Corporate Compliance

CMS issues transmittal on physician signature requirements

Medicare Weekly Update, September 3, 2008

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As reported below, CMS issued a transmittal last week (Change Request 6100) updating Section 80.6.1 of Chapter 15 of the Medicare Benefit Policy Manual to clarify the physician signature requirements for diagnostic tests. The revised manual section states:

NOTE: No signature is required on orders for clinical diagnostic tests paid on the basis of the clinical laboratory fee schedule, the physician fee schedule, or for physician pathology services.

I have two comments about this change. First, although clinical diagnostic lab tests furnished to hospital outpatients are generally paid under the clinical laboratory fee schedule, it is not entirely clear to me that CMS intends for Section 80.6.1 to apply to tests furnished to hospital patients. Although not clear, I suspect that Section 80.6.1 is intended to provide interpretative guidance on 42 CFR § 410.32, which provides conditions of coverage for “diagnostic x-ray tests, diagnostic laboratory tests, and other diagnostic tests.” For many years, CMS has taken the position that the conditions of coverage set forth in 42 CFR § 410.32 do not apply in a hospital setting. In the 1998 Physician Fee Schedule final rule, CMS stated:

Comment: Several commenters requested clarification of the applicability of the diagnostic test ordering provision, adopted in the final rule of November 22, 1996, to diagnostic procedures performed in hospital settings: the responses to comments seemed to indicate that, although the intent of the new policy was primarily directed at nonhospital testing, the requirement applied in all settings.
 
Response: The policy was set forth in §410.32, which generally addresses diagnostic tests covered under section 1861(s)(3) of the Act and payable by Part B carriers rather than fiscal intermediaries. Regulations other than §410.32 govern the coverage of diagnostic tests furnished to hospital patients, which are payable through fiscal intermediary payment mechanisms. Specifically, the coverage of diagnostic tests furnished to hospital outpatients is addressed in §410.28, and the coverage of diagnostic tests furnished to hospital inpatients is addressed in §409.16. Therefore, the test ordering policy adopted in the final rule of November 22, 1996, effective for procedures furnished beginning January 1, 1997, does not apply to diagnostic tests furnished in hospitals.[1]

Second, even if CMS really does intend for Section 80.6.1 to apply in a hospital setting, it seems to me that hospitals should be cautious about performing lab tests without a signed order. Even if CMS does not require a signed order, it is possible that there may be some accreditation requirement or state regulatory provision requiring signed orders for lab tests.


 

[1] Note, however, that 42 CFR § 410.28(f) states that, “The rules for clinical diagnostic laboratory tests set forth in §§410.32(a) and (d)(2) through (d)(4) of this subpart are applicable to those tests when furnished in hospitals and CAHs.” Also, CMS stated in the “Business Requirements Table” of Change Request 6100 that the “FIs” have some implementation responsibility in connection with the Change Request.

 



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