[House Hearing, 109 Congress]
[From the U.S. Government Publishing Office]
HEARING ON MANAGING THE USE OF IMAGING SERVICES
=======================================================================
HEARING
before the
SUBCOMMITTEE ON HEALTH
of the
COMMITTEE ON WAYS AND MEANS
U.S. HOUSE OF REPRESENTATIVES
ONE HUNDRED NINTH CONGRESS
FIRST SESSION
__________
MARCH 17, 2005
__________
Serial No. 109-29
__________
Printed for the use of the Committee on Ways and Means
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COMMITTEE ON WAYS AND MEANS
BILL THOMAS, California, Chairman
E. CLAY SHAW, JR., Florida CHARLES B. RANGEL, New York
NANCY L. JOHNSON, Connecticut FORTNEY PETE STARK, California
WALLY HERGER, California SANDER M. LEVIN, Michigan
JIM MCCRERY, Louisiana BENJAMIN L. CARDIN, Maryland
DAVE CAMP, Michigan JIM MCDERMOTT, Washington
JIM RAMSTAD, Minnesota JOHN LEWIS, Georgia
JIM NUSSLE, Iowa RICHARD E. NEAL, Massachusetts
SAM JOHNSON, Texas MICHAEL R. MCNULTY, New York
ROB PORTMAN, Ohio WILLIAM J. JEFFERSON, Louisiana
PHIL ENGLISH, Pennsylvania JOHN S. TANNER, Tennessee
J.D. HAYWORTH, Arizona XAVIER BECERRA, California
JERRY WELLER, Illinois LLOYD DOGGETT, Texas
KENNY C. HULSHOF, Missouri EARL POMEROY, North Dakota
SCOTT MCINNIS, Colorado STEPHANIE TUBBS JONES, Ohio
RON LEWIS, Kentucky MIKE THOMPSON, California
MARK FOLEY, Florida JOHN B. LARSON, Connecticut
KEVIN BRADY, Texas RAHM EMANUEL, Illinois
THOMAS M. REYNOLDS, New York
PAUL RYAN, Wisconsin
ERIC CANTOR, Virginia
JOHN LINDER, Georgia
BOB BEAUPREZ, Colorado
MELISSA A. HART, Pennsylvania
CHRIS CHOCOLA, Indiana
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
SAM JOHNSON, Texas JOHN LEWIS, Georgia
DAVE CAMP, Michigan LLOYD DOGGETT, Texas
JIM RAMSTAD, Minnesota MIKE THOMPSON, California
PHIL ENGLISH, Pennsylvania RAHM EMANUEL, Illinois
J.D. HAYWORTH, Arizona
KENNY C. HULSHOF, Missouri
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C O N T E N T S
__________
Page
Advisory of March 10, 2005, announcing the hearing............... 2
WITNESSES
Medicare Payment Advisory Commission, Mark Miller................ 5
______
American College of Radiology, James Borgstede, M.D.............. 23
University of Chicago, Chicago, Illinois, Kim Allen Williams,
M.D............................................................ 30
National Coalition for Diagnostic Imaging Services, Houston,
Texas, Cherrill Farnsworth..................................... 41
Philips Medical Systems, Milpitas, California, David Rollo, M.D.. 46
SUBMISSIONS FOR THE RECORD
American Association of Orthopaedic Surgeons, Kathryn Pontzer,
statement...................................................... 71
American College of Obstetricians and Gynecologists, Vivian M.
Dickerson, M.D., statement..................................... 74
American Society for Therapeutic Radiology and Oncology, Fairfax,
VA, Lisa Shuger Hublitz, statement............................. 75
Buchholz, Marilyn K., Omaha, NE, letter.......................... 76
Cardiovascular Computed Tomography, Stephan Achenbach, Damascus,
MD, statement.................................................. 77
Coalition for Quality Ultrasound, Columbia, MD, letter........... 81
National Imaging Associates, Inc., Thomas G. Dehn, Hackensack,
NJ, letter..................................................... 84
Petrikin, Timothy M., Nashville, TN, letter...................... 86
Society for Maternal-Fetal Medicine, statement................... 87
Wagner, Judith A., Mequon, WI, letter............................ 89
HEARING ON MANAGING THE USE OF IMAGING SERVICES
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THURSDAY, MARCH 17, 2005
U.S. House of Representatives,
Committee on Ways and Means,
Washington, DC.
The Subcommittee met, pursuant to notice, at 10:11 a.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
March 10, 2005
HL-4
Johnson Announces Hearing on
Managing the Use of Imaging Services
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 managing the use of imaging
services. The hearing will take place on Thursday, March 17, 2005, in
the main Committee hearing room, 1100 Longworth House Office Building,
beginning at 10:00 a.m.
In view of the limited time available to hear witnesses, oral
testimony at this hearing will be from invited witnesses only.
Witnesses will include a representative from the Medicare Payment
Advisory Commission (MedPAC) and representatives from physician groups
that perform medical imaging. 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:
According to MedPAC, between 1999 and 2002, per-beneficiary growth
in the volume and complexity of imaging services was twice as high as
the growth for all services paid under the Medicare physician fee
schedule. MedPAC attributes the increase in imaging services to
technological innovations that have improved diagnostic services and
allowed for service delivery in physicians' offices. Other factors
contributing to the growth of imaging services include a possible
misalignment of Medicare's payment rates and costs of services,
physician interest in capturing revenues from the provision of
ancillary services, and patient desire to receive diagnostic tests in
convenient settings.
As the delivery of imaging services has migrated from hospitals to
physician offices, these services are subject to less stringent
oversight. MedPAC recommended that Medicare develop quality standards
for all providers that receive payment for performing and interpreting
imaging studies. It believes that these standards will improve the
accuracy of diagnostic tests, which will increase quality of care and
help control spending. In addition, MedPAC recommended that Secretary
Leavitt, of the U.S. Department of Health and Human Services, expand
coding edits on billing for imaging services, measure and compare
physician use of imaging services, and strengthen rules that restrict
physician investment in imaging centers to which they refer.
In announcing the hearing, Chairman Johnson stated, ``Given the
significant growth in imaging services, we need to carefully examine
the existing quality and safety of these services provided in
physicians' offices before requiring providers to meet new quality
standards. Is there a problem, and if so, how widespread is it? What
types of services are involved? I want to ensure that seniors have
access to appropriate, safe, and high quality imaging services.''
FOCUS OF THE HEARING:
The hearing will focus on MedPAC's recommendations for managing the
use of imaging services, especially the need to require physicians to
meet quality standards as a condition of payment. Witnesses will
present evidence supporting or opposing MedPAC's recommendations.
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Chairman JOHNSON. Good morning, everyone.
Today the Subcommittee focuses our attention on diagnostic
imaging services in Medicare. These are services such as X-
rays, PET scans, MRIs, which provide the opportunity for better
quality care, often at reduced costs. Fortunately, the day is
gone when physicians routinely used exploratory surgery to make
a diagnosis. Today, instead of an open biopsy of the breast,
women may receive a needle biopsy guided by ultrasound to
evaluate lesions. Instead of placing a catheter into the
bladder, many urologists use a small ultrasound machine to
measure the extent of problems associated with prostate
enlargement.
As a result of these advances and other factors, the
Medicare Payment Advisory Commission (MedPAC) reports that
spending on imaging services has skyrocketed. Between 1999 and
2002, imaging services per beneficiary grew twice as fast as
all physician services. More recent data from 2003 shows that
growth in imaging services has moderated but continues to
exceed overall growth.
MedPAC offers several reasons for this, including
technological advances that allow physicians to use imaging for
diagnosis more often and allow them to provide imaging services
in their offices. Second, patients want to receive diagnostic
tests in more convenient settings by physician's offices.
Third, Medicare may not be paying appropriately for these
services. Finally, physicians may be increasing in office
imaging services to increase their Medicare reimbursements.
MedPAC concludes that the growth in imaging services is
disproportionate and problematic and makes several
recommendations to Congress to restrain this growth.
Specifically, MedPAC recommends that Medicare develop quality
standards for all providers who receive payment for performing
and interpreting imaging studies; expand coding edits on
billing for imaging services; measure and compare physician use
of imaging services; and strengthen rules that restrict
physician investment in imaging center to which they refer.
The medical community is not united behind these
recommendations. Some agree with all of MedPAC's
recommendations; others would limit their application to
certain types of imaging services; and still others would make
no changes to current Medicare practices. Our witnesses will
help us evaluate the existing quality and safety of imaging
services provided in physicians' offices and the extent of
overuse of services. We want seniors to have access to
appropriate, safe, and high-quality imaging services. So, we
need to understand if there are problems across all imaging
services or if problems are limited to certain types of
services. Are these problems widespread or, in fact, are they
nonexistent?
Our witnesses will help us evaluate these questions. We
will hear first from Mark Miller, the Executive Director of
MedPAC. He will provide us with more details about the MedPAC
recommendations and the evidence supporting these
recommendations.
Our second panel includes witnesses from the imaging
community. Dr. Borgstede represents the American College of
Radiology. Radiologists provide the bulk of imaging services.
Dr. Williams represents the American College of Cardiology and
the Coalition for Patient-Centered Imaging. Dr. Williams will
provide us with a view from the nonradiologist community. Ms.
Farnsworth represents the National Coalition for Quality
Diagnostic Imaging Services, a coalition of outpatient imaging
centers which advocates for public and private sector standards
for quality and safety in imaging. Our final witness, Dr.
Rollo, who represents the National Electrical Manufacturers
Association, which develops standards for medical imaging
equipment, will conclude the second panel.
We look forward to your testimony and to an opportunity to
dialog with the witnesses.
Let me recognize now Mr. Stark.
Mr. STARK. Thank you, Madam Chair, for holding what
promises to be a fascinating hearing, and I am so, curious to
hear all about it that, as I said, I was going to skip over how
we could save billions of dollars by getting to the important
things like cutting out overpaying managed care plans. I will
not talk about that today.
We are treading some exciting new ground here, and I
suspect that we are going to hear from a series of specialists,
and I guess somebody--Russell Long used to say, ``Don't tax
you, don't tax me, tax the fellow behind the tree.'' I am
surprised that the chiropractors are not here protecting their
rights to take X-rays, and we are going to have to sort out a
lot of interests and, I suppose, decide at some point who is
going to be in charge of setting standards and enforcing them,
something that Medicare has basically never done. It has been
left to the States. If a doctor is licensed, they pretty much
can do whatever they want.
So, I am interested and I am sure we will have a lot of
time to discuss this, and I would be interested in Dr. Miller's
recommendations. Thank you very much for calling us together.
Chairman JOHNSON. Thank you very much.
Mr. Miller, please proceed.
STATEMENT OF MARK E. MILLER, PH.D., EXECUTIVE DIRECTOR,
MEDICARE PAYMENT ADVISORY COMMISSION
Mr. MILLER. Chairman Johnson, Congressman Stark, and
distinguished Members of the Subcommittee, I am Mark Miller,
Executive Director of the Medicare Payment Advisory Commission,
and I appreciate being asked here to talk about the
Commission's recommendations on diagnostic imaging.
Improvements in imaging technology have lowered the cost of
purchasing these machines for physicians and reduced the size
of these technologies. This has allowed this technology to
diffuse from institutional settings to office settings.
Imaging technology has an important role in medicine. It
improves diagnosis, it leads to better treatments, and it
certainly improves convenience for the patients. But several
issues arise in this context.
The first is that there has been substantial growth--and
this first slide is an illustration of this--substantial growth
in the volume of imaging services per beneficiary. What this
figure shows is the horizontal line is the average increase in
volume of services for all physician services under the fee
schedule, and you can see from the far right bar that imaging
services are growing at twice the rate of all physician
services. The time period is 1999 to 2003. The growth rate for
physician is 22 percent for all services, and for imaging it is
45 percent.
This chart also shows that certain imaging modalities are
growing even more aggressively. Here the horizontal line is the
average growth for all imaging, 45 percent over the same time
period, and certain modalities, like MRI, excluding the brain,
nuclear medicine, and CT scans, excluding the head, are growing
between 82 percent and 99 percent.
Some will argue that this represents a shift in the site of
care. This is not correct. Our analysis suggests that the
growth in these services is not offset by declines in the
institutional setting. Less than a fifth of this growth is
offset by declines in institutional settings.
Another important point on these growth numbers that I want
to make, which was alluded to, is that these represent volume
of services. They do not represent expenditures. We have taken
out the impacts of payment increases. The expenditure impacts
are actually larger than these, and as all of us know, those
costs are borne by the program and by the beneficiary through
their premiums and the copayments.
A second concern is that, at least at a population level,
there is not a clear linkage between more imaging services and
quality outcomes. We consulted with the Dartmouth Group, which
has been looking at geographic variation for a couple of
decades now, and a couple of things I think are worth noting.
First of all, across the country, there is threefold
variation in the use of these services among the Medicare
population, and that variation is not linked to health status.
The variation is more a product of the supply of these services
and the physician's practice style.
Furthermore, when we asked them if there was a relationship
between outcomes in areas with higher imaging use, better
outcomes in higher imaging use, there was no relationship. They
looked at three conditions that are important to the Medicare
population--heart attack, colon cancer, and hip fracture--and
in areas that have higher imaging, there is not better survival
rates for these conditions.
Now, the point I want to make here is that we do not
dispute that imaging can lead to better diagnosis and better
treatment and better outcomes. But in the aggregate, the
question is whether all imaging is related to better quality
outcomes.
A third concern is variation in the quality of the
services. In a review of the literature and presentations in
front of the Commission from private sector experts who look at
these modalities for non-Medicare populations, we have found
that there is variation in the quality of the images that are
produced and in the quality of the interpretations.
A fourth concern that the Commission identified is that in
moving out to the office setting, there is--less clear quality
standards apply, and that is a concern.
So, imaging is an important part of medicine, but there is
a question about whether the volume growth that we see in
Medicare is all beneficial and whether the quality of the
services being provided is clear.
As many of you know, as part of our mandated reports, we
delivered our March report, which gives a series of payment
recommendations for Medicare. One of the themes of that report
was that Medicare payment needs to become more sophisticated
about how it reimburses providers, to, in fact, reimburse
providers differentially on the basis of quality. We believe
the imaging recommendations are in the spirit of that theme.
One other point before I just briefly touch on the
recommendations is that there are 17 Commissioners; 16 were
present on the day that we considered these recommendations,
and the votes on these were unanimous.
So, very quickly, with the remaining time I will just make
these points.
The first recommendation is that Congress direct the
Secretary to set quality standards for all providers who bill
Medicare for performing and interpreting diagnostic imaging
services.
Two points I would like to make about this. Some people
characterize this recommendation as directed toward limiting
imaging to radiologists only, billing for imaging to
radiologists only. That is not correct. We believe that the
standards should apply to all physicians, and if physicians
meet those standards, they should be able to bill.
A second thing, that while this is new ground, it is not
without precedent. The Mammography Quality Standards Act passed
in 1992 makes these types of recommendations for mammography
services.
Just to finish up, the Secretary should measure physician
use of imaging services So, that physicians can confidentially
compare their practice patterns with those of their peers; that
the Secretary improve Medicare's coding edits for imaging; and,
finally, that the Secretary strengthen rules that govern
physician investment in imaging centers.
I appreciate being asked here and look forward to your
questions.
[The prepared statement of Mr. Miller follows:]
Statement of Mark Miller, Executive Director, Medicare Payment Advisory
Commission
Chairman Johnson, Congressman Stark, distinguished Subcommittee
members. I am Mark Miller, Executive Director of the Medicare Payment
Advisory Commission (MedPAC). I appreciate the opportunity to be here
with you this morning to discuss ways to improve imaging services for
Medicare beneficiaries.
The Commission has concluded that it is time for the Medicare
program to start to differentiate among providers when making payments.
Currently, Medicare pays providers the same regardless of their
quality. In its March report to the Congress MedPAC discusses several
important steps towards differentiation which, taken together, will
improve the quality of care for beneficiaries and lay the groundwork
for obtaining better value in the Medicare program. For example, MedPAC
recommends pay for performance linked to quality. As requested, this
testimony focuses on the Commission's recommendations for imaging
services contained in the March report.
Technological progress in imaging over the past years, and its
promise for improving diagnosis, treatments, and health outcomes are
impressive. In addition, improvements in technology have made those
services available outside the hospital in settings such as imaging
centers and doctors' offices--with concomitant improvements in
convenience for patients. However, at the same time there has been
rapid and sustained growth in the volume of imaging services for
Medicare beneficiaries; and there are concerns about potential overuse
of imaging services, possible poor quality, and that Medicare payment
policy has not kept up with technological changes. As an example of the
rapid growth in imaging, according to the Wall Street Journal, there
are now more magnetic resonance imaging (MRI) scanners in the
Pittsburgh area than in all of Canada and, in 2003, there were over 13
computed tomography (CT) scans provided for every 100 members of the
largest health plan in the area.
The Commission has investigated these issues through data analysis,
consultations with private sector experts in management of imaging
services, discussions with specialty medical societies, and a review of
the available literature. After public discussion and deliberation the
Commission, by a unanimous vote among those present, has recommended
that:
the Secretary of HHS improve Medicare's coding edits for
imaging studies,
the Congress direct the Secretary to set standards for
all providers who bill Medicare for performing and interpreting
diagnostic imaging studies,
the Secretary measure physicians' use of imaging services
so that physicians can compare their practice patterns with those of
their peers, and
the Secretary strengthen the rules that govern physician
investment in imaging centers to which they refer patients.
Taken together, these actions should help add value to the imaging
services Medicare buys.
Growth has been dramatic
Diagnostic imaging services paid under Medicare's physician fee
schedule grew more rapidly than any other type of physician service
between 1999 and 2003. While the sum of all physician services grew 22
percent in those years, imaging services grew twice as fast, by 45
percent (see figure 1). This measure is the growth in the volume and
intensity of services per beneficiary; we have removed changes
resulting from increases in the number of beneficiaries and changes in
prices during those years. Not all imaging services grew at this rate;
some grew even faster. Advanced imaging services and nuclear medicine
led the way: MRI of parts of the body other than the brain grew by 99
percent; nuclear medicine grew 85 percent; and CT of parts of the body
other than the head grew 82 percent (see figure 2).
In dollar terms, Medicare spending for imaging services paid under
the physician fee schedule grew over 60 percent, from $5.7 billion in
1999 to $9.3 billion in 2003. Beneficiaries' spending on these services
has also increased, both directly through copayments and indirectly
through increased Part B premiums.
Imaging shows highest cumulative growth in services per beneficiary
(1999-2003)
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Some argue that much of this increase was attributable to the
movement of imaging from the outpatient setting to settings where the
technical charge is included in the physician fee schedule. However, of
the $1.6 billion increase in fee schedule imaging spending from 2001 to
2003, only $300 million was offset by the decrease in imaging provided
in hospital outpatient departments. In addition, the movement of
imaging from outpatient departments to physician offices raises another
concern: the institutional standards that govern the performance and
interpretation of studies in hospitals are usually absent in physician
offices.
Cumulative growth in imaging volume per beneficiary varies (1999-2003)
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Note: MRI (magnetic resonance imaging), CT (computed tomography),
cath (cardiac catheterization)
Source: MedPAC analysis of Medicare claims data
The growth in imaging services could be driven by various factors,
among them:
technological innovation that has improved physicians'
ability to diagnose disease and made it more feasible to provide
imaging procedures in physician offices,
patients' desire to receive diagnostic tests in more
convenient settings,
physicians practicing defensive medicine,
possible misalignment of fee schedule payment rates and
costs, and
physicians' interest in supplementing their professional
fees with revenues from ancillary services.
Some of these factors raise concerns that not all of the growth in
the use of imaging services may be appropriate, and that quality
safeguards may need to be put in place.
Variation in use not linked to quality
The use of imaging services varies widely across the country. In
fact, the average use of imaging services in one area can be three
times the average use in another area. This variation is twice that
seen in the use of major procedures. This finding raises a concern
about the value of some of those services because geographic areas with
a disproportionate use of health services in general do not have better
health outcomes, according to Dartmouth researchers Fisher and
Wennberg. Those researchers also find that wide variations in the use
of discretionary services, such as imaging and diagnostic tests, are
sensitive to the supply of physician and hospital resources rather than
to the health status of the population.
In a separate study, Dartmouth researchers have found that regions
providing more imaging services do not have higher survival rates among
Medicare beneficiaries. Their study examined whether long-term survival
in three cohorts--patients with heart attacks, colon cancer, and hip
fractures--was better in regions with higher versus lower imaging use.
They found that increased use of imaging services was not associated
with improved survival in any of the three study populations.
Quality varies
According to published studies, health plans, and experts we
consulted, providers vary in their ability to perform quality imaging
procedures. In one study, published in Radiology, BlueCross BlueShield
of Massachusetts inspected 1,000 imaging providers to evaluate the
quality of their equipment, technical staff, and other features. Nearly
one-third of the providers had at least one serious deficiency, such as
film processing problems, failure to monitor radiation exposure, poor
image quality, or lack of an equipment calibration report. Eleven
percent of the providers had severe problems that could not be easily
remedied, while 20 percent had deficiencies that could be remedied.
Chiropractic and podiatric offices were the most likely to have
deficiencies; cardiology, radiology, and surgical specialty offices
were the least likely. According to a study in the American Journal of
Roentgenology, another health plan that inspected almost 100
nonradiologist offices that provided radiography services identified
serious problems in 78 percent of the offices. These problems included
lack of proper image identification (e.g., noting left or right) and
use of equipment that had not been inspected during the previous year.
In our March 2004 public meeting a panel of health plans and
imaging benefit managers informed us that some providers fail to meet
standards because their imaging equipment is old or not working
properly. Physician offices sometimes acquire used equipment from a
hospital and continue to use that equipment beyond its useful life.
Problems identified by purchasers may lead to inaccurate studies,
missed or inaccurate diagnoses, and inappropriate treatment. A recent
study published in the Journal of Vascular Surgery found that vascular
ultrasound providers that were not accredited often produced inaccurate
carotid ultrasound examinations. In that study, carotid ultrasound
tests performed by nonaccredited labs were repeated by an accredited
lab that follows standards for diagnostic criteria, testing protocols,
and technician training. For 61 percent of the patients, findings by
this lab contradicted findings by the nonaccredited providers in a
clinically significant way.
There may also be problems with the quality of interpretation of
imaging. For example, in one study published in the Annals of Emergency
Medicine, over 500 CT scans that were interpreted by emergency
physicians were also read by radiologists. Radiologists disagreed with
the emergency physicians' interpretations in 39 percent of the cases,
most of which were potentially clinically significant
misinterpretations (e.g., major false negatives or positives). Another
study by an imaging benefit company found interpretation reports, which
are an integral part of a diagnostic examination, to be incomplete. The
study found half of the reports examined lacked information on the
indication for the study and many lacked information on the views
taken.
Setting standards for imaging providers and interpreters
The lack of quality oversight for imaging tests provided in
physician offices, concerns about use of imaging studies, and rapid
volume growth lead to our first recommendation: The Congress should
direct the Secretary to set standards for providers who bill Medicare
for performing and/or interpreting diagnostic imaging studies. The
Secretary should select private sector organizations to administer the
standards. As many physicians integrate imaging services into their
office practices, ensuring that these studies are done by skilled
technicians using appropriate equipment and interpreted by qualified
physicians should improve the accuracy of diagnostic tests and reduce
the need to repeat studies, thus enhancing quality of care and helping
to control spending.
Requiring physicians to meet quality standards as a condition of
payment for imaging services provided in their offices represents a
major change in Medicare's payment policy. Traditionally, Medicare has
paid for all medically necessary services provided by physicians
operating within the scope of practice for the state in which they are
licensed. We believe that this policy change is warranted by the growth
of imaging studies provided in physician offices and the lack of
comprehensive standards for this setting. There are some limited
precedents for this policy in imaging, but they are not comprehensive.
Current standards
Aside from a physician supervision requirement, no national
Medicare standards for imaging apply to physician offices, and many
imaging modalities, such as MRI, are not covered by any government
standards. CMS has developed national standards for imaging provided in
hospitals and independent diagnostic testing facilities. For example,
hospitals that treat Medicare beneficiaries must comply with Medicare's
conditions of participation, which include standards for radiology
services. In addition, several Medicare carriers have minimum standards
for the technical quality of some types of ultrasound studies performed
in physician offices, but these standards have not been adopted
nationally. Even when standards exist for an imaging modality, they may
not be comprehensive or well enforced.
There are also two limited cases where standards are set for
imaging interpretation. First, the Medicare carrier for New York
(Empire) sets standards for physicians who wish to bill for
interpreting an echocardiography study. Another exception is contained
in CMS's recent decision to cover positron emission tomography (PET)
scans for the diagnosis of patients with mild cognitive impairment and
early dementia. The coverage decision specifies that tests be
interpreted by physicians only in certain specialties, such as nuclear
medicine and radiology, who have expertise in reading these scans.
There is a national standard for mammography. Under the Mammography
Quality Standards Act, the Food and Drug Administration (FDA) develops
and enforces quality assurance standards for mammography equipment,
technical staff, and the physicians who interpret mammograms. The GAO
has credited the FDA standards with improving the quality of mammograms
without decreasing access. Failure rates for image quality decreased
from 11 percent before the act to 2 percent after.
State radiation control boards license facilities that use
radiation-producing equipment, but their primary mission is to ensure
patient safety rather than the quality of images, and the standards are
not always comprehensive or rigorously enforced.
Several of the private insurers we interviewed require that
hospital outpatient departments, freestanding facilities, and physician
offices that provide imaging services meet basic standards. These
standards relate to the quality of imaging equipment, the
qualifications of radiology technicians, the resulting quality of the
images, the procedures for ensuring patient safety, and qualifications
of interpreting physicians. Plans and their vendors often require that
providers become accredited by a private organization, such as the
American Institute for Ultrasound in Medicine (AIUM), American College
of Radiology (ACR), or the Intersocietal Accreditation Commission
(IAC).
Developing standards
The Congress should grant the Secretary authority to develop
standards. The Secretary could review the criteria used by private
plans and accreditation organizations, and consult with imaging
accreditation organizations, physician specialty groups, and
manufacturers when developing these requirements. CMS should strongly
consider setting standards for at least the following areas: the
imaging equipment, qualifications of technicians, qualifications and
responsibilities of the supervising physician, technical quality of the
images produced, procedures for ensuring patient safety, and the
professional training, experience, and education of the physicians who
interpret studies.
Although private plans sometimes base permission to bill for
imaging procedures on the physician's specialty, the Commission has not
recommended this approach. The practice of medicine is evolving
quickly, and specialty training may change over time. Thus, CMS should
develop criteria that allow physicians of different specialties to
receive payment for interpreting imaging studies. Similar to the
requirements set by private accreditation organizations for
interpreting physicians, Medicare's standards should be based on some
combination of physician training, experience, and continuing
education. Standards will vary for each major imaging modality.
Several private accreditation programs and one government agency
have already developed standards for physicians who interpret certain
types of imaging studies and prepare the reports. Accreditation
organizations, such as the AIUM, ACR, or IAC, generally set minimum
standards for some combination of professional training, experience,
and education of the physicians who interpret studies at accredited
providers. The IAC has forged agreement among different specialties on
common standards. The IAC has had representatives of several specialty
groups jointly develop facility and physician standards for:
echocardiography, nuclear medicine, and vascular ultrasound.
To reduce CMS's administrative burden, the agency should authorize
private accreditation organizations to verify that providers meet the
quality standards set by the Secretary. CMS should also have the
authority to change the roster of organizations that verify compliance.
Private insurers often rely on accreditation programs to certify that
their providers meet quality standards.
To allow CMS to implement national standards in all settings, the
Congress should provide the Secretary with specific statutory authority
to do so. Although CMS has set quality standards for various types of
providers (such as hospitals and skilled nursing facilities), there are
very few examples of federal standards for physician offices (the
primary exceptions are mammography and clinical laboratory services,
which are authorized by statute).
Measuring physicians' use of imaging services
The Commission also recommends: The Secretary should use Medicare
claims data to measure fee-for-service physicians' resource use and
share results with physicians confidentially to educate them about how
they compare with aggregated peer performance. The Congress should
direct the Secretary to perform this function. Educating physicians
about their resource use should encourage those who practice
significantly differently than their peers to reconsider their practice
patterns. This initiative applies to all physicians. In regard to
imaging, it should focus on the physicians who order imaging studies,
because under Medicare, radiologists (with few exceptions) may only
perform studies with an order from the treating physician. CMS would
develop measures of imaging volume per beneficiary for patients seen by
the ordering physician. Because radiologists sometimes suggest
modifications to the original order, their resource use could also be
measured.
Expanding coding edits
The Commission's third recommendation is: The Secretary should
improve Medicare's coding edits that detect unbundled diagnostic
imaging services and reduce the technical component payment for
multiple imaging services performed on contiguous body parts. This
action would improve Medicare's ability to detect improper claims and
help the program pay more accurately for multiple imaging services.
Currently, Medicare uses edits to determine whether a claim meets the
program's payment rules.
Some private insurers have developed their own set of coding edits
that go beyond Medicare's current edits. First, some plans have
implemented more rigorous policies to address unbundling of services--
that is, separately billing for two procedures when one is a component
of the other--and billing for mutually exclusive procedures. For
example, one imaging benefit manager does not pay for both a CT of the
head and CT of the maxillofacial region at the same time because the
head includes the maxillofacial area.
Second, a number of plans use coding edits to adjust payments when
providers bill for multiple imaging services performed on contiguous
body parts. Medicare already has a similar policy for surgical
services: it pays the full rate for the most expensive surgical
services and a discounted rate for other services. For imaging, private
insurers usually pay the full amount for the first service but a
reduced amount (usually half) for the technical component of an
additional study that is of the same modality (e.g., MRI or CT). This
strategy is based on the premise that savings in clerical time,
technical preparation, and supplies occur when multiple studies of the
same modality are performed on contiguous body parts during one patient
encounter. For example, according to a panel of experts that reported
at our March 2004 public meeting, a CT of the pelvis, performed
immediately after a CT of the abdomen, takes much less time than if
performed separately because the patient has already been prepared for
the procedure.
In developing more extensive coding edits for imaging services, CMS
should consult with private plans and imaging benefit managers that
have developed such edits, encourage physicians to review and comment
on the edits, and communicate them in advance to physicians so they can
bill correctly.
Strengthening the rules that restrict physician investment in imaging
centers
The Commission also recommends strengthening the rules restricting
physician investment in imaging centers to which they refer Medicare or
Medicaid patients. Specifically, it recommends the Secretary should:
include nuclear medicine and PET procedures as designated
health services under the Ethics in Patient Referrals Act, and
expand the definition of physician ownership in the
Ethics in Patient Referrals Act to include interests in an entity that
derives a substantial proportion of its revenue from a provider of
designated health services.
These changes should reduce physicians' financial incentives to
refer patients for additional imaging services, which should help
control Medicare spending on these services.
Physician ownership of health care facilities may create a
financial incentive to order additional services. In addition, some
argue that rather than referring patients to the facility providing the
best care, physician investors might refer patients to the facilities
they own. Studies by the GAO and others have found that physicians who
invest in diagnostic imaging centers or who have imaging equipment in
their offices refer their patients more frequently for MRI, CT, nuclear
medicine, and ultrasound.
The Ethics in Patient Referrals Act (also known as the Stark law)
prohibits physicians from referring Medicare or Medicaid patients for
certain services to providers with which the physician has a financial
relationship. It also prohibits those entities from submitting claims
for services provided to patients referred by the physician-investor.
The law applies to a set of ``designated health services'' (DHS), which
includes radiology and certain other imaging services (MRI, CT, and
ultrasound).
In a final rule, CMS excluded nuclear medicine from the Stark law's
prohibitions. This decision allowed physicians to invest in
freestanding centers that provide nuclear medicine procedures and refer
Medicare or Medicaid patients to these facilities. The Commission
recommends CMS add nuclear medicine to the list of designated health
services because of the recent rapid growth of these services and its
similarity to other designated health services. Prohibiting physicians
from referring Medicare or Medicaid patients to nuclear medicine
facilities they own should reduce their financial incentives to refer
patients for these services.
CMS curently permits physicians to own entities that provide
services and equipment to imaging centers and other DHS providers, as
long as the physicians do not own the actual entity submitting claims
to Medicare or Medicaid. The rule implementing the Stark law defines
``ownership'' of an entity only as an interest in the entity that
submits claims to Medicare or Medicaid. However, this definition allows
arrangements that may be inconsistent with the intent of the law. For
example, physicians can buy a MRI machine from a manufacturer, lease it
to an imaging center, and be reimbursed a fixed amount per use (figure
3). This arrangement creates a financial incentive for the physicians
who lease the MRI to the center to refer patients to that center.
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Impacts
Setting standards should increase the quality of imaging services
provided to Medicare beneficiaries, not decrease access, and
potentially decrease spending by reducing duplication of images and
eliminating unnecessary services. Physician resource measurement should
educate physicians who have higher use, and has the potential to
decrease spending in the long run. Improved edits should reduce
inappropriate billing and thus decrease spending. Strengthening
restrictions on ownership will reduce financial incentives to provide
additional services. Beneficiaries will not only experience higher
quality imaging services if these recommendations are implemented, but
will also benefit from reduced cost sharing and Part B premiums.
Chairman JOHNSON. Thank you very much, Mr. Miller.
The issue of the significance of the increase in volume is
really a difficult one. When imaging is being so integrated
into both diagnostic procedures and treatment procedures, it is
very hard to rely on gross figures of increased use to draw any
conclusions about overuse. That is separate from the issue that
you raise of the quality of the work.
What specific evidence did you base--was most significant
in your mind and the Commission's work to indicate that the
rise in volume represented some degree of overuse? How would
you differentiate the overuse from the natural explosion of
imaging in its appropriate use?
Mr. MILLER. I think there are probably a couple of things,
if I understand the question. I want to be clear here that I
don't think in this growth in volume you can very well
distinguish between appropriate and inappropriate. I think that
is what in part drives us to the quality standards, because I
think measuring--I think there is absolutely--there is
absolutely that you could find specific clinical evidence that
linkage between given procedures and given outcomes, but the
Dartmouth evidence suggests that when you look at it in the
aggregate, there is not a clear linkage.
I think another piece of evidence was that the variation in
the error rates and in the quality of the imaging across the
physicians suggests that perhaps not all of this is directly
linked to quality.
Actually, if I could just say, our attempt here is we
acknowledge that you cannot, when you look at these gross
figures, differentiate between appropriate and inappropriate
growth, but that is what some of the hope of setting the
quality standards is, to have physicians and machines--machines
calibrated and physicians educated to move more toward the
types of modalities that will produce better outcomes.
I will say one last thing on this. Also, in looking at some
of this--I think this is related to your question. I might be a
little off track here. Also, when you look at the growth, some
of this you might expect if it is not--if it is all necessary,
you might expect some of a reduction to occur in the
institutional settings, and we are not seeing that one-to-one
tradeoff. Some of these modalities, like MRI, CT, you are
seeing very rapid growth both in the office setting and in the
institution.
Chairman JOHNSON. It does seem to me, though, in doing the
research that it would have been wise to look at, for example,
the use of imaging in oncology or in various specialties and
sort of evaluate whether that is now common practice, whether
that is the standard of care that you would be held to, and to
what extent that imaging is a rise in volume that is to be
expected and recognized. Then the question of whether
physicians are doing that well or not, that is a different
question. I have not asked you this question in terms of
evidence for the quality, and we will get to that. But I am not
asking that because I want to give my colleagues time here, but
in doing your research, to just look at volume without sort of
severing out from the volume those areas that have seen a lot
of growth in a sense for good reason, because this is a new
tool that improves accuracy and precision and quality and so on
and so forth, leaves us weaker in terms of trying to understand
that volume and how to deal with it. You certainly would not
want to just respond to volume. As you have said yourself, you
cannot tell what it means.
Mr. MILLER. Right, but also I think it is fair to say that
we did not look just at volume. As I said--in 5 minutes it is
hard to glide through this.
Chairman JOHNSON. Yes.
Mr. MILLER. But we also looked at the literature, and the
literature suggests that there are significant differences,
again, in the quality of the images being produced and in the
interpretation of those images. So, volume was certainly a
starting point, and when you see something growing this fast,
it is going to catch your attention. Then we looked at the
literature. We had people come in front of the Commission and
talk about this phenomenon in the non-Medicare population. That
is what drove us, rather than saying, for Medicare to go in and
say this is the right condition in this procedure to do, what
we are trying to say is can you set minimum standards for the
facility and the interpreting physician before they start
billing to Medicare.
Chairman JOHNSON. Thank you.
Mr. Stark?
Mr. STARK. Thank you. Just a couple of questions. Perhaps
we will get a second round here. But I guess you are saying
that while we have not previously required physicians to meet
quality standards or competence standards, whatever you want to
call it, do you feel that imaging services uniquely require
those standards? Or should we begin requiring standards for
other aspects of medical care?
Mr. MILLER. I think that is a fair question, and I think my
answer to that--I am always here representing the Commission,
which is 17 people, and I do not want to get too far out in
front of them.
Mr. STARK. Oh, go ahead.
[Laughter.]
Mr. MILLER. Okay. Thanks.
I would not close the door that we could be back talking to
you about other services. For example, on one of the slides
that I showed you, while imaging is growing very aggressively,
so is diagnostic testing. Diagnostic testing has some of the
same kind of supply-driven characteristics that imaging has. I
do not think it is out of the question that we could come back
and talk to you about that. I cannot say for sure. I think
there is something about imaging and its recent movement from
the institutional to the office setting that drove some of
these discussions. But I do not know that it is unique in that
sense.
Mr. STARK. You may not have done a study on this, but I am
sure that you might have a suspicion or an opinion. Is the
marginal cost in an imaging procedure minuscule as it is in,
say, punching out pills? Once you have got the formula and you
are cranking out pills, to punch out another couple of pills
costs next to nothing. Once you have cranked up the MRI and the
staff has got there for the day and they have made their coffee
and opened the store and turned on the power, is the difference
between whether they do 10 or 11 scans in a day insignificant,
or is it pretty level? I am just trying to get some sense.
Mr. MILLER. I am going to give you two pieces, I think, in
response to that.
First of all, yes, I do think that the marginal cost goes
down as you run your imaging. You have a big up-front
investment, and these machines can be expensive, and then the
marginal cost goes down as you run a patient through it.
Frankly, in some of the advertisements you see in magazines,
some of the economic analysis is laid right out there. If you
pass 1.5 patients per week through this, you have this or you
break even; if you pass 10 per week, you start to make these
kinds of returns. That is one thought.
A second thought inside our recommendations, which, again,
is hard to detail with an opening statement, is the notion of
the coding edits, and there is a precedent in Medicare where
you pay less for the second surgical procedure that is done.
The private sector does this for imaging; Medicare does it for
surgical procedures. One of our coding edit recommendations is
that there is also a marginal difference between the first and
second image that you take on a patient in terms of positioning
the patient, having the machine and the technician all there.
So, in both of those senses, yes, I think there is a marginal
cost issue.
Mr. STARK. Is there an issue--well, I guess I am about out
of time here. Let me skip over that, and maybe I will get you
on the second round.
You recommend that the Secretary have a private sector
organization administer any new standards for imaging
providers. Do you have a specific private sector organization
in mind? Why would you pick that, say, over FDA or Health and
Human Services, Surgeon General, a public sector person?
Mr. MILLER. Completely fair question, and I want to parse a
couple of pieces of this answer. The Commission's view on this
is that the Secretary's standards would be administered. So, I
want to be very clear on this. This is not that the standards
are shipped out to private organizations. The Secretary will
pull together a range of actors, associations, physician
societies, benefit managers, manufacturers, bring all them
together, set a standard, arrive at standards for the facility
and the physician. I could give you some more sense of that.
But then purely for efficiency reasons, we would see that the
Secretary would in a sense contract this out----
Mr. STARK. As they do for the intermediaries.
Mr. MILLER. Exactly.
Mr. STARK. Okay.
Mr. MILLER. The notion here is we don't have a specific
organization. It could be societies; it could be benefit
managers; it could be any range of things.
Mr. STARK. Thank you.
Thank you, Madam Chair.
Chairman JOHNSON. Mr. Ramstad?
Mr. RAMSTAD. Thank you, Madam Chairman, for your leadership
on this issue and for convening this hearing. Dr. Miller, thank
you for your testimony.
Is it a fair and accurate restatement of your testimony
that over-utilization of imaging services will simply not end
if we transfer which doctor does the test, if we simply
transfer which doctor does the test? Is that a fair statement
of your testimony?
Mr. MILLER. Transfer the--I am not sure I follow.
Mr. RAMSTAD. Well, it seems to me it is a very complex
issue that we are talking about here and that over-utilization
of imaging services will not end if we simply, for example,
with respect to cardiovascular imaging, take that function away
from the cardiologist and transfer it to the radiologist.
Mr. MILLER. I think I now get your question. I am sorry. I
missed it the first time through.
A couple of things I want to make sure that I get across to
you. One is our recommendations do not say that a cardiologist
cannot perform these tests. That is not--and we have been
characterized in the press and some other places as saying
that. That is not what we are saying. We would say any
physician can bill Medicare as long as there is minimum quality
standard met there. So, we are not saying this can only be done
by a radiologist. First point.
Second point, the quality standard part of our
recommendation, I think it is sort of indirectly aimed at,
controlling volume in the following way. What you see when
there are no standards is tests having to be redone because the
image was improper, because the interpretation was not quite
complete. We would hope for efficiencies through that kind of
phenomenon.
Mr. RAMSTAD. I am happy to hear your response. I would hate
to see this become nothing more than a turf battle. It seems to
me it is a very--over-utilization is a very complex issue
involved factors like defensive medicine, provider preference
care, supply-sensitive care. Consumer demand for the best test
certainly would be a factor here.
I would also like in my remaining time, Mr. Miller, to ask
you certainly you and the Commission have reviewed empirical
data, I am sure, as far as utilization of imaging services. I
would cite a Wall Street Journal article from January that
discussed one such survey in northern California, eight imaging
centers doing a simple head CT scan, and the costs ranged from
$250 for the same test to $8,000--$250 to $8,000.
Now, I would get mine at the $250 center, and I would hope
that our Medicare dollars would encourage similar frugality.
Isn't this in essence what you are trying to do with your
recommendations?
Mr. MILLER. Not quite, at least on the payment side of
things. I am actually glad that you asked this question.
Mr. RAMSTAD. Thank you.
Mr. MILLER. I am glad everyone asked their questions. I
don't mean to be parsing here.
[Laughter.]
Mr. MILLER. I think this is where I get in trouble.
Okay. To your payment issue, actually I think there is
another issue here which I could see MedPAC talking about in
the future that would be part of our agenda. We think that
there may actually be some pricing problems--pricing here now.
The unit price of paying for a diagnostic image may not be
properly calibrated here. It gets technical. I will not get
into it. There are some parts of the practice expense, of the
physician fee schedule on these services that I think needs to
be re-examined. So, I could see us actually moving to looking
at that.
Another issue that I was going to get to is there are
differences in how we pay between the outpatient hospital
setting and in the physician setting. In some instances, that
technical component to the physician is higher than the
outpatient hospital setting. I think there is some calibration
there that probably creates some incentives here.
Mr. RAMSTAD. Let me just conclude--and thank you for your
responses--by saying there is nothing better than the Executive
Director of the Medicare Payment Advisory Commission having a
sense of humor.
I yield back.
[Laughter.]
Mr. MILLER. Thank you. I appreciate that.
Chairman JOHNSON. Thank you very much.
Mr. Lewis?
Mr. LEWIS. Thank you very much, Madam Chair, for holding
this hearing. Thank you very much, Mr. Miller, for being here
today. The only thing I would say, don't be afraid to get in
trouble. Sometimes trouble can be very good trouble.
Mr. MILLER. I understand what you are saying.
Mr. LEWIS. So, don't be afraid.
In response--I guess maybe you responded to Mr. Stark's
question, but let me try to ask you in a different way. Who
should be responsible for setting quality standards for
facilities and for physicians?
Mr. MILLER. In our recommendations, for the purposes of
billing Medicare, it is the Secretary of the Department of
Health and Human Services (HHS). That is what we are saying in
our recommendations.
Mr. LEWIS. Now, Dr. Williams in his written testimony--we
are going to hear from him--later said Medicare imaging is
increasing in part because doctors are using images instead of
more costly invasive procedures. Have you found evidence that
this is the case? Is Medicare spending less on surgical or
other invasive procedures as a result of imaging?
Mr. MILLER. That is a really good question, and it is a
fair point. I saw that testimony about 24 hours ago and noticed
that point in there.
We did not directly measure whether there was an offset on
invasive surgery as a result of increases in imaging. We are
aware that there are clinical studies that say there is such a
relationship, that if you do imaging, you can reduce the kinds
of invasive studies.
There is one thing I would say about that. This is not
unlike the evidence that you see where you can find specific
cases where this is true. But when you look at it in the
aggregate--for example, the Dartmouth research, which looks at
geographic areas, tends to find that when an area is high, it
is high on everything: high imaging, high testing high
admissions to the hospital, high surgery--everything.
So, I am absolutely sure that you can find studies that say
there was a substitution effect in a narrow case, specific
modality type of sense. But when you look at this in the
aggregate in Medicare data, it does not always show up.
Mr. LEWIS. Thank you, Mr. Miller.
Do you think that a one-size-fits-all standard is
advisable?
Mr. MILLER. No. The standards in our recommendations would
be specific to modality, so that there would be different
standards for different imaging modalities. But I think your
question is more directed at is this one set of standards for
all physicians, and I think my answer to that would be yes, we
would be looking for a set of minimum standards for all
physicians to meet.
Mr. LEWIS. If you have a heart specialist and maybe a
urologist, what type of standards--would they be similar?
Mr. MILLER. This is the way we see this working. For
example, for a given modality, you would say that--you would be
basing a physician's qualifications, whether they meet the
standards, on their training, the numbers of times they have
done a particular procedure. There might be requirements for
continuing education, that type of thing. For a given modality,
for an imaging modality, you would set a set of standards. And
one physician might meet those standards because of their
training and education. Another physician might be a mix of
education and their experience.
The set of standards that I just ticked through for you,
those are the same standards that the Mammography Quality
Standard Act used in 1992.
Mr. LEWIS. Did MedPAC consider the value of imaging and
medical technology to patients?
Mr. MILLER. Consider the value? I have two things to say
about that. One is we certainly acknowledged throughout all of
our work the notion of improved diagnosis, better treatment,
convenience to the patient, absolutely. But I think your
question is also directed at a different point, which is many
people cite David Cutler's research--okay, that's where--all
right. Many people cite David Cutler's research, and what that
research said is that when you look at technology, it has a net
economic benefit to society. When you look at the growth of
technology--and he has very sophisticated methodologies that he
uses to get at that. We will stipulate to that research.
The second step in that research which David Cutler talks
about--and we had him actually into the Commission to discuss
this, and he does it in other of his writings and
presentations. He always goes to the second step, which many
people do not speak about, which is he believes that that cost-
benefit ratio can be improved. He talks about specific
incentives for physicians to do quality--procedures that are
related to quality and avoid those that are wasteful.
So, even within the context of that argument, he argues
that the cost-benefit ratio can be improved.
Mr. LEWIS. Thank you very much.
Mr. MILLER. Yes, sir.
Mr. LEWIS. Thank you, Madam Chair.
Chairman JOHNSON. Thank you very much.
Mr. Emanuel? Well, you were here before--is that all right?
Okay. Mr. Thompson, the gentleman is yielding.
Mr. THOMPSON. Thank you, Madam Chair. Thank you, Mr.
Miller.
Do you have any comparison data on capitated programs such
as Kaiser and as to how these issues play with them?
Mr. MILLER. I think my answer is going to be--and I was
just told no.
[Laughter.]
Mr. THOMPSON. What is the short answer?
Mr. MILLER. I think it would still be no. We did in our
March 2004 meeting have a medical director from Blue Cross/Blue
Shield in Michigan and a woman who was Tufts Medical Plan, and
I believe that may have a capitation component to it. They all
spoke of some variation across physicians in these standards,
but I do not have a specific comparison.
Mr. THOMPSON. Will there be any followup on that?
Mr. MILLER. To be very directly about it, I had not had
that on an agenda, my agenda.
Mr. THOMPSON. Okay. The specialty societies argue that they
are kind of lumped in with the limited service providers and
associate them with lower-quality outcomes. And they would
argue, the specialty folks would argue that the standards
should be established differently.
Did MedPAC decide to recommend that all physicians meet the
standards instead of just the limited service providers?
Mr. MILLER. Correct, we recommended all physicians should
meet the standards.
Mr. THOMPSON. And why not differentiate between the limited
service providers?
Mr. MILLER. A couple of--I think a couple of reasons, to
answer that question. We think that--first of all, I do want to
say I don't think in our work we lump people together. To the
extent that the literature parses those effects, to the extent
that the presentations in front of the Commission parse those
effects, we reported them and say that in the report. And there
are differences in the rates, and we try and address those, or
at least point them out to the community.
I think the reason that we did this, I think are two
things. First of all, we think that medicine can change, is
changing radically, and that the notion of coming in and
saying, okay, this specialty can and this specialty cannot is
short-sighted; that a training program for a given specialty
may change and encompass a new imaging modality, and then they
might be perfectly qualified and trained to do that.
A second thing is the way we think about it is not by
specialty; we think about it by modality, that you would set
standards for the specific imaging modality.
Mr. THOMPSON. Have you found anything that--Dr. Williams--
and he will speak later--makes the case that the growth in
medical imaging has substituted for more costly and more
invasive procedures. Have you found anything, is Medicare
spending less on surgical or other invasive procedures as a
result of the growth in imaging?
Mr. MILLER. We did not have a direct analysis of the
relationship between the increases in imaging and the
reductions in invasive surgery. I absolutely believe that in
the clinical literature you can find specific examples, and the
last thing I will say is that the Dartmouth group, when you
look at that geographic variation, you tend to find in areas of
high utilization, they are high utilizers on a range of
services, including surgery, imaging, that type of thing.
So, to the extent that they have looked at it, at a
population level you do not find that. But I do not want to
dispute it. I absolutely believe that you can find specific
clinical cases where substitution occurs.
Mr. THOMPSON. Thank you. I yield back, Madam Chairman.
Chairman JOHNSON. Mr. Emanuel?
Mr. EMANUEL. Thank you. Madam Chair, I appreciate this
hearing because it relates to the hearing last week on the
community hospitals versus specialty hospitals. And although
you do not look at the same issues, they are dealing with the
same kind of topic.
One of the questions I had--and I know you don't look at
the motivation and the pricing as it relates to the referral.
You have doctors who are not radiologists doing tests, the
imaging here. We are dealing, again, with physician hospitals,
investor hospitals, whether they were referring cases to their
own hospitals last week.
Mr. MILLER. Right.
Mr. EMANUEL. And one of the issues I have and one of the
issues I would like to--their conclusion was it did not seem
like economics was a motivating factor, one's self-interest was
not a motivating factor here.
Now, you do not look at it specifically from that
standpoint. Did you have any concern as in relation to whether
physicians are referring or doing some of the imaging that
should be referred out to radiologists and that economics or
one's own self-interest would be a motivating factor here?
Mr. MILLER. I think we do have some of these concerns. And,
again, it was very brief in my opening statement. We have a
recommendation that strengthens the Stark regulations on self-
referral. And those specific recommendations refer to two
things.
In the drafting--so the answer is yes, we have this
concern. We don't think that this is necessarily the only thing
that is driving this. We say in the report the things that the
Chairman said at the beginning, that there are many reasons
that this may be happening. But we make some specific
recommendations.
We say that nuclear medicine, PET scans should be included
in the definition of designated health services which you are
not allowed to self-refer to. That was left out of the
definition when the regulation was implemented.
A second thing that we do--and I have a picture of this,
and I have to have the picture to do this because I am going to
get this wrong. But what happens here is right now on the
right-hand side of that picture, a physician is not allowed to
refer to an imaging center in which they have ownership.
However, what you can do is purchase a machine, lease it to
that imaging center, and get reimbursed on a per click basis.
And what we are saying is that the regulation should be revised
to prevent that left-hand box, and it is kind of a complicated
definition that you can have an interest in an entity that
derives a significant proportion of its revenue from the other
entity.
Mr. EMANUEL. But what concerns me, last week--first of all,
we have a point here, imaging, if I am not mistaken--I am going
off a report here--has gone up by 45 percent, and that by 22
percent--the question is: If it is not--I don't want to get
into a philosophical discussion, but the whole notion is that
people are motivated by their own self-interest. Forget the
medical field. Maybe what we should be studying then is why
people in the medical field are motivated by their own self-
interest, which would be self-referral or having an economic
interest in an imaging machine doing that. There is clearly a
dramatic increase in imaging that is going on. There is clearly
a dramatic increase also in purchasing of these machines. And I
appreciate that maybe one way to deal with it is by setting a
standard, and that may de-incentivize, if there is a term there
for that, doctors' self-referral in this case.
Again, it bleeds over to the subject we talked about last
week as it dealt with community hospitals versus physician-
invested hospitals. And I know you only have a brief comment on
it, but it seems to me--do you really think that setting
regulations is the right way to do it rather than some other
type of standard to ensure that we are not having--I do not
want to say ``self-dealing'' because I am not willing to make
that judgment yet. But we are not putting economic interests
ahead of proper medical care.
Mr. MILLER. Your concerns are shared by the Commission,
both on this issue and on the specialty hospital issue, which
is--we issued that report. And the Commission is trying to--and
it is precisely the balancing act between the notion of being
sure that one is not stopping innovation and efficiency in a
center, because there is something to the notion that if you
are in the physician's office and you can get a test----
Mr. EMANUEL. No problem.
Mr. MILLER. So, you want to be careful----
Mr. EMANUEL. As the son of a pediatrician, no problem.
Mr. MILLER. Right, you do not want to blow that away. But,
on the other hand, there is this concern and there are
Commissioners on the Commission who regularly articulate the
kind of concern that you are articulating here. And the
Commission has not closed the door on any of these issues, but
this--I can only tell you that this is as far as we have come
on this issue.
Mr. EMANUEL. Can I ask one other question? I know my time
is up. Chairman Johnson, can I ask one question?
Chairman JOHNSON. If it is brief.
Mr. EMANUEL. Very brief. Since you came at this based on a
certain set of regulations, what were some of the things that
did not come out of your recommendation but you looked at as
the alternative way to do it?
Mr. MILLER. Fair enough, and here is the way I will answer
it. The other way people are dealing with this in the private
sector, for example, are prior authorization; setting networks
and saying if a physician does not meet standards, they cannot
be in the network; privileging, and privileging on the basis of
specialty or the quality of the physicians.
I do not know if other people go at it through the ``you
cannot have self-referral.'' There may be. I just do not know.
Mr. EMANUEL. The only thing I would ask--and then I am
going to stop--is that if there was ever a time that we can
look at why those were rejected or not pushed forward, that
would be great.
Thank you.
Chairman JOHNSON. My intent is, we are not going to go with
a second round of questions right now with Dr. Miller, because
I believe after we hear the other panel, we will need him to
come to one of our seminars where we can toss these things back
and forth in rather greater depth.
But I know how hard it is for people to get back after the
votes. We are going to have a series of three votes in a few
minutes, and I would like to give you a chance to hear as many
of the people in the next panel as possible before we go. Then
those of us who come back will hear the rest.
Mr. Stark?
Mr. STARK. I would just ask, Mark, when you come back, if
you could get some comparative information, say with the VA and
a capitated plan as to the same type of illness and what is the
volume utilization for a variety of these diagnostics tests,
how it compared with other plans that are privately paid, I
think that would be interesting.
Chairman JOHNSON. Thank you very much, Mark, for your help
this morning.
Mr. MILLER. Thanks.
Chairman JOHNSON. We look forward to talking about this
with you further.
Chairman JOHNSON. I would like to ask the next panel to
come forward. We are going to have votes soon. You never quite
know what they mean by ``soon,'' so if we can get through
everyone's opening statement, that would be to the advantage of
the Committee Members since everyone's schedule crowds out
coming back when there has been a 20-minute hiatus. So, we will
start immediately with Dr. James Borgstede, the Chair of the
Board of Chancellors of the American College of Radiology, and
then go to Dr. Kim Williams, Professor of Medicine and Director
of Nuclear Cardiology at the University of Chicago hospitals;
Cherrill Farnsworth, Chairperson of the National Coalition for
Diagnostic Imaging Services from Texas; and Dr. David Rollo,
Chief Medical Officer of Philips Medical Systems from
California.
Dr. Borgstede? Would you turn your microphone on, please.
Thank you.
STATEMENT OF JAMES P. BORGSTEDE, M.D., CHAIR, BOARD OF
CHANCELLORS, AMERICAN COLLEGE OF RADIOLOGY (ACR)
Dr. BORGSTEDE. Thank you, Madam Chairman. I am Dr. James
Borgstede, Chair of the American College of Radiology Board of
Chancellors and a private practice radiologist from Colorado.
As the physician specialist who received 4 to 6 years of unique
post-medical school education in medical imaging, we encourage
and support the advances in diagnostic imaging that have
improved the quality of health care while producing savings
through less invasive diagnostic techniques. However, we are
deeply concerned with the exponential growth in office-based
imaging by those who may lack the education, training,
equipment, and clinical personnel to safely and effectively use
these studies to better their patients' health.
The real harm is excessive examinations and unnecessary
exposure to radiation leading to misdiagnoses, which can result
in additional patient injury or even patient death. For this
reason, the ACR supports many of the MedPAC recommendations
that link Medicare reimbursement to quality, safety, and
training standards for physicians and facilities which provide
medical imaging services. Private payers such as United
Healthcare, Anthem, and Blue Cross and Blue Shield have already
enacted similar guidelines with little additional burden on
physicians to comply with these quality measures and no decline
in patient access to care. Our Medicare patients deserve no
less.
The MedPAC recommendations also have government precedent.
In 1992, Congress enacted the Mammography Quality Standards
Act. Since then earlier detection through quality imaging has
saved thousands of women's lives. Medicare has always required
accreditation of hospitals. In addition, the New York Medicare
contractor requires not only facility accreditation but also
sets physician standards regarding an important cardiology
procedure--transthoracic echocardiography--at the request of
cardiologists.
The recent MedPAC recommendations on imaging standards are
merely an evolution of existing policy. At present, many office
imaging facilities lack accreditation, may use equipment that
is not maintained properly, not subject to quality assurance
programs, and may not employ certified technologists. Poorly
maintained equipment with poorly trained operators can lead to
poor images, misdiagnoses, duplicate tests, and more invasive
procedures, as well as unnecessary radiation exposure, although
the adverse effects of this exposure may not show up in the
form of increased cancer risk for decades. A recent Blue Cross
and Blue Shield study showed that nearly a third of imaging
procedures performed by nonradiologists are unwarranted.
In their MedPAC report, MedPAC also identified drastic
fluctuations in imaging growth with regards to medical
specialty and geography as factors in their decision to make
quality and safety recommendations. Let me give you some vivid
examples of this fluctuation.
A study published in the Journal of the American Medical
Association pointed out that physicians who own imaging
equipment are up to 7 times more likely to order tests than
those who refer patients to facilities in which they have no
financial interest.
More striking are the Medicare numbers that show from 1998
to 2003, in Alabama and Ohio, in-office MRI and CT utilization
among nonradiologists was up more than 3,000 percent, 30 times
the national average by all providers during that span.
Office-based expansions have been inaccurately justified by
claims of patient convenience, yet convenient access to poor-
quality or unnecessary services is not a patient benefit. Also,
Medicare billing data shows that only 3 percent of imaging
procedures done by nonradiologists are billed on the same claim
as the office visit. Medicare data further shows that this
trend is not merely a shift in site of service. Imaging has
increased significantly, both in hospitals and office settings,
since 2000.
The ACR urges Congress to act now with a quality-based
approach to this problem that will improve care and produce
needed Medicare savings. Over the next 10 years, lesser-quality
imaging mills will represent an increasing share of Medicare
spending unless quality standards are enacted to deter these
operators from entering the marketplace.
Given the likelihood that Medicare spending on the highest-
cost modalities may approach $100 billion over the next decade,
deterring just 5 percent of projected spending would represent
a substantial savings to the Medicare program and improve
patient care.
The ACR is pleased to work with this Committee in its
efforts to ensure appropriate utilization of diagnostic imaging
services.
Thank you very much.
[The prepared statement of Dr. Borgstede follows:]
Statement of James Borgstede, M.D., Chair, Board of Chancellors,
American College of Radiology
Chairwoman Johnson and Distinguished Members of the Subcommittee,
My name is James Borgstede, M.D. and I am the Chair of the Board of
Chancellors for the American College of Radiology. I am a general
radiologist from Colorado Springs, Colorado. It is a pleasure and an
honor to represent the 32,000 members of the American College of
Radiology before this distinguished body. The College is the nation's
largest radiology specialty organization representing diagnostic
radiologists, radiation oncologists, interventional radiologists,
nuclear medicine physicians and medical physicists. Today, I will be
addressing the increased utilization of imaging services and ACR
support of the Medicare Payment Advisory Commission's (MedPAC)
recommendations to reduce those increases while promoting quality and
safety in the Medicare program.
Increased Utilization of Imaging Services
The ACR encourages and supports the technological innovations and
advances in diagnostic medical imaging, which have unequivocally
improved the quality of health care while producing cost savings
through less invasive diagnostic techniques. As medical physicians who
have been devoted for over 75 years to studying, researching,
understanding and practicing the science and clinical application
behind this medical technology, the ACR and its members' experience,
expertise and passion is focused on medical imaging. The College
appreciates and supports the tremendous developments imaging has
brought to patient care. However we have concerns regarding the
quality, safety and costs associated with the dramatic rise in the
volume of procedures and forward growth trends in high-cost diagnostic
imaging modalities. We suspect some of this growth is economically
driven by physicians who own and operate imaging equipment in their
office, and would like to address these concerns in our testimony.
MedPAC's June 2004 and March 2005 reports to Congress share the
College's concerns, stating that diagnostic medical imaging is the
fastest growing type of medical expenditure within the category of
physician services in the United States, boasting an annual growth rate
that is more than two times that of general medical procedures. The
ACR, as well as lawmakers, federal regulators and private payer
insurers, recognize that this trend line, which is growing
exponentially every year, is unsustainable and that the growth of
imaging utilization, some of which may be inappropriate, must be
controlled. As troubling as the rising costs associated with over-
utilization of imaging services is, MedPAC also has expressed a growing
concern that both the quality and safety necessary for effective
diagnosis may be decreasing.
The ACR shares MedPAC's concerns regarding the quality, safety and
costs associated with the dramatic rise and variation in the volume of
procedures utilizing high-cost diagnostic imaging modalities. In
response to MedPAC's and the private payer insurers' desire to address
this alarming imaging utilization trend, the College has worked closely
with these groups to establish a Medicare physician payment policy
focused on quality of care, patient safety and expertise of the
physician interpreter to obtain needed cost savings and quality
assurances in the area of diagnostic medical imaging services. More
importantly, implementation of these recommendations will help assure
that America's over 65 population receives high quality, safe and
effective medical imaging.
MedPAC believes this policy is appropriate as evidenced by its
unanimous approval of recommendations to establish quality standards
for the provision and interpretation of imaging services. The MedPAC
recommendations, many of which the College fully supports, were
published in its March 2005 report to Congress. The ACR urges the
Subcommittee to seriously consider and follow the advice of its
Advisory Commission.
In short, MedPAC's recommendations, which are not specialty
specific, call for all diagnostic imaging providers to meet quality
standards for imaging equipment, non-physician staff, images produced,
patient safety protocols, and increased training for physicians who
bill Medicare for interpreting diagnostic imaging procedures. As
suggested by MedPAC in its March 2005 report, these standards would be
determined by the Secretary of Health and Human Services (HHS) in
consultation with physician specialty associations and nationally
recognized accreditation organizations. Therefore, those physicians
that are conscientious and committed to obtaining the training,
education, personnel and equipment necessary to meet these standards
will continue to be able to provide services to their patients. Those
physicians, who may have unethical reasons for performing imaging
studies, may see the quality and safety requirements as a deterrent and
no longer provide them.
The College's policy (see ACR Principles of Proposed Legislation
attachment) parallels MedPAC's quite closely. However, the ACR proposes
that HHS set standards only for Magnetic Resonance Imaging (MRI),
Computed Tomography (CT), Positron Emission Tomography (PET) and any
``fusion'' technologies that may be developed in the future. MedPAC
acknowledges this option in its March 2005 report and states, ``. . .
the agency (CMS) might want to first focus on modalities that receive
higher payment rates and are growing fastest. MRI, CT and nuclear
medicine (including PET) fall within this high priority category.''
According to data compiled for the ACR, congressional
implementation of the MedPAC recommendations, designed in part to stem
the financial incentive associated with some of the growth in imaging
utilization, could save the Medicare program a minimum of $4-6 billion
over ten years (the analysis behind this cost savings has been
previously provided to Committee staff). Given the likelihood that
Medicare spending on the highest-cost modalities may approach $100
billion over the next ten years, deterring just 5 percent of projected
spending would represent a substantial savings to Medicare. Moreover,
the quality of care Medicare beneficiaries receive, with fewer
duplicative studies and better image quality, should significantly
improve with the implementation of quality and safety requirements for
medical imaging.
Quality and Imaging Services
Probably the best example of the effectiveness of a quality-based
imaging program is the Mammography Quality Standards Act or MQSA. This
congressionally established program sought to increase the quality of
mammographic images by setting standards for the facility, technicians
and physicians involved in the mammography process, thus improving
breast cancer diagnosis and ultimately breast cancer survival. Both
MedPAC and the ACR have used MQSA's accreditation and physician
qualification policies to model their current proposals.
As evidence of the success of this image-quality initiative, a 1998
report published by the United States Government Accountability Office
(GAO) stated that ``MQSA's quality standards and the related
accreditation process have had a substantial
effect on improving the quality of services.'' GAO further writes, ``We
believe it is reasonable to attribute a large part of the quality
improvement to MQSA processes that enforced accreditation standards
that were not previously met by many facilities. . . .''
ACR believes that if Congress thought it was important to ensure
quality for the x-ray procedures involved in mammography, then it is
logical that Congress would want to enact similar standards for other
imaging procedures that are more complex, such as CT, in which the
radiation dose is 100 times that of a conventional chest film. Clearly
the Centers for Medicare and Medicaid Services (CMS) has begun to move
in this direction as is evidenced by its October 1, 2004 transmittal
number 24 which incorporated into Medicare regulation a national
coverage determination for PET scans that includes facility
accreditation and demonstrated physician interpreter expertise as a
requirement of coverage. Specifically, the CMS languages states ``The
FDG-PET scan is performed in a facility that has all the accreditation
necessary to operate nuclear medicine equipment. The reading of the
scan should be done by an expert in nuclear medicine, radiology,
neurology, or psychiatry, with experience interpreting such scans in
the presence of dementia.''
While the value of quality and safety standards are innate, their
need is also supported by evidence. MedPAC has clearly articulated an
objective review of many important studies that illustrate the basis
for their recommendations. MedPAC specifically cites studies by
Moskowitz and Verrilli, both of which were published in peer reviewed
journals, thus assuring their quality. While some criticize these
studies, it is significant to note that they were conducted in separate
states and resulted in very similar findings. In both studies,
different private health insurers implemented imaging guidelines for
equipment and health care providers performing and interpreting the
study. In each instance, the private health insurer saw a quality
improvement and cost savings.
Concerns
Many medical specialty organizations do not share the ACR's and
MedPAC's concerns regarding the growth in diagnostic imaging
utilization. While those that oppose implementation of the MedPAC
recommendations for MRI, CT and PET suggest that these modalities are
dominated by radiologists, they neglect to mention the exponential
growth rates of non radiologists providing these services.
Analysis of Medicare claims data reveals that between 2000 and
2003, imaging by nonradiologist physicians grew at a rate of 12% per
year, while imaging by radiologists grew at a rate of 10% per year.
However, the differences in utilization between radiologists and
nonradiologist physicians are more pronounced when one focuses the
analysis on the inordinate volume of CT and MRI emanating from the
office setting. For example, in-office CT per 1,000 beneficiaries by
radiologists grew at a rate of 16% per year in number of procedures and
14% per year in dollars, whereas in-office CT per 1,000 beneficiaries
by nonradiologist physicians grew at a rate of 20% per year in number
of procedures and 27% per year in dollars. Additionally, in-office MRI
per 1,000 beneficiaries by radiologists grew at a rate of 14% per year
in procedures and 13% per year in dollars, whereas in-office MRI per
1,000 beneficiaries by nonradiologist physicians grew at a rate of 25%
per year in number of procedures and 28% per year in dollars.
Furthermore, some opponents suggest that the shift in the site of
service from inpatient hospital to physician offices has inflated the
increase in imaging utilization. However, analysis of imaging
procedures in Part B Medicare (measured in terms of number of
procedures as well as professional component RVUs per 1,000
beneficiaries), showed increases in both inpatient and office settings.
As per the Physician Supplier Procedures Summary (PSPS) Masterfile, the
three-year growth in imaging per 1,000 beneficiaries for the period
2000-2003, in all sites of service combined, was 17% (5.3% per year) in
number of procedures and 26% (7.9% per year) in professional component
RVUs. In other words, since there are increases in both the inpatient
and office settings, it cannot be suggested that all of the growth in
office imaging is replacing imaging performed in other settings.
Other medical specialty organizations cite patient convenience and
``one stop shopping'' as a reason not to pursue quality and safety
standards for imaging procedures. This concern is unwarranted. Patient
convenience will not go away with the implementation of quality and
safety standards and it seems reasonable to point out that convenient
access to poor quality or unnecessary services is hardly a patient
benefit. Rather, patients will be assured that their health care
provider, regardless of specialty, is qualified to perform and
interpret these expensive, highly technical and advanced imaging
studies when they receive them in the offices of their physician.
Established Diagnostic Imaging Quality and Safety Programs
The use of accreditation standards is one mechanism to help attain
the goal of increasing quality and safety, while at the same time
reducing utilization costs to Medicare. MedPAC's imaging standards
recommendations are based on the concept of accreditation and are
similar to the standards facilities and physicians who perform
mammograms must meet under the federally established Mammography
Quality Standards Act of 1992. Accreditation programs evaluate the
imaging equipment specifications and calibration, dose (where
appropriate), patient image quality, physician and non-physician
personnel qualifications, and quality control among other items.
The ACR's history of developing and administering accreditation
programs that assess the quality of imaging facilities dates back to
1963 and is a testimony to the College's dedication to quality patient
care in imaging and radiation therapy. While there may be some who
believe that the important requirements associated with accreditation
may be covered by state radiation protection programs, it must be
understood that these programs vary by state and typically only address
imaging equipment utilizing ionizing radiation (i.e., x-rays) and not
MRI or ultrasound. Further, state radiation protection programs
typically only inspect facilities for radiation safety compliance, not
necessarily image quality performance. State radiation protection
programs do not evaluate the entire imaging system (including patient
image quality) the way accreditation does.
Currently, the ACR has established and maintains nine different
accreditation programs, all with pathways for radiology and
nonradiology practices to receive accredited status. I want to
emphasize the ability of both radiologists and nonradiologists to
receive accreditation through the ACR programs. For example,
approximately 15% of the facilities accredited by the ACR in nuclear
medicine are cardiology practices. Also, 144 nonradiology specialty or
multispecialty clinics have received ACR accreditation for CT or MRI.
The College is also ready and willing to collaborate with other
specialty organizations in the development of our quality and safety
resources. For example, the ACR Stereotactic Breast Biopsy
Accreditation Program was developed in collaboration with the American
College of Surgeons.
Today, many private insurers have recognized the need for quality
improvement in medical imaging, as well as cost savings associated with
implementing higher standards. To improve image quality and reduce
costs, some insurers are following accreditation models similar to
those proposed by MedPAC and ACR. One local Medicare contractor has
even implemented facility accreditation requirements and standards for
physicians in the area of transthoracic echocardiography, a service
typically provide by cardiologists. A list of some insurers and states
utilizing ACR Accreditation is attached to this testimony and include
Aetna, Blue Cross of California, Highmark Blue Cross of Pennsylvania,
Blue Cross Blue Shield of Alabama, United Health Group, Cigna of
Connecticut and Oxford to name a few.
Conclusion
The ACR is the premier organization with unmatched breadth, depth
and expertise in radiological sciences, medical imaging, radiation
safety, radiation protection, dose delivery and image interpretation
programs. The College has demonstrated its commitment to evidence based
decision making in healthcare and dedication to high quality, safe and
effective patient care through all of its available resources.
The American College of Radiology recognizes that the unbridled
growth of high cost diagnostic imaging services within the Medicare
program is unsustainable and that the costs associated with
inappropriate volume must be contained. The policy recommendations
developed by MedPAC currently being reviewed by Congress can
significantly help accomplish this goal.
With rapidly increasing healthcare costs, patient co-pays and
deductibles, the physician community and Congress have an obligation to
the American public to promote quality based initiatives and guard
against the unnecessary use of healthcare services. If Congress fails
to remedy this issue, the added cost of unnecessary and lower quality
imaging procedures threatens the solvency of the Medicare program and
many state Medicaid programs, which could ultimately result in across-
the-board cuts in physician reimbursement rates. A decline in
reimbursement rates in conjunction with skyrocketing malpractice
insurance rates would drive qualified imaging providers from the field,
restrict patient access to quality care and discourage investment in
new diagnostic imaging modalities. Clearly, the patients have the most
to lose.
The American College of Radiology appreciates this opportunity to
testify and looks forward to working with the Subcommittee, MedPAC, CMS
and other medical specialties to establish quality standards in
diagnostic imaging services that will benefit our patients and the
health care system overall.
----------
ACR PRINCIPLES OF PROPOSED LEGISLATION
I. FACILITY CERTIFICATION. Certification by the Secretary of HHS is
required for lawful operation of all facilities under the regulatory
jurisdiction of the United States that provide computed tomography
(``CT''), magnetic resonance imaging (``MRI''), and positron emission
tomography (``PET''), except when such service is provided for the
purpose of radiation therapy treatment planning or image guided
therapy. These certificates shall be issued or renewed for three-year
periods. The Secretary has discretion to include new, emerging
technologies in the certification process.
II. FACILITY ACCREDITATION. In order to be certified, a facility
must be accredited by a private, non-profit organization with
experience in diagnostic medical imaging accreditation, including the
American College of Radiology, the Intersocietal Commission for the
Accreditation of Nuclear Medicine Laboratories, or other such entity
designated by the Secretary.
III. QUALIFIED MEDICAL PHYSICIST. A qualified medical physicist
must perform annual surveys, reviews and inspections at a facility
providing CT, MRI, and/or PET. They must be trained to evaluate the
performance of CT, MRI, and PET equipment as well as facility quality
assurance and quality control programs and be certified and/or State
licensed.
IV. QUALIFIED RADIOLOGIC TECHNOLOGIST. A qualified radiologic
technologist is an individual, including radiographers, nuclear
medicine technologists, and radiologist assistants, specifically
trained in the use of CT, MRI, and PET equipment and the positioning of
patients for studies performed with such equipment, who performs such
studies in a facility and possesses unrestricted State licensure and/or
certification.
V. QUALIFIED INTERPRETING PHYSICIAN. Clinical images produced
during CT, MRI, or PET studies performed at a facility must be formally
interpreted by a qualified interpreting physician, who is a radiologist
or other licensed physician who meets the appropriate education,
training, and experience requirements established by the Secretary in
consultation with accrediting organizations.
VI. ALTERNATIVE STANDARDS FOR RURAL AND MEDICALLY UNDERSERVED AREAS
AND TELERADIOLOGY. The Secretary shall have the authority to establish
alternative standards for rural or medically underserved areas to
assure access to quality diagnostic medical imaging. The interpretation
of a clinical image produced at a certified facility may occur either
at the facility where the study was conducted or offsite within the
United States via teleradiology.
VII. MEDICARE REIMBURSEMENT. With respect to expenses incurred for
CT, MRI, and PET, Medicare shall only pay for the professional
component of the services if the physician interpreting the clinical
image produced by such study is a qualified interpreting physician, and
shall only be made for the technical component if the facility
conducting the study is a certified facility.
VIII. ADVISORY COMMITTEE. An advisory committee consisting of
physicians, consumer advocates, CMS, and industry shall be established
to serve as primary advisor to the Secretary.
----------
Table 1. Private Third-Party Payers with ACR Accreditation Requirements
of Some Form
------------------------------------------------------------------------
Private Third-Party Payers with ACR
Accreditation Requirements of Some Form (as ACR Accreditation Program
of March 1, 2004) Required
------------------------------------------------------------------------
Aetna US Healthcare MRI, Mammography, OB
Ultrasound
------------------------------------------------------------------------
Auto Insurance Regulations in Florida MRI
------------------------------------------------------------------------
Blue Cross of CA (NIA) MRI
------------------------------------------------------------------------
Blue Cross-NEPA/FPH MRI
------------------------------------------------------------------------
Health Now New York, Inc. MRI
------------------------------------------------------------------------
Highmark Blue Cross of PA MRI (in lieu of their own
program)
------------------------------------------------------------------------
One Call Medical MRI
------------------------------------------------------------------------
Blue Cross/Blue Shield of Alabama MRI, CT, PET
------------------------------------------------------------------------
New York Medical Imaging, PLLC (NYMI) MRI, Ultrasound
------------------------------------------------------------------------
Oxford Health Plans CT, PET, Nuclear
Cardiology
------------------------------------------------------------------------
United Healthcare of Wisconsin Nuclear Cardiology
------------------------------------------------------------------------
Cigna of CT OB Ultrasound
------------------------------------------------------------------------
Health Net of Northeast, Inc. (NIA) OB Ultrasound
------------------------------------------------------------------------
Blue Cross of PA OB Ultrasound
------------------------------------------------------------------------
Intermountain Healthcare of UT OB Ultrasound
------------------------------------------------------------------------
PHS Health Plans (NIA) OB Ultrasound
------------------------------------------------------------------------
Blue Cross of NJ (maintain set minimum
quality standards for any
provider of imaging)
------------------------------------------------------------------------
----------
Table 2. State Legislatures Who Require ACR Accreditation of Some Form
------------------------------------------------------------------------
State Legislatures Who Require
ACR Accreditation of Some Form:
(unlawful to operate without ACR Accreditation Program Required
accreditation as of March 1,
2004)
------------------------------------------------------------------------
California OB Ultrasound (for Prenatal Diagnosis
Centers)
------------------------------------------------------------------------
Massachusetts Stereotactic Breast Biopsy
------------------------------------------------------------------------
New Jersey Radiation Oncology
------------------------------------------------------------------------
New York Radiation Oncology (must have review
every 5 yrs. by approved body)
------------------------------------------------------------------------
Ohio Freestanding Radiation Oncology
facilities
------------------------------------------------------------------------
Connecticut MRI
------------------------------------------------------------------------
Rhode Island MRI
------------------------------------------------------------------------
Chairman JOHNSON. Thank you very much.
Dr. Williams?
STATEMENT OF KIM ALLAN WILLIAMS, M.D., PROFESSOR OF MEDICINE,
DIRECTOR OF NUCLEAR CARDIOLOGY, UNIVERSITY OF CHICAGO, CHICAGO,
ILLINOIS
Dr. WILLIAMS. Chairman Johnson, Members of the
Subcommittee, on behalf of the American College of Cardiology
and more than 20 health care organizations that comprise the
Coalition for Patient-Centered Imaging, I am honored to be here
and welcome the opportunity to testify about the use of medical
imaging to deliver health care, particularly its irreplaceable
contribution to the best practices of patient care. As you
know, an extension of my remarks is provided for the record.
First I have to give my conflict of interest. As you noted,
I am an academician at the University of Chicago, board-
certified in internal medicine, cardiology, nuclear medicine,
and nuclear cardiology, and so none of the things that I am
going to discuss today are actually going to benefit me or my
institution. But I am here today to speak about the fact that
office-based medical imaging performed by well-trained
physician specialists, like the ones that I train, is good
medical care and is in the best interest of patients.
Let me begin by saying that we do take exception to the
concept implied by MedPAC that physician specialists are
providing substandard care for their patients by providing
poor-quality medical imaging in their offices. There is really
no creditable evidence to support that notion. We agree with
MedPAC that safety and patient quality of imaging are of utmost
importance, and we agree with the fact that there needs to be
careful study of the growth in medical imaging services. But
let's keep safety and quality in the in-office medical imaging
as the focus, not the agenda of one physician group or another.
Patients are really the issue, not the turf war that is
frequently discussed in some of the literature of my colleague
in the American College of Radiology, of which I am a member,
by the way.
This group and MedPAC cite the same studies, recommending
an agenda that to some of us appears to be aimed at restricting
imaging to non-specialists. That is a concern because the
people that I train actually do very well because they know the
organ to begin with and then the imaging comes on top of that.
With proper training, they do extremely well and they become
the experts at this.
Now, MedPAC looked at a number of studies in developing its
recommendations, but these studies did not specifically examine
the quality of imaging interpretations done by both the
physician specialists and radiologists in MRI, CT, and nuclear,
particularly PET. So, this is a problem because MedPAC has
recommended that if these modalities become the high priority,
we do not want to see overgeneralization of these studies to
other modalities because that would be erroneous and
inappropriate.
With regard to medical imaging utilization, our data says
that imaging is not really growing twice as fast as all the fee
schedule services. It depends on how you do the analysis. We
had an analysis done by the Lewin Group, which is soon to be
published. When all Part B services are included and we account
for the shift in delivery of imaging services from hospitals to
physician offices, imaging actually grew at an annual rate of
about 8 percent from 2001 to 2003, and all Part B actually grew
at a rate of 10 percent. So, in fact, our data is showing that
the rate of growth actually may be stabilizing or even slowing.
With regard to my own field, nuclear cardiology,
cardiologists are actually performing 73 percent of these tests
now, and as Congressmen Lewis and Thompson have pointed out,
nuclear cardiology is starting to supplant the invasive
diagnostic cardiac catheterization. It can be done outside the
hospital, is less risky, less expensive, and often predicts
outcomes of the patient better than the invasive tests. So,
this growth is really highly beneficial to patients, translates
to saving lives, and there is no evidence that anyone has that
this is not appropriate, time-efficient, or cost-effective.
So, quality in imaging can be from my point of view
optimized for patients by ordering the right test at the right
time, performed well, and interpreting it well. And the
American College of Cardiology is partnering with other
organizations to develop appropriateness criteria for imaging
in an effort to define the right test at the right time.
Now, we believe that MedPAC's recommendations requiring
physician privileging as stated runs counter to the
Subcommittee's goal of improving quality care by tying
physician payment process to outcomes. You have to do sort of
one or the other. Simply directing CMS to determine the
competency of individual physicians as a condition of payment
does not ensure that those people who are deemed competent are
actually applying the technology in the way that benefits
patients.
Now, accreditation is one step physicians may consider when
it comes to ensuring the safety and quality of medical imaging.
In the absence of a system wide quality measurement, though,
accreditation has served as a proxy for quality, we admit. Now,
more evidence is needed to prove that it produces measurable
and significant improvements in quality of care. In addition,
sufficient time has to be given to providers to meet any new
requirements.
So, in closing, I respectfully urge the Committee to
carefully weigh the complexity of the medical imaging issue
before acting on any of MedPAC's recommendations. Remember that
cardiologists, urologists, orthopedic surgeons, obstetricians,
neurologists, and other specialty physicians are uniquely
qualified to provide imaging services specific to their
specialty because they are trained in both the diagnostic
imaging technique and the structure and function and clinical
manifestation of disease in that organ system that they are
imaging.
So, we are asking Congress, therefore, to, one, mandate the
solid, credible studies be commissioned to examine the quality
and safety of imaging services among all modalities among all
physicians disciplines; two, we ask that you support the
development of peer-reviewed evidence that accreditation
results in measurable and significant improvements in quality
of care, and convene a multi-specialty panel to discuss the
results and subsequent next steps; and lastly, refrain from
removing or limiting the in-office ancillary exception to the
physician ownership referral laws. We want sound policy that is
based on sound evidence.
Thank you again.
[The prepared statement of Dr. Williams follows:]
Statement of Kim Allen Williams, M.D., Professor of Medicine, Director
of Nuclear Cardiology, University of Chicago, Chicago, Illinois
Chairman Johnson and members of the Subcommittee, on behalf of the
American College of Cardiology (ACC) and more than 20 physician and
other healthcare organizations representing a broad range of
specialists and practices that comprise the Coalition for Patient-
Centered Imaging (CPCI), I welcome the opportunity to testify about the
use of medical imaging in the delivery of health care, and particularly
its irreplaceable contribution to best practices for patient care. I am
a Professor of Medicine and Radiology and Director of Nuclear
Cardiology at The University of Chicago School of Medicine. I am board-
certified in Internal Medicine, Cardiology, Nuclear Medicine, and
Nuclear Cardiology.
Today I would also like to speak to you about the growth in
utilization of medical imaging, specifically why growth is occurring,
and why physician specialists depend on medical imaging. I will also
address some of the myths surrounding accusations of inappropriate use
of medical imaging. I will articulate why the imaging that I and other
specialists perform and interpret for our patients is in the best
interest of the patient, is timely, and is cost-effective. We believe
imaging kept in the hands of experienced and qualified specialists is
safe, appropriate, of the highest quality, and critical to the emerging
demand for outcomes-based disease state management, both in the medical
and public policymaking arenas.
I remember being in cardiology training just a few short decades
ago when invasive diagnostic testing was ``standard'' practice in
cardiology. I was told by my mentors that if we didn't have ``30
percent normal angiograms,'' we were being too selective and would miss
disease in a large segment of our patients. Well, those days are gone
due to highly accurate, noninvasive imaging tests that more accurately
predict outcomes for cardiac patients than the old-fashioned invasive
``standard.''
Medical Imaging Is Good Medicine
Advancements in medical imaging have changed the way cardiologists,
oncologists, obstetricians and gynecologists, urologists, family
practitioners, neurologists, orthopaedic surgeons and other surgeons
and many other physicians deliver patient care on a daily basis. By
integrating medical technology into care plans, patients are receiving
more prompt, efficient, effective and cost-effective care. In addition
to traditional diagnostics employing medical imaging, we now use
imaging to guide minimally invasive treatments and to track ongoing
treatment protocols through judicious use of medical imaging. We are
enabled as physicians to adjust patient care plans mid-therapy to
achieve the best possible outcomes. Several specialist groups
intimately integrate medical imaging in the most delicate and intricate
aspects of their care. The prudent use of medical imaging in the actual
treatment regimen is not only excellent medicine: it also manages
short- and long-term costs by minimizing wasteful and ineffective
treatments.
Patient Value
We cannot overestimate the patient values of choice, comfort,
convenience and peace of mind when it comes to the provision of in-
office imaging. The in-office setting affords patients greater choice
about who they want to perform and interpret their test results.
Patients can now have imaging tests performed by physicians who know
their medical history and who will ultimately make treatment decisions
and provide ongoing continuity of care. Patients also can have their
imaging tests performed in a setting that is comfortable and convenient
to them, oftentimes resulting in one office visit instead of three--or
more. This is efficient not only from a patient's point of view, but
for society as a whole.
Physician Value
In my field of cardiovascular medicine, advancements in noninvasive
medical imaging have significantly changed the way we diagnose and
treat patients with acquired and congenital cardiovascular disease.
Today, cardiologists can do for their patients what was not possible
even 10 years ago. There is unquestionable value for physicians being
empowered to integrate imaging into their practices. With the aid of
medical imaging, physicians make more precise diagnoses in a time-
efficient manner, leading to earlier detection of disease. As Medicare
and private payers begin to focus on disease state management, we are
learning one of the greatest obstacles to effectively managing the care
of patients with chronic conditions is compliance. Physicians know when
they have to order a test for a patient outside their office, there is
a question of when, or even whether, that patient will follow through.
Better compliance means maintaining a continuum of care that is
critical in treating and managing disease.
Most often in medicine, timeliness in imaging improves outcomes. A
diagnosis delayed is essentially a treatment denied. This is true
whether we are speaking of diagnosing a critically narrowed and life-
threatening coronary artery which is soon to close completely, or a
stress fracture in a runner's foot that could become a complete bone
break with the next training session.
Value to Payers and Society
Advances in technology can decrease healthcare spending, if they
lead to less expensive treatments, or they can increase spending by,
for example, rendering previously untreatable or partially treatable
conditions treatable. Technological advancements can also lead to
significant improvements in health outcomes that can clearly offset the
direct costs of new technology.
Last year, a study by MEDTAP International on the value of
healthcare spending revealed that the value of the health improvements
in the U.S. population over the past 20 years has significantly
outweighed the additional healthcare expenditures that have accompanied
these improvements. According to the report, every additional dollar
spent on overall treatment for heart attacks has resulted in health
gains of $1.10.\1\
---------------------------------------------------------------------------
\1\ The value of investment in health care. Bethesda, MD: MEDTAP
International. http://bcbshealthissues.com/relatives/20846.pdf.
---------------------------------------------------------------------------
A study by David M. Cutler, Ph.D., and Mark McClellan, M.D., Ph.D.,
published in 2001 \2\ found that benefits of improvement in heart
attack treatment over a 10-year period exceeded treatment costs by
$87,000 per person who had a heart attack. Another study \3\ found that
more than half of the cost growth for heart attacks from 1984 to 1998
was attributable to technological developments, most often in the
expansion of existing technologies within new patient populations. In
general, there is a notable body of literature that finds that new
medical technologies create desired value and health care improvements
that far outweigh their costs.
---------------------------------------------------------------------------
\2\ David M. Cutler, Mark McClellan, ``Productivity Change in
Health Care,'' American Economic Review 2001;91(2):281-286.
\3\ David M. Cutler, Mark McClellan, Joseph P. Newhouse, and Dahlia
Remler, ``Are Medical Prices Declining? Evidence from Heart Attack
Treatments.'' Quarterly Journal of Economics 1998;113(4):991-1024.
---------------------------------------------------------------------------
The Medicare Payment Advisory Commission's (MedPAC) recent report
to Congress made little mention of the value that medical imaging has
brought to patients, physicians or the healthcare system as a whole.
This is a notable omission.
Before Congress considers policies that could ultimately discourage
or restrict certain specialists from providing appropriate imaging
services to their patients, cost-effectiveness studies are needed to
better determine the incremental costs of procedures in relation to
their incremental health benefits in order to determine whether imaging
technologies provide reasonable value for their cost.
While there is high value for patients receiving medical imaging
services by their physician specialists in an office setting, current
costs to Medicare for imaging performed in hospital or non-hospital
settings remain neutral. The migration, however, to office-based
noninvasive diagnostic imaging and image-guided therapy, has the
potential to create significant cost savings.
When physicians must refer their patients to a hospital or imaging
facility for needed tests, the process of a referral to a radiologist
can itself increase costs to both Medicare and to patients. The
referral can result in as many as three or more appointments and
visits--one to see the physician and learn an image is needed, a second
to have the image taken, and then a followup appointment and visit to
the referring physician to receive the treatment plan based on the
image. Although difficult to quantify, by reducing the number of
visits, in-office imaging should directly reduce costs to both patients
and Medicare, while increasing convenience and improving the timeliness
of subsequent diagnosis and treatment. In addition, with fewer visits
and a shorter delay between the initial visit and treatment, both
patient compliance and health outcomes are improved.
Analyzing Utilization of Medical Imaging
Shift in Site of Service
In its just-released report to Congress, MedPAC found that between
1999 and 2002 the growth rate in the use of imaging services was twice
as high as the growth rate for all fee schedule services (10.1 percent
vs. 5.2 percent). MedPAC also found that growth in imaging moderated
from 2002 to 2003, but imaging services were still higher (8.6 percent)
than all services (4.9 percent).
While MedPAC acknowledged about 20 percent of the growth in imaging
services paid under the physician fee schedule between 1999 and 2002
was due to a shift of site of services out of hospitals and into
physician offices, MedPAC does not directly account for this shift in
its growth comparisons. Failure to appropriately account for site of
service changes presents a misleading interpretation of growth in
imaging services. In addition, MedPAC does not include all Part B
services in its comparison. In particular, MedPAC omits durable medical
equipment, chemotherapy drugs and other drugs covered under Part B, and
ambulance services. When we include all Part B services and account for
changes in site of service for imaging, imaging actually grew at an
annual rate of 8 percent from 1999-2003, and all Part B services grew
at an annual rate of 7.8 percent over the same period.
Furthermore, the growth rate of imaging is stable or even slowing
slightly (8.1 percent in 1999-2001 and 8 percent in 2001-2003), while
the growth rate for all services is increasing (5.7 percent in 1999-
2001 and 10 percent in 2001-2003). These omissions are important since
MedPAC bases, in part, its rationale for greater government oversight
of imaging services on the competitive growth of these services.
Average Annual Growth in Physician and Outpatient Hospital Services
from 2001-2003
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Source: The Lewin Group's analysis of the Medicare Physician/
Supplier Master Summary File.
* All Imaging includes BETOS categories I1A-I4B
** Growth in Hospital Outpatient Services spending is estimated by
using growth in allowed charges deflated by the hospital market basket.
This is then weight averaged with the growth in physician services,
using total allowed charges for the weights, to estimate growth in All
Medical Services for Physician/Hospital Outpatient in RVU equivalents.
Among all medical specialties, cardiology has the second highest
utilization of imaging services behind diagnostic radiology, a fact
largely attributable to advances in treatment and improved standards of
care, and to the ultimate integration of echocardiography and coronary
angiography into the everyday practice of cardiologists. Consistent
with results reported by MedPAC, we found that nuclear medicine, along
with other advanced imaging procedures, has tended to grow faster than
other imaging services. However, an analysis by The Lewin Group showed
that, without accounting for shift in site of service, growth in
nuclear imaging and MRI (other than of the brain) is overstated by a
third.
The Case Against Self-Referral as a Cause of Increased Utilization
Because of the documented shift in site of service, physicians are
performing more medical imaging tests in their offices, and the number
of imaging services billed under Part B is increasing. Imaging is
considered an ancillary service, and under the ``Stark Laws'' there is
an exception for ``in-office ancillary services'' that permits
physicians to legally perform imaging and other ancillary services in
their offices. We would vigorously oppose any attempt to remove or to
limit in any way the in-office ancillary exceptions protected by the
Stark Laws.
Unfortunately, some have begun to equate such allowed self-referral
with inappropriate utilization of imaging services. While no credible
body, including MedPAC, has been able to quantify whether and to what
degree imaging performed in an office setting is inappropriate, we
understand there may be inappropriate use of these healthcare services,
like any other care financed through Medicare. But self-referral, as it
is labeled by self-interested groups outside the physician specialty
community, is not the primary driver in growth in imaging services.
Important findings of the Lewin analysis, not examined by MedPAC,
undermine the claim that the primary driver of growth in imaging
services is self-referral. First, utilization of MRI and CT, which have
experienced relatively high growth rates compared with other types of
services, was examined. The average growth rate for CT from 2001-2003
was 16 percent, with radiology dominating 84 percent of CT scans
performed. Similarly, the average growth rate for MRI during this same
time period was 19 percent, with radiology dominating 65 percent of
use. Because MRI and CT are dominated by radiologists, these results
suggest that eliminating the ability of specialty physicians to perform
and interpret imaging tests in their offices is no protection against
the growth in utilization.
Second, central to the argument that self-referral is a significant
cost-driver is the idea, supported by MedPAC, that physicians will
automatically over-utilize imaging services to increase their
practices' revenue and income. However, two studies \4,5\ demonstrate
that physicians order more images when they have access to on-site
imaging equipment, even when they do not own it and have no financial
incentives to do so.
---------------------------------------------------------------------------
\4\ R.P. Strasser, M.J. Bass, M. Brennan, ``The effect of an on-
site radiology facility on radiologic utilization in family practice,''
Journal of Family Practice 1987;24:619-623.
\5\ K.K. Oguz, D.M. Yousen, T. Deluca, E.H. Herskovitz, N.J.
Beauchamp, ``Effect of emergency department CT on neuroimaging case
volume and positive scan rates.'' Academic Radiology 2002;9:1018-1024.
---------------------------------------------------------------------------
Clinical Substitution as a Result of More Effective Technology
In its March 2003 report, MedPAC acknowledged new indications for
existing technologies may contribute to imaging growth rates, and
decreases in some services, and in some cases more costly services, may
result of substituting one service for another. In nuclear cardiology,
my particular area of training and expertise, the data indicate that
nuclear cardiology is supplanting hospital-based invasive cardiac
catheterization in many cases.
The average growth rate from 2001-2003 for cardiac nuclear imaging
by radiologists and cardiologists combined was 18 percent, down from an
average of 19 percent during 1999-2001. Comparatively, the average
annual growth rate for invasive cardiac catheterization, a procedure
not performed by radiologists, dropped from 8 percent in 1999-2001 to
negative-4 percent in 2001-2003. This shows a direct and positive
correlation between increases in cardiac nuclear imaging and decreases
in invasive diagnostic cardiac catheterization. The significance of
this substitution is that nuclear cardiology and other noninvasive
imaging can be done outside of hospitals, is less expensive, is less
risky in terms of complications, requires no patient recuperation, and
often predicts the outcome of the patient better than invasive
tests.\6\
---------------------------------------------------------------------------
\6\ Iskandrian, et al. Journal of the American College of
Cardiology 1993;22:665-670.
---------------------------------------------------------------------------
Advancements in Technology
As we eliminate the theory that self-referral is a primary driver
of medical imaging utilization, we can begin to examine the true
reasons why utilization has increased in this area of medicine.
While MedPAC has acknowledged the role of technological innovation
in the growth of imaging services, it does not adequately include this
factor in its analysis, especially the issue of substitution of one
treatment or diagnosis method for another.
Growth in the use of imaging services is, in part, reflective of
growing applications for these technologies. In fact, in its March 2003
report, MedPAC states, ``. . . it appears that use of well-established
technologies is increasing. CAT, for example, was introduced in the
1970s. MRI began to diffuse as a new technology in the 1980s. Thus, the
indications for use of these technologies may be changing.''
As I have mentioned, technology improvements have resulted in new
imaging techniques that replace more invasive and generally more risky
diagnostic procedures, and this trend of substitution isn't just
occurring in cardiology. For example, ultrasound guidance can allow
needle biopsies to replace open biopsies of the breast, and it also can
enable more accurate biopsies of prostate legions with fewer tissue
samples.
In breast surgery, ultrasound-guided breast biopsies can reduce
performance of potentially unnecessary and invasive procedures and
surgeries. Ultrasound-guided breast biopsy allows for less-invasive
evaluation of mammographic lesions, with more reliable tissue
differentiation, more streamlined patient care and characterization,
and improved staging of disease.
Urology offers another example where advancements in medical
imaging have led to less-invasive and less-painful procedures. Older
men often experience difficulty urinating because of prostate
enlargement. To evaluate this problem, physicians must learn how much
urine is retained in the bladder after voiding, known as ``residual
urine.'' For many years this was determined by passing a catheter
through the urethra and into the bladder, the amount of urine drained
from the bladder was then measured. Introducing a catheter into the
bladder, in addition to being uncomfortable, also may introduce
infection. Today, many urologists employ a small ultrasound machine
designed specifically for this task. This test can be done in the
urologist's office and eliminates the use of a catheter and the danger
of infection. In addition, 15 percent of Americans will have a kidney
stone in their lifetime, and during acute episodes there is much pain
and disability, often resulting in hospitalization and loss of work.
The CT stone protocol provides for a rapid, accurate diagnosis of the
vast majority of kidney stones. Using a CT scanner, a patient does not
have to be given intravenous contrast, which can be toxic, as would be
needed with the traditional intravenous pyleogram (IVP). The CT scan
also allows for the diagnosis of non-calcium stones that may not be the
case with IVP. This provides more efficient health care for the
economy, for providers and far better patient care.
Today in cardiology, we routinely use an arsenal of high-tech
equipment to combat and treat disease. With the use of CT, we can see
the heart beating in three dimensions which allows us to define the
adequacy of coronary perfusion as well as plaque within a vessel wall.
We can track heart disease at every state, visualizing what we could
only imagine in the past. The expectation of society, and of our
patients, is that we will employ all of these marvels to achieve best
practice outcomes for every care interlude. That means medical imaging
as part of the treatment plan delivered in a physician's office is here
to stay.
Changing Demographics
Managing heart disease is one of the most significant success
stories in modern health care. Over the past 30 years, there has been a
substantial increase in the life expectancy of Americans that directly
correlates with downward trends in heart disease mortality and
disability. We know that prevention efforts are important contributors
to the reduced mortality rates, but many of the benefits are attributed
to better and earlier detection and improved treatment.
We anticipate that as the population ages, because medical imaging
will continue to be an essential tool for treating heart disease,
growth in utilization is bound to continue. Consider this: Based on the
National Heart, Lung, and Blood Institute's Framingham Heart Study, the
average annual rates of first major cardiovascular events rise from
seven per 1,000 men at ages 35-44 to 68 per 1,000 at ages 85-94. For
women, comparable rates occur as men, but about 10 years later in life.
At the same time, the prevalence of diseases associated with heart
disease, such as obesity, hypertension, diabetes, and high cholesterol
also continue to grow.
Advancements in technology and changing demographics are factors
that can be expected to continue to fuel growth in Medicare and overall
health expenditures. Furthermore, while technological advances
sometimes increase expenditures, they can also decrease costs by
allowing less invasive and less costly treatments to replace older,
more invasive treatments. In addition, new imaging technologies can
improve early detection, which can allow us to treat diseases at a
lower level of intensity, and thus at a lower cost than if they were
detected later. It is important, therefore, that Congress move
cautiously when considering policies to limit the use of imaging
services, because imprudent limits on the use of diagnostic imaging
could increase total Medicare expenditures for non-imaging services.
Quality Medical Imaging is Safe and Appropriate
Quality
Quality is a top priority in health care as providers, payers, and
regulators strive for a system that reduces errors and rewards
physicians for exemplary clinical practice. CMS and private payers have
begun to implement programs that tie physician reimbursement to patient
care outcomes--a growing trend called ``pay for performance.''
Emphasizing and rewarding quality is good for patients. However, this
process must recognize that, by necessity, physicians will need to use
advanced technology to meet high quality standards and ensure optimal
care. Newer imaging modalities provide more accurate and precise images
with lower patient risk, helping physicians to diagnose and treat
diseases more effectively. To make objective evaluations of patient
progress tied to payment, medical imaging will undoubtedly expand to
provide clear, unequivocal valuations of care protocols and procedures.
Who owns these technologies and how widely they are utilized have
become critical questions for our patients and physicians.
The American College of Cardiology and the Coalition for Patient-
Centered Imaging support the delivery of the highest quality care. But
the debate over medical imaging, one that is playing out in the press,
in state legislatures and here in Congress, stands to pit one physician
group against another. The College has sat at the table with the
leadership of the American College of Radiology, and has sought to
reach agreement on what defines quality in imaging. To date, our
results have been mixed. Not working together as a physician community
is the ultimate disservice to our patients and, ultimately, to the
payer community.
The literature comparing the quality of interpretations of imaging
studies conducted by ``nonradiologists,'' and radiologists remains
limited.\7\ Of the studies that do exist, the findings do not suggest
that physician specialists (limited license providers excluded) have
lower quality of performance in diagnostic imaging than radiologists.
In an article published last year in the Journal of the American
College of Radiology, and disconcertingly titled, ``Turf Wars in
Radiology: The Quality of Interpretations of Imaging Studies by
Nonradiologist Physicians--A Patient Safety Issue,'' the authors David
Levin and Vijay Rao cite studies that compared the performance on plain
radiographs (x-rays), an imaging modality dominated by radiologists,
rather than more specialized modalities such as CT and MRI--which is
where much of the increase in utilization is occurring. In particular,
modalities primarily used by other specialties (such as
echocardiography, which is used primarily by cardiologists, and
transrectal prostate ultrasound, which used primarily by urologists)
were excluded. Furthermore, the studies quoted by Levin and Rao
actually found that cardiologists perform and interpret chest X-rays as
well as radiologists, but that fact was not brought out in the article.
Our point here is, specialists who learn a medical imaging technique
will perform that technique with quality and will accept nothing less
for patients for whom they care.
---------------------------------------------------------------------------
\7\ Levin DC, Rao VM. Turf wars in radiology: the quality of
imaging facilities operated by nonradiologist physicians and of the
images they produce. J Am Coll Radiol 2004;1:649-51.
---------------------------------------------------------------------------
None of the studies cited in the MedPAC report examined the quality
of imaging interpretations by nonradiologists and radiologists in the
modalities that MedPAC actually recommended that CMS consider a ``high
priority''--MRI, CT, and nuclear medicine (including PET).\8\ One study
by Harold Moskowitz, published in the American Journal of
Roentgenology, specifically excluded CT, MR, sonography and nuclear
studies from the results.\9\ The only modality analyzed in the study
results was X-ray. Another study cited in the report by CareCore
National also only examined X-ray studies.\10\ These studies are not
relevant to the issues at hand. The inability of those practitioners,
who rarely read X-rays, to read them better than radiologists who read
X-rays frequently, has nothing to do with the ability of cardiologists,
for example, who read echocardiographs almost daily to read them better
than radiologists, who see echocardiographs as one modality among many.
---------------------------------------------------------------------------
\8\ MedPAC Report to Congress: Medicare Payment Policy, March 2005,
pp. 166.
\9\ Moskowitz, H., J. Sunshine, D. Grossman, et al. 2000. The
effect of imaging guidelines on the number and quality of outpatient
radiographic examinations. American Journal of Roentgenology 175, no. 1
(July): 9-15.
\10\ MedPAC Report to Congress: Medicare Payment Policy, March
2005, pp. 160.
---------------------------------------------------------------------------
MedPAC has recommended to Congress that it consider privileging as
a means to improve the quality of imaging interpretations and as a
condition of Medicare payment for physicians who want to interpret
imaging tests.
Before Congress directs CMS to become involved in determining
competencies of individual physicians in this country, we suggest that
solid, credible studies be commissioned that examine the quality of
imaging services among all modalities and among all physician
disciplines.
We believe MedPAC's recommendation requiring physician privileging
leads us down a road that runs counter to this Subcommittee's goal of
improving the quality of patient care by tying physician payment to
process and outcomes measures. By simply directing CMS to determine the
competency of physicians as a condition of payment, it does not ensure
that those deemed ``competent'' are in fact appropriately applying
medical technology in a way that best benefits patients.
Appropriateness
Physicians must carefully incorporate new technologies in patient
care plans only after their effectiveness has been proven. Congress and
CMS should consider the dialogue occurring between physician societies
and private sector payers about how to ensure that imaging being
delivered to patients is indeed appropriate.
At the American College of Cardiology, we are developing specific
appropriateness criteria for imaging in an effort to define ``what to
do,'' ``when to do it'' and ``how often'' in the context of local care
environments when combined with patient and family preferences.
Ideally, appropriateness criteria would encompass ``cost-effective''
and ``benefit vs. risk'' analysis of available care alternatives. The
criteria will be simple, reliable, valid, and transparent. They will
provide cardiovascular specialists with meaningful feedback on their
care practices relative to national standards. The College's first
focus will be on appropriateness criteria for nuclear cardiology. The
process, expected to be complete by early summer, is underway as an
abstraction, distillation, and in some cases, expansion of the
scientifically sound, evidence-based ACC/American Heart Association
Clinical Practice Guidelines and Expert Consensus Documents. Developing
appropriateness criteria is a complex and often very divisive issue,
but it will allow cardiologists, payers and patients to quantify
quality.
There are some who claim if CMS simply ``weeds out'' all
inappropriate utilization, the result would be significant cost savings
to Medicare. Before arriving at this conclusion, policymakers must
quantify appropriate and inappropriate utilization in order to
effectively estimate cost savings. Again, I point to the efforts
underway between the American College of Cardiology and the private
payers to develop appropriateness criteria.
We are aware that the American College of Radiology is projecting
estimates of Medicare cost savings to drive their quest for
``designated imaging provider'' legislation in the states and in
Congress. In articles published in the Journal of the American College
of Radiology, hypothetical cost savings are based arbitrarily on the
assumption that the level of referrals to radiologists by physicians
who do not have access to on-site imaging equipment ``delineate the
necessary and appropriate utilization rate of imaging.'' \11\ It is no
less valid to assume that patients whose physicians do not have access
to on-site imaging equipment are underserved, and thus receive
substandard care. Even MedPAC noted in its report that a 1994 GAO study
examining referrals to specialty physician-owned imaging facilities did
not address whether the additional services were appropriate or
not.\12\
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\11\ David C. Levin, Vijay M. Rao, ``Turf wars in radiology: the
overutilization of imaging resulting from self-referral,'' Journal of
the American College of Radiology, 2004;1(3):169-172.
\12\ MedPAC Report to Congress: Medicare Payment Policy, March
2005, pp. 167.
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Training and Safety
Training of Physicians
Radiology was first introduced into medical practice in the early
1900s with the discovery of X-rays. Since then, medical imaging has
significantly progressed and gained widespread clinical use. Some of
the first diagnostic imaging technologies used by cardiologists to
assess cardiac conditions were chest X-rays, electrocardiography,
coronary angiography, and cardiac catheterization. Cardiologists' use
of new technologies such a nuclear cardiology, cardiac MR and CT are a
natural extension of the strong and appropriate dominance that
cardiologists have held in cardiac imaging for the last three decades.
Today, cardiologists dominate the use of chest X-rays, nuclear
medicine, echocardiography, cardiac catheterization, and
electrocardiography, in part because cardiologists have generally
obtained better training in these areas, and have the clinical
expertise to evaluate the procedures.
Cardiologists, urologists, orthopaedic surgeons, obstetricians and
gynecologists, neurologists and other specialist physicians are
uniquely qualified to provide imaging services specific to their
specialty because they are trained in both diagnostic imaging
techniques, and in the structure and function of the organs and systems
they are imaging.
In ultrasound, the need to codify training and education for the
performance and interpretation of examinations has already been
thoroughly addressed by the medical community. There is no evidence to
support additional standards being placed upon physicians and their
practices. The American Medical Association (AMA) has concluded that
ultrasound is integral to the practice of appropriately trained
physicians \13\ and that office-based ultrasound is cost effective and
essential to patient care.\14\ The AMA further recognized that it is
inappropriate to apply educational standards developed for one medical
specialty group to that of another. Because of the different and unique
applications of ultrasound within the various physician specialties,
the AMA called for each specialty to define ultrasound standards for
its members to fit their clinical environment,\15\ which is what has
occurred in the specialties of breast surgery and emergency medicine.
---------------------------------------------------------------------------
\13\ American Medical Association House of Delegates Resolution
108.
\14\ American Medical Association House of Delegates Resolution
802.
\15\ ibid.
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To practice clinical nuclear cardiology, for example, a physician
must receive two years of general cardiology training and up to six
months dedicated to nuclear cardiology training. This training is
critical to accurate interpretation of imaging studies. By contrast,
the American Board of Radiology has no specific requirements for
training time, mentoring, or case load in nuclear cardiology prior to
certifying a radiologist as competent in this area.
The American College of Cardiology and other cardiovascular health
organizations have been leaders in the development of training program
standards, clinical competency statements, and clinical practice
guidelines that contain recommendations regarding the necessary
knowledge and skills, as well as the appropriate use of imaging
procedures.
Therefore, we believe all physicians who meet the appropriate level
of training ought to be able to provide imaging services to patients.
Specialty designation alone is not an appropriate basis on which to
determine physician qualifications.
The critical piece of data for the referring physician is not just
to have the dictation of the findings from the images, but to receive
clinical input for the patient's care management based on those
findings from the image interpreter--something the specialist routinely
does but the general imager does not necessarily do. The radiologist's
comment ``please correlate clinically'' is often appended to image
reports, while the specialist has completed this ``clinical
correlation'' automatically and communicates this to the referring
physician.
A study published in a recent issue of The Journal of Bone & Joint
Surgery further illustrates this point. The study compared the findings
of a radiologist's report and an orthopaedic surgeon's preoperative
diagnosis, following an examination and reading of any images with
actual surgical findings. Not surprisingly, the surgeon's preoperative
diagnosis was significantly more accurate than the radiologist's
report. The study concluded that ``the formal interpretation of the MRI
scan by the radiologist commonly had inaccuracies and may not correlate
with the initial diagnoses . . . reliance on the radiologist's formal
interpretation can lead to diagnostic inaccuracies and to delay in
appropriate treatment.'' \16\
---------------------------------------------------------------------------
\16\ Luhmann SJ, Schootman M, Gordon JE, Wright R, ``Magnetic
Resonance Imaging of the Knee in Children and Adolescents. Its Role in
Clinical Decision-Making.'' J. Bone Join Surg. Am., Mar 2005; 87:497-
502.
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Accreditation of Facilities
Accreditation is a step payers and physicians may consider when it
comes to ensuring the safety and quality of medical imaging. Let me
begin by saying that I do not agree, nor do any credible studies
suggest, that the imaging we are performing outside the hospital is
sub-optimal or unsafe. The costs to physicians, in both time and money,
to complete accreditation processes are significant. If mandatory,
accreditation should be accompanied by clinical evidence that
accreditation results in measurable and significant improvement in
quality of care and compliance mandates should include sufficient time
to allow providers to achieve accreditation.
Furthermore, and most importantly, accreditation should not be
limited to the standards of just one accrediting body. For example, for
cardiovascular laboratories, accreditation bodies include the
Intersocietal Accreditation Commission (IAC) and the American College
of Radiology (ACR), and the differences between these programs must be
recognized. In a February 10, 2005, statement to this Subcommittee,
that National Coalition for Quality Diagnostic Imaging Services
(NCQDIS) stated that ACR has full accreditation programs for many
diagnostic procedures and implied that only offices accredited by ACR
perform the highest quality imaging services.
We want to set the record straight on this point and on a study
cited by both MedPAC and by NCQDIS. This study stated an imaging site
inspection program ``revealed that over \1/3\ of imaging facilities
operated by nonradiologist physicians had one or more significant
quality deficiencies, while only 1 percent of facilities operated by
radiologists had such deficiencies.'' \17\ What NCQDIS does not tell
the reader is that 92 of the 150 sites that failed inspection (62%)
were operated by limited license providers (chiropractic and
podiatry).\18\ Cardiologists, in fact, had a lower failure rate than
radiologists.
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\17\ National Coalition for Quality Diagnostic Imaging Services.
Written testimony to the House Ways and Means Subcommittee on Health;
Feb. 10, 2005.
\18\ MedPAC Report: Purchasing Strategies. June 2004, pp. 108.
---------------------------------------------------------------------------
Conclusion
In closing, I want to emphasize that medical imaging performed and
interpreted in physicians' offices is an integral and cost-effective
part of the specialists' patient care continuum. To prevent or limit
the practice of in-office imaging would move the field of medicine in
the wrong direction, just as clinical advancements are improving
patient care and outcomes. Furthermore, attempting to restrict
physician eligibility to perform and interpret tests for their patients
in the most efficient and effective setting is antithetical to the
aggressive disease state management paradigm now being promoted by CMS
through multiple pilot projects.
We also have seen a clear connection between better and faster
diagnosis and improved quality of life, enhanced productivity and
contained costs compared with more invasive treatments at later-stage
disease arrest. Medical imaging, while not the sole factor in gaining
ground in the fight against disease, certainly is a leading cause for
this remarkable turnaround, particularly in heart disease.
We respectfully urge the Subcommittee to carefully weigh the
complexity of the medical imaging debate before enacting any
governmental restraints against specialty physicians from performing
and interpreting medical images. Our patients deserve better, and they
are accustomed to receiving care which incorporates medical imaging in
their personal physician's office. Turning back the clock at this stage
will surely retract many of the gains we have achieved in the last 20
years through the use of medical imaging in our patient care protocols.
Thank you.
Chairman JOHNSON. Thank you very much, Dr. Williams.
Ms. Farnsworth?
STATEMENT OF CHERRILL FARNSWORTH, EXECUTIVE DIRECTOR, NATIONAL
COALITION FOR DIAGNOSTIC IMAGING SERVICES, HOUSTON, TEXAS
Ms. FARNSWORTH. Thank you, Madam Chairman, Congressman
Stark, and Members of the Committee, for the opportunity to
testify today and for your personal involvement and interest in
this important health care issue. I am Cherrill Farnsworth, the
President and CEO of a company, Health Help. I also serve as
Executive Director of the National Coalition for Quality
Diagnostic Imaging Services.
Health Help is a company that manages radiology benefits
for the private sector companies throughout the country who
also face rising imaging costs and fears about quality and
safety.
NCQDIS represents more than 2,400 outpatient imaging
centers and hospital outpatient departments, promoting
strategies for health care cost savings, and advocating for
public and private sector standards for diagnostic imaging
services. It is my privilege to testify before the Committee
today as CEO and to share valuable practical experience of what
we see bringing these very solutions in the private sector.
Both organizations I am representing today support the
MedPAC recommendations. We have been there, we have seen it,
and we know that it works. We have all heard testimony citing
the increasing costs in the use of diagnostic imaging service
as well as the growing concern about quality of these medically
necessary imaging procedures. But there is good news. The
private sector has faced these issues, has been forced to take
a closer look and take a stand on the problem.
The issues described by MedPAC are not unique to Medicare.
They have been experienced by the commercial plans. The only
difference is that in the private sector they have taken action
to address the costs, the overuses, and to promote quality and
safety.
The MedPAC Commission's recommendations surround three
areas: First, privileging. Privileging in the private sector
has generally taken a stance that in those areas where a
specialty or medical provider, health care provider, is trained
in his training to do the test, he should be allowed to do the
test, to bill for it, and be paid for it. Where he has not had
the training, it is not safe, it is not practical, and it is
not reasonable that he would be performing, billing, or be paid
for those services.
An example I would like to give you is a very recent one
from the private sector where a health care plan that we work
for in the State of Texas introduced privileging standards
almost immediately after we did the analysis. An example out of
the analysis is that they had spent more than $15 million in
the State of Texas for psychiatrists to perform and evaluate
PET scans. Psychiatrists are not trained in the very complex
imaging procedures behind PET. They have not been trained in
the physics behind PET in order to keep their patients safe.
This is a frightening thing that is happening as far as costs
of the Medicare program and safety to the Medicare beneficiary.
Also, the second point that Mr. Miller talked about was
correct billing initiatives. When the CPT codes were developed
for imaging many years ago, the technology was very different.
Today, it is time that we modernize those CPT codes to reflect
the advances in technology and how they perform today.
Quality standards, I believe they are an imperative.
Imaging is a $100 billion business. I don't think there are
very many people running a $100 billion business without any
quality standards.
In the private sector, for our insurance companies, we are
finding used equipment, equipment without maintenance
contracts, equipment where you cannot even buy parts for this
equipment today. Certainly the standards are there and they are
enforced by the manufacturers who manufacture this equipment.
We are talking about enforcing that the maintenance contracts
and the quality be maintained through the use of that
equipment.
We also see things that point to the lack of training of
those people performing the tests in the center or the
department, things like the use of collimation. Collimation was
developed a hundred years ago. This is not new. It is like
shutters on a camera where we make sure that the radiation is
only going to that area of the body that we are looking at.
This is important that we not get scatter radiation throughout
the patients' body. In our company, when we are looking at
imaging centers without trained technologists that do not have
radiology oversight or oversight by a physician trained in that
type of imaging, more than 92 percent of the time no
collimation is used.
Our chief medical officer in Health Help uses an example
where we see a film with the entire baby. This baby was there
to have his lower abdomen examined, so we should have seen only
that part of his lower abdomen. But the baby has radiation in
his brain, throughout his body, and we know from the evidence
that the earlier a patient has radiation and maintains the
effects of that radiation throughout his life, the more likely
the cancer.
In closing, this issue is not about costs. I do not believe
this issue is about a turf battle. I believe it is about the
Medicare beneficiary and the viability of the Medicare program
in light of these kinds of exponential cost growth. It is about
quality patient care and the importance of maintaining safety
for the Medicare enrollee. Medicare has the opportunity to take
advantage of efforts that are seen in the private sector. And
the MedPAC recommendations are an important first step in
addressing imaging issues.
Medicare beneficiaries deserve the same rights and should
have the same protection as other patients, and NCQDIS stands
ready to assist the work of the Committee as this issue
proceeds. I thank you again for the opportunity to testify and
would be glad to answer questions the Committee may have.
[The prepared statement of Ms. Farnsworth follows:]
Statement of Cherrill Farnsworth, Chairperson, National Coalition for
Diagnostic Imaging Services, Houston, Texas
Chairwoman Johnson, I am pleased to have this opportunity to
testify before the House Ways and Means Subcommittee on Health and
commend you for being so personally involved in addressing Medicare
quality of care issues and the wise use of Medicare funds. My name is
Cherrill Farnsworth, and I am the Executive Director of the National
Coalition for Quality Diagnostic Imaging Services (NCQDIS), as well as
the President and CEO of a company called Health Help, Inc. NCQDIS is
comprised of more than 2,400 outpatient imaging centers and departments
in the United States. The coalition promotes ``best industry
practices,'' strategies for healthcare cost savings, and advocates for
public and private sector standards for quality and safety in
diagnostic imaging services.
Advances in diagnostic imaging have led to great strides in patient
care: from reducing the need for invasive surgical procedures to early
detection of life-threatening diseases. NCQDIS and its members are at
the forefront of medical technology, providing physicians and patients
with the most state-of-the-art innovations, techniques and procedures
available in diagnostic imaging.
I am pleased to have this opportunity to testify to the House Ways
and Means Subcommittee on Health on the opportunities that exist to
increase quality of care to Medicare patients, while addressing the
Committee's cost concerns about diagnostic imaging services. We share
the concerns expressed by the Medicare Payment Advisory Commission
(MedPAC) regarding utilization of diagnostic imaging services in
Medicare. The time is right to address the significant costs associated
with increased utilization, as well as quality concerns regarding the
use of this constantly evolving technology.
Fortunately, Congress can address these cost concerns while
increasing the quality and safety of services provided to Medicare
patients. Today, many of the policies and standards supported by NCQDIS
have been implemented by private payers to successfully reduce costs
and improve patient safety and quality. The coalition believes that the
same policies and programs that are working in the private sector
should be available to protect Medicare beneficiaries and safeguard the
Medicare Trust Fund.
Medicare Should Incorporate the Innovations of the Private Sector
On a day to day basis, I run a company that does in the private
sector what Medicare should be doing with regard to the management of
diagnostic imaging benefits. Empirical evidence demonstrates that
private sector privileging strategies promote high quality care. Tufts
Health Plan uses an Imaging Privileging Program to address quality and
utilization issues for non-emergency, outpatient diagnostic imaging
provided by nonradiologists. Privileging to perform specialty-
appropriate imaging procedures is granted based on a provider's
specialty designation, and otherwise must be provided by a radiologist
or imaging facility. Miriam Sullivan, representing Tufts Health Plan,
has testified to MedPAC that by expanding the use of freestanding
imaging facilities and increasing competition, physician groups have
less desire to purchase equipment and more incentives to use Tufts'
quality and evidence-based guidelines.\1\
---------------------------------------------------------------------------
\1\ Medicare Payment Advisory Commission, Meeting Transcript, March
18-19, 2004, page 53.
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We firmly believe that private sector quality standards should also
be available to Medicare beneficiaries. Highmark uses privileging
guidelines where imaging facilities must have a documented Quality
Control Program, Radiation Safety Program, and As Low As Reasonably
Achievable (ALARA) Program. Highmark providers must be appropriately
licensed and meet the physician specialty criteria in the plan's
privileging guidelines.\2\
---------------------------------------------------------------------------
\2\ http://icael.org/icael/reimbursement/highmark_press.htm.
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States have also become concerned payers of diagnostic imaging
services and are increasingly taking action at the state level to limit
physician self-referral of services. The State of Maryland passed
legislation in 2000 that is similar to the federal Stark ban on
physician self-referral, except that Sec. 1-301(k)(2) of the law
specifically excludes magnetic resonance imaging services, radiation
therapy services, and computer tomography scan services from the in-
office ancillary services exception. The Maryland Attorney General
released a legal opinion on January 5, 2004, stating that this law bars
a nonradiologist physician from referring patients for tests on an MRI
machine or CT scanner owned by that practice.
Other states are considering action to limit physician self-
referral of services. The State of Texas introduced legislation (HB
3281) on March 11, 2005 relating to financial arrangements between
referring health care providers and providers of designated health
services and supplies. Under this bill, a health care provider may not
refer a patient for the provision of designated health services,
including diagnostic imaging services, to a person in which the health
care provider is directly or indirectly an investor or has an
investment interest. In addition, a health care provider may not
present a claim for payment to any person or third-party payer for a
referred health service prohibited under this bill. This bill will soon
go into hearing. Medicare should have the same opportunities to
increase quality, contain unnecessary utilization and limit conflicts
of interest that are being addressed at the state level.
Protecting Beneficiaries and the Trust Fund Requires Medicare Take a
Closer Look At Use of Imaging
As you know, data from MedPAC and the GAO have raised concerns
about the growth of diagnostic imaging performed by nonradiologists.
Nevertheless, research shows that services performed by radiologists
account for a small portion of the growth of diagnostic imaging. MedPAC
found that imaging services increased by 9% between 1999 and 2002.\3\
Other research has defined the growth in imaging services between 1993-
2002 as 49% by nonradiologists. Interestingly, services provided by
radiologists who typically have no incentive to self-refer have grown
only by 7%. In addition, the growth in Medicare payments for radiology
services grew by 72% for radiologists and by 119% for
nonradiologists.\4\
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\3\ Report to the Congress: Medicare Payment Policy, MedPAC, March
2003, page 77.
\4\ Levin DC, Intenzo CM, Rao VM, Frangos AJ, Parker L, Sunshine
JH. Comparison of recent utilization trends in radionuclide myocardial
perfusion imaging among radiologists and cardiologists. J Am Coll
Radiol, in press.
---------------------------------------------------------------------------
Nonradiologist physicians owning their own equipment use diagnostic
imaging tests more frequently than physicians who refer their patients
to radiologists. One study found physicians owning equipment used
imaging 2-8 times more often than physicians who refer their patients
to radiologists.\5\ A similar 1994 GAO study revealed physicians owning
their equipment use imaging 2-5 times more often than referring
physicians.\6\
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\5\ Hillman BJ, Olson GT, Griffith PE, et al. Physicians'
utilization and charges for outpatient diagnostic imaging in a Medicare
population. JAMA 1992; 268:2050-2054.
\6\ Medicare: Referrals to Physician-Owned Imaging Facilities
Warrant HCFA's Scrutiny; GAO, HEHS-95-2, October 20, 1994.
---------------------------------------------------------------------------
Based on this evidence, we believe that radiologists and
independent diagnostic testing facilities (IDTFs) can provide the most
cost-effective care. In addition, there is no differential in Medicare
payment if services shift from nonradiologist physicians to
radiologists and independent diagnostic testing facilities, where
identical payments are made under the physician fee schedule. Updated
statistics show that there are sufficient radiologists in the U.S. to
meet patients' needs.
Medicare Beneficiaries Should Be Assured of Access to the Highest
Quality Imaging Services
Like private payors, Medicare should only pay for imaging services
that meet quality standards. Medical literature shows that imaging
equipment and facilities operated by nonradiologists is often sub-
optimal. One private sector imaging site inspection program revealed
that over \1/3\ of imaging facilities operated by nonradiologist
physicians had one or more significant quality deficiency, while only
1% of facilities operated by radiologists had such deficiencies.\7\
Quality standards for equipment and facilities would reduce the need
for duplicate scans or expensive therapy from incomplete images or
misdiagnosis.
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\7\ Orrison & Levin, Radiology 2002; 225(P):550.
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In addition, the recycling of obsolete diagnostic imaging equipment
should be curtailed by implementing strong equipment standards. Dr.
Thomas Ruane, BC/BS of Michigan, testified to MedPAC that, ``The
diagnostic equipment that becomes somewhat obsolete in our tertiary
medical centers often does not go to the Third World. It often goes
down the street to another doctor's office where it lives another
life.'' \8\ NCQDIS believes that Medicare patients deserve better.
---------------------------------------------------------------------------
\8\ Medicare Payment Advisory Commission, Meeting Transcript, March
18-19, 2004, page 34.
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NCQDIS Promotes the Appropriate Use of Diagnostic Imaging By Trained
Specialists
Radiologists spend 4-6 years in residency training to learn imaging
techniques and interpretation. Most nonradiologist physicians have
limited or no formal training in image interpretation. Although some
physicians in other specialties get limited amounts of training in
certain areas of imaging, the training is often informal and does not
meet defined standards. To protect patient safety and reduce medical
errors, physicians billing Medicare for imaging services should meet
certain training and education standards.
Radiologists working with other clinicians provide an important
second opinion in clinical diagnosis, helping to minimize medical
errors. As is being discussed in the hearing today, the best clinical
outcomes are achieved when a team approach is used to manage patient
care. Radiologists serve as an important second opinion in clinical
diagnosis, treatment, and management of patients needing diagnostic
imaging services.
It is important to note that imaging centers owned by radiologists
and IDTFs do not create a demand for imaging services. Business is
independently referred to imaging centers from third party physicians
who determine that a patient needs a diagnostic imaging test.
Therefore, radiologists and IDTFs are limited in their ability to
generate business outside of that which is referred.
Evidence also demonstrates that quality of care is improved if
appropriately trained physicians read diagnostic images. In 2000, one
research group used a standardized set of chest radiographs to compare
the accuracy of interpretation of radiologists and nonradiologists. The
composite group of board-certified radiologists demonstrated
performance far superior to that of nonradiologist physicians. Even
radiology residents in training out-performed nonradiologist
physicians.\9\
---------------------------------------------------------------------------
\9\ Potchen, RADIOLOGY 2000; 217:456.
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NCQDIS Recommends That Medicare Take Steps Now to Protect Medicare
Beneficiaries
Medicare has a unique opportunity now to address the issues related
to diagnostic imaging services. NCQDIS is pleased to submit its
recommendations to the House Ways and Means Subcommittee on Health on
the best way to promote quality of care in diagnostic imaging. Congress
has the opportunity to act now to address this important issue. The
private sector has already taken many of these steps.
1. Congress should enact a privileging policy for high cost high
technology imaging, i.e. procedures where high level training is
required to interpret and perform the test. We propose a privileging
policy for MRI, CT, and PET that would require that physicians meet
certain professional standards in order to directly bill Medicare for
the technical and professional components of these procedures. This
policy would allow current billing practices to continue for cardiac
ultrasound procedures and plain X-rays. Medicare should promote quality
of care and patient safety by reimbursing only those doctors who are
certified and have the appropriate training in diagnostic imaging
services. This approach would avoid the provision of low-quality
images, interpreted by inadequately trained nonradiologists using sub-
standard technology. NCQDIS supports privileging policies that address
the professional and technical components of diagnostic imaging
services. CMS conditions of coverage could require that a physician
become certified by CMS as a qualified ``designated physician imager''
in order to bill Medicare for diagnostic imaging tests.
2. NCQDIS also suggests that CMS address the technical component of
diagnostic imaging services by implementing standards for equipment
quality. An image produced by a poor quality piece of equipment will
inevitably lead to errors, misdiagnoses, and the need for repeat
testing.
3. NCQDIS supports coding edits to allow financial intermediaries
to detect improper billing.
NCQDIS understands that more expansive privileging policies
targeting other procedures and specialties take time to develop and
test. Therefore, NCQDIS recommends that Medicare be authorized to
implement a broader privileging policy based on private sector
privileging policies, to be implemented within one year from the date
of enactment using a panel of experts. This policy should detail by
medical specialty those imaging tests permitted by the specialty.
Chairman JOHNSON. Thank you very much. We are going to have
to suspend, Dr. Rollo, before your testimony. We have about 4
minutes or 3 minutes left before the vote concludes. Then there
will be two 5-minute votes. There is always a little time
between, so we will resume at 25 of.
Thank you very much.
[Recess.]
Chairman JOHNSON. Welcome back. I apologize for the longer
interlude. There was one more vote than I had expected.
Dr. Rollo will----
Mr. STARK. May I introduce him?
Chairman JOHNSON. Oh, sorry, yes, absolutely. I yield to my
colleague.
Mr. STARK. Dr. Rollo has been trying to ignore this, but I
used to represent Milpitas, and he has jumped clear, but
welcome, doctor. But for the reapportionment, you would still
be my constituent. We are happy to have you here.
Chairman JOHNSON. Thank you, Dr. Rollo.
STATEMENT OF F. DAVID ROLLO, M.D., CHIEF MEDICAL OFFICER,
PHILIPS MEDICAL SYSTEMS, MILPITAS, CALIFORNIA, ON BEHALF OF THE
NATIONAL ELECTRICAL MANUFACTURERS ASSOCIATION (NEMA)
Dr. ROLLO. Madam Chairman and Members of the Subcommittee,
my name is David Rollo. I am a physician and Chief Medical
Officer at Philips Medical Systems. I am speaking on behalf of
the National Electrical Manufacturers Association, known as
NEMA, the largest association representing medical imaging
manufacturers in the world. It is also the world's primary
standard setting organization for medical imaging equipment.
Madam Chairman, I want to discuss several key points in my
testimony today. First, consumers are safer, healthier and live
longer today because of medical imaging. Frankly, it is hard to
overstate the clinical significance of medical imaging. By
providing clinicians with a remarkable vision of the body
structure and function, medical imaging has redefined virtually
all aspects of medical diagnosis and treatment. It has played a
central role in our modern day approach to heart disease,
stroke and cancer, and has been instrumental in the dramatic
mortality reductions in each of these diseases. It is not
surprising that the New England Journal of Medicine called
imaging one of the top 11 innovations of the past 1,000 years,
ranking it alongside such milestones as the discovery of
anesthesia and also antibiotics. In fact, it is this remarkable
capacity to better and less invasively provide more careful
information related to the care of individuals, and this is one
of the reasons for the heart of the dramatic growth in the use
of medical imaging.
My second point. Medical imaging is rigorously tested,
reviewed and regulated to ensure safety. Before imaging
products reach the market, they undergo careful testing within
companies. The products are then reviewed by the Food and Drug
Administration to make sure they comply with its regulations
and requirements as well as the safety and efficacy defined by
the manufacturers. This includes inspections of all
manufacturers plants, review of all labeling and post-marketing
surveillance and reporting. Once products clear FDA the
manufacturer must install imaging equipment in compliance with
all referenced standards and quality control requirements.
At that point the States get into the act, requiring
routine inspections of hospitals and physicians offices.
On the question of safety, let me add one more point.
Medical imaging comprises a wide range of modalities, not all
of which use x-rays or ionizing radiation to generate images.
Ultrasound uses sound waves. Magnetic resonance imaging uses
radio frequency pulses. Nevertheless, the FDA regulates all
imaging devices to ensure their safety. For those that use x-
rays, FDA also insists that they meet a special FDA safety
standard for x-ray equipment. In addition, both the Nuclear
Regulatory Commission and OSHA impose additional requirements.
The third point that I want to emphasize, Madam Chairman,
is that if Congress requires additional standards for imaging
or imaging quality, NEMA should play a central role. This is a
key point. As I said earlier, NEMA is not only an association
of imaging manufacturers, it is also a standard setting
organization. For the past 75 years NEMA had developed hundreds
of standards for product quality, safety and performance. That
has included standards involving x-ray, magnetic resonance
imaging, ultrasound, nuclear imaging and more. Even now, NEMA
diagnostic imaging equipment standards are in use by the
American College of Radiology, by the U.S. Food and Drug
Administration, and by the Institute of Electrical and
Electronics Engineers, to mention a few.
My fourth point, and perhaps the most important, is the
controversy that we are discussing today is at its core a
battle over reimbursement. Payers are seeking to pass the blame
for rising costs and specialists are fighting over what they
perceive as an increasingly limited reimbursement pool. In many
ways this is business as usual. But what is troubling in this
particular case is that charges about safety and quality have
become weapons in this battle. We find such charges unfortunate
and in many cases incorrect. Conclusions about the use and
value of medical imaging should be based upon a full and
accurate reflection of the peer-reviewed evidence in the
literature, not upon a narrow slice of the literature or
information that is anecdotally reported.
To be sure, Madam Chairman, no technology can be perfect,
nor can every provider, and we would welcome intelligent
evidence-based discussions of the appropriate utilization of
medical equipment, but to suggest a quality problem of the
scale that MedPAC has suggested is inappropriate and
inaccurate. In fact, the suggestion contradicts MedPAC's own
report which in recent years have lauded the clinical value of
these very technologies, and stated more than once that they
represented no serious threat to Medicare.
Let me close with a short note from Dr. Tom Ruane, Medical
Director of PPO and Care Management Programs for Blue Cross
Blue Shield of Michigan. He testified before MedPAC in March
2004. This is what Dr. Ruane said when he addressed the
question of why there has been such significant growth in the
use of medical imaging among physicians throughout the United
States?
He stated: ``I think the number one driver of the trend is
technological advancement. These are wonderful tests that are
available that really have improved the care of patients. Our
fundamental business is making these tests available to
people.''
Our industry stands ready to work with Congress, MedPAC,
private payers and others to address the cost concerns facing
Medicare in the United States health care system. But in so
doing we believe that one thing is critical, the kind of
honesty and candor about the value of medical imaging that was
expressed by Dr. Ruane.
Thank you.
[The prepared statement of Dr. Rollo follows:]
Statement of David Rollo, M.D., Chief Medical Officer, Philips Medical
Systems, Milpitas, California
Madam Chairman and Members of the Subcommittee:
My name is David Rollo. I am a physician and Chief Medical Officer
of Philips Medical Systems. I am speaking on behalf of the National
Electrical Manufacturers Association.
NEMA is the largest association representing medical imaging
manufacturers in the world. It represents companies whose sales
comprise more than 90 percent of the global market for x-ray imaging,
computed tomography (CT), radiation therapy, diagnostic ultrasound,
nuclear medicine imaging, magnetic resonance (MRI), and medical imaging
informatics equipment. NEMA is also the world's primary standards-
development organization for medical imaging equipment. Such standards
are voluntary guidelines that establish commonly-accepted methods of
design, production, and distribution for products destined for national
and international commerce. Sound technical standards benefit the user,
as well as the manufacturer, by improving safety, fostering
efficiencies, eliminating misunderstandings between manufacturer and
purchaser, and assisting the purchaser in selecting and obtaining the
appropriate product. We have been setting standards for 75 years.
Medical Imaging Means Better Safety, Quality, and Value
Madam Chairman, one of the most important points I would like to
stress in my testimony is that consumers are safer, healthier, and live
longer today because of medical imaging.
Frankly, it is hard to overstate the clinical significance of
medical imaging. By providing clinicians with a remarkable vision of
the body's structure and function, medical imaging has redefined
virtually all aspects of medical diagnosis and treatment. It has played
a central, defining role in our modern-day approach to heart disease,
stroke, and cancer--to name only a few--and has been instrumental in
the dramatic mortality reductions in each of those diseases. It is not
surprising that the New England Journal of Medicine called medical
imaging one of the top 11 innovations of the past 1,000 years--ranking
it alongside such milestones as the discovery of anesthesia and
antibiotics. In fact, it is this remarkable capacity to provide better,
less invasive, and more successful care that lies at the heart of the
dramatic growth in use of medical imaging in virtually all parts of
healthcare delivery.
NEMA has assembled a selection of evidence about the clinical and
economic value of medical imaging in a special website at
www.medicalimaging.org. The site includes peer-reviewed literature from
such publications as The New England Journal of Medicine, Lancet,
Radiology, Stroke, and Journal of the American Medical Association. It
is excellent reading for anyone who doubts either the value of imaging
or the depth of the evidence--sound, reliable, independent, peer-
reviewed evidence--supporting that value.
Addressing Overutilization the Right Way
In light of the fact that the MedPAC Report to the Congress:
Medicare Payment Policy, March 2005, raises doubts about the value of
imaging and, in particular, bases much of that concern upon the rapid
growth in imaging utilization, we believe it is important to cite a few
recent examples from the peer-reviewed literature that shed additional
light on this critical point.
At the outset, let me say that the medical imaging industry is
committed to appropriate utilization. We believe the best way to
achieve that is to develop practice guidelines and protocols based upon
sound evidence. Such guidelines are issued by a wide variety of
organizations such as the American College of Radiology and the
American College of Cardiology.
We do not, however, believe that growth in utilization is per se
proof that such utilization is inappropriate or excessive.
How much of the growth in utilization of medical imaging
is a result of growth in the percentage of women receiving mammograms,
which have been shown to save lives and catch cancer at its least
costly stage?
How much of the growth in utilization of medical imaging
is a result of greater use of MRI or CT in identifying the nature and
location of strokes so that doctors can undertake drug therapy or other
treatments that have been shown to save money?
How much of the growth in utilization of medical imaging
comes from expanded use of minimally invasive therapies, such as
coronary angioplasty or fibroid embolization, which have been shown to
reduce costs when compared to more costly treatments?
The fact is, many of the criticisms of growth in the utilization of
imaging--perhaps most, in fact--do not look behind the numbers to see
whether the underlying use was, in reality, cost-increasing or, in
fact, cost-decreasing. This is unfortunate because much medical imaging
substitutes for more costly and invasive treatment. Or it creates
productivity gains that far outweigh the costs--whether such gains are
measured in the number of patients who can recover in half the time and
avoid going onto disability or the reduced costs brought about by fewer
complications, shorter hospital stays, or fewer exploratory surgeries.
Let me cite a few recent examples of such technologies from the
peer-reviewed literature:
The American Heart Association journal Stroke reported
last November that a ``scan-all'' strategy for stroke patients
ultimately saved money--when compared to later or lesser use of CT
scans for such patients--because the information from the scans led to
better diagnoses that led to better outcomes and shorter hospital
stays.\1\
---------------------------------------------------------------------------
\1\ ``Immediate Computed Tomographic Scanning of Acute Stroke is
Cost-Effective and Improves Quality-of-Life,'' Wardlaw, JM; Seymour JC;
Keir S; Lewis S, and Sandercock P, Stroke, November 2004, pp. 2477-
2483.
---------------------------------------------------------------------------
Physicians at Massachusetts General Hospital reported in
the American Journal of Roentgenology in 2004 that increased use of
state-of-the-art CT imaging in treating facial trauma patients led to a
reduction in overall imaging costs of 22 percent per patient between
1992 and 2002. The primary explanation for the findings, according to
the researchers, is that CT costs less than it did 10 years ago, does
more, and increasingly substitutes for X-ray examinations, which
dropped by 50 percent over the period.\2\
---------------------------------------------------------------------------
\2\ Trends in the Use of CT and Radiography in the Evaluation of
Facial Trauma, 1992-2002: Implications for Current Costs,'' Turner BG,
Rhea JT, Thrall JH, Small AB, Novelline RA; American Journal of
Roentgenology, 2004; 183:751-754.
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The U.S. Preventive Services Task Force recommended in
the Annals of Internal Medicine in February 2005, that elderly males
who are at high risk of abdominal aortic aneurysms--which are often
fatal--should be screened by ultrasound. The recommendation was based
on an analysis of four studies, involving 125,000 patients, that found
that screening reduced the chances of death by 43 percent. Separately,
the USPSTF also concluded that the ultrasound exam was cost-
effective.\3\
---------------------------------------------------------------------------
\3\ ``Screening for Abdominal Aortic Aneurysm: A Best-Evidence
Systematic Review for the U.S. Preventive Services Task Force,''
Fleming C, Whitlock EP, Beil TL, Lederle FA; Annals of Internal
Medicine, Feb. 2005, Vol. 142, No. 3; 203-211. Also, ``Screening for
Abdominal Aortic Aneurysm: Recommendation Statement, U.S. Preventive
Services Task Force, Annals of Internal Medicine, Feb. 2005, Vol. 142,
No. 3; 198-202.
Madam Chairman, in each of these cases, more utilization of imaging
is better, not worse. Rather than increasing costs, greater utilization
could actually reduce costs. In our view, policymakers should applaud
such utilization, not criticize it. And they should be wary of
concluding that if utilization goes up beyond an expected level that it
is, by definition, wrong, inappropriate, or harmful.
Medical Imaging is Thoroughly Tested and Regulated to Ensure Safety
The second major point that I want to emphasize, Madam Chairman, is
that medical imaging technologies are rigorously tested, reviewed, and
regulated to ensure safety. A quick reading of the MedPAC report could
suggest otherwise.
Before imaging products reach the market, they undergo testing
within companies, often in conjunction with academic medical centers.
Once this is complete, the product is then reviewed by the Food and
Drug Administration to make sure it complies with its regulations and
requirements. This includes inspections of all manufacturer plants,
systems, and operations; review of all labeling and marketing; and
post-marketing surveillance and reporting. In addition, all imaging
devices must meet international standards.
It is important to recognize that medical imaging comprises a wide
range of modalities--not all of which use X-rays, or ionizing
radiation, to generate images. Ultrasound uses sound waves; MRI uses
radiofrequency pulses. Nevertheless, FDA regulates all imaging devices
to ensure their safety.
For those that use X-rays, FDA also insists that they meet a
special FDA safety standard for X-ray equipment. In addition, both the
Nuclear Regulatory Commission and OSHA impose additional requirements
on imaging equipment using ionizing radiation.
After FDA review, then the States get into the act. Although the
FDA does not inspect imaging equipment once the purchaser takes
possession, most states require routine inspections of hospitals and
physicians offices. In some cases, these are annual inspections. These
regulations are uniform throughout the U.S. and are a high priority for
states. State regulators hold authority over the owners of the imaging
equipment and can require that it be in full compliance with their
regulations.
Attachment 1 to my testimony provides more detail on the state,
federal, and international regulations that apply to medical imaging.
NEMA Role in Standards Development
Madam Chairman, the third point I want to emphasize is that if
Congress requires additional standards for medical imaging or imaging
quality to be developed, NEMA should play a central role.
As I said earlier, NEMA is not only an association of imaging
manufacturers, it is also a standards-setting organization. For the
past 75 years, NEMA has developed hundreds of standards for product
quality, safety, and performance. That has included numerous standards
involving medical imaging.
NEMA developed a standard for ultrasound equipment
enabling the physician or sonographer to monitor the acoustic output
display in real time, during an ultrasound examination. This helps
minimize the ultrasound exposure, while maximizing the diagnostic
information that can be acquired from the exam.
NEMA developed a performance standard and quality control
guidelines for single photon emission computed tomography (SPECT)
devices used in nuclear medicine, to inform clinical users whether
their SPECT devices are performing properly, and therefore suitable for
use with patients.
NEMA successfully developed, and continues to update, one
of the most significant standards in improving efficiency and
communications in healthcare delivery. The Digital Information and
Communications in Medicine (DICOM) standard established a common
digital ``language'' to facilitate the interchange of information
between digital imaging computer systems in medical environments.
Despite NEMA's experience and background, we were troubled by the
failure of the recent MedPAC report to include NEMA, or an organization
like it, in the development of the standards the Commission calls for.
MedPAC Proposal for Setting Quality Standards
The March 2005 MedPAC Report to Congress recommends that Congress
direct the Secretary of Health and Human Services to set standards for
all providers who bill Medicare for performing diagnostic imaging
studies. The report provides additional guidance in implementing this
recommendation, saying that ``. . . CMS should strongly consider
setting standards for at least the following areas: the imaging
equipment, qualifications of technicians . . . technical quality of the
imaging and procedures for ensuring patient safety.'' \4\
---------------------------------------------------------------------------
\4\ March 2005 MedPAC Report to Congress on Medicare Payment
Policy, p. 166.
---------------------------------------------------------------------------
Further, the March report recommends that for this new process the
Secretary should select private organizations to administer the
standards. However, when the report talks about developing the
standards, we were disappointed to read that, according to MedPAC, ``.
. . CMS should consult with imaging accreditation organizations and
physician specialty groups when developing these requirements.'' \5\
---------------------------------------------------------------------------
\5\ Ibid.
---------------------------------------------------------------------------
That leaves out the people and companies who develop the technology
that is used to produce the images that help save lives and costs. As I
have indicated, NEMA not only represents this industry, but has a long
and successful track record as a standards-setting organization. This
is true in the field of medical imaging, but also in many other parts
of the electro industry. Even now NEMA diagnostic imaging equipment
standards are in use by the American College of Radiology, by the U.S.
Food and Drug Administration, and by the Institute of Electrical and
Electronics Engineers to mention only a few. NEMA and its member
companies know equipment standards, and we believe that if equipment
and equipment-related standards are under discussion that we can add
value to that discussion.
Thus, if Congress decides to require development of the kinds of
standards that MedPAC calls for, we strongly recommend that NEMA is
made a central part of that effort.
Processes for Standards Development
I would like to add one more word about the process that Congress
might use in setting such standards.
We believe that any Medicare program to promote the safety, quality
and medical effectiveness of diagnostic imaging services must adhere to
a set of basic principles and processes:
An open and collaborative standards development process
that involves all affected parties, including diagnostic imaging
manufacturers;
Minimal administrative and financial burden on
participating providers and the Medicare program;
Mechanisms for timely updating of the standards program
to keep pace with advances in technology and medical practice;
Program administration by multiple, objective entities
that are fully accessible to all parties; and
Timely process and transition mechanisms to ensure no
interruption in Medicare beneficiary access to necessary care.
If the Committee does decide to move forward on the MedPAC
recommendations, we would encourage you to include these principles in
any legislation toward that end.
Key Issues Involving Standards Development
In your invitation to testify, Madam Chairman, you also asked about
our experience in the development and implementation of standards.
Attachment 2 provides information in response to your inquiry. In
summary, we believe that the most successful standards are those that
adhere to the principles I just outlined--openness, inclusiveness,
timely updating, and minimal administrative or operational burdens.
The Real Debate is Reimbursement, Not Safety
My final point Madam Chairman is, in many ways, the most important:
That is, we believe that this entire controversy raised by the MedPAC
report is, at its core, a battle over reimbursement--nothing else.
Payers are seeking to pass the blame for rising costs; and
specialists are fighting over what they perceive as an increasingly
limited reimbursement pool. In many ways, this is business as usual.
But what is troubling in this particular case is that charges about
safety and quality have become weapons in this battle. We find such
charges unfortunate. It is time we based conclusions about the use,
role, and value of medical imaging upon a full and accurate reflection
of the peer-reviewed evidence, not upon a narrow slice of it or upon
narrowly focused studies from payers or other self-interested groups.
To be sure, Madam Chairman, no technology can be perfect; nor can
every provider. And we would welcome intelligent, evidence-based
discussions about the appropriate utilization of medical imaging. But
to suggest a quality problem of the scale that MedPAC has suggested is
inappropriate. In fact, the suggestion contradicts MedPAC's own reports
which have lauded the clinical value of these very technologies--and
which have concluded that they represented no serious cost threat to
Medicare.
For example, it is interesting to note how MedPAC described medical
imaging in its overview of new hospital technologies for fiscal year
2002--right in the middle of the period of dramatic growth in imaging
that MedPAC now criticizes:
``Over the past several decades, tremendous quality-of-care
enhancements have been achieved in the fields of radiology,
imaging, and nuclear medicine. In the next year, new imaging
technology and additional applications of existing technologies
including magnetic resonance imaging, positron emission
tomography, ultrasound and computed tomography, will continue
to increase costs for hospitals. MedPAC believes that diffusion
of advances in these areas will have a small impact on total
hospital costs. . . .'' \6\
---------------------------------------------------------------------------
\6\ ``Report to the Congress: Medicare Payment Policy,'' March
2001, Appendix A, p. 165.
Two years earlier, in 1999--at the beginning of the period of rapid
increases in the use of medical imaging that MedPAC now criticizes--
MedPAC came to virtually the same conclusion. Only the Commission was
even more complimentary of medical imaging innovations. MedPAC pointed
---------------------------------------------------------------------------
out that, among other things:
``A new generation of computed tomography scanners will
soon be available that are faster than previous devices and provide
improved clarity. This newer technology may result in expanding the use
of computed tomography scanners in trauma, vascular, and cardiac
scanning.'' \7\
---------------------------------------------------------------------------
\7\ ``Report to the Congress: Medicare Payment Policy,'' March
1999, Appendix C, p. 152.
---------------------------------------------------------------------------
``Technical developments have increased the speed and
versatility of magnetic resonance imaging, including imaging for many
cardiac conditions.'' \8\
---------------------------------------------------------------------------
\8\ Ibid.
---------------------------------------------------------------------------
``High-speed magnetic resonance methods are capable of
imaging the entire brain with a temporal resolution of a few seconds.''
\9\
---------------------------------------------------------------------------
\9\ Ibid.
---------------------------------------------------------------------------
``Recent developments and advances in contrast
echocardiography have improved the diagnosis and evaluation of cardiac
structures and function. The new developments in acoustic
instrumentation with new contrast agents have improved studies
previously obtained by standard two-dimensional echocardiography.''
\10\
---------------------------------------------------------------------------
\10\ Ibid., p. 153.
None of this was presented with criticism, worry, or doubt; nor was
there concern expressed over appropriateness, clinical value, safety,
or overutilization. To be sure, things can change in a few years. But
we believe these quotations support our contention that there is no
safety or quality issue truly in question here.
Conclusion: ``These are wonderful tests.''
Madam Chairman, I would like to close my comments today with a
short quote from Dr. Tom Ruane, Medical Director of PPO and Care
Management Programs for Blue Cross Blue Shield of Michigan. He
testified before MedPAC in March 2004, when the Commission began
exploring utilization of imaging. This is what Dr. Ruane said when he
addressed the question of why there has been such significant growth in
the use of medical imaging among physicians throughout the U.S.:
``I think the number one driver of the trend is technological
advancement. These are wonderful tests that are available that
really have improved the care of patients. Our fundamental
business is making these tests available to people.'' \11\
---------------------------------------------------------------------------
\11\ MedPAC Public Meeting, March 18, 2004, p. 25.
Our industry stands ready to work with Congress, MedPAC, private
payers, and others to address the cost concerns facing Medicare and the
U.S. healthcare system. But in so doing, we believe that one thing is
critical: The kind of honesty and candor about the value of medical
---------------------------------------------------------------------------
imaging that was expressed by Dr. Ruane.
----------
Attachment 1
Medical Imaging Safety
Addressed by Legislation, Regulations, and Enforcement
Medical imaging is regulated by a wide range of federal, state, and
international requirements. This document highlights some of those laws
and requirements.
Food and Drug Administration
FDA regulates manufacturers of medical imaging
technologies through both premarket and post-approval requirements. The
focus is to ensure that products are safe and effective. Products must
clear FDA through one of two review tracks--a premarket approval or a
premarket notification.
The premarket approval application (PMA) requires
clinical trials before the application is submitted, reviewed and
approved by FDA. The PMA would include reference to standards the
equipment should meet, e.g. the FDA Diagnostic X-ray standard, the
International Electrotechnical Committee (IEC) medical imaging
standards, and the NEMA medical imaging standards. Referencing these
standards means the manufacturer has committed to comply with them.
The second FDA premarket method of regulating medical
imaging equipment is through a Premarket Notification Application or
510K. In general a full scale clinical trial is not required, however,
in some cases smaller studies are required. The same standards
mentioned earlier for a PMA, when referenced in a premarket
notification application, become obligatory.
The FDA inspects company manufacturing facilities where
imaging equipment is made to examine the manufacturing process against
the FDA Quality System regulation. The FDA also reacts to Medical
Device Reports (MDR) and can recall devices if they are found to be
unsafe or ineffective.
The manufacturer is required to install medical imaging
equipment in accordance with installation instructions leaving the
device in compliance with all referenced standards and quality control
requirements. The manufacturers also provide a maintenance procedure
and schedule with the customer designed to keep the imaging equipment
to original specifications. Most NEMA member companies offer service
contracts to their customers in order to keep equipment in top shape.
FDA requires reviews and takes action on reports received
from clinicians and other providers when problems arise with a medical
device.
FDA can bring legal action against manufacturers to stop
sale, production, marketing of a medical device.
Three major laws define FDA regulation. They are the
Medical Device Amendments (1976-2002) to the Federal Food Drug and
Cosmetic Act; the Radiation Control for Health & Safety Act of 1968;
and the Mammography Quality Standards Act 1992-2004.
FDA regulations implementing these laws can be found at:
21 CFR Chapter 1, Food and Drug; Subchapter H--Medical Devices;
Subchapter I--Mammography Quality Standards Act; Subchapter J--
Radiological Health.
U.S. Nuclear Regulatory Commission
NRC regulates the use, manufacture, and transportation of
nuclear by-product material used with or in medical imaging devices.
NRC provides licenses to users based on approval of
satisfactory applications and the inspection of user facilities.
NRC provides certification to authorize applicants to
manufacturer and ship nuclear materials.
NRC inspects licensees and can issue legal sanctions to
violators.
U.S. Department of Labor
Occupational Safety & Health Administration (OSHA)
OSHA requires employers to provide a safe environment to
workers in medical imaging facilities through standards and
inspections.
OSHA prepares standards or references published
standards/guidelines for workplace safety.
State Regulatory Health Agencies
States regulate imaging facilities and equipment.
States adopted regulations from Council of State
Governments Recommended regulations.
Inspection of medical imaging facilities and equipment
(old and new) is a high priority.
State equipment safety regulations are consistent with
the FDA regulation.
21CFR 1020.30; Diagnostic X-ray systems.
----------
Attachment 2
Standards for Imaging
Overview
NEMA has been engaged in the development of industry standards for
over 75 years, since its founding in 1926. This document outlines some
of the key elements of standards setting, implementation, and cost.
What is a NEMA Standard?
A NEMA standard defines a product, process, or procedure
with reference to one or more of the following elements: nomenclature,
composition, construction, dimensions, tolerances, safety, operating
characteristics, performance, rating, testing and the service for which
it is designed. A NEMA Standard pertains to engineering, technical, or
safety considerations in terms of characteristics of the products.
Standards enable customers to more easily select from a
range of safe, effective and compatible electrical products.
NEMA standards exist for a wide variety of products
including lighting systems, motors and generators, transformers,
industrial controls and power and building equipment. In the medical
area, standards have been developed for magnetic resonance devices,
ultrasound imaging equipment, nuclear medicine imaging systems, x-ray
imaging systems and for digital imaging and communications in medicine
(DICOM)
NEMA standards are voluntary but are used extensively
throughout the world.
How are NEMA Standards Developed?
A subcommittee or work group initiates a project to
develop a new standard or revise an existing standard:
Subcommittee develops draft standard.
Subcommittee approves standard and gives recommendation
for approval to respective NEMA product section.
Section approves standard by ballot. (Up to this point,
the ``standard'' is considered a ``draft'' and is not an official NEMA
standard).
A NEMA draft standard must be reviewed and approved by
the NEMA Codes and Standards Committee. It then becomes an official
NEMA standard, and is made available to standards buyers around the
globe.
NEMA Product Sections conduct regularly scheduled,
mandatory reviews of all industry standards. Every NEMA standard must
be either affirmed, rescinded or revised every 5 years. When the need
for a new standard is identified, or when an existing standard is being
reviewed for revision or withdrawal, the product section seeks guidance
from both users and manufacturers. FDA input is also considered. By
incorporating the views of these groups, the association ensures the
design of effective and safe products.
Participation in International Standards Activities
In addition to NEMA developing its own standards, NEMA members
actively participate in international standards activities. Frequently,
a NEMA standard will become the basis of an international standard.
NEMA is involved with such international standards organizations as
the International Electrotechnical Commission (IEC) and International
Organization for Standardization (ISO). In these organizations, NEMA
representatives participate with representatives from other countries
to develop performance and safety standards which can be used by the
international community.
Examples of NEMA Standards on Safety and Quality
One NEMA ultrasound standard enables the physician or
sonographer to monitor the acoustic output display of an ultrasound
system in real time, during an ultrasound examination, so that clinical
operators may minimize ultrasound exposure, while at the same time
maximizing the diagnostic information which may be acquired from the
exam.
NEMA developed a performance standard and quality control
guidelines for single photon emission computed tomography (SPECT)
devices used in nuclear medicine, to inform clinical users whether
their SPECT devices are performing properly, and therefore suitable for
use with patients.
NEMA developed quality control guidelines for
intraoperative gamma probes. Gamma probes are used by the surgeon to
detect whether breast cancer has metastasized to the lymph nodes.
Similarly as with the SPECT guidelines, these guidelines set forth
measurement methods to help the user determine whether the probe is fit
for use, prior to being employed on patients.
How are Standards Administered?
NEMA standards are used to enable manufacturers to
develop products which meet agreed upon criteria for performance or
safety.
NEMA standards are employed by users of NEMA products to
assess the safety and performance of these products both prior to
accepting these products into their facilities, and for continuing to
measure their performance after acceptance on an ongoing basis.
NEMA standards are frequently incorporated into the
regulatory requirements for marketing products. For example, x-ray
manufacturers must comply with x-ray performance standards in order to
comply with FDA 510(k) requirements.
Example--Ultrasound 510(k) Applications
For ultrasound 510(k) applications, FDA requires
conformity to the ultrasound acoustic output measurement standard and
the ultrasound output display standard.
International standards as well are often incorporated
into regulatory system requirements, e.g. international EMC standards.
For compliance with FDA regulations for ultrasound 510(k)
applications, a declaration of conformity is needed to a standard
recognized by FDA Center for Devices and Radiological Health to
demonstrate thermal, mechanical or electrical safety, such as IEC
60601-1, UL 2601 UL 544, CSA C22.2 No. 125 and BSI 5724. Standards such
as IEC 60601-1 apply to all diagnostic imaging devices.
Patient biocompatibility for patient contact materials
must satisfactorily meet tests according to ISO-10993-1.
How Much Does it Cost to Develop and Apply Standards?
Taking the Digital Information and Communications in
Medicine (DICOM) standard as an example, the cost to develop and update
this standard is estimated to be over one million dollars per year.
Costs for development and application of NEMA standards
includes expenditures for convening meetings of experts, including
travel and associated expenses, association staff personnel time, and
time of experts developing the standards. Application of standards
requires expenditures of staff and equipment to assess the performance
of medical devices by manufacturers and users.
Chairman JOHNSON. Thank you very much. And I thank the
panel, and I appreciate that Members have come back after the
votes to conclude our discussion.
Let me just ask you all what you think the impact of
MedPAC's coding changes will be? I mean clearly there are
issues of reimbursement here and I am interested in whether the
issues of reimbursement kind of parallel the issues of
reimbursement that we are seeing in other areas. We don't have
a logical continuum of reimbursement policy in the
rehabilitation area from long term care, rehab hospitals to
rehab in other settings. We don't have an honest continuum of
care in the hospital area in cardiology and other areas, and
that is part of the reason we are getting boutique hospitals.
Will the coding changes more accurately reimburse for
imaging services, and will they be less likely to drive site
issues? Dr. Borgstede? I am looking for every one of you to
respond to this.
Dr. BORGSTEDE. As I answer that question, I want to make
this clear that my answer is prefaced by the comment that this
is not a turf battle. If this were a turf battle, we would
envision that the imaging would come to radiologists that is
not done by radiologists right now. What we are saying is that
there is inappropriate imaging and that that imaging should go
away, and if it is inappropriate it shouldn't be done by a
radiologist either.
The other thing that I would say in answer to your question
is that if we merely do studies at this point in time and the
Medicare program is hemorrhaging and we need to stop the
hemorrhage and the study won't solve that problem. Now I will
answer your question as the colleges represented to the
Relative Value Update Committee, that value is CPT codes. What
we have done recently, the Practice Expense Advisory Committee
that has addressed the technical component reimbursement for
imaging studies, along with the other 7,000 CPT codes. The
valuation that the Practice Expense Advisory Committee came up
with will take effect January 1st, 2006. So, there will be an
opportunity there to see if some of the coding changes or the
changes that the PEAC recommended will also control cost.
But if those issues don't, the way the PEAC addresses this
doesn't control the problem, then certainly we can understand
where MedPAC is coming from with their coding----
Chairman JOHNSON. What is the difference between what the
CPT Coding Committee is doing and what MedPAC is recommending
on coding?
Dr. BORGSTEDE. What MedPAC is recommending would be when
you do multiple examinations, for example, on the same patient,
let us say a CT scan chest, abdomen, pelvis, that you are doing
multiple body parts, there would be some reduction in payment
for the second body part that you do and the third body part,
similar to what is done in the surgical coding, and that is
certainly one approach that could be done. The only comment I
would make is that the PEAC has already looked at these codes,
CT scan chest, abdomen, pelvis, all the 7,000 CT codes and has
recommended devaluations for the technical component
reimbursement, but those recommendations will not take effect
until January 1st, 2006. When they take effect you will see
some changes as well.
So, you might want to consider that.
Chairman JOHNSON. Are they reducing the technical component
for body part 2 and body part 3?
Dr. BORGSTEDE. Yes, ma'am.
Chairman JOHNSON. So, that has the effect of doing what
MedPAC is recommending, does it not?
Dr. BORGSTEDE. But they are doing it in a different way.
What they have done is not only body part 2 and 3, but they
have devalued body part 1 on the technical component as well.
They devalued all of the technical components, so even when you
start out with one body part, there will be less valuation.
Chairman JOHNSON. That is the difference between MedPAC and
new CPT codes on this issue.
Dr. BORGSTEDE. Yes.
Chairman JOHNSON. So, your comment is that the changes that
have just been that will soon go into effect realize the coding
goals, roughly, that MedPAC is recommending and as have some
effect on the overall cost.
Dr. BORGSTEDE. What they realize is that there are
reimbursement issues that need to be addressed, and they are
addressing them in a slightly different manner, but, yes, they
are addressing the reimbursement as a global concept.
Chairman JOHNSON. Dr. Williams?
Dr. WILLIAMS. Thank you. I would just like to comment that
as I understand the MedPAC--I don't really want to speak for
them--but as I understand their points, one of them is that
they would like to see coding edits in place that look at
appropriateness, and we agree with that, that there needs to be
a filter or a sentinel effect, if you will, of someone saying,
``Is this test appropriate for this particular patient based on
the disease state that they have?''
So, my point would be that they need to make sure that
MedPAC or whoever sets up the Commission to develop it looks at
the specialists who are experts in that organ system to help
derive what is appropriate and what is not. As long as that is
done, the appropriateness criteria will help the edits and
reject the claims of those who are doing tests for reasons
that----
Chairman JOHNSON. Do you think that we know enough for
those appropriateness edits to be accurate?
Dr. WILLIAMS. Well, certainly in cardiology. We have been
doing this for a while, and we have had people look at
appropriateness and even OIG looked at it and noticed, and
noted that in nuclear cardiology the tests seemed to be doing
exactly what they were supposed to be, and we would like to see
more of that and we indeed at the American College of
Cardiology are developing test by test for the heart
appropriateness criteria.
Chairman JOHNSON. Thank you.
Ms. Farnsworth.
Ms. FARNSWORTH. I would like to say that I think what
MedPAC is recommending goes a step further than what is being
stated here and has a lot of the same thinking that the CCI,
the correct coding initiatives had initially. They just did not
have the imaging expertise to really take it to that level.
What we are finding in the private sector, my company, a part
of what we do is coding in MedPAC study out company and others.
We save over and above the correct coding initiatives and what
our plans are doing with their fraud departments and other
things. We save between 2 and 4 percent more of their entire
imaging spend, and it has to do with appropriate reimbursement.
What we do is strictly on the technical component, has to do
with the technology because honestly, the professional
component, when the physician reads it there's more information
than there ever was before, so he's doing more work. But the
technology is so fast today. CT of the abdomen, CT of the
pelvis that Dr. Borgstede is referring to. To do that second
body part takes, depending on the equipment, maybe 5 seconds.
It wouldn't be expected to be paid twice for that extra 5
seconds. So, there's very little pushback from the physician
community because it is expected that these will be aligned at
some point.
So, to quantify, to give some quantification to the answer,
that is what we are seeing, depending on the plan, 2 to 4
percent more than the CCI or the fraud filters they have in
place.
Chairman JOHNSON. So, in other words, they can reduce the
technical component 2 to 4 percent more?
Ms. FARNSWORTH. They are saving 2 to 4 percent of their
entire imaging spend. It is a substantial amount of dollars.
Chairman JOHNSON. And they are private sector what, payers?
Ms. FARNSWORTH. Payers, self-insured employers and FIs.
Chairman JOHNSON. Thank you.
Dr. Rollo?
Dr. ROLLO. I think my main point would be that as we look
at any kind of a reimbursement change and coding change, as has
been mentioned before, it is really important to have experts
who are representatives from the various modalities involved in
those discussions. I think it is very easy to make a comment
about how long it takes to do a particular study, the body
parts that are involved. But I think that there is something
beyond simply collecting the images. The interpretation of
those studies does in fact require a select number of images,
images that are obtained for certain periods of time, and
information content that allows the accuracy of the diagnosis
to be obtained. All of these things should be included in the
recommendations of, number one, the coding, but also in
recommendations in terms of the reimbursement.
All of the societies, whether it be magnetic resonance
imaging, ultrasound, nuclear, both PET and SPECT as well as
cardiology have reimbursement committees that continue to look
at the value of the individual procedures that are performed,
and I think they would all welcome the opportunity to
participate in discussions, in decisions that are made
regarding the final coding, but also the reimbursement that
would be selected.
Chairman JOHNSON. Are they aware of the recent changes made
to the CPT codes by that review committee that will go into
effect January 1st, 2006?
Dr. ROLLO. Yes.
Chairman JOHNSON. And are they satisfied with those?
Dr. ROLLO. Yes.
Chairman JOHNSON. Thank you.
Mr. Stark?
I am going to come back some, but I am going to pursue a
single subject and give everybody a chance.
Mr. STARK. I want to thank all of you for your testimony. I
am afraid that I suspect I see a little bit of a turf war here.
Dr. Williams, if I am correct, you represent, in addition
to cardiologist, oncologists, obstetricians, gynecologists,
urologists, family practitioners, neurologists and orthopedic
surgeons.
Dr. WILLIAMS. Indeed.
Mr. STARK. How about chiropractors and podiatrists?
Dr. WILLIAMS. No.
Mr. STARK. Stride-Rite Shoe Stores?
[Laughter.]
Dr. WILLIAMS. Not part of the CPCI, no.
Mr. STARK. All right. So, they are on their own.
Dr. Rollo, is there anybody to whom you would not sell any
of the equipment you make? There is a list of six things that
Philips makes----
Dr. ROLLO. Yes, for Philips, correct.
Mr. STARK. Would you sell them to chiropractors?
Dr. ROLLO. I think that most of the manufacturers will sell
to those who are interested.
Mr. STARK. Okay. I am a little--and I guess this is between
Dr. Borgstede and Dr. Williams. Both of you say that you want
to protect the patients, and I suspect you both agree that
there ought to be standards. That makes some sense. Is that
fair to say in terms of how the imaging is performed? Is that
fair?
Dr. WILLIAMS. Yes.
Dr. BORGSTEDE. That is fair, and I think that the quality
metrics that we are proposing, MedPAC is proposing, should be
equal for everyone. We are not trying to favor one specialty
over the other. If the imaging is inappropriate it should go
away. So, we think the standard should be the same for
everyone. We are not asking for any special standards for one
specialty versus another?
Mr. STARK. Are you comfortable with that, doc?
Dr. WILLIAMS. I would like to refine that a little bit,
please. It sounds like some of this is turf war, but I think we
are saying a lot of the same things, and that is there needs to
be three things in place: appropriateness; we need to have some
sort of credentialing for physicians; and some way of making
sure that the images themselves are good. And we are all in
agreement about that. The question is how do you do it?
Mr. STARK. Let me make a statement and see if I can get you
guys to disagree.
Dr. WILLIAMS. Okay.
Mr. STARK. I have had some experience with ultrasound and I
guess it would be obstetricians. And I think it is very handy
for the obstetrician when you are wondering is it a boy or a
girl or whatever. It is there. You do not have to go across
town and make an appointment for next week. I have watched
ultrasounds and it looks to me like I could do it now, I have
seen it so often. You don't want to come to me, but I could.
[Laughter.]
Mr. STARK. So, that sounds like it is okay, but here is the
rub. Who are you willing to allow to do this? Medicare has
basically--with the exception of mammography where we got into
it, we have never set practice procedures or standards.
Congress isn't competent to do that. As wonderful staff as we
all have, you don't want us to. I doubt if CMS has got a big--
now maybe FDA can do it, maybe MedPAC can hire it out.
But I remember some years ago suggesting to one of your
specialties that specialists, to qualify for Medicare
reimbursement, should be required to pass a test every 7 years,
and the specialty societies came off the wall screaming that
government was interfering. I said, all right. They said, ``We
do it anyway.''
Well, okay, if you require your members to be in the
college of whatever college you are running to take the test,
are you willing to see government require those tests? If you
guys write the tests, let us say. I am not suggesting this is
``Leave No Doctor Behind,'' but I am just saying you write the
test, but there then has to be, somebody has to oversee it,
have oversight. Are you willing to see the government, in this
case CMS, enforce that? Either or both. Go ahead, Dr.
Borgstede, you go first.
Dr. BORGSTEDE. The answer is yes. That is the short answer.
I used to be President of the Colorado State Board of Medical
Examiners, and so I had to deal with physician credentialing
from that perspective as well. What we are looking at here is a
more comprehensive approach to this problem.
Mr. STARK. That is fine. I just want to get through this
thing about we don't want government interference, because it
sounds to me like that is where we are heading and it is new
turf for us.
How about Dr. Williams, how about your group?
Dr. WILLIAMS. That is a difficult question. If you ask most
physicians, they don't want government interference.
Mr. STARK. You are right, they don't.
Dr. WILLIAMS. And I agree with your point on that. The fact
of the matter is, the professional societies have done in a
large degree a good job coming up with training and
credentialing guidelines, and to the extent that they are
followed, we agree that that should be the standard, and so I
am not sure it is really necessary to put another level of----
Mr. STARK. Let me tell you where it isn't. JCAHO, they are
lousy. They do a poor job. They miss serious problems in
hospitals and they're not responsible to anybody except
themselves, not even to the hospital. I mean they are out there
as a loose cannon on the deck and they have just done a
miserable job of inspecting hospitals. There are some of us who
would say, wait a minute, they ought to be responsible to CMS
if they are going to deem, because somebody has to answer to
this sooner than later. All I am thinking is, prospectively
here, if you guys are going to have to agree on how it has to
be regulated. I do not think we are going to get into that
fight.
Dr. WILLIAMS. Well, having said that, I would like to add
that, for example, nuclear cardiology, we helped set up the
certifying board for nuclear cardiology, and we actually apply
to the Nuclear Regulatory Commission to be one of the tests
that actually is used for licensure for the safeness of
radioactive materials. I don't have a problem, and I don't
think most people would, of having a society come up with
criteria, come up with an exam and then submit it for review,
and say, ``Yes, this is a good process. Look at what is in the
exam. Does it really test what we want, which is quality?'' As
long as that is the process, that should go well.
Mr. STARK. Dr. Borgstede?
Dr. BORGSTEDE. Yes. I think what we need to focus on are
two things here. First off, this needs to a comprehensive
approach to accreditation and that is what MedPAC is really
talking about. It is not just the physician, it is the
physician, it is the technologist who performs the examination,
and it is the equipment and it is physics inspections to make
sure the equipment continues.
With all due respect to NEMA, you know the equipment may be
perfect when it comes out of the box, but the equipment isn't
necessarily going to be perfect on and on and on.
One other comment I would like to make, and that is, while
cardiology does have training requirements in imaging, it is
the only other specialty that has that. There are no other
mandatory training requirements for physicians other than the
cardiologist. So, you have a lot of other people out here doing
imaging with no qualifications.
Mr. STARK. If I could just finish up. What I see out there
is in fact, I suspect in California--Dr. Rollo would probably
know--I don't suppose that there is any procedure that a
licensed physician in California can't perform. You may not
want him or her to do it to you, but I think they could be a
psychiatrist or a brain surgeon, whatever, and all they got to
do is have a ticket to practice medicine in California. The
hospital might----
So, it has always been an assumption that you all, in your
profession, would rate each other, but if we are now going to
get to a point where we are going to restrict how we pay and
who we pay, you are getting into an area that you may or may--I
just say that, but you have to come up with kind of a uniform
agreement among the various specialties because for us to get
into that--like the SHAL study, you guys got together on the
SHAL study, for better or worse, and agreed. We did not have to
make that decision, and I would urge you to get to that.
Dr. BORGSTEDE. I would concur. I am pleased at what I am
hearing today, is that there is an agreement that quality
metrics are important and that we need to have those as
requirements. I would also point out that, currently, CMS is
involved in a pay-for-performance approach on dialysis patients
and providing dialysis care. So, again, this is not necessarily
plowing completely new ground.
Mr. STARK. Thank you, Madam Chair, for indulging me.
Chairman JOHNSON. Mr. Lewis.
Mr. LEWIS. Thank you very much, Madam Chair.
Let me thank each Member of the panel for being here.
Dr. Williams, let me just ask you, who paid for the study
completed by Lewin and has their study been published by any
peer review journal? As an interested party how can you assure
Members of the Committee that the study funded by your
collected interests is not biased in some way?
Dr. WILLIAMS. Thank you for answering the question.
[Laughter.]
Mr. LEWIS. I didn't mean to answer, Dr. Williams. I am just
trying to get some information here, sir.
Dr. WILLIAMS. No, seriously, no, I wasn't being flippant.
You are absolutely right that it was our responsibility to look
at the data in a responsible way, and so we hired a credible
organization to try to go back and look at it. So, the answer
to the middle portion of the question is that I have seen a
draft of it. They have been working on it, and there is a lot
of areas other than the data that we presented that need
refinement.
I understand that that brings a lot of questions because
you have a credible MedPAC and a credible organization that
give you different answers. So, I would like to say that we
would be more than happy to have all of the parties get
together and talk through what the differences are so that the
methodologies are comparable and come up with what answers
would actually satisfy the Committee.
But I don't really want to say that this is all about
imaging or about image volume. I think that sort of detracts
from the message. It really is about whether or not that
increase in volume has value clinically. Is it clinically
useful? Does it save lives? And as long as that is the case, we
need to look at that before we start talking about ways of
restricting it.
Mr. LEWIS. Thank you very much, Dr. Williams.
Dr. Rollo, you in your written and prepared statement you
made a very strong and definitive statement that consumers are
safer, healthier and live longer because of medical imaging.
Would you like to elaborate more? You have proof and evidence
and data that would demonstrate what you stated?
Dr. ROLLO. I am sorry. I missed the first part. Is this
related to the----
Mr. LEWIS. Yes. In the very beginning of your written
statement you mention that consumers are safer, healthier and
live longer today because of medical images.
Dr. ROLLO. Those comments were based on information that we
have posted on the website, examples where consumers are safer
as a result of the special regulations that have been imposed
by the FDA but also by the various organizations that regulate
the placement of the technology in the hospital settings, the
safety regulations. It was mentioned, for example, that the
joint commission may not do a good job, but one of the things
they do, including in their assessment, is when technology is
installed there are requirements that technology be
continuously maintained, and that there are records that the
quality control measures and quality management programs for
those technologies are in fact completed.
When the joint commission comes in for their evaluation, if
they show that the records have not in fact been kept and
there's not evidence that the system continues to perform as
was intended by the original manufacturer, they can be cited,
and in fact can lose, in the extreme case, their Medicare
capabilities of performing within that system.
So, I think there is evidence as we look at the literature
on the results of evaluation of hospitals and facilities that
the equipment is safer, which is what I am relating to here,
because of the special requirement for shielding, the
insulation requirements and the ever-ongoing maintenance of
that technology.
Mr. LEWIS. Not any of you are suggesting today that we
should look to the specialty societies rather than the
Secretary of Health and Human Services. Could you sort of
clarify that for me because I think Mr. Miller said you should
stay with the Commission, with the Secretary, and maybe not
look to the specialty societies?
Dr. ROLLO. Let me address that. This goes back to a
question before because I think that one of the--we keep
throwing out the word ``quality'' without defining what we mean
by quality.
Mr. LEWIS. What is quality?
Dr. ROLLO. That is the point. I think that quality, when
you talk about quality in health care, it isn't necessarily
living and dying; as people keep saying, well, there is quality
so we have improvements in life or we have improvements in the
necessary, the length of an individual's survival. It is truly
how you get there. The appropriateness of the procedures that
are performed. In certain cases no therapy should be applied
because of the end stage of the patient. It is the curing and
the understanding of the way that cure is administered to that
individual patient, and it is the quality of life that
individual may enjoy. If people have end stage disease we don't
always do surgery, we don't always provide the latest in terms
of therapeutic agents. We provide them with agents which we
think are consistent with the quality of life that they are
capable of sustaining.
So, I think quality, when we talk about imaging, it has to
do with not only the quality of the images in terms of the
diagnostic content, but also the clarify with which a physician
can have confidence in the interpretation of that image. What
is really important to understand is doctors don't perform
procedures except for the therapeutics, cardiologists, for
example, performing a procedure. The images are obtained by a
technologist who acquires the images, does the preparation of
the images and does the display of those images for the
physician. If you have a quality image, meaning that it has
diagnostic information which can be easily diagnosed, doctors
can in fact do that interpretation.
Where we get into the unnecessary, inappropriate
procedures, more often than not, it is a case where the image
does not clearly define the presence of the abnormality that a
physician is looking for, and they therefore recommend another
procedure to clarify and confirm that diagnosis.
Mr. LEWIS. Madam Chair, could you be patient with me just
for a second?
Chairman JOHNSON. Yes. The others members wanted to
comment.
Mr. LEWIS. Yes, I would love for the others to comment.
Dr. WILLIAMS. I would really like to respond to the issue
of specialty involvement. We put together collaborations. For
example, the American Society of Nuclear Cardiology has
guidelines about the performance of tests. It involves the
radiologist, the nuclear medicine doctors and the cardiologists
in our organization. When we do this with the American College
of Cardiology, American Heart Association, American Society of
Nuclear Cardiology to make guidelines for radionuclide imaging,
we call upon the expertise of the people who actually do this,
the ones who are publishing. We use peer-reviewed literature
and use that as the arbiter of making guidelines, saying this
is Class I-A, meaning that this is something that is definitely
going to help your patients for this particular disease
disorder, and there is good evidence behind it.
That is the process that we should go through, and I think
it would be very difficult for the government or some third
party, as MedPAC was saying, to do that. You need to rely on
the specialists who know the patients, who know the diseases.
Dr. BORGSTEDE. Yes. I would envision that the Secretary
would go about setting the standards, and then choose among a
variety of physician specialties to put forth their standard,
just like what my colleague talked about. The American College
of Radiology has appropriateness criteria that were developed
with other specialties. So, we would envision that that would
be one way that you would approach this, the appropriateness
criteria. We have accreditation programs. College has been
involved in accreditation since 1965. So, we have multiple
accreditation, not only in cardiac imaging, but in nuclear
medicine, in MR, in CT scan, in mammography. We are very
comprehensive that way.
But we don't envision that this would be exclusive, that
the American College of Radiology would be the accrediting
body. It would probably, we would hope, would be one of them.
We would hope that our standards would be a baseline standard,
but there are other organizations who are very credible out
there who can also be involved in accreditation, and we would
welcome any organization that has credibility in that regard to
be involved in this.
Ms. FARNSWORTH. I think in today's world and certainly what
we are seeing in the private sector, and I feel certain that
MedPAC was alluding to this, we are at a different level as far
as looking at the definition of quality today in health care.
The Institute of Medicine's report on medical mistakes--and I
am sure you have all taken a look at that--talks about we have
to get away from opinion-based medicine in our country and get
to evidence-based medicine. I think pulling together the
societies to debate the issues and to bring their peer-reviewed
to the table is an important piece.
What we are looking at is the data, and the standardized
code and data sets that Congress enacted are really assisting
the sciences to look at the data and to see--I think quality is
defined by the outcome. I think that defines quality. For the
first time we can begin to see it. We are studying it. The data
that we pull in from the insurance companies, we are looking at
it financially, we are looking at the outcome. There are many
pieces of peer-reviewed literature that say that more tests do
not produce a better outcome; it is the right test. And also we
have to take patient safety into consideration.
So, I would encourage Congress to not only listen to that
dialog of the societies, but take it to another level which
MedPAC and others can do. Look at the data. Look at the
outcome.
Mr. LEWIS. Thank you very much.
Chairman JOHNSON. I thank the panel. Are there other
questions?
Mr. LEWIS. I think Dr. Rollo----
Chairman JOHNSON. One more, Dr. Rollo?
Dr. ROLLO. Yes. I just want to make a comment in endorsing
comments that are made, that I think that the individual
medical specialties have a better understanding of the types of
procedures and the type of information they require in order to
do the interpretation of the images in their area. Each of the
individual groups, individual professional organizations, would
have the responsibility for the education. But one of the
single biggest problems I have with the way we set up within
the professional organizations, we have something called the
guidelines. The guidelines are an indication of when to do a
study, but a typical guideline, for example, may say, if you
feel that this patient has signs, symptoms and history
consistent with congestive heart failure, one of the ways to
determine that is to do an injection fraction either using
nuclear medicine or echocardiography.
But they don't tell you how to do the procedure. In other
words, there is not a protocol. And each of the equipment
manufacturers have different features associated with their
equipment, so to simply make a statement that says ``do a
particular procedure,'' you require a protocol in order to
optimize the images and the information that is available.
One of the things I would like to see if we were to go to
an accrediting body, for example, American College of
Cardiology, American College of Radiology and others, is to
have them also take the next step which would be to define the
protocols so we would have consistency in the information which
is obtained on patients and go back to the manufacturers where
the manufacturers would have the responsibility to certify that
their technology does in fact provide the information, the
optimized images which are required in the system.
Chairman JOHNSON. Interesting. Mr. Borgstede.
Dr. BORGSTEDE. The American College of Radiology has done
that.
Chairman JOHNSON. Mr. Stark.
Mr. STARK. I just want to go back again to this idea of
government, and I guess I would almost say I don't much care,
but it seems to me, Dr. Williams, that the leading professors
of medicine will cease to be Moliere and Shaw, and pretty soon
be people who deal with not opinion based, as Ms. Farnsworth
suggested, but outcomes, research and standards of practice
which I think it is fair to say there has been a tremendous
amount of resistance in the physician community to having that
imposed from afar. I don't care whether it is government or
where, but it seems to me the more technology becomes
sophisticated and complicated, the more we are going to be
pushed, you are going to be pushed to dealing with protocols
that are more precise and more based on--and one of the things
that I think that government will have to do to see that come
about in a reasonable amount of time. I am saying the next
couple of decades the government is going to have to say ``This
is it guys. Here is the way you are going to keep records, at
least for Medicare.'' Where we are paying we can say that.
Because otherwise it is going to be different. It is going to
be different in North Dakota and California and New York.
I would hope that we would get tremendous help in doing
that from organized medicine, if you would, and then it would
work better. All these things we are talking about now, the
Chair has talked about, technology and IT, and we are talking
today about quality, and all of these things, and we are
heading in that direction with nothing to guide us. If we can't
work together in that, it could be a mess. If we can work
together, I sense that it is a major change, a quantum change
in how your students and members will practice in the future,
and it is fascinating to watch. I hope you don't just resist
it. Go ahead.
Dr. WILLIAMS. It is interesting that you bring that up. We
actually would take credit for it. If you look at the
guidelines I just quoted and the fact that we make levels of
evidence. Those levels of evidence are based on objective
outcomes-related research. And it is interesting that nuclear
cardiology has grown. Part of that is the fact that we actually
showed that the gold standard in cardiology for so many years,
invasive testing, was not the gold standard in terms of
outcomes. In fact, the patient's outcome, as I testified, is
better related to their nuclear perfusion result than to the
invasive images. Once that happened that is when you saw the
upswing in the number of nuclear cardiology tests because
people knew that they could have a test that they could rely on
to actually say what is going to happen to the patient.
I would say that it actually started with the medical
societies, and we agree that outcomes is the best way to manage
this.
Chairman JOHNSON. Mr. Borgstede.
Dr. BORGSTEDE. I think that we need to look beyond
cardiology though. We need to look more comprehensively at all
of medicine, and clearly, from the government's point of view,
you are the biggest insurer, single insurer in the United
States, and we need to make sure that that money is being spent
appropriately. Imaging is oftentimes done very early in a
patient's disease process, and if the imaging is not done
correctly, you head off on the wrong pathway, and then you end
up with imaging being repeated, wrong examinations, wrong
surgery and everything else.
So, I don't envision that there is going to be a choice as
to whether we are going to participate in this or not. I mean
there is going to have to be a change. The pay-for-performance
concept, by whatever you want to call it, is out there, and we
are going to have to step up to the plate or someone will do it
to us, and that is why we would rather be proactive, the
College, and be out there working with you, rather than resist,
resist, resist.
Chairman JOHNSON. Ms. Farnsworth.
Ms. FARNSWORTH. I think it is important, in all due respect
to the fact that the societies have looked at outcomes, that
you as fiduciaries for the Medicare program, it is not just
about the outcome, the medical outcome, it is about the
financial outcome and how those two things tie together. When
medical economists look at an outcome, we are looking at what
dollars were spent produced a better outcome, which didn't. So,
it is more complex than just pulling the societies together to
look at that medical outcome. I just want to remind you of
that, that we are now at a level where we look at the
financials and the dollars, as well as the science.
Chairman JOHNSON. Let me ask a micro question and conclude
with that, and a macro comment.
How does all this stuff about setting standards and so on
pertain to the other specialties in which imaging has now
become integral? For instance, oncologists use imaging
constantly to get the treatment to precisely the right site.
Obstetricians use imaging constantly. It has become a tool in
the process of care. Now, you certainly don't want to--I would
rather have an obstetrician who is looking at these images of
fetal development constantly than somebody who is doing all
kinds of work and only occasionally looks at that kind of
material. So, do you think that there is a deficit in the
training of physicians who are specialists in other areas in
the use of imaging? It seems to me they get that training as
they learn to use the equipment. Since their whole diagnosis
and treatment process depends on it, they get very good at it.
So, do we want to impose a whole new superstructure that
addresses standards of practice in each of these areas? I find
that daunting.
Dr. BORGSTEDE. Just a comment I would make. I would refer
you to the American College of Graduate Medical Education Green
Book which talks about imaging training, and I would be happy
to provide you a copy of that. But the only two specialties
that have training requirements that I am aware of are the
American College of Radiology and the American College of
Cardiology. So, there are no other specialties that have those
requirements.
Chairman JOHNSON. Correct, but do we have any evidence that
the training of physicians that has developed as part of the
process of using this new--think of the difference between
doing laser surgery and non-laser surgery, so there is lots of
new technology coming into medicine that you had better learn
to use right.
Mr. STARK. Would the gentlewoman yield?
Chairman JOHNSON. Yes, in just a minute.
So, I heard what you said earlier about you are the only
two disciplines where there is formal training, so that is why
I am raising this question. I mean do we now impose formal
training on every other specialty that uses imaging, or do we
look more carefully and see where they are getting the training
and what the outcome of their training is and whether their
training appears to be generally good or appears to be
generally inadequate.
Let me yield to Pete and then we will go to that one.
Mr. STARK. I just wonder, like orthopedic guys who set
bones and stuff, they are not trained in how to read?
Dr. BORGSTEDE. There are no formal imaging training
requirements. I am not saying that they don't look at images,
but if----
Mr. STARK. But they don't ask to go to Dr. Williams' class.
Dr. BORGSTEDE. The other thing, getting back to the MedPAC
report, I think they were really addressing the three high-end
imaging modalities, PET, CT and MR. So, if we stay focused on
those and you look at baseline requirements that are again
comprehensive, that not only deal with physician training but
deal with the equipment, deal with the technologist who is
performing that examination, I think it would be across the
board a level playing field. Whoever wants to do imaging,
particularly in those three areas where we are focused right
now, could do imaging as long as you could meet those
requirements. That would be I think a very fair and very
appropriate way to do this.
Chairman JOHNSON. Any other comments on that? Ms.
Farnsworth.
Mr. STARK. Cherrill, yes, do you notice a difference--you
go around and consult--between radiologists and cardiologists
and people who didn't get trained? What do you see?
Ms. FARNSWORTH. What we see is that we believe--and there
is certainly evidence--that OBs are well trained in reading OB
ultrasound. I think what Dr. Borgstede is talking about is they
might not have all of the training on the physics behind the
machine and all that sort of thing, but they look at films,
they learn this in their medical training, and they are good at
it. Orthopedic surgeons are good at looking at x-rays.
What we are seeing happen in the private sector is if you
are not formally trained, then we won't pay you to do it. OBs
are paid to do OB ultrasound. But let us say the patient is in
the office and is having a little pain, and the OB says,
``Well, I have this ultrasound; let me take a look at her gall
bladder.'' He is not trained at looking at gall bladders, so we
don't pay an OB to do gall bladder ultrasound. I use the Mark
Twain quote, ``When you've got a hammer, everything looks like
a nail.'' So, just because you have it in your office we don't
want you to utilize it on our enrollee necessarily. So, it is a
lot about--and certainly cardiologists are trained in echo and
nuclear cardiology. They are doing it. They should do it. They
are the right people to do it, and we are advocates of that.
Chairman JOHNSON. Do you find in general that specialists
who use imaging in the line of their specialty work are well
trained in the use of imaging in their specialty?
Ms. FARNSWORTH. In their specialty. It is when they wander
out of that area because maybe sort of----
Chairman JOHNSON. So, what you are saying is we just need
to make sure that the coding pays you for specifically the work
that we think you are doing, and doesn't pay you for work in
other areas.
Ms. FARNSWORTH. Correct.
Dr. BORGSTEDE. But I think it is important to remember that
patients don't come in with saying that ``My problem is my
heart.'' Patients come in with a symptom, and they come in with
chest pain.
Chairman JOHNSON. I appreciate that. But there are some
specialties where it is well integrated, where this is
definable and excludable from the overall issue of the kind of
training that radiologists have had, and I would say OB,
orthopedics, oncology, are certainly three of those.
Dr. Williams?
Dr. WILLIAMS. Yes. I really just wanted to echo, if I could
use a cardiac term, what you are saying, Chairman Johnson. The
specialists have the criteria. They have the training, and they
are doing a good job, and it would be good if everyone had
written guidelines. I can't speak for the OBs or the
ophthalmologists who are now checking for cataract maturity
with ultrasound devices. I can't speak for them, but I think
first of all our principles are that you have to give the
people the time to develop, as we have.
And then our real reason for being here is the fact that a
lot of the literature that was going around with some of my
colleagues here was talking about things like the Manhattan
Project, which seemed to be exclusive of other specialties.
Now, at the table here we haven't heard any of that, so I am
very uplifted----
Chairman JOHNSON. What is the Manhattan Project?
Dr. BORGSTEDE. The Manhattan Project is an educational
project that is not restricted to any specialty and it is to
educate people in cardiac imaging.
Dr. WILLIAMS. Let me speak of that. That is good that he
says it that way.
Chairman JOHNSON. You mean it would educate people who are
not cardiologists to do cardiac imaging?
Dr. BORGSTEDE. It would educate radiologists, cardiologists
or any other individual who wanted to enroll in the program. It
is run by a number of academic institutions.
Chairman JOHNSON. Do we have similar programs that would
educate radiologists to read orthopedic films and----
Dr. BORGSTEDE. We have a residency program. We do that
during our residency. But the reason this program was started
is because cardiac imaging was becoming very sophisticated with
MR and CT, for example, much different than what had been done
in nuclear cardiology and echocardiography. The project was
initiated to look at educating individuals who want to learn
particularly those two imaging modalities and it is not
restricted to any specialty.
Chairman JOHNSON. Dr. Williams, do you think that a
radiologist doing that kind of work in cardiology is not as
good for the patient as the cardiologist being able to do that
for himself?
Dr. WILLIAMS. That is indeed what our experience is. I
applaud the American College of Radiology for coming up with
the educational aspect of the Manhattan Project, but a lot of
the hoopla that went along with it was talking about excluding
other people, and I am very glad to hear that they are moving
away from that. What we had heard is that the applicants to the
programs were 10 to 1 cardiologists, and that they were being
rejected unless they came with a radiologist.
Our data that we have looked at says that the people who
understand imaging in cardiology the best are the cardiologists
who train, and they spend 4 years doing this typically, as well
as their internal medicine training, and to compare that with a
five-day course which was being proposed by the Manhattan
Project really isn't a fair comparison. So, the performance of
cardiac tests is, yes, indeed much better at the level of a
cardiologist.
Dr. BORGSTEDE. I would like to come back to a comment that
I started earlier, and that is the fact that we have to
remember that patients come in with a symptom. They have chest
pain, and their chest pain may be cardiac in origin, it might
be a blood clot in their lung, it might be a musculoskeletal
problem, they might have a collapsed lung. And if all you have
trained in is looking at the heart, we are sort of back to the
Mark Twain analogy. You begin to look at that organ, but you
don't look at the rest, and I think that is what the
radiologists bring to the table, is that we can look at the
comprehensive exam.
Chairman JOHNSON. Okay. I think what you need to think
about is, and what I certainly will be thinking about is, how
do we look at the problems that we face from the perspective of
reforms to the payment system that are going to integrate
quality considerations with pay? If we integrate quality
considerations with pay, then you will attend to your training,
you will attend to your technicians' training. Having been the
lead sponsor on the mammogram bill, it did make a big
difference years ago that we set standards for the mammogram
machinery and equipment, and put in place a better oversight
capability of is that equipment being maintained.
But I will read your testimony in more detail to see how
many structures we already have in place, how much could they
be doing better than they are doing? But I think, I am very
concerned with putting in a whole group of new structures
because the system is structure heavy, and if there is anything
the Institute of Medicine Quality Chasm Report demonstrated is
that we know a lot more than we are able to deliver. So, I am
not sure putting more delivery oversight is really what we
need. I don't know what the answer is. But I do think more
accurate coding is an obvious part. Coding needs to change as
medicine modernizes itself. I am very pleased to hear that the
CPT system is working, and we will certainly see how that
works.
I need you to think through from what you know, both about
the tensions between various people who use imaging in their
work, and the ability of the specialty societies and of the
payers to look at quality and outcomes. What is it we would
require of you? Because what is going to happen really is the
specialty organizations are going to be involved in setting
quality standards, something this year, something next year,
and each year we are going to have to progress up a quality
ladder that is going to have multi components. Some will be do
you have the computer capability to get the information to us?
How much of it will be process? How much of it will be
outcomes, what the mix will be, what the staging will be?
Those are all things that you in the private sector can
have a voice in and must have a voice in if this is going to
work because this is a collaborative effort. I don't know how
many of you are familiar with what went on in the New Jersey
gain sharing example, but that was phenomenal. The only reason
it made a difference, the doctors earn more, the hospitals earn
more and Medicare was saved 2 percent.
Now, it all rested on an integrated relationship between
doctors and hospitals. It was deeply collaborative. What we
have built is a deeply uncollaborative system. In fact, it
punishes collaboration. In fact, that very promising demo
stopped because it abrogated Federal law in certain ways that
the courts decided that the Administration couldn't waive. In
other words, we have been thinking illness treatment for so
long; we have been thinking we pay you for incidents and
actions for so long, that we are going to have a hard time
rethinking. How do we think about the whole patient? How do we
think now about diagnosis and treatment capabilities that cross
the old lines?
So, think about the recommendations of MedPAC, but think
about how we can foster the level of collaborative action out
there on which quality is really going to depend in the long
run, rather than our setting a whole bunch of new standards,
some of which will be appropriate.
I am just having a lot of my lab technicians--I don't know
whether you have had this or not--but they are outraged. They
have been in the work a long time. There are lots of checks on
their work. And they are in hospitals, so by gum, if they start
doing it wrong, it comes out pretty quick out there in the
patient management arena. They are not only having to take this
test, but if they can't take it on exactly the day, they have
to go to Chicago. They have to pay $500 to take the test. Now,
for people doing lab tech work in our society, they are not
affluent, and 500 bucks to take this test when you are doing a
good job and all of the oversight instruments in place say you
are doing a good job, it is just sort of dumb. But we did it
and we did it on purpose. We thought we were improving the
system.
So, be careful what you ask for. Help us right now when we
are at a stage where we have to rethink how we pay physicians.
See this as an opportunity. So, take all the controversies that
are wrapped up in this imaging issue--and I was very glad that
MedPAC kept stressing that we do not know from volume whether
this is good or bad. You can't tell much about that. We don't
want to impede the integrated use of a plethora of technologies
because this is going to get worse, not better, because of the
complexity of the body and the extraordinary mechanisms now we
have developed to get at that complexity.
Think about it and then get back to us about what you would
like to see in terms of how much could be done through steps on
the quality ladder in the payment system, and what needs to be
done through the old mechanism of somebody setting new
standards and what standards are already in place that just
need to be enforced.
I thank you for your testimony and your discussion and your
preparation for this hearing. Thank you.
[Whereupon, at 12:47 p.m., the hearing was adjourned.]
[Submissions for the record follow:]
Statement of Kathy Pontzer, American Association of Orthopaedic
Surgeons
Chairman Johnson, Ranking Member Stark, and Members of the
Subcommittee, the American Association of Orthopaedic Surgeons,
representing 18,000 U.S. board-certified orthopaedic surgeons, thanks
you for the opportunity to comment. AAOS, along with the vast majority
of the physician community, have serious concerns with the Medicare
Payment Advisory Commission's (MedPAC) March 2005 Report to Congress on
imaging, which includes recommendations that, if implemented, would
directly impact an orthopaedic surgeon's ability to provide diagnostic
imaging services to his or her patients. Our comments focus
particularly on MedPAC's recommendations regarding the creation of
standards for physicians performing and reading images and for
increased restrictions on physician ownership. Additionally, we would
like to address some of the arguments surrounding imaging utilization
and discuss the important role imaging plays in the provision of
quality orthopaedic care.
MedPAC Recommendations
Standards
MedPAC recommends the creation and implementation of standards for
physicians who interpret images and provide imaging services under
Medicare.
This recommendation equates to credentialing, which has never been
done for physicians in the Medicare program and sets a dangerous
precedent that may have severe repercussions on Medicare beneficiaries'
access to imaging services. The AAOS has serious concerns about how CMS
would set the standards recommended by MedPAC as there is little to no
consensus among the physician community as to what standards for
training and experience are appropriate for each modality. It is
absolutely imperative that orthopaedic surgeons be involved in the
creation of any standards which orthopaedic surgeons will have to meet.
Once standards have been created, MedPAC recommends that ``private
organizations'' be used to verify and enforce the standards. However,
MedPAC's report is unclear about what this will entail. There is
justifiable apprehension among nonradiologist physicians that the
standard setting process will be used as a means to restrict the
provision of imaging services to only radiologists. To prevent this, it
is essential that CMS recognize multiple accreditation organizations.
Orthopaedic Training and Testing: AAOS takes exception to the
notion that the imaging services provided by nonradiologist physicians
are of inferior quality compared to radiologists. There is no evidence
in MedPAC's report to support this. In addition, AAOS strongly
disagrees with the argument that orthopaedic surgeons are not as
qualified as radiologists to provide imaging services to patients with
orthopaedic conditions. Because imaging is so integrated into the
provision of quality orthopaedic care, orthopaedic surgeons receive
extensive training in the reading and interpretation of radiological
images. During residency, orthopaedic residents are required to
interpret images, including x-rays, computed tomography (CT) scans and
magnetic resonance images (MRI), on almost every patient seen. In
addition, a majority of residency programs require orthopaedic
residents to perform a full radiology rotation. The nature of
orthopaedics, with the treatment of bones, joints and surrounding
structures, requires some type of imaging in nearly every case. Even in
the treatment of acute low back pain, where orthopaedic surgeons advise
that images are not necessary in the early stages of most cases, by the
time a patient has been referred to an orthopaedic surgeon, images most
likely have already been taken and the orthopaedic surgeon must
interpret them.
The American Board of Orthopaedic Surgery (ABOS), which administers
the orthopaedic surgery board examination, requires lengthy training in
performing and interpreting diagnostic imaging studies. As a result,
the orthopaedic surgery board examination, which is in two parts,
contains extensive testing on the reading and performance of imaging
services. Part One is written and is taken immediately after finishing
residency. Fifty percent of the questions require the interpretation of
images. Part Two is oral and is taken after an orthopaedic surgeon has
practiced in the same location for two years following residency. In
Part Two, the candidate brings ten cases from his or her practice,
including images, to be discussed in detail. As a result, one hundred-
percent of cases comprising Part Two of the examination involve the
interpretation of images.
Physician Ownership
MedPAC recommends that nuclear medicine and PET procedures be added to
the list of designated health services. In addition, MedPAC recommends
expansion of the Stark law to prohibit financial relationships between
physicians and entities that provide imaging services.
AAOS would adamantly oppose any effort to eliminate the in-office
ancillary exception in the Stark law, which allows patients the option
of receiving imaging services in the convenience of their physicians'
offices. Advancements in medical imaging technology greatly benefit the
quality of care available to patients, and efforts to restrict in-
office imaging would negate the results of decades of technological
improvements and application of best practices. Added convenience and
high quality care are, however, not the only positive results of in-
office imaging--patients are also able to receive care in a time-
sensitive, efficient, and cost-effective manner, which benefits
patients, physicians, and payers.
Utilization
AAOS objects to the contention that the increased use of imaging
services is wholly inappropriate and, therefore, action needs to be
taken to restrict the provision of such services. Advances in
technology, the shift in site of service from hospitals to the in-
office setting, and higher standards of patient care have all
contributed to the increased use of imaging, though few, if any, would
argue that these are negative changes in the direction of health care.
The purpose of MedPAC's report was initially to examine increases
in utilization and determine whether the growth is appropriate. In its
final report, MedPAC recommends credentialing as a way to control
volume. However, AAOS believes that credentialing does nothing to
address volume control and could be used to severely restrict who is
able to provide imaging services instead of ensuring quality.
In its report, MedPAC refers to inappropriate utilization of
imaging services, but no evidence is cited to support this allegation.
While there is likely some degree of inappropriate usage, just as there
is with all health services, it is important to note that the vast
majority of imaging services, including MRIs and CT scans, are
performed and read by radiologists, even on patients that present with
orthopaedic conditions. For example, in 2003, there were a total of
34,557 CT scans of upper extremities billed under Medicare--32,228
(93.3%) were performed by radiologists; nonradiologists billed for only
2,329 (6.7%) scans. During the same year, there were 553,352 MRIs on
lower extremities billed under Medicare--radiologists performed 464,150
(83.9%) of these MRIs. Since radiologists clearly control most of the
imaging done in the United States, if there is indeed concern about
inappropriate utilization, it makes sense to also examine the
utilization practices of radiologists.
It is true that there has been an increase in the usage of imaging
services, such as MRIs. However, AAOS takes exception to the argument
that increased usage is linked to greed on the part of physicians
trying to make up for decreasing reimbursements. For orthopaedic
surgeons, the increased usage of MRI is due in large part to the fact
that orthopaedic surgeons are becoming increasingly aware of the
benefit of MRI in the diagnosis of various orthopaedic conditions, in
particular with the foot and hand. Only a short time ago, it was rare
to obtain MRIs on the extremities, but now it is much more routine as
orthopaedic surgeons have learned how to use that information to help
with the diagnosis. Clearly this is a positive medical advancement for
patients. For instance, x-rays demonstrate changes in bone, but do not
show ligaments meaning that, in the past, there were many ligamentious
injuries in and about the wrist that were unable to be properly
diagnosed. MRIs are much more accurate at showing ligaments; therefore,
orthopaedic surgeons can prevent things such as scapholunate
disassociation, which previously was not diagnosed until there was
instability and required a rather sizable operation on the wrist. With
a MRI, orthopaedic surgeons can diagnose this accurately and perform a
less invasive procedure preventing degeneration in the wrist.
Quality Orthopaedic Care
Diagnostic imaging services are an integral component of quality
orthopaedic care. When a patient is able to receive imaging services in
an orthopaedic surgeon's office, important judgments about the course
of care can be made without delay. Forcing patients to leave an
orthopaedic surgeon's office in order to receive a diagnostic imaging
service can cause additional harm and injury to a patient, especially
with elderly patients. It is untenable for an orthopaedic surgeon to
remove a cast and then send a patient across town to obtain an x-ray in
order to decide if the cast needs to be replaced. In addition to being
inconvenient to a patient, it is dangerous. The patient must make two
appointments at the orthopaedic surgeon's office--the initial
appointment and then the followup after the imaging service is
performed. In addition, since the extremity would be unsupported during
transfer, or at least during x-ray, it is dangerous if the fracture is
not completely healed.
Most orthopaedic surgeons have some type of imaging equipment in
their offices, which provides patients with the convenience of
receiving a full range of care in one location. Excluding those who
rent office space from a hospital or those employed by a university or
hospital, almost all orthopaedic surgeons own x-ray machines, and
approximately 25-percent own MRI machines.
It is critical that the Subcommittee understand that an orthopaedic
surgeon never makes a surgical decision, such as whether surgery is
necessary or what type of procedure is appropriate, strictly from a
radiologist's report. An orthopaedic surgeon never makes a diagnosis
strictly on an x-ray, a MRI, or a piece of lab work. It must be
correlated with history and physical findings. An orthopaedic surgeon's
read of a patient's images is a crucial part of the evaluation and
treatment process. The orthopaedic surgeon is able to add functional,
anatomical and clinical assessments--resulting in patient-specific
information--to the interpretation of an image. For example, with a
fracture of a distal radius, which is the most common fracture in
adults, it cannot be ascertained from a radiologist report whether the
fracture needs an operative approach versus a closed approach, and what
type of operation must be done. It must depend on the orthopaedic
surgeon's interpretation of the actual image. In addition, unlike
radiologists, orthopaedic surgeons have the advantage of examining
patients and being intimately familiar with the specifics of a
patient's case, outside of just what is seen in a diagnostic image. For
example, the orthopaedic surgeon who has performed knee replacement
surgery on a patient is the most qualified to interpret the results of
a followup imaging study.
The fact that the orthopaedic surgeon plays a vital role in the
interpretation of images is supported by a recent study done at the St.
Louis Children's Hospital and the Shriners Hospital for Children in St.
Louis, Missouri (Scott J. Luhmann, Mario Schootman, J. Eric Gordon, and
Rick W. Wright, ``Magnetic Resonance Imaging of the Knee in Children
and Adolescents. Its Role in Clinical Decision-Making.'' Journal of
Bone and Joint Surgery. Am., Mar. 2005; 87:497-502). The study examined
ninety-six pediatric patients with abnormal knees who underwent
arthroscopy all performed by the same orthopaedic surgeon. The
radiologist's report and the orthopaedic surgeon's preoperative
diagnosis for each patient were compared with the actual post-surgical
findings to determine the level of initial accuracy in the diagnosis.
The results of the study are telling: ``The preoperative diagnoses
by the surgeon (physical examination and review of x-rays and MRIs)
were significantly better than the formal interpretation of the
magnetic resonance imaging scans by the radiologist . . . the formal
interpretation of the magnetic resonance imaging scan by the
radiologist commonly has inaccuracies and may not correlate with the
initial clinical diagnoses.'' For example, patients with discoid
lateral meniscus were correctly diagnosed by the radiologist 46-percent
of the time, versus 100-percent for the orthopaedic surgeon.
Orthopaedic surgeons correctly diagnosed an anterior cruciate ligament
tear 100-percent of the time, versus 78-percent for radiologists. The
radiologist correctly diagnosed an osteochondral fracture only 65-
percent of the time, versus orthopaedic surgeons who were correct in
90-percent of these cases.
The authors conclude that ``by combining the history and the
findings on physical examination, plain radiographs, and magnetic
resonance imaging scans, we were able to achieve the highest overall
diagnostic accuracy yet reported.'' The study validates AAOS' belief
that orthopaedic surgeons are able to provide patients with a more
accurate and thorough diagnosis of orthopaedic conditions versus a
radiologist's report alone because the orthopaedic surgeon is more
intimately involved in the care of the patient.
Conclusion
The AAOS is committed to promoting quality orthopaedic care, and we
hope that this information provides the Subcommittee with a look at the
vital role diagnostic imaging plays in the practice of orthopaedics.
Orthopaedic surgeons receive extensive training and testing in imaging
services and are well-qualified to provide such services. In addition,
a review of a patient's diagnostic image, whether the surgeon provided
the service or not, is critical to an orthopaedic surgeon's
decisionmaking on the proper course of treatment. Finally, AAOS wishes
to emphasize the importance of physician involvement from all
specialties in the setting of standards for physicians performing and
interpreting images.
Advances in medical technology have benefited patients through the
ability to deliver better care. One of the greatest advances has been
in the field of medical imaging. Orthopaedic surgeons rely on medical
imaging every day as they strive to provide the highest level of
orthopaedic care to their patients. We urge Congress to move cautiously
and deliberately through this debate, examining all of the facts and
weighing all decisions against how patients will be affected if undue
restrictions are put on the provision of imaging services.
Again, thank you for the opportunity to provide comment.
Statement of Vivian M. Dickerson, M.D., American College of
Obstetricians and Gynecologists
On behalf of 46,000 physicians dedicated to women's health, the
American College of Obstetricians and Gynecologists (ACOG) is pleased
to have an opportunity to submit testimony on this important issue.
ACOG is concerned with MedPAC's recent recommendations and any
similar federal legislation that may be introduced to restrict
physicians' ability to perform needed imaging services to patients. We
firmly believe, and data support, that ob-gyn imaging use is clinically
appropriate, high-quality and done in the best interest of patients. We
urge the Congress to recognize the value and quality of imaging by
obstetrician-gynecologists.
Radiologists actually perform the vast majority of Medicare imaging
procedures. In fact, radiologists perform more than two-thirds of the
two ob-gyn related ultrasounds that make up 83% of Medicare ob-gyn
imaging.
Ob-gyns, on the other hand, perform a small but critical portion of
in-office imaging for Medicare recipients. These include obstetric
ultrasonography for pregnant women with disabilities--many of whom have
higher rates of pregnancy complications than the average privately
insured pregnant patient--and gynecologic ultrasonography.
Patients need access to timely imaging in ob-gyn offices and labor
and delivery rooms. Waiting for a radiologist to arrive, or sending a
pregnant patient to another office for ultrasound, can delay urgent
care. Many exams need to be performed immediately, such as when a woman
experiences unexplained bleeding, pelvic pain, or discovery of a mass.
Many emergencies, like ectopic pregnancies or complications during
active labor, can be life-threatening and require immediate imaging so
the patient, and her baby, can be cared for quickly. Ob-gyns are most
often the appropriate physician to provide these services. Radiologists
often are not on call throughout the night and on weekends when many
emergencies occur. It is critical that ob-gyn patients have access to
diagnosis and treatment when they need it.
The June 2004 Commission report discusses the use of private sector
purchasing strategies to contain imaging service growth. Ob-gyn imaging
utilization is given high marks by private insurers for
appropriateness. In particular, a study by Highmark Blue Cross Blue
Shield and National Imaging Associates, a radiology benefit management
firm, found that ob-gyns rate the best among specialists in appropriate
utilization. In addition, the much-cited Maryland law--which creates
one of the country's most restrictive state limits on self-referral--
exempts ultrasound from these limits because legislators did not detect
any abuse of these self-referral privileges.
Ob-gyns are trained, experienced and qualified to perform and
interpret diagnostic imaging procedures, and failure rates in ob-gyn
imaging are very low. Diagnostic ultrasonography is part of ob-gyn
residencies and a part of the certifying examinations of the American
Board of Obstetrics and Gynecology. Procedures performed by ob-gyns
include sonography to assist in the diagnosis of certain pregnancy
complications, gynecological cancers, or sources of pelvic pain or
postmenopausal bleeding. Maternal-fetal medicine specialists, who work
with high-risk pregnant women, also are trained in use of fetal
echocardiography to investigate fetal heart problems. Patients
requiring advanced imaging procedures--such as magnetic resonance
imaging (MRI), computed tomography (CT), and positron emission
tomography (PET)--are generally referred to radiologists.
Ob-gyns are the most appropriate specialists to provide these
services. Ob-gyn residents are trained in, and use obstetric and
gynecologic ultrasound throughout their four-year residency, while
radiology residents often have fewer than 4 weeks of obstetric
sonography training per year. An October 2001 study in the American
Journal of Radiology found that ``current levels of experience in
obstetric sonography may not be providing sufficient experience to
allow [radiology] residents to appropriately manage call cases.'' \1\
---------------------------------------------------------------------------
\1\ Claudia J. Kasales, et al. Training in Obstetric Sonography for
Radiology Residents and Fellows in the United States. American Journal
of Roentgenology 2001 Oct.; 177:763-767.
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The growth of Medicare ob-gyn imaging is controlled and consistent
with advances in medical technology. Part of this increase reflects a
shift in the site of service from hospitals to physician offices, which
helps hold down Medicare costs and is better for patients. With
advances in ultrasound equipment, patients can now have procedures done
in an ob-gyn's office that used to require a hospital MRI or CT. And
diagnostic imaging has led to a drastic shift from invasive to non-
invasive procedures and has virtually eliminated the need for
exploratory surgery for some conditions. For instance, in-office
ultrasound can now rule out masses that previously required invasive
procedures in patients with abnormal uterine bleeding.
Thank you for considering our views.
Statement of American Society for Therapeutic Radiology and Oncology
(ASTRO), Fairfax, VA
On behalf of the American Society of Therapeutic Radiology and
Oncology, we appreciate this opportunity to submit written testimony to
the House Ways and Means Subcommittee on Health on managing the use of
medical imaging services.
ASTRO is the largest radiation oncology society in the world, with
more than 8,000 members who specialize in treating patients with
radiation therapies. As a leading organization in radiation oncology,
biology and physics, the Society is dedicated to the advancement of the
practice of radiation oncology by promoting excellence in patient care,
providing opportunities for educational and professional development,
promoting research and disseminating research results and representing
radiation oncology in a rapidly evolving socioeconomic healthcare
environment.
Cancer is the leading cause of death in the United States and the
number one health concern for Americans. One in three people will
develop cancer in their lifetime. This year, more than 1.3 million
Americans will be diagnosed with cancer and more than 560,000 will die
of this disease. Nearly two-thirds of all cancer patients will receive
radiation therapy during their illness. In light of these realities,
curing patients of cancer requires a constant commitment to progress at
many levels in the healthcare system. To ensure excellence in patient
treatment and improved outcomes, we must invest in the latest
technology available. The practice of radiation oncology depends
heavily upon these state-of-the-art technologies as we seek to offer
our patients an improved opportunity for cure or more durable
palliation. Medical imaging and radiotherapy are inextricably linked
with an eye clearly on the future.
Radiation oncologists are an integral part of the multidisciplinary
management of the cancer patient, collaborating closely with physicians
in related disciplines in the overall management of patient care. The
practice of radiation oncology is an ever growing and evolving area of
medicine. Every day, researchers and physicians are looking for new and
innovative ways to treat cancer and benign diseases with radiation. As
the practice continues to advance technologically, the use of medical
imaging devices has become an integral component of the overall
treatment plan.
Insofar as radiation oncology is deeply rooted in the evolution of
the overall field of radiology, medical imaging is an indispensable and
fundamental element in the practice of radiation oncology and is given
focused attention during the residency program. Therefore, we believe
that radiation oncologists are adequately qualified to perform medical
imaging procedures as a component of the cancer treatment plan.
Over the past decade, improvements in medical imaging modalities,
such as CT, ultrasound, MRI and PET, have been incorporated into the
practice of radiation oncology. This has led to the development of a
new treatment paradigm called ``image-guided radiotherapy'' or IGRT.
IGRT is radiotherapy that uses cross-sectional images of the patient's
internal anatomy to better target the radiation dose in the tumor while
reducing the radiation exposure to healthy organs. Image guidance leads
to improved control of the tumor while simultaneously reducing the
potential for acute side effects due to irradiation of healthy tissue
surrounding the tumor. Further, studies show that by combining an X-ray
volume imaging system and radiotherapy equipment to provide ``real
time'' images of the tumor during treatment, the accuracy of the
radiation can be significantly improved.
Another new technology on the horizon in the area of image-guided
guided radiotherapy is four-dimensional (time varying) computed
tomography (4-CT). This new technology may even surpass the use of
three-dimensional imaging that is currently being used to treat lung
cancer. This new form of treatment will enable the radiation oncologist
to take into account the phases of inhalation and exhalation to
minimize damage to healthy lung tissue. One of the major challenges in
treating lung tumors with radiation is precisely targeting a moving
tumor while simultaneously decreasing the amount of healthy tissue that
may be exposed. This technology is promising because it may improve the
ability to develop more precise treatment plans for the delivery of
radiation therapy to lung cancer patients.
The most important and relevant aspect of the use of medical
imaging in radiation oncology is the benefit that it lends to millions
of patients around the world. A number of reports have attributed the
rising costs in healthcare to the proliferation of medical imaging.
Clearly, imaging should be done by well trained physicians. Obviously,
ASTRO would be concerned if steps taken to reduce availability of
imaging would impair radiation oncologists' use of imaging as they
treat cancer patients.
In the case of radiation oncology, a patient is usually treated
over a series of weeks. The use of image-guided radiotherapy permits
the radiation oncologist to precisely target the treatment to a
localized area, minimizing the number of visits a patient may require
for treatment of their cancer. In many cases, that means avoiding
unneeded surgery or hospitalization. The use of imaging technology
saves money by reducing or eliminating nonessential or inappropriate
treatment. For example, PET scans can eliminate as much as half the
futile surgeries for lung cancer patients.
Medical imaging is an essential tool in the practice of radiation
oncology. Patient safety and quality of care would be severely
compromised without imaging technology in our specialty. Researchers
stand on the brink of life-saving discoveries in the area of image-
guided radiotherapy treatments. The use of medical imaging in the
modern radiation therapy treatment plan is revealing exciting
possibilities with the potential to revolutionize the way we treat
cancer.
Therefore, we respectfully request, that as the Subcommittee
explores options for managing the use of diagnostic imaging, the vital
and integral role that therapeutic imaging plays in the practice of
radiation oncology is recognized and ensures that the radiation
oncologist's ability to use all appropriate medical imaging modalities
be protected now and in the future.
Omaha, Nebraska 68131
March 22, 2005
To Whom It May Concern:
I have worked in healthcare for over 20 years; I have been
associated with Radiology all of those 20 years. I have worked in
Nebraska, Ohio, Wisconsin and Indiana as the Director of Radiology in
each of these locations. I have always worked in a hospital setting,
most were not-for-profit but my current employer is a for-profit
entity. I have thoroughly enjoyed all of my time spent in healthcare
but recent trends have me concerned about the future of healthcare,
Medicare and the economy as a whole.
When I first began working as a radiological technologist there
were very few independent Imaging Centers and the Radiologists worked
for the hospital. Over the years the Radiologists became private
contractors and Imaging Centers began to appear; Radiologists' groups
owned most of these independent Imaging Centers. Since Radiologists
cannot order tests this did not appear to be too much of a problem but
the Radiologists could influence where referrers sent their patients.
The inequality that began many years ago has bloomed into true
favoritism for outpatient (OP) Imaging Centers. Radiologists and any
number of other physicians now cooperatively own many OP Imaging
Centers. They are permitted to self refer and are even rewarded,
monetarily, for doing so. The reimbursement at OP Imaging Centers can
be much higher and many of the limitations that apply in the hospital
setting are not relevant in the OP setting. Global billing allowances
gives OP centers certain advantages and no penalties exist to ordering
physicians who refer their patients to an Imaging Center that they are
part owner of. Nor is there any means of communicating their ownership
of this entity to their patients, they refer them to the Imaging Center
saying that the patient will receive better and more timely care. Many
tests are ordered that would not be `medically necessary' if the
physician had to send them for this test where the ordering physician
did not receive a portion of the profits.
In many cities, such as Green Bay, Wisconsin and Marion, Indiana to
name just a couple, competition from privately owned Imaging Centers
has driven up the cost of healthcare. It has also created a hardship on
the hospitals that have been in existence for many years that have
routinely provide charity care. `Cherry picking' is practiced in many
places; the practice of sending self-pay or charity care patients to
the hospital for their imaging tests while insured patients are
referred to these privately owned OP centers.
With the advantages given by Medicare and other governmental
programs, it pays for physicians to open these OP Imaging Centers and
refer to them almost exclusively. These centers are not inspected by
governmental bodies as frequently, if ever, as hospitals are. The
stringent documentation regulations, indications for examinations and
medical necessity guidelines, are not imposed on them as strictly as
for hospital radiology departments. Does a pregnant woman really need
an OB ultrasound every other month? Does a patient need a MRI of the
spine before they even have plain films taken? What is the incidence of
diagnostic mammograms needed at an OP center versus a hospital setting?
Why would a woman have wire localization on her breast at an OP Imaging
Center and then drive a couple of miles down the road to a surgery
center for her biopsy? How does a physician talk this woman into this
when she knows that she can have this same procedure done in the same
building as her surgery without having to get into a vehicle and drive
with a needle in her breast? He owns a portion of the Imaging Center!
Most people still abide by the direction of their physician and since
they do not have to disclose their ownership in this other entity the
patient assumes that their physician is looking out for their best
interest and not his/her own.
With the advent of the MQSA regulations many OP Mammography Centers
closed because the quality of their work was substandard and bringing
these services up to par would have been too expensive. Since patient
safety should be our highest priority the amount of radiation received
should be a great concern. Trained technologists and board certified
Radiologists provide a level of care second to none where quality
examinations and radiation safety is concerned. The MQSA centered on
mammography but the radiation received from a mammogram is much less
than that received during a CT scan. Even though OP Imaging Centers
owned by surgeons, family practice and orthopedic physicians, continue
to perform many unnecessary tests because they can get reimbursed for
these tests. There have been many studies done over the past 10 years
that point out the over usage of testing when imaging is owned by
referring physicians. The Stark laws have never touched the imaging
section of healthcare. Imaging is a very lucrative business and
therefore has attracted many people who have quality as a side note
instead of their focus. Although imaging is not the only area where
abuses are seen it is the one area I am familiar with. I am hoping that
by passing legislation of this kind that maybe some type of Medicare
system might still be around when my children are old and in need; if
no legal action is taken healthcare will continue to be more and more
costly to all.
Marilyn K. Buchholz
Statement of Society of Stephan Achenbach, Cardiovascular Computed
Tomography, Damascus, Maryland
The Society of Cardiovascular Computed Tomography (SCCT) is a
professional society that was formed earlier this year by the leading
authorities in the field of non-invasive cardiology to promote research
and to advance the appropriate use of CT in the diagnosis of
cardiovascular disease. SCCT serves as an independent organization
committed solely to the further development of cardiovascular CT
through education, training, accreditation, advocacy, quality control,
and research. SCCT is delighted to have this opportunity to submit
testimony in conjunction with the Ways and Means Health Subcommittee's
hearing on medical imaging.
SCCT is deeply committed to incorporating cardiac CT into the
diagnostic workup of patients with known or suspected cardiovascular
diseases in a way that results in the provision of the highest possible
quality of care. We believe that CT technology has the potential to
significantly improve the safety and quality of cardiovascular care by
substantially reducing the need for more invasive diagnostic cardiac
catheterization and by substituting for potentially more costly and
sometimes less accurate diagnostic tests. Among SCCT's objectives are
the establishment of comprehensive practice and training guidelines for
cardiovascular CT.
SCCT has reviewed the MedPAC recommendations regarding diagnostic
imaging that were the subject of the hearing held by the House Ways and
Means Committee Health Subcommittee's hearing of March 17, which are
set forth in detail below.
I. Background
Due to technological developments that have increased the speed of
CT scanning, now for the first time, CT scanners can consistently image
lesions of the native coronary arteries. The new CT scanners have the
technological capability to rule out coronary artery disease in
patients complaining of chest pain, thus frequently eliminating the
need for more invasive diagnostic cardiac catheterizations.
Moreover, CT coronary artery examinations are not just single two-
dimensional images. They consist of hundreds of slices that can be
manipulated on a workstation in a number of ways to produce two or
three-dimensional reconstructions, as necessary for the diagnosis of a
particular patient.
In addition to evaluating the presence or absence of coronary
artery disease in patients with chest pain, cardiac CT may have useful
clinical application in a number of other areas:
Evaluating patients with equivocal results from stress
tests.
Assessment of suspected patients with congenital coronary
anomalies of coronary circulation or great vessels.
Evaluating ventricular function. CT can image the heart
in both the systolic and diastolic phases and can accurately measure
ventricular volumes or ejection fractions.
Assessment of cardiac chamber anatomy and pathology,
especially the left atrium and the pulmonary veins before and after
radiofrequency ablation of atrial fibrillation. Cardiac CT may
facilitate the planning and followup of patients undergoing
radiofrequency ablation. Post-ablation pulmonary vein thrombosis and
stenosis are two rare but serious complications associated with
radiofrequency ablation.
Presurgical evaluations of the heart (especially with
patients who have had coronary artery bypass graft surgery and need
followup).
Followup of patients after coronary artery bypass graft
surgery to assess the patency and function of bypass grafts.
CT has the ability to image the heart as part of a larger
chest scan, so the coronary CTA also may be used as a generalized chest
scan in which aortic aneurysm and dissection, tumors, pulmonary
embolisms, and other anomalies may be identified.
SCCT is committed to exploring these and other potential
applications of this enormously powerful diagnostic tool offered by
today's CT technology.
CT, as a diagnostic imaging modality, is already highly regulated
by both federal and state authorities, since the technology uses
ionizing radiation and nephrotoxic contrast agent. In fact, the FDA,
the OSHA, and state regulatory authorities all have jurisdiction over
the safety of CT equipment and services.
II. Diagnostic Imaging Quality
In reviewing MedPAC's recommendations on diagnostic imaging, we are
particularly concerned about the implication that the performance of
diagnostic imaging services outside the hospital setting somehow
impugns the quality of the services and thus should require more
stringent federal regulatory oversight.
In this regard, we note that the studies that MedPAC cited in
support of the proposition that additional federal regulation is
required to assure the quality of non-hospital based services are quite
meager. Specifically, MedPAC makes two recommendations with respect to
quality standards. First, MedPAC recommends the establishment of
federal standards for MRI, CT and PET facilities, including the
establishment of standards in the areas of diagnostic imaging
equipment, proper credentialing of non-physician personnel, and image
quality. There are only two studies, to our knowledge, that focus on
the quality of diagnostic imaging facilities. Both studies were
conducted by private payers and involved on-site surveys of diagnostic
imaging facilities. Neither survey indicated any significant quality
concern with facilities operated by cardiologists; in fact, the track
record of cardiologists in one survey was superior to that of
radiologists.\1\ The quality issues that did arise focused primarily on
facilities operated by podiatrists and chiropractors, who have limited
billing rights for diagnostic imaging services under Medicare.
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\1\ Interestingly, cardiologists' excellent quality record is not
set forth in the data table included in the study, which is an
unpublished study authored by a radiologist. The data was obtained
informally from the study sponsor.
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Second, MedPAC recommends the establishment of federal standards
for physicians who interpret MRI, CT, and PET studies. The only studies
cited by MedPAC justifying the need for quality standards with respect
to interpreting physicians focus on vascular ultrasound and x-rays, and
not on CT (or CTA), MRI, or PET services. We are not aware of any
studies establishing that physician interpretations of MRI, CT/CTA, PET
studies overall are substandard.
While neither of these two recommendations pertaining to quality is
well-supported by the current medical literature, these two
recommendations are otherwise quite distinguishable and should be
considered separately. While many types of service providers (including
hospitals, home health agencies, nursing facilities, ambulatory
surgical centers, and others) are subject to facility standards (in
many cases enforced by accreditation organizations such as the JCAHO),
the Medicare program historically has been reluctant to establish
professional standards for individual physicians, with a few notable
exceptions, such as mammography.
A. Facility Standards
While the need for federal facility standards has not been
demonstrated by objective data, SCCT does not object to legislation
that would direct the Secretary to develop such standards so long as
any such standards are developed with the input of all affected
specialty groups and are implemented in a manner that does not
effectively limit approval to radiologists or any other particular
specialty group. We also believe that any such legislation should
include at least 2 years for facilities to come into compliance.
However, we are troubled by MedPAC's suggestion that such standards
should be implemented exclusively through national accreditation
organizations. Today, a facility that is subject to Medicare conditions
of participation (under Part A) or conditions of coverage (under Part
B) may do so either by being surveyed by a state health agency (which
conducts the survey under contract with CMS) or by becoming accredited
by an accreditation organization that has been approved by CMS (i.e.
that have obtained ``deemed status''), in which case the facility is
deemed to be in compliance with the Medicare conditions. MedPAC appears
to be recommending that any new standards for CT, MRI, and PET
facilities be implemented exclusively through accreditation
organizations that have obtained ``deemed status.''
In the case of CT, however, the only nationally recognized
accreditation organization at this time is operated by the American
College of Radiology, which has an acknowledged interest in ensuring
that cardiac CT remains in the hands of radiologists. While SCCT hopes
to work with the Intersociety Accreditation Commission to establish an
accreditation organization for CT that is not governed by a single
medical specialty group, this accreditation program is not yet
operational.
Recommendation: IF Congress decides to require the establishment of
facility standards despite the lack of data, it should provide a route
for facilities to be approved other than through an ACR-sponsored
accreditation program. It should also require the standards to be
developed with input from all affected medical specialties and should
provide a reasonable transition period (of at least 4 years) to enable
existing facilities to qualify.
B. Standards for Interpreting Physicians
While we are not completely convinced that federal facility
standards for CT/CTA are necessary, we understand the perceived need
for such standards. However, we believe that federal standards for
interpreting physicians would be far more troublesome. Federal
physician credentialing--especially in an area that is constantly
changing, such as diagnostic imaging--has the potential to exclude
highly qualified physicians from performing diagnostic-imaging services
that are integral to the care of their patients, and to thereby
adversely affect access to high quality care.
Without a doubt, special training is necessary to properly perform
and interpret these tests. However, since cardiac CTA is an emerging
technology, there is simply no consensus regarding the training,
experience, and other requirements that are necessary to interpret
these studies, and there is no established body of literature that even
attempts to answer this question.
What is clear is that standards in this complex and evolving area
cannot and should not be based solely on a physician's specialty, which
is the basis that historically has been used by those private third
party payers that have implemented physician credentialing programs.
Optimal interpretation of coronary CTA will always take into account
detailed knowledge of the patient's condition, history, and the
possible treatment options. Cardiologists are more familiar with
clinical indications and contraindications--as well as diagnostic and
therapeutic options and alternatives to such procedures--than
radiologists. It would be poor medical care to exclude cardiologists--
particularly for those cardiologists who are well-trained and properly
credentialed--from performing and interpreting coronary CTA. And, in
light of the current acute shortage of radiologists, it is unclear
whether there would be enough radiologists willing to undergo the
necessary education and training to become proficient in coronary CTA.
MedPAC appears to agree that specialty-based credentialing would be
inappropriate. How, then, could a CMS official determine the
appropriate training, experience, and other requirements for physicians
interpreting cardiac CTA, when the professional societies themselves
have not done so and approval based on specialty designation, as such,
is inappropriate?
Recommendation: SCCT recommends that Congress reject MedPAC's
recommendation to establish federal standards for interpreting
physicians. We respectfully submit that determinations of this nature
do not naturally fall within the expertise of CMS and are not properly
the role of the federal government. This is especially the case when
cost savings to the Medicare program are unlikely, implementation costs
could be substantial, and the agency is already struggling to meet the
demanding deadlines of the Medicare Modernization Act.
III. Utilization and Physician Ownership
The MedPAC report on diagnostic imaging notes that diagnostic-
imaging services on the whole appear to be growing at a significantly
faster rate than all services reimbursed under the Physician Fee
Schedule from the period from 1999 to 2002, and that CT services are
among those diagnostic imaging services that are growing the fastest.
While SCCT firmly believes that CT ultimately will become a
powerful and cost-efficient tool in the diagnosis of cardiovascular
disease, at this stage, Medicare coverage of cardiac CT is somewhat
limited, and is determined on a locality by locality basis by the
Medicare carriers. Currently, according to the American College of
Radiology, only approximately 9% of the claims for all CT services are
submitted by nonradiologists. It seems clear from these statistics
alone that the rapid growth in CT/CTA over the past 5 years has not
been fueled primarily by physician ownership of CT facilities but by
the clinical utility of CT technology.
The benefits of in-office diagnostic imaging cannot be disputed. In
the field of cardiology, two diagnostic imaging technologies are
frequently performed in the office setting--cardiac ultrasound and
nuclear cardiology. Both have become invaluable tools in the timely
diagnosis of heart disease and have contributed substantially to the
significant reduction in mortality and morbidity of heart disease over
the past several years. We would hope and anticipate that cardiac CT
will follow a similar path.
In light of the advantages of in-office diagnostic testing in the
field of cardiology, we are quite concerned about the underlying
assumption that in-office testing is the primary cause of the increase
in diagnostic imaging utilization over the past several years. In fact,
Medicare spending for the services of independent diagnostic testing
facilities (IDTFs)--which are already precluded by federal self-
referral laws from having financial relationships with referring
physicians except under specific narrowly defined circumstances--nearly
doubled between 2000 and 2002, from $385 million to $741 million, while
Medicare spending for all imaging services paid under the physician fee
schedule grew at half that rate during the same period. This data,
along with data indicating that the growth in diagnostic imaging in
hospital settings has likewise increased, strongly suggests that it is
the clinical utility of diagnostic imaging rather than physicians'
financial incentive to perform in-office testing, that has been the
primary fuel driving the utilization increases noted by MedPAC.
Furthermore, there is a national shortage of radiologists in the U.S.,
and by limiting specialists, like cardiologists, from performing
imaging examination on the organ that is of main interest to the
specialty is counterproductive to the general movement to provide
quality overall healthcare to the population at large.
Significantly, too, one of the most significant private sector
experiments in limiting ``physician self-referral'' of diagnostic
imaging services ended in abject failure. In January 1993, the United
Mineworkers of America Health and Retirement Funds (the Funds)
implemented a policy to limit the incentives for self-referral for
imaging services among nonradiologist physicians. While still paying
physicians the standard fee for taking the images, the new policy
eliminated payments to self-referring, nonradiologists for reading the
images, effectively reducing payments to these nonradiologists by about
30%. The Funds assumed that its costs would be reduced without reducing
the quality of care for its beneficiaries.
Teams of researchers from the University of Virginia and the New
England Medical Center, under subcontract with the Funds, assessed
whether this policy reduced the Funds' costs and utilization without
also reducing quality of care and patient satisfaction. Fifty-seven
physicians serving Funds' and non-Funds' patients and 1,433 patients
participated in the two parallel studies. The first study found no
consistent impact on utilization or costs, and the second study found
that there were no apparent differences in outcomes or satisfaction
when Funds' and non-Funds' patients and self- and radiologist-referring
physicians were compared.\2\
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\2\ University of Virginia researchers also did a retrospective
economic evaluation of claims and expenditures for diagnostic imaging
studies filed by physicians practicing in the 20 U.S. counties that had
the greatest number of Funds' beneficiaries, both in 1992, and in 1993
after the new policy went into effect. It found that the high-
concentration areas experienced a significant increase in utilization
after the reimbursement change. These results were published in the
Journal of the American Medical Association (9/20/95). While offering a
number of hypotheses, the authors of this additional study admit that
their ``data do not permit investigation of why this occurred.''
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IV. Conclusion
SCCT is ready and willing to work with Congress in studying the
appropriate and inappropriate uses of cardiac CT over the coming years.
However, we caution that measures aimed at regulating nonradiologist
involvement in cardiac imaging may have a myriad of unintended
consequences, and are unlikely to resolve the complex underlying
clinical issues involved in distinguishing between necessary and
unnecessary utilization increases. We would hope that issues of quality
and issues of utilization will each be evaluated on their own merits
and on the basis of objective and published peer-reviewed data, and
that additional regulation will be imposed only when and to the extent
necessary to protect Medicare beneficiaries and the financial integrity
of the Medicare program.
Thank you for your time and consideration of our views. If you have
any questions regarding this testimony, please do not hesitate to
contact SCCT through Bill Nelligan, the Society's Executive Director,
at 301-253-5208.
Sincerely yours,
Stephan Achenbach, MD
President
Columbia, Maryland 21045
March 24, 2005
Rep. Nancy Johnson
House Ways and Means Health Subcommittee
Washington, DC
Dear Representative Johnson:
The Coalition for Quality in Ultrasound (``CQU'') is pleased to
hear of your interest and shares the Subcommittee's objective in
appropriately controlling the increasing utilization of diagnostic
medical ultrasound imaging procedures and improving the quality of
those services. CQU also supports those recommendations from the
Medicare Payment Advisory Committee (MedPAC) suggesting that the
Medicare program should adopt quality standards for imaging procedures.
We write this letter to explain the steps that we recommend that the
Medicare program take in this important area.
The CQU is an alliance of twelve (12) of the leading diagnostic
medical ultrasound societies and organizations, with combined
membership of over 100,000 ultrasound professionals, that is committed
to the implementation of nationwide accreditation and/or credentialing
requirements for Medicare reimbursement of all diagnostic medical
ultrasound services. The research, experience and expertise of CQU's
diverse constituents have demonstrated that appropriate utilization of
ultrasound services, as well as the protection of the Medicare program
and of Medicare beneficiaries, can best be achieved and maintained by
the accreditation of the laboratories in which the services are
provided and by requiring the private credentialing of the personnel
performing the technical component of the services. Thus, the CQU
represents a clear consensus of ultrasound providers in the medical
community in support of these important recommendations. We commend the
Subcommittee for examining this issue, and we are pleased to offer our
comments.
CQU believes the growth in diagnostic medical imaging services is
of concern. Although there are differing opinions as to why diagnostic
medical imaging services are outpacing some other components of the
Medicare program, CQU believes the solution lies not in the creation or
perpetuation of ``turf'' issues, but in consensus-driven quality
standards that qualified providers and suppliers will provide
appropriate services. To that end, CQU recommends the implementation of
a Medicare policy requiring facility accreditation and technical
component personnel credentialing in diagnostic medical ultrasound
services. The implementation of such a policy would allow Congress to
be assured that existing resources are directed only to those providers
who are willing to commit reasonable and necessary services utilizing
facility and personnel requirements. Studies have suggested accredited
ultrasound facilities are cost effective and help to eliminate
unproductive and inaccurate diagnostic ultrasound services, reducing
false positive and false negative diagnostic results and their
attendant costs. At present, at least thirty-nine (39) states have
implemented or recommended directives that incorporate this standard
for Medicare reimbursement of various types of ultrasound studies.
Thus, these requirements are well-established means to control costs
and to ensure quality for patients. These policies now need to be
adopted more widely within the Medicare program.
A peer-reviewed study conducted by David Stanley, M.D., a vascular
surgeon affiliated with a facility in Tennessee that is accredited by
the Intersocietal Commission for the Accreditation of Vascular
Laboratories (``ICAVL''), reinforces the need for accreditation and
credentialing requirements. This study used standard criteria to
compare the results of a repeat vascular study performed by Dr.
Stanley's accredited laboratory to the results of studies that were
initially performed by accredited and unaccredited laboratories. The
findings of the study indicated an 83% correlation rate to studies that
were initially performed at accredited laboratories. However, when the
initial study was performed by a laboratory that was not accredited,
the correlation rate fell to 45%. This study suggests that services
performed by unaccredited providers are more-often-than-not,
inaccurate. Published in the June 2004 issue of the Society for
Vascular Ultrasound's (``SVU's'') Journal for Vascular Ultrasound
(``JVU''), this study provides powerful evidence for the commonsense
point that we advocate--there can be no cost-effective quality control
when unaccredited and uncredentialed providers are permitted to bill
the Medicare program.
We have found similar results in other areas of ultrasound. For
example, the American Institute of Ultrasound in Medicine (``AIUM'')
compared the scores of case studies of accreditation applications with
their respective scores at the time of reaccreditation three years
later. The study concludes that practices that seek and receive
ultrasound accreditation are able to improve the scores of case studies
and to achieve compliance with AIUM minimum standards and guidelines
for the performance of gynecologic and obstetric ultrasound
examinations. This study was published in the Journal of Ultrasound in
Medicine in August of 2004 in an article entitled, ``The Accreditation
of Ultrasound Practices: Impact on Compliance with Minimum Performance
Guidelines.''
Another study, which was conducted by SVU and the Society of
Diagnostic Medical Sonography (``SDMS'') in 2003, resulted in similar
findings. This study involved a survey of vascular technologists and
sonographers in Indiana and Kentucky.\1\ The study found that an
average of 12% of all carotid duplex exams (a total of 4,872 in this
study of only two states) were repeated annually due to errors that
were attributable to the absence of a credentialing or accreditation
requirement. The investigators commented that the 12% estimate
represents the ``lucky'' patients, because that figure does not include
all of the ``disturbingly high'' instances in which defective studies
were performed and relied upon in determining the course of treatment.
The study documented other adverse effects of poor studies, including
instances of false positive, missed diagnoses, and false negatives.
This small sample alone represents a huge expenditure for poor quality
imaging studies, a situation that could have been mitigated by
implementing quality control policies such as accreditation and
credentialing.
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\1\ One hundred SVU and SDMS members were surveyed. There was a
thirty percent return rate, which is comparable to the return rate that
CMS uses in surveys.
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As you know, the Medicare Payment Advisory Commission (MedPAC), the
independent federal advisory body that advises Congress on issues
affecting the Medicare program, has also expressed concern about the
growth and overutilization of diagnostic medical imaging procedures
over the past several years. Consequently, MedPAC has begun to address
the complex and multifactorial reasons for the increase in utilization.
After considering various strategies to manage the use of diagnostic
imaging services, MedPAC recently issued draft recommendations on this
topic, which were unanimously approved by the MedPAC Commissioners on
January 12, 2005 and were released in MedPAC's March 2005 Report to the
Congress: Medicare Payment Policy on March 1, 2005. One of these
recommendations urges Congress to direct the Secretary to adopt private
standards for all providers who bill Medicare for performing diagnostic
imaging services. Significantly, much of MedPAC's work in this area
focused on the credentialing of technical component personnel and the
accreditation of laboratories.
The CQU fully supports MedPAC's recommendations to ``set standards
for all providers of diagnostic imaging studies and that the Secretary
should select private organizations to administer the standards.'' The
CQU believes that accreditation and/or credentialing standards for
diagnostic ultrasound imaging studies meets the ``reasonable and
necessary'' standard under the Medicare program. It is because we see
and acknowledge the serious value and necessity of ultrasound services
accreditation and credentialing in this context that we have committed
our organizations to successfully implement policies that require just
that.
For illustrative purposes, we suggest the following language for
your consideration as part of a Medicare reform package:
``Notwithstanding any other provision under this title, the Secretary,
or the carriers and fiscal intermediaries, as delegated by the
Secretary, shall institute diagnostic laboratory accreditation and non-
physician technical component certification requirements for diagnostic
ultrasound services no later than January 1, 2008. Only a range of
nationally-recognized medical ultrasound laboratory accreditation and/
or technical component personnel standards may be imposed under this
section.''
We do not believe that it would be appropriate for Congress to cut
reimbursement for diagnostic ultrasound services. Such cost cuts would
actually impede the adoption of appropriate standards. Congress can
best realize cost savings in this area by ensuring the standards set
for the delivery of these services are set appropriately and ensure
that the tremendous costs associated with poor quality services are not
borne by the Medicare program. In our view, this area of Medicare
services presents an excellent opportunity for a pay for performance
initiative.
In light of MedPAC's quality standard recommendation, and given our
coalition's extensive research and experience in the area of diagnostic
ultrasound, we urge you to consider the adoption of consensus-based
quality ultrasound standards such as laboratory accreditation and
technical component personnel credentialing. In our view, there is
nothing more important Congress can do to control imaging costs, while
improving patient-care related quality than to ensure that only
appropriate diagnostic ultrasound services are received by Medicare
beneficiaries and are paid for by the Medicare program. Thank you again
for this opportunity to provide our input to the House Subcommittee.
Please let us know if we may provide additional information or
assistance.
Sincerely,
On behalf of the Coalition for Quality in Ultrasound:
American Institute of Ultrasound in Medicine
American Registry for Diagnostic Medical Sonography
Cardiovascular Credentialing International
Intersocietal Commission for the Accreditation of Vascular
Laboratories
Joint Review Committee on Education in Diagnostic Medical
Sonography
Society of Diagnostic Medical Sonography
Society of Interventional Radiology
Society for Vascular Medicine and Biology
Society for Vascular Surgery
Society for Vascular Ultrasound
National Imaging Associates, Inc.
Hackensack, New Jersey
March 29, 2005
Committee on Ways and Means--Subcommittee on Health
U.S. House of Representatives
1102 Longworth House Office Building
Washington, D.C. 20515
Mr. Chairman,
Thank you for the opportunity to submit this comment in conjunction
with your recent March 17 ``Subcommittee on Health of the Committee on
Ways and Means'' hearing on managing the use of diagnostic imaging
services. I would like to take this opportunity to introduce to you and
the members of this committee, National Imaging Associates, the
nation's largest single manager of radiology benefits. Allow me to
further elucidate a number of the key issues facing the radiology
industry and how NIA is working with many of the nation's leading
health plans to solve these problems through clinically appropriate and
economical use of diagnostic imaging.
National Imaging Associates, Inc. (NIA) is the nation's leader in
Radiology Benefits Management (RBM) and serves more than 14 million
health plan members in 30 states, touches more than 185,000 physicians,
and manages $2.5 billion in radiology expenditures annually. We are a
utilization and quality management company performing pre-procedure
evaluation and consultation services (outpatient Diagnostic Imaging)
for a number of health plans nationwide, including large plans such as
Highmark of Pennsylvania, Anthem of Colorado, Harvard Pilgrim
Healthcare as well as regional plans such as QualChoice of Ohio and
Network Health of Wisconsin. I am Doctor Thomas G. Dehn, M.D., the
Executive Vice President and Chief Medical Officer of National Imaging
Associates (NIA). I am a Board Certified radiologist and Fellow of the
American College of Radiology.
With radiology costs reaching over $100 billion annually,
diagnostic imaging is one of the fastest growing cost areas in American
healthcare. Unmanaged radiology spending is expected to continue
growing at a rate of 20% annually for some time, driven by the advances
in imaging technology, advertising directed at patients and an aging
population. For example, Highmark, one of NIA's larger clients notes
payments for advanced imaging services for its members, including
magnetic resonance imaging (MRI) and computerized axial tomography
(CAT), to have increased more than 20 percent annually in each of the
last three years. Much of the recent growth in diagnostic imaging is
the appropriate result of technological advances that allow physicians
and other healthcare professionals to more accurately identify a
patient's condition or avoid more invasive treatments but a significant
driver is, simply, inappropriate or non-contributory utilization often
delivered by marginally competent providers.
NIA, holder of both URAC and NCQA certification as well as URAC
Privacy Accreditation (for taking the necessary steps to safeguard
Protected Health Information in accordance with the HIPAA Privacy
Rules), is working to ensure patients who are members of health plans
served by NIA will receive clinically appropriate care, thereby
reducing radiation exposure and mitigating insurance co-pays. NIA's
pre-procedure review and related quality review processes help patients
receive the most appropriate care while helping health plans realize
reductions in imaging expenses as well as greater control over the
quality of their imaging infrastructure (networks).
The challenge of improving the quality of utilization of Diagnostic
Imaging services is one of national proportion. Today, National Imaging
Associates reviews ``appropriateness'' in the use of Diagnostic Imaging
on behalf of more than fourteen million citizens of all ages, in 32
states, including commercial, Medicare and Medicaid enrollees of both
public and private health plans. As a company, we are certified/
accredited by all three of the nationally recognized oversight bodies
in the industry.\1\
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\1\ NCQA, URAC and the JCAHO.
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While the ``management'' of the use of Diagnostic Imaging is
commonly thought of as spurred by economic impetus, it is of far
greater importance as a quality and safety initiative. Nearly all
Diagnostic Imaging involves the use of ``ionizing radiation'' the risks
and benefits of which must always be considered when contemplating its
use. For example, the common comparison is that the radiation received
from a total body CT scan is equivalent to that received by an
individual positioned just one and a half miles from ``ground zero'' in
the Hiroshima Nuclear Explosion.\2\ To put it in today's terms, the
amount of radiation exposure to the breast from a chest CT scan is
equivalent to twenty mammograms! \3\ NIA data, indicates that,
typically, more than one-thousand examinations will be delivered to
every one-thousand individuals in the 0-65 year old age group and three
times that amount to the Medicare population. This means that, on an
actuarial basis, each member of this committee is likely to receive at
least one imaging examination in the next year. Recently, the National
Blue Cross Association prepared a ``white-paper'' on just this issue
and noted a year-over-year increase of twenty-plus percent in the use
of diagnostic imaging.\4\ Several State Commissions have conducted
similar studies, including Massachusetts, which revealed a staggering
increase in utilization with no evidence of improved health to the
population! \5\ Clearly, given the magnitude of the everyday use of
this technology, the Medical Profession has an ethical mandate to use
it judiciously. The facts, however, demonstrate that without a formal
program of management the public is at risk. These, however, are
percentages, where physicians treat people.
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\2\ David J. Brenner, PhD, DSc and Carl D. Elliston, MA, Estimated
Radiation Risks Potentially Associated with Full-Body CT Screening
Radiology 2004; 232:735-738.
\3\ American Journal of Roentgenology 2001:176;303-306.
\4\ Medical Technology as a Driver of Healthcare Costs: Diagnostic
Imaging, BCBS Association, working draft, fall 2003.
\5\ DIAGNOSTIC IMAGING: A NEW COST DRIVER, Health Point, Division
of Health Care Finance and Policy, State of Massachusetts, Two Boylston
Street, Boston, MA, 02116, fall 2003.
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The following vignettes are taken directly from recent NIA files
and are representative of a nationwide trend and experience:
Requests for Nuclear Cardiology studies by a Family
Practitioner for women who are pregnant or breastfeeding. The
examinations were deferred because of the radiation exposure to the
fetus/infant.
NIA processes frequent requests for CT of head on
children. This involves significant radiation to the child's eyes and
thyroid gland, if any study is necessary NIA will recommend a MRI which
does not involve ionizing radiation.
Frequent requests for CT of the abdomen on children with
suspected appendicitis. The diagnosis of acute appendicitis should be
made on a clinical (examination) basis and not by the use of X-ray.
Again a very large and unacceptable radiation dose to a child's gonads
and developing organs.
The ``knee-jerk'' request for MRI of the back on patients
presenting with ``back pain.'' Nearly all should have a trial of
conservative therapy before diagnostic imaging because of the
astounding number of false positive findings. Nearly sixty percent of
asymptomatic people (committee included) will likely have an abnormal
back MRI! \6\
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\6\ Borenstein G, Boden SD, Wiesel SW, et al. ``The value of
magnetic resonance imaging of the lumbar spine to predict low-back pain
in asymptomatic individuals: A 7-year followup study. J Bone Joint [am]
2001; 83:320-34.
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The three year doubling of the performance of Nuclear
Cardiac procedures in Connecticut, coincident with the widespread
purchase of Nuclear Medicine equipment by cardiologists. This raises
the serious question of inappropriate self-referral and potential
violations of, at least the spirit of, the Stark II laws.\7\
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\7\ ``A Stark II Primer: The Impact of the Federal Physician Self-
Referral Ban on Health Care Providers' Business Relationships,'' by
Andrew B. Wachler, Phyllis A. Avery, and Tracy Silverman Weissman,
Laches, January 2002.
The solution, educate the ordering physician at the time of
decision by implementation of a pre-procedure review/consultation
program. In such a program the physician provides accountability beyond
the office doors and learns of the most up-to-date use of this rapidly
changing technology. In the most extreme condition, when a study is
denied, the committee should know that the requesting physician will
speak to a reviewing physician in a peer-to-peer discussion and is
clearly advised that this only means denial-of-payment; the physician
should always exercise best clinical judgment and in all cases they are
informed of their appeal rights.
Nationwide, of each one hundred requests for advanced imaging
studies submitted for prior-approval, approximately ten will either be
disapproved or voluntarily withdrawn. Of these less than one percent
will be appealed or .1% of all decisions will be contested.
For example, in Highmark's situation, to help improve the quality
and ensure the appropriate use of advanced imaging services, Highmark
chose NIA to assist them in introducing a new radiology management
program for all its health programs in the 29 counties of Western
Pennsylvania. The program NIA/Highmark program includes two vital
components:
Privileging: To receive Highmark reimbursement, all
providers who perform imaging services--radiologists, physicians,
etc.--must become privileged. To become privileged, an imaging provider
must meet certain minimal requirements to deliver imaging services. The
privileging process for Highmark's imaging network began in July 2004.
Notification: Started in late 2004, all privileged
imaging providers will be asked to notify Highmark when they perform
certain MRIs, CT scans and positron emission tomography (PET) studies.
In late 2005, Highmark will initiate a pre-authorization requirement,
focusing on selected imaging services that have wide variation in how
they are used.
This program, as it exists in many states, may cause a minor
inconvenience to the requesting physician; it is never applied to an
emergency condition. I trust that the Committee will concur that
solutions are possible that benefit the quality and safety of the
citizens of America and that the ``processes'' far outweigh the
perceived inconvenience.
Speaking on behalf of the dedicated staff of NIA, we would like to
offer our good offices to your Committee and staff as it considers the
scope of, and solution to the Diagnostic Imaging challenge.
Respectfully submitted,
Thomas G. Dehn, M.D., FACR
Executive Vice President, Chief Medical Officer
Nashville, Tennessee 37205
March 16, 2005
Dear Congressmen:
Our company partners with cancer specialists and local hospitals to
offer positron emission tomography (``PET'') scanning services to
cancer patients. A PET scan is the most advanced imaging technology for
the detection and evaluation of cancer. The whole-body scan generates
high-resolution images of abnormal metabolic activity. Abnormal
metabolic activity often takes place before physical changes are
identifiable by other imaging exams. Cancer specialists use PET images
to determine the extent of disease, the effectiveness of chemotherapy,
radiation therapy or surgery and possible recurrence.
I am writing in connection with CMS's proposal to change the
definition of ``radiology and certain other imaging services'' and
``radiation therapy services and supplies'' under the Stark law to
include diagnostic and therapeutic nuclear medicine services and
supplies, respectively.\1\ The practical effect of this change would be
to include nuclear medicine procedures as ``designated health
services'' under the Stark law, thus prohibiting a physician with a
financial relationship with an entity from referring a patient to that
entity for the furnishing of nuclear medicine services such as PET
scans. I would like to express my opinion that the proposed change may
not be implemented by regulation. Rather, only Congress can amend the
Stark law to include PET scans as a ``designated health service.''
Please recall that Congress recently amended the Stark law to implement
another CMS policy objective--the imposition of a moratorium on
physician-owned specialty hospitals--that CMS itself did not have the
authority to implement by regulation.
---------------------------------------------------------------------------
\1\ This proposal is included as Item 1046 in CMS's latest semi-
annual regulatory agenda, published December 13, 2004 in the Federal
Register.
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As you are aware, under the Stark law, a physician with an
ownership interest in a facility providing ``designated health
services'' may not make a referral to that facility. Congress has set
forth eleven categories of designated health services. One of these
categories is radiology services. The actual language of the statute
defines the category as ``radiology, including magnetic resonance
imaging, computerized axial tomography scans, and ultrasound
services.'' \2\
---------------------------------------------------------------------------
\2\ 42 U.S.C. Sec. 1395nn(h)(6)(D).
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In the preamble to final Stark rules published on January 4, 2001,
CMS indicated that it was ``excluding [from the definition of
designated health services] nuclear medicine services since those
services are not commonly considered to be radiology.'' \3\ Since the
Stark law does not list PET scans as a discrete category of designated
health services, CMS can only categorize PET as a designated health
service if it fits within one of the eleven categories of designated
health services found in the statute. The only designated health
service listed in the statute that might include PET scans is
``radiology, including magnetic resonance imaging, computerized axial
tomography scans, and ultrasound services.'' Although the agenda item
refers to a possible change in the definition of ``radiation therapy
services and supplies,'' this definition cannot have any relevance to
diagnostic PET scans. PET is considered by no one to be therapeutic.
Since PET scans can only be included under the statute if they
constitute radiology services, CMS can only expend the definition of
``designated health services'' to include PET if PET is considered a
radiology service.
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\3\ 66 Fed. Reg. 856 at 924 (Jan. 4, 2001).
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CMS itself has concluded that nuclear medicine services (and thus
PET services) are not radiology services. In the preamble to the final
regulations published in January of 2001, CMS indicated that it was
excluding nuclear medicine services from the radiology category ``since
those services are not commonly considered to be radiology.'' \4\ To
reverse its published, considered position now would suggest that the
agency is giving in to pressure from interest groups (such as the
American College of Radiology) who are interested in limiting access to
PET services to those situations where radiologists have control over
the service.
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\4\ 66 Fed. Reg. 856 at 927 (January 4, 2001).
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I would urge Congress not to expand the list of designated health
services to include PET. There is no historical evidence of over-
utilization of PET resulting from physician ownership, and PET imaging
technology is unlikely to be over utilized. PET is used primarily to
confirm a diagnosis of cancer, stage cancer for treatment planning, or
monitor the effectiveness of treatment. PET scans are performed after
injecting the patient with a radioactive tracer. The exposure to a
radioactive substance combined with the fact that patients in need of a
PET scan are often very ill diminish the chance of abuse and eliminates
any need for regulatory action. In addition, the Medicare coverage
rules already contain tight utilization controls.
Expanding the list of designated health services to nuclear
medicine--which includes PET imaging technology--would limit the access
of desperately ill cancer patients to potentially life saving
technology. The growth of PET in the United States has largely been
through freestanding centers. Hospitals have been slow to adopt the
technology, perhaps due to capital restraints. A state-of-the-art PET
scanner costs approximately $2,500,000. Limiting the ability of
physicians to participate in the application of PET imaging technology
will stop the development of PET imaging centers in markets where non-
physicians are unwilling to risk the substantial capital needed to
develop a PET imaging center.
Although cancer patients residing in the largest of cities with
major medical centers or teaching institutions may continue to have
access to the new technologies like PET, cancer knows no geographic
boundaries and when you are that ill travel is difficult. If the local
cancer specialists in Tulsa and Oklahoma City, Oklahoma as well as
Sugar Land and Garland, Texas had not been able to personally invest in
PET scanning technology, taking significant financial risk, their
patients may still be required to travel to Dallas, Kansas City or the
Texas Medical Center in Houston for state-of-the-art PET imaging. Often
the local hospitals and/or radiologists simply lacked the capital and
professional resources to provide the latest cancer tools. A policy
reversal by CMS at this point, with no evidence of inappropriate
utilization, will unnecessarily impede access to this vital new
technology as well as others.
If Congress is, however, intent on prohibiting physician investment
in PET centers, I would urge Congress to at least grandfather existing
facilities as it did when it placed a moratorium on the development of
further physician-owned specialty hospitals. The failure to grandfather
any existing facilities would cripple those businesses that made
significant capital investments in reliance on CMS's historical
position and the actual language of the Stark law and its regulations.
I would be happy to discuss these issues with you at any time.
Sincerely,
Timothy M. Petrikin
Statement of Society for Maternal-Fetal Medicine
The Society for Maternal-Fetal Medicine (SMFM) appreciates the
opportunity to provide our views regarding the use of imaging services.
SMFM is concerned with the Medicare Payment Advisory Commission's
recent deliberations regarding the growth of in-office diagnostic
imaging and efforts to eliminate or restrict the in-office ancillary
exception to the Stark law. While we are aware of the growth of imaging
volume, we firmly believe, and data supports, that Ob-Gyn generalists
and Maternal Fetal Medicine subspecialists' use of self-referral is
clinically appropriate, of high-quality and done in the best interest
of patients. We respectfully request that the in-office access to
ultrasonography be maintained.
There are approximately 2,000 board certified Maternal Fetal
Medicine (MFM) subspecialists in the United States. A major portion of
their clinical activity when caring for high risk mothers and their
unborn high risk fetuses is the performance of complex ultrasound
diagnostic and therapeutic procedures, most commonly for women referred
by generalist Obstetrician-Gynecologists. MFM subspecialists have
developed a number of diagnostic procedures to determine fetal risk as
well as diagnostic and treatment strategies to diminish the likelihood
of later disability or death.
MFM subspecialists must complete 3 additional years of training
following completion of their Ob-Gyn training. Much of the three years
is devoted to diagnostic ultrasound procedures in referred high-risk
patients. MFMs perform a small but critical portion of in-office
imaging for Medicare recipients. These include obstetric
ultrasonography for pregnant women with disabilities--many of whom have
higher rates of pregnancy complications than the average pregnant
patient--and many because of their ultrasound skills also perform
gynecologic ultrasonography. Radiologists actually perform the vast
majority of Medicare imaging procedures. In fact, radiologists perform
more than two-thirds of the two Ob-Gyn related ultrasounds that make up
83% of Medicare Ob-Gyn imaging.
Patients need access to timely imaging in Ob-Gyn offices and labor
and delivery rooms. Waiting for a radiologist to arrive, or sending a
pregnant patient to another office for ultrasound, can delay urgent
care and cause significant delay and inconvenience to patients, many of
whom do not have adequate transportation. Many exams need to be
performed urgently, such as when a woman experiences unexplained
bleeding, pelvic pain, or discovery of a mass. Many emergencies, like
ectopic pregnancies or complications during active labor, can be life-
threatening and require immediate imaging so the patient can be cared
for quickly. Ob-Gyns are most often the appropriate physician to
provide these services. Radiologists often are not on call throughout
the night and on weekends when many emergencies occur. It is critical
that Ob-Gyn patients have access to diagnostic ultrasound in a timely
and convenient manner that does not cause undue hardship relative to
time and transportation.
The June 2004 Commission report discusses the use of private sector
purchasing strategies to contain imaging service growth. Ob-Gyn and MFM
imaging utilization is given high marks by private insurers for
appropriateness. In particular, a study by Highmark Blue Cross Blue
Shield and National Imaging Associates, a radiology benefit management
firm, found that Ob-Gyn physicians' rates of appropriate utilization
are the best among specialists. In addition, the much-cited Maryland
law--which creates one of the country's most restrictive state limits
on self-referral--fails to limit ultrasound because legislators did not
detect any abuse of self-referral privileges in that modality.
Ob-Gyns are trained, experienced and qualified to perform and
interpret diagnostic sonographic imaging procedures. Training in
diagnostic ultrasonography is part of Ob-Gyn residencies and a part of
the certifying examinations of the American Board of Obstetrics and
Gynecology. Procedures performed by Ob-Gyns include sonography to
assist in the diagnosis of certain pregnancy complications,
gynecological cancers, or sources of pelvic pain or post-menopausal
bleeding. Maternal-Fetal Medicine subspecialists, who take care of
high-risk pregnant women, are also trained in the use of fetal
echocardiography to investigate fetal heart problems in addition to
other screening procedures for developmental defects.
Ob-Gyn generalists and their MFM subspecialty colleagues are the
most appropriate specialists and subspecialists to provide certain
ultrasound imaging services. Ob-Gyn residents often use obstetric
ultrasound throughout their four-year residency, while radiology
residents often have fewer than four weeks of obstetric sonography
training per year. An October 2001 study in the American Journal of
Radiology found that ``current levels of experience in obstetric
sonography may not be providing sufficient experience to allow
[radiology] residents to appropriately manage call cases.''
The growth of Medicare Ob-Gyn imaging is controlled and consistent
with advances in medical technology. Part of this increase reflects a
shift in the site of service from hospitals to physician offices, which
helps hold down Medicare costs and is better for patients. With
advances in ultrasound equipment, patients can now have procedures that
formerly required scheduling of a hospital MRI or CT at a later time,
followed by yet another visit back to the Obstetrician, done during one
visit to an Ob-Gyn's or MFM physician's office. Further, diagnostic
imaging has led to a drastic shift from invasive to non-invasive
procedures and has virtually eliminated the need for exploratory
surgery for some conditions. For instance, in-office ultrasound can now
rule out masses that previously required invasive procedures in
patients with abnormal uterine bleeding.
Thank you for the opportunity to present these comments regarding
the use of imaging services.
Mequon, Wisconsin 53092
March 15, 2005
Congresswoman Nancy L. Johnson,
Subcommittee on Health
1136 Longworth House Office Building
Washington, D.C. 20515
Dear Congresswoman Johnson and Subcommittee on Health,
I am submitting the following statement to the Subcommittee hearing
``Managing the Use of Imaging Services'' on March 17, 2005.
I am a nurse, breast cancer survivor, and patient advocate, who has
been working with great determination for the past 2 years to inform
women about quality breast imaging in an effort to help improve the
quality and outcome of their breast care, as it relates to screening
mammography, diagnostic evaluation, and breast biopsy procedures.
I am including a brief background as to what lead up to my
advocacy. Two years ago I had a yearly screening mammogram in the
facility where I initially had my very first screening mammogram and
never questioned the level of care provided. After a suspicious lesion
was found on my screening mammogram, a diagnostic mammogram was
performed by a dedicated radiologist and he recommended an image-guided
needle breast biopsy. But at this facility I was referred to a surgeon,
who attempted to perform a stereotactic-guided needle biopsy and
indicated he could not visualize the lesion, so the biopsy was not
performed. In this facility, only surgeons perform the stereotactic
breast biopsies. I then went to another breast center for a second
opinion, where a dedicated radiologist, accredited in stereotactic-
guided needle biopsy identified my lesion, performed a biopsy and
established the diagnosis of DCIS (an early, non-invasive form of
breast cancer).
Puzzled by the fact that one physician could and the other
physician could not perform my stereotactic-guided needle biopsy, I
began my research to learn more about the standards for physicians who
perform image-guided breast biopsy procedures.
Mammography Quality Standards Act (MQSA), which was introduced in
1992, requires all institutions performing screening mammography to
achieve a set level of performance with annual certification or face
possible fines and/or closure of its facility. But physicians
performing image-guided needle breast biopsy procedures to include
ultrasound-guided biopsy and stereotactic-guided breast biopsies are
not required to be accredited at the present time. Only a voluntary
accreditation process is available through the American College of
Radiology (ACR).
I believe this is another issue of grave importance to women as it
relates to the Management of Imaging Services and the related costs to
the payer and patient not only financially, but also in the quality of
the service provided which in the end leads to quality outcomes.
I have attended the most recent Institute of Medicine study,
``Improving Mammography Quality Standards,'' in September 2004. I was
able to make a statement and submitted a written statement to the
committee of experts, who were gathering information to complete the
study.
I want to see change in a positive direction for the performance of
the image guided breast biopsy procedures so that the following will be
accomplished:
All physicians who perform these procedures must meet the
exact same standards of practice with mandated accreditation to
quality.
There cannot be multiple standards of care as the
consumer does not know where to find the experts who practice in
accredited settings. I continually hear the following question when I
speak to women's groups, ``How do we know one when we see one?''
The cost of medical care is on the increase. We need to
set standards of practice for the imaging procedures that remains in a
continual mode of improvement and are delivered by those physicians who
are committed to quality and excellence.
I am enclosing excerpts from articles that I have read that have
caused me great concern as a nurse and patient advocate and more
especially as a woman, who has been a recipient of different qualities
of breast biopsy imaging procedures performed by physicians.
The first excerpt is from an article titled, Strict
attention to detail enhances sensitivity of breast US 4/17/03, By:
Deborah R. Dakins.
``When high-quality equipment is paired with meticulous attention
to scanning details, breast ultrasound yields increasingly definitive
diagnostic information.''
``By applying a strict algorithm for differentiating benign from
malignant lesions, sonographers can make more specific diagnoses,
prevent biopsy of benign lesions, and find palpable malignant tumors
missed by mammography,'' said Dr. A. Thomas Stavros, chief of
ultrasound at Radiology Imaging Associates in Greenwood Village, CO.
Moreover, such findings can be correlated with the Breast Imaging
Reporting and Data System (BI-RADS) developed for mammography by the
American College of Radiology.
Based on as-yet-unpublished work, Stavros reported achieving better
than 98% sensitivity with ultrasound when adhering to a strict
algorithm, one that demands identification of multiple characteristics
of malignant or benign lesions.
``Breast cancer is too heterogeneous to be solved by a single
finding,'' Stavros said. ``The average cancer that we see has five or
six positive findings.''
It is this strict attention to detail that all physicians who
perform imaging services must reach in order that all imaging
procedures are performed by a committed physician with the greatest
imaging ability, not just because the physician has equipment in his
office.
The next excerpt is from an article titled, Miami Breast
Cancer Conference.
Breast Surgeons Performing Own Ultrasound, By Robert H. Carlson
Palpable Lesions
``Open biopsy is no longer an appropriate way to establish a
diagnosis of a solid breast mass,'' Dr. Dixon said, ``when core biopsy
is done for small lesions it should be done with image guidance.''
``A surgeon can do this as easily as a radiologist, because most
solid lesions are easy to see,'' said Dr. Dixon, who advised that a
picture of the needle within the lesion be obtained for the records.
``This technique is particularly easy to learn by surgeons, who already
perform many other image-guided procedures.''
Not Expensive
He pointed out that ultrasound machines are not expensive. The
machine he uses in his clinic, made by Honda--which made for good
automobile analogies from this entertaining speaker--cost under
US$10,000 ``And it's very easy to use, even for a surgeon,'' Dr. Dixon
continued.
Dr. Dixon concluded by saying he knows many surgeons who would like
to use ultrasound but they need to be trained: ``Accredited courses in
breast ultrasound for surgeons are needed urgently. And anyway, why
should radiologists have all the fun?''
I find this article very disturbing. This is like saying we should
have ``a car in every garage and a chicken in every pot.'' It is about
having an ultrasound machine in every office, so the surgeon can
perform the procedure and it trivializes the significance of the
imaging ability that is required of the physician performing the
procedure.
Remember that for ultrasound to be performed with the
highest of standards there needs to be ``Strict Attention to Detail to
Enhance Sensitivity.'' This requires a dedicated professional.
The last excerpt that I am enclosing is from the
following article:
The Role of Ultrasound in Treating Breast Disease
The following is an excerpt from an interview with Dr. Richard A.
Lopchinsky, a board certified surgeon.
Dr. Richard A. Lopchinsky is Clinical Assistant Professor, Mt.
Sinai School of Medicine, and is in private practice at Mt. Sinai and
Lenox Hill Hospital. He is also Treasurer of the New York Head and Neck
Society. Dr. Lopchinsky teaches an ultrasound course available on the
Internet.
``Ten years ago ultrasound was used primarily for determining
whether or not a lump was a cyst. It was a very crude, coarse
evaluation of a radiologic abnormality. Today, ultrasound aids
identification of structures down to the 1-2mm size. Physicians have
also learned to characterize ultrasound abnormalities with far greater
precision, allowing them to label a finding absolutely or almost
absolutely benign, indeterminate or highly suspicious. This technology
change has allowed physicians to fine-tune their diagnostic
capabilities. By increasing the resolution of the machinery, the
ultrasound can guide a biopsy. Real-time needle placement during
ultrasound allows the surgeon to exactly place the needle and see it
penetrate the abnormality. With ultrasound-guided biopsy a benign
diagnosis is 99.9% accurate.''
``When learning ultrasound, it is very important to take several
courses--either the same course more than once or several different
courses. The first course teaches a certain level of basic knowledge.
Once surgeons actually begin practicing ultrasound they are able to
assimilate information that initially they may have been unable to
grasp. It is basically the same concept as continuing education--a base
needs to be built before getting started. Once a surgeon starts doing
the procedures, he/she needs to increase that knowledge base by
reviewing the material. Having the course on the Internet enables the
surgeon to re-visit the course as often as needed''
I find this article the most disturbing when I read the statement,
``once the surgeon begins practicing ultrasound.'' This surgeon
advocates buying his course on the Internet, buying an ultrasound
machine, taking a few courses to assure competency. Then the surgeon
can order the procedure and perform it with ease. This is why I believe
that the standards of practice need to be the same for every single
physician who performs imaging procedures. I believe that the final
burden of this issue is on this Subcommittee. The increase in medical
costs can be significantly reduced when procedures are performed by
physicians who adhere to ``one set of standards'' regardless of their
medical specialty. This will lead to quality outcomes and the patient
will be protected and receive the best care possible.
I thank you for your time and consideration as to this statement.
Respectfully,
Judith A. Wagner, R.N.