Support Use Of Innovative Technologies in Diabetes Care

Background

The Department of Health and Human Services (HHS) is working to promote the use of telehealth technologies across many platforms to improve access to care and health outcomes, particularly for patients with chronic conditions like diabetes. For example, the 2018 Medicare Physician Fee Schedule includes a revised code that allows Medicare providers to be paid for collecting and interpreting biometric data that a patient generates remotely, e.g. glucose monitoring. However, wording in coverage decisions by the Centers for Medicare and Medicaid Services (CMS) for Continuous Glucose Monitors (CGMs) does not recognize the value of technology innovations, such as smartphone apps, and prevents patients and healthcare providers from taking advantage of remote monitoring and its benefits.

Continuous Glucose Monitors

CGMs are physician-prescribed devices that detect and display blood glucose levels, revealing real-time trends. Trigger alarms and alerts notify CGM users of drops or spikes in glucose levels, allowing patients to respond before their glucose levels become dangerous. The FDA-approved CGM system includes a free smartphone app, which allows patients to share their CGM glucose data, alerts and alarms with family members, caregivers or a healthcare provider. The sharing of data is extremely important to clinical endocrinologists to be able to adjust medication and to provide information-based decisions to improve patient care and patient outcomes.

The Problem

Although CMS has approved certain CGM systems for Medicare coverage, the instructions issued by the local Medicare contractors to implement this coverage prohibits beneficiaries from using the smartphone app as a display device, either separately or in conjunction with the CGM receiver. The coverage instructions state that Medicare will not cover the cost of the CGM system if a beneficiary uses a display device that is not considered durable medical equipment, such as a smartphone, either separately or in combination with a CGM receiver. These instructions regarding what is included in the coverage decision simply makes no good clinical sense!

The CGM Solution

CMS should revise its policy and instructions for coverage, so that Medicare contractors will cover a CGM system if a patient is using data shown on the CGM receiver, regardless of whether a smartphone also displays the data. If a receiver is used and the data is also sent to a smart phone for easier access and/or to be shared with others, it should not impact Medicare coverage of the CGM.

Request

Please contact the following CMS representative to urge the agency to revise its language in the CGM local coverage instructions, to clarify that beneficiaries may use a smartphone app in conjunction with their CGM device without losing Medicare coverage.

Demetrios L. Kouzoukas
Deputy Administrator, Centers for Medicare and Medicaid Services
Director, Center for Medicare
7500 Security Boulevard, Mail-stop C5-15-12
Baltimore, MD 21244
P) 202-619-0630 or 410-786-3350
E) demetrios.kouzoukas@cms.hhs.gov

The Broader Solution

With respect to the broader issue of incorporating new technologies into patient care for better health outcomes, CMS policies and coverage decisions must be updated so there is flexibility to cover innovations in patient care as they become available.