Question:

When do labs meet the definition of “applicable laboratory” under CLFS?

Answer:

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).

This question was answered in an edition of our Laboratory Compliance Manager. For more hot topics relating to laboratory services, please visit our store or call us at 1.800.252.1578, ext. 2.

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