The final pricing decision for a set of six new CPT codes covering genomic sequencing procedures has been delayed by the agency.
Earlier this year, the US Centers for Medicare and Medicaid Services unveiled preliminary pricing figures for genomic sequencing procedures, creating a wave of concern across the laboratory and diagnostics industries. There were fears that the low reimbursement rates would hinder labs from conducting essential tests. However, CMS recently revealed its final pricing determinations for a variety of new codes, including the six genomic sequencing procedure codes, and these determinations have alleviated some of the worries previously expressed by stakeholders.
The set of new CPT codes includes a total of six codes, with three dedicated to tissue-based testing and three focused on cell-free DNA testing. The tissue codes specifically target genomic sequence analysis panels for solid organ neoplasms. Code 81457 encompasses DNA analysis and microsatellite instability, while code 81458 encompasses DNA analysis, copy number variants, and microsatellite instability. Lastly, code 81459 covers a comprehensive range of DNA analysis, combined DNA and RNA analysis, copy number variants, microsatellite instability, tumor mutation burden, and rearrangements.
The initial pricing recommendations for the new CPT codes, ranging from $1,759.60 to $4,375, were based on crosswalking, matching the new code to an existing code and assigning the same payment. However, due to backlash from stakeholders and public comments, the agency decided in November to postpone the pricing until the following year through a process called gapfilling.
According to the CMS website, Medicare administrative contractors are required to create MAC-specific gapfilled amounts for each test code and report them by April 1 of the following year. Once these prices are published on the CMS website, there will be a 60-day period for public comments on the new amounts. CMS will then accept reconsideration requests for the final gapfilled payments within a 30-day window. After the reconsideration process concludes, the payment amount becomes definitive. CMS implements local MAC-specific gapfilled amounts based on the median of final gapfilled rates for the test code across all MACs.
