The Trump administration is seeking to loosen certain privacy requirements for patients with a history of addiction to make it easier for doctors to share information and improve care.
The rules, known as 42 CFR Part 2 regulations, have been in place for more than four decades. They predate other privacy requirements implemented under the Health Insurance Portability and Accountability Act of 1996, Health and Human Services Secretary Alex Azar told reporters.
The conflict between the two sets of privacy requirements has created added burdens for doctors and patients and barriers to care, he said.
The Part 2 rules were put in place to protect patients' records created under federally assisted programs for substance-use disorder, or SUD, treatment.
But the opioid crisis in the U.S. has highlighted the problems patients and providers run into because of the Part 2 regulations, officials said.
For instance, Azar said, doctors considering prescribing an opioid or a drug that may interact with it, like benzodiazepines, cannot query a central database to see if the patient was in treatment for opioid addiction.
He noted that some cases where that information was not available have resulted in patients relapsing into addiction or dying of an overdose.
"Not having that information can literally be deadly," Azar told reporters.
Some doctors have not put information about a patient's history of addiction in medical records because of the onerous nature of complying with the strict Part 2 rules, the HHS secretary said. The requirement has also led to some doctors choosing not to treat patients with SUD, he added.
"We are proposing to change that," Azar said.
He emphasized the revisions to the Part 2 regulations would not change patients' privacy protections.
"None of the changes proposed today change consent requirements," he said.
The revisions are intended to make various processes less burdensome for patients with SUD and their providers, Azar said.
Currently, if a patient with SUD wants to send records to the Social Security Administration to apply for disability benefits, the person would have to locate a specific employee at the agency and provide consent to that individual as the recipient of the disclosure, the secretary said.
The agency employs 60,000 workers.
Under the proposed rule, the patient would be able to provide the Part 2 consent to the agency generally, making it easier to apply for benefits online and not having to identify a specific person as the recipient for the disclosure, Azar said.
He also noted that under the current rule, if a patient sends a text or email to an SUD treatment provider's cell phone and that program is discontinued, the provider must clear the device of all information — sanitize it — which could render it unusable.
Under the HHS proposal, the provider would be permitted to simply delete the messages, Azar said.
The proposal to revise the Part 2 rules was based on the November 2017 recommendations from a White House commission tasked with providing advice about how to combat the U.S. opioid epidemic, the HHS secretary said.
HHS also heard from a number of patients and doctors about the need to revise the regulations, he added.
The U.S. House had adopted legislation last year to revamp Part 2 under a sweeping bill to address the opioid crisis, but it was not included in the final package adopted by Congress and signed into law.
The bill to reform Part 2, known as the Overdose Prevention and Patient Safety Act, was reintroduced in the House earlier this year, noted Reps. Greg Walden, R-Ore., and Michael Burgess, R-Texas, the ranking members on the Energy and Commerce Committee and its health subcommittee, respectively.
"This bipartisan bill strikes the right balance of permitting limited sharing of SUD treatment records within the health care community, while ensuring that individuals suffering from addiction can seek and receive treatment without fear of discrimination," they said in an Aug. 22 statement.
