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LEGAL ALERT
Mandatory Electronic Prescribing –
Yes or No?
The Michigan State Medical Society (MSMS) has received several inquiries regarding the status of electronic prescribing. Much of the confusion is due to mandates from both the federal and state governments.
The federal SUPPORT for Patients and Communities Act, which was passed and signed into law in 2018, requires the use of electronic prescribing of con- trolled substances for all controlled substances under Medicaid Part D by January 1, 2021. However, the 2021 Medicare Physician Fee Schedule Rule released on November 30, 2020, provides additional guidance regarding this Medicare e-prescribing mandate. Although the requirement takes effect on January 1, 2021, the enforcement of this requirement has been delayed until January 1, 2022. Below are two excerpts from the Rule regarding compliance:
• We are aware of the difficulties that clinicians may face when implementing EPCS. However, with potentially broad public health implications, we believe a January 1, 2021 effective date complies with the statutory intent and would enable the safety and other benefits previously discussed to be put in place during the current pandemic. However, in order to help ensure that the burden on prescribers is not unreasonable, we are finaliz- ing a compliance date of January 1, 2022 such that prescribers who do not implement the NCPDP SCRIPT 2017071 standard for electronic prescrib- ing of Schedule II, III, IV, and V controlled sub- stances until January 1, 2022 will still be consid- ered compliant with the requirement.
• After consideration of the comments received, we are finalizing the provision with an effective date of January 1, 2021 and a compliance date of January 1, 2022 to encourage prescribers to implement EPCS as soon as possible, while helping ensure that our compliance process is conducted thoughtfully.
Michigan’s statute (Public Acts 134, 135, and 136 of 2020), which requires prescribers to electronically transmit all prescriptions, including those for con- trolled substances, to the patient’s chosen pharmacy, is scheduled to take effect on October 1, 2021. The statute specifically excludes the following situations from the electronic prescribing mandate:
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• If the prescriber is a veterinarian.
• If Electronic prescribing is not available due to a temporary technological or electrical failure.
• If the prescriber has received a waiver.
• If the prescriber reasonably believes that elec- tronically transmitting would be impractical to the patient who is the subject of the prescription to obtain the prescription in a timely manner and that the delay would adversely affect the pa- tient’s medical condition
• If the prescription is orally prescribed.
• If the prescription is to be dispensed out of state.
• If the prescription is to be dispensed by an out of state prescriber in the state.
• If the prescription is issued and dispensed in the same health care facility and the individual for whom the prescription is issued uses the drug exclusively in the health care facility.
• If the prescription contains content that is not supported by the National Council for Prescrip- tion Drug Programs Prescriber/Pharmacist interface script standard.
• If the prescription is for a drug for which the FDA requires the prescription to contain content that cannot be transmitted electronically.
• If the prescription is issued under circumstances in which the prescriber is not required to include on the prescription the name of the patient for whom the prescription is issued.
• If the prescription is issued by a prescriber who is prescribing the drug under a research protocol.
Currently, the state is in the process of promulgat- ing rules that will address the waiver process. MSMS is monitoring this process, which will include a public comment period.
In the meantime, below are some tips for prescrib- ers interested in starting the electronic prescription of controlled substances (EPCS).
Prescribers using an electronic health record (EHR), should check with their EHR vendor to determine which compliance pathway they must follow (depends on whether the system is registered to an individual DEA number or to an institutional or shared DEA num-
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