[House Hearing, 108 Congress]
[From the U.S. Government Publishing Office]
MEDICARE CHRONIC CARE IMPROVEMENT PROGRAM
=======================================================================
HEARING
before the
SUBCOMMITTEE ON HEALTH
of the
COMMITTEE ON WAYS AND MEANS
U.S. HOUSE OF REPRESENTATIVES
ONE HUNDRED EIGHTH CONGRESS
SECOND SESSION
__________
MAY 11, 2004
__________
Serial No. 108-51
__________
Printed for the use of the Committee on Ways and Means
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COMMITTEE ON WAYS AND MEANS
BILL THOMAS, California, Chairman
PHILIP M. CRANE, Illinois CHARLES B. RANGEL, New York
E. CLAY SHAW, JR., Florida FORTNEY PETE STARK, California
NANCY L. JOHNSON, Connecticut ROBERT T. MATSUI, California
AMO HOUGHTON, New York SANDER M. LEVIN, Michigan
WALLY HERGER, California BENJAMIN L. CARDIN, Maryland
JIM MCCRERY, Louisiana JIM MCDERMOTT, Washington
DAVE CAMP, Michigan GERALD D. KLECZKA, Wisconsin
JIM RAMSTAD, Minnesota JOHN LEWIS, Georgia
JIM NUSSLE, Iowa RICHARD E. NEAL, Massachusetts
SAM JOHNSON, Texas MICHAEL R. MCNULTY, New York
JENNIFER DUNN, Washington WILLIAM J. JEFFERSON, Louisiana
MAC COLLINS, Georgia JOHN S. TANNER, Tennessee
ROB PORTMAN, Ohio XAVIER BECERRA, California
PHIL ENGLISH, Pennsylvania LLOYD DOGGETT, Texas
J.D. HAYWORTH, Arizona EARL POMEROY, North Dakota
JERRY WELLER, Illinois MAX SANDLIN, Texas
KENNY C. HULSHOF, Missouri STEPHANIE TUBBS JONES, Ohio
SCOTT MCINNIS, Colorado
RON LEWIS, Kentucky
MARK FOLEY, Florida
KEVIN BRADY, Texas
PAUL RYAN, Wisconsin
ERIC CANTOR, Virginia
Allison H. Giles, Chief of Staff
Janice Mays, Minority Chief Counsel
______
SUBCOMMITTEE ON HEALTH
NANCY L. JOHNSON, Connecticut, Chairman
JIM MCCRERY, Louisiana FORTNEY PETE STARK, California
PHILIP M. CRANE, Illinois GERALD D. KLECZKA, Wisconsin
SAM JOHNSON, Texas JOHN LEWIS, Georgia
DAVE CAMP, Michigan JIM MCDERMOTT, Washington
JIM RAMSTAD, Minnesota LLOYD DOGGETT, Texas
PHIL ENGLISH, Pennsylvania
JENNIFER DUNN, Washington
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C O N T E N T S
__________
Page
Advisory of May 4, 2004, announcing the hearing.................. 2
WITNESSES
Centers for Medicare and Medicaid Services, Hon. Mark McClellan,
Administrator.................................................. 10
______
American College of Cardiologists, Janet S. Wright............... 36
American Heart Association, Vince Bufalino....................... 40
Disease Management Association of America, Christobel Selecky.... 29
SUBMISSIONS FOR THE RECORD
AdvaMed, statement............................................... 56
Alzheimer's Association, statement and attachment................ 57
American Association of Diabetes Educators, Virginia Zamudio,
Chicago, IL, statement......................................... 60
American College of Physicians, statement........................ 62
American Geriatrics Society, New York, NY, statement............. 65
McKesson Health Solutions, Sandeep Wadhwa, San Francisco, CA,
statement...................................................... 67
National Kidney Foundation, Brian J.G. Pereira, New York, NY,
statement...................................................... 70
Urban Institute, Robert A. Berenson, statement................... 5
MEDICARE CHRONIC CARE IMPROVEMENT PROGRAM
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TUESDAY, MAY 11, 2004
U.S. House of Representatives,
Committee on Ways and Means,
Subcommittee on Health,
Washington, DC.
The Subcommittee met, pursuant to notice, at 2:14 p.m., in
room 1100, Longworth House Office Building, Hon. Nancy L.
Johnson (Chairman of the Subcommittee) presiding.
[The advisory announcing the hearing follows:]
ADVISORY
FROM THE
COMMITTEE
ON WAYS
AND
MEANS
SUBCOMMITTEE ON HEALTH
CONTACT: 202-225-3943
FOR IMMEDIATE RELEASE
May 04, 2004
HL-8
Johnson Announces Hearing on Medicare Chronic Care Improvement Program
Congresswoman Nancy L. Johnson (R-CT), Chairman, Subcommittee on
Health of the Committee on Ways and Means, today announced that the
Subcommittee will hold a hearing on the Chronic Care Improvement
Program authorized by the Medicare Modernization Act. The hearing will
take place on Tuesday, May 11, 2004, in the main Committee hearing
room, 1100 Longworth House Office Building, beginning at 2:00 p.m.
In view of the limited time available to hear witnesses, oral
testimony at this hearing will be from invited witnesses only. However,
any individual or organization not scheduled for an oral appearance may
submit a written statement for consideration by the Committee and for
inclusion in the printed record of the hearing.
BACKGROUND:
As part of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA) (P.L. 108-173) that was signed on
December 8, 2003, Congress provided for a Chronic Care Improvement
Program (CCIP) within fee-for-service Medicare. On April 20, 2004, the
Centers for Medicare and Medicaid Services (CMS) released a Request for
Proposals (RFP) for chronic care improvement programs focused on
congestive heart failure, diabetes, and chronic obstructive pulmonary
disease. CMS will select programs to operate in 10 regions of the
country to evaluate different approaches to the management of chronic
conditions. The initial phase of the CCIP will be based on improved
quality in health outcomes, beneficiary satisfaction, and financial
savings to the Medicare program.
Medicare beneficiaries with five or more chronic conditions
represent 20 percent of the Medicare population but account for 66
percent of program spending. The CCIP represents a new way of
approaching the care of beneficiaries within the fee-for-service
program by shifting from a focus on acute episodes to the management of
on-going chronic conditions.
In announcing the hearing, Chairman Johnson stated, ``The chronic
care improvement program is a major step forward for the Medicare
program and the quality of health care it provides. It represents a
fundamental shift in how we think about caring for our seniors and
people with disabilities. This is a key element of how the Medicare
Modernization Act truly modernizes the Medicare program by improving
discussion and coordination between Medicare beneficiaries and their
physicians.''
FOCUS OF THE HEARING:
CMS released the RFP for the CCIP on April 20, 2004. Proposals are
due back to the agency in early August. Panel members at the hearing
will include representatives from prospective bidders, physician
groups, and beneficiary organizations. The hearing continues the series
of hearings held by the Subcommittee on the implementation of the
Medicare Modernization Act.
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Chairman JOHNSON. Today, I am pleased to chair this hearing
on the Chronic Care Improvement Program (CCIP) that was passed
as part of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA) (P.L. 108-173). The program is
a major step forward for the Medicare Program and the quality
of health care that it provides. It represents a fundamental
shift in how we think about caring for our seniors and people
with disabilities. The CCIP is a key element in how the MMA
truly modernizes the Medicare Program by improving discussion
and coordination between Medicare beneficiaries and their
physicians.
Medicare beneficiaries with five or more chronic conditions
represent 20 percent of the Medicare population that account
for 66 percent of the program spending. The CCIP represents a
new way of approaching the care for beneficiaries within the
fee-for-service program by shifting from a focus on acute
episodes to the management of ongoing chronic conditions.
This new way of thinking will become even more essential as
we approach the retirement of the baby boom generation. The 40
million beneficiaries currently in Medicare will double to more
than 80 million over the next 30 years. More and more of those
beneficiaries will be living with chronic conditions. The steps
we are taking today to rethink how Medicare provides health
care will be essential as the number of beneficiaries increases
in future years. The Centers for Medicare and Medicaid Services
(CMS) currently has several demonstration projects in place to
test various types of disease management programs, but none
matches the scale and scope of the CCIP included in last year's
Medicare law.
I am extremely happy that this fundamental change in the
program is rapidly being implemented. To a large degree, that
is as a result of the firm resolve and strong support for this
program from Members of Congress, Secretary Thompson, and
Administrator McClellan as well as his staff.
The CMS released this Request For Proposal (RFP) on April
20 and will carry out Phase I of the CCIP in 10 regions of the
country over the next 3 years. The first phase will focus on
beneficiaries with congestive heart failure, diabetes, and
chronic obstructive pulmonary disease. The initial phase of the
CCIP will be based on improved quality and health outcomes,
beneficiary satisfaction, and financial savings to the Medicare
program, and successful programs will be expanded to more
beneficiaries in the fee-for-service program.
I might point out that this is the first time we have been
able to build into Medicare a capacity on the part of the
Secretary to pilot things that will make a positive health
improvement in our seniors and then to roll them out
automatically under his authority. This will accelerate the
pace at which quality improvements in Medicare actually become
available by not requiring that Congress have another vote,
another bill, another go, before positive changes can be
implemented in Medicare.
I welcome today Dr. Mark McClellan in his first appearance
before Congress as CMS Administrator. It is really a pleasure
to welcome you, Mark. You have broad experience both in
government and as a physician; and I welcome you before our
panel to discuss CMS plans for implementing this terribly
important program that I know you are not only well familiar
with, but a strong advocate of.
I also look forward to the testimony of our second panel,
Christobel Selecky, President-Elect of the Disease Management
Association of America, who will provide us with some insights
into the ways in which various organizations are working
together to respond to the RFPs for this program. Dr. Janet
Wright, speaking on behalf of the American College of
Cardiologists, will provide a practicing physician's viewpoint
on the importance of the CCIP to the Medicare population.
Dr. Vince Bufalino from the American Heart Association
(AHA) will discuss the impact that CCIPs can have on the lives
of beneficiaries; and Dr. Robert Berenson of the Urban
Institute had planned to provide us with a researcher's
perspective on the program. Unfortunately, they had an
evacuation of the airport from which he was to leave, and it is
extremely unlikely he will be able to join us. His testimony is
very important both to the consideration of this RFP in the
long term, to our consideration of how we reform our payment
system for physicians. So, we will consider his testimony as
part of the base from which we will question panelists, and we
will share that testimony with him at a time when he can be
present.
[The prepared statement of Dr. Berenson follows:]
Statement of Robert A. Berenson, Urban Institute
Madame Chairman, Mr. Stark, and members of the subcommittee: Thank
you for inviting me to this important session dedicated to reviewing
the challenge of better serving the growing number of Medicare
beneficiaries with multiple and complex chronic conditions.
Americans are living longer than ever, because of new medical
treatments and technologies, better prevention, and healthier
lifestyles. At the same time, people are living longer with chronic
conditions, such as heart disease, diabetes, neuro-degenerative
diseases, and even cancer. Diseases that used to be fatal early on in
their course can now be managed effectively for years. And as we live
longer, more of us are contending with multiple and complex chronic
conditions that require a high degree of medical management and
monitoring and a new commitment to encouraging and supporting patient
self-management.
Policymakers are just beginning to realize the implications for
Medicare of beneficiaries living longer with chronic illness,
particularly multiple chronic diseases.\1\ About 20 percent of
beneficiaries have five or more chronic conditions, account for over
two-thirds of Medicare spending, see about 14 different physicians in a
year, and have almost 40 office visits.\2\ The chances of an otherwise
unnecessary hospitalization--for conditions that can and should be
managed effectively on an outpatient basis--increase from about 1
percent for a beneficiary with just one condition to about 13 percent
for a beneficiary with five conditions and about 27 percent for a
person with eight chronic conditions.\3\ It would seem then that
beneficiaries with multiple chronic conditions have unattended
complications despite their high health care use. It also would appear
that the number of chronic conditions has more influence than age on
health care spending in the Medicare population.\4\
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\1\ Among a number of recent policy documents that examine the
issue of chronic conditions and Medicare is Eichner, June and
Blumenthal, David, eds. Medicare in the 21st Century: Building a Better
Chronic Care System. National Academy of Social Insurance. Washington,
DC. January 2003.
\2\ Partnership for Solutions, Medicare: Cost and Prevalence of
Chronic Conditions. Johns Hopkins University, Baltimore, MD. July 2002.
\3\ Wolff J. et al. Archives of Internal Medicine, November 11,
2002.
\4\ Berenson R, Horvath J, Clinical Characteristics of Medicare
Beneficiaries and Implications for Medicare Reforms. Prepared for the
Center for Medicare Advocacy, March 2002. Accessed February 2004,
www.partnershipforsolutions.org/DMS/files/MedBeneficiaries2-03.pdf. It
is also true that the presence of chronic conditions is associated with
age; however, costs and use are similar for beneficiaries with multiple
chronic conditions regardless of age.
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Section 721 of the Medicare Modernization Act (MMA) provides for a
new Chronic Care Improvement (CCI) program within the traditional
Medicare program; the law also requires a new emphasis on chronic
illness management within the restructured Medicare Advantage program.
The CCI program is essentially a vendor-operated disease management
program targeting beneficiaries with chronic obstructive pulmonary
disease, congestive heart failure, diabetes mellitus, and other
diseases that the Secretary may specify. The Centers for Medicare and
Medicaid Services (CMS) recently published a Request for Proposals that
makes clear that entities other than a disease management organizations
are encouraged to apply, although the emphasis will be on organizations
with large scale and scope, because of the risk requirement, generally
far beyond that of even large group practices. The CCI will be tested
for three years after which the Secretary will evaluate the program for
financial outcomes (program savings), clinical quality (hospital
readmission rates and adherence to clinical guidelines), and
beneficiary satisfaction.
In general, a CCI vendor must guide beneficiaries in managing their
health. Every enrolled beneficiary will have a care plan that is to
include disease self-management education and collaboration with
physicians and other providers to enhance communication of relevant
clinical information. Care plans can also include use of monitoring
devices to facilitate transmission of clinical indicators. CCI vendors
must also have tracking systems to follow beneficiaries across settings
and record and monitor outcomes in each setting.
In recent years, there has been growing dissonance between the
evolving use of disease management by private health plans, convinced
of its utility in improving patient care, and the continuing dearth of
peer-reviewed evidence of its cost-effectiveness. One desirable aspect
of the CCI program is that the technique will be tested in formal
trials that should help provide data to better assess the cost-
effectiveness of disease management for the Medicare population in the
context of the traditional Medicare program.
I would direct the subcommittee's attention to a potential problem
in the study design mandated in the MMA. The requirement that
individual patients are to be randomized to intervention and control
will make it very difficult for practice-based organizations to compete
for an award because such an organization would normally provide the
intervention to all of its patients that would benefit from the care
coordination approach. For these applicants a trial that permits
matching rather than randomization would be more appropriate. I would
urge the Congress to give the CMS the flexibility to a study design
that accommodates the circumstances of different applicants.
Although the CCI program may be a good start, in my opinion it is
insufficient for truly addressing chronic care needs in Medicare
because it lacks a focused physician component. The Administration
emphasizes that the new program creates a ``business platform'' that
will permit innovation, but the CCI program ignore the reality that
beneficiaries look to their personal physicians for responsibility for
their health care--and not business platforms--whether health plans,
disease management companies, or other third party-vendors.
Policymakers need to tackle the difficult challenge of engaging
those responsible for health care quality and use, namely the doctors
and other health care professionals. Further, in order to be
successful, disease management and related case management should work
better with the active involvement of the patient's physician.\5\ Again
and again studies have shown that care coordination only works with
real physician involvement. Unfortunately, the CCI initiative is quite
removed from the physician, although the legislation correctly calls
for an individual's care plan to include physician education and
collaboration.
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\5\ Chen, A, Brown, R; et al. Best Practices in Coordinated Care.
Prepared for the Health Care Financing Administration. Mathematica
Policy Research, Princeton, NJ. March 2000. Accessed February 2004 at
www.mathematica-mpr.com/pdfs/bestsum.pdf.
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Consistent with the overall philosophy of the MMA, this approach to
addressing the growing need for improved care for those with chronic
health conditions is a corporate one, focused on providing contracts to
third-party vendors, rather than directly enabling professionals to
better serve their patients. The traditional Medicare program has an
unrealized opportunity to lead the restructuring of how physicians
organize and deliver health services, as called for by the Institute of
Medicine in its seminal ``Crossing the Quality Chasm'' report.\6\
Instead, the MMA would have Medicare merely follow private sector
approaches have been tested in younger and somewhat healthier
populations and that may not be as well suited to the Medicare
beneficiaries.
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\6\ Institute of Medicine. Crossing the Quality Chasm: A New Health
System for the 21st Century. National Academy of Sciences. Washington,
DC. March 2001.
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Disease management can likely bring important benefits, such as
improved functioning and decreased hospitalizations, to relatively
healthy individuals, with a well-defined chronic condition. It is also
proper that CCI programs are required to identify and address enrollee
co-morbidities. However, these programs have not generally been
designed to address successfully the needs of medically complex
patients, whose needs go well beyond learning disease self--management
techniques and who have multiple professionals affecting the care and
treatments of their different conditions. Nor are they designed to meet
the needs of individuals with dementia, and, therefore cannot benefit
form disease management's heavy emphasis on patient self-education.
It will be challenging for disease management companies and other
vendors who may be awarded contracts under the initiative to develop
the necessary links with physicians, especially because the law
provides no new reason for physicians to engage with them. Creating
effective relationships with treating physicians is further complicated
by the probability that these management companies will be operating
across great distances from a central location with no particular
connection to the communities in which they will operate.
Medicare disease management would benefit a certain segment of
beneficiaries, and this approach could certainly be part of a
comprehensive strategy to improve the care provided to Medicare
beneficiaries with multiple chronic conditions. But it is not a
sufficient response.
These private-sector approaches have arisen partly because many
physicians have been impervious to the altered needs of a patient
population with far more well-established, chronic conditions and far
fewer acute medical events than their training has prepared them for.
In addition, the financial underpinnings of a typical medical practice
do not support physicians who actually do recognize the need to be more
fully engaged in the components of chronic care coordination. These
include: teaching patient self-management; communicating more often
with patients outside of face-to-face office visits; managing
polypharmacy; coordinating care among many other professionals and
providers to avoid redundancy and errors; developing and maintaining
more appropriate medical information summaries, preferably inside an
electronic health record; and more forthrightly helping prepare
patients and their families for death and dying. Simply stated, the
Medicare payment system does not pay for these activities, so
physicians either do not deliver these services directly or go unpaid
when trying to do so.
Bounced around the system, too many Medicare beneficiaries do not
even recognize a particular physician who is responsible for
coordinating their care. Where no physician is in charge, disease
management certainly serves a useful stopgap role. Nevertheless, the
program goal should be to promote a patient relationship with a primary
care physician or a specialist willing to take overall responsibility
for care coordination and the other functions that I identified
earlier. Although disease management can assist a patient's primary
physician in caring for patients with multiple chronic conditions, its
role should be viewed clearly as supplementary to the personal
physician's responsibility. Disease management currently appears to
serve a useful purpose because of a quality chasm in how health care is
delivered. The policy objective should be to address the causes of the
chasm and not merely provide a partial stopgap.
As stated earlier, among other areas that need attention is the
overlooked issue of physician payment policy. Simply put, the
incentives inherent in most fee-for-service payment systems, including
Medicare's and those of most private payers, penalize primary care
physicians who would alter their professional interactions with
patients to respond to the challenge posed by the reality of patients
with multiple complex chronic conditions.
Yet, the MMA mostly ignores alternative payment approaches
affecting physician behavior. These payment approaches should go hand
in hand with the new chronic care program to ensure the kind of change
needed to improve care for Medicare beneficiaries. I would note that
Sec 646 of the MMA, the Medicare Health Care Quality Demonstration
Program, provides a possible platform for examining new payment
approaches. This demonstration should be given high priority and should
explicitly address chronic care improvement incentives for physicians
and medical groups.
Imagine if in the early 1980s, Congress, confronted with soaring
Medicare Part A hospital costs produced partly as a result of an
inherently inflationary, cost-plus payment system, had decided not to
implement the Prospective Payment System. Imagine, instead, that
Congress had chosen to fund third-party vendor, utilization review
organizations to try to reduce lengths of stay for Medicare patients.
That approach might have had some marginal beneficial effects on cost
reduction--and plenty of unpleasant confrontations with physicians and
hospital staff. Overall, trying to improve hospital efficiency while
ignoring the incentives inherent in the basic payment system would have
been foolhardy. Congress showed good sense by going to the root of the
problem.
I would argue that we now face a similar challenge to get the
physician payment systems right, and to do so would mean entering
mostly unchartered territory. But is it logical to think you can
improve the medical care provided to Medicare beneficiaries with
chronic conditions while ignoring physicians?
One of the problems, of course, is that the medical profession
itself has been slow to recognize that the nature of the practice of
medicine is changing and it has not been very assertive in proposing
new billing codes and payment approaches that would support altered
physician activities. Indeed, as I noted above, I am not sure that most
physicians even recognize the care gaps that result from maintaining a
traditional orientation to responding expertly to acute medical events,
while ignoring the less dramatic, but significant, needs of those with
progressive chronic conditions.
Recently, the specialty associations representing the primary care
physicians who serve Medicare beneficiaries, including the American
Academy of Family Physicians, the American College of Physicians, and
the American Geriatric Society, have begun to address this particular
quality gap and have supported specific legislation that I believe goes
in the right direction. I urge the Committee to work with these and
other interested parties to explore new payment approaches that should
be intrinsic to any serious effort to refocus Medicare on the unique
burden of chronic disease. Physicians should be paid and supported for
taking responsibility for assertively coordinating care for patients
with complex chronic conditions. Part of that coordination certainly
might involve interacting with nurses and others from disease
management vendors.
We should be testing various new payment approaches. There are
already limited precedents in the Medicare physician payment system for
the kinds of changes that would be needed. In contrast to true
prospective payment systems used for other provider types, the
physician payment system suffers for being ``fee for individual items
of service.'' Yet, renal physicians for many years have received a
monthly capitation payment for their professional services for end-
stage renal disease. Similarly, Medicare pays for a few ``care plan
oversight services,'' e.g., for patients under the care of home health
agencies. These small payment precedents should be examined and built
on.
Payment models could distinguish how well a medical practice is
integrated. For example, solo and other small practices might receive
relatively small care management fees that essentially would enable
them to better communicate with disease management vendors. On the
other hand, larger, more integrated practices would receive larger care
management fees and possibly Part B or maybe even Part A payments under
some circumstances. This would that permit them to directly manage
disease, without the need for a separate third-party organization. The
additional payments initially might be focused on care coordination for
those patients with multiple and complex chronic conditions, but over
time I envision that traditional Medicare might pay some multi-
specialty group practices forms of capitation for a much broader range
of their patients.
One new payment model has appeared in slightly different forms in
Medicare legislation in the past two sessions of Congress, but
ultimately lost out to the corporate approach.\7\ A token Medicare Care
Management Demonstration, Section 649, similar to this approach,
survived in the final MMA. It would place on physicians and their
staffs responsibility and accountability for clinical care coordination
of medically complex individuals. Participating physicians would
coordinate clinical care, consult with other providers as necessary,
and receive a monthly administrative payment for the extra time and
attention involved. The model could be expanded in a number of ways.
For instance, physicians could be required to have on staff or under
contract a case management function to make referrals to community
resources that could address the supportive service needs of these
patients.
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\7\ Most recently, the complex clinical care payment concept was
included as a demonstration in the Senate version of the Medicare
reform legislation, Section 443 of S. 1, in June 2003. The provision
set new standards for physicians willing to participate, including
conducting a range of care coordination activities that linked medical
and supportive services oriented to the beneficiary and family
caregivers.
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In addition, CMS has proposed another approach to changing the
nature of physician practice--the physician group practice
demonstration, which I understand is scheduled to begin next year if
the Office of Management and Budget signs off. However, the
demonstration is limited to large-group practices that have at least
200 full-time physicians. The physician group would receive bonus
payments to the extent that spending is below established targets. This
demonstration is on the right track, although it does not target the
population with multiple chronic conditions. The size of the physician
group would limit how well the model can be replicated if it proves
successful. Nevertheless, it is another approach that attempts to
change physician payment incentives and reward greater integration of
physician practice and, accordingly, it deserves to be as high a
priority as the CCI program.
CMS has numerous other demonstrations to test care management and
disease management models. However, all of them have design issues that
will likely limit their success for medically complex individuals.
Several projects target specific diseases, rather than beneficiaries
with multiple conditions. And the demonstration models typically ignore
addressing the crucial role of the treating physician in care
management.
In conclusion, I applaud the efforts of Congress in general and
this subcommittee in particular for recognizing the unique challenge
posed by the growing number of Medicare beneficiaries living with
multiple and complex chronic conditions. The disease management
initiatives are a useful response, but, in my opinion, an insufficient
one. The traditional Medicare program has the opportunity to pioneer in
the area of payment policy, as it has successfully done a number of
times in other areas. Working with the willing in the medical
community, Medicare can help produce overdue restructuring of the
practice of medicine and reorient at least some of the delivery system
to chronic care management.
While the MMA provisions are a start, I believe they are overly
focused on a corporate, vendor solution--a business platform--for
problems in the program that would be served better by involving those
who actually deliver health care at the front line--physicians and
other clinical professionals in their own medical practices.
Chairman JOHNSON. So, I thank you all for appearing before
us today. I believe that the CCIP is one of the most
transformational elements of the Medicare modernization bill,
as it challenges all of us to begin thinking about medicine and
health care in new ways. I look forward to the testimony of all
of our witnesses. Now, Mr. Stark, if you would like to make an
opening statement.
Mr. STARK. Thank you, Madam Chairman. I am pleased that we
are here today to discuss the CCIP that was included in the
bill last year. I must say I am pleased you are having the
hearing. It is a tribute to your power and party that you could
close an airport to keep my witness from attending, but I bow
to political pressures these days all the time. I do know that
we will have a chance to hear him, Dr. Berenson, at another
time.
The disease management approaches, such as the CCIP, I
guess, that use patient coaches, and they can be helpful tools,
but I hope we will also get to discuss today the difference
between young working people with chronic illnesses and those
of us who are older and often have far more, larger, multiple
chronic illnesses. I think that it is fair to ask whether our
money might be better spent on programs that enable chronically
ill patients greater access to physicians rather than rely on
corporate vendors that actually kind of remove the patients
further from their doctors and funnel money to for-profit
disease management companies.
I want to encourage the Secretary to look into the
effectiveness and efficiency of these vendor-based programs and
to determine their value to Medicare relative to other
approaches. I understand that they have been having some
success with managed care plans, but a small percentage of our
seniors are in those, and I think that we can't overlook the 70
or 80 percent of beneficiaries who rely on a primary care
physician. Because of the expense of covering seniors, we
have--they are sort out of the employment-based insurance
system, and we have the oldest and sickest people in America in
our system, the Medicare system. So, approaches that work with
younger, healthier problem might not apply to the far more
complex situation that we find in many of our Medicare
beneficiaries.
I know you have expressed interest in advancing chronic
care in Medicare and I think this is an area we could continue
to work on. I think we should. I have been working for some
time and currently have a bill to provide a comprehensive
chronic care benefit in Medicare, and I think that is something
we are going to have to work on with physicians to find what a
chronic care protocol should be, and can there be one that we
can define, as we now do various codes that we use to reimburse
physicians.
There are a whole lot of things that I don't think we have
the expertise in this Committee to define, but I think we have
to encourage CMS perhaps and the various medical groups to come
up with their suggestions as to what they think ought to be the
physicians' role in this, because I think without them, we may
not get the results that we both want. Thank you very much. I
look forward to hearing our witnesses.
Chairman JOHNSON. Dr. McClellan, welcome.
STATEMENT OF THE HONORABLE MARK MCCLELLAN, M.D., PH.D.,
ADMINISTRATOR, CENTERS FOR MEDICARE AND MEDICAID SERVICES
Dr. MCCLELLAN. Thank you, Chairman Johnson, Representative
Stark, and Representative Crane. It is a real privilege to be
here with you today at this critical time for the Medicare
program to discuss the new CCIP. This is a major step for us, a
new step for us, to improve the care of chronically ill
beneficiaries in Medicare fee-for-service; and it is a real
privilege to be involved at this time when we are taking so
many new steps in Medicare. I want to thank you for your
leadership in making this possible.
Medicare beneficiaries living with chronic conditions in
the traditional fee-for-service program face a particularly
challenging task in managing their conditions. The goal of the
CCIP, this program, is to work closely with health care
professionals to assist those beneficiaries in using the latest
evidence-based management techniques and information technology
to get better outcomes.
The widespread failings in chronic care management are a
major public health concern today. In my own experience in
medical practice, I have often seen doctors and nurses and
other health professionals provide high-quality care for people
with chronic illnesses in spite of, rather than because of, the
systems in which they practice. Yet too often, Medicare
beneficiaries do get less than optimal care for their chronic
conditions because they have a lot of problems and can suffer
if the care is fragmented and if they aren't well informed
about how to follow their doctor's treatment plan.
Fragmentation leads to poor health outcomes.
Since chronic illnesses account for most of the deaths
among Medicare beneficiaries today, this is a big deal for our
Medicare beneficiary population. It can also lead to high
medical costs. Beneficiaries with five or more chronic
conditions represent 20 percent of our population; that is 66
percent of our program spending, and most Medicare expenditures
for the care of these beneficiaries are for multiple and often
preventable hospitalizations. Currently, our payments are not
designed to promote disease prevention and avoid poor outcomes.
Instead, as Representative Stark noted, we pay for services
that are primarily related to dealing with disease
complications themselves, missing opportunities to prevent the
complications in the first place.
The new MMA is our best opportunity ever to change the
focus to prevention, and the CCIP is an important part of that
effort. As my written testimony describes in more detail,
chronic care management programs have repeatedly demonstrated
an ability to reduce costs while improving health and the
satisfaction of beneficiaries.
Many Medicare Advantage health plans have engaged in
disease management activities for our beneficiaries in the past
2 years. In one such program, hospital admissions for
congestive heart failure were reduced by 70 percent. By
preventing these acute complications, the plan saved $3 for
every $1 it invested. Lower complications is one reason that
Medicare Advantage plans save so much money for beneficiaries
of chronic illnesses compared to fee-for-service Medicare, and
that is why it is important for us to make sure that these
kinds of plans are available to beneficiaries who prefer them,
especially beneficiaries with limited means.
Despite the proven advantages of chronic care improvement
programs, however, millions of beneficiaries who are most
likely to benefit from them have the least access because they
aren't part of fee-for-service Medicare. That is going to
change now. As called for under the MMA, the Secretary will
enter into agreements with qualified organizations,
collaborative groups, including physician organizations and
others, to run large-scale regional CCIPs for 3 years using
prospectively identified beneficiaries with congestive heart
failure, complex diabetes, and chronic obstructive pulmonary
disease. We expect that the CCIPs will collectively serve
between 150,000 and 300,000 fee-for-service Medicare
beneficiaries during this first phase pilot program.
These programs will be evaluated through randomized,
controlled independent trials using the best scientific
techniques available. We published the notice in the Federal
Register announcing this program last month. Completed
proposals from potential awardees are due by August 6 of this
year, and we expect to implement the first service agreements
on schedule by December 8, 2004. We expect the program
operations will begin and services will be provided in full by
early 2005.
It is important to note in this program that beneficiary
participation is completely voluntary and that beneficiaries
can get access to the full set of fee-for-service benefits
throughout this program. In fact, the point of the program is
to help them get the most out of their fee-for-service
benefits.
The payment to program awardees will be performance-based.
They don't get paid unless they improve performance:
performance in quality, performance in saving money for the
Medicare Program at the same time. Fees paid to awardees will
be at risk for performance improvements in clinical quality, in
beneficiary and provider satisfaction, and for reduced costs
across their assigned target populations compared to regional
control groups.
I want to emphasize again, we fully expect this program to
improve beneficiary health outcomes, to increase their
satisfaction with the services they receive, to improve the
partnership between care givers, health professionals, and
patients, and to save the Medicare Program money. It is an
innovative model for care delivery, and it is a real pleasure
to have the opportunity to be here working with you to
implement it. Thank you for your time. I have more detailed
written testimony that I would ask be read into the record, and
I would be happy to answer any questions you may have.
[The prepared statement of Dr. McClellan follows:]
Statement of The Honorable Mark McClellan, M.D., Ph.D., Administrator,
Centers for Medicare and Medicaid Services
Chairwoman Johnson, Representative Stark, distinguished members of
the Committee: I thank you for inviting me here today to discuss the
new Chronic Care Improvement Program, (CCIP) about which we at CMS are
very excited. As you know, this voluntary program was created by
Section 721 of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA). The CCIP could be a major new step in
improving the quality of care for chronically ill beneficiaries under
Medicare fee-for-service. I would like to make particular note of the
work that Chairwoman Johnson did to champion this new program and let
her know that we believe that her work will make a real difference in
the lives of hundreds of thousands of Medicare beneficiaries across the
country who suffer from chronic ailments. Today, I would like to
address the questions of how the CCIP may help Medicare beneficiaries,
and how Phase I will work, including beneficiary selection, payment,
and criteria for expanding the program nationwide under Phase II.
HOW CAN THIS PROGRAM BE HELPFUL?
Medicare beneficiaries living with chronic conditions in the
traditional fee-for-service Medicare program face a particularly
challenging task in effectively managing their conditions. The goals of
the CCIP are to assist these individuals utilizing the latest in
evidence-based care management and information technology, as well as
personal interactions with caregivers to ensure better outcomes. We
believe that Medicare may be able to utilize these proven measures not
only to improve the fiscal outlook of the program, but also to more
adequately assist our beneficiaries in living healthier lives.
Widespread failings in chronic care management are a major national
concern. Many of these failings stem from systemic problems rather than
lack of effort or intent by providers to deliver high quality care.
Medicare beneficiaries are disproportionately affected because they
typically have multiple chronic health problems. Fragmentation of care
can lead to poor health outcomes. In addition, Medicare beneficiaries
with five or more chronic conditions represent 20 percent of the
Medicare population but 66 percent of program spending. Most of
Medicare expenditures for care of these beneficiaries are for multiple
and often preventable hospitalizations.
Congestive Heart Failure (CHF) and diabetes are among the five most
common chronic diseases in the Medicare population. According to
findings from the 2002 Medicare Current Beneficiary Survey, individuals
with CHF, and coronary artery disease represent 21.3 percent of non-
institutionalized fee-for-service Medicare beneficiaries and account
for 36.8 percent of Medicare expenditures, including treatment for all
their health problems. Individuals with diabetes represent 19.4 percent
of beneficiaries and 30.4 percent of fee-for-service Medicare
expenditures. Beneficiaries with these diseases tend to have complex
self-care regimens and medical care needs, that when neglected, or
uncoordinated, can lead to complications and acute care crises. The
health risks of these beneficiaries depend heavily on how effectively
they are able to control their conditions in their daily lives and
whether or not they receive appropriate medical care and effective
coordination of their care. Efforts to control their conditions
successfully may benefit from ongoing guidance and support beyond
individual provider settings.
Prevalence rates of diabetes and CHF are even higher among
minorities than among all Medicare beneficiaries. For example, as shown
in Figure 1, the Centers for Disease Control and Prevention reports
that 23.0 percent of black males and 23.5 percent of Hispanic males
ages 65-74 have diabetes compared to 16.4 percent of white males and
15.4 percent of all individuals in that age group. Black and Hispanic
females in that age group have diabetes prevalence rates of 25.4
percent and 23.8 percent, respectively, compared to 12.8 percent for
white females and 15.4 percent for all individuals in that age group.
Given these prevalence figures, improving quality and adherence to
evidence-based care has the potential to improve outcomes and reduce
racial and ethnic health disparities, consistent with HHS' Healthy
People 2010 goals.
[GRAPHIC] [TIFF OMITTED] T9671A.001
Figure 1
The Medicare fee-for-service system is structured and financed to
manage acute care episodes, not to manage and support individuals with
progressive chronic diseases. Providers of care are organized and paid
for services provided in discrete settings (for example, hospitals,
physician offices, home health care, long-term care, or preventive
services). Patient care can be fragmented and poorly coordinated and
patient information difficult to integrate among settings. Providers
may lack timely and complete patient clinical information to fully
assess their patients' needs and to help prevent complications. Ongoing
support to beneficiaries for managing their conditions outside their
physicians' offices is rare.
Fragmentation of care can be a serious problem for Medicare
beneficiaries. The average Medicare beneficiary sees seven different
physicians and fills upwards of 20 prescriptions per year. In a recent
survey, 18 percent of people with chronic conditions reported having
duplicate tests or procedures and 17 percent received conflicting
information from providers.\1\ Providers reported feeling ill-prepared
to manage chronically ill patients and reported that poor coordination
of care led to poor outcomes. Physicians and other practitioners desire
to, and often do, provide very high levels of care in this country, but
the challenges they face in integrating all of their efforts often
frustrate their excellent intentions. As a practicing internal medicine
physician I encountered these same challenges. I believe that the CCIP
will assist currently practicing physicians and health care providers
to avoid some of the challenges that I was faced with while actively
treating patients.
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\1\ Anderson, G. Chronic Conditions: Making the Case for Ongoing
Care. Partnership for Solutions and the Robert Wood Johnson Foundation,
p. 32.
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The gap between accepted standards of appropriate care for patients
with chronic diseases and the care they actually receive is
significant. According to findings of a recent national study published
in the New England Journal of Medicine, only 56 percent of patients
with chronic diseases received recommended care based on well-
established guidelines referenced by the researchers. Among patients in
the study sample who had CHF, only 64 percent received recommended
care, and among those with diabetes, only 45 percent received
recommended care. Specifically, only 24 percent of diabetes patients in
the study received three or more glycosylated hemoglobin tests over a
two-year period. Similarly, in a recent study of practice patterns
under Medicare, researchers found that, across all States, an average
of 66 percent of Medicare beneficiaries with heart failure received ACE
inhibitors and 16 percent with diabetes received a lipid test.
A concerted effort to coordinate care and enhance patient
compliance will result in fewer acute episodes of care, fewer disease
complications and will help eliminate redundant services as physicians
and other providers repeat tests and evaluations previously performed
because they lack the ability to access results of those services.
These changes alone have the potential to generate substantial savings.
Currently, Medicare fee-for-service payments do not encourage
prevention of diseases, good outcomes and performance. Instead, the
payment system provides money for acute events, missing a potential
opportunity to prevent these situations which could be beneficial from
a cost standpoint, but, more importantly, from a health perspective. In
a sense, payment incentives are the opposite of the way they should be.
The CCIP seeks to address this problem, as well as others described
above, by rewarding efforts to prevent acute episodes and improve
health. Under CCIP, awardees will work to increase patient compliance,
facilitate communication between patients and providers, and better
coordinate care among providers caring for the same individual. In a
much more direct way than ever before under fee-for-service Medicare,
economic incentives will be directly lined up with prevention and
performance. We hope to reward high quality care, rather than high
volume and high intensity care.
Our work with CCIP will nicely complement previous efforts to
provide consumers with information on quality outcomes in nursing
homes, home health agencies, and hospitals, and to line up economic
incentives with quality standards. This shift in payment and emphasis
is a demonstration of the Administration's commitment to a coordinated,
patient-centered approach to healthcare.
CMS is also working to line up physicians' economic incentives with
quality care through such programs as the physician group practice
demonstration project that will provide bonus payments for improvements
in quality. We also will be conducting a demonstration under Section
649 of the MMA to encourage physicians to promote continuity of care,
use established clinical guidelines and prevent or minimize
exacerbations of chronic conditions. Additionally, beginning in 2006,
all Medicare Advantage plans will be required to operate chronic care
improvement programs of their own. These plans will be able to use
varying payment methodologies to line up economic incentives with
quality care from providers. The CCIP under Section 721, although
important in its own right, is not the only tool CMS will be using to
assist Medicare beneficiaries with chronic conditions to effectively
manage their care.
CHRONIC CARE IMPROVEMENT POTENTIAL
To date, there has not been a sufficient number of thorough tests
of whether chronic care improvement will improve health care quality
and reduce costs in Medicare. However, private companies have been
utilizing the techniques called for under CCIP for some time, and have
demonstrated some success in improving health outcomes.
Michael Rich and colleagues found that a nurse-directed
multidisciplinary intervention program reduced net cost of care an
average of $153 per patient, per month, for the treatment group versus
the control group. Readmissions in the control group were nearly double
that of the treatment group.\2\
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\2\ Michael W. Rich, Valerie Beckham, Carol Wittenberg, Charles L.
Leven, Kenneth E. Freedland, and Robert M. Carney, ``A
Multidisciplinary Intervention to Prevent the Readmission of Elderly
Patients with Congestive Heart Failure,'' New England Journal of
Medicine, 333, no. 18, November 2, 1995: 1190-1195.
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A major U.S. company reported that a disease management program for
diabetic patients run out of an on-site clinic realized savings of more
than $600,000 in reduced sick time usage in its first year of
operation.\3\
---------------------------------------------------------------------------
\3\ Annemarie Geddes Lipold, ``Disease Management Comes of Age, Not
a Moment Too Soon,'' Business and Health, June 19, 2002.
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Ronald Aubert and colleagues found significant decreases in fasting
glucose levels among patients who were provided with the services of a
nurse case manager who was also a certified diabetes educator. These
patients reported perceived improvement in their health status more
than twice as often as their control group counterparts.\4\
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\4\ Ronald E. Aubert, William H. Herman, Janice Waters, William
Moore, David Sutton, Bercedis L. Peterson, Cathy M. Bailey, and Jeffrey
P. Koplan, ``Nurse Case Management to Improve Glycemic Control in
Diabetic Patients in a Health Maintenance Organization,'' Annals of
Internal Medicine, 129, no. 8, October 15, 1998: 605-612.
---------------------------------------------------------------------------
Researchers at Geisinger Health Plan found that patients who chose
to enroll in its diabetes management program had higher scores on
diabetes-related HEDIS (Health Plan Employer Data and Information Set)
performance measures and lower average monthly claims. Inpatient days
per patient, per year, were lower, though there were more primary care
visits.\5\
---------------------------------------------------------------------------
\5\ Jaan Sidorov, Robert Shull, Janet Tomcavage, Sabrina Girolami,
Nadine Lawton, and Ronald Harris, ``Does Diabetes Disease Management
Save Money and Improve Outcomes?'' Diabetes Care, 25, no. 4, April
2002: 684-689.
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Another study found that telephonic nurse guidance for CHF patients
following initial hospital admission resulted in a 47.8 percent
decrease in heart failure readmissions at six months. The authors
reported medical care cost savings net of intervention costs.\6\
---------------------------------------------------------------------------
\6\ B. Riegel et al., ``Effect of a Standardized Nurse Case-
Management Telephone Intervention on Resource Use in Patients with
Chronic Heart Failure,'' Archives of InternalMedicine, 25 March 2002:
705-712. Reported in Health Affairs, Sandy Foote, July 30, 2002.
---------------------------------------------------------------------------
In another study, readmissions for heart failure were reduced 56
percent in the first ninety days after discharge for high-risk CHF
patients age seventy or older.\7\
---------------------------------------------------------------------------
\7\ M.W. Rich et al., ``A Multidisciplinary Intervention to Prevent
the Readmission of Elderly Patients with Congestive Heart Failure,''
New England Journal of Medicine, 2 November 1995: 1190-1195. Reported
in Health Affairs, Sandy Foote, July 30, 2002.
---------------------------------------------------------------------------
The Diabetes Care Connection program, implemented in 2000 by the
Hawaii Medical Service Association (HMSA), targeted all of its 40,000
beneficiaries with diabetes, including more than 6,000 Medicare
beneficiaries. Cap Gemini Ernst and Young found that a much higher
percentage of beneficiaries had their blood glucose levels tested
during the first year of the program than in the baseline year. Also,
total per capita claims costs were lower for HMSA Medicare
beneficiaries with diabetes in 2000 than in 1999, mainly because of
reduced hospital costs.\8\
---------------------------------------------------------------------------
\8\ Hawaii Medical Service Association, a licensee of Blue Cross
Blue Shield Association in Hawaii, has a cost-based contract to operate
a fee-for-service Medicare plan. Myra Williams, HMSA vice-president,
care management, confirmed study findings, also discussed with David
Plocher, Cap Gemini Ernst and Young; and with Robert Stone, American
Healthways. Reported in Health Affairs, Sandy Foote, July 30, 2002.
---------------------------------------------------------------------------
Despite these proven successes, Medicare beneficiaries who are most
likely to benefit from chronic care management services are unlikely to
participate in them because they have been unavailable under the fee-
for-service program. Many of the Medicare Advantage health plans have
engaged in one form or another of disease management in the past few
years. These programs have assisted beneficiaries enrolled in those
plans to reap the benefits of more coordinated and effective care
management. In one such Medicare Advantage disease management program,
their CHF program has produced a 70 percent decrease in hospital
admissions. They calculate that for every dollar they invest in their
disease management program, they realize a savings of three dollars. In
their diabetes management program, this health plan has seen a 45
percent decrease in amputations made necessary by advanced conditions
of the disease. New cases of retinopathy have declined by 20 percent
among participants in the disease management program. The plan
estimates that the 10 year benefit will save $1,500 per patient, or $30
million over that time frame. Unfortunately, the benefits of a disease
management program have been unavailable to beneficiaries in the fee-
for-service program until now. The CCIP will move toward changing this
situation.
The programs cited above resulted in patients who were healthier,
who spent fewer days in the hospital and who were happier with the care
they received. So what kinds of things do chronic care improvement
organizations do to make such a positive impact in people's lives?
Mrs. Jones, a beneficiary with heart failure, was given the option
of using a 1-800 number to call and report her weight on a daily basis,
or the equipment that would report automatically. If her weight
increases by more than a certain amount over a week, her physician
would be notified immediately. The weight gain could be an indication
that Mrs. Jones is retaining fluid, which could be a reflection of her
heart failure flare-up. With such a timely notification, the physician
could adjust Mrs. Jones' medication over the phone, or do a simple,
quick checkup in the office before a serious complication occurs,
saving Mrs. Jones an unpleasant trip to an emergency room or worse.
Another example might be Mr. Smith, a beneficiary with COPD. He
could receive home health care on a regular basis to help ensure that
his home environment does not exacerbate his condition. Since
beneficiaries with COPD often have limited oxygen intake, his home
health aid could help ensure that activities such as reaching for a jar
from a kitchen cabinet are made easier, that he has air filters in his
home, or that he has hypo-allergenic bed sheets, for example. These are
all simple activities that could send Mr. Smith to the emergency room.
Another example might be Mr. Rodriguez, a beneficiary with
diabetes. He could be in need of transportation services to get to the
physician. He could have a history of failing to seek diabetic wellness
visits due to transportation issues. These could have led to acute
exacerbations of his diabetes, where he had to spend time in the
hospital. His nurse case manager could help him obtain transportation
so he does not miss critical preventive check-ups. These preventive
check-ups, such as retinal exams, glycosolated hemoglobin tests, blood
pressure tests, foot exams, etc. have documented benefits in preventing
acute diabetic crises.
Another example might be Mrs. Johnson, a beneficiary with CHF and
depression. She could have had severe problems with medication
compliance and general wellness stemming from her depression. A nurse
in an IPA could reach out to her on a regular basis, provide self-care
support for diet and exercise, and ensure medication compliance. The
physician's office could also bring her in for group therapy and
schedule preventive check-ups with the physician. The IPA could use an
electronic health record to track Mrs. Johnson's progress and
communicate with her other physicians.
We expect many CCIPs to rely on innovative uses of IT equipment,
including electronic monitoring, records, prescribing and alerts, to
help them carry out their programs. These tools, when properly
utilized, are tremendously powerful in aiding physicians, pharmacists
and other caregivers to provide the best possible care. Individual
physicians, nurses, home health agencies and other health providers may
utilize electronic records or prescribing systems within their own
practices, but it is often a challenge to integrate these systems so
that information gleaned by one provider can be available to others who
serve the same beneficiary. Part of the CCIP concept is that awardee
organizations will work with the beneficiary and through their own
innovative IT systems to ensure effective communication between the
beneficiary's providers. That sort of overarching view of things is
expected to greatly assist these providers in their effort to overcome
the fragmented state of care often encountered today. Additionally, we
expect that when these individuals see the benefits of this technology
they may be more apt to integrate it more fully into their broader
practice.
To put it in human terms, patients served by one of these
organizations have said the following:
``[The program] is the best thing that ever happened to
me. Thank God for you. Keep up the good work.'' E.A. 60 yrs. Lake City
``Please keep this program. It helps in many ways. Keeps
you on top of your health, and helps you understand what's happening
when things do go wrong. Good Program.'' P.D. 51 yrs. Titusville
``I am very pleased to have someone help me to take
better care of myself and my self esteem is stronger knowing others
care about me. This program should extend to everyone.'' M.M. 58 yrs
Palm Coast
``The help I have received through your staff and
educational material has helped keep me out of the hospital. Thanks a
million. I also appreciate your personal phone calls. They are a great
help.'' D.B. 57 yrs. Pounce de Leon
``[The program] nurses have been a great help to me. I
feel that with their help I have been able to control my CHF and the
notes to the doctor have really helped getting the doctor to pay more
attention to my problems and get to me faster when needed.'' C.W. 51
yrs. Ocala
``My nurse is fantastic. She is very informative and
cares about your condition and helps you to get better or take care of
yourself as best that you can. She is the best. Thank you for assigning
her to me. I feel blessed to know her.'' L.G. 35 yrs. Jacksonville
These outcomes represent the kinds of results we hope to accomplish
through the CCIP.
HOW THE PROGRAM WILL WORK
On April 23, 2004, CMS published in the Federal Register a notice
informing chronic care improvement organizations of the possibility of
working with CMS in providing services to Medicare beneficiaries under
the new program established by Section 721 of the MMA.
In Phase I, the Secretary will enter into agreements with qualified
organizations to run large-scale regional CCIPs for 3 years, for
prospectively identified beneficiaries with CHF, complex diabetes, and
chronic obstructive pulmonary disease (COPD). There is some evidence
that self-care support, education, and other tools targeted at
beneficiaries with these conditions are particularly effective at
improving clinical outcomes, reducing overall cost, and improving
beneficiary and provider satisfaction. The CCIPs are to be implemented
in approximately ten regions where at least 10 percent of the Medicare
population resides. We expect the CCIPs will collectively serve between
150,000 and 300,000 chronically ill fee-for-service Medicare
beneficiaries. These programs will be evaluated through randomized,
controlled trials, with at least 10,000 beneficiaries in the control
group for each program. The evaluations will be conducted by an
independent entity.
Each program will offer self-care guidance and support to
chronically ill beneficiaries to help them manage their health, adhere
to their physicians' plans of care, and ensure that they seek (or
obtain) medical care that they need to reduce their health risks. The
programs will include collaboration with participants' providers to
enhance communication of relevant clinical information. The programs
are intended to help increase adherence to evidence-based care, reduce
unnecessary hospital stays and emergency room visits, and help
participants avoid costly and debilitating complications. CCIPs will be
required to assist participants in managing their health holistically,
including all co-morbidities, relevant health care services, and
pharmaceutical needs. CMS will test models that use a wide variety of
interventions to bring about improvements in clinical quality,
satisfaction and reduced costs.
As intended by Congress, CMS will seek to partner with awardees
whose CCIPs are designed to support and improve the patient-physician
relationship, not interfere with it. CMS is particularly interested in
programs that have a track record of success in, or a comprehensive
plan for, engaging beneficiaries' physicians and other providers. Given
the considerable time constraints that today's physicians face, we
anticipate that physicians will appreciate the timely, actionable
information that these services could provide. We also anticipate that
physicians will appreciate better-educated patients and better
information about what is happening with patients outside their
offices. There is nothing about these programs that will supplant a
physician's autonomy.
Completed proposals from potential awardees are due by August 6,
2004 and we expect to sign the first service agreements by December 8,
2004. We anticipate that program operations will begin and services
will be provided by early 2005.
ELIGIBLE ORGANIZATIONS AND BIDDING
Organizations eligible to apply to implement and operate programs
under CCIP include: (1) disease management organizations; (2) health
insurers; (3) integrated delivery systems; (4) physician group
practices; (5) a consortium of such entities; or (6) any other legal
entity that meets the requirements of the solicitation in the Federal
Register, published April 23, 2004.
The bidding process is designed to allow different approaches to be
reviewed in a comparable manner. Applicant organizations will propose
the geographic region(s) they wish to serve. CMS will provide
applicants with a de-identified nationally representative sample
dataset of the type of beneficiaries who would be included in this
pilot, on which applicants will base their bids. Finalists will be
provided with geographic specific data to enable bids to be adjusted,
if necessary, for regional variations.
The beneficiary participation process will be conducted in a way
that balances giving beneficiaries the greatest opportunity to
participate if they want to, while protecting them if they do not. It
is important to note that participation is completely voluntary.
Beneficiaries who participate may terminate participation at any time.
This program is not a form of managed care, in the sense that it has no
gate-keeping function, operating to limit services, or do a pre-service
review of appropriateness of care. Beneficiaries will remain enrolled
in the traditional fee-for-service program and have access to the full
range of Medicare benefits as they currently stand. Additionally,
beneficiaries who participate in the program will have access to any
participating Medicare provider. The beneficiary participation
verification process works as follows:
1. CMS identifies eligible beneficiaries. All beneficiaries in a
chosen geographic area will be screened for eligibility based on
historical claims data. Those beneficiaries who are deemed eligible
will be randomly assigned to one of two groups--the intervention group
or the control group.
2. CMS contacts enrollees by letter. All beneficiaries in the
intervention group will be notified of the opportunity to participate
through a letter from the Medicare program including the information
specified in the legislation. The letter will provide a description of
the program and give the beneficiary an opportunity to decline to be
contacted by the CCIP organization. The letter will detail how the
beneficiary can obtain further information about the program.
3. If the beneficiary says `No,' awardee would not contact
beneficiaries who opt not to be contacted regarding the opportunity.
4. If the beneficiary is silent--awardee attempts to contact
beneficiaries to confirm participation. CMS will then expect each
awardee to contact all intervention group beneficiaries in its area who
were silent to describe the program and ask if the beneficiary would
like to participate. CMS will provide a specific protocol that each
awardee must use during the initial contact. With regard to non-
responders, we will expect applicants' proposals to specify detailed
descriptions about their outreach protocols, including, for example,
frequency and number of outreach attempts, and how the applicant will
ensure that outreach efforts are respectful of beneficiaries. CMS may
negotiate limits on the number and/or frequency of outreach attempts
during the outreach period, and may specify that awardees will be
required to cease further outreach efforts after the outreach period.
5. If the beneficiary is contacted and says `Yes' or `No,' the
awardee will record the beneficiaries' responses. Beneficiaries who
agree to participate will be considered participants until they either
become ineligible (for example, joining a Medicare Advantage plan) or
notify the awardee or CMS that they no longer want to be contacted by
the awardee.
Again, participation is always voluntary. Participants can notify
the awardee or CMS at any time that they no longer want to be contacted
by the awardee.
Awardee organizations will be responsible for serving an entire
population assigned to them by CMS. They will be held accountable for
improving clinical, satisfaction, and financial outcomes over the
entire assigned population. Because of this fact, the program is
considered to be ``population based.'' Awardees are held responsible
for beneficiaries who choose to participate in the program, as well as
those who choose to not participate. A valid comparison between
beneficiaries offered the opportunity to participate in the
intervention group and beneficiaries in the control group requires that
awardees performance measures include data from intervention group
beneficiaries who choose not to participate, since we would have no way
of knowing the rate at which beneficiaries in the control group might
similarly participate or not.
The CCIP will be set up so that its activities, including
contacting physicians with beneficiary health information, are health
care operations of Medicare fee-for-service, and therefore, entail
permissible disclosures under the Health Insurance Portability and
Accountability Act (HIPAA). Health care operations, allowed under the
HIPAA privacy rule, include population-based activities relating to
improving health or reducing health care costs, case management and
care coordination, contacting of health care providers and patients
with information about treatment alternatives, and other related
functions. Furthermore, CCIP organizations would be considered business
associates of CMS, and therefore it would be permissible to transmit
health information to them.
PAYMENT
The CCIP contracting model is flexible enough to accommodate a wide
range of program models, but payment methods in all instances will be
performance-based. Fees paid to awardees will be at risk for
performance improvements in clinical quality, beneficiary and provider
satisfaction, and reduced costs across their assigned target
populations compared to their regional control groups. The statute
purposely links payment and quality. The underlying premise of the CCIP
initiative is that through performance-based contracting, improvements
in quality will lead to better financial, health, and satisfaction
outcomes
As a condition of continued participation in the CCIP,
organizations will be required to demonstrate improvements in quality
of care for beneficiaries in the intervention group. Prior to award,
the specific measures for improved quality and satisfaction will be
negotiated with the organizations based upon the quality parameters
listed in the solicitation as a minimum. CMS reserves the right to
reduce or withhold payments should the mutually agreed upon quality
targets not be achieved. The specific guidelines for such action will
be negotiated with each organization prior to award.
The goal of the CCIP is to reduce Medicare costs in traditional
fee-for-service, while simultaneously improving beneficiary outcomes.
CMS is requiring a guaranteed minimum of 5 percent savings to the
Medicare program, including all CCIP fees for the assigned population
compared to the control group's experience. The exact amount of savings
is contingent upon a number of unknown variables such as the total
number of sites and beneficiaries who will be served across the program
and whether CMS will receive and accept proposals with more aggressive
savings guarantees.
As part of the application process, all organizations will be
required to show proof of their financial solvency and ability to
assume financial risk up to 100 percent of their monthly fees, up to
the 5 percent net savings guarantee. The agreements between CMS and the
awardees will specify the exact mechanism for guaranteeing performance
and security. Their ability to achieve proposed Medicare savings
targets will be evaluated on an individual basis based upon their
proposed program designs, the results of site visits, and evidence of
prior achievements. CMS plans to hold a bidders conference on May 13
for organizations interested in providing CCIP services under this new
program. The conference will provide participants an opportunity to
gain knowledge of issues associated with applying to implement and
operate a chronic care improvement program as part of Phase I of CCIP.
CMS has already enrolled as many potential bidders as it can to attend
the conference.
EXPANSION OF THE PROGRAM
Phase II, the potential expansion phase of CCIP, depends on the
success of Phase I. The statute provides for the Secretary to expand
successful CCIPs or program components, possibly nationally. The
Secretary may begin Phase II expansion not earlier than 2 years, and no
later than 3= years, after implementing Phase I. Quality and
satisfaction measures will continue to be a key part of contracts with
CCIP awardees through Phase II.
CONCLUSION
We at CMS fully expect this program to improve beneficiary health
outcomes, increase their satisfaction with the services they receive
through Medicare, better the partnership between caregivers and
patients, and save the Medicare program money. It is an innovative
model for care delivery, focusing on preventing problems, rather than
allowing them to develop in the first place. We appreciate the
Congress' support in providing the means for this program to take place
and look forward to sharing the results with you as it progresses.
Thank you for your time and I would be glad to answer any questions.
Chairman JOHNSON. Thank you, Dr. McClellan, for your
testimony and your written testimony, which was very useful.
Could you enlarge somewhat on the demonstration under section
649 where you have the chance to encourage physicians to
promote continuity of care?
Dr. MCCLELLAN. That is another program that we are
undertaking to achieve the same goals, improving quality at a
lower cost. That is a demonstration program, because some of
the techniques that we are going to implement there, such as
more direct payments for performance to physicians and the
like, have not been as well evaluated yet as some of the
disease management and care management that will be part of the
CCIP.
So, that is a demo program that can help us with
complementary approaches to get at the same goal, getting
better outcomes to beneficiaries at a lower cost by supporting
and encouraging providers to prevent complications in the first
place. I think it can complement here what we are doing here
well. That demonstration is still under development internally,
and we will have more to say about that in the coming months.
Chairman JOHNSON. Thank you. I hope it will allow smaller
physician practices to participate, because I do think the
issue, at least in developing this part of the law, was very
unclear to us. I think it is still unclear how much of this
function of management can be integrated into standards of
practice for individual specialties, and we need a better
handle on that as we move forward so that we only employ a
coordinator where a coordinator is necessary, perhaps across
specialties or whatever.
A lot of what we are talking about should be part of the
next round of physicians' standards of practice. Therefore,
this whole issue of chronic disease management is going to be
present as we deal with one of our other responsibilities that
we have from the passage of the MMA, which is to rethink of how
we pay physicians or we will be able to pass real reform under
the physician payment section of the Medicare law.
So, as we think about how we are going to change how we pay
physicians, we need to think about the fundamental flaw in the
Medicare Program, which is that it is acute episode focused and
not focused on what really has become the challenge in
medicine, which is to prevent the development of acute
episodes.
So, in that framework, there were a number of interesting
comments by Dr. Berenson in his testimony. One of the briefer
ones that he mentioned was they need to look at not just
randomized controls, but matching, to allow smaller entities to
compete in the trials. Do you have a comment on that?
Dr. MCCLELLAN. We are using randomized approaches in this
pilot program that was actually mandated by Congress, as you
know, in the MMA. In many of our demonstration programs,
however, we rely on other techniques to identify what the
effects of a particular program might be. In some settings
where it is not feasible to do randomizations, which might be
the case involving small physician groups, matching may be a
good alternative. I do want to try to take further steps to be
able to implement steps, implement methodological approaches
even in smaller settings. I would emphasize these CCIP programs
are not going to succeed if they don't work well with physician
offices.
Most Medicare beneficiaries get their care primarily
through small physician groups; and because you have to improve
the outcomes for a population in order to get the performance
reward in the CCIP program, therefore, the groups are going to
have to work well with these small physician offices, even in
the CCIP. I think we can learn something from this effort and
from the randomization techniques used here, about what works
well in small physician groups, that can carryover to the
broader goals you mentioned about improving our payment systems
to physicians.
Chairman JOHNSON. In your RFP, are you very specific about
how that project should relate to physicians?
Dr. MCCLELLAN. We are very specific in emphasizing that we
expect these programs to work well with physicians and other
health professionals. In my own experience in dealing with a
variety of disease management programs, the ones that I found
to be most helpful were the ones that supported my work, the
ones that reminded my patients that they needed to come in for
a follow-up exam or to get another laboratory test done, or the
ones that helped my patients identify when they were having
complications early before they got to a very serious stage,
such as a little bit of weight gain in patients with heart
failure, so they could come into the office if necessary and
get that complication headed off. Those kinds of steps are
built into this program, and we are backing it up by including
provider satisfaction measures as part of the formal
evaluation. The payments to these organizations that
participate in CCIP will depend on how well they do with
doctors and other health professionals.
Chairman JOHNSON. Thank you. So, you will be evaluating
that particular piece of the connection and the motivation for
physician involvement as you determine which of all the really
many proposals you will select. I am pleased, what a tremendous
response you are having for the informational seminar that is
coming up this week.
Dr. MCCLELLAN. It is tomorrow. We are oversubscribed. The
auditorium at our headquarters in Baltimore is going to be
full. We have more than 550 participants, and they span the
spectrum. It not only includes disease management business, but
also includes a number of physician group organizations, a
number of academic medical center organizations.
We have a very broad range of participants, and in many
cases, I expect these different groups will be working together
in order to serve the whole beneficiary population, which
includes a lot of patients that are treated by small physician
groups, includes a lot of patients with disabilities, cognitive
impairments and the like. Again, you can't do well on the
performance measures unless you do well for all of these
groups.
Chairman JOHNSON. Are you having sufficient interest from
those States that have geriatric centers to participate in that
demo, where we want to look at how a geriatric center would
pair with physicians, for example, in rural areas so we can
look at physician performance, small office performance in this
context?
Dr. MCCLELLAN. We are going to include rural areas and
geriatric programs that work with our rural providers and rural
beneficiaries in this effort. As you know, there are other
demonstrations and other initiatives in the MMA that are also
targeted at geriatric research programs and geriatric programs
in rural areas as well, so that will be part of this overall
effort to learn more about how we can help doctors and other
health professionals improve the quality of care for their
patients.
Chairman JOHNSON. Thank you, Dr. McClellan. I reserve the
rest of my questions. Mr. Stark.
Mr. STARK. Dr. McClellan, first of all, welcome to the
Committee. I am puzzled just by a couple of things; and as a
physician, you can help me here. I don't--and this is how a
patient might react and a physician might react, but it seems
to me, as I have read through this, that there is nothing--if I
am under care or going to an internist and I think of the
internist as my doctor, okay, and I develop diabetes or high
blood pressure and a bunch of different things, I will be
contacted in one way or another by CMS. Will I get a letter or
phone call?
Dr. MCCLELLAN. You would initially get a letter from CMS
that will inform you that you have the option to participate in
this program.
Mr. STARK. Will it reference my doctor at all?
Dr. MCCLELLAN. The initial contact won't. It will be based
on beneficiaries.
Mr. STARK. I would probably run to my doctor, right? I
might say, what is this? First of all, I would be a little
curious as to how you knew I had all of these problems, but--
and that is a question of privacy that I want to get to in a
minute. It is my understanding that this--the provider, the
company or the corporation that is going to do this management,
is going to try and entice my physician into cooperating, but
not necessarily pay him or her anything for doing anything; is
that right?
Dr. MCCLELLAN. The plans or the organizations that support
these programs are going to have a hard time succeeding if they
don't have buy-in from that internist that you mentioned.
Mr. STARK. How are they going to buy in? Are they going to
pay the doctor something?
Dr. MCCLELLAN. They don't necessarily have to pay directly,
but they do need to make clear to the physician why this is in
their best interest to participate, and it is to make sure----
Mr. STARK. As a practicing physician, would it be a fair
statement to say that physicians as a general rule--I won't put
this in order--but somewhere between ``resent'' and ``rail
against Congress'' for interfering with their practice, CMS
interfering with their practice, Blue Cross interfering with
their practice, nurse practitioners telling them how to
practice, or pharmacy detail people telling them how to do
their practice. They tend to be relatively independent folk.
How is my doctor going to react when some corporate guy calls
them up and says, why don't you check up on Stark and make sure
he is losing weight and not smoking and doing all those things?
I have a disconnect there that I think could be problematical
from the physician standpoint.
Dr. MCCLELLAN. Speaking as one of them, what I found most
frustrating is when I was contacted by many of the types of
individuals you described who were telling me to do something
that I thought was not in the best interest of my patient. At
other times, I have been contacted by disease management
organizations, patient advocates and others who had some very
helpful things to say, some things that I found useful in
improving the care that my patients got and doing it in a way
that helped me.
Mr. STARK. I would understand how this would work if Kaiser
decides to do it, and Kaiser Permanente tells all the doctors
in their group, we are going to do this and we are going to
cooperate, because they are all on salary. I have one other
question, and that is a little bit off the topic, but we had
some problems last year on estimates from the actuaries. Both
you and Secretary Thompson have promised us publicly and in
private to reinstate our access to the Office of the Actuary.
Does that still stand?
Dr. MCCLELLAN. We have both promised transparency in
working with the actuary and access to estimates that you need.
Mr. STARK. We have a couple of analyses at this point that
we understand are completed. These are previous requests, not
new work for them, that we understand are complete and are not
being released. Would you get them to release those studies?
Dr. MCCLELLAN. If you will send me the details, we
definitely want to pass along final results.
Mr. STARK. I hate to beat a dead horse. I didn't mean
Secretary Scully as a dead horse. Thank you, Madam Chairman.
Chairman JOHNSON. I would like to recognize Mr. Crane, a
diligent Member of our Subcommittee, always present at our
hearings. Thank you very much.
Mr. CRANE. Thank you, Madam Chairman. Dr. McClellan, the
goal of this new program is to reduce Medicare costs while also
improving beneficiary outcomes. Do you believe that Phase I of
the new CCIP, will meet both of these goals? If so, how much do
you estimate Phase I will provide in savings to the Medicare
Program?
Dr. MCCLELLAN. I do think it will meet both of the goals,
that performance contracts that we are setting up envision a 5-
percent reduction in costs. Some of these programs that I
mentioned in my oral testimony have achieved far larger savings
than that.
To stay on the conservative side, our actuaries have
estimated a 1-percent cost savings for all of the beneficiaries
that will be involved in this program, but that is an important
savings if we are achieving better health results at the same
time. So, we are going to wait and see. The reason we are doing
this as a pilot is to see which methods work best, and we can
get the maximum savings and the maximum improvements in
outcomes.
Mr. CRANE. We all know that preventive health care services
save the Medicare Program money, but it is often hard to track
the savings of providing these services. I imagine it will be
difficult to quantify the savings from the new disease
management initiative. How will the CCIPs be evaluated and
measured to ensure that they are improving clinical outcomes
and actually reducing costs?
Dr. MCCLELLAN. It is hard to get a handle on the actual
impact of things that we do on outcomes, but that is why I
appreciate the foresight of Congress in this case, asking us to
do a randomized, careful study where we have two populations of
patients, one population that gets access to this new pilot
program and the other population which is from the same area
and has exactly the same kind of characteristics.
We are going to compare the outcomes for those populations,
not just look at the people that a disease management program
manages to sign up, a chronic care improvement program manages
to sign up, but the whole population. We will compare those
outcomes with the control group, and based on what I have seen
of successful chronic care improvement programs, we should be
able to see some improvements in outcomes in a pretty short
timeframe.
Some of the programs that have been implemented already to
reduce complications from diabetes or heart failure pay for
themselves more than one time over within a matter of months in
terms of avoided hospitalizations with complications of the
disease. So, we will be watching that very carefully and will
be reporting to you along the way about how the programs are
doing.
Mr. CRANE. Critics have asserted that the CCIP initiative
is removed from the physician and that the program does not
promote a relationship between the patient and his or her
doctor. Can you respond?
Dr. MCCLELLAN. I think we are going to make sure that these
programs do have elements that encourage an effective
relationship between patients and providers. Those
relationships are strained today as many Medicare beneficiaries
are seeing more doctors than ever before. A Medicare
beneficiary, on average, sees seven physicians in a year, and
there is a lot of evidence out there that Medicare
beneficiaries are not getting the best possible evidence-based
care for their chronic illnesses.
So, there is a lot of room for improvement, and I think
some of the main ways that improvements can occur are ways that
physicians may well appreciate, like having services that
remind patients when they need to follow up with their
physicians and helping patients understand their disease so
they will understand why it is so important to comply with the
treatment plan that their physician has provided for them, as
well as taking steps to help beneficiaries spot complications
from their diseases early, as I mentioned before, when their
weight is up a little bit, when their blood sugar levels are
off a little bit, rather than down the road when they get into
costly complications requiring hospitalizations.
All of these steps may actually increase the amount of
contact through appropriate office visits with physicians. The
difference is, the physicians will be seeing the patients to
prevent the complications rather than seeing the patients after
the complications have occurred. So, in short, we will be
getting much more for our money, and physicians will be able to
get much more out of the time that they spend with patients.
This is going to be a challenge, and we will be watching
closely how well we do and why we will be evaluating these
programs in part based on the satisfaction that providers have
with the services being provided.
Mr. CRANE. Thank you, Dr. McClellan. We look forward to
working with you.
Chairman JOHNSON. Dr. McClellan, to follow up on that
point, since it has been so frequently raised, why not just
develop a code that shows what you need to coordinate and just
change Medicare to pay doctors?
Dr. MCCLELLAN. Well, first, we are paying doctors more.
That was another set of provisions in the MMA; it is very
important for access to high-quality physician care in this
country. I think there are some further steps we can take to
figure out whether there are better ways to pay doctors.
As you mentioned in your earlier questions, we have other
demonstrations going on and a lot of interest in CMS right now
in developing appropriate pay for performance methods where you
do get paid more for delivering higher-quality results, for
providing better care and not just for having more visits and,
in effect, more complications leading to higher payments. So,
we will keep looking at the best ways to do this.
The advantage of these CCIPs is that, I think, they are
appropriately at a stage where they can be piloted on a large
scale and then used on a large scale. There are proven
approaches in these chronic care improvement ideas that can
potentially have a large-scale, positive impact for
beneficiaries.
I think we will learn more along the way in this program
and in other demonstration programs about other ways which we
might want to improve the payment system, but I don't think it
is a question of paying more under the current system. I think
it is a question of how we can develop the best evidence to
guide modifications through our payment system to get better
outcomes at a lower cost. Chronic care improvement is one
valuable way to do that; and I think there are probably others,
and we will keep pursuing them.
Chairman JOHNSON. It is my hope that out of the combination
of pilots and demos that are in process, and others that you
have the authority to develop, that we will be able over time
to sort out this issue of how much can be integrated into
individual physician practice standards and payments, and at
what point there is a benefit and a real value added to having
a coordinator across specialties or across community-based
support programs versus traditional medical support programs.
So, I think we need to keep our eye on that ball, how much this
can be ultimately implemented through physician payment
structures involving coordination of care and how much needs to
go beyond that, what kinds of patients need more assistance in
that. That leads me to my last question.
Almost all of the chronic programs involve a greater level
of patient involvement, patient knowledge, patient education,
patient management, and for a patient with dementia, this is
hard. We were conscious of that in writing the bill. We do
mention the issue of dementia and have some demonstrations that
are working specifically on this issue of how do you manage
disease management with a patient that has dementia. So, that
is an issue raised by Dr. Berenson as well as one that we
worked a lot on. Would you talk a little about that in the
context of these pilots?
Dr. MCCLELLAN. First of all, at a broad level, we need to
be preparing for dealing with dementia issues on even a larger
scale. As we are getting better treatments for many other
diseases, more and more of our beneficiaries are living longer.
Until we get truly effective treatments for dementia, this is
going to be an important and probably growing part of our
patient population, and dealing with it effectively is an
essential part of providing high-quality care to all of our
beneficiaries and doing so at the lowest possible cost.
You mentioned a number of demo programs; also, Medicare
Advantage programs are going to be specifically targeted to
these types of populations, building on successes that we have
already seen in particular instances. That is an important part
of our response.
I would highlight that in the CCIP itself, the program
participants are going to be required to cover and improve
outcomes and reduce costs for a whole beneficiary population.
They don't get to cherry-pick the healthy beneficiaries. They
don't get to target their interventions only at beneficiaries
without dementia, without other kinds of cognitive impairments
or other types of impairments that might make them harder to
work with in terms of the standard management of care
approaches.
So, they will be evaluated on performance for improving
outcomes for these segments of our population, and if they
don't improve it, then they are not going to get the financial
rewards, they are not going to be selected to expand coverage
more broadly. We are absolutely committed to make sure these
chronic care improvement services work for all, for our
increasingly diverse population of beneficiaries, and that
means effective techniques to work with people with Medicare
who have cognitive impairments as well.
Chairman JOHNSON. Thank you very much, Dr. McClellan.
Mr. STARK. Dr. McClellan, could I deal with some concerns
on privacy? Let's assume that I start out with one of these
organizations, and then I decide I want to quit. What happens
to my medical information that that chronic care group would
have? Is it protected?
Dr. MCCLELLAN. It is protected. The CCIP information is
part of Medicare operations, and it is protected as part of our
Medicare-specific activities. It doesn't continue to be
available.
Mr. STARK. Once XYZ corporation has my medical records and
I decide not to continue participating, what happens to those?
How am I guaranteed that they won't sell them?
Dr. MCCLELLAN. The same Health Insurance Portability and
Accountability Act 1996 (HIPAA) (P.L. 104-191) protections
apply to these records as applied to other confidential medical
information.
Mr. STARK. Why aren't they a covered entity instead of a
business associate? Covered entity, they could be subject to
fines if they misbehaved.
Dr. MCCLELLAN. They are covered in the sense that they are
part of our business operations.
Mr. STARK. Stop a minute. You could either be a business
associate under HIPAA or you could be a covered entity, a
provider. A covered entity has stricter disclosure regulations
and more severe penalties for violating those. Why wouldn't
these groups be a covered entity?
Dr. MCCLELLAN. If they use confidential medical information
improperly and share it outside of the Medicare operations,
they are subject to HIPAA sanctions and penalties just like
anyone else who uses our Medicare information inappropriately.
Mr. STARK. My staff tells me that there are two
classifications. If they are classified as business associates,
the violations are not as tight and the penalties are less
severe than if they are, in fact, a provider or covered entity.
By putting these activities under, quote, ``health care
operations,'' it is my understanding that beneficiaries don't
need to give permission for their information to be shared nor
can they track the sharing of information. So, there are some
highly technical things in there that I hope you can look at.
Dr. MCCLELLAN. I want to get that right and do want to
emphasize that as business partners, they are subject to the
HIPAA rules for business partners. If a beneficiary at their
option decides not to participate in this program, they won't
collect any more information, in the first place; and even for
those beneficiaries that do participate and stay in the
program, they are subject to the same HIPAA rules that apply to
our health care providers and others involved in our business
operations. I do want to work with you to make sure we address
this effectively, so that confidentiality and security is a
very important part.
Mr. STARK. So much for my questions; now my free advice.
The Chair has discussed the idea of how we would reimburse
physicians, and the only thing I can think of--and maybe you
know of others--is with end-stage renal disease, that the
dialysis and the drugs are paid for on a schedule.
There is a capitated fee to the physician to supervise this
end-stage renal patient. I don't know how it is designed or how
the payment was arrived at, but ought we not to look for
something in this chronic care that parallels that? It doesn't
cover the tests that they made and everything, but it is kind
of a global fee--I am not sure ``capitation'' is the right
word--that the principal or primary physician would receive for
checking up on the patient and doing the extra work. Would that
make sense?
Dr. MCCLELLAN. I think any proven steps that move toward
paying for what we really want, which is better outcome for
patients and then giving the doctors the flexibility they need
in this era of very modern and complex medicine, to provide
that care as effectively as possible, that is a step in the
right direction. I think the question for us is, how do we
develop better evidence on whether those models can work?
The capitated payments to dialysis organizations are a bit
different than trying capitated payments for doctors and small
groups who treat a very diverse range of Medicare patients. The
small-group doctors may not be in as good a position as the
dialysis organization is to provide those supportive services
themselves. They may be better served by working with
organizations like the CCIP organizations. I don't know, but we
are going to find out more about that.
They may not want to bear the financial risks that come
with those capitated payments. They are not in as good a
position to have a predictable idea of what their costs are
actually going to be for providing high-quality care as the
dialysis organizations are. There are some challenges there. I
agree with the goal that we need to be pursuing all the steps
we can to learn about what really works in paying for
performance and giving health professionals the support they
need.
Mr. STARK. How many years is it going to take--2, 3, 5
years?
Dr. MCCLELLAN. The CCIP program is going to be a 3-year
pilot, but we will be evaluating it before then.
Mr. STARK. My worry is that they are not going to
participate if they don't get paid.
Dr. MCCLELLAN. There is a surprisingly large amount of
interest from many medical group associations, medical doctors,
and others that come in to talk to me about wanting to focus
more on the bottom line of improved patient outcomes. So, I
think there is more interest there than before.
This is by no means the only approach that we are taking. I
think you are seeing, across the board, more interest than ever
in CMS, more efforts than ever to develop better quality
measures, to try out demonstration programs for what can work,
and giving doctors the incentives and support they need to
provide better care. So, this program will be an important part
of finding the answers. This is an urgent question and I would
like to work with you.
Mr. STARK. I think we should let the doctors do it. You
guys should come to us and say, we don't know all the words. We
can't talk Latin. I think just as we did in the Resource-Based
Relative Value Scale, let the doctors come and say--look to do
this type of protocol. It might be one, two, three, four
chronic diseases. If you have five rates higher, we will have
to check this and respond to the CCIP person, and we will have
to order tests and check up on the patient, and we think in the
course of the year, it will take this much involvement, and set
a fee for them.
Let them come up with it, and you guys can bargain. If the
doctors don't design it, they are going to resent us telling
them what they ought to charge for a new kind of way to
practice. I would encourage us to ask the physicians to come
and see what they think would be a fair relative to other
procedures that they provide.
Dr. MCCLELLAN. I agree with you about getting physician
input. I think we can learn a lot from health professionals
about the best ways to meet our policy goals, and we have a lot
in already and have heard a lot of good ideas about how to do a
whole range of new initiatives successfully, ranging from e-
prescribing to management programs to the section 649 and
section 646 demos. You name it. There is a lot of physician
interest out there, a lot of health professional interest that
we can build on, and I intend to keep working with you all to
do that.
Mr. STARK. Thank you.
Chairman JOHNSON. Thank you very much, Dr. McClellan. I
think this issue of what portion of disease management can be
supplemental to a physician action and what portion of disease
management needs to cut across a larger swath of medical
activity than any one individual physician would be prepared to
manage is something we will learn from the demos and the pilots
that we have out there. It is a very important issue.
We are going to learn something more about how we reimburse
for coordinated care as we work through the challenge of
reimbursing oncologists and chemotherapists for cancer care. We
have tried to, but not successfully, so, we have some example
of trying to reimburse for better coordination of care for a
bundle of services. In some places we have succeeded, and other
places, we have failed.
I appreciate it and I am delighted to have you as CMS
Administrator and the experience that you bring to the table.
It is extremely important to us achieving the kinds of goals
that Pete and I and other Members of the Committee have.
In closing, I just want to recognize David Kreiss, who has
done so much work on this section of the law and, furthermore,
who has worked so constructively and progressively and openly
with the disease management experts, with disease management
companies, with physicians themselves, and with a whole array
of people over several years to get the base for these pilots
broadly established. I thank him for his constancy and his
work.
I thank you for your intense interest in it and this
tremendous step forward as you put out these RFPs. We will
follow carefully the progress of the project and we will all
learn a lot from it. We hope you will work closely with us as
we look at the issue of physician payment and see if there
aren't steps forward we can make, away from the old acute care,
incident-oriented, test-oriented payment structure of current
Medicare toward a more holistic approach.
I think physicians are much more interested now than they
were a few years ago. I see that out there. That is what they
ask you about. That is what they want to know. They are
beginning to say, why are you so out of touch with what it is
we are now trying to do? Thank you for your testimony and thank
you for the good work of you and your staff.
Dr. MCCLELLAN. Chairman Johnson, it is really a pleasure
working with you. I want to thank you especially for
recognizing David Kreiss and the rest of the CMS staff. They
have done a terrific job in putting together a very innovative
approach.
The biggest pleasure of this job for me in the month I have
been there has been the enthusiasm and the talent and, really,
the experience and expertise of the staff in taking these new
opportunities we have to do a much better job of delivering
high-quality, personalized care to all of our beneficiaries. It
is going to be a real pleasure working with you.
Chairman JOHNSON. We will invite the second panel up:
Christobel Selecky, President-Elect and Chair of the Disease
Management Association of America; Dr. Janet Wright, the
Medical Director of Cardiology for the Enloe Medical Center of
Chico, California; Vince Bufalino, Dr. Bufalino, a member of
the Expert Panel on Disease Management of the AHA from
Naperville, Illinois. As I say, we will respect Dr. Berenson in
his absence, but continue to work with him when next we have a
chance to meet with him. Dr. Selecky.
STATEMENT OF CHRISTOBEL SELECKY, PRESIDENT-ELECT AND CHAIR,
GOVERNMENT AFFAIRS COMMITTEE, DISEASE MANAGEMENT ASSOCIATION OF
AMERICA
Ms. SELECKY. Thank you, Chairman Johnson, and thank you for
the promotion. I am not a doctor and I don't play one on
television. I would like to thank you very much for inviting me
to appear here. As you know, my name is Christobel Selecky. I
am the President-Elect of the Disease Management Association of
America, which is a nonprofit, interdisciplinary association
dedicated to the advancement of health improvement for people
with chronic disease. I also am the Chief Executive Officer
(CEO) of LifeMasters Supported SelfCare, which is a 10-year-
old, privately held disease management organization that
provides coaching, education, and support to more than 300,000
people with chronic disease nationwide.
The fact that our health care system does not adequately
care for people with chronic disease has been well documented.
When chronically ill patients do not receive the right
treatment for their conditions, they get sicker and end up in
the hospital; and this not only results in poor quality of life
for the beneficiaries, but it costs our taxpayers and our
health care system a great deal of money.
This gap in care occurs because patients are inadequately
trained to manage their illnesses and rushed practitioners do
not always have the time, information, and systems to follow
evidence-based guidelines and to follow up with their patients
and other health care providers. The care gap is particularly
acute among our Nation's seniors in traditional Medicare. Prior
to last year's MMA, recommended solutions to this problem were
piecemeal, incremental, and measuring their impact on cost
containment and quality improvement was difficult, if not
impossible.
Fortunately, the MMA has created a framework for
transforming chronic care in America. Most notably, section 721
will make large-scale, population-based disease management
available to beneficiaries in traditional Medicare. In the
first phase, financial savings, quality improvement and
satisfaction are guaranteed. This approach represents real
innovation and an opportunity for Congress and CMS to support
delivery system change and outreach to chronically ill
beneficiaries.
Disease management programs work. My company, LifeMasters,
provides services to a population of mostly aged, blind, and
disabled fee-for-service Medicaid beneficiaries in the State of
Florida. Over a 2-year period, we were able to reduce total
health care costs by $12.6 million on a population of just
3,500 beneficiaries with congestive heart failure and co-
morbidities of Chronic Obstructive Pulmonary Disease, coronary
artery disease, diabetes, and mental illness. This represented
a 5.6-percent net cost savings to the State of Florida.
This group also experienced a 38-percent reduction in
hospital days, significant improvements in evidence-based care,
and made significant lifestyle changes as well. I do want to
say, too, physicians were actively involved in this program. In
a survey we recently conducted, 89 percent of them said they
would very highly recommend this program to their colleagues.
These outcomes are typical of disease management programs.
Extrapolating these savings to the Medicare CCIP, this could
save billions of dollars to our health care system while
improving the quality of life for millions of beneficiaries.
There are many models possible under MMA, and CMS has
encouraged consortia to apply for pilot projects. I would like
to describe how a couple of these different kinds of consortia
might work.
A multispecialty medical group with sophisticated
information technology and established disease management
programs could contract directly with CMS. They might
subcontract with a call center to do the outreach and
enrollment function, but they would perform all of the chronic
care improvement functions on their own.
A health plan might contract with CMS and either provide
the disease management services themselves or subcontract with
a disease management organization. The health plan could
provide high-risk case management and home health services, and
they could also work with its physician network to develop
physician incentive programs to reward active engagement in the
program.
A disease management organization could contract directly
with CMS for a program. It would provide all of the standard
disease management services and could subcontract with the home
health agency, a biometric monitoring company and a high-risk
case management company if necessary. At the local level, the
disease management organization could also identify and develop
relationships with community organizations devoted to providing
services to seniors.
Finally, a pharmacy benefit management company that is
planning on being a prescription drug provider under the new
drug benefit could partner with an entity that has an
established disease management program. The pharmaceutical
benefits manager could use per-member per-month payments from
CMS to both cover the disease management costs and possibly
even to fund a modified drug benefit that would start before
the 2006 start date and also provide an integrated medication
therapy management program.
I would like to close with a few recommendations that I
hope might help improve the effectiveness of this valuable
program. Congress should support CMS with sufficient resources
to build the infrastructure necessary to administer and monitor
this program. Second, in order to ensure consistency and a
standard level of quality, the Administration should consider
accreditation by one of the major accrediting bodies or at
least a minimum set of quality criteria as a threshold for
contracting.
Third, because the goal of Phase I is to identify models
that can be successfully used nationwide, in Phase II, the
Administration should ensure that models selected in Phase I
have proven outcomes and can be scaled to take care of millions
of people.
Fourth, in order to more quickly realize financial savings
and ensure equitable and consistent measurement of results, the
Administration should consider implementing all of the pilot
programs simultaneously. Fifth, Congress and the administration
should be open to expanding the program earlier than currently
specified when the results begin to show expected cost savings
and quality improvement. Finally, Congress should consider the
implementation of disease management programs whenever you take
up Medicaid reform.
In closing, I would like to express my sincere appreciation
on behalf of the entire disease management community to you,
Chairman Johnson, and to the entire Committee, Chairman Thomas,
Secretary Thompson and the leadership and staff at CMS, for
making these important services available to the millions of
seniors with chronic conditions who need the support to help
them live a better quality of life. Thank you.
[The prepared statement of Ms. Selecky follows:]
Statement of Christobel Selecky, President-elect and Chair, Government
Affairs Committee, Disease Management Association of America
I would like to thank Chairman Johnson for inviting me to speak
before the Committee today.
My name is Christobel Selecky and I am the President-elect of the
Disease Management Association of America, a non-profit,
interdisciplinary association dedicated to the advancement of health
improvement for people with chronic disease.
DMAA's membership comprises the spectrum of entities that have an
interest in the advancement of chronic care improvement:
Healthplans and insurance companies;
Disease management organizations;
Academic institutions;
Integrated delivery systems;
Physician group practices;
Employers;
Monitoring and information technology companies;
Pharmaceutical benefit mangers (PBMs); and
Pharmaceutical companies
I am also the CEO of LifeMasters Supported SelfCare, a ten year old
privately held Disease Management Organization that provides coaching,
education, and support to more than 300,000 chronically ill individuals
nationwide.
The fact that our healthcare system is not set up to adequately
care for people with chronic disease is well documented. In its
landmark report, Crossing the Quality Chasm, the Institute of Medicine
(IOM) gave us a roadmap for the creation of a new health system for the
21st Century--a system that is patient centric and focused on closing
the gap--the chasm--between best practice and actual care received.
This gap was discussed in a well publicized study published just last
year in the New England Journal of Medicine\1\ in which it was reported
that people with chronic conditions receive recommended care only about
50% of the time.
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\1\ McGlynn, Asch et al, The Quality of Health Care Delivered to
Adults in the US NEJM 2003; 348:2635-48.
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When chronically ill patients do not receive the right treatment
for their condition, they end up getting sicker and winding up in the
hospital--sometimes when it's too late to help them. This not only
results in poor quality of life but also costs our healthcare system--
and ultimately the taxpayers in the case of Medicare--more money.
The gap between actual and recommended care occurs because patients
are inadequately trained to manage their illnesses, rushed
practitioners do not always have the time or information to follow
evidence-based practice guidelines, and systems don't exist at the
provider level to actively follow-up with their patients and other care
providers to ensure the best outcomes. Our delivery system needs to
change toward the Chronic Care Model described by Ed Wagner and others.
But most physicians are operating in 2-3 person offices without
resources, platform or staffing to achieve this--it costs a lot of
money to build these capabilities--money that most physician practices
simply do not have access to.
The IOM recommended using sophisticated information technology
systems to facilitate the conscientious, explicit, and judicious use of
current best evidence and knowledge of patient values by well-trained,
experienced clinicians. The goal is to integrate a fragmented system by
building strong information pathways between all the stakeholders--
patient, physician, family members and caregivers, and payors and
facilitating a team approach. Information technology provides the
platform to create that integration.
Fundamentally, disease management is the platform that can
facilitate the delivery of evidence-based medicine on a population-wide
basis with a goal of helping each individual in that population achieve
optimal health. Disease Management Organizations (DMOs) and other
healthcare organizations with substantial resources and access to large
patient populations have built the technology platforms and developed
the processes and specially trained staff necessary to achieve this
goal. And Disease Management supports the Chronic Care Model without
imposing financing or access restrictions like capitation and by
providing the scalability necessary to handle millions of beneficiaries
with chronic conditions.
In fact, DMOs create systems to ensure that the guidelines
developed and proven over many years of research by academic and
clinical institutions get implemented and that the patients are
following the treatment plans prescribed by their physicians.
Disease management programs work by:
Analyzing, on an ongoing basis, all available data (self-
reported, claims, administrative, clinical, encounter) to create a
profile of the beneficiary that identifies how severe their illness is
and how wide the gaps in the standard of care
Contacting beneficiaries proactively to gain a better
understanding of their psychosocial profile and their willingness to
participate and to engage them in an intervention appropriate to their
level of severity
Educating beneficiaries and their family members on self-
care skills and providing support to help them adhere to the treatment
plan prescribed by their physician and make necessary lifestyle changes
Monitoring changes in vital signs and symptoms that are
indicative of changes in clinical status
Notifying the beneficiary's personal physician of
relevant changes and gaps in the standard of care
Measuring and reporting on improvements in clinical,
financial, and satisfaction outcomes on an ongoing basis
The care gap is particularly acute among our nation's seniors who
have high rates of chronic disease and, in the Traditional fee for
service Medicare program, there are neither programs nor financing for
care coordination on a large scale. Medicare beneficiaries with five or
more chronic conditions represent 20 percent of the Medicare population
but 66 percent of program spending.\2\ They utilize healthcare services
at a very high rate and, in the Traditional fee for service Medicare
program, have a very fragmented healthcare experience. On average,
they:
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\2\ Berenson & Horvath, ``The Clinical Characteristics of Medicare
Beneficiaries, March 2002.
Fill 49 prescriptions per year;
Have 37 physician office visits per year;
Visit 14 different (unique) providers each year; and
Stay 7 days in the hospital.
Several approaches have been suggested to fixing this problem in
Medicare including:
Introducing capitation or a gatekeeper structure into the
fee for service program
Increasing reimbursement to physicians who provide care
to patients with chronic conditions
Expanding the benefit structure by adding a variety of
chronic care components such as home health visits, prescription drugs,
and virtual (email or telephonic) office visits
While all of these suggestions have merit, the challenge is that
these are all incremental changes and do not address the fundamental
problems with chronic care that Disease Management can.
The impact of any one of these changes can't be measured
or controlled--which components are truly creating value? How can CMS
make sure that services being rendered are truly appropriate to the
management of chronic disease? How will the overall cost savings to the
trust fund be measured? Population based disease management programs
incorporate all of the components required to improve chronic care and
are measurable at the population level.
It is premature to change the physician payment structure
without the platform to measure quality and outcomes. Arguments to pay
doctors more are about the increased amount of time and staffing
resources necessary to care for chronically ill patients. Disease
Management programs do nothing to reduce the number of office visits
(and, as a result, do not compromise physician reimbursement) but do
improve the efficiency of office visits and provide information and
support to patients, thereby improving the cost effectiveness of each
visit. As a result, the physician's time is more efficiently used and
they can treat more patients with less office staff.
Taking a piecemeal approach to chronic care management
would significantly increase CMS's oversight requirements and
administrative cost--determining appropriate reimbursement levels,
defining eligible services, increasing the number of transactions
(claims), etc. With population based Disease Management programs, CMS
would need to work with fewer contractors and wouldn't need to change
the basic structure of Traditional Medicare.
These changes are primarily provider-centric and do
nothing to reach out to and engage beneficiaries with chronic disease.
However, because people with chronic disease are providing their own
monitoring and treatment 24 hours a day, they need support and tools to
enhance their self-management skills. Population-based Disease
Management programs provide this outreach and support.
Capitation and gatekeeper models limit access to care and
eliminate the element of choice fundamental to the Traditional Medicare
program. Chronically ill patients generally need to see multiple
physicians. The problem isn't one of overutilization, it's how to avoid
preventable utilization. Disease Management programs often increase
access to primary care and specialist physicians, reduce avoidable
hospitalizations and emergency room visits, and operate as effectively
in fee for service environments as they do in managed care.
Disease Management programs have been available for several years
to Medicare beneficiaries in M+C programs and employer retiree health
benefit programs with documented improvements in clinical quality and
reduced costs and, as a result, improved quality of life and
satisfaction for patients and their physicians.
In spite of being the largest insurance company in the world,
however, the Medicare program has lagged the commercial marketplace.
This is not for lack of trying. In the past several years, CMS and the
legislature have been experimenting with disease management through a
variety of small demonstration projects.
Fortunately, the Medicare Modernization Act has now created a
framework for transforming chronic care in America. Several sections
are devoted to improving care for chronically ill beneficiaries:
Requirement to coordinate Medication Therapy Management
Programs (Section 1860D-4) with DM
Consumer-directed Chronic Care Demos (Section 648)
Care Management Pay for Performance Demos (Section 649)
Requirement for Medicare Advantage (M+C) Plans to have DM
(Section 722)
Increases in payments to Medicare Advantage Plans--such
payments to be passed along to beneficiaries--can be used to fund DM
programs
Benefit changes
Coverage of Rx
Coverage of preventive physical exams
Coverage of diabetes screening tests
Coverage of cardiovascular screening tests
Most important, however, Section 721 will make large scale,
population based Disease Management available to beneficiaries in
traditional Medicare. It will for the first time ever provide:
A single point of contact for beneficiaries to reduce
fragmentation
Education for beneficiaries and caregivers to help manage
their self-care
Technological support and education for physicians and
other providers to help them better manage clinical information about
the beneficiary
Biometric monitoring technologies and processes to
enhance exchange and timely response to clinical information
Information to beneficiaries about hospice, end of life,
and palliative care
This approach represents real innovation and an opportunity for
Congress and CMS to support delivery system change, outreach to
chronically ill beneficiaries, and real, measurable reductions in
healthcare cost trend and improvements in the quality of life for
beneficiaries, their family members, and their physicians. Rather than
taking an incremental approach, this bill has jump started the
fundamental and necessary change to deal with the chronic care crisis
in America.
It takes a holistic approach to helping beneficiaries
deal with their chronic conditions--ensuring that CCIOs focus not just
on the primary condition to be managed but also on co-morbidities
(other chronic conditions that exist simultaneously in the same person)
and that efforts are made to enhance education, access to care, and
physician/patient communication
It is patient/beneficiary centric rather than provider
centric and will provide support for beneficiaries that busy physicians
cannot afford to provide
It anticipates the use of proven models of disease
management and chronic care improvement that can handle large
populations and will be scalable after the initial evaluation phase
It will result in improved efficiency and increased time
for physicians because it addresses many of the problems that
chronically ill patients create for physician practices
It will result in the opportunity to provide enhanced
quality of care and quality of life for millions of Medicare
beneficiaries without increasing costs to the Trust Fund. In fact, it
will result in a guaranteed reduction in costs to the Trust Fund and
where else in Medicare have we seen that requirement?
In addition to resulting in cost savings, it will require
clinical quality improvement and enhancement of patient and physician
satisfaction
It will provide incontrovertible proof of the benefits of
disease management because of its use of a randomized control
methodology and a third party evaluator
It recognizes the critical importance of Information
Technology and data analysis in large scale chronic care improvement
efforts
It has the opportunity to provide measurable, large scale
savings because it is population-based (meaning that it holds CCIOs
accountable for engaging and then improving quality and reducing costs
for all people in the population and it initially targets the
conditions (CHF, Diabetes, and COPD) that will yield the greatest
immediate savings for the Trust Fund
It provides an opportunity for all stakeholders to
benefit--no one is cut out:
Primary care physicians and specialists
Home health agencies
Community organizations
Health insurance carriers
Disease Management Organizations
Technology companies
Beneficiaries
Taxpayers (through a more efficient and effective use
of the Medicare Trust Fund)
At LifeMasters, we have two recent examples of programs like this
that have generated significant results in relevant populations--
retirees in a PPO and fee for service Medicaid beneficiaries.
We provided a Disease Management program to the Ohio State Teachers
Retirement System whose members received their healthcare through a
PPO. We saved the system $8.6 million in total healthcare costs in one
year on a 6,000 member subset of their population with CHF, COPD, CAD,
and Diabetes. This represented a 6.9% net reduction in total healthcare
costs for a 3.5 to 1 return on investment. These savings were generated
through an 18% reduction in hospitalizations and resulted in a greater
than 90% rate of high satisfaction with the program.
We also provided a Disease Management program to fee for service
Medicaid beneficiaries in the state of Florida. Over a two year period
we saved the state of Florida approximately $12.6 million on an average
population of 3,500 fee for service Medicaid beneficiaries with CHF and
comorbidities of COPD, Diabetes, CAD, and mental illness. This
represented a 5.6% net reduction in total healthcare costs for a 1.5 to
1 return on investment. These savings were generated through a 38%
reduction in hospital days. The group also experienced significant
increases in evidence based care including a 32% increase in patients
taking ACE inhibitor/angiotensin receptor blocker therapy and a 77%
increase in cholesterol screenings. In addition, there were significant
lifestyle changes including an average of 5 pound weight loss across
the entire population and 25% of participants quitting smoking.
In another example, American Healthways has provided disease
management for one of the nation's remaining Medicare cost-plus plans
with its diabetes population since July 1, 2000. It has done the same
for this plan's Medicare cost-plus members with cardiac disease since
November 1, 2001. In the first two years, the net savings of the
diabetes program was $12.9 million, with $5.1 million savings in year
one and $7.8 million savings in year two. Net savings in the first year
of the cardiac program was $20.2 million. The rates of savings are
consistent with American Healthways results in other populations and
geographic locations.
These kinds of outcomes have been repeatedly shown in Medicaid,
Medicare+Choice, and commercial populations across the country.
Extrapolating these savings to the Traditional Medicare population,
Disease Management or chronic care improvement programs could save
billions of dollars while concurrently enhancing the quality of life
for millions of beneficiaries and their family members.
There are many models possible under MMA and CMS has encouraged
consortia to apply for pilot projects. I can attest that my company and
several members organizations of DMAA are actively working toward
building solutions that are collaborative in nature.
Here's how some of these consortia might work:
A multispecialty physician group or integrated delivery
system with sophisticated information technology including electronic
medical records and claims analysis capabilities, established disease
management programs, and a high risk case management program contracts
directly with CMS. The physician group subcontracts with a call center
company to perform the outreach and enrollment functions to get the
intervention group engaged but performs all of the chronic care
improvement functions on its own and holds all of the financial risk.
The revenue flows to the physician group or IDN which uses the money to
fund its services and subcontract and also to establish differential
payment systems (pay for performance) for their physicians based on the
outcomes and their willingness and effectiveness in participating.
A health plan subcontracts with a DMO. The DMO provides
the outreach, educational, support, and monitoring services. The health
plan provides high risk case management and home health services. The
revenue flows to the healthplan which uses the money to pay the DMO for
its services and also to cover its high risk case management costs,
home health costs, and a risk premium to hold the bulk of the financial
risk. The DMO retains a portion of the financial risk to ensure that
incentives are aligned.
A DMO contracts directly with CMS for a program. It
provides all of the standard disease management services and
subcontracts with a home health agency, a biometric monitoring company,
and a high risk case management company if needed. At the local level,
the DMO also identifies and develops relationships with community
agencies that provide social services to seniors. The revenue flows to
the DMO which uses it to cover its own costs and to pay the
subcontractors and perhaps even provide funding for the community
agencies. The financial risk is carried by the DMO which may allocate
some of this risk to its partners depending on what services they
provide.
A pharmacy benefit management company (PBM) that is
planning on being a Prescription Drug Provider (PDP) under the new drug
benefit partners with a physician group practice with an established
disease management program or a DMO. The PBM begins offering a modified
drug benefit prior to the 2006 drug benefit start date and includes a
Medication Therapy Management (MTM) program. The DMO provides the DM
services. The PBM and DMO integrate their data systems and builds
interfaces between the DM and MTM programs.
In closing, I'd like to express my sincere thanks on behalf of the
entire disease management community to you, Mrs. Johnson, and the
entire Committee, Chairman Thomas, Secretary Thompson, and the
leadership at CMS for your leadership in making these important
services available to the millions of seniors with chronic conditions
in America who need the support and programs to help them lead a better
quality of life.
As you may know, DMAA has submitted an extensive set of comments
and recommendations to CMS in response to the RFP recently issued for
Phase 1 of the Chronic Care Improvement program. In addition to that
submission, I'd also like to make a few recommendations that I hope
might help improve the effectiveness of this valuable program:
That you continue to support CMS with the resources they
will need to build the infrastructure necessary to administer and
monitor this program
That you consider the implementation of disease
management programs whenever you take on Medicaid reform
That CMS consider accreditation by one of the major
accrediting bodies--or at least a set of minimum criteria--as a
threshold for contracting in order to ensure consistency and a standard
level of quality
That CMS consider incentivizing chronic care improvement
organizations to devote resources over and above those necessary to
achieve the minimum net savings requirement by allowing them to receive
a share of savings over and above the 5% minimum guaranteed financial
savings
That CMS consider implementing all of the pilot programs
simultaneously rather than staging implementation over an extended
period of time in order to ensure that results can be measured
equitably and consistently
That you and CMS be open to expanding the program earlier
that the currently specified two years from inception when the results
begin to show the expected cost savings and quality improvements
That CMS ensures that models selected provide a win-win
for all stakeholders in the chronic care community
Yet at same time, ensure that models selected have proven
outcomes and reflect models that can be easily scaled for Phase 2.
While we applaud the concept of experimentation, we want to make sure
that this program is successful in reducing costs and improving the
quality of life for the millions of beneficiaries with chronic disease
and their families
Thank you again for the opportunity to comment on the Chronic Care
Improvement program and I would be happy to try and answer any
questions you might have.
Chairman JOHNSON. Thank you very much, Ms. Selecky. Dr.
Wright.
STATEMENT OF JANET S. WRIGHT, MEDICAL DIRECTOR OF CARDIOLOGY,
ENLOE MEDICAL CENTER, CHICO, CALIFORNIA
Dr. WRIGHT. Good afternoon. I also appreciate this
opportunity to come before you. As I mentioned in my written
comments, I couldn't presume to represent all the opinions of
cardiologists in the country, but I do come here on behalf of
my patients and what I think--on behalf of the hope that this
is a breakthrough to improve medical care. I decided rather
than read to you excerpts from my written comments that I would
tell you a story that I hope illustrates my personal experience
with the transformation of medical care.
Bill Cosby started an album, ``A long time ago, I started
out as a child.'' Well, I started out as a medical child. My
father practiced family medicine in a small town in Arkansas
for almost 50 years. He took care of a chunk of people in
northeast Arkansas. For many of those years, my mother was his
nurse. At night, on weekends, summer and Christmas vacations, I
ran the front desk. I took cash and I recorded dutifully--on
those folks who came under a farm account, I recorded their
care in a ledger. The three of us were essentially the health
care delivery system.
I learned a lot of things from my parents and I learned, I
think, how to do medicine. My father was available 24/7. He did
not have an unlisted number. Everyone knew my dad's number. I
learned to answer the phone, ``Dr. Wright's residence.'' I
learned early on to hear the anxiety that is in a sick person's
voice.
We used to joke that a light went on in the water tower
when we sat down to dinner, because that is when the phone
started to ring. I remember that my father felt privileged to
be a physician. He drew tremendous satisfaction from his job. I
think the reason he did is that he worked hard, he prepared
well, but he also felt he was doing a good job for his
patients. I also remember him escaping occasionally the 30
miles or so to Memphis to spend a night in a hotel. He did what
I called the death sleep where we often wondered whether he was
alive, but he used it as a recovery.
That deep satisfaction made a great impact on me and, in
fact, it bent my career early toward medicine. I could have
done nothing else. So, I will tell you about the 48 hours that
I spent before I came here. I was on call for my group of
seven. As I said, I am a cardiologist so that limits my scope
already. I think I had 56 patient encounters in that 48 hours.
I took the numbers down because I thought you might be
interested.
Out of those 56 encounters, 27 of those people were over
the age of 80. As you know, we make problem lists and no
patient had a problem list shorter than three; that was the 39-
year-old. Everyone else had problems listing up to 12 or 15.
I was usually one of three specialists on each of those
person's case. If you think that the lab sheet we look at,
about 3 different sets of lab sheets and 3 times 58 comes out
to be 168 or something, there were a lot of lab tests to go
over.
My practice is different than my father's practice, but the
requirement for satisfaction is just as great; and although a
different reimbursement might give me some satisfaction, taking
better care of my patients will give me the best satisfaction.
I think that is what pulls my interest into disease management.
From what I have read and what I have observed, their
approach, looking at large numbers of people with similar
medical problems who still need individual care and who need
care continuously rather than episodically, makes a lot of
sense; and I think physicians need the benefit of their
expertise.
I think physicians, as you mentioned, Representative Stark,
are beleaguered. In addition to the five sources of information
telling me how to practice, I also have the entire Internet
source telling me how to practice, but I do need some
assistance. I think there is hope in this program to learn from
the initial experiments and then apply those in wider
spectrums, not just to all my beneficiaries, but in different
settings of practice; not just in large groups, as you said,
Chairman Johnson, but in the smaller, individual practices. I
appreciate all of your efforts on our behalf.
[The prepared statement of Dr. Wright follows:]
Statement of Janet S. Wright, M.D., Medical Director of Cardiology,
Enloe Medical Center, Chico, California
Chairman Johnson and members of the subcommittee:
I am here today as a practicing cardiologist and a Fellow of the
American College of Cardiology, (ACC) an organization whose mission is
to advocate for quality cardiovascular care-through education, research
promotion, development and application of standards and guidelines-and
to influence health care policy. My comments reflect the policy
position of the College, although I could not presume to represent the
diverse opinions of the over 30,000 members of the ACC. I do however,
represent the interests of my patients and on their behalf, I express
my gratitude for the efforts you make on a daily basis to improve
health care in America. I believe that your contributions will initiate
an historic improvement in the quality of health care for Medicare
beneficiaries.
Any policy maker, health care professional or sick person in
America knows that our health care system is broken. Our striking
success in combating life-threatening illnesses has extended the lives
of millions of Americans, and in that victory, converted acute events
into chronic conditions. Our older citizens suffer multiple diseases,
visit an average of seven doctors a year, and take more than twice that
many medications each day. These patients need near-constant oversight
and continuous care coordination to stabilize their conditions and to
avoid the episodic, usually urgent and costly rescue from a preventable
deterioration.
As seniors' complex medical conditions multiply, the physician
workforce is shrinking due to unmet needs for job satisfaction,
adequate reimbursement, and liability protection, among other factors.
Quality medical care takes time and resources to deliver and good
doctors are struggling these days to care for the burgeoning chronic
disease population. The therapeutic alchemy of the patient-physician
relationship disintegrates under the pressures of today's fragmented
care interaction. When the personal connection breaks down between
patient and doctor, so does adherence to advice, trust, satisfaction,
and inevitably, the clinical outcome. To deliver excellent care,
physicians need additional resources to provide patient and family
education, to track practice adherence to established guidelines, and
to supply our statistics to a variety of ``measurers'' in the health
care arena. To practice 21st century medicine, practitioners must have
current, complete, and accurate data. Those data, and the resources for
gathering them, are absent in most medical practices today.
Advances in science, funded robustly by this Congress, have been
translated into evidence--or guideline-based medicine, setting the
standards of care and shaping medical decision-making. Yet few doctors
can afford the information technology or human resources to bring these
recommendations to the point of care delivery, much less to record,
track, and report their performance, an increasingly common requirement
in the medical marketplace. Despite best efforts of well-trained and
dedicated physicians, our own measures of quality have demonstrated
dispiriting gaps in care. Health care has metamorphosed; health care
delivery systems have not.
Although I do not know the solutions to our complex health care
crisis, I can list the basic characteristics of those solutions.
Collaboration is critical as the problems are clearly insurmountable by
any single organization or entity. Improvements will be incremental or
staged because the distance we must travel from our present state to a
significantly better one is staggering. Evidence or guideline-based
medicine is the accepted standard, and a steady focus on quality, with
all the attendant difficulties, will help guide us to a better system
of care. The solution must be comprehensive, in the sense that quality
care is to be delivered in all settings, for all conditions. Finally,
and most importantly, the new system will be marked by enhanced
communication on the macro level by adaptable IT and appropriate
infrastructure, and on a personal level by a resuscitated patient-
physician relationship.
The approach known formally as disease management has grown
exponentially in the current chaos because it provides among other
things, vital systematic links among participants in the health care
system. Emphasis on populations, self-care instruction, and continuous
cross-talk between patients and the care team mark a few of the unique
features of the disease management approach that are missing in the
traditional care model. Disease management harnesses information
technology and other important tools to assist with application of
evidence-based medicine, data collection and analysis, patient and
physician adherence, and performance enhancement. Disease management
brings constructive additions to current health practices and holds
promise for improvements in care delivery.
As an example of highly effective disease management, I call your
attention to a mature and profoundly valuable program which has
provided education in self-management and health preservation, linked
patients and doctors through frequent progress reports, and not just
satisfied, but indeed, life-changed its participants. That program is
one of the original disease management approaches known as Cardiac
Rehabilitation. The design has from its inception been
multidisciplinary, bringing together cardiac nurses, exercise
physiologists, dieticians, and cardiologists with expertise in disease
prevention and health promotion. These sophisticated programs begin
with detailed intake interviews, identifying not only the medical
conditions which require monitoring and management, but also the social
and psychological hurdles to achieving and maintaining good health. The
structured weekly sessions provide the continuous and repetitive
feedback proven to effect changes in behavior. The care team members
support these gradual, key behavioral shifts, become trusted sources of
information, and most importantly, serve as community-extended radar,
detecting early signs of decompensation, medication errors or poor
adherence, and new or recurrent disease states.
Patients undergoing cardiac rehabilitation ``graduate'' armed with
knowledge of their disease process, their prognosis, and their
limitations; the latter most certainly reduced by the personalized
protocol of exercise, nutritional counseling, stress-reduction
training, and medical supervision. In these days of ``drive-by'' open
heart surgery and two-day admissions for heart attacks, the educational
process is so critical for the restoration of physical and mental
health and improved functional status takes place in one and only one
place: Cardiac Rehabilitation. Even with the fiscally constrained reach
of cardiac rehabilitation programs, the disease management principles
have succeeded in improving the outcomes and outlook for patients with
cardiac disease.
The Voluntary Chronic Care Improvement Programs will incorporate
many features present in the CR/DM model, features which are
fundamental to solving our health care crisis. This unique design calls
for collaboration among the system experts (DM), the medical pros
(physicians and health care team), and the payers in a mutually
rewarding arrangement for the benefit of patients with congestive heart
failure, complex diabetes, and chronic obstructive pulmonary disease.
The successful models/components will be identified in a three-year
process and made available to the appropriate Medicare population in a
staged fashion. Outcome measures of quality and satisfaction will be
selected in advance, monitored, and reported, highlighting the use of
information technology and reinforcing the practice of guideline-based
medicine.
Even though there are specific targeted diseases in the Phase I
programs, the approach is most appropriately comprehensive in the
attention given to co-morbid conditions and overall health status. This
is both complicating for the program administrators and absolutely
necessary for the applicability of these approaches to real-life
medical care of aged and disabled Americans. Cost data will be
important, but not sole determinants of program success. Although
typically unprofitable for hospitals, cardiac rehabilitation programs
achieve striking gains in quality of life, patient satisfaction, and
clinical outcomes. Phase I programs that predominantly emphasize well-
established clinical outcomes are in the patients' and ultimately, the
country's best interest. In fact, the very foundation of a disease
management strategy is that early and frequent intervention ( whether
education, medication adjustment, further evaluation, and/or alteration
in treatments) improves the patient's ability to function at the
highest level possible. I strongly encourage selection of programs that
focus on quality improvement, as those are most likely to result in
concomitant enhancements in beneficiary and provider satisfaction.
Finally, I trust that the programs selected for Phase I will recognize
the therapeutic value of a healthy patient-physician relationship and
will support fluid communication among members of the care team, family
members, and caregivers.
In Section 721 of the Medicare Prescription Drug, Improvement, and
Modernization Act (MMA) of 2003, Congress has broken new ground in
health care delivery design. Many aspects of the MMA are revolutionary
in the transformation of health care in the United States. New
partnerships will be formed, innovative approaches will be tested, and
the underlying audacious concept is that quality medical care will lead
to better financial, satisfaction, and clinical outcomes.
That said, I believe that the greatest achievements of this
legislation will be realized in an evolutionary way. Section 721 sets
in motion a new direction in health care which will find expression in
ways we cannot anticipate. We will learn from the experience of Phase
I, and future innovators and disseminators will adapt the processes as
populations and medical conditions mandate. I expect to discover
through the Phase I project, the techniques and processes that work and
those that need further modification or perhaps application in a
different subset of patients. Learning where and how and in whom to
apply these principles of care will be an invaluable lesson. I
anticipate that practices, health plans, and other care delivery
systems which are not part of the Phase I projects will follow the
progress reports closely and begin to implement the winning strategies.
The goal is to improve the quality of care for all, to close the gaps
that still exist, and to do so in a cost effective manner which will
enable us to provide care to all in need. It is my hope that as much
meticulous care and concern go into these future designs as was
invested in the crafting of this legislation and in its implementation.
I encourage physicians to investigate the Chronic Care Improvement
Programs, to consider the potential benefits to their patients and
their practices, and to participate however possible so that the
ultimate delivery model reflects what we know to be true: compassionate
individualized care is effective, essential, and rewarding. We will
always treat one human being at a time and, in that moment, serve the
larger population well. The opportunity now presents to combine this
best practice of the healing arts with a high tech, population-based
approach, a challenge which calls for the integrity and commitment of
the brightest minds in health policy, system design, and medicine.
In closing, I share a physician's wish list for the future perfect
state of medical care. Many of these wishes could come true in the
Phase I and II programs and they are essential components of a fit and
functional health care system.
1. I want to be on the design team for the process of care.
(Physician involvement)
2. I want to know my ``score,'' how it is calculated, and to whom
it is reported (Quality/performance measurement)
3. I want my patients to have ready access to a team of experts in
my practice and community who can extend health care beyond our office
visit. (Team care, primary and secondary prevention)
4. I want current, accurate, complete data available when I need
it so that I can incorporate it into my practice. (Information
technology)
5. I want my patients to have validated, self-care advice when
they need and so they can use it. (Patient education, prevention,
information technology)
6. I must have the ability to afford to deliver this care.
(Adequate reimbursement for a chronic care management system)
I deeply appreciate the efforts of this subcommittee in improving
our health care system. Your dedication and commitment challenge all
participants in health care to contribute our best to achieve creative
and cooperative solutions.
Chairman JOHNSON. Thank you very much, Dr. Wright. Dr.
Bufalino.
STATEMENT OF VINCE BUFALINO, M.D., MEMBER, EXPERT PANEL ON
DISEASE MANAGEMENT, AMERICAN HEART ASSOCIATION, NAPERVILLE,
ILLINOIS
Dr. BUFALINO. Thank you. Good afternoon, Madam Chairman,
Representative Stark, Representative Crane. I thank you for the
opportunity to testify on this important initiative. My name is
Vince Bufalino. I am a practicing cardiologist for 22 years and
the President/CEO of Midwest Heart Specialists, a 55-physician
practice in suburban Chicago.
I have been an active volunteer for the AHA over the last
20 years and the incoming Chairman of the Advocacy Coordinating
Committee nationally, and also serve as the Chairman of the
Emergency Cardiac Care Committee where we direct
Cardiopulmonary resuscitation and Advanced Cardiac Life Support
programs for the United States. Currently, I am the president
of the Midwest Region, of the seven States, and have been named
to the board of directors. Finally, and why I am here is, I am
a member of the AHA's Expert Panel on Disease Management.
I am speaking today on behalf of the AHA's 22.5 million
volunteers. As the largest voluntary health organization, the
AHA's mission is to reduce cardiovascular disease and stroke by
25 percent by the end of this decade. Our organization is
unique. Our volunteers are patients, physicians, nurses, and
other stakeholders, all dedicated to fighting heart disease and
stroke, our Nation's number one and number three killers.
The AHA believes that chronic care management programs, if
properly structured and carefully implemented, may help
transition the Medicare Program into a more responsive and
comprehensive health care program for America's seniors.
We are encouraged that the voluntary CCIP appears to be an
important step in this regard. We applaud your leadership,
Madam Chairman, in ensuring that this issue was addressed in
the MMA. We look forward to working with you, this Committee,
and CMS to ensure that the CCIP fulfills its considerable
promise to demonstrate improvements in patient outcomes and
quality of life.
We believe CMS has done an admirable job in developing the
RFP. Much of what will ultimately matter most, however, cannot
be explicitly detailed in an RFP. True success will depend on
the extent to which this program recognizes and promotes
practices to provide value to our patients. By this, I am
referring to improved patient outcomes, the translation of
evidence-based research into practice, the institution of
measures to promote primary and secondary disease prevention,
and effective beneficiary outreach so the beneficiaries can
understand the true benefits of this program. If, however, the
program becomes overly focused on reducing expenditures, we are
concerned that much of the potential value to the patient may
not be realized.
I would like to devote my comments today to a series of
recommendations focused on these issues that we believe address
the improved patient outcomes for Medicare beneficiaries. After
conducting extensive research, the AHA's Expert Panel has
established a set of principles on disease management and
chronic care management. We believe these principles should be
applied to chronic care management programs in both the public
and private sectors and consistently across disease states and
patient populations.
Although the number of existing disease management programs
and chronic care programs seek to balance cost containment with
quality, quality and improved patient outcomes must always be
the priority. The AHA recommends the following guiding
principles for the implementation of the CCIP.
Number one, the main goal of CCIPs should be to improve the
quality of care and patient outcomes. The core principle
underlying all of our recommendations is ensuring treatment and
practices that improve outcomes. We appreciate the fact that
this principle was the motivation for the inclusion of the CCIP
in the MMA. Our challenge, however, is to implement this
program in a way that meets the objective.
Number two, evidence-based guidelines should form the
foundation for all CCIPs. Efforts to manage beneficiaries with
chronic conditions should incorporate the use of guidelines
such as those developed by the AHA and other organizations in
the medical community that provide clear direction as to how to
reduce the risk of these chronic conditions and to ensure the
beneficiaries received optimal care.
Number three, performance measures should be designed to
improve quality of care in clinical outcomes. Scientifically
based quality indicators should be the key measurement upon
which the success of the CCIP is evaluated. Careful attention
should be given to the appropriate translation of these
scientifically based guidelines into chronic care practices.
Number four, to ensure the optimal patient outcomes, the
CCIP must address the complexities in medical co-morbidities.
According to recent research, 78 percent of the medical
beneficiaries in Medicare have at least one chronic illness.
Almost 32 percent have four or more. Chronic care improvement
must include the management strategies for these complex
interactions.
Number five, scientifically based evaluations should be a
critical component of all of these programs. Ongoing evaluation
efforts should examine the extent to which the chronic care
management efforts have produced better quality of care and
improved clinical conditions for our beneficiaries.
Number six, the chronic care management program should
exist within an integrated and comprehensive system of care in
which the patient-physician relationship is central. Chronic
care management services should not substitute a patient-
provider relationship, particularly the patient-physician
relationship, that is critical to the delivery of care.
Instead, chronic care management programs should be one of
several strategies to support and enhance the patient-provider
relationship.
A significant challenge exists for the enrollment of these
beneficiaries in the CCIP. Successful enrollment will be
closely linked to beneficiary education and outreach. Outreach
efforts should include clear and easily understood information
for beneficiaries that helps them understand the impact of this
program. Beneficiaries should know that this new program will
not force them to give up their doctor or reduce their current
benefits. Instead, this pilot program should help them
coordinate what is oftentimes a fragmented health care system
through which the beneficiaries receive their care.
In addition, beneficiary participation will be influenced
by its impact on the patient-physician relationship.
Individuals will not be receptive to a program that threatens
their ability to be treated by their physician of choice or
otherwise intrudes on this relationship. We urge CMS to reject
proposals that attempt to supplant the care provided by the
patient's provider.
A beneficiary willing to participate in the CCIP is also
dependent on his or her understanding of this program, its
benefits, its processes, and its objectives. The CMS must
ensure that chronic care improvement organizations engage in
substantial education efforts to inform the beneficiaries how
the CCIP will improve quality of care, prevent future adverse
events, and improve outcomes. Patients and their physicians
must be convinced that the program will utilize the best
science to aid in determining the most effective treatment
course.
Finally, it is important to recognize that each geographic
area chosen for this program will have its own unique cultural
and linguistic characteristics. In order for any beneficiary
communication effort to be effective, it must consider these
factors and develop outreach activities in a culturally
significant manner. The AHA appreciates the opportunity to
testify before the Committee on this important issue, and we
look forward to working with you and CMS on this important
initiative. Thank you.
[The prepared statement of Dr. Bufalino follows:]
Statement of Vince Bufalino, M.D., Member, Disease Management Expert
Panel, American Heart Association, Naperville, Illinois
Introduction
Good morning, Madame Chairperson and members of this Committee.
Thank you for the opportunity to testify on behalf of the American
Heart Association before your committee on this important initiative.
My name is Vince Bufalino. I am the President/CEO of Midwest Heart
Specialists, a 55 physician Cardiology practice in the Chicagoland area
with fifteen offices located in the western and northern suburbs. As
chairman of the Midwest Heart Foundation, a non-profit research arm of
Midwest Heart Specialists, I oversee approximately 30 clinical research
trials.
I have been an active volunteer for the American Heart Association
for the past 20 years. I am the incoming chair of Advocacy Coordinating
Committee nationally and serve as national chairman of the Emergency
Cardiac Care Committee with responsibility of directing the CPR and
Advanced Cardiac Life Support Programs for the United States.
I am also currently president of the American Heart Association's
Greater Midwest Affiliate and have recently been named to the AHA Board
of Directors and Administrative Cabinet, both at the national level.
Finally, I am an active member of the AHA's Expert Panel on Disease
Management.
I am speaking today on behalf of the American Heart Association and
its 22.5 million volunteers and supporters. As the largest voluntary
health organization, the American Heart Association's mission is to
reduce cardiovascular disease and stroke by 25% by 2010. Our
organization is unique. Our volunteers includes patients, physicians,
nurses and other stakeholders dedicated to fighting cardiovascular
disease and stroke, our nations #1 and #3 killers respectively.
The American Heart Association believes that chronic care
management programs, if properly structured and carefully implemented,
may help transition the Medicare program into a more responsive and
comprehensive health care program for America's seniors.
We are encouraged that the Voluntary Chronic Care Improvement
Program appears to be an important step forward in this regard. We
applaud your leadership, Madame Chairperson, in ensuring that this
issue was addressed in the Medicare Modernization Act. We look forward
to working with you, this committee, and the Centers for Medicare and
Medicaid Services (CMS) to ensure that the Voluntary Chronic Care
Improvement Program fulfills its considerable promise to demonstrate
improvement in patient outcomes and quality of life.
We believe CMS has done an admirable job in developing the request
for proposals for this program. Much of what will ultimately matter
most, however, cannot be explicitly detailed in an RFP. True success
will depend on the extent to which the program recognizes and promotes
practices that provide value to the patient. By this, I am referring to
improved patient outcomes, the translation of evidence-based research
into practice, the institution of measures to promote primary and
secondary disease prevention, and effective beneficiary outreach so
that beneficiaries can understand the benefits of this program. If,
however, the program becomes overly focused on reducing expenditures,
we are concerned that much of the potential value to the patient will
not be realized.
American Heart Association's Principles for Chronic Care Improvement
Programs
I would like to devote my comments today to a series of
recommendations focused on issues that we believe must be addressed to
ensure improved patient outcomes for Medicare beneficiaries in the
implementation of the Chronic Care Improvement Program. After
conducting extensive research, the American Heart Association Expert
Panel on Disease Management established a set of principles on disease
management and chronic care management. We believe that these
principles should be applied to chronic care management programs in
both the public and private sectors and consistently across disease
states and patient populations.
Although a number of existing disease management programs and
chronic care management programs seek to balance cost containment and
quality, quality and improved patient outcomes must always be the
priority.
The American Heart Association recommends the following guiding
principles for the implementation of the chronic care improvement
program to ensure improved patient outcomes for Medicare beneficiaries:
1. The main goal of chronic care management should be to improve
the quality of care and patient outcomes.
Evaluation of chronic care management programs should be based on
more than just a reduction in health care expenditures. The emphasis
should be on the ``value'' of chronic care management (i.e., the extent
to which chronic care management efforts result in better quality for a
given investment rather than on cost savings alone). Improvements in
quality of care and patient outcomes should be the primary indicator of
successful chronic care management. The use of performance standards in
assessing quality of care and outcomes is critical in evaluating
success.
2. Scientifically derived, evidence-based, consensus-driven peer
reviewed guidelines should be the basis of all chronic care management
programs.
Chronic care management strategies should be derived when available
from scientifically-based guidelines such as those written by the
American Heart Association/American Stroke Association and groups such
as the American College of Cardiology and the American Academy of
Neurology. These guidelines represent consensus in the cardiovascular
disease and stroke communities regarding appropriate treatment and
management of patients with cardiovascular disease and stroke. Careful
attention must be given to the appropriate translation of these
scientifically based guidelines into chronic care management practices.
3. Chronic care management programs should include consensus-
driven performance measures.
Improved quality of care and outcomes for patients with
cardiovascular disease and stroke should be the pivotal measurement
upon which the success of a chronic care management program is
evaluated. To measure improved quality of care and outcomes, consensus-
based performance measures should be used to evaluate a chronic care
management program's effectiveness. Performance measures used in
evaluating chronic care management programs should be those measures
that are developed by a broad consensus-driven process such as the
National Quality Forum and/or others. Ideally, these performance
measures should be evidence-based.
4. To ensure optimal patient outcomes, chronic care management
programs should address the complexities of medical co-morbidities.
Many chronic care management programs are designed to treat single
disease states. A significant population of patients with chronic
disease suffers from multiple co-morbidities. Some of the greatest
challenges in caring for these patients involve the complex
interactions of these co-morbidities. Chronic care management programs
and guideline committees should develop algorithms and management
strategies to fully address patients with co-morbidities.
5. All chronic care management efforts must include ongoing and
scientifically based evaluations, including clinical outcomes.
Chronic care management programs have not traditionally undergone
rigorous scientific evaluation regarding their impact on patient
outcomes. The true measure of any health intervention is whether
patients are better off having received the service or care provided.
This determination requires a meaningful examination of clinical
outcomes. Frequent scientifically-based evaluations should be included
as a critical component of any chronic care management program, and
these evaluations should allow for continued improvement in the program
to maximize benefit.
6. Chronic care management programs should increase adherence to
treatment plans based on best available evidence.
An important focus of chronic care management should be to
influence the behavior of providers, patients and other caregivers to
better understand and adhere to treatment plans that will help improve
patient outcomes. The targets of such efforts may include a broad
community of caregivers, e.g., physicians, nurse practitioners, family
members and community-based organizations. To be meaningful, it is
essential that such treatment plans be derived from the best available
clinical and scientific evidence. The evidence and resulting treatment
plans should be revisited periodically to reflect evolving standards
and scientific knowledge.
7. Chronic care management programs should be developed to address
members of the under-served or vulnerable populations.
Currently, most chronic management programs arise from employer-
based, private health plans. Although a number of states have begun
using chronic care management approaches within their Medicaid
programs, in general, most chronic care management programs serve an
employed, insured and healthier population. Chronic care management
programs should be developed to incorporate or to specifically address
the unique challenges of the under-served and vulnerable populations.
8. Chronic care management programs should exist within an
integrated and comprehensive system of care, in which the patient-
provider relationship is central.
Chronic care management services should not substitute for the
patient-provider relationship(s), particularly the physician-patient
relationship that is critical to the delivery of effective care.
Instead, chronic care management programs should be one of several
strategies employed to support and enhance the patient-provider
relationship, resulting in an overall improvement in the quality of
care and coordination of care delivered to patients with cardiovascular
disease and stroke.
9. Organizations involved in chronic care management should
scrupulously address and avoid potential conflicts of interest.
Organizations that provide chronic care management services should
act in the best interest of the patient and avoid conflicts of
interest. The primary goal of chronic care management organizations
should be to improve patient outcomes. Efforts to achieve secondary
goals such as product marketing or product sales, should not adversely
affect the primary goal of improving patient outcomes. To the extent
any conflict of interest arises that may compromise the primary goal of
improving patient outcomes, it should not be pursued.
Beneficiary Outreach and Education Should be Prioritized
A significant challenge exists for enrollment of beneficiaries in
the new chronic care improvement program. Successful enrollment will be
closely linked to beneficiary education and outreach.
Outreach efforts should include clear and easily understood
information for beneficiaries that will help them understand the impact
of this new program. Information and outreach to beneficiaries should
be provided to help them understand that this program will not replace
their relationship with their physician but instead, if done correctly,
it will supplement or enhance the patient-physician relationship.
Beneficiaries should know that this new program will not force them to
give up their doctor or reduce their current benefits in any way.
Instead, this pilot program should help coordinate what often times is
the fragmented health care system through which beneficiaries receive
care.
In addition, beneficiary participation is influenced by its impact
on the physician-patient relationship. Individuals will not be
receptive to a program that threatens their ability to be treated by
their physician of choice or otherwise intrudes upon the physician-
patient relationship. In order to succeed, the CCIP must be viewed and
implemented as a tool to support and enhance existing provider-patient
relationships. We urge CMS to reject proposals that attempt to supplant
the care provided by a patient's provider of choice.
A beneficiary's willingness to participate in the CCIP also is
dependent upon his or her understanding of the program--its benefits,
processes, and objectives. Thus, beneficiary education and outreach are
essential. CMS must ensure that chronic care improvement organizations
engage in substantial education efforts to inform beneficiaries about
how the CCIP can improve the quality of care, prevent future adverse
events, and improve patient outcomes. Patients and their physicians
must be convinced that the program will utilize the best scientific
research to aid in determining the most effective course of treatment.
Patient communications must facilitate enrollment. Special efforts
should be made to emphasize the voluntary nature of this program with
beneficiaries. If the enrollment process is perceived as too complex,
it may serve as a disincentive to beneficiary participation.
Finally, it is important to recognize that each geographic area
chosen for the program will have its own unique cultural and linguistic
characteristics. In order for any beneficiary communication effort to
be effective, it must consider these factors and develop outreach
activities in a culturally sensitive manner.
The American Heart Association appreciates the opportunity to
testify before the Committee on Ways & Means Subcommittee on Health on
this important issue, and we look forward to working with Congress and
CMS on this important initiative.
Chairman JOHNSON. I thank you all for your testimony. I
want to clarify. First of all, you have all pointed to
important aspects of how this program must work. Certainly it
must work with physicians and not be dictated to physicians. It
has to be collaborative at every level and throughout its
parts. I do want to point out something about the underlying
law that some of you may be aware of, but not all of you.
While these RFPs do require that you demonstrate savings,
the underlying law does not. The Secretary retains the
authority to roll out to the broad Medicare Program things that
improve health quality, the quality of care and patient
satisfaction, even if they do not save money. Now, he does not
have that authority if they cost money, but he does have that
authority if they just improve quality and do not save money.
So, we were very deliberate in how we wrote the law so that
saving money would not be one of the criteria that you had to
meet in order to roll out an initiative in this area. You have
to meet a criterion that enables you to demonstrate there is an
improvement in patient quality and patient satisfaction. So,
while I was not entirely happy with the 5-percent savings, I
think, on these particular ones they are starting out with,
that should be able to be met; and there seems to be no
disagreement in the provider community that that was able to be
met, and certainly the huge response to these RFPs indicates
that that does not seem to be a problem.
I did want you to know that that does not hamper the
Secretary's authority in the future. I also want to thank you,
Dr. Wright, for the story about your father's practice and your
practice. That is a very, very important story. It is important
that there were three of you in most of these cases.
It is important that the quantity of medical knowledge is
exploding at such a rate that it is very hard to keep track. I
have had many physicians report to me to have some program that
can remind your patient to come back, can make sure they bought
the next refill of their prescriptions to keep the process of
care moving accurately in a way that it would be very hard for
a physician and his staff to do without today's technology and
the automatic flags that it can raise.
I also want to mention an experience that we had at the
press conference, that the Secretary and I had, announcing the
RFPs, because your comment about needing care immediately as
opposed to intermittently is really the heart of this change
and doctors know it. It is not that they do not know it; it is
that we do not know it, and we cannot recognize it in our
payment structure. We do not recognize it until something is
bad enough, until it triggers a doctor's office visit or
hospital visit.
We had very interesting testimony or a comment at the press
conference from a well-educated gentleman who was about 80, who
was diagnosed with diabetes when he was 48 or 42. He was
experienced as a young person in managing diabetes, he was
experienced as a retiree in managing diabetes; and about 5
years earlier he had gotten into one of these chronic disease
management programs.
What was spectacular about it was that his mental health
was so much better. He understood so much more about his
disease. He felt so at home about it. He made the statement
that, ``I always felt sort of selected for this terrible
burden, resentful of this terrible burden, angry at this
terrible burden of diabetes; and now I understand it is just
part of my body. It is the way things function. I can
understand it. I know about it. I can manage it. Furthermore, I
have an expert friend who is there as close as the telephone to
ask any question about it.''
Now, when you look at how we are using the Internet and the
possibilities for communicating, no doctor can absorb all of
those communications and still see the number of patients that
it is important for him or her to see. So, if you want to talk
about any aspect of that, this continuity of care and this
continuousness of care, that is what is unique about chronic
disease management, it would be helpful to us or anything else
you want to add. Dr. Wright.
Dr. WRIGHT. Thank you. I had the privilege of sitting in on
that press conference and that patient's words, what he said
exactly was, ``I finally got friendly with my diabetes.'' I
thought that was so powerful after having fought it so long as
the enemy.
Chairman JOHNSON. It is not that he did not have good
coverage. He had terrific coverage. He had retiree coverage.
There is a need that incident-based health care cannot meet and
we have got to understand that.
Now, there is also a way in which not only does our payment
system not reimburse for that, but we are positively hostile to
it. The Inspector General will look over your shoulder and say,
you did not need to do that; that was not necessary. So,
meeting this challenge as to how we restructure the payment
system is going to be a big challenge, and I think this variety
of pilots will help us. You need to make sure that the doctors
in your area, in your specialty, and the doctors in other
specialties begin to think about this, and that you work
collaborative.
I want to know, if all three of you on these cases sat down
and figured this out, what solution would you--would you tell
us, what would you tell us to pay for and how would you tell us
to pay for it? So, in your spare time if you would raise that.
Dr. WRIGHT. Yes. I have a plane ride back tonight. The
frightening thing to me is not so much that 48 hours of call
and the fact that there were so many specialists, but my
hospital, which is an excellent institution, it has invested in
a good computerized system, not a computerized medical record,
but at least lab data that pops up and we can download it on a
computer and get access to it. So, we are caring for those
patients in-house pretty well.
Those patients are discharged from the hospital into those
specialists' offices, all of which are spread out over a two-
county area, and there is no link between the nephrologist's
office and my own except for me. That is where the system
really disintegrates, trying to manage chronically ill
patients, people who are sick every day of their lives, trying
to help manage them episodically. We do it and we wait until
they get sick enough to come back into the hospital. That is
not a good plan.
Dr. BUFALINO. One other comment to add to that. The
congestive heart failure that we are talking about today is
surely one of our biggest challenges. These are our sickest
patients. So, your comments about the need for continuum are
critical.
Although we have episodic care when they are really sick in
the hospital, our biggest need is over the time frame when they
are at home and needing follow-up. Most of these patients are
on 8 to 12 drugs, with a fair number of interactions,
obviously. We have had to, in our own practice, extend
ourselves by using nurse clinicians in the office setting by
being able to connect to them at home, to be able to follow up
and do some of the visits, because we cannot meet the need.
So, we are always in need of more effort to be able to
connect to this sickest group of patients, and they tend to
have the most confusing set of problems altogether. A lot of
what you heard today is that four or five illnesses are routine
in a lot of the Medicare patients because these things all
interact together. They have diabetes, high blood pressure,
high cholesterol, bad arteries and a weak heart all together.
That is a typical story. So, we are clearly challenged.
Chairman JOHNSON. It is important for all of you and
particularly for your group and their nurse practitioners to be
able to think through exactly what do those nurse practitioners
do. We tried to do that in the disease management section of
the bill with enormous help from the disease management
professionals. We need to know, what are those practical things
that we would include were we to give a reimbursement, so there
is as clear a delineation as possible? Because the clearer the
regulations are, the less the Inspector General causes
problems. Now, I have respect for the Inspector General, but
you can micromanage this law so that you do not have much left
at all.
So, I do appreciate those comments and I urge you to
encourage the physicians to think, if we were to accept a
global fee for all of this, what would be the things that we
needed to say we would be able to do? Even to look at these
requests for proposals, if that were out there just as a
reimbursement for you all, rather than a whole system of care,
does it include everything that you do? What would be the
appropriate payment?
So, we do face a lot of challenges, but we cannot, we
cannot continue with the current system we have. That is why
passage of this bill called the MMA was crucial, because we
were making no progress on what is the most underlying
challenge in Medicare and that is to modernize what it is we
are paying for and how we are relating to our own providers.
So, thank you very much. Mr. Stark.
Mr. STARK. Thank you, Madam Chairman.
I guess CCIP fills the gap for certain people. I guess
mostly those who are healthy enough to manage their own care
and respond to suggestions that are for their benefit. I am
concerned about those who are not responsible for reasons of
dementia or a whole host of other, perhaps economics and they
cannot perhaps buy the drugs that are required.
I can see a potential conflict between the vendors that
have to cut 5 percent and the pharmaceutical companies who want
to sell more drugs and perhaps the physician who has prescribed
the drug that the benefit manager might try to cut out. I am
not sure there is not some conflict brewing in that area. It is
just this year, after 35 years or whatever it is, of Medicare
that we decided to pay for an initial physical examination. In
other words, Medicare beneficiaries were pretty much charged
with going around and picking their own specialist if a
specialist would take them without a referral because there was
no way to get clocked into the system. I can see the advantage
of having Ask a Nurse or any of these benefit groups helping us
along the way.
I guess my question to the physicians on the panel is, does
the physician not have to start out by assessing a patient and
determining what is wrong, how many of these diseases does this
patient have, and what ought to be the plan? Is that not where
it all starts, or am I missing something?
Dr. BUFALINO. I will be glad to answer that. I think you
are absolutely right. The initial diagnosis is clearly made
with the physician, either the family practice internist or a
cardiologist, depending on the care loop. Those diagnoses are
made and then a plan is laid out in terms of what needs to be
done in terms of their therapy. So, most definitely.
Mr. STARK. That plan has to be designed by a physician,
does it not?
Dr. BUFALINO. I think the initial plan, whether they are in
the office or in the hospital is laid out by the physician. The
question remains then is the follow-up, I think what Chairman
Johnson was referring to, and the continuous loop. Although
that initial interaction where we evaluate, decide the
magnitude of their problem, do whatever diagnostic tests are
necessary, the follow-up there is this chronic problem of
trying to keep them out of the hospital.
I guess from our reading of a lot of the savings, it is
about, can we keep folks at home with these chronic conditions
as opposed to having them have to come back through the
hospital because they did not take the right drug or did not
take the right dose or had not had that close follow-up.
Whether it be the physician or another entity, somebody needs
to be watching that they are taking their medications properly,
clearly.
Mr. STARK. Dr. Wright, what is your take on that?
Dr. WRIGHT. I would perish if someone took away my job of
outlining a plan for my patient. That is the diagnostic and
therapeutic process. Therapeutic process, that is what I do. I
think the way I see disease management techniques benefiting
just an average physician like me is to select data to record
and report data for me that I do not have time or the
inclination, but I desperately need in order to assess my own
performance. I see them assisting in the notification and the
execution of the plan that I have set up with my patient. I
agree with you that there are tremendous hurdles, not just in
the complexity of these medical problems, the number and
complexity, but also in the patients who have the cognitive
deficits.
Mr. STARK. Now, the practice of geriatrics, I guess, I was
looking for their testimony which was submitted. Do they not
attempt, the people who call them, whatever they call
themselves, geriatrists?
Dr. WRIGHT. Geriatricians, I think.
Mr. STARK. Geriatricians. Is not that their role in a sense
with old guys like me? Do they not say, okay, we are going to
manage you, Stark, and look at you because you have problems at
your age that younger people will not have. They are really, I
hate to say ``glorified internists;'' that may be mean to
somebody, but is that not their role then to refer them, if I
have a heart problem, to you all, or if I have sciatica, to
send me to a neurosurgeon or to a physical therapist.
Dr. WRIGHT. I would have to tell you that at least in
northern California, and I think this applies in more places, I
also am a geriatrician because of the depth and breadth of
cardiologic problems and because of the paucity of
geriatricians in smaller communities. I would be delighted if
someone came to town, but because of what I do every day, I am
taking care of that population.
Mr. STARK. Go ahead.
Dr. BUFALINO. Your assessment is right. These are
internists who specialize in patients over the age of 65 or
over the age of 70. So, I think you are right on.
Unfortunately, in our world, half of our patients are over the
age of 65 just by the nature of heart disease.
Mr. STARK. Then I am getting that once you all have
determined what the protocol for keeping all of my moving parts
in working order should be, you turn to Ms. Selecky and say,
here is the plan for Mr. Stark; will you guys call him, follow
up. You have determined that I am not in very serious dementia,
and I can answer the phone; and maybe somebody comes by the
house and checks to see where the pill bottles are, and then
they come back to you. Is that the way you see the system
working?
Ms. SELECKY. Yes, thank you, Mr. Stark. My company was
actually founded by a physician who was trying to find ways of
delivering better care to his chronically ill patients, because
these people have the disease 24 hours a day, 7 days a week,
and the physician cannot be available all the time.
Mr. STARK. They can if you pay the $1,500 for the boutique
kind.
Ms. SELECKY. What we do as an entity really is to support
the physician's plan of care. We very strongly support the
doctor-patient relationship. We understand what the plan of
care is. We try to reinforce it with the patient to make sure
they understand why their physician told them to do something,
why it is important to follow through with that. We help remind
them to do things that they need. To your earlier point about
people with dementia and people who otherwise have trouble
understanding the program, these people still have family
members that need to care for them.
In the case where we cannot communicate directly with the
patient, we communicate with their family member, because we
are generally held accountable for the outcome of the entire
population. Regardless of whether we can really engage that
individual or not, we look for other ways of engaging them. So,
there are a lot of things that we do to customize the program
to the individual needs of our patient populations.
While we do provide services to the commercial, employed
populations, I would say the majority of people we take care of
are people more in their seventies and eighties and people who
have very serious combinations of chronic conditions.
Mr. STARK. Thank you. I thank the panel very much.
Chairman JOHNSON. Thank you very much. This issue, the
physician retaining control and that relationship with their
patient, is of course central. You cannot have a health care
system if you do not protect that relationship. I was very
interested, Dr. Wright, in your comments about these three
doctors, and then the comments about follow on care even if it
is just one doctor; this issue of continuous need for care and
continuous need for care of patients with multiple illnesses.
This RFP, what we started with was those seniors that have
multiple chronic conditions, so we are starting with that group
that go beyond the one physician but have three physicians who
have gone through this care plan and made decisions; and how do
we integrate those plans?
We also require everyone in the RFP to deal with patients
who are cognitively impaired because there is no sense in
learning how to do all of this when half of the population of
our retirees have some level of cognitive compromise. So, we do
need to learn that from the ones that are totally compromised
to the ones that are just partially compromised. Recognizing
the real dearth of geriatric physicians, we did have two of the
demonstrations, I think it is two, specifically focused on: how
do you couple a geriatric center capability with, particularly,
small-practice physician capability? Because there the
practicing physician is making the plan, and we are going to
create a collaborative organization to oversee the
implementation of that plan when there are multiple illnesses
involved, but having that geriatric capability to look at that
situation is going to be very useful to us. How do we spread
the power of the geriatrician over a larger number of
physicians, since there is never going to be a geriatrician in
every community even as our population ages?
So, I just wanted to clarify that, that the RFP is about
multiple illness and involves people with cognitive problems so
that we will get the full variety of solutions out there to
this challenge. Mr. Crane.
Mr. CRANE. Thank you, Madam Chairman. Dr. Wright, when you
were reminiscing about your dad being a physician, it reminded
me of my own personal experience. My dad got his first
doctorate in psychology and he was treating at Northwestern. My
mom went into labor on a Saturday and the obstetrician was out
of town. So, my dad said he put newspapers on the bed and
started boiling water and had the dog come in and sit at my
mother's side and he delivered me. I said, Pop, were you not a
little intimidated by that? He said, oh, we delivered pigs and
cows at the farm; it was no big deal.
Then he got his medical doctorate and he delivered the next
three of my siblings at home on purpose. He used to do surgery
on the dining room table. My great-grandmother, when she was
92, had cataracts in both eyes, and he operated on one and
restored her vision in one eye. We were excited to hear about
that, and we said, well, that is just one eye. Are you not
going to do the other? He said that she is 92. All she needs is
one.
Dr. WRIGHT. Cost conscious even then.
Mr. CRANE. I could not follow in his footsteps. I could not
even stand to look at a needle going in your skin and my kid
brothers got their doctorates, one dentist and one physician,
but I was overwhelmed by that sort of thing. I still reminisce
for entertainment purposes about those years growing up.
I would like to ask you one question about your testimony.
You discussed the success of the cardiac rehabilitation
program. Can you provide some insights as to why these programs
have been so successful and what lessons from them should be
incorporated into the CCIP and Medicare?
Dr. WRIGHT. Thank you, I would love that opportunity. I
learn, I hope, I am getting wiser with time. I did not
understand why I had always been interested in cardiac rehab,
and then when disease management came across the radar, it
struck me as something that was fascinating and important. It
was not until I tried to put this essay together--it has been a
while since I have written an essay, by the way--that I
realized how linked they are, that cardiac rehab is actually
one of the original disease management programs.
I think there are many parallels between the successful
programs that we have come to see in the medical care system,
that we see right now, and the original one. Cardiac rehab,
first of all, is based in science and it is successful because
it builds personal relationships. When a sick person knows that
the person caring for them is invested in them, actually cares
about the outcome, and that contact is not continuous but
frequent, and that the medical care person is well informed
about the specifics of that person's medical situation, that is
a very powerful mechanism for healing. I think that is what
cardiac rehab does.
It is so much more than an exercise program. It actually
allows surveys of that patient's medical world, if you will,
their environment, so that if a patient who has a recent
angioplasty, starts to have a little chest discomfort on the
track, the patient already has a contact with the nurse, the
nurse already knows what that patient looks like going around
the track, and when he or she starts to look a little
different, questions are asked. Immediately we know that
something is brewing and the patient gets referred early and
the patient gets restudied or stented, restented, whatever the
situation is.
So, it works for prevention. It works for disease
surveillance and treatment. It reinforces that the medical care
system is designed to deliver medical care through to each
individual according to his or her needs.
Mr. CRANE. Ms. Selecky, in your testimony, you talk about
the different ways that organization will partner to respond to
the RFPs. Given the objectives of the RFP and the unique needs
of Medicare beneficiaries with multiple chronic conditions, do
you believe that an approach involving multiple organizations
will be necessary and do you think such consortia can be
successful?
Ms. SELECKY. I think that what is necessary is
understanding that disease management is really about creating
a team environment to take care of people. People who have
chronic disease, as we have already talked about here, not only
have several different physicians, but there are a lot of
people who are involved and a lot of entities that are involved
in trying to make them successful in managing their health.
Really, what disease management organizations are about is
trying to defragment that system and make kind of a central
location for all of that information and all of those efforts
to be coordinated. So, it is very important that we not view
this as an opportunity for any particular kind of an entity to
be successful here. I think what is important is that all of
these efforts really reach out and make an effort to connect
the different entities in the health care system.
That being said, I think that what is important in this is
really that the programs and the groups of providers and
suppliers and whatever that come together to do these programs
really understand what their role is and that there is good
data integration among them and they come with some proven
outcomes, that they can actually show CMS that the approach
that they are going to take is going to be one that will
enhance the outcomes for the beneficiaries as well as reduce
cost.
Mr. CRANE. Very good. Now, my neighbor, I would like to ask
you this final question here. Dr. Bufalino, throughout your
testimony you discussed the need for evidence-based performance
measurements to evaluate quality of care and beneficiary
satisfaction. Can you discuss further the types of measurement
that CMS might want to consider in reaching agreements with
bidders under the CCIP?
Dr. BUFALINO. Thank you. I think it is a complex issue.
They already have in the RFP a number of quality measures, and
many of them are physician--driven. They are the assessment of
that patient's heart muscle function.
If we talk about heart failure, which is my area of
interest, and the measure of are they on the right drugs, is
their blood pressure controlled, how often are they
hospitalized, how often are they rehospitalized, how many trips
do they make to the emergency room, those are all measures
there.
I think we would love to have the opportunity at the AHA,
involved with the National Quality Forum, to help set some
further outcomes, the opportunity to take science and give some
meaningful measures. We want to know that these patients have
better quality of life because of this program. Do they feel
better? Are they able to spend more time with their family? Are
they able to function at a higher level is important as part of
this measure. Also, do they live longer? As much as this is a
chronic disease and we are talking about do we keep them out of
the hospital, do we prolong their lives is a critical question
for us in terms of the benefits.
I think those are important things, and we would like to
participate in an opportunity that helps set those clearly
science-based outcomes because we think there is an opportunity
to make this meaningful. I think the Chairman has made it very
clear here that this is about doing a better job, and we would
love to participate in this. Our goal as physicians, or part of
the organizations we are involved in is, how do we reduce death
and disability from this disease? We still lost a million lives
last year to heart disease, a huge problem. We have about 4.5
million folks in the country with heart failure. So, we can use
all the help we can get, quite frankly. I think our plea is
that we would like to be involved in helping improve those
outcomes. I think there is a tremendous opportunity there to
work on this together.
Mr. CRANE. Thank you very much. I thank all three of you
for your testimony, and we look forward to working with you in
the future.
Chairman JOHNSON. I thank you all for being with us here
today. I hope as we work on this together and we see how these
pilots work and we combine our experience now in the government
arena with your experience as practicing physicians, we can
within the near future develop a sounder approach to
encouraging coordinated care and integrated care in our health
system systematically.
I would also ask that you think, because all of you are
where these decisions are made, what are we going to draw from
this in terms of helping patients deal with end-of-life care
decisions? Because we cannot continue--this is my personal
opinion; this is nobody else's opinion; this does not come from
the Subcommittee. If we are going to serve twice as many
seniors in the future, we have to enable them to live a
healthier life, and this is crucial to that. We have to get
them more involved in their health care, and this will do that.
We also have to more intelligently understand the declining
process and at what point does one really look for just
palliative care, supportive care, those kinds of support
systems that recognize that we are now in a different era of
medical experience and personal experience. So, we need to
think about, how does disease management better prepare us for
understanding when the disease process is reaching a point at
which it has a logic of its own and interventions are of little
human value and of great social cost? So, I do not ask you to
respond to that.
Ms. SELECKY. I could though, Chairman Johnson, if you do
not mind. I think, speaking to what Dr. Wright said earlier, it
is about the personal relationships that you build with your
patients and, in our case, with our program participants. That
whole process is also a team approach where you have family
members and physicians.
Chairman JOHNSON. Are you seeing some of that?
Ms. SELECKY. We see much of it because we take care of tens
of thousands of people with congestive heart failure, and it is
a terminal disease. We do end up spending a lot of time working
with people, to have them understand what the consequences are
of their condition; and as it appears that that might be
something that we need to help them with, we refer them to
hospice programs. We talk to them about living wills. We talk
to them about advance directives. I tell you, it is always very
sad when one of our program participants passes away, but we
have many cases in which their family members have called us
afterward and thanked our nurses for the care and consideration
that they have shown them. So, it is a process. It is about
trying to make people's quality of life better regardless of
what that quality of life entails.
Chairman JOHNSON. Do either of you want to comment?
Dr. BUFALINO. Two ends of the spectrum: I think the one
thing that the MMA saw, very importantly, was to do a
preventive piece, which we were missing, the idea to do
screenings and get this disease early so we can do something
about it. We have the tools and the ability to make a
difference. We just sometimes do not get the chance.
So, to prevent heart failure before it happens is where
there is a huge savings to the country, and to that individual
patient obviously.
On the other end, I think it is fascinating to see the
difference--and I think you are very insightful on your
comments about having people be comfortable when the end is
near, and that really comes with that physician-patient
relationship and with the family.
I am sure Janet has the same experience to be able to sit
and talk to that family and say, you know what, we have done
everything we could for Grandma; I think we should keep her
comfortable. I find many, many more patients today and their
families much more comfortable with that decision than there
were 10 or 15 years ago. They know where this could go and the
outcome is not likely to be any better.
Heart failure is cancer of the heart. We just call it
something different. It is a terminal disease. So, we prepare
them from the beginning, once that diagnosis is made, that
there is only so much we will be able to accomplish. We do want
to keep them comfortable, but we need to decide when we have
done all we can do.
Dr. WRIGHT. I do not have anything else. They have said it
and said it beautifully, and I do appreciate your interest in
this also. I do not think we have done as good of a job as we
should, but I would like to just add two quick thoughts about
this legislation. Frankly, Chairman Johnson, hearing you speak
about the potential impact for it and seeing your dedication
and that of the Committee, it has given me hope.
I did not tell you that my dad was disappointed when I went
into medicine. He told me not to because the government was
going to meddle in it, and I would not be able to enjoy
practicing. I am glad I ignored him. It is the only piece of
advice I ignored.
My hope is that what we have seen happen with women's
health will happen with chronic disease health. By that I mean,
in the early days of doing cardiology, we knew that women were
dying, but we did not understand why. We did not understand
that they were actually different than men. It sounds like such
a novel thought.
Women were not part of the research protocols, not because
of a gender bias, but because women are hard to study. You
cannot pick a research subject that is literally, from day to
day, might be pregnant or might be nursing or in the menopause
years, a period of 5 or 6 years. The woman is different
literally from day to day; I can testify to that.
So, women were not selected for research until this body,
until Congress said, you will include women; they are tough
research subjects, but you will include them; we mandate that
so we can learn about them. As a result, we have a flood of
information. We have learned so much that will protect women
and prevent heart disease, not to mention all the other
problems, as a result of the action of this body. I have the
same hope that this legislation and its implementation will
create that kind of transformation in the care of older people
with multiple diseases.
Chairman JOHNSON. Thank you. I think we are capable of that
and we are capable of some other alternatives which I hope to
block. So, I appreciate your testimony today. This is a
challenging time. It is an exciting time both in medicine and
in government policymaking. I thank you for your participation
in the process, in being with us today. Thank you. The hearing
is adjourned.
[Whereupon, at 4:00 p.m., the hearing was adjourned.]
[Submissions for the record follow:]
Statement of AdvaMed
AdvaMed is pleased to provide this testimony on behalf of our
member companies and the patients and health care systems we serve
around the world. AdvaMed is the largest medical technology trade
association in the world, representing more than 1100 medical device,
diagnostic products, and health information systems manufacturers of
all sizes. AdvaMed member firms provide nearly 90 percent of the $71
billion of health care technology products purchased annually in the
U.S. and nearly 50 percent of the $169 billion purchased annually
around the world.
Significant advances in health care technologies--from health
information systems that monitor patient treatment data to innovative
diagnostics tests that detect diseases early and lifesaving implantable
devices--improve the productivity of the health care system itself and
vastly improve the quality of the health care delivered. New
technologies can reduce medical errors, make the system more efficient
and effective by catching diseases earlier--when they are easier and
less expensive to treat, allowing procedures to be done in less
expensive settings, and reducing hospital lengths of stays and
rehabilitation times.
AdvaMed would like to thank the Congress for passing the Medicare
Prescription Drug, Improvement, and Modernization Act of 2003 (MMA)
(P.L. 108-173). We share your goals for the new law to make the
Medicare program more efficient and effective for providers and
Medicare beneficiaries. We believe it is in the best interest of
patients and the Medicare program to have the system capitalize on
advanced technologies, which have revolutionized the U.S. economy and
driven productivity to new heights and new possibilities in many other
sectors.
Chronic Care Improvement Programs: Improving Patient Care and
Modernizing Medicare
AdvaMed strongly supported the inclusion of the Chronic Care
Improvement Program (CCIP) in the MMA to establish a voluntary pilot
program in fee-for-service Medicare focusing on congestive heart
failure, diabetes, and chronic obstructive pulmonary disease. If
designed appropriately, coordinated care for patients with chronic
conditions and diseases will keep patients healthier and happier, as
well as reduce the number of expensive hospital visits from
complications related to the chronic illnesses.
In fact, a report published in February 2004 by MEDTAP
international entitled ``The Value of Investment in Health Care: Better
Care, Better Lives,'' shows the benefits of investing in health care
far outweigh the costs, and it measures those benefits in human and
economic terms. The study shows from 1980 to 2000 that each additional
dollar spent on health care in the U.S. produced tangible health gains
of $2.40 to $3. Overall findings by the year 2000 show that annual
mortality rates declined 16%; disability rates declined 25%; life
expectancy increased 4%, or 3.2 years; and hospital days fell 56%. In
the four major diseases studied, the report finds in the year 2000,
mortality from heart attack was cut almost in half; deaths from stroke
were cut by over one third; breast Cancer mortality declined 20%; and
diabetes management improved dramatically and produced a 25 percent
reduction in complications such as blindness, kidney failure, stroke
and death.
The Important Role of Technology in Designing a Successful CCIP
AdvaMed is monitoring implementation of the CCIP to ensure that it
delivers the value promised to Medicare beneficiaries by the Members of
this subcommittee who crafted the pilot program. In choosing
organizations to participate in the pilot program, CMS should consider
an organization's ability to integrate a range of technologies into its
proposed chronic care improvement program. Such technologies include,
but are not limited to, remote monitoring devices, implantable devices,
and information technology-based solutions. In addition, CMS should set
per patient per month fees paid to organizations at a rate sufficient
to cover the costs of the technologies and the staff necessary to
employ them.
We worked closely with CMS in between passage of the MMA and the
issuance of the Request for Proposals (RFP) on April 20th and have
provided comments to CMS with our specific concerns and questions about
the RFP. Specifically, clinical management of patients with multiple,
progressive, chronic conditions--such as complex diabetes, congestive
heart failure, and chronic obstructive pulmonary disease--often
requires intensive monitoring and intervention. However, the CMS
solicitation for the CCIP states that there will be no change in the
amount, duration, or scope of a participant's fee-for-service Medicare
benefits. AdvaMed seeks clarification from CMS as to whether existing
Medicare Part B utilization controls will be modified or suspended
under the CCIP. We are concerned that requiring awardees to reduce
preventable hospitalizations, health care costs, and adverse health
outcomes, in the context of an acute care-oriented program in which
strict utilization controls continue to be enforced, could frustrate
the purpose of the CCIP.
For example, in an attempt to obtain and maintain tighter glycemic
control, an organization might require certain patients with complex
diabetes to perform blood glucose self-monitoring more often than
current Medicare policies allow. Under current Medicare program
guidelines, without additional medical necessity documentation,
Medicare Part B reimbursement for blood glucose reagent strips and
lancets is limited to 100 every three months in patients with
noninsulin-treated diabetes. Instead of a rigid formula, CMS should
provide CCIP contractors sufficient flexibility to maximize patient
outcomes.
In addition, as part of the per patient per month fees,
organizations submitting bids must include the costs of services not
currently covered by Medicare. CMS has left it unclear how these
organizations should treat services for which the coverage varies by
local carrier.
Lastly, under the CCIP, organizations will be financially at risk
for their fees if they fail to meet agreed upon performance guarantees
for clinical quality, beneficiary and provider satisfaction, and
savings targets. Notwithstanding the enforcement role of the threat of
financial penalties, it would be in the best interests of the
beneficiaries and organizations alike if the organizations' programs
improve themselves throughout the duration of the CCIP to increase the
chances of executing Phase II. Therefore, AdvaMed has requested that
CMS consider requiring each organization, as part of its beneficiary
satisfaction and quality assurance measures, to establish an internal
Beneficiary Ombudsman. The Ombudsman would ensure a clear channel of
communication between beneficiaries and the organization, as well as
provide the organization with a check on the quality of care that its
beneficiaries are receiving.
Conclusion
AdvaMed thanks the Subcommittee members again for their
collaborative efforts to improve and strengthen the Medicare program.
We look forward to working with the Administration and this Committee
on designing a comprehensive and successful CCIP to improve the quality
of care for Medicare patients.
Statement of the Alzheimer's Association
Since our founding in 1980, the Alzheimer's Association has
provided more than $150 million to support research into the
prevention, treatment and eventual cure for Alzheimer's. Our nationwide
network of chapters offer frontline support to individuals affected by
Alzheimer's with services that include 24/7 information and referral,
safety services, and education and support groups.
Section 721 of the Medicare Prescription Drug, Improvement, and
Modernization Act authorizes Chronic Care Improvement Programs that
will focus on one or more of three threshold conditions: congestive
heart failure (CHF), diabetes, and chronic obstructive pulmonary
disease (COPD). The Act requires entities that implement a Chronic Care
Improvement Program to ``have a process to screen each targeted
beneficiary for conditions other than threshold conditions, such as
impaired cognitive ability and other comorbidities, for the purpose of
developing an individualized, goal-oriented care management plan.''
When Alzheimer's disease is present, the Medicare costs of already-
expensive conditions like COPD, congestive heart failure or diabetes
double. The attached fact sheets show: 1) the proportion of Medicare
beneficiaries with each of the threshold conditions who also have
Alzheimer's disease and other dementias; and, 2) the impact of
coexisting Alzheimer's and other dementias on total Medicare
expenditures and hospital use for beneficiaries with the threshold
conditions. Although it might be assumed that older average age of
beneficiaries with the threshold conditions plus Alzheimer's or other
dementias explains the higher Medicare expenditures and hospital use,
data presented in the fact sheets show that this is not true. In fact,
the difference between average Medicare expenditures for beneficiaries
with any of the threshold conditions plus Alzheimer's or other
dementias vs. beneficiaries with the threshold condition but no
Alzheimer's or dementia is greatest in the youngest age group
(beneficiaries age 65-74).
Entities that implement Chronic Care Improvement Programs should
have procedures in place to accurately identify Alzheimer's and
dementia in their program participants. In addition, these entities
should have procedures in place for developing and implementing a care
management plan that takes into account the effects of Alzheimer's and
dementia-related cognitive impairment on a person's ability to follow
treatment recommendations, take medications as prescribed, and manage
other aspects of his or her care. These entities should have procedures
for identifying a family caregiver, if any, and managing care for
participants with Alzheimer's and other dementias who do not have
family caregivers.
Patient self-care and self-management approaches, which are used in
many disease management programs are unlikely to be effective for many
program participants with Alzheimer's and other dementias. The entities
that implement the Chronic Care Improvement Programs will have to adapt
these approaches for participants with Alzheimer's and dementia. Use of
community services, including Alzheimer's Association chapter services,
is likely to improve outcomes for program participants with Alzheimer's
and other dementias. The entities that implement the Chronic Care
Improvement Programs will have to develop effective ways of linking
program participants with Alzheimer's and dementia to these essential
services.
______
Medicare Beneficiaries with Congestive Heart Failure And Co-existing
Alzheimer's Disease or Other Dementias
Prevalence of co-existing Alzheimer's disease and other dementias in
Medicare beneficiaries with congestive heart failure (CHF)
Medicare claims data for a 5% national random sample of fee-for-
service Medicare beneficiaries age 65+ indicate that in 1999, 11% of
these beneficiaries had CHF. Of the beneficiaries with CHF, 21% also
had Alzheimer's disease or other dementias (AD/D). In 2000, 12% of
Medicare fee-for service beneficiaries age 65+ had CHF, and 21% of
these individuals also had AD/D.\1\
Medicare expenditures and hospitalizations for beneficiaries with CHF
and co-existing Alzheimer's and other dementias
In 1999, average Medicare expenditures and hospital use were
substantially
higher for beneficiaries with CHF and AD/D than for beneficiaries with
CHF but no AD/D.
Total average per person Medicare expenditures for those
with CHF and
AD/D were 47% higher than for those with CHF but no AD/D ($22,459 vs.
$15,271).\1\
Average per person Medicare hospital expenditures for
those with CHF and
AD/D were 40% higher than for those with CHF but no AD/D ($13,210 vs.
$9,414).\1\
Medicare beneficiaries with CHF and AD/D were almost
twice as likely as those with CHF but no AD/D to be hospitalized and
almost twice as likely to have a preventable hospitalization.
In 2000, total average Medicare expenditures and average hospital
expenditures were about 50% higher for those with CHF and AD/D than for
those with CHF but no AD/D.1
Increased expenditures for CHF with Alzheimer's disease and other
dementias are not explained by older age
Total Medicare expenditures for Beneficiaries with CHF by AD/D Status and Age\1\
----------------------------------------------------------------------------------------------------------------
Beneficiaries with CHF Beneficiaries with CHF % Increase associated
Age and no AD/D and AD/D with AD/D
----------------------------------------------------------------------------------------------------------------
65-74............................... $17,993................ $34,304................ 91%
75-84............................... 15,515................ 25,368............... 64%
85 and over......................... 11,947................ 17,632................ 48%
----------------------------------------------------------------------------------------------------------------
Medicare Beneficiaries with Diabetes And Co-Existing Alzheimer's
Disease or Other Dementias
Prevalence of co-existing Alzheimer's disease and other dementias in
Medicare beneficiaries with diabetes
Medicare claims data for a 5% national random sample of fee-for-
service Medicare beneficiaries age 65+ indicate that in 1999, 16% of
these beneficiaries had diabetes. Of the beneficiaries with diabetes,
11% also had Alzheimer's disease or other dementias (AD/D). In 2000,
17% of Medicare fee-for-service beneficiaries age 65+ had diabetes, and
12% of them also had AD/D.1
Medicare expenditures and hospitalizations for beneficiaries with
diabetes and co-existing Alzheimer's and other dementias
In 1999, average Medicare expenditures and hospital use were much
higher for those with diabetes and AD/D than for beneficiaries with
diabetes but no AD/D.
Total average per person Medicare expenditures for those
with diabetes and AD/D were 144% higher than for those with diabetes
but no AD/D ($19,395 vs. $7,940).\1\
Average per person Medicare hospital expenditures for
those with diabetes and AD/D were 163% higher than for those with
diabetes but no AD/D ($11,192 vs. $4,254).\1\
Medicare beneficiaries with diabetes and AD/D were 3
times as likely as those with diabetes but no AD/D to be hospitalized
and more than three times as likely to have a preventable
hospitalization.\2\
In 2000, total average Medicare expenditures were 150% higher and
average hospital expenditures were 160% higher for those with diabetes
and AD/D than for those with diabetes but no AD/D.\1\
Increased expenditures for diabetes with Alzheimer's disease and other
dementias are not explained by older age
Medicare beneficiaries with diabetes and AD/D are older on average
than those with diabetes but no AD/D. In 2000, 29% of those with
diabetes and AD/D were age 85+ compared with only 8% of those with
diabetes but no AD/D;\1\ however, older average age does not explain
the higher Medicare expenditures for those with diabetes and AD/D. In
fact, the difference between average Medicare expenditures for those
with diabetes and AD/D vs. those with diabetes and no AD/D was greatest
for beneficiaries age 65-74.
Total Medicare Expenditures for Beneficiaries with Diabetes by AD/D Status and Age, 2000
----------------------------------------------------------------------------------------------------------------
Beneficiaries with Beneficiaries with % Increase associated
Age diabetes and no AD/D diabetes and AD/D with AD/D
----------------------------------------------------------------------------------------------------------------
65-74............................... $7,469................. $24,392................ 227%
75-84............................... 8,563................. 19,920................ 133%
85 and over......................... 8,979................. 16,569................ 85%
----------------------------------------------------------------------------------------------------------------
Medicare Beneficiaries with Chronic Obstructive Pulmonary Disease And
Co-existing Alzheimer's Disease and Other Dementias
Prevalence of co-existing Alzheimer's disease and other dementias in
Medicare beneficiaries with chronic obstructive pulmonary
disease (COPD)
Medicare claims data for a 5% national random sample of fee-for-
service Medicare beneficiaries age 65+ indicate that in 1999, 10% of
these beneficiaries had COPD. Of the beneficiaries with COPD, 15% also
had Alzheimer's disease or other dementias (AD/D). In 2000, 10% of
Medicare fee-for-service beneficiaries age 65+ had COPD, and 15% of
them also had AD/D.\1\
Medicare expenditures and hospitalizations for beneficiaries with COPD
and co-existing Alzheimer's disease and other dementias
In 1999, average Medicare expenditures and hospital use were
substantially higher for beneficiaries with COPD and AD/D than for
beneficiaries with COPD but no AD/D.
Total average per person Medicare expenditures for those
with COPD and
AD/D were 93% higher than for those with COPD but no AD/D ($23,614 vs.
$12,220).\1\
Average per person Medicare hospital expenditures for
those with COPD and AD/D were 90% higher than for those with COPD but
no AD/D ($14,225 vs. $7,472).\1\
Medicare beneficiaries with COPD and AD/D were twice as
likely as those with COPD but no AD/D to be hospitalized and almost
twice as likely to have a preventable hospitalization.\2\
In 2000, average Medicare expenditures were 90% higher and average
hospital expenditures were 84% higher for those with COPD and AD/D than
for those with COPD but no AD/D.\1\
Increased expenditures for COPD with Alzheimer's disease and other
dementias are not explained by older age
Medicare beneficiaries with COPD and AD/D are older on average than
those with COPD but no AD/D. In 2000, 32% of those with COPD and AD/D
were age 85+ compared with only 12% of those with COPD but no AD/D;\1\
however, older average age does not explain the higher Medicare
expenditures for those with COPD and
AD/D. As shown below, the difference between average Medicare
expenditures for those with COPD and AD/D vs. those with COPD and no
AD/D was greatest for beneficiaries age 65-74.
Total Medicare Expenditures for Beneficiaries with COPD by AD/D Status and Age, 2000
----------------------------------------------------------------------------------------------------------------
Beneficiaries with COPD Beneficiaries with COPD % Increase associated
Age and no AD/D and AD/D with AD/D
----------------------------------------------------------------------------------------------------------------
65-74............................... $12,059................ $28,463................ 136%
75-84............................... 12,782................ 24,416................ 91%
85 and over......................... 12,847................ 19,557................ 52%
----------------------------------------------------------------------------------------------------------------
REFERENCES
\1\ These figures come from FY 1999 and FY 2000 Medicare claims for
a 5% national random sample of fee-for-service Medicare beneficiaries
age 65+. Those with no claims are included. Medicare beneficiaries who
were enrolled in Medicare managed care and beneficiaries under age 65
are excluded. Beneficiaries were classified as having COPD based on
Clinical Classification Software (CCS) categories. Beneficiaries were
classified as having AD/D if they had at least one Medicare claim with
an ICD-9 code diagnosis 290, 294, or 331 in the relevant year.
\2\ Bynum JPW, Rabins PV, Weller W, et al., ``The Relationship
Between a Dementia Diagnosis, Chronic Illness, Medicare Expenditures,
and Hospital Use,'' Journal of the American Geriatrics Society,
52(2):187-194, 2004.
Statement of Virginia Zamudio, American Association of Diabetes
Educators, Chicago, Illinois
Thank you, Chairwoman Johnson, Ranking Member Stark, and members of
the Subcommittee, for holding this important hearing today on the newly
instituted Medicare Chronic Care Improvement Program (CCIP). I am
Virginia Zamudio and I am a registered nurse, certified diabetes
educator, and President of the American Association of Diabetes
Educators. On behalf of AADE, a group of health care professionals
dedicated to improving the care of people living with chronic disease,
I am submitting this written testimony to express our strong support
for the CCIP and to suggest additional measures the Committee should
consider in its efforts to strengthen the Medicare program to improve
care for beneficiaries with diabetes.
About the American Association of Diabetes Educators
Founded in 1973, the American Association of Diabetes Educators is
a multi-disciplinary professional membership organization dedicated to
advancing the practice of diabetes self-management training and care as
integral components of health care for persons with diabetes, and
lifestyle management for the prevention of diabetes.
AADE's more than 10,000 members are healthcare professionals who
are members of the diabetes care team. They include nurses, dieticians,
pharmacists, physicians, social workers, exercise physiologists and
other members of the diabetes teaching team. AADE currently has 105
local chapters and 17 specialty practice groups.
The Burden of Chronic Disease
Chronic diseases such as heart disease, diabetes, and cancer are
the leading cause of death in the United States, killing seven out of
ten Americans. The costs of chronic disease are staggering--more than
75 percent of health care expenditures in the United States are for
chronic illness. And that figure is expected to grow. By 2020, $1
trillion, or 80 percent of health expenditures, will be spent on
chronic diseases. More than 125 million Americans live with some form
of chronic disease, and millions of new cases are diagnosed each year.
The challenges of treating chronic disease are myriad--patients often
have more than one chronic condition and therefore see multiple health
care providers. This results in un-coordinated care, duplicitous and
sometimes contradictory treatment plans, and healthcare inefficiencies.
Chronic diseases are especially burdensome in the Medicare program.
Beneficiaries with more than five chronic conditions account for only
20 percent of the Medicare population, yet 66 percent of Medicare's
budget is spent treating these individuals. We can and should do more
to improve disease management programs under the Medicare program.
The Burden of Diabetes
Diabetes poses a particular burden for the Medicare program. As you
know, diabetes is a serious, debilitating chronic illness that afflicts
more than 18 million Americans, including eight million Medicare
beneficiaries. An additional eight million seniors suffer from a
condition known as ``pre-diabetes'' that, when left untreated, will
develop into diabetes.
Diabetes' devastating complications--kidney failure, blindness,
lower extremity amputation, heart disease and stroke--result in
significant costs to the program. Although beneficiaries with diabetes
comprise only 20 percent of the Medicare population, spending on
diabetes related complications account for more than 30 percent of
expenditures. With the current obesity epidemic, the aging of the baby
boom generation, and the expected growth in numbers of Medicare
beneficiaries with diabetes, the cost of diabetes related complications
could seriously undermine the financial stability of the Medicare
program.
The Value of Diabetes Self Management Training
While the costs and complications of diabetes are daunting, there
is much that can be done to prevent diabetes and reduce its
complications. Patient self-management is cornerstone of chronic
disease care, and in no case is that more true than diabetes self-
management. Diabetes self-management training (DSMT), also called
diabetes education, provides the skills that patients with diabetes
need to successfully manage their illness. DSMT helps patients identify
barriers, facilitate critical thinking and problem solving and develop
coping skills to effectively manage their diabetes. Initial diabetes
self-management training occurs over a four to six month period, with
additional follow-up as needed.
The goal of diabetes self-management training is to achieve
measurable behavioral change outcomes in areas such as physical
activity; meal planning; medication administration; blood glucose
monitoring; problem solving for high and low blood glucose and sick
days; reducing risk factors for diabetes-related complications; and
living with diabetes/psychosocial adaptation. National standards for
Diabetes Self-Management Programs were established in the 1980s.
Certified Diabetes Educators (CDEs) are highly trained healthcare
professionals--often nurses, pharmacists, or dieticians--who specialize
in helping people with diabetes develop these skills. To earn the CDE
designation, a health care professional must be licensed or registered,
or have received an advanced degree in a relevant public health
concentration, have professional practice experience and have met
minimum hours requirements in diabetes self-management training, and
have met certification and recertification requirements.
The value of DSMT is well documented. The Diabetes Prevention
Program study of 2002 demonstrated that participants (all of whom were
at increased risk for developing type 2 diabetes) were able to reduce
that risk by implementing the lifestyle changes taught as part of DSMT.
Additional studies have found that patients with diabetes achieved
significantly better outcomes when part of comprehensive diabetes
management programs.
Diabetes Self Management Training and the Medicare Program
The Chronic Care Improvement Program is an important measure aimed
at improving the quality of care for chronically ill beneficiaries
under Medicare fee-for-service. While we support this effort, we feel
it is important to note that this is not the first time that Congress
has attempted to improve disease management for beneficiaries with
diabetes.
Congress recognized the value of DSMT when it enacted the Balanced
Budget Act (BBA) of 1997. Section 4105 of BBA provided coverage and
reimbursement for DSMT by physicians and other individuals or providers
who were eligible to bill Medicare for services or supplies, provided
that DSMT was furnished incident to other covered services, regardless
of whether those items or services are related to diabetes care.
Under current law, all recognized providers can bill Medicare for
DSMT, provided CMS guidelines and American Diabetes Association
education recognition criteria are met. Because Certified Diabetes
Educators are not recognized as Medicare providers, however, they are
precluded from directly billing Medicare for DSMT. They must bill
either through a hospital-based program or through a physician's
office. We believe that it is counterintuitive and counterproductive to
exclude the group of health care providers that are most skilled and
capable of providing this critical benefit.
This provision could also seriously threaten beneficiary access to
DSMT. As it is, the Centers for Medicaid and Medicare Services (CMS)
reports that the DSMT benefit is underutilized--only 30 percent of
eligible beneficiaries are receiving DSMT. This situation is likely to
grow worse, however, as hospital based DSMT programs are closing at a
rate of 2-5 per month. Absent legislative action, fewer and fewer
Medicare beneficiaries will be able to access the services of a CDE.
H.R. 3194, introduced by Congressman Curt Weldon and Congresswoman
Diana DeGette, would correct this problem by recognizing CDEs as
providers under the Medicare program. This legislation would help
realize Congress' intent in BBA, which was to expand access to DSMT
programs for all beneficiaries with diabetes. As this committee
considers ways to improve disease management for patients with chronic
illnesses, we strongly recommend the enactment of H.R. 3194.
Conclusion
In conclusion, we wholeheartedly support efforts to improve
diabetes care, such as CCIP. We feel it is incumbent upon the Congress,
however, to ensure that measures already in place to improve diabetes
care--such as the DSMT benefit--are strengthened so that beneficiaries
with diabetes can gain the critical skills they need to manage their
illnesses.
Thank you, Madam Chairwoman, for allowing AADE this opportunity to
express its concerns. We welcome the opportunity to work with you, and
this Subcommittee, to further our mutual goals of improving diabetes
care under the Medicare program.
Statement of the American College of Physicians
The American College of Physicians (ACP), representing over 115,000
internal medicine physicians and medical students, is pleased to
provide written comments on Section 721 of the Medicare Modernization
Act of 2003, the Medicare Chronic Care Improvement (CCI) demonstration
program. These comments are provided in follow-up to the May 11, 2004
hearing on the CCI program held by the Subcommittee on Health of the
House Ways and Means Committee.
1. Care for Chronically Ill Medicare Patients with Multiple Co-Morbid
Conditions is Fragmented and Unduly Costly Under Medicare Fee-
for-Service, Making CCI Pilot Testing Crucial for Medicare's
Future
The CCI program represents an attempt to study the cost-
effectiveness, quality of care outcomes, and provider and patient
satisfaction which may result from using a coordinated care approach
for selected chronically ill Medicare patients. According to the
Centers for Medicare and Medicaid Services (CMS), while Medicare
patients with 5 or more chronic conditions represent 20 percent of the
total Medicare population, this group represents 66 percent of all
Medicare spending, making it vital that their care be more cost-
effective. The CCI program's initial focus on patients with congestive
heart failure or complex diabetes is a recognition by CMS that these
beneficiaries have exceptionally high self-care burdens and high risks
of experiencing poor clinical and financial outcomes.
Case management of the care of chronically ill Medicare patients is
a vital, high level service which, until now, has not been duly
recognized and compensated under Medicare fee-for-service (FFS). Yet,
there is accruing evidence that case management of the chronically ill
can have a significant positive impact on the quality of patient care
and reduce costs, when compared to receiving care in a fragmented, hit-
or-miss fashion under Medicare FFS.
In a January 2004 Issue Brief, Georgetown University's Center on an
Aging Society concludes that ``disease management programs can reduce
health care use and expenditures'' by being ``successful at improving
self-care practices and reducing use of various health care services,
including hospital admissions and emergency room visits. As a result,
health care expenditures for certain populations with chronic
conditions have decreased.''
The Disease Management Association of America (DMAA), in a paper
titled, ``The Benefits of Disease Management in Medicare and
Medicaid,'' cites evidence of how disease management improves quality
of care and lowers cost. These positive findings led to DMAA's
statement that it ``fully supports and commends the Congress and CMS
for promoting the expansion of disease management programs in its
efforts to modernize and revitalize Medicare+Choice and through
coordinated care provisions of the Medicare, Medicaid, SCHIP Benefits
Improvement and Protection Act of 2000 (BIPA), and other demonstration
projects.''
Unlike a number of other CMS chronic care demonstration programs,
which are experiments with no statutory requirement for later adoption,
the CCI program is intended to identify new approaches to coordinating
and paying for chronic care case management which ultimately will
become a permanent part of Medicare. As such, ACP applauds Congress's
willingness to use the CCI pilots to determine which models of care
oversight work best for chronically ill patients, in terms of cost-
effectiveness and improved patient outcomes, and then implement them
nationally for the benefit of all Medicare patients.
2. Internists Are Best Suited to Lead and Oversee the Care of
Chronically Ill Patients
ACP believes strongly that a physician skilled in the management of
multiple chronic adult illnesses should lead the care management team.
Only doctors of internal medicine are specially trained and experienced
in caring for these complex patients. By using a patient-centered,
physician-guided approach to care, all elements of care are supervised
and monitored by a single responsible medical expert, who places the
patient's well being at the heart of care. Not only does this permit
much tighter coordination of a patient's care than is possible with a
disease management (DM) organization, the physician team leader is free
to make the best choices for high quality efficient care for their
patients, without profit motives which impact clinical decision making.
3. A Patient-Centered, Physician-Guided CCI Pilot Model Should Include
a Physician Case Management Fee and Incentives for Performance
It is ACP's position that the heightened responsibility of this
physician team leader position, as well as its potential to produce
better patient outcomes at lower cost, clearly warrant an augmented
payment to physicians for the extra coordination work this entails, as
well as an additional incentive payment for improved patient outcomes
and lowered costs.
ACP's position on the importance of using a patient-centered,
physician-guided model which is linked to payment incentives is echoed
loudly in the testimony of Robert A. Berenson, M.D., Senior Fellow at
the Urban Institute, provided to the Subcommittee on Health on May 11,
2004:
``Although the CCI program may be a good start, in my opinion
it is insufficient for truly addressing chronic care needs in
Medicare because it lacks a focused physician component . . .
The financial underpinnings of a typical medical practice do
not support physicians who actually do recognize the need to be
more fully engaged in the components of chronic care
coordination--Bounced around the system, too many Medicare
beneficiaries do not even recognize a particular physician who
is responsible for coordinating their care--Among other areas
that need attention is the overlooked issue of physician
payment policy. Simply put, the incentives inherent in most
fee-for-service payment systems, including Medicare's and those
of most private payers, penalize primary care physicians who
would alter their professional interactions with patients to
respond to the challenge posed by the reality of patients with
multiple complex conditions. Yet, the Medicare Modernization
Act mostly ignores alternative payment approaches affecting
physician behavior. These payment approaches should go hand in
hand with the new chronic care program to ensure the kind of
change needed to improve care for Medicare beneficiaries.''
ACP agrees strongly with the CCI program's provision of a per
enrollee per month case management fee to organizations winning CCI
contracts with CMS. However, since these fees are paid to the
contractors, we would urge CMS ensure that, wherever a physician case
manager is the head of the care delivery team, that participating
organizations be required to share this fee with their physician case
managers
The CCI program's RFP also does not explicitly call for or preclude
contractors from paying performance bonuses to their physician case
managers. The major issue is that contractors' are at risk for their
case management fees, meaning if negotiated health improvement targets
for their chronic care enrollees are not met in terms of cost savings,
the shortfalls will be taken out of their case management fees.
Considering the novelty of the CCI pilots in terms of care delivery
models being tested and size of pilot populations, contractors may be
hesitant to risk using case management fees for expanding IT adoption
or paying physician case managers for performance in the early stages
of the program.
In developing health care improvement targets for CCI contractors
and their physician case managers, it is important for CMS to keep in
mind that these performance goals be limited to elements of care
completely under the physician's control. To the degree possible, each
physician case manager's caseload must be appropriately risk adjusted
for the complexity of their patients, while patients who fail to comply
with prescribed care plans should not be counted when measuring
physician performance.
The CCI program is available to a wide array of organizations:
Health insurers, disease management companies, physician group
practices, integrated delivery systems, consortia of these entities,
and any other legal entity that meets the requirements of the
solicitation in the Federal Register. The scope of the CCI program is
vast, operating in at least 10 pilot locations and requiring each
contractor to oversee the care of 15,000 to 30,000 Medicare
beneficiaries--far out of the reach and capabilities of the small
physician group practice. Among ACP's practicing members, 67.4 percent
are in practices of 10 or less, while 50.2 percent are in practices of
5 or less. Clearly, the CCI program is biased in favor of large
organizations such as DMs, making it virtually impossible that a small
physician group practice could win a CCI contract.
Since, by statute, elements of the CCI program pilots which prove
themselves successful will eventually become a permanent components of
Medicare, it is critically important to have practicing physicians
fully vested in the all the care models tested, in order to demonstrate
that physician case management is the key to successful CCI efforts
4. Use of Advanced Information Technology Should be an Essential
Element of CCI Phase I Pilot Testing
ACP is a strong advocate of bringing the advances of information
technology (IT) to enhance the quality of patient care, as reflected in
two major papers released in 2004 (see references at end of this
testimony). We believe optimal case management of chronic care patients
cannot occur without instantly accessible electronic information from
all sources of care, the goal of an interoperable national health care
information system--a goal ACP supports and is actively pursuing. The
CCI program represents an ideal opportunity to provide incentives for
adoption of quality enhancing IT. Having rapid electronic access to all
vital patient information, as well as clinical decision support
software such as ACP's Physician Information and Education Resource,
will be crucial in assuring the physician case manager can optimally
serve his/her patients, which is why incentives for IT adoption are so
important. The CCI program's Request for Proposal (RFP) does encourage
contractors to assist care providers in adopting enhanced
communications technology, though any such support they provide to
physicians and other providers must come out of their negotiated case
management fee.
However, ACP believes there is sufficient leeway for CMS, in
negotiating case management fees and health improvement targets with
contractors, to allow contractors to offer information technology
incentives. ACP would thus urge CMS to assign one or more of its pilot
sites to test use of these additional incentives.
Summary
ACP strongly encourages CMS to ensure that one or more of its CCI
pilot sites utilize a patient-centered, physician-guided approach to
care as defined above, to be certain this model is fairly evaluated
against all other models tested. ACP also urges this model include a
physician case management fee and incentives for physician performance
and IT adoption. If such a model is not selected for testing in Phase I
of the CCI program, ACP would ask Congress to pass corrective
legislation to address this major oversight.
ACP also heartily endorses CMS's stated goals for the CCI pilot
program, listed on the CMS website, as follow:
It leads toward a stronger focus on improving health
outcomes for prospectively identified targeted populations who are not
well served by the fragmented FFS health care delivery system.
It creates a new focus on setting measurable performance
goals and tracking improvements in clinical quality, provider and
beneficiary satisfaction, and cost-effectiveness in a regional,
population-based framework.
It develops and tests the concept of tying contractor
payment to results in achieving quality and cost targets and
satisfaction levels.
It helps modernize Medicare by creating incentives for
the private sector to harness advances in information technology and
innovation in care management on behalf of FFS Medicare beneficiaries
It addresses quality failings without changing
beneficiary's benefits, providers, or access to care.
It is an approach that is regional, yet potentially
replicable nationally.
It is a substantial investment for those beneficiaries
who need it most that will help reduce avoidable costs.
Minority populations suffer disproportionately from
chronic diseases and will stand to benefit most from the program.
ACP urges CMS to ensure that a physician-centric CCI model is
tested at a least one of its 10 pilot sights. ACP also stands ready to
work with any CCI bidders that offer a physician-centric model that
includes the incentives identified above, and would also encourage use
of its clinical decision support tool, PIER. For any bidder which
offers a physician-centric model which, upon close inspection meets all
ACP requirements, the College may be willing to endorse the bidder's
proposal and encourage ACP members residing in that particular
geographic area to participate in the pilot program
References
\1\ The Paperless Medical Office: Digital Technology's Potential
for the Internist, ACP Discussion Paper, March 2004. Available at:
http://www.acponline.org/hpp/paperless.pdf?hp
\2\ Enhancing the Quality of Patient Care Through Interoperable
Exchange of Electronic Healthcare Information, ACP Policy Paper, April
2004. Available at: http://www.acponline.org/hpp/quality_care.pdf?hp
Statement of American Geriatrics Society, New York, New York
The following written testimony is on behalf of the American
Geriatrics Society (AGS), an organization representing geriatricians
and other health care professionals dedicated to the care of older
adults.
Brief History of Geriatrics
Geriatric medicine promotes preventive care, with emphasis on care
management and coordination that helps patients maintain functional
independence in performing daily activities and improves their overall
quality of life. With an interdisciplinary approach to medicine,
geriatricians commonly work with a coordinated team of other providers
such as nurses, pharmacists, social workers, and others. The geriatric
team cares for the most complex and frail of the elderly population.
Geriatricians are primary--care oriented physicians who are
initially trained in family practice or internal medicine, and who,
since 1994, are required to complete at least one additional year of
fellowship training in geriatrics. Following their training, a
geriatrician must pass an exam to be certified and then pass a
recertifying exam every 10 years. There are almost 7,000 geriatricians
in the United States.
The Frail Elderly/Chronically Ill Population
Americans are not dying typically from acute diseases as they did
in previous generations. The Partnership for Solutions, a Robert Wood
Johnson founded initiative of which we are a partner, has found that
about 78% of the Medicare population has at least one chronic condition
while almost 63% have two or more. Of this group with two or more
conditions, almost one-third (20% of the total Medicare population) has
five or more chronic conditions, or co-morbidities.
In general, the prevalence of chronic conditions increases with
age--74% of the 65 to 69 year old group have a least one chronic
condition, while 86% of the 85 years and older group have at least one
chronic condition. Similarly, just 14% of the 65-69 year olds have five
or more chronic conditions, but 28% of the 85 years and older group
have five or more.
Medicare Reform and the Geriatric Patient: How Does Disease Management
Differ from Geriatric Care?
The Medicare program has recently undergone major reforms: the
addition of outpatient prescription drug coverage and disease
management. Will these new changes address the problems faced by frail
older persons and the physicians who treat them?
Little is being done to change the nature of the system from acute
episode care to sustained chronic care. As today's hearing notes, the
Medicare bill included several new chronic care provisions, including a
new study on chronic care, a small scale physician-oriented
demonstration program, and, of relevance today, a larger scale disease
management pilot program. Unfortunately, the new disease management
program may not adequately address the needs of persons with multiple
chronic conditions.
The new disease management pilot program establishes chronic care
improvement organizations (CCIOs) under the Medicare fee-for-service
program. CCIOs, which may include disease management organizations,
health insurers and integrated delivery systems, will be required to
improve clinical quality and beneficiary satisfaction and achieve
spending targets in Medicare for beneficiaries with certain chronic
conditions. CCIOs will be held at full risk for their role in helping
beneficiaries manage their health through decision-support tools and
the development of a clinical database to track beneficiary health.
Why aren't disease management programs sufficient to transform the
system of care for frail older persons?
Disease management covers many different activities influencing
individual health status and the use of health care services.
Typically, disease management programs treat patients with specific,
clearly-defined diseases, such as diabetes, asthma, congestive heart
failure or chronic obstructive pulmonary disease where the evidence is
clear and management strategies are straightforward. Disease management
focuses on patient education and evidence-based self-management
strategies as tools to improve care. Disease management relies on
improved disease outcomes to improve health and reduce disease-specific
health care utilization. Patients who are the best candidates for
disease management programs are those who have the motivation and
cognitive skills to appreciate their role in illness management and
implement self-management strategies.
Geriatric care is another term for coordinated care or care
management. Care coordination programs generally enroll patients with
multiple chronic conditions. The combinations of conditions puts the
patients at high risk of medical and social complications that requires
specific interventions tailored to the specific needs of each enrollee.
These interventions include an array of services, such as telephone
coordination with other physicians, extensive family caregiver support,
referrals for social supports, and high levels of medication
management.
While disease management is appropriate for certain Medicare
beneficiaries with a single chronic condition, such as diabetes, asthma
or hypertension, it fails to address key issues for patients that have
multiple chronic illnesses and/or dementia. This issue is further
explored below.
First, disease management is not typically appropriate for persons
with more than one chronic condition. Imagine putting a patient with
diabetes, hypertension, dementia, asthma, and COPD into a disease
management program for each of these conditions. Most of the people who
are most costly to Medicare have multiple conditions and the care for
these people can not be segmented into different disease management
programs. In fact, many of these individuals with one or more chronic
conditions also have Alzheimer's disease or another dementia. Disease
management focusing on diabetes without taking dementia into account
wouldn't be successful. While some disease management companies suggest
that they have taken a new holistic approach to patient care, this
evidence remains anecdotal.
Second, when used for patients with multiple co-morbidities,
disease management can disrupt a patient's critical relationship with a
primary care physician. Some disease management programs utilize
specialists that focus only on specific interventions tailored to one
condition. The nature of chronic illness requires a comprehensive, care
coordination based approach that utilizes a variety of interventions.
Disease management programs that lack a physician component do little
to coordinate the care of older persons with multiple illnesses and
little to mitigate the safety hazards of fragmented, redundant care
delivered by multiple providers. Significantly, a recent, large-scale
Mathematica best practices study noted that maintaining and fostering
the physician-patient relationship is critical to the success of
chronic care delivery.
Third, a major component of disease management involves self-
management and patient education. These simply do not work for persons
with Alzheimer's disease or a related dementia. Diabetes self
management often involves patient education or patient self management
which is inappropriate for a beneficiary with Alzheimer's disease or
related dementia. Likewise, disease management for asthma and
hypertension depends on patient compliance with treatment
recommendations; this would not be effective for persons with
Alzheimer's disease or related dementia. In comparison, care
coordination models rely on engaging family and caregivers and
maximizing their involvement.
Fourth, disease management does not always address functional
issues that are common in old age or the complications that arise from
multiple chronic illnesses.
Fifth, treatment guidelines provide little guidance when multiple
chronic illnesses co-exist. Therapeutic decisions are less
straightforward, making treatment decisions less amenable to
algorithmic self-management protocols.
Finally, disease management programs place little importance on
using social support services, a major component of a care coordination
approach which relies on a holistic model of patient care.
Additional physician participation and attention to the needs of
multiple chronic conditions and especially dementia could improve
project outcomes, but the model remains different from the approach of
a new fee-for-service care coordination benefit.
Instead, the AGS recommends the legislative authorization of a new
Medicare fee-for-service chronic care benefit, which would include a
physician assessment and team based care management benefit. This is
based on the Geriatric Care Act, legislation introduced in the House by
Congressman Gene Green (D-TX) and in the Senate by Senator Blanche
Lincoln (D-AR) and the Medicare Chronic Care Improvement Act,
legislation introduced in the House by Congressman Pete Stark (D-CA)
and in the Senate by Senator John D. Rockefeller IV (D-WVA).
Conclusion
While the introduction of the CCIO program represents a modest step
forward in the delivery of chronic care, we remain convinced that a
significant portion of our nation's needs will remain unmet without the
addition of a related but different physician directed chronic care
benefit within the fee-for-service system. We hope to work with the
Subcommittee on Health on such a change.
Statement of Sandeep Wadhwa, McKesson Corporation, San Francisco,
California
I am pleased to submit this statement on behalf of McKesson
Corporation to the Subcommittee on Health of the House Committee on
Ways and Means, subsequent to the May 11, 2004 hearing on the Medicare
Chronic Care Improvement Program (CCIP).
As the world's largest healthcare services company, McKesson is an
industry leader in the provision of disease management services to the
Centers for Medicare and Medicaid Services (CMS) through our Medicaid
fee-for-service contracts with seven states. We commend the members of
the Committee and the Congress for incorporating a disease management
program for Medicare beneficiaries within the Medicare Modernization
Act and are pleased to share our perspective on the use of disease
management programs to improve quality and clinical outcomes in CMS
populations while decreasing health care costs.
Our disease management clients cover a broad host of purchasers of
health care, including:
State contracts for the Fee-for-Service Medicaid
populations in Mississippi, Washington, Oregon, Colorado, Florida, New
Hampshire, and Montana
Managed Medicaid plans such as Triple-C (Puerto Rico) and
the Santa Clara Family Health Plan
Individual high risk insurance pools like CoverColorado
and the Oklahoma Health Insurance High Risk Pool, Utah High Risk Pool
Commercial health plans such as Blue Cross Blue Shield
Federal Employees Program and Blue Cross Blue Shield of Texas
Medicare+Choice plans such as Order of Saint Francis and
Group Health Insurance
McKesson is the industry leader in care management services and
software and also has market leadership positions in demand management
and utilization criteria. Furthermore, we are leading providers of
physician and quality profiling software and case management workflow
software. As an early provider of these programs, we have been
delivering disease management services since 1996. McKesson's disease
management programs leverage our experience with patient services,
pharmacy management, and health care quality improvement activities.
Many of these programs and services reflect the capabilities and
expertise of our 170 year old company, one of the largest nationwide
distributors of pharmaceuticals and health care products and the
largest health information technology company in the world.
Over the past three years, many states have turned to disease
management programs to help contain their rising Medicaid budgets and
provide better services for low-income population groups. Our analyses
of the Medicaid fee-for-service (FFS) population show a surprising
similarity to many of the issues confronting the Medicare FFS
population. In particular, the blind and disabled Medicaid utilization
patterns are similar to the Medicare population that we serve in
Medicare+Choice plans. Like the Medicaid FFS blind and disabled
population, the Medicare population has highly complex health care
needs. Both groups are considered vulnerable populations because of
their age, poverty or disability. Additionally, both are able to see
any physicians or emergency rooms that accept Medicaid or Medicare
payment.
In the following sections, we provide comments on the CCIP through
the lens of our experience overseeing similar interventions in the
Medicaid FFS population. Some of the specific concerns likely to be
factors in the CCIP have been addressed in our Medicaid FFS experience.
Patient Identification and Participation
One of the most significant barriers to the success of the CCIP
will be successfully engaging patients to participate in these
interventions in a manner that is respectful and non-discriminatory.
Experience in the Medicaid fee-for-service setting is illustrative.
Patients are identified for these programs primarily through historical
claims analysis. This process is highly efficient and accurate and
allows for a comprehensive population based identification method
rather than relying on costly and more fallible chart reviews at
physicians' offices. Initially, the physicians of these identified
patients are also contacted. Direct mailings then go out to the
patients informing them of the chronic care management program's design
and goals. Community based awareness campaigns help to raise awareness
among patients and physicians.
Once patients have been identified, enrollment campaigns ensue.
Initial enrollment and assessment takes place telephonically or through
face-to-face meetings with patients. In our experience, fewer than five
percent of eligible patients have opted out of these programs, and the
highest rates of participation are among those who are the sickest, the
frailest and the most vulnerable. These patients are also the heaviest
utilizers of services and thus afford the greatest opportunities for
generating savings. Interviews we have conducted indicate tremendous
appreciation for these outreach services. These programs also comply
with all HIPAA standards. The proposed methodology for enrollment for
the CCIP by CMS will largely follow this Medicaid model. In our
experience, this process is highly respectful, professional, and well-
received by beneficiaries.
In the Medicare population, we also anticipate much higher rates of
cognitively impaired beneficiaries due to dementia, which is similar to
the cognitive impairment of the Medicaid population due to
schizophrenia. Disease management programs which serve the Medicaid
schizophrenia population make strong efforts to involve the
beneficiaries' caregivers. Caregiver involvement is a key tenet for all
disease management programs; for patients with cognitive impairments
and insight disorders, it is especially critical. Our experience has
shown that caregivers appreciate the emotional support, skill training,
and counseling services that are provided. Furthermore, we have found
that these programs help sustain and renew caregivers in providing care
for an often unappreciated and demanding role. Similar services need to
be provided to those who are acting as caregivers to the Medicare
population.
Provider Involvement
During the recent hearing, concern was expressed that those who are
awarded CCIP contracts to provide disease management services will find
it challenging ``to develop the necessary links with physicians''.\1\
Most disease management programs are successfully able to overcome
physicians' concerns that these programs replace or disrupt their care.
Prior to contacting patients, disease management organizations
typically engage in an extensive physician awareness campaign about the
programs' methods and objectives. These efforts have dramatically eased
physicians' concerns about the nature of disease management programs
and have increased physician participation. It is critical to educate
physicians that disease management programs promote adherence to their
treatment recommendations and provide their patients with education
services to augment their efforts. In Mississippi, McKesson has
partnered with the University of Mississippi Medical Center and with
the Mississippi Primary Health Care Association, the Mississippi trade
organization of community health centers, to educate Mississippi
providers about the disease management initiative. Similar types of
interventions will be beneficial for providers before Medicare patients
are enrolled.
---------------------------------------------------------------------------
\1\ Robert Berenson, Testimony to Subcommittee on Health of House
Ways and Means Committee, May 11, 2004.
---------------------------------------------------------------------------
A key issue in treating the Medicare population is the slow
adoption of national clinical practice guidelines. The elderly are more
apt to be under treated. An important component of disease management
interventions is to accelerate the adoption of these national clinical
practice guidelines. Patients are educated on the guideline
recommendations and encouraged to discuss the appropriateness of the
recommendations with their physicians. Disease management firms are
able to present reports to physicians on the gaps that exist between
practice and guideline recommendations. Patient safety deliberations
often focus on medical errors that have been committed, rather than on
errors which result from omitted treatment. Through clinical decision
support tools and patient empowerment, disease management programs are
designed to reduce these errors of omission.
Care Coordination
In Medicare FFS, patients often see multiple physicians without one
serving as a primary coordinator of care. The absence of a physician
``quarterback'' contributes to excessive testing, medication errors,
and miscommunications. A key dimension of the CCIP will be to assist
the patient in identifying a ``medical home'', which is a physician or
a clinic primarily responsible for treating and managing the patient's
chronic condition. Once a medical home is established, the disease
management nurse cements the relationship by serving as an advocate for
the patient and informing the physician of symptoms, self management
practices, and gaps with nationally accepted clinical guidelines. The
quality of the patient/physician interaction is enhanced through
patient education and nurse advocacy.
CMS has recommended greater communication and collaboration among
those involved in caring for the elderly, and the CCIP provides
incentives for such increased collaboration between disease management
organizations and providers. McKesson welcomes the opportunity to
further integrate our services and enhance our collaboration with
provider organizations to fulfill the vision of a population-based,
patient-centered, provider-coordinated chronic care model.
Proven Benefits from Disease Management Programs
McKesson programs have demonstrated dramatic improvements in the
health status of patients, with marked reductions in hospitalization
and emergency room visits that have resulted in net reductions in
health care costs. In order to achieve improved outcomes, our programs
focus on teaching patients self-management principles, symptom control
strategies and optimal medical management practices. Overall, patients
in our programs have reported very high satisfaction with the service
and noted improvements in their overall quality of life. Attached are
case studies that summarize the positive results achieved in the
Washington, Oregon and Mississippi state Medicaid programs.
Conclusion
In conclusion, the experience we have obtained from providing
Medicaid FFS disease management services indicates that many of the
expected barriers and concerns with the Medicare population can be
addressed and overcome. Realization of cost savings, patient
participation, provider involvement, adherence to guidelines and
coordination of care are all barriers that have been surmounted in
similar settings, through a rigorous process that provides the
necessary respect and privacy for those who participate in the program.
The outcomes-focused, evidence-based interventions provided in disease
management programs improve patients' ability to participate in their
care and to assist physicians by reinforcing their medical
recommendations. As Congress continues to deliberate about new ways to
improve the quality and delivery of health care, we believe the greater
utilization of disease management programs is a vital way to enhance
care outcomes for the elderly and other vulnerable populations while
concurrently reducing the cost of delivering better care.
We look forward to working with you and members of this
Subcommittee as you address these important concerns.
Statement of Brian J.G. Pereira, National Kidney Foundation, New York,
New York
The National Kidney Foundation (NKF) congratulates Congress for
authorizing the Secretary of the Department of Health and Human
Services to develop a program of chronic care improvement under
Subtitle C of the Medicare Prescription Drug, Improvement and
Modernization Act of 2003 (MMA). This program could promote better
outcomes for the 20 million Americans who have chronic kidney disease
and are at risk for developing End Stage Renal Disease (ESRD), many of
whom are Medicare beneficiaries. Nevertheless, we maintain that this
chronic care improvement program would be enhanced if the Centers for
Medicare and Medicaid Services (CMS) included a specific focus on
chronic kidney disease in its implementation of the legislative
mandate. We recommend that this be accomplished in two ways: first, by
establishing a chronic care improvement program specifically designed
for Medicare beneficiaries with chronic kidney disease, and secondly,
by refining the request for applications for diabetes care and heart
failure that the CMS published on April 20, 2004. Evidence-based
clinical practice guidelines developed by the NKF provide the
scientific foundation for the development of the programs that we
recommend. Those guidelines are part of NKF's Kidney Disease Outcomes
Quality Initiative (K/DOQI) program.
I. Basis for a Chronic Care Improvement Program for Chronic Kidney
Disease
MMA provides that chronic care improvement programs shall be
designed to improve clinical quality and patient satisfaction for
Medicare beneficiaries with one or more threshold conditions as well as
enhance provider satisfaction and reduce avoidable costs. The term
``threshold condition'' is defined in section 721 (a)(2)(D) of Public
Law 108-173 as a chronic condition, such as congestive heart failure,
diabetes, chronic obstructive pulmonary disease (COPD), or other
diseases or conditions, as selected by the Secretary as appropriate for
the establishment of a chronic care improvement program.'' (Emphasis
added.) For the reasons stated below, we believe that chronic kidney
disease meets the statutory criteria for a chronic care improvement
program.
a. The K/DOQI Guidelines for the Evaluation, Classification and
Stratification of Chronic Kidney Disease establish that chronic kidney
disease is a major public health problem in the United States, based on
data from the 1998 report from the third cycle of the National Health
and Nutrition Examination Survey (NHANES III). NHANES III, conducted
from 1988 to 1994, estimated that 6.2 million individuals over 12 years
of age had reduced kidney function, as defined by serum creatinine
concentration. This represents an almost 30-fold higher prevalence of
reduced kidney function compared to the prevalence of ESRD during the
same interval.
b. Timely identification and treatment of patients at risk of
developing End Stage Renal Disease is crucial. The United States Renal
Data System's (USRDS) 2003 Annual Report estimates that the number of
patients with ESRD may reach 2.24 million by 2030. (As of December 31,
2002 there were a total of 297,928 people on dialysis in the U.S.) The
rates of ESRD are high in both minority and elderly populations and the
projected growth of minority populations, coupled with the rising age
of the post-World War II ``baby boomers,'' show the potential for a
dramatic increase in the number of people needing ESRD therapy in the
next 30 years. Disease management could play a significant role in
delaying and preventing the progression of chronic kidney disease and/
or its complications and, thereby reduce avoidable costs. See, for
example, the study by Hock Yeoh, et al., ``Impact of Predialysis Care
on Clinical Outcomes,'' published in Hemodialysis International last
year.
c. The K/DOQI Clinical Practice Guidelines for Chronic Kidney
Disease: Evaluation, Classification, and Stratification specify the
diagnostic criteria that can be used to identity patients in the
various stages of chronic kidney disease and suggest interventions that
would be appropriate to prevent or delay the progression of chronic
kidney disease and/or its complications at each stage.
II. Kidney Disease and Chronic Care Improvement for Diabetes and Heart
Failure
The Notice that CMS published on April 20, 2004 to implement the
Section 721 initiative reads: ``In these initial programs, we will
focus primarily on implementing and evaluating programs for
beneficiaries with congestive heart failure (CHF) and/or diabetes with
significant co-morbidities (hereafter referred to as complex
diabetes).'' (Emphasis added.) However, the terms ``diabetes with
significant co-morbidities'' and ``complex diabetes'' are not defined
anywhere in this 76-page document. The CMS should specify that kidney
disease is a significant co-morbidity for Medicare beneficiaries with
diabetes and that relevant diagnostic and therapeutic interventions for
individuals with diabetes and kidney disease be included in proposals
to participate in this pilot project.
According to the USRDS 2003 Annual Report, the population of
existing patients whose ESRD is caused by diabetes, which tripled from
1990 to 2000, is expected to grown ten-fold by 2030, to 1.3 million,
and the number of patients diagnosed each year with ESRD caused by
diabetes is expected to grow from 41,000 in 2000 to 300,000 in 2030, a
600 percent increase. Furthermore, according to Guideline 14 of the
National Kidney Foundation's Guidelines for Evaluation, Classification
and Stratification of Chronic Kidney Disease, the risk of
cardiovascular disease, retinopathy and other diabetic complications is
higher in patients with diabetes and kidney disease than in diabetic
patients without kidney disease.
An expanded focus on chronic kidney disease in Medicare
beneficiaries with diabetes would require expansion of the initial
chronic care improvement program guidelines. For example, on April 20,
2002, the CMS published a core set of clinical quality indicators for
which applicants are required to establish expectations. ``Monitoring
for nephropathy (test for microalbumin)'' is appropriately included
among the diabetes measures. On the other hand, there is an important
indicator of chronic kidney disease missing from this core set.
Medicare beneficiaries with diabetes should be evaluated for possible
decline in kidney function through estimates of Glomerular Filtration
Rate (GFR). GFR estimates are the best overall indices of the level of
kidney function. Individuals with reduced GFR should, in turn, be
evaluated and treated for complications of reduced GFR. This includes
measurement of anemia, nutritional status and bone disease. Estimated
GFR should be monitored yearly in patients with chronic kidney disease
and diabetes.
Similarly, non-diabetic patients with chronic kidney disease have
an increased prevalence of cardiovascular disease compared to the
general population. (K/DOQI Guideline 15 for Evaluation, Classification
and Stratification of Chronic Kidney Disease.) Measures for chronic
care improvement for Medicare beneficiaries with heart failure should
be expanded to include assessment of kidney function (by GFR
measurement) and kidney damage (by tests for protein in the urine).
III. Conclusion
The National Kidney Foundation respectfully requests that the
Committee monitor the implementation of the MMA chronic care
improvement program by the CMS to insure that Medicare beneficiaries
with chronic kidney disease, as a co-morbidity with diabetes and/or
heart failure, benefit to the fullest extent possible from the agency's
initial program announcement. Furthermore, while diabetes is the
largest single cause of End Stage Renal Disease, constituting 44% of
new ESRD cases annually, more than half of new ESRD patients do not
have diabetes. Additionally, there could be millions of Medicare
beneficiaries with chronic kidney disease but without diabetes, who
could benefit from the diagnostic and therapeutic interventions that
are recommended by the K/DOQI program. Therefore, we respectfully
request that the Committee urge the CMS to develop a chronic care
improvement program for chronic kidney disease in the near future.