Dive Brief:

• The Centers for Medicare and Medicaid Services opened up Medicare coverage for therapeutic continuous glucose monitors, eliminating a rule that beneficiaries must use a blood glucose monitor and require at least four self-monitoring blood glucose (SMBG) tests per day to have devices covered.
• CMS eliminated the requirement because "there is no evidence to support that frequent SMBG (≥4 times per day) as a prerequisite for initiating CGM use is predictive of improved health outcomes," according to the local coverage determination document. The coverage change, published June 3, will take effect July 18.
• Top CGM makers Abbott Laboratories and Dexcom said in emailed statements that opening up eligibility will improve patient access to CGMs. "Medicare’s coverage change has the potential to significantly expand the number of Medicare patients who are eligible for therapeutic CGM reimbursement," according to a statement from Abbott.

Dive Insight:

Use of diabetes technology such as CGMs and insulin pumps has been steadily growing in recent years, a trend that accelerated during the coronavirus pandemic as patients flocked to more tech-based healthcare services.

Dexcom and insulin pump makers Insulet and Tandem Diabetes Care had strong 2020s and carried that success into the first quarter of 2021, beating sales expectations and raising full-year guidance. While Abbott is not solely a diabetes company, FreeStyle Libre CGM systems have consistently been successful products for the medtech giant.

However, as the use of diabetes tech has grown and companies look to further penetrate the market and expand to new patient populations, questions have arisen about access issues for patients.

A spokesperson for the American Diabetes Association said in February that along with device costs that can be out of reach for patients who could benefit from CGM use, coverage complications through private insurance and Medicare can also limit access to the devices.

The ADA applauded the coverage change on Twitter after the local coverage determination was published, calling it a "big win for the diabetes community."

The removal of this criterion has been an effort long-led by the ADA, on which we have been actively engaged with CMS. People with #diabetes on Medicare will now be able to more easily access this critical piece of technology, leading to better diabetes management ...

— amdiabetesassn (@AmDiabetesAssn) June 12, 2021

The change could be significant for the Medicare population as diabetes affects about 20% of beneficiaries aged 65 years and older, according to Abbott. CMS also wrote that the "percentage of adults with diabetes increases with age, reaching 26.8% (14.3 million) among those aged 65 years or older."

CMS analyzed available studies to determine if the four-times-per-day testing requirement was linked to any improved health outcomes for patients with Type 1 and Type 2 diabetes that require intensive insulin treatment. However, the agency found no evidence that higher testing-frequency requirements led to better health outcomes compared to lower frequency SMBG testing. CMS found that studies requiring a minimum testing-per-day requirement had varying benchmarks, and no study had a minimum requirement of specifically four days.

Furthermore, CMS said groups like the ADA, Endocrine Society, Diabetes Canada, and the Chinese Diabetes Society do not have a required minimum testing frequency as part of their CGM use guidance.

The agency noted the U.K.'s National Institute for Health and Care Excellence guidance includes a glucose testing requirement of at least 10 times per day if the CGM is used to manage hyperglycemia. However, CMS wrote the recommendation "appears to be based on cost; with the authors noting that based on their sensitivity analyses, SMBG 10 or 8 times remained the most cost-effective strategy, while CGM was always more effective, but more costly."

The rule change is for therapeutic CGMs, meaning the use of the devices is to inform insulin treatment. The new coverage includes any CGM device provided to a beneficiary by any supplier enrolled as a DME supplier in fee-for-service Medicare, including pharmacies, according to a statement from a CMS spokesperson.

The inclusion of pharmacies is crucial as top CGM makers Abbott and Dexcom sell their products primarily through pharmacy channels rather than the DME channel, which Medtronic primarily sells devices through.