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CPAP & the DOT

Sleep Apnea and Trucking: Where Are We Now?

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http://www.sleepreviewmag.com/2014/10/sleep-apnea-trucking-now/#sthash.vKcGUHjM.dpuf

A sleep physician with knowledge of the trucking industry addresses questions and problems, offers possible solutions and food for thought.

Obstructive sleep apnea (OSA) has, is, and will continue to be an important issue for the commercial transportation industry, particularly trucking. Stakeholders include physicians, dentists, other healthcare providers, sleep testing and treatment facilities, equipment manufacturers, employers, payors, regulators, attorneys, society in general, and, most importantly, the drivers. Many current and proposed solutions are impractical or controversial.

This article assumes a reasonable knowledge of the subject as space is not sufficient to detail extensive background information and statistics relating to OSA in the trucking environment. The reader is referred to references available at the bottom of this webpage, in particular the review by Zhang et al,1 accompanying editorial by Gurubhagavatula,2 and a paper by Collop,3 which addresses technical aspects of OSA devices for out-of-center testing.

It is not the intent of this article to debate whether driver testing should be mandated, the severity of OSA that requires treatment, or the statistics on crashes. Like it or not, rules and regulations are here now or coming. We must address the issues, include our input, and find reasonable answers to difficult questions. Other disorders may cause driver fatigue but this article is about trucking and OSA.

Many of the issues reviewed here are detailed in my comments of February 1, 2012 and posted on the FMCSA Notice: Meetings: Joint Subcommittee of Motor Carrier Safety Advisory Committee and Medical Review Board ID: FMCSA-2011-0131-0013 Tracking Number: 80fab3d9,4 my May 17, 2013 letter to the administrator of the FMCSA responding to a letter of February 21, 2012 addressed to the FMCSA from the Motor Carrier Safety Advisory Committee (MCSAC) along with the MCSAC-MRB Task 11-05 Report.5

Trucking Industry Viewpoints

There are individual drivers and owner-operators who believe the government is on a witch hunt, that sleep testing and CPAP treatment is a money grab, that most trucking accidents are caused by passenger vehicles, that truckers are being unjustly targeted, and do not agree on suggested requirements for sleep testing; also if many drivers are medically disqualified, the roads will not be as safe with less experienced drivers. These arguments have some merit as many drivers are uninsured, have high deductibles, are sometimes asked to pay exorbitant amounts for services, and are constantly subjected to increasing regulation. Some drivers do not understand that it’s not only their job at stake but also health, performance, longevity, and quality of life. On the other hand, some trucking companies, usually the larger ones with more resources, are proactive with screening, testing, and treatment, some with highly organized programs, which result in lower healthcare costs, reduced liability, and happier, more productive employees.

Medical Industry Viewpoints

Recent media coverage has resulted in increasing awareness that OSA is a major public health problem; however, many primary care physicians and (non-sleep) specialists are not aggressive in screening and testing for sleep apnea. While most are generally aware of the importance of sleep disorders, they are busy, have had little formal training in sleep medicine, and/or lack the credentials to perform or interpret sleep tests. Some physicians do not order sleep tests when indicated as they may not be comfortable acting on the results. Low reimbursement, onerous record keeping, and prohibitions to providing CPAP are deterrents as well. Many non-sleep specialists refer to pulmonologists, who are busy with their practices and hospital work.

OSA Screening

While BMI, neck size, and age are objective parameters for assessing the risk of OSA, there are many other risk factors, including upper airway and cranio-facial anatomy, excessive daytime sleepiness, loud snoring, observed apneas during sleep, high blood pressure, type 2 diabetes, morning headaches, age over 50, acid reflux or heartburn, bruxism, large tongue or crowded pharynx, cardiac conditions, recent traffic accident (including passenger vehicles), insomnia, restless legs, close relatives with OSA, mood disorders, erectile dysfunction, and others.

Answers on subjective questionnaires for assessing OSA risk are not always reliable if employment is at stake. Individuals classified as “low risk’’ based on a particular set of signs and symptoms may in fact be at very high risk for OSA based on other factors. There should also be criteria for exclusion of patients with certain comorbidities or suspected coexisting sleep disorders where home sleep testing may not be appropriate. The decision for testing should be based on the evaluation by the DOT examiner or the treating physician.

Attended PSG vs Unattended HST

PSG: Attended PSG and attended CPAP titration are the so called gold standards for the diagnosis and determination of treatment for OSA. Advantages include the ability to stage sleep, diagnose coexisting sleep disorders, mask fitting and ensure chain of custody. Limitations include cost, travel, first night effect, scheduling, geographic access, and requirements for preauthorization. Split night studies can reduce time and costs but often do not show frequent respiratory events in the first part of the night leaving inadequate time for titration.

HST: HST costs less than PSG (some argue that long term costs are the same or greater), is more acceptable to patients, is easier to schedule, does not interfere with daily activities, and is performed in the driver’s home, cab, or other location reducing the first night effect, facilitates access, and allows some patients to begin auto-adjusting CPAP (APAP) without CPAP titration. Since HST is a limited channel and unattended study, it’s imperative to properly select individuals at high OSA risk, exclude those with certain comorbid conditions, and ensure that appropriate protocols, based on the HST results, are in place so further diagnostic testing is recommended when indicated.

Most HST devices do not record EEG and true total sleep time (TST) so the apnea-hypopnea index (AHI) is calculated using total recording time (TRT) or an indirect estimate of TST. “AHI” derived from HST = apneas + hypopneas/TRT. This means if the “AHI” from a HST is ≥ 5, the true AHI is underestimated since TRT is usually > TST, and the lower the sleep efficiency (TST/TRT x 100), the greater the underestimate will be. False negatives (ie, AHI< 5) could occur as well. As with any single night study, OSA severity may also be underestimated due to lack of or limited supine and/or REM sleep.

Confusion and lack of standardization of HST results are due to use of different abbreviations for AHI and respiratory disturbance index (RDI), sometimes used interchangeably, and inconsistent definitions among HST device manufacturers, payors, in publications, and PAP machine data downloads. Here is the current standard terminology: AHI = apneas + hypopneas per hour of sleep (EEG); REI = apneas + hypopneas per hour of sleep or recording time3; RERA = respiratory effort related arousal per hour of sleep (EEG); RDI = apneas + hypopneas + RERAs. RDI, sometimes reported with HST, is a misnomer as arousals cannot be detected without EEG. Also, flow limitation, based on waveform shape, and snoring have sometimes incorrectly been incorporated into RDI on HST reports.

The HST-APAP Model

If the HST-APAP model is to be used for its intended purpose (ie, reducing costs and improving access while maintaining quality) a formal consistent protocol for screening, analyzing, acting on the results of the HST, and monitoring treatment is necessary.

Here is a suggested decision tree to analyze and act on data obtained by HST and for follow-up of APAP. It is assumed the HST device is a Level III, limited channel HST recording airflow, oxygen saturation, pulse rate, and respiratory effort. The actual values for AHI and O2 desaturations and the terms high, low, and significant used here are arbitrary. It is intended the algorithm be modified as the provider sees fit.

For convenience, the term AHI as used here in most instances will mean REI using TRT or indirect estimates of TST as the denominator. RDI, although sometimes equivalent, will not be used. The actual values for AHI, O2 desaturations and the terms high, low, frequent, and significant are arbitrary and should be determined by the treating physician.

Suggested Decision Tree

Screen and identify individuals at high risk for OSA —>Perform HST
AHI < 5—>Attended PSG or split if indicated
AHI ≥ 5 and AHI very high—>Attended PAP titration
AHI ≥ 5 and SpO2 very low—>Attended PAP titration
AHI ≥ 5 and frequent central apneas or CSR—>Attended PAP titration and/or referral to sleep specialist
AHI ≥ 5 and using HST device without respiratory effort—>Attended PAP titration
AHI ≥ 5 and none of above—>Begin APAP
SpO2 during HST normal—>Data downloads—>Adjust APAP to minimize respiratory events
SpO2 during HST low—>Data downloads—>Adjust APAP to minimize respiratory events—>Overnight oximetry during APAP to assure correction of SpO2
(if not—>PFT)
Symptoms persist after APAP trial—>Attended PAP titration and/or referral to sleep specialist

Caveats, Other Recommendations

AHI by HST or PSG is not the only parameter on which the severity of OSA (and treatment need) should be based. Significant O2 desaturations may be as or more important. Portions of the recording may show more frequent respiratory events in spite of a “normal” or mildly increased “average AHI” for the night, eg, “average AHI” < 5, a portion of the recording, perhaps 30 minutes in supine and/or REM sleep, shows 20 respiratory events equivalent to an AHI of 40 which may be associated with O2 desaturation 80% or less. This patient may need treatment as much as or more than one with an AHI (TST) of 8 with no “effectively increased” AHI and mild desaturations. These events should be confirmed by review of raw data.

Individuals tested with HST that may require facility-based testing include: AHI <5, HST shows OSA and CPAP titration is recommended due to the severity of OSA and/or desaturations, HST shows OSA and a significant number of central apneas, HST shows OSA and another sleep disorder suspected, HST is suggestive of OSA but the testing device does not detect respiratory effort, and if symptoms persist after a reasonable trial of APAP.

If AHI determined by HST is used to determine the need for PAP or medical clearance to drive, remember this value will usually underestimate the true AHI based on actual sleep time.

Treatment of OSA

With the exception of a few cases of substantial weight loss and certain surgical procedures (which require repeat testing to document effectiveness), CPAP, APAP, and BiLevel PAP are the only acceptable treatments for OSA as these currently are the only treatments that verify compliance. Some newer oral appliances (OA) for mandibular advancement have monitoring chips but OA are only effective in certain cases of OSA and are not currently accepted in commercial transportation.

PAP-Data Downloads-Compliance

CPAP titration determines optimum fixed pressure, ensures correction of O2 desaturations, and optimizes mask fit. APAP machines are a bit more expensive, may reduce costs if started after PSG or HST, and provide higher pressures if needed.

Data downloads from PAP units should be reviewed at intervals clinically indicated or mandated by industry requirements. Data should be reviewed by the supplier and physician to document adherence/compliance, mask leak, and respiratory events, and the physician should adjust PAP appropriately.

The arbitrary “rule” that minimally acceptable PAP usage of at least 4 hours per night for 70% of the nights is inadequate. If PAP is used only 4 hours per night more frequent and severe events may occur at other times, particularly later in the night, during REM sleep. Thus many individuals treated for OSA can be fully “compliant” but in effect may not be deriving any benefit from PAP. While possibly better than nothing sometimes there may be more harm than good by giving a false sense of security. PAP should be used 100% of the nights all night. There is need of a better system to assess the effectiveness of PAP. Objective measurements of outcome would better confirm effectiveness of treatment but could eliminate the cost and inconvenience of compliance monitoring.

Other general suggestions include weight loss, good sleep hygiene, education about consequences of untreated sleep apnea, review of medications, avoidance of caffeine, alcohol, tobacco and respiratory depressants near bedtime, caution against driving or operating machinery if sleepy, and the treating physician should use the HST interpretation and recommendations in conjunction with the overall clinical evaluation and treatment.

Chain of Custody

The chain of custody (COC) refers to whether the HST was performed on the intended person. This is an issue when a job is at stake as there may be an inclination to influence the test results. Much has been made of the COC, but my view is that this issue is procedural rather than technical.

Most HST devices do not reliably detect sleep and, if unattended, cannot ensure the COC as it is possible to remain awake during an unattended HST, and no apneas would be recorded. Since only “high risk” individuals should undergo HST, if for any reason the HST is “normal” (AHI < 5) in a high-risk individual, attended PSG should be recommended. It does not matter if the test was “fooled” or is a true false negative. The incentive to influence the result is minimized if a person knows a “negative” HST will result in the recommendation for a PSG, which will incur more cost and time.

The above is consistent with the position of the American Academy of Sleep Medicine and section IV. C. 2. a. of the MCSAC-MRB Task 11-05 Report.5 Drivers should be aware they may be required to attest that the HST will be done on them and that, to the best of his/her knowledge, neither the driver nor any other person has tried to change or otherwise alter any aspect of the HST, that the driver understands that deliberate falsification may invalidate the test and any certificate issued based on the results of the HST, and that a civil penalty may also be levied under 49 U.S.C.521(b)(2)(b).

DOT Examiner and Employers

There is not uniform agreement or rules regarding information DOT examiners require. When a driver is flagged as possibly at risk for OSA, the DOT examiner typically issues a 30, 60, or 90 day card, during which time the driver is required to get tested and treated. If OSA is diagnosed, drivers will have to show compliance with PAP to be certified to drive. Examiners may initially require 2 weeks to 30 days of data, issue a temporary card, request another download in 30 days or more, and may certify the driver for the balance of the time until the next physical. Going forward, drivers should be prepared to provide a full year of compliance data if requested.

PAP Challenges, Questions

Many challenges are faced by long-haul drivers regarding the use of PAP. One is powering the PAP unit. Idling increases fuel consumption and is restricted in many areas, “shore power” is not always available, auxiliary power units are expensive and not all trucks have them. A solution is wiring an inverter to a deep cycle battery but some manufacturers recommend against this. Some newer PAP units consume less power, run off the cigarette lighter, and have batteries that charge during non-sleeping hours.

Payments for sleep testing and PAP are another problem. Occasionally these are paid up front by an employer, who may require return of the equipment if the driver leaves the company or may charge the cost back to the driver by monthly salary deduction. Sometimes health insurance covers all or part of the costs, but many drivers are uninsured or have very high deductibles.

Who does the data downloads and provides the reports, and to whom? What happens when a driver changes from a company that has a formal sleep apnea program and no longer provides data downloads?

When a DOT examiner or employer requests a driver gets tested and if necessary treated for OSA, how does the driver know where and how to get this done?

Where can the driver get a prescription, from a licensed physician, PA, or nurse practitioner, which is required for all sleep testing and PAP machines? The options are few. Some large employers have company physicians or contract with clinics but most do not. Some DOT examiners will write the prescription but most will not. Many drivers do not have a family physician and finding a physician or sleep specialist adds time and expense.

Regulation Rules vs Guidelines

Public Law #113-45, aka the “sleep apnea bill,” was signed into law and effective October 15, 2014. This law requires that the formal rule-making process be followed regarding sleep apnea screening, testing, and treatment of truckers and other commercial motor vehicle operators and forbids the issuing of any informal guidance on this subject. Some stakeholders are happy with Public Law #113-45, but others warn of negative consequences. Many in the trucking industry applaud the new law, which allows medical experts, drivers, and other stakeholders the opportunity to provide input via a public forum for the FMCSA to consider as regulations are developed. Formal rule-making will require an analysis of the benefits and costs of regulating sleep apnea, which is not required for the issuance of guidance. The costs of mandated testing and treatment could be an excessive burden on the industry, much of which could fall on individual truckers, some of whom would have to pay out of their own pockets due to lack of medical insurance or high deductibles, forcing them to leave the profession and making it more difficult to recruit and retain drivers. While some feel that the law is a step in the right direction, opponents argue the formal rule-making process will take valuable time that could be used to diagnose and treat truck drivers and that rule-making will result in a long delay, if anything is done at all. Recently a pair of US representatives stated in a letter to the FMCSA that some organizations that train certified medical examiners are skirting the law by telling examiners to test truckers for sleep apnea. No rules prevent trucking companies from requiring drivers to be tested based on existing guidance; they can do what they believe is the right thing without regulation. Many trucking companies are proactive and have various types of sleep apnea programs, which reduce insurance premiums, liability, accidents, and healthcare cost.

DOT Examiner Registry

The National Registry of Certified Medical Examiners is a new FMCSA program that establishes minimum training and testing requirements for all state-licensed healthcare professionals who perform qualification examinations for truck and bus drivers. Commercial drivers whose current medical certificate expires on or after May 21, 2014, must be reevaluated by a DOT examiner listed on the National Registry. Medical certificates issued prior to May 21, 2014 remain valid until the expiration date. Only medical examiners that have completed training and successfully passed a test on FMCSA’s physical qualification standards will be listed on the National Registry.

The FMCSA issued the rule in response to the statutory requirements in the Safe, Accountable, Flexible, and Efficient Transportation Equity Act: A Legacy for Users, the surface transportation reauthorization legislation enacted in 2005. The final rule will improve safety by ensuring examiners have completed training and testing concerning FMCSA’s physical qualifications standards and only issue medical certificates to individuals who meet those standards.

The objectives of the National Registry are to: ensure examiners understand fully the medical standards in the Federal Motor Carrier Safety Regulations and related guidance, how they apply to CMV drivers, maintain competency of examiners through training, testing, certification, and recertification, and promote public confidence in the quality of the examinations of CMV drivers.

The FMCSA will not collect or store medical examination reports and they will not be entered into the National Registry. However, since the driver’s CDL is linked to the examiner’s registry number and examiners will be better trained, more high-risk individuals will be identified and the opportunity for “doctor shopping” minimized.

Outcomes and Follow-Up

Improved quality of life and both subjective and objective clinical improvement are the ultimate goals. Subjective improvement can be accessed using questionnaires and objective improvement with performance testing such as the MWT, psychomotor vigilance test (PVT), or driving simulators, although currently these are usually employed in research or are industry specific. Published in the October issue of the Journal of Clinical Sleep Medicine, a new study from Finland reports that the Oxford Sleep Resistance Test (OSLER) and the multiple unprepared reaction time (MURT) test are practical and reliable tools for measuring improvement in vigilance in drivers with OSA that are treated with PAP. If a patient is unwilling or unable to tolerate PAP, an oral appliance could be considered (not currently acceptable for truckers). If a patient is still symptomatic after a reasonable trial of adherent PAP, additional testing or referral to a sleep specialist should be considered.

Conclusions

Are there any practical solutions? The short answer is no. The proverbial 3-legged stool, in this case cost, quality, and timely accessibility, is shaky at best, considering there are more than 3 million over the road drivers, not to mention other high risk commercial vehicle drivers, the relatively small number of sleep specialists, geographic distribution of drivers, and payor differences. Drivers, employers, healthcare providers, and regulators must work together, be flexible, and make necessary compromises to reach practical solutions with hope that emerging research and technologies will help reduce the burden.

It is difficult to develop rules and regulations. While the goal is to improve health and quality of life, reduce accidents and liability all at lower cost, the changes will affect many stakeholders and, once adopted, standards that govern the industry will have significant long-term and sometimes unintended consequences. I urge all providers and recipients of sleep medicine products and services and the FMCSA to consider the issues addressed here and provide input to the decision making process. SR

Edward D. Michaelson, MD FACP FCCP FAASM, is based in Ft Lauderdale, Fla, and a member of Sleep Review’s Editorial Advisory Board. Information in this article is drawn from sources including: review of multiple trucking industry publications, hundreds of LinkedIn threads, frequent phone conversations with drivers, as a regular trucking radio talk show guest host, and from a detailed review of home sleep testing (HST) and a proposed algorithm for analyzing HST results.6

REFERENCES

1. Zhang C, Berger M, Malhotra A, Kales SN. Portable diagnostic devices for identifying obstructive sleep apnea among commercial motor vehicle drivers: considerations and unanswered questions. Sleep. 2012 Nov 1;35(11):1481-1489. Published online Nov 1, 2012. doi: 10.5665/sleep.2194 www.ncbi.nlm.nih.gov/pmc/articles/PMC3466795
2. Gurubhagavatula I. Does the rubber meet the road? Addressing sleep apnea in commercial truck drivers. Sleep. 2012 Nov 1;35(11):1443-1444. Published online Nov 1, 2012. doi: 10.5665/sleep.2180 www.ncbi.nlm.nih.gov/pmc/articles/PMC3466788
3. Collop N. Home sleep testing: appropriate screening is the key. Sleep. 2012 Nov 1;35(11):1445-1446. Published online Nov 1, 2012. doi: 10.5665/sleep.2182. www.ncbi.nlm.nih.gov/pmc/articles/PMC3466789
4. federal.eregulations.us/rulemaking/commenthome/fmcsa-2011-0131-0013/1
5. mcsac.fmcsa.dot.gov/Documents/Aug2011/Task_Statement_11-05.docx
6. HST: The Elephant in Sleep Medicine: A Perspective and an Algorithm. Michaelson E. respiratory-care-sleep-medicine.advanceweb.com/features/articles/hst-the-elephant-in-sleep-medicine.aspx?CP=2

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