November is not always a spicy month where federal agencies are concerned, but FDA and CMS have come through to give us something to talk about. Below are a couple of items to mull over as you enjoy a leisurely, stress-free drive or comfy, un-cramped flight to celebrate Thanksgiving with loved ones.
CMS makes a virtue of necessity
The final guidance for the Medicare coverage with evidence development (CED) program is a relatively brief document considering the impact it will have, but also considering the length of the draft that birthed it.
One thing CMS did make clear in the final is that Medicare administrative contractors (MACs) will not be issuing CEDs despite that the agency had floated such a notion in the draft. However, CMS was very un-specific about how to closeout a CED study in the final, stating little more than that it has its eye on the coverage transition between the termination of a study and the agency's decision about non-trial coverage.
One can understand how CMS might want to maintain flexibility, but the draft version raised more questions than it answered. Other than the MAC/CED thing, just what do we know now that we didn't know before? I guess brevity is the key virtue with this document.
FDA clamps down on morcellation
FDA announced November 24 that it will require that manufacturers apply a black box warning to power morcellators as well as contraindications, a move designed to eliminate the spread of uterine sarcomas and other cancers as a consequence of morcellation.
One cannot complain about FDA's concern over the potential for debilitating and lethal cases of cancer, but there are those who believe the agency has overreacted in requiring that labels convey a contraindication for peri-menopausal women. Understandably risk averse device makers have already pulled their offerings from the market, but at least one private-sector insurer has abandoned coverage of the procedure, and a number of hospitals have forbade use of these devices in their facilities as well.
When it comes to things like this, I always wonder why more people never get upset about device lag (cought*TAVR*cough), which has undoubtedly cost far more than the dozen lives FDA has attributed to morcellation. We should not want to actively do things that promote morbidity and mortality, but is benign neglect that leads to death and debilitation really any better?
As an aside, FDA used the immediately-in-effect (IIE) guidance mechanism to communicate its concerns about power morcellators without offering the 60-day comment period it had required of itself in the final standard operating procedure for these guidances. Unless I'm mistaken, the IIE is a tool for addressing urgent medical situations based on recent scientific or evidentiary developments. If FDA feels it can make this declaration without offering stakeholders 60 days to comment, why would it bother to ask for public comment any other time it wants to use the IIE mechanism?
Since it is quite apparent that the use of morcellation is already in sharp decline, we can reasonably conclude that FDA is of the do-as-I-say-not-as-I-do school of thought when it comes to its own regulations. And some people wonder why other people are skeptical of government.