In brief: FDA and Philips, Advent and Life Tech, Humana and Kindred at Home

WASHINGTON – The U.S. Food and Drug Administration says efforts by Philips Respironics to notify patients and others of its recall of certain ventilators and CPAP and BiPAP devices and the risk of harm from the polyester-based polyurethan (PU-PUR) sound abatement foam used in those products have been “inadequate.” 

The FDA on March 10 issued a notification order to Philips Respironics requiring the company to notify all device users, DME suppliers, distributors, retailers, and health care providers who prescribe the products about the recall and the health risks posed by the foam used in the products. 

“The FDA has heard the frustration expressed by patients and DME suppliers who are unaware of the recall and have received insufficient information on their next steps regarding the recall process,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Taking this action enables the FDA to mandate that Philips Respironics improve its communication about the recall and the serious risk posed by the foam used in the recalled products with patients and the public and to ensure that individuals who rely on these essential devices are receiving the important information they need from the company.” 

The order also directs Philips to maintain language to patients regarding the risk of using ozone cleaners on the recalled devices on their main webpage for the recall, and to provide instructions for device users to register their devices on the Philips website.  

Additionally, the FDA recommends that Philips provide monthly updates to device users who register their devices on the Philips website that include information on expected time for replacement and current rate of replacement of recalled devices, and provide detailed information to device users, DME suppliers, distributors, retailers, and health care providers on the replacement process.  

The same day the FDA issued the notification order, Philips provided an update on the recall, saying it has reached the vast majority of the installed base in the U.S. through two rounds of customer and patient outreach. It says about 2.6 million devices have been registered. 

“Based on feedback from the FDA, Philips Respironics will be working with its DME customers to allow the company to directly contact those patients and other end-users that may not yet have received notice of the recall,” the company stated. 

Philips also says it continues to use its mobile application DreamMapper to send notifications to patients and consumers about the recall. The notifications direct them to the recall website for information on the process of registering and maintaining such registration for a replacement device. 

To date, Philips says it has shipped more than 650,000 replacement devices to customers in the U.S. and in the fourth quarter of this year it plans to complete the repair and replacement program. 

Advent Home Medical acquires Life Tech

PONTIAC, Mich. – Advent Home Medical has acquired Life Tech, doubling its size and creating the largest provider of home-based invasive ventilation in the country, the company says. 

Founded in 2001, the Elmhurst, Ill.-based Life Tech specializes in providing respiratory therapy services and durable medical equipment and supplies to highly acute pediatric patients in the home, serving patients through four facilities in Illinois, Missouri, Wisconsin, and Indiana. 

“This partnership with Life Tech is truly transformational,” said Rob Hensley, CEO of Advent. “Life Tech and Advent share the mission of getting complex patients’ home and the similarities in culture, beliefs and service offerings are astounding. We’re elated that our combined companies will be able to serve a greater number of patients and their families.” 

Life Tech, a previous HME Excellence Winner, has a robust referral network of leading hospitals and health care systems, consisting primarily of large pediatric hospitals and employs an industry-leading team of respiratory therapists to support its patient population 

Brian Dacy, CEO of Life Tech, will remain actively involved in Life Tech and will serve as president and chief strategy officer for the combined organization. 

“We could not be happier to be joining the Advent family,” he said. “This partnership will help us spread our mission of providing exceptional care to even more patients and their families nationwide.” 

Founded by a respiratory therapist in 2004, Advent is a Joint Commission-accredited, high-tech medical equipment provider. It received a majority equity investment from New Harbor Capital in March 2021. 

Humana rebrands home health division 

LOUISVILLE, Ky. – Humana has started to transition Kindred at Home’s home health division to the CenterWell Home Health Brand in Washington, Oregon, Idaho, Nevada, Arizona, New Mexico and North Carolina. 

The insurer launched the CenterWell brand a year ago to represent its payer-agnostic health care service offerings. 

“While the CenterWell Home Health brand is new, our commitment to high-quality, compassionate care is stronger than ever,” said Andy Agwunobi, M.D., MBA, president of Humana’s home business. “Patients will continue receiving the personalized in-home care from the clinicians they’ve come to know and trust. CenterWell Home Health helps reinforce all we’re doing to expand our home health capabilities to better manage the comprehensive care needs of our patients.” 

Last August, Humana announced that it had completed the acquisition of Kindred at Home (KAH) to reinforce its commitment to invest in home-based clinical solutions that can improve patient outcomes, increase satisfaction for patients and providers, and create value for health plan partners. It also acquired onehome last year. 

The rebranded locations will now display new interior and exterior signage reflecting the CenterWell Home Health brand, and employees in these locations will receive new uniforms, apparel and other branded materials. When the rebranding is finished, CenterWell Home Health will support patients from more than 350 locations across 38 states. 

“Bringing the CenterWell Home Health brand to life in my branch has created a lot of positive energy and excitement,” said Dori Shane, executive director in Everett, Wash. “Many of our clinicians and patients connect deeply with the brand’s mission and goals, and feel that this refresh is a more accurate reflection of the quality, personalized care we’ve always delivered. The rebrand to CenterWell Home Health also creates a lot of optimism in our future because we are becoming part of a growing, national brand that’s focused on providing better experiences not only to patients and their families, but to frontline clinicians too.” 

 Team Gleason, Permobil Foundation partner for ALS 

NEW ORLEANS – Team Gleason has partnered with the Permobil Foundation for the fifth year in a row to provide seat elevators to individuals living with ALS.  

The partnership includes donated seat elevators on new chair orders for 700 people living with ALS.   

“Our goal is to ensure that every person has the right to mobility, and through impactful partnerships with nonprofits, such as Team Gleason, and assisting individuals who are denied by insurance, we can better fulfill a life of independence for our customers needing assistance with complex rehab technologies,” said Ashley Davis, executive director of the Permobil Foundation. “Additionally, for ALS, we take this a step further by fast tracking orders through production to ensure each ALS patient gets the chair they need in a timely manner.” 

In addition to providing seat elevators, the Permobil Foundation will also sponsor a Team Gleason Adventure, a program that empowers individuals living with ALS and creates life-changing memories for their families. 

Seat elevation provides a level of normalcy for individuals living with ALS, said Blair Casey, executive director of Team Gleason. 

"Our continued partnership with the Permobil Foundation allows for more people with ALS to have the ability to interact with their environment and decrease caregiver burden," he said. “This generous gift from the Permobil Foundation allows us to make a much greater impact." 

Aeroflow inks national payer deal 

ASHEVILLE, N.C. - Aeroflow Healthcare has signed a national contract with Friday Health Plan, a health insurance company catering to individuals and small businesses purchasing their own health plans. Through this partnership, Aeroflow will provide Friday Health Plan patients with its full suite of DME, including breast pumps, maternity compression, incontinence supplies, catheters, continuous glucose monitors and CPAP supplies. "We are excited to partner with Friday Health Plans, which is transforming the industry through a consumer-driven health insurance model," said Asheley Carter, strategic partnerships associate at Aeroflow. "This partnership provides individuals and small businesses across the nation with simple and affordable access to our outstanding customer service, supplies, and support.” Friday Health Plans has more than 300,000 members in seven states, with plans to expand offerings into multiple new states each year. 

ADA to rebrand under United Access name 

HOUSTON – Adaptive Driving Access (ADA) will rebrand its five Texas stores to United Access this month. The name change brings the total number of United Access locations in Texas to 10, making it the largest mobility dealer in the state, the companies say. “We’re changing our name, but not our passion for serving our customers,” said James Norris, ADA Pasadena’s general manager. “When you enter our stores, you’ll be greeted by the same great staff and same big smiles. The only difference is the sign on the building.” Like ADA, each United Access dealership works with individuals with mobility challenges to customize their ideal mobility solution. In addition to new or preowned wheelchair accessible vehicles, the dealerships also provide rental wheelchair vans, wheelchair and scooter lifts, driving controls, scooters, transfer seats and more. Including the ADA locations in Houston, Pasadena, Bryan, McAllen and Corpus Christi, United Access now operates 30 retail stores across 11 states. The two companies originally joined forces in 2019. 

Super Bowl champ secures multi-million deal 

VALENCIA, Calif. – Roland Williams, an eight-year NFL veteran and Super Bowl Champion with the St. Louis Rams, has secured a multi-year production deal for his company, J2 Medical Supply, to manufacture nitrile examination gloves in a deal worth more than $400 million annually. J2 Medical Supply's J2-100 Advanced Premium Nitrile Examination Glove is a powder-free, textured, ASTM D6319 & D6978 chemo-rated glove. "The J2-100 Advanced Premium Nitrile Examination Glove provides a winning solution for clients looking to reduce costs, access a high-quality product, while meeting their Tier 1 & Tier 2 supplier diversity goals," said Williams, J2 Medical Supply’s co-founder and president. "Honored to join my partners in becoming an even more reliable and robust teammate for health care, government and business clients committed to economic equity within their supply chain." U.S. demand for nitrile examination gloves nearly doubled in 2021, according to Becker Hospital Review. In addition to gloves, J2 Medical Supply manufactures and imports disposable non-sterile apparel, N95 and KN95 masks, COVID test kits, crutches, walkers and more. 

NCPA to CMS: Implement changes we suggested in Part D rule 

ALEXANDRIA, Va. – The National Community Pharmacists Association said it has strong concerns about CMS’s proposed Medicare Part D rule, which outlines the latest efforts by the agency to lower out-of-pocket drug costs for patients and address pharmacy direct and indirect remuneration fees. In comments submitted on the rule, NCPA CEO B. Douglas Hoey said that without incorporating changes suggested by the association, the proposed rule “will fail to achieve its intended goals.” Some of those changes: ensure transparency of pharmacy reimbursement at the point of sale; close the coverage gap loophole; address the effects on pharmacy cash flow; and enforce existing network adequacy and contract provision requirements. “On behalf of the 19,400 independent community pharmacies across the country, NCPA urges CMS to address the concerns we have raised in this letter in the final rule for CY2023 to ensure the continued vibrancy and financial solvency of the independent pharmacies serving millions of patients in their local communities every day," Hoey wrote. The NCPA's concerns are being echoed by more than 200 pharmacy stakeholder comments.  

Better Medicare Alliance encourages CMS to delay some proposed changes 

WASHINGTON – The Better Medicare Alliance has issued comments in response to CMS’s 2023 Medicare Advantage and Part D Advance Notice and proposed rule, asking the agency to consider the full impact of maximum out-of-pocket costs. “As we heartily support CMS in many of these efforts, our comments also encourage the agency to consider the full impact of maximum out-of-pocket changes that could disproportionately impact plans that serve higher proportions of dual-eligible beneficiaries and curtail supplemental benefit offerings,” said Mary Beth Donahue, president and CEO. “Better Medicare Alliance additionally encourages CMS to consider a delay of its proposed pharmacy price concession changes, which could limit access to zero-dollar premium plans and raise costs for the 9 in 10 Medicare Advantage beneficiaries enrolled in an integrated MA-PD plan. We look forward to a final rule and rate announcement that preserves and strengthens Medicare Advantage for the more than 28 million satisfied, diverse beneficiaries counting on its coverage and care.” In its comments, the Better Medicare Alliance asks CMS to address: social determinants of health and advancing health equity, end-stage renal disease payment, web-based consumer assessment of health care providers and systems survey, maximum out-of-pocket limit, and pharmacy price concessions in the negotiated price. 

NSM taps Gurganus to lead new branch 

NASHVILLE, Tenn. – National Seating & Mobility has opened a new branch in Hattiesburg, Miss., expanding its presence in the south. David Gurganus, an industry veteran, will join the NSM team and manage the branch. “Strategically growing our footprint allows us to ensure more people have access to the most advanced mobility and access solutions available,” said Bill Mixon, NSM CEO. “We are excited to partner with individuals in and around Hattiesburg as they pursue greater independence and are proud to welcome David to the NSM team.” Gurganus, a former area college baseball player, has been working in the complex rehab industry since 2004 and earned his ATP certification in 2013. He says he plans to take a team approach in leading the Hattiesburg brand. “Playing college baseball taught me about teamwork,” he said. “Every player has to be ready and willing to do their job at an above average rate to be successful. Those same principles can be applied to the CRT world.” In all, NSM operates more than 190 locations across the United States and Canada. 

Soleo Health expands in Atlanta 

NORCROSS, Ga. – Soleo Health has relocated its Atlanta pharmacy four miles to a new 7,200-square-foot facility in Norcross, Ga. The new facility, double the size of the former facility, features an expansive specialty pharmacy with a custom-built ISO 5 clean room and five private ambulatory infusion suites for patients receiving complex biologic and infusion therapies. “Our expansion in the Atlanta area directly results from our need to better accommodate the increased patient demand we have witnessed during the past several years,” said Jennifer Joiner, RN, BSN, a regional business manager who will head up the new facility. “From our expanded specialty pharmacy facility, we can now better serve our patients and cater to the type of complex specialty pharmacy care they need and have come to expect from Soleo Health.” From the new facility, Soleo Health manages the delivery of a broad range of specialty pharmacy services and infusion therapies, employing more than 40 people, including skilled clinicians who deliver care on-site at the new facility and patients in their homes. It serves patients throughout Georgia, including those in Norcross, Dunwoody, John’s Creek, Alpharetta, Duluth, Lawrenceville and Cummings and surrounding areas, and extends services to North Carolina, South Carolina and Florida.  

Ozarks Healthcare buys pharmacy 

WEST PLAINS, Mo. – Ozarks Healthcare recently acquired Bradford Pharmacy in West Plains, Mo., according to Ozark Radio News. Katie Mahan, director of Ozarks Healthcare Pharmacy, told the radio station that the company needed more space. Bradford Pharmacy, founded in 1996, has transitioned to Ozark Healthcare Pharmacy. Ozark Healthcare is a health system that comprises a 114-bed acute care hospital, as well as family medicine and specialty clinics, and offers rehabilitation and home care services. It employs about 1,300 and serves an eight-county area in south-central Missouri and north-central Arkansas. 

Inogen names new CFO 

GOLETA, Calif. – Inogen has appointed Kristin Caltrider as executive vice president and CFO effective March 21. Caltrider joins Inogen from Quidel Corp., a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems that is listed on NASDAQ. “Kristin is a proven executive who brings deep experience in leading the financial operations of health care businesses,” said CEO Nabil Shabshab. “She has a clear track record of partnering cross functionally to successfully develop strategic plans and execute against a clear set of financial and business goals to add scale and drive profitable growth.” At Quidel, where she most recently served as vice president of finance, Caltrider oversaw global finance and accounting functions, which included all aspects of transactional and technical accounting, tax and treasury, financial planning and analysis, cash management and forecasting, and finance-related M&A activities, as well as global analytics and sales operations. She helped the company aggressively scale its manufacturing capacity and significantly expand revenue and profitability. Caltrider succeeds Mike Sergesketter, who joined the company as interim CFO in December 2021. Sergesketter will remain at the company through June 24 to facilitate a smooth transition. 

Rhythm expands customer base beyond Southeast 

ST. PETERSBURGH, Fla. – Rhythm Healthcare has opened a new distribution center in Ontario, Calif., that will allow the company to better serve customers in the western United States. “Our new California distribution center will improve our service levels and drive supply chain efficiencies, while also expanding our customer base beyond the Southeast,” said Doug Francis, president and CEO. “Our plans to transform our business from a regional manufacturer of mobility products to a national respiratory manufacturer that also does mobility products is underway.” Rhythm Healthcare was formerly known as Lifestyle Mobility Aids, which has been in business since 1992.  

OPGA, Össur award grant 

WATERLOO, Iowa – The Orthotic Prosthetic Group of America (OPGA) and Össur announced Cristalei Polk as recipient of the Russell Walker CP, LP Emerging Leader Grant Program at the Academy Annual Meeting & Scientific Symposium on March 3, 2022. Polk is a current prosthetic resident at ProCare Prosthetics in Buford, Ga. “I can’t say enough how proud we are to partner with Össur on this new initiative,” said Todd Eagen, president of OPGA. “The Rusty Walker Grant is designed to pay tribute to a practitioner that was passionate about mentoring the next generation of O&P leaders. Cristalei Polk is an exceptional inaugural recipient.” OPGA, a division of VGM & Associates, and Össur developed grant program to provide annual funding to a current O&P resident to attend and participate in two different events that are outside of the clinical setting and realm but are highly important to the O&P profession and the patients it serves.