CMS updates CGM, insulin use criteria for Medicare beneficiaries
CMS will now allow Medicare beneficiaries with diabetes to use any insulin along with continuous glucose monitor 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 Afrezza (MannKind). The policy change also eliminates the four times per day testing requirement to qualify for a CGM device. The updated criteria go into effect July 18.
Local coverage determination is a decision made by a Medicare Administrative Contractor (MAC) on whether a particular service or item is reasonable and necessary, and therefore covered by Medicare within the specific jurisdiction that the MAC oversees.
In a press release, MannKind, which lobbied for the change, said the criteria change lifts the restriction on patients of “having to choose between the two diabetes tools.”
“Prior to this change, Medicare denials were occurring for patients using CGMs and inhaled insulin as an alternative to injected mealtime insulin,” Michael Castagna, PharmD, CEO of MannKind Corp., said in the release. “MannKind is committed to providing convenience for patients and believes that patients should have the choice to use any of today’s tools to help manage their diabetes.”
The Association of Diabetes Care & Education Specialists has also lobbied for the change, according to a spokesperson. In a post on the association’s blog Perspectives in Diabetes Care, Kate Thomas, chief advocacy and external affairs officer for ADCES, called the Medicare decision an important step to make CGM more accessible for Medicare beneficiaries with diabetes.
“Our work is not done,” Thomas wrote. “We know there are more changes that must be made and ADCES is working with the Diabetes Technology Access Coalition to push for additional improvements, including removing the requirement for multiple daily injections of insulin to qualify for a CGM device.”
CMS. Future local coverage determination: Glucose monitors. Available at: https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?lcdid=33822&ver=31&fbclid=IwAR3Y6kzpk9AVnWZePeMHT4-nAAzQpgTLJPqbT9PZJWxVzp8-K-IatjEHIA4. Accessed July 8, 2021.
Thomas K. Medicare updates CGM benefit. Perspectives in Diabetes Care. ADCES. June 14, 2021. Available at: https://www.diabeteseducator.org/news/perspectives/aade-blog-details/adces-perspectives-on-diabetes-care/2021/06/14/medicare-updates-cgm-benefit. Accessed July 8, 2021.