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HHS proposes substance use disorder regulatory reforms to increase sharing of information

Current regulations are so complex that some providers opt not to serve substance use disorder patients.

Susan Morse, Managing Editor

The Department of Health and Human Services has announced proposed changes to federal regulations governing the confidentiality of patient records created by federally-assisted substance use disorder treatment programs, known as 42 CFR Part 2.

Part 2 predated HIPAA and today imposes significant barriers to care, said HHS Secretary Alex Azar.

Currently, Part 2 is so complex that some providers opt not to serve these patients.

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The changes will allow for the integration of substance use disorder health with overall health, Azar said. HHS has heard from both patients and those in the medical field for the need for more coordinated care.


The basic framework for confidentiality protection of substance use disorder patient records will not be altered under the proposed rule.

The proposed rule establishes revisions that support coordinated care while maintaining privacy safeguards.

It updates the definition of what constitutes a Part 2 record and its applicability.

It 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 substance use disorder patients or   recording SUD information due to onerous legal requirements.

It allows patients to send information to the Social Security Administration without having the name and contact information of a specific person.

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 through record deletion when a substance use disorder 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 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.

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.


The emergence of the opioid crisis has created significant clinical and safety challenges for providers.

A growing recognition of the value of coordinated care and integrating physical and behavioral healthcare has prompted calls for reform.


One of the reasons for the rule change is President Trump's focus on the opioid crisis, Azar said.

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.

The proposed changes to Part 2 are the first proposed regulations released under the Regulatory Sprint to Coordinated Care.

Initially promulgated in 1975, 42 CFR Part 2 was designed to protect patients from the stigma associated with substance abuse that often deters them from entering treatment.


"As part of our Regulatory Sprint to Coordinated Care, these proposed changes are just the beginning of a comprehensive agenda for reforming regulations that govern the delivery and financing of American healthcare, with the ultimate goal of better care, and better health, at a lower cost," said HHS Deputy Secretary Eric Hargan.

"The lack of critical substance use history in a patient's medical record can lead to potentially damaging consequences for a person with a substance use disorder and can further stigmatize these conditions," said Assistant Secretary Elinore F. McCance-Katz. 

"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," Azar said.

Twitter: @SusanJMorse
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