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CMS Preliminary Pricing for Genomic Procedures Raises Alarm Among Stakeholders
December 12, 2023After the US Centers for Medicare and Medicaid Services recently released preliminary pricing figures for genomic sequencing procedures, stakeholders across the laboratory and diagnostics industries are concerned that incentives for providing these tests will dwindle.
The recommended prices for the codes ranged between $1,759.60 and $4,375 depending on the code’s complexity and resource requirements, and a CMS advisory panel convened in July agreed with five out of six of those recommendations. Stakeholders like the American Clinical Laboratory Association, AdvaMed, the Association for Molecular Pathology, and the College of American Pathologists also supported those prices, but in releasing its preliminary pricing at the end of September, CMS bypassed the recommendation and the agency priced the codes at $597 each.
The pricing decision will affect laboratory-developed tests that do not already have PLA codes — unique codes that apply to one specific, proprietary test. Some diagnostic companies offering these tests, such as Foundation Medicine and Guardant Health, have PLA codes for their tests that are separately priced and won’t be impacted by the recent CMS decision.