Tuesday, March 28, 2017

Brief Blog: CMS Rolls Out CGM Coverage; Window into Numbingly Complex Policies

In the summer of 2016, CMS began losing administrator judge cases when it tried to defend its poorly-enunciated policy that continuous glucose monitors were not a medical product  category eligible for Medicare payment.

In January 2017, CMS released a lengthy, legalistic ruling reversing its position.

On March 23, 2017, CMS DME MACs released a provisional policy that describes actual coverage of CGM through claims processing.

Details after the break.

Background: Medicare, DME, and CGM

Medicare statute provides coverage to a wide range of service categories - among them, physician services, hospital services, ambulance services, and DME products and supplies.   DME products and supplies are defined by law to include blood glucose monitors.  (Otherwise, BGM's might not be "durable" equipment like wheelchairs and sleep apnea pumps.)  

For a decade, very cryptic and incomplete CMS policy statements indicated that continuous glucose monitors (CGM) weren't simply non-covered - they actually were deemed to fall outside of the available benefit categories as medical devices.  (This seems cockeyed since CGM are FDA-approved PMA medical devices.)  

By 2016, CMS was regularly losing legal challenges against its classification of CGM as outside coverage categories (my article, here.)   CMS wasn't just losing; judges were disparaging the poorly-argued CMS position.

January 2017:  CMS Flips Policy via Legalistic Ruling

In January 2017, in a legalistic and complex Administrator's Ruling, CMS determined that CGM devices that were FDA-labeled for insulin adjustments were eligible for coverage (my article, here.)  Not necessarily covered, but eligible for coverage by LCD or NCD.

March 2017:  Provisional DME MAC Article on CGM Coverage

On Friday, March 24, 2017, CMS MACs released an article stating that a specific CGM coverage policy continued to be in-the-works.  In the interim, they stated a working coverage policy.   Readers of this MAC article may be confused by its reference to "claim by claim" claims processing.   So far, CMS has not actually updated all of its existing policies that provide coverage only for conventional BGM, and CMS MACs will require more time, apparently, to put a formal CGM LCD in place.  Therefore, CMS MACs are releasing a temporary "article" that states how they will process CGM requests "claim by claim" or "case by case" in the absence of an LCD.
  • The new March 2017 DME MAC article about CGM is online here.  
  • The existing legacy LCD for BGM (L33822) is online here.
  • An existing legacy article (A52464) attached to the LCD is online here
  • Noridian's webpage for all lof its CGM/BGM related articles and policies is here.
I've put a Zip file of the new article, the Administrator's Ruling, and L33822/A52464 in the cloud, here.

For a news article about this March 2017 MAC document release, see MedCity, here, and a Dexcom press release, here.

The Noridian BGM homepage lists over a dozen linked articles or PDFs.  The CGM Ruling is 16 pages long. The LCD for BGM is 18 pages long and the accompany article is 7 pages long.

What's the bottom line of all this?  The new CGM coverage will be applied to insulin-using diabetes (whethe rthey use injection or pump insulin) who test their blood glucose
four or more times per day" and also if "the regimen requires frequent adjustments by the beneficiary, based on CGM results."   It sounds like the DME MACs haven't worked out what "frequent" adjustments by CGM means... Or how you determine how frequent the individual's CGM-based adjustments will be ahead of the time you first prescribe the CGM meter.