Sitting through a recent day-long session of the Medicare Coverage Advisory Committee, or MCAC, I was reminded of the vast changes the last several years have wrought in the way Medicare treats its drug and device manufacturer stakeholders. It's an evolution that might be termed "FDAization," by which I intend no criticism or value judgment. 
Today, manufacturers are indeed Medicare stakeholders, no longer relegated to the status of mere upstream vendors to the institutions and professionals that provide care directly to beneficiaries, but instead enjoying direct, bilateral relations with CMS. At one level, this is evident from the obvious things, like the fact that there's now an "Open Door Forum" targeted to manufacturers' issues. But at a deeper level, one need take only a quick dip into the Federal Register to be struck by the many issues and conventions -- the DRG new technology regimen, the outpatient PPS pass-through program, to name two -- that have as their antecedents the priorities of drug and device developers.
Moreover, the process by which Medicare interacts with technology types has been become . . . well . . . an actual process. Gone are the days of Medicare's "physicians panel," a quasi-mystical, black-box operation. In its place has arisen a national coverage process that seems intent on becoming (though clearly has not yet become) as open, structured, and ordered as any FDA pre-market review.
And finally, none of this has been lost on the manufacturers themselves. My recent MCAC meeting was packed with technology company reps -- a far cry from the near-deserted room I encountered at my first MCAC session in September 1999. Indeed, most drug and device companies have created whole new career tracks devoted to reimbursement (try plugging "reimbursement" into Monster), not unlike the way the life sciences industries bulked up on regulatory expertise after major changes to the Food & Drug Act.
And so, yes, stakeholder status represents a key change, and it's all fine and good. But is sure hasn't meant less time spent in meetings.
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