[House Hearing, 108 Congress]
[From the U.S. Government Printing Office]

                           MODERNIZATION ACT



                               before the

                         SUBCOMMITTEE ON HEALTH

                                 of the

                        HOUSE OF REPRESENTATIVES

                      ONE HUNDRED EIGHTH CONGRESS

                             SECOND SESSION


                           SEPTEMBER 21, 2004


                           Serial No. 108-117


       Printed for the use of the Committee on Energy and Commerce

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96-096                      WASHINGTON : 2004
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                      JOE BARTON, Texas, Chairman

W.J. ``BILLY'' TAUZIN, Louisiana     JOHN D. DINGELL, Michigan
RALPH M. HALL, Texas                   Ranking Member
MICHAEL BILIRAKIS, Florida           HENRY A. WAXMAN, California
FRED UPTON, Michigan                 EDWARD J. MARKEY, Massachusetts
CLIFF STEARNS, Florida               RICK BOUCHER, Virginia
PAUL E. GILLMOR, Ohio                EDOLPHUS TOWNS, New York
JAMES C. GREENWOOD, Pennsylvania     FRANK PALLONE, Jr., New Jersey
CHRISTOPHER COX, California          SHERROD BROWN, Ohio
NATHAN DEAL, Georgia                 BART GORDON, Tennessee
RICHARD BURR, North Carolina         PETER DEUTSCH, Florida
ED WHITFIELD, Kentucky               BOBBY L. RUSH, Illinois
CHARLIE NORWOOD, Georgia             ANNA G. ESHOO, California
BARBARA CUBIN, Wyoming               BART STUPAK, Michigan
JOHN SHIMKUS, Illinois               ELIOT L. ENGEL, New York
HEATHER WILSON, New Mexico           ALBERT R. WYNN, Maryland
JOHN B. SHADEGG, Arizona             GENE GREEN, Texas
Mississippi, Vice Chairman           TED STRICKLAND, Ohio
VITO FOSSELLA, New York              DIANA DeGETTE, Colorado
STEVE BUYER, Indiana                 LOIS CAPPS, California
GEORGE RADANOVICH, California        MICHAEL F. DOYLE, Pennsylvania
CHARLES F. BASS, New Hampshire       CHRISTOPHER JOHN, Louisiana
JOSEPH R. PITTS, Pennsylvania        TOM ALLEN, Maine
MARY BONO, California                JIM DAVIS, Florida
GREG WALDEN, Oregon                  JANICE D. SCHAKOWSKY, Illinois
LEE TERRY, Nebraska                  HILDA L. SOLIS, California
MIKE FERGUSON, New Jersey            CHARLES A. GONZALEZ, Texas
DARRELL E. ISSA, California
C.L. ``BUTCH'' OTTER, Idaho

                      Bud Albright, Staff Director

                   James D. Barnette, General Counsel

      Reid P.F. Stuntz, Minority Staff Director and Chief Counsel


                         Subcommittee on Health

                  MICHAEL BILIRAKIS, Florida, Chairman

RALPH M. HALL, Texas                 SHERROD BROWN, Ohio
FRED UPTON, Michigan                   Ranking Member
JAMES C. GREENWOOD, Pennsylvania     HENRY A. WAXMAN, California
NATHAN DEAL, Georgia                 EDOLPHUS TOWNS, New York
RICHARD BURR, North Carolina         FRANK PALLONE, Jr., New Jersey
ED WHITFIELD, Kentucky               BART GORDON, Tennessee
CHARLIE NORWOOD, Georgia             ANNA G. ESHOO, California
  Vice Chairman                      BART STUPAK, Michigan
BARBARA CUBIN, Wyoming               ELIOT L. ENGEL, New York
JOHN SHIMKUS, Illinois               GENE GREEN, Texas
JOHN B. SHADEGG, Arizona             DIANA DeGETTE, Colorado
Mississippi                          CHRIS JOHN, Louisiana
STEVE BUYER, Indiana                 BOBBY L. RUSH, Illinois
JOSEPH R. PITTS, Pennsylvania        JOHN D. DINGELL, Michigan,
MIKE FERGUSON, New Jersey              (Ex Officio)
  (Ex Officio)


                            C O N T E N T S


Testimony of:
    Clancy, Carolyn, Director, Agency for Healthcare Research and 
      Quality, U.S. Department of Health and Human Services......    10
    Heinrich, Janet, Director, Healthcare/Public Health Issues, 
      U.S. Government Accountability Office......................    17
    Woolf, Steven H., Executive Vice President for Policy 
      Development, Partnership for Prevention....................    19
Material submitted for the record by:
    American Cancer Society, prepared statement of...............    52
    American Occupational Therapy Association, prepared statement 
      of.........................................................    70



                           MODERNIZATION ACT


                      TUESDAY, SEPTEMBER 21, 2004

                  House of Representatives,
                  Committee on Energy and Commerce,
                                    Subcommittee on Health,
                                                    Washington, DC.
    The subcommittee met, pursuant to notice, at 2:13 p.m., in 
room 2123, Rayburn House Office Building, Hon. Michael 
Bilirakis (chairman) presiding.
    Members present: Representatives Bilirakis, Hall, Norwood, 
Shimkus, Brown, Stupak, and Green.
    Staff present: Ryan Long, majority professional staff; 
Melissa Bartlett, majority counsel; Chuck Clapton, majority 
counsel; Eugenia Edwards, legislative clerk; and Amy Hall, 
minority professional staff.
    Mr. Bilirakis. Good afternoon. This hearing will now come 
to order.
    Today the Health Subcommittee will be focusing on a very 
important issue, the new preventive benefits now being offered 
by the Medicare program. Coverage of these new preventive 
benefits, which were authorized by the Medicare Prescription 
Drug Improvement and Modernization Act of 2003, MMA, is a 
serious initiative to make Medicare a modern prevention-focused 
    I would like to thank the witnesses who are here before us 
    Carolyn Clancy, Dr. Clancy, is Director of the Agency for 
Health Care Research and Quality, and she will discuss the 
findings of the United States Preventive Services Task Force. 
We also have Ms. Janet Heinrich, Director of Health Care, 
Public Health Issues, at the U.S. Government Accountability 
Office, GAO. And Dr. Steven Woolf, who I understand is a former 
resident of the Tampa area--welcome to Washington, Dr. Woolf--
who is Executive Vice President for Policy, Development at 
Partnership for Prevention.
    I look forward to hearing from all of you today. I am sure 
we all do.
    Since the program's inception in the mid-1960's, in 1965, 
Medicare has paid the health care costs for beneficiaries when 
they are sick. In 1965, this was an appropriate approach to 
health care.
    Today, with rapidly increasing technology, health care is 
changing from diagnostic to preventive care. However, while the 
climate has changed, the Medicare program, I think we all would 
agree, has drug its feet. Over the past few years, Medicare has 
been incrementally changing to add preventive services to the 
program. In the 1980's, Medicare began coverage of certain 
vaccinations. In 1984, Medicare established the U.S. Preventive 
Services Task Force to make evidence-based recommendations on 
the appropriateness of preventive services. In 1991, Medicare 
began coverage for mammography screenings, and the Balanced 
Budget Act of 1997, BBA, expanded coverage to include 
colorectal and prostate cancer screenings, pelvic exams, and 
osteoporosis tests.
    With the implementation of MMA beginning in 2005, 
beneficiaries' access to preventive benefits has been brought 
to a whole new level. One of the most important new benefits is 
what we call the ``Welcome to Medicare Physical,'' a complete 
preventive examination for all new Medicare beneficiaries 
entering the program. I am particularly proud of this new 
benefit because I fought for its inclusion from the beginning. 
My good friend, a gentleman who has been a geriatric physician 
who retired to Florida many years ago because he had a health 
problem--thank God he has been with us for a long time down 
there--came up with this idea. He told it to me years ago and 
how important it was for beneficiaries to have a complete 
physical so that their health can be carefully evaluated and 
any potential problems can be realized. And I am referring to a 
Dr. William Hale.
    Under this new physical, Medicare will now cover influenza 
and hepatitis B vaccines, mammograms, Pap smears, and pelvic 
examinations and screening tests for prostate cancer, colon 
cancer, glaucoma, and osteoporosis. As part of the exam, 
Medicare will pay for an electrocardiogram, an assessment of a 
person's risk of depression, hearing and vision tests, and a 
review of a person's agility to perform routine activities such 
as bathing, eating, and getting in and out of bed. 
Additionally, education and counseling for any problems 
discovered in exams will also be covered.
    Other preventive benefit provisions in MMA include Medicare 
coverage of blood tests for the screening and detection of 
cardiovascular disease for any individual, and coverage of two 
diabetes screening tests each year for at-risk beneficiaries.
    Over 64 million Americans live with cardiovascular disease, 
and it is the leading cause of death in this country, and most 
of those people are over the age of 65. The economic impact of 
cardiovascular disease in our health care system continues to 
grow, and according to CDC will reach $368 billion in 2004, 
including health care expenditures and lost productivity from 
death and disability.
    What makes this even more atrocious is that cardiovascular 
disease is largely preventable. Expanding Medicare coverage for 
cardiovascular disease will help seniors who may believe that 
they are healthy realize potential problems early rather than 
later. This will increase the health of the individual and 
reduce the overall cost of health care.
    This hearing is, I think, especially timely right now. The 
Centers for Medicare and Medicaid Services released their 
Physician Fee Schedule Proposed Rule which contains their 
proposed guidelines for these preventive benefits in early 
August, and comments, I guess--were they completed last week? 
This Friday. Comments are due by this Friday.
    Again, thank you for being here today. And I very gladly 
yield to--I say ``gladly,'' I may be sorry that I used that 
word--to the ranking member of the subcommittee, the gentleman 
from Ohio, for an opening statement.
    Mr. Brown. I am never that, Mr. Chairman. Thank you. Thank 
you for holding the hearing today, and thank you, all three 
panelists, for joining us, some of you as repeats. Thank you 
for that.
    I appreciate the opportunity to be recognized for an 
opening statement. The opportunity to make opening statements, 
which we all took for granted, has long been recognized in this 
committee as a member's right, was unilaterally and improperly 
usurped by Chairman Barton last Wednesday, September 15. I 
suggest in the future that any attempt to gag Democratic 
members of the subcommittee, which Mr. Bilirakis has never done 
and I would never expect someone of his integrity to do, but I 
would hope that any attempt to gag members of the full 
committee will be counterproductive, and I urge the committee 
precedent tradition be respected in the future.
    Along these lines, Mr. Chairman, I would like to address 
colleagues on the other side of the aisle who will invariably 
criticize my opening statement today as a partisan attack. If 
the Republican majority would dispassionately consider the 
problems with its new prescription drug law as readily as it 
promotes the bill's benefits, with tens and tens and tens of 
millions of taxpayer dollars on television and mailings and all 
other ways, then our concerns wouldn't be called partisan, they 
would be called germane. We have been given no such opportunity 
when it comes to making the most sweeping changes ever to 
Medicare. American seniors and other American taxpayers don't 
want an air-brushed sale; they want the truth.
    The truth is, the drug law establishes several important 
preventive benefits, to be sure. It is also true that Congress 
should not have to mandate coverage of new preventive benefits. 
Medicare is authorized to cover new diagnosis and treatment 
benefits without waiting for congressional approval or mandate. 
Preventive benefits should be treated the same way.
    I have sponsored legislation which will enable CMS to 
approve new preventive benefits through the national coverage 
process. I hope colleagues on both sides of the aisle will 
consider cosponsoring this commonsense bill.
    Nonetheless, the new preventive benefits are a positive 
addition to Medicare. Had they been offered as a stand-alone 
bill, I am sure the bill would have passed with overwhelmingly 
bipartisan support. But lacing last year's prescription drug 
law with a couple of new preventive benefits, no matter how 
attractive, doesn't begin to compensate for the dollars wasted 
lining the pockets of the insurance industry and the drug 
companies, or the opportunity wasted, the opportunity to work 
on a bipartisan basis and add a real drug benefit to Medicare. 
It doesn't compensate for the time wasted on red-herring 
discount cards, on HMO experiments, all because the Republican 
majority and the Republican President don't much like Medicare 
the way it is, or at least the way it was, and do really like 
the drug industry and the insurance industry and the way that 
they both operate; because in the new drug law, Medicare 
premiums are going to increase by more than 17 percent next 
year, the highest increase in Medicare history. Seniors will 
receive a cost-of-living in their Social Security benefits of 
less than 3 percent. Premiums increase 17 percent.
    It didn't have to be that way. The new law, as we know, 
hands HMOs bonus payments of over $23 billion. Last March, HMOs 
got their first checks from Federal taxpayers totaling $229 
million. In April they got another $229 million. In May they 
got another $229 million. Yet there was no prescription drug 
benefit yet. In June, $229 million; July, August, September, 
all the way through next year, yet still no prescription drug 
benefit, but plenty of dollars for Medicare HMOs. And, 
remember, even before these new payments, the Bush 
administration itself admitted that HMOs were being overpaid. 
They already said they were overpaid, but now we are giving 
them $229 million a month. Not that it would have anything to 
do with political contributions to the President from the 
insurance industry or to Republican leadership. This bill 
forces private HMOs regardless of--forces them on seniors 
regardless of what seniors want and despite the fact that HMOs 
add billions to Medicare's price tag. The new law prohibits the 
Federal Government from negotiating volume discounts on RX 
drugs, as the VA does, a concept that no one I have ever met in 
Ohio understands, except to be explained away by drug company 
contributions to George Bush.
    Drug industry profits will increase by $182 billion thanks 
to this new law, with seniors and taxpayers footing the bill. 
The new law would never have passed if the administration had 
not lied about the cost of Medicare, had not threatened the 
Medicare functionary, did not threaten his job if he sang to 
Congress or the American people about the cost. And--
undoubtedly. But we got a bill because we--we got that bill 
because some people didn't tell the truth. It never would have 
passed if seniors knew they would be paying dramatically higher 
Medicare premiums, 17 percent higher, so that the Medicare--
that the Republican majority and the President could privatize 
Medicare, boost the profits of the drug industry, and line the 
pockets of the HMOs. There are beneficial preventive benefits 
and a shameful Medicare drug law. That is not a partisan 
attack, it is simply the truth.
    I yield back.
    Mr. Bilirakis. The Chair would now yield to Dr. Norwood for 
an opening statement.
    Mr. Norwood. Thank you very much, Mr. Chairman. I wasn't 
going to say anything, but I am stimulated to have a remark or 
    First of all, thank you for this hearing. It is very 
important, I believe, that we continue to point out prevention. 
In my profession, we have been into that a long, long time. It 
is high time that we got into that with Medicare.
    A couple of points I would make, so Mr. Brown would know. 
The premium increase that was set out was to help stop the 4.5 
percent reduction in fees to our providers, which, had that not 
been done, access to health care would have drastically been 
cut. So the Democrats who supported that, we appreciate that, 
and it is time to bring out at this hearing that that was a 
good thing.
    The Democratic substitute called for increased payments to 
HMOs. You know, their substitute wasn't any different. So it 
would be better, just quit being partisan about this bill. 
There are a lot of good things in this Medicare bill, and I 
guess to start with, prevention would be at the top of my list.
    Second, I am on a number of committees, as we all are, and 
many of our committees, Mr. Chairman, don't have opening 
statements other than the chairman and the ranking member. And 
I don't know about tradition in the Commerce Committee, but 
that is not a bad rule, particularly 2 months before an 
election when people aren't really trying to dig into the sense 
of the problem but are playing politics. And, you know, for me 
to encourage you to do that on this subcommittee means I don't 
get to make an opening statement too. But I do want to say that 
sometimes it is real appropriate not to have an opening 
statement and listen to the people we have asked to come to 
Washington to help us learn.
    With that, Mr. Chairman, I will----
    Mr. Bilirakis. Would you yield?
    Mr. Norwood. I would yield.
    Mr. Bilirakis. I would just like to say, none of us are 
happy about the premium increase. We should remember, of 
course, when Medicare was first devised back in the mid-1960's, 
it was supposed to be a 50/50 situation; all of the costs would 
be shared 50 percent by the beneficiaries, 50 percent by the 
taxpayers, by the government, if you will. And as time went on, 
that was reduced to something like 75/25. And we passed the law 
some time back that said that 25 percent would be the share 
that would be paid by the beneficiaries, and that is a formula 
type of thing.
    And regardless of who might be in the White House and 
regardless of which party will be in charge this year, it would 
come out to this dollar figure because it is a flat-out 75/25. 
And my colleagues know this. And I would hope that they would 
not play basically political games with that particular point.
    I mean, was I distressed when I saw that happening? Of 
course I was. But it came out to--it is a formula type of a 
    Having said that----
    Mr. Norwood. Mr. Chairman, if I could, one last sentence on 
my time.
    Mr. Bilirakis. One last sentence.
    Mr. Norwood. The premium increase also is part of why we 
can afford to have the preventive benefits. Preventive benefits 
are lifesaving benefits. It was the right thing to do.
    Mr. Bilirakis. And I daresay that Mr. Brown's ideas of 
additional preventive benefits, which I don't think my good 
friend has directly made me aware of, but if he has, you know, 
it was at a time maybe when it didn't stick. But that is 
certainly something that I generally would support, and we just 
haven't sat down and talked about them specifically. But that 
would probably also increase the Part B premium in the future 
with additional preventive benefits added therein.
    Anyhow. Mr. Green, for an opening statement.
    Mr. Green. Thank you, Mr. Chairman. I wasn't planning to 
enter in on that, but part of that increase that we had in the 
Medicare bill and was widely reported a few minutes ago, that 
part of the increase, that we are paying more dollars for the 
Medicare+Choice, that actually costs more than regular Medicare 
for our constituents. But, again, I think that came from CMS 
when they talked about it.
    Mr. Chairman, I just wanted to thank you for the hearing, 
because there were new preventive benefits in the bill. At the 
end of the day I voted against the bill because of its 
incomplete prescription benefit, and in general I believe it 
does more harm than good to the Medicare program and the 
beneficiaries who depend on the program for their health care. 
And I think the proof is in the fewer number of people than 
expected to take up that benefit.
    That being said, the new law does provide three extremely 
new important preventive benefits: a physical upon enrollment 
in Medicare; a cardiovascular screening blood test; and a 
diabetes screening test. Each of these preventive benefits will 
help save lives, and it is worth noting that in the long run 
these new benefits will save significant costs for Medicare 
because we will be able to catch many of these debilitating 
illnesses in the early stages instead of treating them in 
advanced stages where costs are skyrocketing.
    Without a doubt, an ounce of prevention is worth a pound of 
cure, and I am pleased that Congress took that message to heart 
in that bill. Diabetes is a major health problem in my State of 
Texas, and more than 1 million adult Texans have diabetes. The 
State estimates that another 500,000 are living with 
undiagnosed diabetes. The State of Texas, and the district I 
represent in particular, has a large Hispanic population which 
studies have shown is at higher risk. That is why I offered the 
amendment, along with now-Governor Fletcher of Kentucky, to 
include diabetes screening in the Medicare bill.
    And I would like to take this opportunity to once again 
thank my colleagues for including it at the committee level. 
And if I had my druthers, Medicare would also include 
screenings for abdominal aortic aneurysms, known as the 
``silent killer.'' Abdominal aortic aneurysms can occur without 
any symptoms or warnings, and less than 15 percent of the 
patients with a ruptured abdominal aortic aneurysm survive, and 
two out of three victims die before they ever reach the 
hospital. With effective screenings, however, AAA can easily be 
detected and repaired with a fairly noninvasive procedure. That 
is why a AAA screening benefit is an excellent candidate for a 
new Medicare preventive benefit.
    My friend Jim Greenwood and I have introduced a bill to 
cover AAA screenings under Medicare, and I am sure he agrees 
and will welcome the support of the subcommittee in this 
    And while we are here today to discuss the implementation 
and effectiveness of these three preventive benefits, we must 
realize that there are great additions to Medicare that cannot 
be examined in a vacuum. There are serious problems with the 
Medicare program; and as more seniors take advantage of the 
program's preventive benefits, they are sure to come up against 
the several roadblocks making these benefits work for them. 
Physicals don't help seniors if the result is a diagnosis of a 
disease that must be treated with a prescription drug regimen 
so expensive that it forces Medicare beneficiaries into a 
doughnut hole where drugs aren't paid for. And, at the end of 
the day, a preventive benefit isn't worth the paper it is 
written on if the program doesn't provide seniors with the 
resources to deal with the diagnosis.
    I am certainly interested in hearing our witnesses' views 
on the issues, and I know they will provide us with important 
insight on the steps we need to take to ensure that new 
preventive benefits are added to Medicare in a timely manner.
    And, again, Mr. Chairman, I appreciate you holding this 
hearing. And I know for a number of years we have had these 
hearings on Medicare, not only for the bill that passed last 
year, but on issues dealing with Medicare. And so I appreciate 
the opportunity.
    Mr. Bilirakis. I thank you, Mr. Green. I oftentimes wonder 
why we can't in a bipartisan manner get together and do 
something about the method that CBO uses to score, which is 
something we run into all the time when we talk about things 
such as preventive health care.
    Mr. Green. Mr. Chairman, you and I have talked about that, 
and it sure would be nice if we could set that so we could take 
advantage of the savings from preventive care. And I know we 
share that.
    Mr. Bilirakis. It is crazy, isn't it? They call it the 
Congressional Budget Office, and yet we don't seem to have any 
control over them.
    In any case, Mr. Hall for an opening statement.
    Mr. Hall. Thank you, Mr. Chairman.
    I would like to start with--and I have admiration and 
respect for both the gentlemen present from the minority, but I 
feel constrained to say that this committee and the chairman of 
this committee ought to always gag anyone that is politicking 
at the expense of this committee's very valuable time at this 
particular time. And as Dr. Norwood has said, and as Mr. Brown 
and Mr. Green both agreed, the increased payments are not 
anything that we would enter into but for some reason. And the 
very reason is that these preventive payments and these 
preventive benefits save money, considerable money, later. The 
savings, not today--it looks like a 17 percent increase today, 
but it is a huge savings down the line. By the time these 
senior citizens get to that stage, they would have a better 
life if they had the prevention now. So it is not only saving 
them money, but it saves in the health of people and the care 
of people and the love of these senior citizens, these folks 
that are the treasure that this program benefits.
    I was in the Texas Senate in 1963 when Medicare and 
Medicaid showed its face, and the Members of Congress came down 
to all the legislators, they came to the Texas legislature and 
told us about these two great programs that they were going to 
initiate. One was called Medicare and one called Medicaid. They 
said if we are not careful, the Medicaid could cost almost a 
billion dollars a year. Imagine that. And Medicare could cost 
as much as up to $7 billion a year. I think that was their 
testimony before our little committee down in Texas.
    Well, you know, last year it was $50, $60 billion, and $150 
or $160 billion or so. I don't know if those figures are 
correct, but I think the comparisons are. But for 2005, the 
Part B premium is going to be more. I don't like that, but I 
understand it. But, you know, there is a saving grace there. 
While it is more--and it consists of outpatient hospital 
services, of home health services, of durable medical 
equipment--still about three quarters of the 2005 premium 
increase is due to additional costs for Part B.
    And I think the record indicates I believe that all the 
members of the minority voted for that, in favor of increased 
physician payments and reimbursements to Medicare Advantage 
plans, where the major provision that led to the increase in 
Medicare premium costs, either on the Democrats' substitute, 
their own substitute for H.R. 1, our own final passage of H.R. 
1 conference. So we are not all that far apart.
    I think we all realize a lot of this is politics, and I 
guess it is a political time, but I just think that we need to 
remember that we, probably most of us, voted for that. And we 
also need to remember that the beauty of the entire price 
increase is more than 6 million low-income beneficiaries will 
see absolutely no premium increase, because they already have 
their entire premium paid by Medicaid. And the real saving 
grace to all of it is they can opt out of it. They are not 
forced into anything. So I don't think we ought to be trying to 
sell that here 6 weeks before the general election.
    I yield back my time.
    Mr. Bilirakis. I thank the gentleman.
    Mr. Stupak for an opening statement.
    Mr. Stupak. Mr. Chairman, while I appreciate the topic of 
today's hearing, the preventive benefits of the new Medicare 
law, I believe there are many more important, more urgent 
topics of concern for American seniors and American taxpayers 
regarding the new law. Let me list a few.
    Topics like cost. Why won't the administration just tell 
American taxpayers the truth about the cost of this new law? It 
seems like every day a new cost estimate comes out. The 
committee deserves a straight answer. Let us face it, the 
administration did not tell the truth to the American people 
and Congress when they said the legislation would cost no more 
than $400 billion over 10 years. Earlier this year, the 
administration admitted the new law would cost 534 billion over 
10 years. This week, a new estimate by the administration says 
$576 billion. What is the true cost of this bill? And how much 
of that cost is going to be to big insurance and HMOs as 
    According to a MEDPAC report that was released to Congress 
last week, Medicare HMOs will get paid 107 percent of what it 
would cost to care for the same seniors under traditional 
Medicare. I thought HMOs are supposed to lower our costs. In 
fact, Medicare spending could be reduced by $50 billion over 
the next decade by paying private plans 100 percent of what it 
pays for fee-for-service coverage. The HMOs and CMS need to 
come before Congress and justify these overpayments. I don't 
think they can be justified, but I am willing to listen to 
their explanations. How much is this giveaway to HMOs and 
prescription drug companies costing American seniors?
    We know that Part B premiums are going up, are going to 
increase by 17.5 percent next year. Seniors deserve to know why 
they are going to be forced to pay the largest dollar increase 
in the history of Medicare. We should be discussing how seniors 
will afford a 17.5 percent increase next year on top of a 13.5 
percent increase this year. We know they can't rely on Social 
    According to a recent administration analysis, which was 
hidden until USA Today recently uncovered it--and I am quoting 
now--a typical 65-year-old can expect to spend 37 percent of 
his or her Social Security income on Medicare premiums, 
copayments, and out-of-pocket expenses in 2006. That share is 
projected to grow to almost 40 percent in 2011, and nearly 50 
percent by 2021.
    How are seniors supposed to make due? Congress should not 
go home until the premium issue increase is addressed.
    Mr. Chairman, there are a lot of questions that need to be 
asked about the true cost of this law to both the taxpayers and 
the seniors and about the quality of benefits. We need to know 
why 3 million low-income seniors who qualify for the $600 
credit under the drug card program have not signed up. We need 
to know why the administration is not automatically enrolling 
the only group of seniors I believe may benefit from this 
otherwise lousy drug card program. And we need to know why, 
when the Secretary of Human Services, Health and Human 
Services, is going to use his authority granted to him under 
the new law to allow the safe importation of prescription drugs 
by our seniors.
    This committee has a lot of questions to ask of the 
administration on issues of great importance and urgency to our 
seniors and taxpayers. I hope you allow us an opportunity to 
ask those questions.
    I yield back the balance of my time.
    Mr. Bilirakis. The Chair recognizes the gentleman from 
Illinois, Mr. Shimkus.
    Mr. Shimkus. Thank you, Mr. Chairman. I will be brief.
    Thank you for this hearing. You know, it is about time that 
we started moving Medicare into the modern era, and we are 
doing that and I think we will find out more with this hearing 
with the ``Welcome to Medicare Physical'' as well as the 
cardiovascular and the diabetes screening that is very 
important. This is educational. It is educational for us so 
that we can talk to our seniors, it is educational for the 
public who will be watching over C-SPAN. The more we learn 
about it, the better we are all going to be.
    And I thank you for coming, Mr. Chairman. I yield back my 
    Mr. Bilirakis. I thank the gentleman.
    [Additional statement submitted for the record follows:]

 Prepared Statement of Hon. Joe Barton, Chairman, Committee on Energy 
                              and Commerce

    Thank you Chairman Bilirakis for holding this important hearing. I 
would also like to thank our witnesses for coming to testify before the 
Subcommittee today. I look forward to hearing your testimony, and your 
views on the new preventive services available to Medicare 
    The landmark Medicare legislation passed last year truly deserves 
the name the Medicare Modernization Act. Medicare is too often behind 
the curve in responding to changes in the practice of medicine. In 
1965, prescription drugs were an afterthought in providing quality 
medical care. The same was true for preventive benefits. The MMA 
recognized the changes that have revolutionized health care since 1965, 
and provided beneficiaries with access to both prescription drugs and 
preventive benefits.
    At its inception, Medicare was designed to treat acute conditions 
after patients became symptomatic. Since that time quantum leaps have 
been made in our understanding of diseases. Although we don't have a 
cure for cancer, we do know that when detected early, patients can beat 
this otherwise fatal disease.
    Thirty-nine years ago, too many diabetics faced living with painful 
diabetic ulcers or having to undergo life-changing amputations. Those 
dangers still exist, but with early recognition of diabetes and proper 
management of the disease, most diabetics can avoid serious 
complications. According to the American Diabetes Association, over 18 
percent of Americans age 60 and older have diabetes. With the 
increasing prevalence of Type II, adult onset, diabetes it is 
imperative for the quality of life of our seniors that we do a better 
job of early detection and treatment of this disease. The Medicare 
Modernization Act will provide seniors at risk for diabetes the 
appropriate screenings for the disease.
    In addition, thanks to the tireless efforts of Subcommittee 
Chairman Bilirakis, seniors for the first time will receive a ``Welcome 
to Medicare'' physical upon their enrollment in the program. The 
importance of this initial exam cannot be overstated. These 
examinations will allow seniors to better understand their current 
health status and take steps to mitigate potential health risks.
    Seniors will now also receive regular cardiovascular screenings. 
According to the American Heart Association, in 2001, over four million 
seniors were discharged from short-stay hospitals with a first listed 
diagnosis of cardiovascular disease. Many of those could have avoided 
hospitalization by early detection of their cardiovascular disease 
    The new preventive benefits provided by the MMA hold the promise to 
dramatically improve patient outcomes. They also hold the potential to 
reduce Medicare spending by identifying and treating conditions before 
they require expensive acute care.
    This year Medicare celebrated its 39th birthday. Thanks to the new 
benefits provided for in the MMA, seniors will begin to see a Medicare 
program that is based on the medicine of the 21st century, not an 
outdated benefits package based on the medicine of decades gone by. 
Thank you again Mr. Chairman for holding this important hearing.

    Mr. Bilirakis. Let us go right into the witnesses. Our 
gratitude for your taking time to be here. I am glad that we 
have shortened our opening statements, so to speak, so that we 
can hear from you.
    Your written statements, of course, are a part of the 
record, and hopefully you will complement and supplement them. 
I will set the clock at 5 minutes, but by all means don't let 
it rush you. In other words, we want to hear what you have to 
say. And hopefully, of course, that doesn't mean you double the 
time, But in any case, whatever. Please help us to better 
understand what we have accomplished, what we hope to have 
accomplished regarding preventive health care in this 
    Dr. Clancy, please proceed.


    Ms. Clancy. Mr. Chairman and members of the subcommittee, I 
am really delighted to have the opportunity today to testify 
about the role of the U.S. Preventive Services Task Force in 
assessing the effectiveness of preventive health care services. 
This year marks the 20th anniversary of the Task Force. 
Composed of 16 private sector experts, the Task Force conducts 
rigorous impartial assessments of the scientific evidence for a 
broad range of clinical preventive services. Indeed, its 
recommendations are considered the gold standard, if you will, 
for preventive services provided in a clinical setting. The 
work of the Task Force complements the important work of CDC's 
Task Force on Community Preventive Services, which, by its 
name, as it implies, examines preventive services delivered in 
community or public health settings.
    Before turning to how the Task Force does its work, I want 
to just make three points to put its work in context:
    First, the Task Force focuses on primary and secondary 
preventive health care services that are delivered in primary 
care clinical settings. So primary prevention is defined as 
interventions that reduce the risk of disease in otherwise 
healthy people. For example, flu shots. Secondary prevention is 
defined as screening to identify risk factors for disease or to 
identify disease before it appears, such as cancer or heart 
    The second point is that the role of the Task Force is to 
identify those preventive services for which there is good-
quality evidence of effectiveness. In medicine, all of us are 
taught that the first cardinal rule is do no harm. The role of 
the Task Force is to identify those preventive services for 
which there is evidence of effectiveness. In other words, that 
the potential benefits outweigh the potential harms.
    The third point is that the Task Force does not speak for 
AHRQ or for HHS. While the director of AHRQ is statutorily 
required to appoint its members and support its work, the Task 
Force is not a Federal advisory body under law. So to date, the 
Task Force has reviewed over 70 topics in the area of primary 
and secondary clinical prevention, ranging from taking aspirin 
to preventing a first heart attack to screening for obesity to 
screening patients for potential problems with depression.
    To determine which topics to review, the Task Force 
solicits inputs from its members, Federal agencies, 
professional organizations, and the public. The Task Force then 
ranks the topics based on the magnitude of the problem as 
defined by the number of people affected, and they work with 
outside experts to identify the fundamental questions that 
should be answered. For example, is a clinical preventive 
service, whether it is screening, counseling, or chemo 
prevention, associated with reduced morbidity and mortality? 
Does early identification of the disease lead to an improved 
outcome compared to the result that would occur if the disease 
were not detected early? And so forth.
    So this decision framework also takes into account 
potential harms of these services, such as the possibility of 
false-positive tests that require further and sometimes 
invasive and potentially risky follow-up tests.
    To rate the quality of the evidence, the Task Force relies 
on AHRQ to coordinate systematic reviews of the evidence 
through our Evidence-based Practice Centers program. The 
Centers first identify all relevant studies, and then they 
assess the quality of those studies to figure out whether they 
are of good, fair, or poor quality. They then synthesize the 
findings. Consistent with our policy and our authorizing 
legislation, the Centers make no recommendations. That role is 
left to the Task Force, which establishes recommendation by a 
formal vote, and how they do this is they assign letter grades.
    An A grade means a very strong recommendation; that there 
is good evidence that the benefits of providing this service 
substantially outweigh the harms.
    A B grade, similar to report cards, means that the Task 
Force recommends a service if there is at least fair evidence 
and the benefits outweigh the harms.
    A C grade means that the Task Force makes no 
recommendations for or against if there is at least fair 
evidence and there is a close balance between the benefits and 
the harms.
    A D grade means that the Task Force recommends against 
routine use of a service that is ineffective or that the harms 
outweigh the potential benefits.
    And an I grade means that the Task Force finds insufficient 
evidence to recommend for or against, since the balance of 
benefits and harms is not known. This I recommendation 
sometimes causes confusion. The I letter simply reflects that 
there is insufficient evidence to make a formal recommendation. 
It is neither a recommendation for nor against providing the 
service on a routine basis. It may mean that few studies have 
been conducted or that the existing studies are flawed or 
contradictory or are not powerful enough statistically to 
provide conclusive evidence.
    Mr. Chairman, supporting the work of the Task Force is just 
one aspect of AHRQ'S much broader prevention agenda. We have 
come to appreciate that there is a large gap between what is 
known and what is actually done in practice, and our work can 
help in three ways:
    First, before we can improve care, we need to understand 
what is known or the state of the science. AHRQ plays an 
increasingly important role in synthesizing that knowledge. We 
now have a formal arrangement to develop such syntheses before 
each consensus conference sponsored by the National Institutes 
of Health, and the MMA directs AHRQ to expand its synthesis 
role. The goal of MMA Section 1013 is to help those who manage 
and are served by the Medicare, Medicaid, and SCHIP programs to 
benefit faster from existing knowledge. In addition, we are 
finalizing three reports related to obesity in the elderly, 
geriatric surgery, and weight loss programs which we hope will 
be very useful to public and private sector policymakers.
    Second, recent experience demonstrates that knowing the 
right thing to do is only the first step. The real challenge is 
ensuring that our broad range of health care delivery systems 
supports rather than frustrates the effort of harried 
caregivers to provide state-of-the-art care; that is, to do the 
right thing. The Institute of Medicine report ``To Err is 
Human,'' which focused on medical errors and patient safety 
made it very clear: It takes a dual focus on effective services 
in effective and efficient ways to organize, manage, and 
deliver those services.
    Third, AHRQ can play a unique role in what is sometimes 
called tertiary prevention or preventing complications in those 
with diseases. From my experience as a practicing physician and 
also from published studies, I can tell you that the critical 
challenge is not developing management strategies for 
individual diseases, it is understanding how to reconcile 
competing recommendations for patients with multiple chronic 
illnesses. For example, 82 percent of people with diabetes have 
at least one other chronic illness. Twenty percent of Medicare 
beneficiaries have five or more chronic conditions. The 
perspective that we bring to chronic care management is 
patient-centered, not disease-specific, and increasingly we are 
shifting our work to ensure that patients and their caregivers 
have better information for assessing these critical tradeoffs.
    This concludes my prepared remarks, and I would be happy to 
take any questions.
    [The prepared statement of Carolyn Clancy follows:]

 Prepared Statement of Carolyn Clancy, Director, Agency for Healthcare 
   Research and Quality, U.S. Department of Health and Human Services


    Mr. Chairman, I welcome this opportunity to testify about the role 
of the United States Preventive Services Task Force in assessing the 
effectiveness of preventive health care services. In fact, this year 
marks the twentieth anniversary of the Task Force. Now in its third 
incarnation, the Task Force is widely viewed by primary care clinicians 
as providing the ``gold standard'' regarding those preventive services 
for which there is good quality scientific evidence of effectiveness.
    I will also comment briefly on the research and synthesis work 
undertaken by the Agency for Healthcare Research and Quality (AHRQ). We 
support the work of the Task Force, a statutory requirement since our 
1999 reauthorization, but we also develop new information regarding the 
effectiveness of preventive health care; synthesize ``state of the 
art'' information regarding preventive health care services for 
patients and their caregivers, and identify approaches for increasing 
the rates at which effective clinical preventive services are delivered 
and used.
    AHRQ's work provides an important complement to the community-
based, public health strategies and interventions that are developed 
and promoted under the leadership of the Centers for Disease Control 
and Prevention (CDC). Both CDC and AHRQ also benefit from the work of 
the National Institutes of Health in developing the basic building 
blocks that underpin public health and clinical preventive services 
interventions. Prevention research is a good example of how the 
Department of Health and Human Services (HHS) is increasingly 
functioning as ``one Department.''
    As requested, my testimony will provide background information on 
how the Task Force and AHRQ approach their work in prevention. However, 
I want to stress that AHRQ maintains a focus on effective preventive 
services for the elderly. In that capacity, each year we submit to the 
Congress a report on the latest recommendations of the Task Force. I 
welcome the opportunity to address any substantive issue following the 
conclusion of my statement.


Context and Scope
    Before turning to how the Preventive Services Task Force undertakes 
its work, there are 3 points that need to be made regarding the context 
and scope of its work.
    First, the Task Force focuses on primary and secondary prevention. 
Since the Office of the Secretary established the first Preventive 
Services Task Force 20 years ago, the Task Force's mandate has focused 
on the delivery in primary care settings of primary or secondary 
prevention services. The Task Force was originally created to provide 
guidance for primary care clinicians in the area of preventive care for 
apparently healthy individuals. Primary prevention is defined as 
interventions that reduce the risk of disease occurrence in otherwise 
healthy individuals. Counseling patients not to smoke and prescribing 
fluoride to children to prevent cavities are examples of primary 
prevention. Secondary prevention can be defined as screening to 
identify risk factors for disease or the detection of disease among 
individuals who are at risk for that disease. Evaluating blood pressure 
in adults is an effective way to identify individuals at risk for heart 
disease and provides an opportunity to intervene before the disease 
occurs. Screening for colon cancer using colonoscopy to detect pre-
cancerous polyps is another example of secondary prevention. The bottom 
line is that individuals who receive primary or secondary prevention 
services have no obvious signs of illness; in clinical terms, they are 
asymptomatic. Consistent with the longstanding commitment by physicians 
and other health care professionals to ``first do no harm,'' providing 
services to individuals who are apparently free of disease requires a 
careful approach to balancing benefits and harms.
    By contrast, the Task Force does not address the category of 
services known as tertiary prevention. Tertiary prevention services are 
provided to individuals who clearly have a disease and the goal is to 
prevent them from developing further complications. For example, 
diabetes care would be considered tertiary prevention in that the care 
provided is focused on limiting the complications of a disease that is 
already present. Tertiary prevention interventions are a focus of 
research by AHRQ and an important component of prevention public 
policy, but they are not within the purview of the Task Force. Unlike 
primary and secondary prevention, there are numerous groups who review 
the literature on medical treatment in order to advise clinicians on 
the optimal way to treat chronic illnesses. Therefore, it remains 
critical for a group such as the Task Force to remain focused on the 
types of preventive service decisions for which most primary care 
clinicians have limited evidence-based guidance.
    Second, the role of the Task Force is to identify those preventive 
services for which there is good quality evidence of effectiveness. 
This is a high standard to meet and has implications for interpreting 
the work of the Task Force and determining what to do in the absence of 
evidence. The first point to recognize is that good quality scientific 
evidence takes time. Thus, when the Task Force concludes that there is 
insufficient evidence upon which to make a recommendation, the Task 
Force is not concluding that a service is ineffective. It may simply 
reflect the fact that few studies have been conducted, or that existing 
studies are flawed, contradictory, or simply not powerful enough 
statistically to provide good quality evidence. Should a finding of 
insufficient evidence preclude guidance from Federal agencies, medical 
societies, or action by policymakers? Not necessarily. Patients and 
their caregivers often need advice or assistance in the absence of 
perfect information and there may be an important public health 
rationale for action before good quality evidence is available. In such 
cases, guidance from Federal agencies or medical societies or action by 
policymakers may be appropriate.
    Third, the Task Force does not speak for AHRQ or HHS. While the 
Director of AHRQ is statutorily required to appoint its members, the 
Task Force is not a Federal advisory body under the law. The Task Force 
is a body of private sector primary care experts and methodologists. It 
is configured to provide expertise in the area of primary and secondary 
clinical prevention to a broad patient population and their primary 
caregivers. I have included at the end of my testimony, a roster of the 
current Task Force membership, which includes a mix of internists, 
family physicians, pediatricians, obstetrician/gynecologists, nurses, 
and methodologists with expertise in issues of screening, counseling, 
and prescribing drugs for reducing the risk of disease in the primary 
care setting.

How the Task Force Operates
    To date the current Task Force has reviewed numerous topics in the 
area of primary and secondary clinical preventions, ranging from 
childhood vision screening to obesity counseling to postmenopausal 
hormone replacement therapy. This range of topic areas and population 
age groups reflects the breadth of such interventions encountered in 
primary care settings. The process that the Task Force uses is as 
    Topic Selection: To determine which clinical preventive topics to 
review, the Task Force solicits topics from its members, Federal 
agencies, professional organizations and the public. The Task Force 
then prioritizes these topics based on the magnitude of the problem as 
defined by the number of people affected or the severity of the 
problem, evolving evidence, and potential impact of the recommendation 
on primary care practice.
    The Framework for Evidence-Based Reviews: For each topic, the Task 
Force establishes the scope of the review by identifying the specific 
populations for which evidence will be evaluated. This decision 
reflects the prevalence of the disease and its manifestation among 
different groups, expressed in terms of age, gender, and risk status.
      The analysis of the scientific literature is guided by the 
ultimate outcomes on which the Task Force focuses. Is a clinical 
preventive service--screening, counseling or prescribing drugs to 
reduce the risk of disease--associated with reduced morbidity and 
mortality? Does earlier identification of disease lead to an improved 
outcome compared to the result that would occur if the disease was not 
detected and treated early? The Task Force then works with external 
experts to develop the specific key questions for each point in the 
analytic framework that will illuminate the effectiveness of screening, 
counseling or treatment on reducing mortality and morbidity. As the 
graphic below demonstrates, the framework also takes into account 
potential harms associated with these activities such as false 
positives, increased anxiety, or adverse effects.


    Rating the quality of the evidence: The Task Force relies on AHRQ 
to coordinate the systematic reviews of the evidence through the 
Evidence-based Practice Centers (EPCs) supported by the Agency. Before 
an EPC can synthesize the scientific literature, it must first assess 
the methodological rigor of each study, asking questions such as:

 Did the investigators use an appropriate research design for the 
        question being asked?
 Did they control for other factors that might affect the outcome 
        (what researchers call ``threats to validity'')?
 Did they use the right statistical tests and calculate them properly?
 Did the study address services provided in the primary care setting?
    After evaluating the relevance and rigor of each individual study, 
the EPC also considers the consistency of evidence across the entire 
body of studies. Based on these components the strength of the evidence 
is categorized as good, fair, or poor and then synthesized. Consistent 
with its approach in other areas, AHRQ directs its EPCs to identify 
strengths and limitations of the existing knowledge base, but these 
evidence reports make no recommendations.
    Developing a recommendation: After reviewing the EPC report and 
considering the overall strength of the evidence and estimates the 
magnitude of the net benefits (based on the balance of benefits and 
harms), the Task Force then establishes recommendations by a formal 
vote. To guide interpretation of its recommendations, it assigns a 
letter grade to each recommendation, reflecting the strength of the 
evidence and the magnitude of benefit. The letter grades include:

A--The Task Force strongly recommends a service, there is good 
        evidence, and benefits substantially outweigh the harms.
B--The Task Force recommends a service if there is at least fair 
        evidence, and the benefits outweigh the harms.
C--The Task Force makes no recommendations for or against a service if 
        there is at least fair evidence, and the benefits and harms are 
        closely balanced.
D--The Task Force recommends against routine use of a service that is 
        ineffective or if the harms outweigh the potential benefits.
I--The Task Force found insufficient evidence to recommend for or 
        against a service since the balance of benefits and harms is 
        not known.
    The ``I'' letter grade simply reflects the lack of adequate 
evidence to make a recommendation; it is neither a recommendation for 
nor a recommendation against providing the service on a routine basis. 
A preventive service could receive an ``I'' letter grade for several 
reasons: Studies may be lacking, existing studies may be of poor 
quality, or good-quality studies may have conflicting results. 
Therefore, an ``I'' recommendation is a call for additional research 
that would provide the appropriate evidence base for the USPSTF to make 
either a positive or negative recommendation.

Two Methodological Issues now under Consideration
    Mr. Chairman, there are two methodological issues under 
consideration by the Task Force that may be of interest to the 
Committee, and we would welcome your input. The first relates to 
special populations. The Task Force addresses recommendations across 
all age groups from birth to death. While the majority of 
recommendations focus on the adult population, the current Task Force 
has addressed 13 topics relating to children and adolescents. 
Challenges exist in making recommendation for these populations for 
multiple reasons. Defining the clinical endpoint can be difficult in 
children because the reduction of morbidity and mortality may not be 
realized until they reach adulthood. The potential benefits or harms of 
clinical preventive services need to be considered for the child and 
adolescent as well as their family. Finally, youth often receive 
services in the school or community setting. To address these 
challenges the Task Force established the Child Health Workgroup which 
is currently discussing these issues and is planning a child health 
expert conference.
    The second issue relates to the consideration of costs and cost-
effectiveness. With the convening of the current Task Force, members 
recognized that cost-effectiveness and value are important issues to 
users of the Task Force recommendations. The Task Force convened a work 
group to assess approaches for addressing cost and cost-effectiveness. 
That assessment is still under way. At this point, the Task Force does 
not consider cost or cost effectiveness as a primary determinate in 
making its recommendations but rather in selected cases summarizes the 
cost data for users in the discussion section of its recommendation 


    Mr. Chairman, supporting the work of the Task Force is but one 
aspect of AHRQ's much broader prevention agenda. Unlike the Task Force, 
our agenda includes tertiary prevention interventions in addition to 
primary and secondary activities. Rather than provide a laundry list of 
those activities, I would like to highlight three unique strengths that 
AHRQ brings to all of its work, including the Department's prevention 
    In recent years we have come to appreciate that there is a large 
gap between what is known and what is done in practice. It is reflected 
in the unacceptably long time line between the funding of pioneering 
research and the point at which most Americans benefit from that 
research investment; at least one analyst estimates that it takes 17 
years. Our work suggests that there are a number of challenges we must 
overcome if we are to ensure that Americans benefit more rapidly from 
our past research investments. Let me highlight just three.
    First, it is hard for physicians and their patients to keep abreast 
of the latest scientific knowledge. The increased pace of publication 
of new scientific findings also enhances this difficulty. As a 
practicing physician, I know how difficult it is to determine whether 
to change my practice on the basis of the latest finding about one of 
many clinical issues I face. Unless research findings are put into 
context, my colleagues and I cannot answer for our patients that vital 
but deceptively simple question: what is known? I am increasingly 
convinced that AHRQ's role in the synthesis of evidence--which we 
undertake for (among others) the Task Force, CMS, FDA, and even NIH as 
a prelude to its consensus conferences--is a vital first step to 
reducing lag time. We need to understand what is known--the ``state of 
the art''--before we can improve. In the area of prevention, for 
example, we have completed three important evidence reports on obesity. 
I expect these reports will be as useful to policymakers as they will 
be for patients and their caregivers.

 CMS commissioned a technology assessment from us to review and 
        analyze the scientific literature on treatments for obesity in 
        the elderly, including behavioral therapies and dietary 
 At the request of Congress, we developed a report on a cost 
        effectiveness analysis of weight loss programs in the elderly.
 One of our Evidence-based Practice Centers recently completed an 
        evidence report on pharmacological and surgical management of 
        obesity. This report was requested by primary care specialty 
        societies. It will be released in the next few days.
    The Medicare Modernization Act (MMA) requires AHRQ to undertake 
more of this type of work so that those who manage and are served by 
the Medicare, Medicaid and SCHIP programs can benefit faster from 
existing knowledge. The MMA also challenges AHRQ to see that physicians 
and patients can access the information on ``what is known'' when they 
need it. We already have an innovative arrangement with the vendor, 
ePocrates, to provide physicians with fast access on their PDAs to the 
bottom line of recommendations from the Task Force. Since a growing 
number of clinicians rely on their PDAs to help keep them current with 
the latest science, AHRQ has developed a free Interactive Preventive 
Services Selector Program for PDAs. Since we made the software 
available for downloading, the web site has been accessed 7,847 times 
and the software has been installed on 1,837 Palm-based PDAs and 775 
Pocket PC PDAs.
    Second, recent experience demonstrates that knowing the right thing 
to do is only the first step. The real challenge is ensuring that our 
broad range of health care delivery systems supports, rather than 
frustrates, the efforts of harried caregivers to do the right thing. 
AHRQ has a unique dual focus on effective services and effective and 
efficient ways to organize, manage, and deliver those services. We 
pioneered the use of preventive services reminder systems and some 
concepts for workflow redesign to improve the rates at which preventive 
services were delivered and used. As my colleagues and I work to make 
AHRQ more of a ``problem solving'' agency, we will focus increasing 
attention on options for overcoming those system, organization, and 
behavioral barriers to increased use of effective clinical services.
    In addition, we will soon be announcing a series of grant and 
contract awards to increase the deployment and use of health 
information technology--precisely because health information technology 
can make the right thing to do the easy thing to do. The awards we will 
be announcing will advance the President's and Secretary's commitment 
to improve the safety and quality of health care and increase the 
utilization of preventive services.
    Third, as the ``baby boomer'' generation ages, the ranks of chronic 
care patients are swelling. AHRQ has and will continue to contribute to 
efforts to develop and assess specific disease management strategies. 
But the unique perspective we bring to chronic care management is a 
patient-centered, not disease-centered, focus. For example, 82% of 
patients with diabetes have another chronic condition and 20% of 
Medicare beneficiaries have 5 or more chronic conditions. In our view, 
the challenge of developing effective individual disease management 
strategies is easily matched, if not exceeded, by the need to reconcile 
disparate disease management programs for patients with multiple 
chronic diseases. Increasingly, our work is shifting to meet this need. 
The number of multiple chronic care patients will only continue to grow 
in the years ahead and we need tertiary prevention strategies that can 
be reconciled at the level of the primary carergiver.


    Mr. Chairman, this concludes my prepared testimony. I would be 
happy to answer questions.

    Mr. Bilirakis. Thank you very much.
    Director Heinrich.


    Ms. Heinrich. Mr. Chairman and members of the subcommittee, 
I too am pleased to be here today as you discuss preventive 
care benefits for the Medicare population. As you stated, the 
Medicare program was originally conceived to help pay for 
people 65 and over who were ill or injured. But over time, 
Congress has broadened coverage to include specific preventive 
services such as immunizations or screenings for different 
types of cancers. Most recently, Congress added coverage for a 
one-time preventive care examination for new enrollees and 
other selected preventive services.
    As these new benefits are implemented, you have asked about 
lessons learned from previous research on delivery options. My 
statement today focuses on the extent to which beneficiaries 
receive preventive services through physician visits and some 
of the expected benefits and limitations of delivering services 
through a one-time prevention examination.
    You have just heard about the Preventive Services Task 
Force and the excellent work that they do. It is clear that 
Medicare does not cover all of the services that the Task Force 
recommends. Under the traditional fee-for-service program, 
there has not been coverage of a regular periodic examination 
where clinicians might assess an individual's health risk and 
provide needed services. Beneficiaries can receive some of 
these services through office visits for other health problems.
    For example, we examined survey data that showed Medicare 
beneficiaries visited a physician at least six times a year, on 
average, mainly for illness and medical conditions. Only about 
10 percent of the visits occurred when a person is well. 
Despite how often beneficiaries visit physicians, few people 
received the full range of recommended preventive services. As 
we reported, although 91 percent of females in our analysis 
received at least one preventive service, only 10 percent 
received screening for cervical, breast, colon cancer, and were 
also immunized against influenza and pneumonia.
    Many beneficiaries may not know that they are at risk of a 
particular health condition. For example, data from a CDC 
survey that includes a physical exam showed that 32 percent of 
persons with an elevated blood pressure were unaware that they 
might have this condition. This translates into about 6.6 
million people who may not have known that they were at risk 
for high blood pressure.
    The new Welcome to Medicare examination may offer an 
opportunity to correct some of these problems. It could be a 
means to ensure that health care providers take the time to 
identify individual beneficiaries' health risks and provide the 
services appropriate for those risks.
    The initial preventive physical exam described in the draft 
regulations is comprehensive, and provides for a physical exam 
as well as education, counseling, and referral for separately 
covered preventive services. Questions remain, however, about 
how follow-up to beneficiaries will be provided and how they 
will be encouraged to make informed choices about screening 
services, immunizations, and avoidance of risky behavior.
    It also is unclear if a one-time examination will actually 
improve beneficiaries' health. For example, one previous CMS 
demonstration tested health promotion and disease prevention 
services, such as preventive visits, health risk assessments, 
and behavioral counseling, to see if this would increase 
beneficiaries' health or lower health care expenditures. The 
results showed some increased utilization of preventive 
measures such as immunizations and cancer screenings, but did 
not consistently improve beneficiary health or reduce the use 
of hospital or skilled nursing services.
    CMS is exploring an alternative for delivering preventive 
care that would provide systematic health risk assessments to 
fee-for-service beneficiaries through a means other than a 
physician visit. The Medicare Senior Risk Reduction program 
currently under design will use a beneficiary-focused health 
risk assessment questionnaire to identify risks. The program 
will test different approaches to provide feedback and follow-
up services, such as referring beneficiaries to community 
services, including physical activity and social support in 
changing risk behavior.
    In conclusion, current data indicate that many 
opportunities exist for Medicare beneficiaries to receive 
preventive care. Our work shows that we also have more to do to 
deliver preventive services to those beneficiaries who most 
need them. A one-time preventive care examination is a good 
start to reduce the gap in preventive services that 
beneficiaries receive.
    Mr. Chairman, this ends my prepared statement. I am happy 
to answer questions.
    [The prepared statement of Janet Heinrich appears at the 
end of the hearing.]
    Mr. Bilirakis. Thank you, Ms. Heinrich.
    Dr. Woolf.

                  STATEMENT OF STEVEN H. WOOLF

    Mr. Woolf. Good afternoon, Mr. Chairman, Mr. Brown, and 
members of the subcommittee. My name is Steven Woolf. I am a 
practicing family physician, a specialist in preventive 
medicine and public health, and a professor at Virginia 
Commonwealth University.
    I am here this afternoon representing Partnership for 
Prevention where I serve as Executive Vice President. 
Partnership for Prevention is a national nonprofit, nonpartisan 
policy research organization committed to helping Americans 
prevent diseases. We have issued reports and convened national 
meetings about preventive services under Medicare, have held 
congressional briefings on the subject, and are now working 
with CMS on strategies to improve the delivery of preventive 
care to America's seniors.
    Mr. Chairman, you and your colleagues are to be commended 
for holding today's hearing on the power of prevention to 
improve the health of America's seniors and to strengthen 
    The inherent logic behind prevention is obvious: The major 
diseases that claim the lives of Americans and that contribute 
mightily to the rising cost of health care are caused largely 
by our health habits, such as smoking, physical inactivity, and 
poor diet. Preventive services, in which doctors help patients 
change these behaviors, give vaccines to prevent infectious 
diseases, and use screening tests to catch them in their early 
stages, deserve greater attention from policymakers. This was 
always true, but especially now, a time when Americans are 
growing older and falling victim to chronic diseases that could 
have been prevented or made less severe through preventive 
    It is a mistake to think that seniors are too old to 
benefit from prevention. Research indicates that seniors will 
live longer and live healthier if they abandon unhealthy 
behaviors, get recommended vaccines, and receive certain 
screening tests.
    It is in the interest of our Nation for America's seniors 
to be healthy instead of infirm, active instead of 
hospitalized, productive instead of costly, and independent 
instead of dependent. Prevention makes sense not only for the 
fundamental reason that it improves health but also for 
economic reasons. The cost of treating the complications of 
diseases are enormous. It is better to pay for prevention than 
to pay for intensive care. As the Governor of Arkansas, Mike 
Huckabee, has stated: Our health care system should build a 
fence at the top of the cliff so we can stop sending ambulances 
to the bottom.
    Although prevention was excluded in the law that created 
the Medicare program 40 years ago, Congress has done much in 
the past decade to expand coverage for preventive services. 
Medicare now covers many of the screening tests and 
immunizations that medical organizations recommend for seniors, 
including some of urgent public health importance, such as 
screening tests for colon cancer and the vaccine that prevents 
    The Medicare Modernization Act furthered this effort by 
expanding coverage for cardiovascular and diabetes screening, 
but also by including coverage for the ``Welcome to Medicare'' 
visit. Offering all new beneficiaries a clinical evaluation by 
their primary care provider is an ideal opportunity to 
determine the individual needs of patients, remind them about 
the importance of prevention, and make arrangements for them to 
receive the counseling, screening, and immunizations that they 
are due. The visit can help set them off on the right foot.
    Partnership for Prevention commends Congress for adding 
these provisions, but there is far more to be done. Preventive 
services under Medicare remain deficient. In particular, I will 
highlight four issues which, in the interest of time, I will 
state briefly. I expand on these points in my written 
testimony, and, on request, can provide the subcommittee with 
our publications on the topic.
    First, the very fact that Medicare coverage of preventive 
service is managed by Congress is itself an issue. When it 
comes to diagnosing and treating disease, Congress allows CMS 
to decide what to cover in consultation with the leading 
experts of the Nation. The same should be true for preventing 
disease, as the Institute of Medicine recommended in 2000. 
Requiring an act of Congress to cover each preventive service 
is not only inconsistent but also inefficient. It slows the 
delivery of preventive care to America's seniors, compromising 
their health and costing the system money. The machinery of 
Congress is not designed for scientific deliberation and is 
less nimble than CMS in keeping pace with rapid changes in 
science and technology. Coverage policies that Congress 
established years ago have become outdated, advocating 
preventive services that medical groups no longer recommend; 
yet CMS is compelled by congressional statute to continue 
offering and paying for them. Partnership for Prevention 
encourages Congress to direct CMS to make coverage decisions 
for preventive services, just as it does for diagnostic and 
treatment services.
    Second, although Medicare now covers screening testing and 
immunizations, it offers little support for clinicians to help 
patients adopt the behaviors that will prevent disease, a 
strategy much more likely to save lives. Help with stopping 
smoking, controlling weight, and eating well, the most 
effective strategies for improving health and reducing costs 
for the Medicare program, is not covered under Medicare. The 
recent decision by CMS to cover obesity treatment is welcomed, 
but Congress should authorize Medicare to cover counseling for 
tobacco cessation, physical activity, and healthy diet.
    Third, although in theory the ``Welcome to Medicare'' visit 
provides an opportunity to deliver or arrange for recommended 
preventive services, greater structure is needed to ensure that 
the visit is used to promote evidence-based preventive services 
that improve health and it is not exploited to use Medicare 
dollars for services of unproven benefit or potential harm. Not 
all screening tests are good for you. Some may do more harm 
than good, which is why expert bodies such as the U.S. 
Preventive Services Task Force and most medical organizations 
recommend only a dozen of the hundreds of screening tests that 
are in existence. Promoting too many screening tests is not 
only an expensive proposition but one that is likely to harm 
the intended beneficiaries.
    In draft regulations issued this summer, CMS proposed to 
configure the ``Welcome to Medicare'' visit as a comprehensive 
history and physical examination in which patients would be 
given a battery of questions and examination procedures. Such 
comprehensiveness has good intentions but is worthy of further 
thought. For one thing, the opportunity for Medicare 
beneficiaries to get comprehensive physicals is already 
available. It is the opportunity for prevention that the MMA 
sought to provide. Second, comprehensive evaluations often set 
off a cascade of diagnostic workups that are of dubious health 
benefit to patients.
    Finally, and most importantly, the distractions introduced 
by a comprehensive physical can lead physicians and patients 
into diverse health complaints and crowd out the focus on 
prevention that the MMA intended. The MMA sought to give 
beneficiaries an opportunity, at least once during their tenure 
with Medicare, to focus on prevention; and that worthy goal 
could be lost if the visit turns into yet another comprehensive 
    Partnership for Prevention is concerned about 
overutilization and recommends that the ``Welcome to Medicare'' 
visit be designed as a focused prevention visit, not as a 
comprehensive physical, aimed at promoting a defined set of 
services that are known to improve health outcomes.
    Fourth, and finally, it is not enough to simply add 
coverage for preventive services. Steps must also be taken to 
ensure that they are delivered and delivered well. If what 
Congress has done to expand coverage is to realize its full 
potential benefits, both beneficiaries and providers must be 
educated about the importance of prevention and how to make use 
of the services that Medicare covers, reminder systems for 
doctors and patients, and modern ideas for quality improvement 
such as the Medicare Web site that patients can use at home to 
manage their prevention program, help ensure that patients 
receive services on time. These tools put patients in charge of 
their health.
    The Medicare program is plagued by racial and ethnic 
disparities in who receives covered services. And research 
shows that a systems approach to delivery can do much to reduce 
such disparities. We therefore encourage data collection 
activities at CMS to track outcomes and evaluate the 
performance of preventive care.
    Partnership for Prevention seeks to better educate 
beneficiaries and clinicians about the ``Welcome to Medicare'' 
visit and preventive care, and it urges Medicare to encourage, 
certainly not to impede, the introduction of systems within 
practices and health care organizations that improve the 
delivery of preventive care.
    Once again, we thank the subcommittee for its commendable 
efforts to promote prevention, and we look forward to working 
with you to make Medicare better. I would be happy to answer 
your questions.
    [The prepared statement of Steven H. Woolf follows:]

  Prepared Statement of Steven H. Woolf, Executive Vice President for 
 Policy Development Partnership for Prevention and Professor of Family 
     Medicine, Preventive Medicine and Community Health, Virginia 
                        Commonwealth University

    The inherent logic behind prevention is obvious. The major diseases 
that claim the lives of Americans and that contribute mightily to the 
rising costs of health care are caused largely by our health habits, 
such as smoking, physical inactivity, and poor diet. Fully 35% of 
deaths in the United States are caused by three behaviors: tobacco use, 
poor diet, and physical inactivity.1
    \1\ Mokdad et al. Acutal causes of death in the United States, 
2000. JAMA 2004;291:1238-45.
    Preventive services--in which doctors help patients change these 
behaviors, give vaccines to prevent infectious diseases, and use 
screening tests to catch diseases in their early stages--deserve 
greater attention from policymakers. Our healthcare system expends most 
of its resources on treating existing disease, but paying for 
prevention could be much more effective. For example, treatments for 
cardiovascular disease, once it has already developed, can save 4,000-
10,000 lives per year, but helping Americans to stop smoking would 
prevent more than 400,000 deaths per year.2
    \2\ Woolf. The need for perspective in evidence-based medicine. 
JAMA 1999;282:2358-65.
    This was always true but especially now, a time when Americans are 
growing older and in greater numbers are falling victim to chronic 
diseases that could have been prevented or made less severe through 
preventive measures. It is a mistake to think that seniors are too old 
to benefit from prevention. Research indicates that seniors will live 
longer and live healthier if they abandon unhealthy behaviors, obtain 
recommended vaccines, and receive certain screening tests. For example, 
lifelong smokers who stop smoking at age 50 live an average of 6 years 
longer than those who continue smoking beyond that age.3 
Prevention can improve function, postpone chronic disease and 
disability, and avoid premature death.
    \3\ Doll et al. Mortality in relation to smoking: 50 years' 
observations on male British doctors. BMJ 2004;328:1519.
    Prevention makes sense not only for the fundamental reason that it 
improves health, but also for economic reasons. The costs of treating 
the complications of diseases are enormous; it is wiser to pay for 
prevention than to pay for intensive care. In Appendix 1 we outline the 
cost savings associated with certain screening tests. As the Governor 
of Arkansas, Mike Huckabee, recently stated, our health care system 
should build a fence at the top of the cliff so we can stop sending 
ambulances to the bottom.
    Although prevention was excluded in the law that created the 
Medicare program 40 years ago, Congress has done much in the past 
decade to expand coverage for preventive services. Medicare now covers 
many of the screening tests and immunizations that medical 
organizations recommend for seniors, including some of urgent public 
health importance such as screening tests for colon cancer and 
pneumococcal vaccine, which helps prevent pneumonia.
    Our nation's leaders have turned the corner in recognizing the need 
to make Medicare a program that emphasizes prevention. President Bush, 
speaking in the State of the Union address, said that ``Medicare is the 
binding commitment of a caring society. We must renew that commitment 
by giving seniors access to preventive medicine.'' 4 In 
other speeches, the President has said that Medicare should be as much 
about keeping seniors healthy as treating them after they become sick. 
The current Administrator of CMS, Dr. Mark McClellan, said in July 
that, ``we mean it when we say we're shifting the focus of the Medicare 
program from treating conditions to preventing them.''
    \4\ President George W. Bush, State of the Union Address, January 
28, 2003. http://www.white
    The Medicare Prescription Drug and Modernization Act of 2003 (P.L. 
108-173) affirmed this commitment by expanding coverage for 
cardiovascular and diabetes screening but also by including coverage 
for a ``Welcome to Medicare'' visit. Offering all new beneficiaries a 
clinical evaluation by their primary care provider is an ideal 
opportunity to determine the individual needs of patients; remind them 
about the importance of prevention; and make arrangements for them to 
receive the counseling, screening, and immunizations to get them up-to-
date on preventive care. If properly designed, the visit can start 
patients off on the right foot and set expectations for an ongoing, 
comprehensive approach to preventive services. It is an opportunity to 
encourage patients to be active participants in managing their health 
and health care needs. Not everything can be done in just one visit, 
but the clinician and patient can leverage the opportunity to develop a 
plan for obtaining recommended services, to arrange follow-up, and to 
remind patients at a later date when repeat screening or immunizations 
are due.
    Partnership for Prevention commends Congress for adding these 
provisions. But there is far more to be done; preventive services under 
Medicare remain deficient. In particular, four issues deserve 
1. The mechanism for determining coverage of preventive services
    It is problematic that decisions about coverage of prevention under 
Medicare are determined by Congress, service by service. This is not 
the way that Medicare decides coverage for diagnostic tests and 
treatments: for those services, Congress directs CMS to decide what to 
cover, in consultation with the nation's leading medical experts. The 
same should be true for preventive services, as many experts have 
recommended. An Institute of Medicine study recommended just such a 
change in its 2000 report, Extending Medicare Coverage for Preventive 
and Other Services.5
    \5\ Institute of Medicine. Extending Medicare Coverage for 
Preventive and Other Services. Washington, DC: National Academy Press, 
    The existing model is failing. Requiring an ``act of Congress'' to 
cover each preventive service is inefficient and slows the delivery of 
preventive care to America's seniors--compromising their health and 
costing the system money. A bill to introduce coverage of Pap smears 
was introduced annually for 15 years before this benefit was added in 
1989. The machinery of Congress is not designed for analyzing science 
and producing medical guidelines, whereas mechanisms in place at CMS 
are designed to more nimbly keep pace with the rapid changes that occur 
in science and technology. The Medicare Coverage Advisory Committee 
(MCAC), which evaluates effectiveness for CMS, is adept at critically 
appraising the quality of evidence for new technologies and is quite 
capable of giving similar advice on the effectiveness of preventive 
services. As new preventive technologies emerge and as guidelines 
change, CMS can update coverage policy much faster and with greater 
scientific rigor than can a legislative body charged with 
responsibilities for the economy, national security, and other diverse 
    The legislative mechanism used by Congress to cover preventive 
services has not performed well in keeping coverage policies current. 
The provisions written into law are time capsules, reflecting the 
advice of the time, but many have now become outdated. For example, in 
1991, Congress authorized Medicare to cover ``baseline mammograms'' to 
be performed on all women at age 35, a practice advocated at the time 
by the American Cancer Society. But today, no major medical group 
(including the American Cancer Society) advocates baseline 
mammograms.6 In 1998, Congress authorized Medicare to cover 
colonoscopy screening as often as every 2 years, presumably because of 
testimony received at the time. But in 2004, no scientific evidence and 
no major gastroenterological organization supports performing the test 
this frequently, even for patients at high risk for colon 
cancer.7 In 1998 coverage was extended to osteoporosis 
screening for high-risk women, the group that seemed most likely to 
benefit. By 2002 the U.S. Preventive Services Task Force had begun 
recommending screening for all women over age 65, but in 2004 Medicare 
coverage remains restricted to women at high risk.
    \6\ Smith et al. American Cancer Society guidelines for the 
detection of cancer, 2004. CA Cancer J Clin 2004;54:41-52.
    \7\ Winawer et al. Colorectal cancer screening and surveillance: 
clinical guidelines and rationale-Update based on new evidence. 
Gastroenterology. 2003;124:544-60.
    Although staff at CMS is aware of these discrepancies, as long as 
the Congressional statute remains in place, the agency is legally 
obliged to continue offering and paying for these unnecessary services. 
CMS publications must inform beneficiaries that these services are 
covered, thereby disseminating the implicit encouragement that 
beneficiaries obtain preventive services at a greater frequency--and at 
greater cost to Medicare--than any medical organization currently 
    Experience has therefore taught us that relying on Congressional 
mandate to cover preventive services under Medicare delays the 
establishment of coverage for preventive services that are recommended 
and the elimination of coverage for services that are not recommended. 
America's seniors deserve a better system.
    In a 2003 report, Partnership for Prevention issued a study, A 
Better Medicare for Healthier Seniors 8, which laid out 6 
options for Medicare coverage of preventive services:
    \8\ Partnership for Prevention. A Better Medicare for Healthier 
Seniors: Recommendations to Modernize Medicare's Prevention Policies. 
Washington, DC: Partnership for Prevention, 2003.

 Retain the status quo
 Tie coverage to an outside group (e.g., U.S. Preventive Services Task 
 Create a Congressional ``fast track''
 Use the regular coverage process
 Introduce a rulemaking change for screening
 Create preventive care accounts
    The study concluded that: Congress should direct CMS to make 
coverage decisions for preventive services, just as it does for 
diagnostic and treatment services. We believe that the ideal option is 
for decisions about Medicare coverage for preventive services to be 
incorporated into the current decision-making process at CMS, based on 
rigorous analysis of scientific evidence. As with other services, CMS 
could use the MCAC model, obtaining expert advice about coverage from 
an MCAC panel on preventive care.
    We also recommended that CMS be given flexibility to determine 
which providers and suppliers can be reimbursed for preventive 
services; that HHS should require greater collaboration on preventive 
care among all Federal agencies and with state and local agencies; that 
Congress should support development of evidence-based recommendations 
for clinical preventive services, health system interventions, 
community programs, and public and private sector policies; that HHS 
should maximize data and related analysis to better track and 
understand beneficiaries' access to and use of preventive services; and 
that Federal agencies sponsor new research to protect and improve 
beneficiaries' health.
    Our recommendations were supported by all seven living former 
Secretaries of Health and Human Services (or Health, Education, and 
Welfare); see Appendices 2-3. Interest in our recommendations has grown 
in Congress. In May 2003, Representatives DeWine, Leach, and Moran and 
Senators Graham and DeWine invited Partnership for Prevention to 
conduct a Congressional briefing. Our recommendations received the 
attention of Representatives Nancy Johnson, Jim Leach, and Jim Ramstad 
and of Senator Bill Frist. They were also discussed with the head of 
the Congressional Budget Office and the staff of Secretary of Health 
and Human Services Tommy Thompson. We are gratified that these 
discussions, along with the diligent work of other organizations that 
share a commitment to prevention, facilitated the expanded focus on 
preventive services that emerged in the Medicare Modernization Act. We 
are also pleased that current legislation under consideration in the 
House and Senate carries forward these recommendations.9
    \9\ Medicare Preventive Services Coverage Act of 2004 (S. 2535 and 
H.R. 4898).
2. Lack of coverage for counseling about health behaviors
    Preventive services include not only screening tests and 
immunizations, many of which Medicare now covers, but also the work 
clinicians do to counsel patients to adopt healthy behaviors, such as 
stopping smoking, controlling weight, staying physically active, and 
eating well. Although screening tests can be beneficial in reducing 
morbidity and mortality from diseases, the benefits of early detection 
are limited because, by definition, the disease process is already 
underway. Screening seeks to identify the disease at an early stage, 
but by then the pathology is already in place and achieving a cure is 
often an uphill battle.
    A more effective strategy than waiting for diseases to develop and 
attempting to catch them early is to prevent them from occurring in the 
first place. Helping patients to change the behaviors that account for 
half of all deaths in the United States is thus an urgent public health 
priority and a prudent economic policy to control the spiraling costs 
of health care. Accordingly, the Surgeon General and major task forces 
in the Federal government have urged doctors to make such counseling a 
routine part of primary care. For example, it is the recommendation of 
the Department of Health and Human Services and the Surgeon General 
that all doctors ask all patients, at every visit, whether they smoke; 
advise them about the importance of quitting; and make arrangements to 
help them in their quit attempts.10
    \10\ Fiore et al. Treating Tobacco Use and Dependence. Rockville, 
MD: US Department of Health and Human Services, 2000.
    It is therefore problematic that Medicare offers little 
reimbursement for clinicians to provide such counseling to their 
patients. The recent decision by CMS to cover obesity treatment is 
welcome, but tobacco use remains the leading cause of death in the 
United States.11 Physical inactivity and unhealthy diets 
cause cancer and other diseases, even in people who are not obese, and 
they are essential to prevent obesity. Counseling about tobacco use, 
regular physical activity, and healthy diet are therefore urgent public 
health priorities, but Medicare does not provide coverage.
    \11\ Mokdad et al. Acutal causes of death in the United States, 
2000. JAMA 2004;291:1238-45.
    The absence of adequate reimbursement discourages physicians from 
carving out the time they need with their patients to identify the 
health behaviors that need attention, provide the information and 
motivation on which patients rely to make lifestyle changes, arrange 
for services within the community to facilitate patients' efforts, and 
conduct follow-up calls and visits to provide the encouragement that 
patients need to maintain changes over time. Neither their efforts, nor 
the services within the community that can help them, are covered under 
Medicare, even though these activities pose the most effective strategy 
to improve the health of the Medicare population and to control 
spiraling health care costs. Counseling about health behaviors costs 
far less than the intensive care required for heart disease, cancer, 
and the others diseases that these behavior changes can avert.
    Congress should authorize Medicare to cover counseling for tobacco 
cessation, physical activity, and healthy diet.

3. The need to control the content of the Welcome to Medicare visit
    Although in theory the Welcome to Medicare visit provides an 
opportunity to deliver or arrange for recommended preventive services, 
greater structure is needed to ensure that the visit maintains its 
focus on prevention and is used to promote evidence-based services.
    Preventive services that are not evidence-based may result in more 
harm than good. For example, it seems self-evident that screening for 
diseases and catching them early must be beneficial, but this is not 
always the case. Due to the inaccuracies of some screening tests and 
the rarity of diseases in the general population, the number of people 
who receive false-positive results may exceed the number of people who 
have true disease. In some cases the tests used to investigate false-
positive results are potentially dangerous. If screening 100,000 people 
for brain tumors finds two people with the disease but causes 1,000 
people to have unnecessary brain surgery or brain biopsies for false-
positive test results, the screening program is likely to result in 
more harm than good. Exposing 1,000 people to the complications of 
brain surgery for the sake of two people with brain tumors raises 
daunting ethical questions.
    Thus, although hundreds of screening tests are in existence, expert 
panels that issue guidelines for screening recommend only a handful of 
screening tests. They refrain not so much out of concerns for costs--
these guideline panels are composed largely of health professionals who 
focus on health outcomes and not economics--but out of a public duty 
and ethical imperative to ensure that screening is for the good of the 
population. Promoting too many screening tests is not only an expensive 
proposition, but one that is likely to harm Americans.
    The large consumer market introduced by the millions of seniors who 
will be entitled to the Welcome to Medicare visit could entice 
commercial entities and certain specialists to promote services at the 
expense of the Medicare program. Encouraging clinicians to use the 
visit for comprehensive assessments is likely to identify issues that 
prompt further investigations, some involving expensive testing, for 
which there is little scientific evidence of benefit. To avert the 
emergence of a Welcome to Medicare ``industry'' and the exploitation of 
Medicare dollars for services of dubious value or potential harm, it is 
important to narrow the scope of the benefit around well-defined 
services that have been proven to enhance health outcomes.
    Below we array the preventive services that the U.S. Preventive 
Services Task Force recommends for seniors and those covered under 


    While the Partnership for Prevention welcomes the entry of services 
into box A, we believe that the services listed in box B should also be 
covered under Medicare. Some services in box B, such as counseling 
about tobacco use, have greater public health urgency than others, such 
as diphtheria-tetanus vaccination, but all are supported by strong 
scientific evidence that recipients have improved health 
outcomes.12 Such evidence is lacking for the services listed 
in box C, for which Congress has authorized coverage under Medicare. We 
believe the resources expended on these services could go farther in 
improving the health of beneficiaries if applied to the services listed 
in box B. Box D is empty but represents the hundreds of preventive 
services for which there is little evidence of benefit.
    \12\ See U.S. Preventive Services Task Force at http://
    In draft regulations issued in July 2004, CMS proposed to configure 
the Welcome to Medicare visit as a comprehensive history and physical 
examination. Physicians are expected to ask about past hospital stays, 
operations, allergies, injuries and treatments; to determine current 
medications and vitamin supplements; to catalogue the patient's family 
history; to review the patient's travel and work history; and to 
discuss social activities. They must review the patient's functional 
ability and level of safety, such as hearing ability, activities of 
daily living, fall risk, and home safety. For any abnormality 
identified by these assessments, physicians are to provide physical 
examination measures, education, counseling, and referrals.
    We are concerned about this broad focus for three reasons. First, 
it is unnecessary. The elements outlined in the regulations are 
standard components of a ``complete physical,'' for which Medicare 
beneficiaries were eligible even before the Medicare Modernization Act 
was passed. At most practices in the United States, new patients 
complete enrollment forms that ask about past hospitalizations, drug 
allergies, and the other items listed above, and established patients 
are often asked to update the information at regular intervals.
    Second, a comprehensive battery of questions and examination 
procedures is likely to set off a cascade of diagnostic workups of 
dubious health benefit to patients. Many studies have documented that 
the putative health benefit of such comprehensive assessments is often 
offset by the harms that result from complications of diagnostic 
procedures and by the considerable costs induced by follow-up testing 
and referrals.
    Third, the focus on prevention is lost amid the comprehensiveness. 
The Welcome to Medicare visit is a unique opportunity for a 
``prevention'' visit: to help patients focus on the health behaviors 
that prevent disease and to identify the screening tests and 
immunizations for which they are due. A visit preoccupied with 
comprehensive questions loses this focus on prevention. In the Welcome 
to Medicare visit, physicians should be asking about tobacco use, not 
compiling a list of drugs to which patients are allergic. In this 
visit, physicians should be asking when patients were last screened for 
breast cancer or immunized against influenza, not learning when an 
appendectomy was performed. In this visit, patients should be counseled 
about the importance of physical activity and healthy diet, not 
arranging referrals for headaches, acid reflux, and other abnormalities 
that will come to light in a comprehensive history.
    We encourage Congress and CMS to authorize coverage of preventive 
services that are recommended by the U.S. Preventive Services Task 
Force or other evidence-based bodies. Coverage policies under Medicare, 
and the content of the Welcome to Medicare visit, should be designed to 
promote a defined set of services that are known to improve health 
outcomes. The aims of the Welcome to Medicare visit should focus 
squarely on prevention, not on offering a ``comprehensive physical.''

4. Addressing quality, along with coverage, of preventive services
    It is not enough to expand coverage for preventive services. Steps 
must also be taken to ensure that they are delivered, and delivered 
well. As of 2001, only 60% of beneficiaries over age 65 had received 
pneumococcal vaccinations, and only 44% had received sigmoidoscopy 
screening for colorectal cancer. Only 10% of older women were up-to-
date on cervical, breast, and colorectal cancer screening. If what 
Congress has done to expand coverage is to realize its full benefits, 
both beneficiaries and providers must be educated about the importance 
of prevention and how to make use of the services that Medicare covers, 
and systems must be in place to expedite the delivery of these 
    CMS communications to beneficiaries currently focus on describing 
coverage benefits and little more. To be motivated to take full 
advantage of the preventive services covered under Medicare, 
beneficiaries first need to know why prevention matters. They need 
encouragement to live healthy lifestyles, with messages that remind 
them about the importance of stopping smoking, staying active, eating 
well, and controlling their weight. They need to understand why 
preventive services from their clinician are important, which ones are 
recommended, and the importance of being ``activated consumers'' who 
know what to ask and expect of their doctors.
    The Department of Health and Human Services has developed excellent 
lay resources to answer these questions for consumers, but because they 
have been developed in ``silos'' other than CMS (e.g., Centers for 
Disease Control and Prevention, National Cancer Institute, Agency for 
Healthcare Research and Quality) CMS staff know little about them, and 
the CMS website and publications do not mention them to beneficiaries. 
We believe that CMS communications should be integrated with the work 
of other components of HHS to disseminate a coordinated health message 
that encompasses health advice, recommended services to obtain, as well 
as the details of coverage policy. Partnership for Prevention is 
currently working with CMS to address these gaps in beneficiary 
    Communications to providers about the Welcome to Medicare visit 
should extend beyond traditional correspondence from CMS, which focuses 
on billing codes and the technical provisions of coverage. To reach and 
persuade providers, information about the Welcome to Medicare visit 
should be channeled through their organizations and specialty 
societies, using their medical journals, newsletters, and annual 
meetings to discuss the provisions of the new law. The new law provides 
an opportunity to introduce a ``culture shift'' toward excellence in 
the preventive care of seniors, but this will not happen without an 
organized educational campaign that involves physician organizations. 
The aims should be to help providers understand how to use the visit to 
enhance the delivery of recommended preventive services and avoid over-
utilization of services that are not recommended. Partnership is 
convening medical specialty societies to carry forward these goals.
    The full benefits of the Welcome to Medicare visit cannot be 
realized without incorporating system solutions within health plans and 
practice to improve the quality with which preventive services are 
delivered. Effective measures include standing orders, financial 
incentives and first-dollar coverage for patients, and feedback reports 
to providers.13 Impediments to delivery must be removed, or 
else reminders will accomplish little in improving care. Obstacles that 
patients and providers face in obtaining tests, counseling, and 
referrals must be addressed. Creative strategies, such as using health 
coaches, social support, and other non-physician outreach workers, can 
facilitate the delivery of preventive care. Finally, the Welcome to 
Medicare visit is a moment in time, but preventive care is a continuum. 
Mechanisms must be in place to connect patients with resources in the 
community and to reinforce the initial steps taken during the visit 
with follow-up visits over time.
    \13\ Southern California Evidence-Based Practice Center. 
Interventions that Increase Utilization of Medicare-Funded Preventive 
Services for Persons Age 65 and Older. Baltimore: Health Care Financing 
Administration, 1999.
    Reminder systems, both those designed for doctors and reminders 
sent to patients, are an important reinforcement tool that has been 
proven to enhance uptake of preventive services. Electronic medical 
records facilitate such reminders and provide useful tools for tracking 
adherence to a health maintenance plan, and greater attention is now 
turning to electronic health systems that give patients greater control 
over their health. For example, a website service for patients that we 
wish to test in a demonstration project would be accessed by patients 
before their Welcome to Medicare visit. After obtaining information 
from the patient, the website would list the preventive services that 
are recommended, offer hyperlinks to web pages that explain the meaning 
of medical terms (e.g., what is a ``colonoscopy''?), and direct 
patients to decision aids to help with complex choices. Patients could 
print summaries to bring to their appointment, thereby giving doctors a 
convenient reminder of which services are due. The website would later 
send patients follow-up emails to remind them to obtain follow-up 
screening tests or, for example, to contact them in the Fall about 
obtaining influenza vaccination.
    As in other health systems, the Medicare program is plagued by 
racial and ethnic disparities in patterns of care. For example, in 2002 
pneumococcal vaccine was received by 66% of white Medicare 
beneficiaries above age 65 but by only 51% of African Americans in the 
same age group.14 Research has shown that such disparities 
can be reduced by adopting reminder systems and other ``systems 
approaches'' that make delivery of services more uniform.
    \14\ Bonito et al. Disparities in immunizations among elderly 
Medicare beneficiaries, 2000 to 2002. Am J Prev Med 2004;27:153-60.
    Finally, the visit provides an opportunity for collecting data that 
can be used for measuring the effectiveness of services and the 
performance of plans and providers and tracking utilization over time. 
These data can be used for research, such as studying the outcomes of 
different mixes of services for specific subpopulations, based on risk 
factors, disease, age, gender, race, and ethnicity. The data can also 
be used to monitor quality and to apply performance metrics and quality 
initiatives, such as ``pay for performance'' programs.
    Partnership for Prevention seeks to better educate beneficiaries 
and clinicians about the Welcome to Medicare visit and preventive care, 
and it urges Medicare to encourage--certainly not to impede--the 
introduction of systems within practices and healthcare organizations 
that improve the delivery and quality of preventive care.
    Summary: The Medicare Prescription Drug and Modernization Act 
updated a program that has served the medical needs of seniors for 
nearly 40 years, but Medicare is in need of further modernization. 
There have been tremendous advances in medical science, including 
knowledge about how to prevent disease and keep people in good health. 
It is time to make Medicare a program that is as much about helping 
beneficiaries stay healthy as about treating them when they get sick 
and need hospitalization.
    Partnership for Prevention is a partnership of public and private 
sector organizations committed to finding solutions to health issues in 
a nonpartisan and rigorously scientific manner. Our membership includes 
national employers, nonprofit policy and research organizations, 
professional and trade associations, voluntary health organizations, 
health plans, and state health departments. See www.prevent.org for 
more details.
    Appendix 1. Cost-benefit of analysis of selected screening tests
    Partnership for Prevention conducted an analysis, using methods 
employed by the Congressional Budget Office, that assume fee-for-
service payment and 2002 dollars:

 Over the first 10 years of coverage, vision screening would result in 
        net savings to Medicare of $148 million. The average net cost 
        per year over the first 10 years would be $18 million.
     Vision screening would prevent 21,000 hip fractures and 4400 
            forearm fractures.
 Cholesterol screening would result in net savings of $436 million 
        over 7-10 years of coverage. The average net cost per year over 
        the first 10 years of coverage would be $82 million.
     Cholesterol screening would prevent 62,362 heart attacks and 
            44,912 strokes
 Tobacco cessation counseling would begin producing a small net 
        savings to Medicare in the 9th and 10th years of coverage as 
        the savings from long-term quitters in prior years accumulate. 
        The average net cost per year over the first years of coverage 
        would be $19.5 million.
     Tobacco cessation counseling would save 95,000 life years.
 The average cost per year over 10 years for the Welcome to Medicare 
        visit would be $137 million.

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     Appendix 3. Letter from Seven Living Former Health Secretaries
                                                      June 25, 2003
The Honorable Mike DeWine
Congressional Prevention Coalition
United States Senate
Washington, DC 20510
    Dear Chairman DeWine, as former Secretaries of Health and Human 
Services (or Health, Education and Welfare), we write to encourage you 
to include disease prevention in discussions about Medicare 
    Congress created Medicare in 1965 based on the knowledge of health 
and medicine at that time. Thus, Medicare came into being as a national 
insurance system to cover hospitalization and visits to clinicians' 
office for diagnoses and treatment.
    In the nearly four decades since Medicare's creation, considerable 
research and practice have yielded proven ways to not just diagnose and 
treat disease, but to prevent it and promote longer, healthier life. 
Today we know that postponing disability, maintaining social function, 
and sustaining independence are achievable for seniors through 
evidence-based health promotion and disease prevention services. It is 
nearly always preferable, both for the individual and for society, to 
prevent disease instead of waiting to treat it.
    Congress has added selected preventive services to Medicare but has 
not included other services that are proven effective, nor has it 
encouraged Medicare to take a comprehensive approach to disease 
prevention and health promotion for America's seniors.
    A recent Harris Poll found that nine in ten American adults want 
Medicare to be modernized and to put as much emphasis on disease 
prevention as it does on disease treatment.
    The roadmap for this Medicare modernization is laid out in a new 
Partnership for Prevention (Partnership) report, A Better Medicare for 
Healthier Seniors: Recommendations to Modernize Medicare's Prevention 
Policies, which you already have received. These recommendations would 
move the U.S. toward realization of our nation's two overarching 
national health goals: increasing life expectancy and improving quality 
of life, and reducing disparities in health among different segments of 
the population.
            Respectfully yours,
                     Joseph A. Calafano, Jr., Richard S. Schweiker,
     Margaret M. Heckler, David Mathews, MD, Louis W. Sullivan, MD,
                       Donna E. Shalala, PhD, and Otis R. Bowen, MD

    Mr. Bilirakis. Thank you, Dr. Woolf.
    Isn't it a revelation, really, that we are at least talking 
about this subject? Only a few years ago we were just concerned 
about caring for the sick and whatnot, but now we are going 
well past that, trying to prevent them from getting sick. And I 
think that in itself is terrific.
    Dr. Woolf, if my son who is an internist were sitting there 
giving your testimony, he would probably say basically the same 
thing that you have. But that, again, is the ideal and we would 
hope that we would strive toward that, but obviously we can't 
do everything that we might think is the right thing to do.
    I guess maybe one question to ask is, will seniors utilize 
these benefits, what they are now and what they may turn out to 
be? I think Mr. Brown's bill--I haven't studied it, but 
basically we are thinking preventive health care. And that is 
good, but we also have to be sure that delivery of these 
benefits will be available and will be done in the right 
manner. We have to hope that of course people will take 
advantage of it.
    Dr. Clancy.
    Ms. Clancy. Sure. I think that is about the most important 
question you could ask. Coverage is the first step. You can't 
get there without coverage. But as the GAO reports and many 
other studies have noted, many of the covered services are 
underused. This has been a big focus for CMS, trying to figure 
out how to encourage more of that. And a lot of it does come 
down to the systems and the settings where people get care.
    For example, when I am--a scenario that happens a lot when 
I see patients, I am sorry to say, is I am seeing a woman and 
we both agree that it is time for a mammogram, and then we move 
on to other things, and then she leaves and I forget to give 
her the piece of paper that she needs to actually get the 
mammogram, because where I see patients we don't have an idiot-
proof system to make sure that it automatically happens. 
Eventually she gets the service, but it is a distraction, and 
some people don't come back for the piece of paper and so 
    So it is that kind of systems approach that is necessary 
not only in getting the services but also in following up and 
making sure that people who have abnormal results are correctly 
identified and referred on when needed, and so forth.
    I think a lot of physicians and patients are increasingly 
aware of this. We clearly have a lot more to do, and it is a 
big focus of the Agency's work.
    Mr. Bilirakis. Ms. Heinrich.
    Ms. Heinrich. One question I have is about participation of 
physicians. When you read through the draft regulations, you 
see that this physical--comprehensive physical exam and battery 
of preventive services will be reimbursed at the same rate as a 
standard new patient evaluation and management fee. And a 
comprehensive exam like this and the battery of preventive 
services would take a lot of time. So I think that is a 
question that has to be asked.
    The second, of course, is will the beneficiaries themselves 
say this is something that I need, that I want, and seek it. 
And as we have said in our previous studies, the utilization 
rate is highly variable, and it does depend on race. Minorities 
utilize these services considerably less than white 
    Mr. Bilirakis. Why is that?
    Ms. Heinrich. I don't think we know the reason 
specifically. It could be an issue of access, it could be a 
matter of really knowing and understanding that the benefit 
exists. And some people, quite honestly, are concerned about 
even accessing the flu vaccines because they are afraid that 
they are going to get sick from the flu vaccine. So they are 
afraid that the intervention will make them sick.
    Mr. Bilirakis. Dr. Woolf, anything further?
    Mr. Woolf. I think you have asked an excellent question. I 
think the Welcome to Medicare visit provides a very good 
leveraging opportunity to try to address this problem by making 
patients aware of the need for preventive services. The visit 
could help induce demand.
    Many times, clinicians don't deliver preventive services 
for innocent reasons. Sometimes they forget that a patient is 
due for them, and there is ample experience in published 
research suggesting that that kind of demand can be helpful.
    Having said that, the agency, CMS, has an uphill battle in 
organizing an educational campaign to make patients aware of 
preventive services and the importance of prevention, because 
this is something that hasn't been done in the past. We are 
working with CMS--and Dr. McClellan is very enthusiastically 
supporting this--to try to change the way communications go out 
to beneficiaries, to make them more aware of the importance of 
prevention as a basic concept and then, more specifically, to 
make them aware of preventive services that are recommended.
    Materials and patient education materials that they have 
not yet developed have been developed by AHRQ and other Federal 
agencies that they are less familiar with because of the silos 
in the Federal Government. And we are working to try to link 
the various agencies together to try to bring out the best-
quality information for beneficiaries.
    Providers also need education about what this new visit 
provision means. Without that type of education, it just 
becomes another billing code and not an opportunity, as we feel 
it could be, to change the culture of how preventive care is 
offered to seniors; and with proper education, that can occur.
    All that said, the points that have just been made are 
fundamental. Paying for preventive services is just the 
starting point, and without the infrastructure for delivering 
it and following up on the abnormalities that are identified, 
the great good that could come from this will not be realized.
    Mr. Bilirakis. Do you all see a good level of cooperation--
maybe it is not the right word, but interest, dedication and 
cooperation on the part of CMS to take into consideration all 
the advice that you have given; the work that you are 
volunteering, your group is volunteering, to get this done 
right; and the education portion, of course, being very 
    Ms. Clancy. Without question, since my glass is half full, 
I thought I would offer a slightly more positive view of this.
    A lot of studies have found that doctors and patients are 
very enthusiastic about prevention. They forget they don't have 
good systems in place and so forth. But the one nice thing 
about this Welcome to Medicare visit is, most studies have 
found that doctors tend to do a much better job in the context 
of something called a checkup, whether it is a comprehensive 
physical, whether it is called a health maintenance visit or so 
forth. So I think I would reiterate Dr. Woolf's point that this 
gets people off on the right foot.
    The other area we are working on closely with CMS is in 
trying to deploy some of the power of information technology to 
give people reminders. Ultimately, I think this is going to be 
powerful for patients, as well. But a lot of times, doctors 
don't do this because they forget or don't realize the time 
sequence has come when it is time for someone's next service. 
And that is fairly easy to correct and reminders make a huge 
    So I think there are some exciting developments in place 
Mr. Bilirakis. Ms. Heinrich, you would anticipate that the 
reimbursement to physicians who would conduct this Welcome to 
Medicare physical would be what, insufficient? Any feeling on 
    Ms. Heinrich. The observation I make is that you have busy 
physicians, and the fact that they would not be reimbursed at a 
rate higher than a regular evaluation, management, first-time 
visit is not a large incentive. Now there are other incentives 
at play.
    Mr. Bilirakis. And that is what you see coming down the 
pike that they probably would not be reimbursed higher?
    Ms. Heinrich. That is the way the regulation reads now.
    Mr. Bilirakis. Mr. Brown to inquire.
    Mr. Brown. Thank you, Mr. Chairman.
    Dr. Woolf, evidence shows that people with coverage for 
preventive service logically use those services more than those 
who don't have coverage. There has been a lot of attention 
recently to consumer-directed health plans, things such as 
medical health savings accounts and the like, which have a high 
deductible and are supposed to encourage consumers/patients to 
make wiser choices.
    Comment, if you will, on what these kinds of plans, these 
consumer-directed health plans would do to people's utilization 
of preventive services.
    Mr. Woolf. It is a very interesting question given what 
appears to be an increasing trend among employers to pursue 
that kind of product. Frankly, the jury is still out on what 
impact they would have on preventive services. Most of the 
experts that are working on this field feel that it is perhaps 
2, 3 years before we will have enough high-quality data to know 
what impact they might have.
    The concern is, we have a large body of research going back 
20 years to suggest that patients who face deductibles or 
copayments are less likely to utilize preventive services. And 
a phenomenon that we used to call ``reverse targeting'' occurs 
where the patients most in need of preventive care, who have 
the greatest risk factors for disease, are often, for 
socioeconomic reasons, more adversely impacted by the added 
costs. To the extent that a consumer-driven health plans mimic 
that phenomenon, they could be at a disincentive to receiving 
preventive care and adversely affect outcomes.
    But there is a counterargument that giving people choices 
would enable them to concentrate their resources on prevention 
and thereby prevent disease. A concern that many have is 
whether patients would have the background and information base 
to make good choices about how to select preventive services 
that are a proven value and not be encouraged to invest the 
resources they have in their accounts on glitzy technologies 
that promise a lot, but haven't been proven to better their 
    Mr. Brown. Have you seen--understanding the body of 
evidence has not accumulated to the degree that you would need 
to analyze this as thoroughly as you would want, do you see--in 
these consumer-directed health plans, have you seen special 
attention paid by the health plan itself to encourage people--
to spend from their pot, if you will, their discretionary money 
to really take advantage of preventive care? Is that something 
these health plans have pushed effectively or pushed at all?
    Mr. Woolf. I am pleased to see several examples of some of 
the major vendors of these products offering first-dollar 
coverage for preventive services and providing a safe harbor, 
if you will, for preventive services under their plans. I don't 
know whether that is generalizable and whether all plans in 
that category are as careful to protect preventive services in 
that way.
    Mr. Brown. Ms. Heinrich and Dr. Woolf, as the chairman was 
talking earlier, I introduced legislation to give CMS authority 
to add preventive benefits to Medicare. We already--Medicare 
has broad discretion to add new and promising treatments to 
Medicare coverage, but doesn't have the discretion to go 
further and offer preventive benefits.
    Ms. Heinrich, would you support giving the Secretary more 
flexibility to add preventive services?
    And, Dr. Woolf, I know your organization has spoken on 
    Would you both just address that issue?
    Ms. Heinrich. We really haven't focused on where the 
decision for covering preventive services is made, but we have 
said that it really needs to be science-based. And, certainly, 
depending on the U.S. Preventive Services Task Force would be a 
good start.
    Mr. Brown. Dr. Woolf?
    Mr. Woolf. We issued a report last year that outlines 
detailed recommendations on this issue and looked at a number 
of different options, and we are trying to address this problem 
and ultimately concluded that authority for covering preventive 
services should be transferred from Congress to CMS, just as it 
is for diagnostic and treatment services.
    Mr. Brown. Thank you, Mr. Chairman.
    Mr. Bilirakis. I would like to, without objection, offer a 
document into the record by the Alzheimer's Foundation of 
America basically making the case that Alzheimer's should be 
included as part of the Welcome to Medicare preventive health 
program. And I have reviewed this with Mr. Brown. Without 
objection, it will be made part of the record.
    [The information referred to follows:]

  Prepared Statement of Eric J. Hall, CEO, Alzheimer's Foundation of 

    Chairman Bilirakis, Ranking Member Brown, and distinguished 
Subcommittee members: On behalf of the Alzheimer's Foundation of 
America (AFA), thank you for holding this important hearing on 
preventive benefits enacted as part of the Medicare Modernization Act 
of 2003 (MMA).
    AFA believes the preventive benefits enacted under the MMA 
represent an important step forward in improving the health of our 
nation's Medicare beneficiaries. In particular, Mr. Chairman, we 
support and applaud your efforts to establish an initial preventive 
screening examination under Medicare.

                             AFA'S MISSION

    An estimated five million Americans currently suffer from 
Alzheimer's disease, and the number is expected to rise to 16 million 
by mid-century. It is therefore critical that we all stand together for 
care as the incidence of this devastating disease continues to rise.
    AFA was founded as a nonprofit 501(c)(3) organization to fill a gap 
that existed on the national front for advocacy of ``care . . . in 
addition to cure'' for individuals affected by Alzheimer's disease and 
related dementias. AFA and its members provide direct services to 
millions of Americans living with Alzheimer's disease and related 
disorders nationwide, as well as their caregivers and families. Our 
goals include improving quality of life for all those affected and 
raising standards for quality of care.
    AFA operates a national resource and referral network with a toll-
free hotline, develops and replicates cutting-edge programs, hosts 
educational conferences and training for caregivers and professionals, 
provides grants to member organizations for hands-on support services 
in their local areas, and advocates for funding for social services. It 
annually sponsors two national initiatives, National Memory Screening 
Day and National Commemorative Candle Lighting. AFA is also working to 
promote healthy aging through prevention and wellness education and to 
expand screening for memory impairment as a tool to facilitate early 
diagnosis and treatment.


    Early recognition of Alzheimer's disease and related dementias is 
essential to maximize the therapeutic effects of available and evolving 
treatments, and screening for memory impairment is the only way to 
systematically find treatable cases. Diagnosis in the early stages of 
the disease is vital, providing multiple benefits to individuals with 
the disease, families and society. Screening can also be beneficial for 
individuals who do not present a diagnosis of Alzheimer's disease by 
allaying fears and providing an opportunity for prevention and wellness 
    Memory screening is a cost-effective, safe and simple intervention 
that can direct individuals to appropriate care, improve their quality 
of life, and provide cognitive wellness information. With no ``silver 
bullet'' for dementia in the immediate future, it is essential to fully 
use all preventive measures and early interventions. AFA supports a 
comprehensive strategy that involves both research for a cure, as well 
as a national system of care that includes cognitive wellness, early 
detection and intervention, and disability compression.
    To advance that objective, AFA launched National Memory Screening 
Day in 2003 as a collaborative effort by organizations and health care 
professionals across the country. AFA initiated this effort in direct 
response to breakthroughs in Alzheimer's research that show the 
benefits of early medical treatment for individuals with Alzheimer's 
disease, as well as the benefits of counseling and other support 
services for their caregivers.
    AFA's annual National Memory Screening Day underscores the 
importance of early diagnosis, so that individuals can obtain proper 
medical treatment, social services and other resources related to their 
condition. With no cure currently available for Alzheimer's disease, it 
is essential to provide individuals with these types of interventions 
that can improve their quality of life while suffering with the 
    During National Memory Screening Day, healthcare professionals 
administer free memory screenings at hundreds of sites throughout the 
United States. A memory screening is used as an indicator of whether a 
person might benefit from more extensive testing to determine whether a 
memory and/or cognitive impairment may exist. While a memory screening 
is helpful in identifying people who can benefit from medical 
attention, it is not used to diagnose any illness and in no way 
replaces examination by a qualified physician.
    Our goal is for individuals to follow up with the next steps--
further medical testing and consultation with a physician, if the 
testing raises concerns. The latest research shows that several 
medications can slow the symptoms of Alzheimer's disease and that 
individuals begin to benefit most when they are taken in the early 
stages of memory disorder. This intervention may extend the time that 
individuals can be cared for at home, thereby dramatically reducing the 
costs of institutional care.
    With early diagnosis, individuals and their families can also take 
advantage of support services, such as those offered by AFA member 
organizations, which can lighten the burden of the disease. According 
to several research studies, such care and support can reduce caregiver 
depression and other health problems, and delay institutionalization of 
their loved one--again reducing the economic burden of this disease on 
    In addition, with early diagnosis, individuals can participate in 
their care by letting family members and caregivers know their wishes. 
Thus, memory screenings are an important tool to empower people with 
knowledge and support. Just as importantly, the screenings should help 
allay fears of those who do not have a problem.
    AFA holds National Memory Screening Day on the third Tuesday of 
November in recognition of National Alzheimer's Disease Month. 
Broadcast personality Leeza Gibbons is the national advocate for this 
event. Ms. Gibbons founded The Leeza Gibbons Memory Foundation in 
response to her own family's trial with Alzheimer's. She lost her 
grandmother to the disease, and her mother now battles with the final 
stages of Alzheimer's.
    This year, National Memory Screening Day will be held on November 
16, 2004. Individuals concerned about memory problems will be able to 
take advantage of free, confidential screenings at hundreds of sites 
across the country with the goal of early diagnosis of Alzheimer's 
disease or related dementias. Early diagnosis is critical, because as 
Ms. Gibbons has noted, ``This is not a disease that will wait for you 
to be ready.''


    As promising research continues in the search for a cure, 
additional resources are also needed in support of efforts to delay the 
progression of Alzheimer's disease and related dementias. The federal 
government can play a critical role in that regard by providing 
resources for a public health campaign designed to increase awareness 
of the importance of memory screening and to promote screening 
    Federal support is essential to expand the scope of ongoing efforts 
in the private sector. Working in partnership with AFA and other 
participating organizations, the federal government can leverage its 
resources cost-effectively to help overcome fear and misunderstanding 
about Alzheimer's disease and related dementias, to promote public 
awareness of the importance of memory screening, to expand options for 
screening nationwide, and to direct Americans to the support services 
and care available in their local communities.
    To that end, AFA is urging the Centers for Medicare and Medicaid 
Services (CMS) to provide screening for memory impairment as part of 
the Medicare initial preventive screening examination. CMS included a 
specific request for public comments on the scope of the exam in its 
proposed rules; therefore, AFA is recommending that CMS include 
screening for memory impairment within the proposed definition of a 
``review of the individual's functional ability, and level of safety, 
based on the use of an appropriate screening instrument.'' The proposed 
rules also state that review of an individual's functional ability and 
level of safety must address activities of daily living and home 
    In that context, unrecognized dementia can increase the likelihood 
of avoidable complications such as delirium, adverse drug reactions, 
noncompliance, etc. These complications reduce the autonomy of affected 
individuals, thereby impeding their ability to perform activities of 
daily living and compromising their safety. In addition, about one-
third of elders live by themselves, and these individuals are at 
greater risks for accidents, injuries, exploitation, and other adverse 
outcomes. Early identification allows safeguards and home assistance to 
assure continued maximization of home placement.
    For the affected individual, identification of early stage dementia 
allows early aggressive use of available treatments. Early 
identification allows optimal therapy with available and emerging 
medications. Most FDA-approved medications can help slow the 
progression of symptoms of Alzheimer's disease and related dementias 
when presented in early stages of dementia.
    Once dementia is identified, health care management can be adjusted 
to incorporate treatment strategies that accommodate a person with 
cognitive impairment. Issues such as patient education, self-
medication, compliance, and hospital care can be adjusted to meet the 
needs of a mildly demented person who is at risk for common 
complications such as delirium and depression. Home-based support 
systems can be adjusted to maximize home placement for these 
individuals. Safeguards can be taken to prevent avoidable complications 
such as delirium during hospitalization.
    Further, the early identification of dementia supports individual 
patient rights and self-determination. Mildly impaired individuals are 
capable of charting the future course of their care and making 
substantial decisions on issues like end-of-life care, resuscitation, 
disposition of wealth, etc. Advanced directives can be initiated that 
incorporate the wishes of individuals with dementia, thereby reducing 
the burden on the family of surrogate decision-making. Individuals with 
the disease can also take advantage of social services and other 
support that can improve quality of life. These include counseling, 
verbal support groups and cognitive stimulation therapies. These 
strategies may prolong activities of daily living, and promote a sense 
of dignity.
    Separately, family caregivers also benefit from early 
identification at several levels. As noted above, early identification 
reduces the family burden with regard to decision-making, because 
families can follow the instructions of their loved ones. This process 
allows family caregivers to benefit early on from support groups, 
education and other interventions that address their unique and 
pressing needs. Such knowledge and support can empower them to be 
better caregivers and can reduce their incidence of depression and 
other mental and physical health problems. Intervention can also help 
on an economic front: lightening the burden on primary caregivers, who 
are also in the workforce, could help reduce employee absenteeism and 
lost productivity.
    Finally, screening can be beneficial for those individuals who do 
not present a diagnosis of Alzheimer's disease. These negative results 
can allay fears and provide reassurance. Just as importantly, 
physicians can take this opportunity to present individuals with 
prevention and wellness education--a strategy that promotes successful 
    We would note that use of available screening instruments to 
identify memory impairment during the Medicare initial preventive 
physical examination is consistent with current clinical practice 
guidelines. Individuals with mild cognitive impairment are at higher 
risk for subsequent development of Alzheimer's disease and related 
dementias. General cognitive screening instruments are available and 
are useful in detecting dementia in patient populations with a higher 
incidence of cognitive impairment (e.g., due to age or memory 
dysfunction). Attached for Subcommittee Members' reference is a summary 
of the relevant American Academy of Neurology practice guidelines for 
    Inclusion of screening for memory impairment is also consistent 
with the recent CMS National Coverage Decision expanding Medicare 
coverage of Positron Emission Tomography (PET) for beneficiaries who 
meet certain diagnostic criteria for Alzheimer's disease and fronto-
temporal dementia.
    AFA believes PET and other neuroimaging devices will be a valuable 
tool in predicting disease and in steering those with a diagnosis of 
Alzheimer's or related illnesses to the appropriate clinical and social 
service resources. Expanded reimbursement for PET studies will drive 
early intervention for the increasing--and alarming--number of 
Americans with Alzheimer's disease. Utilization of this technology will 
become even more critical in the future, as the number of Americans 
with dementia is projected to triple by mid-century.


    Expanded screening to facilitate the early identification of memory 
impairment will produce tangible benefits to society by protecting 
individuals, improving quality of life, and reducing the costs of 
health care. Enhancing compliance and protecting individuals with 
dementia also produces tangible financial benefits to the health care 
system. Intervention can enable individuals to remain independent 
longer and can reduce the costs of insurance, absenteeism and lost 
productivity at work for primary caregivers--currently estimated at $60 
billion annually.
    AFA commends the Subcommittee's leadership in striving to improve 
preventive care for our nation's Medicare beneficiaries. We would 
likewise welcome the opportunity to work collaboratively to improve the 
quality of life for Alzheimer's patients, their families and 
caregivers. Please feel free to contact me at 866-232-8484 or Todd 
Tuten at 202-457-5215 if you have questions or would like additional 
    Thank you for the opportunity to share our views.

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    Mr. Bilirakis. Mr. Green, you weren't here a moment ago, 
but you are now, so the Chair will recognize you to inquire.
    Mr. Green. Thank you, Mr. Chairman. I appreciate the chance 
and I appreciate your having the committee hearing.
    Dr. Clancy, it is my understanding that the U.S. Preventive 
Services Task Force is currently working on a new 
recommendation for the abdominal aortic aneurysm screens.
    Are you aware of a timeframe for delivering that 
    Ms. Clancy. November of this year. And we will make sure as 
soon as it is released, you will get a copy and your staff.
    Mr. Green. In your testimony, it details two main questions 
that the task force recommendation process seeks to answer: 
first, that the task force seeks to determine if the preventive 
services screening indicates that AAA is associated with 
reduced risk of morbidity or mortality. The statistics we have 
on AAA indicate it is a condition that has no symptoms or 
warning signs, and that less than 15 percent with a ruptured 
abdominal aortic aneurysm actually survive. It seems to me that 
preventive services isn't just associated with a reduced risk 
of morbidity or mortality, that about the only way to reduce 
that is if you have a preventive test.
    And second, in your testimony, the task force determines 
whether the early identification of the condition leads to an 
improved outcome compared to the result if these are not 
detected and treated early. And I think most vascular surgeons 
would agree that early detection and treatment of AAA would 
mean catching it before the aneurysm ruptures. And again the 
relevant statistics that we have are that 85 percent of 
individuals with a ruptured AAA die. And when caught before the 
rupture, AAA, it is curable up to 95 percent of the 
individuals. And, you know, to me, it seems a slam dunk that 
the task force would understand the need for a screening 
    Ms. Clancy. Let me say I agree with your points. When the 
official recommendation and specific language is released, you 
will get a copy, and just also add that I have an uncle who was 
one of the lucky ones who ruptured his aortic aneurysm a couple 
of years ago and lives close enough to a major medical center 
that he made it through, but it was a pretty humbling reminder 
of what a terrible disease that is.
    Mr. Green. I have a constituent near the Texas Medical 
Center who made it there, but it took her 4 weeks of intensive 
care in the hospital to be able to deal with it, and the cost 
was outrageous. And they were Medicare beneficiaries, both she 
and her husband.
    I am one of the cochairs of the Congressional Vision 
Caucus. I am real interested in preventive benefits regarding 
common vision problems, and I know Medicare typically doesn't 
deal with it. A preventive benefit to screen for glaucoma is 
extremely important since approximately half of the individuals 
aren't aware that they have the disease. And since January 
2002, at-risk Medicare beneficiaries have been able to receive 
these screenings.
    Can you give us any information on the statistics or any 
analysis on the effectiveness of that benefit? If you don't 
have them today----
    Ms. Clancy. We can look into it and follow up on that.
    Mr. Green. I appreciate it, one for the caucus but also for 
our health subcommittee.
    Dr. Woolf, cost-sharing deductibles in Medicare can act as 
a barrier to accessing preventive services. As I understand it, 
the initial Welcome to Medicare exam is still subject to the 
deductible, which will soon be increasing by 10 percent and the 
20 percent coinsurance.
    On top of that, seniors will have the burden, as we 
discussed in our opening statement, of paying premiums which 
are increasing by 17 percent. Given that half of all seniors 
have incomes under 200 percent of poverty, don't you think, for 
some beneficiaries, such out-of-pocket expense would deter them 
from seeking this preventive benefit? And do you support 
eliminating the cost sharing and the deductible for preventive 
    Mr. Woolf. The evidence indicates Congressman, that the 
presence of copayments and deductibles does act as a 
disincentive for the uptake of preventive services. So the 
science would tell us that that is going to pose a problem, 
especially for disadvantaged populations.
    I can't resist, though, using your earlier questions as a 
way of responding to Mr. Brown's earlier question, and that is 
your analysis of the effectiveness of screening for abdominal 
aortic aneurysms and for glaucoma. I think you are identifying 
some important analytic arguments. But again, our view as an 
organization is that the scientific details of how to evaluate 
the effectiveness of these screening modalities center on 
issues that experts around the country normally deal with 
through the process that CMS currently uses for diagnostic and 
treatment services.
    The issue of whether to screen for abdominal aortic 
aneurysms, for example, turns very much on the likelihood of 
progression of small aneurysms into large ones and on the 
performance characteristics of the available screening 
modalities. Deliberating on these fine technical details in 
this environment at the same time that you must contend with 
national security, economy, tax policy and so forth strikes me 
as inefficient, especially when, in Baltimore, regularly 
experts convened by CMS deal with much more complex technical 
issues as they determine whether to cover diagnostic and 
treatment services.
    While I agree with the direction of your intention to cover 
these preventive services and think many of the scientific 
arguments have merit, we would encourage the notion of 
transferring the authority for this type of scientific analysis 
to CMS.
    Mr. Green. And if I could follow up, I agree Congress and 
our country have a lot of concerns, but having had some 
constituents and family members who--I don't know if we are 
going to worry about our tax policy or terrorism--but depending 
on whether my great uncle bleeds from an aneurysm or not, that 
is our job and our subcommittee here, and we will deal with 
that. And maybe if we had a different tax policy we would have 
more resources to deal with it.
    Mr. Bilirakis. Dr. Clancy's response to you regarding 
triple-A, now you are in the process of preparing a report in 
that regard, so you can't tell us where that might be in terms 
of that particular area?
    Ms. Clancy. Not today, but again, it is just a few weeks 
off, and because it gets down to debating and being very 
specific about the details, what size of aneurysm would make a 
difference and so forth in how often people should get a 
    Mr. Green. And, Mr. Chairman, having talked with vascular 
surgeons, there are people, when it is discovered, it is not a 
threat immediately, but by knowing it, they can continue to 
have it monitored instead of waiting until it bursts and you 
bleed out.
    Mr. Bilirakis. Well, there aren't any other members.
    Anything further, Mr. Brown?
    That being the case, again our gratitude. Your written 
statements, of course, your testimony here today will be 
nothing but helpful. But again, keep in mind, we are always 
open to suggestions.
    Dr. Woolf, we sort of have to keep our feet on the ground. 
We have to be concerned, of course, about accountability and 
the dollars and things of that nature. So, you know, we can't 
do everything, as we much as many of us would like to. But any 
suggestions you may have in addition to what you have made here 
today that might be helpful to us, fine.
    And, you know, the CMS argument, they are making these 
decisions, that is an interesting point. I don't know, I guess 
the Secretary decided that obesity should be a covered area, 
and he has decided that it is a disease, which means apparently 
he has some control or power in that regard. How far that might 
go or should go is another question.
    Thank you very much. The hearing is adjourned.
    [Whereupon, at 3:25 p.m., the subcommittee was adjourned.]
    [Additonal material submitted for the record follows:]

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