CMS’s New Breakthrough Device Policy May Be a Disappointment, Monique Nolan Tells Law360

Life Sciences & Healthcare Regulatory counsel Monique Nolan, M.D., J.D., was recently quoted in the Law360 article, “CMS Takes Baby Steps In New 'Breakthrough' Device Policy.” The article details the Centers for Medicare and Medicaid Services (CMS)’s new guidance on the Transitional Coverage for Emerging Technologies (TCET) coverage pathway for breakthrough medical devices, but effectiveness may be limited by CMS’ plans to accept only five products for coverage.

Nolan told Law360 that the agency’s suggestion that diagnostic products generally would not fall under the new TCET pathway “may be a disappointment from the public's perspective.”

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