October 24, 2022
U.S. Department of Transportation
1200 New Jersey Avenue, SE, West Building, Ground Floor, Room W12-140
Washington, DC 20590-0001
RE: Comments – Draft Medical Examiner Handbook FMCSA-2022-0111
Dear Chief Hydock:
The American College of Occupational and Environmental Medicine (ACOEM) appreciates the opportunity to comment on the Notice of Proposed Regulatory Guidance – Qualifications of Drivers: Medical Examiner’s Handbook and Medical Advisory Criteria. ACOEM is the nation’s largest medical society dedicated to promoting the health of workers through preventive medicine, clinical care, research, and education. Our membership is comprised of 3,500 physicians, nurses, physician assistants, nurse practitioners, and other health care professionals who specialize in occupational and environmental medicine (OEM).
As the only major organization that has been training commercial driver medical examiners long before the creation of the National Registry of Certified Medical Examiners (NRCME), ACOEM’s NRCME training program strives to ensure that examiners have knowledge of not only the information required by the core curriculum, but also awareness of other evidence or expert consensus-based resources, primarily those commissioned by the Federal Motor Carrier Safety Administration (FMCSA). This includes the Evidence Based Reviews (EBR), Medical Expert Panel (MEP) recommendations and the considerations and recommendations from the FMCSA’s Medical Review Board Advisory Committee (MRB). ACOEM’s NRCME training program carefully delineates the medical standards, guidance from FMCSA versus guidance and recommendations found in other sources such as the EBR, MEP, and MRB resources. We highlight that while these resources may have been produced under FMCSA auspices, they are NOT official FMCSA guidance. Furthermore, ACOEM consistently advises trainees about the differences between regulation, official FMCSA guidance, and recommendations or other guidance. With its training, ACOEM strives to support the goal of improving examiner quality and exam consistency.
We are keenly focused upon the overall NRMCE process of certification and training regarding its effectiveness in improving examination quality and validity. In general, when any health care provider training and certification program is instituted, one major goal should be to improve both interrater and intrarater reliability. These reliabilities in most cases are best accomplished by the introduction, focus, and consistent application of evidence-based medicine and evidence-based decision making whenever possible. Thus, we strongly encourage FMCSA to introduce this Draft Handbook with that goal in mind. In other words, regardless of which certified medical examiner consults this Handbook, there should be enough information contained within that ensures that the same medical determination on certification is made, regardless of examiner.
One of our major concerns with the Draft Handbook is the inconsistent referencing of FMCSA commissioned resources and deliberations on their content, including by the public and the FMCSA’s MRB. The information from the 2013 Medical Expert Panel’s report – “Medical Examiner Physical Qualification Standards and Clinical Guidelines for Cardiovascular Disease and Commercial Motor Vehicle Driver Safety” as presented in the Draft Handbook is useful guidance and is similar in breadth to what was in the original ME Handbook. However, it is the only guidance from similar reports presented in this detail. In addition, this was the only MEP report that was NOT presented to the MRB nor available for public comment. While we are not opposed to the inclusion of this guidance, we feel that prior to final inclusion, the MRB and interested members of the public should have the opportunity to comment on its contents.
Whether or not similar detailed guidance tables should be included for all conditions where the FMCSA has commissioned an EBR and MEP with review and deliberations by the MRB and comments from the public, we feel strongly that all available FMCSA-related resources such as those mentioned above, should also be referenced.
ACOEM has no objection to the statement below which is used for many medical conditions, but this should be included for all medical conditions where reports, deliberations and guidance exist.
“With respect to…… the FMCSRs do not include any specific requirements for waiting periods, maximum certification periods, specific diagnostic procedures or treatment, or specific diagnostic results. For additional guidance on certification of drivers with….., one source MEs could consider is the……..”
In the attached copy of the Draft Handbook, with comments summarized below, ACOEM has attempted to include the information of all such resources that we believe to exist, and to the extent possible where they can be found. We hope that by including them and the statement above, that as for any action in the practice of medicine, health care providers (HCPs) should be aware of and consider all available evidence and expert consensus-based guidance and in reaching their final medical practice decisions.
While not mentioned above, two other resources directly provided by FMCSA but not included in relevant sections of the 2022 Draft ME Handbook are the Frequently Asked Questions (https://www.fmcsa.dot.gov/faq?keyword=&term_node_tid_depth=17416)
, the FMCSA Resource Table (https://www.fmcsa.dot.gov/regulations/medical/medical-regulations-and- guidance-resource-links
) and pertinent Regulatory Guidance (https://www.fmcsa.dot.gov/guidance).
Another concern that we have is that while the content of the Medical Advisory Criteria (MAC) is not a requirement, and as defined in this Draft Handbook – “such guidance itself is only advisory and not mandatory”
it had been codified and any changes in the past had been published in the Federal Register
and the changes highlighted. There were many significant changes and if those reviewing this document did not look closely, they would not be aware of what changes were being offered. Although Task 16-2 of the Medical Review was the review of the MAC, few of the comments were incorporated into the proposed revisions. An example is under cardiac, 49 CFR 391.41(b)(4), the MRB had recommended including arrythmia as a in the cardiovascular disease which would be of concern. Under 49 CFR 391.41(b)(12) Drug Use, the statement that “this exception does not apply to methadone” (the MRB had suggested adding Suboxone) was removed. (MRB recommended adding Suboxone). Some of the information which had been in the MAC was moved into the body of the document. While other changes might have been reasonable, given that Appendix A to 49 CFR 391.41 is codified, it would have been reasonable to highlight those changes in a format which would have been simple to review.
One of the requirements for an examiner to be listed on the NRCME is that they are “licensed, certified, and/or registered in accordance with applicable State laws and regulations to perform physical examinations.” This does not describe the extent nor purpose of the physical examination being conducted. MEs must be able to perform a risk assessment of the fitness for duty of any driver they are certifying, be able to evaluate the risk of sudden or gradual impairment or incapacitation over the duration of the issued medical certification. To do so, the ME must have knowledge of the medical condition; the ability to identify the condition, understand its symptoms, treatment, and prognosis as well as co-morbidities and the potential impact of co-existent medical conditions. Without this knowledge the ME cannot conduct that risk assessment. The original ME Handbook, while not meaning to be a “cookbook,” at least provided “starting points”
to those examiners who did not have the detailed knowledge on a medical condition.
Of course, the ME could attempt to obtain information from the treating clinician (TC) but as FMCSA point out, the ME is responsible for making that certification determination, not just deferring to the treating clinician (TC). As many MEs can attest, the TC has no understanding of the roles and responsibility of the CMV operator and will either “clear” the individual based on their limited understanding of the job or the “they look good enough” principle. TC’s have a duty to the individual as their client and patient, not to public safety.
This Draft Handbook is inconsistent in the extent to which it attempts to “teach” what should be basic knowledge to any health care provider performing these examinations and conducting that fitness for duty/risk assessment. FMCSA must also recognize that examiners will vary in their knowledge base, background, education, and experience. Simply including facts about a condition will not provide sufficient information to perform the risk assessment necessary to determine whether the individual is at risk of sudden or gradual impairment or incapacitation over the duration of the medical certification. Of course, the ME could obtain information from the treating clinician, but the ME is ultimately responsible for making that certification determination, not just deferring to the treating clinician (TC) As many MEs can attest, the TC has no understanding of the roles and responsibility of the CMV operator and will either “clear” the individual based on their limited understanding of the job or the “they look good enough” principle.
Another area where there is concern is how non-insulin treated diabetes is addressed. The prior diabetes standard addressed diabetes that “required insulin for control,” recognizing that poorly controlled diabetes independent of recognized cardiac, kidney or vision longer term complications. The comment that – “if a driver’s poorly controlled blood sugar levels frequently result in hypoglycemic episode,”
ignores that fact that the first significant hypo or hyperglycemic episode could have a critical outcome. Poorly controlled diabetes, in and of itself, should require more frequent examinations or even disqualification. Without more detailed knowledge and guidance, some examiners would not be aware that they should obtain additional information on the stability and control of the non-insulin treated diabetic. The use of the form recommended by the MRB should be included as an optional method to obtain additional information.
When the NRCME was implemented, the MEs were all trained in the guidance on “waiting periods, maximum certification periods, specific diagnostic procedures or treatment, or specific diagnostic results”
and all at least had the same starting point to them perform that individualized assessment. This guidance was thought of in terms of establishing “best practices” in making driver certification decisions. With the current Draft Handbook, unless all MEs are at least pointed to the existing resources and expected to at least consider them, some examiners will revert to the pre-NRCME process which will decide in the drivers looks “good enough” while those that are trained in the full evaluation and treatment of medical conditions of concern, will attempt to use evidence-based risk assessment in reaching that fitness determination.
Specific comments on the 2022 Draft ME Handbook
The following represent concerns identified during review of the Draft Handbook, while some of the earlier comments may be addressed later in the Draft Handbook, an ME might not also see the later information and for some situations, redundancy may be beneficial. The attached document notes exactly where the specific comment belongs.
- Are not FAQs also guidance and should not they be included under the applicable sections in this Handbook?
- Notes that examiner may consider guidance, but should document rationale if deviating significantly from this guidance?
- Contents of ALL the reports/recommendations should be included or at least linked for easy access by examiners.
- While not in the regulations, should not an individual tasked with determining safety risk understand the medical condition, diagnosis, treatment, and prognosis of that condition. This was less relevant when the Agency provided more specific guidance.
- When discussing examination document retention should not that “or consistent with state medical record requirements” as had previously been included. The MER would be considered a medical record and many states have medical record retention requirements longer than 3 years.
- This would be the place to include the information on if the examiner changes employers and that the forms can be stored electronically as per recent FAQs
- Should there be something to indicate that once an examination is begun, an outcome should be documented, even if incomplete.
- In discussing exemptions, please indicate that the while the driver may have a signed medical certificate, this is not valid unless and until that exemption is granted.
- While information on the commercial drivers’ license and the Federal drug testing programs in 49 CFR 382 and 383 are this is important, in this setting (CDME), the definitions are more relevant. It is Important for examiners (AND EMPLOYERS) to understand that 390.5 and 391 are not only relevant to those drivers that carry CDLs but to anyone that meets the definitions in 391. Many employers refer to the CDME as a CDL exam (covers more than just CDL drivers) or DOT (which is also incorrect as rails and aviation also require medical evaluations).
- This section notes that “this examination is considered by FMCSA to be a physical qualification examination. During the physical qualification examination, the ME’s fundamental task is to determine whether the driver meets FMCSA’s physical qualification standards.” Isn’t this also a fitness for duty evaluation to determine if the individual is able to safely perform the duties of commercial motor vehicle operator , both driving and non-driving tasks as previously stated by FMCSA?
- Please add that a driver is medically certified to perform any duties of a CMV operator, that the certification is not tied to a specific employer.
- Aren’t FAQs also considered guidance, why are they not included in the list types of guidance?
- With respect to the statement – “Separately, the handbook also provides information to the public regarding existing requirements under the law or FMCSA policies. The public (including MEs) is free to choose whether to utilize such guidance or recommendations as a basis for decision-making.” Why would the public be choosing to utilize guidance on the ME Handbook - this should be up to the MEs and if the ME chooses to not follow the provided guidance, should not they document their rationale if they it should not.
- With respect to the statement – “For example, non-insulin-treated diabetes mellitus is not discussed in one of the 13 standards but could be considered as part of §391.41(b)(8) if the condition is likely to cause of loss of consciousness.” So, is there no expectation that DM should be controlled? Should the only concern be loss of consciousness, what about sudden or gradual impairment or incapacitation. Cognitive effects, vision effects, etc.
- Should note that if the individual required corrective lenses, then it is not necessary to document vision without (should not require someone to remove CL to fill in boxes) This had previously been pointed out as the one box which is NOT required to be completed.
- Should include here as well as with the alternative vision standard, that if the worse eye is ABLE to be corrected to 20/40 (but chooses not to do so), the person would not be eligible for the Alternative standard.
- Should point out here as well that the alternative vision standard would not be applicable if the person is unable to meet the color vision requirement. Also, MRB voted unanimously that chromatic lenses should not be permitted.
- Need title for the Hypertension Table and other Tables from the 2013 Cardiovascular report but would suggest that it is clearly note that this is guidance in the title to each table copied in total from the 2013 MEP, otherwise will be interpreted as requirements.
- This Hypertension table has been confusing. for some. It might be clearer if there is not a page break within the same category (Hypertension (<169/109mm Hg)1: Presents with BP measurement of 140- 169/90-109 mmHg. or if under Certification Approved if, Not Approved if – used the same between notations. Is this meant to indicate that a driver who presents for the first examination with BP is between 140-169/90-109 mmHg and is on meds, the guidance is that they should not be certified at all? So, the driver who has been diagnosed with hypertension in the past but has not been on meds for some time but then presents with a BP of 142/92 should be disqualified. Is the re-certification category meant to be any recertification examination or only a Recertification AFTER which the individual has been identified as having hypertension?
- Continue to question why similar detailed guidance from other MEP reports, especially where MEs may have less knowledge of the conditions is also not included such as for Parkinson's Disease/ Multiple Sclerosis or Chronic Kidney Disease is not also included.
- Not consistent with MRB recommendations, did not add arrhythmia as cardiovascular symptom which may be of concern. Noted that normal and resting stress EKG has been removed and guidance on ICD has been significantly modified.
- Much of the guidance provided in this section and others would still require an ME to understand the condition, the diagnosis, treatment, and prognosis and without that they might not pick up on the statements which require the ability to apply the information or “read between the lines.” The statement “In general, thoracic aneurysms that are less than 5.0 cm and are asymptomatic are not likely to rupture” is a good example where a competent ME would think that if <5.0 and asymptomatic – not a concern but if > 5.0 or symptomatic should not be qualified.
- Under arrhythmias, is sudden death the only concern? Many other outcomes of arrhythmias can lead to impairment or incapacitation.
- The statement – “Has treatment been shown to be adequate, effective, safe, and stable?” appearing in cardiovascular disease as well as other places raises the question – how would someone who has never been trained in the diagnosis, treatment and prognosis of a medical condition be able to determine if “adequate, effective, safe, and stable.” The prior ME Handbook gave specific parameters to at least require all MEs to start from the same point. Without that common starting point, MEs with no training or current experience in a condition such as the treatment of arrhythmias be able to assess whether a treatment been shown to be adequate, effective, safe, and stable? The TC may think adequate for an office worker but would not understand the additional risk for the public in a commercial motor vehicle operator.
- The statement – “Greatest risk for complications occurs in the first 3 months after surgery. A significant risk associated with CABG surgery is the high long-term re-occlusion rate of the bypass graft, which typically occurs after 5 years and may indicate the necessity of an ETT,” seems to suggest that this would represent best practice but will all MEs read it the same?
- The statement on degree of abnormality of EF appears to suggest that this would represent best practice but will all MEs read it the same? That moderately below normal should, in most circumstances be disqualifying or should only severely below normal be of concern?
- Does Renal Dialysis really belong in cardiovascular? If is caused by other conditions than just cardiovascular conditions. And why would the CKD report which did have MRB and public comment not be included? The evidence report is in the Resource Table, https://rosap.ntl.bts.gov/view/dot/16503, and although the Expert Panel recommendations are not, they should be included as a possible resource as they had been open for public comment and were reviewed and accepted by the MRB. https://www.fmcsa.dot.gov/sites/fmcsa.dot.gov/files/docs/MEP-Recommendations- Renal-v2-prot.pdf.
- Significant changes in the MAC which are not consistent with MRB Task 16-02 report. Of significance is that they recommended that “Drivers requiring supplemental oxygen should be disqualified from operating a CMV in interstate commerce.”
- Shouldn’t the ME be concerned if the individual has already had more than one pneumothorax?
- The statement that “some CNS infections increase the likelihood of later seizures” – is very important but does not provide information on which infections increase risk nor the duration for which this risk is present.
- Information on Cerebrovascular Disease is in the Seizure section but is a cardiovascular condition. Seizure is only one of the risks with cerebrovascular disease. Key is risk is of recurrence of the cerebrovascular event as well as the risk of seizures. Why is the MEP https://www.fmcsa.dot.gov/regulations/medical/expert-panel-recommendations-stroke-and-commercial-motor-vehicle-driver-safety not included?
- Why is the report on Narcolepsy not included as resources https://rosap.ntl.bts.gov/view/dot/29009.
- Under syncope, the guidance from the Medical Advisory Criteria, 15 pages earlier should be included. The Medical Advisory criteria do recommend 6 months and while noted earlier, is relevant here as well “2 When a driver has had a single episode of loss of consciousness of unknown cause, the medical examiner may certify the driver if the medical examiner determines recurrence of loss of consciousness or loss of ability to control a motor vehicle is unlikely and the driver is not taking antiseizure medication. The determination should be made on an individual basis by the medical examiner in consultation with the treating provider. Before certification is considered, it is suggested that a 6-month waiting period elapse from the time of the episode.”
- The lack of information on non-insulin treated diabetes is inadequate as some commenters had already noted. The prior standard included the concept of whether the diabetes was “controlled.” There should be some guidance (even though no specific standard) on the complications and co-morbidities of non-insulin treated diabetes . Individuals have had uncontrolled DM as they try to avoid insulin due to the prior restrictions and now the additional requirements. There is even an open task for the MRB 21-1 to consider the non-Insulin treated diabetic. All the issues listed for Insulin-treated Diabetes are also relevant for the diabetic who is not treated with insulin. The MRB had proposed a form for that group, and it should be included as an optional as proposed https://www.fmcsa.dot.gov/advisory-committees/mrb/draft-non-insulin-treated- diabetes-mellitus-assessment-form.
- It is pointed out that the ME “may” certify a driver for two years but should not any condition which requires regular follow up such as diabetes unless stable for a prolonged period be followed more frequently. MEs will interpret this as 2 years is the default and only if problematic would a shorter certification be applicable.
- Same comment as previously made – An ME should have the basic knowledge that is included in the Draft Handbook, the challenge is understanding how to assess the risk of a psychological condition. Many MEs are not familiar with assessing the risk of sudden or gradual impairment or incapacitation. as they do not understand diagnosis, treatment, prognosis, clinical course, etc. of many of these conditions.
- Under CLP/CDL Information - please note that this does not need to be updated if the CLP holder obtain a CDL
- Should note that if the individual required corrective lenses, then not necessary to document vision without (should not require someone to remove CL to fill in boxes.
- Please note that all sections must be completed including hernia examination.
In conclusion, ACOEM stands ready and willing to assist FMCSA in the revision, update, and authorship of this MEH going forward as you see fit. We would also point out that it is best practice to establish a cadence for updates to handbooks such as these, and as medicine is always changing and new treatments and new information is garnered, there will need to be periodic reviews. Our suggestion is to establish that cadence now instead of waiting for the future.
Our organization has a number of subject matter experts that would be more than willing to assist in the goals of improving evidence-based decision making, and both interrater and intrarater reliability for commercial driver medical examinations via involvement with this Handbook. The focus of creating best practices for these examinations is, in our view, paramount to ensuring public safety. Additionally, such best practice establishment will create an atmosphere where “doctor shopping” and unnecessary questions regarding differences in certification and certification intervals among different examiners given the same driver or set of driver circumstances can be eliminated.
If you have questions or comments, please do not hesitate to contact us.
Douglas W Martin MD, FAAFP, FIAIME, FACOEM