Independent Clinical Laboratories & Clarification of Signature Issues on Requisitions
Palmetto GBA has noted, through the Comprehensive Error Rate Testing program (CERT), several areas of concern expressed by independent clinical laboratories regarding record requests sent by the CERT contractor, AdvanceMed.
The purpose of this article is to clarify the distinction between the documentation criteria used by independent clinical labs for their day-to-day operations versus what is needed in the course of a medical record review by Medicare contractors. Because certain requirements differ, reviewers must often take further steps to conclusively establish the involvement of the ordering-treating providers.
For this article, the term 'provider' means physician or qualified non-physician practitioner or NPP. NPPs include nurse practitioners, physician assistants and clinical nurse specialists.
Medicare Part B Claim Reviews: Determining Medical Necessity & Signatures/Incomplete Requisitions
When conducting medical reviews or audits of billed clinical laboratory tests rendered by an independent lab, two things will occur:
- The first is obtaining corroborating test results which show the billed services were rendered
- The second is verifying that the tests were medically necessary based upon documentation sent to the laboratory by the requesting provider
One integral component for establishing medical necessity that review contractors must pursue involves verifying the ordering-treating provider’s intent and involvement with requesting the patient’s tests. Therefore, the presence of some type of 'signed' (electronic or otherwise) order by the authorizing provider is often the simplest means by which to validate the tests performed and billed by an independent clinical laboratory. However, it is not the only means.
Independent Labs Please Note: In accordance with the "Program Integrity Manual" or PIM, CMS Publication 100-08, Chapter 3, 3.4.1.2 and 42 CFR §410.32, review contractors must first ask the billing laboratory for relevant records to establish medical necessity. It is hoped a signed order might be provided in response to this original request, because it is the simplest approach to confirm the physician’s/NPP’s intent and determine medical necessity.
Once information is obtained from a lab, a preliminary examination of these records is conducted by the reviewing entity. If lab requisitions are ambiguous and/or no valid provider signature is present, reviewers must solicit documentation directly from the ordering provider because initial attempts through the independent laboratory were unsuccessful.
Additional, substantiating records are frequently obtained directly from the ordering physician/NPP. They include provider comments/testing notations located in patients’ medical files-orders, progress notes, chart entries, etc., which do require valid signatures.
If the ordering physician/NPP fails to respond with the necessary documentation, the lab services will be denied and the independent clinical laboratory assumes financial responsibility for the overpayment. Therefore, it is imperative that lab clients such as ordering physicians, NPPs and staff understand their responsibility in documenting and establishing coverage for tests submitted to Medicare contractors.
Medicare Part B Testing/Billing Purposes: No Signature Required On Requisitions, per CMS
The basic, substantiating orders and results are usually maintained in-house by the billing laboratory. Both documents are recognized by labs, CMS and Palmetto GBA as acceptable when performing and billing the services. When required, laboratories are to supply this information for Medicare auditing purposes in accordance with 42 CFR §410.32.
- Independent clinical laboratory orders (signed or unsigned) from the ordering-treating provider and corresponding test results must support submitted Medicare Part B claims for each date of service
- A signature is not 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
- In some instances, independent clinical laboratories have their own policies making a provider’s signature mandatory for authorizing tests through their facilities
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