ASCP Supports COVID-19 Reporting Requirement with Changes

On Nov. 2, ASCP submitted comments on the recent Interim Final Rule on COVID-19 test reporting. The regulation, which was published in the Federal Register on Sept. 2, changes the Centers for Medicare and Medicaid Services (CMS) COVID-19 reporting requirement for COVID-19. The new requirement alters the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations to require all laboratories—including Certificate of Waiver laboratories—to report SARS-CoV-2 test results to the Department of Health and Human Services within 24 hours of test performance. Under the new policy, laboratories are required to report both positive and negative SARS-CoV-2 results, regardless of test method used. Hospitals, critical access hospitals and long-term care facilities will also now have to provide more detailed reporting information on COVID-19 patients. For more details on the rule, click here.

In comments to CMS, ASCP agreed with CMS that securing more comprehensive data would better inform federal, state, local and tribal responses to the pandemic, though ASCP urged several changes to lessen the compliance burden/costs. ASCP urged that the federal government to provide funding to offset the COVID-19 test reporting requirement in a supplemental appropriations bill or by increasing payment for COVID-19 testing.

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