A/B MAC (B) - Clinical Laboratory Services - Claims

80.6.1 - A/B MAC (B) - Clinical Laboratory Services - Claims 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.