As Medicare heads into what is likely its last "real" week of 2006, two issues -- concerning policies on clinical trials and Part B/D drugs -- seem to be gathering quiet momentum. Though playing out on less grand a stage than the politically explosive (but now-accomplished) physician SGR fix, these issues promise fireworks of their own in the year ahead, with the possibility of a minor detonation or two this coming week.
On Wednesday, MCAC turns to a CMS-proposed reconsideration of the current national coverage decision on reimbursing certain routine costs of clinical studies. This issue has been in play since last summer, but it took a new turn with last week's CMS release of a content-packed, 11-page concept paper for the MCAC denizens to chew on. Usually, CMS seems fairly circumspect in advance of MCAC sessions, but this time the agency let rip with assorted policy observations and near proposals.
In the latter category was the idea that a study "required and reviewed by the FDA as a post-approval study" be "deemed" -- i.e., determined to constitute the kind of "good" research for which Medicare pays. Given the nexus CMS seems to be trying to draw between reimbursed clinical trials and Coverage with Evidence Development (specifically, the Coverage with Study Participation branch of the doctrine), one has to wonder whether at least some of the products subject to these post-approval studies are on a fast track to CED-land. This is one of the questions to which considerable attention will no doubt be devoted, starting Wednesday and extending into 2007.
We've written previously on the Part B/D identity crisis that afflicts certain Medicare-reimbursed drugs ("Part B v. Part D Drug Coverage: Bombs Away"). When last we visited this topic, CMS said it would give the new Part D adventure a couple of years before trying anything fancy. Well, one of those years is now up, and the Part B/D jockeying has begun:
Item: In its current rulemaking on crosshatching Part D claims data with that from Parts A and B, CMS noted that it has underway a new study that's examining "the relationship between Part B and Part D drug coverage," with said study to include "an assessment of the impact of such a change on beneficiaries, Part D sponsors and the Federal budget."
Item: The Medicare bill on physician fees that Congress passed early Saturday contains a provision that provides for vaccines that are Part D drugs to be paid as Part B drugs in 2007, then bounce back to Part D in 2008 (something like that).
Item: Published reports suggest stakeholders are organizing on the Part B/Part D issue and talking with CMS about ways to map a new frontier between the competing reimbursement regimes.
So the B/D dot on the horizon is getting larger, and, like clin trials policy, will be upon us in 2007.
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Several of you seemed to like our previous dalliance with Medicare transmittals ("Editorially Unlikely: Transmittals We Love"). So we wanted to update you on the latest addition to the collection . . . "PECOS to FISS Interface Via Extract File" . . . which translates (in some language) to . . . happy holidays!
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