**[Reatha Williams D.O.]{.underline}**

**[Heart and Family Health Institute of Port St Lucie]{.underline}**

**[Phone 772 335 9600]{.underline}**

August 13, 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 **\[Port St Lucie,
Florida** **\]** to comment on CMS' proposed rule for physician payment
for 2009. **For the diagnosis and treatment of breast diseases including
breast cancer, I utilize in-office US daily. I perform at least 5 breast
US examinations a day and also at least 5 US guided needle biopsies a
week in my office. I also utilize in-office US for image guidance for
mammosite balloon placement for accelerated partial breast
irradiation.** **\]** On average, I see **\_300\_** 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. This requirement is
unnecessary as I have the training and expertise needed to supervise
these studies. **My US training** **was done at Emory in Atlanta, Ga,**
**USF with** **Moffiet Cancer Treatment Ctr, Tampa, FL,** **and with
American Society of Breast Surgeon's courses. I** **perform** **at least
400 breast US examinations and related procedures per year** **.\]**

**There is no supervising radiologist that would be available in my
clinic and no supervising radiologist in the area that would supervise**
**these procedures**

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 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.

**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, I would have less confidence in
negative findings based biopsies in which I have not performed or
observed the targeting of the specimen. 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 772-633-0093 with questions or if I can
provide you with additional information.

Sincerely,

Reatha Williams, D.O.