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CMS Acknowledges Stakeholder Concerns Over Decision Not to Cover Germline NGS in Early Cancer Patients

NEW YORK (GenomeWeb) – The Centers for Medicare & Medicaid Services issued a notice this week acknowledging the confusion over its coverage policy for germline next-generation sequencing for cancer patients.

"CMS is sensitive to the concerns of its stakeholders regarding the interpretation of this policy and will work with the [Medicare administrative contractors] to adjust their respective claims processing systems accordingly," the agency said in a transmittal to labs this week.

In early January, Medicare contractor Palmetto updated its local coverage decision for BRCA1 and BRCA2 testing to align with CMS' national coverage determination for NGS testing for advanced cancer. That NCD, initiated by Foundation Medicine for its FoundationOne CDx tumor profiling test, extends coverage for this and similar NGS panels for patients with recurrent, relapsed, refractory, metastatic, or advanced stage III or IV disease who are seeking treatment.

By instructing MACs to align their local coverage terms with this NCD, CMS is essentially cutting off long-established coverage for germline NGS testing for assessing cancer risk in early-stage patients when knowledge of a risk mutation would be most valuable for taking preventive actions. If CMS maintains this stance, it would not only have a significant impact on labs that perform this testing, but also on patients since approximately 60 percent of cancer patients have stage I or II disease.

In response, 60 organizations and groups from all sectors of the healthcare community wrote to CMS to express their concerns, and many patient and industry groups have met directly with the government payor to point out the flawed logic of this policy. CMS this week publicly acknowledged their concerns, and extended the implementation date from March 6 to April 8.

It's not clear what headway, if any, stakeholders have made in convincing CMS to retract this policy, however. Reimbursement experts believe that a formal coverage revision request may be necessary to start a six-to-nine month process of reversing this policy. Those in close contact with CMS about this issue have indicated that the agency lacks precedent for retracting coverage instructions that result from an NCD, and doing so may result in having to reopen the NCD on NGS panels for advanced cancer.