A bipartisan group of U.S. senators is calling on the Biden administration to refine its proposed rule on addiction treatment privacy to better align with a law designed to prevent opioids from being prescribed to people in recovery. The move highlights ongoing efforts to balance patient confidentiality with the need for efficient information sharing among health care providers.
On Tuesday, Senators Shelley Moore Capito (R-W.Va.), Joe Manchin (D-W.Va.), Jeff Merkley (D-Ore.), Amy Klobuchar (D-Minn.), and Susan Collins (R-Maine) sent an open letter to the U.S. Department of Health and Human Services (HHS). The senators emphasized the need to ensure that the proposed rule fully reflects the intentions of the Protecting Jessica Grubb’s Legacy Act, legislation passed in March 2020 as part of the CARES Act.
“Today’s letter recommends improvements to those proposed changes to ensure HHS is fully implementing the Legacy Act as Congressionally intended,” the senators wrote.
Understanding the Proposed Rule
The proposed rule, released in November 2022, seeks to modernize 42 CFR Part 2, a federal regulation that requires strict confidentiality of substance use disorder (SUD) patient records. The law is essential for protecting people in addiction treatment from stigma, discrimination, and legal consequences that could arise if their treatment information were disclosed.
The goal of the new rule is to bring 42 CFR Part 2 in line with broader patient privacy laws such as the Health Insurance Portability and Accountability Act of 1996 (HIPAA). By updating these regulations, the rule seeks to improve addiction treatment privacy while enabling providers to share necessary information safely.
The rule has already drawn significant public attention. During a two-month comment period, HHS received 232 submissions, reflecting input from patients, providers, advocacy groups, and other stakeholders. The feedback underscores the complexity of updating confidentiality regulations without compromising addiction treatment privacy or creating excessive administrative burdens.
Why Reforming 42 CFR Part 2 Matters
Behavioral health providers have long argued that 42 CFR Part 2, while critical for maintaining addiction treatment privacy, has unintended consequences. The law’s strict confidentiality requirements can:
- Hinder care coordination between providers, making it difficult for patients to receive integrated treatment
- Create administrative burdens that slow clinical workflows and limit efficiency
- Reduce adoption of electronic health records (EHRs) in behavioral health, limiting the benefits of digital recordkeeping and secure information sharing
By reforming the rules, the proposed updates aim to preserve addiction treatment privacy while enabling providers to share information safely and efficiently—a critical step in addressing the opioid epidemic and broader substance use crises.
Key Recommendations from Senators
In their letter, the senators outlined specific recommendations to improve the proposed rule:
- One-time initial written consent for sharing information between providers, reducing the need for repeated paperwork
- One-time written revocations of records sharing, simplifying processes for patients who wish to withdraw consent
- Clarification around intermediaries, ensuring that third-party organizations handling sensitive data are properly defined and regulated
- Additional technical assistance for providers navigating compliance with updated regulations
“Now, more than two years since the passage of the Legacy Act, it is important that we finalize this rule,” the senators wrote. “This will allow us to improve care coordination, while protecting patient privacy, in order to ensure we are addressing the drug epidemic to our fullest potential.”
Protecting Jessica Grubb’s Legacy Act
The Protecting Jessica Grubb’s Legacy Act was enacted to address a critical concern: preventing the over-prescription of opioids to individuals in recovery while supporting safe and controlled information sharing among health care providers. The law reflects Congress’s intent to balance patient safety with treatment privacy.
However, without finalization of the proposed rule, 42 CFR Part 2 remains in effect, leaving behavioral health providers and patients in a state of uncertainty. Many industry stakeholders support alignment with HIPAA standards, but also stress that clarity and guidance are needed to reduce administrative burden and allow providers to confidently share information while maintaining addiction treatment privacy.
“While we are pleased to see alignment with HIPAA … we have concerns regarding ensuring there is clarity to reduce administrative burden and prevent unnecessary data segmentation,” the senators wrote. “We hope that with some additional clarity, we will be able to meet the goals of reducing administrative burdens and ensuring certain providers will be able to share information confidently.”
Implications for Patients and Providers
The push to finalize and refine the rule has implications across the behavioral health landscape:
- For patients, clearer rules mean better care coordination without sacrificing addiction treatment privacy. Integrated care can lead to improved outcomes, particularly for those managing multiple health conditions alongside recovery
- For providers, reduced administrative burdens and guidance on record sharing can free up resources to focus on treatment rather than paperwork. Electronic health records could become more widely adopted, enhancing efficiency and communication across the care continuum
- For the healthcare system, aligning 42 CFR Part 2 with HIPAA could standardize processes and reduce fragmentation, enabling a more cohesive approach to combating substance use disorders and the opioid epidemic while ensuring strong addiction treatment privacy protections
Looking Ahead
As HHS reviews the feedback and considers refinements, the behavioral health community will be watching closely. Finalizing a rule that balances addiction treatment privacy, provider efficiency, and care coordination could be a turning point in improving outcomes for individuals in recovery while addressing the broader substance use crisis.
The bipartisan letter underscores the urgency of this work, emphasizing that careful implementation of the Protecting Jessica Grubb’s Legacy Act is not only a regulatory necessity but also a crucial step in strengthening the nation’s response to addiction and improving behavioral health care overall.
