[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 1507 Introduced in Senate (IS)]







110th CONGRESS
  1st Session
                                S. 1507

To amend title XVIII of the Social Security Act to provide for drug and 
                    health care claims data release.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                              May 24, 2007

  Mr. Grassley (for himself and Mr. Baucus) introduced the following 
  bill; which was read twice and referred to the Committee on Finance

_______________________________________________________________________

                                 A BILL


 
To amend title XVIII of the Social Security Act to provide for drug and 
                    health care claims data release.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Access to Medicare Data Act of 
2007''.

SEC. 2. DRUG AND HEALTH CARE CLAIMS DATA RELEASE.

    (a) In General.--Section 1860D-42 of the Social Security Act (42 
U.S.C. 1395w-152) is amended by adding at the end the following new 
subsection:
    ``(c) Drug and Health Care Claims Data Release.--
            ``(1) Drug and health care claims data release.--
        Notwithstanding any provision under this part that limits the 
        use of prescription drug data collected under this part, for 
        the purpose of improving the public's health through research 
        on the safety, effectiveness, and quality of health care 
        services provided under the program under this title, the 
        Secretary shall--
                    ``(A) utilize such data collected; and
                    ``(B) acting through the Centers for Medicare & 
                Medicaid Services--
                            ``(i) enter into data release agreements on 
                        an annual basis with the agencies described in 
                        paragraph (2) to provide access to relevant 
                        data submitted by prescription drug plans and 
                        MA-PD plans under this part, excluding 
                        negotiated price concessions (such as 
                        discounts, direct or indirect subsidies, 
                        rebates, and direct or indirect remunerations), 
                        and linked to hospital, physician, and other 
                        relevant medical claims, utilization, and 
                        diagnostic data collected under this title and 
                        title XIX; and
                            ``(ii) permit agencies described in 
                        paragraph (2) to link data provided under this 
                        subsection with other relevant health data, 
                        including survey data, vital statistics, and 
                        disease registries, as needed by the agency in 
                        order to accomplish its research objectives.
            ``(2) Agencies described.--The agencies described in this 
        paragraph are as follows:
                    ``(A) The Food and Drug Administration.
                    ``(B) The Centers for Disease Control and 
                Prevention.
                    ``(C) The Agency for Healthcare Research and 
                Quality.
                    ``(D) The National Institutes of Health.
                    ``(E) Any other agency or center within the 
                Department of Health and Human Services as the 
                Secretary determines appropriate.
            ``(3) Use of the data provided.--Data provided under a data 
        release agreement under paragraph (1)(B)(i) shall only be used 
        for the following purposes:
                    ``(A) FDA.--In the case of the Food and Drug 
                Administration, to enhance postmarketing surveillance 
                by--
                            ``(i) studying health risks associated with 
                        such utilization, particularly with respect to 
                        improving the speed of risk identification in 
                        order to mitigate or resolve such risks; and
                            ``(ii) performing such other functions, 
                        consistent with the purposes of this subsection 
                        and the mission of the Food and Drug 
                        Administration, as are determined appropriate 
                        by the Secretary.
                    ``(B) CDC.--In the case of the Centers for Disease 
                Control and Prevention, to--
                            ``(i) improve surveillance of clinical 
                        outbreaks and emerging threats;
                            ``(ii) study immunization rates;
                            ``(iii) study outcomes of specific 
                        diseases;
                            ``(iv) develop and monitor the use of 
                        preventive screening protocols using claims 
                        data;
                            ``(v) study drug and medical utilization in 
                        order to promote consumer education and 
                        treatment for specific public health risks; and
                            ``(vi) perform such other functions, 
                        consistent with the purposes of this subsection 
                        and the mission of the Centers for Disease 
                        Control and Prevention, as are determined 
                        appropriate by the Secretary.
                    ``(C) AHRQ.--In the case of the Agency for 
                Healthcare Research and Quality, to--
                            ``(i) carry out the research obligations of 
                        the Agency for Healthcare Research and Quality 
                        under section 1013 of the Medicare Prescription 
                        Drug, Improvement, and Modernization Act of 
                        2003;
                            ``(ii) conduct research consistent with the 
                        mission of the Agency for Healthcare Research 
                        and Quality to improve the quality, safety, 
                        efficiency, and effectiveness of health care; 
                        and
                            ``(iii) perform such other functions, 
                        consistent with the purposes of this subsection 
                        and such mission, as are determined appropriate 
                        by the Secretary.
                    ``(D) NIH.--In the case of the National Institutes 
                of Health, to--
                            ``(i) help prevent, detect, diagnose, and 
                        treat disease and disabilities; and
                            ``(ii) perform such other functions, 
                        consistent with the purposes of this subsection 
                        and the mission of the National Institutes of 
                        Health, as are determined appropriate by the 
                        Secretary.
                    ``(E) Other agency or center within the department 
                of health and human services.--In the case of an agency 
                or center described in paragraph (2)(E), to conduct 
                research, consistent with the purposes of this 
                subsection and the activities conducted under 
                subparagraphs (A) through (D), as determined 
                appropriate by the Secretary.
            ``(4) Timeframe for data release.--A data release agreement 
        entered into under this subsection shall provide for the 
        release of information as needed by an agency described in 
        paragraph (2) for the uses described in paragraph (3).
            ``(5) Data release procedures.--
                    ``(A) Determining appropriate level and elements of 
                data for release.--
                            ``(i) In general.--The Secretary shall 
                        establish a process to determine the 
                        appropriate level and elements of data to be 
                        released to an agency described in paragraph 
                        (2) under this subsection in order to ensure 
                        that the agency, and researchers within the 
                        agency, are able to conduct meaningful analyses 
                        while maintaining the confidentiality of the 
                        data provided under the data release agreement.
                            ``(ii) Relationship to procedures for 
                        release to private researchers.--The process 
                        established under clause (i) may be analogous 
                        to the process used by the Centers for Medicare 
                        & Medicaid Services for the release of data to 
                        private researchers.
                    ``(B) Agency feedback on analyses conducted.--The 
                Secretary shall establish a process for agencies 
                described in paragraph (2) that are provided data under 
                a data release agreement under this subsection to 
                provide the results of the analyses conducted using 
                such data to the Centers for Medicare & Medicaid 
                Services for use in the administration and assessment 
                of programs administered by the Centers for Medicare & 
                Medicaid Services, including the program under this 
                part.
                    ``(C) Review of data procedures.--The Secretary 
                shall establish a process to review and update the 
                following:
                            ``(i) The processes established under 
                        subparagraphs (A)(i) and (B).
                            ``(ii) Procedures for transmission and 
                        retention of data released under this 
                        subsection.
            ``(6) Notification of inaccuracies discovered in data 
        provided.--The Secretary shall establish procedures to ensure 
        that an agency described in paragraph (2) that is provided data 
        under this subsection notifies the Secretary of any 
        inaccuracies discovered in the data by the agency within a 
        reasonable time of such discovery.
            ``(7) Access by contractors and subcontractors.--In the 
        case of a public or private entity that enters into a contract 
        or subcontract with an agency described in paragraph (2) to 
        conduct activities for such agency under this subsection, any 
        access by such entity to data from the program under this title 
        under this subsection shall be provided in accordance with, and 
        subject to the same requirements under, subsection (d) (other 
        than the requirement under paragraph (4)(B)(ii)(V)(aa) of 
        subsection (d), unless the Secretary determines that the 
        application of such requirement is appropriate).
            ``(8) Report.--The Secretary shall report to Congress on an 
        annual basis (beginning with 2008) an evaluation of the data 
        release agreements entered into under paragraph (1)(B)(i), 
        including a list and a description of the reports and analyses 
        conducted by agencies using data provided under such an 
        agreement.
            ``(9) Authorization of appropriations.--There are 
        authorized to be appropriated such sums as are necessary to 
        carry out the purposes of this subsection.''.
    (b) Research Center and Organization Drug and Health Care Data 
Use.--
            (1) In general.--Section 1860D-42 of the Social Security 
        Act (42 U.S.C. 1395w-152), as amended by subsection (a), is 
        amended by adding at the end the following new subsection:
    ``(d) Research Center and Organization Drug and Health Care Data 
Use.--
            ``(1) In general.--Notwithstanding any provision under this 
        part that limits the use of prescription drug data collected 
        under this part, for the purpose of improving the public's 
        health through research on the safety, effectiveness, and 
        quality of health care services provided under the program 
        under this title, the Secretary shall--
                    ``(A) enter into data use agreements with the 
                research centers and organizations described in 
                paragraph (2) to provide access to relevant data 
                submitted by prescription drug plans and MA-PD plans 
                under this part, excluding negotiated price concessions 
                (such as discounts, direct or indirect subsidies, 
                rebates, and direct or indirect remunerations), and 
                linked to hospital, physician, and other relevant 
                medical claims, utilization, and diagnostic data 
                collected under this title and title XIX;
                    ``(B) permit research centers and organizations 
                described in paragraph (2) to link data provided under 
                this subsection with other relevant health data, 
                including survey data, vital statistics, and disease 
                registries, as needed by the research center or 
                organization in order to accomplish its research 
                objectives; and
                    ``(C) prepare the linked sets of data described in 
                subparagraph (A) for release not later than July 1, 
                2008.
            ``(2) Research centers and organizations described.--The 
        research centers and organizations described in this paragraph 
        are as follows:
                    ``(A) A university-based research center.
                    ``(B) Any other research center or organization--
                            ``(i) whose primary mission is to conduct 
                        public research on the safety, effectiveness, 
                        and quality of health care services; and
                            ``(ii) which the Secretary determines can 
                        appropriately conduct analyses consistent with 
                        the purposes of this subsection.
            ``(3) Use of data and penalties.--
                    ``(A) Use of data.--
                            ``(i) In general.--Data provided to a 
                        research center or organization under a data 
                        use agreement under this subsection shall be 
                        used solely for purposes of research on the 
                        safety, effectiveness, and quality of, 
                        disparities in, and related aspects of, health 
                        care use by individuals entitled to, or 
                        enrolled for, benefits under part A, or 
                        enrolled for benefits under part B, conducted 
                        for the purpose of developing and providing 
                        generalizable knowledge to inform the public 
                        health through scientific publication and other 
                        forms of public dissemination.
                            ``(ii) Approval by review board for the 
                        protection of human subjects.--Such use shall 
                        be approved by a review board for the 
                        protection of human subjects.
                            ``(iii) Review process.--The Secretary 
                        shall establish a review process to ensure 
                        that--
                                    ``(I) data use agreements under 
                                this subsection include a detailed 
                                description of how the data is to be 
                                used under the agreement; and
                                    ``(II) such use is consistent with 
                                the purposes described in clause (i).
                    ``(B) Penalties.--
                            ``(i) In general.--A research center or 
                        organization who knowingly or intentionally 
                        uses data provided under a data use agreement 
                        under this subsection for any purpose other 
                        than the purposes described in subparagraph 
                        (A)(i) shall be subject, in addition to any 
                        other penalties that may be prescribed by law, 
                        to--
                                    ``(I) a civil money penalty of not 
                                less than $25,000 for each infraction; 
                                and
                                    ``(II) disqualification from 
                                receipt of any data under this section 
                                for not less than 2 years.
                            ``(ii) Procedure.--The provisions of 
                        section 1128A (other than subsections (a) and 
                        (b) and the second sentence of subsection (f)) 
                        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).
            ``(4) Release of data.--
                    ``(A) In general.--A data use agreement entered 
                into under paragraph (1)(A) shall provide for the 
                release of information--
                            ``(i) according to a schedule approved by 
                        the Secretary under the criteria developed in 
                        accordance with subparagraph (B); and
                            ``(ii) for a timeframe appropriate to 
                        accomplish the research objective (as 
                        determined by the Secretary).
                    ``(B) Criteria for approving research 
                applications.--
                            ``(i) Development.--The Secretary, in 
                        consultation with health services researchers 
                        and academicians, shall develop criteria for 
                        the approval of a data use agreement under this 
                        subsection.
                            ``(ii) Criteria.--The criteria developed 
                        under clause (i) shall include the following 
                        requirements:
                                    ``(I) The research center or 
                                organization has well-documented 
                                scientific expertise, a record of 
                                scholarship on the topic of the 
                                proposed study, and a likelihood of 
                                successful publication, as demonstrated 
                                by a prior record of relevant 
                                publication by key staff and other 
                                evidence of appropriate scientific 
                                qualifications of the proposed research 
                                team.
                                    ``(II) The research center or 
                                organization demonstrates a credible 
                                capability to conduct and complete the 
                                proposed study, including experience 
                                with scientific investigations using 
                                similar types of data.
                                    ``(III) The research center or 
                                organization demonstrates the public 
                                health importance of the proposed 
                                study, and the potential of such study 
                                to provide public knowledge needed to 
                                improve the safety, use, and outcomes 
                                of treatments, the administration of 
                                the program under this title, and the 
                                care provided to individuals entitled 
                                to, or enrolled for, benefits under 
                                part A, or enrolled for benefits under 
                                part B.
                                    ``(IV) The research center or 
                                organization develops a data management 
                                plan that describes in detail the 
                                measures that will be implemented to 
                                safeguard the data and protect the 
                                privacy of individuals entitled to, or 
                                enrolled for, benefits under part A, or 
                                enrolled for benefits under part B, 
                                including any proposed data linkages.
                                    ``(V) The research center or 
                                organization enters into an agreement 
                                under which the research center or 
                                organization agrees to--
                                            ``(aa) place detailed 
                                        results of the proposed study 
                                        in the public domain through 
                                        publication in a reasonable 
                                        timeframe, not to exceed 1 year 
                                        after completion of such study, 
                                        including a thorough 
                                        description of the methodology 
                                        used to conduct the study;
                                            ``(bb) make available to 
                                        the public, without charge, any 
                                        product or tool developed using 
                                        the data provided under this 
                                        subsection; and
                                            ``(cc) not sell such data 
                                        to other entities or create 
                                        commercial data products (such 
                                        as data extracts or analytical 
                                        files) using such data.
                                    ``(VI) The research center or 
                                organization and the proposed research 
                                team provide assurances that such team 
                                is independent from the sources of 
                                funding or any other party and has the 
                                right to independently and freely 
                                publish the scientific findings of the 
                                study.
                                    ``(VII) Such other requirements, 
                                consistent with the purposes of this 
                                subsection, as the Secretary determines 
                                appropriate.
                    ``(C) Timely review and action on requests.--The 
                Secretary shall provide for timely review of, and 
                action on, requests for a data use agreement under this 
                subsection, taking into consideration the reasonable 
                needs of the research center or organization.
                    ``(D) Public disclosure.--The Secretary shall make 
                available to the public the criteria developed under 
                subparagraph (B)(i) that is used to grant or deny a 
                data use agreement under this subsection.
            ``(5) Feedback by research center or organization.--
                    ``(A) Notification of inaccuracies discovered in 
                data provided.--The Secretary shall establish 
                procedures to ensure that a research center or 
                organization that is provided data under this 
                subsection notifies the Secretary of any inaccuracies 
                discovered in the data by the center or organization 
                within a reasonable time of such discovery.
                    ``(B) Feedback on data collection.--The Secretary 
                shall permit researchers to provide feedback on the 
                collection of data with respect to the programs 
                administered by the Centers for Medicare & Medicaid 
                Services and make recommendations with respect to the 
                collection of additional data elements with respect to 
                such programs.
            ``(6) Confidentiality.--
                    ``(A) Determining appropriate level of data to be 
                provided.--The Secretary shall establish a process to 
                determine the appropriate level of data to be provided 
                to a research center or organization under this 
                subsection in order to ensure that the center or 
                organization, and researchers within the center or 
                organization, are able to conduct meaningful analyses 
                while maintaining the confidentiality of the data 
                provided under the data use agreement.
                    ``(B) Safeguards to protect confidentiality of data 
                provided.--
                            ``(i) In general.--The Secretary shall 
                        establish safeguards to protect the 
                        confidentiality of data after it is provided to 
                        a research center or organization under this 
                        subsection. Such safeguards shall not provide 
                        for greater disclosure by the research center 
                        or organization than is permitted under any of 
                        the following:
                                    ``(I) The Federal regulations 
                                (concerning the privacy of individually 
                                identifiable health information) 
                                promulgated under section 264(c) of the 
                                Health Insurance Portability and 
                                Accountability Act of 1996.
                                    ``(II) Sections 552 or 552a of 
                                title 5, United States Code, with 
                                regard to the privacy of individually 
                                identifiable beneficiary health 
                                information.
                            ``(ii) Confidentiality of physicians and 
                        medical practices.--The safeguards established 
                        under clause (i) shall ensure that the data 
                        provided to a research center or organization 
                        under this subsection that identifies 
                        individual physicians or medical practices is 
                        not released by the research center or 
                        organization, or otherwise made public in a 
                        manner that identifies individual physicians or 
                        medical practices.
            ``(7) Access by contractors and subcontractors.--In the 
        case of a public or private entity that enters into a contract 
        or subcontract with a research center or organization described 
        in paragraph (2) to conduct activities for such research center 
        or organization under this subsection, any access by such 
        entity to data from the program under this title under this 
        subsection shall be provided in accordance with this subsection 
        and subject to the same requirements as access for a research 
        center or organization under this subsection.
            ``(8) Report.--The Secretary shall report to Congress on an 
        annual basis (beginning with 2008) an evaluation of the 
        agreements entered into under paragraph (1)(A), including a 
        list and a description of the research conducted by research 
        centers and organizations using data provided under such an 
        agreement.
            ``(9) Reasonable fee.--The Secretary may charge a research 
        center or organization a reasonable fee based on the cost of 
        preparing and providing data to such center or organization 
        under this subsection.''.
            (2) Criteria development and publication.--The Secretary 
        shall develop and publish the criteria required under section 
        1860D-42(d)(4)(B)(i) of the Social Security Act, as added by 
        paragraph (1), not later than 180 days after the date of 
        enactment of this Act.
                                 <all>