SAMHSA Proposes Updates to Substance Abuse Privacy Rules

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By Alex Ruoff

Feb. 5 — The federal government Feb. 5 proposed several long-awaited changes to privacy rules for sharing substance abuse treatment records among health-care providers.

The proposed rule from the Substance Abuse and Mental Health Services Administration would “modernize” privacy rules that have remained unchanged for 25 years. Federal regulators said they want to ensure that patients with substance use disorders can participate in new integrated health-care models without adverse consequences that could result from inappropriate disclosure of patient records.

SAMHSA is proposing to update the rules to account for the expanded use of electronic health records by doctors and the increased focus on quality improvement by federal regulators, the Department of Health and Human Services said in a release.

“We are moving Medicare, and the health care system as a whole, toward new integrated care models that incentivize providers to coordinate and put the patient at the center of their care, and we are modernizing our rules to protect patients,” HHS Secretary Sylvia Mathews Burwell said in the release.

SAMHSA will publish the proposed rule (SAMHSA-4162-20) (RIN0930-AA21) in the Federal Register Feb. 9. The agency is accepting comments on the proposed rule until April 11.

Part 2 Issues

The privacy regulation governing substance abuse treatment records, 42 CFR Part 2, restricts providers' ability to electronically share patient data related to substance and alcohol abuse treatment by requiring that patients specify who may see their treatment data.

The regulation often is referred to simply as Part 2. Some 12,034 hospitals and 14,148 substance abuse treatment facilities provide services covered under Part 2, according to SAMHSA.

Health information exchange (HIE) organizations, quality improvement analysts and health-care provider organizations often don't store substance abuse data in EHR systems for fear of accidentally disclosing it.

Federal officials are concerned that Part 2 rules make it difficult for anyone whose health record contains substance abuse treatment data to receive care from providers participating in alternative payment models, because these models emphasize coordinating patient care with other providers and analyzing patient records for insight into quality improvement, SAMHSA said in its proposed rule.

SAMHSA has received numerous complaints from HIEs, accountable care organizations and integrated delivery systems that the Part 2 rule has prevented them from properly treating patients who have received substance abuse treatment, even after obtaining their consent to access their sensitive records, the agency said in 2014.

Proposed Rule's Provisions

SAMHSA's proposed rule would make it easier for health-care providers, particularly substance abuse treatment facilities, to electronically transmit patient records that contain substance abuse treatment information and to share their records with researchers.

The agency is suggesting the creation of broader consent forms for Part 2 data, Chuck Ingoglia, senior vice president for the National Council for Behavioral Health, told Bloomberg BNA Feb. 5. Under the proposed rule, people would be allowed to broadly permit health-care providers to access their substance abuse treatment data rather than having to consent each time the information is shared with a provider.

Part 2 rules require patients to consent every time their information is shared, making it difficult for health-care organizations to share their data with researchers who wish to study it.

Research Implications

SAMHSA has also proposed changes to Part 2 rules that would allow researchers to more easily access substance abuse treatment data, Nicholas Bagley, a law professor with the University of Michigan, told Bloomberg BNA Feb. 5.

Bagley said the changes to Part 2 could be a boon for researchers trying to study the growing epidemic of drug overdoses in the U.S.

The proposed rule would allow any holder of Part 2-covered data to share substance abuse treatment data with researchers, he said. Previously, only health-care providers could share this data.

“What happened was it didn't allow Medicare or Medicaid or payers to share this data with researchers,” Bagley said.

Researchers still would be required to follow Common Rule requirements for obtaining and using substance abuse treatment data, according to the proposed rule.

To contact the reporter on this story: Alex Ruoff in Washington at

To contact the editor responsible for this story: Patty Logan at