[Code of Federal Regulations]
[Title 42, Volume 2]
[Revised as of October 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR410.33]

[Page 271-272]
 
                         TITLE 42--PUBLIC HEALTH
 
                    CHAPTER IV--CENTERS FOR MEDICARE
                          & MEDICAID SERVICES,
                        DEPARTMENT OF HEALTH AND
                             HUMAN SERVICES
 
PART 410_SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS--Table of Contents
 
               Subpart B_Medical and Other Health Services
 
Sec. 410.33  Independent diagnostic testing facility.

    (a) General rule. (1) Effective for diagnostic procedures performed 
on or after March 15, 1999, carriers will pay for diagnostic procedures 
under the physician fee schedule only when performed by a physician, a 
group practice of physicians, an approved supplier of portable x-ray 
services, a nurse practitioner, or a clinical nurse specialist when he 
or she performs a test he or she is authorized by the State to perform, 
or an independent diagnostic testing facility (IDTF). An IDTF may be a 
fixed location, a mobile entity, or an individual nonphysician 
practitioner. It is independent of a physician's office or hospital; 
however, these rules apply when an IDTF furnishes diagnostic procedures 
in a physician's office.
    (2) Exceptions. The following diagnostic tests that are payable 
under the physician fee schedule and furnished by a nonhospital testing 
entity are not required to be furnished in accordance with the criteria 
set forth in paragraphs (b) through (e) of this section:
    (i) Diagnostic mammography procedures, which are regulated by the 
Food and Drug Administration.
    (ii) Diagnostic tests personally furnished by a qualified 
audiologist as defined in section 1861(ll)(3) of the Act.
    (iii) Diagnostic psychological testing services personally furnished 
by a clinical psychologist or a qualified independent psychologist as 
defined in program instructions.
    (iv) Diagnostic tests (as established through program instructions) 
personally performed by a physical therapist who is certified by the 
American Board of Physical Therapy Specialties as a qualified 
electrophysiologic clinical specialist and permitted to provide the 
service under State law.
    (b) Supervising physician. (1) An IDTF must have one or more 
supervising physicians who are responsible for the direct and ongoing 
oversight of the

[[Page 272]]

quality of the testing performed, the proper operation and calibration 
of the equipment used to perform tests, and the qualification of 
nonphysician personnel who use the equipment. This level of supervision 
is that required for general supervision set forth in Sec. 
410.32(b)(3)(i).
    (2) The supervising physician must evidence proficiency in the 
performance and interpretation of each type of diagnostic procedure 
performed by the IDTF. The proficiency may be documented by 
certification in specific medical specialties or subspecialties or by 
criteria established by the carrier for the service area in which the 
IDTF is located. In the case of a procedure requiring the direct or 
personal supervision of a physician as set forth in Sec. 
410.32(b)(3)(ii) or (b)(3)(iii), the IDTF's supervising physician must 
personally furnish this level of supervision whether the procedure is 
performed in the IDTF or, in the case of mobile services, at the remote 
location. The IDTF must maintain documentation of sufficient physician 
resources during all hours of operations to assure that the required 
physician supervision is furnished. In the case of procedures requiring 
direct supervision, the supervising physician may oversee concurrent 
procedures.
    (c) Nonphysician personnel. Any nonphysician personnel used by the 
IDTF to perform tests must demonstrate the basic qualifications to 
perform the tests in question and have training and proficiency as 
evidenced by licensure or certification by the appropriate State health 
or education department. In the absence of a State licensing board, the 
technician must be certified by an appropriate national credentialing 
body. The IDTF must maintain documentation available for review that 
these requirements are met.
    (d) Ordering of tests. All procedures performed by the IDTF must be 
specifically ordered in writing by the physician who is treating the 
beneficiary, that is, the physician who is furnishing a consultation or 
treating a beneficiary for a specific medical problem and who uses the 
results in the management of the beneficiary's specific medical problem. 
(Nonphysician practitioners may order tests as set forth in Sec. 
410.32(a)(3).) The order must specify the diagnosis or other basis for 
the testing. The supervising physician for the IDTF may not order tests 
to be performed by the IDTF, unless the IDTF's supervising physician is 
in fact the beneficiary's treating physician. That is, the physician in 
question had a relationship with the beneficiary prior to the 
performance of the testing and is treating the beneficiary for a 
specific medical problem. The IDTF may not add any procedures based on 
internal protocols without a written order from the treating physician.
    (e) Multi-State entities. An IDTF that operates across State 
boundaries must maintain documentation that its supervising physicians 
and technicians are licensed and certified in each of the States in 
which it is furnishing services.
    (f) Applicability of State law. An IDTF must comply with the 
applicable laws of any State in which it operates.

[62 FR 59099, Oct. 31, 1997, as amended at 64 FR 59440, Nov. 2, 1999]