[Congressional Record Volume 152, Number 114 (Thursday, September 14, 2006)]
[Senate]
[Pages S9633-S9636]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]

      By Mr. GRASSLEY (for himself and Mr. Baucus):
  S. 3897. 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; from the 
Committee on Finance; to the Committee on Finance.
  Mr. GRASSLEY. Mr. President, I am pleased to join my colleague from 
Montana, Senator Baucus, in introducing the Medicare Data Access and 
Research Act. Senator Baucus and I have long enjoyed a good working 
relationship in our roles as chairman and ranking member of the Finance 
Committee. Our work on this bill once again demonstrates our commitment 
to working in a bipartisan manner.
  The Medicare Data Access and Research Act establishes a process 
through which Federal agencies and other researchers can access 
Medicare data for the purpose of health services research. This might 
seem like a pretty mundane issue to some people, but I can assure you 
that it is far from it. Medicare processes 500 million claims for 
benefits each year; millions of prescriptions have been filled under 
the new Medicare prescription drug benefit.
  Linking data on hospital and physician services provided to Medicare 
beneficiaries to prescription drug data will offer a tremendous 
resource for researchers in our Federal agencies, as well as those 
based at universities and other research centers. What of research can 
these data support? They can support studies and analyses related to 
postmarketing surveillance of prescription drugs and research on drug 
safety. More concretely, analyzing the Medicare claims data can help 
agencies, such as the Food and Drug Administration FDA, identify 
situations like the one involving Vioxx more quickly, and provide a new 
valuable tool to enable the FDA to take swifter action to protect the 
public's health and well-being.
  The Centers for Disease Control and Prevention, the Agency for 
Healthcare Research and Quality, and the National Institutes of Health 
all have missions that require the conduct of meticulous health 
services research. The Medicare database and access to it established 
under the bill we are introducing today will help these agencies 
fulfill their missions to study immunization rates; to develop and 
monitor the use of preventive screenings; conduct research on the 
clinical comparative effectiveness of prescription drugs; and to help 
prevent, diagnose, and treat disease.
  To ensure access to the data, the bill requires the Secretary of 
Health and Human Services to enter data release agreements on an annual 
basis with these agencies. In entering the data release agreements, the 
Secretary must take appropriate steps to protect the confidentiality of 
the information, while maintaining the ability of researchers at 
Federal agencies to conduct meaningful analyses.
  The bill also permits the Secretary to enter into data use agreements 
to permit researchers at universities and other organizations to have 
access to the data. As will be the case for the Federal agencies, these 
researchers may only use the data for purposes of advancing the 
public's health. They can conduct studies on the safety, effectiveness, 
and quality of health services.
  Some people might be concerned that these data will be given to just 
anyone. That is not the case. In applying for data access, researchers 
at universities and other organizations will have to meet strict 
criteria. They must have well-documented experience in analyzing the 
type and volume of data to be provided under the agreement. They must 
agree to publish and publicly disseminate their research methodology 
and results. They must obtain approval for their study from a review 
board. They must comply with all safeguards established by the 
Secretary to ensure the confidentiality of information. These 
safeguards cannot permit the disclosure of information to an extent 
greater than permitted by the Health Insurance Portability and 
Accountability Act of 1996 and the Privacy Act of 1974.
  The final section of the bill ensures that congressional support 
agencies, including the Congressional Budget Office, the Congressional 
Research Service, the Government Accountability Office, and the 
Medicare Payment Advisory Commission, also have access to data they 
need to carry out their functions and responsibilities. This body 
depends on the research and analyses conducted by those agencies to 
inform our deliberations and decisions on the Medicare Program.
  Last year, Senator Baucus and I introduced the Medicare Value-Based 
Purchasing Act to establish a pay for performance system under 
Medicare. That bill was aimed at promoting quality and ensuring value 
under the Medicare Program. The bill that we are introducing today 
complements that objective. How can we promote quality and ensure value 
in Medicare? By having a better understanding of what services are 
effective, by knowing how we can help beneficiaries avoid illness and 
disease, by having insight about potential over-use and under-use of 
health care services, and by identifying troubling trends and patterns. 
How can we learn about those topics? By supporting rigorous health 
services research.

[[Page S9634]]

  Mr. President, the Medicare Data Access and Research Act creates a 
sound framework for accomplishing that objective.
  I ask unanimous consent that the text of the bill be printed in the 
Record.
  There being no objection, the text of the bill was ordered to be 
printed in the Record, as follows:

                                S. 3897

       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.

[[Page S9635]]

       ``(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.

[[Page S9636]]

       ``(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.''.

  Mr. BAUCUS. Mr. President, today, I am pleased to join Chairman 
Grassley in introducing the Medicare Data Access and Research Act. This 
bill will take an important step to advance the safety, efficacy, and 
quality of health care services delivered to people under the Medicare 
Program and it will help improve the care delivered to all Americans.
  This bill requires the Secretary of Health and Human Services, HHS, 
to make Medicare data accessible to Federal health agencies and the 
health services research community for the purpose of conducting 
studies that will serve the public health. As the largest single payer 
of health care services in the United States--covering over 40 million 
lives, 70 million hospital days, and processing nearly a billion 
physician claims per year--Medicare collects and maintains a wealth of 
information on the health services delivered to a significant portion 
of the population. This information has been a national resource for 
research and analysis of health care. And with the addition of the 
Medicare prescription drug benefit, it will be the most comprehensive 
resource our Nation has to study the effects of diseases and the 
treatments we have for them.
  The Centers for Medicare and Medicaid Service, CMS, currently 
releases certain Medicare data to the public and more comprehensive 
data to the research community. This bill would build on current 
activities by requiring CMS to link hospital claims, physician claims, 
and other relevant information to data collected under the new Medicare 
drug benefit.
  In addition, the Secretary will provide yearly access to the linked 
Medicare dataset to all Federal health agencies within the department, 
such as the Food and Drug Administration, the Centers for Disease 
Control, the National Institutes of Health, and the Agency for 
Healthcare Quality and Research. These agencies will enter into data 
use agreements with CMS to ensure that the type and level of Medicare 
data shared is appropriate, that the agencies conduct research in 
accordance with their missions and the purpose of furthering the public 
health, and that the privacy of the data is protected. The goal is to 
give Federal health agencies another tool to evaluate the safety, 
efficacy, and quality of care delivered to Medicare beneficiaries--a 
large segment of the health system.
  This bill also provides public health researchers access to the 
linked Medicare dataset. Expanding access to Medicare data will open up 
a new era in our health system. It will enable scientists to more 
quickly identify both short- and long-term safety concerns with drug 
regimens and health treatments. It will enable more treatments to be 
compared. And it will promote more development of guidelines, so 
providers and patients know more about what works best.
  Some may argue that access to linked Medicare data should not be 
limited to researchers and should be available for commercial purposes. 
But the full Medicare database should be used exclusively for the 
public good and not for private or commercial gain. This is the crux of 
this bill. Hence, the bill limits the use of data to the purpose of 
providing ``generalizable knowledge to inform the public health through 
scientific publication and other forms of public dissemination.'' 
Strict penalties will be imposed on any unauthorized use of the data 
including civil money penalties and disqualification from receiving 
Medicare data for at least 2 years.
  CMS will publish criteria used to approve research applications to 
ensure that those selected are qualified and experienced to conduct 
analyses and maintain the confidentiality of Medicare information. 
Researchers will also make public their detailed results and methods 
within 1 year from completing their studies. They will make available 
to the public at no charge any tool developed through this program. 
They must agree not to sell data or create commercial data products 
using such data and abide by safeguards protecting the confidentiality 
of the data established by the Secretary.
  The final section of the bill ensures that congressional support 
agencies, including the Congressional Budget Office, the Congressional 
Research Service, the Government Accountability Office, and the 
Medicare Payment Advisory Commission, also have access to the full 
range of data they need to carry out their functions and 
responsibilities. Congress depends on the research and analyses 
conducted by these agencies to inform our deliberations and decisions 
on the Medicare Program.
  Last year, I worked with Senator Grassley to introduce the Medicare 
Value-Based Purchasing Act, which establishes a pay for performance 
system under Medicare. An important element of that system is the 
collection and reporting of quality measures to CMS and to the public. 
The bill we are introducing today complements those activities. We can 
improve health care by allowing Medicare to become a value-based 
purchaser of services and by reporting quality measures through the 
Medicare Program. And we can improve health care for all by allowing 
rigorous health services research to be conducted using the resource of 
Medicare data.
  Mr. President, the Medicare Data Access and Research Act will allow 
us to expand our knowledge of health care and improve the quality of 
care for all Americans.
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