The Trump administration on Thursday unveiled long-anticipated proposals to pare back extra privacy regulations around addiction that critics claim have exacerbated overdose rates in the opioid epidemic.
Senior officials described these regulations, known as CFR Part 2, as "so complex" they have deterred clinicians from getting involved in treating addiction despite the escalating need.
Under revisions proposed by the Substance Abuse and Mental Health Services Administration and introduced by HHS Secretary Alex Azar and his deputies, records of a substance abuse disorder and treatment would no longer be subject to the extra privacy laws that pre-date HIPAA.
Primary-care doctors will be able to note their patients' addiction treatment history in their regular, HIPAA-protected patient records. The goal is to harmonize behavioral and primary-care health treatments and expand the number of clinicians who can move into treating addiction.
Hospitals and doctors not covered by Part 2 could check central registries to see if their patients are already enrolled in an opioid treatment program and on medication. This is supposed to avert accidental overprescriptions.
Another proposed change would clear hurdles for patients with addictions who want to claim Social Security benefits. Currently, anyone subject to the Part 2 privacy restrictions has to contact a specific employee within the Social Security Administration before filing a claim. Under the SAMHSA proposal, the claim can be generally transmitted to the agency.
Rules around scrubbing patient data would also be relaxed. Currently, any doctor who has treated a patient with an addiction must "sanitize" his or her phone if the patient happens to send a text. In the new regulation, the provider would only have to delete the text message.
Azar touted the move as a major part of the Trump administration's push to peel away burdensome regulations, as well as the fight to curb the opioid epidemic. The opioid crisis loomed large in the regulatory language that described the proposed changes.
"The prompt revision of this rule is necessary to help address one of the largest drug crises in the nation's history," SAMHSA said in the proposed rule, citing "extensive information concerning the nature and magnitude of the crisis" compiled by HHS and the Justice Department.
"We want addiction care to expand," HHS Assistant Secretary Dr. Elinore McCance-Katz told reporters.
The proposed rule won't satisfy all calls for reform of the Part 2 protections. Azar said officials went as far as they believe they can under law with these changes.
Hospitals and other groups have been calling for a total overhaul that would align the Part 2 protections with HIPAA laws. That would require congressional action.
In 2018, as House and Senate committees negotiated major opioid legislation, a core group of lawmakers tried to get this reform included but ultimately failed in the face of major opposition from some leading members of Congress and groups like the American Medical Association.
But the AMA has backpedaled on its opposition, and sponsors of that bill are hoping to try again before the end of the year.
Two leading House Republicans took the opportunity on Thursday to reiterate their own support for a legislative change.
"This builds on our efforts last Congress, when the House overwhelmingly passed the Overdose Prevention and Patient Safety Act, which unfortunately was not taken up in the Senate," Reps. Greg Walden (R-Ore.) and Michael Burgess (R-Texas) of the House Energy and Commerce Committee said in a statement. "We welcome the administration's partnership in this effort with today's announcement. But passing this legislation into law is the best way to fully and permanently ensure healthcare providers can effectively treat patients with substance use disorders."
The proposed rule got mixed reactions from addiction treatment professionals, who raised concerns over whether the change would jeopardize privacy protections of patients receiving treatment.
During a call Thursday with HHS Deputy Secretary Eric Hargan and McCance-Katz, Randy Anderson, founder of Minnesota-based treatment provider Bold North Recovery, raised concerns the move could make it easier for non-healthcare related entities, such as law enforcement and employers, to access sensitive information and subsequently penalize those seeking treatment.
"I just see a whole host of problems that this could create," Anderson said.
McCance-Katz said privacy protections would remain in place under the rule change. She said the entirety of the Part 2 record that the patient gives consent to being released to their primary-care provider would not be included within their electronic health record but instead be limited to certain pieces of information pertinent to their care, such as diagnosis, medication prescribed, dosages, treatments, and success of their treatment. She stressed that patients under the proposed rule would still have the option to request to keep their entire record private.
The American Hospital Association welcomed the proposed changes, but reiterated the call for statutory reform.
"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," AHA's executive vice president Tom Nickels said in a statement.