The Omnipod insulin management system (Insulet Corporation) may be covered now under the Medicare Part D (prescription drug) program, according to the Centers for Medicare and Medicaid Services (CMS).
Omnipod performs the same functions as a traditional insulin pump, but with a different design. Rather than a pump that attaches via tubing connected to an infusion site on the body, the insulin-containing “pods” are worn directly on the body and insulin infusion is controlled wirelessly by a “personal diabetes manager [PDM]” that also houses a glucose meter.
Because of its unique design — the PDM is nondisposable, but the pods that delivers the insulin are replaced every 3 days — the system does not meet the criteria for durable medical equipment under Medicare Part B, the way other insulin pumps are covered.
Instead, CMS has deemed the system reimbursable under Part D as a medical supply “associated with the injection of insulin,” a category that also includes syringes and pens, needles, and alcohol swabs. Another insulin delivery device, the V-Go (Valeritas), is also covered under Medicare Part D.
“We expect that technology will continue to advance and ‘medical supplies associated with the injection of insulin’ will become significantly more sophisticated. Part D sponsors may include such supplies in their benefit,” Jennifer R Shapiro, Acting Director of the Medicare Drug Benefit and C&D Data Group, Baltimore, Maryland, wrote in a letter to Part D Plan carriers.
But coverage isn’t mandatory, she said. “While CMS recognizes such products as medical supplies that are alternatives to insulin syringes, CMS does not require Part D sponsors to include them on their formularies, and sponsors may apply utilization management criteria if they include such products on their formularies.”
Insulet’s account executives are now working with Part D carriers to obtain coverage. Because that process is expected to take time, the company is also offering customers help in securing formulary exemptions, and if denied, appeals. Patients who already use or wish to begin using Omnipod can call Insulet’s Medicare Access Team at 877-939-4384.
Endocrine Society Praises the Move
The Endocrine Society says it is “elated” by the CMS move.
“The guidance will give people with diabetes greater access to a wider range of insulin delivery devices. This opens the door for older Americans to gain coverage,” the organization said in a statement, pointing out that prior to this, Omnipod was the only FDA-approved insulin pump system not covered by Medicare.
People with diabetes who aged into Medicare at 65 years old had to pay out of pocket to continue using Omnipod, and many lost access to the device.
“For years, the Society has championed the importance of covering the Omnipod in discussions with policymakers and regulators. Such access gives people with diabetes the freedom to choose the device that best suits their individual needs and helps them manage the chronic condition,” the Endocrine Society added.
The CMS guidance also allows Insulet to work toward gaining Medicaid coverage at the state level, as many state-run Medicaid programs follow CMS prescription drug guidance.
The guidance follows CMS’ decision last year to extend Medicare coverage to continuous glucose monitors (CGMs), another move advocated for by the Society. And CMS announced last week it will provide coverage for the new Abbott FreeStyle Libre CGM, “offering consumers an additional choice.”
Insulet Focus on Gaining Coverage of Omnipod for Type 1 Diabetes
Insulet expects that the Omnipod will be covered for patients with type 1 diabetes as well as some with type 2 diabetes who meet criteria for insulinopenia, consistent with Medicare’s coverage for other insulin pumps.
However, “While we believe there are opportunities to deliver the significant benefits of the Omnipod system to the type 2 diabetes user base as we move forward, we are initially mainly focused on the type 1 diabetes community for this coverage,” the company states.
It says that obtaining Medicare coverage will extend access to Insulet’s Omnipod to those with type 1 diabetes in the United States, including lower-income individuals and families for whom Omnipod is currently not an option.
In related news, starting July 1, 2018, Insulet will begin directly distributing Omnipod and providing training and customer support in Europe, as it does in the United States and Canada. Until then, the distributor Ypsomed will continue to provide customer support in Europe.
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