2006 proposed fee schedule - American Society of Clinical Oncology

2006 proposed fee schedule - American Society of Clinical Oncology 2006 proposed fee schedule - American Society of Clinical Oncology

19.02.2013 Views

excluding screening mammography)” as described in section 1833(a)(2)(E)(i) of the Act. For these reasons, we believe that the Congress 298 intended “radiology services” in section 1877(h)(6) of the Act to include diagnostic and therapeutic nuclear medicine. While we believe that diagnostic nuclear medicine is a subset of radiology, even if it is not, it is an imaging service covered by 1861(s)(3) of the Act, and of the type that the Congress intended to prohibit. Similarly, we believe it is proper to interpret the DHS category described in section 1877(h)(6)(E) of the Act, “radiation therapy services and supplies” to include therapeutic nuclear medicine services. Radiation therapy is the treatment of disease (especially cancer) by exposure to radiation from a radioactive substance. Therapeutic nuclear medicine employs radioactive substances known as radionuclides. Medicare covers therapeutic nuclear medicine services and other forms of radiation therapy under section 1861(s)(4) of the Act, which authorizes coverage and payment for “X-ray, radium, and radioactive isotope therapy.” Although our proposal to include as DHS diagnostic nuclear medicine services and therapeutic nuclear medicine services and supplies is based primarily on our view that nuclear medicine services are radiology and radiation therapy within the meaning of section 1877(h)(6) of the Act,

we would resolve any doubt on the matter in favor of our 299 proposal because of the risk of abuse and anti-competitive behavior inherent in physician self-referrals for nuclear medicine services. The risk of abuse and anti- competitiveness is exacerbated by the greater affordability of nuclear medicine equipment, by our expansive coverage of nuclear medicine services, and by the setting in which mostly diagnostic and some therapeutic nuclear medicine services now are primarily performed. At the time we were preparing the Phase I final rule, the vast majority of nuclear medicine procedures were already subject to the physician self-referral prohibition because they were primarily performed in hospital facilities rather than in physician-owned freestanding facilities. Thus, they were performed as inpatient or outpatient hospital services and were therefore DHS subject to the self-referral prohibition in accordance with section 1877(h)(6)(K) of the Act. Since publication of the Phase I final rule, however, many more nuclear medicine procedures have been performed in physician offices or in physician-owned freestanding facilities. This has occurred for several reasons. First, positron emission tomography (PET) scanners may be used outside of a hospital setting. Second, there have been significant technological advances; an entity does not have to own a particle accelerator to

we would resolve any doubt on the matter in favor <strong>of</strong> our<br />

299<br />

proposal because <strong>of</strong> the risk <strong>of</strong> abuse and anti-competitive<br />

behavior inherent in physician self-referrals for nuclear<br />

medicine services. The risk <strong>of</strong> abuse and anti-<br />

competitiveness is exacerbated by the greater affordability<br />

<strong>of</strong> nuclear medicine equipment, by our expansive coverage <strong>of</strong><br />

nuclear medicine services, and by the setting in which<br />

mostly diagnostic and some therapeutic nuclear medicine<br />

services now are primarily performed.<br />

At the time we were preparing the Phase I final rule,<br />

the vast majority <strong>of</strong> nuclear medicine procedures were<br />

already subject to the physician self-referral prohibition<br />

because they were primarily performed in hospital facilities<br />

rather than in physician-owned freestanding facilities.<br />

Thus, they were performed as inpatient or outpatient<br />

hospital services and were therefore DHS subject to the<br />

self-referral prohibition in accordance with section<br />

1877(h)(6)(K) <strong>of</strong> the Act. Since publication <strong>of</strong> the Phase I<br />

final rule, however, many more nuclear medicine procedures<br />

have been performed in physician <strong>of</strong>fices or in<br />

physician-owned freestanding facilities. This has occurred<br />

for several reasons. First, positron emission tomography<br />

(PET) scanners may be used outside <strong>of</strong> a hospital setting.<br />

Second, there have been significant technological advances;<br />

an entity does not have to own a particle accelerator to

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