Medicare CGM eligibility widened in potential boon for Abbott, Dexcom

Diving letter:

• CMS opened Medicare coverage for therapeutic continuous glucose monitors, removing the rule that beneficiaries must use one glucose meter and at least four Blood Sugar Self-Monitoring (SMBG) Tests per day to cover devices.
• CMS eliminated the requirement because “There is no evidence that frequent SMBG (≥ 4 times per day) as a prerequisite for initiating CGM use predicts improved health outcomes, ”the local document determining coverage reads. The coverage change published on June 3rd goes into effect. July 18th.
• Leading CGM makers Abbott Laboratories and Dexcom said in email statements that opening up the credential will improve patient access to CGMs. “The change in Medicare insurance coverage has the potential to significantly increase the number of Medicare patients eligible for CGM therapeutic reimbursement, ”Abbott said in a statement.

Dive Insight:

The use of diabetes technologies like CGMs and insulin pumps has grown steadily in recent years, a trend that accelerated during the coronavirus pandemic as patients flocked to more technology-based health services.

Dexcom and insulin pump makers Insulet and Tandem Diabetes Care had a strong 2020s and carried that success into the first quarter of 2021, exceeding sales expectations and increasing the forecast for the year. While Abbott isn’t just a diabetes company, FreeStyle Libre CGM systems have been consistently successful products for the medical technology giant.

However, as the use of diabetes technology has increased and companies seek to further penetrate the market and expand to new patient populations, questions about patient access issues have arisen.

A spokesman for the American Diabetes Association said in February that in addition to device costs, which may be inaccessible to patients who might benefit from CGM use, coverage complications from private insurance and Medicare can limit device access.

The ADA welcomed the change in coverage on Twitter after the local coverage statement was posted, calling it a “great win for the diabetes community”.

The deletion of this criterion was an effort led by ADA for a long time, in which we have actively participated with CMS. People with #diabetes on Medicare will now have easier access to this important technology, leading to better diabetes management …

– amdiabetesassn (@AmDiabetesAssn) June 12, 2021

The change could be significant for the Medicare population, with diabetes affecting around 20% of patients aged 65 and over, according to Abbott. CMS also wrote that “the percentage of adults with diabetes increases with age, reaching 26.8% (14.3 million) among those over 65”.

CMS analyzed available studies to determine whether testing requirement four times a day was associated with improved health outcomes for patients with type 1 and type 2 diabetes who require intensive insulin treatment. However, the agency found no evidence that higher test frequency requirements resulted in better health outcomes than lower frequency SMBG tests. CMS found that studies that required a minimum requirement of tests per day had different benchmarks and no study had a minimum requirement of specifically four days.

In addition, CMS said groups like the ADA, Endocrine Society, Diabetes Canada and the Chinese Diabetes Association have not established a minimum required frequency of testing as part of their CGM application guidelines.

The agency found that the UK’s National Institute for Health and Care Excellence guidelines include a glucose test requirement of at least 10 times per day when using the CGM to treat hyperglycemia. However, CMS wrote the recommendation “appears to be cost based; with the authors finding that 10 or 8 times based on their sensitivity analyzes, SMBG remained the most cost-effective strategy, while CGM was always more effective but more costly.”

The rule change affects therapeutic CGMs, that is, the use of the devices provides information about insulin treatment. The new coverage includes any CGM device made available to a beneficiary by a provider enrolled as a DME provider with Paid Medicare, including pharmacies, a CMS spokesman said.

The involvement of pharmacies is critical as the leading CGM manufacturers Abbott and Dexcom sell their products primarily through pharmacy channels rather than the DME channel, which Medtronic uses primarily to sell devices.

source https://dailyhealthynews.ca/medicare-cgm-eligibility-widened-in-potential-boon-for-abbott-dexcom/