SAMHSA Revises Privacy Rule 42 CFR Part 2 for Substance Use Patients

July 13, 2020 - The Department of Health and Human Services’ Substance Abuse and Mental Health Services (SAMHSA) announced the agency has revised the Confidentiality of Substance Use Disorder Patient Records regulation, 42 CFR Part 2.  

In the last few years, industry stakeholders and lawmakers have asked for an update to 42 CFR Part 2, which is seen as outdated and burdensome for providers when it comes to sharing the patient records of substance use disorder patients. Other leaders have pressed for an alignment with HIPAA to reduce those challenges. 

The rule was drafted in 1972 and intended to shield patients from any stigma or bias associated with substance abuse, which could deter those patients from attempting to receive treatment. However, given its strict requirements on the use and disclosure of those records, 42 CFR Part 2 often prevented providers from attempting to treat patients with substance use disorders.

In comments to Congress in 2018, the American Hosptial Association warned "partitioning a patient’s record to keep SUD diagnoses and treatments hidden from the clinicians entrusted to care for the patient, as required by 42 CFR Part 2, is dangerous for the patient, problematic for providers and contributes to the stigmatization of mental and behavioral health conditions.” 

In 2019, HHS proposed a reform of the rule that would better support care coordination and improve privacy protections. The latest announcement confirms SAMHSA has now adopted some of those proposed changes as part of the HHS Regulatory Sprint to Coordinated Care, “while maintaining its confidentiality protections against unauthorized disclosure and use.” 

“This reform will help make it easier for Americans to discuss substance use disorders with their doctors, seek treatment, and find the road to recovery,” said HHS Secretary Alex Azar, in a statement. “Thanks to the valuable input of stakeholders, our final rule will make it easier for Americans to seek and receive treatment while lifting burdens on providers and maintaining important privacy protections.” 

According to the announcement, Part 2 outlines that “a federally assisted substance use disorder program may only disclose patient identifying information with the individual’s written consent, as part of a court order, or under a few limited exceptions.” 

HHS officials believe that the changes will allow providers, with the consent of patients, to increase patient safety, training, program integrity, claims management, and quality improvement efforts. Further, the revised rule is designed to increase alignment between Part 2 CFR 42 and HIPAA. 

The HHS fact sheet detailed the changes made to several major sections of the rule, including ensuring that the treatment records created by providers who are not covered by the Part 2 rule, and based on their own patient encounters, are not explicitly covered by the rule, unless the substance use disorder records were previously received from a Part 2 program are incorporated into those records. 

“Segmentation or holding a part of any Part 2 patient record previously received can be used to ensure that new records created by non-Part 2 providers will not become subject to Part 2,” according to the fact sheet. 

The revised rule also clarifies the specific situations that fall in the scope of permissible disclosures for audits or program evaluation purposes, while declaring emergencies that disrupt treatment services and facilities a “bona fide medical emergency” to disclose SUD records with patient consent under Part and support clinically appropriate communications and access to SUD care. 

Further, the rule states that non-opioid treatment program (OTPs) and non-central registry treatment providers are now eligible to query a central registry to determine whether their patient is already receiving treatment through another program. 

“OTPs are permitted to enroll in a state prescription drug monitoring program (PDMP) and permitted to report data into the PDMP when prescribing or dispensing medications on Schedules II to V, consistent with applicable state law,” the fact sheet stated. 

The fact sheet details each change and intended purpose. But HHS stressed that the basic framework for the confidentiality and protection of substance use disorder patient records created by federally assisted SUD treatment programs. 

The 42 CFR Part 2 will continue to prohibit the law enforcement’s use of SUD patient records in criminal prosecutions against patients without a court order. And the rule maintains restrictions on the disclosure of SUD treatment records without patient consent, unless it’s a bona fide national medical emergency, an audit, scientific research, or program evaluation, or appropriate court order. 

“Modernizing 42 CFR Part 2 will strengthen the nation’s efforts to reduce opioid misuse and abuse and to support patients and their families confronting substance use disorders,” HHS Assistant Secretary for Mental Health and Substance Use Elinore F. McCance-Katz, MD, said in a statement. 

“We need an all-hands-on-deck approach to treating substance use disorders,” she added. “We must do all we can to ensure the greatest access and availability to care for individuals living with substance use disorders. Although well-intentioned, the non-disclosure of critical, lifesaving information the previous rule permitted is itself stigmatizing.”