§40.141 How does the MRO obtain information for the verification decision?

Question: Is a Medical Review Officer (MRO) permitted to accept an employee’s prescription for medication obtained over the Internet?

Answer:

• An MRO is authorized to accept an employee’s prescription for medication obtained over the Internet only if there is proof that a legitimate doctor-patient relationship had been established.
• The following four elements generally serve as an indication that a legitimate doctor-patient relationship has been established:
  • A patient has a medical complaint;
  • A medical history has been taken;
  • A physical examination has been performed; and
  • Some logical connection exists between the complaint, the medical history, the physical examination, and the drug prescribed.
• Standing alone, the completion of an online questionnaire reviewed later by a pharmacy-employed doctor fails to establish a proper doctor-patient relationship.
• The MRO should, at a minimum, consider the following items when verifying the test result:
  • The name, physical location, and state(s) of licensure of the prescribing practitioner;
  • Whether the employee was professionally evaluated for the current medical complaint by the prescribing practitioner, and the last time the employee was in direct contact with the prescribing practitioner;
  • Whether the employee initiated the request to the pharmacy for a particular medication; and
  • Whether a proper doctor-patient relationship existed.
• It is the employee’s responsibility to provide sufficient documentation to address MRO inquiries as to whether there was a legitimate doctor-patient relationship.

Also applies to:

• §40.137 On what basis does the MRO verify test results involving marijuana, cocaine, amphetamines, semi-synthetic opioids, or PCP?
• §40.151 What are MROs prohibited from doing as part of the verification process?

Question: Recently, the Drug Enforcement Administration (DEA) issued an order (Order) that reclassified FDA-approved drug products derived from marijuana and marijuana products regulated by a State medical marijuana license from Schedule I to Schedule III drugs under the Controlled Substances Act (CSA). When reviewing a laboratory reported marijuana positive drug test result, can a Medical Review Officer (MRO) deem the test a “negative” if the employee alleges the positive resulted from consuming a State licensed marijuana product?

Answer:

• No. Currently, there is no instance when the MRO could verify a laboratory-confirmed marijuana positive drug test result as ”negative” when an employee claims the positive was caused by a State licensed marijuana product.
• Even after rescheduling, State-dispensed marijuana does not constitute an FDA-approved drug. Without FDA approval for a controlled substance, it cannot be prescribed.
• A ”legitimate medical explanation” requires use of a legally prescribed controlled substance in compliance with Federal laws governing such a prescription. 49 CFR §§40.137(a); 40.141(b).
• Although the MRO may be presented with documentation such as State-issued medical marijuana cards, physician recommendations or certifications, or dispensary records or receipts, these documents do not satisfy part 40 requirements for a “legitimate medical explanation.”
• Marijuana use under State marijuana programs or other non-prescription sources do not qualify as a “legitimate medical explanation” under 49 CFR §40.137(a). In addition, marijuana use is not compatible with safety-sensitive functions.