UPDATE: August 26, 2019: The piece has been updated to reflect criticism of the rule by legal and patient advocates.
- HHS is proposing a rule that would eliminate barriers to patient records as physicians treat those with substance use disorders as part of an ongoing push to cut outdated or unnecessarily strict regulations in healthcare.
- The agency is attempting to modify a nearly four-decade old federal confidentiality law that predates HIPAA that it says carries "onerous" legal requirements. Critics of the law maintain it's a barrier to coordinating mental, behavioral and physical health services for patients with SUD.
- Currently, before prescribing an opioid, a physician cannot query the available databases to see if the patient is under treatment for SUD. This rule, if finalized, would allow access to that information.
The law, referred to as 42 CFR Part 2 or just Part 2, was initially designed to protect records for those seeking treatment for substance use disorders, or SUD. Providers say it's created confusion and added administrative overhead for them as they're bound by HIPAA.
The latest proposal from the government's healthcare regulator seeks to smooth that friction. If enacted, it would clarify what information is and isn't protected by Part 2 and that records don't have to be deleted if they are related to a SUD patient. Additionally, non-Part 2 providers would for the first time have access to central registries to see if a patient is undergoing treatment for opioids, to ensure they wouldn't prescribe any medications that could set back the patient's recovery.
The move is generally popular among providers and payers, though it has sparked concerns from patient privacy advocates that worry it would weaken protections against unauthorized disclosure of SUD records.
Relaxing existing protections "will only prevent people who need SUD treatment from entering care out of fear that their private health information would be used against them in harmful ways," the Campaign to Protect Patient Privacy Rights, a coalition composed of over 100 stakeholder groups, said in a statement.
The proposed rule comes as America struggles with an opioid addiction crisis that has claimed the lives of more than 700,000 from 1999 through 2017, according to the Centers for Disease Control and Prevention, and as overall life expectancy in the country continues to decline.
The proposal is designed to make it easier for physicians to coordinate care and better treat the "whole" person and not just one aspect of care.
The Partnership to Amend 42 CFR Part 2, which represents stakeholders including the American Hospital Association and America's Health Insurance Plans, has advocated for modernizing health information laws to help curb the misuse of opioids.
Not having access to those patient records can be deadly, HHS Secretary Alex Azar, told reporters Thursday evening. Senators also have urged Azar to amend the Part 2 law.
The AHA applauded the proposed rule but urged Congress to go even further.
"We urge Congress to further this progress by enacting legislation to align requirements for information sharing for the treatment of substance use disorder with HIPAA," Tom Nickels, executive vice president of AHA, said in a statement.
The rule maintains patient protections and consent is still needed for disclosure of SUD records. Additionally, law enforcement will still not be allowed to use SUD patient records in any criminal prosecution against the patient.
Rebecca Pifer contributed reporting.