Progress Made in Diabetes Technology Coverage, Access Among Medicare Beneficiaries

Recently, 2 separate district courts secured a pair of victories for Medicare beneficiaries who use continuous glucose monitor (CGM) technologies to manage their diabetes, while bipartisan legislation aimed at increasing access to the Medicare Diabetes Prevention program (MDPP) was introduced by Senators Tim Scott, R-South Carolina, and Mark Warner, D-Virginia.

In recent years, CGM systems have become popular among patients with diabetes as a way to quickly and accurately monitor their blood glucose levels, and in early September, Abbott’s FreeStlye Libre 2 CGM system became available to Medicare patients who meet certain eligibility coverage criteria. However, the coronavirus disease 2019 (COVID-19) pandemic has further emphasized the importance and potential of remote diabetes management.

On September 23, the second Circuit Court of Appeals ruled that Medicare beneficiaries can combine claims denied by Medicare to meet the dollar amount necessary for judicial review, according to a press release from Parrish Law Offices.

The case, Bloom v Azar, was brought by a Medicare beneficiary (Jonathan Bloom) who used a CGM device to manage type 1 diabetes (T1D) and sought coverage to offset the CGM costs. However, Bloom was denied coverage by the Medicare Appeals Council and subsequently challenged the decision.

Previously, a Third District Court ruled that Medicare must cover CGMs, but ruled 2 of the 3 challenged decisions did not meet the $1500 amount-in-controversy threshold for federal court jurisdiction. The court also held the Medicare Act did not permit Bloom to cure the jurisdictional deficiency by aggregating the 3 amounts.

However, “the Second Circuit held, based on the text of the statute and reinforced by its regulatory and legislative history, that the Medicare Act does not prohibit plaintiff from aggregating his claims for the first time in district court,” according to Justia Law. The findings ultimately allowed for recovery on all 3 claims.

In a separate case, Zieroth v Azar, the district court for the Northern District of California found Medicare’s claim that CGMs are not “primarily and customarily used to serve a medical purpose” unreasonable and not entitled to deference. The District Court ordered coverage of CGM claims and reflects the Fourth District Court’s ruling that Medicare’s position is contrary to law.

Although these rulings mark a step in the right direction for patients, Medicare beneficiaries still face significant hurdles securing access to CGM technology, Parrish Law Offices states, as Medicare and Medicare Advantage plans continue to deny coverage of some CGMs. A class action lawsuit is currently filed in the District of Columbia seeking coverage as far back as 2012 for beneficiaries whose CGM claims were denied.

In addition to CGM technologies, virtual diabetes management programs have gained traction in recent years. In 2017, the digital health provider Noom won full CDC recognition for mobile and online applications of the Diabetes Prevention Program (DPP). The program was the first virtual provider to achieve this status and was first offered to Medicare beneficiaries in 2018 as part of the Medicare DPP (MDPP).

“Noom’s virtual DPP program delivers the same positive outcomes as in-person MDPP programs and has the added benefit of being accessible anywhere and at any time, as part of our mission to help more people lead healthier lives,” said Noom cofounder and CEO Saeju Jeong.

The recently introduced PREVENT Diabetes Act (S 4709) aims to increase access to the MDPP Expanded Model by allowing CDC virtual suppliers, like Noom, to participate in the program.

“To ensure that all individuals have the tools needed to combat this preventable disease, the PREVENT DIABETES Act would help expand access to virtual classes under the existing Medicare Diabetes Prevention Program,” Warner said.

Specifically, the MDPP Extended Model leverages evidence-based interventions to prevent onset of type 2 diabetes (T2D) in at-risk Medicare beneficiaries, but it is currently only available through in-person sessions. By expanding virtual access to the model, individuals in rural or medically underserved areas will be able to participate in the program.

“This commonsense and cost-saving expansion will ensure that more Americans at-risk of developing diabetes who are living in either rural or medically underserved communities, can participate in this critical program that has been proven to delay the full onset of this preventable disease,” Warner continued.

In the wake of COVID-19, HHS has temporarily allowed beneficiaries to access the program via a virtual platform, but bill authors argue that the change still excludes a number of providers and does not ensure long-term access to a virtual benefit.

“The introduction of the PREVENT Diabetes Act is a positive first step toward ensuring all seniors are able to access this critical preventive service through the Medicare DPP Expanded Model. We urge Congress to expeditiously advance this bill as part of its digital health care agenda,” Jeong said.

The bill received support from the American Diabetes Association, the American Medical Association, and the National Kidney Foundation, among others.