Big news program in the Diabetes Community!

In a back-to-aft high-five, Medicare coverage is directly Satisfactory'd for some the OmniPod tubeless insulin pump and the newly-sanctioned Abbott FreeStyle Libre instant glucose monitoring system!

The Centers for Medicare and Medicaid Services (CMS) made these two separate decisions in the first week of 2018, starting off the New Yr with a bang for our country's aging diabetes population. And since CMS typically sets the phase for what private insurers will cover, this is a whopping win for PWDs (people with diabetes) of wholly ages!

In addition, one of the new CMS decisions clarifies the federal agency's policy and appears to admissive the threshold to coverage for next-generation closed loop engineering science that we'll certainly be beholding more than 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 red-hot progressive position toward tech tools that have proved impactful.

Here's the near along what CMS has recently done, and what needs to bump as we go off forward in 2018:

OmniPod on Medicare (and Medicaid)

Insulet has literally been struggling to get CMS coverage of its tubeless OmniPod insulin pump for eld. The company's VP of Food market Access still did a intro about this at our nigh recent DiabetesMine Innovation Summit in November.

We first caught wind of CMS' modification of heart in a tweet on the afternoon of Friday Jan. 5 from Senator Susan Tom Collins in Maine, World Health Organization sits happening the Senat Diabetes Caucus and has been a directional advocate on diabetes issues and for Medicare coverage for OmniPod specifically for much of the past year.

She tweeted:

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We followed up with Insulet, after coincidentally talking with their execs earlier that day who at the time indicated, "information technology's a work in get on and we're hoping to know much soon." By the day's end, Collins' nip had made Insulet aware the execute was afoot. That evening, CMS issued its official policy speech and ended the weekend Insulet prepared its full-court press about Medicare's new insurance coverage eligibility.

The Boston-area company estimates that approximately 450,000 additional PWDs with type 1 in the U.S. 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.

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  • What part of Medicare? This all falls under Medicare Part D, the prescription do drugs benefit aspect of the regime indemnity broadcast, rather than through Part B, which covers doctor's visits and Durable Medical Equipment (DME).
  • Nary Guarantee: To be clear, Medicare reporting of the OmniPod isn't guaranteed, it's just possible now thanks to this CMS policy letter.
  • Details TBD: Medicare vendors and carriers essential now work out the details, such as specific criteria and what the pricing reimbursements will be. That testament have some time.
  • Starting When? It's TBD whether this will utilize from the date of the Jan. 5 policy alphabetic character from CMS, or if it will first take effect from whenever the vendors establish their taxon coverage policies. The outlook is that Medicare Part D coverage leave actually begin in 2019.
  • Types of Diabetes? There's nothing to indicate this is exclusively for type 1, and CMS has a people reporting decision for all insulin pumps that applies to both T1 and T2, then the 15-Aug is that both are included unless otherwise spelled out at some point.
  • Utilization Review: The CMS policy does mention something called "Utilization Reassessmen," which substance Medicare beneficiaries will plausibly have to go done some type of "medical necessity" evaluation before obtaining coverage. No doubtfulness, that'll in all probability intend more or less denials happen and PWDs will deman to appeal and fight for their OmniPod coverage (sigh).
  • Earphone Hotline: Insulet has created a Medicare Access Squad, which you can call directly at 877-939-4384.
  • FAQs: Hera's an FAQ page the company has put together online with more information.
  • Medicaid Pathway: Ohio yes, and Medicaid… Away securing this Medicare Start D coverage conclusion, Insulet now has a unilateral pathway to set out Medicaid reporting at the state level since many of the state-run Medicaid programs follow CMS prescription do drugs guidance in determining coverage.
  • Future D-Tech: By using the term "medical devices related to 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 of necessity the handheld Individual Diabetes Manager (PDM) to operate. It didn't fit into the customary family of DME (Durable Medical Equipment) because of that disposable aspect, and that's been the barricade in obtaining Medicare coverage, we'atomic number 75 told.

Notably, the new Medicare insurance still doesn't categorize OmniPod as DME. Or else, they basically signalize that nonentity in their archetype policy from 2005 should have been understood to imply that the tubeless OmniPod could non be covered… wow!

What's amazing is that IT took 13 years for CMS to issue a document clarifying this, and clearly stating that OmniPod coverage for Medicare beneficiaries is actually OK. That's a loooong time to wait, for many another patients who desperately wished-for the system.

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Just hey, let's look at the positive and move forward, right…?

We'atomic number 75 stimulated to see this insurance coverage now accomplishable, and excited that PWDs who have been using OmniPod leading up to Medicare age and those reaching that point now have the option to remain this spot pump as a covered benefit if they want to.

FreeStyle Libre + Medicare, Besides

IT was actually one day forwards of the OmniPod decision when the declaration came that CMS would allow Medicare insurance coverage for the red-hot Abbott FreeStyle Libre system of rules — a new sympathetic of glucose monitor just approved away FDA in September 2017 and launched by Abbott Diabetes Care at the end of this previous year.

This potential happened so apace ascribable the Dexcom G5 system decision a year ago in January 2017. CMS signed off connected the Dexcom G5 straight glucose monitor atomic number 3 a "therapeutic" tool because it's now been FDA-cleared to be accurate plenty 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 just allowing for narrow case-aside-character Medicare coverage; it did not part a comprehensive policy for national coverage, or offer any details on how that reporting would atomic number 4 enforced. In the following months, some Medicare vendors crafted policies on how that might work, and new charge codes for this "therapeutic" designation were developed.

Fast forward to New Year's 2018, and here we are with an first Medicare coverage finding for the Libre.

In its press free, Abbott noted, "Medicare patients can access the FreeStyle Libre system of rules by prescription through Edgepark Medical Supplies, Byram Health care, Solara Medical Supplies, Edwards Health Care Services, Finer Living Now and Mini Apothecary's shop in the U.S."

The logistical details aren't fully worked come out of the closet 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 cost able to choose between the deuce systems. Information technology's important to note that the ongoing first-gen Libre is a other kind of Flash Glucose Monitoring (FGM) system that does non offer alerts or a continuous swarm of data that can be shared like Dexcom operating room traditional CGMs; still, it's a superior that may be more than appealing for those who aren't interested in a total CGM.

Medtronic is the lone CGM company without Medicare reporting, but that could change before long formerly its stand firm-alone Guardian CGM system gets through with the FDA and is lendable.

This CMS determination to cover Libre should actually facilitate competitor Dexcom when it comes to pursuing Medicare coverage for its hot G6, once that's approved by Food and Drug Administration and launched. Information technology's TBD whether Dexcom testament move forward with its original design for once-daily calibration in its next-gen G6 mannikin, or strive to go directly for a no-calibration approval from regulators at some point this yr.

Naturally, so there's the whole issue of Medicare actually covering the full spectrum of G5 use up as it relates to the Dexcom smartphone app…

Wherefore Not CGM Smartphone Apps?

Despite a agelong period of advocacy, none one really likely Medicare to agree to cover Dexcom's G5 thus soon — a full year earlier than many predictions.

While it was a good step cheeky, CMS only sign-language off on the detector device, but did not dea the important issue of G5-users using a smartphone. Basically, the Medicare folk have prohibited mass from using the smartphone app that connects directly to the Dexcom data-communion service. That means users can't share data with mob, which diminishes the effectivity of the tool! Especially for many PWDs age 65 and older WHO may rely on mob members or friends to follow their CGM information 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 component of the G5 arrangement — potentially leading to Medicare cutting off coverage if those beneficiaries don't stop using it.

Frankly, this is stupid, and we're hoping information technology gets resolute soon.

Dexcom continues discussing the need for a policy change on this with CMS, and patients are fighting for Medicare to recognize the demand — and to clarify that app use doesn't make the agency responsible for to pay for people's smartphones (duh!).

Recently, the Diabetes Patient Advocacy Coalescence (DPAC) and some sacred individuals have started an advocacy campaign targeting Coition, hoping to arrange Thomas More legislative-pressure on CMS to better understand and handle mHealth.

We'll see what comes from all of this, but we're hoping information technology won't live drawn-out before they clear astir the G5 confusion.

Meanwhile — Thanks, Medicare for pickings these strides in diabetes tech coverage. We hope the momentum continues!