In brief: Mobility study, ADS-StrideMD partnership, SoClean clearance  

PITTSBURGH – Clinical investigators from the University of Pittsburgh and the Medical University of South Carolina recently published a study that shows different types of mobility devices and certain characteristics of people with limited mobility are associated with reported falls. 

The study, published in the journal Disability & Rehabilitation: Assistive Technology, and based on an analysis of more than 11,000 deidentified cases from the Functional Mobility Assessment and Uniform Dataset (FMA/UDS) Registry, found: 

• 52% of people reported at least one fall in the three months prior to their assessment for a new mobility device 
• 47% of people who reported a fall were using a walking aid or no device at all 
• People with progressively acquired disabilities (i.e., Parkinson’s disease, osteoarthritis, and cardiopulmonary disease) reported higher rates of falls than those with congenital disabilities (i.e., cerebral palsy and spina bifida) 
• Fewer falls were also reported in people using custom fitted manual wheelchairs and powered mobility devices 

Commentary: 

“The findings from this study provide more evidence as to how properly fitted mobility devices matched to a person’s needs can contribute to the reduction of falls,” said Mark Schmeler, study co-author, who oversees management of the FMA/UDS Registry as an occupational therapist and associate professor at Pitt’s Department of Rehabilitation Science and Technology. 

“The findings indicate earlier interventions for fall prevention, including professional wheelchair evaluations, may be warranted,” said lead author Corey Morrow, assistant professor and LeaRRn Scholar at MUSC and an occupational therapist. “However, further research will explore the long-term impact of properly prescribed mobility devices on falls.” 

“I thank all members and clinical partners who are contributing to the registry as large data and research is essential to advocate for the field of complex rehabilitation technology,” said Tyler Mahncke, president of U.S. Rehab, a division of VGM & Associates, which supports the FMA/UDS Registry. 

Background: 

The study was developed under a corporate research agreement between Pitt and VGM and funded as a sub-award through the Learning Health Systems Rehabilitation Research Network. LeaRRn is supported by the National Institutes of Health through the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Institute of Nursing Research, and by the National Center for Advancing Translational Sciences. 

ADS expands wellness offering 

CARLSBAD, Calif. – Advanced Diabetes Supplies is expanding its membership wellness initiatives through a new partnership with StrideMD, a management service organization that specializes in connected care solutions. ADS will now offer StrideForward, a program featuring remote patient monitoring and virtual care support services from a team of endocrinologists, certified diabetes educators and other medical professionals, to a select group of members with Type 2 diabetes, with plans to expand access in 2025. “ADS is dedicated to supporting our members in the effective management of their diabetes,” said Bill Mixon, ADS CEO. “Our partnership with StrideMD prioritizes the patient-centered care that is critical to the health of those we serve through access to an integrated team of experts and tools providing virtual and in-person wholistic support.” ADS will also offer members access to the StrideMD remote patient monitoring platform, offering real-time glucose readings, data aggregation and actionable insights. “Partnering with ADS, a leader in continuous glucose monitor distribution, is a perfect fit for StrideMD,” said Spencer Weiss, CEO. “Personal experience with the devastating impact of diabetes underscores the critical need for advanced care solutions. Our combined expertise and resources will drive better health outcomes.” 

ADS also recently expanded its Part B services to retail pharmacies to include management of diabetes supplies 

FDA grants auth to SoClean device 

WASHINGTON – The U.S. Food and Drug Administration has granted a marketing authorization to SoClean for its SoClean 3+ bacterial reduction device for use with CPAP accessories (two hoses ResMed ClimateLine Air tubing and SlimLine tubing) and one mask (ResMed Mirage FX mask) for the ResMed AirSense 10 CPAP device. The SoClean 3+ does not replace the cleaning steps recommended by manufacturers of CPAP devices. To date, there are no FDA cleared or approved devices for cleaning, disinfecting or sanitizing CPAP devices. Source: FDA Roundup for Aug. 16, 2024. 

F&P fills board seat 

AUCKLAND, New Zealand – Fisher & Paykel Healthcare has appointed Mark Cross to the board as a non-executive director effective Oct. 1. Cross, who currently chairs the board of Chorus, where he has been a director since 2016, replaces Scott St. John, who will retire from the board at the end of August. “Mark is a strategic thinker who understands the technology and innovation sector and brings a fresh perspective,” said St. John. “With strong business acumen and a background in global finance, his skills will complement those of the other directors. We welcome him to the board and look forward to getting his insights.” Cross is also a director of Xero and a board member and chair of the Investment Committee for Accident Compensation Corp. He is the former chair of Milford Asset Management and a former director of Z Energy, Genesis Energy and Argosy Property. At F&P, Cross will be an independent director and chair the Audit and Risk Committee. 

van Halem Group adds two consultants 

ATLANTA – The van Halem Group has added Dr. William Felix and Melissa Pederson, RN, to its team of consultants. “We are thrilled to welcome Melissa and Will to our team,” said Wayne van Halem, president, The van Halem Group. “Their background, skills and expertise are perfectly aligned with the services we provide to our clients, and we are lucky to have them.”  

• Felix previously served as the medical director of policy at Cohere Health. His extensive experience includes chief medical officer for Medicare DMEPOS and medical director of the Pricing, Data Analysis and Coding (PDAC) division at Palmetto GBA. In these roles, he developed coding standards for various medical devices and played a pivotal role in helping CMS recognize 3D printing as a viable method for custom fabricating orthoses. 
• Pederson, whose career in nursing spans 27 years, previously worked for Noridian, a DME MAC. During her tenure there, she played a crucial role as a clinical reviewer of DME claims in the redetermination department. 

Founded in 2006, the van Halem Group offers a full array of reactive and proactive reimbursement and HIPAA-compliance support solutions, helping providers, manufacturers and health care attorneys navigate the complex regulatory issues related to submitting claims, responding to audits and filing appeals, and avoid violations of federal and state laws and other payer policies and requirements. 

ResMed expands board of directors 

SAN DIEGO – ResMed has expanded the size of its board of directors to 11 and has elected Christopher DelOrefice to the board. DelOrefice, who currently serves as executive vice president and CFO of Becton, Dickinson and Company, was appointed during ResMed’s regularly scheduled board meeting on Aug. 15 and will stand for re-election with the rest of the company’s directors at its annual meeting on Nov. 21. “Chris has proven himself an experienced global leader in corporate finance and business strategy, as well as in global operations management across multiple business sectors, including in his current role as CFO of a multi-billion dollar, global med-tech company,” said Mick Farrell, chairman and CEO of ResMed. “My fellow board members and I were impressed with Chris’ achievements, as well as his humility, hard-working nature, and leadership capabilities, all of which are highly relevant to his service as a ResMed director. Chris’ financial experience in health care and medical technology will complement the leaders already serving as ResMed directors.” ResMed has also appointed DelOrefice to the board’s audit committee. He has more than 30 years of audit, finance and strategic expertise that includes roles at Johnson & Johnson, AstraZeneca, AET Films and Ametek. 

FODAC opens second location 

SAVANNAH, Ga. - Friends of Disabled Adults and Children of Atlanta has chosen Savannah, Ga., for its second location. The nonprofit will partner with Goodwill of Southeast Georgia to collect gently used equipment like wheelchairs, walkers and crutches from the public at all its 17 retail stores around the coastal area. The new location was made possible with support from Sen. Raphael Warnock, D-Ga., and by a grant of $478,000 from the Department of Health and Human Services, through the Health Resources and Services Administration (HRSA), part of the Congressionally Directed Spending (CDS) initiative. "This grant represents our ongoing commitment to ensuring that individuals with disabilities have access to the resources and support they need to thrive,” said Chris Brand, FODAC’s executive director. “We offer wheelchairs, hospital beds, walkers, and much more. The expansion of FODAC into Savannah will undoubtedly make a meaningful difference in the lives of countless individuals and families in our community." To celebrate the milestone, FODAC will host a ribbon-cutting ceremony on Aug. 22 at the new location. 

Stryker adds care.ai to health care IT offering 

PORTAGE, Mich. – Stryker has signed a definitive agreement to acquire care.ai, a privately held company specializing in delivering artificial intelligence-assisted virtual care workflows, smart room technology and ambient intelligence solutions. The company says the acquisition will strengthen its growing health care IT offering and wireless connected medical device portfolio. “This acquisition underscores our commitment and focus on our customers," stated Andy Pierce, group president, medsurg and neurotechnology, Stryker. “care.ai will help Stryker significantly accelerate our health care IT and digital vision to provide customers with real-time, smart and connected decision-making tools that enhance the lives of caregivers and their patients.”  Stryker previously acquired Vocera Communications, a platform for clinical communication and workflow. The company says care.ai adds complementary technology that will integrate seamlessly with the Vocera platform and Stryker’s devices, providing customers with an enterprise-wide ecosystem that can deliver dynamic clinical workflows and further the development of smart care facilities.  

Woman charged with enteral fraud scheme 

DENVER – Colorado Attorney General Phil Weiser has filed fraud and theft charges against a woman in an alleged Medicaid fraud scheme that cost taxpayers more than $1.2 million in losses. Natasha Sawyer is accused of submitting false claims when she worked as a Medicaid biller for Element Medical Supply, a DME company. An investigation by the Medicaid Fraud Control Unit in the Colorado Department of Law found that from May 2020 to March 2021, Sawyer allegedly submitted false claims for enteral formula. While she billed millions of calories of formula, only about 5% of the product billed to Medicaid was delivered to patients. Investigators were able to link a username and IP addresses used to submit the claims in question to Sawyer’s location and identity. She is charged with Medicaid fraud and waste false claims of $1 million or more and cybercrime theft of $1 million or more, both class two felonies. The case is filed in Denver County District Court, case number 24CR04818. The filing of criminal charges is a formal accusation that an individual committed a crime under Colorado law; all defendants are presumed innocent until proven guilty.