In brief: Vent correction, Medtrade ‘Insider,’ documentation update 

CAMBRIDGE, Mass. – Philips Respironics has issued a voluntary correction for Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal and Trilogy EV300 ventilators regarding the use of in-line nebulizers. 

The company has determined that, in some circumstances, the use of in-line nebulizers placed in certain locations may lead to aerosol deposits forming over time on the ventilator flow sensor. Should this occur, there is a possibility of patient impact due to one or more of the following conditions: inoperative following stand by or powering off, leading to delay in therapy; and over-delivery of inhaled and exhaled air (tidal volume) and/or under-delivery of oxygen for devices with a specific concentration setting (FiO2).  

Philips is sending health systems and equipment distributors urgent medical device corrections with additional usage instructions and guidance for continued use of affected devices: 

• All Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal, and Trilogy EV300 users, regardless of in-line nebulizer use are advised to take the following steps from the device Instructions for Use: Ensure that specific alarms are set appropriately for patients, and ensure that alternate sources of ventilation are available in case a ventilator ceases to function. 
• If using a Trilogy Evo O2, Trilogy Evo Universal, or Trilogy EV300 device with a specific oxygen concentration (FiO2) setting: Ensure patients receive adequate oxygenation by continuous pulse oximetry (SpO2) monitoring in accordance with treatment protocols; use an external FiO2 analyzer in specific patient cases, and switch to an alternative ventilator if an external FiO2 analyzer is not available; and as indicated in the Instructions for use, maintain an immediately available back‐up device or alternative ventilator for rapid therapy transition. 
• If using in-line nebulizer treatments: Follow the visual instructions in the field safety notice for correct nebulizer placement; for specific prescriptions indicated in the field safety notice, transition patient to alternate device configurations. 

Philips says it has not received any specific complaints of device malfunctions resulting from in-line nebulizer use, but the issue was identified through a retrospective review of flow sensor performance. At the time of the notification, the company says no deaths have been reported. 

The company says it is investigating a solution and will provide additional information when available. 

For the full update, go here. 

Sunset Healthcare launches pediatric line 

CHICAGO – Sunset Healthcare Solutions has launched Brighter Pediatrics, a new product line dedicated to enhancing outcomes for home care providers serving pediatric patients. The line features pediatric NIV/CPAP masks, such as the Ray Pediatric Nasal and Full-Face Masks; an assortment of ventilator circuits and closed ventilation suction systems; and the Microflow Microdial Flowmeter which allows for precise and repeatable micro-step flow adjustments for infants requiring supplemental oxygen. “We are committed to expanding our capabilities and product offerings as we broaden our reach across various health care sectors,” said PJ Ruflin, vice president of business development. “This growth enables us to identify unique opportunities to deliver meaningful value. The pediatric space is especially vital, and we are thrilled by the innovative advancements taking place. Our goal is to strategically position ourselves to seize these opportunities and support our customers in every way possible. We look forward to deepening our engagement in this area.” Sunset Healthcare celebrates its 20th year in business in 2024. 

HoneyNaps is official in US 

BOSTON – HoneyNaps, which is based in South Korea, has delivered its artificial intelligence sleep disorder diagnostic software SOMNUM to two medical institutions in the United States, it announced Oct. 7. "The U.S. is the largest sleep medicine market in the world and still holds significant growth potential,” a company representative said. “As we officially enter the U.S. market, we will solidify our business strategy to achieve a 10% market share within three years." HoneyNaps is currently strengthening its B2B business with major companies in South Korea, while simultaneously selling through its U.S. subsidiary in Boston and its West Coast dealer channels and expects continuous growth in export volume. SOMNUM is an algorithm that analyzes bio signal data during sleep and provides disease diagnoses in under five minutes using its self-developed AI model. The company says the software can be integrated into any medical and health care market using real-time, large-scale bio signal. HoneyNaps recently raised an additional $11.6 million in funding. 

PSN Labs responds to Philips lawsuit 

PITTSBURGH – PSN Labs has disputed claims made by Philips that the lab caused “significant damage” to the company by conducting “numerous egregious errors in its testing and analysis” related to recalled sleep and respiratory devices. In a response filed Sept. 27 in the U.S. District Court for the Western District of Pennsylvania, PSN says the company “has continued to mischaracterize testing results in an effort to conceal the ultimate foam degradation issue.” “Philips, similar to its attempts against other third parties, is attempting to deflect attention to PSN Labs and away from Philips’ own failures, negligence, concealment and recklessness,” it stated. Philips, in a lawsuit filed July 29, says PSN’s work was a big reason it initiated a worldwide recall of more than 15 million sleep and respiratory devices in June 2021 and that the company would have pursued a “different and more focused recall” had PSN not “overestimated the potential threats to patients.” In its 48-page response, PSN points out that Philips did not engage the lab until 2021, well after the company began researching the foam degradation issue in 2016. “PSN Labs’ one report is not the reason or the basis for the Philips recall,” the response stated. PSN has called for a jury trial. 

Noridian updates medical records requirements 

WASHINGTON – In the event of a claim review, information contained directly in the contemporaneous medical record is the source required to justify payment, except as noted elsewhere for prescriptions, according to an update posted by Noridian Healthcare Solutions. The medical record is not limited to records from treating physician/practitioner offices but may include records from hospitals, nursing facilities, home health agencies and other health care professionals. Records from suppliers or health care professionals with a financial interest in the claim outcomes are not considered sufficient by themselves for determining that an item is reasonable and necessary. Noridian reminds DMEPOS suppliers that: 

• Supplier-produced records, even if signed by the prescribing physician/practitioner, and attestation letters (e.g. letters of medical necessity) are deemed not to be part of a medical record for Medicare payment purposes. 
• Templates and forms are subject to corroboration with information in the medical record. 
• Medical information intended to demonstrate compliance with coverage criteria may be included on a prescription but must be corroborated by information contained in the medical record. 

In addition to the general requirements discussed above, certain DMEPOS items may have specific documentation requirements. Details regarding these policy specific requirements are contained in the applicable LCD-related policy article. 

 For the full update, go here. 

Invacare wins award for ‘Move’ campaign 

ELYRIA, Ohio – Invacare’s “Move for Mobility” campaign, held in May, has won the Web Marketing Association’s 20234 WebAward in two categories: “Medical Standard of Excellence” and “Non-Profit Standard of Excellence.” The campaign, in partnership with Free Wheelchair Mission, brought together 425 Invacare employees worldwide to “get moving” and raised $28,000, funding 294 wheelchairs for people in remote communities. “We are incredibly proud to receive the 2024 WebAward for our Move for Mobility campaign in partnership with Free Wheelchair Mission,” said Arielle Favard, digital communications specialist. “It’s been a rewarding and inspiring project with a purpose that has had a real positive impact. The award inspires all of us at Invacare to continue innovating and providing the resources, platforms and voice that our communities need to lead active, independent lives.” Invacare says the award was given to "Move for Mobility” for “our purpose-built web platforms used during the campaign.” The company and Free Wheelchair Mission plan to partner on the campaign again in May 2025. 

Medtrade’s ‘Insider’ rates go live 

DALLAS – The lowest registration rates for Medtrade 2025 are now in effect. These “Insider” rates include a $49 expo pass and a $199 conference pass. “A conference pass provides access to all educational sessions, the expo floor and the Consultant Cocktail Hour,” said Kerry Tyler, associate show director. “At $199, it’s an excellent deal, but the time is highly limited. Whether you want the expo pass or the conference pass, now is the time to take advantage.” “Insider” rates are in effect through Oct. 26, followed by “SmartSaver” rates from Oct. 27 through Nov. 16. Medtrade is scheduled for Feb. 18-20 at the Kay Bailey Hutchinson Convention Center in Dallas. Register here. 

Integrated Home Care Services names CMO 

MIRAMAR, Fla. - Integrated Home Care Services, an independent benefit manager of home health, DME and home infusion services, has announced that Ajani Nimmagadda, MD, has been named chief medical officer. Nimmagadda, who has nearly three decades of experience in health care, both as a practicing internal medicine and infectious diseases physician and as a health care executive, will assume clinical and medical management leadership across the organization. "Dr. Nimmagadda's leadership in driving clinical outcomes, quality of care, and healthcare affordability will be instrumental in helping us continue to fulfill our mission and support our continued growth," said Christopher Bradbury, CEO of IHCS. "Her proven track record of achieving better outcomes for patients, providers, and health plans and her expertise across the healthcare ecosystem will further accelerate our innovation and value-based care solutions." Most recently, Nimmagadda served in a variety of leadership roles at Cigna Healthcare, where she oversaw comprehensive medical and pharmacy utilization management programs and specialty drug clinical programs, including gene therapies. The announcement comes as IHCS celebrates significant expansion and growth fueled by the company's home care benefit management services model supporting health plans in their Medicare Advantage, managed Medicaid, commercial and ACA offerings. The company says its integrated model, which is tailored to the specific needs of each health plan, improves timeliness to high quality care and clinical outcomes, enhances member experience, reduces health care costs, and simplifies administration of care in the home.   

AOPA names recipient of digital award 

ALEXANDRIA, Va. - The American Orthotic & Prosthetic Association recently awarded the 2024 Professor Hans Georg Näder Digital O&P Care Award to Joshua Steer at its National Assembly. AOPA’s Digital O&P Care Workgroup chose Dr. Steer based on his research, Insights into Transtibial Prosthetic Socket Design from Expert UK Clinicians’ Digital Records. “Congratulations to Dr. Steer for being this year’s recipient,” said Eve Lee, executive director of AOPA. “We appreciate his contribution to digital clinical care research that will help advance the profession. AOPA is proud to award the Professor Hans Georg Näder Digital O&P Care Award for the third year. It is important to recognize contributions to improvements in digital clinical care for the individuals our profession serves.” The award was established in 2022 through a gift from Ottobock Healthcare in honor of Professor Hans Georg Näder and his many contributions to the field of orthotics and prosthetics worldwide. The purpose of the award is to prepare the O&P profession for the future as digital care and innovations in technology continue to lead the direction of patient care.