GERMANTOWN, Md.--(BUSINESS WIRE)--Senseonics Holdings, Inc. (NYSE American: SENS), a medical technology company focused on the development and commercialization of the first and only FDA-approved, long-term, implantable continuous glucose monitoring (CGM) system for people with diabetes, announced today that the Centers for Medicare and Medicaid Services (CMS) finalized a national payment rate for Eversense that was recently published in the calendar year 2020 Physician Fee Schedule Final Rule. The Eversense CGM system will be the first CGM technology to be reimbursed through the Part B Medical Services benefit for Medicare beneficiaries and expands access to the latest innovation in continuous glucose monitoring.
This recent update to the physician fee schedule will allow for health care providers (HCPs) to insert Eversense immediately in their clinic once a patient and HCP agree that Eversense CGM is the right choice for them. After the insertion of Eversense, HCPs may bill Medicare directly with the existing CPT codes that will include the cost of the Eversense CGM system and the procedure time. This approach fundamentally changes how patients access CGM in that the HCP will be able to offer the technology directly in their office as opposed to a patient having their CGM system processed through their durable medical equipment benefit. This step forward will improve both the patient and HCP experience by reducing the amount of paperwork needed to secure CGM and it affords improved coordination of care for patients managing diabetes by removing procurement barriers.
“We are very pleased that Eversense will now be available to Medicare patients with either Type 1 or insulin requiring Type 2 diabetes. The unique features of Eversense – including on-body vibratory and audible alerts, no self-insertions and strong accuracy, especially at the low glucose range – can make a positive impact for Medicare beneficiaries,” said Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics. “CMS’s decision to set payment for both the Eversense system and the insertion and removal procedures is beneficial for both patients and providers. Reimbursement as a physician service will provide more streamlined access for patients while improving diabetes management. We look forward to serving this population.”
The Eversense® Continuous Glucose Monitoring (CGM) System is indicated for continually measuring glucose levels in persons age 18 and older with diabetes for up to 90 days. The system is expected to be used to replace fingerstick blood glucose (BG) measurements for diabetes treatment decisions. Fingerstick BG measurements will still be required for calibration twice per day, and when symptoms do not match CGM information or when taking medications of the tetracycline class. The sensor insertion and removal procedures are performed by a health care provider. The Eversense CGM System is a prescription device; patients should talk to their health care provider to learn more. For important safety information, see https://eversensediabetes.com/safety-info/.
Senseonics Holdings, Inc. is a medical technology company focused on the design, development and commercialization of transformational glucose monitoring products designed to help people with diabetes confidently live their lives with ease. Senseonics' CGM systems, Eversense® and Eversense® XL, include a small sensor inserted completely under the skin that communicates with a smart transmitter worn over the sensor. The glucose data are automatically sent every 5 minutes to a mobile app on the user's smartphone.
FORWARD LOOKING STATEMENTS
Any statements in this press release about future expectations, plans and prospects for Senseonics, including statements about the potential impact or meaning of coverage decisions, and the potential life-enhancing benefits Eversense offers people with diabetes, including the potential to replace fingerstick BG measurements, and other statements containing the words “believe,” “expect,” “intend,” “may,” “projects,” “will,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties in the development and regulatory approval processes, uncertainties inherent in the commercial launch and commercial expansion of the product, and such other factors as are set forth in the risk factors detailed in Senseonics’ Annual Report on Form 10-K for the year ended December 31, 2018, Senseonics’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2019, and Senseonics’ other filings with the SEC under the heading “Risk Factors.” In addition, the forward-looking statements included in this press release represent Senseonics’ views as of the date hereof. Senseonics anticipates that subsequent events and developments will cause Senseonics’ views to change. However, while Senseonics may elect to update these forward-looking statements at some point in the future, Senseonics specifically disclaims any obligation to do so except as required by law. These forward-looking statements should not be relied upon as representing Senseonics’ views as of any date subsequent to the date hereof.