Overcoming Data-Sharing Challenges in the Opioid Epidemic

Health Update

Editor’s Note: In a new white paper, prepared for the California Health Care Foundation, Manatt Health examines the laws that regulate substance use disorder (SUD) information sharing and how providers responding to the epidemic navigate those laws. The paper, summarized below, focuses on primary care practices that have taken on increased responsibility for SUD care, as the opioid epidemic has stretched the capacity of specialized SUD treatment centers. Click here to download a free copy of the complete white paper.


It is difficult to exaggerate the impact of the opioid epidemic on the nation’s health. According to the Centers for Disease Control and Prevention, in 2016, over 63,000 Americans died from drug overdoses, more than three times the rate in 1999. Approximately two-thirds of those overdose deaths were from the use of opioids, with the death rate from heroin alone climbing approximately 600% in this 17-year period. These numbers represent not only lost lives but destroyed families and communities.

Primary Care Practices Step Up to Treat Addiction but Face Roadblocks

In response to the opioid epidemic, states and the federal government have sought to increase the availability of SUD treatment. Through medication-assisted treatment (MAT) programs and other efforts, primary care practices have taken a more prominent role in providing SUD care.

Primary care practices are stepping up to treat addiction due to many factors, including:

  • Recognition of the role that the medical system plays in driving opioid overuse and addiction;
  • Shifting of attitudes about addiction with the acceptance of SUD as a chronic disease; and
  • Insufficient specialized treatment resources to address growing demands, especially in rural areas.

Common roadblocks for primary care practices, however, are the inability to communicate with SUD providers efficiently and effectively and a lack of clear guidance about how to share SUD and primary care treatment information.

The opioid epidemic comes at a time when the delivery system for SUD care is evolving, as states and providers aim to break down treatment siloes and encourage care coordination among different providers and integrated with other forms of healthcare, including physical and mental health services. Yet better care coordination is only possible if traditional SUD providers can effectively exchange information with other parts of the healthcare system, such as primary care physicians. This type of information sharing can be a significant challenge for providers, as they are required to balance the stringent privacy protections in federal and state laws with the new goals around coordinating care.

Key Findings

Manatt Health examined the federal SUD confidentiality regulation, 42 Code of the Federal Regulations (CFR) Part 2, which protects the privacy of certain information related to the treatment of opioid use and other SUDs. We explored how these federal rules compare to other state and federal privacy protections applicable to SUD information, analyzed the rules from the perspective of primary care practices that treat individuals for opioid use and other SUDs, and developed suggested strategies that primary care practices can undertake to achieve compliance with these privacy protections while promoting information sharing that benefits patients needing opioid use treatment. We also identified modest changes to the Part 2 rules that might simplify SUD data sharing without compromising patient privacy.      

Below is a summary of key findings:

  • 42 CFR Part 2 typically does not allow a patient’s information that is subject to the regulation to be disclosed without the patient’s written consent. This even applies for the purpose of treatment (except in a medical emergency).
  • Part 2 applies to a federally assisted primary care practice if the practice “holds itself out” as providing SUD services. Primary care practices meet this test if they maintain a license to provide SUD services or otherwise indicate that the practice has specialized SUD expertise through advertising, signage, personnel classifications or other means. There is substantial ambiguity as to when a practice crosses the line into “holding itself out” when engaging in these types of activities.
  • In interviews, primary care practices subject to Part 2 reported that a key challenge is developing record systems that segregate information subject to Part 2 from other medical information. These practices may have a system under which personnel outside the Part 2 program cannot access a patient’s SUD record unless the patient has consented.
  • Avoiding Part 2 regulation simplifies data sharing among practitioners serving patients with SUDs. Some primary care practices delivering SUD care may be able to avoid regulation under Part 2 by limiting the scope and active promotion of their SUD services.
  • Primary care practices that operate Part 2 programs can best integrate care if they utilize a single electronic health record (EHR) system that segregates Part 2 records from other records. This system could potentially rely on technical safeguards such as firewalls or administrative safeguards such as access-control policies coupled with audits.
  • The administrative burden of obtaining consent can be reduced by integrating consent requests into standard workflows. Consents should be written as broadly as the law allows and the patient permits and may be combined with other forms.
  • Primary care practices also stated in interviews that specialized SUD providers generally do not share their records, because they typically do not obtain a patient’s written consent to share records with other providers. In some cases, SUD providers may fear that their patients will be stigmatized if their data is shared with practitioners outside of the SUD program. In other cases, the process of consent may be viewed as an avoidable burden in an environment where resources are extremely limited.
  • Primary care practices can gain greater access to SUD treatment information by working with specialized SUD programs in their communities to standardize consent forms and procedures for requesting consent. Communitywide electronic health information exchanges can also improve access to Part 2 records.
  • Modest changes to the Part 2 rules could improve access to SUD information. These changes could include permitting consent forms to designate a class of recipients (rather than just individual providers), clarifying that the type of Part 2 records being disclosed can be described in general terms, and allowing care coordinators to be recognized as “qualified service organizations” so they can access Part 2 records on behalf of Part 2 programs without patient consent.


pursuant to New York DR 2-101(f)

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