Centers for Medicare and Medicaid Services (CMS) has just issued guidance to address Medicare Part D coverage for newer insulin delivery devices for the treatment of diabetes. Medicare Part D has historically covered “medical supplies associated with the injection of insulin,” such as syringes, needles, alcohol swabs, gauze and other supplies directly associated with insulin delivery. CMS has also specified that insulin delivery devices not otherwise covered under the Part B benefit, such as insulin pens and needle-free syringes, would be covered under Part D.

Since this time, newer insulin delivery devices in the form of mechanical and electronic insulin pumps have been introduced, but these pumps were generally not covered under the Part B benefit for durable medical equipment and supplies. CMS has now clarified that these more sophisticated devices may be covered under Part D if they are directly associated with delivering insulin into the body, and do not otherwise meet coverage requirements for durable medical equipment under Part B. Part D coverage, however, does not mean that Part D sponsors must include these devices on their formularies. Sponsors may also apply prior authorization requirements to evaluate these products for medical necessity and, subject to the Part D coverage determination and appeals process, restrict use of these devices accordingly.