In a previous Payment Matters article, we reported that CMS had proposed to retract its rule requiring a physician or qualified non-physician practitioner (NPP) to sign the requisition for a clinical diagnostic laboratory test. “CMS Proposes Rule on Signature on Laboratory Requisitions – A Trip Back to the Future” (July 14, 2011) The proposed rule was viewed as extremely good news by independent clinical laboratories and hospital laboratories that furnished services to non-hospital patients because of the difficulty they were having in obtaining signed requisitions from physicians and NPPs. We cautioned, however, that the proposed rule included potentially bad news – the agency did not appear willing to abandon totally the physician signature requirement. CMS indicated that, although the test requisition would not need to be signed, it would require generally that there be a signed order for a clinical laboratory test, such as a signed entry in the medical records.

The physician fee schedule final rule for calendar year 2012 [PDF] adopts the proposed rule’s provision eliminating the requirement that laboratory requisitions include a physician’s signature. CMS, however, restated its position that a clinical laboratory test must be supported by an order signed by the physician or NPP. CMS states: “The requirement that the treating physician or NPP must document the ordering of the test remains, as does our longstanding policy that requires orders, including those for clinical diagnostic laboratory tests, to be signed by the ordering physician or NPP.” This requirement could leave laboratories potentially more vulnerable than they were when CMS required a signed laboratory requisition. A laboratory that received a signed requisition knew that the physician signature requirement was satisfied. If it received an unsigned requisition, it had the opportunity to follow up with the physician’s or NPP’s office promptly and to assert that CMS required a signature on the requisition. As a result of the rule change, clinical laboratories are likely to receive fewer test requisitions that are signed by the physician or NPP, which may serve as an acceptable test order. A laboratory that performs a test based on an unsigned requisition – and which receives Medicare payment for the service – will be vulnerable to a recoupment action if the physician’s records do not include a signed test order. CMS states in the final rule that it is permissible for a laboratory to require a physician or NPP to sign a requisition. Laboratories, however, will have substantial difficulties requiring physicians to sign test requisitions, after CMS has expressly stated that they are not required to do so.