Rules Change Again Regarding Certification of Commercial Motor Vehicle Drivers with Insulin-Treated Diabetes Presenting New Challenges for Medical Examiners

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 driver 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 insulin-treated diabetes mellitus (ITDM) to be qualified to operate commercial motor vehicles (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 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), the healthcare professional who manages, and prescribes insulin for, the treatment of the individual’s diabetes, provides the Insulin-Treated Diabetes Mellitus Assessment Form (ITDM Assessment Form), MCSA-5870, to the certified ME indicating that the individual maintains a stable insulin regimen and proper control of his or her diabetes.

The certified ME then determines that the individual meets FMCSA’s physical qualification standards and can operate CMVs in interstate commerce.[1]

This new rule eliminates all prior diabetic waivers and exemptions that required approval by FMCSA for ITDM-drivers to qualify to drive a Commercial Motor Vehicle (CMV) and shifts a lot of the liability back to the medical examiner 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 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 that perform 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 a FMCSA-issued letter that states the driver may be qualified by operation of 49 CFR 391.64(a).

There are still roughly a 100 drivers from the mid ‘90s waiver program still driving with old diabetic waivers. They have been who grandfathered for more than two decades with proof of original FMCSA letter from 1996 granting them the right to continue to drive under §391.64. However, their grandfather 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 was put in place in 2003. The initial rule contained very stringent stipulations that made it very hard for IDDM truck drivers to qualify. In fact, between 2003 and 2005, only four exemptions were granted to diabetic truck drivers.

On November 8, 2005, the FMCSA overturned some of the harsh rules in the 2003 diabetic exemption program. The 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.

To apply for a diabetes exemption under the old program administered by FMCSA, the individual had to submit a letter application with medical documentation showing the following:

  1. 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 to 10 percent, inclusive, and (ii) signed a statement regarding his or her determinations;
  2. The ITDM individual has obtained a signed statement from an ophthalmologist or optometrist indicating that the individual has been examined, has no unstable proliferative diabetic retinopathy, and meets the vision standard in § 391.41(b)(10); and
  3. 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 that the individual meets all physical qualification 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 professional and issued a diabetic exemption certificate number that the ME put 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 medical examiner (ME) as long as the driver can meet all the other physical qualification requirements of 391.41(b) and they have their treating clinician (TC) complete the new MCSA-5870 form and submit it to the ME with-in 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 that hire ITDM individuals, and FMCSA.

[1] Federal Motor Carrier Safety Administration

49 CFR Part 391

[Docket No. FMCSA–2005–23151]

RIN 2126–AA95

Qualifications of Drivers; Diabetes Standard

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Final rule.

https://federalregister.gov/d/2018-20161

 

Table 1. Requirements of the Diabetes Exemption Program vs. the New Rule

The new 4-page Insulin-Treated Diabetes Mellitus Assessment Form (ITDM Assessment Form), MCSA-5870 is now available on-line at the FMCSA website,[1]and must be submitted to the ME with 45 days of completion.

According to the new rules, the Treating Clinician (TC) is defined as the  health care provider who manages and prescribes insulin for the individual. The TC is to review 3 months of glucose logs and attests that 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.

It is then up to the certified ME then determines that the individual meets the FMCSA’s physical qualification standards and can operate CMVs in interstate commerce.

Revised Diabetes Standard

September 19, 2018

  • Sec. 391.41 Physical qualifications for driver (b) (3) Has no established medical history or clinical diagnosis of diabetes mellitus currently treated with insulin for control, unless the person meets the requirements in Sec. 391.46;

Sec. 391.46 Physical qualification standards for an individual with diabetes mellitus treated with insulin for control.

(a) Diabetes mellitus treated with insulin. An individual with diabetes mellitus treated with insulin for control is physically qualified to operate a commercial motor vehicle provided:

(1) The individual otherwise meets the physical qualification standards in

Sec. 391.41 or has an exemption or skill performance evaluation certificate, if required; and

(2) The individual has the evaluation required by paragraph (b) and the medical examination required by paragraph (c) of this section.

(b) Evaluation by the treating clinician. Prior to the examination required by § 391.45 or the expiration of a medical examiner’s certificate, the individual must be evaluated by his or her “treating clinician.” For purposes of this section, “treating clinician” means a healthcare professional who manages, and prescribes insulin for, the treatment of the individual’s diabetes mellitus as authorized by the healthcare professional’s State licensing authority.

(1) During the evaluation of the individual, the treating clinician must complete the Insulin-Treated Diabetes Mellitus Assessment Form, MCSA-5870.

(2) Upon completion of the Insulin-Treated Diabetes Mellitus Assessment Form, MCSA-5870, the treating clinician must sign and date the Form and provide his or her full name, office address, and telephone number on the Form.

Sec. 391.46 Physical qualification standards for an individual with diabetes mellitus treated with insulin for control

(c) Medical examiner’s examination.

  • At least annually
  • Within 45 days of completion of Form MCSA-5870 by TC
  • Determine if medically qualified and free of complications from DM that might impair ability to operate a commercial motor vehicle safely.
  • ME must receive properly completed Form, MCSA-5870, from TC
  • Form maintained as part of Medical Examination Report Form, MCSA-5875.

Sec. 391.46 Physical qualification standards for an individual with diabetes mellitus treated with insulin for control

(d) Blood glucose self-monitoring records.

  • Individuals with ITDM must self-monitor blood glucose in accordance with treatment plan of TC.
  • Must maintain blood glucose records measured with an electronic glucometer that stores all readings
  • Records date and time of readings
  • Data must be able to be electronically downloaded.
  • Printout of electronic blood glucose records or the glucometer must be provided to TC at time of evaluations required by this section

Sec. 391.46 Physical qualification standards for an individual with diabetes mellitus treated with insulin for control

(e) Severe hypoglycemic episodes.

(1) Individual with ITDM who experiences a severe hypoglycemic episode is prohibited from operating a CMV and must report to and be evaluated by TC as soon as “reasonably practicable”

The management of severe hypoglycemic episode requires the TC to determine that the cause has been addressed and that the individual is maintaining a stable insulin regimen and proper control of his or her diabetes mellitus. The TC completes a new Form, MCSA-5870 which the driver retains the new form and provides to ME at 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 drive would need to undergo a medical examination, even if his current medical certificate has not expired.

The burden and negligent issuance malpractice exposure is now on the DOT medical examiners, and it is important for MEs to rely on more information that 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 exam that 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 completed the old diabetes examination forms four times a year. Also, many health insurance plans would not pay for the extra services required to comply the old DOT exemption program.

Now the new rule is a lower cost option and is much quicker process.

BEST PRACTICES

  1. Charge more for the exam that requires you to review MCSA 5870 Form. We tell drivers and employers up front that there will be a $150 extra charge on top of our regular DOT medical exam charge for this expanded service.

 

  1. The standard of care demands that MEs not just rely on the MCSA 5870 form completed by the TC. Verify the decision by the TC to sign off on the control of a driver’s diabetes with insulin. Review the TC’s records and ensure that the driver is on a stable dose of insulin. It is essential that the ME confirm that the driver does NOT have hypoglycemic episodes documented and he is monitoring his glucose electronically. It is best practice to confirm the logs actually exist.

 

  1. While no longer required any driver that uses insulin to control his diabetes will have still be required to have an annual eye exam at my office. I have found proper eye care for ITDM drivers is really lacking. I give drivers the two-page Vision Evaluation Checklist from the Federal Diabetes Exemption Program to get completed along with the MCSA 5870 before I certify an IDDM driver (page 13/14 of expired Exemption Program application form[2]). Drivers with severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy should be disqualified.

 

  1. If the urine dipstick shows glucosuria, I get very concerned and do a glucose fingerstick. I send them back to their TC for an updated evaluation before I medically clear them to drive.

 

 

Bottom-line with the advent of ME-certification of ITDM drivers negligent issuance risk expands and it imperative medical examiners MUST stay current with “established

best medical practices” and appropriately charge for their time.

 

[1] https://www.fmcsa.dot.gov/sites/fmcsa.dot.gov/files/docs/regulations/medical/422521/itdm-assessment-form-final.pdf

 

[2] https://www.fmcsa.dot.gov/sites/fmcsa.dot.gov/files/docs/regulations/medical/driver-medical-requirements/10436/diabetesexemptionpackage0706508cln_0.pdf

 

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