QUESTION: I understand that the Department of Health & Human Services (“HHS”) has proposed that changes be made to the Federal Drug & Alcohol Regulations. Those regulations haven’t been touched since 1987, nearly 30 years ago. They’re the “gold standard” when it comes to medical record confidentiality. What’s up with that?
ANSWER: HHS described what’s up with that back in 2014 when it announced that it was holding a “public listening session” to allow interested parties the opportunity to share their views prior to HHS initiating changes to the federal regulations concerning drug and alcohol treatment medical records.
In its announcement, HHS acknowledged the tension between the current federal requirements regarding confidentiality and patient consent for such records to be shared and the need for providers to share such information in order to better coordinate care and control costs. As HHS wrote:
“Over the last 25 years, significant changes have occurred within the U.S. health care system that were not envisioned by these regulations, including new models of integrated care that are built on a foundation of information sharing to support coordination of patient care, the development of an electronic infrastructure for managing and exchanging patient data, the development of prescription drug monitoring programs and a new focus on performance measurement within the health care system. When the regulations were written, substance abuse treatment was primarily conducted by specialty treatment providers, and as a result, the impact on coordination of care was not raised as a core issue.
“[We have] heard from stakeholders that some of the current consent requirements make it difficult for these new health care organizations including health information exchange organizations (HIEs), Accountable Care Organizations (ACOs), and others to share substance abuse treatment information.”
Nonetheless, HHS also stated: “[T]reatment for substance abuse disorders is still associated with discrimination.…There continues to be a need for confidentiality protections that encourage patients to seek treatment without fear of compromising their privacy.”
In February of this year, HHS, through the Substance Abuse and Mental Health Services Administration (“SAMHSA”), published these long-awaited drug and alcohol (“D&A”) proposed revised regulations.
It’s significant that HHS decided to open these D&A regulations to changes. What we’ve been waiting for is to see how much they would change.
Bottom line: The proposed revisions are most notable for what they do not do. There is no landmark or revolutionary change in these proposed regulations. SAMHSA retained the requirement that the patient has to consent to the sharing of electronic D&A records (“ED&A records”). That means any covered D&A patient has the ability to prevent his or her ED&A records from being shared with a Health Information Exchange, for example.
Did SAMHSA make the right choice? The American Hospital Association (the “AHA”) expressed its concerns about this approach in its comment letter on the proposed regulations dated April 5, 2016. Retaining such strong patient consent protections, the AHA noted, requires health care providers to maintain a strict separation of a patient’s behavioral health-related data from other patient data.
As per the AHA: “The separate privacy structure under [the proposed regulations] especially creates challenges for the integration of behavioral and physical health care simply because patient data related to behavioral health cannot be handled like all other health care data. Estimates are that one in four Americans experiences a behavioral illness or substance use disorder each year, and the majority of these individuals have a co?morbid[ity] physical health condition. Moreover, primary care has become the prevailing location for patients to receive treatment that addresses all their health needs, behavioral as well as medical. Evidence confirms that integrating mental health, substance abuse and primary care services produces the best outcomes and proves the most effective approach to caring for people with multiple health care needs.”
The AHA also stated: “Furthermore, at the highest stage of care integration, the focus is not merely on improving medical outcomes for individual patients but managing population health while reducing total costs for the overall health care delivery system. To meet the needs of the many individuals with complex health needs, however, providers must be able to share patient behavioral health information as easily as information related to physical health for purposes of treatment, payment and health care operations.”
This is a situation in which conflicting needs very much collide. We’ll see how SAMHSA resolves it when SAMHSA issues the final D&A Regulations later this year.