Today, the Centers for Medicare & Medicaid Services announced amendments to its Medicare Program Integrity Manual in accordance with the 21st Century Cures Act to modify the procedures by which Medicare Administrative Contractors (MACs) arrive at Local Coverage Determinations (LCDs). While any move in the direction of increased transparency is laudable, it remains to be seen what practical effect these changes will have, as well as how they will contribute to CMS’ stated goal of increasing access to new technologies.

Much has been written regarding the speed, or lack thereof, with which CMS and its contractors have responded with coverage of new advancements in medical technology. Today’s changes introduce a new LCD request process by which interested parties can request a new LCD, as well as an informal process by which parties may meet with MACs prior to such a request. However, in recent years, MACs have made significant gains in responsiveness to stakeholder requests, and while a standardized process will increase transparency, the connection between this standardization and better access to new treatments and technologies is thus far unclear.

Once consideration of a new or amended LCD has begun, these revisions will ensure more consistent scientific justifications and an increased role for both the Contractor Advisory Committee and the public. MACs have interpreted many of these requirements from 21st Century Cures as applying only to those LCD revisions which narrow coverage, and it remains to be seen if they will apply them to cases in which they are ostensibly broadening coverage policies.

As of this posting, Chapter 13 of the Program Integrity Manual had not been updated to reflect these changes. While we are grateful for CMS’ work toward expanded access to emerging medical technologies in a transparent fashion, we look forward to observing in the coming months how these changes are implemented so as to improve beneficiary access to lifesaving medical advancements.