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After Delays, Federal E-Prescribe Mandate Takes Effect

ASC-based prescribers without access to an EHR may request a waiver

BY ALEX TAIRA | JANUARY 2023

The new federal requirements related to electronic prescribing (e-prescribing) of controlled substances went into effect on January 1, 2023. Any prescriber who issues more than 100 qualifying controlled substance prescriptions in a calendar year will be required to transmit at least 70 percent of prescriptions electronically in 2023. While ASCA expects that controlled substance prescriptions will often be written from the physician office, all providers are subject to the new federal mandate.

Prescribers may be eligible for waivers in cases of “extraordinary circumstances” that prevent the required e-prescribing. Among the “extraordinary circumstances” that the Centers for Medicare & Medicaid Services (CMS) outlines is technological limitations, which may apply to prescribers who are ASC-based and do not have regular access to an electronic health record (EHR). Prescribers can request a waiver after the measurement year is complete via their Health Care Quality Information Systems (HCQIS) Access Roles and Profile (HARP) account.

Background

Congress passed the federal mandate in October 2018 as part of the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, or the SUPPORT for Patients and Communities Act. The SUPPORT Act contained numerous policies aimed at combating the ongoing opioid epidemic; according to the Centers for Disease Control and Prevention (CDC), more than 80,000 people died in 2021 due to opioid overdose. While the federal e-prescribe mandate technically went into effect on January 1, 2021, CMS delayed enforcement of the mandate twice due to the COVID-19 pandemic. More than 30 states also have passed state-level requirements related to e-prescribing.

Requirements and Enforcement

The mandate covers all controlled substances under schedules II, III, IV and V, and applies to prescriptions written for covered Medicare Part D drugs under a prescription drug plan or a Medicare Advantage prescription drug (MA-PD) plan. Prescribers who issue 100 or fewer qualifying Part D prescriptions in a calendar year are exempt from compliance. Other prescribers who may be exempt include those located in an emergency or disaster geographic area or those who are the same entity as the dispensing pharmacy.

CMS will monitor compliance via retroactive review of Medicare Part D claims data; prescribers will not need to register or report additional data to CMS. The Drug Enforcement Administration (DEA) governs the technical standards for electronic prescription transmission, which can be found in the electronic Code of Federal Regulations (eCFR) at 21 CFR Part 1311. For vendors, the current standard is the National Council for Prescription Drug Programs (NCPDP) SCRIPT Version 2017071. Prescribers may not meet the standard via a fax transmission because the prescription must be generated by an electronic system such as an EHR.

CMS will begin analyzing Medicare Part D claims for the first fill of controlled substance prescriptions using prescribers’ national provider identifiers (NPI) after the end of the calendar year. Noncompliant prescribers will be issued a notification of noncompliance during the 2024 calendar year, and CMS will propose penalties for future years via rulemaking, likely in the annual updates to the Medicare Physician Fee Schedule. Enforcement for prescriptions for beneficiaries in long-term care (LTC) facilities will not begin until January 1, 2025.

Resources

CMS has created a central e-prescribing webpage with numerous resources, including frequently asked questions and a quick reference guide. Interested stakeholders can also sign up for an e-prescribe listserv to be notified of any program changes.

Write Alex Taira, ASCA’s regulatory policy and research manager, with any questions.