On February 5, 2015, the Substance Abuse and Mental Health Administration (SAMHSA) released a long-awaited proposed rule to modify the confidentiality rules that apply to patient identifying information generated by federally assisted substance use disorder treatment programs (42 CFR Part 2). The proposed revisions to the rules, which if finalized would be the first material revision in almost 30 years, attempt to modernize 42 CFR Part 2 to account for changes in the way health information is used and shared in the U.S. health care system, and for new health reform priorities, such has value-based payment and population health management, while retaining protections more stringent than HIPAA for substance use disorder treatment records maintained in connection with the performance of a 42 CFR Part 2-covered program (Part 2 Records).

42 CFR Part 2 only covers a limited subset of individually identifiable health information relating to substance use disorder diagnosis and treatment. In order for 42 CFR Part 2 to apply, the information must have been obtained from a “federally assisted” alcohol or drug abuse treatment “program”, and must identify the individual as an alcohol or drug abuser. The definition of “program” is currently limited to individuals or entities (other than general medical care facilities) who hold themselves out as providing, and provide, alcohol or drug abuse diagnosis, treatment or referral for treatment; or identified units within a general medical facility that provide such care. Accordingly, if a patient were to tell his or her psychiatrist that he or she was depressed on account of a problem with substance use disorder, that information would not be protected by 42 CFR Part 2 when added to a patient’s electronic medical record, unless the psychiatrist was holding him or herself out as providing alcohol or drug abuse diagnosis, treatment, or referral for treatment. The same information, however, when disclosed to a federally assisted program, would be protected. 42 CFR Part 2 interprets “federally assisted” broadly to include any program that participates in Medicare, or has received tax-exempt status from the Internal Revenue Service.

The proposed rule would extend this paradigm to general medical practices and individual practitioners within them. This proposed change would clarify that while general medical practices are not covered by 42 CFR Part 2, the records of individual practitioners within the practice could be covered by 42 CFR Part 2 if they are federally assisted and: (1) hold themselves out as an identified substance use disorder treatment unit; or (2) are identified as primarily performing substance use disorder diagnosis, treatment or referral for treatment.  SAMHSA proposed this change to account for increasing provision of substance use treatment services in integrated care settings. This proposal, if finalized, could create challenges for general medical practices that implement a common electronic health record (EHR).  General medical practices’ EHRs would need to be capable of tracking whether information relating to a patient’s substance use disorder was added to the EHR by a provider meeting the definition of a “program” under 42 CFR Part 2, or instead by a provider that is not covered by 42 CFR Part 2.  Only the substance use disorder diagnosis or treatment information entered into the EHR by a “program” would be considered a Part 2 Record. The general medical practice would also need to prevent Part 2 Records from being visible through the EHR to other practitioners within the practice unless a patient had signed a written consent in compliance with 42 CFR Part 2 permitting other practitioners to access the information.

Under HIPAA, health care providers and payors are permitted to share health information for treatment, payment and health care operations without first obtaining an individual’s authorization. 42 CFR Part 2, however, generally requires substance use disorder treatment programs covered by the regulation, as well as any lawful recipient of Part 2 Records, to obtain written patient consent before sharing Part 2 Records, even for treatment, payment or health care operation purposes. The written consent must, among other things, specify the name or title of the individual, or the name of the organization to which disclosure is to be made. This model made sense when Part 2 was first issued, as medical records were paper records and disclosures occurred manually and only sporadically. These requirements, however, when considered against the modern backdrop of increasing exchange of health information to support the legitimate efforts of clinically integrated care networks, essentially preclude patients of substance use disorder treatment programs from benefitting from advancements in care coordination and quality improvement. It is unrealistic for patients of substance use disorder treatment programs to provide a consent permitting the program to disclose Part 2 Records to a clinically integrated care network, because neither the patient nor the substance use disorder treatment program could name all providers participating in the clinically integrated care network with specificity.

The proposed rule acknowledges that the 42 CFR Part 2 consent requirements have prevented substance use disorder treatment programs and their patients from participating in new integrated care models, which require health information to flow more freely among a patient’s treating health care providers. The proposed rule proposes to create a new consent pathway that would permit substance use disorder treatment programs to disclose Part 2 Records to an integrated care network under a written consent from a patient, generally designating a class of network participants that have a treating relationship with the patient. For example, under the proposed rule, a patient could consent to a substance use disorder treatment program’s disclosure of Part 2 Records to a clinically integrated care network with the general designation that the Part 2 Records may be shared with all providers involved in the patient’s past, present and future care within that clinically integrated care network. The clinically integrated care network could then, based on the same consent, disclose the information to all individuals involved in the patient’s past, present and/or future care. As long as quality improvement is specified by the consent as a purpose for the disclosure of Part 2 Records, it would also appear that entities or individual providers within the clinically integrated care network that are involved in the patient’s care could use the Part 2 Records to perform quality improvement as well as treatment.

The proposed rule, however, does not permit patients to consent to a clinically integrated care networks’ disclosure of Part 2 Records to other entities or classes of providers that are not involved in the patient’s care. As a result, any quality administrator or provider not involved in a patient’s care, or not part of an entity involved in the patient’s care, would need to be listed by name on a patient’s consent form to receive Part 2 Records from the clinically integrated care network. A clinically integrated network might elect instead to enter into a Qualified Service Organization Agreement (similar to a Business Associate Agreement under HIPAA) with the appropriate substance use disorder treatment programs to perform population health management on the treatment program’s behalf. A Qualified Service Organization performing quality improvement or population health management services, however, may only disclose Part 2 Records within the office or unit responsible for quality improvement and population health, or back to the substance use treatment program.

To compensate for the perceived risks of making Part 2 Records more readily available through integrated care networks to all of a patient’s past, present or future treating providers, SAMHSA has proposed requiring a variety of additional safeguards. Chiefly, SAMHSA proposes to require clinically integrated care networks to: a) have a mechanism in place to determine whether a treating provider relationship exists with the patient whose information is being disclosed; and b) maintain a list of disclosures made to treating providers and produce a list of disclosures to patients upon request. The “list of disclosures” requirement stands in contrast to HIPAA, which does not currently require covered entities to include within an “accounting of disclosures” those made for purposes of treatment, payment, or health care operations.  SAMHSA’s list of disclosure requirement closely resembles a proposal from the Office for Civil Rights (OCR) from 2011 to require covered entities to maintain an “access log” of treatment, payment, and health care operations uses and disclosures. OCR’s proposal was criticized by some for being overly burdensome to both health information technology vendors and health care providers, and OCR delayed its implementation in 2014 to obtain additional public comment, and it is still outstanding.  SAMHSA attempts to distinguish its proposal from OCR’s by only requiring that the list of disclosures to include the entities that receive Part 2 Records, rather than the individual health care providers who access the information.  For example, if an HIE disclosed Part 2 Records to a doctor at ABC Hospital, the list of disclosures would only need to inform the patient that the HIE disclosed Part 2 Records to ABC Hospital, and would not need to list the individual doctor who received or accessed the information. 

Nevertheless, HIEs, ACOs, and other clinically integrated care networks might still find SAMHSA’s two requirements to be technologically burdensome. Some, but not all, clinically integrated care networks can track whether or not a treating relationship exists between a particular provider within the integrated care network and the patient in question. Other clinically integrated care networks would need to build this capability or create a mechanism that requires providers to attest that they are treating providers before permitting them to access Part 2 Records.  Additionally, health information technologies implemented by clinically integrated care networks may not be capable of producing a human readable report with a list of disclosures, or “accesses” to the information on demand. As a result, these entities would also need to invest in this capability. If the price tag for such changes is significant, HIEs, ACOs, and clinically integrated care networks could choose instead to not integrate with substance use disorder treatment programs. Due to the uncertainty of OCR’s accounting of disclosures proposal, HIEs, ACOs, and clinically integrated care networks may also be hesitant to make an investment in creating “list of disclosures” without knowing whether the technology would be consistent with future OCR mandated requirements. Finally, clinically integrated care networks wishing to accept Part 2 Records would need to implement technologies that segment Part 2 Records from other information within the clinically integrated care network to prevent Part 2 Records from being used for quality improvement activities unless an appropriate consent or Qualified Services Organization Agreement was in place.

In addition to the changes to written consent, the proposed rule also attempts to modernize 42 CFR Part 2’s research provisions. The proposed rule would permit researchers covered by the Common Rule and/or the HIPAA Privacy Rule to follow the Common Rule and HIPAA Privacy Rule pathways for performing research on identifiable information when the informed consent or authorization is waived. The proposed rule would also, however, require additional research protections unique to researchers that receive Part 2 Records. For example, an individual or entity conducting research would need to agree to be fully bound by 42 CFR Part 2 with respect to Part 2 Records, and would be required to resist in judicial proceedings disclosures of Part 2 Records sought by law enforcement. Additionally, the proposed rule would only permit researchers who receive Part 2 Records without the consent of the patient to link Part 2 Records to other data sets if the data sets come from federal data repositories, such as “research identifiable files” from CMS. SAMHSA expressed a preference for federal data repositories because of the policy framework in place at the federal level for ensuring the privacy and security of such data sets. SAMHSA requested comment on allowing additional data linkages.  The data linking limitations, if finalized, could research efforts aimed at determining connections between behavioral health and other medical conditions more difficult because it would eliminate access to other data assets, even those accompanied by robust data protections.  SAMHSA will likely consider this balance during the comment period.

SAMHSA’s proposed changes come at a time in which there is increasing public awareness in the importance of substance use disorder treatment due to rising rates of opioid addiction and overdose. 42 CFR Part 2 was designed to ensure the confidentiality of Part 2 Records due to the stigma attached to getting treatment, and the fear that the exposure of Part 2 Records could create criminal justice or employment status consequences. Some argue, however, that 42 CFR Part 2 has had the unintended effect of segmenting substance use disorder care from other forms of health care, thereby perpetuating the stigma the rule is meant to protect against.  While SAMHSA’s proposal could potentially create a pathway for health information exchange that does not exist currently under 42 CFR Part 2, the proposed rule still maintains the current paradigm of protecting Part 2 Records above and beyond HIPAA’s protections, without providing protection for equally sensitive substance use disorder treatment information that is not generated by federally assisted substance use disorder treatment programs. Currently, there are multiple bills in consideration by Congress that would increase funding to substance use disorder treatment and attempt to change the paradigm of separating substance use disorder care from other types of care. One such bill currently under consideration, the Helping Families in Mental Crisis Act (H.R. 2646), would change 42 CFR Part 2’s authorizing statute so that HIEs, ACOs, health homes, and other integrated care arrangements that exchange electronic health records would be exempt from complying with 42 CFR Part 2 altogether. Advocates for broader exchange of Part 2 Records with other care providers may continue to push for legislative changes like this in light of the stringent requirements that would remain in place if the proposed rule is finalized.

The comment period for the proposed rule will run until April 11, 2016. Interested parties should submit comments electronically through the Federal eRulemaking Portal.