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In an opinion piece at Stat News, Arizona State University's Roger Klein calls the Centers for Medicare & Medicaid Services' decision to limit access to next-generation sequencing-based tests for hereditary cancers a "grievous error."

As GenomeWeb has reported, a Medicare contractor recently said it would not cover NGS-based multi-gene panels that gauge whether patients are predisposed to develop breast and ovarian cancer for patients with early-stage disease. This, it noted, is despite Medicare Administrative Contractors covering germline BRCA1 and BRCA2 testing for patients for years without any disease stage-based restrictions. The contractor, GenomeWeb adds, made the change to bring its policy in line with a CMS policy on next-generation sequencing tests for advanced cancer patients, though that policy was largely thought to be limited to somatic variant testing.

The move drew the attention of lab and advocacy groups, GenomeWeb added in a separate article. Last month, more than 60 healthcare companies and organizations — organized by the Association for Molecular Pathology, on whose board Klein sits — penned a letter to CMS Administrator Seema Verma that said that this interpretation would "restrict patients' access to medically necessary and relevant testing of germline mutations" and "adversely impact cancer patients' care and outcome."

Klein adds in his opinion piece at Stat News that it "injures individuals with hereditary cancer by denying them the possibility of identifying the genetic causes of their cancers and any predispositions they may have to develop additional malignancies" and calls on the agency to reverse the change.