Confidentiality of Substance Abuse Treatment Information: HHS Considers Changes to the Part 2 Regulations and Requests Comment

The Department of Health and Human Services’ Substance Abuse and Mental Health Services Administration (SAMHSA) is considering significant changes to the “Part 2” regulations (the Confidentiality of Alcohol and Drug Abuse Patient Records Regulations, 42 C.F.R. Part 2). In the nearly three decades since the last change to the Part 2 regulations, the U.S. health care system has changed significantly. The current regulations present many challenges to coordinated care, use of health information exchanges (HIEs), and Accountable Care Organizations (ACOs). There is a short fuse for providing input on these potential changes. Comments are due June 25, 2014.

SAMHSA has requested comment on several areas including:

• Providers covered by the Part 2 regulations: SAMHSA is considering expanding Part 2 to cover any federally assisted health care provider (any provider receiving Medicare or Medicaid reimbursement) that provides a patient with substance abuse treatment services. This could potentially expand the Part 2 regulations to many general health care providers not currently covered by Part 2. SAMHSA indicates this would not include pre-treatment screening.
• Consents required for disclosures: Current regulations require written consents to include the specific name of the individual or organization to which the disclosure will be made. As a result, substance abuse treatment information is often not incorporated into HIEs or used in coordinated care settings. SAMHSA is considering relaxing the consent requirement from a specific name of the recipient to a general description of the recipient. SAMHSA also is considering requiring HIEs to provide patients with a list of all providers or organizations that may access their information. This could require HIEs to provide an updated list when any new providers or organizations are added.
• Redisclosures: SAMHSA is considering limiting the prohibition on redisclosure to only information that would identify the individual as a substance abuser, allowing other health information to be redisclosed if legally permissible. SAMHSA also notes the limitations in most EHRs regarding data segmentation and requests comment on technical solutions in an EHR or HIE environment.

Another possible change involves granting providers more discretion in determining when an emergency exists, expanding the release of substance abuse information for research purposes, and modifying the definition of a Qualified Service Organization (QSO) to explicitly include care coordination and population health management.

SAMHSA recognizes the challenges pharmacies face in obtaining the required consents to send prescription information to Prescription Drug Monitoring Programs. SAMHSA also recognizes that when patients do not consent to a redisclosure for e-prescribing and bring a paper prescription to the pharmacy, the prescription given to the pharmacy by the patient is no longer protected by Part 2.

SAMHSA hosted a public listening session on June 11, 2014 to foster a discussion of the challenges and privacy concerns related to substance abuse records. SAMHSA requests comments on the availability and use of technologies to better allow for coordinated and integrated care and patient privacy concerns. Comments are due by Wednesday, June 25, 2014.