CMS to Recognize CGMs for Treatment Decisions in Diabetes

January 13, 2017

After much lobbying from organizations such as the JDRF (formerly Juvenile Diabetes Research Foundation), the US Centers for Medicare and Medicaid Services (CMS) has recognized continuous glucose monitors (CGMs) approved by the US FDA for use in making diabetes treatment decisions as "durable medical equipment," meaning they could soon be eligible for coverage by CMS.

Although most private American insurers cover personal-use CGMs for diabetes patients who meet certain clinical criteria, Medicare has not, until now, and neither did about 20 state Medicaid programs that follow Medicare's lead.

So Medicaid patients in those states have been unable to get these devices covered, while those who had been using them for long periods of time — CGMs have been on the US market for over a decade — have been forced to give them up or pay out of pocket for the supplies when they age into Medicare.

As CMS has now determined CGM devices are "durable medical equipment," the program can now cover them on a case-by-case basis, says JDRF in a press release.

"Medicare beneficiaries should work with their healthcare professional and CGM provider to obtain coverage," it adds.

JDRF Encouraged by Decision, Hope It Paves the Way to Greater Coverage

CGMs are small, wearable devices that monitor glucose levels every few minutes, day and night, which helps people with type 1 diabetes to manage insulin dosing and to see whether their levels are trending high or low. Numerous CGMs are approved by the FDA and prescribed by physicians, and their use is recommended by national diabetes clinical guidelines and covered by nearly all private US health plans.

JDRF says that extensive clinical evidence shows that CGM use significantly improves diabetes management, enabling users to avoid potentially dangerous episodes of hypoglycemia and the devastating long-term complications associated with chronic hyperglycemia.

Seniors with type 1 diabetes in particular are at elevated risk for hypoglycemia, leading not only to adverse health outcomes but to increased use of costly emergency-room visits and hospitalizations.

Aaron J Kowalski, PhD, JDRF's chief mission officer, says: "JDRF is encouraged by this decision, which will bring us one step closer to Medicare coverage for continuous glucose monitors. We want to thank the tireless JDRF advocates and Congressional champions who have made this progress possible."

"Medicare coverage of CGM devices would have real health benefits for Medicare recipients with type 1 diabetes, and we'll continue to work with CMS and other diabetes advocates to get there," Dr Kowalski added in a quote provided to Medscape Medical News.

"Some people who have managed their diabetes pretty well with CGM devices have been forced to give them up once they switched from private insurance to Medicare. Seniors are at particular risk for hypoglycemia and the costly hospitalizations that can result, so it's very important that they have access to the diabetes care they need," he stressed.

JDRF adds in its press release: "We look forward to working with the incoming Congress and administration to ensure broad and affordable access to exciting new type 1 diabetes therapies like the artificial pancreas systems and to advance the interests of the type 1 diabetes community at every level."

There is no news, however, on whether CMS plans to also recognize OmniPod (Insulet) as "durable medical equipment." OmniPod is a tubing-free insulin-delivery system that performs identical functions as currently available insulin pumps, and it has also been on the US market for over a decade.

This lack of recognition means OmniPod users face the same risk as CGM users did — ie, that many Medicaid patients have been unable to get the OmniPod covered, while many of those who have been using them for long periods of time are forced to give them up or pay out of pocket when they age into Medicare.

Follow Lisa Nainggolan on Twitter: @lisanainggolan1. For more diabetes and endocrinology news, follow us on Twitter and on Facebook.

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