In brief: Oz’s vision, sleep’s slowdown, NY’s unused DME

WASHINGTON – Dr. Mehmet Oz, who now leads CMS, shared his initial vision for the agency, including identifying and eliminating fraud, waste and abuse. 

Oz was confirmed by the Senate as CMS administrator on April 3. 

“I want to thank President Trump and HHS Sec. Kennedy for their confidence in my ability to lead CMS in achieving their vision to Make America Healthy Again,” he said. “Great societies protect their most vulnerable. As stewards of the health of so many Americans – especially disadvantaged youth, those with disabilities, and our seniors – the CMS team is dedicated to delivering superior health outcomes across each program we administer. America is too great for small dreams, and I’m ready to get work on the president’s agenda.” 

CMS is the largest agency under HHS, with a $1.7 trillion budget. 

Under Oz's leadership, CMS will work to modernize Medicare, the Marketplaces and Medicaid by: 

• Empowering the American people with personalized solutions they can better manage their health and navigate the complex health care system. As a first step, CMS will implement the President’s Executive Order on Transparency to give Americans the information they need about costs. 
• Equipping health care providers with better information about the patients they serve and holding them accountable for health outcomes, rather than unnecessary paperwork that distracts them from their mission. For example, CMS will work to streamline access to life-saving treatments. 
• Identifying and eliminating fraud, waste, and abuse to stop unscrupulous people who are stealing from vulnerable patients and taxpayers. 
• Shifting the paradigm for health care from a system that focuses on sick care to one that fosters prevention, wellness and chronic disease management. For example, CMS operates many programs that can be used to focus on improving holistic health outcomes. 

As CMS administrator, Dr. Oz oversees Medicare, Medicaid, the Children’s Health Insurance Program and the Health Insurance Marketplace and is responsible for delivering health outcomes for more than 160 million people.  

• Related: Dr. Oz would seek to modernize MA. 

Sleep patient volume growth slows 

NEW YORK – Sleep patient volume growth was slower in the last 12 months but is expected to improve in the next 12 months, according to the 1Q25 HME Sleep and Oxygen Survey from Needham. 

Respondents saw their sleep patient volume increase by an average of 3.4% in the last 12 months (vs. 4.3% in the prior survey) and expect their sleep patient volume to increase by 7.2% in the next 12 months (vs. 6.1% in the prior survey). They reported having a 0.3 month patient backlog, down from 0.7 months in the 3Q24 survey. 

Outside factors 

While 76% of respondents indicated they were unsure how many of their sleep patients were on GLP-1 drugs, the remaining 24% estimated that an average of 8.5% of their sleep patients were on a GLP-1 drug. Of the sleep patients currently taking GLP-1 drugs, respondents indicated that 2.2% had stopped using CPAP therapy, up from 1.2% in our 3Q24 survey. 

“While the numbers are still small, we think that this indicates that GLP-1 drugs may be resulting in an increasing number of patients stopping CPAP therapy,” Needham stated. 

Market share 

• In the next 12 months, respondents expect Resmed's share of their flow generator purchases to decrease 4.8% from 89.8% to 85.0% and its share of their mask purchases to decrease by 1.8% from 54.5% to 52.7%. 
• Respondents expect Philips Respironics' share of their flow generator purchases to increase by 1% from 0.8% to 1.8% and its share of their mask purchases to decrease by 4.4% from 18.3% to 14.0%. 
• They expect React Health's share of their flow generator purchases to increase 4% from 8.8% to 12.8% and its share of their mask purchases to increase by 2.8% from 2.7% to 5.5%.  
• They expect Fisher & Paykel's share of their mask purchases to increase by 2.0% from 19.2% to 21.2%. 

Resmed had the highest rated flow generators, nasal masks and nasal pillow masks and was tied for the highest rated full-face masks. 

Pricing 

Respondents indicated that flow generator prices increased by 0.9% in the last 12 months vs. a 3.6% increase in the 3Q24 survey. This marks the sixth consecutive decrease in price increases, likely due to increasing supply of flow generators. 

Respondents indicated that mask prices increased by 2.9% in the last 12 months vs. 1.1% growth in the 3Q24 survey. 

NY Comptroller: DME left unused, unserviced 

NEW YORK – Only 324 of 247,394 DME items that were procured during the onset of the COVID-19 pandemic, including ventilators, were distributed during the public health emergency, according to an audit by the New York state comptroller. This DME sits unused in storage facilities across the state, missing recommended maintenance and costing taxpayers storage expenses, the audit says. “During the pandemic, New York state quickly purchased medical equipment to address the public health crisis,” said State Comptroller Thomas DiNapoli. “Now, hundreds of thousands of unused devices sit idle. I urge the Department of Health to develop and execute a strategic plan for the maintenance and use of these and future medical equipment purchases, so New York is well prepared for the next public health emergency.” Based on paid vouchers and credit card transactions provided by the state Department of Health, the state comptroller determined it incurred costs of $452.8 million to procure 247,343 items of DME and received 51 items donated by others or received from the federal government, for a total of 247,394 items procured during the onset of COVID-19 (as of November 2020).  After the PHE ended, according to DOH officials, a Medical Stockpile Steering Committee recommended the department retain 51,140 items of DME in its cache, of which 4,468 items (9%) should receive scheduled preventive maintenance, leaving almost 200,000 DME items without a strategic plan for utilization. DOH has conducted surveys of the medical community, with facilities expressing interest in 24,585 DME items, but has taken limited action overall to reduce its stockpile. The state comptroller has made the following recommendations: 

• Maintain basic internal controls during emergency scenarios to ensure stewardship over state assets that address concepts such as conducting transactions in an ordinary manner, recording transactions, effective communication, and documenting receipt of purchases. 
• Document and preserve the process and/or key factors used when making significant decisions, and keep documentation of key events, such as the Steering Committee’s recommendation of DME to be retained and to receive preventive maintenance. 
• Develop and implement a statewide public health strategic plan to utilize surplus DME. 
• Develop and implement a strategic plan for DME preventive maintenance so that it is ready and reliable for use during public health emergencies. 

CMS delays final LCD for skin substitutes 

WASHINGTON – As part of the transition to the new administration, CMS is reviewing its coverage policies for skin substitute products. This means the final local coverage determinations for skin substitute grafts/cellular and tissue-based products for the treatment of diabetic foot ulcers and venous leg ulcers will be delayed until Jan. 1, 2026. “CMS believes it is important to maintain patient access to skin substitute products with high quality evidence of effectiveness,” the agency stated. As such, CMS is asking that any peer-reviewed publications and high-quality findings from other public sources of skin substitute study results be submitted at CAGInquiries@cms.hhs.gov by Nov. 1, 2025. The agency says it will ensure all evidence received will be sent to the MACs to review to determine if revisions to the LCD are appropriate. The agency’s announcement follows an article in the New York Times, “Medicare bleeds billions on pricey bandages and doctors get a cut.” 

VGM adds payer relations expert 

WATERLOO, Iowa – VGM Government Relations has added Melanie Ewald to its team as vice president of payer relations. Ewald’s previous experience includes roles in a holistic hospital-based clinic, the Minnesota Hospital Association and the DME industry. “As a payer relations expert, Melanie has honed her skills in payer contracting, enrollment, credentialing, compliance and audits,” VGM stated. “Her ability to navigate complex regulatory landscapes and optimize payer relationships has earned her recognition as a leader in the field.” Ewald’s commitment to the health care industry expands beyond her professional roles. She has been active in several DME associations, including as a former board member of the Ohio Association of Medical Equipment Services and as a member of the Payer Relations Council of AAHomecare. Ewald is also an attorney who specializes in health law. 

Duke opens home infusion pharmacy 

DURHAM, N.C. – Duke HomeCare & Hospice has opened Duke Home Infusion Pharmacy, a cutting-edge pharmacy designed to enhance patient care and expand the number of patients served in the community. It offers a range of infusion therapies, including antibiotics, TPN, inotropes, chemotherapy drugs and specialty medications, throughout North Carolina, Virginia and South Carolina. Duke HomeCare & Hospice comprises home health care, home infusion, palliative care, hospice care and bereavement services. It’s a part of Duke Health, which integrates the Duke University Health System (all of our hospitals and clinics), Duke University School of Medicine, Duke-NUS Medical School, Duke University School of Nursing, Duke Health Integrated Practice (Duke physicians practice), and incorporates the health and health research programs within the Duke Global Health Institute, as well as those in schools and centers across Duke University, including the Duke Robert J. Margolis Center for Health Policy.  

Dexcom gets clearance for long-wearing CGM 

SAN DIEGO – Dexcom has announced that the U.S. Food and Drug Administration has cleared its G7 15 Day Continuous Glucose Monitoring System for people over the age of 18 with diabetes in the United States. With an overall mean absolute relative difference (MARD) of 8%, Dexcom G7 15 Day builds on the performance of Dexcom CGM, which the company says is clinically proven to lower A1C, reduce hyper- and hypoglycemia and increase time in range. “The approval of Dexcom G7 15 Day marks another major innovation for Dexcom,” said Jake Leach, executive vice president and COO at Dexcom. “By listening to the needs of our users, we’re proud to offer the longest lasting wearable and most accurate CGM, giving people the knowledge to better control their diabetes with our best-in-class technology. This milestone sets a new standard in CGM and is a testament to our continued leadership in glucose biosensing. We look forward to bringing it to market, but in the meantime, we encourage our users to upgrade to our current G7 system.” Dexcom is working closely with its insulin pump partners to ensure that Dexcom G7 15 Day will be compatible with automated insulin delivery systems upon launch. Dexcom G7 15 Day is expected to launch in the US in the second half of 2025. 

Soleo Health secures Qfitlia 

FRISCO, Texas – Soleo Health has been named the exclusive in-network specialty pharmacy for Qfitlia (fitusiran) by Sanofi, the first antithrombin-lowering therapy for hemophilia. The U.S. Food and Drug Administration recently approved its use for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A or B with or without factor VIII or IX inhibitors. "We are pleased to be selected by Sanofi to help bring its first-of-its-kind hemophilia medication to patients,” said Drew Walk, CEO. “Therapies like Qfitlia can have a significant impact on patients living with hemophilia and we look forward to supporting patients who will benefit from this innovative treatment option. Our team continues to work collaboratively with our pharma partners to bring ground-breaking medical treatments to patients to make a meaningful impact on their lives.” Soleo Health has 26 pharmacy locations with national nursing coverage and pharmacy licensure in 50 states and is accredited by URAC, ACHC with Distinction in Rare Disease and Orphan Drugs, and the National Association of Boards of Pharmacy. Additionally, the company operates more than 30 infusion suites and centers throughout the U.S. 

EnsoData enhances home sleep apnea test 

MADISON, Wis. – EnsoData is enhancing the EnsoSleep PPG, a home sleep apnea testing solution that’s cleared by the U.S. Food and Drug Administration, by integrating three new physical channels. The company says the new channels will provide additional physiological data to support sleep clinicians in diagnosing and treating sleep disorders using FDA-cleared pulse oximeters. “Adding three new channels is a major step forward for EnsoSleep PPG,” said Fred Turkington, SVP of product management, EnsoData. “The new flow, snore and actigraphy data are added on top of the existing respiratory analysis of peripheral arterial tone. These channels make raw data interpretation more intuitive for physicians by aligning PPG-based home sleep testing more closely with in-lab PSGs and legacy HSAT signals. Best of all, we accomplished this with no extra hardware for patients to manage. They need only their smartphone and a pulse oximeter." EnsoData says the FDA-cleared Drowzle Pro, rebranded as Celeste+, captures acoustic flow and snore data from the microphone of a mobile device, while the actigraphy channel displays movement data from accelerometers embedded in existing PPG-enabled devices. Celeste+ also includes the EnsoData Audio Respiratory Score (eARS), a metric that tracks the number of breathing interruptions per hour using only the built-in microphone on the patient’s smartphone. EnsoData is providing the new channels, which don’t require additional hardware, at no extra cost.