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Sleep Apnea: The Tireless Debate

Sleep Apnea: The Tireless Debate


The Transportation Newsletter
(April 13, 2015)

The Federal Motor Carrier Safety Administration (FMCSA) estimates that three out of ten commercial drivers suffer from Obstructive Sleep Apnea (OSA). It is a condition familiar and critically important to all those in the commercial trucking industry. The safety issues associated with sleep apnea have been widely discussed; however, the debate as to the FMCSA's role in the health certification of commercial drivers is far from over.

First, what is OSA? How is it defined? Medically, the term can be applied to a number of different types of respiratory issues, which have a number of different treatments, making the management of OSA particularly problematic for the Motor Carrier, Medical Professional, and the Regulators.

Requirements Versus Guidelines
In January, the FMCSA published a Bulletin to Medical Examiners and Training Organizations Regarding Obstructive Sleep Apnea (the "Bulletin") (U. S. Dept. of Transportation, Federal Motor Carrier Administration, National Registry of Certified Medical Examiners, Bulletin to Medical Examiners and Training Organizations Regarding Obstructive Sleep Apnea (January 2015). The stated purpose of the Bulletin is to remind medical examiners and trainers on the FMCSA's National Registry of Certified Medical Examiners of the physical qualifications standards and advisory criteria concerning the respiratory system for commercial drivers, specifically, how the "requirements" apply to drivers who may suffer from OSA. Bulletin at p. 1.

Commercial drivers are required to obtain a Medical Examiner's Certificate in order to lawfully operate a commercial vehicle. Federal Motor Carrier Safety Regulation § 391.41(b)(5) encompasses OSA and prohibits individuals from receiving the required Medical Examiner's Certificate if the driver has a medical history or clinical diagnosis of a respiratory dysfunction likely to interfere with their ability to safely operate a commercial motor vehicle. The Federal Motor Carrier Safety Regulations (FMCSRs) set forth physical qualification standards and advisory criteria and/or guidelines regarding drivers' health. Key provisions focusing on respiratory dysfunction and the issuance of a Medical Examiner's Certificate are found at §§ 391.41 and 391.43 of the FMCSRs. Over the years, misunderstanding and confusion regarding the application of these provisions has permeated the medical examiner community and raised questions as to whether the guidelines were actually requirements and whether individuals who exhibit indicators of OSA must undergo follow-up testing and treatment. This confusion has been exacerbated during the past year by purported inaccurate instruction on suspected OSA as part of the required examiner certification training. Many within the industry have argued that such confusion has led to unnecessary follow-up tests and the application of inconsistent standards among drivers.

In the fall of 2013, Congress sent the FMCSA a mandate that if the FMCSA intended to provide guidance on OSA screening and testing, it could only do so after following the formal rule-making process. Act of October 15, 2013, Pub. L. 113-45, 127 Stat. 557. To date, FMCSA has not done so. Confusion has persisted among medical examiners as to how to screen and test for OSA. In response to Congressional inquiries requesting that the FMCSA clarify that there are no requirements as to OSA, only guidelines, the FMCSA issued the Bulletin seeking to provide clarification on this issue.

FMCSA January 2015 Bulletin On Obstructive Sleep Apnea
Although the FMCSRs do not specifically identify OSA, the Bulletin makes clear that the FMCSA considers OSA a respiratory condition likely to interfere with safe driving. Bulletin at p. 2. The Bulletin reiterates that advisory criteria published in 2000 remains in effect; however, the Bulletin attempts to clarify that the advisory criteria are not to be construed as standards or requirements. Id. To this end, the Bulletin "encourages" medical examiners to consider the following in making a medical certification decision:

  • The primary safety goal regarding OSA is to identify drivers with moderate-to-severe OSA to ensure these drivers are managing their condition to reduce to the greatest extent practical the risk of drowsy driving. Moderate-to-severe OSA is defined by an apnea-hypopnea index (AHI) of greater than or equal to 15.
  • The Agency does not require that these drivers be considered unfit to continue their driving careers; only that the medical examiner make a determination whether they need to be evaluated and, if warranted, demonstrate that they are managing their OSA to reduce the risk of drowsy driving.
  • Screening: With regard to identifying drivers with undiagnosed OSA, FMCSA's regulations and advisory criteria do not include screening guidelines. Medical examiners should consider common OSA symptoms such as loud snoring, witnessed apneas, or sleepiness during the major wake periods, as well as risk factors, and consider multiple risk factors such as body mass index (BMI), neck size, involvement in a single-vehicle crash, etc. [Emphasis added]
  • Diagnosis: Methods of diagnosis include in-laboratory polysomnography [sleep study], at-home polysomnography [sleep study], or other limited channel ambulatory testing devices which ensure chain of custody.
  • Treatment: OSA is a treatable condition, and drivers with moderate-to-severe OSA can manage the condition effectively to reduce the risk of drowsy driving. Treatment options range from weight loss to dental appliances to Continuous Positive Airway Pressure (CPAP) therapy, and combinations of these treatments. The Agency's regulations and advisory criteria do not include recommendations for treatments for OSA and FMCSA believes the issue of treatment is best left to the treating healthcare professional and the driver. [Emphasis added]

Bulletin at p. 3. The Bulletin includes additional language in which the FMCSA disclaims that it is providing screening, diagnosis, or treatment guidelines regarding OSA; rather, medical examiners are to exercise their professional medical judgment when examining a driver and determining whether to issue a medical certificate, for what duration, and treatment options. Id. By mandating that medical examiners exercise their professional judgment when examining a driver, the FMCSA seeks to remove any question as to whether it is imposing OSA screening and testing requirements. Removing doubt as to what is expected of medical examiners, and putting the decision to issue a medical certificate squarely with their professional judgment, may result in fewer or unnecessary OSA follow-up tests and treatment. Whether the Bulletin will have such an effect remains to be seen.

Click here to view the full spring 2015 Edition of the Transportation Newsletter.

Authors
Marc C. Tucker
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