Dentists who treat sleep apnea are often called on to serve patients who are employed in safety-sensitive positions. These patients may include commercial motor vehicle operators employed in interstate commerce (e.g., truck drivers); individuals requiring an Airman Medical Certificate or Medical Clearance (e.g., pilots and air traffic controllers); U.S. Coast Guard officers and mariners with a qualified rating; and employees of certain Class I rail operators. These patients typically have fitness-for-duty requirements that prohibit working with various degrees of severity of sleep apnea unless under current and effective treatment.

These requirements are not discretionary, and they vary by state. They do not have an impact on insurance reimbursement and are not, in fact, a burden on the dental sleep care provider at all. They are of critical importance to patients, however, because noncompliance could affect their licensure and livelihood.

The web of federal and state laws that govern these groups vary widely and change often. When I have questions about the Department of Transportation (DOT) regulations and guidelines, I reach out to Bob Stanton, referral coordinator for Dedicated Sleep. He characterizes himself as “just a truck driver with sleep apnea.” I have known Bob for over a decade, yet we have never met because he is always on the road.

I asked Bob the big questions every dentist with an interest in dental sleep medicine should know the answers to when considering treating a patient who works under DOT licensure. As you will see, Bob is clear and highly detailed in his responses to my questions.

My interview with Bob will cover a series of questions you as a dental provider of oral appliance therapy for obstructive sleep apnea should understand and be able to review with your truck driver patients. This article assumes medical management of each patient by a physician board-certified in sleep medicine.

Randy Clare: Why is treating a truck driver different from treating anyone else?

Bob Stanton: To legally drive a commercial motor vehicle — any vehicle over 26,000 pounds in gross vehicle weight or designed to carry more than 16 passengers — in interstate commerce, you must have both a commercial driver’s license (CDL) and a valid DOT medical card issued by the Federal Motor Carrier Safety Administration (FMCSA), under guidance issued by the FMCSA Medical Review Board (MRB) in determining if drivers meet the requirements set forth in 49 CFR 391.11.

DOT medical examinations are made by a certified medical examiner (CME) currently in the National Registry of Certified Medical Examiners (NRCME) maintained by FMCSA. The exams will find a driver safe to operate a CMV in interstate commerce for a period of not more than two years. Shorter certification periods will be given when conditions needing more monitoring are found.

All drivers with a diagnosis of sleep apnea should get one-year certifications. Drivers considered high risk for sleep apnea, but not yet tested, may be given a 90-day certification pending completion of a sleep study.

The specific regulation is FMCSA’s physical qualifications standard that prohibits operating a commercial motor vehicle in interstate commerce with an “established medical history or clinical diagnosis of a respiratory dysfunction likely to interfere with his or her ability to control and drive a commercial motor vehicle safely” (49 CFR 391.41[b][5]).

Obstructive sleep apnea (OSA) is considered a respiratory dysfunction when there is a determination that it is likely to interfere with the driver’s ability to operate safely because of the severity of the disease. This is the only specific regulation that applies to truck drivers about sleep apnea.

RC: Is there one guiding regulation about OSA or is it all just “guidance” from numerous sources?

BS: In applying the regulations to drivers in making certification decisions, CMEs use guidance issued by the FMCSA MRB. In 2008, the FMCSA MRB began reviewing sleep apnea and issued the first of several guidance documents to medical examiners about sleep apnea. This became a political controversy within trucking due to the costs of testing and treatment. Financial or contractual arrangements between CMEs and sleep apnea testing facilities aggravated the perceived issue.

A common theme in trucking-industry news outlets and among truck drivers is that sleep apnea is a made-up condition just to rake in money from the pockets of drivers. This resulted in efforts from trucking-industry lobbying groups in 2014 to get Congress to pass Public Law 113-45. This simple statute prohibits FMCSA from issuing guidance or regulatory guidance on sleep apnea without using the formal rulemaking process. To give a dental provider of oral appliance therapy for obstructive sleep apnea a view of how well trucking lobbying efforts were on this measure, the bill was introduced to Congress during a budget shutdown, and was passed in three weeks.

In 2016, the FMCSA, working with the Federal Rail Authority (FRA), began joint rulemaking on sleep apnea in compliance with 113-45. FMCSA and FRA held a series of listening sessions — aka public hearings — to gather information and comments.

In August 2017, they withdrew the rulemaking, citing that the current safety programs are the appropriate avenues to address sleep apnea. This political and regulatory “kicking the can down the road” on sleep apnea has created the “no-rule rules.” There is no specific guidance or regulatory guidance for a CME or sleep medicine provider to use and follow.

Drivers often argue that there is no regulation requiring them to get tested or receive any form of treatment for sleep apnea. They are correct.

The question of whether to issue a DOT medical card is solely based on the best expert medical opinion of the CME. The CME may or may not choose to use existing guidance documents. As the level of experience and training among CMEs varies widely, a CME may be an M.D., D.O., N.P., P.A., or D.C. The level of sleep apnea training given to doctors of chiropractic varies greatly from the other medical certifications able to take the NRCME certification exam.

RC: What is “chain of custody” for home sleep testing and why is it important?

BS: Given the “no-rule rules” of sleep apnea testing and treatment for CMV drivers, one facet will be proving that sleep study results include verification that the driver was tested.

As a driver who gets a 90-day conditional certification pending completion of a sleep study will often not have any current health insurance benefits or a large unmet deductible, the motivation to cheat the home sleep test (HST) and avoid treatment costs is great.

With the CME understanding these factors, a negative result on a sleep apnea HST from a patient with a high pretest probability of sleep apnea will be viewed with suspicion. It is not unheard of for a CME to require a confirming polysomnogram (PSG) for a negative sleep apnea test result. Both the 2012 and 2015 FMCSA MRB guidance to CMEs on sleep apnea include that all testing should establish chain of custody.

RC: What apnea-hypopnea index (AHI) requires treatment from a DOT perspective and what does treatment look like?

BS: Not all truck drivers with an apnea-hypopnea index greater than five (AHI > 5) may require treatment. Given the “no-rule rules,” FMCSA and CMEs generally agree that only moderate and severe sleep apnea (AHI > 15) rise to the level of a respiratory dysfunction likely to interfere with the ability to control and drive a commercial motor vehicle safely.

In general, AHI greater than five but less than 15 may not require treatment for FMCSA medical card purposes. In these cases, seeking the expert medical opinion of the M.D. interpreting the HST or doing a post-study consultation on treatment is important.

Having the M.D. chart state that “this patient does not have sleep apnea to the severity that it would interfere with their ability to drive a commercial motor vehicle in interstate commerce,” or something to that effect, is important. Similar language should be used with titration studies done to establish efficacy of treatment with the oral appliance (OA) if AHI less than five is not accomplished with the OA.

RC: Is continuous positive airway pressure (CPAP) compliance failure sufficient for a truck driver to qualify for oral appliance therapy?

BS: You can try, but as the “no-rule rules” apply, the CMEs have latitude in their certification decisions. The 2012, 2015 and recent Sept. 29, 2021, MRB discussions about using oral appliance therapy (OAT) for drivers have all concluded that it is not a first-line treatment option for truck drivers.

The MRB is not willing to certify drivers for OAT unless they have a documented CPAP failure. Presenting American Academy of Sleep Medicine (AASM) and American Academy of Dental Sleep Medicine (AADSM) current clinical practice statements on the topic has not changed this guidance. On many different conditions, treatment and efficacy requirements for CME certification are more restrictive than for the general public.

There are some cases where individual CMEs have certified drivers for OAT without a documented CPAP failure, but they are rare. If considering this as a treatment plan, confer with the driver’s CME in advance. Getting a second opinion from a different, more enlightened or OSA-aware CME may be needed.

RC: Is treatment compliance monitoring available for drivers treated with OAT?

BS: Yes — and don’t even try without it. Currently there are two OA compliance chips on the market, from Braebon and Theramon^®. A CME will want to see evidence that the driver is compliant with treatment. All discussions with the MRB on OAT have included or assumed that the OAT would use a compliance chip. FMCSA will not approve OAT unless it provides a level of monitoring equal to or better than CPAP.

The tradeoffs and considerations for a dental sleep medicine (DSM) provider between the two chips could be the topic of an entire article. Drivers will need compliance monitoring for life. How the chip battery is replaced or recharged is a big consideration. If using the Braebon chip, which must be replaced rather than recharged, an OA that can be cold-cured in the DSM office rather than having to be sent back to a lab for chip replacement is an issue.

Theramon, which has a remote Bluetooth chip reader, allows for remote compliance monitoring, rather than requiring a face-to-face, in-office encounter for collecting chip data. This feature should be considered.

OAT compliance costs will not be reimbursable through third-party insurance. A dental provider of oral appliance therapy for obstructive sleep apnea will have to decide how to charge driver patients. Some dentists successfully treating drivers absorb the compliance-chip costs and do not charge the driver.

RC: How will the sleep appliance titration and treatment efficacy be demonstrated and documented for these patients?

BS: Because we have already assumed that the dentist is working with an M.D. on the treatment plan, a titrating home sleep study (HST) should be performed. Having the M.D. write an “under current-and-effective treatment” letter to the CME rather than having this come from the dentist’s office is strongly suggested. Attaching copies of the OA compliance-chip treatment report for both the M.D. and CME works well.

One more issue to consider is whether the driver is safe to drive while the OA is being titrated. This often involves consultation between the CME, M.D. and DSM provider, and will depend on the severity of the OSA.

Often, the best treatment plan is to have the driver continue CPAP or use adjunct therapy until the OA is fully titrated and a titrating HST result is available. A newly diagnosed driver will often be on a 90-day conditional DOT medical card, pending completion of a sleep study. It’s often unrealistic to get these patients tested and under treatment with an OA within 90 days, given insurance pre-authorization delays; lab fabrication, if needed; titration; and a titration HST.

Collaboration between the M.D., CME and dentist on reasonable extensions of the DOT medical card is often involved.

Truck drivers and other safety-sensitive employees can be effectively treated for their OSA using OA therapy. Many pilots have a CPAP at home and use an OA when on overnight flights. Truck drivers, even those with severe OSA, have been successfully treated using OA and have current, valid DOT medical cards.

The problem for a dental provider of oral appliance therapy for obstructive sleep apnea will be that, in addition to all the insurance and other treatment requirements for a “normal” patient, specific treatment plan issues and considerations for truck drivers and other safety-sensitive position patients will need to be taken into account.

At the bare minimum, you need to know if they must have a DOT or other medical card for work. All other treatment decisions will stem from this one key point of distinction for this important patient population.