April 17, 2008 Herb B Kuhn Acting Administrator Centers for by ps94506


									April 17, 2008

Herb B. Kuhn
Acting Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS–1385-P
PO Box 8018
Baltimore, MD 21244–8018

Re:     Medicare Program; Proposed Revisions to Payment Policies Under the Physician
        Fee Schedule, and Other Part B Payment Policies for CY 2008 (CMS–1385–P)

Dear Mr. Kuhn:

The American Society for Therapeutic Radiology and Oncology, Inc. (ASTRO) 1 appreciates the
opportunity to expand on our written comments on the “Proposed Revisions to Payment Policies
Under the Physician Fee Schedule, and Other Part B Payment Policies for CY 2008” published
in the Federal Register as a proposed rule on July 12, 2007. Specifically, these comments
supplement our comments dated August 20, 2007 related to physician self-referral issues that
were raised in the proposed rule.

“Per Click” Arrangements

ASTRO supports CMS' intention to utilize its authority under section 1877(e)(1) of the Social
Security Act to disallow “per click” equipment lease arrangements. ASTRO believes per click
arrangements can lead to – and in some cases increase – improper referral incentives.

In previous comments to CMS, ASTRO expressed its general concern that the in-office ancillary
service exception has been used – even abused – by some group practices in partnership with for-
profit business entities whose business model involves “dropping” highly sophisticated, often
unintegrated, designated health services into these group practices, frequently at remote
locations. These arrangements encourage specialty service referrals by non-radiation oncology
trained physicians based on financial considerations. As part of these referral incentive

 ASTRO is the largest radiation oncology society in the world, with nearly 9,000 members who specialize
in treating patients with radiation therapies. As the leading organization in radiation oncology, biology
and physics, the Society is dedicated to improving patient care through education, clinical practice,
advancement of science and advocacy.
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April 17, 2008
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packages, group practice physicians are also sometimes invited by venture sponsors to become
joint owners in an equipment leasing entity. The physicians’ capital contribution for their
equipment company ownership rights may be quite nominal. The physician-owned leasing
entity, created by the for-profit sponsor, then leases back to the group practice highly specialized
equipment on a per click basis. When the leased equipment has been fully depreciated and all
profit benefits extracted, the equipment is then sold or simply returned back to its manufacturer,
sometimes at an additional “buy back” profit.

ASTRO's previous comments to CMS focused solely on the use of the in-office ancillary service
exception to cover “dropped in” radiation therapy services into another specialized practice.
Radiation therapy services comprise a sophisticated, specialized and complex array of treatment
alternatives performed by highly trained expert staff utilizing very expensive, technical
equipment. We have previously advised CMS that we disagree strenuously with the notion that
these sophisticated services could somehow comprise “ancillary” services, thereby qualifying for
coverage under the in-office ancillary services exception. When radiation therapy services are
dropped into a group practice through use of this exception, and non-specialists are offered the
opportunity to participate in per click equipment lease of, for example, an expensive linear
accelerator, this combination of financial relationships only adds to a business environment
which encourages referrals motivated by profit. Such referral activity often occurs to the
detriment of patient choice and a sober evaluation of treatment alternatives.
ASTRO understands that per click arrangements may be established at “fair market value rates,”
and therefore, under Stark definitions, may not be considered to technically comprise
compensation paid “based upon the volume or value of referrals.” This seems ironic, since even
“fair market value” per click arrangements permit the leasing company to make a commercially
reasonable per-referral profit in addition to covering the actual costs involved in the ownership
and operation of the equipment itself. When physicians control the referrals and the equipment,
the direct connection between referrals and per click profit could not be clearer.
For these reasons, we support CMS' reconsideration of the appropriateness of time-based and
unit of service-based payment models for space and equipment leases. A careful reevaluation of
the consequences of such arrangements – including overutilization – is most appropriate before
their future use is permitted. Indeed, among the various compensation arrangements now
“excepted” under Stark, ASTRO believes per click arrangements, where compensation is based,
by definition, precisely on the number of referrals made – are uniquely susceptible to the very
abuse the Stark Law was intended to eliminate.

Overuse of Therapeutic Treatments

The American Cancer Society estimates that 186,320 new prostate cancer diagnoses would be
made in 2008. Due to increased early detection rates made possible through prostate-specific
antigen (PSA) testing, more than 90% of all prostate cancers are now discovered in the local and
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April 17, 2008
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regional stages. The 5-year survival rate for these patients whose tumors are diagnosed at these
early stages approaches 100%. While prostate cancer accounts for 25% of all cancer diagnoses
in men, it is the cause of only 10% of cancer-related deaths in men. 2

Part of this favorable survival rate is related to early detection; the other part is related to the
reliable treatment options that are available for prostate cancer patients. On February 4, 2008,
the Agency for Healthcare Research and Quality (AHRQ) released its report “Comparative
Effectiveness of Therapies for Clinically Localized Prostate Cancer.”3 In this report, AHRQ
states, “no one therapy can be considered the preferred treatment for localized prostate cancer
due to limitations in the body of evidence as well as the likely tradeoffs an individual patient
must make between estimated treatment effectiveness, necessity and adverse effects.” ASTRO
supports AHRQ’s conclusion that the treatment options for localized prostate cancer –
prostatectomy, external beam radiation therapy (IMRT), and brachytherapy – are equivalent
treatments. Thus, the right treatment for any particular prostate cancer patient depends on his
interests, age, concerns, disease status, and physiology. There are times when the best treatment
might be no treatment at all. For example, a 75 year old man with a low PSA may decide to
monitor to see if there is disease progression.

While some may argue that therapeutic services cannot be overused, we are concerned that
because of inappropriate financial incentives, prostate cancer patient choice is being significantly
eroded and treatment overutilization may be occurring. Specifically, our members report
allegations of instances where patients who might otherwise be appropriately monitored for
disease progression (i.e., watchful waiting) are being treated in urology practices that drop
radiation therapy services (IMRT) into their practices via the in-office ancillary exception. Thus,
patients who might otherwise choose to monitor disease progression are undergoing significant
treatments because of the diagnosing physician’s financial incentives. In instances where disease
progression is quite limited, these services may be unwarranted.

Additionally, we have received allegations that because of the financial incentive to use “in-
office” ancillary services, those practices that choose to drop radiation therapy services into their
practice may prescribe external beam radiation (IMRT) to the vast majority, if not all of their
patients. Thus, patients who might otherwise choose to undergo a prostatectomy or who would
choose brachytherapy as the preferred treatment no longer have the choice among options. In
this instance, there is overuse of one particular treatment modality over other equally appropriate
options due to the financial incentives of the diagnosing physician. All patients facing the
diagnosis of cancer face a great deal of uncertainty about their future. Every patient deserves to
have all treatment options, with their associated risks and benefits carefully spelled out for them
by their physician. Patients should not be steered to a specific treatment because the physician
has a financial incentive.
    American Cancer Society. Cancer Facts & Figures 2008. Atlanta: American Cancer Society; 2008.
    AHRQ Publication No. 08-EHC010-EF, February 2008
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We look forward to working with CMS in the future as the agency considers further revisions to
the self-referral provisions. As stated in our previous comments, ASTRO strongly believes that
radiation therapy services are not ancillary services and therefore should not be included in the
group of designated health services which qualify for coverage in the “in-office ancillary
services” exception. Radiation therapy services are a distinct service within the cancer treatment
continuum, not ancillary services such as lab tests.

If you have any questions, or if ASTRO can provide you with further analysis or examples of
arrangements that are of concern, please feel free to contact Laura Gogal, ASTRO General
Counsel at (703) 839-7306.


Laura I. Thevenot
Chief Executive Officer

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