Medicare Continues to Fight CGM Coverage in Court, and Told to Pay

If people with diabetes thought that last year’s CMS decision to cover the Dexcom G5 for Medicare beneficiaries would end court cases over coverage for continuous glucose monitoring (CGM), they were mistaken.

On January 29, the day he was sworn in as HHS Secretary, Alex Azar’s name was substituted as the defendant in a case involving Jonathan A. Bloom, DDS, just in time for US District Court Judge Geoffrey W. Crawford of Vermont to remand a case filed in April 2016, and order Azar to pay for the beneficiary’s CGM and necessary supplies.

Despite an official policy that says Medicare covers CGM for those with type 1 diabetes (T1D), or those with type 2 diabetes (T2D) who require intensive insulin therapy, attorney Debra Parrish told The American Journal of Managed Care^® in an email that HHS not only continues to fight these cases, but that some beneficiaries are still denied CGM because it is “precautionary,” and suppliers don’t want to offer CGM.

“Medicare will not pay for sufficient test strips to calibrate the CGM, but suppliers are required to provide all supplies necessary for effective use of a device, and few suppliers have been willing to supply a CGM to Medicare beneficiaries,” Parrish wrote.

Bloom’s case, in fact, was a harbinger of this problem. According to court filings in the federal district in Vermont, Bloom has lived with T1D since 1974, is extremely hypo-unaware, and experiences significant fluctuations in blood glucose that his Medtronic MiniMed CGM has helped him manage. Despite his previous successful appeals involving CGM, Medicare in 2015 refused to pay for the sensors and receiver that help make up a functioning system. A Medicare Appeals Council said these were supplies that were Bloom’s responsibility.

As Bloom’s case proceeded in 2016, an FDA panel held a daylong hearing that found the Dexcom G5 was safe for dosing insulin, and by year’s end approved the product for this use. Medicare finally approved the Dexcom G5 as durable medical equipment (DME) January 12, 2017, at the end of the Obama administration.

Parrish, who won the landmark case, Whitcomb v. Burrell that paved the way for other Medicare beneficiaries to gain CGM access through appeals, said Crawford is the fourth District Court judge to reject the HHS Secretary’s assertion that CGM is precautionary. For years, this term has been used to justify denying coverage, but Crawford wrote, “the evidence does not support the conclusion that Dr. Bloom uses his CGM as ‘backup’ or emergency equipment,” akin to a “spare” oxygen tank. “The evidence is that [Bloom] uses it routinely to avoid hypoglycemia.”

In fact, Crawford deemed the “precautionary” label entirely irrelevant. The fact that the Dexcom G5 must be calibrated periodically with a fingerstick doesn’t mean that it doesn’t have a primary medical use, and “a technology’s purpose is not altered just because it must be calibrated or confirmed by another technology.”

Parrish said Medicare will only pay for 4 sensors even though the FDA approval for the Dexcom G5 calls for 5. Dan Patrick, a T1D patient who wrote a 2016 commentary for Evidence-Based Diabetes Management™ about his successful Medicare CGM appeal in the wake of the Whitcomb ruling, said he has experienced issues with getting enough sensors from suppliers.

Two other CGM makers, Abbott, which makes the Freestyle Libre, and Insulet, which makes the Omnipod, have recently secured Medicare coverage but opted to distribute their products through the pharmacy supply chain.

Parrish also cited Medicare’s ban on letting beneficiaries to connect their Dexcom G5 CGM with a cell phone in addition to their receiver, and said it might take court action to resolve this. It’s potentially unsafe for those who have hypo-unawareness, she said. These beneficiaries would benefit from having a caregiver or family member monitor their blood glucose levels remotely.

Patrick noted he has other family members with diabetes, including a young grandchild. “I can watch their numbers, but no one can watch mine,” he said.