Updates in the examination of the Commercial Driver Michael Berneking, M.D. ◦ Concentra, Inc. Center Medical Director, Grand Rapids ◦ U.S. Army Reserve ◦ American Academy of Sleep Medicine Occupational Sleep Wellness Presidential Committee Medical Review Officer Certified Medical Examiner, NRCME Senior Aviation Medical Examiner Civil Surgeon, USCIS
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Updates in the examination of the Commercial Driver - MOEMA
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Updates in the examination of the Commercial Driver
Michael Berneking, M.D.◦ Concentra, Inc.
Center Medical Director, Grand Rapids◦ U.S. Army Reserve
◦ American Academy of Sleep MedicineOccupational Sleep Wellness Presidential Committee
Medical Review OfficerCertified Medical Examiner, NRCMESenior Aviation Medical ExaminerCivil Surgeon, USCIS
Disclosures and Disclaimer
• No conflict of interest disclosures
• The views expressed are those of the author and do
not reflect official policy of AASM, FMCSA, DOT, the
State of Michigan or any other person/organization.
• Not for public distribution
• For educational use only; not for commercial use,
distribution or duplication.
Objectives• Provide an update to the
commercial driver exam forms and
the new status options
• Provide background and update
on OSA and the commercial driver
• Make clinicians aware of changes
to drug testing
• Provide answers to common
questions
Sources: American Trucking Association and the FMCSA
Over 4 million miles of road in U.S.
Commercial Driver Medical Exam
• Who needs a CDL?o Driver of vehicle or combination weighing 26,001 pounds or more
o Carrying placarded hazardous waste
o Transport 16 + pax including driver
• Who does not?o Active duty military with appropriate license
o Police/fire while operating emergency vehicles
o Farmers within 150 air miles of the farm
o Motor homes
History of the driver exam
• Initial criteria for commercial drivers
in 1939 was “Good physical and
mental health; good eyesight;
adequate hearing; no addiction to
narcotic drugs and no excessive
use of alcoholic beverages or
liquors”.
• Physical exams were not required
by the then Interstate Commerce
Commission until 1954.
• Department of Transportation was
created in 1970 and issued more specific and tighter qualification
standards.
Why the recent changes?• In 1999, a driver crashed a motor
coach in New Orleans.
• The accident was part of a systemic
failure of the medical certification
process to detect and remove
medically unqualified drivers from
service.
• Twenty-two individuals were killed, and
sixteen were seriously injured.
• The NTSB noted that the driver should
not have been medically qualified.
Mother’s Day Crash• Some of the passengers that
were interviewed after the crash
observed that the driver seemed
dazed, avoided eye contact, and
didn’t perform his normal duties.
• Minutes before the crash, they
said that the driver slumped at
the wheel then sat up.
• Moments later, he drove the bus
over an embankment.
• The driver survived the crash
only to die later.
Post Accident Findings• He was morbidly obese, hypertensive, had Stage IV
Congestive Heart failure and Stage V renal failure awaiting transplant.
• NTSB found that the driver was in the hospital the night before with complications of his dialysis and had less than six hours sleep.
• He took multiple medications including diphenhydramine and also tested positive for THC.
• Driver checked “no” on all health questions on his medical exam including those for heart and kidney problems
• Doctor’s notes however list “heart failure” and “hypertension” and medically qualified him.
• NTSB and FMCSA recognized that there were wide spread systemic failures with the medical certification process which led to the creation of the National Registry.
SAFETEA-LU
• Signed into law by President Bush
in 2005, the Safe, Accountable,
Flexible, Efficient Transportation
Equity Act: A Legacy for Users
(SAFETEA-LU) formally established
a Medical Review Board and the
National Registry of Certified
Medical Examiners (NRCME)
NRCME• Prior to establishment of the NRCME, any licensed
healthcare clinician could perform examo No training requirements or demonstration of competence to perform
exams
• NRCME requires:o Specific, mandatory training
o Pass a standard examination
o Refresher training and re-examination periodically
o Removal of examiners that do not comply
Summary of Changes
New Status Choices
• Under the new rule, all results, including PENDING and INCOMPLETE, are to be reported to the National Registry of Certified Medical Examiners (NRCME).
• Ultimately, by June 2018, all results must be reported by midnight the next calendar day to NRCME.
Pending• If the exam was
completed but examiner needs more information before making a certification decision, the ME can now use PENDING status.
• The ME does not certify the driver, but is not disqualifying the driver.
Things to Know:• No MEC is issued• Driver can continue to drive until current
certification expires or the Pending exam is resolved (whichever comes first)
• Not appropriate for drivers with a disqualifying condition
• Date for follow up must be 45 days or less• When the driver returns the exam can be
amended, i.e. the exam does not need to be repeated
• When the driver returns for pending review, a new exam does not need to be completed
• Resolving “pending” status results in a new status of either qualified or disqualified
• Expiration will be calculated from the date the MEC is issued - not from the original exam date!
Resolution of PendingDate of Exam• The date of the pending
determination follow-up is used if/when the driver returns for the pending determination.
Expiration Date• Calculated from the
date the MEC is issued (the date the ME has the information needed to make the certification decision).
Incomplete
• Once the ME starts the
exam, the DOT requires
the ME to report a result,
even if the exam was
not finished for some
reason. Unfinished
exams are
“incomplete.”
Things to Know:• No MEC is issued• The reason for the incomplete
exam must be recorded• When the driver returns, a new
exam must be completed since the driver was reported to the NRCME as incomplete
• If they are Incomplete, their existing (MEC) remains in effect until current certification expires or the Incomplete exam is resolved (whichever comes first)
Interstate or Intrastate• 22 year old FedEx delivery
driver has a route completely
inside Kent County, Michigan.
Is he:o Interstate?
o Intrastate?
• Why?
• Why is this important?
Interstate vs IntrastateType of Certification InTRAstate InTERstate
Status Options: Qualified Disqualified
Qualified Disqualified Incomplete Pending
Interstate:From one state to another state or to a foreign country;Between two places within a state, but the route takes the vehicle through another state or foreign country; orBetween two places within a state, but your cargo came from or will be delivered to another state or foreign country.
Intrastate: Driving a commercial motor vehicle within one state and does not meet any of the interstate descriptions.
Summary of Form Changes
Card extensions
• Extending cards not an option
• Whole new exam done
• Each certification period is stand alone
• Does not affect bp guidance
Can another doctor sign?
• Certificate, card, and registry all have to matcho If a clinician needs to redo a card or forgets to sign, but is not available, a
whole new exam would be needed
o Copy of card is as good as original
• Pending CAN be completed by another clinician
“in the same office”
A medical diagnosis was cited by NTSB as one causal factor. What was it?
A. MIB. Sleep ApneaC. Alcohol intoxicationD. OTC medication use
What is the most common cause of
fatigue in this country?
• A. OSA
• B. Pharmaceuticals (both licit and illicit)
• C. Circadian disruption
• D. Lack of sleep
NHTSA
OSA The Problem
• Common problemo Estimates run from a minimum of 28% to a maximum of 78% in commercial
drivers
• Large Schneider trucking study estimated about 30%1
o Significantly larger than the general public
1. Berger M, Varvarigou V, Rielly A, Czeisler CA, Malhotra A, Kales SN Employer-mandated sleep apnea screening and diagnosis in commercial drivers. J Occup Environ Med 2012;54:1017-25.
Does it matter?• OSA is linked to crashes
o Most recent data shows 5 times elevated crash risk in untreated drivers vs.
treated
o Treatment reduced risk to baseline
• OSA linked to significant co-morbid conditionso 20-37% increased risk of hypertension depending on severity
o Relative risk increased
• 1.79 for CVD
• 2.15 for fatal stroke
• 1.92 for all cause mortality
Sleep apnea is fatal• OSA cited as factor in over 20 deaths in NTSB
investigationso NTSB: Factor in 9 accidents in all transportation modes
o Number of major accident deaths due to MI, hypoglycemia: 0
o Tip of the iceberg
• Number goes WAY up when fatigue is considered
June 29,2009
The SUV first to be
struck – 50+ yards off
the road!
This was a minivan
The 10th fatality was not
found until the tractor
trailer was lifted off the
van…
Our previous accident:
• “that the probable cause of this accident was the Volvo truck driver’s fatigue, caused by the combined effects of acute sleep loss, circadian disruption associated with his shift work schedule, and mild sleep apnea, which resulted in the driver’s failure to react to slowing and stopped traffic ahead by applying the brakes or performing any evasive maneuver to avoid colliding with the traffic queue.”
• The driver did not report his sleep apnea on any of his physical examinations
Highway Accident Report Truck-Tractor Semitrailer Rear-End Collision Into Passenger Vehicles On Interstate 44 Near Miami, Oklahoma June 26, 2009, NTSB Number: HAR-10/02, NTIS Number: PB2010-916202
• I-44 near Miami, Oklahoma• Traffic stopped for a minor accident further up• A CMV driver operating his tractor-trailer did not
react to the stopped vehicles and initially collided with a Land Rover SUV but continued on to override a Hyundai Sonata, a Kia Spectra, and a Ford minivan.
• 10 people died, 6 injured including the driver of the tractor-trailer
• NTSB cited the following:
Metro Rail
• 4 deaths, 61 injuries
• National Transportation Safety
Board determined in this case the
probable cause of the accident
was the engineer’s non-
compliance with the 30 mph
speed restrictiono The reason? He feel asleep due to undiagnosed
severe sleep apnea
• This was an entirely preventable
accident NTSB
Would you evaluate and
treat someone for a
diagnosis with significant
morbidity and mortality
and that was relatively
easy and cost effective to
diagnose and treat?
Why is this so difficult?
• OSA attracts little attention from public despite the
high costs
• Under-diagnosed: only 15-20% of OSASo 18.9 million undiagnosed in U.S.
o Primary care neither routinely address sleep nor screen for OSA
• Effective but uncomfortable technology treatso Low compliance
• Payers and employers not convinced of value of
treatment
Harvard Medical School: The Price of Fatigue
Present Guidance
• The party line:o “Based on Administration changes there is no definitive direction for this
rulemaking at this time.”
o MEs are not prohibited from using the August 2016 MRB recommendations
and other best practices.
• FMCSA and FRA withdrew the ANPRM for OSA in
safety sensitive workers
Who should be screened
• Everyoneo AASM recommends screening be conducted as part of the routine fitness
for duty exams for safety sensitive workers.
o MRB/MCSAC: “Certified Medical Examiners (CMEs) must screen drivers
presenting for medical certification for OSA diagnostic testing”
Screening criteria
• Obesity is the number one risk factoro Having a BMI one standard deviation above average
translates to 3x risk of OSA
o More than 50% of individuals with BMI > 40 have OSA
Other risks• Mallampati
• Neck size
• Micrognathia/retrognathia
• Male sex
• Resistant hypertension
• Increasing age
• History of stroke,
• CVD, MI
• Diabetes
Who should be tested• Those who screen positive
• No regulation stating what
screening criteria to useo STOP BANG
o AASM
• Board certified sleep specialist
generally considered best qualified
MRB/MCSAC Recommendation
• Individuals with a BMI ≥ 40 mg/kg2 OR
• Individuals with a BMI ≥ 33 and < 40 mg/kg2 in
addition to and at least 3 or more of the following:• Hypertension (treated or untreated);
• Type 2 diabetes (treated or untreated);
• History of stroke, coronary artery disease, or arrhythmias;
Joint MRB-MCSAC recommendations related to Medical Review Board Task 16-1. November 21, 2016
Certification• No diagnosis but suspected
o 90 days pending evaluation
• Diagnosed and adequately treatedo 1 year max
o 70% use for 4+ hours per night is standard for CPAP
• New to treatment?o Varies. Newest recommendation is 30 days of compliance prior to
certification
o AASM recommends one week, then 30 days
• Untreatedo DQ but…
Alternate treatment
• Oral Deviceso Not a lot of data
• Efficacy in mod-severe OSA and outcome data lacking
o Can approve but recommend examiner document CPAP intolerance
and compliance data
• Hypoglossal nerve stimulatorso New to the table
o Again, no data
o Proof of efficacy, limited certification
SAMHSA Drug Screen changes
• SAMHSA is lead agency for drug screening in
federally regulated employeeso Other agencies generally follow SAMSHA rules
• As of 10/1/2017 several changeso Add synthetic opioids oxycodone, oxymorphone, hydrocodone,
hydromorphone to panel
o Remove MDEA but added MDA
o Lower pH cutoff for substitution raised from 3 to 4
o MRO retraining required q 5 years
o Alternative specimen collection
DOT Changes
• Adopted the changes to the panels
• Removed requirement that employers submit blind
specimens
• Still in Notice of Proposed Rulemaking stageo Anticipate it will move forward
• Drug and Alcohol clearinghouseo Database for confirmed positives and RTT
o Compliance by 1/6/2020
o Closes pre-employment loophole
Oral Fluid• SAMSHA proposed in May of 2015
o DOT silent
• Possible goal for implementation in 2018 – very
optimistic
• No rules or procedures yet published.
Tales from the front line• Common FAQ’s from the field
• Actual cases though names and circumstances
may be changed
Suboxone
• New hire DOT
• Found in medical records to be on suboxoneo Not disclosed to examiner
o Records showed taking for history of opioid dependence
• PCP and specialist say he is OK to drive and has no
side effects
• Your plan?
And the guidance is…• There is no official regulation regarding suboxone
from FMCSAo Previous guidance suggesting not to certify withdrawn
• State of the science is that suboxone is used for
pain control and treatment of opiate
addiction/dependenceo Can have significant side effects and impairment
• Not recommended for commercial driverso ME makes final determination
• Methadone still specifically disqualifying
Who gets the paperwork
• Driver presents for new hire - company pays for
exam.
• Company does not want card or form provided to
the driver because they paid for it.
• Driver wants a copy?
• What would you do?
And the answer is…
• Individuals are entitled to their medical records.
Period.o “Card belongs to the driver”
o Company only required to have a copy of the card
o Card per FMCSA belongs to driver and must, by regulation, be provided
to driver at time of exam
Privacy concern
• 26 year old female driver presents for
recertification exam. Company paid for exam
and expects copy of long form. Driver signed
routine HIPAA release.o Admits to use of hormones as is transgender but asks you not to write it
down because she does not want company to know
o Records show stable with no side effects or other concerns
• Document or no?
• Provide long form?
Best practices
• Need to document accurate history
• Employer not required to have copy of long form,
only copy of card
• Since driver not OK with release of information
needs to revoke HIPAA
• Do not release but can give copy of long form to
driver and let her make decision.
English as a second language
• Driver come presents for exam. Speaks only
Croatian.
• His wife is with him and is able to translate
• Regulation says?o Motor carriers are responsible for ensuring that the driver meets the
general qualification requirements of 49 CFR 391.11.
o Includes English language
• What do you do?
The ME’s job
• The ME has to be able to obtain a health history
• It is NOT an ME requirement to ensure compliance
with 49 CFR 391.11.
• Use of translator is not forbiddeno Can you provide forms in other languages?
o No (can’t alter forms)
The Pot Paradox
• Driver presents for a DOT certificationo Has chronic pain controlled with marijuana
o Provides valid Rx and records to confirm
o Interstate driver
• Certify?
Marijuana
• Marijuana is a Schedule 1 drug and is thus illegal for
CMV drivers in interstate commerce
• What if intrastate?o State regulations apply but best science applies
• What if is not a commercial driver but a Lyft driver?o Company and state rules apply
The “deactivated” ICD
• 56 year old presents for exam with history of ASCVD.
Has implanted combination pacemaker and ICD.o Cardiologist states that ICD is turned off.
• Qualify?
• Not recommended
• No way to monitor
• Was a reason for implantation in first place
• FMCSA is not certifying those with exemption
request.
The devil is in the details• Do they have to have a driver license?
o No; just report NONE on the form
• Does the address have to match the driver license?o No, has to be the current address
• What if I did not do any exams last month?o Must report to NRCME – grounds for removal if not
• Driver has a disqualifying condition in history – do I have to do
the examo Yes
• Can somebody in my office fill out the forms for the drivero No, driver has to do it themselves and sign
• CDL vs. CLP vs. non-CDL – driver marked wrong one
or didn’t have one before!o Non-issue. Purely for data collection by FMCSA
o Remember, license is state regulated
• Can a completed exam be amended?o No, once final determination made, a whole new exam would be
required
• I’ve been certified for 5 years, what refresher
training is required?o FMCSA will be posting this soon. Examiners will have one year to
complete.
o Keep email address up to date with FMCSA and read what they send
you!
Exemptions
• Two official exemption programso Insulin, Vision
• Two informalo Hearing, seizure
• Driver or employer can apply for exemption to any
regulation but these are the four that are
established.
Examiner’s Role
• Ensure are in all other respects qualified
• If so, issue MECo Needed for exemption
o Mark appropriately on MEC
• School bus driver presents for certification. Has
been a bus driver since 2005. Diagnosed with
diabetes in 2007. Placed on insulin in 2014. Is in all
other respects qualified. Would you:
A. Qualify and issue Michigan Bus Driver Certificate of Medical Fitness. B. Qualify for one year and require a Federal insulin exemptionC. Qualify for one year and require a Michigan exemption.D. Disqualify. Insulin is disqualifying.
How to properly certify an insulin
using bus driver in Michigan• This process changed with a law
taking effect in June of 2010
• If the operator has been a bus driver PRIOR to June 22, 2010 AND were diabetic than the “grandfather clause” applies
o The driver does not have to be continuously employed or even with the same employer
o The driver does not have to have been on insulin before the law change, just diabetic.
• If these criteria are met, than the medical examiner makes the determination whether or not the driver has satisfactory control of his/her diabetes and if so, issues the BLUE State of Michigan School Bus Driver Certificate of Medical Fitness
• Since this is a state specific exam, it is NOT reported to the NRCME
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How to properly certify insulin
using bus drivers in Michigan• EVERYONE ELSE!
• Examiner evaluates and if satisfied that the diabetes is controlled and stable and driver is
in all other respects qualified: issue regular white card with “accompanied by ______ exemption” marked. The examiner should fill in “insulin/diabetes”.
• This IS reported to the NRCME since it is a Federal Exam
• The driver will have to obtain the appropriate exemption from the FMCSA or the waiver from the State of Michigan.
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Note that the waiver from the state only allows the driver to cross state lines if dropping off or picking up students. It does NOT apply to field trips or sporting events outside of the state. The driver would need a Federal exemption for this.
Parting thoughts• Employers and motor carriers identified
incompetent ME’s as a significant concern
• 7% of all exams reviewed had errors
• Only 87% of clinicians do a hernia check and/or
listen to heart and lungs with a stethoscope
routinely.
• Would you feel comfortable with the driver
operating a tractor trailer next to you, your family?
Source: American Transportation Research Institute