In brief: CGM outcomes, Vent360+ launch, O&P WOY, AdaptHealth refi 

DALLAS – Patients living with diabetes who use continuous glucose monitoring devices had 35% lower total cost of care and 23% higher device adherence when therapy was provided through a medical vs. pharmacy benefit, according to peer-reviewed research conducted by CCS and published in the Journal of Medical Internet Research Diabetes (JMID). 

Non-adherent patients who use CGMs also had a higher rate of therapy reinitiation when therapy was provided through a medical (22%) vs. pharmacy (10%) benefit. 

“CGMs are only effective if people use them,” said Dr. Arti Masturzo, chief medical officer at CCS. “This first-of-its-kind research demonstrates that a physician’s decision to direct a patient to use their medical benefit instead of their pharmacy benefit when accessing a medical device can seriously impact health outcomes and costs of care. Data-driven insights like this are highly valuable to clinicians and care teams who are the first line of defense when it comes to improving patient outcomes and reducing waste in our healthcare system.”   

CCS recently presented supporting research on the study, which used a retrospective claims analysis, at the ADCES and ISPOR conferences. 

This new research builds on the company’s previous research on the need for better education and support for patients to manage their conditions, something it believes diabetes suppliers are well-positioned to do. That research found only about 50% of people who use CGM report they received diabetes self-management education and support. 

• To review the study as published in JMIR Diabetes, please visit: https://bit.ly/4c8PSOl. 
• Related: CCS recently launched a new AI-powered predictive model, PropheSee, that identifies patients at risk of falling off therapy and deploys impactful, hyper-personalized interventions that help to improve patient adherence by as much as 50% compared to control group. 

Encore Healthcare, Trace Medical jointly launch Vent360+ 

LIVINGSTON, Tenn. - Encore Healthcare and Trace Medical have formed a strategic partnership to launch Vent360+, a solution designed to simplify and streamline the provision of ventilator services for HME providers. 

The one-stop solution integrates ventilator rentals, clinical management and compliance oversight – all under one convenient, all-inclusive monthly price. 

“This partnership is a game-changer for the industry,” said Zach Gantt, president & CEO of Encore Healthcare. “With Vent360+, we’re offering more than just ventilators or services; we’re delivering a comprehensive management package that allows providers to focus on what matters most—caring for their patients. Together with Trace Medical, we are simplifying the process and driving improved outcomes.” 

Key benefits of Vent360+ include: 

• Ventilator rentals: Convenient and reliable access to high-quality ventilator equipment. 

• Clinical management: Ongoing clinical support and monitoring to ensure optimal patient outcomes. 

• Compliance management: Complete oversight of compliance needs to ensure peace of mind for providers. 

• One monthly price: All services and equipment are provided at one fixed, transparent cost 

“Trace Medical is excited to collaborate with Encore Healthcare on Vent360+,” said Greg Apostolou, CEO of Trace Medical. “This partnership allows us to extend our service beyond rentals, providing a comprehensive solution that supports the entire patient journey, from equipment to management to compliance.” 

O&P Woman of the Year seeks to inspire others 

WATERLOO, Iowa – Sheryl Sachs, MSPO, a certified prosthetist orthotist (CPO) at Dankmeyer in Maryland, has been selected as the 2024 O&P Woman of the Year. 

The Orthotic Prosthetic Group of America (OPGA) presented Sachs, a lead advocate for the state’s “So EveryBODY Can Move” initiative, with the award at the AOPA National Assembly on Sept. 13. 

“I am honored to have been chosen as the 2024 (O&P) Woman of the Year," she said. "I hope that my passion and commitment to the O&P profession serves as an inspiration and motivation to other women to make sure their voices are heard, and we have the power to make positive change a reality in and beyond O&P.” 

In addition to her role as a clinician, Sachs has taken a mentorship role within the American Academy of Orthotists and Prosthetists and has been a member of AOPA’s Government Relations Committee. Additionally, she serves on the Executive Committee of the NCOPE Board of Directors and is the chair of its Residency Standards committee. 

The O&P Woman of the Year award, sponsored by Össur and presented by OPGA, a division of VGM & Associates, is open to all women who work in the orthotic and prosthetic profession. A selection committee of four O&P professionals reviewed nominations and selected finalists by considering the nominees’ contributions throughout their careers to patients, the community and the O&P profession. 

• In August, OPGA announced the four finalists for the award. Sachs was joined by Dr. Justina Appel, PhD, CO, BOCP, LPO, clinical specialist with NuTech Synergies; Jenna Calomeris, vice president of sales with ThorWear, DBA Elevate Movement; and Dr. Sara Peterson, PhD, L/CPO, FAAOP(D), clinical research scientist/certified prosthetist orthotist (CPO) with O&P Clinical Innovations. 

Senseonics, Ascensia launch one-year CGM system 

GERMANTOWN, Md., and PARSIPPANY, N.J. – Senseonics and Ascensia Diabetes Care have announced that the U.S. Food and Drug Administration has cleared the next-generation Eversense 365 CGM, the first one-year CGM system. “The approval of Eversense 365 represents a significant leap in CGM innovation,” said Tim Goodnow, PhD, president and CEO of Senseonics. “Extending sensor longevity to a full year, coupled with seamless device connectivity and a high level of accuracy, provides both freedom and peace of mind to patients living with diabetes. Eversense 365 was ‘designed for real life’ and is optimally suited to help people with diabetes increase time in range of desired glucose levels and lower A1c. The delivery of the world’s first 365-day sensor is a seminal event for Senseonics and we’re excited to bring it to people with diabetes.” The Eversense 365 CGM has been approved by the FDA for Type 1 and Type 2 diabetes for people aged 18 years and older. It has been approved as an integrated CGM system, meaning it can integrate with compatible medical devices, including insulin pumps, as part of an automated insulin delivery system. The companies say a one-year system has numerous benefits, including no frequent sensor changes, and only one insertion and one “Day 1” every year, compared to every 10 to 14 days with a short-term system. Ascensia expects to initiate the launch of Eversense 365 in the U.S. in the fourth quarter of 2024, with work ongoing to transition coverage availability to facilitate immediate access to as many users as possible. 

Tactile secures coding for Nimbl 

MINNEAPOLIS – Tactile Systems has announced that the Pricing, Data Analysis and Coding (PDAC) contractor for CMS has approved the use of HCPCS code E0651 to bill for its Nimbl pneumonia compression platform. The PDAC’s approval follows the company’s 510(k) clearance from the U.S. Food and Drug Administration in June. “The receipt of PDAC approval for Nimbl comes earlier than expected, and we are pleased that CMS recognizes the potential health and quality-of-life enhancing benefits this device offers for Medicare patients struggling with lymphedema and chronic venous insufficiency,” said Sheri Dodd, CE at Tactile Medical. “Nimbl’s new sleeker design and technical advancements reflect our commitment to meaningful product innovation that seeks to meet the patient wherever they are in the treatment pathway. I am proud of the work our team has accomplished in developing this new platform, which I believe will elevate lymphedema therapy and increase patient acceptance and adherence.” Tactile Medical plans to make Nimbl commercially available in the U.S. in the coming weeks. The device is the next generation of the company’s basic lymphedema compression solution and is indicated for the treatment of lymphedema, chronic edema, venous insufficiency and wound healing. The company says it features several key patient-friendly enhancements over prior generations, including a 40% and 68% reduction in size and weight, respectively, making it more portable and ideal for active lifestyles. Nimbl also offers connectivity to the company’s Kylee digital application, enabling patients to actively track their therapy progress and share results with their care team. 

AdaptHealth refinances, reduces debt 

PLYMOUTH MEETING, Pa. – AdaptHealth has closed a $950 million senior secured credit facility, consisting of a fully funded $650 million Term Loan A and a $300 million revolving line of credit. Proceeds from the new $650 million Term Loan were used to fully repay, without penalty, the company’s existing Term Loan due to reach final maturity in January 2026. The new $300 million revolver replaces the company’s existing $450 million revolving credit facility, which had no balance drawn at the time the credit facility closed. The reduced revolver size decreases undrawn commitment fees. The interest rate pricing for the new senior secured credit facility decreased from the interest rate pricing in AdaptHealth’s existing bank credit facility, and the new maturity is extended up to Sept. 13th, 2029. Thirteen lenders participated in the company’s new credit facility, including Regions Bank as Administrative Agent. Regions Capital Markets, a division of Regions Bank, BOFA Securities, Capital One, National Association, Citizens Bank, N.A., Fifth Third Bank, National Association, JPMorgan Chase, N.A. and Truist Securities acted as joint lead arrangers and joint bookrunners. 

Matia Mobility secures coding for standing mobility device 

SALT LAKE CITY – Matia Mobility has announced that CMS has granted a HCPCS code to its Tek RMD (Robotic Mobilization Device). The company says the milestone makes standing mobility more accessible to individuals with walking disabilities confined to wheelchairs, providing new opportunities for independence and improving both physical and mental well-being. "We are incredibly excited about this development," said Steven Boal, CEO of Matia Mobility. "Receiving the HCPCS code from CMS means more people will have access to the life-changing benefits of the Tek RMD. Whether through Medicare, private insurance, or VA benefits, our goal is to help as many individuals as possible reclaim their independence and improve their quality of life." Matia Mobility has made insurance prior authorization accessible via its website at https://www.matiamobility.com. The company says standing mobility has numerous health benefits, including improving circulation, reducing muscle atrophy, enhancing bone density and aiding in digestive functions. It also helps ease activities of daily living, including household chores and going to work. 

Breg restructures leadership 

CARLSBAD, Calif. – Breg has appointed Dave Mowry as CEO and Matt Simons as CFO. Mowry will also continue as chairman of the board of directors. “After an evaluation of the business and market, during my time serving as Interim CEO, my optimism about Breg’s vast opportunities has only grown,” Mowry said. “We are excited about becoming the leader in an under-appreciated market segment. We are already building momentum within the business as we shift the focus toward true innovation and category and channel expansion.  We have a long road ahead, but I have great confidence in the team as we build discipline and consistency to achieving our financial objectives both in the short and long term.” Breg has also appointed Steve Ingel executive vice president and chief commercial officer. The company’s newly restructured organization is designed to leverage both new and existing talent, enhance cross-functional collaboration, consolidate complementary functions and strengthen accountability. With this new structure and a disciplined approach to execution, Breg is well-positioned to meet its commitments to patients, healthcare providers, and employees, it says. “Partnering with our new owners, a newly established, industry-experienced board of directors, and a talented and well-respected leadership team is a tremendous honor,” Mowry said. “Matt, Steve, and I are truly excited to represent such a well-known and respected orthopedic brand.  Together, we intend to leverage Breg’s long-standing commitment to clinical outcomes and support for the providers and a renewed alignment with our distribution partners to become the leading global pure-play bracing and support business.” 

Doctor agrees to settle fraud claims 

WILMINGTON, Del. – Dr. Vishal Patel, a Wilmington, Del., physician, has agreed to pay more than $1 million to resolve allegations that he violated the False Claims Act by ordering medically unnecessary DME for patients covered by Medicare and the Federal Employees Health Benefits Program. According to the U.S. Attorney’s Office, District of Delaware, Patel allegedly referred patients for more than 1750 orthotic devices, including wrist, shoulder, knee, ankle, and back braces, even though he had no medical relationship with these patients. The government says these referrals were based on brief reviews of the patient medical charts, which failed to establish any legitimate medical justification for the devices. It says charts were provided to Dr. Patel by RediDoc, LLC, a purported telemedicine company based in Phoenix, whose owners pleaded guilty to participation in a $64 million health care fraud conspiracy in May 2022. “We expect that federal health care providers submit necessary orders for patients they are actually treating,” said Derek M. Holt, special agent in charge, the Office of Personnel Management Office of the Inspector General.  “We applaud our law enforcement partners and colleagues at the Department of Justice for their hard work in protecting the FEHBP and other federal health care programs from fraudulent claims.” The claims resolved by the settlement are allegations only and there has been no determination of liability. 

CGM company joins ŌURA 

HELSINKI, Finland – Veri, which makes a continuous glucose monitor, has announced that it has joined ŌURA, which makes the Oura Ring. The two companies partnered last year to integrate ŌURA data into Veri’s CGM so users could see how their daily scores and biometrics impacted glucose levels, training and daily life. “Veri and ŌURA are aligned in many ways; we were both founded in Finland with an approach to health that draws upon the Finns’ balanced and holistic way of living,” said Tom Hale, CEO of ŌURA . “We are both mission-driven companies with lofty and ambitious goals to radically change health outcomes for people, and we believe in the role of technology in enabling that change.” Moving forward, the Veri team will join ŌURA to bring advanced metabolic health capabilities as part of ŌURA’s value proposition. Veri will discontinue its CGM operations, and the Veri app will sunset by the end of 2024 to “make way for something even more advanced through this partnership,” the company says.