II 

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. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Access to Medicare 

5 Data Act of 2007’’. 

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

7 (a) IN GENERAL.—Section 1860D–42 of the Social 

8 Security Act (42 U.S.C. 1395w–152) is amended by add9 ing at the end the following new subsection: 


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1 ‘‘(c) DRUG AND HEALTH CARE CLAIMS DATA RE2 LEASE.— 

3 ‘‘(1) DRUG AND HEALTH CARE CLAIMS DATA

4 RELEASE.—Notwithstanding any provision under 

5 this part that limits the use of prescription drug 

6 data collected under this part, for the purpose of im7 proving the public’s health through research on the 

8 safety, effectiveness, and quality of health care serv9 ices provided under the program under this title, the 

10 Secretary shall— 

11 ‘‘(A) utilize such data collected; and 

12 ‘‘(B) acting through the Centers for Medi13 care & Medicaid Services— 

14 ‘‘(i) enter into data release agree15 ments on an annual basis with the agen16 cies described in paragraph (2) to provide 

17 access to relevant data submitted by pre18 scription drug plans and MA–PD plans 

19 under this part, excluding negotiated price 

20 concessions (such as discounts, direct or 

21 indirect subsidies, rebates, and direct or 

22 indirect remunerations), and linked to hos23 pital, physician, and other relevant medical 

24 claims, utilization, and diagnostic data col25 lected under this title and title XIX; and 


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1 ‘‘(ii) permit agencies described in 

2 paragraph (2) to link data provided under 

3 this subsection with other relevant health 

4 data, including survey data, vital statistics, 

5 and disease registries, as needed by the 

6 agency in order to accomplish its research 

7 objectives. 

8 ‘‘(2) AGENCIES DESCRIBED.—The agencies de9 scribed in this paragraph are as follows: 

10 ‘‘(A) The Food and Drug Administration. 

11 ‘‘(B) The Centers for Disease Control and 

12 Prevention. 

13 ‘‘(C) The Agency for Healthcare Research 

14 and Quality. 

15 ‘‘(D) The National Institutes of Health. 

16 ‘‘(E) Any other agency or center within the 

17 Department of Health and Human Services as 

18 the Secretary determines appropriate. 

19 ‘‘(3) USE OF THE DATA PROVIDED.—Data pro20 vided under a data release agreement under para21 graph (1)(B)(i) shall only be used for the following 

22 purposes: 

23 ‘‘(A) FDA.—In the case of the Food and 

24 Drug Administration, to enhance postmarketing 

25 surveillance by— 


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1 ‘‘(i) studying health risks associated 

2 with such utilization, particularly with re3 spect to improving the speed of risk identi4 fication in order to mitigate or resolve such 

5 risks; and 

6 ‘‘(ii) performing such other functions, 

7 consistent with the purposes of this sub8 section and the mission of the Food and 

9 Drug Administration, as are determined 

10 appropriate by the Secretary. 

11 ‘‘(B) CDC.—In the case of the Centers for 

12 Disease Control and Prevention, to— 

13 ‘‘(i) improve surveillance of clinical 

14 outbreaks and emerging threats; 

15 ‘‘(ii) study immunization rates; 

16 ‘‘(iii) study outcomes of specific dis17 eases; 

18 ‘‘(iv) develop and monitor the use of 

19 preventive screening protocols using claims 

20 data; 

21 ‘‘(v) study drug and medical utiliza22 tion in order to promote consumer edu23 cation and treatment for specific public 

24 health risks; and 


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1 ‘‘(vi) perform such other functions, 

2 consistent with the purposes of this sub3 section and the mission of the Centers for 

4 Disease Control and Prevention, as are de5 termined appropriate by the Secretary. 

6 ‘‘(C) AHRQ.—In the case of the Agency 

7 for Healthcare Research and Quality, to— 

8 ‘‘(i) carry out the research obligations 

9 of the Agency for Healthcare Research and 

10 Quality under section 1013 of the Medi11 care Prescription Drug, Improvement, and 

12 Modernization Act of 2003; 

13 ‘‘(ii) conduct research consistent with 

14 the mission of the Agency for Healthcare 

15 Research and Quality to improve the qual16 ity, safety, efficiency, and effectiveness of 

17 health care; and 

18 ‘‘(iii) perform such other functions, 

19 consistent with the purposes of this sub20 section and such mission, as are deter21 mined appropriate by the Secretary. 

22 ‘‘(D) NIH.—In the case of the National 

23 Institutes of Health, to— 

24 ‘‘(i) help prevent, detect, diagnose, 

25 and treat disease and disabilities; and 


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1 ‘‘(ii) perform such other functions, 

2 consistent with the purposes of this sub3 section and the mission of the National In4 stitutes of Health, as are determined ap5 propriate by the Secretary. 

6 ‘‘(E) OTHER AGENCY OR CENTER WITHIN

7 THE DEPARTMENT OF HEALTH AND HUMAN

8 SERVICES.—In the case of an agency or center 

9 described in paragraph (2)(E), to conduct re10 search, consistent with the purposes of this sub11 section and the activities conducted under sub12 paragraphs (A) through (D), as determined ap13 propriate by the Secretary. 

14 ‘‘(4) TIMEFRAME FOR DATA RELEASE.—A data 

15 release agreement entered into under this subsection 

16 shall provide for the release of information as needed 

17 by an agency described in paragraph (2) for the uses 

18 described in paragraph (3). 

19 ‘‘(5) DATA RELEASE PROCEDURES.— 

20 ‘‘(A) DETERMINING APPROPRIATE LEVEL

21 AND ELEMENTS OF DATA FOR RELEASE.— 

22 ‘‘(i) IN GENERAL.—The Secretary 

23 shall establish a process to determine the 

24 appropriate level and elements of data to 

25 be released to an agency described in paraVerDate Aug 31 2005 20:54 May 27, 2007 Jkt 059200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S1507.IS S1507

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1 graph (2) under this subsection in order to 

2 ensure that the agency, and researchers 

3 within the agency, are able to conduct 

4 meaningful analyses while maintaining the 

5 confidentiality of the data provided under 

6 the data release agreement. 

7 ‘‘(ii) RELATIONSHIP TO PROCEDURES

8 FOR RELEASE TO PRIVATE RESEARCH9 ERS.—The process established under 

10 clause (i) may be analogous to the process 

11 used by the Centers for Medicare & Med12 icaid Services for the release of data to pri13 vate researchers. 

14 ‘‘(B) AGENCY FEEDBACK ON ANALYSES

15 CONDUCTED.—The Secretary shall establish a 

16 process for agencies described in paragraph (2) 

17 that are provided data under a data release 

18 agreement under this subsection to provide the 

19 results of the analyses conducted using such 

20 data to the Centers for Medicare & Medicaid 

21 Services for use in the administration and as22 sessment of programs administered by the Cen23 ters for Medicare & Medicaid Services, includ24 ing the program under this part. 


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1 ‘‘(C) REVIEW OF DATA PROCEDURES.— 

2 The Secretary shall establish a process to re3 view and update the following: 

4 ‘‘(i) The processes established under 

5 subparagraphs (A)(i) and (B). 

6 ‘‘(ii) Procedures for transmission and 

7 retention of data released under this sub8 section. 

9 ‘‘(6) NOTIFICATION OF INACCURACIES DISCOV10 ERED IN DATA PROVIDED.—The Secretary shall es11 tablish procedures to ensure that an agency de12 scribed in paragraph (2) that is provided data under 

13 this subsection notifies the Secretary of any inac14 curacies discovered in the data by the agency within 

15 a reasonable time of such discovery. 

16 ‘‘(7) ACCESS BY CONTRACTORS AND SUB17 CONTRACTORS.—In the case of a public or private 

18 entity that enters into a contract or subcontract with 

19 an agency described in paragraph (2) to conduct ac20 tivities for such agency under this subsection, any 

21 access by such entity to data from the program 

22 under this title under this subsection shall be pro23 vided in accordance with, and subject to the same 

24 requirements under, subsection (d) (other than the 

25 requirement under paragraph (4)(B)(ii)(V)(aa) of 


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1 subsection (d), unless the Secretary determines that 

2 the application of such requirement is appropriate). 

3 ‘‘(8) REPORT.—The Secretary shall report to 

4 Congress on an annual basis (beginning with 2008) 

5 an evaluation of the data release agreements entered 

6 into under paragraph (1)(B)(i), including a list and 

7 a description of the reports and analyses conducted 

8 by agencies using data provided under such an 

9 agreement. 

10 ‘‘(9) AUTHORIZATION OF APPROPRIATIONS.— 

11 There are authorized to be appropriated such sums 

12 as are necessary to carry out the purposes of this 

13 subsection.’’. 

14 (b) RESEARCH CENTER AND ORGANIZATION DRUG

15 AND HEALTH CARE DATA USE.— 

16 (1) IN GENERAL.—Section 1860D–42 of the 

17 Social Security Act (42 U.S.C. 1395w–152), as 

18 amended by subsection (a), is amended by adding at 

19 the end the following new subsection: 

20 ‘‘(d) RESEARCH CENTER AND ORGANIZATION DRUG

21 AND HEALTH CARE DATA USE.— 

22 ‘‘(1) IN GENERAL.—Notwithstanding any provi23 sion under this part that limits the use of prescrip24 tion drug data collected under this part, for the pur25 pose of improving the public’s health through reVerDate Aug 31 2005 20:54 May 27, 2007 Jkt 059200 PO 00000 Frm 00009 Fmt 6652 Sfmt 6201 E:\BILLS\S1507.IS S1507

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1 search on the safety, effectiveness, and quality of 

2 health care services provided under the program 

3 under this title, the Secretary shall— 

4 ‘‘(A) enter into data use agreements with 

5 the research centers and organizations de6 scribed in paragraph (2) to provide access to 

7 relevant data submitted by prescription drug 

8 plans and MA–PD plans under this part, ex9 cluding negotiated price concessions (such as 

10 discounts, direct or indirect subsidies, rebates, 

11 and direct or indirect remunerations), and 

12 linked to hospital, physician, and other relevant 

13 medical claims, utilization, and diagnostic data 

14 collected under this title and title XIX; 

15 ‘‘(B) permit research centers and organiza16 tions described in paragraph (2) to link data 

17 provided under this subsection with other rel18 evant health data, including survey data, vital 

19 statistics, and disease registries, as needed by 

20 the research center or organization in order to 

21 accomplish its research objectives; and 

22 ‘‘(C) prepare the linked sets of data de23 scribed in subparagraph (A) for release not 

24 later than July 1, 2008. 


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1 ‘‘(2) RESEARCH CENTERS AND ORGANIZATIONS

2 DESCRIBED.—The research centers and organiza3 tions described in this paragraph are as follows: 

4 ‘‘(A) A university-based research center. 

5 ‘‘(B) Any other research center or organi6 zation— 

7 ‘‘(i) whose primary mission is to con8 duct public research on the safety, effec9 tiveness, and quality of health care serv10 ices; and 

11 ‘‘(ii) which the Secretary determines 

12 can appropriately conduct analyses con13 sistent with the purposes of this sub14 section. 

15 ‘‘(3) USE OF DATA AND PENALTIES.— 

16 ‘‘(A) USE OF DATA.— 

17 ‘‘(i) IN GENERAL.—Data provided to 

18 a research center or organization under a 

19 data use agreement under this subsection 

20 shall be used solely for purposes of re21 search on the safety, effectiveness, and 

22 quality of, disparities in, and related as23 pects of, health care use by individuals en24 titled to, or enrolled for, benefits under 

25 part A, or enrolled for benefits under part 


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1 B, conducted for the purpose of developing 

2 and providing generalizable knowledge to 

3 inform the public health through scientific 

4 publication and other forms of public dis5 semination. 

6 ‘‘(ii) APPROVAL BY REVIEW BOARD

7 FOR THE PROTECTION OF HUMAN SUB8 JECTS.—Such use shall be approved by a 

9 review board for the protection of human 

10 subjects. 

11 ‘‘(iii) REVIEW PROCESS.—The Sec12 retary shall establish a review process to 

13 ensure that— 

14 ‘‘(I) data use agreements under 

15 this subsection include a detailed de16 scription of how the data is to be used 

17 under the agreement; and 

18 ‘‘(II) such use is consistent with 

19 the purposes described in clause (i). 

20 ‘‘(B) PENALTIES.— 

21 ‘‘(i) IN GENERAL.—A research center 

22 or organization who knowingly or inten23 tionally uses data provided under a data 

24 use agreement under this subsection for 

25 any purpose other than the purposes deVerDate Aug 31 2005 20:54 May 27, 2007 Jkt 059200 PO 00000 Frm 00012 Fmt 6652 Sfmt 6201 E:\BILLS\S1507.IS S1507

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1 scribed in subparagraph (A)(i) shall be 

2 subject, in addition to any other penalties 

3 that may be prescribed by law, to— 

4 ‘‘(I) a civil money penalty of not 

5 less than $25,000 for each infraction; 

6 and 

7 ‘‘(II) disqualification from receipt 

8 of any data under this section for not 

9 less than 2 years. 

10 ‘‘(ii) PROCEDURE.—The provisions of 

11 section 1128A (other than subsections (a) 

12 and (b) and the second sentence of sub13 section (f)) shall apply to a civil money 

14 penalty under this subparagraph in the 

15 same manner as such provisions apply to a 

16 penalty or proceeding under section 

17 1128A(a). 

18 ‘‘(4) RELEASE OF DATA.— 

19 ‘‘(A) IN GENERAL.—A data use agreement 

20 entered into under paragraph (1)(A) shall pro21 vide for the release of information— 

22 ‘‘(i) according to a schedule approved 

23 by the Secretary under the criteria devel24 oped in accordance with subparagraph (B); 

25 and 


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1 ‘‘(ii) for a timeframe appropriate to 

2 accomplish the research objective (as deter3 mined by the Secretary). 

4 ‘‘(B) CRITERIA FOR APPROVING RESEARCH

5 APPLICATIONS.— 

6 ‘‘(i) DEVELOPMENT.—The Secretary, 

7 in consultation with health services re8 searchers and academicians, shall develop 

9 criteria for the approval of a data use 

10 agreement under this subsection. 

11 ‘‘(ii) CRITERIA.—The criteria devel12 oped under clause (i) shall include the fol13 lowing requirements: 

14 ‘‘(I) The research center or orga15 nization has well-documented sci16 entific expertise, a record of scholar17 ship on the topic of the proposed 

18 study, and a likelihood of successful 

19 publication, as demonstrated by a 

20 prior record of relevant publication by 

21 key staff and other evidence of appro22 priate scientific qualifications of the 

23 proposed research team. 

24 ‘‘(II) The research center or or25 ganization demonstrates a credible caVerDate Aug 31 2005 20:54 May 27, 2007 Jkt 059200 PO 00000 Frm 00014 Fmt 6652 Sfmt 6201 E:\BILLS\S1507.IS S1507

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1 pability to conduct and complete the 

2 proposed study, including experience 

3 with scientific investigations using 

4 similar types of data. 

5 ‘‘(III) The research center or or6 ganization demonstrates the public 

7 health importance of the proposed 

8 study, and the potential of such study 

9 to provide public knowledge needed to 

10 improve the safety, use, and outcomes 

11 of treatments, the administration of 

12 the program under this title, and the 

13 care provided to individuals entitled 

14 to, or enrolled for, benefits under part 

15 A, or enrolled for benefits under part 

16 B. 

17 ‘‘(IV) The research center or or18 ganization develops a data manage19 ment plan that describes in detail the 

20 measures that will be implemented to 

21 safeguard the data and protect the 

22 privacy of individuals entitled to, or 

23 enrolled for, benefits under part A, or 

24 enrolled for benefits under part B, in25 cluding any proposed data linkages. 


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1 ‘‘(V) The research center or or2 ganization enters into an agreement 

3 under which the research center or or4 ganization agrees to— 

5 ‘‘(aa) place detailed results 

6 of the proposed study in the pub7 lic domain through publication in 

8 a reasonable timeframe, not to 

9 exceed 1 year after completion of 

10 such study, including a thorough 

11 description of the methodology 

12 used to conduct the study; 

13 ‘‘(bb) make available to the 

14 public, without charge, any prod15 uct or tool developed using the 

16 data provided under this sub17 section; and 

18 ‘‘(cc) not sell such data to 

19 other entities or create commer20 cial data products (such as data 

21 extracts or analytical files) using 

22 such data. 

23 ‘‘(VI) The research center or or24 ganization and the proposed research 

25 team provide assurances that such 


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1 team is independent from the sources 

2 of funding or any other party and has 

3 the right to independently and freely 

4 publish the scientific findings of the 

5 study. 

6 ‘‘(VII) Such other requirements, 

7 consistent with the purposes of this 

8 subsection, as the Secretary deter9 mines appropriate. 

10 ‘‘(C) TIMELY REVIEW AND ACTION ON RE11 QUESTS.—The Secretary shall provide for time12 ly review of, and action on, requests for a data 

13 use agreement under this subsection, taking 

14 into consideration the reasonable needs of the 

15 research center or organization. 

16 ‘‘(D) PUBLIC DISCLOSURE.—The Sec17 retary shall make available to the public the cri18 teria developed under subparagraph (B)(i) that 

19 is used to grant or deny a data use agreement 

20 under this subsection. 

21 ‘‘(5) FEEDBACK BY RESEARCH CENTER OR OR22 GANIZATION.— 

23 ‘‘(A) NOTIFICATION OF INACCURACIES DIS24 COVERED IN DATA PROVIDED.—The Secretary 

25 shall establish procedures to ensure that a reVerDate Aug 31 2005 20:54 May 27, 2007 Jkt 059200 PO 00000 Frm 00017 Fmt 6652 Sfmt 6201 E:\BILLS\S1507.IS S1507

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1 search center or organization that is provided 

2 data under this subsection notifies the Sec3 retary of any inaccuracies discovered in the 

4 data by the center or organization within a rea5 sonable time of such discovery. 

6 ‘‘(B) FEEDBACK ON DATA COLLECTION.— 

7 The Secretary shall permit researchers to pro8 vide feedback on the collection of data with re9 spect to the programs administered by the Cen10 ters for Medicare & Medicaid Services and 

11 make recommendations with respect to the col12 lection of additional data elements with respect 

13 to such programs. 

14 ‘‘(6) CONFIDENTIALITY.— 

15 ‘‘(A) DETERMINING APPROPRIATE LEVEL

16 OF DATA TO BE PROVIDED.—The Secretary 

17 shall establish a process to determine the ap18 propriate level of data to be provided to a re19 search center or organization under this sub20 section in order to ensure that the center or or21 ganization, and researchers within the center or 

22 organization, are able to conduct meaningful 

23 analyses while maintaining the confidentiality of 

24 the data provided under the data use agree25 ment. 


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1 ‘‘(B) SAFEGUARDS TO PROTECT CON2 FIDENTIALITY OF DATA PROVIDED.— 

3 ‘‘(i) IN GENERAL.—The Secretary 

4 shall establish safeguards to protect the 

5 confidentiality of data after it is provided 

6 to a research center or organization under 

7 this subsection. Such safeguards shall not 

8 provide for greater disclosure by the re9 search center or organization than is per10 mitted under any of the following: 

11 ‘‘(I) The Federal regulations 

12 (concerning the privacy of individually 

13 identifiable health information) pro14 mulgated under section 264(c) of the 

15 Health Insurance Portability and Ac16 countability Act of 1996. 

17 ‘‘(II) Sections 552 or 552a of 

18 title 5, United States Code, with re19 gard to the privacy of individually 

20 identifiable beneficiary health infor21 mation. 

22 ‘‘(ii) CONFIDENTIALITY OF PHYSI23 CIANS AND MEDICAL PRACTICES.—The 

24 safeguards established under clause (i) 

25 shall ensure that the data provided to a reVerDate Aug 31 2005 20:54 May 27, 2007 Jkt 059200 PO 00000 Frm 00019 Fmt 6652 Sfmt 6201 E:\BILLS\S1507.IS S1507

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1 search center or organization under this 

2 subsection that identifies individual physi3 cians or medical practices is not released 

4 by the research center or organization, or 

5 otherwise made public in a manner that 

6 identifies individual physicians or medical 

7 practices. 

8 ‘‘(7) ACCESS BY CONTRACTORS AND SUB9 CONTRACTORS.—In the case of a public or private 

10 entity that enters into a contract or subcontract with 

11 a research center or organization described in para12 graph (2) to conduct activities for such research cen13 ter or organization under this subsection, any access 

14 by such entity to data from the program under this 

15 title under this subsection shall be provided in ac16 cordance with this subsection and subject to the 

17 same requirements as access for a research center or 

18 organization under this subsection. 

19 ‘‘(8) REPORT.—The Secretary shall report to 

20 Congress on an annual basis (beginning with 2008) 

21 an evaluation of the agreements entered into under 

22 paragraph (1)(A), including a list and a description 

23 of the research conducted by research centers and 

24 organizations using data provided under such an 

25 agreement. 


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1 ‘‘(9) REASONABLE FEE.—The Secretary may 

2 charge a research center or organization a reason3 able fee based on the cost of preparing and pro4 viding data to such center or organization under this 

5 subsection.’’. 

6 (2) CRITERIADEVELOPMENT AND PUBLICA7 TION.—The Secretary shall develop and publish the 

8 criteria required under section 1860D– 

9 42(d)(4)(B)(i) of the Social Security Act, as added 

10 by paragraph (1), not later than 180 days after the 

11 date of enactment of this Act. 

Æ 


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