On November 17, 2016, Surgeon General Vivek Murthy released the first report on substance use disorder (SUD) in the U.S. This landmark document described the tremendous toll of alcohol and drug use on the health and well-being of our nation. With the report, the Surgeon General issued a call to action, stating “how we respond to this crisis is a test for America.” Highlighted in the recommendations was the need to address the segregation of SUD treatment outside of medical care and the need to fight persistent stigma. However, full implementation of these recommendations remains nearly impossible so long as the archaic federal privacy law known as 42 CFR part 2 remains in place.
The intentions of 42 CFR part 2 were good and necessary in the era before the Health Insurance Portability and Accountability Act of 1996 (HIPAA). These strict federal confidentiality regulations were enacted in response to concerns that stigma and fear of prosecution might discourage patients from entering addiction treatment. In the 1970s and 1980s drug and alcohol use disorders were still viewed as moral failings, and fears around disclosure of treatment for these illnesses were justified. However, this confidentiality becomes a stumbling block because 42 CFR part 2 requires addiction treatment providers to obtain written consent from patients in order to share any information with non-addiction clinicians — the only exception being for “true emergencies.” Designed to protect stigmatized patients, ironically this added layer of protection now creates virtual care silos, hinders good medical care, and perpetuates stigma in the contemporary era of electronic health records (EHRs), health information exchanges, behavioral health integration, and HIPAA privacy protections. The Substance Abuse and Mental Health Services Administration (SAMHSA) issued a final rule on January 18, 2017, which will be effective March 31; SAMHSA also sought comments on the disclosure of 42 CFR Part 2 covered data by entities such as contractors and legal representatives until February 17, 2017. Despite these changes, the final rule continues to make 42 CFR part 2 applicable to any program or clinic that holds itself out to be an addiction treatment provider, even those integrated in a health system (42 §CFR 2.11).
The outdated nature of 42 CFR part 2 is most apparent in practice. Designed in an era when addiction treatment occurred exclusively in the segregated systems Dr. Murthy seeks to end, the law blocks integration of addiction treatment into mainstream medicine. As an example, consider the case of an addiction medicine physician who also practices general medicine. When that physician treats a patient’s opioid use disorder with the addiction treatment medication buprenorphine within a primary care setting, the records of this care are protected by HIPAA but not 42 CFR part 2, and can be seen by other clinicians within the health system who care for the patient. However if that same physician treats that same patient with the same medication in a clinic that identifies itself as an addiction treatment provider, all notes, labs, problem, and medication lists suddenly must be sequestered behind 42 CFR part 2 and remain invisible to other non-addiction members of the care team. This example is not theoretical: the authors both work in hospital systems with buprenorphine induction programs whose records are not visible to the primary care physicians to whom they refer. This situation has real negative impacts on care. Imagine the harm that occurs when a patient with opioid use disorder goes to see a physician who is not able to see that patient’s diagnosis due to 42 CFR part 2, and unknowingly prescribes opioids.
The harms of 42 CFR part 2 are not just clinical. Requiring additional releases perpetuates stigma by sending the message that these are secret, shameful conditions that must be treated differently from any other disease. At many hospitals, the EHR systems require a separate log-in to access records sequestered under 42 CFR part 2. These additional administrative burdens are hardly a selling point to new clinicians at a time when we need more physicians willing to care for patients with addiction. The message is also hypocritical: physicians and patients are told addiction is a disease like any other, but also that this disease requires a level of secrecy higher than diabetes, cancer, or HIV.
State and Federal Changes Needed
The comparisons with HIV are not far-fetched. 42 CFR part 2 was enacted in the late 1980s, when fear and stigma related to HIV and related risk behaviors (including illicit drug use) were at their peak. However, while the approach to confidentiality around HIV testing and treatment has evolved over the last three decades, the approach to privacy for addiction remains stuck in 1987. To improve the approach to diagnosis and management of HIV, antiquated consent requirements around testing and treatment were revised: for example, testing no longer requires written consent. Similarly, what is needed for substance use addiction treatment is legal protection from discrimination, not laws that impede information sharing for legitimate clinical purposes.
Notably, in HIV’s transition from a highly stigmatized, deadly condition to a chronic disease, protections under state and federal disability statutes were crucial in providing recourse for individuals living with the disease who experienced discrimination. Discrimination remains a real problem for SUDs because individuals who are not in remission are excluded from protections under the Americans with Disabilities Act (ADA). Individuals with a “history of drug addiction but who are not currently using drugs and have been rehabilitated” are protected from discrimination under the ADA, but stigma and shame likely prevent them from pressing their case. Clearly, more needs to be done around enforcement of the ADA as it relates to SUD and modification of the exclusion of individuals with addictive disorders who continue to struggle with their disease.
The staggering mortality from untreated substance use disorders continues to rise. In the midst of the current opioid epidemic we cannot afford to provide outdated, siloed addiction treatment governed by antiquated privacy laws. 42 CFR Part 2 has outlived its usefulness. If we truly believe addiction is a disease like any other, the time has come to treat it as such.