,health1 ,education1 ,labor1 and ,pensions1 the ,committee on ,finance1 and the ,committee on ,commerce1 ,science1 and ,transportation of the ,senate2 and 7iii7 the ,committee on ,education and ,labor1 the ,committee on ,energy and ,commerce1 the ,committee on the ,judiciary1 and the ,committee on ,ways and ,means of the ,house of ,representatives4 7c7 ,availability of data from health care claims database 7#a7 ,in general ,subject to paragraph 7#b71 the entity maintaining the health care claims database described in subsection 7b77#e77;,a7 shall make available1 at cost1 the data submitted under subsection 7d7-- 7,a7 to patients to inform such patients about the cost1 quality1 and value of their health care2 7,b7 to health care providers and hospitals-- 7i7 to assist such providers and hospitals in making informed choices while providing health care2 and 7ii7 to enable such providers and hospitals to improve health care services provided to patients and health care outcomes for such patients by benchmarking their performance against that of other health care providers and hospitals2 7,c7 to group health plans and health insurance issuers offering individual or group health insurance coverage to assist such group health plans and health insurance issuers in evaluating and reducing health care costs for enrollees of such group health plans and individual or group health insurance coverage1 respectively2 7,d7 to ,states to facilitate ,state-led initiatives to lower health care costs and improve the quality of health care2 7,e7 to any ,state all-payer claims database and regional health care claims database operated pursuant to the authorization of each ,state covered by such regional health care claims database2 7,f7 to any individual or entity conducting research2 7,g7 to the ,secretary of ,defense for purposes of carrying out the ,,tricare program under chapter #ee of title #aj1 ,united ,states ,code2 7,h7 to the ,director of the ,office of ,personnel ,management for purposes of carrying out the ,federal ,employees ,health ,benefits ,program established under chapter #hi of title #e1 ,united ,states ,code2 and 7,i7 to the ,director of the ,congressional ,budget ,office1 the ,comptroller ,general of the ,united ,states1 the ,executive ,director of the ,medicare ,payment ,advisory ,commission1 and the ,executive ,director of the ,medicaid and ,,chip ,payment ,advisory ,commission4 7#b7 ,authorization for access to data 7,a7 ,in general ,the entity maintaining the health care claims database described in subsection 7b77#e77;,a7 may only make available the data described in paragraph 7#a7 to an individual or entity described in any of subparagraphs 7,a7 through 7,f7 of such paragraph if such individual or entity submits an application to such entity requesting authorization for access to such database in accordance with this paragraph4 7,b7 ,application ,an application under this paragraph shall be submitted at such time1 in such manner1 and containing such information as the ,secretary may require and shall include-- 7i7 in the case of an individual or entity requesting access to the health care claims database described in subsection 7b77#e77;,a7 for research purposes-- 7,i7 a description of the uses and methodologies for evaluating health system performance using the data from such database2 and 7,,ii7 documentation of approval of such research purposes by an institutional review board1 if applicable for a particular plan of research2 and 7ii7 in the case of a group health plan1 health insurance issuer1 third-party administrator of a group health plan1 or health care provider requesting access to such health care claims database for the purpose of quality improvement or cost-containment1 a description of the intended uses for the data from such database4 7,c7 ,data use and confidentiality agreement ,upon approval of an application under subparagraph 7,b71 the authorized user shall enter into a data use and confidentiality agreement with the entity that approved such application1 which shall include a prohibition on attempts to reidentify and disclose protected health information and proprietary financial information4 ,in the case of an approval of an application for quality improvement or cost-containment purposes under subparagraph 7,b77ii71 access to data from the health care claims database described in subsection 7b77#e77;,a7 shall be provided in a form and manner such that the authorized user may not obtain individually identifiable price information with respect to direct competitors4 7#c7 ,availability of reports and analyses based on data 7,a7 ,in general ,subject to subparagraph 7,b71 the entity maintaining the health care claims database described in subsection 7b77#e77;,a71 in consultation with the advisory committee convened under subsection 7e71 shall make available to all individuals and entities who are authorized users pursuant to paragraph 7#b7 any report or analysis based on data from such database1 including aggregate data sets1 free of charge4 7,b7 ,customized reports ,group health plans may request customized reports from the entity maintaining the health care claims database described in subsection 7b77#e77;,a71 at cost1 but subject to the requirements of the ,,hippa privacy regulation4 7d7 ,submission of data to health care claims database 7#a7 ,in general ,subject to paragraphs 7#b7 and 7#c71 a group health plan 7through its sponsor1 third-party administrator1 pharmacy benefit manager1 or other entity designated by the group health plan7 or a health insurance issuer offering group or individual health insurance coverage shall electronically submit to the health care claims database maintained under this section all claims data 7including claims with respect to treatment of substance use disorders and prescription drug claims7 with respect to the plan or group or individual health insurance coverage1 respectively4 7#b7 ,scope of information and format of submission ,the entity maintaining the health care claims database under this section1 in consultation with the advisory committee convened under subsection 7e71 shall-- 7,a7 specify the data elements required to be submitted under paragraph 7#a71 which shall include all data related to transactions described in subparagraphs 7,a7 and 7,e7 of section #aagc7;a77#b7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;d-#b7;a77#b771 including all data elements normally present in such transactions when adjudicated1 and enrollment information2 7,b7 specify the form and manner for submissions under this subsection and the historical period to be included in the initial submission2 and 7,c7 offer an automated submission option to minimize administrative burdens relating to the submission of data under this subsection4 7#c7 ,de-identification of data ,the entity maintaining the health care claims database under this section1 in consultation with the advisory committee convened under subsection 7e71 shall-- 7,a7 establish a process under which data is de-identified in accordance with section #afd4ead7;a7 of title #de1 ,code of ,federal ,regulations 7or any successor regulations71 while retaining the ability to link data longitudinally for the purposes of research on cost and quality and the ability to complete risk adjustment and geographic analysis2 7,b7 ensure that any third-party subcontractors who perform the de-identification process described in subparagraph 7,a7 retain the minimum necessary information to perform such process and adhere to effective security and encryption practices in data storage and transmission2 7,c7 store claims and other data collected under this subsection only in de-identified form1 in accordance with section #afd4ead7;a7 of title #de1 ,code of ,federal ,regulations 7or any successor regulations72 and 7,d7 ensure that data is encrypted1 in accordance with the ,,hipaa privacy regulation4 7#d7 ,other data 7,a7 ,medicaid data ,the ,administrator of the ,centers for ,medicare ,medicaid ,services shall submit all health care claims data with respect to the ,medicare program under title ,,xviii of the ,social ,security ,act 7#db ,u4,s4,c4 #acie et seq47 and the ,medicaid program under title ,,xix of such ,act 7#db ,u4,s4,c4 #acif et seq47 in accordance with scope1 format1 and de-identification requirements applicable pursuant to paragraphs 7#b7 and 7#c74 7,b7 ,,tricare ,the ,secretary of ,defense shall submit all health care claims data with respect to the ,,tricare program under chapter #ee of title #aj1 ,united ,states ,code1 in accordance with scope1 format1 and de-identification requirements applicable pursuant to paragraphs 7#b7 and 7#c74 7,c7 ,,fehb ,the ,director of the ,office of ,personnel ,management shall submit all health care claims data with respect to the ,federal ,employee ,health ,benefits program in accordance with scope1 format1 and de-identification requirements applicable pursuant to paragraphs 7#b7 and 7#c74 7,d7 ,state data ,the entity maintaining the health care claims database under this section may collect data from ,state all-payer claims databases that seek access to such health care claims database4 ,a ,state may require health insurance issuers and other payers to submit claims data to a ,state-mandated all-payer claims database1 provided that such data is submitted in a form and manner established by the ,secretary4 ,a ,state may also require health insurance issuers and other payers to submit claims data to the health care claims database maintained under this section1 provided that such data is submitted in a form and manner established by the ,secretary and consistent with scope1 format1 and de-identification requirements applicable pursuant to paragraphs 7#b7 and 7#c74 7#e7 ,prohibition ,any individual or entity required to submit data under this subsection may not place any restrictions on the use of such data by authorized users under subsection 7c77#b74 7e7 ,advisory committee 7#a7 ,in general ,not later than the date that is #ahj days after the date of the enactment of this ,act1 the ,secretary shall convene an advisory committee 7referred to in this subsection as the ,committee7 to advise the ,secretary1 any entity awarded a contract under subsection 7b71 and ,congress on the establishment1 operations1 and use of the health care claims database established and maintained under this section4 7#b7 ,membership 7,a7 ,appointment ,in accordance with clause 7ii71 the ,secretary1 in consultation with the ,comptroller ,general of the ,united ,states1 shall appoint members to the ,committee who have distinguished themselves in the fields of health services research1 health economics1 health informatics1 or the governance of ,state all-payer claims databases1 or who represent organizations likely to submit data to or use the health care claims database established and maintained under this section1 including patients1 health care providers1 group health plans1 health insurance issuers1 and third-party administrators of group health plans4 7,b7 ,composition ,for purposes of clause 7i7-- 7i7 the ,secretary shall appoint to the ,committee-- 7,i7 one member to serve as the chair of the ,committee2 7,,ii7 the ,assistant ,secretary for ,planning and ,evaluation of the ,department of ,health and ,human ,services2 7,,iii7 one representative from the ,centers for ,medicare ,medicaid ,services2 7,,iv7 one representative from the ,agency for ,health ,research and ,quality2 7,v7 one representative from the ,office for ,civil ,rights of the ,department of ,health and ,human ,services with expertise in data privacy and security2 and 7,,vi7 one representative of the ,national ,center for ,health ,statistics2 and 7ii7 the ,comptroller ,general of the ,united ,states shall appoint to the ,committee-- 7,i7 one representative from an employer that sponsors a group health plan2 7,,ii7 one representative from an employee organization that sponsors a group health plan2 7,,iii7 one academic researcher with expertise in health economics or health services research2 7,,iv7 one patient advocate2 7,v7 one representative of ,designated ,standards ,maintenance ,organizations named by the ,secretary of ,health and ,human ,services to maintain standards adopted under regulations promulgated under section #bfd7;c7 of the ,health ,insurance ,portability and ,accountability ,act of #aiif 7#db ,u4,s4,c4 #acbj;d-#b note72 7,,vi7 one representative with expertise in the governance of ,state all-payer claims databases2 and 7,,vii7 two additional members4 7,c7 ,terms and vacancies ,members of the ,committee shall serve three-year terms on a staggered basis4 ,a vacancy on the ,committee shall be filled by appointment in a manner consistent with the requirements of this subsection not later than #ij days after the vacancy arises4 7#c7 ,duties ,the ,committee shall-- 7,a7 assist and advise the ,secretary on the management of contracts awarded under subsection 7b72 7,b7 assist and advise entities awarded such contracts in establishing-- 7i7 the appropriate uses of data by all individuals and entities who are authorized users pursuant to subsection 7c77#b71 including developing standards for the approval of applications submitted pursuant to such subsection2 and 7ii7 the appropriate formats and methods for making available to the public reports and analyses based on the health care claims database maintained under this section2 7,c7 conduct an annual review of whether data from such health care claims database was used according to the appropriate uses described in subparagraph 7,b77ii72 7,d7 report1 as appropriate1 to the ,secretary and ,congress on the operations of such health care claims database and opportunities to better achieve the objectives of this section2 7,e7 establish additional restrictions on researchers who receive compensation from entities specified by the ,committee in order to protect proprietary financial information2 and 7,f7 establish objectives for research and public reporting4 7f7 ,funding 7#a7 ,initial funding ,there are authorized to be appropriated1 and there are appropriated1 out of monies in the ,treasury not otherwise appropriated1 #bj1jjj1jjj for fiscal year #bjba1 for the implementation of the initial contract and establishment of the database under this section4 7#b7 ,ongoing funding ,there are authorized to be appropriated #ae1jjj1jjj for each of fiscal years #bjbb through #bjbf1 for purposes of carrying out this section 7other than the grant program under subsection 7h774 7g7 ,annual report ,not later than ,march #a1 #bjbb1 and ,march #a of each year thereafter1 the entity with a contract in effect under subsection 7b7 shall submit to ,congress and the ,secretary1 and make publicly available on an internet website1 a report containing a description of-- 7#a7 trends in the price1 utilization1 and total spending on health care services1 including a geographic analysis of differences in such trends2 7#b7 limitations in the data set2 7#c7 progress towards the objectives of this section2 and 7#d7 the performance by the entity of the duties required under such contract4 7h7 ,grants to ,states 7#a7 ,in general ,the ,secretary may award grants to ,states for the purpose of establishing and maintaining ,state all-payer claims databases that improve transparency of health care claims data4 7#b7 ,funding ,there is authorized to be appropriated #ajj1jjj1jjj for the period of fiscal years #bjba through #bjbh for the purpose of awarding grants to ,states under this subsection4 7i7 ,exemption from public disclosure 7#a7 ,in general ,data submitted to the health care claims database under subsection 7d7 shall not be considered public records and shall be exempt from any ,federal law relating to public disclosure requirements4 7#b7 ,restrictions on uses for certain proceedings ,such data may not be subject to discovery or admission as public information or evidence in judicial or administrative proceedings without the consent of the affected parties4 7j7 ,definitions ,in this section3 7#a7 ,,hipaa privay regulation ,the term ,,hipaa privacy regulation has the meaning given such term in section #aahj7;b77#c7 of the ,social ,security ,act 7#db ,u4,s4,c4 #acbj;d-#i7;b77#c774 7#b7 ,,phsa definitions ,the terms group health plan1 group health insurance coverage1 health insurance issuer1 and individual health insurance coverage have the meanings given such terms in section #bgia of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#ia74 7#c7 ,protected health information ,the term protected health information has the meaning given such term in section #afj4ajc of title #de1 ,code of ,federal ,regulations 7or any successor regulations74 7#d7 ,proprietary financial information ,the term proprietary financial information-- 7,a7 means data that would disclose the terms of a specific contract between an individual health care provider or facility and a specific group health plan1 ,medicaid managed care organization or other managed care entity1 or health insurance issuer offering group or individual health insurance coverage2 and 7,b7 does not include any billing or payment information from claims between such a provider or facility and such a health plan1 managed care organization or other managed care entity1 or health insurance issuer4 7k7 ,conforming amendments 7#a7 ,,phsa ,subpart ,,ii of part ,a of title ,,xxvii of the ,public ,health ,service ,act 7#db ,u4,s4,c4 #cjj;gg-#aa et seq47 is amended by adding at the end the following new section3 #bgcj4 ,health care claims database reporting requirement ,a group health plan and a health insurance issuer offering group or individual health insurance coverage shall comply with the provisions of section #a7;d7 of the ,federal ,all-,payer ,claims ,database ,act of #bjbj4 4 7#b7 ,,erisa 7,a7 ,in general ,subpart ,b of part #g of subtitle ,b of title ,i of the ,employee ,retirement ,income ,security ,act of #aigd 7#bi ,u4,s4,c4 #aahe et seq47 is amended by adding at the end the following new section3 #gaf4 ,health care claims database reporting requirement ,a group health plan and a health insurance issuer offering group health insurance coverage shall comply with the provisions of section #a7;d7 of the ,federal ,all-,payer ,claims ,database ,act of #bjbj4 4 7,b7 ,clerical amendment ,the table of contents in section #a of such ,act is amended by inserting after the item relating to section #gad the following new items3 ,sec4 #gae4 ,additional market reforms4 ,sec4 #gaf4 ,health care claims database reporting requirement4 4 7#c7 ,,irc 7,a7 ,in general ,subchapter ,b of chapter #ajj of the ,internal ,revenue ,code of #aihf is amended by adding at the end the following new section3 #ihaf4 ,health care claims database reporting requirement ,a group health plan shall comply with the provisions of section #a7;d7 of the ,federal ,all-,payer ,claims ,database ,act of #bjbj4 4 7,b7 ,clerical amendment ,the table of sections for such subchapter is amended by adding at the end the following new items3 ,sec4 #ihae4 ,additional market reforms4 ,sec4 #ihaf4 ,health care claims database reporting requirement4 4 #c4 ,study and reports by ,comptroller ,general 7a7 ,study ,the ,comptroller ,general of the ,united ,states shall conduct a study on-- 7#a7 the performance of each entity awarded a contract under subsection 7b7 of section #a2 7#b7 the privacy and security of any data submitted to such entity under subsection 7d7 of such section2 and 7#c7 the costs incurred by such entity in performing duties under such a contract4 7b7 ,reports ,not later than two years after the effective date of the first contract awarded under section #a7;b71 and again not later than four years after such effective date1 the ,comptroller ,general of the ,united ,states shall submit to ,congress a report containing the results of the study conducted under subsection 7a71 together with recommendations for such legislation and administrative action as the ,comptroller ,general determines appropriate4