Medicare Reimbursement: CMS Limits NGS Early Cancer Test Coverage but Industry Fires Back

Getting Medicare to cover Next Generation Sequencing (NGS) tests has been a slow go. And the latest CMS National Coverage Determination (NCD) for early stage cancer NGS testing of patients with hereditary risks is the latest disappointment. Here's a look at the NCD and what the lab industry is doing to get it revised.

The NCD & Shift on NGS Testing
The NCD was requested for an NGS test for Medicare beneficiaries with advanced cancer. Even though the request was limited to a somatic-based test, CMS instructed Medicare Administrative Contractors (MACs) to apply the NCD to both somatic and germline NGS testing. This is significant because it suggests that patients with early-stage cancer who have a genetic predisposition based on family history or other acceptable criteria should not be eligible for Medicare coverage for testing using NGS-based methods.

Explanation: MACs have adopted local coverage determinations (LCDs) providing coverage of NGS-based genetic testing for mutations associated with inherited cancer syndromes, like BRCA mutations and Lynch syndrome. But because an NCD supersedes an LCD, the new NCD would cancel out those favorable LCDs allowing patients with early-stage cancers to access hereditary testing.

Industry Reaction
The American Clinical Laboratory Association (ACLA) and other organizations are pushing back against the Medicare coverage policy shift. On Jan. 31, the ACLA and 60 other health care organizations and companies sent a letter to CMS administrator Seema Verma asking the agency to revise the NCD. The letter makes two principle arguments:

Poorer Outcomes: The letter contends that denying NGS testing for early stage cancers to patients with hereditary risks will lead to poorer outcomes. "It is essential that CMS unequivocally maintain coverage for medically necessary NGS-based tests," argues ACLA President Julie Khani. "Imposing broad restrictions on standard of care testing will have serious consequences for Medicare beneficiaries and negatively impact their care." 

Lack of Policy Review: The letter also points out that CMS adopted the NCD with no notice or comment period on its impact and the fact that under the new coverage policy only tests utilizing older, less advanced and more expensive non-NGS methods will be eligible for Medicare coverage. The 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.

What Next?
As of the date we went to press, CMS has yet to issue its response to the letter or clarify its position on the NCD. So, stay tuned for further developments.