Last week's post-July 4 fireworks at CMS blew out the way we will categorize -- and talk about -- Medicare coverage policy. The context . . .
Back when things were simple (though, as we'll explain, not so beneficial to patients), Medicare drew a clear, unalterable line that separated "mainstream" health care from that which was "experimental." If care was "mainstream," then it was was good and could thus be covered; if it was "experimental," it was bad (even Frankensteinesque) and thus could not. 
Indelible borders don't last long in health care, and this proved no exception. By 1994, Medicare officials were talking openly about adding some zags to the mainstream/experimental frontier. The following year, then-HCFA and FDA decided to pay for certain "Category B" devices in IDE trials, and five years after that, in 2000, Medicare put in place a policy to pay for certain "routine" costs of clinical trials -- concepts, all, to which most private insurers today pay fealty.
So the line was eroding already. What happened last week is that CMS pretty much erased it altogether.
The two key actions: (1) issuance of a revised "Coverage with Evidence Development," or "CED" guidance document; and (2) initiation of a reconsideration of the 2000 policy on coverage of "routine" clinical trial costs. Though they fell as separate shoes, the two changes need to be considered together to get the full effect. To wit:
Medicare's mainstream/experimental line had always teetered atop the statute's "reasonable and necessary" provision, which basically says that items and services must be "reasonable and necessary" to be covered. But in addition to this "big daddy" reasonable/necessary provision, the statute is littered with little, pint-sized reasonable/necessary progeny, one of which says that an item/service can be covered if reasonable/necessary within the confines of a particular type of government research program. Until now, this provision has for the most part lain dormant (though it did make a cameo in the 2000 debut of the clinical trials policy).
What CMS did last week was to organize CED into separate wings -- one for "regular" coverage, another for research-oriented coverage, the latter being fused into the clinical trials policy by virtue of "little" reasonable/necessary. In all, the situation devolves to the following: An item or service can now be "covered" under a national "coverage" decision, yet not satisfy "reasonable and necessary" in the traditional, big-daddy sense of the term. This means that at one level our vocabulary will need to morph as we tangle with the new parameters of "coverage" and new flavors of "reasonable and necessary." More broadly, CMS seems to have brought a tidy conclusion to the mainstream v. experimental debate by establishing a means to address items/services for which payment previously would have been verboten.
It's too soon to assess last week's full effects. Gauged along the axis of history, however, you get the sense that patient access to care is making steady (if often frustratingly slow) progress.
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