[caption id="attachment_4320" align="alignleft" width="186"]G-man dropped for a loss[/caption]
There are times when we in the private sector think you have to be crazy to want to work at FDA or CMS, but the true unemployment rate is still in excess of 10%. Who in their right mind is going to turn down a steady paycheck in this economy?
Still, working at these agencies is a lot like being an offensive lineman in the NFL: Nobody who's watching the game knows you're there at all unless someone on the other team knocks the stuffing out of the quarterback. Following are a few stories of government plays that already have or still might go horribly wrong.
Another MAC attack
Medicare administrative contractors (MACs) rarely make the news, but NHIC – which seems to serve as the MAC bellwether for DME and prosthetics – recently decided it would not cover lower-limb prostheses in a memo that debuted in July with a comment period ending Aug. 31.
We discussed recently the background for a non-coverage decision NHIC rendered for continuous glucose monitors, and the evidence seems to support that non-coverage decision. The problem for NHIC in this latest memo is that it appears it will affect those who have served in our nation's military. Indeed, former Senator Bob Kerry likened the decision to coverage standards that existed during the Viet Nam War, and the memo triggered a march on Washington along with a petition at WhiteHouse.gov. The latest development is that two current members of Congress have asked HHS Secretary Sylvia Burwell to get involved.
Some believe NHIC was too clever by far in publishing the draft when Congress was out of town for summer recess. Whether this calls for a dusting-off of the conspiracy theorist's playbook is up to each of us to decide, but it looks awful either way.
If you scroll down to the 38th page of the non-coverage memo, you'll see a number of HCPCS codes that apparently have been adjusted in one way or another to arrive at this outcome, but this scrum suggests it's time for a national coverage analysis of the more technologically advanced devices that would be covered under some of these codes. There are some pretty pricey offerings for the lower limbs after all (not to mention the latest DARPA artificial arm), and some of them are too expensive to leave to a MAC.
The guidance that isn't
Few things can bollix up a play like a delay-of-game penalty, which might be the sensation device makers get when they think of several different documents published over the past two years by Uncle Sam. Companies can't simply stop everything just to wait for the government to finalize these rules and documents, but there is that sense of something lurking.
Among these is the draft device classification rule from March 2014, which CDRH director Jeff Shuren said earlier this year was intended to clarify rather than to change the process. The draft says among other things that some stakeholders think clinical trials would make wonderful special controls for class II devices. My response to Shuren's clarification claim is, "if this is your idea of clarification, what does it look like when you're really throwing down?"
Device makers are still waiting for NIH to come up with a final version of its notice of proposed rulemaking (NPRM) regarding clinical studies and the clinicaltrials.gov website, a document that's sure to provoke a lot of unhappiness. Also, the comment period for the adaptive device clinical trials draft guidance closed in early August, but device makers had few unkind words for this document.
If there's a candidate for the three-and-out award for draft guidances, it's the 2013 draft for medical device reports. Device makers are already notorious for filing MDRs for events that don't qualify, and the e-MDR requirement is now in force, which some believe will up the ante on meaningless MDRs.
The principal criticism of this draft is that it would exacerbate that over-reporting trend even further, which is the main reason industry hopes it has done enough to sack this document for good.