[Code of Federal Regulations]

[Title 42, Volume 2]

[Revised as of October 1, 2005]

From the U.S. Government Printing Office via GPO Access

[CITE: 42CFR410.33]



[Page 330-332]

 

                         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



[[Page 331]]



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 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.



[[Page 332]]



    (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]