CMS expands Medicare coverage for all CGMs
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CMS will expand Medicare coverage for all types of continuous glucose monitors, including adjunctive and non-adjunctive CGMs.
The final rule, issued Dec. 21, classifies adjunctive CGMs under the Medicare Part B benefit for durable medical equipment (DME) and finalizes certain DME payment provisions that were included in two interim final rules. It will be effective starting 60 days after official publication.
“The Durable Medical Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) final rule aligns with the key goals of the administration to create a health care system that results in better accessibility, quality, affordability, empowerment and innovation,” CMS stated on its web site.
In a fact sheet, noted it is not finalizing the proposed categories of supplies and accessories and fee schedule amounts for three types of CGM systems.
“After consideration of public comments, CMS does not believe it is necessary at this time to further stratify the types of CGMs beyond the two categories of non-adjunctive and adjunctive CGMs,” the agency stated. “The fee schedule amounts for the newly covered adjunctive CGMs and related supplies and accessories will be established in accordance with existing regulations for establishing fee schedule amounts for new durable medical equipment items and services without a fee schedule pricing history at 42 CFR 414.238(b).”
The rule change follows a CMS decision in July, reported by Healio, that allowed Medicare beneficiaries with diabetes to use any insulin along with CGM therapy and eliminate a four times per day testing requirement, part of a policy change to the local coverage determination. The policy change to the local coverage determination L33822 allows beneficiaries with diabetes to use CGM when prescribed “multiple daily administrations” of insulin — updated from “injections” or the use of insulin pump therapy — which helps to provide a coverage pathway for people using inhaled insulins, like AfrezzaMannKind). The policy change also eliminated the four times per day testing requirement to qualify for a CGM device. The updated criteria went into effect July 18.
CMS first classified CGMs as “durable medical equipment” in 2017.
In a press release, Jeff Farkas, vice president of health economics, reimbursement and government affairs for the diabetes business at Medtronic, said the change will empower people with diabetes to choose the therapies that best meet their management needs. The final rule includes CGMs that integrate with Medtronic insulin pumps.
"This is a very important benefit expansion for our customers who have experienced significant clinical and quality of life benefits from their integrated Medtronic insulin pump systems and are now able to receive coverage for all components of their system on Medicare,” Farkas said in the release.
The expanded coverage also ensures continuity of therapy for people on certain Medtronic insulin pump systems transitioning into Medicare — including Medtronic hybrid closed-loop systems which rely on integrated CGM. Medtronic will continue to offer its CGM access discount to all Medicare customers until the ruling takes effect, the company said in the release.
Reference:
Medicare durable medical equipment, prosthetics, orthotics and supplies (DMEPOS) final rule fact sheet. Available at: https://www.cms.gov/newsroom/fact-sheets/medicare-durable-medical-equipment-prosthetics-orthotics-and-supplies-dmepos-final-rule-cms-1738-f. Accessed Dec. 22, 2021.
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