The Centers for Medicare & Medicaid Services (CMS) proposed a new rule on October 27, 2020 that would expand coverage of important diabetes management devices. If finalized, this proposed regulation would expand Medicare coverage to all FDA-authorized continuous glucose monitors (CGMs) beginning on April 1, 2021.
This proposed rule is welcomed by Breakthrough T1D as we have long advocated for coverage, affordability and choice of all therapies to help ensure people with type 1 diabetes (T1D) have what they need to survive. Currently, CMS only covers therapeutic CGMs, or those approved by the Food and Drug Administration (FDA) for use in making diabetes treatment decisions based solely on the readings of the CGM. This change would give people with diabetes under the Medicare program greater choice in the type of CGM they use, whether alone or as part of an artificial pancreas system.
JDRF, alongside the T1D community, has always spoken up in large numbers around the clear medical need of CGMs. These FDA-authorized, physician-prescribed devices detect and display blood-glucose levels continuously and can also reveal trends beyond using finger sticks alone. Clinical evidence shows that CGM use significantly improves diabetes management, enabling users to avoid potentially deadly crises (hypoglycemia) and long-term complications associated with chronic high blood-sugar (hyperglycemia). CGMs were not covered under Medicare until 2017, when CMS determined that they were eligible for Medicare coverage – a decision that was and still is, a celebrated victory for Breakthrough T1D and the T1D community.
The initial coverage ruling in 2017 came thanks to the extensive advocacy by Breakthrough T1D volunteers and staff, clinician support, and strong bipartisan support from Congress and is critical work that Breakthrough T1D continues to pursue to secure broad and affordable access to T1D therapies and technology.
Breakthrough T1D thanks everyone involved in making Medicare coverage of CGM a priority including our Breakthrough T1D advocates, the Centers for Medicare & Medicaid Services (CMS) and our T1D champions who helped drive this bipartisan effort which include: Congressional Diabetes Caucus Co-Chairs, Representative Diana DeGette (D-CO-1st) and Representative Tom Reed (R-NY-23rd), and Senate Diabetes Caucus Co-Chairs, Senator Susan Collins (R-ME) and Senator Jeanne Shaheen (D-NH).
CMS will be accepting public comment on this proposed rule, which in addition to classifying all FDA-authorized CGMs as eligible for coverage, includes operational matters such as Medicare fee schedules determining payment for CGMs and their supplies and accessories. Breakthrough T1D will be examining the details of the rule more closely in the coming weeks to develop its formal comments to the agency.
