Updated 42 CFR Part 2’s New Definition for SUD Counseling Notes

In 2024, HHS amended 42 CFR Part 2 to improve alignment with HIPAA. One of these changes involves new protections for “substance use disorder (SUD) counseling notes.” The Center of Excellence for Protected Health Information, funded by the Substance Abuse and Mental Health Services Administration (SAMHSA), released a brief resource guide to assist providers in understanding the new regulations.

SUD counseling notes are defined as notes by an SUD or mental health professional at a Part 2 program, that the clinician voluntarily maintains separately from the rest of the patient’s SUD treatment and medical record in which they document or analyze the contents of a conversation from an SUD counseling session. This is analogous to protections in HIPAA for psychotherapy notes.  The definition excludes progress notes that document medication prescription and monitoring, counseling session start and stop times, modalities and frequencies of treatment provided, results of any clinical tests, and a summary of the following: diagnosis, functional status, treatment plan, symptoms, prognosis, or progress to date. 

Key Points about the New Provisions:

• Part 2 now provides stricter confidentiality protections for SUD counseling notes.
• SUD counseling notes must be separated from the rest of the patient’s record in order to meet the definition.  This is analogous to protections in HIPAA for psychotherapy notes.  (These are NOT progress notes which are maintained in the medical record)
• A Part 2 program may not require a patient to sign a consent authorizing use or disclosure of SUD counseling notes as a condition of treatment.

For more information on substantive changes to 42 CFR Part 2, please refer to the HHS Fact Sheet 42 CFR Part 2 Final Rule.