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Withdrawal of Advanced Notice of Proposed Rulemaking (ANPRM) on Obstructive Sleep Apnea (OSA) Does Not Mean Examiners and Employers Should Ignore Safety Risks

Hartenbaum, Natalie P. MD, MPH, FACOEM

Journal of Occupational and Environmental Medicine: August 2018 - Volume 60 - Issue 8 - p e432–e433
doi: 10.1097/JOM.0000000000001374
LETTERS TO THE EDITOR
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OccuMedix, Inc., Dresher, PA.

Address correspondence to: Natalie P. Hartenbaum, MD, MPH, FACOEM, OccuMedix, Inc., Maple Glen, PA 19025 (natah@comcast.net; (occumedix@comcast.net).

The authors have no conflicts of interest.

To the Editor:

I appreciate Dr. Gurubagavatula and her colleague's comments and acknowledge that the AASM recommendations1 would work toward identifying a large number of drivers that might have any degree of obstructive sleep apnea (OSA). Although many agree that there is an increased risk of crash in drivers with OSA and that treatment decreases that risk, a major report by the US Preventative Medicine Task Force found insufficient evidence to identify OSA's contribution to risk of crash, independent of age, body mass index (BMI), and other potential confounders.2 Furthermore, individual differences in OSA symptomatology are well documented, and not all drivers with OSA are sleepy. Indeed, most drivers with OSA will not crash and those who are not sleepy or have other comorbidities might have no greater risk for crash than drivers with heart disease or obesity without OSA.3,4

There is also little agreement on the best criteria to use to determine which commercial vehicle operators should be referred for OSA diagnostic testing. Furthermore, although FMCSA advises that the focus should be on those with moderate-to-severe OSA, others believe that even mild OSA should be required to be treated in the commercial driver. From a practical standpoint, there is much greater agreement that eliminating all potential OSA risk is not feasible at this time due to budgetary, regulatory, and feasibility barriers. Instead, the ongoing argument is how to agree on criteria that will focus on identifying those drivers at highest risk of having OSA and at highest risk of being involved in a serious crash due to that diagnosis.

In attempting to reach guidance criteria regarding which CMV operators should be referred for an OSA diagnostic sleep study, it is important to understand that in the trucking industry most drivers do not work for large trucking companies. Instead, most drivers work as independent owner–operators or as subcontractors. Thus, recently hired drivers might not have health insurance at the time of their medical certification examination or even during the initial months of their employment. Furthermore, insurance deductibles for OSA testing may be high or the testing may not be covered at all if the driver does not meet criteria for OSA testing. A recent study by the American Trucking Research Institute (ATRI)5 found that 53% of drivers referred for sleep studies paid some or all of the test costs with an average of $1220 out-of-pocket expenses.

Although the AASM advocates that employers should cover the costs for diagnostic testing and monitoring, employers are not required to cover the cost of the commercial driver medical examination itself. In addition, employers do not pay for additional assessments or treatments which the examiner (often consistent with FMCSA guidance) determines are necessary to determine certification status. Examples where the driver will be referred to their personal health care provider for additional evaluation or treatment include; a more detailed vision examination and corrective lenses; laboratory studies to evaluate the stability of diabetes; exercise stress testing after a myocardial infarction or; complete neurologic and cardiac workups after an episode of syncope.

In this instance, the perfect appears to be the enemy of the good. Instead of requiring all or a large percentage of drivers to undergo OSA testing, which is not feasible, a more reasonable approach to implementation—and one with a far greater likelihood of success—is to begin with those drivers most that are most likely at risk for moderate-to-severe OSA and OSA-related crashes. Then, over time, more stringent criteria can be applied. Such a stepwise approach has been highly successful in other regulatory domains. For example, since the earliest drunk driving legislation, legal blood alcohol levels have been reduced as increasing evidence revealed a decrease in DUI crashes. Those of us with a commitment to sleep health and public safety should adopt a similar approach. Let's try to start with those criteria, ensuring that drivers who meet those criteria have diagnostic studies and if found to have moderate-to-severe OSA or other risks for crashes are treated. Then, we can evaluate the data to determine if there has been a significant decrease in CMV crashes, especially those deemed serious, and modify the screening criteria accordingly.

FMCSA has directed the medical examiner to the 2016 Medical Review Board recommendations which were derived from an evidence review and extensive input from various stakeholders. Most of these recommendations are consistent with the AASM recommendations aside from the criteria for referral. The rulemaking was withdrawn,6 not because OSA was not an area of concern, but because there was not agreement on which criteria to use. I regularly urge examiners and other medical professionals to utilize these recommendations as a starting point to determine which drivers should have diagnostic testing, especially when they are directed to this information by FMCSA or the information is through FMCSA-supported reviews such as other Medical Expert Panel or evidence-based reviews. It is reasonable for employers to support certified examiners medical decision-making, but employers should not more be responsible for making medical decisions regarding OSA than they would be responsible regarding diabetes or heart disease. As one successful model, the Federal Aviation Administration (FAA) was recently able to provide criteria for OSA screening and testing of airmen7 for the Aviation Medical Examiner.

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REFERENCES

1. Gurubhagavatula I, Sullivan S, Meoli A, et al. Management of obstructive sleep apnea in commercial motor vehicle operators: recommendations of the AASM Sleep and Transportation Safety Awareness Task Force. J Clin Sleep Med 2017; 13:745–758.
2. US Preventive Services Task Force. Screening for obstructive sleep apnea in adults: US Preventive Services Task Force Recommendation Statement. JAMA 2017; 317:407–414.
3. Ronna B, Thiese M, Ott U, et al. The association between cardiovascular disease risk factors and motor vehicle crashes among professional truck drivers. J Occup Environ Med 2016; 58:828–832.
4. Anderson JE, Govada M, Steffen TK, et al. Obesity is associated with the future risk of heavy truck crashes among newly recruited commercial drivers. Accid Anal Prev 2012; 49:378–384.
5. American Trucking Research Institute. Commercial driver perspectives on obstructive sleep apnea. Available at: http://atri-online.org/2016/05/26/commercial-driver-perspectives-on-obstructive-sleep-apnea/. Accessed May 16, 2018.
6. Hartenbaum NP. Withdrawal of Advanced Notice of Proposed Rulemaking (ANPRM) on Obstructive Sleep Apnea (OSA) does not mean examiners and employers should ignore safety risks. J Occup Environ Med 2017; 59:e374–e376.
7. Guide for Aviation Medical Examiners. Decision considerations disease protocols—obstructive sleep apnea (OSA). OSA reference. Available at: https://www.faa.gov/about/office_org/headquarters_offices/avs/offices/aam/ame/guide/dec_cons/disease_prot/osa/ref_materials/. Accessed May 16, 2018.
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