- More than 60 leading healthcare organizations representing patients, providers, and academic medical centers have called on CMS to revise its interpretation of the National Coverage Determination (NCD) for next-generation sequencing (NGS) within Medicare.
In a letter to CMS Administrator Seema Verma, 63 organizations said they were concerned that the broad interpretation would limit patients’ ability to access medically necessary testing.
NGS-based testing has become a standard of care for cancer patients, and the new interpretation implies that NGS will not be covered for many Medicare beneficiaries. This includes those with early-stage cancer who may have a genetic predisposition to certain outcomes based on family history or other criteria.
“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 letter stated.
“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 group said that this interpretation may lead to unintended consequences for Medicare beneficiaries, and represents a significant policy overreach by CMS.
While MACs have implemented local coverage determinations (LCDs) providing coverage for germline cancer testing, CMS’s new interpretation will reverse previously established policies, and the NCD will replace LCDs that provide coverage for NGS testing in patients who don’t have advanced cancer.
The organizations wrote that these changes could result in Medicare patients failing to receive the best possible care.
“Consequently, only tests utilizing older, less-advanced, and more expensive non-NGS methods will be eligible for Medicare coverage,” the letter said.
“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.”
With this letter, the organizations aim to maintain NGS coverage for beneficiaries, and ensure they receive quality cancer care.
“Our organizations urge CMS to revise its current interpretation of the NCD by limiting it to somatic tumor testing and to communicate this change to the MACs. CMS should not create additional barriers to Medicare beneficiaries’ access to clinically appropriate NGS-based testing to which other non-Medicare patients have access,” the letter concluded.
“As providers, patient advocates, diagnostic test manufacturers, and laboratories, our collective aim remains to ensure that high quality, clinically-proven NGS-based testing continues to be available broadly when appropriate. We welcome the opportunity to work with CMS to ensure that the agency’s coverage policies do not negatively impact cancer patients.”