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HHS/SAMHSA RIN: 0930-AA21 Publication ID: Fall 2016 
Title: Confidentiality of Substance Use Disorder Patient Records 
Abstract:

The final rule will amend 42 CFR part 2 to update the regulations for the modern health care context with respect to health information technology and new health care models. The goal of this rule is to  balance the need for information exchange in new health care models and applications with appropriate privacy protections for those undergoing treatment for substance use disorders. The revisions to the regulations would remain consistent with 42 USC 290dd-2 (confidentiality of records)

 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
EO 13771 Designation: uncollected 
CFR Citation: 42 CFR 2   
Legal Authority: 42 U.S.C. 290dd-2   
Legal Deadline:  None

Statement of Need:

The last substantive update to these regulations was in 1987. Over the last 29 years, significant changes have occurred within the U.S. health care system that were not envisioned by the current regulations, including new models of integrated care that are built on a foundation of information sharing to support coordination of patient care, the development of an electronic infrastructure for managing and exchanging patient information, and a new focus on performance measurement within the health care system. SAMHSA wants to ensure that patients with substance use disorders have the ability to participate in, and benefit from new integrated health care models without fear of putting themselves at risk of adverse consequences. These new integrated models are foundational to HHS's triple aim of improving health care quality, improving population health, and reducing unnecessary health care costs.

Summary of the Legal Basis:

The statutory authority for the part 2 regulation is based on 42 U.S.C. 290dd-2, which protects the confidentiality of records  with respect to the identity, diagnosis, prognosis, or treatment of any patient records that are maintained in connection with the performance of any federally assisted program or activity relating to substance abuse education, prevention, training, treatment, rehabilitation, or research. [1]    Under the part 2 statute and current regulations, a federally assisted substance abuse program may only release patient identifying information related to substance abuse treatment services with the individual’s written consent; pursuant to a court order; or under a few other limited exceptions.   

Alternatives:

Failure to finalize the rule would result in the existing regulations staying in place, with none of the changes proposed being adopted.

Anticipated Costs and Benefits:

Over the 10-year period of 2016-2025, the total undiscounted cost of the part 2 changes will be about $241 million in 2016 dollars. When future costs are discounted at 3 percent or 7 percent per year, the total costs become approximately $217,586,000 or $193,098,000, respectively.  The benefits would be improvements in the integration and coordination of substance use disorder treatment with the broader health system and improved use of data to inform the development improvement of the substance use disorder treatment system.

Risks:

If this rule is not finalized, it will result in significant scrutiny from a variety of stakeholders, who have been pushing for an update to the rule.  It would also inhibit integrated care for substance use disorders and prevent the use of some data in research related to substance use disorder treatment at a time when the issue is a key priority to the Department as a result of the opioid crisis.

Timetable:
Action Date FR Cite
NPRM  02/09/2016  81 FR 6987   
NPRM Comment Period End  04/11/2016 
Final Action  11/00/2016 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: Yes 
RIN Data Printed in the FR: No 
Agency Contact:
Kate Tipping
Public Health Advisor
Department of Health and Human Services
Substance Abuse and Mental Health Services Administration
1 Choke Cherry Road,
Rockville, MD 20850
Phone:240 276-1652