I 
111TH CONGRESS 
1ST SESSION H. R. 3361 
To provide a process for public comment and Medicare Evidence Development 
& Coverage Advisory Committee review of certain Medicare national 
coverage determinations, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
JULY 28, 2009 
Mr. BOUSTANY (for himself, Mr. ROE of Tennessee, Mr. GINGREY of Georgia, 
Mr. FLEMING, Mr. OLSON, Mr. LINDER, Mr. REICHERT, Mr. BOOZMAN, 
and Mr. ALEXANDER) introduced the following bill; which was referred 
to the Committee on Energy and Commerce, and in addition to the Com-
mittee on Ways and Means, for a period to be subsequently determined 
by the Speaker, in each case for consideration of such provisions as fall 
within the jurisdiction of the committee concerned 
A BILL 
To provide a process for public comment and Medicare Evi-
dence Development & Coverage Advisory Committee re-
view of certain Medicare national coverage determina-
tions, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Medicare Patient Safe-
guards Act of 2009’’. 
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SEC. 2. FINDINGS. 
The Congress finds the following: 
(1) The 2009 Medicare Trustees Report esti-
mates that Medicare spending could grow from 3.2 
percent of the U.S. economy to 11.4 percent during 
the next 75 years and warns of the significant cost 
burden growth of this magnitude would place on 
workers, Medicare beneficiaries, and the Federal 
budget. 
(2) In 2009, Congress provided $1,150,000,000 
for comparative effectiveness research, including 
cost-effectiveness analysis. 
(3) The Medicare Payment and Advisory Com-
mission suggested that the Centers for Medicare & 
Medicaid Services use cost effectiveness analysis to 
look at groups of services used to treat specific ill-
nesses that have small differences in quality but 
large differences in cost. 
(4) MedPAC has reported concerns that the 
rigid use of cost effectiveness analysis might limit 
Medicare beneficiaries’ access to certain services, ra-
tion rather than promote appropriate care, slow in-
novation, and interfere with the practice of medicine. 
(5) MedPAC has listed methodological and re-
porting shortcomings of cost effectiveness analysis, 
including not using all available clinical evidence, not 
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sufficiently reporting on the extent to which the re-
sults are applicable to the general population, selec-
tively reporting results, and placing undue emphasis 
on certain results of such analysis. 
(6) While serving as the head of Congressional 
Budget Office, White House Budget director Peter 
Orszag said determining which treatment was most 
cost effective for a given population would involve 
placing a dollar value on an additional year of life. 
(7) While serving as the head of Congressional 
Budget Office, White House Budget director Peter 
Orszag suggested the possibility of limiting Medicare 
coverage for more effective but more expensive serv-
ices. 
(8) CMS recently described cost effectiveness 
analysis expertise as one of its most critical needs to 
Medicare Evidence Development & Coverage Advi-
sory Committee, which advises CMS on national cov-
erage determinations (NCDs). 
(9) CMS, through proposed rule making, has 
twice failed in attempts to formally incorporate cost 
effectiveness analysis into NCDs. 
(10) CMS officials report that the agency con-
siders potential cost savings before deciding to make 
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changes to a NCD that narrows coverage under the 
Medicare program. 
(11) AARP has stated that comparative effec-
tiveness research is intended to help consumers and 
providers determine the best treatment, not just the 
least costly treatment. AARP warned that this infor-
mation from comparative effectiveness research 
should not be used as a means to deny individuals 
access to appropriate therapeutic options. 
(12) The Congressional Black Caucus, focusing 
in particular on the exacerbating of health inequities 
across subpopulation groups, expressed concerns 
that comparative effectiveness research should not 
be used as rationale for limiting care to the care 
that works best for the average patient, rather than 
providing coverage for the care that works best for 
each individual patient. 
(13) Congressional New Democrats— 
(A) argued that any application of com-
parative effectiveness research must protect 
against the use of this research to deny access 
to care solely based on cost; and 
(B) urged Congress to ensure that clinical 
effectiveness and medical outcomes are the 
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focus of comparative effectiveness research 
funding.
(14) The American Heart Association— 
(A) urges Congress to include patient safe-
guards in legislation to prevent the misuse of 
cost effectiveness analysis; and 
(B) argues that the primary focus of com-
parative effectiveness research should be opti-
mizing clinical outcomes and value for patients 
and society and not for the purpose of mini-
mizing costs. 
SEC. 3. SENSE OF CONGRESS. 
It is the sense of the Congress that— 
(1) efforts to make the Medicare program fi-
nancially sustainable, including the application of 
comparative effectiveness research, should not— 
(A) deprive patients of medically necessary 
care solely due to the cost of such care; or 
(B) limit access to needed health care serv-
ices due to a patient’s age, gender, ethnicity, or 
disability status; and 
(2) Congress should protect patients’ access to 
needed care by ensuring that the Administrator of 
CMS relies on adequate clinical expertise when the 
Administrator proposes to narrow coverage for a 
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