In the 2023 Medicare Physician Fee Schedule, the Centers for Medicare and Medicare Services (CMS) updated the Electronic Prescribing of Controlled Substances (EPCS) requirement and provided clarifications about several aspects of this important policy.

EPCS Overview

Some state regulations have required providers to electronically prescribe controlled substances for years, but EPCS is front of mind for many providers right now as the federal compliance date is coming up on January 1, 2023 (with an exception for long-term care facilities until January 1, 2025). So starting in 2023, most providers must be e-prescribing 70% of their Schedule II-V drugs under Medicare Part D, unless they prescribe fewer than 100 qualifying controlled substances in a calendar year.

Finalized EPCS Changes and Clarifications for Calendar Year 2023 and Beyond

All of CMS' proposed changes to the EPCS requirement have been finalized this year, 

• CMS will evaluate whether prescribers qualify for an exception for falling below the 100 prescription threshold based Schedule II, III, IV, and V prescriptions written for Part D during the performance year, rather than during the year prior.
  • CMS clarifies that they are not currently able to track the number of prescriptions in real-time, but that they aspire to develop a real-time dashboard that will enable providers to keep track of their eligibility for this exception as the year progresses. 

• CMS clarified that the disaster zone exemption will only apply to Schedule II-V prescriptions written during the period of a declared disaster (as declared by the local, state or federal government), not to prescriptions written during other portions of the performance year.
• The data source used for the disaster zone exemption has changed to be from the NCPDP Pharmacy database to the PECOS database. This change will ensure that all providers within the disaster zone are exempted, even if their prescriptions go to pharmacies outside of the disaster zone. 
  
  • For providers who do not have addresses in PECOS, CMS will use NPPES data to locate providers. 
• The final change is to delay the application of non-compliance penalties by an additional year (to begin in CY2025, instead of CY2024), limiting penalties for 2023 and 2024 non-compliance to a  a non-compliance notice sent to prescribers that CMS believes are violating the EPCS requirement.
  
  • While CMS has used the term "non-compliance letter" in reference to this compliance action in the past, they have clarified the terminology as "notice" because the notification will only be a physical letter if an email (linked to PECOS or NPPES database) is unavailable. 

CMS is still considering responses to their Request for Information in this year's proposed rule regarding future non-compliance actions and penalties in 2025 and beyond. We'll update you when we have more information on what those penalties could be.

Next Steps

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