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FMCSA Seeks Comment on Medical Review Report for Proposed Diabetes Rule

Another step has been completed in a proposed rulemaking that would allow commercial vehicle drivers with controlled insulin-treated diabetes mellitus (ITDM) to operate commercial motor vehicles in interstate commerce without first obtaining an individual exemption for that medical condition from the Federal Motor Carrier Safety Administration, reports Heavy Duty Trucking.

Sixteen months ago, the agency proposed that the rules be changed to simplify the obtaining of exemptions by drivers who treat their diabetes with insulin.

As HDT reports:

The proposed rule would let drivers with ITDM obtain a Medical Examiner’s Certificate (MEC) at least annually to operate in interstate commerce if the treating clinician— the healthcare professional responsible for prescribing insulin for the driver’s diabetes— provides documentation to the Medical Examiner that the condition is “stable and well-controlled.”

FMCSA said in its notice of proposed rulemaking that it believes this new procedure would “adequately ensure that drivers with ITDM manage the condition so that it is stable and well-controlled, and that such a regulatory provision creates a clearer, equally effective and more consistent framework than a program based entirely on exemptions.”

The agency added that its own evidence reports as well as ADA studies and other data “indicate that drivers with ITDM are as safe as other drivers when their condition is well-controlled.”

The public comment period on the NPRM closed back on July 6, 2015. That same month, FMCSA requested that its Medical Review Board (MRB) review and analyzie the over 1,250 comments received and provide recommendations the agency “should consider when making a decision about the next steps in the diabetes rulemaking.”

Now, FMCSA has announced the MRB report is available and that it is seeking public comment on the board’s recommendations.

In its notice published in the Federal Register for Sept. 9, the agency said it “believes that public comment on the [MRB] recommendations will assist it in evaluating the advice it has received from the MRB.”

Comments— which are due by November 8, 2016– must be limited to addressing the recommendations in the MRB final report. The report is available in the docket (No. FMCSA-2005-23151) for this rulemaking as well as on the agency’s web site.  

FMCSA summarizes the major recommendations of the MRB report thusly:

  • “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. 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 DiabeticMacular Edema).
  • “The MRB recommended that medical examiners be allowed to certify an ITDM driver as medically qualified for a time period of no longer than1 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. 2) Blood sugar less than 60 milligrams per deciliter (mg/dL) demonstrated in current glucose logs. 3) Hypoglycemia appearing in the absence of warning symptoms (i.e., hypoglycemic unawareness). 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. 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. 6) Stage 3 or 4 diabetic retinopathy; a driver should be permanently disqualified. 7) Signs of target organ damage; a driver should be disqualified until the matter is resolved by treatment, if possible. 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).
  • “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.”

Comments (which, again, are due by Nov. 8) must bear Docket No. FMCSA-2005-23151 and may be sent in by any of these methods:

  • Federal eRulemaking Portal: Go to www.regulations.gov and follow the on-line instructions for submitting comment
  • Mail: Docket Management Facility, U.S. Department of Transportation, Room W12-140, 1200 New Jersey Avenue SE., Washington,DC 20590-0001
  • Hand Delivery or Courier: West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., ET, Monday through Friday, except Federal holidays
  • Fax: 1-202-493-2251

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