LCD Alert: Multiplex Nucleic Acid Amplified Tests for Respiratory Viral Panels During the COVID-19 PHE (Noridian and Palmetto)
Issue: Covered under limited circumstances
Introduction and Disclosure: Lighthouse RCM Solutions is a revenue enhancement and laboratory coding auditing firm that provides consultation to US based laboratories. In our normal course of business and engaging with our clients, we are accustomed to researching topics that will have a direct negative impact on either their revenue or compliance programs.
Synopsis: Upon having conversations with our clients and colleagues in both the Noridian and Palmetto MACs, it has come to our attention that there is confusion in regards to reimbursement as it pertains to multiplex NAATs for Respiratory Viral Panels (RVP), CPTs 87631, 87632, and 87633 for example) while under the national Public Health Emergency (PHE) for the COVID-19 pandemic.
As the nation came under the PHE on March 13, 2020, it was recognized early on that there would be a need to distinguish between SARS-CoV-2/19 and other viral respiratory pathogens. Eager to fill the void of testing to properly identify disease etiology, many labs rose to the challenge of either acquiring an FDA EUA molecular assay or developing their own LDT to aid in the diagnosis of COVID-19. These labs also foresaw the need of being able to properly rule out other diseases.
Under the CARES Act, passed into legislation on March 27, 2020, the rules for reimbursing COVID-19 testing were established and appropriate CPT codes were assigned. As we saw in COVID-19, Influenza, and RSV Clinical Diagnostic Laboratory Tests for which Medicare Does Not Require a Practitioner Order During the PHE published by CMS on May 5th, 2020, they identify the extensive list of tests that DO NOT REQUIRE A PRACTITIONER ORDER and proceed to asterisk the page with: Other Medicare conditions of coverage and payment continue to apply, including any applicable local coverage determinations. This point, too, is again reinforced in the CMS FAQs in response to question 11 on page 8 where it states: The table should not be interpreted as a statement of coverage for the listed codes. There may be some codes for which there are local coverage determinations that non-cover or limit coverage of certain tests.
However, even under the broad rules and blanket waivers that have been issued, the Act left in place the current and restrictive measures as they pertain to performing NAATs for RVPs. The most restrictive to this particular audience has to do with the place of service description listed in the LCD on page 4 in the first two sentences of the first paragraph: These codes are covered under limited circumstances. They may be billed in places of service 20, 21, or 23 (Urgent care, Inpatient hospital, or Emergency room respectively) by a provider of any medical specialty for whom the ordering of this test is within the provider’s scope of practice and institutional privileges. To further restrict reimbursement of independent laboratories, the LCD continues with: Outside of one of these places of service, the test must be ordered by an infectious disease specialist who is diagnosing and treating the beneficiary.
To help address the issue of independent laboratories, CAP, AMP and other professional organizations penned a letter to CMS Administrator on April 28th, 2020, asking for relief in providing this valuable service. Citing the need to curb the tide of COVID and the possible reemergence of the virus, they state, “it is critical that laboratories be well equipped with an appropriately comprehensive laboratory test menu and for this to be feasible they must be reimbursed commensurate with the resources required to provide such testing.”
Results and Impacts: We are now seeing a number of our clients discontinue this panel type testing, but we are also seeing some of our clients continue RSV testing, and they are being reimbursed at their own peril. We have weighed in that these codes are non-covered, even during the PHE.
The resulting health and economic impact will be substantial. Without adequate viral testing, patients and their families will receive inadequate health information. Our lab clients are already calculating revenue decreases that will not be offset by COVID-19 testing alone.
We are very interested in knowing how many NILA member laboratories are offering these respiratory panels, or have stopped offering respiratory panels because of these reimbursement issues, or have decided not to offer these respiratory panels because of the uncertainty of reimbursement for the respiratory panels.
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