In brief: SoClean complaint, Drive recall, Woman of the Year announcement

PETERBOROUGH, N.H. – SoClean has filed an amended complaint in its lawsuit against Philips that takes into account a new inspection report from the U.S. Food and Drug Administration. 

The company highlighted the following points in the amended complaint: 

“Philips has known for years that the company’s products created a serious risk of harm to consumers.” 

“The FDA report also confirmed that Philips had been receiving customer complaints about its foam long before SoClean machines were even on the market and with respect to ventilator devices for which SoClean is not compatible.” 

“The FDA report did not contain a single reference to ozone.” 

SoClean filed its original complaint on Oct. 12, alleging Philips has sought to blame it for problems related to a recall of certain respiratory devices. 

SoClean seeks damages from Philips in excess of $200 million. 

Drive initiates voluntary recall for bed rails 

WASHINGTON – The U.S. Consumer Product Safety Commission and Drive DeVilbiss Healthcare have announced a voluntary recall of four different models of its bed assist handles and bed assist adult portable bed rails. 

Drive has received two reports of entrapment deaths associated with two of its bed assist handle bed rails (models 15064 and RTL15073). The deaths occurred in February 2011 and February 2015 and involved a 93-year-old woman at her home in California and a 92-year-old man at an assisted living facility in Canada. 

“In both incidents, the bed rails were not securely attached to the bed and the users became entrapped between the product and their mattress,” according to a release from the CPSC. 

The voluntary recall affects about 496,100 units in the United States, as well as 68,000 units in Canada and 119 units in Mexico, that were sold at medical supply stores nationwide and online at www.amazon.com and www.walmart.com.  

Consumers should immediately stop using the recalled bed rails and contact Drive DeVilbiss at 877-467-3099 to receive a full refund, according to the CPSC. 

Registration open for HME Woman of the Year event 

WATERLOO, Iowa – Registration is now open for the HME Woman of the Year Awards Presentation & Panel Discussion taking place at 11 a.m. CT on Dec. 16.  

The virtual event will feature a panel discussion with the four finalists, providing attendees with the opportunity to learn valuable insights, actionable advice and keys to success.  

This year’s finalists and panelists are: 

• Trisha Bailey, CEO, Medical Hotspots Inc./Bailey’s Medical 

• Neidi Mack, Vice President for Ancillary Services, Prism Health Care Services/The Alden Network 

• Katie Stevens, CEO, Reliable Medical Supply 

• Victoria Peterson, Administrator, RespMed 

“This year’s HME Woman of the Year finalists are exceptional leaders and role models in their companies and communities,” said Christa Miehe, president of Moxie, a division of VGM. “We are thrilled to honor these relentless advocates whose dedication, innovation and selfless service make a difference every single day—for their patients and the industry as a whole. It is our pleasure to honor these accomplished women.” 

This year’s award drew 64 nominations for 38 nominees from 19 states. The nominees included a broad spectrum of providers, manufacturers and other professionals in the HME, rehab, respiratory and mastectomy industries.  

Finalists were selected by an honorary selection committee that included 2020 HME Woman of the Year Patty Mastandrea, CEO of MedCare Equipment Co.; Liz Beaulieu, editor at HME News; Andrew Miller, regional vice president of AdaptHealth; Jeff Bowman, vice president of HME sales at McKesson; and Jack Hogan, president and CEO of Health Complex Medical. The committee chose the finalists using criteria that included implementing new business processes, advocating on behalf of the industry, improving the lives of patients, and impacting their community through volunteerism.  

Register for the event here. 

Non-invasive therapy might be better for COVID-19 patients, analysis finds 

LONDON – Studies indicate that non-invasive respiratory support (NIRS) for patients with COVID-19 is safe, improves resource utilization and might be associated with better outcomes, according to a new analysis published in The Lancet Respiratory Medicine. 

For the analysis, researchers identified two randomized controlled trials and 83 observational studies compromising 13,931 patients that examined the effects of NIRS modalities—high-flow nasal oxygen, continuous positive airway pressure, and bilevel positive airway pressure—on patients with COVID-19. 

Of 5,120 patients who were candidates for full treatment escalation, 1,880 (37%) progressed to invasive mechanical ventilation and 3,658 of 4669 (78%) survived to study end. Survival was 30% among the 1,050 patients for whom NIRS was the stated ceiling of treatment. 

“The two randomized controlled trials indicate superiority of non-invasive ventilation over high-flow nasal oxygen in reducing the need for intubation,” researchers wrote. 

To guide clinical decision making, prospective, randomized studies are needed to address timing of intervention, optimal use of NIRS modalities—alone or in combination—and validation of tools such as oxygenation indices, response to a trial of NIRS, and inflammatory markers as predictors of treatment success, according to the analysis. 

Better Health program boosts outcomes 

SAN FRANCISCO – Better Health, an online supplier of urological and ostomy supplies, has released a white paper on the positive impacts of its Peer Coaching Program. 

Among the findings in the paper: Humana members reported a 67% decrease in stress levels after just one coaching session. 

“We’ve found that peer support and coaching is a proven, cost-effective strategy to improve outcomes for ostomy care and chronic care management,” said Naama Stauber Breckler, CEO and co-founder. “Coaching is just one part of the holistic solution that we offer and we’re already seeing significant results.” 

The program, launched earlier this year, is initially targeting individuals with an ostomy, who often don’t receive the care and support they need following their surgeries. Ostomy patients have a 29.1% readmission rate, the second-highest 30-day readmission rate for surgical procedures, according to the company. 

Other findings in the paper include: 

• 64% reported they were able to avoid a visit to their doctor or hospital as a direct result of participating in a coaching session. 
• Nearly 85% of participants showed ostomy adjustment in as little as two weeks following coaching. 
• Over 35% reported decreased anxiety. 
• Nearly 50% reported reduced psychological distress. 

Better Health is working with Medicare Advantage payers looking for solutions to better serve these previously neglected populations. The company also plans to expand its holistic care model and offer a greater variety of telehealth services that will be covered by insurance plans. 

Federal judge halts vaccine mandate 

WASHINGTON – A federal judge in Georgia has temporarily halted the Biden administration’s COVID-19 vaccine mandate for federal contractors across the country, AAHomecare reports. The vaccine requirement does not apply to HME providers. The action puts a hold on a Sept. 9 Executive Order requiring federal contractors and their subcontractors to comply with workplace safety guidelines developed by a federal task force that, ultimately, mandated that their employees be fully vaccinated by Jan. 18, 2022. This action follows two other recent developments pausing proposed federal vaccination requirements that could have impacted the HME community and other health care providers.  On Nov. 30, a federal judge in Louisiana blocked implementation of a CMS Interim Final Rule mandating that certain health care facilities become fully vaccinated by Jan. 4, 2022; and on Nov. 19, OSHA suspended further implementation of their Emergency Testing Standard laying out vaccination and testing requirements for employers with 100 or more employees. AAHomecare will continue to monitor the status of these proposals. 

NCART publishes position paper on telehealth 

EAST AMHERST, N.Y. – NCART has published a position paper on why Congress must preserve the current telehealth option for complex rehab-related services required by Medicare beneficiaries with disabilities. The paper lists the benefits to beneficiaries of a permanent telehealth option, including reduced exposure to viruses and other health risks, improved access to qualified practitioners, reduced transportation challenges and improved understanding of functional activities in the home. “This CRT telehealth option must be made permanent for Medicare beneficiaries with disabilities, many of whom have multiple co‐morbidities, so they can continue to have remote access to CRT evaluations, fittings, and training when an in‐person visit is not possible due to medical risks and other factors,” it states. “Rather than allowing these proven flexibilities to expire and cause harm to Medicare beneficiaries with disabilities, Congress must take legislative action to make these CRT telehealth policies permanent.” The paper asks Congress to, specifically, permanently add “therapy services, physical and occupational therapy, all levels” CPT codes needed for CRT to the Medicare Telehealth Services List; and permanently add PTs and OTs as authorized Medicare telehealth services practitioners for the provision of CRT services covered by these codes.” 

Aeroflow donates $25K on GivingTuesday 

ASHEVILLE, N.C. – To celebrate GivingTuesday 2021, Aeroflow Healthcare announced donations of $5,000 each to five local nonprofits. Aeroflow's donations represent the company's continued dedication toward enriching and supporting its local community in western North Carolina. The recipients are: Pisgah Legal Services, an organization that addresses the social determinants of health to improve the well-being of those in their community; Babies Need Bottoms, a community-supported diaper bank; Mt. Zion Community Development, through their Nurturing Asheville Area Families initiative, which is working to reduce infant mortality among minority families; The Arc of Buncombe County, which supports individuals and families with intellectual and developmental disabilities; and Helpmate, which supports victims of domestic violence with a 24/7 hotline, safe shelter facilities, counseling court advocacy and more. GivingTuesday, which takes place the Tuesday after Black Friday, began in 2012 as a way to empower individuals and organizations to give back to their communities. 

NCPA launches new PBM ad campaign 

ALEXANDRIA, Va. – The National Community Pharmacists Association is going live in the Washington, D.C., media market with a seven-figure television ad buy urging senators to finalize language to reform PBM direct and indirect remuneration fees in Medicare Part D. CMS has disclosed that PBMs increased these retroactive fees on pharmacies by 91,500% from 2010-19. “PBMs are gaming the system at the expense of patient access and local pharmacies, and they won’t stop until they’re forced to,” said B. Douglas Hoey, NCPA CEO. “Policymakers in states across the country are working to rein them in but, unfortunately, despite bipartisan support for change, the federal government has been slow to act. Community pharmacy will keep fighting on all fronts to regulate PBMs and change our health care system so it better supports the patients and programs it’s supposed to serve, but the federal government has to take action to defend seniors and small businesses.” The *ad will run at least through the end of December. 

AOPA announces 2022 board of directors 

ALEXANDRIA, Va. – The American Orthotics & Prosthetics Association has named its 2022 board of directors. Members of the executive committee are: Dave McGill, president; Traci Dralle, immediate past president; Teri Kuffel, president-elect; Mitchell Dobson, vice president; and Rick Riley, treasurer.  “AOPA is very fortunate to have exceptional board members who use their expertise and energy to work tirelessly for their fellow AOPA members,” said Eve Lee, executive director. “This coming year is an exciting one for AOPA, as we rollout a new vision, mission and strategic plan. I look forward to working with the board and staff to implement the strategic plan, which will continue to ensure that all AOPA members get the support they need to run their business and provide quality patient care.” New to the board is Jim Kingsley. He joins Jeff Brandt, Elizabeth Ginzel, Kimberly Hanson, John “Mo” Kenney, Linda Wise, Shane Wuderman and Jim Young. 

Tomorrow Health joins Diamond program 

WASHINGTON – Tomorrow Health is expanding support for HME advocacy by becoming an AAHomecare Diamond Corporate Partner. “Tomorrow Health brings strong technological capabilities and expertise with increasingly important value-based care models to our partnership cohort,” said Tom Ryan, president and CEO of AAHomecare. “They are signaling their commitment to strengthening our industry’s capability to deliver public policy results that recognize the importance of quality home-based care.” Tomorrow Health joins other industry leaders, including AdaptHealth, Apria, Cardinal Health, ResMed and Philips, as part of AAHomecare’s inaugural members of the program. Vijay Kedar, CEO of Tomorrow Health, says the company’s technology and analytics help providers operate their businesses efficiently, deliver high quality care and succeed in a changing reimbursement and policy landscape. “HME suppliers play a critical role in shifting care to the home and delivering value-based care,” he said. “The equipment and supplies patients are a critical pillar of home-based health care. This industry has the potential to deliver outsized results for patients.” AAHomecare launched the program in November. 

Medicare spending on physician services dropped in 2020 

CHICAGO – Medicare spending on physician services fell an estimated $13.9 billion, or 14% below expected levels, in 2020, according to a new report from the American Medical Association. Despite a mid-year rebound after sharp declines early in the year, spending during 2020 never recovered to pre-pandemic levels, the report found. “Physicians experienced a significant and sustained drop in Medicare revenue during the first 10 months of the pandemic,” said Gerald Harmon, MD, president of the AMA. “Medicare practices that have not buckled under financial strain continue to be stretched clinically, emotionally and fiscally as the pandemic persists. Yes, physicians face an array of planned cuts that would reduce Medicare physician payments by nearly 10% for 2022. The AMA is strongly urging Congress to avert the planned payment cuts.” The AMA based the report on an analysis of Medicare claims data exclusive to physician services. Other findings: Medicare spending on physician services for 2020 declined regardless of service type, setting or specialty, and state or region; and spending on telehealth increased dramatically in 2020 but was concentrated in a handful of service categories like mental health. 

 SMRC reviews claims for surgical dressings 

WASHINGTON – Noridian Healthcare Solutions, the Supplemental Medical Review Contractor for CMS, is conducting post-payment reviews of claims for surgical dressings billed on dates of service from Jan. 1, 2019, through Dec. 31, 2019. Surgical dressings are ranked in the top four categories with the highest improper payment rate at 62.8%, according to the 2019 Comprehensive Error Rate Testing Improper Payment Report. Medicare provides reimbursement for surgical dressings under the DMEPOS benefit, but only for primary and secondary surgical dressings used on the skin on specified wound types. Types of surgical dressings include but are not limited to alginate or other fiber gelling dressing, collagen or wound filling dressing and foam filling dressing.  

Kubat acquires pharmacy 

ASHLAND, Neb. – Kubat HealthCare has acquired Ashland Pharmacy and plans to expand its services. “Kubat HealthCare’s growth initiative is to enter communities that have been under served by their health care options and provide customers additional services, such as respiratory, infusion, home medical equipment, compounding pharmacy and long-term health care alternatives previously not offered,” said Jim Rich, CEO of Kubat HealthCare. Staci Hubert acquired Ashland Pharmacy in 1994. The pharmacy will continue to offer a full-service pharmacy out of its current location in Ashland, Neb., with the same operating hours. Patients can still receive their vaccines, pick up their diabetic supplies and prescriptions, or shop in the retail section of the store. Earlier this year, Kubat HealthCare acquired Blake’s Pharmacy in Louisville, Neb.