Withdrawal of Advanced Notice of Proposed Rulemaking (ANPRM) on Obstructive Sleep Apnea (OSA) Does Not Mean Examiners and Employers Should Ignore Safety Risks
Once again, government action has led many to believe that screening and/or treatment for obstructive sleep apnea (OSA) in commercial motor vehicle (CMV) drivers is no longer necessary nor permitted. This action by the Department of Transportation and its agencies announcing the withdrawal of the Advanced Notice of Proposed Rulemaking (ANPRM)1 on the Evaluation of Safety Sensitive Personnel for Moderate-to-Severe OSA2 has resulted in confusion for medical examiners and employers.
This rulemaking would have created specific requirements for examiners to follow—including criteria for screening, diagnostic testing, and treatment of CMV operators and railroad workers—rather than having them relying on the current process of using various guidance sources to determine whether additional evaluation is appropriate or, in some cases, believing that as there is no specific requirement and that they can entirely ignore OSA as a safety concern. What has been overlooked in much of the press coverage of the rulemaking withdrawal is that it included in the withdrawal notice is a statement by the agencies which reinforces the view that:
The Federal Railroad Administration (FRA) indicated that it felt that the rulemaking addressing fatigue risk management would be an appropriate way to address OSA in railroad workers. And, the Federal Motor Carrier Safety Administration (FMCSA) has repeated many times, most recently in the withdrawal notice,1 as well as on several recent National Registry of Certified Medical Examiner (NRCME) webinars, that while there are no specific criteria that examiners are required to follow, examiners can use any available resource, such as the January 2015 Bulletin to Medical Examiners and Training Organizations Regarding Obstructive Sleep Apnea,3 or the 2016 Medical Review Board (MRB) recommendations, Task 16–1.4 Specifically, the notice of withdrawal includes the statement:
So clearly, examiners are not prohibited from identifying drivers who may be at risk of moderate-to-severe OSA and, if there is a concern, the driver should be referred for diagnostic testing and treatment. FMCSA specifically points to the 2015 Bulletin to Examiners and the 2016 MRB recommendations, as resources the examiners should consult.
Furthermore, in the above referenced 2015 Bulletin, FMCSA notes states “it is clear that FMCSA has considered OSA a respiratory dysfunction that interferes with oxygen exchange.” The Agency recommended that “if a medical examiner believes the driver's respiratory condition is in any way likely to interfere with the driver's ability to safely control and drive a commercial motor vehicle, the driver should be referred to a specialist for further evaluation and therapy.”
What examiners must remember is that the commercial driver medical examinations are not meant to be “cookbook” examinations. We are expected to draw upon our medical training and experience, as well as recent medical literature including expert reports, and then consider the individual, in making the final qualification determination. Although we cannot place restrictions (aside from corrective lenses, hearing aids, or hearing, vision, diabetes, or seizures exemptions), we can require additional testing and information or even shorten the duration of the certification. Most of what we use to evaluate whether any medical condition or treatment may place a CMV operator at risk of sudden or gradual impairment or incapacitation is guidance, not regulation. The Advisory Criteria,5 which had been part of the examination form until recently, the content of the Medical Examiner (ME) Handbook, and even the Frequently Asked Questions are all guidance. FMCSA has explained the intent behind guidance in the ME Handbook:
Other sources of guidance available to examiners include the evidence reviews, Expert Panel Recommendations, and the MRB recommendations, all available through the FMCSA's MRB website.