Enforcement of Medicare e-prescribing mandate delayed; waiver process established for state e-prescribing

As ISMA has reported, new federal and state requirements for the electronic prescribing of controlled substances will take effect on Jan 1. However, the enforcement date for the federal Medicare e-prescribing requirement was recently extended by one year. In addition, the Indiana Board of Pharmacy has established a process to apply for waivers from the state electronic prescribing requirement. This waiver process is separate from the statutory exceptions that are available under the law.

The waiver process and statutory exceptions to the state e-prescribing law are both discussed in ISMA’s updated E-Prescribing Guidance, available here.

Medicare e-prescribing enforcement

In 2018, President Donald Trump signed the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (known as the “SUPPORT for Patients and Communities Act”). Beginning Jan. 1, 2021, this law requires a prescription for a covered Medicare Part D drug under a prescription drug plan for a schedule II, III, IV, or V controlled substance to be “transmitted by a health care practitioner electronically.” However, on Dec.1, the Centers for Medicare and Medicaid Services (CMS) released a Final Rule for the 2021 Medicare Physician Payment Schedule and Quality Payment Program that impacts the enforcement date for this Medicare e-prescribing requirement.

Specifically, in the Final Rule, CMS states that, while the Medicare e-prescribing requirement will still take effect on Jan. 1, 2021, its enforcement of the requirement has been delayed until Jan 1, 2022. According to CMS, this means that “prescribers who do not implement … the standard for [e-]prescribing of Schedule II, III, IV, and V controlled substances until Jan[.] 1, 2022 will still be considered compliant with the requirement.”

State mandate updates

In 2019, the Indiana General Assembly passed a law requiring prescribers to issue prescriptions for controlled substances electronically starting Jan. 1, 2021. This law was intended to coincide with the Medicare e-prescribing requirement.

In addition to setting forth several statutory exceptions to the e-prescribing requirement, the law required the Indiana Board of Pharmacy to establish a separate process for the filing and granting or denying of waivers from the requirement. At its Dec. 14 meeting, the Pharmacy Board adopted an emergency rule formally establishing that waiver process. The emergency rule sets forth the details of how the waiver process will work and also clarifies that prescribers who use one of the statutory exceptions are not required to obtain a waiver.

To learn more about the e-prescribing waiver process or to apply for a waiver, go here.