CMTP Issues Draft Framework for Covering NGS Testing

An influential not-for-profit group has issued a draft framework for how next-generation sequencing tests for oncology care should be reimbursed by payers.

The report from The Center for Medical Technology (CMPT) comes at a time when anxiety regarding the rates of reimbursement for molecular- based tests has been running high. Many of the regional fiscal intermediaries for Medicare have lagged in providing guidance on payment, prompting many commercial insurers to not cover many tests themselves, or offer payments at rates far lower than what the laboratories consider reasonable. And intermediary Palmetto GBA's efforts to create standardized codes for such tests through its MolDX system have also caused the laboratory sector additional anxiety. Meanwhile, many labs have been releasing and touting tests and platforms that rely on next-generation sequencing.

At the same time, the report suggested that labs may not be in the ideal position to advocate for their own products. "At issue is a growing flood of new genomic variants in need of study and a lack of economic and commercial incentives for testing companies and laboratories to perform the kinds of studies payers and health technology assessment groups generally expect to see," the report noted.

"NGS testing methods are potentially important new tools to enable clinical genomics and the realization of personalized medicine," said Donna Messner, a CMTP vice president and director, who led the guideline development effort, in a statement. "However, there is currently substantial uncertainty over future health plan coverage policy for genomics and how to accelerate evidence development for this testing."

Through its Green Park Collaborative, CMTP developed the guidelines in consultation with the laboratory, provider, and insurer sectors through a variety of phone calls and conferences held in the summer of 2014 and last spring.

The working group reached consensus on two specific points: Coverage should be provided for panels of up to 50 genes that are analyzed for a subset of five or more genes that are considered to be standard-of-care for use with a given diagnosis such as stage four lung adenocarcinomas and other forms of advanced cancers (although payers had expressed concerns about covering any panel with 50 or more genes at all). And whole exome and whole genome sequencing should still be considered investigational assays and therefore should not be covered by payers. Among the other recommendations in the framework:

• Payers should require laboratory accreditation through the College of American Pathologists, particularly for all NGS-related requirements mandated by that organization.
• The cost of performing NGS should not exceed the cost of individual sequencing of the target genes by other methods.
• Payers should consider compensating labs that submit new variant data to well-curated, public access databases of somatic mutations.

CMTP is now accepting public comments on the guidelines. The organization said it would use those comments and continued meetings with the major laboratory and payer organizations and the U.S. Food and Drug Administration to try to solidify more details for NGS-related coverage, data sharing from NGS testing, and even coverage of NGS-related off-label use for certain targeted cancer therapies that are employed as the result of the tests.

"The lack of predictable coverage and reimbursement policies that anticipate the rapid emergence of new genomic tools could become a hindrance to cancer care," said CMTP CEO Sean Tunis in a statement. "Getting agreement on guidelines for coverage of targeted NGS gene panels is a crucial first step toward more comprehensive and forward-looking policies for genomics in clinical medicine."

Takeaway: The CMTP is trying to provide some coherence for the lab and insurer sectors regarding coverage for NGS-based testing.