By David J. Fletcher, MD
In years past, the medical decision-making for DOT medical examiners for drivers who required insulin to control their diabetes was easy; it was one of four absolute disqualifications for drivers who wanted medical certification to drive a commercial motor vehicle. Like the loosening of requirements for drivers with vision, hearing, and seizure issues, the Federal Motor Carrier Safety Administration (FMCSA) has provided new options for drivers with properly controlled insulin-treated diabetes mellitus (ITDM) to be qualified to operate commercial motor vehicles (CMVs) in interstate commerce.
Effective November 19, 2018, FMCSA revised its regulations to permit individuals with a stable insulin regimen and properly controlled ITDM to be qualified to operate CMVs in interstate commerce. Previously, ITDM individuals were prohibited from driving CMVs in interstate commerce unless they obtained an exemption from FMCSA, which was expensive to comply with and took almost three months to qualify. This rule enables a certified medical examiner (ME) to grant an ITDM individual a Medical Examiner’s Certificate (MEC), MCSA-5876, for up to a maximum of 12 months. To do so, the treating clinician (TC) provides the Insulin-Treated Diabetes Mellitus Assessment Form (ITDM Assessment Form), MCSA-5870, to the certified ME indicating the individual maintains a stable insulin regimen and proper control of his or her diabetes.
According to the new rules, the TC is defined as the healthcare provider who manages and prescribes insulin for the individual. The TC is to review three months of glucose logs and attest the individual maintains a stable insulin regimen and proper control of his or her diabetes on the form which the examiner reviews and then performs an exam. The certified ME then determines if the individual meets FMCSA’s physical qualification standards and can operate CMVs in interstate commerce.
This new rule eliminates all prior diabetic waivers and exemptions that required approval by FMCSA for ITDM drivers to qualify to drive a CMV and shifts a lot of the liability back to the ME to make an appropriate certification decision when asked to determine fitness for driving.
Managing diabetes for a long-haul operator that requires insulin treatment on the road can be very challenging dealing with syringes, needles, and blood glucose monitoring in a less-than-ideal sterile environment. Factors such as fatigue, lack of sleep and exercise, disruptions in circadian rhythm, poor diet, limited access to consistent medical treatment, stress, smoking, and other chronic illnesses compound the dangers for the ITDM driver.
Occupational health programs performing commercial driver medical exams (CDME) must stay current on these ever-changing regulations regarding drivers who take insulin and also budget extra time and charge more for these complicated exams.
The first special diabetes waiver study program was established in 1993 as part of a research study to investigate whether drivers with insulin-treated diabetes admitted to the program could safely operate CMVs. Participating drivers were required to have a minimum of three years of recent CMV driving experience while using insulin, a safe driving record, and certification by an endocrinologist and an ophthalmologist. As a result of litigation, that waiver program was terminated in 1996. The diabetic waiver drivers who qualified in this study program received an FMCSA-issued letter stating the driver may be qualified by operation of 49 CFR 391.64(a).
There are still roughly 100 drivers from the mid-’90s waiver program still driving with old diabetic waivers. They have been grandfathered for more than two decades with proof of the original FMCSA letter from 1996 granting them the right to continue to drive under §391.64. However, their grandfathered status will end with the new rule that went into effect on November 11, 2018. These drivers will have until November 19, 2019, to comply with new diabetes certification regulations. That waiver program was replaced by the first ITDM exemption program that agency started accepting applications for the revised diabetic exemption program on September 22, 2005. This exemption program still was not that easy to obtain and required their application to be published in the Federal Register.
THE EXEMPTION PROGRAM VS. THE NEW RULE
To apply for a diabetes exemption under the old program administered by FMCSA, the individual had to submit a letter of application with medical documentation showing:
- The ITDM individual has been examined by a board-certified or board-eligible endocrinologist who has (i) conducted a comprehensive evaluation, including one glycosylated hemoglobin test (HbA1C) with a result within a range of 7-10%, inclusive, and (ii) signed a statement regarding his or her determinations.
- The ITDM individual has obtained a signed statement from an ophthalmologist or optometrist indicating the individual has been examined, has no unstable proliferative diabetic retinopathy, and meets the vision standard in §391.41(b)(10).
- The ITDM individual has obtained a signed copy of both a certified ME’s Medical Examination Report Form, MCSA-5875, and an MEC, MCSA-5876, showing the individual meets all physical standards in §391.41(b) other than the diabetes standard.
FMCSA made its decision whether to grant the exemption based on individual applications and supporting documentation from healthcare professionals and issued a diabetic exemption certificate number the ME puts in the medical certificate.
This diabetes exemption application review by FMCSA took a long time. Processing time for 3,674 exemption applications accepted between 2012 and 2016 through the centralized FMCSA diabetes exemption program took an average of 77 days to make a decision. This lengthy review process has now been completely eliminated. Certification is now up to the ME as long as the driver can meet all the other physical qualification requirements of 391.41(b), and they have their TC complete the new MCSA-5870 form and submit it to the ME within 45 days.
According to FMCSA analysis, revising these regulations will reduce the regulatory burden and result in a $6.21 million cost savings per year – the aggregate of cost savings to ITDM drivers, motor carriers hiring ITDM individuals, and FMCSA.
The new four-page Insulin-Treated Diabetes Mellitus Assessment Form (ITDM Assessment Form), MCSA-5870 is now available online at the FMCSA website and must be submitted to the ME within 45 days of completion.
The management of severe hypoglycemic episodes requires the TC to determine the cause has been addressed and that the individual is maintaining a stable insulin regimen and proper control of his diabetes mellitus. The TC completes a new form, MCSA-5870, which the driver retains the new form and provides to ME at the next medical examination.
While there is no requirement under 391.46(e) for ME to see a driver following a hypoglycemic episode under CFR 391.45c, the motor carrier still has the obligation to determine if this illness renders the driver medically unqualified. Hence, this ITDM driver would need to undergo a medical examination, even if his current medical certificate has not expired.
The burden and negligent issuance malpractice exposure are now on the DOT medical examiners, and it is important for MEs to rely on more information than just provided by the treating clinician on the Insulin-Treated Diabetes Mellitus Assessment Form (ITDM Assessment Form), MCSA-5870.
Since the change in November 2018, I have had several drivers apply for CDME exams who previously were unable to drive due to insulin and had not yet applied for the cumbersome diabetes exemption. Several said they could not find an endocrinologist to treat them and complete the old diabetes examination forms four times a year. Also, many health insurance plans would not pay for the extra services required to comply with the old DOT exemption program.
Now the new rule is a lower-cost option and is a much quicker process. With the advent of ME-certification of ITDM drivers, negligent issuance risk expands, and it is imperative medical examiners
stay current with “established best medical practices” and appropriately charge for their time.
BEST PRACTICES
- Charge Appropriately: Charge more for the exam that requires you to review the MCSA 5870 form. Inform drivers and employers upfront about the additional cost—suggest a $150 extra charge on top of the regular DOT medical exam fee for this expanded service.
- Thorough Verification: The standard of care demands that MEs not solely rely on the MCSA 5870 form completed by the TC (Treating Clinician). Verify the TC’s decision to sign off on the control of a driver’s diabetes with insulin. Review the TC’s records to ensure the driver is on a stable dose of insulin. It’s essential for the ME to confirm that the driver does not have documented hypoglycemic episodes and is actively monitoring glucose electronically. Verify the existence of glucose logs.
- Annual Eye Exam: Even though it’s no longer required, emphasize the importance of an annual eye exam for drivers using insulin to control diabetes. Encourage proper eye care for ITDM drivers. Provide drivers with the two-page Vision Evaluation Checklist from the Federal Diabetes Exemption Program to be completed along with the MCSA 5870 before certifying an ITDM driver. Disqualify drivers with severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy.
- Monitor Glucosuria: If the urine dipstick shows glucosuria, express serious concern and conduct a glucose fingerstick. Consider sending the driver back to their TC for an updated evaluation before medically clearing them to drive.
