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IDSA Expresses Concern over Palmetto GBA final LCD for Multiplex Nucleic Acid Amplified Tests for Respiratory Viral Panels

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Medicare A/B Contractor Palmetto GBA recently finalized its draft local coverage determination (LCD) for Multiplex Nucleic Acid Amplified Tests for Respiratory Viral Panels (L37713), effective Nov. 12. Although Palmetto initially proposed a non-coverage policy, arguing that “one size fits all” panels did not meet the need for Medicare’s coverage criteria of “reasonable and necessary” tests, the final LCD allows for limited coverage in susceptible populations. Specifically, the policy limits coverage to panels of 3-5 pathogens for tests ordered in a healthcare setting equipped to care for critically ill patients or for tests ordered by an infectious diseases specialist.

IDSA and other concerned stakeholders requested in a May 2018 comment letter that Palmetto allow for coverage of these assays when they are determined to be clinically warranted, and especially in three clinical scenarios: immunocompromised individuals; adult patients with acute respiratory infections in outpatient settings; and select patients who are admitted to the intensive care unit. IDSA also submitted a sign-on letter from members in Palmetto’s jurisdiction, which comprises seven states, to underscore the importance of these tests in quickly diagnosing and treating vulnerable patients.

Palmetto’s expanded coverage in certain indications is in accordance with IDSA’s recommendations. However, the Society is concerned that tests ordered in the emergency department and outpatient clinics, as well as panels of six or more pathogens, will not be covered. Also concerning is that the panels listed in the LCD all contain six or more pathogens, which implies non-coverage unless Palmetto will allow coverage when only 3-5 pathogens are reported on.

Palmetto did not post a response to public comments, which is not in accordance with CMS guidelines. IDSA has inquired about the omission and will continue to advocate for appropriate reimbursement for critical infectious diseases diagnostic tests.

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