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CMS Sets Reimbursement Rates for SARS-CoV-2 Serology Tests

NEW YORK – The US Centers for Medicare & Medicaid Services announced on Tuesday new reimbursement rates for SARS-CoV-2 serology tests.

Tests billed under CPT code 86769 are reimbursed for $42.13, and tests billed under code 86328 are paid at $45.23. Code 86769 is for SARS-CoV-2 antibody tests with multiple-step methods, while 86328 should be billed for antibody tests with a single-step method immunoassay, such as a reagent strip. At the end of last month, CMS announced it would cover serology tests but did not set the reimbursement rates.

American Clinical Laboratory Association President Julie Khani released a statement following the news, saying the new rates "will encourage a broad cross section of laboratories to rapidly scale up capacity for accurate and reliable serologic testing for SARS-CoV-2."

Khani added that the "lack of sufficient reimbursement" for molecular SARS-CoV-2 tests was "a barrier to entry for many laboratories." In April, CMS increased payment rates for high-throughput SARS-CoV-2 diagnostic tests to $100 from previous rates between $35.91 and $51.33, depending on the test. The agency also released guidance last month requiring private insurers to cover diagnostic and serology tests for SARS-CoV-2 without cost sharing.

There have been concerns over the reliability of serology tests, leading the US Food and Drug Administration to tighten validation requirements for antibody tests receiving Emergency Use Authorization.  

Currently, 12 serology tests have received EUA from the FDA, including those from Abbott, Roche, Bio-Rad Laboratories, and Cellex