Volume 3, Issue 1

42 CFR Part 2 as a Major Legal Barrier to Implementation Research at NIDA
By Dennis McCarty, PhD, Oregon Health & Science Univerity
and Tim Hartnett, CODA of Portland, Oregon

The Affordable Care Act can be a catalyst for integrating addiction treatment into patient-centered primary care medical homes. The workgroup report, therefore, encourages implementation research to address the unique needs within medical care settings. At the same time, the report cautions that the federal alcohol and drug confidentiality regulations (42 CFR Part 2) inhibit the integration of addiction treatment into medical settings and asserts the need for modification to support implementation of treatment interventions for substance use disorders (SUDs) into routine medical care.

The confidentiality regulations were initially promulgated in 1970 to implement protections required in the Comprehensive Alcoholism Prevention, Treatment and Rehabilitation Act (also known as the Hughes Act). The Comprehensive Act authorized the creation of the National Institute on Alcohol Abuse and Alcoholism, created the National Advisory Council on Alcohol Abuse and Alcoholism, required the identification of a state alcoholism authority, established federal formula grants for states, required state plans for treatment and prevention, encouraged hospitals to admit alcoholics, and funded research. Finally, it protected the confidentiality of patient records, with these protections designed to encourage individuals struggling with alcoholism to seek care with the assurance that the treatment would be confidential. 42 CFR Part 2 prohibits disclosure that an individual is in care or has been in care unless the patient signs a consent authorizing the release of the information for a specific reason and to a specific person. The regulations effectively prohibit routine release of information to physicians, inhibit inclusion of addiction treatment information in electronic medical records, and isolate addiction treatment programs.

Although the health care system has changed dramatically since 1970, 42 CFR Part has not been amended to reflect current electronic technology and did not adequately anticipate today's efforts toward increased integration with medical care. This barrier is of great significance for at least in theory, electronic health records can alert medical practitioners to a history of alcohol and drug use disorders, facilitate better care, and reduce adverse events related to medication interactions with buprenorphine and naltrexone prescriptions. Further, the Health Insurance Portability and Accountability Act (HIPAA) substantially increased the confidentiality of all medical records and arguably eliminated the need for a separate confidentiality standard for addiction and alcohol problem treatment records.

A casual assessment of the landscape for healthcare reform, however, finds little potential for legislation or litigation to change 42 CFR Part 2. Specialty addiction treatment centers are segregated from medical settings and the complexities of complying with the confidential regulations discourage integrated care. The standards promote the status quo and inhibit change. Specialty addiction treatment centers seem to use the regulations to resist evolution and change. Unfortunately, they also miss the opportunities created within the Affordable Care Act. Oregon provides a case study.

Oregon Case Study. The innovative Oregon Health Plan (Medicaid) is a national leader in healthcare reform. State legislation (passed with bipartisan support) authorized Coordinated Care Organizations (CCOs) to manage care for Medicaid recipients. CCOs (similar to the Accountable Care Organizations in the Affordable Care Act) integrate physical and behavioral health care in a single point of accountability (a patient centered primary care medical home) to increase access to care, control healthcare costs and improve health outcomes. Global budgets and shared savings promote quality of care rather than quantity of care. The locally governed, regional coalitions of health care providers and community stakeholders assume financial risk. Medicaid resources, previously separated for behavioral health and primary care services, are merged. Integration with primary care promotes access to and utilization of services for alcohol and drug use disorders. Integrated funding fosters incentives for primary care teams to incorporate behavioral health specialists to address alcohol, drug and mental health disorders. Healthcare organizations and practitioners share cost savings. CCOs are accountable to their membership and include consumers in the organizational governance. Financial performance standards and quality of care metrics monitor CCO performance.

Beginning in August 2012, the Oregon Health Authority authorized 15 regional CCOs (see website for details http://www.oregon.gov/oha/OHPB/Pages/health-reform/certification/index.aspx). A review of the applications suggests little change in the organization and delivery of addiction treatment services in Oregon. Most CCOs plan to subcontract with local addiction treatment services and purchase care on a fee-for-service basis. A few propose integrated behavioral healthcare specialists who triage patients with suspected alcohol, drug and mental health disorders into specialty care. In interviews, CCO leaders report concerns about 42 CFR Part 2 as a barrier to more integrated care.

As a result, few of the addiction treatment centers are major players in their regional CCOs. They miss the opportunity to manage population-based care, promote screening and brief intervention, and develop services to help patients manage chronic alcohol and drug use disorders. As long as care is provided on an episodic fee-for-service basis, addiction treatment centers are unlikely to share in savings achieved through reductions in utilization of emergency and inpatient services. There is little incentive to change. Oregon has also implemented an All-Payer All-Claims database to provide a population-based perspective on access to and utilization of care among residents and to enhance system management to reduce disparities. The database could provide a comprehensive analysis of the population burden of alcohol, tobacco, and drug use disorders. Currently, however, because of concerns with 42 CFR Part 2 some health plans have refused to submit claims for alcohol and drug treatment and the Oregon Health Authority has excluded those claims from the public use data file. Oregon is missing the opportunity for a more complete understanding of how alcohol and drug use disorders interact with other health problems and the burdens they impose on systems of care.

Implementation Science Proposal. If 42 CFR Part 2 is a barrier to system evolution, what are the options? Implementation science and implementation research may be part of the answer. Integrated care for alcohol and drug use disorders may be the leading implementation research challenge facing the National Institute on Alcohol Abuse and Alcoholism and the National Institute on Drug Abuse. The NIDA workgroup report recommended creation of a systems-based research network to study intervention effectiveness, adoption and sustainability. The first challenge for the network is an assessment of the impact of integrated electronic health records. Within the context of a research protocol it may be feasible to integrate addiction treatment data into the patient health record. Research can investigate the positive (e.g., better health care) and negative (e.g., loss of confidentiality) results associated with the integrated electronic health record. The research could document the continued need, if any, for 42 CFR Part 2 protections and delineate the benefits and risks of integrated health records.

The NIDA workgroup recommended construction of a new research network. The National Drug Abuse Treatment Clinical Trials Network (CTN), they felt, was not structured and staffed to support implementation science. The CTN, however, has matured into an adaptable infrastructure with multiple linkages to service systems. They can rapidly recruit investigators and study sites and conduct a large scale test of electronic health records within integrated systems of care.

The leadership to challenge the continuing need for 42 CFR Part 2 is not going to come from the Substance Abuse and Mental Health Services Administration, the Legal Action Center, existing treatment providers, or patient advocacy groups. NIDA can support the research that could be the basis for modification of these standards (perhaps in partnership with NIAAA, SAMHSA, and major foundations) and assure an unbiased analysis of the data. The addiction treatment field needs to know – do the safeguards created by 42CFR Part 2 enhance or inhibit access to care, utilization of care, quality of care, coordination of care and confidentiality of care? Answering this question must be a priority for NIDA's portfolio of implementation science research.

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