August 19, 2008

Kerry Weems, Acting Administrator

Centers for Medicare and Medicaid Services

Department of Health and Human Services

Room 445-G

Hubert H. Humphrey Building

200 Independence Avenue, S.W.

Washington, D.C. 20201

**Re: Medicare Program; Revisions to Payment Policies Under the
Physician Fee Schedule and Other Revisions to Part B for CY 2009;
\[CMS-1403-P\]**

Dear Acting Administrator Weems,

I am writing as a practicing breast surgeon in Sierra Vista, AZ to
comment on CMS' proposed rule for physician payment for 2009. I am a
general and breast surgeon working in an underserved area. The majority
of my patients are sent to me with breast pathology and I diagnose an
average of two new breast cancers each and every week. I am the only
physician in our county of over 100,000 people who performs minimally
invasive breast biopsies using ultrasound and stereotactic imaging. On
average, I see fifty Medicare beneficiaries a month to diagnose or
manage their breast disease.

I am concerned about the proposal to require physicians to enroll as
IDTFs in order to provide diagnostic testing services. This would
require me to enroll as an IDTF in order to continue to diagnose and
manage my patients using ultrasound.

In my breast surgical practice, ultrasound is deeply integrated into the
care that I provide my patients. I operate the equipment myself to make
immediate patient management decisions and to guide minimally invasive
diagnostic and therapeutic procedures.

IDTF regulations require the presence of a "supervising physician" and
it is my understanding that, under local carriers policies, I would not
qualify as a "supervising physician". This would mean that I would have
to hire a radiologist to supervise my use of breast ultrasound in my own
office. It is extremely unlikely that I would even be able to find a
radiologist willing to assume such a position, as they would be assuming
unnecessary professional liability for my work. This requirement is
unnecessary as I have the training and expertise needed to supervise
these studies. I have taken certification courses and have performed
ultrasound exams on well over a thousand patients.

My primary concern is that the expense and administrative burden of
hiring another "supervising physician," as well as the additional
unwarranted burdens imposed under the IDTF regulations, may force me to
forego performing ultrasound in my practice. This would deny my patients
the full benefits of a technology that not only decreases the costs of
caring for women with suspected breast pathology but also results in
fewer invasive procedures. There is a significant difference between
performing a real-time ultrasound evaluation in conjunction with my
physical examination of the patient and sending the patient out for an
ultrasound examination by others. In many cases in which I have
identified an area of concern in my patient, I would be reluctant to
rely on a report and static images from an outside imaging facility to
rule out the need for a surgical biopsy. I am concerned that my
inability to perform ultrasound evaluations in real time will result in
my performing more open surgical biopsies. Having to send a patient out
to another facility for her ultrasound also means another delay before I
am able to diagnose a patient who is understandably anxious to know if
she has breast cancer.

I am also concerned that the proposed regulation might require that I
enroll as an IDTF in order to continue to perform stereotactic biopsies
on Medicare patients. As in the case of ultrasound, I am fully qualified
to perform these procedures. Should I have to send my patients to other
facilities for stereotactic biopsies, the patient would have to travel
one and a half to three hours from her home in Cochise County to Tucson
in order to find a facility to do the procedure. I would also have less
confidence in negative findings based biopsies in which I have not
performed or observed the targeting of the specimen. Unnecessary
fragmentation of care in this manner never makes for good medicine. As
in the case of ultrasound analyses, my concerns over reliance on outside
findings and analyses might lead me to perform more open surgical
biopsies.

Imposing IDTF requirements on my practice will not improve the quality
of healthcare or decrease costs, and it will be detrimental to my
patients. I urge CMS to withdraw the proposal and to refrain from any
proposal that would subject breast surgeons to IDTF regulations in order
to diagnose and manage their patients using ultrasound.

I greatly appreciate the opportunity to submit these comments. Please do
not hesitate to contact me at (520) 452-0144 with questions or if I can
provide you with additional information.

Sincerely,