CMS Pub. 100-04, ch. 16, § 10

B3-2070, B3-2070.1, B3-4110.3, B3-5114

Diagnostic X-ray, laboratory, and other diagnostic tests, including materials and the services of technicians,

are covered under the Medicare program. Some clinical laboratory procedures or tests require Food and Drug

Administration (FDA) approval before coverage is provided.

A diagnostic laboratory test is considered a laboratory service for billing purposes, regardless of whether it is

performed in:

• A physician’s office, by an independent laboratory;

• By a hospital laboratory for its outpatients or nonpatients;

• In a rural health clinic; or

• In an HMO or Health Care Prepayment Plan (HCPP) for a patient who is not a member.

When a hospital laboratory performs laboratory tests for nonhospital patients, the laboratory is functioning as

an independent laboratory, and still bills the A/B MAC (A). Also, when physicians and laboratories perform

the same test, whether manually or with automated equipment, the services are deemed similar.

Laboratory services furnished by an independent laboratory are covered under SMI 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 preventive screening service.

See the Medicare Benefit Policy Manual, Chapter 15, for detailed coverage requirements.

See the Medicare Program Integrity Manual, Chapter 10, for laboratory/supplier enrollment guidelines.

See the Medicare State Operations Manual for laboratory/supplier certification requirements.