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In brief: Stakeholders push back, Owens & Minor upsizes offering, Merits expands

In brief: Stakeholders push back, Owens & Minor upsizes offering, Merits expands

WASHINGTON – AAHomecare, the Council for Quality Respiratory Care and VGM are raising concerns with CMS and lawmakers about the access issues and the negative health outcomes that could result from a recent draft proposal for noninvasive positive pressure ventilation. 

CMS on March 11 released a proposed decision in response to the request to reconsider NCD 280.1 to establish coverage policies for the use of noninvasive home mechanical ventilators and respiratory assist devices for Medicare beneficiaries with COPD.   

Stakeholders are encouraging providers, in particular, to submit comments on the proposal by April 10. 

“Our groups will be submitting official comments, as well,” said AAHomecare in a bulletin. “But your comments, with an emphasis on first-hand perspectives on the potential impacts to patient care, are critical to making sure that CMS takes into account the real-world practical impact the proposals will have on patients.” 
 
AAHomecare is providing key concerns for providers to use in their messaging. They include:  

Concern that there is no grandfathering of patients already receiving RAD or HMV therapies 

Patients already relying on these devices are unlikely to have the documentation required by the draft NCD in their medical records. Moreover, if a physician/prescriber believes that the patient continues to benefit from the device, it would be inappropriate to remove the device from their home and risk hospitalization or death. 

Concern with the six-month re-evaluation and its impact on continued therapy 

The proposed six-month requirement will make it even harder for chronically ill patients, especially those in rural areas, to access essential ventilation therapy. Many patients already struggle to see their doctors annually, and more frequent visits will create additional barriers to care. Many patients may not have the financial ability to cover the cost-sharing required by these additional visits. This could lead to delays or disruptions in critical treatment, worsening health outcomes. 

Concern with the requirement that a repeat Arterial Blood Gas (ABG) is obtained every six months as part of the re-evaluation 

Strict qualifying criteria, such as requiring a painful and invasive ABG draw is unnecessary and burdensome for this chronically ill patient population. Excluding the use of other reliable and less invasive tests like VBG or ETCO₂ will further limit access to care, particularly in rural areas lacking specialty facilities.  

Concern with the requirement for a patient to utilize the therapy on average five hours per day 

The requirement is not consistent with current industry standards and policies, which define adherence to therapy as using PAP for more than four hours per night on 70% of nights during a consecutive 30-day period anytime during the first three months of initial usage. The implementation of a new measure has the potential to disrupt patient care, especially considering the complexities of adoption that will be faced by suppliers and device manufacturers.  

More tips on submitting effective comments can be found here
 
To submit comments, click the ‘Submit Public Comment’ blue button towards the top of the NIPPV Proposed Decision Memo posting page. From there, you will be led to a comment submission page where you will need to copy and paste your comments into the online form. 

Merits expands portfolio with Aergo 

Plans include incorporating Aergo’s ‘clinically validated technology’  

FORT MYERS, Fla. – Merits Health Products has acquired Aergo, a U.K.-based company specializing in postural management solutions for wheelchair users. 

The acquisition accelerates Merits’ roadmap toward creating a fully integrated ecosystem of smart mobility solutions that leverage data and connectivity to improve outcomes and health care provider insights. 

“The acquisition of Aergo Health aligns perfectly with our mission of enabling independence and accessibility for all,” said Jonathan Cheng, president of Merits. “By incorporating Aergo’s clinically validated technology into our product lineup, we’re taking a significant step forward in enhancing our seating and positioning solutions for customers worldwide.” 

Aergo’s patented smart air cells automatically adjust the seat positions of wheelchair users in real time, providing personalized support and comfort through an IoT-enabled system. The company has also been developing AI capabilities to personalize and automate postural management set up. 

Sheana Yu, founder and CEO of Aerogo, will join Merits as U.K. product manager, where she will oversee the integration of Aergo’s technology into Merits Health Products and work with the team to strengthen the company’s seating portfolio. 

“I’m excited to join the excellent team at Merits Health Products and continue our work in revolutionizing wheelchair seating technology,” she said. “This acquisition provides us with the resources and global reach to make our dynamic postural management solutions available to more people who can benefit from them.” 

Study finds link between sleep deficiency, Alzheimer’s 

DARIEN, IL — A new study demonstrates an important association between sleep health and long-term brain health and it highlights potential opportunities to reduce the risk of Alzheimer’s disease. 

According to the study, published March 31 in the Journal of Clinical Sleep Medicine, individuals with lower proportions of time spent in slow wave sleep and rapid eye movement sleep had smaller volumes in critical brain regions, particularly the inferior parietal region, which is known to undergo early structural changes in Alzheimer’s disease. The results were adjusted for potential confounders, including demographic characteristics, smoking history, alcohol use, hypertension, and coronary heart disease. 

“Our findings provide preliminary evidence that reduced neuroactivity during sleep may contribute to brain atrophy, thereby potentially increasing the risk of Alzheimer’s disease,” said lead author Gawon Cho, who has a doctorate in public health and is a postdoctoral associate at Yale School of Medicine. “These results are particularly significant because they help characterize how sleep deficiency, a prevalent disturbance among middle-aged and older adults, may relate to Alzheimer’s disease pathogenesis and cognitive impairment.” 

The study involved an analysis of data from 270 participants with a median age of 61 years. Fifty-three percent were female, and all participants were white. Individuals were excluded from the analysis if they previously had a stroke or probable dementia or other significant brain pathology. The research utilized polysomnography to assess baseline sleep architecture. Advanced brain imaging techniques were used to measure brain volumes 13 to 17 years later. 

The researchers emphasized that further investigation is needed to fully understand the causal relationships between sleep architecture and Alzheimer’s disease progression. 

“Sleep architecture may be a modifiable risk factor for Alzheimer’s disease and related dementias, posing the opportunity to explore interventions to reduce risk or delay Alzheimer’s onset,” said Cho. 

ITEM Coalition supports H.R. 2005 

WASHINGTON – The ITEM Coalition has lent its support to H.R. 2005, a bill to reestablish 75/25 blended Medicare DME reimbursement rates in non-rural/non-competitive bidding areas. In a letter to the bill’s lead sponsors, the coalition states: “H.R. 2005 is squarely in line with the goals of the ITEM Coalition to ensure that all people can access the specialized devices and services they need to ensure their health and independent function. For these reasons, we are proud to support this critically important legislation and look forward to working with your office to ensure its enactment into law in order to preserve and protect access to affordable, timely, and quality home medical equipment for Medicare beneficiaries. The group of ITEM Coalition members highlights the importance of the bill by emphasizing the coalition does not usually address reimbursement issues as they make their case: The ITEM Coalition typically does not address reimbursement issues and tends to focus on coverage and coding of assistive devices and technologies. However, when reimbursement policies materially impact patient access to care, we feel it is important to weigh-in with our members’ concerns.” 

NHIA welcomes two new board members 

ALEXANDRIA, Va. – The National Home Infusion Association has added two new companies to its 2024-2025 board of directors: Pentec Health and Vital Care. Pentec Health, a national provider specializing in renal nutrition and intrathecal home infusion with plans to expand the home infusion market, will be represented by Matthew Deans, CEO. Vital Care, a national provider with 135 active home infusion pharmacy and ambulatory infusion suites and a rapidly expanding franchised provider with 42 more locations in development, will be represented by Logan Davis, executive vice president of trade relations and strategy. Additionally, Upstate Home Care, Froedtert Health and Amerita have been elected to additional terms. “Being elected to the board of directors is the highest level of dedication and investment in NHIA and demonstrates a desire to work collaboratively with peer organizations to advance the infusion industry,” said Connie Sullivan, NHIA president and CEO. “We are excited to welcome Pentec Health and Vital Care and thank you to all our board companies as their participation in NHIA brings diverse perspectives that will help the association effectively address member needs.” Leaving the board will be Past Board Chair Tim Affeldt, representing Fairview Pharmacy Services; and Leena Samuel, representing Paragon Healthcare. 

Resolute Health rebrands as Resolve Sleep Health 

HALIFAX, N.S. – Resolute Health, Canada's largest privately held sleep health company with more than 80 locations, is rebranding to Resolve Sleep Health. The new name reflects the company's renewed commitment to providing innovative, comprehensive sleep therapy for a broader spectrum of sleep health challenges, while focusing on improving the overall health and well-being of individuals affected by sleep disorders. "We are thrilled to introduce Resolve Sleep Health as our new name, which very concisely represents our mission and vision for the future," said Heather Shantora, CEO of Resolve Sleep Health. "Sleep is a critical aspect of one's overall health, so we will be at the forefront of growth, innovation, and expertise to help Canadians achieve healthier, more restful lives." The rebranding aligns with Resolve Sleep Health's efforts to expand its services and enhance its offerings in the rapidly growing field of sleep health. The organization remains committed to helping individuals with sleep apnea, insomnia, snoring and other sleep-related issues with a range of diagnostic and therapeutic solutions. "We believe that by evolving into Resolve Sleep Health, we can more effectively communicate our comprehensive approach to sleep care and reinforce our dedication to resolving the challenges that affect so many people," said Brooke Allen, COO. "This is just the beginning of a new chapter, and we are excited about the future." 

Saskatchewan expands CGM coverage 

BURNABY, B.C. – The government of Saskatchewan has expanded public coverage for continuous glucose monitoring (CGM) systems. The expansion, which now provides full coverage for CGMs for young adults ages 18 to 25 and seniors ages 65 and over, marks a significant step toward improving clinical outcomes and enhancing the quality of life for nearly 10,000 individuals living with diabetes in the province, Dexcom says. "Managing diabetes presents unique challenges for Canadians who rely on insulin,” said André Côté, vice-president and general manager, Dexcom Canada. “While insulin is life-sustaining, determining the appropriate dosage can be challenging without the data provided by continuous glucose monitoring systems. The government of Saskatchewan’s decision is a significant and positive step forward for the diabetes community." As part of the provincial government’s recent Budget 2025 announcement, Dexcom G7 and Dexcom G6 CGM systems are now publicly covered for residents living with diabetes age 18-25 and those over 65 who use any type of insulin, in addition to the previously reimbursed group of people ages 2-18. 

Owens & Minor upsizes offering to $1B 

RICHMOND, Va. – Owens & Minor has upsized its recently announced private offering to from $600 million to $1 billion aggregate principal amount of senior secured notes. The notes will bear interest at the rate of 10% per year and will mature April 15, 20230. The proceeds will be used to finance its acquisition of Rotech Healthcare, along with cash on hand and expected borrowings under a new senior secured incremental term loan B facility. Proceeds will also be used for other transactions contemplated by the related merger agreement, including the repayment of Rotech debt and to pay acquisition-related fees and expenses. Any remaining net proceeds will be used for working capital and general corporate purposes. The notes will be fully and unconditionally guaranteed, jointly and severally, on a senior secured basis by the company and certain of its domestic subsidiaries that guarantee the company’s existing term loan facility and revolving credit facility. If the issue date occurs prior to the closing of the acquisition (and subject to applicable grace periods), the notes will be secured only by a first-priority security interest in the escrow account and all funds on deposit therein. The offering is expected to close April 4. 

Cardinal Health finalizes ADSG acquisition 

DUBLIN, Ohio – Cardinal Health has completed its acquisition of the Advanced Diabetes Supply Group (ADSG). Cardinal announced in November 2024 that it had entered into a definitive agreement to acquire ADSG for about $1.1 billion in cash, with plans to merge the company into its at-Home Solutions business. ADS, led by CEO Bill Mixon, serves about 500,000 patients annually. “Today marks an important milestone for Cardinal Health at-Home Solutions, and one that will, ultimately, allow us to serve more people in the home,” said Rob Schlissberg, president, Cardinal Health at-Home Solutions. “With the addition of ADSG, we are strengthening our core and strategically positioning our business to grow alongside the demand for accessible diabetes care. Our goal remains unchanged, which is to simplify quality care in the home. This is yet another pivotal step in that mission. We are excited to see where this next chapter takes us.” The acquisition is synergistic with Cardinal Health at-Home Solutions’ strategy to expand patients served and accelerate growth in key areas, including the increasing diabetes patient population. The ADSG team will become a part of Cardinal Health’s at-Home Solutions business. 

InfuSystem’s Dilorio to step down in May 

ROCHESTER HILLS, Mich. – InfuSystem Holdings has announced that CEO Richard DiIorio will be stepping down May 19, 2025, and that Carrie Lachance, the company’s president and COO and a member of the s board directors, will assume the role at that time. “Carrie has been at the center of InfuSystem’s succession plan for the past several years, and she is the ideal person to succeed Rich having spent the last decade plus working her way up through ever greater positions of responsibility within the company,” said Scott Shuda, chairman of the board. Lachance previously held senior roles as senior vice president of clinical and customer services. Prior to that, she was a territory sales manager. Dilorio will serve as an advisor to Lachance during the transition.

 

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