Tuesday, April 10, 2018

Federal Courts Continue to Blast CMS CGM Policy as Arbitrary and Capricious

For years, Medicare did not cover continuous glucose monitors (CGM) as a medical device, and the rationale was amazingly scanty - such as limited passing remarks that CGM was "preventive" rather than "medical."   (If the CGM shows your glucose is way too high or low, it's a medical problem, not some kind of opportunity for prevention.)

I blogged in July 2016 that Administrative Law Judges were treating the CMS position as nonsensical, here

CMS came out with a narrow ruling allowing CGM in some cases (an "Administrator's Ruling," January 2017, here.   The implementation is painfully complex; I don't track every nuance but have one blog on that, from March 2017, here.

The Parrish Law Firm has won a long line of cases, both administratively and in federal court; see their press releases here.   In April 2018, they won an additional court case, Lewis v Azar in Federal District Court of Massachusetts.   I've clipped the press release below the break.  Parrish writes that three district court cases now support the medical use of CGM, and this follows "more than sixty favorable ALJ rulings" as well.   She adds that, "In the last six months, three different district courts have issued three decisions finding that Medicare’s denial of coverage of a continuous glucose monitor is either just plain wrong or arbitrary and capricious and not supported by substantial evidence."

As Dexcom began rolling out products in August 2017 to Medicare beneficiaries, here's another twist, according to Parrish:
Medicare further stated that it would not cover a CGM if a Medicare beneficiary used a cell phone app to share glucose readings with caregivers or family members. This has forced Medicare beneficiaries to choose between Medicare coverage and sharing glucose levels with those who could intervene in a crisis. 
This position against advanced medical software on smartphones echoes a ruling on assistive speech generating devices, which can run on smartphone-like devices as DME but only if every possible function of the device is disabled, other than the medical speech generating function.

As a sidebar, see my April 2018 article on how the digital cardiology company Heartflow won a several year battle about misclassification as a non payable medical device.

As another sidebar, in CY2017, Medtronic attempted to get a HCPCS code for its advanced FDA approved artificial pancreas device.  Such a code would distinguish the product for twenty-year-old insulin pump technology.  CMS declined to issue a code to Medtronic


April 2018 Press Release from Parrish Law Firm


Third District Court Rules Medicare Must Cover CGM

On April 6, 2018, the District Court of Massachusetts found that a continuous glucose monitor meets Medicare’s definition of durable medical equipment and is covered by Medicare. See Lewis v. Azar. Medicare had denied CGM claims stating that CGM served no medical purpose. The court stated that the Secretary’s assertion that a medical device loses its medical purpose if it is used in conjunction with a medical device is contrary to law. In the last six months, three different district courts have issued three decisions finding that Medicare’s denial of coverage of a continuous glucose monitor is either just plain wrong or arbitrary and capricious and not supported by substantial evidence. In response to Medicare’s assertion that a CGM does not have a medical purpose if its readings must be confirmed with a finger stick, all three District Court judges noted the medical function that a CGM serves that finger stick does not. These District Court rulings follow more than sixty favorable administrative law judge rulings reaching a similar conclusion.

Despite these victories, Medicare beneficiaries still face significant hurdles securing access to CGM technology. In January 2017, Medicare indicated that it would cover only CGM that did not require a confirmatory finger stick before making an adjustment, but also indicated that it would only pay suppliers for a portion of the supplies necessary to effectively use the CGM although suppliers are required to provide all supplies necessary for effective use.  Accordingly, it appears Dexcom had difficulty identifying suppliers that would provide the Dexcom CGM to Medicare beneficiaries, so Dexcom was forced to become a supplier. Dexcom began supplying CGMs to Medicare beneficiaries in August 2017. Medicare further stated that it would not cover a CGM if a Medicare beneficiary used a cell phone app to share glucose readings with caregivers or family members. This has forced Medicare beneficiaries to choose between Medicare coverage and sharing glucose levels with those who could intervene in a crisis.

It remains to be seen whether Medicare will change its position with respect to CGM coverage in view of the three District Court decisions. The Medicare Appeals Council has taken the position that the District Court decisions only benefit those Medicare beneficiaries who live in the same jurisdiction. In the interim, Medicare beneficiaries continue to appeal CGM claims denied after the January 2017 ruling and, although Medicare Advantage Plans are required to cover everything Medicare covers, Medicare beneficiaries with Medicare Advantage Plans continue to lack access to Medicare-covered CGMs. Parrish Law Offices represented the Medicare beneficiaries who sued a Medicare Advantage Plan and Medicare in District Courts in Wisconsin, Vermont and Massachusetts for coverage of CGM devices. 

[emphasis added]