The Department of Health and Human Services (HHS) has announced proposed changes to the federal regulations governing the confidentiality of patient records created by federally-assisted substance use disorder treatment programs, known as 42 CFR Part 2.
HHS Secretary Alex Azar
The proposed rule establishes important revisions that support coordinated care among providers that treat substance use disorder (SUD), while maintaining privacy safeguards for patients seeking treatment for SUD. The proposed rule is the first of four regulations that have been identified in HHS’s Regulatory Sprint to Coordinated Care that seeks to promote value-based outcomes for patients by examining federal regulations that impede coordinated care among health providers.
“President Trump has promised Americans a healthcare system that provides affordable, high-quality, patient-centric healthcare — a system that treats you like a person, not a number. But outdated regulations have often stood in the way of delivering that kind of care, and our proposed reforms to 42 CFR Part 2 aim to change that,” said HHS Secretary Alex Azar. “These changes also reflect the high priority that the Trump Administration places on improving the quality and availability of behavioral healthcare, especially as we combat our nation’s crisis of opioid addiction and substance abuse.”
Initially promulgated in 1975, 42 CFR Part 2 was designed to protect patient records created by federally-assisted programs for the treatment of SUD from the stigma associated with substance abuse that often deters patients from entering treatment. The emergence of the opioid crisis has created significant clinical and safety challenges for providers that has highlighted the need for thoughtful updates to 42 CFR Part 2 to enhance patient safety and increase care coordination for all providers involved in the treatment of SUD. A growing recognition of the value of coordinated care and integrating physical and behavioral healthcare has also prompted calls for reform.
The proposed rule modifies several sections of 42 CFR Part 2 to encourage care coordination among providers, including updating the definition of what constitutes a Part 2 record and its applicability. This is designed to give providers clarity about what is, or should be, protected by Part 2 and to ensure non-Part 2 providers are not discouraged from caring for SUD patients or recording SUD information due to onerous legal requirements. The rule also clarifies that personal devices not used by a Part 2 program in the regular course of business do not have to be sanitized (i.e. record deletion) because an SUD patient sends an incidental message to their physician’s personal device. Non-Part 2 providers under this rule will now have access to central registries to determine if a patient is enrolled in an Opioid Treatment Program (OTP) and receiving medications as part of SUD treatment to ensure at-risk patients are not accidentally overprescribed or given prescriptions for which they are seeking treatment. The basic framework for confidentiality protection of SUD patient records created by federally-assisted treatment programs will not be altered under the proposed rule. Further, 42 CFR Part 2 will continue to prohibit law enforcement use of SUD patient records in criminal prosecution against the patient, and will also continue to restrict the disclosure of SUD treatment records without patient consent unless an exception applies.