The final rule will retain a basic framework to protect the records of patients with substance use disorder, but will remove barriers to coordinated care and enable providers to share more patient information, according to HHS' Substance Abuse and Mental Health Services Administration.
While the changes should boost information-sharing among providers, insurers, government agencies and law enforcement, patients will still have to agree to share information under most circumstances.
"Modernizing 42 CFR Part 2 will strengthen the nation's efforts to reduce opioid misuse and abuse and to support patients and their families confronting substance use disorders," said Dr. Elinore McCance-Katz, HHS assistant secretary for mental health and substance use.
The rule changes take effect Aug. 14.
Many policymakers and industry insiders worry that existing regulations safeguarding patient privacy make it too difficult to provide care to people with substance use disorder, hamstringing national efforts to curb the opioid crisis.
"The final rule opens the door to driving greater access to substance use treatment records, which can mean life or death to millions of Americans and can help save the U.S. healthcare system an estimated $11.3 billion annually," group purchasing organization Premier said in a statement.
But a number of patient advocates, privacy groups and behavioral health providers worry that people won't get help if they think their privacy won't be protected or their information could be used against them by insurers or law enforcement.
Unlike other public health concerns, substance abuse and misuse can have life-altering legal implications for those suffering from it. People in communities of color, immigrant communities and low-income neighborhoods might be afraid to seek treatment if they're worried about being criminally prosecuted or immigration enforcement actions against their family members.
The final rule is largely unchanged from what SAMHSA proposed last fall. But Congress made several changes to the law that allows regulators to create rules around patient confidentiality when it passed the CARES Act in March.
"Most notably, some sections in the new statute seek to align the part 2 confidentiality standards more closely with the Health Insurance Portability and Accountability Act of 1996," SAMHSA said in the rule.
The CARES Act changes are broadly in line with the Trump administration's new rule, but new regulations based on those changes can't go into effect before March 2021. In the interim, federal regulators believe the new rule will safeguard patient privacy and take "important first steps toward the greater flexibility for information-sharing envisioned by Congress," SAMHSA said in the regulation.
Many providers, health plans, suppliers and state agencies widely supported the new rule when SAMHSA announced it, but they were concerned it could conflict with HIPAA. Now that regulators have the power to align the two laws, their concerns should be mostly alleviated. Regulators said they plan to propose new confidentiality rules for patients with substance use disorder based on the updated statute.