The Partnership to Amend 42 CFR Part 2
ABHW spearheaded a coalition of 50 health care organizations to come together and urge HHS to modernize health information laws to help stem the tide of opioid misuse.
Opioid misuse and overdoses have reached epidemic proportions in the United States (U.S.) and created a health care crisis for patients, families, and the entire country. The onset of the COVID-19 pandemic, which led to social isolation, high unemployment, and diversion of public health resources, has highlighted the urgent need to address the ongoing opioid crisis. According to the Centers for Disease Control and Prevention (CDC), in the 12 months ending in March 2024, over 103,000 lives were lost to overdose.
What is 42 CFR Part 2?
42 CFR Part 2 (Part 2) is the federal regulation, initially developed in the 1970s, that governs the confidentiality of substance use disorder (SUD) treatment and prevention records and sets requirements limiting the use and disclosure of a patient’s SUD records. The law aims to protect the privacy of individuals seeking SUD treatment while ensuring they receive the care they need. Part 2 imposes specific legal requirements different from the Health Insurance Portability and Accountability Act (HIPAA) and other privacy regulations. These regulatory differences make integrating SUD treatment services with other care challenging. Part 2 data is retained in a separate database or isolated from a patient’s overall health record. The different management of Part 2 records contributed to the stigma around SUDs since these records are the only health records treated in this manner. As a result, the law created a barrier to communication between healthcare providers serving persons with SUDs and has created silos of healthcare delivery.
Amidst this challenging environment, Congress took decisive action in 2020 and passed the Coronavirus Aid, Relief, and Economic Security (CARES) Act including the Protecting Jessica Grubb’s Legacy (Legacy Act). The CARES Act takes great strides to align 42 CFR Part 2 (Part 2) with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) for the purposes of health care treatment, payment, and operations (TPO). This alignment will allow appropriate access to patient information essential for providing an accurate diagnosis, effective treatment, and whole-person care. This law also strengthens protections against using SUD records in any civil, criminal, administrative, or legislative proceedings conducted by any federal, state, or local authority.
The Partnership to Amend 42 CFR Part 2 (Partnership) applauds the congressional champions of the Legacy Act, Senators Joe Manchin (I-WV), Shelley Moore Capito (R-WV), Markwayne Mullin (R-OK), and Representative Earl Blumenauer (D-OR), for this important legislation and their tireless work and dedication to addressing the opioid epidemic.
New Regulations
In February of 2024, the U.S. Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) and the Substance Abuse and Mental Health Services Administration (SAMHSA) issued the Part 2 final rule. The rule promotes partial alignment between Part 2 and HIPAA, though the two privacy frameworks remain distinct, particularly for consent purposes. This partial alignment will help curb the substance use disorder (SUD) epidemic and allow for the appropriate sharing of SUD records while simultaneously strengthening patient privacy.
Who We Are
The Partnership to Amend 42 CFR Part 2 is a coalition comprised of 50 national organizations representing a wide range of healthcare stakeholders, including patients, clinicians, hospitals, biopharmaceuticals, the mental health community, pharmacists, electronic health record vendors, and payers, committed to aligning Part 2 with HIPAA to allow appropriate access to patient information that is essential for providing whole-person care. Learn more here.