Sens. Reintroduce Privacy Law for Substance Use Disorder Treatment

Sens. Joe Manchin, D-West Virginia, and Shelley Moore Capito, R-West Virginia, reintroduced the Protecting Jessica Grubbs Legacy Act, a privacy bill designed to modernize 42 CFR Part 2 regulations to improve data sharing and privacy around the medical records of substance use disorder patients.

As it stands with the current 42 CFR Part 2, it’s difficult or impossible to share addiction records. The bill was first introduced during the Obama Administration in response to a patient story: Jessica Grubbs was recovering from substance use disorder when she had surgery. However, the discharging doctor did not see that information and sent Grubbs home with oxycodone. She later died of an overdose.

“No family or community should ever have to go through the senseless and preventable tragedy that Jessica Grubb and her family had to endure,” Manchin said in a statement. “This bipartisan bill is essential to combatting the opioid epidemic and ensuring that these painful deaths are prevented.”

“By making changes to the existing regulations regarding the medical records of patients with substance use disorder, we can save thousands of lives,” he continued. “No one should go to the doctor expecting to receive help and instead be thrown back into the nightmare of addiction. We must do more to combat this crisis as a country.”

The senators have since made updates to the initial bill that would still bolster data sharing, while protecting patient privacy. For one, the bill requires affirmative, written consent from patients to opt into and share their medical records.

The bill also added an education component to ensure patients understand what patients are consenting to before opting into data sharing and expands the scope the bill to align it completely with all HIPAA regulations. There will also be an opt-out clause to give patients the right to rescind consent if they change their minds in the future.

The proposed legislation also protects patients from discriminatory behavior targeted at substance use disorder, including access to treatment, employment termination, worker’s compensation receipt, rental housing, social services, and benefits.

Lastly, the legislation also ensures all industry stakeholders are included in the implementation of the act by requiring the Department of Health and Human Services’ Secretary to collaborate with legal, clinical, privacy, and civil rights experts to update the code of federal regulations to implement the bill’s provisions.

Industry stakeholders have been pushing for an update to 42 CFR Part 2 for a number of years but have yet to come to an agreement. The rule has been called "cumbersome and out-of-date” by 39 state attorneys general, HHS has been asked to align the rule with HIPAA, and efforts have asked Congress to do the same.

In August, HHS released its own proposal to overhaul privacy restrictions for substance abuse treatment programs of 42 CF Part 2.

Manchin and Capito’s proposal has received overwhelming support from a number of industry stakeholders. Premier called the bill a “carefully balanced approach” that will address care coordination, while strengthening privacy protections.

The National Association of ACOs (NAACOS) also supports the bill, saying it “should draw broader support to update privacy protections for patients with substance use disorders.”

“After decades of obstacles to providing coordinated care for these patients, it is critical that barriers from outdated laws be removed, which this bill would do,” a NAACOS spokesperson said in a statement. “While this won’t provide full alignment with HIPAA that NAACOS has been pushing for, it would make an important update to improve the treatment of patients with substance use disorder.”

“Accountable care organizations and their clinicians have largely been blind to the medical history of their patients because they were made responsible for patients’ care but only give part of their data,” they added. “Moving to a system that better pays for quality and value requires well-coordinated care, and providers must be given a better understanding of their populations, while respecting patient privacy.”