Stakeholders Urge CMS to Revise NCD Interpretation for NGS Tests

February 1, 2019

More than 60 healthcare stakeholders have signed a letter urging the Centers for Medicare and Medicaid Services (CMS) to revise its interpretation of the National Coverage Determination (NCD) for Next Generation Sequencing (NGS).

The 63 stakeholders—which include patients, providers, academic medical centers, laboratories, and diagnostic manufacturers—have sent a letter to CMS Administrator Seema Verma contending that the agency’s interpretation is overly broad. As a result, they assert, it will adversely impact cancer care by restricting access to clinical testing of germline mutations for Medicare beneficiaries.

In March 2018, CMS issued a final NCD that expanded eligibility for Medicare reimbursement by adding coverage for patients with Stage III metastatic, recurrent, relapsed, or refractory cancers, in addition to the Stage IV relapsed or refractory cancers included in an earlier draft NCD.

The final NCD also included repeat testing when a new primary cancer diagnosis is made by the treating physician and the patient meets other clinical criteria—but removed coverage with evidence development for tests not authorized by the FDA.

“It is our understanding that despite the NCD being requested for a somatic-based test, CMS has instructed Medicare Administrative Contractors (MACs) to apply the terms of the NCD to both somatic and germline NGS-based testing for patients with cancer.  The implication of this interpretation is both germline and somatic tumor NGS-based testing will become non-covered for Medicare beneficiaries with early-stage cancer,” the stakeholders wrote in the letter.

They urged CMS to revise its interpretation of the NCD by limiting it to somatic tumor testing and to tell the MACs of the change: “CMS should not create additional barriers to Medicare beneficiaries’ access to clinically appropriate NGS-based testing to which other non-Medicare patients have access.”

Since then, MACs have implemented local coverage determinations (LCDs) providing coverage for germline testing of cancer when supported by clinical guidelines, including NGS-based tests for germline mutations for breast, ovarian and colon cancers.

CMS’ interpretation will supersede existing LCDs that provide coverage for NGS-based testing for hereditary breast and ovarian cancer syndromes and Lynch syndrome in patients who do not have advanced cancer, the stakeholders said.

“Consequently only tests utilizing older, less-advanced, and more expensive non-NGS methods will be eligible for Medicare coverage,” they added. “If the agency continues to proceed with this problematic interpretation that expands the NCD to germline testing for patients with cancer, patients with early stage cancer will receive suboptimum care. 

“This action will harm patients!” declared Sue Friedman, Executive Director of FORCE: Facing Our Risk of Cancer Empowered, in a statement. “We are extremely disappointed that there was never an opportunity for patient advocacy groups to formally comment or discuss the implementation of this policy and frustrated that these medically necessary tests are now not eligible for Medicare coverage.”