As might be expected, device makers have a lot of nice things to say about a recent proposal by the U.S. Centers for Medicare & Medicaid Services (CMS) to automatically cover technologies designated as breakthrough devices by the FDA. However, two trade associations and the Medicare Payment Advisory Commission (MedPAC) all expressed serious misgivings about a proposal to define the term “reasonable and necessary” as possibly contingent on private payer coverage.

If a new federal rule withstands politics and potential court challenges, U.S. health care prices may finally be freed from their historic black box. The Centers for Medicare & Medicaid Services, along with the Departments of Labor and the Treasury, issued the Transparency in Coverage final rule Oct. 29 requiring most private health plans to disclose pricing and cost-sharing information so Americans will know in advance how much they will have to pay for prescription drugs, medical devices and other health care products and services.