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;

• Micrognathia or retrognathia;

• Loud snoring;

• Witnessed apneas;

• Small airway (Mallampati);

• Neck size > 17 inches (male), > 15.5 inches (female);

• Hypothyroidism (untreated);

• Age 42 and above; or

• Male or post-menopausal female

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

Thank You!

• Questions?