Page 95 - Medicare Benefit Policy Manual

Section 410.32(b) of the Code of Federal Regulations (CFR) requires that diagnostic tests
covered under §1861(s)(3) of the Act and payable under the physician fee schedule, with
certain exceptions listed in the regulation, have to be performed under the supervision of
an individual meeting the definition of a physician (§1861(r) of the Act) to be considered
reasonable and necessary and, therefore, covered under Medicare.

However, effective January 1, 2021, the basic rule at 42 CFR 410.32(b)(1) requires that
diagnostic tests covered under §1861(s)(3) of the Act and payable under the physician fee
schedule must be furnished under the appropriate level of supervision by a physician as
defined in §1861(r) of the Act or, to the extent that they are authorized to do so under
their scope of practice and applicable State law, by a nurse practitioner, clinical nurse
specialist, certified nurse-midwife, certified registered nurse anesthetist or physician
assistant. Services furnished without the required level of supervision are not reasonable
and necessary.

The regulation defines these levels of supervision for diagnostic tests as follows:

General Supervision - means the procedure is furnished under the physician’s overall
direction and control, but the physician’s presence is not required during the performance
of the procedure. Under general supervision, the training of the nonphysician personnel
who actually performs the diagnostic procedure and the maintenance of the necessary
equipment and supplies are the continuing responsibility of the physician.

Direct Supervision - in the office setting means the physician (or other supervising
practitioner) must be present in the office suite and immediately available to furnish
assistance and direction throughout the performance of the procedure. It does not mean
that the physician (or other supervising practitioner) must be present in the room when
the procedure is performed.

Personal Supervision - means a physician must be in attendance in the room during the
performance of the procedure.

One of the following numerical levels is assigned to each CPT or HCPCS code in the
Medicare Physician Fee Schedule Database:

0 Procedure is not a diagnostic test or procedure is a diagnostic test which is not
subject to the physician supervision policy.

1 Procedure must be performed under the general supervision of a physician.

2 Procedure must be performed under the direct supervision of a physician.

3 Procedure must be performed under the personal supervision of a physician. (For
services rendered on or after 01/01/2019 diagnostic imaging procedures performed by
a Registered Radiologist Assistant (RRA) who is certified and registered by the
American Registry of Radiologic Technologists (ARRT) or a Radiology Practitioner