[Congressional Bills 109th Congress]
[From the U.S. Government Publishing Office]
[S. 3897 Introduced in Senate (IS)]








109th CONGRESS
  2d Session
                                S. 3897

To amend titles XI and XVIII of the Social Security Act to provide for 
  the sharing of certain data collected by the Centers for Medicare & 
     Medicaid Services with certain agencies, research centers and 
           organizations, and congressional support agencies.


_______________________________________________________________________


                   IN THE SENATE OF THE UNITED STATES

                           September 14, 2006

  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 titles XI and XVIII of the Social Security Act to provide for 
  the sharing of certain data collected by the Centers for Medicare & 
     Medicaid Services with certain agencies, research centers and 
           organizations, and congressional support agencies.

    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 ``Medicare Data Access and Research 
Act''.

SEC. 2. FINDINGS.

    Congress makes the following findings:
            (1) The new Medicare drug benefit under part D of title 
        XVIII of the Social Security Act is delivered through private 
        prescription drug plans. Private plans submit administrative 
        and beneficiary level data to the Centers for Medicare & 
        Medicaid Services as a condition of participation and payment 
        in the new Medicare drug program.
            (2) Data from the new Medicare drug benefit can be linked 
        with hospital, ambulatory care, and other data to create a new 
        comprehensive resource for the study of drug safety and 
        effectiveness of medical care in older adults and low-income, 
        disabled, and vulnerable populations. With appropriate 
        protections for privacy, this data should be available to the 
        Food and Drug Administration, the Centers for Disease Control 
        and Prevention, the Agency for Healthcare Research and Quality, 
        and the National Institutes of Health, and university-based 
        research centers and other research organizations interested in 
        furthering the public health through research on the safety, 
        effectiveness, and quality of health care services provided 
        under the Medicare program under title XVIII of the Social 
        Security Act.
            (3) Timely and ready access to certain data from the new 
        Medicare drug benefit will allow congressional support agencies 
        to inform and advise Congress on the cost, scope, and impact of 
        the new benefit and assess its quality.

SEC. 3. DRUG AND HEALTH CARE DATA RELEASE.

    (a) In General.--Title XI of the Social Security Act (42 U.S.C. 
1301 et seq.) is amended by inserting after section 1121 the following 
new sections:

               ``drug and health care claims data release

    ``Sec. 1121A.  (a) In General.--Notwithstanding any provision under 
part D of title XVIII that limits the use of prescription drug data 
collected under such part, for the purpose of improving the public's 
health, the Secretary, acting through the Centers for Medicare & 
Medicaid Services, shall--
            ``(1) enter into data release agreements on an annual basis 
        with the agencies described in subsection (b) to provide access 
        to relevant data submitted by prescription drug plans and MA-PD 
        plans under part D of title XVIII, excluding negotiated price 
        concessions under such part (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 titles XVIII and XIX, including data from the 
        uniform reporting systems established under section 1121(a); 
        and
            ``(2) permit agencies described in such subsection to link 
        data provided under this section 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.
    ``(b) Agencies Described.--The agencies described in this 
subsection are as follows:
            ``(1) The Food and Drug Administration.
            ``(2) The Centers for Disease Control and Prevention.
            ``(3) The Agency for Healthcare Research and Quality.
            ``(4) The National Institutes of Health.
    ``(c) Use of the Data Provided.--Data provided under a data release 
agreement under subsection (a)(1) shall only be used for the following 
purposes:
            ``(1) FDA.--In the case of the Food and Drug 
        Administration, to enhance post marketing surveillance by--
                    ``(A) studying patterns of drug and vaccine 
                utilization over time after a drug has been placed on 
                the market;
                    ``(B) 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;
                    ``(C) studying drug utilization in order to promote 
                consumer education that would allow consumers and 
                health care providers to make informed product choices 
                and informed drug compliance choices; and
                    ``(D) performing such other functions, consistent 
                with the purposes of this section and the Agency's 
                mission, as are determined appropriate by the 
                Secretary.
            ``(2) CDC.--In the case of the Centers for Disease Control 
        and Prevention, to--
                    ``(A) improve surveillance of clinical outbreaks 
                and emerging threats;
                    ``(B) study immunization rates;
                    ``(C) study outcomes of specific diseases;
                    ``(D) develop and monitor the use of preventive 
                screening protocols using claims data;
                    ``(E) study drug and medical utilization in order 
                to promote consumer education and treatment for 
                specific public health risks; and
                    ``(F) perform such other functions, consistent with 
                the purposes of this section and the Agency's mission, 
                as are determined appropriate by the Secretary.
            ``(3) AHRQ.--In the case of the Agency for Healthcare 
        Research and Quality, to--
                    ``(A) carry out the Agency's research obligations 
                under section 1013 of the Medicare Prescription Drug, 
                Improvement, and Modernization Act of 2003;
                    ``(B) conduct research consistent with the Agency's 
                mission to improve the quality, safety, efficiency, and 
                effectiveness of health care; and
                    ``(C) perform such other functions, consistent with 
                the purposes of this section and such mission, as are 
                determined appropriate by the Secretary.
            ``(4) NIH.--In the case of the National Institutes of 
        Health, to--
                    ``(A) help prevent, detect, diagnose, and treat 
                disease and disabilities; and
                    ``(B) perform such other functions, consistent with 
                the purposes of this section and the Agency's mission, 
                as are determined appropriate by the Secretary.
    ``(d) Timeframe for Data Release.--A data release agreement entered 
into under this section shall provide for the release of information as 
needed by the Agency for the uses described in subsection (c).
    ``(e) Data Release Procedures.--
            ``(1) Determining appropriate level and elements of data 
        for release.--
                    ``(A) In general.--The Secretary shall establish a 
                process to determine the appropriate level and elements 
                of data to be released to an Agency under this section 
                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.
                    ``(B) Relationship to procedures for release to 
                private researchers.--The process established under 
                subparagraph (A) may be analogous to the process used 
                by the Centers for Medicare & Medicaid Services for the 
                release of data to private researchers.
            ``(2) Agency feedback on analyses conducted.--The Secretary 
        shall establish a process for Agencies that are provided data 
        under a data release agreement under this section 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 part D of title XVIII.
            ``(3) Review of data procedures.--The Secretary shall 
        establish a process to review and update the following:
                    ``(A) The processes established under paragraphs 
                (1)(A) and (2).
                    ``(B) Procedures for transmission and retention of 
                data released under this section.
    ``(f) Notification of Inaccuracies Discovered in Data Provided.--
The Secretary shall establish procedures to ensure that an Agency that 
is provided data under this section notifies the Secretary of any 
inaccuracies discovered in the data by the Agency within a reasonable 
time of such discovery.
    ``(g) Report.--The Secretary shall include (beginning with 2007), 
as part of the annual report submitted to Congress under section 
1875(b), an evaluation of the data release agreements entered into 
under subsection (a)(1), including a description of the reports and 
analyses conducted by agencies using data provided under such an 
agreement.
    ``(h) Authorization of Appropriations.--There are authorized to be 
appropriated such sums as are necessary to carry out the purposes of 
this section.

    ``research center and organization drug and health care data use

    ``Sec. 1121B.  (a) In General.--Notwithstanding any provision under 
part D of title XVIII that limits the use of prescription drug data 
collected under such part, for the purpose of improving the public's 
health, the Secretary shall--
            ``(1) enter into data use agreements with the research 
        centers and organizations described in subsection (b) to 
        provide access to relevant data submitted by prescription drug 
        plans and MA-PD plans under part D of title XVIII, excluding 
        negotiated price concessions under such part (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 titles XVIII and XIX, including data from the 
        uniform reporting systems established under section 1121(a);
            ``(2) permit research centers and organizations described 
        in such subsection to link data provided under this section 
        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
            ``(3) prepare the linked sets of data described in 
        paragraph (1) for release not later than July 1, 2007.
    ``(b) Research Centers and Organizations Described.--The research 
centers and organizations described in this subsection are as follows:
            ``(1) A University-based research center.
            ``(2) Any other research center or organization--
                    ``(A) whose primary mission is to conduct public 
                health research; and
                    ``(B) which the Secretary determines can 
                appropriately conduct analyses consistent with the 
                purposes of this section.
    ``(c) Use of Data and Penalties.--
            ``(1) Use of data.--
                    ``(A) In general.--Data provided to a research 
                center or organization under a data use agreement under 
                this section 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 of title XVIII, or enrolled for benefits 
                under part B of such title, conducted for the purpose 
                of developing and providing generalizable knowledge to 
                inform the public health through scientific publication 
                and other forms of public dissemination.
                    ``(B) 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.
                    ``(C) Review process.--The Secretary shall 
                establish a review process to ensure that--
                            ``(i) data use agreements under this 
                        section 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 subparagraph (A).
            ``(2) Penalties.--
                    ``(A) In general.--A research center or 
                organization who knowingly or intentionally uses data 
                provided under a data use agreement under this section 
                for any purpose other than the purposes described in 
                paragraph (1)(A) 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.
                    ``(B) 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 paragraph in the same manner 
                as such provisions apply to a penalty or proceeding 
                under section 1128A(a).
    ``(d) Release of Data.--
            ``(1) In general.--A data use agreement entered into under 
        subsection (a)(1) shall provide for the release of information 
        according to a schedule approved by the Secretary under the 
        criteria developed in accordance with paragraph (2).
            ``(2) Criteria for approving research applications.--
                    ``(A) Development.--The Secretary, in consultation 
                with health services researchers and academicians, 
                shall develop criteria for the approval of a data use 
                agreement under this section.
                    ``(B) Criteria.--The criteria developed under 
                subparagraph (A) 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 title XVIII, and the care provided to 
                        individuals entitled to, or enrolled for, 
                        benefits under part A of title XVIII, or 
                        enrolled for benefits under part B of such 
                        title.
                            ``(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 of title XVIII, or 
                        enrolled for benefits under part B of such 
                        title, including any proposed data linkages.
                            ``(v) The research center or organization 
                        enters into an agreement under which the 
                        research center or organization agrees to--
                                    ``(I) 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;
                                    ``(II) make available to the 
                                public, without charge, any product or 
                                tool developed using the data provided 
                                under this section; and
                                    ``(III) 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 section, as the 
                        Secretary determines appropriate.
            ``(3) 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 section, taking into 
        consideration the reasonable needs of the research center or 
        organization.
            ``(4) Public disclosure.--The Secretary shall make 
        available to the public the criteria used to grant or deny data 
        use agreements under the criteria developed under paragraph 
        (2)(A).
    ``(e) Feedback by Research Center or Organization.--
            ``(1) 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 section notifies the Secretary of any inaccuracies 
        discovered in the data by the center or organization within a 
        reasonable time of such discovery.
            ``(2) 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.
    ``(f) Confidentiality.--
            ``(1) 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 section 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.
            ``(2) Safeguards to protect confidentiality of data 
        provided.--
                    ``(A) 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 section. 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.
                    ``(B) Confidentiality of physicians and medical 
                practices.--The safeguards established under 
                subparagraph (A) shall ensure that the data provided to 
                a research center or organization under this section 
                that identifies individual physicians or medical 
                practices is not released by the research center or 
                organization, or otherwise made public.
    ``(g) Report.--The Secretary shall include (beginning with 2007), 
as part of the annual report submitted to Congress under section 
1875(b), an evaluation of the agreements entered into under subsection 
(a).
    ``(h) 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 section.''.
    (b) Criteria Development and Publication.--The Secretary shall 
develop and publish the criteria required under section 1121B(d)(2)(A) 
of the Social Security Act, as added by subsection (a), not later than 
180 days after the date of enactment of this Act.

SEC. 4. ACCESS TO DATA ON PRESCRIPTION DRUG PLANS AND MEDICARE 
              ADVANTAGE PLANS.

    (a) In General.--Section 1875 of the Social Security Act (42 U.S.C. 
1395ll) is amended--
            (1) in the heading, by inserting ``to congress; providing 
        information to congressional support agencies'' after ``and 
        recommendations''; and
            (2) by adding at the end the following new subsection:
    ``(c) Providing Information to Congressional Support Agencies.--
            ``(1) In general.--Notwithstanding any provision under part 
        D that limits the use of prescription drug data collected under 
        such part, upon the request of a congressional support agency, 
        the Secretary shall provide such agency with information 
        submitted to, or compiled by, the Secretary under part D 
        (subject to the restriction on disclosure under paragraph (2)), 
        including--
                    ``(A) only with respect to congressional support 
                agencies that make official baseline spending 
                projections, conduct oversight studies mandated by 
                Congress, or make official recommendations on the 
                program under this title to Congress--
                            ``(i) aggregate negotiated prices for drugs 
                        covered under prescription drug plans and MA-PD 
                        plans; and
                            ``(ii) bid information (described in 
                        section 1860D-11(b)(2)(C)) submitted by such 
                        plans; and
                    ``(B) access to drug event data submitted by such 
                plans under section 1860D-15(d)(2)(A), except, with 
                respect to data that reveals prices negotiated with 
                drug manufacturers, such data shall only be available 
                to congressional support agencies that make official 
                baseline spending projections, conduct oversight 
                studies mandated by Congress, or make official 
                recommendations on the program under this title to 
                Congress.
            ``(2) Restriction on data disclosure.--
                    ``(A) In general.--Data provided to a congressional 
                support agency under this subsection shall not be 
                disclosed, reported, or released in identifiable form.
                    ``(B) Identifiable form.--For purposes of 
                subparagraph (A), the term `identifiable form' means 
                any representation of information that permits 
                identification of a specific prescription drug plan, 
                MA-PD plan, pharmacy benefit manager, drug 
                manufacturer, drug wholesaler, or individual enrolled 
                in a prescription drug plan or an MA-PD plan under part 
                D.
            ``(3) Timing.--The Secretary shall release data under this 
        subsection in a timeframe that enables congressional support 
        agencies to complete congressional requests.
            ``(4) Use of the data provided.--Data provided to a 
        congressional support agency under this subsection shall only 
        be used by such agency for carrying out the functions and 
        activities of the agency mandated by Congress.
            ``(5) Confidentiality.--The Secretary shall establish 
        safeguards to protect the confidentiality of data released 
        under this subsection. Such safeguards shall not provide for 
        greater disclosure than is permitted under any of the 
        following:
                    ``(A) 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.
                    ``(B) Sections 552 or 552a of title 5, United 
                States Code, with regard to the privacy of individually 
                identifiable beneficiary health information.
            ``(6) Definitions.--In this subsection:
                    ``(A) Congressional support agency.--The term 
                `Congressional support agency' means--
                            ``(i) the Medicare Payment Advisory 
                        Commission;
                            ``(ii) the Congressional Research Service;
                            ``(iii) the Congressional Budget Office; 
                        and
                            ``(iv) the Government Accountability 
                        Office.
                    ``(B) MA-PD plan.--The term `MA-PD plan' has the 
                meaning given such term in section 1860D-1(a)(3)(C).
                    ``(C) Prescription drug plan.--The term 
                `prescription drug plan' has the meaning given such 
                term in section 1860D-41(a)(14).''.
    (b) Conforming Amendment.--Section 1805(b)(2) of the Social 
Security Act (42 U.S.C. 1395b-6(b)(2)) is amended by adding at the end 
the following new subparagraph:
                    ``(D) Part d.--Specifically, the Commission shall 
                review payment policies with respect to the Voluntary 
                Prescription Drug Benefit Program under part D, 
                including--
                            ``(i) the factors affecting expenditures;
                            ``(ii) payment methodologies; and
                            ``(iii) their relationship to access and 
                        quality of care for Medicare beneficiaries.''.
                                 <all>