In brief: Numotion resolves allegations, AdaptHealth taps new exec, FDA strengthens oversight 

PHOENIX, Ariz. – United Seating and Mobility, d/b/a Numotion, has agreed to pay $13.5 million to resolve allegations that the company violated the federal False Claims Act. 

The settlement resolves allegations by the United States that Numotion submitted false claims to Medicare and other federal health care programs for custom wheelchairs and wheelchair parts.  According to the allegations, the claims were false because they were based on patient evaluations that were unlawfully authored, completed or signed by Numotion employees rather than being authored, completed or signed by qualified medical professionals.  

“The custom wheelchairs and parts involved in this investigation are critical to helping patients who rely on federal health care programs, including America’s veterans, meet their medical needs and thrive,” said U.S. Attorney Gary Restaino. “But medical professionals must evaluate the need, not sales personnel from the supplier. Thanks to Numotion for self-reporting this conduct and cooperating in the investigation, and to the Inspector General for protecting the public fisc and ensuring accountability.” 

Through a series of self-disclosures, Numotion voluntarily reported several overpayments and cooperated with the investigation. The United States considered Numotion’s self-disclosures as one of several factors in reaching the settlement, which was conducted by the Office of Inspector General.  

The settlement is neither an admission of liability by Numotion, nor a concession by the United States that its claims are not well founded. 

• Read the full settlement agreement 

AdaptHealth taps new COO 

PLYMOUTH MEETING, Pa. – AdaptHealth has named Scott Barnhart as COO, effective September 23, 2024.  

Barnhart replaces current COO Shaw Rietkerk, who will transition to the role of chief business officer by the end of September, according to a recent 8-k filing. It’s the latest in a series of internal restructuring moves. In July, Josh Parnes announced he would step down as president of Aug. 31 and from the board of directors Dec. 31. In May, Suzanne Foster took the reins as CEO. 

Barnhart has more than 30 years of leadership experience in global operations including supply chain management, manufacturing, procurement, logistics, customer service and product portfolio management. Most recently, he served as COO of Qurate Retail Group, a leading global retail group, where he led operational and productivity improvements across the fulfillment center network and last mile customer delivery. Prior to that, Mr. Barnhart served in senior executive positions including as president of Global Medical Products & Supply Chain at Cardinal Health.  

“The change we’re announcing today supports our ongoing efforts to create clear roles and responsibilities, drive effective management, and align the organization’s structure to best reflect our business processes,” said Foster. “The skillsets Scott brings will help us advance our commitment to delivering exceptional care to our patients while fostering organic growth through disciplined operational excellence. There’s a bright future for AdaptHealth and this change serves to best position us to seize upon the opportunities ahead.”  

• Related: AdaptHealth sees mixed results for Q2 

FDA to strengthen oversight of medical devices 

WASHINGTON – The Food and Drug Administration has begun building a surveillance system to look for potential safety issues in medical products ranging from surgical masks to implantable pacemakers. 

More than 1.7 million injuries and 83,000 deaths over a recent 10-year period in the U.S. have been potentially linked to faulty medical devices, according to a 2018 study by the Government Accountability Office. 

Active postmarket surveillance involves the ongoing review of evidence—derived from the analysis of data sources such as electronic health records, billing claims, pharmacy and other data—to detect medical device safety issues that may otherwise go unreported. FDA has taken steps to establish an active postmarket surveillance system for medical devices. These include: 

establishing a coordinating center in 2016 to partner with FDA to organize a network of data sources (health systems and other collaborators); 

completing in 2021 the cloud-based data infrastructure necessary to collect evidence of medical device performance while protecting patient privacy; and 

planning to begin active postmarket surveillance of two medical devices by December 2024, with plans to expand over 5 years (see figure). 

Administration awards $100 million to health care navigators 

WASHINGTON - The Biden-Harris Administration has awarded a new round of $100 million to help organizations that work with underserved communities, consumers and small businesses find and enroll in health coverage through healthcare.gov, the Health Insurance Marketplace. Navigators offer free assistance to people exploring health coverage options through HealthCare.gov, from reviewing available plans to assisting with eligibility and enrollment forms, and post-enrollment services such as using their coverage to get care. Navigators can also assist people in helping enroll in or renew Medicaid and Children’s Health Insurance Program (CHIP) coverage. Navigators are vetted and trained to provide support for the millions who have enrolled in ACA coverage under the Biden-Harris Administration. “The Biden-Harris Administration believes that health care should be a right. We are committed to ensuring that all communities and individuals are connected to affordable, high-quality health coverage. And to help make that possible, we are making the single largest investment ever in the history of the Navigator program,” said HHS Secretary Xavier Becerra. “Under President Biden and Vice President Harris, Navigators have helped educate and enroll millions in quality coverage, contributing to the lowest uninsurance rate in our nation’s history, including record enrollments in communities often left behind.” This year’s Marketplace Open Enrollment begins Nov. 1. During the plan year 2024 Marketplace Open Enrollment Period, a record 21.4 million people selected health care plans through HealthCare.gov and state-based Marketplaces. 

F&P issues half, full-year 2025 guidance 

AUCKLAND, New Zealand – Fisher & Paykel Healthcare has released guidance of revenue in the range of approximately $940 million to $950 million for the first half of its 2025 financial year, which ends Sept. 30, 2024. Full 2025 financial year guidance is expected to be in the range of approximately $1.9 billion to $2.0 billion, with full year net profit after tax to be in the range of approximately $320 million to $370 million. “The year to date has begun strongly across all products and regions,” said Lewis Gradon, managing director and CEO. “In the hospital product group, contributions include ongoing change in clinical practice, and a good response to new product introductions. In addition, early indications are that the year to date includes a relatively high hospital census during the period in both the Northern and Southern Hemispheres as Northern Hemisphere seasonal hospitalizations persisted into the beginning of this current financial year and hospitals have returned to more normalized staffing and capacity.” 

TwelveStone ranks on Inc. 5000 

FRANKLIN, Tenn. - For the fifth consecutive year, TwelveStone Health Partners has ranked in the Inc 5000, coming in at No. 3810, with a three-year revenue growth of 121%. “We are thrilled to be recognized in this select group of companies,” said Shane Reeves, CEO. “TwelveStone’s mission is to improve and support patients with chronic, complex conditions through a differentiated patient experience. We attribute our exceptional growth to our incredible employees who provide an excellent level of high-touch service to our patients.” TwelveStone is a provider of infusion therapy services for patients with chronic, complex conditions that started in 1980 by Richard Reeves and Ronald Powell with a single retail pharmacy location called Reeves Powell Saveway Drug Store. In 1994 Shane Reeves and Rick Sain launched Reeves-Sain and over 20 years grew the organization to include seven companies. In 2015 Reeves Sain Drug Store, Inc., a retail pharmacy, and its specialty pharmacy, EntrustRx were sold to Fred’s, Inc. In 2016 Shane Reeves launched TwelveStone Health Partners.   
 
Therma Bright adds U.S. distribution partner 

TORONTO – Therma Bright has announced the addition of a new nationwide U.S. DME distribution partner that has launched an initial Venowave sales program to gauge Medicare/Medicaid reimbursement timelines and billing procedures. "We are thrilled to welcome our nationwide distribution partner to our team, and look forward to working with them closely on this program to demonstrate to their medical network the speed of reimbursement, as well as our efficient order and delivery process," shared Rob Fia, CEO of Therma Bright. "We expect the program to be successful, leading to a significant increase in Venowave orders on a monthly basis and accelerating our revenue growth." The Venowave VW5 is a series of compact, battery-operated peristaltic pumps that generate a wave-form motion. When worn below the knee, strapped firmly to the calf, the device results in compression of the calf and consequently an increased upward volumetric displacement of venous and lymph fluid. The new partner's name will be disclosed in the future. 

HME Home Health added to MSA 

RICHMOND, B.C. – HME Home Health has announced its inclusion to the Interior Region of the Master Service Agreement, effective immediately. This will allow its team to serve clients of the Ministry of Social Development and Poverty Reduction; Ministry of Children and Family Development; ICBC and WorkSafe across the Okanagan, Thompson, Cariboo and Shuswap regions. “Today’s addition means that HME now covers three of the five regions in B.C. – Region 1 (Interior), Region 3 (Lower Mainland) and Region 4 (Vancouver Island),” said Robert Boscacci, CEO & co-founder. “HME Kelowna’s team is excited to provide the same great HME service to residents in the Interior that our Lower Mainland and Vancouver Island clients have received.” HME Home Health has eight locations and more than 80,000 square feet of office and warehouse space in Richmond, Victoria, Surrey, Nanaimo, North Vancouver, Kelowna, and now Sechelt. HME Home Health offers a vast array of mobility and accessibility devices and medical equipment. Items include wheelchairs, power chairs, walkers, hospital beds, mattresses, other durable medical equipment, stairlifts, vertical platform lifts, ramps, and other installed products. 

Williams Brothers celebrates 14th location 

WASHINGTON, Ind. – Williams Brothers Healthcare will hold a grand opening celebration of their new store location in Evansville, Ind., at 54-01 Vogel Road. The location, the company’s 14th, opened in July and has scaled operations to provide a high level of respiratory care in Vanderburgh and surrounding counties. The independent, family-owned company was founded in 1899 and provides services including long-term care and compounding pharmacy services, respiratory and infusion therapy, home medical equipment and home modifications.