Page 97 - Medicare Benefit Policy Manual

the supervision requirements applicable to their practitioner benefit category pursuant to
State scope of practice laws and under the applicable State requirements.

Because the diagnostic tests benefit category set forth in §1861(s)(3) of the Act is
separately enumerated and distinct from the “incident to” benefit category set forth in
§1861(s)(2)(A) of the Act, diagnostic tests cannot be billed to the Medicare program as
“incident to” services. Accordingly, the supervision requirements under the “incident to”
benefit category are not applicable to the diagnostic tests benefit category.

80.1 - Clinical Laboratory Services
(Rev. 79; Issued: 10-19-07; Effective: 01-01-03; Implementation: 11-19-07)

Section 1833 and 1861 of the Act provides for payment of clinical laboratory services
under Medicare Part B. Clinical laboratory services involve the biological,
microbiological, serological, chemical, immunohematological, hematological,
biophysical, cytological, pathological, or other examination of materials derived from the
human body for the diagnosis, prevention, or treatment of a disease or assessment of a
medical condition. Laboratory services must meet all applicable requirements of the
Clinical Laboratory Improvement Amendments of 1988 (CLIA), as set forth at 42 CFR
part 493. Section 1862(a)(1)(A) of the Act provides that Medicare payment may not be
made for services that are not reasonable and necessary. Clinical laboratory services
must be ordered and used promptly by the physician who is treating the beneficiary as
described in 42 CFR 410.32(a), or by a qualified nonphysician practitioner, as described
in 42 CFR 410.32(a)(3).

See section 80.6 of this manual for related physician ordering instructions.

See the Medicare Claims Processing Manual Chapter 16 for related claims processing
instructions.

80.1.1 - Certification Changes

(Rev. 1, 10-01-03)
B3-2070.1.E

Each page of the lists of approved specialties also includes a column “Certification
Changed” in which the following codes are used:

“C” indicates a change in the laboratory’s approved certification since the preceding
listing.

“A” discloses an accretion.

“TERM” - Laboratory not approved for payment after the indicated date which
follows the code. The reason for termination also is given in the following codes:

1. Involuntary termination - no longer meets requirements