In brief: Invacare has new leadership, MA enrollment has doubled, Walgreens has finalized CareCentrix acquisition

ELYRIA, Ohio – Matt Monaghan has left his role as chairman, president and CEO of Invacare. 

Geoffrey Purtill, who has been serving as the company’s senior vice president and general manager, EMEA and APAC, is interim president and CEO. 

“After careful consideration, the board determined that now is the right time for a change in leadership to oversee the successful execution of Invacare’s business transformation,” Cliff Nastas, Invacare’s lead independent director. “We welcome Geoff who has distinguished himself throughout his tenure with Invacare. The board has full confidence that he has the right skillset and industry experience to lead the company through this transition as we search for a permanent successor who can accelerate the achievement of our objectives. We thank Matt for his years of service. We look forward to having Geoff advance our strategic initiatives.” 

Invacare’s board of directors has launched a search to identify and appoint a permanent CEO. 

The company has also announced that Michael Merriman, Jr. has been appointed a director and named non-executive chairman of the board. Merriman, who previously served on Invacare’s board and served as chair of its Audit Committee from 2014 to 2018, will also serve on the company’s Strategy Committee. He succeeds Cliff Nastas as the company's lead independent director. 

Purtill has served as senior vice president and general manager, EMEA and APAC, since December 2021 and, prior to that, led Invacare’s global strategy efforts. Previously, he served for 11 years as vice president and general manager of the company’s Asia Pacific region. 

FDA releases alert on Philips BiPAP machines 

WASHINGTON – The U.S. Food and Drug Administration is alerting patients, caregivers and health care providers that Philips Respironics has recalled 386 affected bi-level positive airway pressure (BiPAP) machines that may contain a plastic contaminated with a non-compatible material. 

“If that plastic is in the device motor, it may release certain chemicals of concern called volatile organic compounds (VOCs),” the FDA stated. “The plastic may also cause the machine to fail and stop working suddenly during use.” 

This new recall is not associated with the sound abatement foam impacting certain BiPAP machines recalled in June 2021. This new recall, however, does apply to some of the devices recalled in June 2021. 

Philips distributed the affected BiPAP machines in the U.S. between August 6, 2020, and September 1, 2021. Philips sent affected customers, including DME providers, an Urgent Medical Device Recall letter on Aug. 26. 

The models, some of which are intended for use only in clinical environments, are A-Series BiPAP A30 (ventilator), A-Series BiPAP A40 (ventilator), A-Series BiPAP V30 (auto ventilator) and OmniLab Advanced+, but only machines with the serial numbers identified in the company’s Urgent Medical Device Recall letter are affected by this recall. 

Philips recommends that health care providers locate all recalled devices in their facilities. It also recommends: 

For the A-Series BiPAP V30 (auto ventilator) and OmniLab Advanced+ machines, which are intended for use only in clinical environments and which are not a part of the June 2021 recall, replace with an unaffected device or discuss with your patient (or their caregiver, as appropriate) whether their plan for care and treatment should change as a result of this recall. 

For the A-Series BiPAP A30 (ventilator) and A-Series BiPAP A40 (ventilator) machines, which are intended for use in either clinical environments or by patients at home and which were also included in the June 2021 recall, no action is needed if the device was already corrected or replaced through the June 2021 recall, as the affected plastic components were also replaced. If the device was not already corrected or replaced, register the device, if not done already, on the Philips website and discuss the best treatment course. 

Medicare Advantage enrollment doubles 

YARMOUTH, Maine – Medicare Advantage enrollment as a share of the eligible Medicare population has more than doubled from 2007 to 2022 (19% to 48%), according to a new analysis by the Kaiser Family Foundation. 

Between 2021 and 2022, total enrollment grew by about 2.2 million beneficiaries, or 8%, a slightly slower growth rate than the prior year (10%). 

The average Medicare beneficiary in 2022 has access to 39 Medicare Advantage plans, the largest number of options available in more than a decade. However, enrollment is concentrated among a small number of insurers, with UnitedHealthcare and Humana together accounting for 46% of all enrollees nationwide. In nearly one-third of counties (29%; or 945 counties), these two firms account for at least 75% of enrollment. 

BlueCrossBlueShield affiliates (including Anthem BCBS plans) account for 14% of enrollment, and four firms (CVS Health, Kaiser Permanente, Centene, and Cigna) account for another 24% of enrollment in 2022. 

UnitedHealthcare has had the largest share of enrollment and largest growth since 2010, increasing from 20% to 28% in 2022. Humana has also had a high share of enrollment, though its share has grown more slowly, from 16% in 2010 to 18% in 2022. 

The Congressional Budget Office projects that the share of all Medicare beneficiaries enrolled in Medicare Advantage plans will rise to 61% by 2032. 

Walgreens finalizes CareCentrix acquisition 

DEERFIELD, Ill. – Walgreens Boots Alliance has completed its majority share acquisition of CareCentrix. 

WBA announced in October 2021 that it planned to invest $330 million for a 55% stake in CareCentrix, as part of a plan to launch Walgreens Health. 

“We created Walgreens Health to reimagine local health care and wellbeing for all,” said Roz Brewer, CEO, WBA. “This partnership advances our ability to address the needs of people across care settings immediately following hospital discharge. Our collaboration with CareCentrix is one of the many ways we are expanding on our pharmacy and patient expertise to surround individuals with care when and how they need it.” 

Walgreens Health says it will continue to advance capabilities that integrate CareCentrix’s data analytics and home care expertise with WBA’s portfolio of health solutions to identify and close care gaps, as well as coordinate patient care across conditions, settings and provider networks. These capabilities will enable WBA to support medication reconciliation for CareCentrix patients transitioning from hospital to home and provide primary care options to patients when needed. 

CareCentrix will also play a critical role in Walgreens Health’s integrated offerings to manage population level risk for benefits management and post-acute spend and outcomes. CareCentrix manages care for 19 million members through approximately 7,400 provider locations. By partnering with health plans and health systems, CareCentrix says it has reduced total cost of care for members by 20%, and reduced emergency department use by more than 11% and skilled nursing costs by 23%.  

“The most challenging part of the health care journey is the last mile – extending health care delivery into people’s homes,” said John Driscoll, CEO, CareCentrix. “Together with Walgreens Health, CareCentrix is able to combine Walgreens trusted community presence with our powerful technology-enabled care to better address patients’ unique health needs in their homes.” 

WBA’s investment gives it majority ownership of CareCentrix, investing approximately $330 million for 55% of the company at an $800 million valuation, net of debt, with the option to acquire the remaining equity interests in the future. In WBA’s fiscal year 2021, CareCentrix delivered pro forma sales of $1.5 billion. 

Following the completion of the investment, CareCentrix will continue to operate as an independent company under its current executive leadership. 

AAH seeks next Homecare Champion 

WASHINGTON - AAHomecare is currently seeking nominations for the 2022 Van Miller Homecare Champion. Nominees should have a longstanding record of service within the home care community; embody the spirit of caring and generosity, which are the hallmarks of this profession; and represent active membership and engagement in AAHomecare. Previous winners include Steve Ackerman, Karyn Estrella, Regina Gillispie and Gary Sheehan. The award will be presented at Medtrade East during the Stand Up for Homecare reception on Oct. 25 at Ventanas in Atlanta. Nominations can be submitted to Sue Mairena, suem@aahomecare.org, by Friday, Sept. 23. Find the nomination form here. Register for Medtrade East here. Register for Stand Up for Homecare here. 

F&P looks to build second campus 

AUCKLAND, New Zealand – Fisher & Paykel Healthcare has entered into a sale and purchase agreement to acquire a 105-hectare site in Karaka for $275 million to build a second campus in New Zealand. “With our current site nearing capacity, we are pleased to take this step towards securing additional land to enable our continued growth,” said Scott St. John, board chair for Fisher & Paykel Healthcare. “We have consistently signaled the importance of long-term infrastructure planning to help us deliver on our sustainable, profitable growth strategy and our aspirations of doubling constant currency revenue every five to six years. In order to take advantage of the opportunities ahead of us, we need more space.” Development of the new campus will occur over a 20- to 30-year period, with a focus on earthworks and core infrastructure over the next five years. The site is 25 kilometers south of F&P’s existing campus. The purchase is conditional on Overseas Investment Office approval. 

NHIA comments on physician fee schedule 

ALEXANDRIA, Va. – The National Home Infusion Association has submitted comments on a CMS proposed rule that would affect Medicare payments and coverage of COVID-19 vaccines and monoclonal antibodies (mAbs) and coding and billing requirements related to the use of single dose containers and drug waste. While NHIA applauds the continued coverage for pre-exposure prophylaxis to COVID-19 with monoclonal antibodies beyond the public health emergency, the association is concerned that patients will not have access to mAbs in the home for treatment or post-exposure prophylaxis following the expiration of the emergency use authorization (EUA). NHIA believes this raises equity issues, particularly for Medicare beneficiaries in rural areas and for those without the means to travel to an infusion center. Continuous access to home infusion should be part of the agency’s future pandemic preparedness strategy. NHIA also noted that CMS’s proposal to require a separate modifier to be included on all claims for drugs with no discarded amounts would be administratively burdensome, cause confusion when a drug has more than one manufacturer (generic drugs) and may require substantial investments to update billing software systems. Instead of creating a new system, NHIA recommends that the Medicare Administrative Contractors provide education regarding use of the JW modifier or limit its use to drugs identified for the rebate program. 

United Spinal to participate in virtual space mission 

NEW YORK – United Spinal Association will participate in a virtual crew to remotely test Callisto, a technology demonstration payload embedded on NASA’s Orion spacecraft, during the upcoming Artemis I mission. The mission will evaluate how Amazon’s Alexa and other innovative technologies integrated with Callisto could be used to assist astronauts in future crewed missions to the moon and beyond. Rhonel Cinous, a member of United Spinal from Miami, will have the opportunity to simulate interactions between Alexa and future astronauts, getting a peek into what a “day in the life” of being onboard Orion could look like during a deep space mission. “I’m honored to represent United Spinal and participate in this historic initiative,” said Cinous. “We believe voice technology, including Alexa, presents many opportunities to make experiences of all kinds more accessible for people with mobility disabilities, while also helping lead to greater quality of life and independence in unprecedented ways.” 

Virtis Health opens AIC in Houston 

HOUSTON – Virtis Health, a division of Soleo Health, a provider of complex specialty pharmacy services, has opened an ambulatory infusion center in Houston near Texas Medical Center. “We are bringing a highly personalized care and service model to patients and providers throughout greater Houston with our new Virtis Health AI,” said Shahram Badrei, regional business leader for Virtis Health Houston. “Since our model brings additional resources and options to patients, providers and payers alike, we are confident it will quickly become a preferred choice for the delivery of outpatient care in our area.” Virtis Health offers therapy management services and treatments for patients with autoimmune disorders, including chronic inflammatory demyelinating polyneuropathy, multiple sclerosis and myasthenia gravis. The AIC also provides treatments for and manages patients with various inflammatory conditions, such as thyroid eye disease, Crohn’s disease, rheumatoid arthritis, ulcerative colitis, primary immunodeficiencies and rare and ultra-rare diseases.   

Philips reaches settlement with DOJ 

AMSTERDAM – Philips has agreed to pay about $4.2 million to settle an alleged violation of the military airworthiness recertification of one of its products. The settlement with the U.S. Department of Justice relates to the sale of certain portable patient monitors to the U.S. military, specifically the IntelliVue MP2 Mobile Patient Monitor, which has since been discontinued. After receiving initial airworthiness and safe-to-fly certifications for the MP2 from the U.S. Army in 2008 and the U.S. Air Force in 2011, Philips made modifications to the device. The DOJ alleged that sales during a period ending in 2018 resulted in false claims per the U.S. False Claims Act because Philips had not adequately notified the military certifying facilities of certain device redesigns that might have required renewed certification testing. In agreeing to the settlement, Philips acknowledges that it did not adequately notify the relevant military certifying facilities to determine whether the device modifications would or would not require retesting to maintain military airworthiness and safe-to-fly certifications. Philips has agreed to pay about $4.2 million. The company has already recorded a provision in connection with the settlement. 

CMS seeks input on emergency preparedness 

WASHINGTON – CMS will host a virtual listening session with health care providers on Sept. 13 to gather information on their experiences during public health emergencies outside of the COVID-19 pandemic. Topics of discussion will include What have been your facility's experiences in developing and implementing emergency preparedness plans under the CMS regulations, and do the current CMS emergency preparedness regulations create any unintended barriers in your work? This session is the second in a multi-part series CMS is hosting on emergency preparedness. To register, go HERE. Due to time constraints, capacity will be capped at 150 registrants. 

AASM to pilot sleep scoring program 

DARIEN, Ill. – The American Academy of Sleep Medicine has created a two-year pilot program to evaluate and certify software that uses auto-scoring functionality to score polysomnograms. The AI/Autoscoring Certification Program will independently verify the performance of auto-scoring systems. To obtain certification, the software must demonstrate accuracy that is equivalent or better than manual scoring. The pilot program is limited to sleep stage scoring. “Artificial intelligence technology has opened the door for fast and accurate auto-scoring solutions that will become more readily available to AASM-accredited sleep facilities in the future,” said Dr. Anuja Bandyopadhyay, a pediatric pulmonologist and sleep physician at the Indiana University School of Medicine, and chair of the AASM’s Artificial Intelligence in Sleep Medicine Committee. “Sleep medicine professionals have a healthy skepticism about AI solutions since they are radically different than traditional manual scoring. This new certification program will assure users that the software has been tested and validated against stringent requirements.” Applications will be accepted starting in late 2022 or early 2023.  

BSN resolves allegations for $785K 

CHARLOTTE – BSN Medical has agreed to resolve allegations that it marketed and promoted various products that did not meet the Medicare or Medicaid program’s reasonable and necessary requirements, causing the submission of false claims for patients, according to the U.S. Attorney’s Office for the Western District of North Carolina. Charlotte-based BSN, which specializes in compression therapy, wound care and orthopedics, has agreed to pay $785,672 to resolve the allegations. From Jan. 1, 2015, through Dec. 31, 2017, BSN allegedly marketed and promoted various products that were not reimbursable because the company had not obtained approval from Medicare’s Pricing, Data Analysis and Coding (PDAC) contractor or approval had expired for three codes specifically, E2607, L0625 and L0626. The allegations arose from a lawsuit filed by a whistleblower under the qui tam provisions of the federal False Claims Act and multiple state false claims act statutes. The claims resolved in the settlement are allegations only and there has been no determination of liability. 

Hospital, B & K Medical enter letter of intent 

HUTCHINSON, Kan. – Geary Community Hospital has entered into a letter of intent with B & K Medical, based here, to provide medical equipment and supplies to local residents, according to the JC Post. “B & K Medical will operate with an emphasis on long-term oxygen therapy in the patient home and sleep therapy, with a focus on management of patients with obstructive sleep apnea and other sleep disorders.” B & K will also provider other DME ranging from hospital beds to walkers to wheelchairs, as well as medical supplies. The company, a branch of B & K Prescription Shop, has a presence in Salina, Hutchinson, Ellsworth and Abilene. 

OIG to CMS: Review eight codes 

WASHINGTON – Eight drug codes met CMS’s price substitution criteria in the first quarter of 2022 by exceeding the 5% threshold for two consecutive quarters or three of the previous four quarters, according to a new Office of Inspector General report. The OIG is providing the eight drug codes to CMS for its review. The OIG says CMS should review the information to pursue price substitutions that would limit excessive payments for Part B drugs. To conduct the study, the OIG obtained average sales price (ASP) and average manufacturer price (AMP) data for Part B drugs for the first quarter 2022 from CMS. It then compared the volume-weighted ASPs and AMPs and identified all drugs with complete data for which the ASPs exceeded the AMPs by at least 5%. The Social Security Act mandates that the OIG compare ASPs with AMPs to monitor market prices and limit potentially excessive payment amounts. 

CarepathRx racks up partnership with another medical system 

MERCER ISLAND, Wash. – CarepathRx has announced a comprehensive home infusion pharmacy partnership with Antelope Valley Medical Center, the only full-service, acute-care hospital serving northern Los Angeles County’s Antelope Valley. The multi-year agreement will expand patient access to a new ambulatory infusion clinic (AIC), as well as home infusion therapies, to include both acute and specialty infusion medications. “Hospital systems across the nation have partnered with CarepathRx to implement and manage home infusion to expand the continuum of care and provide an exceptional patient experience,” said Keith Crawford, Chief Strategy Officer at CarepathRx. “CarepathRx is excited to partner with Antelope Valley Medical Center to deliver a turnkey home infusion therapy program.” As the region’s largest and most comprehensive hospital, Antelope Valley Medical Center provides care to more than 220,000 patients every year. CarepathRx has previously announced similar partnerships with Mount Sinai Health System and University of Chicago Medicine. 

ProSomnus secures $30M in financing 

SAN FRANCISCO – ProSomnus Sleep Technologies, a manufacturer of oral appliance therapy devices, has announced definitive agreements with institutional investors led by funds affiliated with or managed by Cohanzick Management and CrossingBridge Advisors. The financing - $30 million of debt comprised of two tranches: $15 million of senior secured convertible notes and $15 million of junior secured convertible notes with maturities of 36 months and 40 months, respectively – will support the previously announced pending merger of ProSomnus and Lakeshore Acquisition I Corp. "The financing is an important step toward closing our business combination with Lakeshore,” said Len Liptak, ProSomnus's CEO. “Together with Lakeshore's remaining cash in trust, this facility will materially strengthen ProSomnus's balance sheet as we begin life as a public company later this year. Taking ProSomnus public is about accessing the resources needed to execute our multi-pronged, strategic growth plan. This facility will be a key component in our ability to drive growth and raise awareness of the value ProSomnus devices bring to patients, physicians and dental sleep medicine providers seeking a more effective treatment for what is a dangerous and highly prevalent disease." The combined company is expected to change its name to ProSomnus and its class A common stock is expected to be traded on the Nasdaq Capital Market under the symbol "OSA". ProSomnus intends to use a portion of the proceeds of the facility to fund multiple strategic growth initiatives, including continued growth of the sales team, which will be charged with enhancing the company’s footprint not only in the core U.S. market, but also outside of the U.S. The company  also plans to complete the development of its next-generation oral appliance therapy, which features embedded sensors allowing sleep physicians to monitor their patients during the critical night hours.  

Former Drive exec joins Angel Care Medical 

BOARDMAN, Ohio – Angel Care Medical has named Dan Halas president and equity partner, according to The Business Journal. Halas has more than 20 years of senior management experience, most recently at Drive Medical. Previously, he also served as a sales executive at Primus Medical. “As the industry evolves, I believe Angel Care Medical is in a position to provide a cost-effective suite of equipment, services and technology that will, ultimately, help Angel Care Medical strengthen partnerships, develop strategic alliances and expand our sales presence throughout the country,” Halas told the journal. Angel Care Medical offers rental and purchase programs for various types of DME, including beds and mattresses, and support and mobility equipment.