When do labs meet the definition of “applicable laboratory” under CLFS?
According to the Clinical Laboratory Fee Schedule (CLFS) (42 C.F.R. § 493.2), a laboratory meets the definitions of “applicable laboratory” when it complies with the following:
- Bills Medicare Part B under its own National Provider Identifier (NPI), or, for hospital outreach laboratories, bills Medicare Part B on Form CMS-1450 under type of bill (TOB) 14x.
- Meets the “majority of Medicare revenues” threshold (that is, receives more than 50 percent of its Medicare revenues from one or a combination of the CLFS or the Medicare Physician Fee Schedule (PFS) in a data-collection period.
- Meets or exceeds the low-expenditure threshold (that is, it receives at least $12,500 of its Medicare revenues from the CLFS in a data-collection period).
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