By: George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
In 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 regulations (42 CFR Part 2). The rule helps to ensure that healthcare providers have more complete information when treating patients with substance use disorders, and also attempts to bring the CFR Rule into alignment with Health Insurance Portability and Accountability Act (HIPAA) Privacy Regulation.
Overview of the New Regulation.
The bipartisan Coronavirus Aid, Relief, and Economic Security Act (CARES Act) partly motivated the Final Rule to align the Federal Rule Part 2 program with the HIPAA Privacy, Breach Notification, and Enforcement Rules.
The Final Rule strengthens confidentiality protections while improving care coordination for patients and providers. Patients can now seek needed treatment and care for substance use disorders, knowing that greater protections are in place to keep their records private. Providers can now better share information to improve patient care, according to the HHS press release.
The New Part 2 Final Rule: What’s Changing?
The Final Rule includes the following notable modifications to 42 CFR Part 2:
1. It now permits the use and disclosure of 42 CFR Part 2 records based on a single patient consent given once for all future uses and disclosures for treatment, payment, and health care operations.
2. It permits redisclosure of 42 CFR Part 2 records by HIPAA “covered entities” and “business associates” in accordance with the HIPAA Privacy Rule, with certain exceptions.
3. The Part 2 regulations grant patients new rights to obtain an accounting of disclosures and to request restrictions on certain disclosures, similar to the rights provided by the HIPAA Privacy Rule.
4. The new Final Rule expands prohibitions on the use and disclosure of Part 2 records in civil, criminal, administrative, and legislative proceedings.
5. The Rule provides HHS enforcement authority, including the potential imposition of civil money penalties for violations of 42 CFR Part 2
6. It outlines new breach notification requirements applying to 42 CFR Part 2 records.
Sources Used:
HHS Press Release of February 8, 2024: (www.hhs.gov/about/news/2024/02/08/hhs-finalizes-new-provisions-enhance-integrated-care-confidentiality-patients-substance-use-conditions.html)
HHS Fact Sheet 42 CFR Part 2 Final Rule (Feb. 8, 2024)
Deloss, G. Final substance use disorder confidentiality rule released. (Feb. 16, 2024, American Health Law Ass’n.).
U.S. Department of Health and Human Services. HHS Finalizes new provisions to enhance integrated care and confidentiality for patients with substance use conditions. (February 8, 2024, U.S. Department of Health and Human Services.)
Consult with a Health Law Attorney Experienced in Representing healthcare Professionals.
The Health Law Firm represents physicians, medical groups, resident physicians, nurse practitioners, mental health professionals and other healthcare providers and institutions to limit the disclosure and use of their 42 CFR Part 2 substance use disorder (SUD) records. They 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. We also defend in federal administrative actions and administrative hearing cases, and defend in civil or administrative litigation of HIPAA/breach of medical confidentiality lawsuits. We represent health professionals and health facilities in administrative hearings on the state level and the federal level. We also defend physicians, nurses, mental health counselors, nurse practitioners and other health professionals accused of impairment, alcohol abuse or drug abuse and who are referred to the Intervention Project for Nurses (IPN) and to the Professionals Resource Network (PRN)
For more information about HIPAA violations, electronic health records or corrective action plans (CAPs), visit our website at https://www.TheHealthLawFirm.com/
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call (407) 331-6620 or call 1-(888) 331-6620 toll-free from Anywhere.
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. The Health Law Firm, 1101 Douglas Avenue, Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 331-6620 Toll-Free: (888) 331-6620. For more information on Mr. Indest, click here:
https://www.thehealthlawfirm.com/about-our-firm/attorneys/george-f-indest-iii/
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