Compliance Alert 

Be Sure You Can Document Medical Necessity of COVID-19 ‘Add-On Tests’

Memo to Lab Compliance Managers: Brace yourself for what may become the next big federal false billing crackdown against labs, specifically labs performing COVID-19 tests. The OIG has let it be known that it suspects that labs may be taking advantage of the unprecedented demand for COVID-19 testing to bill Medicare for high reimbursing and medically unnecessary add-on tests. As a result, one of the new items listed in the agency’s June work plan is an investigation of recent test billings to confirm whether its suspicions are warranted.

What the OIG Is Worried About

The objective of COVID-19 testing is to determine whether an individual has the virus. However, as the OIG points out in the work plan item, labs can also perform add-on tests, e.g., to confirm or rule a diagnosis other than COVID-19. In the new work plan item expresses, the agency says it has “program integrity concerns” related to add-on tests in conjunction with COVID-19, particularly the potential of fraudulent billing for associated respiratory pathogen panel (RPP) tests, allergy tests or genetic tests.

The OIG Game Plan

To address these concerns, the OIG plans to perform a study analyzing Medicare claims data for lab testing to identify trends in the use of RPP, allergy and genetic testing and identify billing patterns indicating that labs may be committing fraud and abuse.

How to Protect Yourself—Do a 3-Part Medical Necessity Documentation Audit

If your lab is performing tests in conjunction with COVID-19 testing, be sure that you have clear and complete records documenting that those tests are medically necessary for the particular patient. Consider performing an internal audit to verify you have the documentation to satisfy not just Medicare Administrative Contractors but private payors of the medical necessity of those tests, focusing on the following three core elements.

  1. Document Test Order

 The first key element to support medical necessity is documentation that the treating physician ordered the test, which may include:

  • A signed requisition;
  • An electronic signature through email; or
  • Signed documentation in the patient’s chart.


Caveat: Documenting orders for add-on tests will be tricky due to the fact that during the public health emergency CMS has relaxed the rules requiring an order from the treating physician or nonphysician practitioner (NPP) for COVID-19 tests. And, according to the OIG, relaxation of physician ordering/NPP rules gives “unscrupulous actors more leeway for fraudulent billing of unnecessary add-on testing.” If you don’t have any of the three forms of documentation listed above, you may need to get a signed attestation from the ordering physician or NPP documenting the test order.

  1. Document Need for the Test

Make sure you have documentation that the test is medically necessary. The patient’s medical record must contain information indicating why not just the COVID-19 test but all of the additional tests performed to rule out or confirm a COVID-19 diagnosis is necessary. Don’t offer such tests in automatic, prepackaged panels because it will raise a bright red flag with the OIG.  Simply putting a statement on your requisition forms that declares that the physician/NPP agrees that by ordering the COVID-19 test, he/she considers the additional tests as medically necessary won’t work, either. Remember, it’s not the recitation of the sentence that’s important but the reason why it’s medically necessary.

  1. Document Use of Test Results

Last but not least, you need documentation of the usage of the test results. Medicare and other payors will likely want to see documentation of review and/or use of the information by the ordering physician/NPP. After all, if the physician didn’t need to review and act on the test results, the payor is apt to question whether the test was medically necessary.


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