1.This Act may be cited as the
Doctor-Patient Relationship and
Research Protection Act
.
2.Federal
Coordinating Council for Comparative Effectiveness Research
(a)Paragraph (1) of section 804(c) of title
VIII of division A of the American Recovery and Reinvestment Act of 2009 (42
U.S.C. 299b–8(c)) is amended to read as follows:
(1)notwithstanding the provisions under the
heading Agency for
Healthcare Research and Quality
of this title and any
other provision of law, have full authority to direct and coordinate all
Federal funding of comparative effectiveness health care research, including
such research conducted or supported by the Departments of Health and Human
Services, Veterans Affairs, and Defense;
and
.
(b)Subsection (d) of section 804 of title VIII
of division A of the American Recovery and Reinvestment Act of 2009 (42 U.S.C.
299b–8) is amended to read as follows:
(d)
(1)The members of the Council shall include one senior
officer or employee from each of the following agencies:
(A)The Agency for
Healthcare Research and Quality.
(B)The Secretary of
Health and Human Services.
(C)The Director of
the National Institutes of Health.
(D)20 members, 9 of
whom are not full-time government employees, appointed by the Comptroller
General of the United States as follows:
(i)3
members representing patients and health care consumers.
(ii)3
members representing practicing physicians, including surgeons.
(iii)3 members
representing agencies that administer public programs, as follows:
(I)1 member
representing the Centers for Medicare & Medicaid Services who has
experience in administering the program under title XVIII of the Social
Security Act.
(II)1 member
representing agencies that administer State health programs (who may represent
the Centers for Medicare & Medicaid Services and have experience in
administering the program under title XIX or the program under title XXI of the
Social Security Act or be a governor of a State).
(III)1 member
representing agencies that administer other Federal health programs (such as a
health program of the Department of Defense Federal employees health benefits
program under chapter 89 of title 5 of the United States Code, a health program
of the Department of Veterans Affairs under chapter 17 of title 38 of such
Code, or a medical care program of the Indian Health Service or of a tribal
organization).
(iv)3
members 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.
(v)3
members representing pharmaceutical, device, and technology manufacturers or
developers.
(vi)1
member representing nonprofit organizations involved in health services
research.
(vii)1 member
representing organizations that focus on quality measurement and improvement or
decision support.
(viii)1 member
representing independent health services researchers.
(ix)1
member representing research in differences in treatment outcomes along the
lines of racial and ethnic background, gender, and geography.
(x)1
member representing research in treating rural populations.
(E)At
least half of the members of the Council shall be physicians or other experts
with clinical expertise.
(2)The Secretary shall serve as Chairman of the Council and
shall designate a member to serve as Vice
Chairman.
.
(c)Subsection (g) of section 804 of title VIII of
division A of the American Recovery and Reinvestment Act of 2009 (42 U.S.C.
299b–8) is amended to read as follows:
(g)
(1)Nothing
in this section shall be construed—
(A)to permit the
Council to mandate or recommend coverage, reimbursement, or other policies for
any public or private payer; or
(B)as preventing the
Secretary of Health and Human Services from covering the routine costs of
clinical care received by an individual entitled to, or enrolled for, benefits
under title XVIII, XIX, or XXI of the Social Security Act in the case where
such individual is participating in a clinical trial and such costs would
otherwise be covered under such title with respect to the beneficiary.
(2)No report submitted under this section or research
findings disseminated by the Council shall be construed as mandates,
guidelines, or recommendations for payment, coverage, or
treatment.
.
(d)Transparency,
credibility, and accessSection 804 of title VIII of division A
of the American Recovery and Reinvestment Act of 2009 (42 U.S.C. 299b–8) is
amended by adding at the end the following:
(h)Transparency,
credibility, and accessThe
Council shall establish procedures to ensure that the following requirements
for ensuring transparency, credibility, and access are met:
(1)
(A)Comment prior to
obligation of funds for researchBefore any Federal funds may be obligated
to conduct or support comparative effectiveness research, the Council shall
provide for a period of not less than 30 days for the public to comment on the
research proposal.
(B)Comment after
research results publishedAfter the publication of the results
of research described in subparagraph (A), the Council shall provide for a
period of 60 days for the public to comment on such results.
(C)Transmission of
public commentsThe Council shall ensure the transmission of
public comments submitted under subparagraph (A) to the entity conducting the
research with respect to which the individual study design is being
finalized.
(2)The Council shall, in addition to the public comment
period described in paragraph (1), support forums to increase public awareness
and obtain and incorporate public feedback through media (such as an Internet
website) on the following:
(A)The identification
of comparative effectiveness research priorities.
(B)Comparative
effectiveness research findings.
(C)Any other duties,
activities, or processes the Council determines appropriate.
(3)The Council shall make available to the public and
disclose through the official public Internet website of the Council, and
through other forums and media the Council determines appropriate, the
following:
(A)The process and
methods for the conduct of comparative effectiveness research pursuant to this
section, including—
(i)the identity of
the entity conducting any such research;
(ii)any links the
entity has to industry (including such links that are not directly tied to the
particular research);
(iii)draft study
designs (including research questions and the finalized study design, together
with public comments on such study design and responses to such
comments);
(iv)research
protocols (including measures taken, methods of research, methods of analysis,
research results, and such other information as the Council determines
appropriate);
(v)the identity of
investigators conducting such research and any conflicts of interest of such
investigators; and
(vi)any progress
reports the Council determines appropriate.
(B)Public comments
submitted during each public comment period under paragraph (1)(A).
(C)Bylaws, processes,
and proceedings of the Council, to the extent practicable and as the Council
determines appropriate.
(D)Not later than 60
days after receipt by the Council of a relevant report or comparative
effectiveness research finding, appropriate information contained in such
report or finding.
(4)
(A)The Council
shall—
(i)in
appointing members to an advisory panel, and in selecting individuals to
contribute to any peer-review process and for employment as executive staff of
the Council, take into consideration any conflicts of interest of potential
appointees, participants, and staff; and
(ii)include a
description of any such conflicts of interest and conflicts of interest of
Council members in an annual report to the Congress, except that, in the case
of individuals contributing to any such peer review process, such description
shall be in a manner such that those individuals cannot be identified with a
particular research project.
(B)In
this subsection, the term conflict of interest means associations,
including financial and personal, that may be reasonably assumed to have the
potential to bias an individual's decisions in matters related to the Council
or the conduct of the comparative effectiveness
research.
.
3.Application of
federally funded clinical comparative effectiveness research
(a)The Administrator of the Centers for Medicare & Medicaid
Services may not use federally funded clinical comparative effectiveness
research data to make coverage determinations under title XVIII of the Social
Security Act for medical treatments, services, and items on the basis of
cost.
(b)Requirement for
implementationFederally funded clinical comparative
effectiveness research and related evaluation and communication activities
shall reflect the principle that clinicians and patients should have the best
available evidence upon which to make choices in health care items and
services, in providers, and in health care delivery systems, recognizing that
patient subpopulations and patient and physician preferences may vary.
(c)Appeals of
certain Medicare coverage determinationsIn the case of a
national or local coverage determination under title XVIII of the Social
Security Act that has been made utilizing federally funded comparative
effectiveness research, an individual entitled to benefits under such title
shall—
(1)be an eligible
requester under section 1869(h)(1)(B) of such Act in relation;
(2)have expedited access (as specified by the
Secretary) to coverage determinations, redeterminations, and appeals relating
to such determinations; and
(3)have full access to all administrative or
judicial review under section 1869 of such Act with respect to such
determinations.
(d)Nothing in this Act or the amendments made by this
Act shall be construed to require coverage of any drug, biological product,
device, or treatment that has been determined by the Food and Drug
Administration to be unsafe.
(e)Disaggregation
of research resultsNo Federal funds may be made available to any
person for any federally funded clinical comparative effectiveness research,
unless the person agrees to ensure that, whenever possible, the methodology and
research protocols will include variables that not only measure, but can be
disaggregated to analyze and identify, any differences along the lines of
racial and ethnic background, gender, and geography that may exist among and
within patient subpopulations.
(f)In this section:
(1)The term
federally funded clinical comparative effectiveness research means
research that—
(A)evaluates and
compares the clinical effectiveness, risks, and benefits of 2 or more medical
treatments, services, and items; and
(B)is conducted or supported in accordance
with provisions of title VIII of division A of the American Recovery and
Reinvestment Act of 2009 or with the use of other Federal funds.
(2)The term
medical treatments, services, and items means health care
interventions, protocols for treatment, procedures, medical devices, diagnostic
tools, pharmaceuticals (including drugs and biologicals), and any other
processes or items being used in the treatment and diagnosis of, or prevention
of illness or injury in, patients.
(3)The term
patient subpopulations means populations of patients of different
racial and ethnic backgrounds, genders, and geographic locations.