CMS released two little-noticed coverage guidance documents last week, both finalizing earlier, draft materials. The first guidance addresses the factors CMS considers in deciding whether to initiate a national coverage decision; the second speaks to the circumstances in which the agency will commission an external technology assessment to support a coverage review. 
Both guidances go out of their way to disclaim any motives related to cost effectiveness. For example, the guidance on new reviews says “[c]ost effectiveness is not a factor CMS considers in making” national coverage decisions. Both guidances invest considerable additional verbiage in driving this point home.
Doth the agency protest too much? Methinks not, reason being that CMS has set the requirements for production of clinical evidence in a way that gives it all the leverage it needs. As we've said before (It's the Medicine, Stupid), reimbursement is increasingly (and paradoxically) less about money and more about the clinical content of care. And so CMS, and perhaps other payers, have no need to trifle with the complex and politically difficult issue of cost effectiveness. Why wander into that thicket when clamping down on clinical evidence will alone do the trick?
In another plot twist, the guidance (the one on opening a review) effectively grafts a new module onto the front end of the national coverage process. Specifically, CMS says it will each quarter post to its Web site a listing of issues on which the agency is thinking about initiating a national coverage review.
So the national coverage process will now start earlier, and it'll include a preview window on the agency's direction. But this is not a passive exercise for industry. Indeed, the agency makes the point that stakeholders "bear the responsibility for reviewing the quarterly list and submitting comments or evidence that they believe to be relevant."
So stay alert, and watch those quarterly notices for any latent cost-effectiveness impulses.
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