On June 30, 2011, CMS published a proposed rule to retract the policy announced in 2010 requiring the signature of a physician or qualified non-physician practitioner (NPP) on requisitions for clinical diagnostic laboratory tests.  76 Fed. Reg. 38342 (June 30, 2011).  Instead, CMS proposed to “reinstate the prior policy that the signature of the physician or NPP is not required on a requisition for Medicare purposes for a clinical diagnostic laboratory test.”  Id.at 38344.  The proposed rule follows through on CMS’s March 31, 2011 statement that it intended to retract the requirement by year’s end.  The proposed rule may be found here.

The proposed rule permits, but does not mandate, individual laboratories to require a physician’s or NPP’s signature on requisitions.  Laboratories may also ensure compliance through internal and external audits, as well as requests for medical records from physicians or NPPs.  Id.at 38346.

CMS outlined its interpretation of 42 C.F.R. § 410.32 to require signatures on requisitions for clinical diagnostic laboratory tests in last year’s Medicare Physician Fee Schedule final rule.  75 Fed. Reg. 73170, 73483 (Nov. 29, 2010).  As outlined in an April 4, 2011 Health Headlines, the final rule required that the requisition contain the physician’s (or qualified NPP’s) actual signature.  Subsequently, on December 20, 2010, CMS told contractors that due to confusion regarding the rule it would spend the first quarter of 2011 conducting an educational campaign before enforcing the regulation.  On March 31, 2011, CMS sent an email to its Provider Resource mailing list announcing that it intended to change the rule by the end of the year.  The email can be seen here.

According to CMS, it decided to change its policy after industry stakeholders “identified many scenarios where it would be difficult to obtain the physician’s or NPP’s signature.”  76 Fed. Reg. at 38344.  In addition, CMS noted that it “can see how requiring the physician or NPP to sign the paper requisition could, in some cases, be very inconvenient and disruptive to the physician, NPP, the beneficiary, and other patients.”  Id.  In summary, CMS had “underestimated the potential impact on beneficiary health and safety.”  Id. Comments on the proposed rule are due August 29, 2011.