FMCSA extends the comment period for its notice of proposed regulatory guidance relating to the draft Medical Examiner’s Handbook (MEH) to October 31, 2022.
The Federal Motor Carrier Safety Administration (FMCSA) is set to publish an updated version of the Medical Examiner “ME” Handbook after 7 years since a draft version was removed from public view.
The issue the government is hoping to remedy is that the draft handbook has never been a final rule, which providers use “as guidance”. This caused a lot of confusion on what interpretations MEs can make.
While publishing a Final version of the handbook will add clarity/regulation to a number of areas, it is important to remember many areas will remain up to the examiner to evaluate and make independent clinical judgement still based on “advisory criteria.”
The FMCSA Medical board has been fighting this for years to make a final version and hopefully offer some consistency with providers.
A notice of proposed regulatory guidance, which features the latest draft of the handbook that is linked above, now allows the public to comment on the proposed changes until Oct 31, 2022.
What is the Medical Examiners Handbook?
The ME handbook provides information about regulatory requirements and guidance to Medical Examiners listed on the FMCSA’s National Registry who perform physical qualification examinations of interstate commercial motor vehicle (CMV) drivers.
Other healthcare professionals, such as treating providers and specialists, may provide additional medical information or consultation, but the ME ultimately decides whether the driver meets the physical qualification standards of FMCSA.
The first version of the ME handbook was posted on FMCSA’s website in 2008 to provide guidance to medical examiners on the physical qualification standards in the regulations.
In 2015, the handbook was pulled down from public view after the Owner-Operator Independent Drivers Association (OOIDA) and others complained that the handbook created confusion for certified medical examiners on what was regulation and what was guidance. This was a 250-page document.
In advance of a Medical Review Board’s meeting the FMCSA released a draft version of the 2019 Medical Examiners Handbook. This was a 78-page document.
Now, after seven years of waiting, we have 45 days to review and comment on the changes in the 116-page draft document in hopes that it becomes a final rule that clarifies much of the issues in the past.
The goal of the updated handbook is to provide information about regulatory requirements and guidance for medical examiners to consider.
Comments are requested on the draft of the proposed MEH, including the revised Medical Advisory Criteria. To the extent possible, comments should identify the page number and section number of the MEH to which the comments apply.
After reviewing the changes, you can submit a comment here until October 31, 2022.
What has changed in the FMCSA Medical Examiners Handbook draft?
The draft handbook has made a lot of reformatting changes, updated definitions, pictures, and much more.
The handbook also does a good job detailing all the various driver examination forms (see below) and detailing the HIPAA privacy rules.
- Medical Examination Report Form, MCSA-5875
- Medical Examiner’s Certificate, Form MCSA-5876
- CMV Driver Medical Examination Results Form, MCSA-5850 (electronic only)
- Insulin-Treated Diabetes Mellitus Assessment Form, MCSA-5870
- Vision Evaluation Report, Form MCSA-5871
- 391.41 CMV Driver Medication Form, MCSA-5895 (Optional)
The most important change to note is how the handbook outlines what is regulation versus guidance (or Medical Advisory Criteria).
For example, in section 4, the handbook describes the regulation first and then if there are any medical advisory criteria to the rule/s for the various physical qualification standards:
- hearing (page 22) has 6 medical advisory criteria to consider
- high blood pressure (page 25) has 4 medical advisory criteria to consider
- cardiovascular (page 28) has 3 medical advisory criteria to consider
- respiratory (page 47) has 2 medical advisory criteria to consider
- rheumatics, arthritic, muscular, and other vascular disease (page 56) has 3 medical advisory criteria to consider
- loss of limb (page 61) has 2 medical advisory criteria to consider
- epilepsy, seizure, or loss of consciousness (page 65) has 6 medical advisory criteria to consider
- psychological disorders (page 80) have 4 medical advisory criteria to consider, and
- drug and alcohol use (page 91) have 7 medical advisory criteria to consider
For example, the respiratory regulation 391.41(b)(5) is where sleep apnea comes into play.
Medical Advisory Criteria for 49 CFR 391.41(b)(5)
1. Many conditions interfere with oxygen exchange and may interfere with the ability to control and drive a commercial motor vehicle safely. These include, but are not limited to, emphysema, chronic asthma, carcinoma, tuberculosis, chronic bronchitis, and obstructive sleep apnea (OSA).
2. If the medical examiner detects an undiagnosed or inadequately treated respiratory dysfunction that is likely to interfere with the driver’s ability to control and drive a commercial motor vehicle safely, the medical examiner should confer with the treating provider or the driver should be referred to a specialist for further evaluation and therapy.
Obstructive Sleep Apnea (OSA)
The FMCSRs do not include requirements for MEs to screen CMV drivers for OSA or provide requirements regarding whether to refer a driver for OSA testing. The FMCSRs also do not include preferred diagnostic testing methods, preferred treatment methods, or requirements by which to assess compliance for OSA treatment. When making a medical certification determination, the ME may consider the driver’s responses to the questions about sleep disorders on the Medical Examination Report Form, MCSA-5875, and readily identifiable risk factors for OSA identified during the physical examination.
FMCSA finds the use of multiple risk factors to be a reasonable approach to identify those drivers at risk for moderate-to-severe OSA, rather than relying only on a single criterion. The multiple risk factors to consider include, but may not be limited to:
- History of a small airway
- Loud snoring
- Witnessed apneas
- Self-reported episodes of sleepiness during the major wake periods
- Obesity, high body mass index (BMI)
- Large neck size
- Cardiovascular disease
- History of stroke, diabetes, or other co-morbid conditions
If an ME observes multiple risk factors for moderate-to-severe OSA, the ME may consider referring the driver for a sleep study if not evaluated previously. If a driver reports a prior sleep study was negative for, or revealed only mild OSA, another sleep study may not be warranted unless the driver reports significant changes in risk factors or symptoms since the prior sleep study. OSA is not a condition that requires testing on a regular schedule, unless a driver reports the return of symptoms or significant changes in risk factors. Typically, for drivers diagnosed with moderate-to-severe OSA treated with continuous positive airway pressure, retesting may occur between 3 and 5 years or as determined by the treating provider.
Considerations for an ME when making a physical qualification determination should include, but may not be limited to, the following:
- Does the driver report or does the ME identify multiple risk factors for or symptoms of OSA?
- Are symptoms reported likely to interfere with the driver’s ability to control and drive a CMV safely?
- If a driver is diagnosed with moderate-to-severe OSA, has treatment been shown to be adequate, effective, safe, and stable?
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