The National Association for Medical Direction of Respiratory Care

When is Ventilation Not Ventilation?

NAMDRC is genuinely a bit different. We focus on issues that others, for understandable and reasonable reasons, might be secondary. But because our mission is to remove regulatory and legislative barriers to access to appropriate care in the pulmonary arena, we try to be vigilant, informative, and on occasion aggressive in our pursuits.

Rather than focus on our track record, let’s look briefly at some of the issues, their complexities, and our approach to solutions. One major issue we’ve tried to tackle focuses on home mechanical ventilation. In 2001 CMS posted a Decision Memo (non binding on contractors, but more on that later) that ostensibly dealt with bi level policies (respiratory assist devices to CMS but no one else), but there was brief mention of the distinction between home mechanical ventilation and appropriate use of bi-level devices. The Decision Memo signaled that a key element of home mechanical ventilation was establishment of an artificial airway AND removal of the mechanical ventilator would lead to death.

Spin forward to 2015 and it is not hard to determine what problems that could trigger. First, despite very specific wording that signals the Memo is not binding, all the Durable Medical Equipment Medicare Administrative Contractors (DME MACs) insist they must adhere to it with no flexibility. Then add the reality of the growth of noninvasive mechanical ventilation and corresponding codes and confusion and inconsistency abounds.

Add the growth of noninvasive mechanical ventilation over the past several years and we’re getting close to chaos. Some providers won’t offer ventilators because of the 2001 Decision Memo, while others flock to devices like the Trilogy marketed by Philips. As it has evolved in the past couple of years, it is actually easier for a physician to document “respiratory failure” and secure a mechanical ventilator than it is to secure what might be a more appropriate bi-level device. Because the criteria for bi-level devices are so inflexible, physicians eager to treat their patients have found this approach workable, perhaps for the wrong reasons. But they’re boxed in because getting the clinically appropriate device is not as smooth as it should be.

So, there are two tangential and somewhat related issues here. First, there is the matter of home mechanical ventilation and the growing success of noninvasive technologies. There are the barriers to bi-level devices. And there are contractors who reject Central Office determinations.

If you have followed the bi-level/RAD evolution, you know that CMS does not follow FDA findings and classifications. “Just because FDA calls a device a ventilator doesn’t make it a ventilator,” is a common refrain from CMS. Nowhere in the clinical literature does the term “respiratory assist device” appear in any context prior to CMS establishing this unique, genuinely undefined device. Likewise, there are payment codes for noninvasive home mechanical ventilation, apparently in 100% contradiction to the 2001 Decision Memo.

Knowing that we will never reach any agreement on what constitutes a mechanical ventilator, we do believe we are going down the correct path by creating a solid clinical definition of respiratory failure. CMS appears to agree that mechanical ventilation is an appropriate and accepted treatment element for respiratory failure. Therefore, if we can come to agreement with CMS on a clinical definition of respiratory failure, it follows somewhat naturally that in documented cases of respiratory failure, mechanical ventilation is integral to the treatment plan. And as we discussed this more and more internally, it struck us that that distinction between invasive and noninvasive ventilation serves little purpose. Let the physician, patient and family members decide what is best.

So, we’re working on this issue, trying to define respiratory failure, agreeing that patients with documented respiratory failure warrant mechanical ventilation, and move the policies from there, removing current contradictions in existing policies. Add to that an effort to make access to bi-level devices more reasonable, and we could have a win for all sides. CMS gets its expenditures for home mechanical ventilation under control, physicians have clear policy pathways to guide treatment, and patients can rest assured that intubation/tracheostomy is only a clinical determination, not one that distinguishes mechanical ventilation from other treatment modalities.

Phil Porte, NAMDRC Executive Director

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