With the dawning of 2008, the outlines of how CMS might use Coverage with Evidence Development, or "CED," have become a little clearer . . . 
Background
Since July 2006, when CMS issued its CED guidance document, there's been a phony war of sorts as agency officials have alluded to, but never moved explicitly to implement, the controversial new doctrine for making Medicare national coverage decisions. But then, suddenly, just before the holidays, CMS struck with three CED proposals in eight days . . . as reported in an article in MX Magazine.
December Proposals
As noted in a previous post ("CED Strains Nomenclature, Vocabulary"), CED can be deployed in either of two forms. The form CMS chose for its December issuances is Coverage with Study Participation, or "CSP " -- the type reserved for items or services that CMS believes cannot be covered by Medicare under the traditional "reasonable and necessary" authority. (The other form of CED, Coverage with Appropriateness Determination, or "CAD," is essentially a means for confirming implementation of a conventional national coverage decision.)
The agency's reliance on CSP was explicit (through actual naming of it or making revealing statutory references) in two of the three December proposed decision memos-- those for computed tomographic angiography and CPAP. For the third, PET (FDG) for Infection and Inflammation, the agency proposed a continuation of national non-coverage, but solicited comments on whether "limited coverage . . . under the . . . CED . . . paradigm" might be warranted. In this context, CMS seems almost certainly to be talking about CSP, for the agency evidently believes the technology cannot be nationally covered in a traditional sense, and thus, in raising the prospect of an exception to this non-coverage, must be referring to the only type of CED that provides such an exception: CSP.
Looking Ahead
Here's some areas that might be worth keeping an eye on in the months ahead:
First, will "CED" effectively mean "CSP?" So far, it looks that way.
Second, will CMS use CED only "in rare instances," as the agency said in the July 2006 guidance document? Hard to say. Interestingly, the proposed decision memos for CT angiography and CPAP both reiterated the "in rare instances" language.
Finally, will CMS stick with CED in its final decision memos? The seeds sown by the agency in December will bear fruit by March, and it'll be interesting to see the public comments and how, if at all, they influence the final decisions. Also, watch for a proposed decision memo on intracranial stening and angioplasty, due by late February. The issue concerns a humanitarian device, and in Boston Scientific's request for national coverage, the company told CMS that it was "receptive . . . to the use of coverage with evidence development . . ."
So, 2008 . . . the year of CED?
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