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  • ACOEM Comments on Task Report on Insulin Treated Diabetes Mellitus and CMV Drivers

    November 8, 2016

    Docket Management Facility
    U.S. Department of Transportation
    Room W12–140
    1200 New Jersey Avenue, SE
    Washington, DC 20590–0001

    Docket No. FMCSA–2005–23151

    To Whom It May Concern:

    On behalf of the American College of Occupational and Environmental Medicine (ACOEM), we welcome the opportunity to comment on the Medical Review Board Task Report on Insulin Treated Diabetes Mellitus and Commercial Motor Vehicle Drivers. ACOEM previously submitted comments on the notice of proposed rulemaking (Docket No. FMCSA –2005-23151) which would allow drivers with stable, well-controlled insulin-treated diabetes mellitus (ITDM) to be qualified to operate commercial motor vehicles. Those comments are attached for reference.

    ACOEM is an international society of approximately 4,000 occupational and environmental physicians and other health care professionals. The College provides leadership to promote the health and safety of workers, stimulate research, enhancing education, and advance the specialty of OEM, the medical specialty devoted to the prevention and management of occupational and environmental injuries and illnesses. As such, ACOEM is the only medical specialty society uniquely involved in the matching of the worker’s capabilities to the job requirements.

    Following are ACOEM’S comments on the MRB’S recommendations.

    “The MRB recommended that ITDM drivers be medically disqualified unless they meet the following requirements demonstrating their stable, well-controlled ITDM:

    1. The driver must provide an FMCSA Drivers With Insulin Treated Diabetes Mellitus Assessment Form (set out in the recommendations) to a medical examiner that has been completed and signed by the treating clinician. The treating clinician must be a Doctor of Medicine, a Doctor of Osteopathy, a Nurse Practitioner or a Physician's Assistant who prescribed insulin to the driver and is knowledgeable regarding the treatment of diabetes.

    ACOEM COMMENT: The examiner reviewing the documentation and making the final determination must have the training and knowledge to evaluate whether the documentation provided is sufficient and consistent with safe operation of a commercial motor vehicle. They must review at least 3-5 years of medical records so they can independently evaluate the absence of complication, end organ damage and actual compliance and control of the condition.

    2. The driver must receive a complete ophthalmology or optometry exam, including dilated retinal exam, at least every 2 years documenting the presence or absence of retinopathy/macular edema and the degree of retinopathy and/or macular edema if present (using the International Classification of Diabetic Retinopathy and Diabetic Macular Edema).

    ACOEM COMMENT: Recommend that this be at least annually as would be consistent with standard of care for diabetics. Drivers who do not meet the medical standard for vision, vision of at least 20/40 in each eye separately and both together and have any diabetic retinopathy, should be precluded from driving.


    “The MRB recommended that medical examiners be allowed to certify an ITDM driver as medically qualified for a time period of no longer than 1 year only if the driver has not experienced any of the 8 disqualifying factors below (which the MRB believes should be listed in 49 CFR 391.46):”

    1. Any episode of severe hypoglycemia within the previous 6 months.

    ACOEM COMMENT: If the driver has had more than one episode of severe (must be defined – perhaps requiring assistance from another person or a blood sugar less than 60 milligrams per deciliter (mg/dL) hypoglycemia, then the duration prior to reconsideration for certification should be progressively lengthened to decrease the risk that the recurrent episodes will occur while driving.

    2. Blood sugar less than 60 milligrams per deciliter (mg/dL) demonstrated in current glucose logs.

    ACOEM COMMENT: This is probably too low as once the sugar is at 60 mg/dL the driver is likely to already be having symptoms and if not, the concern would be of hypoglycemic unawareness. If the sugar is below 70 mg/dL, they should not be permitted to drive until all glucose logs show levels above 70 mg/dL for at least 6 months with progressive duration of out of service with recurrent episodes.

    3. Hypoglycemia appearing in the absence of warning symptoms (i.e., hypoglycemic unawareness).

    ACOEM COMMENT: See above – should have adequate logs to demonstrate glucose control. If the blood sugar drops below 60 mg/dL and the driver is not experiencing symptoms, they should be permanently barred from CMV operation.

    4. An episode of severe hypoglycemia, blood sugar less than 60 mg/dl, or hypoglycemic unawareness within the previous 6 months; the driver should be medically disqualified and must remain disqualified for at least 6 months.

    ACOEM COMMENT: As above. If at some point the driver is able to demonstrate they are now aware of hypoglycemia and are certified, if the hypoglycemic unawareness recurs, they should be permanently barred from commercial operations.

    5. Uncontrolled diabetes, as evidenced by Hemoglobin A1c (HbA1c) level greater than 10 percent. A driver could be reinstated when HbA1c level is less than or equal to 10 percent.

    ACOEM COMMENT: And remains so for at least 3 months.

    6. Stage 3 or 4 diabetic retinopathy; a driver should be permanently disqualified.

    ACOEM COMMENT: Agree

    7. Signs of target organ damage; a driver should be disqualified until the matter is resolved by treatment, if possible.

    ACOEM COMMENT: Agree but should not be at risk of that target organ damage recurring.

    8. Inadequate record of self-monitoring of blood glucose; a driver should be disqualified for inadequate records until the driver can demonstrate adequate evidence of glucose records (minimum 1 month).

    ACOEM COMMENT: What would be defined as adequate self monitoring? This may differ based on the treatment but if left to the examiner to determine if adequate, then must be an examiner who can evaluate and treat drivers who use insulin. Or would the criteria mirror the monitoring criteria of the exemption program – prior to driving and every 4 hours while driving.

    ***

    In addition, the MRB stated that, if a driver is medically disqualified due to not meeting the ITDM criteria listed above, the driver should remain disqualified for at least 6 months. ACOEM believes this should only be if the disqualifying condition has completely resolved with no risk of recurrence. With each successive disqualifying situation, there should be a progressively longer duration of out of service.

    Thank you for your consideration of our comments. Please do not hesitate to contact me or Patrick O’Connor, ACOEM’s Director of Government Affairs at 703/351-6222, should you have any questions.

    Sincerely,

    James A. Tacci, MD, JD, MPH, FACOEM, FACPM
    President

    Natalie P. Hartenbaum, MD, MPH, FACOEM
    Chair, Transportation Section

    Enclosure: ACOEM Comments to Docket No. FMCSA –2005-23151, July 6, 2015