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Notice: This CMS-approved document has been submitted - Philips ... Notice: This CMS-approved document has been submitted - Philips ...
CMS-1403-FC 1, 2008), we stated that we planned to issue clarifying guidance as to what constitutes the “office of the billing physician or other supplier” within the following 12 months (73 FR 405). We proposed the clarification and other revisions in the CY 2009 PFS proposed rule in order to introduce the possible changes under consideration. The revisions being finalized in this regulation stem from that proposal and we believe that sufficient time has been given for consideration of and response to the anti-markup revisions. Irrespective of whether “pod lab” arrangements otherwise would continue to exist or proliferate, we believe that the anti-markup provisions are needed in order to address potential program and patient abuse through the ordering of unnecessary diagnostic tests. Although several commenters made mention of MIPPA and the impact that it may have, we are not swayed by these arguments. MIPPA is a separate authority with a different focus than that of the anti-markup provisions. If, in the future, the anti-markup provisions are impacted through our implementation of MIPPA, we will address this in subsequent rulemaking. j. Miscellaneous Comment: One commenter, a professional association of pathologists, suggested an exception from the anti-markup 512
CMS-1403-FC provisions for single-specialty pathology physician groups and independent laboratories. The commenter suggested that such entities be defined as those in which all physicians within the group are pathologists and for which 75 percent of all CPT codes billed by the entity are pathology and laboratory CPT codes. According to the commenter, such an exception would “clarify” that dedicated pathology groups and independent laboratories are not subject to the anti- markup provisions for certain purchased diagnostic tests and interpretations or the ordering of special stains to perform better the tests ordered by outside, independent physicians. The commenter asserted that its proposed exception would be consistent with the physician self- referral’s exclusion from the definition of “referral” for services ordered by pathologists (and radiologists and radiation oncologists) pursuant to a consultation with another physician. According to the commenter, the exclusion from the definition of “referral” reflects the Congress’s recognition that services ordered by such physicians pursuant to a consultation with another physician do not pose the same risk of abuse that physician self-referral generally poses. The commenter also suggested an alternative to its proposed exception, for independent laboratories for which at least 75 percent of 513
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<strong>CMS</strong>-1403-FC<br />
provisions for single-specialty pathology physician groups<br />
and independent laboratories. The commenter suggested that<br />
such entities be defined as those in which all physicians<br />
within the group are pathologists and for which 75 percent<br />
of all CPT codes billed by the entity are pathology and<br />
laboratory CPT codes. According to the commenter, such an<br />
exception would “clarify” that dedicated pathology groups<br />
and independent laboratories are not subject to the anti-<br />
markup provisions for certain purc<strong>has</strong>ed diagnostic tests<br />
and interpretations or the ordering of special stains to<br />
perform better the tests ordered by outside, independent<br />
physicians. The commenter asserted that its proposed<br />
exception would be consistent with the physician self-<br />
referral’s exclusion from the definition of “referral” for<br />
services ordered by pathologists (and radiologists and<br />
radiation oncologists) pursuant to a consultation with<br />
another physician. According to the commenter, the<br />
exclusion from the definition of “referral” reflects the<br />
Congress’s recognition that services ordered by such<br />
physicians pursuant to a consultation with another<br />
physician do not pose the same risk of abuse that physician<br />
self-referral generally poses. The commenter also<br />
suggested an alternative to its proposed exception, for<br />
independent laboratories for which at least 75 percent of<br />
513