Wednesday, June 13, 2018

CMS to Cancel Bizarre Policy that Disallowed CGM if Used By Individual with Smartphone

Update September 2018: Trade press, CMS interview about this decision.  Here.


I've written several times about bizarre CMS policies about Continuous Glucose Monitors (CGMs), most recent in March 2018 (here).

One of the most bizarre tangents was a DME MAC article that disallowed supply payments (such as, oh, say, insulin supply and tubing supply and sensor patch supply) to a CGM system if the user used a smartphone in conjunction with it in any way.   See original article here, and if it is taken down, see archive here.

The pivotal text is:
  • Coverage of the CGM system supply allowance is limited to those therapeutic CGM systems where the beneficiary ONLY uses a receiver classified as DME to display glucose data.  
  • If a beneficiary uses a non-DME device (smart phone, tablet, etc.) as the display device, either separately or in combination with a receiver classified as DME, the supply allowance is non-covered by Medicare
See a September 2017 article at Medscape here, a July 2017 blog here, another article here.

CMS Will Change Smartphone Ban Soon

According to a June 13, 2018 article at Medscape, CMS has now promised to have the above policy statement withdrawn.  Here.  Another June 2018 trade article here and here.

Medscape states in part,
     Although diabetes advocates had praised CMS for the overall coverage decision, they also decried the agency's lack of recognition for the use of modern-day technology, which also left seniors without access to the "share" function, whereby loved ones could remotely follow blood glucose readings.
     One endocrinologist deemed the lack of coverage for use of the device with the smartphone app "absolutely ridiculous."
     Turns out, CMS was listening. "CMS heard from numerous stakeholders who shared their concerns that Medicare's CGM coverage policy limited their use of CGMs in conjunction with their smartphones...After a thorough review of the law and our regulations, CMS is announcing that Medicare's published coverage policy for CGMs will be modified to support the use of CGMs in conjunction with a smartphone, including the important data sharing function they provide for patients and their families," the agency said in a statement.

The source of the news is the DME Center Website at, here.  Cloud here.

click to enlarge

June 2018 Court Case

For a flat-out CMS loss in June 2018, in which federal court even awarded attorney's fees to the plaintiffs, see here.  Courts can award lawyers' fees in cases where the Fed position is unable to "satisfy a reasonable person" or is not "reasonable in law and fact."  There must be a "reasonable connection between the facts alleged and the theory propounded" by the government.  The government failed these tests, so fees could be awarded.

Interesting reading.  Regarding the tortuous and generally undefined use of "precautionary" in CGM cases, judge finds that the "circular reasoning is entirely unhelpful."   If CGM is not "medical," says the judge, HHS was unable to explain "what non-medical purpose it believes [CGM] serves."

The court notes that previous cases had found the HHS position to be "head scratching" and that "a string of losses" in many court cases can be indicative of an untenable position.  The standard rate awarded to attorneys, barring exceptions, is $125/hr.  The judge's award in this case (including special rates) was $70,000.  At $500/hr, that would be about 140 hours.

For a July 6, 2018, article at MedPageToday, here.