CMS will release any day now the final guidance document on Coverage with Evidence Development, or "CED" -- a fundamental reorientation in Medicare's evaluation of medical evidence for purposes of national coverage decisions. But that's not all.
The key precursor is a draft CED guidance that CMS put out over a year ago and that the agency touted as a way to get innovations to patients faster. This is the "glass is half full" interpretation -- i.e., that the policy will result (impliedly) in Medicare paying for services that would not otherwise qualify. Stakeholders generally opt for the "glass is half empty" interpretation -- i.e., that CED is simply another way to impose stiff new evidentiary requirements on beneficial innovations. Sources of contention to date have centered on areas like implantable defibrillators, PET scanning, and colorectal cancer drugs.
CED is unquestionably significant, with antecedents tracing back to a 1988 lecture -- "Outcomes Management: A Technology of Patient Experience" -- in which Paul Ellwood (he of HMO and Jackson Hole fame) suggested use of postmarket observational data to make tough health care decisions. The concept has been refurbished of late by former CMS official Sean Tunis, in an article to which the current agency administrator, Mark McClellan, contributed. But CED achieves its full policy resonance only when considered as one notch in a full-throttle rejiggering of Medicare's evidentiary dimensions.
The winds of change have been evident for some time (see "The Coming Data Convergence . . . Straws in the Wind"), but look what the latest gusts have blown our way:
Item: CMS posts new, largely unnoticed Web page to address "Post Coverage Analysis" -- essentially a place to share with family and friends "before" and "after" snapshots of young but covered technologies (PET, BPH, and TMR being the current exemplars). The "before" shots record what a technology's sponsor said would happen if coverage were granted; the "after" snaps reveal an in-the-light-of-morning look at actual experience, based on claims data.
Item: NY Times article (free registration required) reports CMS will release data on complications encountered among Medicare beneficiaries with implantable defibrillators. Thus, CMS looks to its postmarket cache as a source of safety-related information, while FDA stakes out this same territory by entering data-mining contracts with private health insurers --all of which suggests emergence of jumbo data repositories that spit out just the facts, mam, and remain oblivious to who's asking and why.
Item: CMS posts innocuous-seeming transmittal that brings to fruition equally innocuous MMA provision on coordinating local coverage decisions. The transmittal sets up a process for local Medicare contractors (themselves acquiring novel data capabilities courtesy of new contractor reforms) to "elevate" local coverage decisions onto the national stage. On the one hand, this is not an altogether new possibility; local decisions have always been susceptible to nationalization. But the very existence of a process devoted to this purpose suggests increased usage, which, in turn, suggests the tossing up of more new technologies and services into CED and CED-like crosswinds.
So buckle up . . . it's going to be a turbulent postmarket ride.
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