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Last month, the U.S. Department of Health and Human Services (HHS) adopted revisions to 42 CFR Part 2—the regulations that serve to protect patient records created by federally assisted programs for the treatment of substance use disorders (SUD). According to the HHS, the rule reform promises to “make it easier for Americans to seek and receive treatment while lifting burdens on providers and maintaining important privacy protections.”

Practically speaking, the update removes administrative hurdles from existing privacy regulations that have been described by physicians as “onerous,” sometimes requiring that they “fill out 11 different kinds of paperwork.” By lifting these restrictions, the HHS believes that healthcare providers, especially primary care clinicians, will no longer be deterred from caring for SUD patients or recording SUD information: “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.

HHS argues that changes increase access to higher-quality, better coordinated care without sacrificing important privacy protections that the rule is meant to safeguard. However, some SUD patient advocate groups warn that loosening privacy restrictions can have the opposite effect—that by loosening privacy restrictions SUD patients may avoid treatment altogether.


History of 42 CFR Part 2


          Similar to HIPPA, which regulates the use and disclosure of protected health information, 42 CFR Part 2 created special protections afforded to patient records that contain a patient’s alcohol and drug abuse information. The privacy provisions in 42 CFR Part 2 were motivated by the understanding that stigma and fear of prosecution might dissuade persons with substance use disorders from seeking treatment. To add an extra layer of protection on these records, the regulations outline under what limited circumstances information about a patient’s treatment may be disclosed with and without the patient’s consent.


Who and What is Covered Under 42 CFR Part 2?

          The purpose of 42 CFR Part 2 is to ensure that a patient receiving treatment for a substance use disorder is not made more vulnerable than an individual with a substance use disorder who does not seek treatment. Patient consent must be obtained before sharing information from a program that is subject to 42 CFR Part 2. Once this information has been disclosed, no redisclosure is permitted without the patient’s express consent to re-disclose or unless otherwise permitted under Part 2.

42 CFR Part 2 applies to any individual or entity that is federally assisted and holds itself out as providing, and provides, alcohol or drug abuse diagnosis, treatment or referral for treatment (42 CFR § 2.11). Most drug and alcohol treatment programs accept federal assistance, and those private practitioners or organizations that do not receive federal assistance may be otherwise subject to the requirements of 42 CFR Part 2 via a State licensing or certification board. In addition, any provider licensed through the DEA to dispense controlled substances for detoxification or maintenance treatment is subject to the regulations.



Examining Changes to the Rule


What Changed?

Why Was This Changed?

Applicability and Re-Disclosure

Treatment records created by non-Part 2 providers based on their own patient encounter(s) are explicitly not covered by Part 2, unless any SUD records previously received from a Part 2 program are incorporated into such 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.

To facilitate coordination of care activities by non-part-2 providers.

Disposition of Records

When an SUD patient sends an incidental message to the personal device of an employee of a Part 2 program, the employee will be able to fulfill the Part 2 requirement for “sanitizing” the device by deleting that message.

To ensure that the personal devices of employees will not need to be confiscated or destroyed, in order to sanitize in compliance with Part 2.

Consent Requirements

An SUD patient may consent to disclosure of the patient’s Part 2 treatment records to an entity (e.g., the Social Security Administration), without naming a specific person as the recipient for the disclosure.

To allow patients to apply for benefits and resources more easily, for example, when using online applications that do not identify a specific person as the recipient for a disclosure of Part 2 records.

Disclosures Permitted w/ Written Consent

Disclosures for the purpose of “payment and health care operations” are permitted with written consent, in connection with an illustrative list of 18 activities that constitute payment and health care operations now specified under the regulatory provision.

In order to resolve lingering confusion under Part 2 about what activities count as “payment and health care operations,” the list of examples has been moved into the regulation text from the preamble, and expanded to include care coordination and case management activities.

Disclosures to Central Registries and PDMPs

Non-OTP (opioid treatment program) and non-central registry treating providers are now eligible to query a central registry, in order to determine whether their patients are already receiving opioid treatment through a member 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.

To prevent duplicative enrollments in SUD care, duplicative prescriptions for SUD treatment, and adverse drug events related to SUD treatment.

Medical Emergencies

Declared emergencies resulting from natural disasters (e.g., hurricanes) that disrupt treatment facilities and services are considered a “bona fide medical emergency,” for the purpose of disclosing SUD records without patient consent under Part 2.

To ensure clinically appropriate communications and access to SUD care, in the context of declared emergencies resulting from natural disasters.


Disclosures for research under Part 2 are permitted by a HIPAA-covered entity or business associate to individuals and organizations who are neither HIPAA covered entities, nor subject to the Common Rule (re: Research on Human Subjects).

To facilitate appropriate disclosures for research, by streamlining overlapping requirements under Part 2, the HIPAA Privacy Rule and the Common Rule.

Audit and Evaluation

Clarifies specific situations that fall within the scope of permissible disclosures for audits and/or program evaluation purposes.

To resolve current ambiguity under Part 2 about what activities are covered by the audit and evaluation provision.

Undercover Agents and Informants

Court-ordered placement of an undercover agent or informant within a Part 2 program is extended to a period of 12 months, and courts are authorized to further extend the period of placement through a new court order.

To address law enforcement concerns that the current policy is overly restrictive to some ongoing investigations of Part 2 programs.



Substance Use Disorder Treatment Industry News will be a regular feature on Romano Law Group blog.  We intend to cover legal topics as well as research concerning Substance Use Disorder as well as other current topics.




At Romano Law Group, Rainer Boggiano is focused on representing plaintiffs in catastrophic injury matters, including wrongful death, negligence, medical malpractice, and products liability litigation.

Rainer earned his Juris Doctor from the University of Florida Levin College of Law in Gainesville, Florida and his Bachelor of Business Administration in Economics from Florida Atlantic University in Boca Raton, Florida.

While attending law school, Rainer served as a judicial extern at Florida’s Fourth District Court of Appeal and a legal intern for ADT Security Services at its corporate headquarters in Boca Raton. He graduated with multiple Dean’s List honors and was a Pro Bono Award recipient in recognition for completing 150+ hours of community service.

Rainer is active in several community organizations, having served as a volunteer for the 15th Judicial Circuit’s Guardian ad Litem Program, a tutor at the Mandel Public Library’s homework center, and a mentor for several local non-profit organizations.



Susan Ramsey is both an attorney and an RN. Ms. Ramsey’s professional experience began as a Registered Nurse in the Intensive Care Unit at Yale New Haven Hospital. While pursuing her Bachelor’s Degree, she was a counselor with the New Haven Rape Crisis Program. During her time with the Program, Ms. Ramsey counseled sexual assault survivors and performed seminars for local police departments, universities, and high schools.

During her time working as a registered nurse, Ms. Ramsey decided to attend law school. Ms. Ramsey graduated from CUNY Law School, and has practiced law in several different State and Federal Courts.  She is a Florida Heath Care Risk Manager and a member of the Palm Beach County Sober Home Task Force. 

Ms. Ramsey actively litigates cases involving catastrophic injuries and wrongful death on behalf of survivors, cases include injuries suffered by victims of professional negligence, product liability and medical negligence.