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The reimbursement rates for the most commonly performed SARS-CoV-2 serologic tests are $42.13 and $45.23, depending on the billing code used.
The cell collection device already has FDA clearance, while the firm intends to conduct trials in support of a filing for marketing clearance of the assay.
Proposals from ACLA, CAP, and others included statistical sampling to collect hard-to-capture lab pricing data from across the industry.
Questions posed by CMS about expanding PAMA data collection expose a rift between labs and other industry stakeholders over who should report lab prices.
Since last year the AMA has issued 23 PLA codes for firms that want to better track use of their tests, but the effect of the codes on improving reimbursement remains to be seen.
The Human Diagnosis Project recently brought in partners in an effort to expand specialty care to underserved populations across the US and measure outcomes.
The AMA noted that since 2014 more than 6,000 doctors have helped generate about 10 million clinical data points in the Human Dx system.
The panel's decisions could change the codes diagnostic companies use to bill payors for these tests, which could affect revenue.