The Drug and Alcohol Testing Industry Association (DATIA) recently held a webinar to address the Department of Transportation (DOT) regulatory changes for Medical Review Officers (MRO) that will take effect on January 1, 2018. The following is a list of questions and frequently appeared during the webinar. For more information regarding these regulatory changes or to watch the full webinar, please visit www.datia.org or email, firstname.lastname@example.org.
Q: How will results be affected if a driver returns a positive drug screen and provides prescription information that is over six-12 months old?
A: The DOT new rule does not address this issue intentionally. However, it does address the subject in the comment section:
“The DEA has not set a maximum duration for the length of time a prescription can be considered to be legally used by the person to whom it was prescribed. Consequently, it would not be appropriate for the Department to substitute its judgment for that of the DEA, which is the Federal agency with the authority for determining what constitutes a valid prescription under the CSA. The MROs are highly qualified individuals who Part 40 requires to make judgment calls. MROs must take into account differences in medications, and other case-specific factors. While some commenters characterize this as “inconsistent” across the breadth of a national program, it carries out the intention that MROs will make individualized determinations for each donor. Although it might be less work and superficially “consistent” for MROs to make decisions on the basis of a “bright line” standard, doing so would not advance the objectives of the program. Consequently, the Department will not create a time limit on the use of a legally valid prescription.”
Q: MROs now have five days to verify a prescription under the new regulation. Am I to understand that the MRO can report a negative before he or she receives confirmation of the donor’s prescription? If they are unable to verify the medication, will he or she be required to alter their findings?
A: The new rule requires that the MRO to allow five days for the donor’s health care professional (HCP) to contact the MRO to discuss the medication in question that may cause the MRO to issue a Safety Concern. It does not change the existing regulations regarding the MRO verification of a donor prescription. As is the current required process, the MRO must follow existing rules in conducting a donor interview and verifying donor prescriptions. The MRO will not issue a negative result until he or she has confirmed that there is a legitimate medical explanation for a positive laboratory result.
Q: Will the testing panel change screen for fentanyl?
A: Although fentanyl is a member of the opioid category, the new DOT Panel will not test for fentanyl.
Q: The MRO has five days to get information from the prescribing HCP. Are employers notified before or after the five days?
A: MROs are not authorized to notify employers that there is a pending safety concern. After five days have elapsed without contact by the donor’s HCP, or after the MRO has discussed the medications with the HCP (which could be less than five days), the MRO will notify the employer if there is still a safety concern.
Q: Are medical disclosures required if someone has a legitimate reason for taking opioids?
A: Assuming “medical disclosures” refers to the situation where the MRO reports safety concerns or specific medical information to an employer or other authorized third parties, there must be signed disclosures if the MRO intends to report a safety concern. If a donor has a legitimate medical explanation (valid prescription) for a positive opioid laboratory test, there may be a safety concern regarding the continued use of the opioid. The review and reporting of a safety concern by the MRO must follow the new regulations effective January 1, 2018.
Q: A company has a non-DOT policy for drug testing when a driver is involved in an accident that doesn’t fit the DOT standards. If the non-DOT drug screen comes back positive for THC, how are the DOT responsibilities impacted?
A: A positive non-DOT test does not invoke the same consequences required by DOT/FMCSA as a DOT test; the resulting process defers to the company policy. Be aware that the Federal Motor Carrier Safety Administration (FMCSA) regulation does speak to “actual knowledge” of drug use – employers should review that part of the FMCSA regulations.
Q: What happens if the donor’s HCP doesn’t contact the MRO within five days?
A: The responsibility for informing the treating physician to contact the MRO falls on the donor. Should the treating physician not contact the MRO for any reason within five days, the MRO is authorized to report a safety concern to the employer at the end of the waiting period.
Q: Instead of talking to a prescribing provider, can MROs review a photocopy of the bottle or communicate with the pharmacy?
A: The intent of the DOT’s new rule for reporting safety concerns is not related to the MRO’s process for verifying prescription information. The MRO will follow existing regulations and internal procedures for verifying prescriptions. Speaking to a pharmacist would not provide the MRO the detail to determine whether there is a safety concern to report.
Q: How will MROs handle valid prescriptions for Vicodin, OxyContin, or similar drugs?
A: The DOT new rule addresses this process, although it does not regulate whether an employee can continue safety-sensitive duties while taking prescribed opioid medications. The purpose is to encourage HCPs to discuss what medications a donor/employee is taking with the MRO. The MRO will also determine whether medications can be changed, or if there is cause for a safety concern. Once prescriptions are validated to represent a legitimate medical explanation for the laboratory positive test result, the MRO will report the negative result to the employer without delay. However, the new rule requires the MRO to refrain from publishing a safety concern until after the discussion with the HCP, or after five days of no contact. At that point, the employer is advised to proceed with a Fitness for Duty assessment, which will determine whether the employee can continue safety-sensitive duties while on his or her prescription medications.
Q: Does the MRO contact the prescribing physician when the threshold levels seem too high or do they verify every opioid positive?
A: Laboratory reported levels of the drug are just one piece of information for the MRO to review. Whether the MRO considers any medication to be a safety concern depends on many more factors than threshold levels, including the data obtained from the donor during the interview. Should any factor cause the MRO to consider a safety concern, even if the test is negative, the MRO will instruct the donor to reach out to his/her HCP to contact the MRO to confirm their findings.
Q: Our MRO is concerned about sitting on a positive result for five days, knowing the driver is still driving. What can they do?
A: This DOT new rule does not suggest in any way that an MRO “sit on a positive.” If the MRO determines that a drug test is positive, the MRO will report it to the employer without delay. The five day waiting period is only applicable after an MRO reports a negative result because of a donor’s legitimate medical explanation for the laboratory positive. If there is a medical explanation from the donor, the MRO must wait to report a safety concern until the new process is complete (i.e., speaking with the donor’s treating physician or waiting five days if the HCP does not contact the MRO).
Q: Will we see a negative with safety concern as a result of an opioid prescription, or will it be released at a positive even if there is a valid prescription?
A: Employers will see a negative result when the MRO has verified the donor’s prescriptions as representing a legitimate medical explanation for a positive laboratory finding for one or more of the tested drugs. Then, after the MRO follows the required process of the new rule, the employer could receive a safety concern for that originally issued negative result, up to five days later. The issuance of a safety concern does not change that initial negative result to a positive.
Q: Could a donor with a prescription receive a verified positive if taking above the proper dosage for therapeutic use?
A: The MRO cannot determine whether an employee is misusing or abusing prescription medication from the results of one drug test. If the employee presents evidence of a valid prescription for the substances reported by the laboratory in a specimen, it constitutes a legitimate medical explanation for the presence of the drug. The result will be a negative test.
Q: If confirmed levels of opioids are within the prescribed dosage but considered by the MRO to be unsafe for a safety-sensitive position, will the test be labeled positive or negative? Will there be a notation to the employer that the employee should not be performing safety-sensitive functions?
A: Employers will see a negative result when the MRO has verified the donor’s prescriptions as representing a legitimate medical explanation for a positive laboratory finding for one or more of the tested drugs. Then, after the MRO follows the required process of the new rule, the employer could receive a safety concern for that initial negative result within five days. The issuance of a safety concern does not change that first negative result to a positive.
Q: If the MRO is satisfied with the prescribing physician’s prescription use for a positive opioid test, then will it be reported as “negative” with no medical disclosure to the employer?
A: Employers will see a negative result when the MRO has verified the donor’s prescriptions as representing a legitimate medical explanation for a positive test. The MRO will then base his/her decision on whether to issue a safety concern (e.g., medical disclosure) on the discussion and information provided by the prescribing physician. Using the required process, the MRO could then be “satisfied” that there is no safety concern and will not issue the safety concern.
Q: Is requiring or asking for a list of medications considered an HR violation?
A: The DOT regulations authorize the MRO to request medical information from a donor who has a positive test result. MROs do not need a release to request and receive this information. Whether an employer can ask for medications is a company decision based on HR policies and employment law.
Q: Is an individual required to report opiate/opioid prescriptions to their employer?
A: The DOT regulations do not require an individual to report to an employer that they are taking a prescription opioid. Absent a DOT requirement, HR policies, and employment law factor into the company’s decision.
Q: During the five day waiting period, can a driver still perform safety-sensitive job functions?
A: Because the MRO is not authorized by the DOT new rule to report any “pending” safety concerns to the employer and because the employer has already received a negative drug test result, there is nothing to keep the employee from performing safety-sensitive duties.
Q: Is the MRO now required to contact the prescribing physician on all non-negative opioid tests? Or is this just done at the MRO’s discretion?
A: The responsibility for informing the treating physician to contact the MRO falls on the donor. At the MRO/Donor interview, the MRO will advise the donor to contact their HCP if there are safety concerns and instruct them to reach out to the MRO. This process is required for all laboratory positives where the donor has valid prescriptions, not only for Opioid medications.
Q: Just for clarification – as the MRO, we cannot express safety concerns until after discussing with the prescribing physician or the five days? We currently require the donor to get a release letter from his prescribing physician at the same time as the prescription info – are we not to do this anymore?
A: As we understand the new regulation regarding reporting of safety concerns, the MRO is not authorized to notify an employer during those five days that safety concern is “pending.” The employer will be notified if five days have elapsed without contact by the donor’s HCP, or the MRO has discussed the medications with the HCP, and there is still a safety concern.
Q: How will the MRO know if there is a safety concern if they don’t have a job description of work duties?
A: The MRO decides that there may be a safety concern because of the donor’s use of certain medications. However, the MRO is not the one that will make the Fitness for Duty determination. Generally speaking, an occupational medicine physician should perform a medication or medical condition fitness for duty evaluation and assessment of an employee. The employer must arrange this assessment within the context of resolving a safety concern raised by the MRO based on a DOT test result verification. The employer or donor will then provide information on the job duties, i.e., the job description.
Q: If the MRO notes a safety concern on a negative drug screen, does this mean that the company must remove the driver from safety-sensitive duties until the proper resolution is obtained?
A: DOT regulations do not require that an employer remove an employee from safety-sensitive duties upon receipt of a safety concern from the MRO. The employer will make that decision according to company policies. Speaking directly to the MRO regarding the medical information that led to the issuance of a safety concern may assist in the decision process.
Q: My understanding of the rule is that the MRO directs the employee to have their prescribing physician contact the MRO. Is this correct?
A: Yes – the MRO will not contact the HCP, but instead instruct the donor to have their HCP reach out to them.
Q: Why wouldn’t an MRO report the opioid positive as a “negative with medical disclosure,” even after speaking with the prescribing physician, if they have any type of safety concern?
A: Based on the laboratory results and the donor interview, the MRO may initially believe a donor’s medications could cause the employee to be medically unqualified according to DOT Agency regulations, or that the donor’s continued performance is likely to pose a significant safety risk. A subsequent conversation with the donor’s prescribing physician may reveal that the employee can safely perform safety-sensitive functions while taking the medication(s). Alternatively, the physician may elect to change the employee’s medication to one that does not pose a significant safety risk or render the employee medically unqualified for their position. After receipt of this type of information from the prescribing physician, the MRO may decide that issuing a safety concern is not necessary.