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In brief: Invacare delay, Philips recall, Rehab Medical expansion, Medicare Advantage payments

In brief: Invacare delay, Philips recall, Rehab Medical expansion, Medicare Advantage payments

ELYRIA, Ohio – Invacare has filed a Form NT 10-K notifying the U.S. Securities and Exchange Commission that it is unable to file its annual report for the period ending Dec. 31, 2022, within the prescribed time period due to its Chapter 11 bankruptcy filing. 

“Due to the considerable time and resources the company’s management is devoting to the Chapter 11 cases, and the need to prepare and review the disclosures required in the Form 10-K as a result of the Chapter 11 cases, the company is unable to prepare and timely file its Form 10-K on or before the March 31, 2023, due date without unreasonable effort or expense,” the company stated. “The company expects to file the Form 10-K on or before the fifteenth calendar day following the prescribed due date of the Form 10-K.” 

Invacare expects its Form 10-K, when filed, will reflect reported net sales of approximately $740 million for 2022 compared to $872 million for 2021. It expects gross profit of approximately $175 million, compared to $239 million, and operating loss of approximately $81 million, compared to $24 million, driven by lower net sales (including product rationalization), higher input costs, and supply chain challenges and restructuring charges, partially offset by pricing actions and lower selling, general and administrative expenses. 

The company expects sequential improvement in revenue, gross margin, net loss and Adjusted EBITDA (non-GAAP) for the fourth quarter of 2022 compared to the third quarter of 2022. However, these key metrics would still be unfavorable compared to the fourth quarter of 2021 as a result of lower reported net sales and supply chain challenges. 

Specifically related to Europe, Invacare says it returned to profitability for the fourth quarter of 2022, with net sales of $106 million and operating profit of $9.3 million, a significant improvement compared to the previous quarter. The improvement was driven by revenue growth, margin expansion related to favorable product mix, pricing actions and operational efficiencies. 

The company will begin to file monthly operating reports with the Bankruptcy Court related to periods subsequent to Jan. 31, 2023. Bankruptcy Court filings and other documents related to the Chapter 11 Cases are available at a website maintained by the company's claims agent Epiq at http://dm.epiq11.com/Invacare. 

Philips recalls certain reworked devices 

WASHINGTON – The U.S. Food & Drug Administration on April 7 announced Philips has recalled certain reworked DreamStation CPAP, BiPAP devices for the risk they may deliver inaccurate or insufficient therapy. 

The company is recalling 1,088 devices that were distributed between Dec. 1, 2021, and Oct. 31, 2022. 

“Philips is recalling certain reworked Philips DreamStations because some devices were assigned incorrect or duplicate serial numbers during initial programming,” the FDA states. “This duplication can cause therapy to be delivered using the wrong prescription or factory default settings. Additionally, it may fail to deliver any therapy at all. There is no warning or indication to the user that the DreamStation is not working the way the doctor intended or prescribed.” 

The FDA says Philips has received 43 complaints related to this issue. 

The company, which initiated the recall on Feb. 10, has sent affected provider customers and patients an “Important Product Notice” with recommendations.  For providers, it says a replacement product will be provided for exchange of affected devices. 

Rehab Medical closes ‘last gap’ in Ohio 

INDIANAPOLIS – Rehab Medical has opened a new office in Cleveland, allowing the company to cover all of the state. 

The company says it’s now the largest complex rehab provider in Ohio. 

“Rehab Medical has a strong presence in the state of Ohio and this expansion allows us to close the last gap,” said President Kevin Gearheart. “This expansion also exemplifies our intentional focus on culture and internal growth. We promoted key employees to move to Cleveland to continue our focus on service, excellence and customer care.” 

Rehab Medical has nine employees working in the Cleveland office, including assistive technology professionals (ATPs). 

It’s the company’s first expansion of 2023, with additional expansions coming to Georgia and Louisiana in May. 

Rehab Medical says it serves more than 15,000 patients per year across 15 states nationwide. 

CMS announces MA payments for 2024 

WASHINGTON – Medicare Advantage plan payments will increase 3.32% from 2023 to 2024, representing about $13.8 billion. 

Previously, in an advance notice, CMS had proposed a 1.03% increase. 

“Medicare should be providing equitable, high-quality affordable care that will be available for our children and grandchildren,” said CMS Administrator Chiquita Brooks-LaSure. “Paying Medicare Advantage plans more accurately for the care they provide is how we ensure that people enrolled in Medicare Advantage, especially populations with the highest health disparities and people in underserved communities, can continue to access the care they deserve.” 

CMS has also proposed policies to strengthen Medicare Advantage that will hold health insurance companies to higher standards by: 

  • cracking down on abusive and confusing marketing schemes; 
  • addressing problematic prior authorization practices that prevent timely access to needed care; 
  • making it easier to access vital behavioral health care; and 
  • raising the bar on quality and driving toward more equitable care. 

Taken together, CMS believes these actions will make the overall Medicare program stronger. 

“The commonsense policies in the Rate Announcement ensure these important programs continue to meet the health care needs of all people with Medicare while improving the quality and long-term stability of the Medicare program,” said CMS Deputy Administrator and Director of the Center for Medicare Meena Seshamani, MD, Ph.D. 

HHS finalizes rule to crack down on MA marketing, streamline PA processes 

WASHINGTON – The Department of Health and Human Services has finalized a rule that it says will strengthen Medicare Advantage and hold health insurance companies to higher standards by cracking down on misleading marketing. 

Per the rule, ads will be prohibited if they do not mention a specific plan name, or if they use the Medicare name, CMS logo and products or information issued by the federal government, including the Medicare card, in a misleading way. The rule also strengthens accountability for plans to monitor agent and broker activity. 

“At HHS, we put seniors and people with disabilities first,” said HHS Secretary Xavier Becerra. “That is exactly what we are doing today. In our latest effort to strengthen Medicare and hold insurance companies accountable, we are putting protections in place so that Medicare Advantage works for beneficiaries and they get the quality care they deserve. We will continue our efforts to deliver on the President’s vision to strengthen this program for the millions of people with Medicare and for future generations to come.” 

Additionally, the rule streamlines prior authorization requirements and reduces disruption for enrollees by requiring that a granted prior authorization approval remains valid for as long as medically necessary to avoid disruptions in care, requiring Medicare Advantage plans to annually review utilization management policies, and requiring that denials of coverage based on medical necessity be reviewed by health care professionals with relevant expertise before a denial can be issued.  

Sleep organizations release OSA resource 

DARIEN, Ill. – Count on Sleep, a collaboration led by the American Academy of Sleep Medicine and the Sleep Research Society, has released a national indicator report for obstructive sleep apnea that provides an in-depth analysis of symptoms, risk factors, prevalence and burden. 

The report was made possible through a grant from the Centers for Disease Control and Prevention’s National Center for Chronic Disease Prevention and Health Promotion.  

“Through this report, we can increase awareness of obstructive sleep apnea with patients, health workers, public health officials, regulators and others to spur prompt diagnosis and management, allowing patients to reap the many benefits of treatment,” said Dr. Indira Gurubhagavatula, chair of the project’s Tool Development and Surveillance Workgroup. “Benefits of treatment include improved daytime alertness, cardiovascular health, performance at home and at work, and quality of life.”   

Obstructive sleep apnea affects an estimated 30 million Americans, with 80% of cases remain undiagnosed. It can lead to substantial costs: Approximately 23.5 million cases of undiagnosed OSA in the U.S. incur $149.6 billion in costs annually due to greater health care utilization, increased motor vehicle and workplace accidents, and reduced productivity.  

Other partnering organizations in the project are the Alliance of Sleep Apnea Partners, American Academy of Dental Sleep Medicine, American Academy of Otolaryngology – Head and Neck Surgery, American College of Chest Physicians, American Society for Metabolic and Bariatric Surgery, American Thoracic Society, and National Sleep Foundation. 

Abbott issues voluntary correction for FreeStyle Libre devices 

ABBOTT PARK, Ill. – Abbott in February initiated a voluntary medical device correction for its FreeStyle Libre, FreeStyle Libre 14 day and FreeStyle Libre 2 readers in the United States due to a limited number of reports (0.0017%) over several years of their lithium-ion batteries swelling, infrequently overheating or, in very rare cases, sparking or catching fire. No readers are being physically recalled and customers can continue to use their readers with the Abbott-provided USB cable and power adapter. The company, however, has outlined steps at ww.FreeStyleBattery.com to provide guidance on how to properly store, charge and use a reader and its accompanying USB cable and power adapter. Abbott has been notifying customers of this matter since February through a variety of communication methods, including email and letters. This communication to customers was done voluntarily, and the U.S. Food and Drug Administration has been informed. Like mobile phones and many other handheld electronic devices, the FreeStyle Libre family of readers use lithium-ion batteries, which are safe when used per instructions outlined at www.FreeStyleBattery.com. Since FreeStyle Libre readers launched in the U.S. in 2017, there have been no reported incidents that have caused serious adverse health consequences or death due to this issue.  

EW refreshes website 

WATERLOO, Iowa – Essentially Women, a division of VGM & Associates, has launched a redesigned website at essentiallywomen.com. Refreshed and enhanced for a more user-friendly experience, this updated site makes it easier for members to find the information they’re looking for. The site also includes a members-only portal, making it even easier to access the resources that are exclusively available to EW members. “At EW, we strive to provide the resources members need to lower costs, maximize revenue, operate more efficiently, and expand business operations,” said Nikki Jensen, vice president of EW. “We understand the daily business challenges women’s health care providers face, and this new website makes it even easier for members to find the valuable information they need so that they can spend more time on their business.” The new Essentially Women website is part of vgm.com, providing a one-stop shop for those members serving both the DMEPOS industry and the women’s health industry. 

AASM launches new accreditation option 

DARIEN, Ill. – The American Academy of Sleep Medicine is launching a new accreditation application type to simplify the accreditation process for multi-site health systems. Sleep medicine practices and facilities that are under the same ownership or legal entity and operate under the same policies and procedures can create an Accreditation Network to streamline and coordinate multiple accredited programs. “It can be complicated to manage multiple accreditations when health care entities add additional sleep medicine services,” said Dr. Lara Wittine, chair of the AASM Accreditation Committee. “The new AASM Accreditation Network allows the programs within a network to coordinate their accreditation processes, resulting in less paperwork, less redundancy, and less time spent on the administrative aspects of accreditation.” Accredited programs within an Accreditation Network can share information across applications, align accreditation expiration dates, coordinate site visit schedules, and receive volume discounts for accreditation applications and renewals. To achieve AASM accreditation, a sleep program must meet or exceed the AASM standards in core areas such as personnel, facility and equipment, policies and procedures, data acquisition, patient care, and quality assurance. Additionally, the sleep program’s goals must be clearly stated and include plans for positively affecting the quality of medical care in the community it serves. Currently, there are more than 2,600 AASM-accredited sleep facilities in the U.S. and Canada.   

Ability Center rebrands as United Access 

ST. LOUIS, Mo. – Ability Center will rebrand its 18 locations to United Access. The name change brings the total number of United Access locations to 50, significantly expanding the brand’s presence along the West Coast and securing its position as the second largest retailer of wheelchair accessible vehicles, mobility products and services in the United States. “We are changing our name, but not our commitment to our customers,” said Chad Blake, senior vice president of sales and store operations for United Access and former Ability Center president. “No matter what store you visit, you’ll experience the same high standards of service and care from the Ability Center consultants and technicians you’ve always known.” Both United Access and Ability Center have served their customers for more than 25 years, selling and servicing mobility equipment for individuals with physical disabilities and mobility challenges. In addition to new or preowned wheelchair accessible vehicles, the dealerships also supply rental wheelchair vans, wheelchair and scooter lifts, driving controls, scooters and transfer seats. United Access is part of the BraunAbility Arch Retail family of brands. 

Quipt snags second large insurance contract 

CINCINNATI – Quipt Home Medical has executed a contract with another top five health insurer in the United States. It’s the second contract the company has signed with a major insurer since April 2022. “Our strong start to the year has continued with the execution of our second national insurance contract with another top five health insurer in the United States,” said Greg Crawford, chairman and CEO of Quipt. “We remain focused on delivering on our robust growth strategy and the signing of this contract is yet another milestone that will assist us in reaching our long-term goals. The execution of this contract continues to expand our patient accessibility profile and is expected to assist us in the acceleration of our organic growth strategy. I am also excited to be able to immediately leverage both our national contracts, which is extremely meaningful in terms of capturing as many eligible patients as possible. I look forward to continuing to update our shareholders with respect to our ongoing operational and financial success.” At present, Quipt is providing care to more than 270,000 active patients across the nation. 

NCPA applauds PBM companion bill 

WASHINGTON – The National Community Pharmacists Association is cheering the bipartisan Drug Price Transparency in Medicaid Act (S. 1038), introduced March 29 by Sens. Peter Welch, D-Vt., and Roger Marshall, R-Kan., which would prevent pharmacy benefit managers from using spread pricing in Medicaid managed care programs. The bill is companion legislation to H.R. 1613, introduced March 16 by Reps. Buddy Carter, R-Ga., Vicente Gonzalez, D-Texas, Rick Allen, R-Ga., Jake Auchincloss, D-Mass., Elise Stefanik, R-N.Y., and Deborah Ross, D-N.C. “Stopping PBMs from abusing taxpayer dollars through harmful spread pricing and underwater reimbursements for pharmacies is a priority of NCPA’s,” said NCPA CEO B. Douglas Hoey, pharmacist, MBA. “We’re glad to see it’s increasingly a priority among members of Congress. We thank Sens. Welch and Marshall for introducing this bill and are eager to continue working together to move toward a fairer system for pharmacies and for patients.” 

Tomorrow Health courts Medicaid MCOs 

NEW YORK – Tomorrow Health has announced new technology that it says can help Medicaid managed care organizations move beyond analog fax and phone workflows for home-based care, get up-to-the minute insight into order status and better manage members with complex cases. The company says its technology can provide an extra layer of efficiency by providing care coordinators with important DME-related information, such as referring provider details, product category estimated delivery date, confirmed delivery date, cancellation reasons, among others. "The Medicaid patient population has unique health and social needs, and requires high-touch care teams to manage all facets of the home-based care experience,” said Vijay Kedar, CEO and co-founder, Tomorrow Health. “Care coordinators act as lifelines for Medicaid MCO members, and often don't have the technology tools they need to ensure timely home-based care is delivered in a member's home. With one in four aging seniors requiring some form of home-based care, our technology can simplify a disjointed ordering and management process for Medicaid MCOs, drive down costs, and most importantly, deliver high-quality home-based care to those most in need." Tomorrow Health says its technology is fully customizable for the Medicaid MCO population, depending on the plan and state. 

Advantage Home Medical Services sells to Montgomery DME 

DALLAS – Generational Equity has announced the sale of its client, Advantage Home Medical Services, to Montgomery DME, a portfolio company of Incline Equity Partners. AHMS, based in Las Vegas, provides DME for rental or purchase, primarily for use by hospice patients in the home. Generational Equity says the company has made a name for itself with its product offerings, competitive pricing, reliability, technology (proprietary software developed in-house) and exceptional customer service. “It was clear from the beginning that joining Montgomery DME would allow the AHMS team to preserve its legacy by continuing to focus on the needs of hospice patients in the Las Vegas community,” said Chris Gain, managing director at Generational Equity. Montgomery DME, based in Sante Fe Springs, Calif., has served the Southern California hospice community for more than 24 years. 

BodiMetrics partners with Carahsoft on messaging 

MANHATTAN BEACH, Calif. - BodiMetrics has partnered with Carahsoft, a large holder of government contracts, on a “call-to-action” email to federal agencies, including Veterans Affairs, highlighting research that has shown oximeters that measure blood oxygen may be inaccurate in people of color. Carahsoft also sent the email to Health and Human Services and CMS, as well as to all 50 states and all major municipalities. “It is estimated over 80,000 people will be receiving the call-to-action,” said Neil Friedman, COO of BodiMetrics. “BodiMetrics is extremely grateful for Carahsoft’s efforts.” BodiMetrics makes a ring called CIRCUL that can, among other things, track blood oximetry day and night and, because it uses sensors that take readings from the palm side of the hand, is unaffected by pigmentation, the company says. Carahsoft has also sent a follow-up email, titled “Put a Ring on it,” to highlight the CIRCUL. 

ResMed’s Pendarvis to retire 

SAN DIEGO – ResMed has announced that David Pendarvis, chief administrative officer, global general counsel and secretary, plans to retire on June 30.  He will remain in a consulting role with the company through Dec. 31, 2023. “Dave has been an integral part of ResMed for over 20 years, helping guide the company into and through its transformation from the pioneer of sleep apnea treatment to a $30 billion-plus global leader in digital health and cloud-connected medical devices,” said CEO Mick Farrell. “On behalf of the entire management team and the board, I want to thank Dave for his two decades of dedicated service and exemplary leadership that has helped build the industry-leading company that ResMed is today. He’s been an important leader in an executive team that has positioned ResMed to improve the lives of many millions of people living with chronic respiratory diseases and countless more seeking to age healthily and outside the hospital. Personally, Dave has been a trusted advisor, partner, friend, and mentor to me through the years, I will miss his guidance, insights, and quick sense of humor.” ResMed has appointed Amy Wakeham, its current vice president of corporate communications & investor relations, as chief communications and investor relations officer to succeed Pendarvis in his role leading corporate public affairs. She will report to the office of the CEO and has joined the company’s executive leadership team. ResMed will conduct an internal search for a new global general counsel and secretary and expects to name a replacement well ahead of Pendarvis’ retirement date to ensure a smooth and seamless transition. 

NSM names Brady Shirley to board 

NASHVILLE, Tenn. – National Seating & Mobility has added Brady Shirley to its board of directors. Shirley currently serves as the president and COO of Enovis, a medtech company that focuses on orthopedics. “Brady will be a welcome addition to our board of directors,” said Bill Mixon, CEO of NSM. “His experience in health care leadership positions and passion for innovative growth will prove invaluable as we continue to evolve to better our clients in the future.” Prior to Enovis, Shirley served as CEO of DJO Global. He joined DJO in 2014 as president of the surgical business and was appointed CEO in 2016, leading the transaction into Colfax in 2019. From 2009-13, he was the CEO of and a director at Innovative Medical Device Solutions, an orthopedic outsource development and manufacturing company. From 1992-2009, he held several key leadership positions at Stryker Corp. “Joining this board to help champion NSM’s mission is an honor,” he said. “I Look forward to supporting the company’s commitment to provide the most advanced mobility solutions to those who rely on complex rehab technology for independence.” 

Belluscura fuels growth in Asia 

LONDON and PLANO, Texas – Belluscura has started manufacturing its X-PLOR portable oxygen concentrator in China. This follows a manufacturing agreement announced in March 2022 with InnoMax Medical Technology to manufacture the X-PLOR in China, enabling the company to accelerate its international expansion by opening up markets in Asia and beyond. "We continue to make good progress, with manufacturing in China commencing, increased orders for X-PLOR and the tremendous reception of DISCOV-R by the industry at Medtrade," said Robert Rauker, CEO. The DISCOV-R, which is scheduled to launch in the U.S. this summer, was awarded the Silver Award in the New Product Pavilion at Medtrade, March 26-28 in Dallas. Belluscura expects to receive regulatory approval and distribution in China over the summer. The company expects strong growth in Asia Pacific, with nearly 100 million people in China with chronic obstructive pulmonary disease and the oxygen concentrator market expected to reach $1 billion by 2027.

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