A Milestone in Modernization of Care for Substance Use Disorder Patients
Final “42 CFR Part 2” privacy rule changes unveiled
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After years of advocacy by the Hazelden Betty Ford Foundation and other health care entities, the U.S. Department of Health and Human Services recently released historic rule changes related to 42 CFR Part 2 — the law that governs the privacy of substance use disorder (SUD) patient records.
The changes represent a significant step forward in enhancing patient care coordination, breaking down barriers to information sharing, and safeguarding patient privacy — and also is a hard-fought advocacy victory to be celebrated in Hazelden Betty Ford’s 75th anniversary year.
“The modernization of Part 2 will help advance efforts to integrate substance use care into the mainstream of health care and expand access to quality, coordinated care for millions of Americans who experience substance use disorders,” said Hazelden Betty Ford Chief Legal, Advocacy and Compliance Officer Emily Piper.
“This will have a profound impact on how we deliver and coordinate patient care,” added Jacki Waltman, the nonprofit’s corporate privacy officer and senior manager of health information management. “The new Part 2 rule promises to usher in a new era of streamlined processes and modern care delivery.”
The changes better align 42 CFR Part 2 — a 1975 law designed specifically to govern substance use disorder treatment records — with the Health Insurance Portability and Accountability Act (HIPAA), the 1996 law designed to govern all other health care records. Differences between the two laws — both in requirements and enforcement — have created onerous barriers for SUD patients and care modernization.
With virtually all health care technology designed to be HIPAA-compliant but not Part 2-compliant — due to the additional complexities required to accommodate a single disease — many SUD patients and providers have not been able to take advantage of innovations such as e-prescribing. And, in this separate-and-unequal environment, record-sharing between Part 2 entities and other health care providers has been inhibited.
Additionally, federal privacy enforcement efforts have, for some time, been focused exclusively on HIPAA rather than on the additional requirements and complexities of Part 2.
“One of the most noteworthy changes is the simplification of patient consent requirements,” Waltman said. “Healthcare providers like us will now be able to obtain a single consent covering all record-sharing related to providing treatment, obtaining payment, and conducting routine healthcare operations. In other words, we’ll be able to share essential information without compromising the confidentiality and privacy rights of the patients, ultimately leading to more informed and timely decision-making. This is consistent with practices involving all other medical records. This will ease the administrative burden on both patients and providers and ensure that relevant information can be shared seamlessly both internally and with other providers, leading to more comprehensive and well-coordinated care.”
Waltman and her team are now analyzing the details of the new rule and developing a strategy, in collaboration with clinical leaders, for how to implement the streamlined requirements into Hazelden Betty Ford’s internal systems and processes.
“We look forward to navigating this exciting journey together as we prioritize our patients’ well-being and strive for excellence in healthcare delivery,” she said.
Background
Hazelden Betty Ford’s advocacy for the modernization of Part 2 began more than a decade ago and included lobbying of policymakers in Washington, DC, position papers and op-eds, letters and blogs, drafted legislative language, media interviews, and Congressional testimony in 2018 by Hazelden Betty Ford’s Jeremiah Gardner, who recently reflected on the historic changes.
Piper and former General Counsel Jenni Lohse led the organization’s successful advocacy efforts, spearheading Hazelden Betty Ford’s participation in a national coalition called The Partnership to Amend 42 CFR Part 2. They made numerous trips to the nation’s capital, including one in the waning days of March 2020 as the Partnership’s proposed bill language was added to the CARES Act (the first comprehensive COVID-19 relief bill) and passed into law. The federal Substance Abuse and Mental Health Services Administration (SAMHSA) then drafted an updated rule to guide the law’s implementation and released it for public comment in 2022.
The final rule was published in February 2024.
“In our advocacy, we have been focused on striking the right balance of eliminating discriminatory barriers while protecting confidentiality and patient rights. This is a significant step forward on that front,” Piper said. “Big thanks and congratulations to our Board of Trustees and senior leadership for prioritizing this issue; to Senators Manchin, Moore Capito, and Klobuchar — among others — for their tireless leadership and championing of the changes; to Corporate Privacy Officer Jacki Waltman and her team as well as the entire Hazelden Betty Ford workforce for their support and for empowering us to be a voice for them and those we serve.”
