In-Depth Post: Electronic Prescribing of Controlled Substances

In-Depth Post: Electronic Prescribing of Controlled Substances

In 2010, the U.S. Drug Enforcement Administration (DEA) published an interim final rule allowing Electronic Prescribing of Controlled Substances (EPCS) in all states. On October 24, 2018, President Trump signed into law the “SUPPORT for Patients and Communities Act,” a comprehensive bill designed to address the opioid abuse epidemic. Included in the law is a mandate for electronic prescribing for controlled substances (EPCS) for prescriptions covered under a Medicare Part-D drug plan (or an MA-PD plan). The deadline to comply with this section of the new law is January 1, 2021.

As that draws near, and concern regarding implementation of the mandate during a pandemic is being discussed with regulators, we thought it best to explore this topic in greater depth.
In-Depth: EPCS
Electronic Prescribing for Controlled Substances is meant to eliminate paper prescriptions and allow clinical prescribers to write prescriptions electronically for controlled substances, making these prescriptions digitalized and trackable for the prescriber and the pharmacy.

In 2010, the Drug Enforcement Agency (DEA) revised its regulations, allowing physicians to electronically prescribe controlled substances through a certified electronic system. EPCS was seen as a way to help eradicate some of the issues created by paper prescriptions, such as forged or stolen prescriptions, by requiring authentication of prescribers, improving security standards, and auditing activity on EPCS platforms.

Today, various factors are driving mandated implementation among the states for e-prescribing of controlled substances. For legislators, EPCS is viewed as a systematic way to reduce levels of substance addiction and abuse in communities through institutionalizing careful monitoring and increased oversight of a patient’s prescription history and use of controlled substances.

As a result, many states have already implemented EPCS mandates, some have laws starting in 2020, and many more have laws on the books. If you regularly prescribe medicines in or near one of the six states requiring EPCS-certification on January 1, 2020, you should be sure to have corrections in place to meet the mandate and be able to prescribe controlled substances after January 1. If you have not met the mandate requirements and you are located in one of the six states listed below, you will be unable to prescribe controlled substances until your systems are updated to meet the mandate.

Arizona, Iowa, Massachusetts, North Carolina, Oklahoma, and Rhode Island are the first states mandated to use EPCS by the federal government. The requirements differ from state to state, so you’ll need to check the particulars for your organization.

Source: ADSC, above

In order for an EPCS system to be considered in compliance with the DEA requirements, it must include:

  • Two-factor authentication for providers who sign an EPCS prescription
  • EHR/e-prescribing application certification
  • ID proof to verify a provider has the authorization to prescribe controlled substances
  • Two-step logical access control that grants EPCS permissions to approved prescribers
  • Detailed reporting that comprehensively shows compliance and identifies auditable events and any incidents around breaches of security
Source: ADSC, above

The Centers for Medicare & Medicaid Services (CMS) has proposed a one-year delay to a congressionally mandated requirement that Medicare Part D providers transmit all prescriptions for controlled substances electronically beginning January 1, 2021.

The SUPPORT Act—the major law passed in 2018 that addressed the opioid crisis—requires there to be electronic prescribing for controlled substances (EPCS) in the Medicare Part D Prescription Drug Program beginning in 2021. As discussed in last week’s Regs & Eggs, in its proposed 2021 physician fee schedule, the Centers for Medicare & Medicaid Services (CMS) proposes delaying this EPCS requirement to 2022 due the ongoing response to the COVID-19 public health emergency. ACEP supports this delay.

However, CMS also released a separate request for information (RFI) on how it should implement the requirement going forward. In this RFI, CMS seeks comments on three issues: 1) compliance with the requirement; 2) enforcement and penalties; and 3) potential exceptions to the requirement.

Last week, ACEP submitted a detailed response to the RFI—particularly focusing on the burden associated with EPCS and whether an exception should be granted to emergency physicians in certain cases.

The Centers for Medicare and Medicaid Services (CMS) in the 2021 proposed physician payment rule floated the idea of postponing the electronic prescribing for controlled substances requirement until 2022 due to the ongoing COVID-19 public health emergency.

While the final rule did NOT postpone implementation of this requirement, it does set a compliance date of January 1, 2022. According to CMS, this was done to encourage prescribers to implement e-prescribing of controlled substances as soon as possible, while allowing physicians more time to come into compliance without penalty.
Iowa is one of the states scheduled to initiate the EPCS requirement on January 1, 2021.The Iowa Board of Pharmacy provided the following response to a question about the mandate.
Question: Is the electronic prescribing mandate waived during this state of emergency?
Answer: The electronic prescribing mandate has not been specifically identified in any of the Governor’s State of Public Health Disaster Emergency proclamations. Iowa Code provides a 19 (Revised November 10, 2020) number of exemptions for the mandate, including an emergency. Under current Board rule, an emergency is defined as including, but not being limited to, issuing a prescription to meet the immediate care needs of a patient after hours when a prescriber may not have access to their electronic prescribing system. During this current COVID-19 pandemic, workflow and operational practices may become untenable which may lead to lack of access to these prescribing systems or other significant barriers. In keeping with the current exemption for emergency situations, a practitioner may transmit a prescription via other than electronic methods in a situation that they deem is an emergency, including when they may not be able to access their electronic prescribing system. Prescribers are encouraged to seek additional guidance from their professional licensing board as those boards are tasked with enforcement of the mandate.
This is an evolving issue; one that we will be tracking closely. Please feel free to contact me if you have any questions, and I will coordinate our team’s response to that inquiry.

Paul Hudson, FACHE
Chief Operating Officer