[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












                                 _____

                 U.S. GOVERNMENT PRINTING OFFICE

23-927                 WASHINGTON : 2005
_________________________________________________________________
For sale by the Superintendent of Documents, U.S. Government 
Printing  Office Internet: bookstore.gpo.gov  Phone: toll free 
(866) 512-1800; DC area (202) 512-1800 Fax: (202) 512-2250 Mail:
Stop SSOP, Washington, DC 20402-0001















                      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

Pursuant to clause 2(e)(4) of Rule XI of the Rules of the House, public 
hearing records of the Committee on Ways and Means are also published 
in electronic form. The printed hearing record remains the official 
version. Because electronic submissions are used to prepare both 
printed and electronic versions of the hearing record, the process of 
converting between various electronic formats may introduce 
unintentional errors or omissions. Such occurrences are inherent in the 
current publication process and should diminish as the process is 
further refined.


















                            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

                              ----------                              


                        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.
      

DETAILS FOR SUBMISSION OF WRITTEN COMMENTS:

      
    Please Note: Any person(s) and/or organization(s) wishing to submit 
for the hearing record must follow the appropriate link on the hearing 
page of the Committee website and complete the informational forms. 
From the Committee homepage, http://waysandmeans.house.gov, select 
``109th Congress'' from the menu entitled, ``Hearing Archives'' (http:/
/waysandmeans.house.gov/Hearings.asp?congress=17). Select the hearing 
for which you would like to submit, and click on the link entitled, 
``Click here to provide a submission for the record.'' Once you have 
followed the online instructions, completing all informational forms 
and clicking ``submit'' on the final page, an email will be sent to the 
address which you supply confirming your interest in providing a 
submission for the record. You MUST REPLY to the email and ATTACH your 
submission as a Word or WordPerfect document, in compliance with the 
formatting requirements listed below, by close of business Thursday, 
March 31, 2005. Finally, please note that due to the change in House 
mail policy, the U.S. Capitol Police will refuse sealed-package 
deliveries to all House Office Buildings. For questions, or if you 
encounter technical problems, please call (202) 225-1721.
      

FORMATTING REQUIREMENTS:

      
    The Committee relies on electronic submissions for printing the 
official hearing record. As always, submissions will be included in the 
record according to the discretion of the Committee. The Committee will 
not alter the content of your submission, but we reserve the right to 
format it according to our guidelines. Any submission provided to the 
Committee by a witness, any supplementary materials submitted for the 
printed record, and any written comments in response to a request for 
written comments must conform to the guidelines listed below. Any 
submission or supplementary item not in compliance with these 
guidelines will not be printed, but will be maintained in the Committee 
files for review and use by the Committee.
      
    1. All submissions and supplementary materials must be provided in 
Word or WordPerfect format and MUST NOT exceed a total of 10 pages, 
including attachments. Witnesses and submitters are advised that the 
Committee relies on electronic submissions for printing the official 
hearing record.
      
    2. Copies of whole documents submitted as exhibit material will not 
be accepted for printing. Instead, exhibit material should be 
referenced and quoted or paraphrased. All exhibit material not meeting 
these specifications will be maintained in the Committee files for 
review and use by the Committee.
      
    3. All submissions must include a list of all clients, persons, 
and/or organizations on whose behalf the witness appears. A 
supplemental sheet must accompany each submission listing the name, 
company, address, telephone and fax numbers of each witness.
      
    Note: All Committee advisories and news releases are available on 
the World Wide Web at http://waysandmeans.house.gov.
      
    The Committee seeks to make its facilities accessible to persons 
with disabilities. If you are in need of special accommodations, please 
call 202-225-1721 or 202-226-3411 TTD/TTY in advance of the event (four 
business days notice is requested). Questions with regard to special 
accommodation needs in general (including availability of Committee 
materials in alternative formats) may be directed to the Committee as 
noted above.

                                 

    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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    \7\ Orrison & Levin, Radiology 2002; 225(P):550.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
      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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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.''
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \1\ NCQA, URAC and the JCAHO.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
      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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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).
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \3\ 66 Fed. Reg. 856 at 924 (Jan. 4, 2001).
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \4\ 66 Fed. Reg. 856 at 927 (January 4, 2001).
---------------------------------------------------------------------------
    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.

                                  
