AINsight: Special Issuance for Sleep Apnea

 - October 11, 2018, 11:59 PM

Screening for sleep apnea became a mandatory part of routine FAA medical exams in 2015. This was in response to DOT and NTSB recommendations, given that fatigue has been found to be a factor in many transportation incidents, including both in aviation and the trucking industry.

I previously discussed the physiologic effects of sleep apnea and why treating it is not only worthwhile for day-to-day living, but might also be a lifesaving therapy in the long run. As pilots who are diagnosed for sleep apnea will require a special issuance authorization, I’ll now discuss more of the nuts and bolts of the program.

In the beta-test that I completed for the Federal Air Surgeon’s office before the issuance of formal guidance to AMEs, I argued that, to improve disclosure and compliance, the program should be user-friendly both to pilots and their AMEs. It wound up being more user friendly for pilots than for AMEs, but that’s better than the alternative. 

While the physicians and staff at the FAA are hard-working and ethical folks who strive to approve as many pilots as they possibly can (within the constraints of the FARs), they do not have face-to-face contact with pilots. The zeal to promote safety has, at times, unintentionally brought about alienation to the pilot group.

This happens when the protocols for various illnesses become seemingly exhaustive to the pilots and their treating physicians. In its defense, please remember that the FAA has administrative and legal obligations and must remain faithful to its mandates.

The AME is in the challenging position of interfacing with the FAA on one side and pilots on the other. Pilots usually feel that they are safe to fly and become discouraged by a system that is perceived to be trying to ground them, not support them. I know it sounds like I’m drinking the Kool-Aid, but in truth the FAA would like to approve every pilot that it ethically can.

In the first year or so after the sleep apnea screening discussions became mandatory, I had many pilots state that they felt somewhat blindsided. They had dutifully filled out the FAA 8500-8 questionnaire via the MedXpress online program, and nowhere on that form did it ask about sleep apnea.

Yet, at the time of exam, suddenly the AME is asking questions about a medical condition that the FAA didn’t require comments about from the pilot when filling out the exam form itself.

I had also discussed this situation with the FAA during the beta-test. It seemed to me that there should be a question about sleep apnea on the exam form, such as in item 18 that asks about medical history. A simple “Are you being treated for sleep apnea?” question would have at least notified the pilot that the FAA is interested in this condition.

It turns out, however, that changing the FAA form itself is exceedingly difficult to do from a logistical and legal standpoint. Perhaps such a question might be on the form in the future, but for now please accept that the AME is required to ask a few screening questions in regard to sleep apnea risks.

The requirement for screening discussions does not mean that all pilots are required to do a formal sleep apnea evaluation. The purpose of the screening questions—and the AME’s opinion based also on exam findings—are simply to identify which pilots might benefit from a formal evaluation. 

Fortunately, from the standpoint of the pilot, obtaining a special issuance in the setting of sleep apnea is reasonably straightforward. One of the points that I argued strongly for in the beta-test was to ensure that the AME could approve the pilot “on the spot,” without having some extended period of time where the pilot is grounded awaiting FAA review.

Behind the scenes, the protocols that the AME must follow appear to be a bit more complex than perhaps they could be, at first glance anyway. Again, this is not a burden on the pilot. Once AMEs have done a few sleep apnea cases, it soon becomes almost second nature to them.

For a pilot to understand, just think back to ancient times and the laborious abnormal procedure checklists, with all the connecting lines and arrows. Then think, “smoke and fire checklist” and you’ll know what the AME is facing. This doesn’t sound very user-friendly, but the AME will quickly become comfortable with the protocols. Fortunately, the pilot will likely never see any of this.

For the pilot, here’s what it takes:

• Get risks evaluated.  As I said in my previous blog, treating sleep apnea is great. It is, in fact, one of the few things we do in medicine where risks for future complications are reduced immediately and the patient also feels better immediately.

• If diagnosed with sleep apnea, remain compliant with the treatment. The most common treatment is CPAP (continuous positive airway pressure). Some patients, however, can be treated with an oral appliance, and sometimes surgery can be curative.

• All newer CPAP machines have the ability to download compliance data and provide a detailed report. The FAA will want to ensure that the pilot is reasonably compliant with the therapy. I will not bore you with all of the individual aspects of the compliance and efficacy measurements, but if a pilot is reasonably compliant with therapy, and the therapy is reasonably successful, the FAA will be quite supportive.

• For the initial FAA medical special issuance submission, the pilot must provide to the AME a copy of the sleep study report that confirms the diagnosis, a preliminary compliance readout, and a “status report” from the treating physician stating the pilot is doing well with treatment. The FAA will be looking for comments that the pilot is stable, compliant, feeling well, and has no lingering “daytime drowsiness.” For the snickering pilots who frequently fly at night, you get the drift. The goal here is that the pilot sleeps well during rest periods and doesn’t have an undue amount of residual drowsiness during waking periods at work.

If the AME reviews data that confirms that a pilot has been properly evaluated, is compliant on the initial therapy, and has reasonably good results with that therapy, a medical certificate can be issued at the time of the exam, with no period of grounding involved. In a few months, the pilot will receive a formal special issuance authorization from the FAA. This document will also more specifically outline follow-up requirements.

Once approved, the FAA will expect annual reports thereafter. The follow-up reports are simple: a compliance readout (of the full year) and a status report confirming stability from the standpoint of the treating physician.

Note that, on the initial submission, the FAA does not expect a pilot to wait until a full year of data is available. As long as the AME is comfortable that enough time has gone by to ensure that the initial treatment is working, a medical certificate can be issued. The full year of compliance data is only required thereafter at the time of the subsequent annual updates.

For both the initial and annual follow-up reports, the pilot also signs a simple compliance form that confirms that he/she continues to utilize the therapy and that it’s still helpful. This might seem redundant, but the FAA does want to see what the pilot thinks about the usefulness of the therapy.

If I’ve made this appear overly complicated, I assure that in real practice it is rather simple. Any AME can outline what is needed once a pilot is being treated for sleep apnea. The process, from the perspective of the pilot, is not overly intensive. Most important for the pilot is that there is no pre-approval extended period of grounding involved, as is often the case for many other special issuance conditions. Annual follow-up requirements are simple to comply with.

If a pilot has sleep apnea, the best advice is to get it treated. The overwhelming majority of pilots being treated will state that they felt better right from the start.

Treatment will reduce long-term health risks and therefore facilitate and augment the pilot’s ability to maintain FAA medical certification into the future. Overall, treating sleep apnea is a “win” for pilots, their spouses, and their passengers.

The FAA special issuance process in the setting of sleep apnea is reasonably user-friendly, and pilots should not be discouraged from disclosing this condition to their AME and the FAA.

Dr. Sancetta is a former DC-10 captain with 11,000 flight hours. He has worked as a Senior AME since 1993 and is appointed as AME Consultant to the Federal Air Surgeon.