February 9, 2016
By Kelly McGee*
On February 5, the U.S. Substance Abuse and Mental Health Services Administration (SAMHSA) announced proposed revisions to 42 CFR Part 2 (Part 2). Promulgated in 1975, Part 2 was intended to provide additional confidentiality protections to patient records related to alcohol and drug use. The last substantive amendments to Part 2 were in 1987, prior to the advent of electronic health records, accountable care organizations (ACOs), and other health care system developments. The proposed rule is based in part on a series of activities conducted by SAMHSA in 2014 to gather stakeholder feedback and comments on the current regulations.
SAMSHA designed the changes “to increase opportunities for individuals with substance use disorders to participate in new and emerging health and health care models and health information technology.” Additionally, this proposed rule recognizes the widespread use of electronic records and updates the terminology to reflect that. SAMHSA also acknowledges a need for disclosing Part 2 data for scientific research purposes to promote understanding of treatment for addiction and other health issues.
Changes to Key Definitions
The proposed rule revises certain key terms in Part 2, including, as follows:
- “Part 2 Program” is added to clarify that programs that are federally assisted must abide by the confidentiality protections of Part 2.
- “Records” is revised to include any information, recorded or not, received or acquired by a Part 2 Program relating to a patient, including paper or electronic form.
- “Substance use disorder” replaces “alcohol abuse” and “drug abuse” and refers to alcohol and drug abuse collectively.
- “Treating provider relationship” is now used regardless of whether there has been an in-person encounter if: (1) a patient agrees to be diagnosed, evaluated, or treated for any condition by an individual or entity; and (2) the individual or entity agrees to undertake diagnosis, evaluation, or treatment of the patient, or consultation with the patient, for any condition.
- “Written” now includes paper and electronic documentation.
Changes to Consent Form Requirements
Stakeholders have expressed concerns that Part 2 restrictions deter patients from participating in programs that encourage information sharing and integration, such as Health information Exchanges (HIEs) or ACOs. In the proposed rule, SAMHSA states its intent to address those concerns with revisions to the patient consent form required for the disclosure of Part 2-covered information.
SAMHSA proposes modifying the “To Whom” section of the patient consent form to allow for both specific and general designations of individuals and entities that may receive Part 2-protected information. For example, a patient may designate an individual or entity by name, as is currently permitted. Additionally, a patient may now list a general designee, such as the name of a particular HIE and individually named providers in that HIE, or may list the name of the HIE plus language such as “my current or future treating providers.” To balance the flexibility of the general designation in the “To Whom” section with concern for informed consent, patients who disclose their substance use disorder-related information to a general designee may request a list of individuals or entities who have received the patient’s information within the previous two years.
SAMHSA also proposes modifying the “Amount and Kind” section of the consent form, by requiring that a patient explicitly state the type of substance disorder-related information to be disclosed. Further, the “From Whom” section would be modified for more specificity, due in part to the permitted general designation in the “To Whom” section of the form. SAMHSA seeks to prevent a patient from consenting to overbroad designations.
The consent form also must include a statement indicating patient understanding of the right to request a list of disclosures and a statement that the patient understands the terms of the consent form. The Proposed Rule permits electronic signature of the consent form, so long as other applicable laws permit electronic signatures. SAMHSA has indicated that it may issue additional guidance, including a sample consent form.
SAMHSA has revised provisions governing disclosure of Part 2 covered information to support research into substance use disorders. For example, the proposed rule permits disclosure of patient-identifying data for research purposes if: (1) the researcher is a Health Insurance Portability and Accountability Act covered entity or business associate and provides documentation of either the patient’s authorization or an Institutional Review Board’s (IRB’s) waiver of authorization; (2) the researcher is subject to the U.S. Department of Health and Human Services (HHS) Common Rule; and (3) the researcher is a covered entity or business associate and subject to the HHS Common Rule. Researchers also may request linked data sets if the data is from a federal repository and the project has IRB approval. SAMHSA invites stakeholders to provide input on specific safeguards for using linked data sets from non-federal data repositories, such as data-use agreements, internal privacy and security protections, or staff confidentiality agreements.
The proposed rule is designed to remedy identified problems with Part 2, while protecting patient confidentiality and facilitating integration and coordination of care. The proposed rule will be published in the Federal Register on February 9. SAMHSA will accept comments through April 1.
*We would like to thank Kelly McGee (Donoghue Barrett & Singal PC, Providence, RI) and Matthew W. Wolfe (Parker Poe Adams & Bernstein LLP, Raleigh, NC) for respectively authoring and reviewing this email alert.