CMS Pub. 100-04, ch. 19, § 80.6.1

Processing

(Rev. 1040, Issued: 08-25-06, Effective: 09-11-06, Implementation: 09-11-06)

Some clinical laboratory procedures or tests require FDA approval before coverage is

provided. Laboratory services furnished by a freestanding facility are covered under

Medicare Part B if the laboratory is an approved independent clinical laboratory.

However, as is the case of all diagnostic services, in order to be covered these services

must be related to a patient’s illness or injury (or symptom or complaint) and ordered by

a physician. A small number of laboratory tests can be covered as a screening and

preventive service. Freestanding facilities bill clinical laboratory services to the

designated A/B MAC (B).

See §80.1 of Chapter 15 of Pub. 100-02, Benefit Policy Manual, for more information on

this benefit.

See Chapter 16 of Pub. 100-04, Claims Processing Manual, for detailed claims

processing instructions.

See Pub. 100-08, Medicare Program Integrity Manual, Chapter 10, for laboratory/supplier

enrollment guidelines.

See Pub. 100-07, Medicare State Operations Manual for laboratory/supplier certification

requirements.