Waleed Hassanein, MD, is president, CEO and a director of TransMedics (Andover, Massachusetts). He founded the company in 1998 and led it through the clinical development, market launch and commercial rollout of the breakthrough Organ Care System (OCS) technology. The OCS is a medical device used for ex-vivo physiologic preservation and assessment of transplantable organs, in both the European and U.S. markets.
The Centers for Medicare & Medicaid Services has published a draft guidance for the new framework for coverage with evidence development, or CED, a very interesting framework indeed. Following is a list of some fascinating tidbits from the draft guidance. Interesting item #1: The passage stating that CMS is examining the question of “whether local contractors should have the discretion to apply CED in local coverage” is pretty close to an earthquake. I’m assuming that most CED trials will have to span more than one Medicare carrier’s jurisdiction, which suggests a patchwork of CED coverage or a need to get...
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