Sleep Apnea Testing in Transportation: It’s not medical guidance anymore, It’s full blown politics now.
Since before 2006 groups like the National Sleep Foundation(NSF) and the National Transportation Safety Board (NTSB) have been
working on making screening for obstructive sleep apnea (OSA) part of fitness for duty medical examination requirements for commercial motor vehicle (CMV) operators through the Federal Motor Carrier Safety Administration’s (FMCSA) Medical Review Board (MRB). Recently Dr. Fred Tilton Chief Aeronautical Medical Examiner (AME) for the Federal Aviation Administration (FAA) proposed OSA screening for flight physicals for pilots and air traffic controllers as part of their AME program.
Both of these efforts have resulted in the topic being taken out of the hands of medical review committees and put them into a formal rulemaking process. In trucking estimates are this will delay implementation of OSA screening and testing for at least 2 and possibly as long as 4 years. No estimates are available on how long it will take FAA.
In trucking the mandate for formal rulemaking by FMCSA came as the result of Public Law 113-45 which was signed by President Obama on October 15, 2013. To give you a concept of how resounding a defeat this was for the NSF’s lobbying efforts, this bill passed both houses of Congress with not a single vote in opposition, not a single member of congress speaking in opposition, and in the middle of the government shut down. In fact this bill received some notice in the mainstream press as one of the few examples of Congress taking action during the shutdown. The NSF was probably the only group in sleep medicine which came out publicly against the legislation. The American Sleep Apnea Association (ASAA) and the American Academy of Sleep Medicine (AASM) both came out in support of the trucking legislation. The ASAA organized two nationwide conferences on sleep apnea in transportation in 2010 and 2011.
With the FAA, Dr. Tilton, Chief FAA AME wrote in an AME newsletter about plans to start OSA screening. In a December 12, 2013 webinar with Dr. Mark Rosekind from NTSB they again covered plans to move forward without formal rulemaking. After a December 18 meeting with FAA Administrator Huerta, Dr. Tilton contacted pilot’s groups informing them the matter would be put on hold pending a review with affected stakeholders. HR-378 which is a bill pending in Congress to mandate FAA use formal rulemaking like trucking is still active in the House.
Why did this happen?
Federal Agencies like FMCSA and FAA are constantly being lobbied for new regulations to improve safety. The first step in the regulatory process is to quantify the safety risk (and quantify the reduction in accidents the new rule or procedure will cause) to compare to the cost to industry for implementing the new rule.
In fairness I am a truck driver with sleep apnea. I was diagnosed in 2002 after driving long haul over the road for 2 years with untreated OSA. Looking back those 2 years scare the “beegeebers” out of me. I was lucky to not cause a major fatigue related accident. Personally I spend much time and effort working to convince other drivers to get tested and treated for OSA. On the other hand, to implement regulations I understand the need to meet regulatory requirements. Failing to meet these will just result in successful legal challenges from trucking industry groups opposed to OSA testing.
In trucking this process started in 2008 with the FMCSA MRB convening a Medical Expert Panel (MEP) on OSA. The MRB MEP was chaired by Dr. Alan Pack, a well respected expert in sleep medicine. All but 2 of the other members of the MRB MEP had received Lifetime Achievement Awards from the NSF. One MEP member while respected within the NSF, was a pediatric sleep medicine expert. Trucking interests questioned the makeup of the MEP as recognized experts in transportation OSA and fatigue were not on the panel. Key Question # 1 was the OSA crash risk correlation. The charge of the MEP was to search the available literature on a variety of questions.
On Key Question # 1 the MEP failed to cite FMCSA Technical Report FMCSA-RT-04-007 which is a statistical analysis of accident data on Dr. Pack’s own research. This report concluded in part “.. no statistical evidence in these data to suggest that the presence of sleep apnea significantly increases the likelihood or the risk of motor vehicle crashes.” A public commenter at the FMCSA’s 2012 Motor Carrier Safety Advisory Committee (MCSAC) joint meeting with the MRB on sleep apnea attempted to bring up this issue. They were interrupted by the MRB chairman with the comment “We’re not going there”. The issue was brought up in formal written comments to the docket for the MCSAC-MRB meetings. Todd Spencer with OOIDA is a member of the FMCSA MCSAC committee and is one of the major opponents to OSA testing in trucking. He got up and left the MCSAC meeting and was later quoted as saying “There was no point in my staying there. They aren’t listening to anyone anyway.” He spent the time meeting with members of Congress. I have little doubt the seeds of Public Law 113-45 were planted in those meetings.
For the FAA one major issue is the position of general aviation (private pilots) and sleep apnea screening. The Aircraft Owners and Pilots Association (AOPA) has been one of the major opponents to OSA testing as part of AME exams. They cite an FAA review of flight safety incidents for the previous 20 years that failed to find ANY flight safety incident related to sleep apnea. They make a case to exclude private pilots in general aviation from any sleep apnea screening requirements. Screening for air traffic controllers may be problematic as prior to 2011 there was no path to certification for an air traffic controller with sleep apnea. The FAA noted that less than .1% of air traffic controllers had been diagnosed with OSA. Changes to fatigue management programs for air traffic controllers in 2011 addressed this issue.
Sleep medicine needs to realize that fitness for duty regulations in transportation will now be closely watched by Congress. In this realm perception is reality. Facts do not matter. The NSF is viewed by Congress and most of trucking as a trade organization lobbying for the business interests of sleep doctors, sleep labs and CPAP manufacturers. Little items foster this perception. Currently FMCSA MRB guidance does not allow certification of drivers using oral appliances. Few NSF members practice dental sleep medicine. MRB-MEP panel was dominated by NSF members. This action is viewed as a trade association taking action to protect the business interests of its members. The fact that the membership of the NSF will see a major increase in business if the regulations their members on the MRB-MEP are enacted, is an additional political perception issue.
Members of sleep medicine need to be aware of how public media comments and stories can be twisted in the political realm. Recent
main stream media coverage of the Bronx Train derailment brought out the potential that the accident might be fatigue related. Press photos of the engineer showed he has typical neck anatomy of an OSA patient. Mainstream press interviews by sleep medicine “experts” included quotes that the train accident might have been prevented if the engineer had been on CPAP the night before.
These mainstream news stories were taken by OSA opponents in trucking to point out “Sleep medicine is a bunch of voodoo science. They can diagnose sleep apnea by just looking at someone’s picture in the news.” Understanding that at this point in an NTSB investigation the fact that the engineer might already be on CPAP cannot be released. The engineer has privacy rights under HIPPA. Yet, sleep medicine “experts” possibly in well meaning efforts to increase awareness of OSA in transportation unwittingly provided more ammunition to OSA testing opponents.
Where do we go from here?
Issues that will have to be addressed in developing workable OSA screening and testing requirements in transportation highlight issues sleep medicine is internally debating. Sleep medicine coming up with consensus decisions on a variety of topics will be needed.
Home Sleep Test (HST) versus in lab PSG. Any OSA regulations in transportation will have to meet a White House Office of Management and Budget (OMB) cost effectiveness review. The cost savings to the public from the decrease in accidents will have to
be greater than the cost to industry to implement the OSA testing and treatment. In an OMB review of transportation safety regulations the cost savings for health care will not be included, only safety costs (sorry if you don’t like this lobby Congress to change the law). To even come close to meeting this requirement HST to auto-titrating PAP (APAP) treatment programs will be the only approach with a hope of meeting the cost issues involved. Current costs estimates for trucking OSA testing and treatment using traditional PSG, titrating PSG and CPAP programs are $ 1 Billion. Further chain of custody or establishing that the person actually taking the HST is the person listed in the medical records is an issue where the potential for falsification of HST is a problem.
At what point do you need to treat OSA? Setting clear clinical guidelines for when treatment is required will be needed when dealing with fitness for duty and litigation issues. Some debate within sleep medicine surrounds treatment for patients with AHI less than 15. Current AASM guidance is an AHI less than 5 (via PSG) is normal. Yet I know of actual cases of truck drivers with AHI=4 (via PSG) being required to use CPAP and one (AHI=4) actually getting fired for non-compliance with CPAP. Fixing these kinds of clinical practice parameter questions will be required to give transportation working regulations they can implement.
Fixing the non-medical barriers to treatment – AKA where do you plug in a CPAP?
In both trucking and aviation the need to be able to use a CPAP while taking required rest breaks is needed.
In trucking the use of sleeper berth equipped trucks in long haul over the road operations is normal. Many 12-V CPAP have come on
the market allowing direct power from the truck. Some innovative portable CPAP allow battery use. Yet, air quality regulations in many areas prohibit the idling of CMV engines. I happen to be working on this article while sitting out a blizzard in St. Louis in below 0 temperatures. The Americans with Disabilities Act as Amended (ADAA) covers sleep apnea as a disability as it affects the basic life process of sleeping. Reasonable accommodations such as exemptions to anti-idling requirements are just as needed as the exemptions for service animals in the hotel and motel industry. Sleep medicine needs to help groups like the ASAA which have been working on lobbying efforts in this area.
The FAA has its own problems. Commercial Pilots are subject to hours of duty regulations. There are requirements for pilots to have access to in-flight rest in certain types of operations. The specifications for these rest areas are laid out in the FAA regulations. Yet, the specifications did not include any requirement for power for a pilot taking in-flight rest. Like truck drivers, how does a pilot on CPAP use their equipment while taking an in-flight sleep period?
Start at home – What’s good for the Goose is good for the Gander.
Sleep apnea in both trucking and aviation is now in a political arena in the formal rulemaking process. Congress will review and have to approve any new medical guidance.
A common theme from opponents to OSA testing in trucking is… If it’s such a good thing make it mandatory for the doc’s.
A simple but probably effective lobbying tactic would be for sleep medicine to make testing for OSA part of the requirements to hold a certification to practice sleep medicine.
Co-coordinator of the Truckers for a Cause chapter of A. W. A. K. E. a patient support group for truck drivers under treatment for obstructive sleep apnea.
Active in lobbying and educational efforts as they apply to FMCSA medical certification guidelines and truck driver health and wellness.