Medicare Curiousities: DME MACs to Hold Complex Advisory Board on Tumor Electrical Field Therapy

In typical Contractor Advisory Committees, a MAC (say, Noridian or Novitas) issues several new or revised LCDs, posts them for a public comment meeting, and also holds a session of its Contractor Advisory Committee, typically about 20 physicians of diverse specialties.  (Note: This process is changing per new 2019 instructions from CMS; here.)

For durable medical equipment, CMS divides the U.S. into four districts, which are managed by a total of two special DME MACs.  Their LCDs are always identical.  These MACs issue new LCDs and hold advisory committees quite rarely.

Elaborate DME CAC on NovuCure Tumor Device

However, an elaborate DME MAC advisory committee is coming up soon.  It will be held on the CMS campus in Baltimore, just like NCD MedCACs, and the agenda is quite formal.   In addition, CMS has assembled an advisory board of specialists. 

The topic is NovoCure's electrical field therapy for glioblastoma, which is delivered on an ongoing basis by a portable device.  Novocure (website here) has annual revenue of about $250M and a market cap circa $5B (which has double in the past year; here.)   See recent investor call here, and trade press here, here, here.   Its device is currently not covered by CMS under LCD L34823.

The Device; The Code; The Price

Novocure is headquartered in Jersey (the island, not the state; near Mont St Michel, France).  Its website lists office in Switzerland, Germany, New Hampshire, New York, Japan, and more.

See the FDA paperwork for the device here; P100034.  Per the company's homepage, it provides "a cancer therapy that uses electric fields to disrupt cell division, inhibiting tumor growth." 

The code is  E0766 here.  This is "Electrical stimulation device used for cancer treatment, includes all accessories, any type" and dates to 2014.

The code is not covered (L34823) and being a non covered DME code, it isn't on the current 2019 DME fee schedule at all.

The LCD L34823 is nearly entirely boilerplate.  It has no scientific citations or discussions, and in the middle of it is a single operational sentence that E0766 is not covered by Medicare.  See also A52711 coding article (no meaningful content).

The Upcoming Contractor Advisory Meeting - March 6, 2019 at CMS Auditorium

Novocure issued a press release last October that a DME CAC meeting was pending - here.

The CMS DME MAC webpage for CAC meetings has come to life with five links.   These include a bibliography, an announcement of the panelists, which include Kevin Camphausen MD, Chief, Radiation Oncology, NCI, and Henry Friedman MD, Chief of Neuro-Oncology at Duke, and many more luminaries.

The committee will discuss a series of Key Questions, with ratings 1-5 for response, similar to a CMS MedCAC.  Teleconference and webcast info is provided, and the agenda runs all day, 9-4, similar to an FDA ad board or CMS MedCAC. 

click to enlarge

Resources in the Cloud

I've put all the webpages and resources cited into a Zip file in the cloud.  Here.


Corporate Presentation

See a 52-page January 2019 corporate slide deck here.
Annual reports are interactive online here.

Timeline

I believe there is no required timeline, after the CAC meeting, for the DME MACs to issue a draft revised LCD.   I also believe that after issuing one, there isn't a timeline for finalizing it, except for a new rule that draft LCDs expire after 1 year.

click to enlarge

image from Google Image Search