By: George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
On February 8, 2024, the U.S. Department of Health and Human Services (HHS) released a final rule modifying the Confidentiality of Substance Use Disorder (SUD) Patient Records federal regulations (42 C.F.R. Part 2). The new regulation will supposedly help ensure that healthcare providers have more complete information when treating patients with substance use disorders and improve that regulations compatibility with the Health Insurance Portability and Accountability Act (HIPAA) Privacy Regulations.
Background.
The SUD final rule came out of the bipartisan Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which, among other things, required HHS to align the Part 2 SUD program with HIPAA Privacy, Breach Notification, and Enforcement Rules.
The final rule strengthens confidentiality protections while improving care coordination for patients and providers. Patients can seek needed treatment and care for substance use disorder knowing that greater protections are in place to keep their records and information private. Providers can also better share information to improve patient care, according to the HHS press release.
View the HHS press release on this new rule in full here. (https://www.hhs.gov/about/news/2024/02/08/hhs-finalizes-new-provisions-enhance-integrated-care-confidentiality-patients-substance-use-conditions.html)
Changes Contained in the New Part 2 Rule.
The new final rule includes the following modifications to Part 2:
1. Permits use and disclosure of Part 2 SUD records based on a single patient consent given once for all future uses and disclosures for treatment, payment, and health care operations.
2. Permits redisclosure of Part 2 SUD records by HIPAA-covered entities and business associates in accordance with the HIPAA Privacy Rule, with certain exceptions.
3. Provides new rights for patients under Part 2 to obtain an accounting of disclosures and to request restrictions on certain disclosures, as also granted by the HIPAA Privacy Rule.
4. Expands prohibitions on the use and disclosure of Part 2 SUD records in civil, criminal, administrative, and legislative proceedings.
5. Provides HHS enforcement authority, including the potential imposition of civil money penalties for violations of Part 2.
6. Outlines new breach notification requirements applying to Part 2 records.
To view a fact sheet from HHS on the final rule click here.
To view the final rule in full, click here.
Consult with a Health Law Attorney Experienced In Representation of Health Care Professionals.
The Health Law Firm represents physicians, medical groups, nursing homes, home health agencies, pharmacies, hospitals, and other healthcare providers and institutions to investigate and defend alleged HIPAA complaints and violations and prepare Corrective Action Plans (CAPs). Our attorneys regularly defend OCR HIPAA audits, defend in HIPAA complaint investigations, assist in preparing a HIPAA Risk Analyses, defend in federal administrative actions and administrative hearing cases, and defend in civil or administrative litigation of HIPAA/breach of medical confidentiality lawsuits.
For more information about HIPAA violations, electronic health records or corrective action plans (CAPs) please visit our website at www.TheHealthLawFirm.com or call (407) 331-6620 or toll-free (888) 331-6620.
Sources:
Deloss, G. (February 16, 2024). Final substance use disorder confidentiality rule released. American Health Law. Retrieved from https://www.americanhealthlaw.org/content-library/health-law-weekly/article/2b7a3093-9e2d-4cd2-ba04-ec240123e94e/Final-Substance-Use-Disorder-Confidentiality-Rule?_zs=9G5tn&_zl=1d1q2
U.S. Department of Health and Human Services. (February 8, 2024). HHS Finalizes new provisions to enhance integrated care and confidentiality for patients with substance use conditions. U.S. Department of Health and Human Services. Retrieved from https://www.hhs.gov/about/news/2024/02/08/hhs-finalizes-new-provisions-enhance-integrated-care-confidentiality-patients-substance-use-conditions.html
About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 331-6620 Toll-Free: (888) 331-6620.
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