CMS Pub. 100-04, ch. 16, § 40.7

B3-5114.1

Ordinarily, neither a physician nor a laboratory bills the Medicare Program for noncovered tests. However, if

the beneficiary (or his/her representative) contends that a clinical laboratory test which a physician or

laboratory believes is noncovered may be covered, the physician or laboratory must file a claim that includes

the test to effectuate the beneficiary’s right to a Medicare determination. The physician or laboratory

annotates the claim that he/she believes that the test is noncovered and is submitting it at the beneficiary’s

insistence. Before furnishing a beneficiary a test which the physician or laboratory believes is excluded from

coverage as not reasonable and necessary (rather than excluded from coverage as part of a routine physical

check-up), the physician or laboratory must obtain a signed Advanced Beneficiary Notice (ABN) from the

beneficiary (or representative) that the physician or laboratory has informed him/her of the noncoverage of the

test and that there will be a charge for the test. This protects the physician or laboratory against possible

liability for the test under the limitation of liability provision.

See Chapter 30, regarding Advance Beneficiary Notices (ABN) and demand bills.