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Diversatek Healthcare Receives New APC Assignment for MiVu™ from CMS for Hospital Outpatient and Ambulatory Surgery Centers

Diversatek Healthcare Receives New APC Assignment for MiVu from CMS for Hospital Outpatient and Ambulatory Surgery Centers

MiVu™ First GERD diagnostic tool to detect esophageal mucosal changes instantly during routine endoscopy; reduces diagnostic and treatment latency

MILWAUKEE, Wis. (December 16, 2021) – Effective January 1, 2022, Diversatek Healthcare announced that the U.S. Centers for Medicare & Medicaid Services (CMS) has assigned C9777 to APC 5303 (Level 3 Upper GI Procedures) and changed the Status Indicator to J1 in the Hospital Outpatient setting, and J8 in the Ambulatory Surgery Center setting.  Additionally, CMS revised the descriptor for HCPCS code C9777 to “Esophageal mucosal integrity testing by electrical impedance, transoral, includes esophagoscopy or esophagogastroduodenoscopy” to describe the service associated with performing both a MiVu™ test and an esophagoscopy or esophagogastroduodenoscopy test. When performed together, HOPDs should use only HCPCS code C9777 and not report a separate HCPCS code for the esophagoscopy or esophagogastroduodenoscopy.

Diversatek Healthcare, in conjunction with Vanderbilt University, developed the MiVu Mucosal Integrity Testing System to detect changes in esophageal mucosal integrity simply and efficiently. MiVu is the only system available to clinicians that provides real-time data of mucosal integrity during routine endoscopy, indicating the existence or probability of gastroesophageal reflux disease (GERD) and other esophageal pathologies in just two minutes.

“The CMS APC assignment is a significant step forward to widespread adoption of MiVu by hospitals and ambulatory centers because adequate reimbursement is one of the keys to greater market penetration,” says Margaret Vierling, president and CEO of Diversatek. “It’s exciting to know that more providers can now integrate MiVu into their practices, and streamline their diagnostic workup.  The MiVu technology delivers a number of patient benefits that will now be more accessible with this decision from CMS.” 

MiVu, which utilizes a balloon probe and proprietary software, measures conductivity of the esophageal epithelium directly, while providing clinicians both a color contour map as well as predictive probability. Its unique design, incorporating both radial and axial impedance sensors, measures mucosal integrity at 180-degree intervals along a 10 cm segment of the esophagus, reducing measurement variability. MiVu enables clinicians to quickly and efficiently differentiate primary esophageal disorders like GERD and eosinophilic esophagitis (EoE) and monitor treatment response – potentially obviating the need for ambulatory reflux testing and multiple invasive biopsies.

For patients undergoing ambulatory reflux diagnostic tests, MiVu can help deliver a more convenient and comfortable experience. MiVu testing can be conducted in two minutes during endoscopy and delivers instant data that can be used immediately by the clinician to direct therapy, potentially helping to reduce the need for unnecessary testing and additional follow-up visits.

“For providers, MiVu allows them to deliver a single point of care for the diagnostic workup of GERD,” adds Vierling. “Since we received FDA clearance in 2019, more and more providers have been adopting MiVu technology because of the clear benefits it delivers.”

According to a study from Cedars-Sinai published in the journal Gastroenterology in December 2019, GERD may affect nearly a third of U.S. adults each week.

The United States Food and Drug Administration (FDA) granted Diversatek Healthcare De Novo clearance for the Mucosal Integrity Testing System in 2019 (DEN180067).  This novel system is the first mucosal integrity testing system cleared by the FDA and is currently indicated to obtain a real time measurement of esophageal epithelial impedance.

To learn more about MiVu or to purchase the product directly, please visit diversatekhealthcare.com.

About Diversatek Healthcare

Headquartered in Milwaukee, Wisconsin, Diversatek Healthcare is a wholly owned subsidiary of Diversatek Inc. A leader in gastroenterological medical devices and diagnostics, Diversatek Healthcare’s tenured management team is committed to making business personal again through a hands-on approach to understanding clinical and patient needs. Diversatek Healthcare is driving science in the GI space while providing comprehensive educational offerings through Diversatek University, including on-site training and virtual platforms. The company offers an extensive range of state-of-the-art diagnostic and therapeutic GI applications from esophageal dilators and endoscopic accessories to high resolution impedance manometry systems and impedance/pH total reflux monitoring. For additional information, visit www.diversatekhealthcare.com or contact us at 800-558-6408.