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Frequently Asked Questions Regarding Michigan’s New e-Prescribing Requirement

Wednesday, November 9, 2022

Effective January 1, 2023, the Michigan Department of Licensing and Regulatory Affairs, Bureau of Professional Licensing (the “Department”) will begin enforcement of the Public Health Code’s requirement that all prescribers electronically transmit all controlled and non-controlled substance prescriptions directly to a pharmacy of the patient’s choice unless an exemption applies (the “e-Prescribing Requirement”). Previously, enforcement of the e-Prescribing Requirement was delayed in order to coincide with the Centers for Medicare & Medicaid Services’ enforcement for Part D prescription drug programs, which will also begin on January 1, 2023.

This article is intended to address frequently asked questions regarding compliance with the e-Prescribing Requirement.

1. How do I comply with the e-Prescribing Requirement?

Pursuant to MCL §333.17754a, the e-Prescribing Requirement requires all prescribers to electronically transmit all controlled and non-controlled substance prescriptions directly to a pharmacy of the patient’s choice. The prescription must be transmitted in a manner that is HIPAA-compliant, and the data of the prescription must not be altered or modified in the transmission process.

The electronically transmitted prescription must contain all of the following information:

  • The name, address, and telephone number of the prescriber.
  • The full name of the patient for whom the prescription is issued, except as otherwise authorized by law.
  • An electronic signature or other identifier that specifically identifies and authenticates the prescriber or his or her agent.
  • The time and date of the transmission.
  • The identity of the pharmacy intended to receive the transmission.
  • Any other information required by state or federal law.

In addition, the electronic equipment or system used to transmit a prescription and communications of prescriptions must provide adequate confidentiality safeguards and be maintained to protect patient confidentiality to ensure against unauthorized access as required under applicable state and federal laws. The electronic transmission of a prescription must be communicated in a retrievable, recognizable form acceptable to the intended recipient. The electronic form used in the transmission of a prescription must also not include “dispense as written” or “d.a.w.” as the default setting.

In most cases, medical practices who already electronically transmit prescriptions to a patient’s chosen pharmacy will not need to take action or make changes to their current practice to comply with the e-Prescribing Requirement, provided that their current system meets the requirements above. Physicians may wish to contact their e-prescribing vendor to ensure their e-prescribing system complies with the e-Prescribing Requirement. See also FAQ #8 below.

2. Are there any exceptions to the e-Prescribing Requirement?

Yes, there are several circumstances under which the e-Prescribing Requirement does not apply, as follows:

  1. The prescriber has applied for and received a waiver from the Department (See FAQ #3);
  2. If the prescription is issued under a circumstance in which electronic transmission is not available due to a temporary technological or electrical failure;
  3. If the prescription is issued by a prescriber who reasonably believes that electronically transmitting the prescription would make it impractical for the patient who is the subject of the prescription to obtain the prescription drug in a timely manner and that the delay would adversely affect the patient's medical condition;
    NOTE: A prescriber who does not electronically transmit a prescription under this circumstance must document the specific reason for his or her belief that the delay would adversely affect the patient's medical condition.
  4. Certain controlled substances orally prescribed in accordance with MCL §333.7333(3) or (4) (See FAQ #7);
  5. If the prescription is issued by a prescriber to be dispensed outside of Michigan;
  6. If the prescription is issued by an out-of-state prescriber to be dispensed by a pharmacy located in Michigan;
  7. 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 (See FAQ #5);
    NOTE: The term "health care facility" includes, but is not limited to, any of the following: a hospital,  a hospice, a dialysis treatment clinic, a freestanding surgical outpatient facility, a skilled nursing facility, or a long-term care facility that provides rehabilitative, restorative, or ongoing skilled nursing care to an individual who is in need of assistance with activities of daily living.
  8. If the prescription contains content that is not supported by the National Council for Prescription Drug Programs Prescriber/Pharmacist Interface SCRIPT Standard;
  9. If the prescription is for a drug for which the FDA requires the prescription to contain content that cannot be transmitted electronically;
  10. If the prescription is issued under circumstances in which the prescriber is not required to include on the prescription a name of a patient for whom the prescription is issued including, but not limited to, a prescription issued under MCL §333.5110;
  11. If the prescription is issued by a prescriber who is prescribing the drug under a research protocol.
  12. If the prescription is dispensed by a dispensing prescriber;
  13. If the prescription is for a dialysis-related drug that is administered as part of or incident to a home-based dialysis treatment; or
  14. If the prescription is issued by a licensed veterinarian.

If a prescriber has not been granted a waiver from the Department and issues a prescription that is not electronically transmitted in reliance on one of the above exemptions, the prescriber must document the applicable exemption relied upon by the prescriber for that prescription and provide that documentation to the Department on request.

3. What if I do not have e-prescribing equipment or software? Can I apply for a waiver from the e-Prescribing Requirement?  

Physicians who do not currently transmit prescriptions electronically should first consider their options for obtaining e-prescribing equipment or software, including confirming that the equipment or software complies with the e-Prescribing Requirement and the cost of obtaining and maintaining such equipment or software. See FAQ #8.

Physicians who cannot meet the e-Prescribing Requirement can alternatively apply for a waiver. The waiver application must be submitted on a form created by the Department, which is available here. The waiver application form requires the applicant to identify the type(s) of prescriptions for which the waiver is being requested (i.e., non-controlled substance prescriptions, controlled substance prescriptions or both). In addition, the applicant must provide evidence that satisfies either of the following requirements:

(1)    The prescriber has received a waiver of the Medicare requirement for electronic transmission of controlled substance prescriptions from CMS (the “CMS Waiver”); or 

(2)    The prescriber is unable to meet the e-Prescribing Requirement and also meets one (1) of the following:

a.       The prescription is dispensed by a dispensing prescriber;
b.       The prescriber demonstrates economic hardship or technological limitations that are not within the control of the prescriber;
c.       The prescriber issues prescriptions from a non-profit charitable medical clinic; or
d.       The prescriber demonstrates by attesting to exceptional circumstances, including, but not limited to:

i.      (Controlled substances only) Prescribing fewer than 100 controlled substances prescriptions per year or the number of controlled substances prescriptions used in the CMS Waiver, whichever is more;
ii.      Intention to cease practice within the next twelve months; or
iii.      Limited practice due to an illness or other unforeseen event.

Examples of supporting evidence will depend on the basis for the waiver request, and may include a copy of documentation confirming receipt of the CMS Waiver; a written letter which summarizes and attests to the existence of economic hardship, technological limitations, or exceptional circumstances; a copy of a fee estimate from an e-prescribing software company identifying the estimated cost to comply with the e-Prescribing Requirement; a letter from a non-profit charitable medical clinic confirming that the applicant prescribes medications for the clinic, etc.

If a prescriber obtains a waiver from the Department, the waiver is valid for 2 years and is applicable to the specific circumstances included in the application. The waiver can be renewed by application to the Department.

Presently, CMS has stated that CMS Waivers for 2023 will not be granted until calendar year 2024. Until then, for purposes of complying with the Michigan e-Prescribing Requirement, physicians applying for a waiver must provide evidence that they meet the other eligibility requirements for a waiver.

4. I issue only a few prescriptions each year. Do I still have to comply with the e-Prescribing Requirement? What if I’m retired from active practice?

The e-Prescribing Requirement applies regardless of the number of prescriptions issued per year or if the prescriber is retired or in active practice. Physicians who cannot meet the e-Prescribing Requirement may apply for a waiver.  See FAQ #3 above.  If a physician does not issue prescriptions (whether due to retirement or otherwise), the physician does not have to comply with the e-Prescribing Requirement and does not have to apply for a waiver in order to maintain his or her medical license. The Department has clarified that the e-Prescribing Requirement only applies when writing prescriptions.

5. What if I prescribe prescription drugs exclusively in a hospital or other facility?

Physicians who prescribe prescription drugs exclusively in a hospital or other “health care facility” setting  may be exempt from the e-Prescribing Requirement 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.

The term "health care facility" includes, but is not limited to, any of the following: a hospital, a hospice, a dialysis treatment clinic, a freestanding surgical outpatient facility, a skilled nursing facility, or a long-term care facility that provides rehabilitative, restorative, or ongoing skilled nursing care to an individual who is in need of assistance with activities of daily living.

If the prescription will be dispensed or taken/consumed by the patient outside of the health care facility, the prescription must be electronically transmitted in compliance with the e-Prescribing Requirement, unless another exception applies.

6. Can I satisfy the e-Prescribing Requirement by faxing the prescription to the patient’s preferred pharmacy?

No. The Department recently issued Frequently Asked Questions confirming that a faxed prescription is not considered an electronic prescription.

7. When can I orally issue a prescription?

MCL §333.17554a specifically allows oral prescriptions when issued in compliance with MCL §333.7333(3) or (4), including the following:

  • In an emergency situation, as described in R 338.3165 of the Michigan Administrative Code, a controlled substance included in schedule 2 may be dispensed on the oral prescription of a practitioner. Within 7 days after authorizing the prescription, the prescriber must deliver to the dispensing pharmacist a written prescription or electronically transmit the prescription. The prescriber must include on the prescription both “Authorization for Emergency Dispensing” and the date of the oral order. See MCL §333.7333(3).
  • Oral prescriptions for schedule 3, 4, or 5 controlled substances. See MCL §333.7333(4).

A prescription may also be orally issued when another exception to the e-Prescribing Requirement applies, such as in the event of a temporary technological or electrical failure. MCL §333.17554a(8) states that a pharmacist who receives a prescription that was not transmitted electronically to the pharmacy may dispense the prescription without determining whether an exception under the e-Prescription Requirement applies. However, a prescriber must still document the applicable exception relied upon when issuing the prescription. See MCL §333.17554a(6).

8. What are recommended tips for incorporating electronic prescribing for controlled substances (EPCS) and non-controlled substances into my medical practice?

If you’re using an electronic health record (EHR), check with your EHR vendor to determine which compliance pathway to follow (this may depend on whether the system is registered to an individual DEA number or to an institutional or shared DEA number) and whether the EHR software version being used is certified and approved for EPCS.  If not, an updated version will be necessary before proceeding.  If it is certified and approved, the following three steps need to be completed before a prescriber is legally able to EPCS:

  • Complete identity proofing in order to obtain an authorization and authorization credential.
  • Set-up two-factor authentication.  This is how the application verifies the person using the application is someone who has been given access.
  • Set software access.  At each location where an EPCS application will be used for controlled substances, at least two individuals must be designated to manage access to the application. At least one must be a DEA registrant (a DEA authorized prescriber). These two individuals will set secure access controls for the electronic prescribing application software.

Prescribers without an EHR also have options.  If you are currently using an electronic prescribing application for non-controlled substances, check with the vendor to see if they have a certified EPCS upgrade.  If you are not using electronic prescribing at all, stand-alone electronic prescribing systems with EPCS are available that do not require an EHR.  There are systems designed to meet a variety of needs, from those that offer simplicity and basic functionality and can be used on a smart phone or tablet (e.g., DrFirst iPrescribe) to those that will offer a fuller range of functionality (e.g., DrFirst EPCS Gold).  When you make your EPCS selection, the three steps outlined above for EHR users must be completed in order to send electronic prescriptions for controlled substances.

Whether you are adding EPCS to your EHR, upgrading your stand-alone eRx system, or just wading into electronic prescribing, getting started now is extremely important. This will not only ensure you are able to have a smooth transition and keep interruptions to patient care at a minimum, but also allow you to have a secure way to prescribe controlled substances.