Medicare coverage: engaging on evidence

Experience tells us that many developers of innovative technologies fail to anticipate the evidentiary needs of insurers, particularly of Medicare. Some assume that Medicare payment begins pro forma upon approval or clearance by the US FDA with little regard to the distinct role of the Centers for Medicare & Medicaid Services (CMS). We offer our own suggestions, hoping they will lead to mutually satisfying discussions as we consider coverage of regenerative medicine technology. Medicare is governed by Title XVIII of the Social Security Act, which among other provisions describes the scope of the insurance benefit, methods of payment for items and services that may be covered and the process timelines for national coverage determinations. CMS implements these provisions with regulations, instructions in manuals and other guidance that are available to the public. We will focus our comments on the 'reasonable and necessary' requirement for coverage under Part A and Part B of items and services in Section 1862(a)(1)(A) of the Social Security Act.