In brief: Dexcom study, test strip fraud, InfuSystem stock buy-back

LONDON – Nearly half of patients with Type 2 diabetes were unaware of the disease’s effects, according to a new study from Dexcom. 

The “Dexcom State of Type 2 Report,” released in conjunction with the launch of the Dexcom ONE+ continuous glucose monitor, also found: 

• 63% of people with diabetes are encountering difficulties in managing their disease, including challenges related to improving their diet or their mental health; and 

• 42% of people with diabetes and caregivers say living with Type 2 has negatively impacted their mental health or that of the person they care for.  

“The Dexcom State of Type 2 report reveals that people trying to manage their Type 2 diabetes face significant impacts on all areas of their lives, including, and perhaps particularly, their mental health,” says Karen Baxter, vice president, Northern Europe, South Africa, Israel, and Malta at Dexcom. “We’re proud to have developed a sensor that addresses the unmet needs of the Type 2 community. Feedback from users and health care professionals already using Dexcom ONE+ indicates that the sensor is easy to use and motivational, as it provides a clearer understanding of how food and exercise choices affect glucose levels. Seeing real-time feedback can help alleviate the frustration many people, especially those with Type 2 diabetes, experience in understanding and managing their condition.” 

The Dexcom ONE+ offers three wear location options, and a “delay first high” option, which allows a user to set a time before which their sensor will not alert them to a high glucose reading, helping to avoid alert fatigue and rebound hypoglycemia due to over treatment. 

Read the full report. 

Two face sentencing in test strip fraud 

MIAMI – Two South Florida men recently pleaded guilty to conspiracy to commit health care fraud for their role in a diversion scheme involving the distribution of adulterated and misbranded diabetic test strips.  

Howard Neil Frank of Marco Island, Fla., owner of two diabetic test strip wholesale businesses, Wholesale Diabetic Supplies Inc and HMF Distributing Inc, and Perfecto Fermin Hallon of Miramar, Fla., former president of another diabetic test strip wholesale business, Medical Care Supplies Inc, acquired the diabetic test strips through illegal importations, theft, or by buying the diabetic test strips from patients who obtained prescriptions but chose to sell rather than use them. 

The wholesale company owners then sold the adulterated and misbranded diabetic test strips to licensed retail pharmacies, some of which they also owned. These licensed retail pharmacies sold the adulterated and misbranded diabetic test strips to patients who did not know their real source. In turn, these licensed retail pharmacies then submitted claims for reimbursement through private and government health benefit plans as retail diabetic test strips. 

To deceive auditors and inspectors, Frank and Hallon altered invoices, purchase orders and shipping records, counterfeited National Drug Code (NDC) numbers, bar codes and accompanying labeling, to appear like they had acquired the diabetic test strip from legitimate manufacturers. 

Hallon’s sentencing hearing is scheduled for May 29 in West Palm Beach. He faces up to 10 years in prison. Frank’s sentencing hearing is scheduled for Aug. 2 in West Palm Beach. He faces up to 10 years in prison. 

To date, four defendants have been indicted in connection with this scheme. In 2021, Mohamed Mokbel was charged with conspiracy to commit health care fraud. The trial is scheduled for October in West Palm Beach. Mokbel is also charged with health care fraud and money laundering in the Southern District of Texas. The trial is scheduled for August in Texas. In 2022, Jason Grama, who pleaded guilty to conspiracy to commit health care fraud, was sentenced to three years supervised release and ordered to pay almost $300,000. 

ResMed studies show efficacy of PAP therapy 

SAN DIEGO – New ResMed-supported research providing insights into the effectiveness of PAP therapy in treating sleep-disordered breathing and its associated clinical benefits was presented at the American Thoracic Society International Conference.  

The studies were among a total of 26 supported by ResMed in collaboration with leading scientists, including Michael Arzt, MD, Universitätsklinikum Regensburg, Germany; Jean-Louis Pépin, MD, Grenoble Alpes University, France; Atul Malhotra, MD, University of California, San Diego; and Holger Woehrle, Ulm Lung Centre, Germany. 

Highlights include: 

• An analysis of data from 27 randomized control trials and non-randomized control studies on the effects of PAP on patients with OSA found mortality was 37% lower on average in patients with PAP-treated OSA vs. untreated OSA. 

• One study looked at nearly 50,000 adults with COPD who were treated via domiciliary NIV and found long-term home use of NIV was strongly associated with a reduced risk of death. 

• Another study projected OSA cases in the United States to increase by 27.6% by 2050 in men and women aged 30-70, with an overall prevalence within this group projected to be 26%. 

• Another study found GLP-1s did not lead to higher discontinuation rates of PAP therapy, rather to higher levels of PAP therapy use. 

HealthWell launches COPD assistance fund 

GERMANTOWN, Md. — The HealthWell Foundation, an independent non-profit charitable organization that provides financial assistance for underinsured Americans, has opened a new fund to provide financial assistance to individuals living with COPD. Through the fund, HealthWell will provide up to $3,250 in medication copayment or insurance premium assistance to eligible Medicare patients with annual household incomes up to 500% of the federal poverty level for the management of their disease. “Individuals with COPD often need multiple medications and treatments that can create financial challenges,” said Jean Wright, M.D., CEO of the COPD Foundation. “We commend the HealthWell Foundation for addressing this issue and enabling people to afford proper treatment plans. Our partnership aims to make medications more accessible and supports the COPD Foundation’s mission to help millions of people live longer and healthier lives.” To determine eligibility and apply for assistance, visit HealthWell’s Chronic Obstructive Pulmonary Disease - Medicare Access Fund page.  

Rehab Medical honored for ‘commitment’ to employees 

INDIANAPOLIS, Ind. – Rehab Medical was named a Top Workplaces 2024 by The Indianapolis Star. The list is based solely on employee feedback gathered through a third-party survey that measures the employee experience and its component themes, including feeling respected & supported, enabled to grow, and empowered to execute. “This award is a testament to our commitment of providing employees with a supportive culture, great engagement programs and career advancement opportunities,” said Jason Carney, vice president of human resources. “When you are growing at 25% per year, your culture becomes a critical part of your growth strategy, and we wear it like a badge of honor. We are honored that our employees have asserted this in their survey responses. If we are going to fulfill our mission to #improvelives, we had better provide our employees with the tools they need.” Rehab Medical was also recently honored by the Indiana Chamber of Commerce as one of the Best Places to Work in Indiana 2024 for a third year. 

InfuSystem to repurchase up to $20 million in stock 

ROCHESTER HILLS, Mich. – InfuSystem Holdings has announced a stock repurchase program authorizing the company to repurchase up to $20 million of its outstanding common stock through June 30, 2026. The program supersedes the previous authorization, which was set to expire June 30, 2024. Under the previous authorization, InfuSystem repurchased approximately 550,000 shares of stock for approximately $6.2 million. “This authorization will continue the company’s long-standing buyback policy and reauthorizes the programs that we have used when appropriate to enhance shareholder value,” said Richard DiIorio, CEO. “I believe the stock repurchase program highlights confidence in the company’s continued solid operations, the strength of our balance sheet and our outlook and guidance for the rest of 2024 and beyond. Our top priority for use of capital remains making strategic investments that position the Company for sustainable growth, although this program provides us with the flexibility to be opportunistic in repurchasing shares when valuations become attractive.” Repurchases will be made through open market purchases, private transactions, or otherwise in accordance with applicable federal securities laws.  

O2matic device shows promise 

COPENHAGEN and AURORA, Colo. – O2matic, a Danish medical device company focused on developing next-generation oxygen therapy and monitoring technologies, has announced that its proprietary technology is the subject of research led by Adit Ginde, MD, professor of emergency medicine and anesthesiology at the University of Colorado School of Medicine. Dr. Ginde and his team’s work has paved the way for the SAVE-O2 trial, a multi-center randomized clinical trial funded by the U.S. Department of Defense that focuses on redefining oxygen requirements in critically ill trauma patients through targeting normoxemia. Preliminary results from analyzing data from approximately 12,000 randomized patients have shown manually targeting normoxemia successfully reduces hyperoxemia without increasing hypoxemia, resulting in lower mortality rates, shortened hospital stays, and decreased supplemental oxygen requirements. “We at O2matic are deeply honored to be part of this significant study and eagerly anticipate the potential impact of our technology on acute and trauma patients,” said Arnt Lund, O2matic’s CEO. “We are also grateful to the IDE sponsor for this study, IDTS Medical, Inc. and its CEO, Mario Nozzarella, who guided us through the U.S. Food and Drug Administration Investigational Device Exemption (US FDA IDE) process and received our final (non-conditional) letter regarding the submission G230325/A001 with a strong sense of urgency.” Dr. Ginde and his team are now evaluating the efficacy of automatic oxygen therapy technology, with O2matic’s proprietary technology chosen for a multi-center study involving 300 patients. This study, named SAVE-O2 AI, and initiated in May 2024, aims to publish results by early 2026.