We are writing to express our views on the Health and Human Services (HHS) proposed rule regarding the confidentiality of substance use disorder (SUD) patient records.
The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.
This notice of proposed rulemaking seeks to remedy the dual obligations of medical providers providing SUD treatment and to increase access to care for patients to avoid discrimination in treatment. However, by aligning privacy standards with HIPAA as opposed to Part 2, standards will weaken because HIPAA is less protective of patient privacy than Part 2.1 There is a likelihood that the rule as proposed could hurt the population it seeks to help.
The rule quotes the National Association of Attorneys General who said in 2019 that the Part 2 regulation was created in a time of “intense stigma” surrounding individuals with substance use disorders and that Part 2 “perpetuates that stigma.” This notice justifies integrating Part 2 records with HIPAA at this point in time, asserting that society has moved past this stigma and the rules need to change to reflect this. While we agree that there is greater understanding of addiction as a disease than there used to be, it is disingenuous to suggest that stigma is no longer an issue for people with SUD. Research has shown that stigma associated with addiction continues to influence the perceptions and sometimes the behaviors of many people, including individuals in health care professions.2 Similarly, a SAMHA report found that 28% of individuals who avoided care for SUD did so because of concerns about confidentiality and the negative impact that disclosure would have on their career or the perceptions of people in their community.3 The bottom line is that stigma surrounding SUD still plays a significant role in access to quality medical care.
We are concerned that the alignment of consent for disclosure with HIPAA may damage quality of care for substance use disorder patients. A major shortcoming is that the rule requires only one consent from the patient for all future uses and disclosures for the purpose of treatment, payment, and health care operations. This means that stigmatizing information may be disclosed to individuals who the patient did not consent to, which could result in unintended discrimination in treatment or care. If this rule were put into effect, we would recommend that each time following the original written consent, patients are required to be notified and given the opportunity to rescind consent before each use, disclosure, and redisclosure of their Part 2 records.
We understand that simplifying the confidentiality requirements for SUD treatment records will place less of a burden on providers and allow for access to complete information when treating patients. However, this should not come at the cost of threatening the privacy of patients seeking treatment for SUD, who have the right to know that their data will not be used without their permission. We urge you to weigh this risk against any potential benefits provided by the new rule.
- Reid, A., et al. (2022) Fundamentals of 42 CFR Part 2 and SUD Treatment Privacy. Legal Action Center. https://www.lac.org/resource/the-fundamentals-of-42-cfr-part-2
- Biancarelli, D., Biello, K., Childs, E, et al. (2019). Strategies used by people who inject drugs to avoid stigma in healthcare settings. Drug Alcohol Depend. 198:80-86. doi:10.1016/j.drugalcdep.2019.01.037
- Substance Abuse and Mental Health Services Administration. (2014) Leading Change 2.0: Advancing the Health of the Nation 2015-2018.