FORT LAUDERDALE, Fla. - Lincoln Health Supply recently highlighted the American Diabetes Association's 60-second Diabetes Risk Test to underscore how the provider can help educate and empower consumers to manage their health. The ADA diabetes risk test is a risk score based on seven criteria that predict the risk of developing diabetes, including age, gender, family history of diabetes, blood pressure, ethnicity, physical activity and BMI and was promoted as part of Diabetes Alert Day in March. “We need to have those important conversations and support these organizations,” said Maximiliano Rojas, CFO. “Diabetes is an incurable disease—it’s not going anywhere—but, managed with proper tools, like the ones we offer, we can help the community.” Founded in January 2019 by a group of five investors, Lincoln Health Supply aims to provide a seamless experience for people with diabetes using continuous glucose monitoring (CGM) systems. It operates in five locations in Florida and served more than 71,000 patients last year. As one example of its commitment to the community, Lincoln Health Supply has partnered with local universities on educational seminars and webinars on nutrition, physical health and CGM usage.  For its part, Lincoln Health works to stay abreast of the rules and regulations of the quickly evolving diabetes market, says Rojas. “It’s a very complex field with a lot of red tape and compliance requirements,” he said. “We have our own dedicated compliance team and a compliance attorney to ensure we adhere to all the evolving regulations going on with Medicare and the industry overall.” While titans like CVS, Walgreens, Publix and Walmart offer the same products online, they don't offer the type of service that Lincoln Health offers, says Rojas.  “We really like to walk the patient through, hold their hand and explain everything to them,” he said. “A lot of people call us and give us great reviews because nowadays when you contact these big companies, they don't have anybody picking up the phone. They don't have time for that, and I think that's what’s really helping us grow.”

Tyler Mahncke estimates the demand for mobility equipment is growing at a 5%-9% annual rate, with approximately 60% paid for by public and private insurance. “There is still a strong retail component to the market, specifically for scooters and wheelchairs,” said Mahncke, president of U.S. Rehab at Waterloo, Iowa-based VGM. “People want a backup and travel device.” Functional Mobility Assessment data reveals that more than 15,000 clients use a mobility vehicle, from manual to power wheelchairs. The fastest growing conditions requiring mobility equipment are stroke and osteoarthritis, followed by spinal cord injuries, neuromuscular disorders like multiple sclerosis and amputation. With mobility clients increasingly part of the baby boom generation, John Wright, vice president of sales management and business development for Torrance, Calif.-based Shoprider, credits them with the rise in demand and retail opportunities. “I have seen a shift to retail purchasing versus (third party) reimbursement as these traditional channels have become more difficult to work through,” Wright said. “Just getting the proper documentation needed from physicians is very problematic. Often, out of frustration many users or family members are accessing these mobility products via Amazon and other internet-based sellers.” Power mobility and scooters remain in high demand, said Jeff Distasio, vice president of Duryea, Pa.-based Pride Mobility. “The makeup of the consumer remains basically unchanged, but their expectations have changed given all the new technology in the market,” Distasio said.“The ability to meet the demands of the consumer in the various environments that they want to explore is key to ensuring the consumer is satisfied.” What users want Desire equates with demand, so knowing what customers want is paramount in delivering the type of products and technologies that match the most popular preferences, sources say. “Every client is different,” Distasio said.“They have different wants, needs and expectations. Providers can position themselves favorably by taking the time to assess those needs on an individual basis.Asking the right questions and having a variety of options across the power wheelchair and scooter categories for a client to test while they are visiting is a crucial part of ensuring client satisfaction and the referrals that can come along with it.” Mahncke says technology is at the heart of what users are asking for – from power chair seat elevation to outdoor vehiclesto electronic accessories. “Power chair seat elevation is disrupting the industry because it hasn’t happened before, he said. “It offers the ability to transfer appropriately instead of just upper body, and the ability to stand and reach things on the counter.” Electronic accessories are in high demand, especially additions that revolve around charging smartphones, tablets and other personal devices, Mahncke said. The integration of carbon fiber into mobility products is making them lighter and easier to transport, spurring demand for this equipment, said A.J. Donatoni, Pride marketing and communications coordinator “More robust suspension systems and the ability to safely achieve higher speeds allow consumers to traverse a wider variety of terrain,” Donatoni said.“The proprietary EZ Turn technology in the Go Go Elite Traveller scooter gives a consumer the ability to enjoy the turning radius and maneuverability of athree-wheelunit but with the stability and control of a four-wheel unit.” A long wait Seat elevation’s arrival has been a long time coming because “third-party payers are historically very slow to recognize benefits derived from either technological or materials advances,” Wright said. “The industry has been fighting for seat elevate functions for many years because it would allow users to be far more independent in an indoor setting and yet Medicare will not approve a power chair if necessary for outdoor activities. This indicates that power chair users are then confined to indoor activities only, which is puzzling.” Even so, Wright said seat elevation “will vastly increase independence for indoor confined users – it is a huge win for them. But how many years has it taken for CMS to recognize the need?” STEADY GROWTH Rolling forward: Wheelchair and scooter growth is expected to grow at an annual rate of 5%-9%, with approximately 60% paid for by public and private insurance. There is still a strong retail component in the market, specifically for wheelchairs and scooters. TECH WISH LIST Spurring demand: Boomers are at the heart of mobility sales and they want technology to accommodate their preferences. From power chair seat elevation, to outdoor vehicles to electronic accessories, customers want elevation to give them the ability to stand and reach, navigate different terrains as well as accessories that revolve around charging smartphones, tablets and other personal devices. PATIENCE REWARDED Time has come: Seat elevation has finally arrived after a long wait. Third-party payers have been historically slow at recognizing the benefits of the advancement and the independence it grants to power chair users.

Recently, I talked to a sleep medicine specialist about the possibilities of AI-enabled technology for that patient population; the next I was talking to a diabetes company about the AI-enabled technology for those patients. I can’t open my inbox without multiple daily pitches on the latest AI technology. It’s all very heady stuff for this writer who, until recently, found my eyes glazing over every time I heard the word algorithm.  But, the more people use it, the more it’s starting to make sense. Take Dr. Anuja Bandyopadhyay, who chairs the Artificial Intelligence in Sleep Medicine Committee for the American Association of Sleep Medicine. She told me that even four or five years ago, when it came to AI’s usefulness, skepticism reigned.  No more. It’s no longer “aliens and robots,” she told me. “I think once people saw how this can be beneficial – it's helping me save time, save resources and improving access to care – then it became a natural solution to quite a few of our problems and that's how people start accepting it more,” she said. More exciting, from my point of view, is how technology empowers patients. Editor Liz spoke with Sam Rusk at EnsoData about that company’s recent partnership with Aeroflow Health (see page 1) to use its predictive tools to identify patients struggling with therapy. By looking at data that includes everything from leaks to AHI, its technology will help providers manage scare resources and, ultimately, improve patient adherence, he says. Even without the AI factor, technology has been growing by quantum leaps over the past few years.  Look at so-called “wearables.” While the U.S. Food and Drug Administration recently approved the Samsung Galaxy Watch to detect signs of OSA, consumers have been using wearable to track everything from steps (remember the pedometer) to heart rates to blood glucose numbers. Really, if you aren’t wearing some sort of wearable at this point, are you even alive? If ever there was a population that tracked data, it’s the diabetes patient. I recently upgraded to the Libre FreeStyle 3. The company has reduced packaging by about half and the latest generation sensor is also much smaller – both great things! But the biggest change (and if I would just read directions for once I would have known this) was that I no longer have to wave the reader (in this case, my phone) over the sensor to get a reading. After two days of confused waving of the phone over my arm, it dawned on me: Just press home and the number is … there. It might seem like a small thing, but it’s one less barrier on the road to better outcomes. Mind-boggling.

WATERLOO, Iowa – VGM Group has announced that Dan Bunting, who was most recently COO and strategic advisor to the CEO of AdaptHealth, has joined its team as a senior advisor. In this role, Bunting will help VGM develop long-term strategies to promote and support its customers and the HME industry. “I don’t think there’s anyone in the United States who knows more about our industry than Dan,” said VGM Group CEO Jeremy Stolz. “The health care industry, and HME in particular, is constantly evolving. And I am thrilled to have Dan’s experience and expertise with us as we continue to shape the future of VGM and the industries we serve.” In all, Bunting’s career spans 40 years, with experience in nearly every aspect of HME, including product development and manufacturing. Born and raised in Manchester, Iowa, less than an hour east of VGM’s headquarters, Bunting has been close to VGM throughout his life and career. He first met Van Miller, VGM’s founder, while attending the University of Iowa. At that time, Miller had an HME business where Bunting worked for two years while getting his degree. Later, when Bunting set out to start his own HME business in Iowa City, Miller and a few of his friends helped finance it. Bunting’s HME business, which sold to Rotech in 1996, was one of VGM’s earliest members. “I have dedicated my entire career to helping advance the HME industry, and I’m honored to continue that work with VGM,” Bunting said. “VGM, in many ways, feels like a return home for me. I am excited to do my part to help VGM in its mission to make a difference—both in the industry and in the communities it calls home.” 

WASHINGTON – DME Service Solutions, a provider of B2B outsourcing solutions specializing in health care, has partnered with the National Association for Home Care & Hospice to connect with a network of professionals focused on effective home care solutions. "We are honored to collaborate with NAHC, whose dedication to providing affordable care aligns with our mission at DME Service Solutions,” said Ryan Holbrook, president of DME Service Solutions. “We look forward to working alongside NAHC and its members to make a meaningful difference in the lives of those we serve." DME Service Solutions offers HIPAA-compliant workforce solutions, including document management, revenue cycle management, multichannel customer engagement and tech support. The NAHC represents the interests of more than 35,000 home care and hospice organizations, their 2 million nurses, aides and therapists, and the 14 million patients they serve annually. 

WASHINGTON – CMS on July 12 announced that additional resources and flexibilities are available in response to Hurricane Beryl in Texas. President Biden on July 12 determined an emergency in the state beginning on July 5, and HHS Secretary Xavier Becerra on July 12 determined a public health emergency in the state beginning July 5. The agency says it will permit Medicare beneficiaries who have lost or realized damage to their DMEPOS as a result of the hurricane to receive replacements for such items and services to ensure beneficiaries can continue to access what they need. “CMS stands ready to assist with resources and waivers to ensure hospitals and other facilities can continue to operate and provide access to care to those impacted by consequences of the hurricane,” the agency stated. CMS will also provide waivers, make available special enrollment periods for the Federal Health Insurance Exchange, activate the Kidney Community Emergency Response program and take other measures. FMI, go here. 

CHICAGO – Access Infusion Care, a portfolio company of Chicago-based New Harbor Capital, has completed its acquisition of Big Sky I.V. Care, a provider of home and specialty infusion services in Kalispell, Mont. This marks Access Infusion Care’s first add-on deal as part of New Harbor and is a key part of its broader strategy to partner with high-quality infusion providers in underserved areas with diversified therapy offerings and delivery settings, and outsized growth potential. “We are excited to add another high-quality infusion business to the Access family,” said Bo Mlnarik, principal at New Harbor Capital. “The combined resources, culture and experience of the teams, as well as the added scale, diversification and growth avenues make this a great fit for our infusion strategy.” Big Sky offers a wide range of infusion therapies, including specialty medications, antibiotics and total parental nutrition for chronically ill patients in their homes and at infusion sites. Founded in 2005 in Kalispell, Mont., by Julie Lyon, BSN, and Dave Grady, BA, Big Sky I.V. Care operates a 503A compounding pharmacy and a state-of-the-art ambulatory infusion center facility with a dedicated team of more than 15 professionals, including pharmacists, technicians and nurses. It is accredited by ACHC for home infusion therapy and features USP and USP compliant clean rooms for sterile compounding.  “We are thrilled to announce our new partnership with the Big Sky I.V. Care team,” said Bruce Kutinsky, CEO of Access Infusion Care. “Julie and Dave have built an impressive and innovative business with a diverse array of service offerings and world-class facilities. This acquisition is a significant step forward in fulfilling our vision of bridging the access gap in healthcare. By improving access to specialized infusion therapies in underserved markets, we are making a tangible difference in the lives of patients who need these services the most.  We are excited about the future and the potential to transform the infusion care landscape through this strategic partnership with Big Sky I.V. Care.” Access Infusion Care was formed in January 2024 through the acquisition of AIC North and JLS Infusion Nurse Staffing Services. 

Trend toward diversity: The HME industry is catching up with wider trends, and more women are taking high-profile roles. A mobile workforce seeking cultural alignment is driving this shift.Educational opportunities: Over the past decade, educational opportunities have expanded, including stronger master’s programs in health administration. Women now have more options for pursuing management careers.Support and empowerment: Women leaders face biases and pay gaps, but there’s growing support for them. Fostering an inclusive management style and embracing technology are essential for success.YARMOUTH, Maine – There’s been a surge in women taking high profile roles at HME companies, a shift that could reshape workplace culture and drive innovation. Most recently, Suzanne Foster took the reins as CEO at AdaptHealth in May, and Robin Menchen was named president and CEO at Rotech Healthcare in February. More broadly, women now hold CEO roles at 10% of Fortune 500 companies. “I think there have been wider trends for some time and the HME industry is beginning to catch up,” says Katie Stevens, CEO at Reliable Medical and 2021 HME Woman of the Year. “There’s a workforce today that is more mobile and that is looking for cultural alignment. A desire for certain types of environments is going to drive a shift toward diversity, so it’s natural that you see more women taking on those positions.” ‘Just more options’ Women have more ways to pursue careers in management than they did even a decade ago, says Michelle Jensen, who became president & CEO of CarePro Health Services in 2015 and then president and CEO of its parent company Rayser Holdings, when it formed in 2018. “I think it’s a combination of, there’s just a lot more educational opportunities – master’s programs in health administration have gotten much stronger, for one,” she said. “And then, we talk to a lot of people that want to pursue health care, a lot of whom are women or older clinicians who decide to go back to school and go into the management side of it after being nurses, for example.” There’s also simply more support now for women pursuing leadership positions, says Gayle Devin, who’s held CEO roles for about 21 years, including her latest at Home Care Delivered. “Early in my career, I was dealing with the biases and the pay gap and the categorization that women are weak and emotional,” she said. “I felt I really had to work harder than the males to prove myself.” Early in her career, Devin was told not to take her job personally – advice she says she ignored. “If I don’t take it personally, then I’m not taking it seriously,” she said. “I’m a very collaborative and inclusive leader and I think my management style has become more participative and empowering.” ‘An industry in need of innovation’ More diversity in leadership positions brings new perspectives to how things are done – or could be done. Stevens strives to create an environment where people feel comfortable “throwing out ideas.” “HME is an industry in need of innovation,” she said. “I think everyone is looking for new models and leaning into technology. We have to look at ways of working smarter but also supporting one another and fostering creativity. Thinking outside the box we can achieve not only success, but profitability, better team environments and, ultimately, a better client experience.” ‘Getting that balance’ More typically, women must also juggle the demands of work and family life, something that women in leadership positions not only try to encourage, but also model, says Danielle Schwiebert, executive director at CarePro Health Services. “It really is about getting that balance – can I get to every kid’s event? No,” she said. “But I get to most of them. My team all know they can reach out to me, and I always push others to do the same.” Advances in technology have been both helpful and harmful in helping women in leadership positions maintain that balance, says Jensen. “It’s hard to leave early at times, but really, it’s all in our heads,” she said. “I think you need discipline and a lot of common sense (about when to disconnect).” ‘This is kind of cool’ The majority of Schwiebert’s team is currently female – something that job candidates take notice of, she says, and will hopefully pave the way for more women in leadership positions. “When we do (hiring) interviews, I’ve had several say notice and say, ‘This is kind of cool,’” she said. **MORE** 

PORT WASHINGTON, N.Y. – Mobility Designed’s portfolio of products will be in good hands at Drive DeVilbiss Healthcare, thanks to the company’s expertise in global manufacturing and supply chain, says Max Younger. DDH announced in June that it had acquired MD’s portfolio of products, including its flagship product, the M+D Comfort Crutch, and named Younger, its co-founder and chief of innovation, as its senior director of industrial design and innovation. “Innovation is not easy,” he said. “Drive brings many things to the table. A well-established global supply chain is a huge strength, along with global sales and marketing teams, and their key relationships in the industry all elevate the potential of this portfolio of products.” The Comfort Crutch, which was named a finalist in Fast Company’s Innovation by Design Awards, and which was the subject of a viral video that reached more than 50 million viewers, shifts the user’s weight to the elbows instead of the armpits or wrists, providing more comfort. Younger started working on the crutch after watching his father, who has had multiple knee surgeries and who became an amputee in 2008, struggle with traditional crutches, and launched MD in 2014. DDH also brings to the table a larger global distribution network, Younger says, including DME providers. MD has been selling the Comfort Crutch through business-to-business and direct-to-consumer channels. “DME providers want to differentiate themselves from e-commerce,” he said. “A new product that’s new and exciting (like ours) allows them to reach a customer base that is unique and that can’t easily go get it yet.” As part of DDH, Younger will initially focus on transitioning manufacturing for MD’s products, but “pretty quickly,” he says, he will move on to DDH’s product development needs, with an eye toward “creating this opportunity for a new experience, new ergonomics and new functions” to not only crutches but also canes, walkers and other equipment. “We have a number of products in the portfolio that we are going to help launch that will take DME to a new level,” he said. “Drive has built themselves to really capitalize on and make innovation a priority. And not just for innovation’s sake, but to solve a problem for a user in way that that customers can afford.” 

ORLANDO, Fla. – Industry consolidation and low reimbursement have created a large gap in the local DME landscape in Florida, and Gilgal Medical Supplies sees that as a “big opportunity,” says Tom Chacko, vice president and one of the company’s owners. The company launched in 2020 amid the COVID-19 pandemic, opening its first store in St. Cloud in the location of a DME that was closing. Six months later, it opened a second location in Orlando in the location vacated by Colonial Medical Supplies, which was acquired by a larger company. “The Florida population is growing – it’s the third largest state – and there’s a big shortage of retailers,” said Chacko. “(During COVID), everybody was closing, there were shortages of medical supplies and people were scrambling. We thought of starting small with gloves and masks. It was a tough start, then we scrambled to get all the (required) licenses.”  Gilgal, which also has locations in The Villages and Fort Myers, carries medical supplies, compression stockings, braces and scrubs, and DME like wheelchairs, hospital beds and rollators. Retail sales make up about 60% of its overall volume, with 25% of sales to tourists to Orlando. One challenge the company has worked to overcome is the “Amazon effect,” Chacko said. While consumers got used to ordering online when COVID hit, there’s always a need for a brick-and-mortar presence. “With something like braces or compression stockings, you might need the right measurements,” he said. “And we warranty all our products. People are losing money buying wheelchairs and scooters online when there’s no way to repair them. We sell our scooters starting at $1,600. Someone can buy online for $800 but it will break down in six months. Here, they have a local store they can go to fix it.” Another challenge: Medicare Advantage plans and closed networks. While Gilgal contracts with several large plans, including Blue Cross Blue Shield and Cigna, it’s had a harder time contracting with giants like Humana and UnitedHealthcare, says Chacko. “It’s a challenge for small companies like ours,” he said. “They close networks, which is such a disservice to beneficiaries, and the reimbursement is just so low. But there’s not many retail DME stores around so that is where we see a huge opportunity to grow our presence and hopefully change that. We would like to open at least 25 locations in Florida.” 

WASHINGTON - NCART and U.S. Rehab are set to host an in-person legislative day on Sept. 24 to address the economic challenges of being a complex rehab technology provider and to advocate for H.R. 5371, a bill that would improve access to titanium and carbon manual wheelchairs. Given the current political upheaval and the unpredictable environment created by the ongoing presidential race, strategic engagement in Washington, D.C., has become increasingly important, stakeholders say. "Taking care of individuals who need CRT equipment isn’t a Republican or Democrat issue,” said Wayne Grau, executive director of NCART. “We can't control what's happening in politics—that’s way above our pay grade—but we will continue to advocate to ensure we can take care of consumers. That’s the real issue.” The legislative day is returning to an in-person format this year, after being virtual for the past few years due to the pandemic. Among the talking points that participants will emphasize during visits with lawmakers and their staff: economic challenges like uncompensated travel time and high service costs, particularly in rural areas. Being reimbursed fairly is crucial to ensuring that providers can continue serving their clients effectively, stakeholders say. “We need our members to be compensated for the work they do,” said Tyler Mahncke, president of U.S. Rehab. Additionally, participants will highlight the health benefits of lighter, more advanced manual wheelchairs. The “Choices for Increased Mobility Act,” if passed, would help to prevent additional health care costs by reducing the need for shoulder injuries that can result from using heavier wheelchairs, stakeholders say. "If a consumer chooses to pay out of pocket for a particular product, they should have the right to do that,” said Grau. “At one point, CMS allowed it, but then they changed their mind. The simple fact is, this wouldn't cost taxpayers any additional money. All we're asking is to allow consumers to make that choice.” 

WASHINGTON – AAHomecare is leading an effort to quantify the differences in outcomes and overall treatment costs for patients with significant respiratory challenges who receive non-invasive ventilation (NIV) therapy versus those who don’t. The research will help to determine the benefits of this therapy using CMS’s own data, potentially providing authoritative data to underpin advocacy to strengthen patient access to NIV, the association says. “This important effort stems from discussions at last year’s Board Strategic Planning Session on how we can limit delays and denials for patients who can benefit from NIV,” said Tom Ryan, AAHomecare president & CEO “Our leaders believe this is an area where credible data on outcomes and overall costs will make a strong impression on policymakers and payers.” AAHomecare has engaged Dobson Davanzo & Associates to conduct research and analyze results. They will involve respiratory stakeholders, including clinicians and HME industry experts, to further develop cohorts and provide oversight. The association says work will begin next week, and the project is expected to be completed in about 10 months. This research is the latest effort by stakeholders to curb denial rates for NIV. They have also partnered with patient advocacy groups like the ALS Association to ask CMS to clarify policy and coverage.  RRI issues new product catalog ST. LOUIS – Responsive Respiratory has released a new Product Solutions catalog for oxygen. The catalog highlights RRI’s newest entry into the oxygen analyzer market, the O2 Checker, and its commitment to high-pressure oxygen products. “The O2 checker is unique in today’s oxygen market,” said Steve Bannon, president. “The user-intuitive interface allows technicians to transition seamlessly between equipment types and features a simulated breath function to detect and measure output efficiently.” The catalog is a complete respiratory resource guide for the home health care, hospital and EMS markets, and features new value-add items like Boost Oxygen and portable oxygen analyzers, and updated disposables like concentrator humidifier adaptors to help round out RRI’s offerings. The catalog is available by request in both electronic and print format. EnsoData expands access to clinical data MADISON, Wis. – EnsoData has acquired sleep testing diagnostic technology from Resonea, adding acoustic flow and microphone data channels to its platform as a new way to use a mobile application to pre-screen patients for sleep apnea and extend the diagnostic capabilities of home sleep testing. These two new channels use a U.S. Food and Drug Administration-cleared app to record auditory data during sleep, securely transfer that data to the cloud and enable breath-by-breath analysis of respiratory flow and snoring to identify events indicative of sleep apnea or other disorders. “We are very excited to bring both acoustic flow and microphone data to the sleep community to expand the clinical data available for the health systems and providers utilizing PPG-based sleep testing,” said Justin Mortara, EnsoData CEO. “This is another step toward simplifying access to sleep care, helping to get more patients with sleep disorders diagnosed and, ultimately, connected with therapy. As a leader in health care AI solutions, EnsoData’s device agnostic approach using pulse oximeters (PPG) and now smartphones supports our strategy to deploy flexible solutions that can easily scale to address the unmet clinical needs for sleep testing in the U.S. and globally.” EnsoData expects to make the new capabilities commercially available in the U.S. this year. Roche receives CE mark for CGM BASEL, Switzerland – Roche has received the CE Mark for its Accu-Chek SmartGuide continuous glucose monitoring (CGM) solution. This significant milestone paves the way for the solution to be made available to people living with Type 1 and Type 2 diabetes who are over the age of 18 and who are on flexible insulin therapy. “Maintaining optimal blood glucose levels and preventing adverse glycemic episodes remains a complex task for people living with diabetes, often necessitating up to 180 therapy decisions a day,” said Matt Sause, CEO of Roche Diagnostics. “Our novel CGM solution with its predictive algorithms will help address significant unmet needs associated with diabetes management, empowering users to take control of their condition and live better and healthier lives.” The Accu-Chek SmartGuide CGM sends glucose values measured in real time to the Accu-Chek SmartGuide app. The app then uses those values and other available information to detect glucose patterns and predict future glucose levels. Its integrated AI-enabled predictive algorithms indicate hypoglycemia risk within the next 30 minutes, continuously forecast how glucose levels will develop within the next two hours and estimate the risk of nocturnal hypoglycemia. Inspire recalls implantable pulse generator MINNEAPOLIS, Minn. – Inspire Medical Systems is voluntarily recalling its Inspire IV Implantable Pulse Generator (IPG) Model 3028 due to a manufacturing defect that can cause system malfunctions after implantation, leading to electrical leakage in the sensing circuit. As a result, patients may need revision surgery to replace the IPG and restore therapy. There have been no reported injuries or death.

WASHINGTON – AAHomecare is leading an effort to quantify the differences in outcomes and overall treatment costs for patients with significant respiratory challenges who receive non-invasive ventilation (NIV) therapy versus those who don’t. The research will help to determine the benefits of this therapy using CMS’s own data, potentially providing authoritative data to underpin advocacy to strengthen patient access to NIV, the association says. “This important effort stems from discussions at last year’s Board Strategic Planning Session on how we can limit delays and denials for patients who can benefit from NIV,” said Tom Ryan, AAHomecare president & CEO “Our leaders believe this is an area where credible data on outcomes and overall costs will make a strong impression on policymakers and payers.” AAHomecare has engaged Dobson Davanzo & Associates to conduct research and analyze results. They will involve respiratory stakeholders, including clinicians and HME industry experts, to further develop cohorts and provide oversight. The association says work will begin next week, and the project is expected to be completed in about 10 months. This research is the latest effort by stakeholders to curb denial rates for NIV. They have also partnered with patient advocacy groups like the ALS Association to ask CMS to clarify policy and coverage.  

ST. LOUIS – Responsive Respiratory has released a new Product Solutions catalog for oxygen. The catalog highlights RRI’s newest entry into the oxygen analyzer market, the O2 Checker, and its commitment to high-pressure oxygen products. “The O2 checker is unique in today’s oxygen market,” said Steve Bannon, president. “The user-intuitive interface allows technicians to transition seamlessly between equipment types and features a simulated breath function to detect and measure output efficiently.” The catalog is a complete respiratory resource guide for the home health care, hospital and EMS markets, and features new value-add items like Boost Oxygen and portable oxygen analyzers, and updated disposables like concentrator humidifier adapters to help round out RRI’s offerings. The catalog is available by request in both electronic and print format. 

MADISON, Wis. – EnsoData has acquired sleep testing diagnostic technology from Resonea, adding acoustic flow and microphone data channels to its platform as a new way to use a mobile application to pre-screen patients for sleep apnea and extend the diagnostic capabilities of home sleep testing. These two new channels use a U.S. Food and Drug Administration-cleared app to record auditory data during sleep, securely transfer that data to the cloud and enable breath-by-breath analysis of respiratory flow and snoring to identify events indicative of sleep apnea or other disorders. “We are very excited to bring both acoustic flow and microphone data to the sleep community to expand the clinical data available for the health systems and providers utilizing PPG-based sleep testing,” said Justin Mortara, EnsoData CEO. “This is another step toward simplifying access to sleep care, helping to get more patients with sleep disorders diagnosed and, ultimately, connected with therapy. As a leader in health care AI solutions, EnsoData’s device agnostic approach using pulse oximeters (PPG) and now smartphones supports our strategy to deploy flexible solutions that can easily scale to address the unmet clinical needs for sleep testing in the U.S. and globally.” EnsoData expects to make the new capabilities commercially available in the U.S. this year.

BASEL, Switzerland – Roche has received the CE Mark for its Accu-Chek SmartGuide continuous glucose monitoring (CGM) solution. This significant milestone paves the way for the solution to be made available to people living with Type 1 and Type 2 diabetes who are over the age of 18 and who are on flexible insulin therapy. “Maintaining optimal blood glucose levels and preventing adverse glycemic episodes remains a complex task for people living with diabetes, often necessitating up to 180 therapy decisions a day,” said Matt Sause, CEO of Roche Diagnostics. “Our novel CGM solution with its predictive algorithms will help address significant unmet needs associated with diabetes management, empowering users to take control of their condition and live better and healthier lives.” The Accu-Chek SmartGuide CGM sends glucose values measured in real time to the Accu-Chek SmartGuide app. The app then uses those values and other available information to detect glucose patterns and predict future glucose levels. Its integrated AI-enabled predictive algorithms indicate hypoglycemia risk within the next 30 minutes, continuously forecast how glucose levels will develop within the next two hours and estimate the risk of nocturnal hypoglycemia.

MINNEAPOLIS, Minn. – Inspire Medical Systems is voluntarily recalling its Inspire IV Implantable Pulse Generator (IPG) Model 3028 due to a manufacturing defect that can cause system malfunctions after implantation, leading to electrical leakage in the sensing circuit. As a result, patients may need revision surgery to replace the IPG and restore therapy. There have been no reported injuries or death. Health care providers should: Notify affected patients of this voluntary recall. Schedule an appointment for the patient to check if their Inspire therapy is working properly by analyzing signals and resistance. Keep an eye out for any changes in the stimulation, lack of therapy effectiveness, or problems with turning the therapy on. Keep doing regular check-ups and tests to analyze signals and resistance at every visit, as these simple tests can spot issues with the device without needing surgery. Patients should:  Contact your health care provider as soon as possible to make sure you have a routine office visit scheduled. If you have already been contacted by your health care provider, follow-up as scheduled.   Attend your scheduled office visit. Routine non-invasive diagnostic monitoring identifies this potential IPG defect.   If you have new symptoms or re-occurrence of symptoms like fatigue, perceived sleepiness, snoring problems, etc., contact your sleep physician for a comprehensive evaluation, which may include a polysomnography. If your provider determines a revision surgery is necessary to replace the IPG, you may contact Inspire’s Patient and Physician Services at 1-844-OSA-HELP for further information.

AMES, Iowa – Retiring provider Kevin Henning looks back at 22 years of owning and building Choice Medical, including how his background as an electrical engineer prepared him for the ups and downs of the HME industry. HME News: What’s been the biggest challenge faced by providers, especially independents, over the years? Kevin Henning: It’s probably been the insurance companies. They've kept cutting reimbursement, and as an independent, we don't have the buying power, so the profit margin is a lot less. They've squeezed out a lot of the independents. The barrier to entry is just horrific. HME: How has health care evolved over the last 22 years? Henning: Most people don't know anything about DME until they need it, then they find out we're here. So, to me, the biggest evolution has been the education of the customer base. It’s been very hard for them in the sense that insurance keeps changing. Our biggest challenge has always been, somebody calls and they don't know their own insurance, which is fine. You buy a policy, and you just think you're covered, but Medicare didn't give you the full answer. HME: What has been your biggest accomplishment? Henning: Starting up a company and jumping through all the hoops the government puts in front of you to help people is a pretty big one. But I think the bigger accomplishment was overcoming challenges every day. Sometimes people ask, why didn't you use your electrical engineering degree? And I point out that I use it all the time, because there’s no textbook that tells you how to get answers. And that's what engineering has taught me: You have to find answers, figure it out and make things work. 

WASHINGTON – The Federal Trade Commission has published an interim report that underscores the negative impact pharmacy benefit managers have on accessibility and affordability of prescription drugs. The FTC’s report, which is part of an ongoing inquiry launched in 2022, details how increasing vertical integration and concentration has enabled the six largest PBMs to manage nearly 95% of all prescriptions filled in the United States. This market structure has allowed PBMs to profit at the expense of patients and independent pharmacists, according to the report. “The FTC’s interim report lays out how dominant pharmacy benefit managers can hike the cost of drugs—including overcharging patients for cancer drugs,” said FTC Chair Lina M. Khan. “The report also details how PBMs can squeeze independent pharmacies that many Americans—especially those in rural communities—depend on for essential care. The FTC will continue to use all our tools and authorities to scrutinize dominant players across health care markets and ensure that Americans can access affordable health care.”   The FTC launched an inquiry into the prescription drug middleman industry in 2022. The report highlights several key insights gathered from documents and data obtained from the FTC’s orders to Caremark Rx; Express Scripts; OptumRx; Humana Pharmacy Solutions; Prime Therapeutics; MedImpact Healthcare Systems, Zinc Health Services, Ascent Health Services and Emisar Pharma Services, as well as from publicly available information: Concentration and vertical integration: The market for PBMs has become highly concentrated, and the largest PBMs are now also vertically integrated with the nation’s largest health insurers and specialty and retail pharmacies. The top three PBMs processed nearly 80% of the approximately 6.6 billion prescriptions dispensed by U.S. pharmacies in 2023, while the top six PBMs processed more than 90%. Pharmacies affiliated with the three largest PBMs now account for nearly 70% of all specialty drug revenue. Significant power and influence: As a result of this high degree of consolidation and vertical integration, the leading PBMs now exercise significant power over Americans’ ability to access and afford their prescription drugs. The largest PBMs often exercise significant control over what drugs are available and at what price, and which pharmacies patients can use to access their prescribed medications. PBMs oversee these critical decisions about access to and affordability of life-saving medications, without transparency or accountability to the public. Self-preferencing: Vertically integrated PBMs appear to have the ability and incentive to prefer their own affiliated businesses, creating conflicts of interest that can disadvantage unaffiliated pharmacies and increase prescription drug costs. PBMs may be steering patients to their affiliated pharmacies and away from smaller, independent pharmacies. These practices have allowed pharmacies affiliated with the three largest PBMs to retain high levels of dispensing revenue in excess of their estimated drug acquisition costs, including nearly $1.6 billion in excess revenue on just two cancer drugs in under three years. Unfair contract terms: Evidence suggests that increased concentration gives the leading PBMs leverage to enter contractual relationships that disadvantage smaller, unaffiliated pharmacies. The rates in PBM contracts with independent pharmacies often do not clearly reflect the ultimate total payment amounts, making it difficult or impossible for pharmacists to ascertain how much they will be compensated. Efforts to limit access to low-cost competitors: PBMs and brand drug manufacturers negotiate prescription drug rebates some of which are expressly conditioned on limiting access to potentially lower-cost generic and biosimilar competitors. Evidence suggests that PBMs and brand pharmaceutical manufacturers sometimes enter agreements to exclude lower-cost competitor drugs from the PBM’s formulary in exchange for increased rebates from manufacturers. The report notes that several of the PBMs that were issued orders have not been forthcoming and timely in their responses, and they still have not completed their required submissions, which has hindered the FTC’s ability to perform its statutory mission. The commission's staff have demanded that the companies finalize their productions required by the 6(b) orders promptly. If, however, any of the companies fail to fully comply with the 6(b) orders or engage in further delay tactics, the FTC can take them to district court to compel compliance. The Commission voted 4-1 to allow staff to issue the interim report, with Commissioner Melissa Holyoak voting no. Chair Lina M. Khan issued a statement joined by Commissioners Rebecca Kelly Slaughter and Alvaro Bedoya. Commissioners Andrew N. Ferguson and Melissa Holyoak each issued separate statements.   AAH seeks data on impact of reimbursement cut WASHINGTON – AAHomecare has launched a nationwide survey on the impact of the expired 75/25 blended Medicare reimbursement rates in non-bid/non-rural areas on the HME industry and patient access to home medical equipment. The association encourages all providers serving patients in these areas to take the survey by July 19. “AAHomecare and other HME stakeholders continue to push for legislation to restore the 75/25 blended rates suppliers in non-bid, non-rural areas, and we want to strengthen our advocacy with state-specific data,” said Tom Ryan, the association’s president & CEO. “Your responses will help us share a clearer picture on how the Jan. 1 cuts are challenging HME suppliers and threatening access to care.” The 75/25 blended reimbursement rates expired on Jan. 1, 2024. AAHomecare says state-specific data on the impact of the expired reimbursement, which has been requested by Capitol Hill, will bolster efforts to include relief as part of a health care or omnibus legislative package later this year. The association says it will only share data in aggregate as state and national figures. It will keep company specific or identifiable information strictly confidential. What’s in play: The DMEPOS Relief Act of 2023(H.R. 5555 and S. 1294) 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.    Encore publishes data on impact of Nexus on COPD patients LIVINGSTON, Tenn. – Home-based COPD management programs led by respiratory therapists using AI-driven software with plan of care goals can have a significant impact on admissions, quality of care metrics and overall cost of care, according to an abstract developed by Encore Healthcare and published by the American Thoracic Society.  HME providers using Encore’s Nexus software for patients using non-invasive ventilation produced the following results: Enrollees who reported at least one hospitalization in the 12-month prior to enrollment experienced 65% fewer admissions post-enrollment It total, patients experienced 34,029 fewer hospitalizations while enrolled in the program vs. the prior year Using a standard DRG-related reimbursement of $7,500 for a COPD-related hospital stay, the program has resulted in an estimated total U.S. health care cost savings of more than $225 million The results are based on 17,394 home-based COPD patients managed from January 2018 to October 2023. In another abstract, HME providers using Encore’s Nexus software for patients using home oxygen therapy produced the following results: Calculated as a per patient per month rate, enrolled patients experienced 94% fewer admissions vs. their 12-month prior history In total, patients experienced 1,156 fewer hospitalizations while enrolled in the program vs. the prior year Using a standard DRG-related reimbursement of $7,500 for a COPD-related hospital stay, the program has resulted in an estimated total U.S. Health care cost savings of more than $8.6 million These results are based on 30,950 COPD and chronic lung supplemental oxygen patients managed from May 2021 to October 2023. NCPA launches nat’l ad ALEXANDRIA, Va. – The National Community Pharmacists Association has released a new TV ad as part of its ongoing campaign to push lawmakers to enact pharmacy benefit manager reform. The ad, titled PBM Career Day, shows a PBM executive struggling to explain his job to curious children. The executive shares that he doesn’t make, prescribe or provide drugs, but he does decide what drugs patients receive and what he pays for them. "PBMs and the massive health insurance companies that they’re affiliated with extract billions in profits from patients and pharmacies worsening pharmacy deserts for consumers and snuffing out small businesses,” said NCPA CEO B. Douglas Hoey, pharmacist, MBA. “Our campaign is designed to shed light on these practices, mobilize the public to demand change, and push policymakers to finish the fight for PBM payment reforms. It is time for transparency and accountability in the health care system." The ad will run nationally on CNN. Researchers develop new CPAP design CINCINNATI – Researchers at the University of Cincinnati are developing a PAP machine that uses vortex airflow technology, a mechanism commonly used in aerospace engineering applications, to eliminate the need for a tight seal. As a result, the VortexPAP is able to use a mask that is designed to barely touch the patient’s face, increasing comfort, researchers say. “Despite the clinical efficacy for CPAP in controlling OSA, patient compliance with the therapy remains a major cause of treatment failure,” said Liran Oren, PhD, research associate professor in the Department of Otolaryngology, Head and Neck Survey, at the UC College of Medicine. “The vast majority of complaints from patients in CPAP therapy revolve around improving the comfort of the mask. However, regardless of design, they all require a tight seal over the face, so that the airway can be pressurized. This design requirement for a tight seal is the main limitation for making CPAP therapy more comfortable.” The project is a collaboration between Oren; Roy Kulick, MD, UC entrepreneur-in-residence; Ephraim Gutmark, PhD, distinguished professor, Ohio Eminent Scholar in the UC Department of Aerospace Engineering; and Ann Romaker, MD, director of the UC Sleep Medicine Center and professor in the UC Department of Internal Medicine. The group's goal is to eventually commercialize the VortexPAP in the U.S., with strong support from the UC Venture Lab.  Inogen names Kevin Smith general counsel, EVP GOLETA, Calif. - Inogen has appointed Kevin P. Smith as general counsel and executive vice president of business development, effective July 22. He joins Inogen from Sirtex Medical, where he served as general counsel and executive vice president, business development, since 2018. “Kevin will be an invaluable addition to our leadership team at Inogen,” said Kevin Smith, president and CEO. “His extensive experience in the medical device and securities field will play an important role in strengthening our legal team and ensuring Inogen remains an organization based on integrity and compliance.” Prior to joining Sirtex, Smith served as vice president and associate general counsel at Flexion Therapeutics, focusing on securities requirements, business development and intellectual property. Previously, he was general counsel for the Danaher Life Sciences Platform. He has also held senior legal leadership positions within Novartis Pharmaceuticals. Before moving in-house, Smith worked for multinational law firms in New York, Silicon Valley and London. Strive Medical expands into CGM through acquisition IRVING, Texas – Strive Medical, a portfolio company of NMS Capital, has acquired ProMed DME, a Stuart, Fla.-based provider specializing in diabetes, urology and wound care supplies. The deal allows Strive Medical, a provider of direct-to-patient urological, wound care and other disposable medical supplies, to expand into the CGM market. “This transaction is a crucial milestone in Strive Medical’s dedication to investing in growth markets and delivering our unique offerings to patients in rapidly expanding disease areas,” said Todd Philbrick, CEO of Strive. “We are excited to collaborate with the ProMed team, known for their patient-first approach, and to enhance our commercial reach. This next chapter for Strive broadens our presence in the health care ecosystem. Strive Medical plans to operate ProMed DME as a Diabetes Center of Excellence, continuing to support the patients who rely on us.” NMS is a private equity firm managing assets of more than $1.5 billion. “The combined scale and reach will further solidify Strive’s position as a leading independent, specialty distributor of medical supplies, which now includes CGM products,” said Luis Gonzalez, senior partner at NMS. sovaSage promotes Caputo PITTSBURGH – sovaSage, a company specializing in AI-based software and services for the management of obstructive sleep apnea, has promoted Jamie Caputo to vice president of sales. Caputo has played a key role in driving the roll out of two products: an AI-based software platform designed to select and fit the best CPAP mask for patients; and TherapistAssist Jeanie, a virtual sleep coach and compliance management platform that’s augmented with live support sleep coaches and respiratory therapists. “Jamie’s extensive experience in PAP compliance management and resupply, his over 25 years in HME and his well-established relationships from previously leading the Philips PAMS and medSage programs have proven invaluable,” said William Kaigler, co-founder and CEO. “I am excited to have Jamie take on this new leadership role and help our customers continue to improve the lives of their patients.” In his new role, Caputo will be responsible for overseeing all sales activities across all products and markets. Previously, he served as the company’s vice president of strategic business development.  

Q. How can automation reduce administrative burdens and enable business growth? A. In the DME industry, necessary administrative tasks consume valuable time and resources. Automation is emerging as a powerful strategy to improve patient care and drive business growth. Routine tasks like billing, patient follow-up, and compliance checks strain the operational capacity of DME suppliers and their medical record review teams. Manual handling of these tasks often leads to costly errors and inefficiencies, creating a need for streamlined technologies. Automated billing ensures accurate invoicing and standardizes processes. According to the Journal of the American Medical Association, administrative complexities, including billing, contribute significantly to the $266 billion wasted annually in health care. Streamlined reminders for equipment delivery and resupply enhance patient adherence to treatment plans, improve outcomes and reduce the workload on suppliers and providers. This makes health care services more efficient and effective. Navigating intricate payer rule sets is another significant burden for DME suppliers. Missteps can lead to extensive audits and damage reputations. Annually, 20% of DME claims face rejection, with 80% of these due to missing or incorrect information. AI-driven compliance solutions monitor payer changes in real time, ensuring documentation meets current standards. Automated compliance software analyzes medical records and coverage criteria, speeding up eligibility checks and claims preparation, boosting back-office efficiency, and reducing errors. Integrating these systems transforms operations, allowing staff to focus more on patient care, enhancing service delivery, and solidifying market positions. Embracing new technologies not only reduces administrative burdens but also paves the way for success in a complex health care market. Adopting these solutions can help reclaim the $266 billion lost annually to administrative inefficiencies. Adam Nadler is co-founder and advisor of CompliantRx. Reach him at adam@compliantrx.ai or 954.540.5425.