CMS Pub. 100-04, ch. 16, § 40.4

SNF 541, A3-3137.1, HO-437, B3-5114.1

When a SNF furnishes laboratory services directly, it must have a Clinical Laboratory Improvement Act

(CLIA) number or a CLIA certificate of waiver, and the laboratory itself must be in the portion of the facility

so certified. Normally the A/B MAC (A) makes payment under Part B for clinical laboratory tests only to the

entity that performed the test. However, the law permits SNFs to submit a Part B claim to the A/B MAC (A)

for laboratory tests that it makes arrangements for another entity to perform on the SNF’s behalf. Section

1833(h)(5) of the Act (as enacted by The Deficit Reduction Act of 1984, P.L. 98-369) requires the

establishment of a fee schedule for clinical laboratory tests paid under Part B and also requires that, with

certain exceptions, only the entity that performed the test may be paid.

The fee schedule applies to all SNF clinical laboratory services.

Where a SNF operates a laboratory that provides laboratory services to patients other than its own patients, it

is functioning as a clinical laboratory. The billing for these laboratory services depends upon the HCPCS code

as defined in the CMS annual fee schedule releases (laboratory and MPFS), and the arrangements made for

payment with the referring entity (e.g., does the SNF or the referring entity bill under the agreement between

the two). The SNF is responsible for ascertaining the necessary information for billing the A/B MAC (A).

Any questions must be referred to the A/B MAC (A).