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CMS Postpones Final Pricing Decision on Genomic Sequencing Procedure Codes

NEW YORK – The US Centers for Medicare and Medicaid Services last month said that it has postponed its final pricing decision for a set of six new CPT codes covering genomic sequencing procedures. 

Earlier this year, the agency released preliminary pricing figures for the code set that raised concerns among stakeholders due to fears the low reimbursement would prohibit laboratories from performing tests. Late last month, CMS released its final pricing determinations for a variety of new codes, including the six genomic sequencing procedure codes, and eased some of those concerns. 

The new CPT codes included three codes for tissue-based testing and three for cell-free DNA testing — the tissue codes cover genomic sequence analysis panels of solid organ neoplasms with interrogation for sequence variants. Code 81457 includes DNA analysis and microsatellite instability, while code 81458 covers DNA analysis, copy number variants, and microsatellite instability. Code 81459 covers DNA analysis or combined DNA and RNA analysis, copy number variants, microsatellite instability, tumor mutation burden, and rearrangements. 

The cfDNA codes, meantime, are for genomic sequence analysis panels of solid organ neoplasms using cell-free nucleic acid with interrogation for sequence variants. Code 81462 encompasses DNA analysis or combined DNA and RNA analysis, copy number variants, and rearrangements; code 81463 covers DNA analysis, copy number variants, and microsatellite instability; and code 81464 includes DNA analysis or combined DNA and RNA analysis, copy number variants, microsatellite instability, tumor mutation burden, and rearrangements.

The recommended prices for those new CPT codes when they were adopted ranged between $1,759.60 and $4,375 depending on the code's complexity and the resource requirements. Those recommended prices were determined by crosswalking, or matching them to another code on the market, and assigning the new code the same payment as the existing code. In this case, the six new CPT codes were recommended for crosswalking to the existing code 81455, which covers a panel analyzing more than 50 genes, with additional modifications depending on other attributes being analyzed. 

An advisory panel convened in June agreed with five of the six recommended prices, but in its preliminary pricing determination, CMS priced the codes at $597 each — crosswalking the codes to existing code 81445, for a panel analyzing between five and 50 genes. In its decision, the agency said it "does not see justification in crosswalking to a code that specifies analyzing more than 50 genes."

After an outcry from stakeholders, including laboratories, professional organizations, and patient advocates, and a review of several public comments, the agency in November decided to postpone its pricing until next year in a process called gapfilling. Gapfilling a code involves reaching out to each CMS jurisdiction and gathering data on what the price of a code should be, then coming to a final determination next year. Gapfilling the codes would allow the resources used in the codes to "be better estimated by a Medicare administrative contractor," CMS said.

According to the agency's website, CMS requests that its Medicare administrative contractors develop MAC-specific gapfilled amounts for each test code and report the amount by April 1 of the following year. Once those prices are reported, CMS posts the prices on its website and accepts public comments on the new amounts for 60 days. After CMS posts the final amounts, it will accept reconsideration requests on the final gapfilled payments for 30 days, but when the reconsideration process ends for the gapfilling schedule, the payment amount is final, it said.

CMS noted that it implements local MAC-specific gapfilled amounts based on the median of final gapfilled rates for the test code across all MACs.