42 U.S.C. § 1320e — Comparative clinical effectiveness re-

Page 2764 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1320e 1 See References in Text note below. or issuer of a medicare supplemental policy of protected health information that is genetic information about an individual for under- writing purposes under the group health plan, health insurance coverage, or medicare supple- mental policy shall not be a permitted use or disclosure. (b) Definitions For purposes of this section: (1) Genetic information; genetic test; family member The terms ‘‘genetic information’’, ‘‘genetic test’’, and ‘‘family member’’ have the mean- ings given such terms in section 300gg–91 of this title, as amended by the Genetic Informa- tion Nondiscrimination Act of 2007.1 (2) Group health plan; health insurance cov- erage; medicare supplemental policy The terms ‘‘group health plan’’ and ‘‘health insurance coverage’’ have the meanings given such terms under section 300gg–91 of this title, and the term ‘‘medicare supplemental policy’’ has the meaning given such term in section 1395ss(g) of this title. (3) HIPAA privacy regulation The term ‘‘HIPAA privacy regulation’’ means the regulations promulgated by the Secretary under this part and section 264 of the Health Insurance Portability and Account- ability Act of 1996 (42 U.S.C. 1320d–2 note). (4) Underwriting purposes The term ‘‘underwriting purposes’’ means, with respect to a group health plan, health in- surance coverage, or a medicare supplemental policy— (A) rules for, or determination of, eligi- bility (including enrollment and continued eligibility) for, or determination of, benefits under the plan, coverage, or policy; (B) the computation of premium or con- tribution amounts under the plan, coverage, or policy; (C) the application of any pre-existing con- dition exclusion under the plan, coverage, or policy; and (D) other activities related to the creation, renewal, or replacement of a contract of health insurance or health benefits. (c) Procedure The revisions under subsection (a) shall be made by notice in the Federal Register pub- lished not later than 60 days after May 21, 2008, and shall be effective upon publication, without opportunity for any prior public comment, but may be revised, consistent with this section, after opportunity for public comment. (d) Enforcement In addition to any other sanctions or remedies that may be available under law, a covered enti- ty that is a group health plan, health insurance issuer, or issuer of a medicare supplemental pol- icy and that violates the HIPAA privacy regula- tion (as revised under subsection (a) or other- wise) with respect to the use or disclosure of ge- netic information shall be subject to the pen- alties described in sections 1320d–5 and 1320d–6 of this title in the same manner and to the same extent that such penalties apply to violations of this part. (Aug. 14, 1935, ch. 531, title XI, § 1180, as added Pub. L. 110–233, title I, § 105(a), May 21, 2008, 122 Stat. 903.) Editorial Notes REFERENCES IN TEXT The Genetic Information Nondiscrimination Act of 2007, referred to in subsec. (b)(1), probably means the Genetic Information Nondiscrimination Act of 2008, Pub. L. 110–233, May 21, 2008, 122 Stat. 881. For complete classification of this Act to the Code, see Short Title note set out under section 2000ff of this title and Ta- bles. Section 264 of the Health Insurance Portability and Accountability Act of 1996, referred to in subsec. (b)(3), is section 264 of Pub. L. 104–191, which is set out as a note under section 1320d–2 of this title. Statutory Notes and Related Subsidiaries EFFECTIVE DATE Pub. L. 110–233, title I, § 105(b)(2), May 21, 2008, 122 Stat. 905, provided that: ‘‘The amendment made by sub- section (a) [enacting this section] shall take effect on the date that is 1 year after the date of the enactment of this Act [May 21, 2008].’’ REGULATIONS Pub. L. 110–233, title I, § 105(b)(1), May 21, 2008, 122 Stat. 905, provided that: ‘‘Not later than 12 months after the date of the enactment of this Act [May 21, 2008], the Secretary of Health and Human Services shall issue final regulations to carry out the revision re- quired by section 1180(a) of the Social Security Act [42 U.S.C. 1320d–9(a)], as added by subsection (a). The Sec- retary has the sole authority to promulgate such regu- lations, but shall promulgate such regulations in con- sultation with the Secretaries of Labor and the Treas- ury.’’ PART D—COMPARATIVE CLINICAL EFFECTIVENESS RESEARCH § 1320e. Comparative clinical effectiveness re- search (a) Definitions In this section: (1) Board The term ‘‘Board’’ means the Board of Gov- ernors established under subsection (f). (2) Comparative clinical effectiveness research; research (A) In general The terms ‘‘comparative clinical effective- ness research’’ and ‘‘research’’ mean re- search evaluating and comparing health out- comes and the clinical effectiveness, risks, and benefits of 2 or more medical treat- ments, services, and items described in sub- paragraph (B). (B) Medical treatments, services, and items described The medical treatments, services, and items described in this subparagraph are health care interventions, protocols for Page 2765 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1320e 1 So in original. Probably should be ‘‘has’’. 2 See References in Text note below. treatment, care management, and delivery, procedures, medical devices, diagnostic tools, pharmaceuticals (including drugs and biologicals), integrative health practices, and any other strategies or items being used in the treatment, management, and diag- nosis of, or prevention of illness or injury in, individuals. (3) Conflict of interest The term ‘‘conflict of interest’’ means an as- sociation, including a financial or personal as- sociation, that have 1 the potential to bias or have 1 the appearance of biasing an individ- ual’s decisions in matters related to the Insti- tute or the conduct of activities under this section. (4) Real conflict of interest The term ‘‘real conflict of interest’’ means any instance where a member of the Board, the methodology committee established under subsection (d)(6), or an advisory panel ap- pointed under subsection (d)(4), or a close rel- ative of such member, has received or could receive either of the following: (A) A direct financial benefit of any amount deriving from the result or findings of a study conducted under this section. (B) A financial benefit from individuals or companies that own or manufacture medical treatments, services, or items to be studied under this section that in the aggregate ex- ceeds $10,000 per year. For purposes of the preceding sentence, a financial benefit in- cludes honoraria, fees, stock, or other finan- cial benefit and the current value of the member or close relative’s already existing stock holdings, in addition to any direct fi- nancial benefit deriving from the results or findings of a study conducted under this sec- tion. (b) Patient-Centered Outcomes Research Insti- tute (1) Establishment There is authorized to be established a non- profit corporation, to be known as the ‘‘Pa- tient-Centered Outcomes Research Institute’’ (referred to in this section as the ‘‘Institute’’) which is neither an agency nor establishment of the United States Government. (2) Application of provisions The Institute shall be subject to the provi- sions of this section, and, to the extent con- sistent with this section, to the District of Co- lumbia Nonprofit Corporation Act. (3) Funding of comparative clinical effective- ness research For fiscal year 2010 and each subsequent fis- cal year, amounts in the Patient-Centered Outcomes Research Trust Fund (referred to in this section as the ‘‘PCORTF’’) under section 9511 of the Internal Revenue Code of 1986 shall be available, without further appropriation, to the Institute to carry out this section. (c) Purpose The purpose of the Institute is to assist pa- tients, clinicians, purchasers, and policy-makers in making informed health decisions by advanc- ing the quality and relevance of evidence con- cerning the manner in which diseases, disorders, and other health conditions can effectively and appropriately be prevented, diagnosed, treated, monitored, and managed through research and evidence synthesis that considers variations in patient subpopulations, and the dissemination of research findings with respect to the relative health outcomes, clinical effectiveness, and ap- propriateness of the medical treatments, serv- ices, and items described in subsection (a)(2)(B). (d) Duties (1) Identifying research priorities and estab- lishing research project agenda (A) Identifying research priorities The Institute shall identify national prior- ities for research, taking into account fac- tors of disease incidence, prevalence, and burden in the United States (with emphasis on chronic conditions), gaps in evidence in terms of clinical outcomes, practice vari- ations and health disparities in terms of de- livery and outcomes of care, the potential for new evidence to improve patient health, well-being, and the quality of care, the effect on national expenditures associated with a health care treatment, strategy, or health conditions, as well as patient needs, out- comes, and preferences, the relevance to pa- tients and clinicians in making informed health decisions, and priorities in the Na- tional Strategy for quality care established under section 399H 2 of the Public Health Service Act that are consistent with this section. Such national priorities shall in- clude research with respect to intellectual and developmental disabilities and maternal mortality. Such priorities should reflect a balance between long-term priorities and short-term priorities, and be responsive to changes in medical evidence and in health care treatments. (B) Establishing research project agenda The Institute shall establish and update a research project agenda for research to ad- dress the priorities identified under subpara- graph (A), taking into consideration the types of research that might address each priority and the relative value (determined based on the cost of conducting research compared to the potential usefulness of the information produced by research) associ- ated with the different types of research, and such other factors as the Institute deter- mines appropriate. (2) Carrying out research project agenda (A) Research The Institute shall carry out the research project agenda established under paragraph (1)(B) in accordance with the methodological standards adopted under paragraph (9) using methods, including the following: (i) Systematic reviews and assessments of existing and future research and evi- dence including original research con- ducted subsequent to March 23, 2010. Page 2766 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1320e (ii) Primary research, such as random- ized clinical trials, molecularly informed trials, and observational studies. (iii) Any other methodologies rec- ommended by the methodology committee established under paragraph (6) that are adopted by the Board under paragraph (9). (B) Contracts for the management of funding and conduct of research (i) Contracts (I) In general In accordance with the research project agenda established under para- graph (1)(B), the Institute shall enter into contracts for the management of funding and conduct of research in ac- cordance with the following: (aa) Appropriate agencies and instru- mentalities of the Federal Govern- ment. (bb) Appropriate academic research, private sector research, or study-con- ducting entities. (II) Preference In entering into contracts under sub- clause (I), the Institute shall give pref- erence to the Agency for Healthcare Re- search and Quality and the National In- stitutes of Health, but only if the re- search to be conducted or managed under such contract is authorized by the gov- erning statutes of such Agency or Insti- tutes. (ii) Conditions for contracts A contract entered into under this sub- paragraph shall require that the agency, instrumentality, or other entity— (I) abide by the transparency and con- flicts of interest requirements under sub- section (h) that apply to the Institute with respect to the research managed or conducted under such contract; (II) comply with the methodological standards adopted under paragraph (9) with respect to such research; (III) consult with the expert advisory panels for clinical trials and rare disease appointed under clauses (ii) and (iii), re- spectively, of paragraph (4)(A); (IV) subject to clause (iv), permit a re- searcher who conducts original research, as described in subparagraph (A)(ii), under the contract for the agency, in- strumentality, or other entity to have such research published in a peer-re- viewed journal or other publication, as long as the researcher enters into a data use agreement with the Institute for use of the data from the original research, as appropriate; (V) have appropriate processes in place to manage data privacy and meet ethical standards for the research; (VI) comply with the requirements of the Institute for making the information available to the public under paragraph (8); and (VII) comply with other terms and con- ditions determined necessary by the In- stitute to carry out the research agenda adopted under paragraph (2). (iii) Coverage of copayments or coinsur- ance A contract entered into under this sub- paragraph may allow for the coverage of copayments or coinsurance, or allow for other appropriate measures, to the extent that such coverage or other measures are necessary to preserve the validity of a re- search project, such as in the case where the research project must be blinded. (iv) Subsequent use of the data The Institute shall not allow the subse- quent use of data from original research in work-for-hire contracts with individuals, entities, or instrumentalities that have a financial interest in the results, unless ap- proved under a data use agreement with the Institute. (C) Review and update of evidence The Institute shall review and update evi- dence on a periodic basis as appropriate. (D) Taking into account potential differences Research shall be designed, as appropriate, to take into account the potential for dif- ferences in the effectiveness of health care treatments, services, and items as used with various subpopulations, such as racial and ethnic minorities, women, age, and groups of individuals with different comorbidities, ge- netic and molecular sub-types, or quality of life preferences and include members of such subpopulations as subjects in the research as feasible and appropriate. (E) Differences in treatment modalities Research shall be designed, as appropriate, to take into account different characteris- tics of treatment modalities that may affect research outcomes, such as the phase of the treatment modality in the innovation cycle and the impact of the skill of the operator of the treatment modality. (F) Consideration of full range of outcomes data Research shall be designed, as appropriate, to take into account and capture the full range of clinical and patient-centered out- comes relevant to, and that meet the needs of, patients, clinicians, purchasers, and pol- icy-makers in making informed health deci- sions. In addition to the relative health out- comes and clinical effectiveness, clinical and patient-centered outcomes shall include the potential burdens and economic impacts of the utilization of medical treatments, items, and services on different stakeholders and decision-makers respectively. These poten- tial burdens and economic impacts include medical out-of-pocket costs, including health plan benefit and formulary design, non-medical costs to the patient and family, including caregiving, effects on future costs of care, workplace productivity and absen- teeism, and healthcare utilization. Page 2767 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1320e 3 So in original. Probably should be ‘‘clause’’. (3) Data collection (A) In general The Secretary shall, with appropriate safe- guards for privacy, make available to the In- stitute such data collected by the Centers for Medicare & Medicaid Services under the programs under subchapters XVIII, XIX, and XXI, as well as provide access to the data networks developed under section 937(f) of the Public Health Service Act [42 U.S.C. 299b–37(f)], as the Institute and its contrac- tors may require to carry out this section. The Institute may also request and obtain data from Federal, State, or private entities, including data from clinical databases and registries. (B) Use of data The Institute shall only use data provided to the Institute under subparagraph (A) in accordance with laws and regulations gov- erning the release and use of such data, in- cluding applicable confidentiality and pri- vacy standards. (4) Appointing expert advisory panels (A) Appointment (i) In general The Institute may appoint permanent or ad hoc expert advisory panels as deter- mined appropriate to assist in identifying research priorities and establishing the re- search project agenda under paragraph (1) and for other purposes. (ii) Expert advisory panels for clinical trials The Institute shall appoint expert advi- sory panels in carrying out randomized clinical trials under the research project agenda under paragraph (2)(A)(ii). Such ex- pert advisory panels shall advise the Insti- tute and the agency, instrumentality, or entity conducting the research on the re- search question involved and the research design or protocol, including important patient subgroups and other parameters of the research. Such panels shall be avail- able as a resource for technical questions that may arise during the conduct of such research. (iii) Expert advisory panel for rare disease In the case of a research study for rare disease, the Institute shall appoint an ex- pert advisory panel for purposes of assist- ing in the design of the research study and determining the relative value and feasi- bility of conducting the research study. (B) Composition An expert advisory panel appointed under subparagraph (A) shall include representa- tives of practicing and research clinicians, patients, and experts in scientific and health services research, health services delivery, and evidence-based medicine who have expe- rience in the relevant topic, and as appro- priate, experts in integrative health and pri- mary prevention strategies. The Institute may include a technical expert of each man- ufacturer or each medical technology that is included under the relevant topic, project, or category for which the panel is established. (5) Supporting patient and consumer rep- resentatives The Institute shall provide support and re- sources to help patient and consumer rep- resentatives effectively participate on the Board and expert advisory panels appointed by the Institute under paragraph (4). (6) Establishing methodology committee (A) In general The Institute shall establish a standing methodology committee to carry out the functions described in subparagraph (C). (B) Appointment and composition The methodology committee established under subparagraph (A) shall be composed of not more than 15 members appointed by the Board. Members appointed to the method- ology committee shall be experts in their scientific field, such as health services re- search, clinical research, comparative clin- ical effectiveness research, biostatistics, genomics, and research methodologies. Stakeholders with such expertise may be ap- pointed to the methodology committee. In addition to the members appointed under the first sentence, the Directors of the Na- tional Institutes of Health and the Agency for Healthcare Research and Quality (or their designees) shall each be included as members of the methodology committee. (C) Functions Subject to subparagraph (D), the method- ology committee shall work to develop and improve the science and methods of com- parative clinical effectiveness research by, not later than 18 months after the establish- ment of the Institute, directly or through subcontract, developing and periodically up- dating the following: (i) Methodological standards for re- search. Such methodological standards shall provide specific criteria for internal validity, generalizability, feasibility, and timeliness of research and for health out- comes measures, risk adjustment, and other relevant aspects of research and as- sessment with respect to the design of re- search. Any methodological standards de- veloped and updated under this subclause 3 shall be scientifically based and include methods by which new information, data, or advances in technology are considered and incorporated into ongoing research projects by the Institute, as appropriate. The process for developing and updating such standards shall include input from relevant experts, stakeholders, and deci- sionmakers, and shall provide opportuni- ties for public comment. Such standards shall also include methods by which pa- tient subpopulations can be accounted for and evaluated in different types of re- search. As appropriate, such standards Page 2768 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1320e shall build on existing work on methodo- logical standards for defined categories of health interventions and for each of the major categories of comparative clinical effectiveness research methods (deter- mined as of March 23, 2010). (ii) A translation table that is designed to provide guidance and act as a reference for the Board to determine research meth- ods that are most likely to address each specific research question. (D) Consultation and conduct of examina- tions The methodology committee may consult and contract with the Institute of Medicine of the National Academies and academic, nonprofit, or other private and govern- mental entities with relevant expertise to carry out activities described in subpara- graph (C) and may consult with relevant stakeholders to carry out such activities. (E) Reports The methodology committee shall submit reports to the Board on the committee’s per- formance of the functions described in sub- paragraph (C). Reports shall contain rec- ommendations for the Institute to adopt methodological standards developed and up- dated by the methodology committee as well as other actions deemed necessary to comply with such methodological standards. (7) Providing for a peer-review process for pri- mary research (A) In general The Institute shall ensure that there is a process for peer review of primary research described in subparagraph (A)(ii) of para- graph (2) that is conducted under such para- graph. Under such process— (i) evidence from such primary research shall be reviewed to assess scientific integ- rity and adherence to methodological standards adopted under paragraph (9); and (ii) a list of the names of individuals con- tributing to any peer-review process dur- ing the preceding year or years shall be made public and included in annual re- ports in accordance with paragraph (10)(D). (B) Composition Such peer-review process shall be designed in a manner so as to avoid bias and conflicts of interest on the part of the reviewers and shall be composed of experts in the scientific field relevant to the research under review. (C) Use of existing processes (i) Processes of another entity In the case where the Institute enters into a contract or other agreement with another entity for the conduct or manage- ment of research under this section, the Institute may utilize the peer-review proc- ess of such entity if such process meets the requirements under subparagraphs (A) and (B). (ii) Processes of appropriate medical jour- nals The Institute may utilize the peer-re- view process of appropriate medical jour- nals if such process meets the require- ments under subparagraphs (A) and (B). (8) Release of research findings (A) In general The Institute shall, not later than 90 days after the conduct or receipt of research find- ings under this part, make such research findings available to clinicians, patients, and the general public. The Institute shall ensure that the research findings— (i) convey the findings of research in a manner that is comprehensible and useful to patients and providers in making health care decisions; (ii) fully convey findings and discuss considerations specific to certain sub- populations, risk factors, and comorbidities, as appropriate; (iii) include limitations of the research and what further research may be needed as appropriate; (iv) do not include practice guidelines, coverage recommendations, payment, or policy recommendations; and (v) not include any data which would violate the privacy of research partici- pants or any confidentiality agreements made with respect to the use of data under this section. (B) Definition of research findings In this paragraph, the term ‘‘research find- ings’’ means the results of a study or assess- ment. (9) Adoption Subject to subsection (h)(1), the Institute shall adopt the national priorities identified under paragraph (1)(A), the research project agenda established under paragraph (1)(B), the methodological standards developed and up- dated by the methodology committee under paragraph (6)(C)(i), and any peer-review proc- ess provided under paragraph (7) by majority vote. In the case where the Institute does not adopt such processes in accordance with the preceding sentence, the processes shall be re- ferred to the appropriate staff or entity within the Institute (or, in the case of the methodo- logical standards, the methodology com- mittee) for further review. (10) Annual reports The Institute shall submit an annual report to Congress and the President, and shall make the annual report available to the public. Such report shall contain— (A) a description of the activities con- ducted under this section, research priorities identified under paragraph (1)(A) and meth- odological standards developed and updated by the methodology committee under para- graph (6)(C)(i) that are adopted under para- graph (9) during the preceding year; (B) the research project agenda and budget of the Institute for the following year; (C) any administrative activities con- ducted by the Institute during the preceding year; (D) the names of individuals contributing to any peer-review process under paragraph Page 2769 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1320e 4 So in original. Probably should be preceded by ‘‘the’’. 5 So in original. (7), without identifying them with a par- ticular research project; and (E) any other relevant information (in- cluding information on the membership of the Board, expert advisory panels, method- ology committee, and the executive staff of the Institute, any conflicts of interest with respect to these individuals, and any bylaws adopted by the Board during the preceding year). (e) Administration (1) In general Subject to paragraph (2), the Board shall carry out the duties of the Institute. (2) Nondelegable duties The activities described in subsections (d)(1) and (d)(9) are nondelegable. (f) Board of Governors (1) In general The Institute shall have a Board of Gov- ernors, which shall consist of the following members: (A) The Director of Agency 4 for Healthcare Research and Quality (or the Di- rector’s designee). (B) The Director of the National Institutes of Health (or the Director’s designee). (C) At least nineteen, but no more than twenty-one members appointed by the Comptroller General of the United States as follows: (i) 3 members representing patients and health care consumers. (ii) 7 members representing physicians and providers, including 4 members rep- resenting physicians (at least 1 of whom is a surgeon), 1 nurse, 1 State-licensed inte- grative health care practitioner, and 1 rep- resentative of a hospital. (iii) at least 3, but no more than 5 mem- bers representing private payers, of whom at least 1 member shall represent health insurance issuers and at least 1 member shall represent employers who self-insure employee benefits. (iv) 3 members representing pharma- ceutical, device, and diagnostic manufac- turers or developers. (v) 1 member representing quality im- provement or independent health service researchers. (vi) 2 members representing the Federal Government or the States, including at least 1 member representing a Federal health program or agency. (2) Qualifications The Board shall represent a broad range of perspectives and collectively have scientific expertise in clinical health sciences research, including epidemiology, decisions sciences, health economics, and statistics. In appoint- ing the Board, the Comptroller General of the United States shall consider and disclose any conflicts of interest in accordance with sub- section (h)(4)(B). Members of the Board shall be recused from relevant Institute activities in the case where the member (or an imme- diate family member of such member) has a real conflict of interest directly related to the research project or the matter that could af- fect or be affected by such participation. (3) Terms; vacancies A member of the Board shall be appointed for a term of 6 years, except with respect to members first appointed, whose terms of ap- pointment shall be staggered evenly over 2- year increments to the extent necessary to preserve the evenly staggered terms of the Board..5 Any member appointed to fill a va- cancy occurring before the expiration of the term for which the member’s predecessor was appointed shall be appointed for the remainder of that term and thereafter may be eligible for reappointment to a full term. A member may serve after the expiration of that member’s term until a successor has been appointed. No individual shall be appointed to the Board for more than 2 terms. Vacancies shall be filled in the same manner as the original appointment was made. (4) Chairperson and Vice-Chairperson The Comptroller General of the United States shall designate a Chairperson and Vice Chairperson of the Board from among the members of the Board. Such members shall serve as Chairperson or Vice Chairperson for a period of 3 years. (5) Compensation Each member of the Board who is not an of- ficer or employee of the Federal Government shall be entitled to compensation (equivalent to the rate provided for level IV of the Execu- tive Schedule under section 5315 of title 5) and expenses incurred while performing the duties of the Board. An officer or employee of the Federal government who is a member of the Board shall be exempt from compensation. (6) Director and staff; experts and consultants The Board may employ and fix the com- pensation of an Executive Director and such other personnel as may be necessary to carry out the duties of the Institute and may seek such assistance and support of, or contract with, experts and consultants that may be necessary for the performance of the duties of the Institute. (7) Meetings and hearings The Board shall meet and hold hearings at the call of the Chairperson or a majority of its members. Meetings not solely concerning mat- ters of personnel shall be advertised at least 7 days in advance and open to the public. A ma- jority of the Board members shall constitute a quorum, but a lesser number of members may meet and hold hearings. (g) Financial and governmental oversight (1) Contract for audit The Institute shall provide for the conduct of financial audits of the Institute on an an- nual basis by a private entity with expertise in conducting financial audits. Page 2770 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1320e 6 So in original. Probably should be ‘‘conducting’’. (2) Review and annual reports (A) Review The Comptroller General of the United States shall review the following: (i) Not less frequently than on an annual basis, the financial audits conducted under paragraph (1). (ii) Not less frequently than every 5 years, the processes established by the In- stitute, including the research priorities and the conduct of research projects, in order to determine whether information produced by such research projects is ob- jective and credible, is produced in a man- ner consistent with the requirements under this section, and is developed through a transparent process. (iii) Not less frequently than every 5 years, the dissemination and training ac- tivities and data networks established under section 937 of the Public Health Service Act [42 U.S.C. 299b–37], including the methods and products used to dissemi- nate research, the types of training con- ducted and supported, and the types and functions of the data networks established, in order to determine whether the activi- ties and data are produced in a manner consistent with the requirements under such section. (iv) Not less frequently than every 5 years, the overall effectiveness of activi- ties conducted under this section and the dissemination, training, and capacity building activities conducted under sec- tion 299b–37 of this title. Such review shall include the following: (I) A description of those activities and the financial commitments related to re- search, training, data capacity building, and dissemination and uptake of re- search findings. (II) The extent to which the Institute and the Agency for Healthcare Research and Quality have collaborated with stakeholders, including provider and payer organizations, to facilitate the dis- semination and uptake of research find- ings. (III) An analysis of available data and performance metrics, such as the esti- mated public availability and dissemina- tion of research findings and uptake and utilization of research findings in clin- ical guidelines and decision support tools, on the extent to which such re- search findings are used by health care decision-makers, the effect of the dis- semination of such findings on changes in medical practice and reducing prac- tice variation and disparities in health care, and the effect of the research con- ducted and disseminated on innovation and the health care economy of the United States. (v) Not later than 8 years after March 23, 2010, the adequacy and use of the funding for the Institute and the activities con- ducted under section 937 of the Public Health Service Act, including a determina- tion as to whether, based on the utiliza- tion of research findings by public and pri- vate payers, funding sources for the Pa- tient-Centered Outcomes Research Trust Fund under section 9511 of the Internal Revenue Code of 1986 are appropriate and whether such sources of funding should be continued or adjusted. (vi) Not less frequently than every 5 years, any barriers that researchers funded by the Institute have encountered in con- ducting studies or clinical trials, including challenges covering the cost of any med- ical treatments, services, and items de- scribed in subsection (a)(2)(B) for purposes of the research study. (B) Annual reports Not later than April 1 of each year, the Comptroller General of the United States shall submit to Congress a report containing the results of the review conducted under subparagraph (A) with respect to the pre- ceding year (or years, if applicable), together with recommendations for such legislation and administrative action as the Comp- troller General determines appropriate. (h) Ensuring transparency, credibility, and ac- cess The Institute shall establish procedures to en- sure that the following requirements for ensur- ing transparency, credibility, and access are met: (1) Public comment periods The Institute shall provide for a public com- ment period of not less than 45 days and not more than 60 days prior to the adoption under subsection (d)(9) of the national priorities identified under subsection (d)(1)(A), the re- search project agenda established under sub- section (d)(1)(B), the methodological standards developed and updated by the methodology committee under subsection (d)(6)(C)(i), and the peer-review process provided under para- graph (7), and after the release of draft find- ings with respect to systematic reviews of ex- isting research and evidence. (2) Additional forums The Institute shall support forums to in- crease public awareness and obtain and incor- porate public input and feedback through media (such as an Internet website) on re- search priorities, research findings, and other duties, activities, or processes the Institute determines appropriate. (3) Public availability The Institute shall make available to the public and disclose through the official public Internet website of the Institute the following: (A) Information contained in research findings as specified in subsection (d)(9). (B) The process and methods for the con- duct of research, including the identity of the entity and the investigators conducing 6 such research and any conflicts of interests of such parties, any direct or indirect links the entity has to industry, and research pro- Page 2771 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1320e 7 So in original. Probably should be ‘‘bequests’’. 8 So in original. No par. (2) has been enacted. tocols, including measures taken, methods of research and analysis, research results, and such other information the Institute de- termines appropriate) 5 concurrent with the release of research findings. (C) Notice of public comment periods under paragraph (1), including deadlines for public comments. (D) Subsequent comments received during each of the public comment periods. (E) In accordance with applicable laws and processes and as the Institute determines appropriate, proceedings of the Institute. (4) Disclosure of conflicts of interest (A) In general A conflict of interest shall be disclosed in the following manner: (i) By the Institute in appointing mem- bers to an expert advisory panel under sub- section (d)(4), in selecting individuals to contribute to any peer-review process under subsection (d)(7), and for employ- ment as executive staff of the Institute. (ii) By the Board in appointing members of the methodology committee under sub- section (d)(6); (iii) By the Institute in the annual re- port under subsection (d)(10), except that, in the case of individuals contributing to any such peer review process, such descrip- tion shall be in a manner such that those individuals cannot be identified with a particular research project. (B) Manner of disclosure Conflicts of interest shall be disclosed as described in subparagraph (A) as soon as practicable on the Internet web site of the Institute. The information disclosed under the preceding sentence shall include the type, nature, and magnitude of the interests of the individual involved, except to the ex- tent that the individual recuses himself or herself from participating in the consider- ation of or any other activity with respect to the study as to which the potential con- flict exists. (i) Rules The Institute,5 its Board or staff, shall be pro- hibited from accepting gifts, bequeaths,7 or do- nations of services or property. In addition, the Institute shall be prohibited from establishing a corporation or generating revenues from activi- ties other than as provided under this section. (j) Rules of construction (1) 8 Coverage Nothing in this section shall be construed— (A) to permit the Institute to mandate coverage, reimbursement, or other policies for any public or private payer; or (B) as preventing the Secretary from cov- ering the routine costs of clinical care re- ceived by an individual entitled to, or en- rolled for, benefits under subchapter XVIII, XIX, or XXI in the case where such indi- vidual is participating in a clinical trial and such costs would otherwise be covered under such subchapter with respect to the bene- ficiary. (Aug. 14, 1935, ch. 531, title XI, § 1181, as added and amended Pub. L. 111–148, title VI, § 6301(a), title X, § 10602, Mar. 23, 2010, 124 Stat. 727, 1005; Pub. L. 116–94, div. N, title I, § 104(d)–(h), Dec. 20, 2019, 133 Stat. 3098, 3099.) Editorial Notes REFERENCES IN TEXT The District of Columbia Nonprofit Corporation Act, referred to in subsec. (b)(2), is Pub. L. 87–569, Aug. 6, 1962, 76 Stat. 265, which is not classified to the Code. The Internal Revenue Code of 1986, referred to in sub- secs. (b)(3) and (g)(2)(A)(v), is classified generally to Title 26, Internal Revenue Code. Section 399H of the Public Health Service Act, re- ferred to in subsec. (d)(1)(A), probably means section 399HH of act July 1, 1944, which is classified to section 280j of this title. AMENDMENTS 2019—Subsec. (d)(1)(A). Pub. L. 116–94, § 104(d), in- serted at end ‘‘Such national priorities shall include re- search with respect to intellectual and developmental disabilities and maternal mortality. Such priorities should reflect a balance between long-term priorities and short-term priorities, and be responsive to changes in medical evidence and in health care treatments.’’ Subsec. (d)(2)(F). Pub. L. 116–94, § 104(e), added subpar. (F). Subsec. (d)(6)(B). Pub. L. 116–94, § 104(g)(1), substituted ‘‘Board’’ for ‘‘Comptroller General of the United States’’. Subsec. (f)(1)(C). Pub. L. 116–94, § 104(f)(1)(A)(i), sub- stituted in introductory provisions ‘‘At least nineteen, but no more than twenty-one members appointed’’ for ‘‘Seventeen members appointed, not later than 6 months after March 23, 2010,’’. Subsec. (f)(1)(C)(iii). Pub. L. 116–94, § 104(f)(1)(A)(ii), substituted ‘‘at least 3, but no more than 5’’ for ‘‘3’’. Subsec. (f)(3). Pub. L. 116–94, § 104(f)(2), in first sen- tence, substituted ‘‘members’’ for ‘‘the members’’ and inserted ‘‘to the extent necessary to preserve the even- ly staggered terms of the Board.’’ before the period at end of first sentence, and inserted ‘‘Any member ap- pointed to fill a vacancy occurring before the expira- tion of the term for which the member’s predecessor was appointed shall be appointed for the remainder of that term and thereafter may be eligible for reappoint- ment to a full term. A member may serve after the ex- piration of that member’s term until a successor has been appointed.’’ after first sentence. Subsec. (g)(2)(A)(iv). Pub. L. 116–94, § 104(h)(1), added cl. (iv) and struck out former cl. (iv) which read as fol- lows: ‘‘Not less frequently than every 5 years, the over- all effectiveness of activities conducted under this sec- tion and the dissemination, training, and capacity building activities conducted under section 937 of the Public Health Service Act. Such review shall include an analysis of the extent to which research findings are used by health care decision-makers, the effect of the dissemination of such findings on reducing practice variation and disparities in health care, and the effect of the research conducted and disseminated on innova- tion and the health care economy of the United States.’’ Subsec. (g)(2)(A)(vi). Pub. L. 116–94, § 104(h)(2), added cl. (vi). Subsec. (h)(4)(A)(ii). Pub. L. 116–94, § 104(g)(2)(A), sub- stituted ‘‘Board’’ for ‘‘Comptroller General’’. Subsec. (h)(4)(B). Pub. L. 116–94, § 104(g)(2)(B), struck out ‘‘and of the Government Accountability Office’’ after ‘‘Institute’’. 2010—Subsec. (d)(2)(B)(ii)(IV). Pub. L. 111–148, § 10602(1)(A), inserted ‘‘, as described in subparagraph Page 2772 TITLE 42—THE PUBLIC HEALTH AND WELFARE § 1320e–1 1 So in original. No subpar. (B) has been enacted. (A)(ii),’’ after ‘‘original research’’ and ‘‘, as long as the researcher enters into a data use agreement with the Institute for use of the data from the original research, as appropriate’’ after ‘‘publication’’. Subsec. (d)(2)(B)(iv). Pub. L. 111–148, § 10602(1)(B), amended cl. (iv) generally. Prior to amendment, text read as follows: ‘‘Any research published under clause (ii)(IV) shall be within the bounds of and entirely con- sistent with the evidence and findings produced under the contract with the Institute under this subpara- graph. If the Institute determines that those require- ments are not met, the Institute shall not enter into another contract with the agency, instrumentality, or entity which managed or conducted such research for a period determined appropriate by the Institute (but not less than 5 years).’’ Subsec. (d)(8)(A)(iv). Pub. L. 111–148, § 10602(2), sub- stituted ‘‘do not include’’ for ‘‘not be construed as man- dates for’’. Subsec. (f)(1)(C)(ii). Pub. L. 111–148, § 10602(3), amend- ed cl. (ii) generally. Prior to amendment, cl. (ii) read as follows: ‘‘5 members representing physicians and pro- viders, including at least 1 surgeon, nurse, State-li- censed integrative health care practitioner, and rep- resentative of a hospital.’’ § 1320e–1. Limitations on certain uses of com- parative clinical effectiveness research (a) The Secretary may only use evidence and findings from research conducted under section 1320e of this title to make a determination re- garding coverage under subchapter XVIII if such use is through an iterative and transparent process which includes public comment and con- siders the effect on subpopulations. (b) Nothing in section 1320e of this title shall be construed as— (1) superceding or modifying the coverage of items or services under subchapter XVIII that the Secretary determines are reasonable and necessary under section 1395y(l)(1) of this title; or (2) authorizing the Secretary to deny cov- erage of items or services under such sub- chapter solely on the basis of comparative clinical effectiveness research. (c)(1) The Secretary shall not use evidence or findings from comparative clinical effectiveness research conducted under section 1320e of this title in determining coverage, reimbursement, or incentive programs under subchapter XVIII in a manner that treats extending the life of an elderly, disabled, or terminally ill individual as of lower value than extending the life of an indi- vidual who is younger, nondisabled, or not ter- minally ill. (2) Paragraph (1) shall not be construed as pre- venting the Secretary from using evidence or findings from such comparative clinical effec- tiveness research in determining coverage, reim- bursement, or incentive programs under sub- chapter XVIII based upon a comparison of the difference in the effectiveness of alternative treatments in extending an individual’s life due to the individual’s age, disability, or terminal illness. (d)(1) The Secretary shall not use evidence or findings from comparative clinical effectiveness research conducted under section 1320e of this title in determining coverage, reimbursement, or incentive programs under subchapter XVIII in a manner that precludes, or with the intent to discourage, an individual from choosing a health care treatment based on how the indi- vidual values the tradeoff between extending the length of their life and the risk of disability. (2)(A) 1 Paragraph (1) shall not be construed to— (i) limit the application of differential co- payments under subchapter XVIII based on factors such as cost or type of service; or (ii) prevent the Secretary from using evi- dence or findings from such comparative clin- ical effectiveness research in determining cov- erage, reimbursement, or incentive programs under such subchapter based upon a compari- son of the difference in the effectiveness of al- ternative health care treatments in extending an individual’s life due to that individual’s age, disability, or terminal illness. (3) Nothing in the provisions of, or amend- ments made by the Patient Protection and Af- fordable Care Act, shall be construed to limit comparative clinical effectiveness research or any other research, evaluation, or dissemination of information concerning the likelihood that a health care treatment will result in disability. (e) The Patient-Centered Outcomes Research Institute established under section 1320e(b)(1) of this title shall not develop or employ a dollars- per-quality adjusted life year (or similar meas- ure that discounts the value of a life because of an individual’s disability) as a threshold to es- tablish what type of health care is cost effective or recommended. The Secretary shall not utilize such an adjusted life year (or such a similar measure) as a threshold to determine coverage, reimbursement, or incentive programs under subchapter XVIII. (Aug. 14, 1935, ch. 531, title XI, § 1182, as added Pub. L. 111–148, title VI, § 6301(c), Mar. 23, 2010, 124 Stat. 740.) Editorial Notes REFERENCES IN TEXT The Patient Protection and Affordable Care Act, re- ferred to in subsec. (d)(3), is Pub. L. 111–148, Mar. 23, 2010, 124 Stat. 119. For complete classification of this Act to the Code, see Short Title note set out under sec- tion 18001 of this title and Tables. § 1320e–2. Trust Fund transfers to Patient-Cen- tered Outcomes Research Trust Fund (a) In general The Secretary shall provide for the transfer, from the Federal Hospital Insurance Trust Fund under section 1395i of this title and the Federal Supplementary Medical Insurance Trust Fund under section 1395t of this title, in proportion (as estimated by the Secretary) to the total ex- penditures during such fiscal year that are made under subchapter XVIII from the respective trust fund, to the Patient-Centered Outcomes Research Trust Fund (referred to in this section as the ‘‘PCORTF’’) under section 9511 of the In- ternal Revenue Code of 1986, of the following: (1) For fiscal year 2013, an amount equal to $1 multiplied by the average number of indi- viduals entitled to benefits under part A, or enrolled under part B, of subchapter XVIII during such fiscal year.