August 20, 2008

Kerry Weems

Acting Administrator

Centers for Medicare & Medicaid Services

Department of Health and Human Services

Attention: CMS--1404-P

Room 445--G, Hubert H. Humphrey Building

200 Independence Avenue, SW.

Washington, DC 20201

RE: Payment Policy for APC image guidance packaging for radiation

therapy services (CPT codes 76000, 76950, 77014, 77417, 77421)

Dear Mr. Weems:

As a Manager for a faith-based community hospital radiation oncology
department I would like to thank you for taking the time to review this
information submitted for your consideration in the development of your
APC payment policy for 2009.

Specifically I would like to point out:

1)  The CMS APC packaged payment for supportive image guidance HCPCS
    codes for CY 2008 and the continuation of this packaging through FY
    2009, specifically for those codes that are reported for supportive
    guidance in the delivery of radiation therapy, such as ultrasound,
    fluoroscopic, CT and stereoscopic services.

2)  2\) The lack of correlation between the intensity of services
    provided with the level of reimbursement and the variability of the
    cost and resource consumption during precision radiation therapy
    treatment delivery.

# [APC packaged payment]{.underline} 

The CMS APC packaged payment for supportive image guidance HCPCS codes
for CY 2008 and the continuation of this packaging through FY 2009
specifically for those codes that are reported for supportive guidance
in the delivery of radiation therapy, such as ultrasound, fluoroscopic,
CT, and stereotactic services.

Image Guided Radiation Therapy (IGRT) utilizes various imaging
technologies to account for changes in the position of the intended
target before and during treatment delivery. IGRT is used for patients
whose tumors are located near or within critical structures and with
inherent setup variations. IGRT is a distinct service, however, it is
also used and documented along with conformal treatment delivery, CPT
77402-77416

and intensity modulated radiation therapy (IMRT), CPT 77418.

Many different imaging modalities are utilized for image guided
radiation therapy.

These include the use of kV and MV imaging via stereoscopic X-ray
guidance (CPT 77421), 2D or 3D ultrasound guidance, 3D cone beam CT
guidance, tracking of respiratory motion (gaiting) via infrared cameras
or video monitoring, and 4D localization and tracking of electromagnetic
transponders. Some image guidance modalities require the implantation of
fiducial markers which also vary in complexity and expense. Other image
guidance modalities incorporate external markers, the organ itself, or
adjacent anatomic structures to reference the location of the target.

CMS has changed the status indicator from separately payable to
unconditionally packaged (status indicator "N") for the CY 2008 OPPS and
has proposed to continue this packaging through 2009. Status indicator
"N" indicates that payment is packaged into payment for other services;
however, there has been no increase in the associated APC values for the
effected independent procedures that employ the image guidance during
precision radiation therapy delivery.

## Intensity of Service vs. Level of Rreimbursement

The lack of correlation between the intensity of services provided with
the level of reimbursement and the variability of the cost and resource
consumption during precision radiation therapy treatment delivery.

CMS packaged payment for CY 2008 and proposes to continue this packaging
through FY 2009 for supportive image guidance services (such as
ultrasound, fluoroscopic, CT and stereoscopic services) required for the
safe and effective delivery of precision radiation therapy to the
patient. Although some diagnostic imaging support services may be
correctly correlated to specific independent procedures, the therapeutic
image guidance services used to enhance the precision delivery of an
independent radiation therapy procedure vary significantly in complexity
and application. Radiation therapy targeting for the specific purpose of
guiding therapy will permit localization of gross disease, microscopic
extension, and the geometric uncertainties in the delivery process.

I disagree with the therapeutic image guidance services being bundled
because none of

the imaging guidance codes can be commonly correlated with any one
specific procedure or even a few specific procedure codes. The variation
in the resource allocation required to perform the independent service
and the resultant valuation produced by the packaging of variable image
guidance services in radiation therapy causes and undervaluation of the
resultant packaged services performed during the independent procedures.

During the Advisory Panel on Ambulatory Payment Classification (APC)
Groups in

September 2007 the panel recommended that image guidance services be
packaged as proposed in the proposed rule, except for radiation oncology
image guidance procedures. CMS did not accept the APC Panel's
recommendation.

Instead, CMS has imposed the same rationale for packaging and bundling
of diagnostic services to the therapeutic services for delivery of
precision radiation therapy. Image guidance in radiation therapy
utilizes images to better appreciate the target for the radiation dose
in the tumor while simultaneously minimizing the toxicity of radiation
exposure to adjacent, healthy organs. Image guidance leads to improved
control of the tumor while reducing the potential for complications due
to radiation of healthy tissue surrounding the tumor.

CMS has incorrectly grouped image guidance procedures with diagnostic
imaging, reflected by the packaging of these codes. These modalities are
not the same and should be treated separately. In terms of the time and
costs and variability of these image guidance services, there is no
direct correlation that can reasonably be made between a specific
guidance procedure and the independent radiation therapy treatment
delivery.

Advances in radiation therapy delivery are associated with higher
technical costs and more demanding, time consuming services to ensure
the safe delivery of treatment to our patients. The packaging of imaging
services in the hospital under the HOPPS reduces the financial viability
for hospitals to reasonably cover their costs for the purchase and
maintenance of the necessary image guidance equipment for these best
practices in therapeutic radiation oncology.

I am requesting on behalf of our department and hospital that CMS to
reconsider the recommendation of its expert APC panel to exclude the
packaging of image guidance from radiation therapy services. I
appreciate the opportunity to comment on this issue. I sincerely hope
that you will give consideration to these suggestions and that CMS
unbundle the image guidance codes currently packaged with radiation
therapy in the hospital outpatient sector.

Respectfully,

Whit Sanders, MBA, RTT

Manager of Radiation Oncology

St. John's Regional Medical Center

2727 McClelland Blvd.

Joplin, MO 64804

417-625-2937

wsanders@stj.com