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Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests


CMS describes the levels of physician supervision required for furnishing the technical component of diagnostic tests for a Medicare beneficiary who is not a hospital inpatient or outpatient. Section 410.32(b) of the Code of Federal Regulations (CFR) requires that diagnostic tests covered under Sec.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 (Sec.1861(r) of the Act) to be considered reasonable and necessary and, therefore, covered under Medicare. The regulation defines these levels of physician 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 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 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.

4 Physician supervision policy does not apply when procedure is furnished by a qualified, independent psychologist or a clinical psychologist or furnished under the general supervision of a clinical psychologist; otherwise must be performed under the general supervision of a physician.

5 Physician supervision policy does not apply when procedure is furnished by a qualified audiologist; otherwise must be performed under the general supervision of a physician.

6 Procedure must be performed by a physician or by a physical therapist (PT) who is certified by the American Board of Physical Therapy Specialties (ABPTS) as a qualified electro physiologic clinical specialist and is permitted to provide the procedure under State law.

6a Supervision standards for level 66 apply; in addition, the PT with ABPTS certification may supervise another PT but only the PT with ABPTS certification may bill.

7a Supervision standards for level 77 apply; in addition, the PT with ABPTS certification may supervise another PT but only the PT with ABPTS certification may bill.

9 Concept does not apply.

21 Procedure must be performed by a technician with certification under general supervision of a physician; otherwise must be performed under direct supervision of a physician.

22 Procedure may be performed by a technician with on-line real-time contact with physician.


66 Procedure must be performed by a physician or by a PT with ABPTS certification and certification in this specific procedure.

77 Procedure must be performed by a PT with ABPTS certification or by a PT without certification under direct supervision of a physician, or by a technician with certification under general supervision of a physician.

Nurse practitioners, clinical nurse specialists, and physician assistants are not defined as physicians under Sec.1861(r) of the Act. Therefore, they may not function as supervisory physicians under the diagnostic tests benefit (Sec.1861(s)(3) of the Act). However, when these practitioners personally perform diagnostic tests as provided under Sec.1861(s)(2)(K) of the Act, Sec.1861(s)(3) does not apply and they may perform diagnostic tests pursuant to State scope of practice laws and under the applicable State requirements for physician supervision or collaboration. Because the diagnostic tests benefit set forth in Sec.1861(s)(3) of the Act is separate and distinct from the incident to benefit set forth in Sec.1861(s)(2) of the Act, diagnostic tests need not meet the incident to requirements. Diagnostic tests may be furnished under situations that meet the incident to requirements but this is not required. However, carriers must not scrutinize claims for diagnostic tests utilizing the incident to requirements.

Reference: http://www.cms.gov/ClinicalLabFeeSched/

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