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Does your practice treat patients with substance use disorders? Does your practice retain substance use disorder records? If the answer to one of those questions is “yes,” you will want to be aware of the recent updates to 42 CFR Part 2 (“Part 2”) requirements.  

Part 2 extends patient privacy protections by applying stringent protections to a patients’ substance use disorder (“SUD”) medical records. Modifications to Part 2 under the Confidentiality of Substance Use Disorder Patient Records Final Rule (“Final Rule”) went into effect on April 16, 2024, with a compliance date of February 16, 2026. The Final Rule modifications better aligned HIPAA and Part 2 standards and clarified previous Part 2 regulations. The following lists key changes that providers should be aware of:

Updated Penalties and Safe Harbor

The new Part 2 regulations apply HIPAA penalties to violations of Part 2. The regulations also create a “safe harbor” for investigative agencies (or those working on behalf of an investigative agency) that act with reasonable diligence before making a demand for records.[1]

Single Consent

The Final Rule “allows a single consent for all future uses and disclosures for treatment, payment, and healthcare operations.”[2]

Updated Content Requirements for Notice of Privacy Practices

The Final Rule creates specific content requirements that a Part 2 program must include in its Notice of Privacy Practices (“Notice”).[3]

A Part 2 Program must include specific information in the header of its Notice, including notifying patients of (1) how their health information may be used and disclosed; (2) their rights with respect to their health information; (3) how to file a complaint concerning a violation of the privacy or security of their health information; (4) their rights concerning their information, and (5) their right to have a copy of the Notice upon request.

In addition, a Part 2 program must include specific descriptions of how it will use and disclose patient records, a list of patients’ rights, such as the right to request restrictions of certain disclosures, a description of how a patient may exercise those rights, and a statement detailing the duties of the Part 2 program.

SUD Counseling Notes

Part 2 creates a new definition describing SUD counseling notes. Under Part 2, SUD counseling notes are “notes recorded (in any medium) by a Part 2 program provider who is a SUD or mental health professional documenting or analyzing the contents of conversation during a private SUD counseling session or a group, joint, or family SUD counseling session and that are separated from the rest of the patient's SUD and medical record.” [4]

The Final Rule mandates that a Part 2 program must obtain consent for any use or disclosure of SUD counseling notes, except:

• To carry out the following treatment, payment, or health care operations:
  • Use by the originator of the SUD counseling notes for treatment;
  • Use or disclosure by the Part 2 program for its own training programs in which students, trainees, or practitioners in SUD treatment or mental health learn under supervision to practice or improve their skills in group, joint, family, or individual SUD counseling; or
  • Use or disclosure by the Part 2 program to defend itself in a legal action or other proceeding brought by the patient.
• Use or disclosure that is required or permitted with respect to the oversight of the originator of the SUD counseling notes.[5]

The Final Rule also adds clarification that a written consent for a use or disclosure of SUD counseling notes may only be combined with another written consent for a use or disclosure of SUD counseling notes.[6]

Next Steps

Practices and providers will want to ensure that any policies are up to date and reflect the changes that are now enforceable under Part 2. We recommend engaging an attorney to review or update your current policies in order to ensure compliance with Part 2 updates.

To learn more about how the updates to 42 CFR Part 2 could impact your practice, please contact BMD Member Jeana Singleton at jmsingleton@bmdllc.com or 330-253-2001. 

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[1] 42 CFR Sec. 2.3. See also, 89 Fed. Reg. 12474 (February 16, 2024), available at https://www.govinfo.gov/content/pkg/FR-2024-02-16/pdf/2024-02544.pdf.

[2] 42 CFR Sec. 2.33. See also, 89 Fed. Reg. 12476 (February 16, 2024), available at https://www.govinfo.gov/content/pkg/FR-2024-02-16/pdf/2024-02544.pdf. See also, Fact Sheet 42 CFR Part 2 Final Rule, U.S. Department of Health and Human Services, available at https://www.hhs.gov/hipaa/for-professionals/regulatory-initiatives/fact-sheet-42-cfr-part-2-final-rule/index.html#ftn1.

[3] 42 CFR Sec. 2.22, See also, 89 Fed. Reg. 12475 (February 16, 2024), available at https://www.govinfo.gov/content/pkg/FR-2024-02-16/pdf/2024-02544.pdf.

[4] 42 CFR Sec. 2.11. See also, 42 CFR Sec. 2.12. See also, 89 Fed. Reg. 12474-12475 (February 16, 2024), available at https://www.govinfo.gov/content/pkg/FR-2024-02-16/pdf/2024-02544.pdf.

[5] 42 CFR Sec. 2.31. See also, 89 Fed. Reg. 12476 (February 16, 2024), available at https://www.govinfo.gov/content/pkg/FR-2024-02-16/pdf/2024-02544.pdf.

[6] Id.