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CMS-1403-FC
required for the TC of a pathology service. According to
the commenter, it is unclear what level of supervision of
the TC must be furnished and where it must be furnished, as
CLIA does not govern the TC of a pathology service. The
commenter suggested that we require that the TC be
supervised by a physician who meets, at a minimum, the
general supervisor requirements under CLIA, including the
requirements for the subspecialties of histopathology or
dermatopathology, as necessary.
Another commenter expressed concerns about supervision
requirements, noting that “the physician who supervised the
TC” is not defined in the proposed rule or CLIA. The
commenter suggested that the supervising physician should
meet the requirements for a laboratory director under CLIA
or use IDTF requirements. The commenter noted that, in a
separate proposal in the CY 2009 PFS proposed rule (73 FR
38533 through 38535), we proposed to require physicians
performing testing in their offices to enroll as IDTFs and
meet the IDTF requirements. Among the applicable
requirements of that proposal are that the supervising
physicians have proficiency in the testing service being
supervised and meet the specific requirements established
by medical specialty groups or carriers.
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