2024 Update: CMS Mandatory E-Prescribing Requirements for Controlled Substances – Final Rule

1. A pharmacist is NOT required to verify that a prescriber has a waiver before dispensing a Part D drug
2. The CMS EPCS requirement does NOT affect the pharmacists’ ability to dispense a covered Part D drug from a valid written, oral, or faxed prescription that meets all laws and regulations
3. CMS will not begin monitoring prescriptions for a beneficiary in a LTC facility until January 1, 2025

Timeline:

Now that CMS has data from 2023 for ALL prescribed controlled substance prescriptions, they will begin to measure the compliance rate this summer. CMS takes the number of electronically prescribed Part D Schedule II through V controlled prescription claims from an individual prescriber (using their NPI) and divides that number by ALL Part D Schedule II through V controlled substance prescription claims found under that NPI and multiplies by 100. If the prescriber’s compliance rate is 70% or higher, they are considered compliant.

If a prescriber is non-compliant, CMS will enforce compliance by sending non-compliance notices to prescribers who do not meet the program requirements. These notices will be sent via email addresses found in the Provider Enrollment, Chain, and Ownership System (PECOS), the National Plan and Provider Enumeration System (NPPES) or regular mail if an email does not exist for a prescriber. First notices will be sent this Fall of 2024 for the 2023 measurement year. A prescriber will have 60 days to request a measurement year waiver if there are circumstances beyond their control in which they were unable to send electronic controlled substance prescriptions. This waiver can be requested via the CMS EPCS Prescriber Portal in the Fall after the measurement year.

In addition to an approved waiver, there are two other exceptions to the program. A prescriber would not be required to comply with the program requirements if they issue 100 or fewer Medicare Part D controlled prescriptions in a measurement year. Secondly, if a prescriber is in an area that has been declared as an emergency or disaster by the Federal, State, or local government, they are not required to comply with the EPCS program. CMS has identified which emergencies and disasters qualify for this exception in the Final Rule linked above.