Washington, D.C.--Republican leaders of the Senate and House Committees with oversight of the Centers for Medicare and Medicaid Services (CMS) are raising concerns with a recent decision to severely restrict coverage of a U.S. Food and Drug Administration (FDA)-approved Alzheimer’s treatment and any similar future treatments, in a disturbing break with precedent.
In a letter to CMS, Senate Finance Committee Ranking Member Mike Crapo (R-Idaho), Senate Health, Education, Labor and Pensions Ranking Member Richard Burr (R-North Carolina), House Ways and Means Republican Leader Kevin Brady (R-Texas) and House Energy and Commerce Republican Leader Cathy McMorris Rodgers (R-Washington) outline how the decision departs from precedent and creates dire new concerns, and ask for information on how CMS arrived at its decision.
From the letter:
“On various fronts, the national coverage determination issued by the agency strays from precedent, subordinates the clinical judgment and expertise of the Food and Drug Administration, and suggests a problematic new standard that risks chilling innovation and jeopardizing access to the cutting-edge treatments of the future. We urge CMS to reconsider this approach and to operate within the bounds of its statutory authorities and directives, which this latest decision oversteps.”
The members outline a number of problems with the final decision, including that:
Full text of the letter is available here.