In brief: Push for timeline, win for knee orthoses, results for Apnimed 

WASHINGTON – AAHomecare, the COPD Foundation, the Council for Quality Respiratory Care and VGM Government Relations have formally requested that CMS establish a clear implementation timeline for the new national coverage determination for non-invasive positive pressure ventilation.  

In a letter sent July 23, the groups asked CMS to delay implementation until at least one year after the NCD’s publication date of June 9. 

“Adopting a clear implementation glidepath will allow the Trump administration to avoid the unintended consequence of Medicare beneficiaries and Medicare Advantage enrollees losing access to or not being able to access life-sustaining respiratory assist devices (RADs) and home mechanical ventilators (HMVs) under the new NIPPV NCD,” the letter states. 

Why a glidepath is needed 

The groups outlined several reasons for a phased approach: 

• Policy clarity: While the NCD addresses coverage for RADs and HMVs, many details remain unclear. Additional guidance is needed to ensure prescribers, suppliers and other stakeholders have a consistent understanding of the new requirements. 
• Education & training: Once the policies are clarified, the community will need time to educate physicians, respiratory therapists and patients—many of whom may be unaware of the changes. 
• Technology updates: Manufacturers must update hardware and software to meet new standards. Providers will then need time to align their compliance and billing systems accordingly. 
• Monitoring burden: The new tracking requirements will significantly increase the workload for suppliers and patients. Encouraging compliance is already challenging; enforcing it will be even more complex. 
• Access to testing: New arterial blood gas (ABG) testing requirements may limit access, especially in areas where such tests are not readily available in outpatient settings. 

Call for consistency across Medicare 

In the letter, the groups also emphasized that any implementation date should apply uniformly to both Medicare fee-for-service and Medicare Advantage claims. 

“We would welcome the opportunity to provide more detail but hope that this overview allows CMS to work with the community to protect patients who need these devices from unintentionally losing access to them or not being able to access them when needed,” the letter continues. “The lack of access to RAD and HMV will result in higher hospitalization rates and substantially higher Medicare costs, as well as lead to a lower quality of life for those patients who medically require these devices.” 

• Related: Win for patients, challenges for providers in new vent policy. 

Proposed knee brace LCD ‘big win,’ says AOPA 

WASHINGTON – The DME MACs have released a draft revision to the Knee Orthoses Local Coverage Determination (LCD) and its corresponding Policy Article. 

DL 33318 comes nearly two years after the American Orthotic and Prosthetic Association (AOPA) made a formal LCD reconsideration request. 

Under the new draft policy, Medicare would cover knee orthoses for medial or lateral tibiofemoral osteoarthritis without requiring joint instability, so long as the following are met and appropriately documented: 

• The patient is ambulatory 
• The patient is experiencing pain or functional impairment due to OA 
• The knee orthosis provides varus or valgus adjustment 
• The patient expresses a willingness to use the orthosis 

Historically, Medicare coverage for knee orthoses required a history of recent knee injury or surgery, or documentation of joint instability. This meant that “unloader” braces—clinically proven to alleviate OA symptoms—were consistently denied as not medically necessary. AOPA has long argued that this outdated policy fails to reflect current clinical best practices. 

“It’s a big win for patients,” Joe McTernan, director of health policy and advocacy for the American Orthotic & Prosthetic Association (AOPA), told HME News. 

CMS will hold a public hearing on Aug. 27, 2025, and AOPA will participate to ensure member interests are represented. AOPA’s Policy Team and Coding & Reimbursement Committee are reviewing the proposed LCD in full and will submit formal comments as needed. 

View the official documents: 

• Proposed LCD – Knee Orthoses (DL33318) 
• Draft KO Policy Article 

UnitedHealth confirms investigation 

MINNETONKA, Minn. - UnitedHealth Group says it has proactively reached out to the U.S. Department of Justice after reviewing media reports about investigations into certain aspects of the company’s participation in the Medicare program. In a statement posted to its website, the company says it has now begun complying with formal criminal and civil requests from the department. It says it has full confidence in its practices and is committed to working cooperatively with the department throughout the process. “The company has a long record of responsible conduct and effective compliance. Independent CMS audits confirm that the company’s practices are among the most accurate in the industry, and, following a decade-long civil challenge by the Department to aspects of our Medicare Advantage business, a court-appointed Special Master concluded there was no evidence to support claims of wrongdoing.” UnitedHealth says it has also proactively launched its own initiative to conduct third-party reviews of policies, practices and associated processes and performance metrics for risk assessment coding, managed care practices and pharmacy services. Earlier this year, The Wall Street Journal reported that federal officials were investigating how the company records diagnoses that lead to extra payments for its Medicare Advantage plans. UnitedHealth’s UnitedHealthcare business covers more than 8 million people as the largest provider of these plans. 

Apnimed announces positive results for sleep apnea pill, plans FDA filing 

CAMBRIDGE, Mass. – Apnimed, a pharmaceutical company developing oral therapies for obstructive sleep apnea (OSA) and related conditions, announced positive topline results from its second pivotal Phase 3 trial of AD109 (aroxybutynin 2.5mg/atomoxetine 75mg). The 12-month LunAIRo study assessed the efficacy and safety of AD109 in adults with mild to severe OSA across various weight classes. The primary endpoint, measured at 26 weeks, was met with a 46.8% mean reduction in AHI compared to 6.8% with placebo (p<0.001). This reduction remained statistically significant at week 51 (p<0.001). AD109 was generally well-tolerated, with mostly mild to moderate side effects consistent with previous studies. No serious treatment-related adverse events were reported. LunAIRo’s results align with those from Apnimed’s earlier SynAIRgy Phase 3 trial, further supporting AD109’s safety and efficacy, the company says. “With two large Phase 3 studies now demonstrating a consistent and significant efficacy profile for AD109, we are closer to delivering the first oral pharmacotherapy for over 80 million U.S. adults with OSA,” said Larry Miller, MD, CEO of Apnimed. “We’re focused on ensuring we have the capabilities, people, and partnerships in place to bring this innovative drug to patients suffering from OSA and the clinicians who treat them.” AD109, a once-a-day pill taken at bedtime, is an anti-apneic neuromuscular modulator, combining aroxybutynin, a novel antimuscarinic, and atomoxetine, a selective norepinephrine reuptake inhibitor (NRI) to target the underlying neuromuscular root cause of OSA. Apnimed plans to submit a New Drug Application to the FDA in early 2026.   

BOC appoints compliance lead 

OWINGS MILLS, Md. - The Board of Certification/Accreditation (BOC) has appointed Tina Culbreth, CHC, CCEP, CHPC, CDME, as director of compliance to oversee its compliance and accreditation operations. In this role, she will provide strategic oversight of business activities like accreditation eligibility reviews, corrective action processes and surveyor communications. She will also collaborate with internal teams and stakeholders to enhance process efficiency and ensure alignment with CMS requirements and BOC’s rigorous standards. “Tina brings a combination of strategic insight, operational excellence and industry-specific compliance knowledge,” said Judi Knott, president & CEO of BOC. “Her leadership and experience will further our commitment to excellence in accreditation and certification.” Culbreth brings more than a decade of experience in compliance leadership, most recently serving in compliance roles at Illumina and Ortho Virginia. At Illumina, she managed global recall compliance and partner audits; at Ortho Virginia, she served as HIPAA Privacy Officer and led enterprise policy and compliance risk management. Culbreth built the compliance department at Dynasplint Systems, where she successfully implemented corporate compliance programs and spearheaded accreditation through BOC and the Accreditation Commission for Health Care (ACHC). Culbreth is a BOC Certified DME Specialist (CDME), Certified in Healthcare Compliance (CHC), Certified in Healthcare Privacy Compliance (CHPC) and a Certified Compliance and Ethics Professional (CCEP). She earned her Bachelor of Business Administration degree from Strayer University. 

DASCO targets Northeast with new location 

WESTERVILLE, Ohio – DASCO Home Medical Equipment has expanded its footprint to Massachusetts with a 3,400-square-foot office in Wilmington, according to Boston Real Estate Times. The company expanded to the Northeast after securing contracts with hospitals in the state, according to Steve Cusano, leasing director for Cummings Properties. The new location will serve as a regional hub for administration, storage and deliveries, and business development throughout the greater Boston area, he said. “Just off I-93, 50 Concord Street offers an ideal strategic homebase for DASCO HME,” he said. “Its direct access to the major local transportation routes will fuel DASCO’s continued growth by making it easier to connect with clients, employees and key markets across the region.” DASCO’s new neighbors on Concord Street include fellow health care providers Beth Israel Lahey Health Primary Care, Concentra Urgent Care, Health Angels Home Care, National Seating & Mobility and Partners in Rehab Physical Therapy, among others, according to Boston Real Estate Times. Founded in 1987, DASCO offers a range of respiratory therapy and durable medical equipment, including oxygen, non-invasive ventilation and mobility support products. The family-owned company operates in more than 30 locations across Ohio, Michigan, Indiana, Kentucky, West Virginia, Texas and Florida. 

Dexcom brings photo meal logging feature to Stelo 

SAN DIEGO – Dexcom has released a new AI-powered photo meal logging feature to Stelo, the first over-the-counter glucose biosensor cleared by the Food and Drug Administration in the United States. The company previously released the feature for its Dexcom G7 earlier this year. “Diet plays a crucial role in managing glucose levels, and our new Smart Food Logging feature removes barriers to food tracking, making it easier to consistently log and understand the impact of meals,” said Jake Leach, president and COO at Dexcom. “Smart Food Logging has long been a highly requested feature from users across our product portfolio, so we’re excited to bring it to market and hope this enhanced tracking feature makes managing glucose levels even simpler.” Stelo and Dexcom G7 users can now simply take a photo of their food in the app where AI will automatically identify the ingredients and populate the meal description. The company says the feature encourages and enables users to log their meals more consistently. Stelo and Dexcom G7 users can now access the Smart Food Logging feature by updating to the latest version of the app on iOS and Android platforms. Other recently announced enhancements to Dexcom’s portfolio include: 

• Weekly Insights in Stelo: More personalized tips, recommendations and education related to diet, exercise and sleep. 
• Stelo integration with Oura: Holistic view of the body’s biometrics, now including glucose.  
• Customizable target range in Dexcom G7: Adjust glucose target ranges in Clarity Card within the Dexcom G7 app, beyond default settings – allowing for greater personalization across user groups. 
• Glucose impact in Dexcom G7 and Stelo: A new focused view for logged events to see a clearer picture and gain a deeper understanding of how meals, activities and sleep patterns affect your glucose levels. 

Soleo Health achieves ACHC accreditation 

FRISCO, Texas – Soleo Health has achieved accreditations from the Accreditation Commission for Health Care (ACHC) for four pharmacy services: Specialty Pharmacy, with a Distinction in Rare Diseases and Orphan Drugs; Ambulatory Infusion Centers; Home Infusion Therapy; and Infusion Pharmacy. “We are dedicated to providing an outstanding patient experience that not only meets but exceeds the highest industry standards,” said Drew Walk, CEO of Soleo Health. “Our recent ACHC accreditations highlight our steadfast commitment to safety, quality, and excellence, ensuring that every patient and stakeholder receives the best care and service.” By earning ACHC accreditation, Soleo Health demonstrates its commitment beyond compliance to the safest, highest-quality patient care and operational excellence, the company says. Soleo Health is also accredited by URAC for Specialty Pharmacy. The company has 26 pharmacy locations with national nursing coverage and pharmacy licensure in 50 states. It also operates more than 30 infusion suites and centers throughout the U.S.