The Centers for Medicare and Medicaid Services (CMS) is considering expanding coverage for continuous glucose monitors (CGMs) which could positively impact the lives of millions of Medicare beneficiaries with diabetes.
As CMS contractors, the Durable Medical Equipment Medicare Administrative Contractors (DME MACs) make coverage decisions for Medicare beneficiaries absent a national coverage policy established by CMS. The DME MAC’s willingness to undertake this review on CGM coverage is a result of the combined efforts of diabetes stakeholders, including the Diabetes Technology Access Coalition, endocrinologists and Applied Policy. Together, this group used the latest diabetes research and clinical evidence and practice to quantify the value to beneficiaries and Medicare of an expansion of CGM coverage. In support of these stakeholders, Applied Policy developed a policy recommendation which outlined a pathway to promote health equity in diabetes care and management that can reduce federal spending for diabetes-related complications.
This recommendation was reflected in a formal local coverage determination (LCD) reconsideration request this past September to expand CGM coverage requirements. In October, and in response to that reconsideration request, the DME MACs published proposed changes to the CGM coverage criteria dramatically expanding access to CGMs for Medicare beneficiaries. These proposed modifications to coverage were considered during a virtual public meeting held this week and a final decision on the expansion is expected in 2023.
Background
According to CMS, over twenty percent of Medicare beneficiaries have been diagnosed with diabetes, a disease that carries with it the risk for amputation, blindness, kidney disease, heart disease, and death. Complications from improperly managed diabetes can be expensive and compounding, adding millions to Medicare’s budget annually.
Proper management of glucose levels is essential in diabetes management. Applied Policy has supported leading clinicians, manufacturers and patient organizations as they have advocated for an expansion of coverage that would make the technology available to a wider segment of Medicare beneficiaries.
CGMs measure interstitial glucose levels on an ongoing basis, transmitting this data to an external monitor or smart device at regular intervals. CGMs differ from traditional blood glucose monitors (BGM) because they eliminate the need for daily finger pricks to measure one’s blood sugar, replacing it with a subcutaneously inserted sensor that continuously measures and transits a patient’s glucose levels right to their phones (or receivers). CGMs can immediately alert a user to unexpected changes and emergencies. They also reveal patterns in glucose levels over time. More recently, CGMs are being used in conjunction with insulin pumps where the algorithm in pumps understand a patient’s glucose readings and whether insulin should be delivered as a result. The interoperability of CGMs and insulin pumps has given patients better tools to manage their diabetes and better health outcomes.
CGMs were first approved by the Food and Drug Administration in 2004 but have only been covered by Medicare since 2017, and only for a narrowly defined patient population. Currently, to qualify for CGM therapy, a Medicare beneficiary must have diabetes mellitus, administer at least three doses of insulin daily or use an insulin pump; and require frequent adjustment to their insulin regimen. In addition, patients must meet with their treating practitioner every six months.
The current coverage and billing requirements prevent Medicare from realizing the full potential of CGMs in managing the care for the one in every five Medicare beneficiaries over the age of 65 diagnosed with diabetes. In fact, a growing body of clinical evidence has demonstrated the value of CGMs to a wider population, including individuals with type 2 diabetes using less than three doses of insulin daily —a significant group not included under the existing coverage criteria or in the current changes being considered.
Recognizing the full potential of CGMs
The value of CGMs in insulin-dependent care regimens for type 1 diabetics is widely accepted and supported by a large body of clinical evidence. The American Diabetes Association (ADA) has stated that, “Access to CGM devices should be considered from the outset of the diagnosis of diabetes that requires insulin management.” And the American Association of Clinical Endocrinologists strongly recommends that “all persons with diabetes treated with intensive insulin therapy” have access to CGMs.
The potential of CGMs in the management of type 2 diabetes has heretofore been less obvious but is also supported by a growing body of research. As noted in Applied Policy’s formal LCD reconsideration submission on behalf of the Diabetes Technology Access Coalition, the authors of a commentary article published in the Journal of the American Medical Association (JAMA) concluded that, “The time has come to broaden access to CGM for patients with Type 2 diabetes.”
The newly proposed coverage criteria expand CGM coverage to persons using insulin at least once a day (compared to three times a day currently) or to those with a history of problematic hypoglycemia, effectively allowing access to CGMs for more patients with type 2 diabetes.
The expansion of CGMs to a broader Medicare population also gives CMS an important opportunity to promote health equity, which the agency previously defined as the first pillar in its 2022 Strategic Plan, and make available a technology that has been hard to obtain by those in marginalized groups.
Type 2 diabetes disproportionately affects socially marginalized groups including racial, ethnic, and low-income populations. These groups also face specific challenges in self-management of their diabetes. While access to CGMs would not address all the barriers faced by these populations, research shows that CGM is an essential tool in narrowing disparities in diabetes management and outcomes.
Realizing the potential
The flexibilities CMS provided during the pandemic by waiving the enforcement of clinical criteria has blurred the lines for whether Medicare beneficiaries who were put on CGM therapy in the two and half years of the pandemic are eligible and will continue to be eligible for the therapy after the public health emergency ends. If the DME MACs implement the proposed changes prior to the end of the public health emergency, at least some of these patients will qualify for the CGM under the newly relaxed coverage criteria. Finalizing the proposed coverage criteria before the end of the PHE will mean that these Medicare beneficiaries will have clarity that they can continue to use their CGM and continue to utilize telehealth visits with their prescribing provider.
The DME MACs will be accepting comments on the proposed LCD through November 19.