Applicable laboratory

Applicable laboratory means an entity that:
(1) Is a laboratory, as defined in ยง 493.2 of this chapter;
(2) Bills Medicare Part B under its own National Provider Identifier (NPI);
(i) For hospital outreach laboratories - bills Medicare Part B on the CMS 1450 under bill type 14x;
(ii) [Reserved]
(3) In a data collection period, receives more than 50 percent of its Medicare revenues, which includes fee-for-service payments under Medicare Parts A and B, prescription drug payments under Medicare Part D, and any associated Medicare beneficiary deductible or coinsurance for services furnished during the data collection period from one or a combination of the following sources:
(i) This subpart G.
(ii) Subpart B of this part.
(4) Receives at least $12,500 of its Medicare revenues from this subpart G. Except, for a single laboratory that offers and furnishes an ADLT, this $12,500 threshold -
(i) Does not apply with respect to the ADLTs it offers and furnishes; and
(ii) Applies with respect to all the other CDLTs it furnishes.


42 CFR § 414.502

Scoping language

For purposes of this subpart -

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