The laboratory sector is awaiting how the Medicare program will price 21 codes for whole genome and exome sequencing procedures, providing some insight as to how much they will receive from both public and private payers for the often complex assays and panels. The codes, which cover CPT numbers 81410 through 81471, include some highly esoteric tests, such as tests for Marfan syndrome, Loeys Dietz syndrome, and Ehlers-Danlos syndrome. However, it also includes tests for fetal chromosomal aneuploidy and circulating cell-free fetal DNA in maternal blood. The tests are currently being paid via the gapfill process, using previously priced codes for specific molecular tests. It is up to the regional Medicare Administrative Contractors, or MACs, to price the codes. The MACs are supposed to submit their initial pricing this month, and the Centers for Medicare & Medicaid Services would likely release them later this spring. The prices would take effect next year. Unlike the prior molecular codes whose prices were set two years ago, the MACs have the option of only submitting the codes they plan to cover for reimbursement in their respective regions. Codes for fetal testing are likely to be excluded by Medicare on statutory principles. However, the […]
The laboratory sector is awaiting how the Medicare program will price 21 codes for whole genome and exome sequencing procedures, providing some insight as to how much they will receive from both public and private payers for the often complex assays and panels.
The codes, which cover CPT numbers 81410 through 81471, include some highly esoteric tests, such as tests for Marfan syndrome, Loeys Dietz syndrome, and Ehlers-Danlos syndrome. However, it also includes tests for fetal chromosomal aneuploidy and circulating cell-free fetal DNA in maternal blood. The tests are currently being paid via the gapfill process, using previously priced codes for specific molecular tests.
It is up to the regional Medicare Administrative Contractors, or MACs, to price the codes. The MACs are supposed to submit their initial pricing this month, and the Centers for Medicare & Medicaid Services would likely release them later this spring. The prices would take effect next year.
Unlike the prior molecular codes whose prices were set two years ago, the MACs have the option of only submitting the codes they plan to cover for reimbursement in their respective regions. Codes for fetal testing are likely to be excluded by Medicare on statutory principles.
However, the stance the MACs take will likely influence the private payers as well. “It is still early in the process, and many private payers have not established how they expect labs to bill. There is some evidence of increased private payer denials when labs submit under the new codes, however, given increased visibility that the test is a genomic sequencing procedure,” wrote Amanda Murphy, analyst with William Blair & Co., in a recent report.
The MACs’ power over pricing—and the fact that they apparently have been tightlipped about the direction they intend to take—has caused some anxiety among the laboratory sector, according to some observers.
“It has been so silent,” said Rina Wolf, vice-president of commercialization strategies, consulting, and industry affairs at Xifin, the San Diego-based laboratory consulting firm. Wolf believes that the MACs may follow the course of MAC Palmetto GBA, whose MolDX coding system has drawn ire from the lab sector as a means to keep payments down.
Palmetto has already indicated analysis of multiple biomarkers would be considered a “panel” and will require each lab to submit them through a unique MolDX identified. Palmetto said it would begin rejecting stacked CPT codes for panels on July 1.
William Blair’s Murphy believes the pricing set by MACs will be conservative, noting that based on comments from Palmetto officials, “pricing for panels will be less than the pricing of the individual genes in aggregate.”
Takeaway: The laboratory sector has experienced some anxiety over the planned pricing for whole sequencing tests.
