CMS is proposing to deny coverage of Lilly’s Alzheimer’s “rule-out” diagnostic Amyvid. The decision is important for biopharma manufacturers for several reasons, both as a demonstration that the agency really will refuse to pay for FDA approved drugs—and for how CMS thinks it can actually use its authority to encourage research on effective AD therapies.

The Centers for Medicare & Medicaid Services’ new list of “potential” topics for National Coverage Decisions includes 33 separate ideas, most proposed by the public. Not one is directly related to a biopharma topic. CMS’ coverage team swears it remains interested in drug-related coverage issues—but still, this is one list it is nice not to be on.

The debate over comparative effectiveness research has focused heavily on standards of evidence to judge the relative value of different therapies and standards for when and how conclusions should drive coverage policy. Less attention has been paid to a more fundamental question: when should the value determination be made. CMS’ top coverage official has an idea that would radically change that process.