Electronic Prescribing of Controlled Substances: Section 2003 of the SUPPORT Act

On November 2, 2021, the Centers for Medicare & Medicaid Services (CMS) issued a final rule that includes updates on policy changes for Medicare payments under the Physician Fee Schedule (PFS), and other Medicare Part B issues, on or after January 1, 2022.

Section 2003 of the SUPPORT Act requires electronic prescribing of controlled substances (EPCS) for schedule II, III, IV, and V controlled substances covered through Medicare Part D. The statute provides the Secretary with discretion on whether to grant waivers or exceptions to the EPCS requirement and specifies several types of exceptions that may be considered. It also gives the Secretary authority to enforce non-compliance with the requirement and to specify appropriate penalties for non-compliance through rulemaking. In December 2020, CMS implemented the first phase of this mandate by naming the standard that prescribers must use for EPCS transmissions and delaying compliance actions until January 1, 2022.

In the PFS final rule, CMS is implementing the second phase of this mandate by finalizing in regulation certain exceptions to the EPCS requirement. An exception will apply if a prescriber meets any of the following:

The prescriber and dispensing pharmacy are the same entity;
The prescriber issues 100 or fewer controlled substance prescriptions for Part D drugs per calendar year; and

The prescriber is in the geographic area of an emergency or disaster declared by a federal, state or local government entity, or
The prescriber has been granted a CMS-approved waiver based on extraordinary circumstances, such as technological failures or cybersecurity attacks or other emergency.

CMS will allow prescribers to request a waiver where circumstances beyond the prescriber’s control prevent the prescriber from being able to electronically prescribe controlled substances covered by Part D.

CMS is also delaying the start date for compliance actions to January 1, 2023, in response to stakeholder feedback. CMS is also delaying the start date for compliance actions for Part D prescriptions written for beneficiaries in long-term care facilities to January 1, 2025. CMS will initially enforce compliance by sending compliance letters to prescribers violating the EPCS mandate.

Read the entire release here – https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2022-medicare-physician-fee-schedule-final-rule