CMS to Require Electronic Prescribing for Controlled Substances Covered Through Medicare Part D Beginning January 1, 2023
In compliance with Section 2003 of the SUPPORT Act, providers must transmit prescriptions for controlled substances electronically for Medicare Part D beneficiaries beginning January 1, 2023.
- Section 2003 of the SUPPORT Act mandates that a health-care practitioner transmit a prescription for a Part D drug under a prescription drug plan (or under an MA–PD plan) for a Schedule II, III, IV, or V controlled substance electronically in accordance with an electronic prescription drug program.
- To promote compliance, apply penalties, and support a waiver process, CMS has established the Electronic Prescribing for Controlled Substances (EPCS) Program. This CMS program is separate from any state EPCS program.
What is required?
The CMS EPCS Program applies to:
- Schedule II, III, IV, and V controlled substance prescriptions under Medicare Part D
- Any prescriber who issues more than 100 qualifying controlled substance prescriptions in a calendar year
Prescribers are required to transmit electronically at least 70 percent of their Schedule II, III, IV, and V prescriptions for controlled substances for patients with Medicare Part D within a calendar year, except in cases where an exception or an approved waiver applies.
Prescribers must follow Drug Enforcement Administration (DEA) guidance for EPCS. More information about the DEA requirements for EPCS can be found here.
Are there exceptions?
Prescribers will be exempt from, or particular prescriptions will not be considered for purposes of determining compliance with, this requirement in the following situations:
- Prescriptions for controlled substances issued when the prescriber and dispensing pharmacy are the same entity
- Prescribers who issue 100 or fewer qualifying Part D controlled substance prescriptions in the calendar year
- Prescribers who CMS determines are in the geographic area of an emergency or disaster declared by a federal, state, or local government entity
- Prescribers who receive a CMS-approved waiver because the prescriber is unable to conduct electronic prescribing of controlled substances due to circumstances beyond the prescriber's control.
Compliance actions for prescriptions for beneficiaries in long-term care (LTC) will begin January 1, 2025.
How will CMS determine compliance?
CMS will analyze Medicare Part D claims and use the prescriber’s National Provider Number (NPI) to measure compliance after the end of each calendar year, allowing time for claims submission and processing. After the EPCS compliance analysis is complete for the 2023 EPCS measurement year, CMS will send a notice of non-compliance to prescribers violating the EPCS mandate.
Notices will be sent by e-mail when possible to available e-mail addresses in the Medicare Provider Enrollment, Chain, and Ownership System (PECOS) and the National Plan and Provider Enumeration System (NPPES), and by regular mail if there is no e-mail address in PECOS or NPPES. CMS strongly recommends that all prescribers keep their e-mail address accurate and up to date in both systems.
CMS will monitor the EPCS program to determine if future non-compliance penalties should be expanded.
Why e-prescribe controlled substances?
EPCS offers many benefits to patients, providers, and pharmacies. These benefits include:
- Improved patient safety and satisfaction
- Workflow efficiencies
- Fraud deterrence
- Improved medication adherence
- Reduced burden
What EPCS support resources are available?
CMS is committed to providing support and resources to clinicians included in the EPCS Program:
- The EPCS website will provide a centralized location for resources and updates for clinicians
- The EPCS listserv will provide general updates on the EPCS Program as they are available and upcoming program deadlines; prescribers can sign up at CMS Listserv
- The EPCS Service Center will serve as the primary point of contact to help address program questions.