CMS Overlooks Early-Staged Cancer in National Coverage Determination for NGS-Based Testing

Over 60 healthcare organizations are pressing the Center for Medicare and Medicaid Services (CMS) to revise its current interpretation of the National Coverage Determination (NCD), which they say wrongly excludes germline next-generation sequencing (NGS)-based testing from Medicare coverage for patients with early-stage cancers.

“CMS’ interpretation of the NGS NCD contradicts and reverses previously established policies,” said Sue Friedman, the executive director of FORCE: Facing Our Risk of Cancer Empowered, in a statement. “The NCD supersedes existing local coverage determinations that provide crucial coverage of NGS-based testing for mutations associated with inherited cancer syndromes…in patients without advanced cancer.”

In its decision memo on the NCD for NGS, CMS determined that Medicare would cover NGS-based testing for patients with recurrent, relapsed, refractory, metastatic, or advanced stages III or IV cancer if they have not been treated previously with the same NGS-based test. The expanded coverage, which went into effect on March 16, 2018, followed the November 2017 FDA approval of the first breakthrough-designated, NGS-based in vitro diagnostic test, FoundationOne CDx.

“These tests can help doctors consult with patients about more targeted care or enrollment in a clinical trial,” Kate Goodrich, MD, the CMS chief medical officer and director of the Center for Clinical Standards and Quality, said in a statement. “The expanded coverage in this final NCD now includes additional tests for relapsed, refractory, and earlier stage III cancers to aid in the treatment of these cancer patients.”

In a letter to CMS, however, the healthcare organizations contend that CMS has negatively impacted patients with early-stage cancer who may have a genetic predisposition to certain cancers by instructing Medicare Administrative Contractors (MACs) to apply the terms of the NCD to both somatic and germline NGS-based testing. The group explained the policy change will override local coverage determinations made by MACs that provide coverage for germline testing, including NGS-based tests for germline mutation testing in breast, ovarian, and colon cancers.

“It is essential that CMS unequivocally maintain coverage for medically necessary NGS-based tests,” Julie Khani, the president of the American Clinical Laboratory Association, commented in a statement. She added that imposing “broad restrictions” to NGS-based testing could lead to poor outcomes for patients with early-stage cancer by restricting their access to hereditary tests.

The healthcare organizations recommend that CMS alter the current interpretation of the NCD by “limiting [the NCD] to somatic tumor testing and to communicate this change to the MACs,” in addition to reinstating Medicare coverage for hereditary cancer tests.

CMS, however, has not offered a comment period for the implementation of the finalized policy.

Reference:

Decision memo for next generation sequencing (NGS) for Medicare beneficiaries with advanced cancer (CAG-00450N). CMS website. cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAld=290. Published March 16, 2019. Accessed February 5, 2019.