I 

111TH CONGRESS 

1ST SESSION H. R. 2824 

To enhance the conduct and support of federally funded comparative 

effectiveness research relating to health care, and for other purposes. 

IN THE HOUSE OF REPRESENTATIVES 

JUNE 11, 2009 

Mrs. CHRISTENSEN (for herself, Mr. HERGER, and Mr. BOUSTANY) introduced the following bill; which was referred to the Committee on Energy 

and Commerce, and in addition to the Committees on Ways and Means, 

Armed Services, and Veterans’ Affairs, for a period to be subsequently 

determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned 

A BILL 

To enhance the conduct and support of federally funded 

comparative effectiveness research relating to health care, 

and for other purposes. 

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 ‘‘Doctor-Patient Rela5 tionship and Research Protection Act’’. 


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1 SEC. 2. FEDERAL COORDINATING COUNCIL FOR COMPARA2 TIVE EFFECTIVENESS RESEARCH. 

3 (a) AUTHORITY.—Paragraph (1) of section 804(c) of 

4 title VIII of division A of the American Recovery and Re5 investment Act of 2009 (42 U.S.C. 299b–8(c)) is amended 

6 to read as follows: 

7 ‘‘(1) notwithstanding the provisions under the 

8 heading ‘AGENCY FOR HEALTHCARE RESEARCH AND

9 QUALITY’ of this title and any other provision of law, 

10 have full authority to direct and coordinate all Fed11 eral funding of comparative effectiveness health care 

12 research, including such research conducted or sup13 ported by the Departments of Health and Human 

14 Services, Veterans Affairs, and Defense; and’’. 

15 (b) MEMBERSHIP.—Subsection (d) of section 804 of 

16 title VIII of division A of the American Recovery and Re17 investment Act of 2009 (42 U.S.C. 299b–8) is amended 

18 to read as follows: 

19 ‘‘(d) MEMBERSHIP.— 

20 ‘‘(1) IN GENERAL.—The members of the Coun21 cil shall include one senior officer or employee from 

22 each of the following agencies: 

23 ‘‘(A) The Agency for Healthcare Research 

24 and Quality. 

25 ‘‘(B) The Secretary of Health and Human 

26 Services. 


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1 ‘‘(C) The Director of the National Insti2 tutes of Health. 

3 ‘‘(D) 20 members, 9 of whom are not full4 time government employees, appointed by the 

5 Comptroller General of the United States as 

6 follows: 

7 ‘‘(i) 3 members representing patients 

8 and health care consumers. 

9 ‘‘(ii) 3 members representing prac10 ticing physicians, including surgeons. 

11 ‘‘(iii) 3 members representing agen12 cies that administer public programs, as 

13 follows: 

14 ‘‘(I) 1 member representing the 

15 Centers for Medicare & Medicaid 

16 Services who has experience in admin17 istering the program under title 

18 XVIII of the Social Security Act. 

19 ‘‘(II) 1 member representing 

20 agencies that administer State health 

21 programs (who may represent the 

22 Centers for Medicare & Medicaid 

23 Services and have experience in ad24 ministering the program under title 

25 XIX or the program under title XXI 


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1 of the Social Security Act or be a gov2 ernor of a State). 

3 ‘‘(III) 1 member representing 

4 agencies that administer other Fed5 eral health programs (such as a 

6 health program of the Department of 

7 Defense Federal employees health 

8 benefits program under chapter 89 of 

9 title 5 of the United States Code, a 

10 health program of the Department of 

11 Veterans Affairs under chapter 17 of 

12 title 38 of such Code, or a medical 

13 care program of the Indian Health 

14 Service or of a tribal organization). 

15 ‘‘(iv) 3 members representing private 

16 payers, of whom at least 1 member shall 

17 represent health insurance issuers and at 

18 least 1 member shall represent employers 

19 who self-insure employee benefits. 

20 ‘‘(v) 3 members representing pharma21 ceutical, device, and technology manufac22 turers or developers. 

23 ‘‘(vi) 1 member representing nonprofit 

24 organizations involved in health services re25 search. 


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1 ‘‘(vii) 1 member representing organi2 zations that focus on quality measurement 

3 and improvement or decision support. 

4 ‘‘(viii) 1 member representing inde5 pendent health services researchers. 

6 ‘‘(ix) 1 member representing research 

7 in differences in treatment outcomes along 

8 the lines of racial and ethnic background, 

9 gender, and geography. 

10 ‘‘(x) 1 member representing research 

11 in treating rural populations. 

12 ‘‘(E) QUALIFICATIONS.—At least half of 

13 the members of the Council shall be physicians 

14 or other experts with clinical expertise. 

15 ‘‘(2) CHAIRMAN; VICE CHAIRMAN.—The Sec16 retary shall serve as Chairman of the Council and 

17 shall designate a member to serve as Vice Chair18 man.’’. 

19 (c) RULES OF CONSTRUCTION.—Subsection (g) of 

20 section 804 of title VIII of division A of the American 

21 Recovery and Reinvestment Act of 2009 (42 U.S.C. 299b– 

22 8) is amended to read as follows: 

23 ‘‘(g) RULES OF CONSTRUCTION.— 

24 ‘‘(1) COVERAGE.—Nothing in this section shall 

25 be construed— 


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1 ‘‘(A) to permit the Council to mandate or 

2 recommend coverage, reimbursement, or other 

3 policies for any public or private payer; or 

4 ‘‘(B) as preventing the Secretary of Health 

5 and Human Services from covering the routine 

6 costs of clinical care received by an individual 

7 entitled to, or enrolled for, benefits under title 

8 XVIII, XIX, or XXI of the Social Security Act 

9 in the case where such individual is partici10 pating in a clinical trial and such costs would 

11 otherwise be covered under such title with re12 spect to the beneficiary. 

13 ‘‘(2) REPORTS AND FINDING.—No report sub14 mitted under this section or research findings dis15 seminated by the Council shall be construed as man16 dates, guidelines, or recommendations for payment, 

17 coverage, or treatment.’’. 

18 (d) TRANSPARENCY, CREDIBILITY, AND ACCESS.— 

19 Section 804 of title VIII of division A of the American 

20 Recovery and Reinvestment Act of 2009 (42 U.S.C. 299b– 

21 8) is amended by adding at the end the following: 

22 ‘‘(h) TRANSPARENCY, CREDIBILITY, AND ACCESS.— 

23 The Council shall establish procedures to ensure that the 

24 following requirements for ensuring transparency, credi25 bility, and access are met: 


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1 ‘‘(1) PUBLIC COMMENT PERIOD.— 

2 ‘‘(A) COMMENT PRIOR TO OBLIGATION OF

3 FUNDS FOR RESEARCH.—Before any Federal 

4 funds may be obligated to conduct or support 

5 comparative effectiveness research, the Council 

6 shall provide for a period of not less than 30 

7 days for the public to comment on the research 

8 proposal. 

9 ‘‘(B) COMMENT AFTER RESEARCH RE10 SULTS PUBLISHED.—After the publication of 

11 the results of research described in subpara12 graph (A), the Council shall provide for a pe13 riod of 60 days for the public to comment on 

14 such results. 

15 ‘‘(C) TRANSMISSION OF PUBLIC COM16 MENTS.—The Council shall ensure the trans17 mission of public comments submitted under 

18 subparagraph (A) to the entity conducting the 

19 research with respect to which the individual 

20 study design is being finalized. 

21 ‘‘(2) ADDITIONAL FORUMS.—The Council shall, 

22 in addition to the public comment period described 

23 in paragraph (1), support forums to increase public 

24 awareness and obtain and incorporate public feedVerDate Nov 24 2008 05:07 Jun 12, 2009 Jkt 079200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6201 E:\BILLS\H2824.IH H2824

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1 back through media (such as an Internet website) on 

2 the following: 

3 ‘‘(A) The identification of comparative ef4 fectiveness research priorities. 

5 ‘‘(B) Comparative effectiveness research 

6 findings. 

7 ‘‘(C) Any other duties, activities, or proc8 esses the Council determines appropriate. 

9 ‘‘(3) PUBLIC AVAILABILITY.—The Council shall 

10 make available to the public and disclose through 

11 the official public Internet website of the Council, 

12 and through other forums and media the Council de13 termines appropriate, the following: 

14 ‘‘(A) The process and methods for the con15 duct of comparative effectiveness research pur16 suant to this section, including— 

17 ‘‘(i) the identity of the entity con18 ducting any such research; 

19 ‘‘(ii) any links the entity has to indus20 try (including such links that are not di21 rectly tied to the particular research); 

22 ‘‘(iii) draft study designs (including 

23 research questions and the finalized study 

24 design, together with public comments on 


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1 such study design and responses to such 

2 comments); 

3 ‘‘(iv) research protocols (including 

4 measures taken, methods of research, 

5 methods of analysis, research results, and 

6 such other information as the Council de7 termines appropriate); 

8 ‘‘(v) the identity of investigators con9 ducting such research and any conflicts of 

10 interest of such investigators; and 

11 ‘‘(vi) any progress reports the Council 

12 determines appropriate. 

13 ‘‘(B) Public comments submitted during 

14 each public comment period under paragraph 

15 (1)(A). 

16 ‘‘(C) Bylaws, processes, and proceedings of 

17 the Council, to the extent practicable and as the 

18 Council determines appropriate. 

19 ‘‘(D) Not later than 60 days after receipt 

20 by the Council of a relevant report or compara21 tive effectiveness research finding, appropriate 

22 information contained in such report or finding. 

23 ‘‘(4) CONFLICTS OF INTEREST.— 

24 ‘‘(A) IN GENERAL.—The Council shall— 


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1 ‘‘(i) in appointing members to an ad2 visory panel, and in selecting individuals to 

3 contribute to any peer-review process and 

4 for employment as executive staff of the 

5 Council, take into consideration any con6 flicts of interest of potential appointees, 

7 participants, and staff; and 

8 ‘‘(ii) include a description of any such 

9 conflicts of interest and conflicts of inter10 est of Council members in an annual re11 port to the Congress, except that, in the 

12 case of individuals contributing to any 

13 such peer review process, such description 

14 shall be in a manner such that those indi15 viduals cannot be identified with a par16 ticular research project. 

17 ‘‘(B) DEFINITION.—In this subsection, the 

18 term ‘conflict of interest’ means associations, 

19 including financial and personal, that may be 

20 reasonably assumed to have the potential to 

21 bias an individual’s decisions in matters related 

22 to the Council or the conduct of the compara23 tive effectiveness research.’’. 


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1 SEC. 3. APPLICATION OF FEDERALLY FUNDED CLINICAL 

2 COMPARATIVE EFFECTIVENESS RESEARCH. 

3 (a) LIMITATION ON CMS.—The Administrator of the 

4 Centers for Medicare & Medicaid Services may not use 

5 federally funded clinical comparative effectiveness re6 search data to make coverage determinations under title 

7 XVIII of the Social Security Act for medical treatments, 

8 services, and items on the basis of cost. 

9 (b) REQUIREMENT FOR IMPLEMENTATION.—Feder10 ally funded clinical comparative effectiveness research and 

11 related evaluation and communication activities shall re12 flect the principle that clinicians and patients should have 

13 the best available evidence upon which to make choices 

14 in health care items and services, in providers, and in 

15 health care delivery systems, recognizing that patient sub16 populations and patient and physician preferences may 

17 vary. 

18 (c) APPEALS OF CERTAIN MEDICARE COVERAGE DE19 TERMINATIONS.—In the case of a national or local cov20 erage determination under title XVIII of the Social Secu21 rity Act that has been made utilizing federally funded 

22 comparative effectiveness research, an individual entitled 

23 to benefits under such title shall— 

24 (1) be an eligible requester under section 

25 1869(h)(1)(B) of such Act in relation; 


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1 (2) have expedited access (as specified by the 

2 Secretary) to coverage determinations, redetermina3 tions, and appeals relating to such determinations; 

4 and 

5 (3) have full access to all administrative or judi6 cial review under section 1869 of such Act with re7 spect to such determinations. 

8 (d) RULE OF CONSTRUCTION.—Nothing in this Act 

9 or the amendments made by this Act shall be construed 

10 to require coverage of any drug, biological product, device, 

11 or treatment that has been determined by the Food and 

12 Drug Administration to be unsafe. 

13 (e) DISAGGREGATION OF RESEARCH RESULTS.—No 

14 Federal funds may be made available to any person for 

15 any federally funded clinical comparative effectiveness re16 search, unless the person agrees to ensure that, whenever 

17 possible, the methodology and research protocols will in18 clude variables that not only measure, but can be 

19 disaggregated to analyze and identify, any differences 

20 along the lines of racial and ethnic background, gender, 

21 and geography that may exist among and within patient 

22 subpopulations. 

23 (f) DEFINITIONS.—In this section: 


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1 (1) The term ‘‘federally funded clinical com2 parative effectiveness research’’ means research 

3 that— 

4 (A) evaluates and compares the clinical ef5 fectiveness, risks, and benefits of 2 or more 

6 medical treatments, services, and items; and 

7 (B) is conducted or supported in accord8 ance with provisions of title VIII of division A 

9 of the American Recovery and Reinvestment 

10 Act of 2009 or with the use of other Federal 

11 funds. 

12 (2) The term ‘‘medical treatments, services, and 

13 items’’ means health care interventions, protocols for 

14 treatment, procedures, medical devices, diagnostic 

15 tools, pharmaceuticals (including drugs and 

16 biologicals), and any other processes or items being 

17 used in the treatment and diagnosis of, or preven18 tion of illness or injury in, patients. 

19 (3) The term ‘‘patient subpopulations’’ means 

20 populations of patients of different racial and ethnic 

21 backgrounds, genders, and geographic locations. 

Æ 


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