Device makers have wondered in the past whether they like the idea of the Centers for Medicare & Medicaid Services (CMS) peering over the U.S. FDA’s shoulders in premarket applications, which might be a concern as well for the Medicare program for coverage of breakthrough devices. Tamara Syrek Jensen, director of the Coverage and Analysis Group at CMS, declined to say whether her office has any influence over what would be designated as a breakthrough device by FDA, stating little more than that “we will constantly be talking with the FDA” about breakthrough devices.

The Medicare clinical lab fee schedule (CLFS) in the U.S. has gone through some twists and convolutions in connection with the rate reset effort, but the suite of expensive, high-end tests is another source of spending concern. The Medicare Payment Advisory Commission (MedPAC) examined that question recently and is considering several possible solutions. Among these are a fixed-rate deflation metric from a starting price point and bundling with a provider’s bundled payment program, two possible solutions that each carry their own set of headaches.