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Gail Javitt Quoted in “Will Medicare Genetic Test Coverage Get Labs to Seek FDA Signoff?”

Bloomberg BNA Health Care Daily Report

Gail H. Javitt, Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in the Bloomberg BNA Health Care Daily Report, in “Will Medicare Genetic Test Coverage Get Labs to Seek FDA Signoff?” by Greg Langlois.

Following is an excerpt:

Medicare’s decision to cover a limited number of personalized medicine tests for cancer patients could nudge laboratory testing companies to ask the FDA to approve them—something the FDA sought for several years.

An announcement by Medicare to cover genetic tests using next-generation sequencing (NGS) technology—only if they are FDA-approved companion diagnostics—could spur laboratory diagnostic testing companies to obtain the FDA’s blessing.

Clinical labs, already regulated by the Centers for Medicare and Medicaid Services (CMS), would prefer to avoid FDA oversight on top of that—what they’ve said would be double regulation. But the promise of Medicare coverage for NGS tests might be too tempting to pass up, even it means their tests have to be treated as medical devices under FDA regulations. …

But the FDA-approval requirement may put some laboratories off, Epstein Becker Green health-care and life sciences member Gail Javitt told Bloomberg Law in an interview.

“This is an industry that has never been subject to FDA oversight, and there’s a lot more that goes along with going through FDA than just the approval,” Javitt said. “You are effectively becoming an FDA regulated device manufacturer. And so for some, it will just not be a viable strategy.”

But NGS tests operating under CMS’s CLIA standards already are in clinical use, and are required under CLIA to show analytic validity, Javitt said.

“[T]he majority of genetic tests are LDTs, and that’s true in cancer and beyond cancer,” she said. “I do think that there’s a bit of a regulatory disconnect between how FDA has been approaching these tests and how clinicians have started to use them, and CMS’ rather narrow approach.”

Although NGS tests without FDA approval will not be covered under CMS’ nationwide policy, individual Medicare administrative contractors (MACs) still have discretion to cover unapproved tests.

“There was some level of relief that CMS left open to the individual MACs whether to cover, but that is a case-by-case basis,” Javitt said. “[I]t could be a very fragmented environment for test coverage.”