The former chief of the Medical Programs Division for the Federal Motor Carrier Safety Administration separates fact from fiction regarding the Advanced Notice of Proposed Rulemaking published in March 2016.
For years, the Federal Motor Carrier Safety Administration (FMCSA) has been researching obstructive sleep apnea (OSA) and its impact on driving a commercial motor vehicle (CMV). The agency searched the scientific literature for evidence, conducted expert panel meetings of sleep specialists, and developed and published reports. FMCSA’s two advisory committees—Medical Review Board (MRB) and the Motor Carrier Safety Advisory Committee (MCSAC)—reviewed the reports, listened to sleep specialists, industry representatives, and drivers, and developed recommendations for FMCSA’s rulemaking and guidance development.1
All of this has been very controversial. The agency’s actions and its positions have been widely misunderstood. Rumors abound.
At last, on March 10, 2016, FMCSA took action. FMCSA and the Federal Rail Administration (FRA) jointly published an Advanced Notice of Proposed Rulemaking (ANPRM) on OSA. Entitled “Evaluation of Safety Sensitive Personnel for Moderate-to-Severe Obstructive Sleep Apnea,” the ANPRM presents information about OSA and the steps each agency has taken to research the condition. The ANPRM asks the public to respond to 20 questions covering the prevalence of OSA, the cost of diagnostics and treatment, safety benefits, screening procedures and diagnostics, medical qualifications of providers, and how to measure treatment effectiveness. Once FMCSA/FRA gather and review the information, they will decide whether to develop a regulation on OSA.2
This ANPRM is spurring the spread of more misinformation. To quash the rumors, people need accurate information and clear explanations of FMCSA’s regulations and guidance on OSA. As the chief of the FMCSA’s Medical Programs Division during the 8 years when FMCSA was researching OSA and the MRB and MCSAC were making their recommendations to the agency, I am intimately familiar with the MRB/MCSAC recommendations on OSA, the Physical Qualifications regulations, and agency policies and procedures. FMCSA’s Medical Programs Division is responsible for all Physical Qualification regulations. As its chief, I oversaw the division’s research, guided the development of regulations and guidance documents, and oversaw its compliance assistance to the public. The Medical Programs Division staff answer over 2,000 phone calls and 2,000 e-mails each month. With many of the questions related to OSA, we developed a clear understanding of the myths and developed factual responses to debunk them. In addition, the Medical Programs staff was the liaison to the MRB. As Division Chief, I also oversaw the OSA research, the development of the National Registry of Certified Medical Examiners (MEs), the development of the ME certification test, and the development of many other programs. My 18 years’ experience in the federal government—15 of which was with OSHA and FMCSA—gave me in-depth knowledge of the Administrative Procedures Act and the operations of regulatory agencies. I bring this knowledge and experience to you to debunk the 8 most widely held misconceptions and give information on how to effectively participate in the rulemaking process.
Myth 1: The MRB recommendations are FMCSA requirements.
Fact: The MRB and the MCSAC are advisory committees with no power to write regulations or guidance. They make recommendations to the agency. They have made several recommendations, but FMCSA has not adopted them.
Myth 2: Currently, FMCSA requires CMV drivers with a neck circumference of 17 or above and/or a BMI of 35 or above to have a sleep study.
Fact: The neck circumference and BMI numbers are recommendations from MCSAC/MRB, but FMCSA has not taken action on their recommendations. The confusion on this point likely stems in part because the MRB/MCSAC recommendations are published on the FMCSA’s webpage to ensure transparency. But until and unless the FMCSA formally adopts the recommendations, which would be indicated by their publication in the Federal Register, they are NOT requirements or even “FMCSA guidance.”
Myth 3: Drivers diagnosed with OSA and using a CPAP must have a follow-up sleep study.
Fact: Follow-up sleep studies are included in the MRB/MCSAC recommendations but not in the FMCSA regulations or Advisory Criteria. As such, follow-up studies are not required by FMCSA.
Myth 4: Drivers must have a CPAP that provides usage recording.
Fact: FMCSA does not require any specific treatment or equipment in its regulations and Advisory Criteria. This may be a standard of practice in the medical community, but it isn’t an FMCSA requirement.
Myth 5: The agency’s ANPRM on OSA immediately requires CMV drivers to have sleep studies, if they exhibit risk factors for OSA.
Fact: An ANPRM is a very early exploration of rulemaking, not a final rule. The purpose of an ANPRM is to notify the public that the agency(ies) are considering a rulemaking and are requesting information to utilize in their deliberations. ANPRMs ask the public for more data and usually request responses to specific questions.
Myth 6: FMCSA arbitrarily establishes rules on OSA without listening to the public.
Fact: As all federal regulatory agencies, FMCSA is required to follow the Administrative Procedures Act. This act mandates that the agency publish its intentions in the Federal Register and give ample time for the public to comment on the proposed regulation. The agency must follow specific steps before issuing a regulation: 1) the ANPRM (optional); 2) a Notice of Proposed Rulemaking (NPRM) based on the information gathered from the optional ANPRM and other documents; and 3) the final rule based on the NPRM and its public comments.3 The whole process, from ANPRM to final rule, usually takes 4 to 6 years.
Through June 8, 2016, FMCSA is asking the public to participate to help write an evidence-based regulation (www.federalregister.gov/articles/2016/03/10/2016-05396/evaluation-of-safety-sensitive-personnel-for-moderate-to-severe-obstructive-sleep-apnea). Responding with statements of fact and research data is the most helpful to the agency’s deliberations. Merely professing like or dislike does not add value.
Responding with signed template letters written by an organization is not helpful to the agency either. The rulemaking process is not a popularity contest. It is a gathering of scientific and economic data to help the agency ensure it is addressing public safety needs without undue burden on the regulated community.
After the ANPRM, the next step for public participation will be the Notice of Proposed Rulemaking. The NPRM defines the actions the agency intends to take, includes the actual proposed provisions and the agency’s rationale for each, and asks for public comment. However, if the agencies decide not to proceed with the regulation, the next step could be a published notice of the agencies’ decision to withdraw the rulemaking.
It is important for people to participate in the ANPRM public comment. Otherwise, the agency lacks information for decision-making. When the NPRM is published, if no one comments, the agency must publish a final rule based on what the agency wrote in the NPRM. The provisions presented in the NPRM become the final rule unless the public comments on them or unless the agency resubmits a new NPRM that changes the proposed rule’s provisions.
Myth 7: FMCSA does not have any regulations or guidance on OSA.
Fact: FMCSA regulation 49 CFR 391.41(b)(5) states, “(b) A person is physically qualified to drive a commercial motor vehicle if that person . . . (5) 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.”4 As a respiratory dysfunction, OSA is covered by this rule. The rule, written very broadly, does not include criteria, diagnostic testing, or treatment regimen.
FMCSA guidance is its Advisory Criteria, published as part of the Medical Examination Report form in 2000. Remaining unchanged since that time, OSA is specifically mentioned,
“3.There are many conditions that interfere with oxygen exchange and may result in incapacitation, including emphysema, chronic asthma, [. . . ] sleep apnea. If the medical examiner detects a respiratory dysfunction, that in any way is likely to interfere with the driver’s ability to safely control and drive a commercial motor vehicle, the driver must be referred to a specialist for further evaluation and therapy.”5
The Advisory Criteria do not specify the type of evaluation studies or treatments.
Myth 8: Since FMCSA has no specific rule or guidance on OSA, medical examiners (MEs) may not require a sleep study, CPAP usage, or recording of the CPAP usage.
Fact: The agency does not list specific criteria for diagnosis and treatment of OSA. But FMCSA gives MEs authority to make determinations and decisions based on their medical knowledge, the results of the driver’s physical examination, and the current medical standards of practice. As mentioned above, the FMCSA’s Advisory Criteria direct the ME to refer the CMV driver to a specialist if a respiratory dysfunction is detected. FMCSA expects the ME to gather additional information to ensure that the driver can safely operate a CMV.
The ME must clearly understand and explain to the driver that the tests he/she is requiring are not FMCSA requirements. Since the driver’s livelihood is involved in the ME’s decision, the ME should make practical recommendations considering the driver’s financial situation and lost work time. If the driver can be effectively diagnosed and treated with less expensive modalities, those should be used.
Key Takeaways
In summary, FMCSA does not require specific diagnostic testing/treatment, but the agency permits the ME to use medical best practices to govern his/her decisions. This nuance is very confusing for drivers, MEs, and carriers.
Lack of specific requirements for OSA results in inconsistent qualification decisions. So, FRA and FMCSA are taking responsible steps to ensure they gather information to determine whether to develop a regulation or guidance. Whatever their decision, it should be based on the most recent data and information.
The best way for the FMCSA to make its decision is to publish an ANPRM (which it published March 10, 2016), ask questions, and obtain recent information from a wide range of people in the regulated community. The best way the public can participate is to obtain accurate information about rulemaking, refrain from spreading rumors, and submit substantive comments to the rulemaking processes.
Prior to founding her occupational and transportation health consulting company, Health and Safety Works, LLC, Elaine Papp, RN, MSN, COHN-S, CM, FAAOHN, worked for 18 years in the federal government for OSHA, SSA, and FMCSA. A board-certified master’s educated occupational health nurse with over 30 years of experience in private companies, international organizations, not-for-profit healthcare institutions, and government entities, Papp is recognized by the American Association of Occupational Health Nurses as a Fellow and has served on the American Board of Occupational Health Nurses, the profession’s credentialing body.
References
1. Federal Motor Carrier Safety Administration. February 6, 2012 MCSAC and MRB Task 11-05- Final Report on Obstructive Sleep Apnea (OSA). Federal Motor Carrier Safety Administration website. www.fmcsa.dot.gov/february-6-2012-mcsac-and-mrb-task-11-05-final-report-obstructive-sleep-apnea-osa. Published February 2012. Accessed March 8, 2016.
2. Evaluation of Safety Sensitive Personnel for Moderate-to-Severe Obstructive Sleep Apnea (Advanced Notice of Proposed Rulemaking; request for public comment). Federal Register 81:47 (March 10, 2016) 12642 available at: www.gpo.gov/fdsys/pkg/FR-2016-03-10/pdf/2016-05396.pdf. Accessed March 10, 2016.
3. US Department of Justice. Administrative Procedures Act. Public Law 404-79th Congress. US Department of Justice Website. www.justice.gov/sites/default/files/jmd/legacy/2014/05/01/act-pl79-404.pdf. Accessed March 8, 2016.
4. Physical Qualifications of Drivers. Code of Federal Regulation 49 CFR 391.41 Federal Motor Carrier Safety Administration website www.fmcsa.dot.gov/regulations/title49/section/391.41. Accessed March 8, 2016.
5. Physical Qualification of Drivers; Medical Examination; Certificate of Physical Examination. Advisory Criteria. Code of Federal Regulations 49 CFR 391.43 Federal Motor Carrier Safety Administration website. www.fmcsa.dot.gov/regulations/title49/section/391.43. Accessed March 19, 2016.
Good straight forward article that cuts through the nonsense that has been posted on this subject.
ok what about us heavy duty truck mechanics and diesel technicians? Why do we have to fall under this scrutiny? We only work 8-12 hrs and we go home to a comfortable bed and get plenty or rest before we go back to work and get a few days off every week. Now I was an owner operator of a hotshot carrier business for 1 1/2 yrs and due to expinsive mechanacl issues I had to fold up shop :(. Not once did I ever fall asleep while driving. I do have my limits and know when its time to stop and go to sleep and not push it.
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But now they want me to have the sleep test and all the other BS that goes with it. being a MO class E lioense holder should be enough to test drive a tractor only or tractor trailer combo after repairs have been completed.
I believe the should be a special cdl for mechanics and technicions maybe a CDL M. Were the mechanic would also have to take all the required test. The skills knowledge and driving test. But to be on a test drive he or she has to have the R O (Repair Order)with them at all times when test driving that truck and or trailer.
any feedback would be great
Thank you
Does not matter the job. I you have a CDL it will require a medical card. You may quit mechanics tomorrow and start driving. Its about the CDL, not about the job you are currently doing.
What about the simple fact not one accident in all of the NTSB reports for the last decade do not have a single cause of sleep apne?
What about the fact the sleep industry see CMV drivers as a captive revenue source and fail to discuss, or recommend any treatment that is not a recurring revenue source?
What about the fact that the reason the FMCSA does not have any guidelines or recommendations is because Congress saw the rampant fraud and back room deals so passed a law ordering them to drag these deals into public light through the rule making process, and that in fact you headed up the section that tried to negate that process prior to that law being passed?
Seems to me you left a few facts out, while including some myths by omission.
What a joke this woman is. She is trying to have her cake and eat it too. So the ME clinics, who only have their very lucrative $100.00 per exam stream of money if they stay in good with the FMCSA, are going to NOT take your previous fiasco “guidance” as the “smart” thing to do? Please give me a break. We can all see the wink,wink nudge,nudge that’s going on here. ME clinics all over the country are still telling drivers that they have to go have sleep studies because it is a DOT/FMCSA requirement and I know because I just had it happen and they were not relying on old info. They told me that their clinic director had spoken to the DOT just the other day and were advised to raise their BMI criteria to 40. That is giving guidance lady and is prohibited by law. I’m fed up to my eyeballs with you so called sleep experts who have never actually spent time in a truck sleeper to see what the challenges are to getting a restful nights sleep. I’ll guarantee you snoring and waking up from snoring is the least of any problem. Furthermore you crackpot doctors are worried about me getting oxygen? You clowns don’t even know that the air quality in a truck sleeper at a truckstop is horrendous. Boy if there’s one thing better than bad air it’s lot’s of it. The fact is you tried to screw the drivers to begin with and we fought back. You’re gone and we’re still here.
Are there any updates on this? To my chagrin, I still cannot confirm any specific or adopted OSA criteria or mandates from DOT or FMCSA.
I am going thru this now. Everything here stated as myth was presented to me as FACT. After telling everyone involved I’m claustrophobic , I sit here trying to fit this full face mask to sleep in. If I can’t wear it 5 hrs a night, I can’t get a medical card and I’m out of a job.
I took A sleep apnea test in 2014..found out I didn’t have sleep apnea. .I have no respiratory illness, ,yet the ME is telling me I need to take another test befor he will sign off on my med card…can I sue him for malpractice.
Sue him, or at least have a lawyer send him a warning letter or find another doctor. Best bet is to have an attorney send him a letter.
This article is a testament to the convoluted intertwinings of bureaucracy and explains their slower than snails pace.
People trying to make a living and solve their health problems do not care about the troubles of the FMSCA or any of the other agencies involved in “rule making”.
The resulting confusion always leads to over-interpretation of the “guidelines” and the unintelligible guidelines create a vacuum for junior rule-makers and false authorities all to eager to stand in for the absence of agency guidance.
After 35 plus years, I have been shut down for 30 days because of my neck size according to ME.I have to test for OSA and wear machine for 30 days.Both the ME and the OSA Doctor say it’s because of the FMCSA and their requirements, I say BS. First time in 35+ years that I have failed to pass a physical.I have been put out of work with no recourse.Drive intrastate and stay in nice motels and have for the last 24 years. Daycab, no sleeper, longest run 3 hours. Same thing every week, only run 4 days a week and work less than 8 hours a day. Do tors don’t care, say it not their fault and blame DOT rules and regulations..HELP ME PLEASE!!!!!
I was told 3 years ago by a ME that I had to have a sleep study and then had to buy a CPAP machine due to DOT requirements. So he didn’t know what he was talking about, but I have a series of 1 yr and 90 day cards. I am responding poorly to CPAP. It keeps me awake or barely asleep since the mask keeps moving around and blowing air in my eyes. So I stay in the bed longer, wake up tired, often grumpy, and not really resting like I was before the CPAP. I keep telling the docs this is harming me, and they show me graphs and studies of how it helped so many people. But there is no reference on me other than 4 hours in a sleep study. I feel worse and just keep getting told it is a DOT Requirement. Now they are exploring removing my tonsils. I’ve over 60 and tired of this C-Crap BS.
I am an MD & DOT Medical Examiner. I strongly feel that the pendulum has swung to far to the right on this issue. I have found my colleagues many time causing drivers ample distress about their sleep apnea. The fact is there is a high correlation between drowsy/sleepy drivers and accident, this does not directly translate to sleep apnea and accidents! Sleep apnea is one of many causes of daytime sleepiness. I find it interesting that we do NOT regularly screen for any of the other common causes of daytime sleepiness (medications use, shift work, alcohol use, stress, etc). We do it for sleep apnea cause their is a treatment, which has generated a lot of income to the producers of CPAP machines.
If we really cared about daytime sleepiness, we should be pulling off all alternating shift workers, anyone on any medications with a drowsiness side effect (this technically includes ibuprofen), and heck, even new parents with infants less than 6 months old !
Don’t get me wrong, if I have someone with a risk for moderate to severe sleep apnea, I will limit their card to allow them time to seek out a consult and treatment if needed. BUT if their sleep disturbance index (AHI) is low (mild sleep apnea) or they cannot tolerate CPAP, I will not revoke a card for not being compliant with this. Instead I would rather work with a driver to find a solution to their health condition that works for them, while maintaining safe driving conditions. That what’s wrong with all these guidelines, they result in some medical providers losing the ability to think critically about the individual case.
I concur. I work as a School bus driver where at any given week being nature of the environment at least 5 drivers are sick. Studys have shown that a sick driver is more impaired then a drunk driver; meanwhile no one has given this issue even a second thought of the danger(s) Not from from safety supervisors all the way to the DOT Examiners. Also, some of these Occupational businesses either own the sleep study or our associated where as the very nature is a conflict of interest. This OSA issue is the BIG thing or topic of the day! Like, all the other fads of the past remember: Global Warming of the 1970`s, Assault Rifle Ban, Pit Bulls and Lock Jaws, Global Warming, Milk Causes Cancer,ect. I cold go on all day lol However, Sleep Apnea is not a joking matter if one has poor sleep, family history, swollen lymphoid/ankles, snores, day time drowsiness ect then sure they should get tested but most of these drivers have no insurance or are so under insured or paid they would be better just working at Walmart
I have had my CPAP for 2 & 1/2 years. I was forced to buy it and am still paying $26 a week for it. I was told, and it has been re-enforced by the doctor’s doing my physicals, that I have to provide CPAP tracking data for usage or I will be denied my medical certification.
This will become a major problem when Medical Examiners are forwarding pass/fail physical results right to the driver’s licensing state. It’s a pile of BS.
Find a medical facility, get your physical and pass, stop in the DMV/BMV and self certify. Send a copy of your new Medical Exam Certificate to your employer.
we just lost our fuel/lube truck driver to this smelly pile of horse dung. He didn’t fully understand what was happening and agreed to apnea testing, now they have to wait for results and they told him he has apnea and will have to wear a mask/machine thing. Meanwhile his med card expired. He’s out of a job and we need a fuel/lube truck driver with CDL and HazMat. Maybe Trump could nip this Horse Dung in the bud. Anybody know what we can do to get our driver out of this nightmare?
This one is so simple. 1st ask the dr for a temp card like 3 month or 6 month if he has sleep apnea its no joke and should be treated. It will ruin your heart and brain! But DOT examiners DO NOT know how to interpret the findings so his primary needs to. Or better yet….Go to a different DR but dont tell them about the first dr at all. Go in fresh like you are just renewing your DOT card. If he passes great! If not he needs go to his primary and fight it out. Also he needs to hire a workers discrimination attorney
I was just told this is a requirement from the fmca by my test facility . I told them to show me the requirements and they said they don’t have a copy . They also failed my test because I denied taking the sleep study . My bmi is 39 . They said it is required to be 33 . I still don’t believe this shit . Now I’m out of work . Thanks a lot . I’m 5’7″ 220 lbs not a huge guy .
Dont be “Out of work” For one thing go to another DOT DR. Ask around for a reasonible one because someone will know one. Thats what I did. I also contacted the FMSCA Also Bill Handel knows about this as I was listening to his show “Handel on the Law” a show out of LA California and he said any DR that trys this, please get a Workers Discrimination Attorney. I`m 238 and 5’7 and I past now bmi and height mean nothing but if you say feel tired during the day,your wife hears you snore/cough ect. You need a sleep study period! But if its just BMI and neck size NO WAY! So first and foremost get a second opinion from a none crooked DOT Physician… Like half the DRs dont even measure the neck…. On that note measure your neck at home with head up and tape tight also video tape and take pics for future, print materials that back the truth from FMSCA or places like here. Try to keep your shoes on when measuring. thick soles, ect. Eat no carbs and a high fat diet or fast before going in. You are close to the bmi cut off anyway. Have your primary DR write you a note. Pay for a dot examination your self somewhere else its only like $60 to $85 or so. But more over join or start a class action. Give them negative Yelp reviews. Call patient relations.
I have had a class A since about 2010 with out any problems. I`m a big guy and always have been my neck has been anywhere from 19 to 17 where I am right now being I don’t lift weights. My height is 5’7 to 5’8+ depending on morning and if I have shoes on type ect. with a BMI of 36 Well, for the last 4 years since I moved from California to Oregon I have been driving Buses and at first everything was cool but this past year I had two DOT Examiners in a row that gave me only 6 months and ordered me to have a sleep study.1ST I am in perfect health never snore, sleep great and have no family history of OSA. I have never slept anywhere except my or hotel bed. Neither my ankles, nor lymphoid are swollen. My primary physician says I dont need a sleep study and the FMSCA says its not right but they will do nothing for me. My insurance for 1 wont pay because to them I dont need one but 2 Even if they said ok will cover it my deductible is $1,500 to $2,500 SO why are these DOT DRs asking for one? Well, they get a kick back for one from the sleep study people but if they can get you to come back every 6mos instead of 2yrs thats extra revenue $$ In any event what you can do is start and or join class actions!
Just got denied a Medical card Monday for no CPAP data. What a bunch of crap. Company will only take physicals done by their own Doctor. This is Bullcrap. Now I am looking for another job. 30 damn years and no violations to be treated like this…Wow. Thanks FMCSA.
The person who wrote this article is a BALD FACED LIAR. Public Law # 113-45 specifically forbids the use of sleep apnea testing without formal Rulemaking.
P. Law 113-45 (October 2013)