II 

111TH CONGRESS 

1ST SESSION S. 1213 

To amend title XI of the Social Security Act to provide for the conduct 

of comparative effectiveness research and to amend the Internal Revenue 

Code of 1986 to establish a Patient-Centered Outcomes Research Trust 

Fund, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

JUNE 9, 2009 

Mr. BAUCUS (for himself and Mr. CONRAD) introduced the following bill; 

which was read twice and referred to the Committee on Finance 

A BILL 

To amend title XI of the Social Security Act to provide 

for the conduct of comparative effectiveness research and 

to amend the Internal Revenue Code of 1986 to establish 

a Patient-Centered Outcomes Research Trust Fund, 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 ‘‘Patient-Centered Out5 comes Research Act of 2009’’. 


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1 SEC. 2. COMPARATIVE EFFECTIVENESS RESEARCH. 

2 (a) IN GENERAL.—Title XI of the Social Security Act 

3 (42 U.S.C. 1301 et seq.) is amended by adding at the end 

4 the following new part: 

5 ‘‘PART D—COMPARATIVE EFFECTIVENESS RESEARCH

6 ‘‘COMPARATIVE EFFECTIVENESS RESEARCH

7 ‘‘SEC. 1181. (a) DEFINITIONS.—In this section: 

8 ‘‘(1) BOARD.—The term ‘Board’ means the 

9 Board of Governors established under subsection (f). 

10 ‘‘(2) COMPARATIVE CLINICAL EFFECTIVENESS

11 RESEARCH.— 

12 ‘‘(A) IN GENERAL.—The term ‘compara13 tive clinical effectiveness research’ means re14 search evaluating and comparing the clinical ef15 fectiveness, risks, and benefits of 2 or more 

16 medical treatments, services, and items de17 scribed in subparagraph (B). 

18 ‘‘(B) MEDICAL TREATMENTS, SERVICES, 

19 AND ITEMS DESCRIBED.—The medical treat20 ments, services, and items described in this sub21 paragraph are health care interventions, proto22 cols for treatment, care management, and deliv23 ery, procedures, medical devices, diagnostic 

24 tools, pharmaceuticals (including drugs and 

25 biologicals), and any other strategies or items 

26 being used in the treatment, management, and 


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1 diagnosis of, or prevention of illness or injury 

2 in, patients. 

3 ‘‘(3) COMPARATIVE EFFECTIVENESS RE4 SEARCH.—The term ‘comparative effectiveness re5 search’ means research evaluating and comparing 

6 the implications and outcomes of 2 or more health 

7 care strategies to address a particular medical condi8 tion for specific patient populations. 

9 ‘‘(4) CONFLICTS OF INTEREST.—The term 

10 ‘conflicts of interest’ means associations, including 

11 financial and personal, that may be reasonably as12 sumed to have the potential to bias an individual’s 

13 decisions in matters related to the Institute or the 

14 conduct of activities under this section. 

15 ‘‘(5) INSTITUTE.—The term ‘Institute’ means 

16 the ‘Patient-Centered Outcomes Research Institute’ 

17 established under subsection (b)(1). 

18 ‘‘(b) PATIENT-CENTERED OUTCOMES RESEARCH IN19 STITUTE.— 

20 ‘‘(1) ESTABLISHMENT.—There is authorized to 

21 be established a nonprofit corporation, to be known 

22 as the ‘Patient-Centered Outcomes Research Insti23 tute’ which is neither an agency nor establishment 

24 of the United States Government. 


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1 ‘‘(2) APPLICATION OF PROVISIONS.—The Insti2 tute shall be subject to the provisions of this section, 

3 and, to the extent consistent with this section, to the 

4 District of Columbia Nonprofit Corporation Act. 

5 ‘‘(3) FUNDING OF COMPARATIVE EFFECTIVE6 NESS RESEARCH.—For fiscal year 2010 and each 

7 subsequent fiscal year, amounts in the Patient-Cen8 tered Outcomes Research Trust Fund (referred to in 

9 this section as the ‘PCORTF’) under section 9511 

10 of the Internal Revenue Code of 1986 shall be avail11 able, without further appropriation, to the Institute 

12 to carry out this section. 

13 ‘‘(c) PURPOSE.—The purpose of the Institute is to 

14 assist patients, clinicians, purchasers, and policy makers 

15 in making informed health decisions by advancing the 

16 quality and relevance of evidence concerning the manner 

17 in which diseases, disorders, and other health conditions 

18 can effectively and appropriately be prevented, diagnosed, 

19 treated, monitored, and managed through research and 

20 evidence synthesis that considers variations in patient sub21 populations, and the dissemination of research findings 

22 with respect to the relative clinical outcomes, clinical effec23 tiveness, and appropriateness of the medical treatments, 

24 services, and items described in subsection (a)(2)(B). 

25 ‘‘(d) DUTIES.— 


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1 ‘‘(1) IDENTIFYING RESEARCH PRIORITIES AND

2 ESTABLISHING RESEARCH PROJECT AGENDA.— 

3 ‘‘(A) IDENTIFYING RESEARCH PRIOR4 ITIES.—The Institute shall identify national 

5 priorities for comparative clinical effectiveness 

6 research, taking into account factors, includ7 ing— 

8 ‘‘(i) disease incidence, prevalence, and 

9 burden in the United States; 

10 ‘‘(ii) evidence gaps in terms of clinical 

11 outcomes; 

12 ‘‘(iii) practice variations, including 

13 variations in delivery and outcomes by ge14 ography, treatment site, provider type, and 

15 patient subgroup; 

16 ‘‘(iv) the potential for new evidence 

17 concerning certain categories of health care 

18 services or treatments to improve patient 

19 health and well-being, and the quality of 

20 care; 

21 ‘‘(v) the effect or potential for an ef22 fect on health expenditures associated with 

23 a health condition or the use of a par24 ticular medical treatment, service, or item; 


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1 ‘‘(vi) the effect or potential for an ef2 fect on patient needs, outcomes, and pref3 erences, including quality of life; and 

4 ‘‘(vii) the relevance to assisting pa5 tients and clinicians in making informed 

6 health decisions. 

7 ‘‘(B) ESTABLISHING RESEARCH PROJECT

8 AGENDA.— 

9 ‘‘(i) IN GENERAL.—The Institute shall 

10 establish and update a research project 

11 agenda for comparative clinical effective12 ness research to address the priorities 

13 identified under subparagraph (A), taking 

14 into consideration the types of such re15 search that might address each priority 

16 and the relative value (determined based 

17 on the cost of conducting such research 

18 compared to the potential usefulness of the 

19 information produced by such research) as20 sociated with the different types of re21 search, and such other factors as the Insti22 tute determines appropriate. 

23 ‘‘(ii) CONSIDERATION OF NEED TO

24 CONDUCT A SYSTEMATIC REVIEW.—In es25 tablishing and updating the research 


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1 project agenda under clause (i), the Insti2 tute shall consider the need to conduct a 

3 systematic review of existing research be4 fore providing for the conduct of new re5 search under paragraph (2)(A). 

6 ‘‘(2) CARRYING OUT RESEARCH PROJECT AGEN7 DA.— 

8 ‘‘(A) COMPARATIVE CLINICAL EFFECTIVE9 NESS RESEARCH.—In carrying out the research 

10 project agenda established under paragraph 

11 (1)(B), the Institute shall provide for the con12 duct of appropriate research and the synthesis 

13 of evidence, in accordance with the methodo14 logical standards adopted under paragraph 

15 (10), using methods, including the following: 

16 ‘‘(i) Systematic reviews and assess17 ments of existing research and evidence. 

18 ‘‘(ii) Primary research, such as ran19 domized clinical trials, molecularly in20 formed trials, and observational studies. 

21 ‘‘(iii) Any other methodologies rec22 ommended by the methodology committee 

23 established under paragraph (7) that are 

24 adopted by the Board under paragraph 

25 (10). 


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1 ‘‘(B) CONTRACTS FOR THE MANAGEMENT

2 AND CONDUCT OF RESEARCH.— 

3 ‘‘(i) IN GENERAL.—The Institute may 

4 enter into contracts for the management 

5 and conduct of research in accordance with 

6 the research project agenda established 

7 under paragraph (1)(B) with the following: 

8 ‘‘(I) Agencies and instrumental9 ities of the Federal Government that 

10 have experience in conducting com11 parative clinical effectiveness research, 

12 such as the Agency for Healthcare 

13 Research and Quality, to the extent 

14 that such contracts are authorized 

15 under the governing statutes of such 

16 agencies and instrumentalities. 

17 ‘‘(II) Appropriate private sector 

18 research or study-conducting entities 

19 that have demonstrated the experience 

20 and capacity to achieve the goals of 

21 comparative effectiveness research. 

22 ‘‘(ii) CONDITIONS FOR CONTRACTS.— 

23 A contract entered into under this sub24 paragraph shall require that the agency, 

25 instrumentality, or other entity— 


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1 ‘‘(I) abide by the transparency 

2 and conflicts of interest requirements 

3 that apply to the Institute with re4 spect to the research managed or con5 ducted under such contract; 

6 ‘‘(II) comply with the methodo7 logical standards adopted under para8 graph (10) with respect to such re9 search; 

10 ‘‘(III) take into consideration 

11 public comments on the study design 

12 that are transmitted by the Institute 

13 to the agency, instrumentality, or 

14 other entity under subsection 

15 (i)(1)(B) during the finalization of the 

16 study design and transmit responses 

17 to such comments to the Institute, 

18 which will publish such comments, re19 sponses, and finalized study design in 

20 accordance with subsection 

21 (i)(3)(A)(iii) prior to the conduct of 

22 such research; and 

23 ‘‘(IV) in the case where the agen24 cy, instrumentality, or other entity is 

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1 tive effectiveness research study for a 

2 rare disease, consult with the expert 

3 advisory panel for rare disease ap4 pointed under paragraph (5)(A)(iii) 

5 with respect to such research study. 

6 ‘‘(iii) COVERAGE OF COPAYMENTS OR

7 COINSURANCE.—A contract entered into 

8 under this subparagraph may allow for the 

9 coverage of copayments or co-insurance, or 

10 allow for other appropriate measures, to 

11 the extent that such coverage or other 

12 measures are necessary to preserve the va13 lidity of a research project, such as in the 

14 case where the research project must be 

15 blinded. 

16 ‘‘(C) REVIEW AND UPDATE OF EVI17 DENCE.—The Institute shall review and update 

18 evidence on a periodic basis, in order to take 

19 into account new research, evolving evidence, 

20 advances in medical technology, and changes in 

21 the standard of care as they become available, 

22 as appropriate. 

23 ‘‘(D) TAKING INTO ACCOUNT POTENTIAL

24 DIFFERENCES.—Research shall— 


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1 ‘‘(i) be designed, as appropriate, to 

2 take into account the potential for dif3 ferences in the effectiveness of health care 

4 treatments, services, and items as used 

5 with various subpopulations, such as racial 

6 and ethnic minorities, women, age, and 

7 groups of individuals with different 

8 comorbidities, genetic and molecular sub9 types, or quality of life preferences; and 

10 ‘‘(ii) include members of such sub11 populations as subjects in the research as 

12 feasible and appropriate. 

13 ‘‘(E) DIFFERENCES IN TREATMENT MO14 DALITIES.—Research shall be designed, as ap15 propriate, to take into account different charac16 teristics of treatment modalities that may affect 

17 research outcomes, such as the phase of the 

18 treatment modality in the innovation cycle and 

19 the impact of the skill of the operator of the 

20 treatment modality. 

21 ‘‘(3) STUDY AND REPORT ON FEASIBILITY OF

22 CONDUCTING RESEARCH IN-HOUSE.— 

23 ‘‘(A) STUDY.—The Institute shall conduct 

24 a study on the feasibility of conducting research 

25 in-house. 


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1 ‘‘(B) REPORT.—Not later than 5 years 

2 after the date of enactment of this section, the 

3 Institute shall submit a report to Congress con4 taining the results of the study conducted under 

5 subparagraph (A). 

6 ‘‘(4) DATA COLLECTION.— 

7 ‘‘(A) IN GENERAL.—The Secretary shall, 

8 with appropriate safeguards for privacy, make 

9 available to the Institute such data collected by 

10 the Centers for Medicare & Medicaid Services 

11 under the programs under titles XVIII, XIX, 

12 and XXI as the Institute may require to carry 

13 out this section. The Institute may also request 

14 and, if such request is granted, obtain data 

15 from Federal, State, or private entities, includ16 ing data from clinical databases and registries. 

17 ‘‘(B) USE OF DATA.—The Institute shall 

18 only use data provided to the Institute under 

19 subparagraph (A) in accordance with laws and 

20 regulations governing the release and use of 

21 such data, including applicable confidentiality 

22 and privacy standards. 

23 ‘‘(5) APPOINTING EXPERT ADVISORY PANELS.— 

24 ‘‘(A) APPOINTMENT.— 


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1 ‘‘(i) IN GENERAL.—The Institute 

2 shall, as appropriate, appoint expert advi3 sory panels to assist in identifying research 

4 priorities and establishing the research 

5 project agenda under paragraph (1). Pan6 els shall advise the Institute in matters 

7 such as identifying gaps in and updating 

8 medical evidence in order to ensure that 

9 the information produced from such re10 search is clinically relevant to decisions 

11 made by clinicians and patients at the 

12 point of care. 

13 ‘‘(ii) EXPERT ADVISORY PANELS FOR

14 PRIMARY RESEARCH.—The Institute shall 

15 appoint expert advisory panels in carrying 

16 out the research project agenda under 

17 paragraph (2)(A)(ii). Such expert advisory 

18 panels shall, upon request, advise the Insti19 tute and the agency, instrumentality, or 

20 entity conducting the research on the re21 search question involved and the research 

22 design or protocol, including the appro23 priate comparator technologies, important 

24 patient subgroups, and other parameters of 

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1 quest of such agency, instrumentality, or 

2 entity, such panels shall be available as a 

3 resource for technical questions that may 

4 arise during the conduct of such research. 

5 ‘‘(iii) EXPERT ADVISORY PANEL FOR

6 RARE DISEASE.—In the case of a compara7 tive effectiveness research study for rare 

8 disease, the Institute shall appoint an ex9 pert advisory panel for purposes of assist10 ing in the design of such research study 

11 and determining the relative value and fea12 sibility of conducting such research study. 

13 ‘‘(B) COMPOSITION.— 

14 ‘‘(i) IN GENERAL.—An expert advi15 sory panel appointed under subparagraph 

16 (A) shall include individuals who have ex17 perience in the relevant topic, project, or 

18 category for which the panel is established, 

19 including— 

20 ‘‘(I) practicing and research clini21 cians (including relevant specialists 

22 and subspecialists), patients, and rep23 resentatives of patients; and 

24 ‘‘(II) experts in scientific and 

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1 ices delivery, and evidence-based medi2 cine. 

3 ‘‘(ii) INCLUSION OF REPRESENTA4 TIVES OF MANUFACTURERS OF MEDICAL

5 TECHNOLOGY.—An expert advisory panel 

6 appointed under subparagraph (A) may in7 clude a representative of each manufac8 turer of each medical technology that is in9 cluded under the relevant topic, project, or 

10 category for which the panel is established. 

11 ‘‘(6) SUPPORTING PATIENT AND CONSUMER

12 REPRESENTATIVES.—The Institute shall provide 

13 support and resources to help patient and consumer 

14 representatives on the Board and expert advisory 

15 panels appointed by the Institute under paragraph 

16 (5) to effectively participate in technical discussions 

17 regarding complex research topics. Such support 

18 shall include initial and continuing education to fa19 cilitate effective engagement in activities undertaken 

20 by the Institute and may include regular and ongo21 ing opportunities for patient and consumer rep22 resentatives to interact with each other and to ex23 change information and support regarding their in24 volvement in the Institute’s activities. The Institute 

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1 pensation to patient and consumer representatives 

2 for their time spent participating in the activities of 

3 the Institute under this paragraph. 

4 ‘‘(7) ESTABLISHING METHODOLOGY COM5 MITTEE.— 

6 ‘‘(A) IN GENERAL.—The Institute shall es7 tablish a standing methodology committee to 

8 carry out the functions described in subpara9 graph (C). 

10 ‘‘(B) APPOINTMENT AND COMPOSITION.— 

11 The methodology committee established under 

12 subparagraph (A) shall be composed of not 

13 more than 17 members appointed by the Comp14 troller General of the United States. Members 

15 appointed to the methodology committee shall 

16 be experts in their scientific field, such as 

17 health services research, clinical research, com18 parative effectiveness research, biostatistics, 

19 genomics, and research methodologies. Stake20 holders with such expertise may be appointed to 

21 the methodology committee. 

22 ‘‘(C) FUNCTIONS.—Subject to subpara23 graph (D), the methodology committee shall 

24 work to develop and improve the science and 

25 methods of comparative effectiveness research 


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1 by undertaking, directly or through subcontract, 

2 the following activities: 

3 ‘‘(i) Not later than 2 years after the 

4 date on which the members of the method5 ology committee are appointed under sub6 paragraph (B), developing and periodically 

7 updating the following: 

8 ‘‘(I) Establish and maintain 

9 methodological standards for com10 parative clinical effectiveness research 

11 on major categories of interventions to 

12 prevent, diagnose, or treat a clinical 

13 condition or improve the delivery of 

14 care. Such methodological standards 

15 shall provide specific criteria for inter16 nal validity, generalizability, feasi17 bility, and timeliness of such research 

18 and for clinical outcomes measures, 

19 risk adjustment, and other relevant 

20 aspects of research and assessment 

21 with respect to the design of such re22 search. Any methodological standards 

23 developed and updated under this sub24 clause shall be scientifically based and 

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1 mation, data, or advances in tech2 nology are considered and incor3 porated into ongoing research projects 

4 by the Institute, as appropriate. The 

5 process for developing and updating 

6 such standards shall include input 

7 from relevant experts, stakeholders, 

8 and decision makers, and shall pro9 vide opportunities for public comment. 

10 Such standards shall also include 

11 methods by which patient subpopula12 tions can be accounted for and evalu13 ated in different types of research. As 

14 appropriate, such standards shall 

15 build on existing work on methodo16 logical standards for defined cat17 egories of health interventions and for 

18 each of the major categories of com19 parative effectiveness research meth20 ods (determined as of the date of en21 actment of the Patient-Centered Out22 comes Research Act of 2009). 

23 ‘‘(II) A translation table that is 

24 designed to provide guidance and act 

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1 mine research methods that are most 

2 likely to address each specific com3 parative clinical effectiveness research 

4 question. 

5 ‘‘(ii) Not later than 3 years after such 

6 date, examining the following: 

7 ‘‘(I) Methods by which various 

8 aspects of the health care delivery sys9 tem (such as benefit design and per10 formance, and health services organi11 zation, management, information com12 munication, and delivery) could be as13 sessed and compared for their relative 

14 effectiveness, benefits, risks, advan15 tages, and disadvantages in a scientif16 ically valid and standardized way. 

17 ‘‘(II) Methods by which efficiency 

18 and value (including the full range of 

19 harms and benefits, such as quality of 

20 life) could be assessed in a scientif21 ically valid and standardized way. 

22 ‘‘(D) CONSULTATION AND CONDUCT OF

23 EXAMINATIONS.— 

24 ‘‘(i) IN GENERAL.—Subject to clause 

25 (iii), in undertaking the activities described 


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1 in subparagraph (C), the methodology 

2 committee shall— 

3 ‘‘(I) consult or contract with 1 or 

4 more of the entities described in 

5 clause (ii); and 

6 ‘‘(II) consult with stakeholders 

7 and other entities knowledgeable in 

8 relevant fields, as appropriate. 

9 ‘‘(ii) ENTITIES DESCRIBED.—The fol10 lowing entities are described in this clause: 

11 ‘‘(I) The Institute of Medicine of 

12 the National Academies. 

13 ‘‘(II) The Agency for Healthcare 

14 Research and Quality. 

15 ‘‘(III) The National Institutes of 

16 Health. 

17 ‘‘(IV) Academic, non-profit, or 

18 other private entities with relevant ex19 pertise. 

20 ‘‘(iii) CONDUCT OF EXAMINATIONS.— 

21 The methodology committee shall contract 

22 with the Institute of Medicine of the Na23 tional Academies for the conduct of the ex24 aminations described in subclauses (I) and 

25 (II) of subparagraph (C)(ii). 


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1 ‘‘(E) REPORTS.—The methodology com2 mittee shall submit reports to the Board on the 

3 committee’s performance of the functions de4 scribed in subparagraph (C). Reports submitted 

5 under the preceding sentence with respect to 

6 the functions described in clause (i) of such 

7 subparagraph shall contain recommendations— 

8 ‘‘(i) for the Institute to adopt meth9 odological standards developed and up10 dated by the methodology committee under 

11 such subparagraph; and 

12 ‘‘(ii) for such other action as the 

13 methodology committee determines is nec14 essary to comply with such methodological 

15 standards. 

16 ‘‘(8) PROVIDING FOR A PEER-REVIEW PROCESS

17 FOR PRIMARY RESEARCH.— 

18 ‘‘(A) IN GENERAL.—The Institute shall en19 sure that there is a process for peer review of 

20 the research conducted under paragraph 

21 (2)(A)(ii). Under such process— 

22 ‘‘(i) evidence from research conducted 

23 under such paragraph shall be reviewed to 

24 assess scientific integrity and adherence to 


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1 methodological standards adopted under 

2 paragraph (10); and 

3 ‘‘(ii) a list of the names of individuals 

4 contributing to any peer-review process 

5 during the preceding year or years shall be 

6 made public and included in annual reports 

7 in accordance with paragraph (12)(D). 

8 ‘‘(B) COMPOSITION.—Such peer-review 

9 process shall be designed in a manner so as to 

10 avoid bias and conflicts of interest on the part 

11 of the reviewers and shall be composed of ex12 perts in the scientific field relevant to the re13 search under review. 

14 ‘‘(C) USE OF EXISTING PROCESSES.— 

15 ‘‘(i) PROCESSES OF ANOTHER ENTI16 TY.—In the case where the Institute enters 

17 into a contract or other agreement with 

18 another entity for the conduct or manage19 ment of research under this section, the 

20 Institute may utilize the peer-review proc21 ess of such entity if such process meets the 

22 requirements under subparagraphs (A) and 

23 (B). 

24 ‘‘(ii) PROCESSES OF APPROPRIATE

25 MEDICAL JOURNALS.—The Institute may 


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1 utilize the peer-review process of appro2 priate medical journals if such process 

3 meets the requirements under subpara4 graphs (A) and (B). 

5 ‘‘(9) DISSEMINATION OF RESEARCH FIND6 INGS.— 

7 ‘‘(A) IN GENERAL.—The Institute shall 

8 disseminate research findings to clinicians, pa9 tients, and the general public in accordance 

10 with the dissemination protocols and strategies 

11 adopted under paragraph (10). Research find12 ings disseminated— 

13 ‘‘(i) shall convey findings of research 

14 so that they are comprehensible and useful 

15 to patients and providers in making health 

16 care decisions; 

17 ‘‘(ii) shall discuss findings and other 

18 considerations specific to certain sub19 populations, risk factors, and 

20 comorbidities, as appropriate; 

21 ‘‘(iii) shall include considerations such 

22 as limitations of research and what further 

23 research may be needed, as appropriate; 


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1 ‘‘(iv) shall not include practice guide2 lines, coverage recommendations, or policy 

3 recommendations; and 

4 ‘‘(v) shall not include any data the 

5 dissemination of which would violate the 

6 privacy of research participants or violate 

7 any confidentiality agreements made with 

8 respect to the use of data under this sec9 tion. 

10 ‘‘(B) DISSEMINATION PROTOCOLS AND

11 STRATEGIES.—The Institute shall develop pro12 tocols and strategies for the appropriate dis13 semination of research findings in order to en14 sure effective communication of such findings 

15 and the use and incorporation of such findings 

16 into relevant activities for the purpose of in17 forming higher quality and more effective and 

18 timely decisions regarding medical treatments, 

19 services, and items. In developing and adopting 

20 such protocols and strategies, the Institute shall 

21 consult with stakeholders, including practicing 

22 clinicians and patients, concerning the types of 

23 dissemination that will be most useful to the 

24 end users of the information and may provide 


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1 for the utilization of multiple formats for con2 veying findings to different audiences. 

3 ‘‘(C) DEFINITION OF RESEARCH FIND4 INGS.—In this paragraph, the term ‘research 

5 findings’ means the results of a study or assess6 ment. 

7 ‘‘(10) ADOPTION.—Subject to subsection 

8 (i)(1)(A)(i), the Institute shall adopt the national 

9 priorities identified under paragraph (1)(A), the re10 search project agenda established under paragraph 

11 (1)(B), the methodological standards developed and 

12 updated by the methodology committee under para13 graph (7)(C)(i), any peer-review process provided 

14 under paragraph (8), and dissemination protocols 

15 and strategies developed under paragraph (9)(B) by 

16 majority vote. In the case where the Institute does 

17 not adopt such national priorities, research project 

18 agenda, methodological standards, peer-review proc19 ess, or dissemination protocols and strategies in ac20 cordance with the preceding sentence, the national 

21 priorities, research project agenda, methodological 

22 standards, peer-review process, or dissemination pro23 tocols and strategies shall be referred to the appro24 priate staff or entity within the Institute (or, in the 


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1 case of the methodological standards, the method2 ology committee) for further review. 

3 ‘‘(11) COORDINATION OF RESEARCH AND RE4 SOURCES AND BUILDING CAPACITY FOR RE5 SEARCH.— 

6 ‘‘(A) COORDINATION OF RESEARCH AND

7 RESOURCES.—The Institute shall coordinate re8 search conducted, commissioned, or otherwise 

9 funded under this section with comparative clin10 ical effectiveness and other relevant research 

11 and related efforts conducted by public and pri12 vate agencies and organizations in order to en13 sure the most efficient use of the Institute’s re14 sources and that research is not duplicated un15 necessarily. 

16 ‘‘(B) BUILDING CAPACITY FOR RE17 SEARCH.—The Institute may build capacity for 

18 comparative clinical effectiveness research and 

19 methodologies, including research training and 

20 development of data resources (such as clinical 

21 registries), through appropriate activities, in22 cluding using up to 20 percent of the amounts 

23 appropriated or credited to the PCORTF under 

24 section 9511(b) of the Internal Revenue Code 

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1 tramural efforts of organizations such as the 

2 Cochrane Collaboration (or a successor organi3 zation) and other organizations that develop 

4 and maintain a data network to collect, link, 

5 and analyze data on outcomes and effectiveness 

6 from multiple sources, including electronic 

7 health records. 

8 ‘‘(C) INCLUSION IN ANNUAL REPORTS.— 

9 The Institute shall report on any coordination 

10 and capacity building conducted under this 

11 paragraph in annual reports in accordance with 

12 paragraph (12)(E). 

13 ‘‘(12) ANNUAL REPORTS.—The Institute shall 

14 submit an annual report to Congress and the Presi15 dent, and shall make the annual report available to 

16 the public. Such report shall contain— 

17 ‘‘(A) a description of the activities con18 ducted under this section during the preceding 

19 year, including the use of amounts appropriated 

20 or credited to the PCORTF under section 

21 9511(b) of the Internal Revenue Code of 1986 

22 to carry out this section, research projects com23 pleted and underway, and a summary of the 

24 findings of such projects; 


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1 ‘‘(B) the research project agenda and 

2 budget of the Institute for the following year; 

3 ‘‘(C) a description of research priorities 

4 identified under paragraph (1)(A), dissemina5 tion protocols and strategies developed by the 

6 Institute under paragraph (9)(B), and meth7 odological standards developed and updated by 

8 the methodology committee under paragraph 

9 (7)(C)(i) that are adopted under paragraph 

10 (10) during the preceding year; 

11 ‘‘(D) the names of individuals contributing 

12 to any peer-review process provided under para13 graph (8) during the preceding year or years, in 

14 a manner such that those individuals cannot be 

15 identified with a particular research project; 

16 and 

17 ‘‘(E) a description of efforts by the Insti18 tute under paragraph (11) to— 

19 ‘‘(i) coordinate the research con20 ducted, commissioned, or otherwise funded 

21 under this section and the resources of the 

22 Institute with research and related efforts 

23 conducted by other private and public enti24 ties; and 


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1 ‘‘(ii) build capacity for comparative 

2 clinical effectiveness research and other 

3 relevant research and related efforts 

4 through appropriate activities. 

5 ‘‘(F) any other relevant information (in6 cluding information on the membership of the 

7 Board, expert advisory panels appointed under 

8 paragraph (5), the methodology committee es9 tablished under paragraph (7), and the execu10 tive staff of the Institute, any conflicts of inter11 est with respect to the members of such Board, 

12 expert advisory panels, and methodology com13 mittee, or with respect to any individuals se14 lected for employment as executive staff of the 

15 Institute, and any bylaws adopted by the Board 

16 during the preceding year). 

17 ‘‘(e) ADMINISTRATION.— 

18 ‘‘(1) IN GENERAL.—Subject to paragraph (2), 

19 the Board shall carry out the duties of the Institute. 

20 ‘‘(2) NONDELEGABLE DUTIES.—The activities 

21 described in subsections (b)(3)(D), (d)(1), and 

22 (d)(10) are nondelegable. 

23 ‘‘(f) BOARD OF GOVERNORS.— 


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1 ‘‘(1) IN GENERAL.—The Institute shall have a 

2 Board of Governors, which shall consist of the fol3 lowing members: 

4 ‘‘(A) The Secretary of Health and Human 

5 Services (or the Secretary’s designee). 

6 ‘‘(B) The Director of the Agency for 

7 Healthcare Research and Quality (or the Direc8 tor’s designee). 

9 ‘‘(C) The Director of the National Insti10 tutes of Health (or the Director’s designee). 

11 ‘‘(D) 18 members appointed by the Comp12 troller General of the United States not later 

13 than 6 months after the date of enactment of 

14 this section, as follows: 

15 ‘‘(i) 3 members representing patients 

16 and health care consumers. 

17 ‘‘(ii) 3 members representing prac18 ticing physicians, including surgeons. 

19 ‘‘(iii) 3 members representing agen20 cies that administer public programs, as 

21 follows: 

22 ‘‘(I) 1 member representing the 

23 Centers for Medicare & Medicaid 

24 Services who has experience in adminVerDate Nov 24 2008 03:06 Jun 10, 2009 Jkt 079200 PO 00000 Frm 00030 Fmt 6652 Sfmt 6201 E:\BILLS\S1213.IS S1213

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1 istering the program under title 

2 XVIII. 

3 ‘‘(II) 1 member representing 

4 agencies that administer State health 

5 programs (who may represent the 

6 Centers for Medicare & Medicaid 

7 Services and have experience in ad8 ministering the program under title 

9 XIX or the program under title XXI 

10 or be a governor of a State). 

11 ‘‘(III) 1 member representing 

12 agencies that administer other Fed13 eral health programs (such as a 

14 health program of the Department of 

15 Defense under chapter 55 of title 10, 

16 United States Code, the Federal em17 ployees health benefits program under 

18 chapter 89 of title 5 of such Code, a 

19 health program of the Department of 

20 Veterans Affairs under chapter 17 of 

21 title 38 of such Code, or a medical 

22 care program of the Indian Health 

23 Service or of a tribal organization). 

24 ‘‘(iv) 3 members representing private 

25 payers, of whom at least 1 member shall 


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1 represent health insurance issuers and at 

2 least 1 member shall represent employers 

3 who self-insure employee benefits. 

4 ‘‘(v) 3 members representing pharma5 ceutical, device, and diagnostic manufac6 turers or developers. 

7 ‘‘(vi) 1 member representing nonprofit 

8 organizations involved in health services re9 search. 

10 ‘‘(vii) 1 member representing organi11 zations that focus on quality measurement 

12 and improvement or decision support. 

13 ‘‘(viii) 1 member representing inde14 pendent health services researchers. 

15 ‘‘(2) QUALIFICATIONS.— 

16 ‘‘(A) DIVERSE REPRESENTATION OF PER17 SPECTIVES.—The Board shall represent a broad 

18 range of perspectives and collectively have sci19 entific expertise in clinical health sciences re20 search, including epidemiology, decisions 

21 sciences, health economics, and statistics. 

22 ‘‘(B) CONFLICTS OF INTEREST.— 

23 ‘‘(i) IN GENERAL.—In appointing 

24 members of the Board under paragraph 

25 (1)(D), the Comptroller General of the 


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1 United States shall take into consideration 

2 any conflicts of interest of potential ap3 pointees. Any conflicts of interest of mem4 bers appointed to the Board under para5 graph (1) shall be disclosed in accordance 

6 with subsection (i)(4)(B). 

7 ‘‘(ii) RECUSAL.—A member of the 

8 Board shall be recused from participating 

9 with respect to a particular research 

10 project or other matter considered by the 

11 Board in carrying out its research project 

12 agenda under subsection (d)(2) in the case 

13 where the member (or an immediate family 

14 member of such member) has a financial 

15 or personal interest directly related to the 

16 research project or the matter that could 

17 affect or be affected by such participation. 

18 ‘‘(3) TERMS.— 

19 ‘‘(A) IN GENERAL.—A member of the 

20 Board appointed under paragraph (1)(D) shall 

21 be appointed for a term of 6 years, except with 

22 respect to the members first appointed under 

23 such paragraph— 

24 ‘‘(i) 6 shall be appointed for a term of 

25 6 years; 


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1 ‘‘(ii) 6 shall be appointed for a term 

2 of 4 years; and 

3 ‘‘(iii) 6 shall be appointed for a term 

4 of 2 years. 

5 ‘‘(B) LIMITATION.—No individual shall be 

6 appointed to the Board under paragraph (1)(D) 

7 for more than 2 terms. 

8 ‘‘(C) EXPIRATION OF TERM.—Any member 

9 of the Board whose term has expired may serve 

10 until such member’s successor has taken office, 

11 or until the end of the calendar year in which 

12 such member’s term has expired, whichever is 

13 earlier. 

14 ‘‘(D) VACANCIES.— 

15 ‘‘(i) IN GENERAL.—Any member ap16 pointed to fill a vacancy prior to the expi17 ration of the term for which such mem18 ber’s predecessor was appointed shall be 

19 appointed for the remainder of such term. 

20 ‘‘(ii) VACANCIES NOT TO AFFECT

21 POWER OF BOARD.—A vacancy on the 

22 Board shall not affect its powers, but shall 

23 be filled in the same manner as the origi24 nal appointment was made. 

25 ‘‘(4) CHAIRPERSON AND VICE-CHAIRPERSON.— 


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1 ‘‘(A) IN GENERAL.—The Comptroller Gen2 eral of the United States shall designate a 

3 Chairperson and Vice-Chairperson of the Board 

4 from among the members of the Board ap5 pointed under paragraph (1)(D). 

6 ‘‘(B) TERM.—The members so designated 

7 shall serve as Chairperson and Vice-Chair8 person of the Board for a period of 3 years. 

9 ‘‘(5) COMPENSATION.— 

10 ‘‘(A) IN GENERAL.—A member of the 

11 Board shall be entitled to compensation at the 

12 per diem equivalent of the rate provided for 

13 level IV of the Executive Schedule under section 

14 5315 of title 5, United States Code. 

15 ‘‘(B) TRAVEL EXPENSES.—While away 

16 from home or regular place of business in the 

17 performance of duties for the Board, each mem18 ber of the Board may receive reasonable travel, 

19 subsistence, and other necessary expenses. 

20 ‘‘(6) DIRECTOR AND STAFF; EXPERTS AND

21 CONSULTANTS.—The Board may— 

22 ‘‘(A) employ and fix the compensation of 

23 an executive director and such other personnel 

24 as may be necessary to carry out the duties of 

25 the Institute; 


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1 ‘‘(B) seek such assistance and support as 

2 may be required in the performance of the du3 ties of the Institute from appropriate depart4 ments and agencies of the Federal Government; 

5 ‘‘(C) enter into contracts or make other ar6 rangements and make such payments as may 

7 be necessary for performance of the duties of 

8 the Institute; 

9 ‘‘(D) provide travel, subsistence, and per 

10 diem compensation for individuals performing 

11 the duties of the Institute, including members 

12 of any expert advisory panel appointed under 

13 subsection (d)(5), members of the methodology 

14 committee established under subsection (d)(7), 

15 and individuals selected to contribute to any 

16 peer-review process under subsection (d)(8); 

17 and 

18 ‘‘(E) prescribe such rules, regulations, and 

19 bylaws as the Board determines necessary with 

20 respect to the internal organization and oper21 ation of the Institute. 

22 ‘‘(7) MEETINGS AND HEARINGS.—The Board 

23 shall meet and hold hearings at the call of the 

24 Chairperson or a majority of its members. In the 

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1 lated to personnel, Board meetings shall be open to 

2 the public and advertised through public notice at 

3 least 7 days prior to the meeting. 

4 ‘‘(8) QUORUM.—A majority of the members of 

5 the Board shall constitute a quorum for purposes of 

6 conducting the duties of the Institute, but a lesser 

7 number of members may meet and hold hearings. 

8 ‘‘(g) FINANCIAL OVERSIGHT.— 

9 ‘‘(1) CONTRACT FOR AUDIT.—The Institute 

10 shall provide for the conduct of financial audits of 

11 the Institute on an annual basis by a private entity 

12 with expertise in conducting financial audits. 

13 ‘‘(2) REVIEW OF AUDIT AND REPORT TO CON14 GRESS.—The Comptroller General of the United 

15 States shall— 

16 ‘‘(A) review the results of the audits con17 ducted under paragraph (1); and 

18 ‘‘(B) submit a report to Congress con19 taining the results of such audits and review. 

20 ‘‘(h) GOVERNMENTAL OVERSIGHT.— 

21 ‘‘(1) REVIEW AND REPORTS.— 

22 ‘‘(A) IN GENERAL.—The Comptroller Gen23 eral of the United States shall review the fol24 lowing: 


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1 ‘‘(i) Processes established by the In2 stitute, including those with respect to the 

3 identification of research priorities under 

4 subsection (d)(1)(A) and the conduct of re5 search projects under this section. Such re6 view shall determine whether information 

7 produced by such research projects— 

8 ‘‘(I) is objective and credible; 

9 ‘‘(II) is produced in a manner 

10 consistent with the requirements 

11 under this section; and 

12 ‘‘(III) is developed through a 

13 transparent process. 

14 ‘‘(ii) The overall effect of the Institute 

15 and the effectiveness of activities con16 ducted under this section, including an as17 sessment of— 

18 ‘‘(I) the utilization of the find19 ings of research conducted under this 

20 section by health care decision mak21 ers; and 

22 ‘‘(II) the effect of the Institute 

23 and such activities on innovation and 

24 on the health economy of the United 

25 States. 


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1 ‘‘(B) REPORTS.—Not later than 5 years 

2 after the date of enactment of this section, and 

3 not less frequently than every 5 years there4 after, the Comptroller General of the United 

5 States shall submit a report to Congress con6 taining the results of the review conducted 

7 under subparagraph (A), together with rec8 ommendations for such legislation and adminis9 trative action as the Comptroller General deter10 mines appropriate. 

11 ‘‘(2) FUNDING ASSESSMENT.— 

12 ‘‘(A) IN GENERAL.—The Comptroller Gen13 eral of the United States shall assess the ade14 quacy and use of funding for the Institute and 

15 activities conducted under this section under 

16 the PCORTF under section 9511 of the Inter17 nal Revenue Code of 1986. Such assessment 

18 shall include a determination as to whether, 

19 based on the utilization of findings by public 

20 and private payers, each of the following are 

21 appropriate sources of funding for the Institute, 

22 including a determination of whether such 

23 sources of funding should be continued or ad24 justed, or whether other sources of funding not 


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1 described in clauses (i) through (iii) would be 

2 appropriate: 

3 ‘‘(i) The transfer of funds from the 

4 Federal Hospital Insurance Trust Fund 

5 under section 1817 and the Federal Sup6 plementary Medical Insurance Trust Fund 

7 under section 1841 to the PCORTF under 

8 section 1183. 

9 ‘‘(ii) The amounts appropriated under 

10 subparagraphs (A), (B), (C), (D)(ii), and 

11 (E)(ii) of subsection (b)(1) of such section 

12 9511. 

13 ‘‘(iii) Private sector contributions 

14 under subparagraphs (D)(i) and (E)(i) of 

15 such subsection (b)(1). 

16 ‘‘(B) REPORT.—Not later than 8 years 

17 after the date of enactment of this section, the 

18 Comptroller General of the United States shall 

19 submit a report to Congress containing the re20 sults of the assessment conducted under sub21 paragraph (A), together with recommendations 

22 for such legislation and administrative action as 

23 the Comptroller General determines appro24 priate. 


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1 ‘‘(i) ENSURING TRANSPARENCY, CREDIBILITY, AND

2 ACCESS.—The Institute shall establish procedures to en3 sure that the following requirements for ensuring trans4 parency, credibility, and access are met: 

5 ‘‘(1) PUBLIC COMMENT PERIODS.— 

6 ‘‘(A) IN GENERAL.—The Institute shall 

7 provide for a public comment period of not less 

8 than 45 and not more than 60 days at the fol9 lowing times: 

10 ‘‘(i) Prior to the adoption of the na11 tional priorities identified under subsection 

12 (d)(1)(A), the research project agenda es13 tablished under subsection (d)(1)(B), the 

14 methodological standards developed and 

15 updated by the methodology committee 

16 under subsection (d)(7)(C)(i), the peer-re17 view process generally provided under sub18 section (d)(8), and dissemination protocols 

19 and strategies developed by the Institute 

20 under subsection (d)(9)(B) in accordance 

21 with subsection (d)(10). 

22 ‘‘(ii) Prior to the finalization of indi23 vidual study designs. 

24 ‘‘(iii) After the release of draft find25 ings with respect to a systematic review 


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1 and assessment of existing research and 

2 evidence under subsection (d)(2)(A)(i). 

3 ‘‘(B) TRANSMISSION OF PUBLIC COM4 MENTS ON STUDY DESIGN.—The Institute shall 

5 transmit public comments submitted during the 

6 public comment period described in subpara7 graph (A)(ii) to the entity conducting research 

8 with respect to which the individual study de9 sign is being finalized. 

10 ‘‘(2) ADDITIONAL FORUMS.—The Institute 

11 shall, in addition to the public comment periods de12 scribed in paragraph (1)(A), support forums to in13 crease public awareness and obtain and incorporate 

14 public input and feedback through media (such as 

15 an Internet website) on the following: 

16 ‘‘(A) The identification of research prior17 ities, including research topics, and the estab18 lishment of the research project agenda under 

19 subparagraphs (A) and (B), respectively, of 

20 subsection (d)(1). 

21 ‘‘(B) Research findings. 

22 ‘‘(C) Any other duties, activities, or proc23 esses the Institute determines appropriate. 

24 ‘‘(3) PUBLIC AVAILABILITY.—The Institute 

25 shall make available to the public and disclose 


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1 through the official public Internet website of the In2 stitute, and through other forums and media the In3 stitute determines appropriate, the following: 

4 ‘‘(A) The process and methods for the con5 duct of research under this section, including— 

6 ‘‘(i) the identity of the entity con7 ducting such research; 

8 ‘‘(ii) any links the entity has to indus9 try (including such links that are not di10 rectly tied to the particular research being 

11 conducted under this section); 

12 ‘‘(iii) draft study designs (including 

13 research questions and the finalized study 

14 design, together with public comments on 

15 such study design and responses to such 

16 comments); 

17 ‘‘(iv) research protocols (including 

18 measures taken, methods of research, 

19 methods of analysis, research results, and 

20 such other information as the Institute de21 termines appropriate) with respect to each 

22 medical treatment, service, and item de23 scribed in subsection (a)(2)(B); 


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1 ‘‘(v) any key decisions made by the 

2 Institute and any appropriate committees 

3 of the Institute; 

4 ‘‘(vi) the identity of investigators con5 ducting such research and any conflicts of 

6 interest of such investigators; and 

7 ‘‘(vii) any progress reports the Insti8 tute determines appropriate. 

9 ‘‘(B) Notice of each of the public comment 

10 periods under paragraph (1)(A), including 

11 deadlines for public comments for such periods. 

12 ‘‘(C) Public comments submitted during 

13 each of the public comment periods under para14 graph (1)(A), including such public comments 

15 submitted on draft findings under clause (iii) of 

16 such paragraph. 

17 ‘‘(D) Bylaws, processes, and proceedings of 

18 the Institute, to the extent practicable and as 

19 the Institute determines appropriate. 

20 ‘‘(E) Not later than 90 days after receipt 

21 by the Institute of a relevant report or research 

22 findings, appropriate information contained in 

23 such report or findings. 

24 ‘‘(4) CONFLICTS OF INTEREST.—The Institute 

25 shall— 


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1 ‘‘(A) in appointing members to an expert 

2 advisory panel under subsection (d)(5) and the 

3 methodology committee under subsection (d)(7), 

4 and in selecting individuals to contribute to any 

5 peer-review process under subsection (d)(8) and 

6 for employment as executive staff of the Insti7 tute, take into consideration any conflicts of in8 terest of potential appointees, participants, and 

9 staff; and 

10 ‘‘(B) include a description of any such con11 flicts of interest and conflicts of interest of 

12 Board members in the annual report under sub13 section (d)(12), except that, in the case of indi14 viduals contributing to any such peer review 

15 process, such description shall be in a manner 

16 such that those individuals cannot be identified 

17 with a particular research project. 

18 ‘‘(j) RULES.— 

19 ‘‘(1) GIFTS.—The Institute, or the Board and 

20 staff of the Institute acting on behalf of the Insti21 tute, may not accept gifts, bequeaths, or donations 

22 of services or property. 

23 ‘‘(2) ESTABLISHMENT AND PROHIBITION ON

24 ACCEPTING OUTSIDE FUNDING OR CONTRIBU25 TIONS.—The Institute may not— 


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1 ‘‘(A) establish a corporation other than as 

2 provided under this section; or 

3 ‘‘(B) accept any funds or contributions 

4 other than as provided under this part. 

5 ‘‘(k) RULES OF CONSTRUCTION.— 

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

7 be construed— 

8 ‘‘(A) to permit the Institute to mandate 

9 coverage, reimbursement, or other policies for 

10 any public or private payer; or 

11 ‘‘(B) as preventing the Secretary from cov12 ering the routine costs of clinical care received 

13 by an individual entitled to, or enrolled for, ben14 efits under title XVIII, XIX, or XXI in the case 

15 where such individual is participating in a clin16 ical trial and such costs would otherwise be cov17 ered under such title with respect to the bene18 ficiary. 

19 ‘‘(2) REPORTS AND FINDINGS.—None of the re20 ports submitted under this section or research find21 ings disseminated by the Institute shall be construed 

22 as mandates, guidelines, or recommendations for 

23 payment, coverage, or treatment. 


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1 ‘‘LIMITATIONS ON USE OF COMPARATIVE EFFECTIVENESS

2 RESEARCH BY THE SECRETARY

3 ‘‘SEC. 1182. The Secretary may only use evidence 

4 and findings from comparative effectiveness research con5 ducted under section 1181 to make a determination re6 garding coverage under title XVIII if such use is through 

7 an iterative and transparent process which meets the fol8 lowing requirements: 

9 ‘‘(1) Stakeholders and other individuals have 

10 the opportunity to provide informed and relevant in11 formation with respect to the determination. 

12 ‘‘(2) Stakeholders and other individuals have 

13 the opportunity to review draft proposals of the de14 termination and submit public comments with re15 spect to such draft proposals. 

16 ‘‘(3) In making the determination, the Sec17 retary considers— 

18 ‘‘(A) all other relevant evidence, studies, 

19 and research in addition to such comparative 

20 effectiveness research; and 

21 ‘‘(B) evidence and research that dem22 onstrates or suggests a benefit of coverage with 

23 respect to a specific subpopulation of individ24 uals, even if the evidence and findings from the 

25 comparative effectiveness research demonstrates 


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1 or suggests that, on average, with respect to the 

2 general population the benefits of coverage do 

3 not exceed the harm. 

4 ‘‘TRUST FUND TRANSFERS TO PATIENT-CENTERED

5 OUTCOMES RESEARCH TRUST FUND

6 ‘‘SEC. 1183. (a) IN GENERAL.—The Secretary shall 

7 provide for the transfer, from the Federal Hospital Insur8 ance Trust Fund under section 1817 and the Federal Sup9 plementary Medical Insurance Trust Fund under section 

10 1841, in proportion (as estimated by the Secretary) to the 

11 total expenditures during such fiscal year that are made 

12 under title XVIII from the respective trust fund, to the 

13 Patient-Centered Outcomes Research Trust Fund (re14 ferred to in this section as the ‘PCORTF’) under section 

15 9511 of the Internal Revenue Code of 1986, the following: 

16 ‘‘(1) For fiscal year 2013, an amount equal to 

17 $1 multiplied by the average number of individuals 

18 entitled to benefits under part A, or enrolled under 

19 part B, of title XVIII during such fiscal year. 

20 ‘‘(2) For each of fiscal years 2014, 2015, 2016, 

21 2017, 2018, and 2019, an amount equal to $2 mul22 tiplied by the average number of individuals entitled 

23 to benefits under part A, or enrolled under part B, 

24 of title XVIII during such fiscal year. 

25 ‘‘(b) ADJUSTMENTS FOR INCREASES IN HEALTH

26 CARE SPENDING.—In the case of any fiscal year beginVerDate Nov 24 2008 03:06 Jun 10, 2009 Jkt 079200 PO 00000 Frm 00048 Fmt 6652 Sfmt 6201 E:\BILLS\S1213.IS S1213

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1 ning after September 30, 2014, the dollar amount in effect 

2 under subsection (a)(2) for such fiscal year shall be equal 

3 to the sum of such dollar amount for the previous fiscal 

4 year (determined after the application of this subsection), 

5 plus an amount equal to the product of— 

6 ‘‘(1) such dollar amount for the previous fiscal 

7 year, multiplied by 

8 ‘‘(2) the percentage increase in the projected 

9 per capita amount of National Health Expenditures 

10 from the calendar year in which the previous fiscal 

11 year ends to the calendar year in which the fiscal 

12 year involved ends, as most recently published by the 

13 Secretary before the beginning of the fiscal year.’’. 

14 (b) COORDINATION WITH PROVIDER EDUCATION

15 AND TECHNICAL ASSISTANCE.—Section 1889(a) of the 

16 Social Security Act (42 U.S.C. 1395zz(a)) is amended by 

17 inserting ‘‘and to enhance the understanding of and utili18 zation by providers of services and suppliers of research 

19 findings disseminated by the Patient-Centered Outcomes 

20 Research Institute established under section 1181’’ before 

21 the period at the end. 

22 (c) PATIENT-CENTERED OUTCOMES RESEARCH

23 TRUST FUND; FINANCING FOR TRUST FUND.— 

24 (1) ESTABLISHMENT OF TRUST FUND.— 


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1 (A) IN GENERAL.—Subchapter A of chap2 ter 98 of the Internal Revenue Code of 1986 

3 (relating to establishment of trust funds) is 

4 amended by adding at the end the following 

5 new section: 

6 ‘‘SEC. 9511. PATIENT-CENTERED OUTCOMES RESEARCH 

7 TRUST FUND. 

8 ‘‘(a) CREATION OF TRUST FUND.—There is estab9 lished in the Treasury of the United States a trust fund 

10 to be known as the ‘Patient-Centered Outcomes Research 

11 Trust Fund’ (hereafter in this section referred to as the 

12 ‘PCORTF’), consisting of such amounts as may be appro13 priated or credited to such Trust Fund as provided in this 

14 section and section 9602(b). 

15 ‘‘(b) TRANSFERS TO FUND.— 

16 ‘‘(1) APPROPRIATION.—There are hereby ap17 propriated to the Trust Fund the following: 

18 ‘‘(A) For fiscal year 2010, $10,000,000. 

19 ‘‘(B) For fiscal year 2011, $50,000,000. 

20 ‘‘(C) For fiscal year 2012, $150,000,000. 

21 ‘‘(D) For fiscal year 2013— 

22 ‘‘(i) an amount equivalent to the net 

23 revenues received in the Treasury from the 

24 fees imposed under subchapter B of chap25 ter 34 (relating to fees on health insurance 


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1 and self-insured plans) for such fiscal year; 

2 and 

3 ‘‘(ii) $150,000,000. 

4 ‘‘(E) For each of fiscal years 2014, 2015, 

5 2016, 2017, 2018, and 2019— 

6 ‘‘(i) an amount equivalent to the net 

7 revenues received in the Treasury from the 

8 fees imposed under subchapter B of chap9 ter 34 (relating to fees on health insurance 

10 and self-insured plans) for such fiscal year; 

11 and 

12 ‘‘(ii) $150,000,000. 

13 The amounts appropriated under subparagraphs 

14 (A), (B), (C), (D)(ii), and (E)(ii) shall be trans15 ferred from the general fund of the Treasury, from 

16 funds not otherwise appropriated. 

17 ‘‘(2) TRUST FUND TRANSFERS.—In addition to 

18 the amounts appropriated under paragraph (1), 

19 there shall be credited to the PCORTF the amounts 

20 transferred under section 1183 of the Social Secu21 rity Act. 

22 ‘‘(3) AMERICAN RECOVERY AND REINVESTMENT

23 FUNDS.—In addition to the amounts appropriated 

24 under paragraph (1) and the amounts credited 

25 under paragraph (2), of amounts appropriated for 


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1 comparative effectiveness research to be allocated at 

2 the discretion of the Secretary of Health and 

3 Human Services under the heading Agency for 

4 Healthcare Research and Quality under the heading 

5 Department of Health and Human Services under 

6 title VIII of Division A of the American Recovery 

7 and Reinvestment Act of 2009 (Public Law 111–5), 

8 $10,000,000 shall be transferred to the Trust Fund. 

9 ‘‘(4) LIMITATION ON TRANSFERS TO PCORTF.— 

10 No amount may be appropriated or transferred to 

11 the PCORTF on and after the date of any expendi12 ture from the PCORTF which is not an expenditure 

13 permitted under this section. The determination of 

14 whether an expenditure is so permitted shall be 

15 made without regard to— 

16 ‘‘(A) any provision of law which is not con17 tained or referenced in this chapter or in a rev18 enue Act, and 

19 ‘‘(B) whether such provision of law is a 

20 subsequently enacted provision or directly or in21 directly seeks to waive the application of this 

22 paragraph. 

23 ‘‘(c) TRUSTEE.—The Secretary of Health and 

24 Human Services shall be a trustee of the PCORTF. 


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1 ‘‘(d) EXPENDITURES FROM FUND.—Amounts in the 

2 PCORTF are available, without further appropriation, to 

3 the Patient-Centered Outcomes Research Institute estab4 lished by section 2(a) of the Patient-Centered Outcomes 

5 Research Act of 2009 for carrying out part D of title XI 

6 of the Social Security Act (as in effect on the date of en7 actment of the Patient-Centered Outcomes Research Act 

8 of 2009). 

9 ‘‘(e) NET REVENUES.—For purposes of this section, 

10 the term ‘net revenues’ means the amount estimated by 

11 the Secretary of the Treasury based on the excess of— 

12 ‘‘(1) the fees received in the Treasury under 

13 subchapter B of chapter 34, over 

14 ‘‘(2) the decrease in the tax imposed by chapter 

15 1 resulting from the fees imposed by such sub16 chapter. 

17 ‘‘(f) TERMINATION.—No amounts shall be available 

18 for expenditure from the PCORTF after September 30, 

19 2019, and any amounts in such Trust Fund after such 

20 date shall be transferred to the general fund of the Treas21 ury.’’. 

22 (B) CLERICAL AMENDMENT.—The table of 

23 sections for subchapter A of chapter 98 of such 

24 Code is amended by adding at the end the fol25 lowing new item: 

‘‘Sec. 9511. Patient-Centered Outcomes Research Trust Fund.’’. 


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1 (2) FINANCING FOR FUND FROM FEES ON IN2 SURED AND SELF-INSURED HEALTH PLANS.— 

3 (A) GENERAL RULE.—Chapter 34 of the 

4 Internal Revenue Code of 1986 is amended by 

5 adding at the end the following new subchapter: 

6 ‘‘Subchapter B—Insured and Self-Insured 

7 Health Plans 

‘‘Sec. 4375. Health insurance. 

‘‘Sec. 4376. Self-insured health plans. 

‘‘Sec. 4377. Definitions and special rules. 

8 ‘‘SEC. 4375. HEALTH INSURANCE. 

9 ‘‘(a) IMPOSITION OF FEE.—There is hereby imposed 

10 on each specified health insurance policy for each policy 

11 year ending after September 30, 2012, a fee equal to the 

12 product of $2 ($1 in the case of policy years ending during 

13 fiscal year 2013) multiplied by the average number of lives 

14 covered under the policy. 

15 ‘‘(b) LIABILITY FOR FEE.—The fee imposed by sub16 section (a) shall be paid by the issuer of the policy. 

17 ‘‘(c) SPECIFIED HEALTH INSURANCE POLICY.—For 

18 purposes of this section: 

19 ‘‘(1) IN GENERAL.—Except as otherwise pro20 vided in this section, the term ‘specified health in21 surance policy’ means any accident or health insur22 ance policy (including a policy under a group health 

23 plan) issued with respect to individuals residing in 

24 the United States. 


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1 ‘‘(2) EXEMPTION FOR CERTAIN POLICIES.—The 

2 term ‘specified health insurance policy’ does not in3 clude any insurance if substantially all of its cov4 erage is of excepted benefits described in section 

5 9832(c). 

6 ‘‘(3) TREATMENT OF PREPAID HEALTH COV7 ERAGE ARRANGEMENTS.— 

8 ‘‘(A) IN GENERAL.—In the case of any ar9 rangement described in subparagraph (B)— 

10 ‘‘(i) such arrangement shall be treated 

11 as a specified health insurance policy, and 

12 ‘‘(ii) the person referred to in such 

13 subparagraph shall be treated as the 

14 issuer. 

15 ‘‘(B) DESCRIPTION OF ARRANGEMENTS.— 

16 An arrangement is described in this subpara17 graph if under such arrangement fixed pay18 ments or premiums are received as consider19 ation for any person’s agreement to provide or 

20 arrange for the provision of accident or health 

21 coverage to residents of the United States, re22 gardless of how such coverage is provided or ar23 ranged to be provided. 

24 ‘‘(d) ADJUSTMENTS FOR INCREASES IN HEALTH

25 CARE SPENDING.—In the case of any policy year ending 


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1 in any fiscal year beginning after September 30, 2014, the 

2 dollar amount in effect under subsection (a) for such pol3 icy year shall be equal to the sum of such dollar amount 

4 for policy years ending in the previous fiscal year (deter5 mined after the application of this subsection), plus an 

6 amount equal to the product of— 

7 ‘‘(1) such dollar amount for policy years ending 

8 in the previous fiscal year, multiplied by 

9 ‘‘(2) the percentage increase in the projected 

10 per capita amount of National Health Expenditures 

11 from the calendar year in which the previous fiscal 

12 year ends to the calendar year in which the fiscal 

13 year involved ends, as most recently published by the 

14 Secretary of Health and Human Services before the 

15 beginning of the fiscal year. 

16 ‘‘(e) TERMINATION.—This section shall not apply to 

17 policy years ending after September 30, 2019. 

18 ‘‘SEC. 4376. SELF-INSURED HEALTH PLANS. 

19 ‘‘(a) IMPOSITION OF FEE.—In the case of any appli20 cable self-insured health plan for each plan year ending 

21 after September 30, 2012, there is hereby imposed a fee 

22 equal to $2 ($1 in the case of plan years ending during 

23 fiscal year 2013) multiplied by the average number of lives 

24 covered under the plan. 

25 ‘‘(b) LIABILITY FOR FEE.— 


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1 ‘‘(1) IN GENERAL.—The fee imposed by sub2 section (a) shall be paid by the plan sponsor. 

3 ‘‘(2) PLAN SPONSOR.—For purposes of para4 graph (1) the term ‘plan sponsor’ means— 

5 ‘‘(A) the employer in the case of a plan es6 tablished or maintained by a single employer, 

7 ‘‘(B) the employee organization in the case 

8 of a plan established or maintained by an em9 ployee organization, 

10 ‘‘(C) in the case of— 

11 ‘‘(i) a plan established or maintained 

12 by 2 or more employers or jointly by 1 or 

13 more employers and 1 or more employee 

14 organizations, 

15 ‘‘(ii) a multiple employer welfare ar16 rangement, or 

17 ‘‘(iii) a voluntary employees’ bene18 ficiary association described in section 

19 501(c)(9), 

20 the association, committee, joint board of trust21 ees, or other similar group of representatives of 

22 the parties who establish or maintain the plan, 

23 or 

24 ‘‘(D) the cooperative or association de25 scribed in subsection (c)(2)(F) in the case of a 


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1 plan established or maintained by such a coop2 erative or association. 

3 ‘‘(c) APPLICABLE SELF-INSURED HEALTH PLAN.— 

4 For purposes of this section, the term ‘applicable self-in5 sured health plan’ means any plan for providing accident 

6 or health coverage if— 

7 ‘‘(1) any portion of such coverage is provided 

8 other than through an insurance policy, and 

9 ‘‘(2) such plan is established or maintained— 

10 ‘‘(A) by one or more employers for the 

11 benefit of their employees or former employees, 

12 ‘‘(B) by one or more employee organiza13 tions for the benefit of their members or former 

14 members, 

15 ‘‘(C) jointly by 1 or more employers and 1 

16 or more employee organizations for the benefit 

17 of employees or former employees, 

18 ‘‘(D) by a voluntary employees’ beneficiary 

19 association described in section 501(c)(9), 

20 ‘‘(E) by any organization described in sec21 tion 501(c)(6), or 

22 ‘‘(F) in the case of a plan not described in 

23 the preceding subparagraphs, by a multiple em24 ployer welfare arrangement (as defined in sec25 tion 3(40) of Employee Retirement Income SeVerDate Nov 24 2008 03:06 Jun 10, 2009 Jkt 079200 PO 00000 Frm 00058 Fmt 6652 Sfmt 6201 E:\BILLS\S1213.IS S1213

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1 curity Act of 1974), a rural electric cooperative 

2 (as defined in section 3(40)(B)(iv) of such Act), 

3 or a rural telephone cooperative association (as 

4 defined in section 3(40)(B)(v) of such Act). 

5 ‘‘(d) ADJUSTMENTS FOR INCREASES IN HEALTH

6 CARE SPENDING.—In the case of any plan year ending 

7 in any fiscal year beginning after September 30, 2014, the 

8 dollar amount in effect under subsection (a) for such plan 

9 year shall be equal to the sum of such dollar amount for 

10 plan years ending in the previous fiscal year (determined 

11 after the application of this subsection), plus an amount 

12 equal to the product of— 

13 ‘‘(1) such dollar amount for plan years ending 

14 in the previous fiscal year, multiplied by 

15 ‘‘(2) the percentage increase in the projected 

16 per capita amount of National Health Expenditures 

17 from the calendar year in which the previous fiscal 

18 year ends to the calendar year in which the fiscal 

19 year involved ends, as most recently published by the 

20 Secretary of Health and Human Services before the 

21 beginning of the fiscal year. 

22 ‘‘(e) TERMINATION.—This section shall not apply to 

23 plan years ending after September 30, 2019. 


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1 ‘‘SEC. 4377. DEFINITIONS AND SPECIAL RULES. 

2 ‘‘(a) DEFINITIONS.—For purposes of this sub3 chapter— 

4 ‘‘(1) ACCIDENT AND HEALTH COVERAGE.—The 

5 term ‘accident and health coverage’ means any cov6 erage which, if provided by an insurance policy, 

7 would cause such policy to be a specified health in8 surance policy (as defined in section 4375(c)). 

9 ‘‘(2) INSURANCE POLICY.—The term ‘insurance 

10 policy’ means any policy or other instrument where11 by a contract of insurance is issued, renewed, or ex12 tended. 

13 ‘‘(3) UNITED STATES.—The term ‘United 

14 States’ includes any possession of the United States. 

15 ‘‘(b) TREATMENT OF GOVERNMENTAL ENTITIES.— 

16 ‘‘(1) IN GENERAL.—For purposes of this sub17 chapter— 

18 ‘‘(A) the term ‘person’ includes any gov19 ernmental entity, and 

20 ‘‘(B) notwithstanding any other law or rule 

21 of law, governmental entities shall not be ex22 empt from the fees imposed by this subchapter 

23 except as provided in paragraph (2). 

24 ‘‘(2) TREATMENT OF EXEMPT GOVERNMENTAL

25 PROGRAMS.—In the case of an exempt governmental 

26 program, no fee shall be imposed under section 4375 


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1 or section 4376 on any covered life under such pro2 gram. 

3 ‘‘(3) EXEMPT GOVERNMENTAL PROGRAM DE4 FINED.—For purposes of this subchapter, the term 

5 ‘exempt governmental program’ means— 

6 ‘‘(A) any insurance program established 

7 under title XVIII of the Social Security Act, 

8 ‘‘(B) the medical assistance program es9 tablished by title XIX or XXI of the Social Se10 curity Act, 

11 ‘‘(C) any program established by Federal 

12 law for providing medical care (other than 

13 through insurance policies) to individuals (or 

14 the spouses and dependents thereof) by reason 

15 of such individuals being— 

16 ‘‘(i) members of the Armed Forces of 

17 the United States, or 

18 ‘‘(ii) veterans, and 

19 ‘‘(D) any program established by Federal 

20 law for providing medical care (other than 

21 through insurance policies) to members of In22 dian tribes (as defined in section 4(d) of the In23 dian Health Care Improvement Act). 


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1 ‘‘(c) TREATMENT AS TAX.—For purposes of subtitle 

2 F, the fees imposed by this subchapter shall be treated 

3 as if they were taxes. 

4 ‘‘(d) NO COVER OVER TO POSSESSIONS.—Notwith5 standing any other provision of law, no amount collected 

6 under this subchapter shall be covered over to any posses7 sion of the United States.’’. 

8 (B) CLERICAL AMENDMENTS.— 

9 (i) Chapter 34 of such Code is amend10 ed by striking the chapter heading and in11 serting the following: 

12 ‘‘CHAPTER 34—TAXES ON CERTAIN 

13 INSURANCE POLICIES 

‘‘SUBCHAPTER A. POLICIES ISSUED BY FOREIGN INSURERS

‘‘SUBCHAPTER B. INSURED AND SELF-INSURED HEALTH PLANS

14 ‘‘Subchapter A—Policies Issued By Foreign 

15 Insurers’’. 

16 (ii) The table of chapters for subtitle 

17 D of such Code is amended by striking the 

18 item relating to chapter 34 and inserting 

19 the following new item: 

‘‘CHAPTER 34—TAXES ON CERTAIN INSURANCE POLICIES’’. 


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1 SEC. 3. COORDINATION WITH FEDERAL COORDINATING 

2 COUNCIL FOR COMPARATIVE EFFECTIVE3 NESS RESEARCH. 

4 Section 804 of Division A of the American Recovery 

5 and Reinvestment Act of 2009 (42 U.S.C. 299b–8) is 

6 amended— 

7 (1) in subsection (c)— 

8 (A) in paragraph (1), by striking ‘‘and’’ at 

9 the end; 

10 (B) in paragraph (2), by striking the pe11 riod at the end and inserting ‘‘; and’’; and 

12 (C) by adding at the end the following new 

13 paragraph: 

14 ‘‘(3) provide support to the Patient-Centered 

15 Outcomes Research Institute established under sec16 tion 1181(b)(1) of the Social Security Act (referred 

17 to in this section as the ‘Institute’).’’; 

18 (2) in subsection (d)(2)— 

19 (A) by redesignating subparagraph (B) as 

20 subparagraph (C); and 

21 (B) by inserting after subparagraph (A) 

22 the following new subparagraph: 

23 ‘‘(B) INCLUSION OF CHAIRPERSON OF THE

24 BOARD OF GOVERNORS OF THE PATIENT-CEN25 TERED OUTCOMES RESEARCH INSTITUTE.—In 

26 the case where the Chairperson of the Board of 


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1 Governors of the Patient-Centered Outcomes 

2 Research Institute established under section 

3 1181(f) of the Social Security Act is a senior 

4 Federal officer or employee with responsibility 

5 for a health-related program, the members of 

6 the council shall include such Chairperson.’’. 

7 (3) in subsection (e)(2), by striking ‘‘regarding 

8 its activities’’ and all that follows through the period 

9 at the end and inserting ‘‘containing— 

10 ‘‘(A) an inventory of its activities with re11 spect to comparative effectiveness research con12 ducted by relevant Federal departments and 

13 agencies; and 

14 ‘‘(B) recommendations concerning better 

15 coordination of comparative effectiveness re16 search by such departments and agencies.’’; 

17 (4) by redesignating subsection (g) as sub18 section (h); and 

19 (5) by inserting after subsection (f) the fol20 lowing new subsection: 

21 ‘‘(g) COORDINATION WITH THE PATIENT-CENTERED

22 OUTCOMES RESEARCH INSTITUTE.—The Council shall co23 ordinate with the Institute in carrying out its duties under 

24 this section.’’. 


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1 SEC. 4. GAO REPORT ON NATIONAL COVERAGE DETER2 MINATIONS PROCESS. 

3 Not later than 18 months after the date of enactment 

4 of this Act, the Comptroller General of the United States 

5 shall submit a report to Congress on the process for mak6 ing national coverage determinations (as defined in section 

7 1869(f)(1)(B) of the Social Security Act (42 U.S.C. 

8 1395ff(f)(1)(B))) under the Medicare program under title 

9 XVIII of the Social Security Act. Such report shall include 

10 a determination whether, in initiating and conducting such 

11 process, the Secretary of Health and Human Services has 

12 complied with applicable law and regulations, including re13 quirements for consultation with appropriate outside ex14 perts, providing appropriate notice and comment opportu15 nities to the public, and making information and data 

16 (other than proprietary data) considered in making such 

17 determinations available to the public and to nonvoting 

18 members of any advisory committees established to advise 

19 the Secretary with respect to such determinations. 

Æ 


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