NGS Tests Gain Further Coverage in the Market

Healthcare overall is increasingly moving toward a model of more personalized care, and in oncology, precision medicine is already well established with targeted therapies approved based on the patient’s genetic makeup or genetic variants of their tumor. Using precision medicine successfully means also using diagnostics and next-generation sequencing (NGS).

Last year, CMS finalized coverage of NGS tests, which are to be used to identify patients that may benefit the most from approved treatments. And it looks like other payers may be following CMS’ lead.

For instance, Anthem will now pay for ClonoSEQ, a DNA-based diagnostic device that measures minimal residual disease to monitor the change in burden of disease for patients with hematological malignancies. This assay test was approved by FDA to test in patients with multiple myeloma (MM) or acute lymphoblastic leukemia (ALL). Anthem will pay for ClonoSEQ to be used when medical necessary.

CMS had previously announced it was granting Medicare coverage for the use of ClonoSEQ in January. The announcement from Palmetto GBA’s MolDX program established coverage for ClonoSEQ for assessment of minimal residual disease in patients with MM or ALL throughout treatment and remission.

In February, the Department of Veterans Affairs National Precision Oncology Program awarded a nationwide contract to Foundation Medicine to cover all its tests for veterans with advanced cancer. However, despite that good news, Foundation Medicine is facing some uncertainty.

At the Florida Society of Clinical Oncology’s annual meeting in Kissimmee, Florida, a panelist noted that the national coverage determination (NCD) that Foundation Medicine received has flaws. James Almas, MD, was previously a medical officer at CMS in the Coverage Analysis Group when Foundation Medicine submitted its request for an NCD.

Almas had said that CMS was going to reopen the NCD for Foundation Medicine and by the end of April, the agency had done just that.

“The NCD that was ultimately issued has flaws in it,” Almas had said at the meeting. Michael Kolodziej, MD, vice president and chief innovation officer at Advi Health, who was in the audience, noted that “When an NCD is reopened, it’s dangerous. In reality, it’s a threat to Foundation Medicine.”

In February, more than 60 healthcare organizations, including the American Medical Association, the American Society of Clinical Oncology, the Association of Community Cancer Centers, the Personalized Medicine Coalition, and Susan G. Komen, had expressed concern that CMS’ clarification on NGS testing would stop Medicare members with early-stage cancers from accessing NGS tests.

“NGS-based testing has become the standard of care for cancer patients, yet nine months after releasing its NCD Decision Memo, CMS has elected to move forward with an overly broad interpretation of the NCD that contradicts and reverses previously established policies,” the groups wrote. The letter further called on CMS to “revise its current interpretation of the NCD” so that the agency is not creating “additional barriers to Medicare beneficiaries’ access to clinically appropriate NGS-based testing to which other non-Medicare patients have access.”