Medicare Coverage for CGM Caught in Regulatory Limbo

Word spread quickly on January 12, 2017, among the close-knit community of people who live with type 1 diabetes (T1D): after years of advocacy, appeals, and a daylong hearing with the FDA, a rule change meant Medicare would cover continuous glucose monitoring (CGM), a modern-day technology that seems perfectly suited for the age group that may no longer sense a hypoglycemic event.

Not so fast, it turns out. In recent days, word has spread just as quickly that Medicare beneficiaries are hitting snags as they try to secure the Dexcom G5, the only CGM device with an FDA approval for insulin dosing, which paved the way for Medicare’s ruling. Before the FDA approval, the Dexcom G5 was considered “adjunctive” technology, meaning it was not necessary; as of January 12, 2017, CMS has determined that it serves a therapeutic purpose, and thus can be classified as durable medical equipment.

Getting from that rule change to actual coverage is easier said than done, however. As beneficiaries get prescriptions and try to file claims for the Dexcom G5, they are running into the complex system of Medicare Administrative Contractors (MACs), who typically make coverage decisions based on Local Coverage Determinations (LCDs).

Suppliers, meanwhile are balking, because no one knows where CGM fits in the group of diabetes supplies reimbursed by Medicare, known as a “bundle.” Until CMS clarifies how it will pay for CGM, vendors do not want to risk being shortchanged for these devices. Dexcom, while a manufacturer of CGM, is not a CMS supplier, according to sources familiar with the process.

An administration source told The American Journal of Managed Care^® that decisions on whether the Dexcom G5 met the test of a therapeutic CGM being “reasonable and necessary” would be addressed on a case-by-case basis, through the LCD process, or through a future National Coverage Determination.

Dexcom, meanwhile, issued a statement that it is awaiting final clarification from CMS on the documentation required to process CGM claim requests. “We are focused on finalizing this process with CMS to ensure our current and new customers get what they need,” the statement said. “We are working to resolve this situation as quickly as we can and hope to have it all resolved by summer.”

Separately, Dexcom is communicating with Medicare beneficiaries who are working to gain CGM access.

A March 28, 2017, notice said those eligible included Medicare beneficiaries with type 1 disease and those with type 2 who are on intensive insulin therapy and test blood glucose levels at least 4 times a day.

The FDA approval for dosing and the subsequent CMS ruling came after years of advocacy, by JDRF and others, including several multi-level appeals through the Medicare system. Debra Parrish, an attorney who handled the first successful case that found CMS’ statement that CGM was precautionary could not be used to block coverage, noted in an email that beneficiaries are being denied CGM coverage now even though the rule is in force.

She pointed to a May 4, 2017, notice from contractor CGS on “frequently asked questions” about CGM, that said a policy article will be “updated shortly.” In the e-mail, Parrish said the lack of certainty is “not sufficient for suppliers.” There is also uncertainty about how many test strips will be covered for those receiving a CGM.

All this is frustrating for Medicare beneficiaries living with T1D. Dan Patrick, who won a third-level appeal for a Dexcom G4, is in the worst kind of limbo—the new rule means he can’t get coverage for supplies for his old CGM, but coverage for a Dexcom G5 is in a No Man’s Land.

“What is happening? Nobody knows,” Patrick said. “There is a lack of clarity in this.”