In March 2018, the laboratory community applauded as the Centers for Medicare and Medicaid Services (CMS) issued a national coverage determination (NCD) in favor of the use of next-generation sequencing (NGS) as a diagnostic laboratory test for patients with advanced cancer.1
But the applause turned to jeers earlier this year, when CMS directed its Medicare administrative contractors to align local coverage determinations with the more-restrictive terms of the NCD, effectively eliminating coverage for NGS testing of patients with a hereditary risk of cancer as well as those with early-stage disease. In response to the agency’s directive, more than 60 healthcare organizations wrote to CMS Administrator Seema Verma, MPH, to express their concern over the agency’s implementation of its 2018 NCD.2
At the end of April, CMS relented, ordering its national coverage analysis on NGS for advanced cancer to be reopened. The agency was careful to limit how far it was willing to let the reopened analysis go: “specifically, we are only reconsidering the evidence available for tests of germline mutations to identify those with hereditary cancer who may benefit from targeted treatments based on results of the test; all other tests are beyond the scope of this reconsideration.”3 Nevertheless, the order has raised hopes that the agency will broaden its interpretation of the 2018 NCD, permitting NGS to be used for patients with hereditary risk or early-stage disease.
Not for the first time, at the beginning of May a similar group of stakeholder organizations wrote to congressional healthcare leaders, urging them to “modernize the statutory oversight of clinical laboratory diagnostics—including laboratory-developed tests and in vitro diagnostics.”4,5
It’s far from clear that laboratory stakeholders will win their appeal with CMS for expanded coverage of NGS testing, or that Congress will be responsive to the call for regulatory modernization from stakeholders in the clinical laboratory community. But in the meantime, organizations are finding a stakeholder identity that unites them in support of clinical laboratory testing—which isn’t a bad achievement in its own right.
- Decision memo for next-generation sequencing (NGS) for Medicare beneficiaries with advanced cancer [CAG-00450N; online]. Baltimore: Centers for Medicare and Medicaid Services, 2018. Available at: www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?ncaid=290&timeframe=7&doctype=all&bc=aaaaiaaaqaaa&. Accessed March 19, 2018.
- Letter from 63 healthcare organizations to Seema Verma, administrator, Centers for Medicare and Medicaid Services [online]. Washington, DC: Association for Molecular Pathology, 2019. Available at: www.amp.org/amp/assets/file/advocacy/group_stakeholder_letter_ngsncd-final-1-31-2019.pdf. Accessed February 7, 2019.
- National coverage analysis (NCA) tracking sheet for next-generation sequencing (NGS) for Medicare beneficiaries with advanced cancer (CAG-00450R). Baltimore: Coverage and Analysis Group, Centers for Medicare and Medicaid Services, 2019. Available at: www.cms.gov/medicare-coverage-database/details/nca-tracking-sheet.aspx?ncaid=296. Accessed April 29, 2019.
- More than 80 leading health organizations call on congress to modernize clinical diagnostic oversight [press release, online]. Washington, DC: American Clinical Laboratory Association, 2019. Available at: www.acla.com/more-than-80-leading-health-organizations-call-on-congress-to-modernize-clinical-diagnostic-oversight. Accessed May 6, 2019.
- Letter from industry stakeholders on diagnostics regulation reform [online]. Washington, DC: American Clinical Laboratory Association, 2019. Available at: www.acla.com/wp-content/uploads/2019/05/diagnostics-reg-reform-stakeholder-ltr-to-hill-5-3-19.pdf. Accessed May 6, 2019.
Chief Editor, CLP