Indiana's e-prescribing mandate for controlled substances begins Jan. 1
Starting Jan. 1, 2022, controlled substance prescriptions written in Indiana must be issued in an electronic format and transmitted electronically to a pharmacy unless an exception applies, or unless the prescriber has received a waiver from the Indiana Board of Pharmacy. This requirement extends to several types of prescribers, including physicians, advanced practice registered nurses, and physician assistants.

The Indiana e-prescribing mandate can be read here. It had previously been in effect starting Jan. 1, 2021, but the ISMA successfully advocated for changes to the mandate during the 2021 legislative session, including a change to the law that moved the effective date to Jan. 1, 2022. The state requirement was intended to coincide with a federal law passed in 2018 that requires prescriptions for covered Medicare Part D drugs under a prescription drug plan for a Schedule II, III, IV, or V controlled substance to be transmitted electronically starting Jan. 1, 2021.

Enforcement of the Medicare Part D e-prescribing mandate had been delayed until Jan. 1, 2022, but a final rule issued by the Centers for Medicare and Medicaid Services pushes the enforcement date back by one more year to Jan. 1, 2023. The state requirement, however, is not impacted by this change and is still set to go into effect on Jan. 1, 2022.

Exceptions
The ISMA also successfully advocated for several exceptions to be included in the state e-prescribing law. If any of the following circumstances apply, a prescriber may issue a prescription for a controlled substance in a written format, faxed format or an oral order:

1. The prescriber cannot transmit an electronically transmitted prescription due to temporary technological or electrical failure.

2. The prescriber cannot transmit an electronically transmitted prescription due to the technological inability to issue a prescription electronically, including but not limited to failure to possess the requisite technology.

3. The prescriber cannot transmit an electronically transmitted prescription due to the inability of the dispensing pharmacy or provider to receive or process an electronically transmitted prescription.

4. The prescriber reasonably determines that it would be impractical for the patient to obtain an electronic prescription in a timely manner and the delay would adversely affect the patient’s medical condition.

5. The prescriber issues a prescription to be dispensed by a pharmacy located outside Indiana.

6. The prescriber and the pharmacist are the same entity.

7. The prescriber issues a prescription that meets any of the following:
  • The prescription contains elements that are not supported by the technical standards developed by the National Council for Prescription Drug Programs for electronically transmitted prescriptions (NCPDP SCRIPT).
  • The federal Food and Drug Administration requires the prescription to contain certain elements that cannot be supported in an electronically transmitted prescription.
  • The prescription is a non-patient-specific prescription in response to a public health emergency or another instance allowable under state law and that requires a non-patient-specific prescription under:
    • - A standing order;
    - Approved protocol for drug therapy;
    - Collaborative drug management; or
    - Comprehensive medication management.
  • The prescription is issued under a research protocol.
8. The prescriber has received a waiver or a renewal of a previously received waiver from the Board of Pharmacy in accordance with Board of Pharmacy rules.

9. The Board of Pharmacy has issued a rule providing for another exception not described above.

Waiver process
Under the state e-prescribing law, the Indiana Board of Pharmacy was required to promulgate rules to implement a waiver process from the e-prescribing requirement for controlled substances due to economic hardship, technological limitations outside the control of the prescriber, or other circumstances determined by the Board.

The state law makes it clear that prescribers who avail themselves of one of the statutory exceptions set forth in items 1 through 7 above do not require a waiver. More information on the waiver process is available on the Indiana Board of Pharmacy’s website.

Enforcement
A physician who fails to comply with the e-prescribing mandate can be subject to disciplinary action by the Medical Licensing Board of Indiana.

  
Solution for ISMA members
ISMA has partnered with iPrescribe by DrFirst to ensure ISMA members who do not currently e-prescribe in their practice have an easy way to comply with the state mandate. iPrescribe works with your EHR or independently and is accessible through a cellphone application. More information is available at www.iprescribe.com. Be sure to enter “ISMA” during the registration process to access ISMA member pricing!

    

The contents of this article should not be construed as legal advice or a legal opinion on any specific facts or circumstances. The contents are intended for general informational purposes only, and you are urged to consult with counsel concerning your situation and specific legal questions you may have.