CMS Proposes New Rules for CGM Coverage Among Medicare Beneficiaries

This week, CMS proposed changes to the Medicare Durable Medical Equipment Prosthetics, Orthic Devices and Supplies (DMEPOS) coverage and payment policies which would expand Medicare coverage for continuous glucose monitors (CGMs).

The announcement comes after years of court battles over whether Medicare would cover CGMs for beneficiaries, one-third of whom currently have diabetes.

The new proposed rule would “expand the interpretation regarding when external infusion pumps are appropriate for use in the home and can be covered as DME under Medicare Part B,” according to a CMS statement. The change would also reduce administrative burdens resulting from government coverage, payment, and coding processes that can hinder innovators from getting products to beneficiaries.

If finalized, the rule would classify all CGMs as DME and establish payment amounts for the items and related supplies.

In September, the FreeStyle Libre 2 CGM, manufactured by Abbott, became available to Medicare patients who meet certain eligibility coverage criteria, following an April FDA authorization for the device’s use in hospitalized patients with coronavirus disease 2019 (COVID-19).

“We are very encouraged by CMS’s proposed rule and commend the agency on taking action to help more people with diabetes,” said Sean Salmon, executive vice present and president of the Diabetes Group at Medtronic.

“We strongly believe this proposal puts patients first and empowers them to choose the therapies that best meet their diabetes management needs. Importantly, the proposed rule would enable continuity of therapy for people on Medtronic insulin pumps aging into Medicare — including Medtronic hybrid closed loop systems which automatically adjust insulin delivery based on readings from the integrated CGM. We look forward to continuing to engage with CMS and other stakeholders in the finalization of this important rule.”

Recent survey results from the Association of Diabetes Care & Education Specialists (ADCES) found individuals living with diabetes feel they are doing everything they can to manage the condition yet believe more can be done.

Of individuals who currently track their blood glucose levels with a blood glucose monitor or continuous glucose monitor, 47% reported their current method is simple and easy, but they also wish it was even more simple and easy to do.

“With the policies outlined in this proposed rule, innovators have a much more predictable path to understanding the kinds of products that Medicare will pay for,” said CMS Administrator Seema Verma. “For manufacturers, bringing a new product to market will mean they can get a Medicare payment amount and billing code right off the bat, resulting in quicker access for Medicare beneficiaries to the latest technological advances and the most, cutting-edge devices available.”

CMS only currently covers therapeutic CGMs or those approved by the FDA for use in making diabetes treatment decisions, like changing one’s diet or insulin dosage based solely on the readings of the CGM.

The rule would also expand classification of external infusion pumps under the DME in cases where assistance from a home infusion therapy supplier is necessary.

As part of the changes, the agency will continue to pay higher amounts to suppliers of DMEPOS items and services in rural and non-contiguous areas of the United States, based on stakeholder feedback indicating unique challenges and higher costs in these regions.