Disc jockeys like to do two-for-Tuesdays and three-for-Thursdays, but we're not spinning music at MDD Perspectives. Today we go into full rebellion mode by offering a Thursday two-fer. Take that, hegemonistic radio stations!
MAC, re-MAC, and MAC again
Writer Jim Boren is noted for having said a good bureaucrat's guidebook would include the recommendation, "when in doubt, mumble; when in trouble, delegate." Has CMS taken this advice to heart? The reason I ask is that Medicare administrative contractors (MACs) typically fly under the radar screen, but lately not so much.
A Medicare administrative contractor for durable medical equipment, NHIC, is in the news for the third time in recent weeks, this time over a coverage memo for pneumatic compression devices (PCDs) to treat lymphedema. Readers of MDD Perspectives know the recent history of NHIC, which issued a reasonable-seeming coverage memo for continuous glucose monitors earlier this year. NHIC found itself in a quagmire with the lower limb prosthesis memo, but the memo for PCDs has a very serious problem: It would seem to overwrite an existing national coverage determination (NCD) for these devices without CMS having withdrawn the NCD.
For what it's worth, at least two private payers (Aetna and UnitedHealthcare) have issued coverage bulletins that draw the same conclusion about four weeks of conservative therapy before covering these compression devices for at-home use, so it's not as if Medicare is an outlier here.
All the same, this series of events raises questions about CMS's use of MACs. I can see using a MAC for the lower-limb prosthesis question, but I'm not so sure about the glucose monitor issue, as that has a lot of political implications that perhaps a MAC is not equipped to handle.
What is clear, however, is that offloading the PCD job to NHIC is a bad move. I get that the coverage and analysis group has its hands full with things like the recent coverage draft for left atrial appendage closure devices, but how does anyone conclude it's appropriate to hand off a coverage problem to a MAC with an NCD already in place? It makes you wonder who's minding the shop at the coverage and analysis group (CAG) at CMS.
The IPO dilemma and Novocure's wild ride
Initial public offerings are no longer as shy as unicorns, but they're not exactly as commonplace as insults hurled between wrestling fans. Novocure had an interesting October with their IPO, as my colleague Amanda Pedersen reported in the Oct. 5 edition of Medical Device Daily. Despite hoping to garner as much as $29 a share, the company opted for a target price of $23-24, but the shares hit $18.28 by the close of business Oct. 2.
Since then, Novocure (NVCR at NASDAQ) has been on quite a trip, approaching $28 a share on Oct. 13, then slipping to a bit more than $19 nine days later. By the end of the month, things had settled back into the $22-23 range, but why did this company – which has a treatment for the notoriously lethal glioblastoma – have so much difficulty?
According to this story at marketwatch.com, Novocure is not the only player in the IPO market to find the going less than hospitable. So that's one exit strategy that still looks dicey for med tech. Amanda also reported, this time in the Oct. 6 MDD, that device and diagnostics companies managed to pull in only about six percent of U.S. venture capital last year, so one might reasonably assume that the dearth of IPO opportunities continues to have a trickle-back effect.
Despite it's struggles, Novocure managed to win an FDA nod for an expanded indication for the Optune, as reported by my colleague Omar Ford in the Oct. 12 issue of Medical Device Daily. So this is one company that's making headway despite the headwinds, although one suspects venture capital will continue to be wary of venturing back into med tech at the levels seen just prior to the 2008 recession.