FDA: Glucose Monitoring Sensor Can Be Implanted By NPs, PAs

November 7th 2018

Eversense's Continuous Glucose Monitoring (CGM) System has received FDA approval for allowing nurse practitioners (NPs) and physician assistants (PAs) to be certified to place the sensor and to file claims with insurance plans.

Eversense®Continuous Glucose Monitoring (CGM) System has received FDA approval for allowing nurse practitioners (NPs) and physician assistants (PAs) to be certified to subcutaneously place the sensor. Previously, the sensor insertion and removal procedure could only be performed by trained physicians.1

The approval was announced this week by Senseonics Holdings, a medical technology company focused on the development and commercialization of a long-term, implantable CGM system for individuals with diabetes.1

“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,” said Tim Goodnow, President and CEO of Senseonics, in a prepared statement.1

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, according to Senseonics, 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 is inserted subcutaneously in the upper arm by a physician, PA or NP through a brief in-office procedure.1

This CGM system was first approved by the FDA in June. Indicated for use in people 18 years of age and older with diabetes, it is the first CGM system approved by the agency to include a fully implantable sensor to detect glucose, and can be worn for up to 90 days.2

According to FDA Commissioner Scott Gottlieb, MD, the Eversense CGM System is a more seamless digital system that provides patients with the ability to effectively manage diabetes, and illustrates the potential for mobile platforms for health care.2

"The FDA is committed to advancing novel products that leverage digital technology to improve patient care,” said Gottlieb, in a prepared statement.2“These technologies allow patients to gain better control over their health."

Along with certification, the new FDA approval also provides PAs and NPs with the ability to file claims with health insurance plans under established CPT codes. Depending on the health plan contracts and state-by-state regulation, PAs and NPs may receive a percentage of the typical reimbursement provided to a medical doctor.1

In a prepared statement, KC Arnold, ANP, from The Diabetes Center in Ocean Springs, MS, said the new FDA approval shows that the agency recognizes the importance of advanced practitioners in a physician practice and in the overall care continuum. “Many health care providers are ready and willing to learn and perfect these types of in-office procedures with the goal of helping more patients in their practice manage their diabetes with the latest technology available on the market,” said Arnold.1

Once PAs and NPs are trained on sensor placement, the Eversense CGM system will be more widely available across the United States market for patients with diabetes, according to Senseonics Holdings.1

Reference

  1. Senseonics Announces FDA Approval to Expand Eversense® CGM Certification to Nurse Practitioners and Physician Assistants [news release]. Germantown, MD; November 6, 2018: Senseonics Holdings, Inc. https://www.businesswire.com/news/home/20181106006086/en. Accessed November 7, 2018.
  2. FDA approves first continuous glucose monitoring system with a fully implantable glucose sensor and compatible mobile app for adults with diabetes [news release]. Silver Spring, MD; June 21, 2018: FDA website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm611454.htm. Accessed November 7, 2018.

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