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Enhancing Privacy Protections for Substance Use Disorder Patient Records

Client Alert
February 16, 2024

On February 8, 2024, the U.S. Department of Health and Human Services (“HHS”) finalized updated rules to 42 CFR Part 2 (“Part 2”) for the protection of Substance Use Disorder (“SUD”) patient records. The updated rules reflect the requirement that the Part 2 rules be more closely aligned with the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) privacy, breach notification, and enforcement rules as mandated by the Coronavirus Aid, Relief, and Economic Security Act of 2020.

Part 2 protects the SUD treatment records of patients who are treated at a Part 2 program. Part 2 programs are those that are (1) federally assisted (they receive federal funding) and (2) hold themselves out as providing, and do provide, substance use disorder diagnosis, treatment, or referral for treatment. The final rules released by HHS this month reflect the inclusion of the public comments from providers, trade associations, health information exchanges, health plans and others.

The final rules make the following modifications to Part 2 regulations, effective February 16, 2026:

  • Patient Consent: One single Part 2 consent will be sufficient for all future disclosures for payment, treatment, and health care operations. All disclosures made with patient consent must include a copy of the consent or a clear explanation of the scope of consent. Previously, a separate consent was needed for each disclosure of Part 2 information. However, the final rules do retain a prohibition on the use of Part 2 records in legal proceedings and testimony in civil, criminal, administrative, and legislative proceedings against a patient without specific consent or a court order.
  • Counseling Notes: Like HIPAA psychotherapy records, a separate patient consent for the use and disclosure of SUD counseling notes is now required. SUD counseling notes include those analyzing the conversation in a SUD counseling session that the clinician voluntarily maintains separately from the rest of the patient’s SUD treatment and medical record.
  • Patient Notice: Part 2 patient notice requirements now align with the requirements of the HIPAA Notice of Privacy Practices.
  • Redisclosure: HIPAA covered entities and business associates that receive records under a Part 2 consent may redisclose those records according to HIPAA regulations. Previously, Part 2 regulations required a specific disclosure that was stricter than HIPAA redisclosure regulations.
  • Public Health: Part 2 records may now be disclosed to public health authorities without patient consent as long as the records are de-identified.
  • Breach Notification: The HIPAA Breach Notification Rule requirements will also apply to breaches of records under Part 2.
  • Segregation of Part 2 Data: Part 2 records are no longer required to be segregated or segmented from other medical records.
  • Fundraising: Patients will be able to opt out of receiving fundraising communications from Part 2 programs.
  • Complaints: Patients will have a right to file a complaint directly with the Secretary of HHS for an alleged violation of Part 2 in addition to filing a complaint with the Part 2 program.
  • Penalties: Part 2 penalties will be aligned with HIPAA by replacing criminal penalties currently in Part 2 with civil and criminal enforcement authorities that also apply to HIPAA violations.

The text of the final rule can be found on the Federal Register. All Part 2 programs must comply with the new requirements by February 16, 2026. The BMD healthcare team can help ensure that you are compliant. Please reach out to Daphne Kackloudis (dlkackloudis@bmdllc.com) or Jordan Burdick (jaburdick@bmdllc.com) for questions or assistance.

Health LawHealthcare Policysubstance abuseDaphne KackloudisJordan Burdick
Client Alert

Ohio Department of Health Releases Updated Charge Limits for Medical Records

March 7, 2022Under Ohio law, a healthcare provider or medical records company that receives a request for a copy of a patient's medical record may charge an amount in accordance with the limits set forth in Ohio Revised Code Section 3701.741. The allowable amounts are increased or decreased annually by the average percentage of increase or decrease in the consumer price index for all urban consumers, prepared by the United States Department of Labor, Bureau of Labor Statistics, for the immediately preceding calendar year over the calendar year immediately preceding that year, as reported by the Bureau. The Director of the Ohio Department of Health makes this determination and adjusts the amounts accordingly. The list is then published, here.Client Alert

No Surprises Act Compliance (Published by NAMAS, 2/25/22)

March 7, 2022The Department of Health and Human Services published three parts to the No Surprises Act towards the end of 2021, which took effect January 1, 2022. The Act is intended to protect consumers from “balance billing,” which occurs when a patient receives a bill with a higher price than they may have anticipated because they did not have knowledge that the provider or facility was out-of-network. The purpose of this article is to note certain requirements that compliance employees will need to be aware of at their facilities, including notice and consent, good faith estimates, and public disclosures.Client Alert

No Surprises Act and You (Published in the SCMS Winter 2022 Newsletter)

March 3, 2022Legislation has been adopted by the United States Congress and the Ohio Legislature known as the “No Surprises Act” which attempts to regulate billing by professionals and facilities to patients who are not in networks with those facilities or providers at those facilities. The federal bill was triggered by some sensational news stories of patients being billed for tens of thousands of dollars for emergency care when the hospital was out of the network under the patient’s insurance plans.Client Alert

Are You Impacted by the Project Labor Agreement Executive Order?

February 28, 2022Project Labor Agreements (PLAs) are a quasi-collective bargaining agreement between employers and unions. They establish the terms and conditions of employment, including dispute resolution. They are put into place on specific projects and apply to the contractor, whether it is union or non-union. Employees hired on the project will be treated as union.Client Alert

No Surprises Act Update: Federal Judge Strikes Portions of the No Surprises Act

February 25, 2022In a win for providers, a Texas federal court granted the Texas Medical Association’s (TMA) motion for summary judgment and struck down portions of a federal rule that establishes a reimbursement rate arbitration process between payors and providers under the No Surprises Act (NSA).
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