Recalls, reimbursement, remote data & referrals all changing the landscape
by Nick Macmillan

Even if you were a great storyteller, you could not have dreamt up the scenario durable medical equipment (DME) suppliers are facing as they grapple with an onslaught of home mechanical ventilation challenges. From the public health emergency to recalls to supply chain constraints, suppliers have proven resourceful and resilient in their response. Let’s break down these challenges to explore the impact and response.

The Elephant in the Room

Let’s start with “the recall,” as it’s so often called. On June 14, 2021, Philips Respironics issued a global recall notification for affected ventilation and sleep apnea devices. Philips advised of potential health risks related to the sound abatement foam used in these devices, including all Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent devices and serial numbers manufactured before April 26, 2021.

At press time, the situation is still fluid. However, there is good news: On Sept. 1, Philips announced it had received approval from the U.S. Food and Drug Administration (FDA) to repair and replace the affected PAP devices. The company anticipates that the process will be completed globally within 12 months. The timeline comes in the wake of calls from providers for better communication from Philips and the FDA. Scott Owsiak, vice president of clinical services at Medical Service Company in Ohio, said that “these delays are impacting care.” Suppliers are encouraged to get the latest updates from their local Philips representatives and at; there is a banner at the top of the page to click on.

Meanwhile, other respiratory manufacturers are doing their best to fill the void not only for existing patients, but also for new ventilation clients. The delta variant of COVID-19 is making this task harder. When asked what is the biggest challenge posed by the recall, Tony Mozzone, vice president of respiratory sales for New Jersey-based PromptCare said, “Getting vents for new patients!”

Several ventilator companies have been promoting and launching products, including Ventec Life Systems with its V+Pro standard ventilator with High Flow Therapy and Breas with its EveryWare cloud-based web application, to name just two. One thing’s for sure: Suppliers that narrowed their purchasing to select manufacturers in an effort to boost their purchasing power are now much more inclined to diversify their product portfolio.

Reimbursement Changes

To address rigid criteria in local and national coverage determinations, the CHEST Health Policy and Advocacy Committee convened the Optimal Noninvasive Ventilation Medicare Access Promotion Technical Expert Panel. The panel’s work addressed the following: thoracic restrictive disease, chronic obstructive pulmonary disease (COPD), hypoventilation, obstructive sleep apnea and central sleep apnea. Regarding ventilation, the aim was to propose national coverage determinations to the Centers for Medicare & Medicaid Services (CMS) for noninvasive ventilation (NIV) and home mechanical ventilation.

While welcomed by numerous industry and clinical constituents, including the American Association for Homecare (AAHomecare) and the Council for Quality Respiratory Care, there remain enough details outstanding to warrant ongoing robust discussions. And the timeline for adoption of these recommendations, if at all, remains to be seen.

“This was a long time coming, as coverage policy and criteria need to change to meet today’s technology,” Roxanne Venard, owner of Colorado-based Ascent Respiratory Care and vice chair of AAHomecare’s Home Medical Equipment and Respiratory Therapy Council said. Venard added that she was especially pleased to see the pulmonary community advocate for coverage of respiratory clinicians in the home.

In the meantime, AAHomecare’s Payer Relations Council has been battling an onslaught of commercial and Medicaid program policy changes around NIV coverage. These changes have been mainly focused on capping reimbursement for noninvasive ventilation, either via bi-level devices or home ventilators. Through the council’s efforts, a number of proposed policy changes have been blocked, delayed or rescinded (for example, a new law in Louisiana prevents payers from capping payments on home ventilators). Advocates have called this a big win for medical equipment providers and more importantly for the patients they serve.

It remains to be seen how any CMS policy changes trickle down to the commercial payers. And since at least 37 states—with others pending—employ commercial managed care organizations (MCOs) for Medicaid program management, one can be assured of a swift Medicaid response, whatever those new policies entail.

No matter the future, suppliers have universally said that the COVID-19-related regulatory changes from CMS are having a positive impact—and that they hope these changes become permanent.

Technology Adoption & Remote Monitoring

While there has not been a significant uptick in new technology in the home ventilation space, existing technology has provided welcome relief, especially in the COVID-19 era. Specifically, remote access to ventilator data and the ability to connect with patients and caregivers via video call applications have provided the tools necessary to effectively monitor and address patient care issues. So remote ventilator monitoring has become the standard of care, and the day-to-day use of this capability has become essential to adjusting patient follow-up methodology.

Despite these technological advantages, utilization among suppliers spans the spectrum. Some suppliers have fully embraced remote visits; some have created hybrid solutions based on patient choice, disease severity or the patient’s experience with ventilation; others have opted to maintain face-to-face visits while safeguarding patients and clinicians through proper precautions.

Most encouraging from these forced changes to care delivery are some of the resulting efficiencies and positive patient outcomes. PromptCare’s Mozzone indicated that the company has created “a new algorithm of care,” citing data that embraces these technologies “helps them wean patients faster.”

Medical Service Company has primarily maintained a comprehensive home visit program, but has used additional data points, including the COPD Assessment Test (CAT) score, to alter care plans that significantly reduce hospital readmissions. Owsiak said that their program, which includes five patient encounters (remote and face-to-face) in the first month, “sets up the patients for success.” He said that the results are so compelling that he intends to submit the company’s findings to a peer-reviewed body for publication.

An additional benefit to using these new technologies is efficiency. Mozzone says that streamlining care has improved profitability. Given the increased cost of equipment and supplies, supply-chain issues and the overall increased costs of doing business, this is welcome news and an impetus for every supplier to continually evaluate their care paths.

Marketing to Physicians

As the delta variant has again impeded access to referral sources, reaching and messaging to them has proved challenging. Most referral sources have indicated that in-person visits are simply not possible. Remote meeting technology can be a friend to this effort.

In fact, as several of the strategic national stockpile ventilators manufactured by Ventec have been employed by hospitals, a comprehensive remote training program developed by Ventec Director of Clinical Operations Jason Sesmundo and Lead Clinical Specialist Craig Morris for use by the hospital’s team of clinical specialists has proven incredibly valuable. The takeaway here is that referral sources and clinicians are open to remote contact, provided it supplies useful information from which they can benefit, such as recall response, ventilator patient data access, follow-up protocols and more.

Life in the Trenches

The interviewees quoted here have all indicated that, for the most part, their respiratory therapists have responded favorably to the required adaptations. Turnover has been minimal, which again points to just how dedicated this sector is. Venard from Ascent uses a lot of reinforcement through fun staff activities and luncheons, while Owsiak from Medical Services Company regularly repeats the mantra “right patient, right time, right therapy.”

And though trying at times, it is heartwarming and gratifying to know that we keep company with the best of the best, and that patient care always trumps adversity.

Nick Macmillan is director of market access and strategy at Ventec Life Systems and principal consultant at Outside the Box Consulting. Mamillan’s experience includes serving as the MED Group’s senior director of MED’s Networks and strategy, home care business segment manager at Vapotherm, national clinical director for Rotech Healthcare, Inc., and other product development and home medical equipment services management roles. Vist