Older Americans will now have access to insulin delivery devices under Part D of Medicare coverage, according to guidance issued by the Centers for Medicare & Medicaid Services (CMS). The CMS guidance clarified that devices not previously covered under Medicare Part B will be covered under Part D of the prescription drug program. As a result, older Americans will now have access to a wider range of insulin delivery devices.

Insulin delivery devices help patients manage blood sugar levels effectively. The devices prevent dangerous blood sugar fluctuations that can lead to complications like hypoglycemia.

In the guidance, the CMS wrote: “With the introduction of new insulin delivery devices to the market, questions have arisen about Part D coverage for these products. Specifically, we have been asked whether newer insulin delivery devices that are not covered under Medicare Part B meet the Part D definition of ‘medical supplies associated with the injection of insulin. … The examples that were previously provided were never intended to be an exhaustive list of products that could be covered under Part D. Instead, they represented our understanding of the types of medical supplies associated with the injection of insulin that were available at the time.”

Since then, new delivery devices have been introduced to market “in the form of both mechanical and electronic insulin pumps” that are not covered under the Medicare Part B durable medical equipment (DME) benefit.

“We expect that technology will continue to advance and that ‘medical supplies associated with the injection of insulin’ will become significantly more sophisticated,” wrote the CMS. “As new products become available, Part D sponsors may evaluate these products for formulary placement and medical necessity and, subject to Part D coverage determination and appeals requirements, allow access and restrict use accordingly.”

According to the guidance, Part D will cover supplies “that are alternatives to insulin syringes,” and the CMS will not require insurers who offer Part D plan coverage to include these on their formularies. If these alternatives are included on formularies, sponsors may use utilization management criteria for the products.

In a statement praising the CMS’s decision, the Endocrine Society wrote: “This opens the door for older Americans to gain coverage for devices such as the Omnipod insulin management system, a popular insulin pump system. Until the new guidance was issued, Omnipod was the only FDA [Food and Drug Administration]–approved insulin pump system not covered by Medicare. Previously, people with diabetes who qualified for Medicare at age 65 had to pay out of pocket to continue using the Omnipod, and many lost access to the device.”

Robert Lash, M.D., chief professional and clinical affairs officer for the Endocrine Society, said in an interview that the new CMS guidance “gives physicians and their diabetic patients access to a wider range of technology options, since individuals with type 1 diabetes prefer the Omnipod’s tubing-free design because it makes it easier to participate in sports and safer to work in certain environments.

“Before this guidance was issued, those patients had to switch pumps or revert to insulin injections when they turned 65 years old. We are pleased this guidance will open the door to greater choice” for patients,” said Dr. Lash.

The CMS’s decision on insulin delivery devices follows a decision last year to cover continuous glucose monitors (CGMs) through Medicare. Last week, the CMS also announced it will provide coverage for the Abbott Freestyle Libre CGM, a welcome move for patients seeking additional choices.