Press release

Disclosures: Salmon is executive vice president and president of the diabetes group at Medtronic. Verma is CMS administrator.
October 29, 2020
2 min read

Proposed CMS change could expand access to diabetes devices


Press release

Disclosures: Salmon is executive vice president and president of the diabetes group at Medtronic. Verma is CMS administrator.
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CMS announced proposed new changes that could expand Medicare coverage for continuous glucose monitors and insulin pumps, according to an agency press release.

Under the proposed rule change for Medicare Durable Medical Equipment, Prosthetics, Orthotic Devices and Supplies (DMEPOS), CMS would expand the interpretation regarding when external infusion pumps are appropriate for use in the home and can be covered as durable medical equipment under Medicare Part B.

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The proposed rule is designed to increase access to drug infusion therapy services in the home — including insulin pumps — and aims to reduce administrative burdens, the agency said in the release.

“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,” CMS Administrator Seema Verma said in the release. “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. It’s clearly a win-win for patients and innovators alike.”

Due to administrative constraints, the process for making Medicare benefit classifications, pricing determinations and creating billing codes for DMEPOS used to routinely take up to 18 months to complete, according to the agency.

“Last year, CMS changed this process through subregulatory guidance to reduce that time frame to 6 months in many cases, and is now proposing to establish a streamlined process for coding, coverage and payment in regulation,” the agency stated in the release.

Under this accelerated process, benefit classification and pricing decisions could happen on the same day the billing codes used for payment of new items take effect.

If finalized, the proposed rule will also expand Medicare coverage and payment for CGMs.

Currently, CMS covers only therapeutic CGMs or those approved by the FDA for use in making diabetes treatment decisions, such as changing one’s diet or insulin dosage based solely on the readings of the CGM. CMS is instead proposing to classify all CGMs as durable medical equipment and establish payment amounts for these items and related supplies and accessories.

“With one in every three Medicare beneficiaries having diabetes, this proposal would give Medicare beneficiaries and their physicians a wider range of technology and devices to choose from in managing diabetes,” the agency stated in the release. “This proposal will improve access to these medical technologies and empower patients to make the best health care decisions for themselves.”

The proposal would also expand classification of external infusion pumps as durable medical equipment in cases where assistance from a skilled home infusion therapy supplier is necessary for safe infusion in the home.

CMS also proposed to continue to pay higher amounts to suppliers for DMEPOS items and services furnished in rural and noncontiguous areas to encourage suppliers to provide access and choices for beneficiaries living in those areas. The proposal is based on stakeholder feedback indicating unique challenges in those areas, according to the agency.

In a statement responding to the proposed change, Sean Salmon, executive vice president and president of the diabetes group at Medtronic, said expanded coverage for CGM would help people with diabetes better manage their disease.

“We are very encouraged by CMS’s proposed rule and commend the agency on taking action to help more people with diabetes,” Salmon said in the release. “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.”