Big news in the Diabetes Community!
The Centers for Medicare and Medicaid Services (CMS) made these two separate decisions in the first week of 2018, starting off the New Year with a bang for our country's aging diabetes population. And since CMS typically sets the stage for what private insurers will cover, this is a big win for PWDs (people with diabetes) of all ages!
Additionally, one of the new CMS decisions clarifies the federal agency's policy and appears to open the door to coverage for next-generation closed loop technology that we'll certainly be seeing more of in the coming years.
CMS has been largely criticized for its slow action on anything diabetes-related in recent years, so hopefully this signals a new progressive attitude toward tech tools that have proven impactful.
Here's the skinny on what CMS has recently done, and what needs to happen as we move forward in 2018:
OmniPod on Medicare (and Medicaid)
Insulet has literally been struggling to get CMS coverage of its tubeless OmniPod insulin pump for years. The company's VP of Market Access even did a presentation about this at our most recent DiabetesMine Innovation Summit in November.
We first caught wind of CMS' change of heart in a tweet on the afternoon of Friday Jan. 5 from Senator Susan Collins in Maine, who sits on the Senate Diabetes Caucus and has been a leading advocate on diabetes issues and for Medicare coverage for OmniPod specifically for much of the past year.
We followed up with Insulet, after coincidentally talking with their execs earlier that day who at the time indicated, "it's a work in progress and we're hoping to know more soon." By the day's end, Collins' tweet had made Insulet aware the action was underway. That evening, CMS issued its official policy language and over the weekend Insulet prepared its full-court press about Medicare's new coverage eligibility.
The Boston-area company estimates that approximately 450,000 additional PWDs with type 1 in the USA may now be eligible for Medicare or Medicaid coverage, and that's not even factoring in all those with type 2 who might also be eligible for the OmniPod.
- What part of Medicare? This all falls under Medicare Part D, the prescription drug benefit aspect of the federal insurance program, rather than through Part B, which covers doctor's visits and Durable Medical Equipment (DME).
- No Guarantee: To be clear, Medicare coverage of the OmniPod isn't guaranteed, it's just possible now thanks to this CMS policy letter.
- Details TBD: Medicare vendors and carriers must now work out the details, such as specific criteria and what the pricing reimbursements will be. That will take some time.
- Starting When? It's TBD whether this will apply from the date of the Jan. 5 policy letter from CMS, or if it will first take effect from whenever the vendors establish their specific coverage policies. The expectation is that Medicare Part D coverage will actually begin in 2019.
- Types of Diabetes? There's nothing to indicate this is only for type 1, and CMS has a national coverage determination for all insulin pumps that applies to both T1 and T2, so the assumption is that both are included unless otherwise spelled out at some point.
- Utilization Review: The CMS policy does mention something called "Utilization Review," which means Medicare beneficiaries will probably have to go through some type of "medical necessity" evaluation before obtaining coverage. No doubt, that'll probably mean some denials happen and PWDs will need to appeal and fight for their OmniPod coverage (sigh).
- Phone Hotline: Insulet has created a Medicare Access Team, which you can call directly at 877-939-4384.
- FAQs: Here's an FAQ page the company has put together online with more information.
- Medicaid Pathway: Oh yes, and Medicaid... By securing this Medicare Part D coverage decision, Insulet now has a direct pathway to get Medicaid coverage at the state level since many of the state-run Medicaid programs follow CMS prescription drug guidance in determining coverage.
- Future D-Tech: By using the term "medical devices associated with the delivery of insulin," CMS appears to be opening the door for coverage of future "Automated Insulin Delivery" or "Artificial Pancreas" technology going forward. That's pretty huge.
What took so long?
Medicare officials hadn't assigned a benefit code for OmniPod, because it consists of a three-day disposable Pod that also needs the handheld Personal Diabetes Manager (PDM) to operate. It didn't fit into the usual category of DME (Durable Medical Equipment) because of that disposable aspect, and that's been the roadblock in obtaining Medicare coverage, we're told.
Notably, the new Medicare policy still doesn't categorize OmniPod as DME. Instead, they basically point out that nothing in their original policy from 2005 should have been interpreted to mean that the tubeless OmniPod could not be covered... wow!
What's amazing is that it took 13 years for CMS to issue a written document clarifying this, and clearly stating that OmniPod coverage for Medicare beneficiaries is actually OK. That's a loooong time to wait, for many patients who desperately wanted the system.
But hey, let's look at the positive and move forward, right...?
We're excited to see this coverage now possible, and thrilled that PWDs who have been using OmniPod leading up to Medicare age and those reaching that point now have the option to stay on this patch pump as a covered benefit if they want to.
FreeStyle Libre + Medicare, Too
It was actually one day ahead of the OmniPod decision when the announcement came that CMS would allow Medicare coverage for the new Abbott FreeStyle Libre system -- a new kind of glucose monitor just approved by FDA in September 2017 and launched by Abbott Diabetes Care at the end of this past year.
This likely happened so quickly due to the Dexcom G5 system decision a year ago in January 2017. CMS signed off on the Dexcom G5 continuous glucose monitor as a "therapeutic" tool because it's now been FDA-cleared to be accurate enough to make insulin dosing and treatment decisions -- and that meant it was eligible for Medicare coverage.
When the Dexcom decision first came down, it was in fact still only allowing for limited case-by-case Medicare coverage; it did not set out a broad policy for national coverage, or offer any details on how that coverage would be implemented. In the following months, some Medicare vendors crafted policies on how that might work, and new billing codes for this "therapeutic" designation were developed.
Fast forward to New Year's 2018, and here we are with an initial Medicare coverage determination for the Libre.
In its press release, Abbott noted, "Medicare patients can access the FreeStyle Libre system by prescription through Edgepark Medical Supplies, Byram Healthcare, Solara Medical Supplies, Edwards Health Care Services, Better Living Now and Mini Pharmacy in the U.S."
The logistical details aren't fully worked out yet but will start materializing in the coming months.
Of course, this now pits the Libre and Dexcom G5 against each other more aggressively, as PWDs on Medicare will be able to choose between the two systems. It's important to note that the current first-gen Libre is a new kind of Flash Glucose Monitoring (FGM) system that does not offer alerts or a continuous stream of data that can be shared like Dexcom or traditional CGMs; still, it's a choice that may be more appealing for those who aren't interested in a full CGM.
Medtronic is the lone CGM company without Medicare coverage, but that could change before long once its stand-alone Guardian CGM system gets through the FDA and is available.
This CMS decision to cover Libre should actually help competitor Dexcom when it comes to pursuing Medicare coverage for its new G6, once that's approved by FDA and launched. It's TBD whether Dexcom will move forward with its original plan for once-daily calibration in its next-gen G6 model, or strive to go directly for a no-calibration approval from regulators at some point this year.
Of course, then there's the whole issue of Medicare actually covering the full spectrum of G5 use as it relates to the Dexcom smartphone app...
Why Not CGM Smartphone Apps?
Despite a long period of advocacy, no one really expected Medicare to agree to cover Dexcom's G5 so soon -- a full year earlier than many predictions.
While it was a good step forward, CMS only signed off on the sensor device, but did not address the important issue of G5-users using a smartphone. Basically, the Medicare folk have prohibited people from using the smartphone app that connects directly to the Dexcom data-sharing service. That means users can't share data with family, which diminishes the effectiveness of the tool! Especially for many PWDs age 65 and older who may rely on family members or friends to keep an eye on their CGM data remotely.
As of now, CMS hasn't clarified its policy, so Dexcom is compelled to flag Medicare patients who are using the FDA-cleared mobile app that's part of the G5 system -- potentially leading to Medicare cutting off coverage if those beneficiaries don't stop using it.
Frankly, this is stupid, and we're hoping it gets resolved soon.
Dexcom continues discussing the need for a policy change on this with CMS, and patients are fighting for Medicare to recognize the need -- and to clarify that app use doesn't make the agency responsible to pay for people's smartphones (duh!).
Recently, the Diabetes Patient Advocacy Coalition (DPAC) and some dedicated individuals have started an advocacy campaign targeting Congress, hoping to put more legislative-pressure on CMS to better understand and handle mHealth.
We'll see what comes from all of this, but we're hoping it won't be long before they clear up the G5 confusion.
Meanwhile -- Thanks, Medicare for taking these strides in diabetes tech coverage. We hope the momentum continues!