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Insulin???

Posted: Thu Sep 20, 2018 8:34 am
by Dr Jeff
I received and email, albeit from a chiropractor, that the insulin waiver will no longer required as of mid November? There will be the req that the driver is on a stable insulin regimen. I find it astonishing that I haven't received any info on this from the NRCME....assuming the email was accurate.

Re: Insulin???

Posted: Thu Sep 20, 2018 8:38 am
by DSCockrum
You are correct. I received an email from the ACOEM Transportation section list-serve, signed by Dr. Natalie Hartenbaum. I've pasted the contents of that email here:

************************************************
"Posted on behalf of Dr. Hartenbaum -
Scheduled to be published in Federal Register 9/19 - Elimination of Insulin Exemption
FMCSA plans to publish in tomorrow’s Federal Register the announcement that “ 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” This will put the responsibility on the examiners, essentially relying on the information provided by the treating clinician on the Insulin-Treated Diabetes Mellitus Assessment Form (ITDM Assessment Form), MCSA-5870.

The Treating Clinician 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.

The driver would be disqualified if they experience a severe hypoglycemic episode - defined as severe hypoglycemic episode as one requiring the assistance of others, or resulting in loss of consciousness, seizure, or coma. Drivers with severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy should also be disqualified.

Significant differences with current process - no exemption, no annual eye exam, no annual visit and quarterly evaluation by endocrinologist"
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I had heard a few months ago that this was in the works. Still debating how best to handle it, though I have had very few insulin-using drivers in my practice (small, rural area).

David

Re: Insulin???

Posted: Fri Sep 28, 2018 9:08 am
by drjchill
This is "a long summary" of the 145 page document from the FMCSA.

The final rule does not limit the TC to a specific discipline or require the TC to be an endocrinologist.

FMCSA defines the TC in the final rule as 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.

The requirement that the TC must be the healthcare professional who manages, and prescribes insulin for, the treatment of the individual who is being evaluated makes it likely that the TC will be the individual’s primary care provider.

The TC would determine that within the previous 12 months the individual had no severe hypoglycemic reaction and had properly managed his or her diabetes.

This final rule continues the two-step process for medical certification in which the TC evaluates the individual’s insulin regimen and control of his or her ITDM, then a certified ME performs an examination and determines whether the individual is physically qualified under all medical standards to operate a CMV.

TC complete an ITDM Assessment Form, MCSA- 5870, rather than simply provide written notification that the individual’s diabetes was being properly managed.

The final rule requires that the TC complete the ITDM Assessment Form, MCSA-5870, to provide additional information for the certified ME about the ITDM individual’s medical history. The Agency has considered the forms and checklists provided by commenters, and has determined that the ITDM Assessment Form, MCSA-5870, collects the appropriate information to enable the certified ME to make his or her certification determination.

A certified ME determines whether an individual meets FMCSA’s physical qualification standards as of the time of the medical certification examination. Therefore, FMCSA has determined that providing information to the certified ME regarding whether an ITDM individual has had a severe hypoglycemic episode in the prior 3 months is generally sufficient.

The final rule requires that, to be eligible for up to the maximum 12-month MEC, MCSA-5876, all ITDM individuals must provide to the TC at least the preceding 3 months of blood glucose self-monitoring records while being treated with insulin. If an individual does not provide the 3 months of records, the certified ME has discretion to grant the individual up to but not more than a 3-month MEC, to allow time for the individual to collect the necessary records. Once the individual has 3 months of blood glucose self-monitoring records, the individual is treated the same as an ITDM individual with 3 months of records.

The form asks has the individual had HbA1C measured intermittently over the last 12 months, with the most recent measure within the preceding 3 months, and, if so, to attach the most recent result. The Agency notes that the lack of HbA1C data does not automatically disqualify an individual from being medically certified.

More specifically, a sentence was added to specify that the certified ME must receive the form and begin the medical examination no later than 45 days after the date on the signed form; however, FMCSA notes that the medical certification determination does not need to be completed within 45 days. The Agency also added a provision that an ITDM individual who is being evaluated after a severe hypoglycemic episode must retain the form and give it to the certified ME at the next medical certification examination.

Additionally, once the TC has signed and dated the form as required, the form is provided to the certified ME by either the ITDM individual or the TC.

FMCSA agrees with commenters who stated that ITDM individuals should not be granted medical certification for a period longer than 12 months. Annual or more frequent recertification by the certified ME allows for earlier detection and consideration of any changes or complications that may impact an ITDM individual’s ability to safely operate a CMV. If a certified ME determines an individual should not be qualified for the maximum 12 months, the certified ME may certify that individual for a shorter period.

FMCSA agrees with commenters that a 2-year recertification period for nonITDM individuals is appropriate and will not adopt the MRB’s 2007 recommendation. FMCSA finds that is not necessary to impose a requirement for annual certification of these individuals because certified MEs have a long history with certification of nonITDM individuals.

This rule does not include a mandatory requirement or specify the frequency for comprehensive eye examinations for ITDM individuals.

The Agency finds that the TC is in the best position to determine for each ITDM individual when a comprehensive eye examination is necessary and, when warranted, to make a referral to an ophthalmologist or optometrist.

The final rule does not change the existing requirement that all individuals must meet the vision standard in § 391.41(b)(10) to operate a CMV.

This final rule requires that the certified ME disqualify permanently from medical certification any ITDM individual who is diagnosed with severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy.

ITDM individuals whose diabetic retinopathy has reached the advanced stages of severe non-proliferative or proliferative diabetic retinopathy are at risk of sudden incapacitation from a detached retina or bleeding. FMCSA agrees, therefore, that ITDM individuals with severe non-proliferative or proliferative diabetic retinopathy should be disqualified permanently from operating a CMV.

The Agency declines to incorporate any specific definition of severe nonproliferative or proliferative diabetic retinopathy in either the ITDM Assessment Form, MCSA-5870, or the regulation.

FMCSA agrees with comments that HbA1C values should not be relied upon as a sole measure of an ITDM individual’s ability to safely operate a CMV. The final rule allows the TC to evaluate all relevant clinical factors to determine whether an individual maintains proper control of his or her ITDM. HbA1C levels are one factor the TC may consider in making that determination.

FMCSA agrees further that making a medical qualification determination based solely on a specific HbA1C level is inconsistent with the rule’s emphasis on individualized assessment. In addition, the National Institute of Diabetes and Digestive and Kidney Disease states that HbA1C test results can be up to 0.5 percent higher or lower than the reported actual percentage; can be unreliable for people of African, Mediterranean, or Southeast Asian heritage; and can be altered by diseases that affect blood or hemoglobin.16 While a high HbA1C level may suggest that complications from diabetes might develop in the future, it does not mean that an individual presently has complications or is unsafe to drive a CMV.

The ITDM Assessment Form, MCSA-5870, asks the TC to report whether the individual has had HbA1C measured intermittently over the past 12 months, with the most recent measure within the preceding 3 months. If so, a copy of the most recent laboratory result is to be attached to the form so that it is available to the certified ME.

The Agency agrees with commenters that an ITDM individual should not be disqualified for a single blood glucose reading that falls below or above a specific limit. The intent of the final rule is for an individualized assessment of the stability of the individual’s insulin regimen and control of his or her ITDM, as determined by the TC, and of whether the individual satisfies the physical qualification standards, as determined by the certified ME. Therefore, FMCSA finds it is appropriate for TCs to set individualized, clinically-based parameters for blood glucose limits for ITDM individuals rather than establishing a regulatory requirement. TCs should look for frequent occurrences of low blood glucose levels and determine the cause. For example, frequent low blood glucose levels may indicate potential improper diabetes management or other underlying medical issues. While the certified ME considers the TC’s input on whether the ITDM individual maintains a stable insulin regimen and proper control of his or her ITDM, it is the certified ME’s responsibility to consider safety and make a physical qualification determination.

A severe hypoglycemic episode is defined as an episode requiring the assistance of others, or resulting in a seizure, coma, or the loss of consciousness.

In view of the potential impact on safety, FMCSA is clarifying in the final rule that an ITDM individual certified as physically qualified to operate a CMV who experiences a severe hypoglycemic episode is prohibited from operating a CMV. The Agency is adding a requirement in the rule that such an individual must report the episode to and be evaluated by a treating clinician as soon as is reasonably practicable.

The driving prohibition continues until the ITDM individual has been evaluated by a TC (who meets the specifications in the rule), and a TC determines that the cause of the severe hypoglycemic episode has been addressed and that the individual again has a stable insulin regimen and properly controlled ITDM. Once a TC completes a new ITDM Assessment Form, MCSA-5870, following the episode, the individual may resume operating a CMV. The rule requires the ITDM individual to retain the form and to provide it to the certified ME at the individual’s next medical certification examination so the certified ME will be aware of the prior episode.

Accordingly, the final rule does not establish a specific timeframe that an ITDM individual is prohibited from operating a CMV following a severe hypoglycemic episode. Rather, the rule defers to a TC to make an individualized assessment as to when the cause of the episode has been addressed and the individual again has a stable insulin regimen and properly controlled ITDM.

FMCSA notes that the existing requirement that a new medical examination and certification must be obtained when an individual has a physical or mental injury or disease that impairs the individual’s ability to perform his or her normal duties17 could, depending on the circumstances, be applicable to the ITDM individual who experiences a severe hypoglycemic episode. Such ITDM individuals would be subject to a new evaluation by the TC, including completion of a new ITDM Assessment Form, MCSA5870, and subsequent medical examination by the certified ME.

FMCSA has determined that hypoglycemia unawareness on its own should not be considered for medical qualification. Hypoglycemia unawareness would be considered by the TC in determining whether the individual has a stable insulin regimen and proper control of his or her ITDM. Due to the individualized effect of occurrences of hypoglycemia unawareness, the assessment, evaluation, and treatment for this condition should be a component of the TC’s individualized management for a stable insulin regimen and proper control of the ITDM individual’s diabetes.

The final rule requires that all ITDM individuals must provide at least the preceding 3 months of blood glucose self-monitoring records while being treated with insulin to the TC to be eligible for up to the maximum 12-month MEC, MCSA-5876. If an individual does not provide the 3 months of records, the certified ME has discretion to grant the individual up to but not more than a 3-month MEC, MCSA-5876, to allow time for the individual to collect the necessary records. Once the individual has 3 months of blood glucose self-monitoring records, the individual is treated the same as an ITDM individual with 3 months of records. The individual must first go to the TC for evaluation and then to the certified ME, who must exercise independent medical judgment, to determine if the individual is eligible for up to the maximum 12-month MEC, MCSA5876.

The final rule does not establish the specific frequency of blood glucose monitoring. FMCSA finds that any regulatory requirement that specifies monitoring frequency does not support the intent of the rule for individualized assessment. Rather, the rule provides that ITDM individuals must self-monitor blood glucose in accordance with the specific treatment plan prescribed by the TC.

ITDM individuals must self-monitor blood glucose in accordance with the specific treatment plan prescribed by the TC. They must maintain blood glucose records measured with an electronic glucometer that stores all readings, that records the date and time of readings, and from which data can be electronically downloaded. A printout of the electronic blood glucose records or the glucometer must be provided to the TC at the time of any evaluation. Handwritten blood glucose records are not acceptable.

The final rule does not require that ITDM individuals carry a readily-absorbable form of glucose.

In the final rule, the Agency continues to require that an ITDM individual must meet the physical qualification standards in § 391.41, have an exemption unrelated to diabetes, or have a Skill Performance Evaluation Certificate, if required. With the exception of diabetic retinopathy, the Agency declines to establish specific regulatory requirements pertaining to complications that may arise from diabetes.

FMCSA agrees with the MRB that an individual who has a complication from diabetes that interferes with safely operating a CMV should not be medically qualified to operate a CMV. The Agency finds, however, that diabetes complications should not automatically preclude medical certification. Such determinations should be based on an individualized assessment and the severity of symptoms. A complication becomes a disqualifying factor only if it impairs the ability to operate a CMV safely. As an alternative to disqualification, a certified ME may determine that an ITDM individual is unqualified until treatment is received and appropriate intervention mitigates or addresses the problem.

The final rule revises the physical qualification standard for ITDM individuals, but does not create any new or additional monitoring or compliance requirements for motor carriers beyond those already set out in general terms in the FMCSRs. See 49 CFR 390.11, 391.11(a), and 391.41(a). The provisions of § 392.3 relate only to determining whether to allow an ill or fatigued individual to operate a CMV. The rule does not require access to any medical records, such as an individual’s Medical Examination Report Form, MCSA-5875, to make that determination.

The Agency finds that there is no available evidence to support holding ITDM individuals to a higher standard in connection with transporting passengers or hazardous materials.

FMCSA retains its position that ITDM individuals with licenses issued in Canada or Mexico are prohibited from operating CMVs in the United States.

In the final rule, FMCSA eliminates the diabetes grandfather provision in § 391.64(a). FMCSA agrees with the commenter that the grandfather provision is redundant of several requirements in new § 391.46. Individuals currently certified under § 391.64 are either already able to meet the requirements of this rule or could meet a less restrictive requirement. FMCSA finds that discontinuing the grandfather provision has no adverse impact on the less than 100 currently grandfathered individuals or on motor carriers. FMCSA provided a year to transition to the new process to avoid any possible hardships for individuals who would need to be certified just after the rule becomes effective. FMCSA is directly contacting the currently grandfathered individuals to further explain the transition process.

The Agency continues to conclude that the crash risk posed by ITDM individuals who maintain a stable insulin regimen and proper control of their diabetes is very low in general and that such ITDM individuals do not create any meaningful risk of injury to themselves or others due to their insulin treatment.

Therefore, an individual would have to provide his or her consent for a TC or certified ME to share medical information with other entities, including the motor carrier.

Paragraph (c), Medical examiner’s examination, sets forth the requirements for the certified ME’s examination, including that the examination must begin no later than 45 days after the individual’s TC evaluation. Paragraph (c)(1) states that the certified ME must have an ITDM Assessment Form, MCSA-5870, for each examination. Paragraph (c)(2) provides that the certified ME is to make a medical qualification determination by considering the information in the ITDM Assessment Form, MCSA-5870, and, using independent medical judgement, by applying the medical qualification standards in the paragraph. The standards provide that an individual must maintain a stable insulin regimen and proper control of his or her diabetes, and cannot have severe nonproliferative diabetic retinopathy or proliferative diabetic retinopathy.


§ 391.45 Persons who must be medically examined and certified.
The following persons must be medically examined and certified in accordance with § 391.43 as physically qualified to operate a commercial motor vehicle:
(a) Any person who has not been medically examined and certified as physically
qualified to operate a commercial motor vehicle;
(b) Any driver who has not been medically examined and certified as qualified to
operate a commercial motor vehicle during the preceding 24 months, unless the driver is
required to be examined and certified in accordance with paragraph (c), (d), (e), (f), or (g)
of this section;
(c) Any driver authorized to operate a commercial motor vehicle only within an
exempt intra-city zone pursuant to § 391.62, if such driver has not been medically
examined and certified as qualified to drive in such zone during the preceding 12 months;
(d) Any driver authorized to operate a commercial motor vehicle only by
operation of the exemption in § 391.64, if such driver has not been medically examined
and certified as qualified to drive during the preceding 12 months;
(e) Any driver who has diabetes mellitus treated with insulin for control and who
has obtained a medical examiner’s certificate under the standards in § 391.46, if such
driver’s most recent medical examination and certification as qualified to drive did not
occur during the preceding 12 months;
(f) Any driver whose ability to perform his or her normal duties has been impaired
by a physical or mental injury or disease; and
(g) Beginning June 22, 2021, any person found by a medical examiner not to be
physically qualified to operate a commercial motor vehicle under the provisions of
paragraph (g)(3) of § 391.43.
4. Add § 391.46 to read as follows:
§ 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
§ 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.
(c) Medical examiner’s examination. At least annually, but no later than 45 days
after the treating clinician signs and dates the Insulin-Treated Diabetes Mellitus
Assessment Form, MCSA-5870, an individual with diabetes mellitus treated with insulin
for control must be medically examined and certified by a medical examiner as
physically qualified in accordance with § 391.43 and as free of complications from
diabetes mellitus that might impair his or her ability to operate a commercial motor
vehicle safely.
(1) The medical examiner must receive a completed Insulin-Treated Diabetes
Mellitus Assessment Form, MCSA-5870, signed and dated by the individual’s treating
clinician for each required examination. This Form shall be treated and retained as part of
the Medical Examination Report Form, MCSA-5875.
(2) The medical examiner must determine whether the individual meets the
physical qualification standards in § 391.41 to operate a commercial motor vehicle. In
making that determination, the medical examiner must consider the information in the
Insulin-Treated Diabetes Mellitus Assessment Form, MCSA-5870, signed by the treating
clinician and, utilizing independent medical judgment, apply the following qualification
standards in determining whether the individual with diabetes mellitus treated with
insulin for control may be certified as physically qualified to operate a commercial motor
vehicle.
(i) The individual is not physically qualified to operate a commercial motor
vehicle if he or she is not maintaining a stable insulin regimen and not properly
controlling his or her diabetes mellitus.
(ii) The individual is not physically qualified on a permanent basis to operate a
commercial motor vehicle if he or she has either severe non-proliferative diabetic
retinopathy or proliferative diabetic retinopathy.
(iii) The individual is not physically qualified to operate a commercial motor
vehicle up to the maximum 12-month period under § 391.45(e) until he or she provides
the treating clinician with at least the preceding 3 months of electronic blood glucose
self-monitoring records while being treated with insulin that are generated in accordance
with paragraph (d) of this section.
(iv) The individual who does not provide the treating clinician with at least the
preceding 3 months of electronic blood glucose self-monitoring records while being
treated with insulin that are generated in accordance with paragraph (d) of this section is
not physically qualified to operate a commercial motor vehicle for more than 3 months. If
3 months of compliant electronic blood glucose self-monitoring records are then provided
by the individual to the treating clinician and the treating clinician completes a new
Insulin-Treated Diabetes Mellitus Assessment Form, MCSA-5870, the medical examiner
may issue a medical examiner’s certificate that is valid for up to the maximum 12-month
period allowed by § 391.45(e) and paragraph (c)(iv) of this section.
(d) Blood glucose self-monitoring records. Individuals with diabetes mellitus
treated with insulin for control must self-monitor blood glucose in accordance with the
specific treatment plan prescribed by the treating clinician. Such individuals must
maintain blood glucose records measured with an electronic glucometer that stores all
readings, that records the date and time of readings, and from which data can be
electronically downloaded. A printout of the electronic blood glucose records or the
glucometer must be provided to the treating clinician at the time of any of the evaluations
required by this section.
(e) Severe hypoglycemic episodes. (1) An individual with diabetes mellitus treated
with insulin for control who experiences a severe hypoglycemic episode after being
certified as physically qualified to operate a commercial motor vehicle is prohibited from
operating a commercial motor vehicle, and must report such occurrence to and be
evaluated by a treating clinician as soon as is reasonably practicable. A severe
hypoglycemic episode is one that requires the assistance of others, or results in loss of
consciousness, seizure, or coma. The prohibition on operating a commercial motor
vehicle continues until a treating clinician:
(i) Has determined that the cause of the severe hypoglycemic episode has been
addressed;
(ii) Has determined that the individual is maintaining a stable insulin regimen and
proper control of his or her diabetes mellitus; and
(iii) Completes a new Insulin-Treated Diabetes Mellitus Assessment Form,
MCSA-5870.
(2) The individual must retain the Form and provide it to the medical examiner at
the individual’s next medical examination.
5. Amend § 391.64 as follows:
a. Revise paragraph (a) introductory text and add paragraph (a)(3); and
b. Effective November 19, 2019, remove and reserve paragraph (a).
The revision and addition read as follows:
§ 391.64 Grandfathering for certain drivers participating in vision and
diabetes waiver study programs.
(a) Until November 19, 2019, the provisions of § 391.41(b)(3) do not apply to a
driver who was a participant in good standing on March 31, 1996, in a waiver study
program concerning the operation of commercial motor vehicles by insulin-controlled
diabetic drivers; provided:
* * * * *

(3) On November 19, 2019, the provisions of paragraph (a) of this section are
removed, and any medical examiner’s certificate issued under § 391.43 of this part on the
basis that the driver is qualified by operation of the provisions of 49 CFR 391.64(a),
related to insulin-controlled diabetic drivers, is void.
* * * * *
Appendix A to Part 391 [Amended]
6. Remove and reserve paragraph II.C. of appendix A to part 391.
Issued under authority delegated in 49 CFR 1.87 on: September 11, 2018

____________________________
Raymond P. Martinez
Administrator, FMCSA
[FR Doc. 2018-20161 Filed: 9/18/2018 8:45 am; Publication Date: 9/19/2018]