Updates in the examination of the Commercial Driver

Updates in the examination of the Commercial Driver

Disclosures and Disclaimer No conflict of interest disclosures The views expressed are those of the author and does 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.

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 Objectives

Over 4 million miles of road in U.S. Sources: American Trucking Association and the FMCSA

Commercial Driver Exam Who needs Driver of vehicle or combination weighing 26,001 pounds or more Carrying placarded hazardous waste Transport 16 + pax including driver Interstate commerce

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 exam No training requirements or demonstration of competence to perform exams NRCME requires: Specific, mandatory training Pass a standard examination Refresher training and re-examination periodically 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 Pending Date 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 vs Intrastate Type 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; or Between 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 match If a clinician needs to redo a card or forgets to sign, but is not available, a whole new exam would be needed 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. MI B. Sleep Apnea C. Alcohol intoxication D. 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 problem Estimates run from a minimum of 28% to a maximum of 78% in commercial drivers Large Schneider trucking study estimated about 30% 1 Significantly larger than the general public 1. Berger M, Varvarigou V, Rielly A, Czeisler CA, Malhotra A, Kales SN Employermandated sleep apnea screening and diagnosis in commercial drivers. J Occup Environ Med 2012;54:1017-25.

Does it matter? OSA is linked to crashes Most recent data shows 5 times elevated crash risk in untreated drivers vs. treated Treatment reduced risk to baseline OSA linked to significant co-morbid conditions 20-37% increased risk of hypertension depending on severity Relative risk increased 1.79 for CVD 2.15 for fatal stroke 1.92 for all cause mortality

Our previous accident: June 29,2009 This was a minivan The 10 th fatality was not found until the tractor trailer was lifted off the van The SUV first to be struck 50+ yards off the road!

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: 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 Source: 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

Metro Rail 4 deaths, 61 injuries National Transportation Safety Board determined in this case the probable cause of the accident was the engineer s noncompliance with the 30 mph speed restriction 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 OSAS 18.9 million undiagnosed in U.S. Effective but uncomfortable technology treats Low compliance Payers and employers not convinced of value of treatment

Harvard Medical School: The Price of Fatigue

Present Guidance The party line: Based on Administration changes there is no definitive direction for this rulemaking at this time. 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 Everyone AASM recommends screening be conducted as part of the routine fitness for duty exams for safety sensitive workers. 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 factor Having a BMI one standard deviation above average translates to 3x risk of OSA 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 use STOP BANG AASM Board certified sleep specialist generally considered best qualified

MRB/MCSAC Recommendation Individuals with a BMI 40 mg/kg 2 OR Individuals with a BMI 33 and < 40 mg/kg 2 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 Source: Joint MRB-MCSAC recommendations related to Medical Review Board Task 16-1. November 21, 2016

Certification No diagnosis but suspected 90 days pending evaluation Diagnosed and adequately treated 1 year max 70% use for 4+ hours per night is standard for CPAP New to treatment? Varies. Newest recommendation is 30 days of compliance prior to certification AASM recommends one week, then 30 days Untreated DQ but

Alternate treatment Oral Devices Not a lot of data Efficacy in mod-severe OSA and outcome data lacking Can approve but must document CPAP intolerance and need compliance data Hypoglossal nerve stimulators New to the table Again, no data Proof of efficacy, limited certification

SAMHSA Drug Screen changes SAMHSA is lead agency for drug screening in federally regulated employees Other agencies generally follow SAMSHA rules As of 10/1/2017 several changes Add synthetic opioids oxycodone, oxymorphone, hydrocodone, hydromorphone to panel Remove MDEA but added MDA Lower ph cutoff for substitution raised from 3 to 4 MRO retraining required q 5 years Alternative specimen collection

DOT Changes Adopted the changes to the panels Removed requirement that employers submit blind specimens Still in Notice of Proposed Rulemaking stage Anticipate it will move forward Drug and Alcohol clearinghouse Database for confirmed positives and RTT Compliance by 1/6/2020 Closes pre-employment loophole

Oral Fluid SAMSH proposed in May of 2015 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 suboxone Not disclosed to examiner 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 FMCSA Previous guidance suggesting not to certify withdrawn State of the science is that suboxone is used for pain control and treatment of opiate addiction/dependence Can have significant side effects and impairment Not recommended for commercial drivers 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. Company only required to have a copy of the card 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. Admits to use of retrovirals for HIV but asks you not to write it down because she does not want company to know Records show stable disease 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 HIV 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? Motor carriers are responsible for ensuring that the driver meets the general qualification requirements of 49 CFR 391.11. 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 regulation Use of translator is not forbidden Can you provide forms in other languages? No (can t alter forms)

The Pot Paradox Driver presents for a DOT certification Has chronic pain controlled with marijuana Provides valid Rx and records to confirm Interstate driver Certify?

Marijuana Marijuana is a Schedule 1 drug and is thus illegal for CMV drivers in interstate commerce What if intrastate? State regulations apply but best science applies What if is not a commercial driver but a Lyft driver? Company and state rules apply

The deactivated ICD 56 year old presents for exam with history of ASCVD. Has implanted combination pacemaker and ICD. 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? No; just report NONE on the form Does the address have to match the driver license? No, has to be the current address What if I did not do any exams last month? Must report to NRCME grounds for removal if not Driver has a disqualifying condition in history do I have to do the exam Yes Can somebody in my office fill out the forms for the driver No, driver has to do it themselves and sign

Can a completed exam be amended? No, once final determination made, a whole new exam would be required I ve been certified for 5 years, what refresher training is required? FMCSA will be posting this soon. Examiners will have one year to complete. Keep email address up to date with FMCSA and read what they send you!

Exemptions Two official exemption programs Insulin, Vision Two informal 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 MEC Needed for exemption 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 exemption C. 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 The driver does not have to be continuously employed or even with the same employer 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 64

How to properly certify insulin using EVERYONE ELSE! bus drivers in Michigan 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. 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. 65

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

Questions? Thank You!