The FDA this week approved an expanded certification for the Eversense Continuous Glucose Monitoring system, allowing qualified health care providers, including nurse practitioners and physician assistants, to be trained and certified to provide patients with the implantable glucose sensor, Senseonics announced in a press release.
Prior to the expanded certification, the sensor insertion and removal procedure could only be performed by trained physicians.
“We are pleased with this FDA approval, we can now include nurse practitioners and physician assistants in the growing list of diabetes care professionals who can be certified to place the Eversense CGM System,” Tim Goodnow, president and CEO of Senseonics, said in the release. “We believe that allowing additional health care providers to perform the in-office placement procedure for Eversense CGM will enable broader access to patients for this compelling long-term diabetes management technology.”
The Eversense CGM System consists of a fluorescence-based sensor, a smart transmitter worn over the sensor to facilitate data communication, and a mobile app for displaying glucose values, trends and alerts. In addition to featuring the first long-term and first implantable CGM sensor, the system is also first to feature a smart transmitter that provides wearers with discreet, on-body vibratory alerts for high and low glucose and that can be removed, recharged and re-adhered without discarding the sensor.
The sensor can now be inserted subcutaneously in the upper arm by a physician, physician assistant or nurse practitioner via a brief, in-office procedure.
The expanded certification follows the initial FDA approval of the device in June, reported by Endocrine Today. Approval of the Eversense GCM was based on clinical trial data that demonstrated safety and efficacy of the CGM over 90 days. An FDA advisory panel unanimously in March recommended approval of the Eversense CGM, noting that the benefits of the CGM system outweigh the risks for adults with diabetes. Safety will continue to be assessed in a postapproval study.
In addition to medical doctors, physician assistants and nurse practitioners will be able to file claims with health insurance plans under established CPT codes, according to the release. Depending on the health plan contracts and state-by-state regulation, physician assistants and nurse practitioners may receive a percentage of the typical reimbursement provided to a medical doctor. – by Regina Schaffer