LETTER TO THE EDITOR Readers are invited to submit letters for publication in this department. Submit letters online at http:// joem.edmgr.com. Choose “Submit New Manuscript.” A signed copyright assignment and financial disclosure form must be submitted with the letter. Form available at www.joem.org under Author and Reviewer information.
Certified Medical Examiners and Screening for Obstructive Sleep Apnea To the Editor: ither untreated or inadequately treated obstructive sleep apnea (OSA) is a medical condition that is related to a higher risk of motor vehicle crash.1–5 It has been estimated that more than 18 million American adults have sleep apnea; however, most are unaware that they have this condition.6 There is no official guidance from the Federal Motor Carrier Safety Administration (FMCSA) to identify the drivers who are at highest risk for OSA and should be required to undergo screening and/or diagnostic studies. The only requirement is that drivers meet the medical standard—“has no established medical history or clinical diagnosis of a respiratory dysfunction likely to interfere with his/her ability to control and drive a commercial motor vehicle safely”. Obstructive sleep apnea is mentioned in the Advisory Criteria, “There are many conditions that interfere with oxygen exchange and may result in incapacitation, including emphysema, chronic asthma, carcinoma, tuberculosis, chronic bronchitis and sleep apnea,” yet there is little mention of how to evaluate the risk. Information regarding OSA, which had previously been provided by the FMCSA, including some which is now inconsistent with current knowledge, was derived from a 1991 Conference Report on Pulmonary/Respiratory Disorders and Commercial Driver.7 The Medical Examiner Handbook8 had indicated that examiners “should not certify the driver with suspected or untreated sleep apnea until etiology is confirmed and treatment has been shown to be stable, safe, and adequate/effective” but offered no specifics on how to identify drivers suspected of having OSA. Additional guidance for examiners had been available in three FMCSA Fre-
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Address correspondence to: Natalie P. Hartenbaum, MD, MPH, FACOEM, President and Chief Medical Officer, OccuMedix, Dresher, PA 19025 ([email protected]). The author declares no conflicts of interest. C 2015 by American College of OccupaCopyright tional and Environmental Medicine DOI: 10.1097/JOM.0000000000000418
quently Asked Questions, which addressed sleep disorders. The FMCSA also had a section of its Web site devoted to sleep apnea, “Spotlight on Sleep Apnea” with information for drivers and carriers. As a result of recent Congressional action, the sections of the Medical Examiners Handbook on OSA, the Frequently Asked Questions on sleep disorders and the Spotlight on Sleep Apnea, were all removed from the FMCSA Web site. There have been several efforts to provide screening criteria to identify drivers at the highest risk of having OSA and presumably at the highest risk of crash. In 2006, a Joint Task Force of the American College of Occupational and Environmental Medicine, the American College of Chest Physician, and the National Sleep Foundation recommended OSA screening criteria for drivers.9 In 2007 and 2008, based in part on an FMCSA supported evidence report,10 the FMCSA’s Medical Expert Panel on Obstructive Sleep Apnea11 and the FMCSA’s Medical Review Board (MRB)12 developed recommendations that would have required testing a larger percentage of drivers than the Joint Task Force. Most recently, the Motor Carrier Safety Advisory Committee (MCSAC), an industry advisory group, and the FMCSA’s MRB jointly offered recommendations in 2012.13 Despite recommendations from the National Transportation Safety Board,14 multiple sets of expert recommendations, including those from the FMCSA’s Medical Expert Panel, the MRB, and the MCSAC and requests from the American College of Occupational Medicine (ACOEM)15,16 and other organizations, the FMCSA has not provided guidance for medical examiners. A Notice of Proposed Rulemaking with guidance derived from the 2012 MCSAC/MRB recommendation was published in the Federal Register17 but withdrawn days later.18 As it seemed that the FMCSA was again about to publish guidance, industry and labor groups successfully lobbied for legislation requiring any new requirement on OSA would have to go through the rulemaking process. Given that there is no specific guidance from the FMCSA, examiners varied in how they evaluated drivers who might be at risk of having OSA. With implementation of the National Registry of Certified Medical Examiners (NRCME), it was hoped that there would be improved consistency among examiners. Unfortunately, although some training programs were teach-
ing what was in the medical examiner handbook and introducing other resources such as MRB, MEP, or MCSAC recommendations, others were teaching that there were specific required criteria for screening drivers for OSA, whereas others were ignoring OSA entirely. The NRCME Sample Training Document19 had noted that training programs could teach material beyond the Medical Examiner Handbook, provided it was clearly highlighted that the material was not endorsed by the FMCSA and that examiners could use more current guidance than was issued by the FMCSA in making certification determinations. The FMCSA had indicated that although the National Registry certification examination would only include information that had gone through public notice and comment, examiners should consider current best practice in making certification determination, not only for OSA but also for other conditions where there was nothing official from the FMCSA such as Parkinson disease or use of potentially impairing medications such as opioids. In August 2014, the American Trucking Association20 issued a statement that “it is the responsibility of the certified medical examiner to use his or her best judgment to certify that a driver is medical qualified to perform the functions of a professional truck driver. An examiner may be, at times, justified in requiring additional testing to rule out sleep disorders. It is not however, a regulatory requirement to test every driver who exhibits a single risk factor (e.g. high BMI).” To further complicate the situation, two Congressmen sent a letter to Acting FMCSA’s Administrator Scott Darling on October 2, 2014,21 complaining that some NRCME training programs are teaching that the FMCSA has specific requirements on screening drivers for OSA. This letter asked the FMCSA to instruct those training programs to inform examiners that they are not to follow any specific steps with respect to sleep apnea and correct the training to those examiners who have received incorrect information. Unfortunately, they also asked that training programs be required to remove all reference to the MRB, MCSAC, and former FMCSA recommendations on sleep apnea from their training program. Administrator Darling responded that the FMCSA will issue an advisory, clarifying examiners’ and training programs’ roles but that training programs are not prohibited from teaching the additional information and that examiners should refer drivers for
JOEM r Volume 57, Number 3, March 2015 Copyright © 2015 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
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evaluation and potential treatment if the examiner suspects a sleep disorder that could affect safe vehicle operation but does not specify the factors to be used in making that determination. In 2009, Durand found that although ACOEM members felt that screening for OSA was important, less than 50% used any specific criteria.22 In the intervening years, even with additional recommendations from medical and industry groups and the implementation of the NRCME, there continues to be no consistency among examiners in which criteria they are utilizing to determine which drivers should be referred for additional testing. Some examiners are utilizing the Joint Task Force, whereas others the MRB, MEP, or MRB/MCSAC recommendation. Some examiners are only referring drivers for evaluation if they admit to daytime sleepiness. This presents challenges for employers who are relying on the medical examiner to make the determination but are finding inconsistent criteria used, even within the same examiner group. Employers are threatening examiners who may be trying to utilize current best medical knowledge that they will use different examiners in the future. There is now also risk of litigation or grievances against employers or examiners who attempt to utilize current best practices and require diagnostic studies in some drivers, and at the same time, there have been lawsuits against examiners and employers when a crash occurred, the driver would be considered to be at high risk on the basis of one or more of the recommendations and was not tested and but later found to have OSA. With the article by Platt et al23 recommending universal screening of commercial drivers for OSA and the comments by Hartenbaum et al24 and Platt Gurubhagavatula,25 this is becoming an even more contentious area with increasing risk exposure for examiners, employers, and third-party administrators as there seems to be no single standard of practice. In an effort to demonstrate the variation of examiner criteria for OSA evaluation, a survey was conducted through the American College of Occupational and Environmental Medicine. Eligible participants were ACOEM members who had completed an NRCME training program, through the ACOEM or another organization and nonACOEM members who completed their training through one of the ACOEM NRMCE training programs. The survey was sent to all ACOEM members (n = 2689) and all ACOEM nonmembers (n = 2045) who had completed their NRCME training through the ACOEM. A total of 323 members (16% response rate) and 282 nonmembers (15% response rate) were asked to choose one of six certification outcomes e20
for each of five scenarios based only on the information provided. Examiners were given the same options for each scenario. a. Certify for 2 years. b. Certify for 1 year. c. Certify for 1 year and instruct the driver to discuss the risk of OSA with the primary care physician (PCP). d. Certify for 3 months and request documentation from the PCP on the risk of OSA. e. Certify for 3 months and require sleep study. f. Do not certify. The five scenarios were as follows: Scenario 1. A 40-year-old male driver with a BMI of 33 kg/m2 and on two antihypertensive agents. The Mallampati score is 4. He denies excessive daytime somnolence or snoring and has never had nor been referred for a sleep study. There are no other medical conditions that would lead to a shortened certification. Scenario 2. A driver with a BMI of 35 kg/m2 and currently on two antihypertensive agents. The Mallampati score is 2. He denies excessive daytime somnolence or snoring and has never had nor been referred for a sleep study. There are no other medical conditions that would lead to a shortened certification. Scenario 3. A driver with a BMI of 40 kg/m2 and currently on no medication. The remainder of the examination is normal, including blood pressure. The Mallampati score is 2. He denies excessive daytime somnolence or snoring and has never had nor been referred for a sleep study. There are no other medical conditions that would lead to a shortened certification. Scenario 4. A driver with a BMI of 45 kg/m2 . Blood pressure is currently well controlled on a single medication. He denies excessive daytime somnolence or snoring and has never had nor been referred for a sleep study. There are no other medical conditions that would lead to a shortened certification. Scenario 5. A driver with a BMI of 35 kg/m2 and currently on two antihypertensive agents. He reports that he had been diagnosed with OSA 5 years before and discontinued continuous positive airway pressure treatment on his own after losing 100 lb. He denies excessive daytime somnolence or snoring.
RESULTS Commercial motor vehicle operators can select any examiner who is listed on the National Registry. This could be an MD or DO, a nurse practitioner, a physi-
cian assistant, a chiropractor, or other licensed health care professionals licensed by their state to perform physical examinations (there are registered nurses and physical therapists also listed). As the goal of this survey was to determine whether a single driver could be examined by different examiners and have widely different certification outcomes, the initial evaluation of the data looked at aggregate responses. For each scenario, a wide variation in examiner determination was found, with some examiners issuing 2-year certification with no discussion of the OSA risk whereas other examiners disqualifying drivers in each scenario. None of the cases had a true “correct” answer on the basis of FMCSA criteria; however, there was actually an incorrect response for all but Scenario 3. The FMCSA guidance suggests that drivers who are on medication for hypertension should be issued no longer than a 1-year certification. In all scenarios where the driver was on one or more antihypertensive agents, some examiners did indicate that they would certify the driver for 2 years. It is possible that some of those examiners were only focusing on the risk of OSA and did not consider the hypertension independently. For Scenario 1, most examiners would have certified the driver for 1 year and advised the driver to discuss the risk of OSA with their primary care provider. For the second, although most would again certify for 1 year and advise discussion with the PCP, almost as many would have certified for 3 months and required a sleep study. Scenario 3 was interesting in that although around 40% of respondents would have certified for 2 years with no discussion of OSA, around 30% would certify for 3 months and require a sleep study. Close to 50% would require a sleep study and issue a 3- month certification in Scenario 4, with around 30% advising to discuss the risk of OSA with personal physician and issuing a 1-year certificate. The final scenario was the one where there was the most consistent response—almost 60% would certify for 3 months and require a sleep study, followed by a 3-month certification with documentation required from the PCP on the risk of OSA or not certifying the driver at all (Fig. 1). Looking at just Scenario 3 and comparing physicians and non-physician, there is still a variety of determinations but the same distribution as seen in the aggregate data (Fig. 2). Additional analysis of the data on Scenario 3 compared ACOEM-trained and non–ACOEM-trained ACOEM member examiners. Although the majority of both groups would have either certified for 2 years or certified for 3 months and required a sleep study—the extremes of option, a
C 2015 American College of Occupational and Environmental Medicine
Copyright © 2015 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
JOEM r Volume 57, Number 3, March 2015
FIGURE 1. (Scenario 1) A 40-year-old male driver with a BMI of 33 kg/m2 and on two antihypertensive agents. The Mallampati score is 4. He denies excessive daytime somnolence or snoring and has never had nor been referred for a sleep study. There are no other medical conditions that would lead to a shortened certification. (Scenario 2) A driver with a BMI of 35 kg/m2 and currently on two antihypertensive agents. The Mallampati score is 2 and he denies excessive daytime somnolence or snoring, has never had nor been referred for a sleep study. There are no other medical conditions that would lead to a shortened certification. (Scenario 3) A driver with a BMI of 40 kg/m2 , and he is currently on no medication and the remainder of the examination is normal, including blood pressure. The Mallampati score is 2, and he denies excessive daytime somnolence or snoring and has never had nor been referred for a sleep study. There are no other medical conditions that would lead to a shortened certification. (Scenario 4) A driver with a BMI of 45 kg/m2 . Blood pressure is currently well controlled on a single medication. He denies excessive daytime somnolence or snoring and has never had nor been referred for a sleep study. There are no other medical conditions that would lead to a shortened certification. (Scenario 5.) A driver with a BMI of 35 kg/m2 and currently on two antihypertensive agents. He reports that he had been diagnosed with OSA 5 years before and discontinued continuous positive airway pressure treatment on his own after losing 100 lb. He denies excessive daytime somnolence or snoring. higher percentage of the ACOEM-trained examiners than non–ACOEM-trained examiners would have certified the driver for 3 months and required a sleep study whereas a the non-ACOEM–trained examiner would have certified for 2 years (Fig. 3).
CONCLUSIONS It is impossible to determine whether similar findings would be observed if this survey included a wider selection of examiners, potentially with a larger selection of nonphysicians. Nevertheless, as drivers and employers can select any examiner on the national registry, with the variation among this group of over 600 examiners, it is likely that variation would continue to be seen. It is also difficult to assess whether additional information on some cases may have altered some responses. Some examiners indicated that they also use neck circumference or questionnaires as part of their assessment but again, it is strongly suspected that variation would still be seen. A final criticism is whether similar variation would be seen for other medical conditions. For those conditions where there is no
guidance from the FMCSA, it is likely that variation would be seen, but for those conditions where there is guidance in the Medical Examiner Handbook, examiners tend to be much more consistent. What makes OSA different from other conditions where the FMCSA does not offer guidance is the higher prevalence in commercial drivers and the higher safety risk. OSA is recognized as a medical condition associated with an increased risk of motor vehicle crashes. Several expert groups have looked at the risk of crash in commercial drivers with OSA and offered recommendations on the basis of medical literature to guide which drivers should be required to undergo diagnostic study. This study demonstrates that there is no consistent criterion used by examiners listed on the NRCME, ranging from 2– year certification with no discussion on the risk of OSA to disqualification. Although it will be impossible to please everyone with whatever guidance may be issued, it is long overdue that the FMCSA issues at least issue guidance to identify those drivers who would be at highest risk of OSA and then adjust that guidance on the basis of findings;
Letter to the Editor
FIGURE 2. (Scenario 3) Others compared with the physician—a driver with a BMI of 40 kg/m2 . He is currently on no medication and the remainder of the examination is normal, including blood pressure. The Mallampati score is 2. He denies excessive daytime somnolence or snoring and has never had nor been referred for a sleep study. There are no other medical conditions that would lead to a shortened certification.
FIGURE 3. (Scenario 3) ACOEMtrained compared with non–ACOEMtrained ACOEM members–A driver with a BMI of 40 kg/m2 . He is currently on no medication and the remainder of the examination is normal, including blood pressure. The Mallampati score is 2. He denies excessive daytime somnolence or snoring and has never had nor been referred for a sleep study. There are no other medical conditions that would lead to a shortened certification. it would provide some consistency to examiners and employers who are trying to ensure that only drivers who are not at risk of sudden or gradual impairment or incapacitation are operating commercial motor vehicles. The current lack of guidance is leading to risk to the motoring public as well as liability to examiners and employers. Natalie P. Hartenbaum MD, MPH, FACOEM OccuMedix, Dresher, Penn.
REFERENCES 1. Catarino R, Spratley J, Catarino I, Lunet N, PaisClemente M. Sleepiness and sleep-disordered breathing in truck drivers: risk analysis of road accidents. Sleep Breath. 2014;18:59–68.
C 2015 American College of Occupational and Environmental Medicine
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2. Basoglu OK, Tasbakan MS. Elevated risk of sleepiness-related motor vehicle accidents in patients with obstructive sleep apnea syndrome: a case-control study. Traffic Inj Prev. 2014;15:470–476. 3. Strohl KP, Brown DB, Collop N, et al.ATS Ad Hoc Committee on Sleep Apnea, Sleepiness, and Driving Risk in Noncommercial Drivers. An official American Thoracic Society Clinical Practice Guideline: sleep apnea, sleepiness, and driving risk in noncommercial drivers. An update of a 1994 Statement. Am J Respir Crit Care Med. 2013;187:1259–1266. 4. Karimi M, Eder DN, Eskandari D, Zou D, Hedner JA, Grote L. Impaired vigilance and increased accident rate in public transport operators is associated with sleep disorders. Accid Anal Prev. 2013;51:208–214. 5. Tregear S, Reston J, Schoelles K, Phillips B. Obstructive sleep apnea and risk of motor vehicle crash: Systematic review and meta-analysis. J Clin Sleep Med. 2009;5:573–581. 6. National Sleep Foundation. Sleep Apnea. Available at: http://sleepfoundation.org/sleepdisorders-problems/sleep-apnea. Accessed January 3, 2015. 7. Federal Motor Carrier Safety Administration. Conference on Pulmonary/Respiratory Disorders and Commercial Drivers—FHWAMC-91-004. Available at: http://www.fmcsa .dot.gov/regulations/medical/conferencepulmonaryrespiratory-disorders-andcommercial-drivers. Published 1991. Accessed January 3, 2014. 8. FMCSA Medical Examiner Handbook. 2014. Currently off website for update. Available at: http://nrcme.fmcsa.dot.gov/documents/FMCSA MedicalExaminerHandbook-2014MAR18.pdf. 9. Hartenbaum N, Collop N, Rosen IM, et al. Sleep apnea and commercial motor vehicle op-
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10.
11.
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13.
14.
15. 16. 17.
erators: statement from the joint task force of the American College of Chest Physicians, American College of Occupational and Environmental Medicine, and the National Sleep Foundation. J Occup Environ Med. 2006;48(9 Suppl): S4–S37. Driver Obstructive Sleep Apnea and Commercial Motor Vehicle Safety: Updated Review (updated 2011). Available at: http://ntl.bts .gov/lib/44000/44400/44452/OSA_Update_ 11302011.docx. Accessed January 3, 2015. Opinions of Expert Panel—Obstructive Sleep Apnea and Commercial Motor Vehicle Driver Safety. Available at: http://www.fmcsa .dot.gov/regulations/medical/opinions-expertpanel-obstructive-sleep-apnea-and-commercial -motor-vehicle. Accessed January 3, 2015. Medical Review Board Meeting Summary January 28, 2008. Available at: http://www .mrb.fmcsa.dot.gov/documents/Fin_Meet_Min_ Jan28_2008MRB_Meet_Revised11-24-09.pdf. Accessed January 3, 2015. Motor Carrier Safety Advisory Committee. February 6, 2012 MCSAC and MRB Task 11-05 Final Report on Obstructive Sleep Apnea (OSA). Available at: http://www.mrb .fmcsa.dot.gov/documents/Meetings2012/ Task11-05FinalCoverLetterandReport_2-21-12 .docx. Accessed January 3, 2015. NTSB Safety Recommendation H-09-015 and 016. Available at: http://www.ntsb.gov/ safety/safety-recs/RecLetters/H09 15 16.pdf. Accessed January 3, 2015. ACOEM letter to Congressmen Howard and Mica. 2010. ACOEM letter to Administrator Ferro. 2013. Federal Register. Proposed recommendations on obstructive sleep apnea. notice; request for comments. Federal Motor Carrier Safety. 2012;77:23794–23797.
18. Federal Motor Carrier Safety Administration, DOT. Proposed Recommendations on Obstructive Sleep Apnea; Withdrawal of Notice. 77 Federal Register 82 (April 27, 2012), pp. 25226–7. Available at: www.gpo.gov/fdsys/pkg/ FR-2012-04-27/html/2012-10176.htm. 19. Medical Examiner Sample Training Handbook. Available at: http://nrcme.fmcsa.dot.gov/ documents/ME Training Document.pdf. 20. ATA Obstructive Sleep Apnea and Commercial Driver Medical Qualification. 2014. Available at: http://www.wvtrucking.com/attachments/ article/214/obstructive sleep apnea and commercial driver medical qualification final. pdf . Accessed January 3, 2015. 21. Letter to FMCSA on OSA and commercial driver. Available at: http://www.ooida .com/IssuesActions/Regulatory/docs/Bucshon_ Lipinski_Letter_on_Sleep-Apnea_100214.pdf. Accessed January 3, 2015. 22. Durand G1, Kales SN. Obstructive sleep apnea screening during commercial driver medical examinations: a survey of ACOEM members. J Occup Environ Med. 2009;51:1220–1226. 23. Platt AB1, Wick LC, Hurley S, et al. Hits and misses: screening commercial drivers for obstructive sleep apnea using guidelines recommended by a joint task force. J Occup Environ Med. 2013;55:1035–1040. 24. Hartenbaum NP, Phillips B, Collop N. Response to “Hits and Misses: Screening Commercial Drivers for Obstructive Sleep Apnea Using Guidelines Recommended by a Joint Task Force” by Platt et al. J Occup Environ Med. 2014;56:119–121. 25. Platt AB, Gurubhagavatula I. Rationale for broader testing of drivers for obstructive sleep apnea: a response to Hartenbaum and colleagues. J Occup Environ Med. 2014;56:121– 122.
C 2015 American College of Occupational and Environmental Medicine
Copyright © 2015 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
Certified Medical Examiners and Screening for Obstructive Sleep Apnea To the Editor: ither untreated or inadequately treated obstructive sleep apnea (OSA) is a medical condition that is related to a higher risk of motor vehicle crash.1–5 It has been estimated that more than 18 million American adults have sleep apnea; however, most are unaware that they have this condition.6 There is no official guidance from the Federal Motor Carrier Safety Administration (FMCSA) to identify the drivers who are at highest risk for OSA and should be required to undergo screening and/or diagnostic studies. The only requirement is that drivers meet the medical standard—“has no established medical history or clinical diagnosis of a respiratory dysfunction likely to interfere with his/her ability to control and drive a commercial motor vehicle safely”. Obstructive sleep apnea is mentioned in the Advisory Criteria, “There are many conditions that interfere with oxygen exchange and may result in incapacitation, including emphysema, chronic asthma, carcinoma, tuberculosis, chronic bronchitis and sleep apnea,” yet there is little mention of how to evaluate the risk. Information regarding OSA, which had previously been provided by the FMCSA, including some which is now inconsistent with current knowledge, was derived from a 1991 Conference Report on Pulmonary/Respiratory Disorders and Commercial Driver.7 The Medical Examiner Handbook8 had indicated that examiners “should not certify the driver with suspected or untreated sleep apnea until etiology is confirmed and treatment has been shown to be stable, safe, and adequate/effective” but offered no specifics on how to identify drivers suspected of having OSA. Additional guidance for examiners had been available in three FMCSA Fre-
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Address correspondence to: Natalie P. Hartenbaum, MD, MPH, FACOEM, President and Chief Medical Officer, OccuMedix, Dresher, PA 19025 ([email protected]). The author declares no conflicts of interest. C 2015 by American College of OccupaCopyright tional and Environmental Medicine DOI: 10.1097/JOM.0000000000000418
quently Asked Questions, which addressed sleep disorders. The FMCSA also had a section of its Web site devoted to sleep apnea, “Spotlight on Sleep Apnea” with information for drivers and carriers. As a result of recent Congressional action, the sections of the Medical Examiners Handbook on OSA, the Frequently Asked Questions on sleep disorders and the Spotlight on Sleep Apnea, were all removed from the FMCSA Web site. There have been several efforts to provide screening criteria to identify drivers at the highest risk of having OSA and presumably at the highest risk of crash. In 2006, a Joint Task Force of the American College of Occupational and Environmental Medicine, the American College of Chest Physician, and the National Sleep Foundation recommended OSA screening criteria for drivers.9 In 2007 and 2008, based in part on an FMCSA supported evidence report,10 the FMCSA’s Medical Expert Panel on Obstructive Sleep Apnea11 and the FMCSA’s Medical Review Board (MRB)12 developed recommendations that would have required testing a larger percentage of drivers than the Joint Task Force. Most recently, the Motor Carrier Safety Advisory Committee (MCSAC), an industry advisory group, and the FMCSA’s MRB jointly offered recommendations in 2012.13 Despite recommendations from the National Transportation Safety Board,14 multiple sets of expert recommendations, including those from the FMCSA’s Medical Expert Panel, the MRB, and the MCSAC and requests from the American College of Occupational Medicine (ACOEM)15,16 and other organizations, the FMCSA has not provided guidance for medical examiners. A Notice of Proposed Rulemaking with guidance derived from the 2012 MCSAC/MRB recommendation was published in the Federal Register17 but withdrawn days later.18 As it seemed that the FMCSA was again about to publish guidance, industry and labor groups successfully lobbied for legislation requiring any new requirement on OSA would have to go through the rulemaking process. Given that there is no specific guidance from the FMCSA, examiners varied in how they evaluated drivers who might be at risk of having OSA. With implementation of the National Registry of Certified Medical Examiners (NRCME), it was hoped that there would be improved consistency among examiners. Unfortunately, although some training programs were teach-
ing what was in the medical examiner handbook and introducing other resources such as MRB, MEP, or MCSAC recommendations, others were teaching that there were specific required criteria for screening drivers for OSA, whereas others were ignoring OSA entirely. The NRCME Sample Training Document19 had noted that training programs could teach material beyond the Medical Examiner Handbook, provided it was clearly highlighted that the material was not endorsed by the FMCSA and that examiners could use more current guidance than was issued by the FMCSA in making certification determinations. The FMCSA had indicated that although the National Registry certification examination would only include information that had gone through public notice and comment, examiners should consider current best practice in making certification determination, not only for OSA but also for other conditions where there was nothing official from the FMCSA such as Parkinson disease or use of potentially impairing medications such as opioids. In August 2014, the American Trucking Association20 issued a statement that “it is the responsibility of the certified medical examiner to use his or her best judgment to certify that a driver is medical qualified to perform the functions of a professional truck driver. An examiner may be, at times, justified in requiring additional testing to rule out sleep disorders. It is not however, a regulatory requirement to test every driver who exhibits a single risk factor (e.g. high BMI).” To further complicate the situation, two Congressmen sent a letter to Acting FMCSA’s Administrator Scott Darling on October 2, 2014,21 complaining that some NRCME training programs are teaching that the FMCSA has specific requirements on screening drivers for OSA. This letter asked the FMCSA to instruct those training programs to inform examiners that they are not to follow any specific steps with respect to sleep apnea and correct the training to those examiners who have received incorrect information. Unfortunately, they also asked that training programs be required to remove all reference to the MRB, MCSAC, and former FMCSA recommendations on sleep apnea from their training program. Administrator Darling responded that the FMCSA will issue an advisory, clarifying examiners’ and training programs’ roles but that training programs are not prohibited from teaching the additional information and that examiners should refer drivers for
JOEM r Volume 57, Number 3, March 2015 Copyright © 2015 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.
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Letter to the Editor
evaluation and potential treatment if the examiner suspects a sleep disorder that could affect safe vehicle operation but does not specify the factors to be used in making that determination. In 2009, Durand found that although ACOEM members felt that screening for OSA was important, less than 50% used any specific criteria.22 In the intervening years, even with additional recommendations from medical and industry groups and the implementation of the NRCME, there continues to be no consistency among examiners in which criteria they are utilizing to determine which drivers should be referred for additional testing. Some examiners are utilizing the Joint Task Force, whereas others the MRB, MEP, or MRB/MCSAC recommendation. Some examiners are only referring drivers for evaluation if they admit to daytime sleepiness. This presents challenges for employers who are relying on the medical examiner to make the determination but are finding inconsistent criteria used, even within the same examiner group. Employers are threatening examiners who may be trying to utilize current best medical knowledge that they will use different examiners in the future. There is now also risk of litigation or grievances against employers or examiners who attempt to utilize current best practices and require diagnostic studies in some drivers, and at the same time, there have been lawsuits against examiners and employers when a crash occurred, the driver would be considered to be at high risk on the basis of one or more of the recommendations and was not tested and but later found to have OSA. With the article by Platt et al23 recommending universal screening of commercial drivers for OSA and the comments by Hartenbaum et al24 and Platt Gurubhagavatula,25 this is becoming an even more contentious area with increasing risk exposure for examiners, employers, and third-party administrators as there seems to be no single standard of practice. In an effort to demonstrate the variation of examiner criteria for OSA evaluation, a survey was conducted through the American College of Occupational and Environmental Medicine. Eligible participants were ACOEM members who had completed an NRCME training program, through the ACOEM or another organization and nonACOEM members who completed their training through one of the ACOEM NRMCE training programs. The survey was sent to all ACOEM members (n = 2689) and all ACOEM nonmembers (n = 2045) who had completed their NRCME training through the ACOEM. A total of 323 members (16% response rate) and 282 nonmembers (15% response rate) were asked to choose one of six certification outcomes e20
for each of five scenarios based only on the information provided. Examiners were given the same options for each scenario. a. Certify for 2 years. b. Certify for 1 year. c. Certify for 1 year and instruct the driver to discuss the risk of OSA with the primary care physician (PCP). d. Certify for 3 months and request documentation from the PCP on the risk of OSA. e. Certify for 3 months and require sleep study. f. Do not certify. The five scenarios were as follows: Scenario 1. A 40-year-old male driver with a BMI of 33 kg/m2 and on two antihypertensive agents. The Mallampati score is 4. He denies excessive daytime somnolence or snoring and has never had nor been referred for a sleep study. There are no other medical conditions that would lead to a shortened certification. Scenario 2. A driver with a BMI of 35 kg/m2 and currently on two antihypertensive agents. The Mallampati score is 2. He denies excessive daytime somnolence or snoring and has never had nor been referred for a sleep study. There are no other medical conditions that would lead to a shortened certification. Scenario 3. A driver with a BMI of 40 kg/m2 and currently on no medication. The remainder of the examination is normal, including blood pressure. The Mallampati score is 2. He denies excessive daytime somnolence or snoring and has never had nor been referred for a sleep study. There are no other medical conditions that would lead to a shortened certification. Scenario 4. A driver with a BMI of 45 kg/m2 . Blood pressure is currently well controlled on a single medication. He denies excessive daytime somnolence or snoring and has never had nor been referred for a sleep study. There are no other medical conditions that would lead to a shortened certification. Scenario 5. A driver with a BMI of 35 kg/m2 and currently on two antihypertensive agents. He reports that he had been diagnosed with OSA 5 years before and discontinued continuous positive airway pressure treatment on his own after losing 100 lb. He denies excessive daytime somnolence or snoring.
RESULTS Commercial motor vehicle operators can select any examiner who is listed on the National Registry. This could be an MD or DO, a nurse practitioner, a physi-
cian assistant, a chiropractor, or other licensed health care professionals licensed by their state to perform physical examinations (there are registered nurses and physical therapists also listed). As the goal of this survey was to determine whether a single driver could be examined by different examiners and have widely different certification outcomes, the initial evaluation of the data looked at aggregate responses. For each scenario, a wide variation in examiner determination was found, with some examiners issuing 2-year certification with no discussion of the OSA risk whereas other examiners disqualifying drivers in each scenario. None of the cases had a true “correct” answer on the basis of FMCSA criteria; however, there was actually an incorrect response for all but Scenario 3. The FMCSA guidance suggests that drivers who are on medication for hypertension should be issued no longer than a 1-year certification. In all scenarios where the driver was on one or more antihypertensive agents, some examiners did indicate that they would certify the driver for 2 years. It is possible that some of those examiners were only focusing on the risk of OSA and did not consider the hypertension independently. For Scenario 1, most examiners would have certified the driver for 1 year and advised the driver to discuss the risk of OSA with their primary care provider. For the second, although most would again certify for 1 year and advise discussion with the PCP, almost as many would have certified for 3 months and required a sleep study. Scenario 3 was interesting in that although around 40% of respondents would have certified for 2 years with no discussion of OSA, around 30% would certify for 3 months and require a sleep study. Close to 50% would require a sleep study and issue a 3- month certification in Scenario 4, with around 30% advising to discuss the risk of OSA with personal physician and issuing a 1-year certificate. The final scenario was the one where there was the most consistent response—almost 60% would certify for 3 months and require a sleep study, followed by a 3-month certification with documentation required from the PCP on the risk of OSA or not certifying the driver at all (Fig. 1). Looking at just Scenario 3 and comparing physicians and non-physician, there is still a variety of determinations but the same distribution as seen in the aggregate data (Fig. 2). Additional analysis of the data on Scenario 3 compared ACOEM-trained and non–ACOEM-trained ACOEM member examiners. Although the majority of both groups would have either certified for 2 years or certified for 3 months and required a sleep study—the extremes of option, a
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JOEM r Volume 57, Number 3, March 2015
FIGURE 1. (Scenario 1) A 40-year-old male driver with a BMI of 33 kg/m2 and on two antihypertensive agents. The Mallampati score is 4. He denies excessive daytime somnolence or snoring and has never had nor been referred for a sleep study. There are no other medical conditions that would lead to a shortened certification. (Scenario 2) A driver with a BMI of 35 kg/m2 and currently on two antihypertensive agents. The Mallampati score is 2 and he denies excessive daytime somnolence or snoring, has never had nor been referred for a sleep study. There are no other medical conditions that would lead to a shortened certification. (Scenario 3) A driver with a BMI of 40 kg/m2 , and he is currently on no medication and the remainder of the examination is normal, including blood pressure. The Mallampati score is 2, and he denies excessive daytime somnolence or snoring and has never had nor been referred for a sleep study. There are no other medical conditions that would lead to a shortened certification. (Scenario 4) A driver with a BMI of 45 kg/m2 . Blood pressure is currently well controlled on a single medication. He denies excessive daytime somnolence or snoring and has never had nor been referred for a sleep study. There are no other medical conditions that would lead to a shortened certification. (Scenario 5.) A driver with a BMI of 35 kg/m2 and currently on two antihypertensive agents. He reports that he had been diagnosed with OSA 5 years before and discontinued continuous positive airway pressure treatment on his own after losing 100 lb. He denies excessive daytime somnolence or snoring. higher percentage of the ACOEM-trained examiners than non–ACOEM-trained examiners would have certified the driver for 3 months and required a sleep study whereas a the non-ACOEM–trained examiner would have certified for 2 years (Fig. 3).
CONCLUSIONS It is impossible to determine whether similar findings would be observed if this survey included a wider selection of examiners, potentially with a larger selection of nonphysicians. Nevertheless, as drivers and employers can select any examiner on the national registry, with the variation among this group of over 600 examiners, it is likely that variation would continue to be seen. It is also difficult to assess whether additional information on some cases may have altered some responses. Some examiners indicated that they also use neck circumference or questionnaires as part of their assessment but again, it is strongly suspected that variation would still be seen. A final criticism is whether similar variation would be seen for other medical conditions. For those conditions where there is no
guidance from the FMCSA, it is likely that variation would be seen, but for those conditions where there is guidance in the Medical Examiner Handbook, examiners tend to be much more consistent. What makes OSA different from other conditions where the FMCSA does not offer guidance is the higher prevalence in commercial drivers and the higher safety risk. OSA is recognized as a medical condition associated with an increased risk of motor vehicle crashes. Several expert groups have looked at the risk of crash in commercial drivers with OSA and offered recommendations on the basis of medical literature to guide which drivers should be required to undergo diagnostic study. This study demonstrates that there is no consistent criterion used by examiners listed on the NRCME, ranging from 2– year certification with no discussion on the risk of OSA to disqualification. Although it will be impossible to please everyone with whatever guidance may be issued, it is long overdue that the FMCSA issues at least issue guidance to identify those drivers who would be at highest risk of OSA and then adjust that guidance on the basis of findings;
Letter to the Editor
FIGURE 2. (Scenario 3) Others compared with the physician—a driver with a BMI of 40 kg/m2 . He is currently on no medication and the remainder of the examination is normal, including blood pressure. The Mallampati score is 2. He denies excessive daytime somnolence or snoring and has never had nor been referred for a sleep study. There are no other medical conditions that would lead to a shortened certification.
FIGURE 3. (Scenario 3) ACOEMtrained compared with non–ACOEMtrained ACOEM members–A driver with a BMI of 40 kg/m2 . He is currently on no medication and the remainder of the examination is normal, including blood pressure. The Mallampati score is 2. He denies excessive daytime somnolence or snoring and has never had nor been referred for a sleep study. There are no other medical conditions that would lead to a shortened certification. it would provide some consistency to examiners and employers who are trying to ensure that only drivers who are not at risk of sudden or gradual impairment or incapacitation are operating commercial motor vehicles. The current lack of guidance is leading to risk to the motoring public as well as liability to examiners and employers. Natalie P. Hartenbaum MD, MPH, FACOEM OccuMedix, Dresher, Penn.
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Letter to the Editor
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