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In brief: FDA update, F&P prediction, home infusion access

In brief: FDA update, F&P prediction, home infusion access

WASHINGTON – The U.S. Food and Drug Administration updated its safety communication for the Philips recall this month, saying it received more than 48,000 medical device reports, including 44 reports of death, associated with the foam breakdown or suspected foam breakdown in certain CPAP devices from May 1, 2022, through July 31, 2022. 

The agency previously reported in May that it received more than 21,000 MDRs, including 124 reports of death, associated with the foam breakdown or suspected foam breakdown from April 2021 through April 2022. 

The FDA says its in-depth review and analysis of these new MDRs will include examining the possible reasons for the increased number of reports during this time. The MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers and patients. A wide range of injuries have been reported in these MDRs, including cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, dyspnea (difficulty breathing), dizziness, nodules and chest pain. 

Although MDRs are a valuable source of information, the FDA acknowledges this passive surveillance system has limitations. It says the incidence, prevalence or cause of an event cannot typically be determined from this reporting system alone, due to under-reporting of events, inaccuracies in reports, lack of verification that the device caused the reported event, and lack of information about details such as frequency of device use. Because of these limitations, it says the MDRs comprise only one of several important post-market surveillance data sources. 

The FDA continues to review and assess the MDRs and will keep the public informed as new information becomes available. 

F&P predicts revenue boost in second half 

AUCKLAND, N.Z. – Fisher & Paykel Healthcare expects operating revenue for the first half of the 2023 financial year to be about $670 million and net profit after tax to be about $85 million to $95 million, assuming current exchange rates and a continuation of trading conditions in the first four months. 

This would represent an increase in revenue on pre-pandemic levels ($570.9 million in the first half of fiscal year 2020) and a decline in revenue compared to the prior comparable period ($900 million for the first have of fiscal year 2022). 

“During the most recent waves of the Omicron variant, fewer patients have required hospitalization and respiratory support,” said CEO Lewis Gradon. “We believe customer stock levels have been elevated during our first half, which impacts our short-term sales. This does not change the fundamentals of our business or our strategy. Our Hospital sales teams are still focused on changing clinical practice and helping ensure the hardware our customers have purchased is used to benefit a broader range of patients requiring respiratory support.” 

For the Hospital product group in the first half of the 2023 financial year, F&P assumes that, in constant currency, hardware revenue reduces to a pre-pandemic level by the end of the half; new applications consumables revenue is about 75% of the prior comparable period, and above pre-pandemic levels; and invasive consumables revenue is approximately equal to the prior comparable period. 

F&P expects gross margin for the first half is expected to be approximately 60%, which is below the company’s long-term target of 65%. However, the company believes that second half revenue for the 2023 financial year will be higher than in the first half, based on higher consumption of hospital consumables in the second half compared to the first half, with hospitalization rates reflecting pre-COVID-19 seasonal patterns; and improving global supply of CPAP hardware and the recent launch of its new Evora Full face mask contributing to continued Homecare growth. 

The company is now targeting constant currency operating expense growth of approximately 10% for the year.  

Home infusion bill gets backing 

WASHINGTON – Health systems, hospitals and group purchasing organizations urged Congress to pass the Preserving Patient Access to Home Infusion Act in a recent letter. 

The *letter to Majority Leader Charles Schumer, Speaker Nancy Pelosi, Leader Mitch McConnell, and Leader Kevin McCarthy asks Congress to support making technical corrections that would remove the physical presence requirement, ensuring payment regardless of whether a health care professional is present in the patient’s home.  

“Unfortunately, the lack of participation in Medicare’s home infusion benefit stems from the manner in which the benefit has been implemented coupled with lack of clarity in the underlying statute, including the definition of ‘infusion drug administration calendar day,’” the letter states. “Insufficient payment for HIT services has contributed to the lack of providers participating in the benefit, which in turn creates challenges in our ability to transition patients from inpatient care to the home setting. This is especially true for high acuity patients who rely on continuously infused medications, such as those who require inotropic therapies to manage severe heart failure. Patients who cannot access home infusion due to lack of availability are increasingly transitioning to long-term care facilities rather than being discharged to home, where they would prefer to receive their care.” 

The letter represents more than 600 health systems and 5,000 sites of care across the country. 

Introduced in 2021, the legislation has 17 House co-sponsors and three Senate co-sponsors. 

O&P WOY finalists announced 

WATERLOO, Iowa – The Orthotic and Prosthetic Group of America has announced the finalists for the 2022 O&P Woman of the Year Award. 

The finalists are: 

Adrienne Hill, CPO, area clinic manager, Hanger Clinic 

Maggie Baumer, area business clinic manager, Hanger Clinic  

Manisha Bhasker, senior director of communications & development, American Academy of Orthotists & Prosthetists  

Nina Bondre, education specialist with Ottobock Healthcare 

“We’re excited to continue recognizing the women in O&P who are creating impactful and positive experiences to the patients and community they serve,” said Adam Miller, president of OPGA, a division of VGM & Associates. “There are so many deserving candidates out there, and we are ready to highlight the woman who exemplifies everything that is exceptional about the O&P community.” 

The winner of the 2022 O&P Woman of the Year award will be announced in the OPGA booth (728) at the AOPA National Assembly on Sept. 29 at 9:45 a.m. CT. 

ACHC names officers 

CARY, N.C. – The Accreditation Commission for Health Care has announced new officers for its board of commissioners. Roy G. Chew, PhD, chair of the board, is retired as president of Kettering Health Network in southwest Ohio; Brock Slabach, MPH, FACHE, vice chair, is COO for the National Rural Health Association; Mark S. DeFrancesco, MD, MBA, FACOG, secretary, is a past president and former national secretary of the American College of Obstetricians and Gynecologists (ACOG) and recently retired from private practice; William R. Letendre, Sr., MS, MBA, treasurer, is vice president of Pharmacy Management Services for Professional Compounding Centers of America, Inc.; Denise Leard, immediate past chair, is an attorney with Brown & Fortunato; and Marshelle Thobaben, RN, MS, PHN, APNP, FNP, officer-at-large, is professor emeritus at Humboldt State University (HSU) in Arcata, Calif., and a nursing consultant. “I am pleased to work alongside this team of officers as they assume their new roles within the Board of Commissioners,” said José Domingos, president and CEO of ACHC. “Each officer brings such valuable expertise that will help us collaborate and continue to work toward our goal of serving accreditation and certification needs across the continuum of care with the quality and customer service that are hallmarks of ACHC’s approach.”  

Atlas launches app 

LAS VEGAS – Atlas Technology Group has released the ATLAS Enterprise Software Off-line App. The app can be loaded on any Windows or Mac laptop to allow users to gather data for an ATP patient evaluation and home assessment without internet access. Once the user is connected to the internet again, they are able to load the collected data into ATLAS Software. “We at Atlas Technology Group are deeply engaged with providers, patients and other medical professionals, seeking ways to continually improve patient care and engagement,” said Bill Paul, CEO. “We know that not every patient has accessibility to the internet and remote evaluations can become less efficient. We listened to our providers and addressed this in our new release of the ATLAS Enterprise Software Off-line App. With this app, patients receive the correct medical equipment and services in an improved delivery time.” 

CitusHealth co-founder recognized by Crain’s 

NEW YORK – Melissa Kozak, co-founder and president of CitusHealth, a digital health solutions provider for the home-based care industry, has been recognized as one of Crain’s New York Business’ 2022 Notable Healthcare Leaders. A registered nurse in both medical/surgical and home infusion settings, Kozak founded CitusHealth to enable better communication methods in health care. “CitusHealth is a reflection of the belief my team and I share that better tools are needed to provide comprehensive support to patients receiving care outside the hospital setting,” said Kozak. “Especially during the onset of the pandemic, we wanted to ensure patients had adequate means to communicate with their care providers and that care teams had ways to collaborate with one another despite remote work environments. Receiving this award from Crain’s is a great honor and I am thrilled to continue to provide solutions to all stakeholders in the post-acute care continuum.” Crain’s publishes its Notable in Heath Care list annually, choosing honorees for their leadership, civic engagement, and other factors.  

Insulet’s Omnipod 5 cleared for use ages two and up 

ACTON, Mass. – Insulet has received U.S. Food and Drug Administration clearance for its Omnipod 5 Automated Insulin Delivery System for individuals aged two years and older with Type 1 diabetes. “We received tremendous first-hand reports of how Omnipod 5 made diabetes management easier for our pivotal trial participants, and the clinical data demonstrated impressive glycemic improvements, as well,” said Dr. Trang Ly, MBBS, FRACP, PhD, Insulet’s senior vice president and medical director. “This expanded indication for younger children gives us great pride, knowing we can further ease the burden of glucose management for these children and their caregivers with our simple to use, elegant, automated insulin delivery system.” Omnipod 5 is a tubeless system that integrates with the Dexcom G6 CGM system and a compatible smartphone to automatically adjust insulin and help protect against high and low glucose levels 2. The system consists of the tubeless Pod enhanced with SmartAdjustT technology, the Omnipod 5 mobile app with integrated SmartBolus Calculator, and the Dexcom G6 CGM.  

NHIA launches payer summit 

ALEXANDRIA, Va. – The National Home Infusion Association will hold its first-ever home and specialty infusion payer summit on Nov. 2 in Dallas. “NHIA is proud to facilitate discussions and education aimed at improving understanding of home and specialty infusion services and how they benefit health plans,” said Connie Sullivan, BSPharm, president and CEO. “Many payers already recognize the value of outpatient and home-based infusion therapy and that is reflected in their benefit design. Our goal with this summit is to deepen payers’ understanding of infusion services and share our vision for the future. Infusion providers have untapped potential to support payers in their efforts to provide an array of value-based care choices to their customers.” There is no fee to attend and breakfast and lunch are provided. Space is limited and reserved on a first-come-first-served basis. Click here to see an agenda and here to register.  

 Amoena to co-host education track 

ATLANTA – Amoena USA will co-host a post-mastectomy education track at the AOPA National Assembly, which takes place Sept. 28-Oct. 1 in San Antonio. Amoena’s National Trainer, Rachel Brown, CMF, CFm, will present on topics including the breast surgery patient journey, and making your practice more profitable and more visible in your community. “Post-mastectomy care is reaching new levels of innovation right now, and we see enthusiasm for it from newly-trained O&P students,” said Brown. It is the first time in 10 years that post-mastectomy education has been offered at this event. “Through its National Assemblies, AOPA is committed to providing robust education that enables O&P professionals to provide the best care possible,” said Eve Lee, AOPA’s executive director. “That is why the Assembly Planning Committee and staff determined it was critical to create the two-day Post Mastectomy track at the 2022 National Assembly. We are excited about how the track has come together and know that mastectomy fitters will leave better informed and inspired.” 

Invacare enters cooperation agreement 

ELYRIA, Ohio – Invacare has entered into a cooperation agreement with its largest shareholder, Azurite Management LLC, which currently owns about 10.3% of the company’s outstanding shares as of June 30, 2022. As part of the agreement, Invacare appointed two new independent directors, Steven Rosen and Ambassador Edward Crawford effective immediately. “Following constructive dialogue and collaboration with Azurite, we are pleased to strengthen our board with the addition of Mr. Rosen and Ambassador Crawford,” said Matt Monaghan, chairman, president and CEO. “They bring a wealth of experience in operations and business transformation, and their familiarity with Invacare’s history will be invaluable. We look forward to collaborating with them on ways to accelerate our business evolution and enhance profitability.” Rosen will serve on the company’s Audit and Compensation and Management Development Committees and Crawford will serve on its Nominating and Governance Committee. As a result of other business commitments, Julie Beck and Stephanie Fehr have resigned from the board. With these changes, the number of Invacare directors remains at eight, seven of whom are independent. The company says it remains committed to appointing at least one director who is racially and/or ethnically diverse by its next annual meeting. 

Survey: Hospital at home ‘no longer an opt-in’ 

CHICAGO – Planning for hospital-at-home has increased considerably, according to a new survey from Chartis Group. Four out of five respondents to the 2022 survey report that they have plans for hospital-at-home compared to two out of three to the 2021 survey, according to “The Race Toward Digital Transformation: 2022 Health System Survey.” “Digital transformation is no longer an opt-in priority for hospitals and health systems,” the report states. “It is a necessary journey for them to not only plan but implement – and time is of the essence. New market entrants are disrupting the digital health space and quickly raising the competitive bar for what patient consumers expect from their care experiences. Without immediate action, provider organizations risk losing their ability to attract new patients, retain their existing ones, build robust provider networks and enter new markets.” Nearly all executives (99%) say it’s important to invest in digital transformation. The top reasons why? To improve outcomes (61%) and reduce cost of care (23%).  

EW launches mother-baby program 

WATERLOO, Iowa – Essentially Women (EW), a division of VGM & Associates, has launched Lily, a new mother-baby program designed to help members grow their business in the fast-growing area of the women’s care industry. The program offers products, services and solutions to help members support women in all stages of motherhood. “Whether you’re starting a new business expanding your current offerings, Lily is our source for EW members to gain access to education, thought leadership, product vendors, services and programs dedicated to helping them succeed in this lucrative segment,” said Nikki Jensen, vice president of Essentially Women. “We’re so excited to embark on the motherhood journey together.” Resources that are part of the program include thought leadership, education and training, discount programs and more. EW’s leading vendor partners are also part of this program.  

 ACHC launches vendor certification 

CARY, N.C. – The Accreditation Commission for Health Care (ACHC) now offers certification to vendors that provide products, such as electronic health records, human resources management solutions, document management tools and more, to their accredited organizations. The new certification provides validation that a vendor’s products meet the requirements of some or all relevant standards. A product can be certified in seven areas, each aligning with a group of standards that an organization must adhere to achieve ACHC accreditation. These areas include evaluating vendor compliance for administration, operations, fiscal management, human resources, provision of care, record management, and quality and risk management. Careficient, an EMR software solutions agency for home health, hospice and home care providers, is the first vendor to receive the certification. 

 CPAP trumps MAD in certain parameters, study finds  

YARMOUTH, Maine – Treatment with CPAP devices was better than mandibular advancement devices at normalizing polysomnographic parameters and improving quality of life in patients with mild obstructive sleep apnea, according to a recent study published in Sleep Breathing Physiology and Disorders. Fatigue was improved in both CPAP and MAD groups, and daytime sleepiness, mood and sustained attention showed no difference. This study was a single-blind, parallel, randomized clinical trial with controls. The sample was composed of individuals between 18 and 65 years of age with a body mass index of < 35 kg/m2 and apnea/hypopnea index above five and less than 15. Participants were submitted to physical examination, polysomnography, and the following questionnaires: Pittsburgh Sleep Quality Index, Berlin Questionnaire, Epworth Sleepiness Scale, Stanford Sleepiness Scale, Karolinska Sleepiness Scale, Modified Fatigue Impact Scale, Functional Outcomes of Sleep Questionnaire, Beck Anxiety Inventory, and Beck Depression Inventory. They were also presented with the following tests: maintenance of wakefulness test and psychomotor vigilance task. Of 79 patients, 25 were in the MAD group, 31 in the CPAP group, and 23 in the control group. 

HealthIV launches in LA 

LOS ANGELES – HealthIV is bringing its in-home infusion therapy services to the Los Angeles metro area. The company, which focuses on full digital interoperability between patients, doctors, pharmacists and home health care workers, offers treatment for everything from chronic illnesses to dehydration. It staffs a team of registered nurses working 24/7. “The arrival of HealthIV in the Los Angeles market is part of the larger goal to expand our footprint within the western U.S.'" said Humza Khan, CEO of HealthIV. "This comes on the heels of our recent availability in Las Vegas and Austin, which was built on our long-established presence in New York, New Jersey and Miami.” HealthIV's expansion into the Los Angeles market follows its successful launch in Las Vegas in November 2021. It was found in 2020 to offer on-site and in-home ambulatory health care and infusion therapies with registered medical professionals. 

ResMed invests in R&D 

SAN DIEGO – ResMed has officially opened a new technology R&D facility in Sandyford in Dublin, alongside Tánaiste Leo Varadkar, to support innovation, technology development and product development. The company is investing 30 million euros in the facility, doubling its Ireland-based software and technology team with 70 jobs over the next four years, including high-skilled, high-paying roles such as mobile, AWS and full-stack software developers and algorithm/machine learning engineers. “I’m thrilled to be in Dublin to officially open this state-of-the-art R&D facility,” said Mick Farrell, CEO. “This investment will support the continued growth of ResMed’s product portfolio to meet the needs of patients across Ireland, Europe, and the world. It will also create new capabilities and skills within our expanding team in Ireland and support our global innovation strategy.” Many of ResMed’s digital innovations are developed or enhanced by the company’s Ireland-based “ResMed Sensor Technologies” division. ResMed’s investment is supported by the Irish Government through IDA Ireland. 

Gov’t charges two in $7.8M scheme 

NASHVILLE – The U.S. Attorney’s Office for the Middle District of Tennessee has charged Tache “Gabe” Georgescu, 45, and Natalia Georgescu, 38, both of Laguna Niguel, Calif., owners and operators of now defunct Lowry Medical Supply, Inc., in Nashville with conspiracy to commit health care fraud and paying illegal kickbacks. According to the charging document, in November 2017, the Georgescus purchased Lowry Medical, and in 2018, they purchased three other DME companies located in Florida, but which were operated interchangeably with Nashville-based Lowry Medical, including Medpros Associates LLC, Alliance DME LLC and AYMS LLC., all of which are also now defunct. The charging document alleges the Georgescus paid illegal kickbacks and bribes in exchange for the referral of Medicare beneficiaries by medical professionals, working with fraudulent telemedicine companies, for back, shoulder, wrist, and knee braces that are medically unnecessary. Some of the charges concern luring Medicare beneficiaries, who were elderly or suffering from dementia, into a criminal scheme where the Georgescus mailed orthotic braces that these beneficiaries never asked for, never wanted and never needed. They then billed Medicare for the cost of the orthotic braces. In the summer of 2018, a Medicare accrediting agency advised the Georgescus that Lowry Medical was violating Medicare rules in many ways. In just 17 months, the Georgescus paid so-called marketing companies approximately $7.8 million in illegal kickbacks and bribes in exchange for those marketing companies providing the Georgescus with ready to bill doctors’ orders for orthotic braces for Medicare beneficiaries.  In turn, the Georgescus billed Medicare approximately $30 million for orthotic brace orders during this same period. If convicted, the defendants face up to ten years in prison.


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