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96–096PDF 2004

KEEPING SENIORS HEALTHY: NEW PERSPECTIVE

BENEFITS IN THE MEDICARE MODERNIZATION

ACT

HEARING

BEFORE THE

SUBCOMMITTEE ON HEALTH

OF THE

COMMITTEE ON ENERGY AND

COMMERCE

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

(

Available via the World Wide Web: http://www.access.gpo.gov/congress/house

COMMITTEE ON ENERGY AND COMMERCE

JOE BARTON, Texas, Chairman

W.J. ‘‘BILLY’’ TAUZIN, Louisiana

RALPH M. HALL, Texas

MICHAEL BILIRAKIS, Florida

FRED UPTON, Michigan

CLIFF STEARNS, Florida

PAUL E. GILLMOR, Ohio

JAMES C. GREENWOOD, Pennsylvania

CHRISTOPHER COX, California

NATHAN DEAL, Georgia

RICHARD BURR, North Carolina

ED WHITFIELD, Kentucky

CHARLIE NORWOOD, Georgia

BARBARA CUBIN, Wyoming

JOHN SHIMKUS, Illinois

HEATHER WILSON, New Mexico

JOHN B. SHADEGG, Arizona

CHARLES W. ‘‘CHIP’’ PICKERING,

Mississippi, Vice Chairman

VITO FOSSELLA, New York

STEVE BUYER, Indiana

GEORGE RADANOVICH, California

CHARLES F. BASS, New Hampshire

JOSEPH R. PITTS, Pennsylvania

MARY BONO, California

GREG WALDEN, Oregon

LEE TERRY, Nebraska

MIKE FERGUSON, New Jersey

MIKE ROGERS, Michigan

DARRELL E. ISSA, California

C.L. ‘‘BUTCH’’ OTTER, Idaho

JOHN SULLIVAN, Oklahoma

JOHN D. DINGELL, Michigan

Ranking Member

HENRY A. WAXMAN, California

EDWARD J. MARKEY, Massachusetts

RICK BOUCHER, Virginia

EDOLPHUS TOWNS, New York

FRANK PALLONE, Jr., New Jersey

SHERROD BROWN, Ohio

BART GORDON, Tennessee

PETER DEUTSCH, Florida

BOBBY L. RUSH, Illinois

ANNA G. ESHOO, California

BART STUPAK, Michigan

ELIOT L. ENGEL, New York

ALBERT R. WYNN, Maryland

GENE GREEN, Texas

KAREN MCCARTHY, Missouri

TED STRICKLAND, Ohio

DIANA DEGETTE, Colorado

LOIS CAPPS, California

MICHAEL F. DOYLE, Pennsylvania

CHRISTOPHER JOHN, Louisiana

TOM ALLEN, Maine

JIM DAVIS, Florida

JANICE D. SCHAKOWSKY, Illinois

HILDA L. SOLIS, California

CHARLES A. GONZALEZ, Texas

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

FRED UPTON, Michigan

JAMES C. GREENWOOD, Pennsylvania

NATHAN DEAL, Georgia

RICHARD BURR, North Carolina

ED WHITFIELD, Kentucky

CHARLIE NORWOOD, Georgia

Vice Chairman

BARBARA CUBIN, Wyoming

JOHN SHIMKUS, Illinois

HEATHER WILSON, New Mexico

JOHN B. SHADEGG, Arizona

CHARLES W. ‘‘CHIP’’ PICKERING,

Mississippi

STEVE BUYER, Indiana

JOSEPH R. PITTS, Pennsylvania

MIKE FERGUSON, New Jersey

MIKE ROGERS, Michigan

JOE BARTON, Texas,

(Ex Officio)

SHERROD BROWN, Ohio

Ranking Member

HENRY A. WAXMAN, California

EDOLPHUS TOWNS, New York

FRANK PALLONE, Jr., New Jersey

BART GORDON, Tennessee

ANNA G. ESHOO, California

BART STUPAK, Michigan

ELIOT L. ENGEL, New York

GENE GREEN, Texas

TED STRICKLAND, Ohio

DIANA DEGETTE, Colorado

LOIS CAPPS, California

CHRIS JOHN, Louisiana

BOBBY L. RUSH, Illinois

JOHN D. DINGELL, Michigan,

(Ex Officio)

(II)

C O N T E N T S

Page

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

(III)

(1)

KEEPING SENIORS HEALTHY: NEW PERSPECTIVE BENEFITS IN THE MEDICARE 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 program.

I would like to thank the witnesses who are here before us today:

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 increVerDate 11-MAY-2000 10:56 Nov 09, 2004 Jkt 000000 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 96096.TXT HCOM1 PsN: HCOM1
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mentally 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.

3

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 preVerDate 11-MAY-2000 10:56 Nov 09, 2004 Jkt 000000 PO 00000 Frm 00007 Fmt 6633 Sfmt 6633 96096.TXT HCOM1 PsN: HCOM1
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miums 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

two.

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.

5

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 thing.

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

6

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 effort.

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

7

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 conVerDate 11-MAY-2000 10:56 Nov 09, 2004 Jkt 000000 PO 00000 Frm 00011 Fmt 6633 Sfmt 6633 96096.TXT HCOM1 PsN: HCOM1
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sists 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

overpayments?

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

9

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 Security.

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 time.

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 beneficiaries.

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 underVerDate 11-MAY-2000 10:56 Nov 09, 2004 Jkt 000000 PO 00000 Frm 00013 Fmt 6633 Sfmt 6621 96096.TXT HCOM1 PsN: HCOM1
10

standing 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 risks.

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 legislation.

Dr. Clancy, please proceed.

STATEMENTS OF CAROLYN CLANCY, DIRECTOR, AGENCY FOR

HEALTHCARE RESEARCH AND QUALITY, U.S. DEPARTMENT

OF HEALTH AND HUMAN SERVICES; JANET HEINRICH, DIRECTOR, HEALTHCARE/PUBLIC HEALTH ISSUES, U.S. GOVERNMENT ACCOUNTABILITY OFFICE; AND STEVEN H.

WOOLF, EXECUTIVE VICE PRESIDENT FOR POLICY DEVELOPMENT, PARTNERSHIP FOR PREVENTION

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

11

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 disease.

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.

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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 stateof-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

13

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

INTRODUCTION

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.

THE UNITED STATES PREVENTIVE SERVICES TASK FORCE

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.

14

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 follows:

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.

15

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.

16

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 statement.

THE AGENCY FOR HEALTHCARE RESEARCH AND QUALITY (AHRQ)

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 initiatives

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 counseling.

• 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

17

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.

CONCLUSION

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

questions.

Mr. BILIRAKIS. Thank you very much.

Director Heinrich.

STATEMENT OF JANET 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 onetime 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

18

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-forservice 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 preVerDate 11-MAY-2000 10:56 Nov 09, 2004 Jkt 000000 PO 00000 Frm 00022 Fmt 6633 Sfmt 6602 96096.TXT HCOM1 PsN: HCOM1
19

ventive 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 Medicare.

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 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, 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

20

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 pneumonia.

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

21

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 physical.

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:]

22

1Mokdad et al. Acutal causes of death in the United States, 2000. JAMA 2004;291:1238-45.

2Woolf. The need for perspective in evidence-based medicine. JAMA 1999;282:2358-65.

3Doll et al. Mortality in relation to smoking: 50 years’ observations on male British doctors.

BMJ 2004;328:1519. 4President George W. Bush, State of the Union Address, January 28, 2003. http://www.white

house.gov/news/releases/2003/01/20030128-19.html

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

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

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.

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.’’

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 recVerDate 11-MAY-2000 10:56 Nov 09, 2004 Jkt 000000 PO 00000 Frm 00026 Fmt 6633 Sfmt 6621 96096.TXT HCOM1 PsN: HCOM1
23

5 Institute of Medicine. Extending Medicare Coverage for Preventive and Other Services. Washington, DC: National Academy Press, 2000. 6Smith et al. American Cancer Society guidelines for the detection of cancer, 2004. CA Cancer

J Clin 2004;54:41-52. 7Winawer et al. Colorectal cancer screening and surveillance: clinical guidelines and rationale-Update based on new evidence. Gastroenterology. 2003;124:544-60. 8Partnership for Prevention. A Better Medicare for Healthier Seniors: Recommendations to

Modernize Medicare’s Prevention Policies. Washington, DC: Partnership for Prevention, 2003.

ommended 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 attention:

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

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 issues.

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.

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 recommends.

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:

• Retain the status quo

• Tie coverage to an outside group (e.g., U.S. Preventive Services Task Force)

• Create a Congressional ‘‘fast track’’

24

9Medicare Preventive Services Coverage Act of 2004 (S. 2535 and H.R. 4898).

10Fiore et al. Treating Tobacco Use and Dependence. Rockville, MD: US Department of Health

and Human Services, 2000. 11Mokdad et al. Acutal causes of death in the United States, 2000. JAMA 2004;291:1238-45.

• 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

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

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.

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’

25

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 Medicare.

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.

26

12See U.S. Preventive Services Task Force at http://www.ahrq.gov/clinic/uspstfix.htm

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.

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 services.

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

27

13Southern 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. 14 Bonito et al. Disparities in immunizations among elderly Medicare beneficiaries, 2000 to

2002. Am J Prev Med 2004;27:153-60.

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.

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 overutilization 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.

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.

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

28

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

Co-Chair

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 modernization.

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

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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 forth.

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 populations.

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

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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 significant?

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 difference.

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 that?

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.

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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 health.

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

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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 that.

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

AMERICA

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.

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THE IMPORTANCE OF MEMORY SCREENING

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 education.

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 disease.

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 society.

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.’’

THE NEED FOR FEDERAL LEADERSHIP

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

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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 initiatives.

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 safety.

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 aging.

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

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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 physicians.

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.

CONCLUSION

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 information.

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 recommendation?

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 benefit.

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.

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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 services?

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?

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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 screening.

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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