by Jared Staheli
June 25th, 2015
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 carrier.
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.