Entities that provide treatment to patients with substance use disorders may find some clarity on federal requirements surrounding patient record confidentiality. The Department of Health & Human Services (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) recently announced much-anticipated proposed changes to the federal regulations at 42 C.F.R. part 2 (Part 2), which govern the confidentiality of patient records created by federally-assisted substance use disorder treatment programs (Proposed Rule). The proposed rulemaking comes at a time when SAMHSA is attempting to balance its continued efforts to align regulations with advances in the U.S. health care delivery system, particularly with respect to coordinated care, while retaining important privacy protections for individuals seeking treatment for substance use disorders (SUDs).
Importantly, much of the Proposed Rule seeks to clarify existing Part 2 standards, rather than establish new or revised standards, especially regarding the scope of records to which Part 2 applies, and the patient consent required for disclosures. Further, with the exception of research, the Proposed Rule dims the hopes of many in the Health Insurance Portability and Accountability Act (HIPAA)-regulated health care industry, who anticipated SAMHSA would use the Proposed Rule to streamline aspects of the two regulatory regimes. As it stands, the HIPAA and Part 2 protections for protected health information will continue to vary significantly and consequently may continue to cause confusion among providers about how to comply with both standards.
In finalizing amendments to Part 2, SAMHSA will consider public comments to the proposed rulemaking, which are due October 25, 2019 and can be submitted here.
Unlike HIPAA, the Part 2 standards generally attach to the records generated by Part 2 providers, and continue to protect those records, even after they are disclosed, regardless of the existence of a business associate or qualified service organization relationship. In other words, once in the hands of a non-Part 2 provider, Part 2 continues to protect records generated by a Part 2 program. The Proposed Rule clarifies, however, that a non-Part 2 provider can, and should, segregate its own records from the records it receives from a Part 2 provider, because Part 2 does not apply to the records generated by the non-Part 2 provider. Importantly, this clarification expressly applies to any SUD information contained in the non-Part 2 provider’s records. While this application of Part 2 mirrors the exact application promulgated in the 2017 Final Rule, SAMHSA acknowledges that the scope of the records to which Part 2 applies has been widely misunderstood in recent years.
Consider the following example: if Patient X enters a SUD program offered by a Part 2 provider, any records generated as part of that program will be protected by Part 2. The Part 2 provider may then send Patient X’s records to his primary care provider for care coordination. While the primary care provider must protect this record in accordance with Part 2, they should store any information captured independently about the patient’s SUD in their existing medical record for Patient X, which will not be regulated by Part 2.
More specifically, the Proposed Rule recommends that Part 2 and non-Part 2 covered records should be segregated, either by using a Data Segmentation for Privacy (DS4P) compliant electronic health record (EHR) platform to segment the electronic SUD patient record received from a Part 2 program, or by physically labeling or holding a Part 2 paper record separate. SAMHSA anticipates comments about the challenges of data segmentation; it received those comments during the 2017 proposed rulemaking. Accordingly, while SAMHSA acknowledges that these challenges exist, it finds data segmentation tools to be important in advancing the needs of providers across the care continuum. As a result, comments in response to this Proposed Rule about the difficulties of data segmentation are unlikely to substantially move the needle. SAMHSA also cautions that non-Part 2 providers should not aim to work around the segregation requirement by transcribing information from the Part 2-covered record into the non-covered record. That said, the Proposed Rule failed to outline any clear guardrails to prevent a provider from doing so.
The Proposed Rule offers greater flexibility to Part 2 program patients with respect to whom the patient may consent to have their Part 2 program records disclosed. Under the current rule, if an intended recipient of the records does not have a treating provider relationship with the patient, then the consent to disclosure form must expressly name the individual(s) to receive the Part 2 records. Part 2 program patients can only use a general designation (for example, a particular health care system or physician group) to identify the recipient of their Part 2 records if that recipient has a treating provider relationship with the patient. SAMHSA created this standard to ensure sensitive information would only be disclosed to those on a patient’s health care team on a need-to-know basis. However, the practical impact has created hurdles for Part 2 program patients applying for new services and benefits, as they have been unable to list these service and benefit providers (for example, social security benefits providers, or halfway house programs) on their disclosure forms without explicit names of contact. As a result, the Proposed Rule broadens the general designation category, and allows Part 2 program patients to consent to the disclosure of their records to organizations without a treating provider relationship with the individual.
The Proposed Rule also identifies a list of 17 permitted payment and health care operations activities for which a Part 2 program may further disclose a patient’s SUD records to contractors, subcontractors, and legal representatives. This 17-item list is not exhaustive but is a direct response to commenter feedback to the 2018 Final Rule requesting clarification on disclosure permissions. In short, so long as the Part 2 program has obtained written consent from the patient identifying the name of the individual(s) or entity(-ies) to which a disclosure will be made, Part 2 programs may make disclosures to facilitate permissible payment and health care operations. SAMHSA clarifies, however, that health care operations activities under Part 2 are intended to be different from those under HIPAA, as a Part 2 program should not disclose an individual’s information for care coordination and case management (which is a permissible health care operations disclosure under HIPAA). SAMHSA believes that Part 2 program patients should have the autonomy to elect which of their health care providers will receive information about their SUD, and as a result, a blanket written consent should not be used as a permission to openly disclose that information to every one of the patient’s health care providers. Accordingly, even if the patient consents to disclosure of their Part 2 records for a health care operations or payment purpose, the Part 2 program must be careful to limit those purposes to exclude, for example, SUD patient diagnosis by a subcontractor to facilitate case management.
As it stands, however, it is unclear how much clarity this 17-item list will actually bring to Part 2 providers seeking to understand when they can disclose information for payment and health care operations purposes. While the list outlines certain express purposes for which information can be disclosed, such as for billing and claims payment or patient safety activities, SAMHSA also proposes an 18th item on the list for “other payment/health care operations not expressly prohibited.” As a result, SAMHSA continues to leave the disclosure restriction open-ended and subject to interpretation.
The Proposed Rule, if finalized, would significantly broaden the types of recipients that can obtain data from SUD treatment records for the purpose of conducting scientific research. Currently, the regulations allow the Part 2 program or other lawful holder of Part 2 data to disclose patient identifying information for research purposes to only three types of recipients of the information – HIPAA covered entities or business associates that have obtained a patient authorization or a waiver of authorization consistent with the HIPAA Privacy Rule, or recipients subject to the HHS regulations regarding the protection of human subjects under the Common Rule at 45 C.F.R. part 46. The proposed changes would allow Part 2 programs or other lawful holders of Part 2 data that are also HIPAA covered entities or business associates to disclose Part 2 patient data to any recipient for the purpose of conducting scientific research, so long as the disclosure is made in accordance with the HIPAA Privacy Rule. The reverse is also true. If a Part 2 program or lawful holder of Part 2 data is not a HIPAA covered entity or business associate, the proposed blanket approval for HIPAA-compliant disclosures for research purposes to non-HIPAA regulated entities or entities subject to the Common Rule, would not apply.
In addition to providing some alignment to the requirements for research disclosures under Part 2 and the HIPAA Privacy Rule, the proposed expansion of permissible recipients of Part 2 patient data for research purposes demonstrates SAMHSA’s acknowledgment that limiting research disclosures under Part 2 to only HIPAA-regulated entities or institutions subject to the Common Rule may create challenges for legitimate stakeholders to obtain data from SUD treatment records for the purpose of conducting scientific research. For example, under the current Part 2 research provisions, the disclosure by a lawful holder of SUD records for the purpose of research to a State agency without a Part 2 patient consent may be barred, given that most State agencies are neither HIPAA-regulated entities nor directly subject to the Common Rule. The expanded recipient categories of SUD records for research purposes under Proposed Rule would resolve this issue and potentially stimulate growth in SUD-related research.
Once finalized, providers impacted by the clarifications and revisions to Part 2 should evaluate whether their practices and internal policies accurately reflect SAMHSA’s interpretation of Part 2, and consider providing workforce training on the scope the rules and how to properly maintain relevant records and handle disclosures, among other components for compliance with Part 2.