FAA Issues New Sleep Apnea Guidelines

The FAA issued new medical guidelines on obstructive sleep apnea (OSA) to its aviation medical examiners on March 2. Revising earlier plans to require OSA screening for all pilots with a body mass index of 40 or greater before issuance of a medical certificate, the new guidelines instead factor in an integrated assessment of history, symptoms and physical/clinical findings.

When announced in January, the new guidelines were lauded by aviation organizations as a practical approach that addressed their concerns without compromising safety. NBAA president and CEO Ed Bolen said the guidance “combines common sense with clinical discipline.” The guidelines require the aviation medical examiners (AME) to “triage the applicant into one of six groups”: (1) already issued a special issuance for OSA; (2) pilot has been diagnosed and is being treated with OSA; (3) AME determines there is no sleep apnea; (4) a pilot at low risk for sleep apnea, but AME must discuss the risk and provide information; (5) AME determines the pilot is at high risk for OSA and requires a sleep apnea evaluation from the pilot’s treating physician; and (6) pilot with severe symptoms and an immediate risk to aviation safety. In the first five groups, the AME can issue the medical certificate, although the pilot might have to comply with further requirements and supply more information, and in some cases there are time limits of 90 days, with possible 30-day extensions depending on the circumstances.

The FAA emphasized, “It is important to note that we are not changing our medical standards regarding OSA but enhancing our screening approach to address industry, congressional, National Transportation Safety Board and our safety concerns about pilots flying with OSA.” The agency has released numerous supporting documents for the medical community, including video guidance, flow charts and other reference materials.

AIN interviewed Dr. Cliff Molin, a board-certified sleep physician based in Las Vegas, to clarify how the new guidelines affect pilots. Molin is concerned that pilots will go for a medical exam hoping to meet the more lenient guidelines but then find themselves ensnared in a special issuance process. While Molin isn’t an AME, he welcomes questions from pilots and also offers the free Zee Apnea Android and iOS apps to help pilots perform a sleep apnea self-assessment.

“The new guidelines are fairly confusing,” Molin said, “and I think it’s important for pilots to understand what [these guidelines] mean and how they may affect them.”

The main point that Molin believes pilots should know is that before the release of the guidelines (and before the FAA brought the issue of OSA to the attention of pilots in late 2013), AMEs weren’t specifically tasked with doing something about pilots who have or might have OSA. “It wasn’t their role to pick them out and there wasn’t a method to channel them correctly,” he explained. “Now there is. Before there were a lot of pilots under the radar. Pilots need to know that with these new guidelines [those with OSA] are going to be identified.”

If the AME identifies a pilot as a high risk for OSA, he added, “the airman is then obligated to be evaluated for sleep apnea. The pilot needs to understand that the evaluation will include a sleep study.”

Under the new guidelines, there are two ways that this could play out for pilots, according to Molin. The first is that a pilot is identified by the AME as a high risk for OSA (group 5). In this case, the AME will require the pilot to be evaluated for OSA, which includes a sleep study. They have 90 days to get the sleep study done but cannot fly after a sleep study that is positive for OSA.

In this instance, the pilot at high risk for moderate or severe OSA must be evaluated by a sleep specialist. If the study is positive for moderate or severe OSA, “the pilot must cease exercising his airman certificate until he is adequately treated and documentation is submitted to the FAA,” he said. For pilots who fall into group six, the FAA noted: “If the AME observes or the applicant reports symptoms which are severe enough to represent an immediate risk to aviation safety of the national airspace…” and the airman will then be grounded right away until the sleep study can be done and the OSA issue resolved.

The problem with both of these situations is that they could result in lengthy delays before the pilot can return to flying. It takes time to schedule a sleep study after the initial assessment by the AME, then more time to generate the results of the study. And if the diagnosis is for moderate to severe OSA, the pilot cannot fly until documentation of compliance with a treatment program is submitted to the FAA. “Once the data is submitted to the FAA,” Molin said, “per my understanding, the pilot is OK to fly pending the special issuance [of the medical certificate].”

A Preferred Outcome

There is a better way to handle a potential severe sleep apnea diagnosis, and Molin believes that the FAA guidelines are helpful in this regard, providing an incentive for pilots to take care of OSA before it causes serious problems. “There are a lot of airmen out there who have not been treated, and they are at high risk,” he said. “We see that every day in our clinic; once diagnosed they feel so much better. Once treated, you can give people’s lives back.”

With this preferred method, the pilot completes the OSA evaluation with a sleep physician before seeing the AME for a formal airman medical examination. Under the new FAA guidelines, Molin said, “if you’re already diagnosed, then you have 90 days from the time of the examination to submit compliance data to the FAA and [continue flying] without any disruption.”

In other words, if a pilot who believes he might be at high risk for severe OSA takes the initiative, he explained, and gets evaluated before the AME exam, that pilot will have more options instead of being grounded while waiting for a test, delivery of test results and treatment for OSA. Pilots are better off, he added, using a sleep physician familiar with dealing with pilots and the FAA. “The key is you want to be evaluated and treated in quick succession so there is limited time between diagnosis and treatment. If you’re an airman, you need to get a sleep study, be treated and get all the compliance data in the shortest period of time so you’re not going to be off work.

“The reality is these guidelines do allow the pilot to continue flying with a disqualifying condition as long as he follows the specific guidelines being provided. I don’t think the FAA has the intention of trying to ground airmen. They’re trying to help; they’re not trying to catch people. They just want to identify individuals at high risk and who could be a flight risk. There is a lot of paranoia that the FAA is trying to screw over airmen [but] they’re trying to do this correctly.”

To help pilots who might be at risk of OSA and need to avoid lengthy downtime, Molin’s Zeeba Sleep Center offers an overnight program where pilots can fly in, spend the night in the sleep lab and have the study done, then if results are positive, get immediate treatment. This usually involves a prescription for a continuous positive airway pressure (CPAP) machine and follow-up monitoring, which can be done remotely via the Internet. “Once the data is submitted,” Molin said, “the pilot is OK to fly. No medical certification lapse occurs. The guidelines are giving pilots the incentive to get treated. The more proactive you are the better.”

Not a High Incidence

Dr. Ian Blair Fries, an AME and the owner-pilot of a TBM 900, agrees that OSA is a serious disease that needs to be treated. But he doesn’t believe it is as common as experts claim. “The FAA has suggested there’s a huge incidence of this disorder,” he said. “I do see it, but it’s not a huge frequency.”

Basically, Fries sees the new guidelines as allowing him more latitude as an AME, unless the pilot applying for a medical certificate is clearly at high risk of severe OSA. “If somebody comes in and he’s falling asleep here in the office–the chances of that happening are close to nil–the AME cannot issue the medical certificate,” he said. “The way this new procedure works, in almost all cases the AME issues the certificate, but depending on how serious he feels the category [of sleep apnea is], that affects whether he [refers the patient to a sleep specialist]. It’s better if the pilot had treatment [before the airman medical examination] and came ready to be set up for special issuance.”

Overall, Fries doesn’t believe that sleep apnea affects a large number of pilots. “The world that I see–I don’t want to downplay this, if somebody has this it can be a significant problem and absolutely should be treated–but the number of pilots who have serious sleep apnea that requires treatment is going to be small. The FAA has been talking about sleep apnea for quite some time and educating us AMEs on it, but there has been no increase in findings. The bottom line is, it’s not causing accidents.”

He pointed out that the AME guidelines for high-risk OSA patients essentially preclude anyone from getting a medical certificate, as they include not only a body-mass index above 35 but also issues such as congestive heart failure, atrial fibrillation, Type 2 diabetes, stroke and others that would disqualify a pilot.

More important for any pilot is that any medical condition needs to be tended to and not ignored, Fries emphasized. “That’s true with any disorder. If you have a disorder, the FAA is far more likely to allow you to fly if it’s treated than untreated. And if you have something, it’s better to be treated. We’re talking about just common sense.”