In brief: SoClean field correction, HCD CEO, reimbursement relief efforts 

PETERBOROUGH, N.H. – SoClean on Nov. 16 issued an urgent medical device field correction that provides clarifications to the user manuals for its SoClean2 and SoClean 3 and notifies users of the availability of a hose and mask adapter for the maintenance systems. 

SoClean is revising its labeling to incorporate additional warnings and contraindications, as well as proper and consistent device setup instructions, including use of a hose and mask adapter to reduce potential risks associated with the previous device design and labeling. 

The company is also providing additional clarity and consistency regarding the systems not being intended to replace CPAP manufacturer cleaning instructions but rather to supplement cleaning for masks and tubing. 

The FDA on Nov. 21 also provided additional information on SoClean’s field correction. 

The company says it has received about 7,417 complaints – about 0.33% of all SoClean 2 and SoClean 3 units sold – that are due to improper setup, unauthorized device modifications and use by individuals for whom the systems are not recommended. Of those complaints, 334 were adverse events reportable to the U.S. Food and Drug Administration, with zero deaths. 

SoClean says common complaints include users not being able to set up or turn on the device; mildew smell in the hose; excessive ozone smell; cough; and exacerbation of preexisting condition(s). 

The company noted that, as stated in its user manual, persons with underlying lung diseases, such as asthma and COPD, and those with cardiovascular disease may be sensitive to ozone and should consult with their health care professional before using the systems. 

HCD announces leadership transition 

RICHMOND, Va. – Home Care Delivered has announced that Founder and CEO Gordy Fox will transition to chairman of the company’s board of directors and will be replaced by Gayle Devin. 

Devin’s tenure as CEO officially starts today, Nov. 27. 

“For 27 years, Home Care Delivered has been delivering essential medical supplies to people living at home with chronic health conditions,” Fox said. “Gayle’s deep industry knowledge and operational expertise will be invaluable as we continue our business expansion and maintain and solidify our industry-leading customer service. Gayle is the perfect next generation leader – an amazing servant leader with a passion to improve our customers’ and teammates' lives by building an inspiring culture of compassion and performance. Gayle’s leadership will accelerate our ability to help more people live at home with confidence and dignity.” 

Devin brings years of expertise in the health services industry to HCD. With a proven track record in HME/specialty medical distribution, she is known for crafting innovative business strategies and implementing successful models that distinguish companies from their competitors, the company says. 

Most recently, Devin was CEO of Alsana, a recovery community for those struggling from eating disorders, and CEO of ActivStyle, a medical supply company that specializes in incontinence products. Both companies are portfolio companies of The Riverside Company. 

HCD, which is private equity backed, recently acquired Medline’s DMEPOS supplier business unit. 

AAH details latest advocacy event 

WASHINGTON – AAHomecare’s third “Hill Day” of the year to advocate for reimbursement relief reached 90 members of Congress, the association says. 

The association, which co-hosted the event with VGM Group, focused on members of committees of jurisdiction on health care finance issues in the House of Representatives and Senate, as well as members who were not connected with in previous events. 

AAHomecare says the three advocacy events this year have resulted in a total of 430 meetings. 

The association encourages continued activity well into the end of the year, in light of new deadlines to pass appropriation legislation on Jan. 19 and Feb. 2, 2024. 

“While a faster timeline for action would make for a happier New Year for HME stakeholders, the move to extend the timeline for omnibus healthcare legislation into next year gives us more time to follow up with your legislators in December and into the early weeks of January,” the association stated in a bulletin. “Your advocacy is making an impression even amidst the staggering volume of political and policy issues that vie for attention on Capitol Hill.” 

Stakeholders have focused their advocacy on H.R. 5555 and S. 1294, which would provide a 90/10 blended Medicare reimbursement rate for most home medical equipment products in competitive bidding areas for all of 2024 and extend the current 75/25 blended rate currently in effect in rural/non-CBA areas through 2024.     

MK Battery strengthens sales team 

ANAHEIM, Calif. - MK Battery has appointed Jason Smith, a 27-year veteran of the company, as its national sales director. In this role, he will direct the efforts of the field sales team and all sales administrative functions. Sean Shirley, who joined the sales team at MK Battery in 2019, has been promoted to regional sales manager for the eastern region of the United States, filling the role vacated by Smith. “These organizational changes reinforce MK Battery’s total commitment to succession planning and promotion-from-within, while assuring continued professional management of our team to best serve our customers,” said Rick Spiegel, vice president of corporate business development. MK Battery, a wholly owned subsidiary of East Penn Manufacturing Co., is a global supplier of quality specialty batteries for use in deep-cycle and standby power applications. 

Medtrade debuts Insider rates 

DALLAS – Medtrade has debuted a new category of registration rates called Insider. Under these rates, registration for an expo pass is $20 and a conference pass is $100 through Dec. 12. “A conference pass provides access to all educational sessions, the expo floor and the Consultant Cocktail Hour,” said Kerry Tyler, associate show director. “At $100, it’s an incredible deal, but the time is highly limited. Whether you want the expo pass or the conference pass, now is the time to take advantage.” When the Insider rates expire, the SmartSaver rates will go into effect from Dec. 13 to Jan. 22. Medtrade is scheduled to take place March 26-28, 2024, at the Kay Bailey Hutchinson Convention Center in Dallas. Register for the event here. 

Annexus Health, Welnfuse partner 

CRANBERRY TOWNSHIP, Pa. - Annexus Health has announced a strategic partnership with Welnfuse, a software platform for infusion therapy and medication delivery. The integration between the platforms of the two companies will allow infusion center staff to navigate seamlessly between Annexus’ AssistPoint for financial assistance management and Welnfuse for patient scheduling, order and inventory management, clinical documentation and more. "Infusion centers across the country rely on our WeInfuse software to optimize efficiency across every aspect of the infusion and injection workflow," said Bryan Johnson, WeInfuse's co-founder and CEO. "By partnering with Annexus Health, we can now offer our clients powerful, customizable solutions to streamline and automate the patient financial assistance process to make infusion therapy more accessible and affordable." Welnfuse has also integrated with Formstack and Twilio to deliver a comprehensive patient engagement solution for its provider clients. 

OIG warns of RPM scam 

WASHINGTON – The Office of Inspector General has posted a consumer alert about a fraud scheme involving monthly billing for remote patient monitoring. The OIG says unscrupulous companies are signing up Medicare beneficiaries for monitoring using medical devices like scales, glucose monitors, blood pressure cuffs, cardiac rhythm devices and other equipment, regardless of medical necessity. The agency says these companies are signing up bennies for these services in several ways, including phone solicitations (“cold calling”), Internet ads (“click bait”) or TV advertising. “These contacts may originate from a DME company or pharmacy,” the OIG says. “Equipment may or may not be sent or is equipment that is not (approved by the U.S. Food and Drug Administration). Billing then occurs for setup, patient teaching and monthly monitoring of data. More often, the monthly monitoring never happens, but the enrollee is billed monthly, anyway.” The OIG recommends that bennies protect themselves by, among other things, not accepting medical equipment that hasn’t been ordered by their health care provider and being suspicious of anyone who offers them free medical equipment and then requests their Medicare number. The agency acknowledges that, when used properly, remote patient monitoring is beneficial for those whose condition might deteriorate quickly, where monitoring can reduce complications, hospitalizations or death. 

HME Home Health, Motion partner on event 

RICHMOND, British Columbia – HME Home Health collaborated with Motion to host a one-day conference on Nov. 14 that highlighted pediatric equipment. The event, which had the theme “Creating & Enhancing Accessibility for Young Lives,” provided local physical therapists and other health professionals with education on best practices in pediatric equipment provision. “HME was excited to partner with Motion, another local pediatric equipment provider, to host this valuable clinical training and education day,” said Robert Boscacci, CEO and co-founder of HME Home Health. “Starting in 2023, HME and Motion have been working together to combine our knowledge and expertise on pediatrics and have become the go-to pediatrics equipment suppliers in B.C. We intend to have this relationship continue with future events and look forward to bringing to the market high-quality, clinical, educational sessions that improve accessibility in our communities for all children.” The event was supported by manufacturers like Motion Concepts, Evergreen Medical Products, Ki Mobility, Permobil and Sunrise Medical. 

Medline makes $250K in donations 

NORTHFIELD, Ill. - Medline has awarded a total of $250,000 in grants to 10 nonprofit organizations through its annual Community Impact Grant programs. The grants will be evenly divided across the organizations, which are all working to address social determinants of health – the economic and social conditions that impact disparities in health status and care, as well as life expectancy. “Medline is proud to be able to aid all of these organizations with this grant,” said Karen Frey, senior philanthropy manager, Medline. “When selecting the grant recipients, we look for organizations that have standing dedication and roots within their community and have proven time after time to be an important resource for the individuals they work with. We look forward to seeing the results this grant has on these communities.” Since launching in 2018, Medline’s Community Impact Grant program has donated a total of $1.4M to non-profit organizations across the United States. Among the organizations receiving grants this year is the American Heart Association, which will use the funding to invest in programs and partnerships that improve health care services and pass policies that transform minority and economically disadvantaged communities by removing barriers to health care access and quality. For a full list of the organizations that have received grants, go here.