The new economic stimulus law frames immediate nuts-and-bolts issues as Federal officials prepare to roll out ambitious new initiatives on comparative effectiveness research – research aimed at identifying which of two or more health care interventions produce better results for a given patient condition.
Comparative effectiveness is nothing new; there has long been authority for it in the law, though it gained widespread prominence only in 2003, with enactment of the so-called section 1013 comparative effectiveness program at AHRQ. What’s new is that the stimulus law heaps onto these existing authorities wheelbarrows-full of new money — $1.1 billion in all — while requiring Federal officials to make haste in how they spend it. For example, the new law requires the Institute of Medicine to publish recommendations by June 30 on national comparative effectiveness priorities. A new Federal Coordinating Council will be reviewing priorities, too, and generally trying to keep the greatly expanded research activities in synch.
For drug and device developers, an immediate task will be to ensure that the process for comparative effectiveness decisions is transparent and participatory. For example, the new law requires recipients of comparative effectiveness research funding to “offer an opportunity for public comment on the research,” but only “to the extent feasible.” Stakeholder will want to work with Federal officials to convert these and other references in the new law into fair and feasible ways for promoting openness and adequate public participation. More generally, because the new research funding is spread across a sizable number of current programs, governed by disparate existing statutes, it will be important to size up the protections that exist already and identify any areas that need strengthening.
This immediate phase of comparative effectiveness – getting the process right – calls to mind similar work that resulted in the relatively transparent process that CMS now uses to make Medicare national coverage decisions. Toiling in the vineyards of process can be a slog, but, in the end, can make for more informed decisions, too.