Diabetes Societies Aim to Gain Medicare Coverage for CGMs, OmniPod

Miriam E Tucker

November 24, 2016

Ongoing efforts from several fronts are aimed at convincing the US Centers for Medicare and Medicaid Services (CMS) to change its coverage plans for Medicare, which currently exclude several diabetes technologies that don't fit the agency's narrowly defined categories for reimbursement.

Although most private insurers now cover personal-use continuous glucose monitors (CGMs) and the insulin-delivery device OmniPod (Insulet Corporation) for patients who meet certain clinical criteria, Medicare doesn't. And neither do about 20 state Medicaid programs that follow Medicare's lead.

Thus, Medicaid patients in those states can't get these devices, while those who have been using them for long periods of time — both CGMs and OmniPod have been on the US market for over a decade — are forced to give them up or pay out of pocket for the supplies when they age into Medicare.

"[CMS officials] just want to be within the bounds of the law. But as a clinician I deal with all these headaches. When patients turn 65 they lose the OmniPod and CGM," George Grunberger, MD, head of the Grunberger Diabetes Institute, Bloomfield Hills, Michigan, and immediate past president of the American Association of Clinical Endocrinologists (AACE), explained to Medscape Medical News.

Issue Relates to Definition of "Durable Medical Equipment"

With both devices, the problem relates to the definition of "durable medical equipment," which applies solely to the active part of devices under Medicare Part B.

In the case of CGMs, the "active" part — the sensor inserted beneath the skin — is discarded after being worn for 6 or 7 days (CGMs from Medtronic and Dexcom, respectively). Both systems also include battery-powered transmitters — either rechargeable (Medtronic) or disposable after 3 months (Dexcom) — and a durable receiver, either housed within an insulin pump (Medtronic), as a separate unit (Medtronic and Dexcom), or as a smartphone app (Dexcom).

The OmniPod is a tubing-free insulin-delivery system that performs identical functions as currently available insulin pumps. But, in contrast to conventional insulin pumps that are connected via tubing to the insertion site on the wearer's body, the wireless pod containing the insulin that is inserted into the body is thrown out after 3 days. A separate durable device, the "personal diabetes manager," wirelessly communicates with the pod and also houses a blood glucose meter.

"It's exactly the same issue with both. CMS says only the sensor and pod are the active parts, when in fact for both CGM and OmniPod, the durable part isn't a convenience, it's essential. They're not passive," Dr Grunberger notes.

On behalf of AACE, Dr Grunberger has joined with representatives from the American Diabetes Association, Endocrine Society, and JDRF (formerly the Juvenile Diabetes Research Foundation) in informal talks with CMS on this and related issues to discuss possible solutions.

Additional Issue With CGMs: "Adjunctive" or Central?

With CGMs, there's an additional issue: CMS has viewed the technology as "adjunctive" to finger-stick blood glucose monitoring, rather than as an essential component of diabetes management.

But Dr Grunberger predicts that will need to change soon, as the US Food and Drug Administration (FDA) has already approved closed-loop insulin-delivery systems in which the CGM is an essential component, first Medtronic's 530G insulin pump and now the 670G insulin pump. The latter is the first product that can technically be termed an "artificial pancreas."

Moreover, in July an FDA advisory panel voted in favor of Dexcom's application to allow its CGM to be used for insulin dosing, thereby replacing finger-stick monitoring (except for calibration and in certain clinical circumstances).

That use was just approved in Canada on November 14, and if the FDA were to follow suit, it would likely force CMS's hand in its classification of stand-alone CGMs, Dr Grunberger pointed out.

OmniPod: Device or Drug?

The durable medical equipment issue might be easier to resolve with the OmniPod, as a solution was already put in place by Congress 8 years ago. Durable medical equipment falls under Medicare Part B, but in 2008, Congress explicitly allowed for "insulin devices that are not otherwise covered under the [durable medical equipment] benefit" to be covered as medication under Part D.

More recently, however, CMS has said that the battery-operated part means that the systems are devices rather than drugs, Insulet spokesperson Dan Knight told Medscape Medical News, adding, "This is the catch-22 for OmniPod."

Dr Grunberger pointed out that there's precedent for Part D coverage: a simple, disposable patch pump, called the V-Go (Valeritas), used primarily in patients with type 2 diabetes. It delivers steady basal insulin, and patients click for more insulin at mealtime.

The V-Go is approved under Medicare Part D, so patients pick up a packet of the devices at the pharmacy along with their insulin vials, akin to syringes. While the OmniPod is a far more sophisticated device, it could conceivably be covered that way, he noted.

According to Dr Grunberger, OmniPod offers important advantages over conventional insulin pumps for some patients. It is easier to insert and doesn't involve tubing that can get caught on things and pulled out.

Patients wear the device continuously for 3 days, including while bathing. "I think OmniPod is much better for kids and older people...but of course I let my patients choose whatever they want. It's like choosing a phone."

Hope for Congressional Action

Regarding Medicare coverage for CGM, Cynthia Rice, senior vice president for advocacy and policy at JDRF, told Medscape Medical News that her organization is urging Congress to act as quickly as possible on two bills, Senate 804 with 50 cosponsors and House of Representatives 1427 with 273 cosponsors. Both have strong bipartisan support, she noted.

Congress is currently working to wrap up other legislation during this lame-duck session, but it's possible the bills could be taken up.

If they are not acted on by year end, they will need to be reintroduced in the new Congress, Ms Rice explained, adding, "The good news is that, of the current bill sponsors, 47 of 50 senators and 240 of 273 house members will be returning to Congress next year, so we'll start with a strong base of support."

Although there is no bill specifically addressing OmniPod, on November 4, Senators Susan Collins (R-ME) and Jeanne Shaheen (D-NH) coauthored a letter to acting CMS administrator Andy Slavitt urging coverage for the device.

CMS Open to Change

On a related issue, Dr Grunberger said that the professional societies are also talking with CMS about revising strict C-peptide and antibody criteria for covering insulin pumps for diabetes patients.

The intent of those rules — dating back more than a decade — was to restrict their use to those with type 1 diabetes, but this has been problematic as some people with type 1 diabetes retain detectable C-peptide early on, even years after diagnosis, whereas some people with type 2 diabetes have autoantibodies.

Thus far, those discussions with CMS have also been informal, but recently it asked the society representatives to submit a formal proposal on the patient-criteria issue.

"These criteria haven't changed since 2004. Even CMS recognizes it might be time for an update. The fact that they agreed to meet with us and encouraged us to submit a formal request to change is encouraging," notes Dr Grunberger.

And in an email to Medscape Medical News regarding coverage of CGM and OmniPod, a CMS representative said that the agency "has been engaged by stakeholders on this issue recently and is giving it a fresh examination."

Dr Grunberger participates in research funded by Medtronic.

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