|Medtronic's MiniMed with Threshold Suspend technology--Courtesy of Medtronic|
Medtronic's ($MDT) new MiniMed 530G with Threshold Suspend technology is now the closest thing to an artificial pancreas with FDA approval. With that in mind, the company is reportedly seeking a separate CMS reimbursement code for the product.
MiniMed 530G is currently covered by existing insurance codes from the Centers for Medicare and Medicaid Services (CMS) for insulin pumps and continuous glucose monitoring (CGM). But a Medtronic spokesperson confirmed to Evidence-Based Diabetes Management (a publication of the American Journal of Managed Care) that the company applied for a new CMS code, in the wake of gaining FDA approval in a new device category.
The FDA signed off on the device in late September under the product classification "OZO: Artificial Pancreas Device System, Threshold Suspend." It addresses the fact that the MiniMed 530G combines glucose monitoring with an ability to automatically stop delivering insulin for up to two hours, based on a preset minimum threshold.
A new CMS reimbursement category could be important and a logical next step. Right now, patients may have approval for an insulin pump but not a CGM device. A combination would, in theory, require automatic approval for both under the current system, which could end up being tricky for next-generation devices that hit the "artificial pancreas" threshold.
Medtronic expects to launch the MiniMed 530G within the next few weeks. While it isn't a true closed-loop artificial pancreas system, it comes close because of the auto-shutdown feature. The company is also testing a next-gen MiniMed device with a closed-loop system in an 85-patient study.
Medtronic faces competition in the artificial pancreas space from Johnson & Johnson ($JNJ), Becton Dickinson ($BD), and Tandem Diabetes Care, among others.
- read the release