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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

Returning to Work: Forecasting the New Normal in Business

April 16, 2020We cannot predict when businesses will reopen across the county. As we publish this Alert, dynamic business leaders are cooperating in comprehensive efforts to create safe work environments so that they can all re-engage the workforce. However, we can predict the new normal in business. Some important studies were published yesterday, and the new normal in business will be facemasks for all employees, and probably all business visitors.Client Alert

Updated Guidance on Ohio Department of Medicaid Telehealth Rules During the Covid-19 Public Health Emergency

April 15, 2020In its initial response to the COVID-19 public health emergency, the Ohio Department of Medicaid (“ODM”) issued emergency rule 5160-1-21, which dramatically expanded reimbursable telehealth services, telehealth providers, allowable technology, location of both providers and patients, and covered billing provider types. See BMD’s initial COVID-19 and Telehealth Resource Guide here. This emergency rule provides wide flexibility for patients to receive necessary healthcare services while Ohio’s Stay-At-Home Order remains in place. Regulations are continually changing in response to the public health crisis, and on April 13, 2020, ODM issued new guidance further expanding telehealth services reimbursable under Ohio’s Medicaid program.Client Alert

Essential Businesses during COVID-19: Identification and Operation FAQs

April 14, 2020During the COVID-19 pandemic, the ability to classify your business as “essential” could be the key to its survival. Almost every state in the United States has imposed a “stay-at-home” or “shelter-in-place” order that restricts the types of businesses that can remain open. In fact, as of the writing of this alert, there are only seven states that have not imposed state-wide restrictions on which businesses can stay open during the Coronavirus pandemic and even those states have individual cities and counties that have imposed stricter orders. However, these orders are not always clear, and interpretation is often left to the individual business. This alert will answer some of the most common questions about essential businesses.Client Alert

UPDATE: Exempt Organizations Filing Deadline Extended Until July 15, 2020

April 13, 2020In a recent announcement, the IRS has expanded the deadline for any taxpayers, whether individuals, trusts, estates, corporations, and other non-corporate tax filers, where a filing or payment deadline falls on or after April 1, 2020 and before July 15, 2020. These taxpayers now have until July 15, 2020 to file and pay any federal income tax that is generally due on April 15. The IRS will not assess any late-filing penalty, late-payment penalty, or interest.Client Alert

New IRS Portal for Non-filing Taxpayers to Enter Payment Information & Receive Economic Impact Payments

April 13, 2020The IRS has created a portal for non-filers to enter payment information in order to receive the economic impact payments. This portal is for taxpayer’s who have gross income that does not exceed $12,200 if single and $24,400 if married filing jointly, or were not otherwise required, or plan, to file a tax return for 2019.
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