In brief: Oxygen NCD, Philips MDRs, Geffert’s new role

WASHINGTON – CMS has changed the implementation date of the new oxygen national coverage determination from Jun 14, 2022, to Jan. 3, 2023. 

“This change only extends the implementation date to Jan. 1, 2023,” AAHomecare stated in a bulletin. “The new oxygen NCD coverage expansion will still be retroactively effective to claims with a date of service on or after Sept. 27, 2021.” 

The new oxygen NCD, among other things, expands access for acute conditions and removes the CMN requirement. 

CMS plans to discontinue the CMN for oxygen, as well as several other products, on Jan. 1, 2023. Industry stakeholders have concerns about the NCD going into effect Sept. 27 but CMNs not being eliminated until Jan. 1, 2023. 

CMS also recently announced it is accepting comments on a proposal to amend the period of initial coverage for certain home oxygen patients from 120 days to 90 days to align with the 90-day statutory time period set out in the NCD. 

Philips recall: FDA reviewing, assessing medical device reports 

WASHINGTON – The U.S. Food and Drug Administration says it received more than 21,000 medical device reports (MDRs), including 124 reports of death, associated with the foam breakdown or suspected foam breakdown of recalled Philips BiPAP and CPAP devices. 

The MDRs received included both mandatory reports from Philips and voluntary reports from health professionals, consumers and patients. A wide range of injuries were reported in the MDRs, including cancer, pneumonia, asthma, other respiratory problems, infection, headache, cough, dyspnea (difficulty breathing), dizziness, nodules and chest pain, according to the FDA. 

“Although MDRs are a valuable source of information, this passive surveillance system has limitations,” the agency stated. “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 frequency of device use. Because of these limitations, MDRs comprise only one of the FDA's several important post-market surveillance data sources. These reports, along with data from other sources, can contribute important information to a medical device's benefit-risk assessment.” 

Manufacturers like Philips are required to submit MDRs when information reasonably suggests that their device may have caused or contributed to a death or serious injury, or has malfunctioned and that device or a similar device they manufacture would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. 

Philips submitted 30 MDRs between 2011-2021 that the company identified as associated with the PE-PUR foam breakdown, with no reports of patient injury or death, according to the FDA. 

In an update posted May 24, the company said at the time the recall notification/field safety notice was issued, it relied on an initial, limited data set and toxicological risk assessment, and assumed a reasonable worst-case scenario for the possible health risks. Following its public statements on the issue and possible risks to users in April 2021, and the announcement of the recall notification/field safety notice in June 2021, it received a steep increase in complaints allegedly associated with possible foam degradation. 

“We regret any concern or inconveniences caused by this field action and we are committed to supporting the community of patients who rely on our sleep and respiratory care solutions for their health and quality of life, and the physicians and customers who are dedicated to meeting patient needs,” said David Ferguson, business leader of Philips Respironics. “We are replacing or repairing the devices related to the Respironics field action as fast as possible and are continuing to update patients and customers about the progress of the program. More than 1,000 of our colleagues are working around the clock on every aspect of the remediation.” 

Central Medical Supply bulks up in Northeast 

FLANDERS, N.J. – Central Medical Supply, a portfolio company of Osceola Capital, has acquired three hospice and home care equipment management companies: Helping Hands Medical Equipment, the hospice assets of Consolidated Medical Surgical Supply and PPD Homecare. 

Helping Hands, an Allentown, Pa.-based provider of DME management solutions to hospice agencies founded by Marty Falk, further expands Central Medical’s presence in eastern and central Pennsylvania. 

Consolidated Medical Surgical Supply, a New Windsor, N.Y.-based provider of DME management solutions to hospice agencies founded by Doug Crana, further expands Central Medical’s presence in upstate New York and Connecticut. 

PPD Homecare, a Mantua, N.J.-based provider of respiratory equipment and services founded by Guy Prasalowicz, expands Central Medical’s service offering and strengthens its footprint in New Jersey. 

"We have known the founders and teams at Helping Hands, Consolidated Medical and PPD Homecare for a long time, and are thrilled to welcome them to the Central Medical family,” said Joe Sacco, founder and CEO of Central Medical. “We care deeply about our hospice partners and their patients, and these three businesses fit perfectly with our culture and vision for growth. These acquisitions further position Central Medical as the premier provider of hospice equipment management solutions in the Northeast, and we look forward to expanding our footprint organically and through acquisitions." 

Central Medical is a provider of outsourced equipment management solutions to the hospice industry. Its product offering includes hospital beds, wheelchairs, mobility equipment, respiratory equipment, oxygen supplies, bariatric products, orthotics and advanced wound care products. 

React Health names Geffert president 

WINTER HAVEN, Fla. – React Health, formerly 3B Medical, has named Clint Geffert as president, commercial operations, effective in June. 

“I am extremely excited to be joining the React Health team,” said Geffert. “I believe React Health continues to position itself well in the industry as a leader and will capitalize on the long-term growth potential of the home medical equipment market.” 

Geffert announced earlier this month that he was resigning from his role as president of VGM & Associates. He joined VGM in 2012. Prior to that, Geffert held roles of increasing responsibility at Philips in their Sleep and Respiratory Care division. 

Tom Pontzius has been React Health’s acting president for both operations and commercial operations for the past seven months. 

“We are happy that Clint is joining React Health’s leadership team,” said Pontzius, president, operations. “Coupled with his leadership, Clint’s Industry experience will allow React Health to continually improve on our customer experience. His knowledge of the customer and patients they serve will allow React Health to continually innovate and offer products and services to meet customer needs and improve patient outcomes.” 

 VirtuOx resolves allegations 

‘We are glad to have this behind us,’ company says in statement 

MIAMI – VirtuOx has agreed to pay $3.15 million to resolve allegations that it submitted or caused to be submitted false claims to Medicare for reimbursement, according to an announcement from the Department of Justice, U.S. Attorney’s Office, Southern District of Florida. 

The Coral Springs, Fla.-based company, which operates Medicare-approved Independent Diagnostic Testing Facilities (IDTFs), allegedly violated the False Claims Act by falsely identifying the place of service for certain services it performed to obtain a higher rate of reimbursement from Medicare from January 2016 to December 2020. In particular, the company allegedly knowingly submitted false claims to Medicare identifying its IDTF located in San Francisco as the location of service for overnight pulse oximetry tests when no services were performed at that location in relation to the overnight oximetry claims. 

The company allegedly also administered overnight pulse oximetry tests and, at times, also billed Medicare for single determination pulse oximetry tests – commonly referred to as an oxygen “spot check” – for the same patient when the only test performed was the overnight test. 

As part of the settlement, VirtuOx entered into a five-year Corporate Integrity Agreement with the U.S. Department of Health and Human Services, Office of Inspector General, that requires, among other things, that the company retain an outside expert to perform annual claims reviews that address the place of service identified on the claim. 

The settlement arose from a lawsuit filed by Amber Watt, who will receive $630,000 in connection with the settlement as the whistleblower. Watt was represented by Andrew Melling, a partner at Burr Forman, based in Columbia, S.C. 

VirtuOx provided the following statement when contacted by HME News: 

“Since 2005, VirtuOx has operated Joint Commission accredited Medicare enrolled IDTFs in California, Florida and Washington, D.C., to help treat patients across the country that suffer from respiratory, sleep and cardiac diseases. One of our competitors, Amber Watt, the owner of BREATHE Oximetry, filed a whistleblower suit against us in 2019 after we sent (the company) a demand letter regarding theft of our intellectual property. The government conducted a thorough investigation and declined to intervene in the suit. Shortly thereafter, federal judge Robert Scola Jr. dismissed BREATHE’s unfounded allegations with prejudice. Amber Watt’s attorneys appealed Judge Scola’s ruling to the 11th Circuit Court of Appeals, and the government worked with Medicare to put VirtuOx on payment suspension while the appeal played out in court. To avoid protracted and costly litigation and to get the payment suspension lifted, VirtuOx decided to settle the lawsuit without admitting any wrongdoing. We are glad to have this behind us and are excited to refocus on providing best-in-class care to our patients across the country.”    

 Are health insurers willing to reform PA process? AMA has its doubts 

CHICAGO – The health insurance industry has made little progress in reforming prior authorization processes, according to the results of a new survey of physicians from the American Medical Association. 

In January 2018, the AMA and other national organizations signed a consensus statement outlining a shared commitment to five key reforms to the prior authorization process that promote safe, timely and affordable access to evidence-based care for patients, enhance efficiency and reduce administrative burdens. 

However, findings from the survey question whether the health insurance industry can be relied upon to voluntarily expedite comprehensive reform to the prior authorization process. 

“Waiting on a health plan to authorize necessary medical treatment is too often a hazard to patient health,” said Gerald E. Harmon, M.D., president of the AMA. “Authorization controls that do not prioritize patient access to timely, optimal care can lead to serious adverse consequences for waiting patients, such as a hospitalization, disability or death. Comprehensive reform is needed now to stem the heavy toll that continues to mount without effective action.”   

The survey, conducted in December 2021, examines the experiences of more than 1,000 practicing physicians with each of the five reforms in the consensus statement and illustrates that the goal of comprehensive reform is far from complete. 

Supplier locations declined slightly, AAH says 

WASHINGTON – AAHomecare has updated its quarterly supplier number tracking sheet with April data, showing a slight decrease in the number of traditional Medicare DMEPOS locations compared to a year ago. The association estimates there are currently about 9,038 DMEPOS locations across the country. Its analysis continues to show about a 30% decrease in DMEPOS locations since 2013. To see state-specific numbers, you can find AAHomecare’s tracking sheet here. 

Movair joins AAHomecare 

WASHINGTON – Movair has joined AAHomecare as a Bronze Level Corporate Partner. The Austin, Texas-based manufacturer of home ventilators launched the LUISA home ventilator in the U.S. in 2021. “As we introduced the LUISA home ventilator less than a year ago in the United States, we knew we had to find ways to become more involved with advocacy partners within the HME industry,” said Bob Ellis, senior vice president of sales & marketing. “Understanding the issues HMEs are faced with in today’s market, and becoming part of the solutions, made the decision easy to join AAHomecare. We look forward to working with AAHomecare, other manufacturers and HMEs in advocating for the necessary changes within the HME industry.” Movair was formerly International Biophysics Corporation, innovator of the AffloVest. Tactile Medical bought the assets of the AffloVest last year. 
NHIA seeks permanent payment for COVID therapy 

ALEXANDRIA, Va. – The National Home Infusion Association has sent a letter to Xavier Becerra, secretary of the U.S. Department of Health and Human Service, asking the agency to make permanent Medicare payment for COVID-19 monoclonal antibodies (mABs). HHS’s vaccine program created coverage for home and suite-based infusions of COVID mABs, but it's set to expire when the public health emergency ends. NHIA points out that access to home infusion for mABs for the treatment and prevention of hospitalization and death due to severe COVID-19 is critical to maintaining preparedness for potential future variants. With no oral therapies approved for prophylaxis, mABs are the only source of preventive therapy for vulnerable patients who do not respond to vaccines, such as transplant patients, cancer patients and the immunocompromised. 

GEMCORE earns HITRUST status 

HUDSON, Ohio – GEMCORE has earned certified status from HITRUST for its operational platform, which includes Microsoft Dynamics GP, Microsoft Office 365, Microsoft D365, Brightree, ProShip, Vertex and PioneerRx. HITRUST risk-based, two-year certified status demonstrates that the organization's operational platforms have met key regulations and industry-defined requirements and appropriately manage risk. "Health care organizations like ours are continually under pressure to deliver the highest degree of data protection," said Matthew Edwards, CEO. "The process to earn this certification was not easy; however, it was well worth the investment and demonstrates to customers our commitment to HIPPA Compliance and the security of protected health information. We are super proud of our team in achieving the HITRUST Risk-based, 2-year certification." GEMCORE is a provider of diabetes management solutions. 

Great Elm Group names former BlackRock director to board 

WALTHAM, Mass. – Great Elm Group has announced that David Matter has joined its board of directors and CEO Peter Reed has stepped down from the board. Matter was most recently a managing director at BlackRock, where he served as the co-chief investment officer of BlackRock Alternative Advisors (BAA), BlackRock’s Hedge Fund Solutions team. “We are delighted to welcome Dave Matter whose significant experience both in growing and managing investment management businesses will be a valuable addition to our Company as we continue our ambitious plan to grow assets under management,” said Jason Reese, executive chairman of GEG. “His expertise and insight will help distinguish GEG’s investment management platform as we seek to create long-term value for our shareholders.” At BlackRock, Matter chaired the BAA Investment Committee and was also a member of the BAA Management Committee and the Co-Investment Portfolio Management Group, He started his career as a financial analyst with American Funds-Capital Group and Bankers Trust, before joining Quellos Group in 1998.  

Medline partners with health system to drive efficiencies  

NORTHFIELD, Ill. – Medline has entered into a multi-year prime vendor partnership with Baptist Health South Florida to identify new strategies for enhancing data-driven operational and clinical efficiencies. As the system’s primary supplier, Medline will exclusively provide an extensive portfolio of essential medical supplies and solutions across the health system’s 12 hospitals and more than 200 outpatient centers and physician practices. “When Medline becomes an extension of a team, as we have with Baptist Health South Florida, our shared commitment to data accuracy and accountability enables us both to reach new levels of actionable insights,” says Jen Cerami, executive account director at Medline. “The Baptist Health South Florida team challenges me to think differently. I am excited to evolve together as we tackle supply chain challenges and create customized, cutting-edge solutions to help healthcare run better.” Baptist Health South Florida will partner with Medline to optimize supply chain processes by leveraging data and technology to eliminate non-value-added activities and enhance financial and operational performance. As part of the strategic relationship, Baptist Health South Florida will have the ability to integrate key metrics, such as item utilization, contract compliance and price accuracy, and spend by product categories through a collaborative analytics-integration process.  

Aeroflow Urology marks Pelvic Floor Awareness Week 

ASHEVILLE, N.C. – Aeroflow Urology has announced its second annual Pelvic Floor Awareness Week, May 23-29, to acknowledge and advocate for those suffering from pelvic floor disorders and dysfunction. The company launched the week to help support and spotlight that one in five people will suffer from a pelvic floor disorder during their lifetime. “The pelvic floor is an incredibly integral part of the human body, yet the importance of maintaining these muscles can often be overlooked," said Aleece Fosnight, MSPAS, PA-C, CSC-S, CSE, NCMP, IF, and medical advisor for Aeroflow Urology. "This week is dedicated to spreading awareness about all things pelvic floor, from different exercises that help strengthen your floor or best care practices for postpartum mothers, to available incontinence products or how people can talk to their doctors about their issues." One-third of all women and 50% of women over the age of 55 are already being affected by a pelvic floor disorder. To learn more about Pelvic Floor Awareness Week, follow Aeroflow Urology on social media and check out the resources at aeroflowurology.com/pelvic-floor-awareness-week. 

Prochant signs on as VGM partner 

CHARLOTTE, N.C. – Prochant has secured a key partnership with VGM & Associates to be the member services organization’s official partner for focused billing solutions. “As experts in revenue cycle management for the HME industry, we feel a responsibility to be present and accessible to HME providers,” said Mathew Mammen, CEO of Prochant. “This partnership with VGM will provide exactly that. Our goal is to show VGM members fast, secure and efficient ways to automate their RCM processes, spend less time buried in paperwork and more time making lives better.” Prochant’s partnership with VGM went into effect March 1. Scott Owen, senior vice president of contracting for VGM & Associates, says connecting members with Prochant is more important than ever due to significant labor shortages and rising costs. “Prochant gives members access to a hybrid workforce of domestic and global labor, providing cost-savings.” Prochant, an international business with domestic leadership, maintains HITRUST CSF certification, the gold standard for HIPAA compliant security certification. 

Bret Tracy promoted at Merits 

FORT MYERS, Fla. – Bret Tracy, ATP, has been named director of sales for Merits Health Products, Avid Rehab, Pilot Stairlifts and Precision Comfort Cushions. Tracy has 22 years of experience in the complex rehab and DME industry. “Bret’s passion for the CRT industry is contagious,” the company says. “He loves advocating for end-user access to CRT (and) has attended several Washington, D.C., fly-ins.” Tracy also serves on the boards of directors for ALS of Nevada, ALS South Carolina Chapter, NAMPS, CAMPS, AZMESA and AAHomecare’s Rehab Council. He joined Merits in 2017 as the regional sales director, Easter U.S. “I joined Merits to help transition the company from DME to CRT,” he said. “I was at Pride when Quantum Rehab was launched. That experience has served me well, as we have launched four rehab powerchairs, a seating division and stairlift division during my time here. I am excited to oversee the sales launch of our 5th rehab base and full redesigned power seating system, which will launch at the end of 2022.”  

Better Living Now debuts in Idaho 

HAUPPAUGE, N.Y. – Better Living Now plans to complete its expansion into the Northwest on June 1. The company’s new 19,000-square-foot distribution facility in Twin Falls, Idaho, will be headed up by Lauren Pope, vice president of operations. “We are thrilled to better service our customers – patients, providers and health plans – located in the Northwest and Southwest region of the United States,” Pope said. “As an essential business, our new facility will have extensive inventory on hand, including critical diabetes, ostomy, urological, incontinence, wound care and breast pump supplies. In addition, we have improved shipping access time to our customers, expanding our one- to two-day service area.” The Twin Falls facility will offer careers in customer service, documentation, insurance verification and billing, sales, and shipping and receiving. Better Living Now is a full-service mail-order and e-commerce supplier with contracts with more than 500 health plans and programs in all 50 states. 

Sedgwick buys Orchid Medical 

MEMPHIS, Tenn. – Sedgwick, a provider of technology enabled risk, benefits and integrated business solutions has acquired Orchid Medical, an Orlando, Fla.-based provider of medical management solutions, including DME and supplies, and orthotics and prosthetics. The acquisition grows Sedgwick's ancillary care network, which ensures that employees of its workers' compensation clients receive prompt, high-value service for DME, transportation, translation, home health, diagnostic imaging and other aspects of care on the road to recovery. "Together with Orchid, we will strengthen our holistic approach to caring for clients' injured and ill colleagues, helping them return to maximum health and productivity," said Andrea Buhl, Sedgwick's president of managed care. "This acquisition enables us to provide employers with a single point of service for a broad range of ancillary care needs while strengthening our workers' compensation and managed care capabilities and our commitment to taking care of people when they need us most."