HHS Releases New Rule Modifying Privacy Regulations Around Addiction Treatment
Late in the day on Thursday, August 22, the Department of Health and Human Services (HHS) announced a proposed rule that would bring significant changes to the privacy regulations around drug addiction treatment that have frustrated providers working to address the ongoing nationwide opioid epidemic in the United States. The proposal changes elements of what has been known as “42 CFR Part 2,” around the confidentiality of substance use disorder patient records.
As posted to the HHS website, the announcement began, “The 42 CFR part 2 regulations serve to protect patient records created by federally funded programs for the treatment of substance use disorder (SUD). SAMHSA [the Substance Abuse and Mental Health Services Administration] is currently proposing to revise part 2, to facilitate better coordination of care for substance use disorders which will also enhance care for opioid use disorder (OUD). These provisions will be an important part of the Federal response to the opioid epidemic, while maintaining part 2 confidentiality protections.”
The first paragraph was followed by this paragraph: “What's Not Changing Under the New Part 2 Rule: The proposed rule will not alter the basic framework for confidentiality protection of SUD patient records created by federally funded treatment programs. Part 2 will continue to prohibit law enforcement use of SUD patient records in criminal prosecution against the patient. Part 2 will also continue to restrict the disclosure of SUD treatment records without patient consent, other than as statutorily authorized in the context of a bona fide medical emergency; or for the purpose of scientific research, audit, or program evaluation; or based on an appropriate court order for good cause.”
The proposed rule addresses seven key provisions in the regulation. They are as follows:
Ø Applicability and re-disclosure: “Treatment non-part 2 providers based on their own patient encounter(s) will not be covered by part 2, unless any SUD [substance abuse disorder] records previously received from a part 2 program are incorporated into such records. Segmentation or holding apart 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.
Ø 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.”
Ø Consent requirements: “An SUD patient may consent to disclosure of his part 2 treatment records to an entity (e.g., the Social Security Administration), without naming a specific person as the recipient for the disclosure.”
Ø Disclosures permitted with written consent: “Disclosures for the purpose of "payment and health care operations" are permitted with written consent, in connection with an illustrative list of 17 example activities.”
Ø Disclosures to central registries and PDMPs: “Non-OTP (opioid treatment program) providers will become eligible to query a central registry, in order to determine whether their patients are already receiving opioid treatment through a member program.
OTPs will be 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.”
Ø Medical emergencies: “Declared emergencies resulting from natural disasters (e.g., hurricanes) that disrupt treatment facilities and services will meet the definition for a "bona fide medical emergency," for the purpose of disclosing SUD records without patient consent under part 2.”
Ø Research: “Disclosures for research under part 2 will be 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).”
Ø Audit and evaluation: “Part 2 will be revised to clarify that some specific situations fall within the scope of permitted disclosures for audits and/or program evaluation.”
Ø Confidential communications: “The standard for court ordered disclosures of SUD records for the purpose of investigating "an extremely serious crime" will be revised, by dropping the phrase "allegedly committed by the patient."
Ø Undercover agents and informants: “Court-ordered placement of an undercover agent or informant within a part 2 program will be extended to a period of 12 months, and courts will be authorized to further extend the period of placement through a new court order.”
Under revisions proposed by the Substance Abuse and Mental Health Services Administration (SAHMSA) and introduced by HHS Secretary Alex Azar and his deputies, records of a substance abuse disorder and treatment would no longer be subject to the extra privacy laws that pre-date HIPAA.
Later in the evening, the Charlotte-based Premier Inc. released a statement credited to senior vice president of public affairs Blair Childs. The statement said, “Premier healthcare alliance applauds HHS’ and SAMHSA’s work to improve care coordination for those afflicted with substance use disorders. The proposed rule opens the door to driving greater access to treatment records that will allow clinicians to more effectively help their patients. This information can mean life or death to millions of Americans and can help save the U.S. healthcare system an estimated $11.3 billion annually. We look forward to commenting on the proposed rule.”
And the statement added, “We also call on Congress to pass the Jessica Grubbs Legacy Act (S. 1012) and the Overdose Prevention and Patient Safety Act (H.R. 2062) to ensure full parity and equity for those dealing with substance use disorders.”
This is a developing story. Healthcare Innovation will update readers on ongoing developments.
