In brief: Philips provides update, Tomorrow Health raises funds, Sen. Thune meets members

AMSTERDAM – A comprehensive testing and research program on the PE-PUR foam in certain CPAP, BiPAP and mechanical ventilator devices has shown very low prevalence of visible degradation, Philips announced in an update on June 28. 

In first-generation DreamStation devices, which represent 68% of registered affected devices globally, testing found:  

• 164 of 36,341 (0.5%) devices with self-reported no ozone use showed significant visible foam degradation. 
• 777 of 11,309 (7%) devices with self-reported ozone use showed significant visible foam degradation. 
• 422 devices of the inspected 60,847 returned/used devices are linked to a reported foam degradation complaint; however, only 18 out of these 422 devices (4%) actually showed visible foam degradation. 

“While certain prolonged tests across the affected product categories are still to be completed, the results to date for the first-generation DreamStation devices, which represent the majority of the registered affected devices, show a very low prevalence of visible foam degradation,” said Frans van Houten, CEO of Royal Philips. “In addition, the new and used first-generation DreamStation devices passed volatile organic compound and respirable particulate emission testing. This is very encouraging. Results to date also indicate that ozone cleaning significantly exacerbates foam degradation.” 

Five certified, independent testing laboratories in the U.S. and Europe conducted testing in accordance with ISO 18562 and ISO 10993 standards. 

The labs also conducted testing on volatile organic compounds (VOCs) and particulate matter (PM) and found: 

• VOC emissions are below established limits based on ISO 18562-3 testing and evaluation of new, lab-aged and used devices. Exposure to the level of VOCs identified to date for the first-generation DreamStation devices is not anticipated to result in long-term health consequences for patients. 
• New devices and used devices (including used devices with visible foam degradation) were tested and were all found to be compliant with ISO 18562-2 allowable limits for PM emissions.  
• Tested PM emissions of used devices with degradation were not statistically different than PM emissions without degradation, suggesting that degradation did not contribute to appreciable elevated levels of respirable particles in the devices tested.  

Philips has also engaged independent testing laboratories to perform additional VOC testing on silicone-based foam. Based on draft reports, no safety issues have been identified. The company expects the assessment to be completed and the final reports subjected to FDA review in the coming months. 

Philips also expects to complete the remaining VOC and PM testing for these devices, as well as the degraded foam toxicological risk assessments (in accordance with ISO 10993), in the coming months.  

The company noted the overall guidance for health care providers and patients in the recall notification/field safety notice remains unchanged at this time. 

Tomorrow Health secures $60M investment 

NEW YORK – Tomorrow Health has closed a $60 million Series B round of funding to expand partnerships and its footprint. 

The company’s total funding to date is now $92.5 million, with this most recent round led by BOND, with participation from Andreessen Horowitz, Obvious Ventures, BoxGroup, and Sound Ventures.  

“For patients navigating the transition home from surgery or managing a chronic condition, lack of access to critical medical equipment, supplies and services can lead to catastrophic outcomes for their care,” said Vijay Kedar, co-founder and CEO of Tomorrow Health. “At Tomorrow Health, we endeavor to restore the home as the patient's primary place of care by seamlessly coordinating the resources they need to heal at home.” 

Tomorrow Health offers a technology and analytics platform to help providers operate their businesses efficiently, deliver high quality care and succeed in a changing reimbursement and policy landscape. The platform covers millions of Americans through partnerships with insurers and home-based care suppliers, leveraging a national footprint that encompasses tens of thousands of providers and hospital systems. 

The company is accelerating to 317% annual recurring revenue (ARR) growth year-over-year from 2021 to 2022, as one in four Americans seek care at home. 

“Home-based health care represents a $195 billion market opportunity,” said BOND General Partner Noah Knauf. “Labor shortages, demographic shifts and evolving patient preferences are helping fuel demand for high-quality home-based care,” . “Tomorrow Health has the team, technology, and deep industry expertise to make quality care at home – and at scale – a reality. Countless patients are already experiencing the value that Tomorrow Health has brought to market.” 

Thune discusses challenges with HME providers 

SIOUX FALLS, S.D. – Sen. John Thune, R-S.D., met with MAMES members in Sioux Falls, S.D., on June 29 to discuss the critical issues facing the HME industry. 

Members, as well as executives from AAHomecare and The VGM Group, discussed critical staffing shortages, cost increases and surcharges, flawed reimbursement rates and burdensome documentation requirements. 

“Sen. Thune spent an hour listening to MAMES members explain how they were an integral part of the health care continuum during the pandemic, playing a critical role in getting patients out of hospitals and long-term care facilities and allowing patients to cover in their homes,” said Rose Schafhauser, executive director of MAMES. “Members also shared the immense challenges they are operating under as health care providers.” 

Members also thanked Thune for his leadership on past legislation, including the CARES Act, which includes a 75/25 blended reimbursement rate for non-bid, non-rural areas. 

Members asked Thune for his help in extending the relief beyond the current public health emergency and getting answers from CMS about the future of its competitive bidding program.  

“MAMES looks forward to working with Sen. Thune as we continue to work to protect our industry, our members and the clients and patients they serve every day,” Schafhauser said. 

ResMed names new sleep lead 

SAN DIEGO – ResMed has promoted Lucile Blaise to president of its global Sleep & Respiratory Care business effective July 1. She is currently the company’s vice president of Sleep & Respiratory Care for Western Europe. “I’m thrilled that Lucile – one of Europe’s leading champions of digital health innovation and adoption, as well as data privacy and security – has accepted this promotion to lead ResMed’s global Sleep & Respiratory Care business,” said ResMed CEO Mick Farrell. “Throughout her 16 years at ResMed and over 25 years in the medtech industry, Lucile has been a key player in improving chronic disease treatment for millions of people with sleep apnea and respiratory insufficiency, as well as supporting physicians, providers, and healthcare systems across Europe, and beyond, through evidence-based decision making. Lucile is committed to collaboration across the company, and the industry, and always places the needs of the patient first. She exemplifies the deep bench of innovative, accomplished leaders across ResMed, bringing in-depth market knowledge, customer insight, and commercial skills to our CEO operations leadership team, as together we continue to transform our business and the market through digital health.” Blaise has led her team’s efforts with industry and public partners to establish payer market access and reimbursement for digital health telemonitoring in France and Belgium. She has served six years on the board of Snitem, a medtech association in France, and was elected its president in June. She has also served on the board of MedTech Europe since 2020. 

Breas Medical, McArthur Medical Sales bring Vivo line to Canada 

NORTH BILLERICA, Mass., and ROCKTON, Ontario – Breas Medical USA and McArthur Medical Sales have partnered to bring Breas Medical’s Vivo 1-2-3 family ofbBi-level devices and the full line of Breas Vivo accessories to the Canadian market. “Breas is thrilled to partner with McArthur Medical Sales to bring Vivo technology to the Canadian marketplace,” said Chris Southerland, general manager, Breas Americas. “We could not imagine working with a stronger, trusted and successful partner to support Canadian clinicians and patients with Breas Vivo technology.” The Vivo 1-2-3 family includes bi-level ventilators designed for comfortable respiratory support across the continuum of care, both non-invasive and invasive (Vivo 3 only), for non-dependent patients with chronic breathing insufficiency. Features include a built-in humidifier with heated wire circuit, a comprehensive set of modes with Auto-EPAP and High Flow Nasal Cannula therapy support plus SpO2 monitoring. “The Vivo product family is going to allow for significant clinical advancement in bi-level therapy,” said Frank Fiorenza, product development and national sales manager, McArthur Medical Sales. “Our highly skilled team of clinicians are looking forward to introducing Vivo to the Canadian healthcare system.” 

Drone delivery takes flight at Cardinal Health 

KANNAPOLIS, N.C. – Cardinal Health, along with Magellan Rx Management and Novant Health, has launched long-range drone deliveries in North Carolina. Using Zipline, a logistics company, organizations and their customers can receive deliveries in as little as 15 minutes. “At Cardinal Health, we’re committed to working diligently to help ensure our health care provider customers have access to the right medication at the right time for their patients, and an effective distribution strategy is required to make this happen,” said Josh Dolan, senior vice president, pharmaceutical operations at Cardinal Health. “Through our work with Zipline, we are able to expand our world class distribution services with innovative delivery methods that will help our customers meet their patients' evolving needs – now and in the future.” The North Carolina Zipline distribution center is capable of serving customers within a 7,800-square-mile area. Cardinal Health, a distributor of pharmaceuticals, medical and laboratory products, is delivering certain pharmaceutical products and medical supplies to Cannon Pharmacy Main to help mitigate risk of inventory stock-outs and reduce barriers for patients accessing the necessary products to fit their needs.  

NCART, U.S. Rehab survey CRT companies 

EAST AMHERST, N.Y. – NCART and U.S. Rehab have teamed up on a 2022 CRT Provider Benchmarking Survey. The collected information will help CRT providers better manage their businesses and will be used in NCART's industry advocacy efforts. This 18-question survey encompasses multiple aspects of operations and will supply critical data on the changes that have occurred over the last two years. All provider-specific information will remain strictly confidential and will not be shared. Participating providers will receive a copy of the compiled survey results and a free gift. Take the survey here. 

Withings appoints former PayPal exec as chief marketing officer 

ISSY-LES-MOULINEAUX, France – Withings, a connected health company, has named Elizabeth Coleon as chief marketing officer to help further its international growth. "After working for inspiring service management companies, I am thrilled to join Withings,” said Coleon. “The healthcare industry is accelerating and being radically transformed by data from connected devices. By developing an ecosystem of services at the center of our users' needs, we are accelerating our mission to create the ultimate home health experience that helps prevent certain diseases.” Prior to joining Withings, Coleon held positions as marketing director and chief revenue officer at Qonto, a French online payment company and as director of commercial growth at PayPal for five years, where she supported and developed customer focus, marketing strategies and helped grow the overall fintech business. Withings offers connected devices, including smart scales, blood pressure monitors, smartwatches and sleep trackers every day to monitor their health and fitness vitals. 

Permobil Foundation gifts power wheelchair to White Sox fan 

NASHVILLE, Tenn. – The Permobil Foundation partnered with the Chicago White Sox, LiveLikeLou and Phi Delta Theta to surprise Michelle Gutierrez with her own team-branded, custom Permobil power wheelchair at a June 26 home game. “We understand that Michelle received her ALS diagnosis just last year after already surviving Stage 3 ovarian cancer,” says Kathy Edson, associate executive director of the Foundation. “Her courage and positivity have been inspiring to those around her and we are so pleased to surprise this lifelong fan with a new Permobil M3 Corpus wheelchair with the custom White Sox colors and logo.” The donation was part of “Lou Gehrig Day” celebrations, during which Major League Baseball honors the late Lou Gehrig, the legendary Yankees player whose career was cut short by ALS. The Permobil Foundation is dedicated to enhancing the quality of life by empowering strength and independence through support and services, so individuals can live a life without limitations. Permobil also fast tracks every ALS chair order through production to ensure each ALS patient gets their custom Permobil wheelchair without any delay. 

ResMed returns to Medtrade East 

SAN DIEGO – ResMed will exhibit at Medtrade East in Atlanta, Oct. 24-26 at the Georgia World Congress Center. “Anytime we get a chance to spend time with our HME partners at an important industry event, it is a valuable opportunity for us,” says Bill Shoop, vice president, North America Sales, ResMed. “With the challenges our industry is facing right now, it's more important than ever to understand how we can best serve our HME partners and collaborate on innovative ways to help ensure patients get the therapy they need.” At Medtrade East, ResMed will feature its broad portfolio of digital health technologies, masks and devices. This is the last year for Medtrade East. Beginning in 2023, there will be one combined event in Dallas on March 28-30. Register for Medtrade East. 

SleepRes surveys attendees on V̇-Com 

NASHVILLE, Tenn. – Ninety two percent of attendees at the recent Association of Professional Sleep Societies (APSS) meeting believe the newly introduced V̇-Com will improve CPAP adherence with new patients and 96% believe it will help with patients struggling with therapy, according to a survey conducted by SleepRes. Additionally, 84% of sleep medicine physicians and mid-levels who responded to the survey believe V̇-Com will decrease phone calls to their offices, as well as to medical equipment company offices. “When you combine decreased phone calls, complaints, pressure changes and mask exchanges with V̇-Com’s increased adherence, no wonder sleep doctors want everyone to have one,” said Kami Harold, vice president of sales for SleepRes. The total response rate for the survey was 16% (52/320). Of the attendees who tried V̇-Com, 76% were sleep medicine physicians, 12% were mid-levels and 12% were polysomnography technicians. V̇-Com is an accessory added between the CPAP mask and hose that is specifically engineered to reduce inspiratory pressure and flow to provide comfort with minimal to no reduction in expiratory pressure (EPAP). After weeks or months, when the patient can easily tolerate the peak flow and inspiratory pressure of PAP therapy, it can be removed.  

RESNA, NMEDA to host mini-events 

ARLINGTON, Va. – RESNA and NMEDA will host in-person mini-events in several cities in July as part of the RESNA Virtual Conference. The events will take place in cities like Dallas, Houston, Phoenix, Seattle and Orlando, allowing attendees to enjoy an evening with AT friends and to connect with local adaptive driving specialists. Registration for the events, which are free, closes July 11. The RESNA Virtual Conference takes place July 13-15. 

Head of BOC announces retirement 

OWINGS MILLS, Md. – The Board of Certification/Accreditation’s President and CEO Claudia Zacharias, MBA, CAE, has announced her plans to retire at the end of 2022. “It is an honor to conclude my professional career as BOC’s CEO,” she said. “I’m electing to retire in December, which aligns with my personal retirement goal timeline and enables a deliberate, thoughtful and disciplined transition for BOC. I am confident of the organization’s continued success as I embark on my next life chapter.” During Zacharias’ tenure, BOC’s facility accreditations increased by an average of 30% each year and BOC’s certification program successfully transitioned from a cost center to a profit center. She also spearheaded new service additions, including the Certified Durable Medical Equipment Specialist certification, which now recognizes professionals working in 40 states and Bermuda. “I’ve worked with Claudia during the majority of her time at BOC, and her passion and dedication to the organization is remarkable,” said BOC Board Chair Wayne Rosen, BOCP, BOCO, LPO, CDME, FAAOP. “She is leaving a legacy of financial stability and disciplined investments, and a capable team to facilitate a seamless transition process and to continue our growth trajectory for years to come.” BOC plans to announce Zacharias’ successor later this year. 

Owens & Minor strengthens medical supply logistics 

RICHMOND, Va. – Owens & Minor, in partnership with West Virginia University Health System, has broken ground on the future site of a center of excellence for medical supplies and logistics in Morgantown, W.Va. Once construction is completed in late 2023, the 350,000-square-foot center will be one of the state’s largest dedicated acute care medical distribution facilities and will include clinical supply capabilities for surgical knitting, customer procedure tray assembly and sterilization. “We are excited for our partnership with Owens & Minor to take shape as we work to strengthen the resiliency of our health care system,” said Albert L. Wright, Jr., president and CEO of WVU Health System. “Our collaboration with Owens & Minor is instrumental in ensuring that we can deliver our commitment for our clinicians and the communities we serve.” The partnership, which represents an estimated $50 million investment in West Virginia and is anticipated to bring more than 100 jobs to the state, was first announced in December 2021. It was expanded to give the state of West Virginia the ability to rapidly leverage Owens & Minor’s logistics expertise and medical supply and distribution capabilities in response to future public health emergencies in January 2022. 

Health system opens home medical shop 

MASON CITY, Iowa – MercyOne Albert Lea Home Medical Shop has opened at the southeast entrance to the mall in Albert Lea. At the shop, customers will find medical equipment to make life at home easier, including bathroom aids, walkers, breast pumps and more. For CPAP, BiPAP, oxygen and ventilator needs, there are respiratory therapists on staff. “We look forward to continuing our commitment to the area by adding our home medical shop to the list of services MercyOne has to offer,” said Connie Morrison, director, MercyOne Durable Medical Equipment. “When you come into the shop, we’re available to help you on the spot. We are here to be sure when you leave, you’ve got the right equipment to make your home life easier.” The home medical shop hosted an open house on June 14. MercyOne is the largest health care system in Iowa spanning 15 counties across the northern part of the state and southern Minnesota. It has more than 230 locations, 18 owned or joint venture medical centers and 23 affiliated hospitals. 

Medicap Pharmacy relocates, expands DME 

EAST NEWTON, Iowa – Medicap Pharmacy of Newton celebrated the grand opening of its new space on June 28, according to the Newton Daily News. The independent pharmacy relocated in November to the former Medicine Shoppe Pharmacy. Pharmacy Manager Chris Forck, RPh, told the newspaper that the company offers free local delivery, immunizations, compliance solutions, mom-and-baby care, and an expanded line of DME at the new location. “We’ve put together a great team and we love our newly renovated space,” he said. “We can’t wait to show all the improvements.” The Medicap Pharmacy franchise began in 1971 with its first store in Des Moines, Iowa, then called Medicine Chest. It now owns 22 pharmacies in central Iowa. 

TwelveStone expands in Nashville area 

MURFREESBORO, Tenn. – TwelveStone Health Partners recently opened a new infusion center to serve Spring Hill, Tenn., and the community south of Davidson County. “We are so pleased to offer patients in Spring Hill and surrounding communities the option to have an infusion done in a comfortable and convenient location for complex medication regimes that can’t be administered at home,” says Shane Reeves, CEO. “Nashville has grown significantly in the past few years and getting into the city can be a challenge for those living with a chronic medical condition.” The outpatient infusion suites allow TwelveStone to administer a broader array of medications with medical oversight, the company says. The first infusion therapy dose of any medication is required to be managed in an outpatient setting so the procedure can be closely monitored by medical professionals, it says. Brook Daniels, a nurse practitioner, is the team lead at the center. The company also has a growing network that includes locations in Chattanooga, Knoxville, Mount Juliet and Murfreesboro, Tenn., as well as Canton, Ga., and Roanoke, Va. TwelveStone has its roots in a retail pharmacy called Sain Drug Store and a specialty pharmacy called EntrustRx, both of which were sold to Fred’s, Inc. In 2016, Shane Reeves launched TwelveStone Health Partners. 

Doc faces charges related to DME scheme 

CHARLOTTE, N.C. – A Charlotte doctor is facing federal charges for her role in a DME scheme that defrauded federal benefits programs of more than $11 million, according to the Department of Justice, U.S. Attorney’s Office, Western District of North Carolina. Sudipta Mazumder, 46, is charged with one count of health care fraud and six counts of making false statements relating to health care matters. According to allegations contained in the indictment, during 2019 and 2020, Mazumder was a doctor in Charlotte who worked as an independent contractor for a Delaware-based telemedicine company. During that time frame, Mazumder allegedly signed fraudulent orders for medically unnecessary durable medical equipment, specifically knee braces, resulting in the submission of thousands of fraudulent reimbursement claims to Medicare and TRICARE totaling approximately $11,436,873. The indictment alleges that Mazumder falsely stated in those orders that she performed medical examinations of Medicare and TRICARE beneficiaries and falsely certified that the braces were medically necessary. According to allegations, Mazumder never examined the beneficiaries. Instead, Mazumder allegedly had little or no interaction with the beneficiaries and made no medical determination whether the devices were medically necessary or the beneficiaries needed the DME. Mazumder allegedly received from the telemedicine company unsigned orders for orthopedic braces for the beneficiaries, which she signed and returned to the telemedicine company in exchange for $20 for each purported assessment that she performed. The health care fraud charge carries a maximum prison term of 10 years and a $250,000 fine. The charge of making false statements relating to health care matters carries a maximum penalty of five years in prison and a $250,000 fine, per count.