In response to the opioid epidemic, states and the federal government have sought to increase the availability of substance use disorder (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--recognition of the role of the medical system in driving opioid overuse and addiction, shifting of attitudes about addiction with acceptance of SUD as a chronic disease, and insufficient specialized treatment resources to address growing demands, especially in rural areas. However, common roadblocks for primary care practices are the inability to efficiently and effectively communicate with SUD providers and a lack of clear guidance about how to share SUD and primary care treatment information. This paper summarizes the requirements of the federal SUD confidentiality rules set forth under 42 Code of Federal Regulations (CFR) Part 2, discusses the steps that primary care practices currently take to effectively coordinate SUD care without violating the rules, suggests additional compliance strategies that might enhance data sharing, and offers for consideration modest revisions to the rules that could promote the integration of care without undermining patient privacy. The key findings of the paper are as follows: (1) 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 providing treatment (except in a medical emergency). (2) Part 2 applies to a federally assisted primary care practice if the practice "holds itself out" as providing SUD services. A primary care practice meets this test if the practice maintains a license to provide SUD services or otherwise indicates 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. (3) 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 must have a system under which personnel outside the Part 2 program cannot access a patient's SUD record unless the patient has consented. (4) 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. (5) 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. (6) 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. (7) 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 are 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. (8) 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. Community-wide electronic health information exchanges can also improve access to Part 2 records. (9) 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 that such coordinators can access Part 2 records on behalf of Part 2 programs without patient consent.
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