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What Do You Need to Know About Changes to 42 CFR Part 2?

What Do You Need to Know About Changes to 42 CFR Part 2?

posted by: Nicole Hovey date: Aug 18, 2020 category: Blog comments: Comments Off on What Do You Need to Know About Changes to 42 CFR Part 2?

The Substance Abuse and Mental Health Services Administration (SAMHSA), part of the U.S. Department of Health and Human Services (HHS), has revised the Confidentiality of Substance Use Disorder Patient Records regulation known as 42 CFR Part 2.

SAMHSA says that this move is intended to aid care coordination between providers while still protecting client privacy.

What is 42 CFR Part 2?

Many individuals do not seek treatment for substance use disorders (SUDs) due to perceived bias from providers, peers, law enforcement, and others. The rule known as 42 CFR Part 2 was drafted in 1972 to protect patients from stigma or bias associated with substance abuse.

However, the rule carried strict requirements regarding the use and disclosure of records for SUD clients. These restrictions have been criticized for hindering provider efforts to treat patients with SUD.

In 2019, HHS proposed reforms to the rule, some of which SAMHSA has now adopted.

What is staying the same?

According to HHS, the basic framework for 42 CFR Part 2 remains unchanged.

Law enforcement is still prohibited from using the records of SUD patients in criminal prosecutions against those patients without a court order.
Disclosure of SUD treatment records without patient consent are still restricted, except with an appropriate court order, when statutorily authorized in a true medical emergency, or for scientific research, audit, or program evaluation.
The rule applies to patient records created by federally assisted SUD treatment programs.

What changed?

Several significant portions of the rule have changed. These areas include:


Treatment records created by non-Part 2 providers based on their own client encounters do not fall under Part 2, unless those records incorporate any SUD records previously received from a Part 2 program.

Client consent

An SUD client may consent to disclosure of their Part 2 treatment records to an entity without naming a specific disclosure recipient. This helps clients more easily apply for benefits and resources.

Records can also be disclosed for 18 activities that constitute “payment and health care operations,” with written consent. These now include care coordination and case management activities.

Disposition of records

If an SUD client sends an incidental message to the personal device of a Part 2 program employee, that employee can “sanitize” their device simply by deleting that message. This ensures that employees’ personal devices do not need to be confiscated or destroyed to stay compliant with Part 2.

Disclosures to Central Registries and Prescription Drug Monitoring Programs (PDMPs)

Treating providers who are not in an opioid treatment program (OTP) or central registry can still consult central registries to determine whether their clients are already receiving opioid treatment through a member program. OTPs can enroll in a state PDMP and report data into the program when prescribing or dispensing medications on Schedules II to V, consistent with state law. This change could help prevent duplicates in SUD enrollment, SUD treatment prescriptions, or adverse drug events related to SUD treatment.

Get the full list of changes from the HHS Fact Sheet.

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