More Work to Do on Part 2

June 7, 2016
Stakeholders seem to agree that the changes proposed by the Substance Abuse and Mental Health Services Administration (SAMHSA) to rules about how providers share data about individuals with substance use disorders do not solve the problem.

In a recent eHealth Initiative webinar, Shawn Griffin, M.D., chief quality and informatics officer for Houston-based Memorial Hermann Physician Network, said that behavioral health is one of the keys to success with population health. “We are all going to have to do a better job on behavioral health,” he said. “It is a massive untouched opportunity.” 

Recognizing the centrality of behavioral health to improving the nation’s overall health system, federal regulators have tried to encourage clinical integration and health information exchange.

In April I wrote something about the American Medical Informatics Association’s written response to changes proposed in February by the Substance Abuse and Mental Health Services Administration (SAMHSA) to rules about how providers share data about individuals with substance use disorders (SUDs).

The regulations, known as 42 CFR Part 2, relate to the confidentiality of alcohol and drug abuse patient records. They were first written in 1975 out of concern that the information could be used against individuals, causing them to avoid seeking needed treatment.  But the way the regulation was written, it required the patient to consent every time their data was shared or accessed, which HIEs and healthcare organizations have found very difficult to implement. Many HIEs have just avoided the issue during their startup phases.

On April 6 AMIA called the proposed revisions “well-intentioned, but ultimately insufficient.” AMIA said the long-anticipated proposed rule takes one step forward – allowing a consent to specify a class of treating providers, but also takes two steps back: (1) potentially making it more difficult to disclose Part 2 information to an organization without a treatment relationship; and (2) providing patients with the right to an accounting of disclosures that HIPAA has shown to be of dubious value in comparison to its burden. 

The comment period on the proposed changes is now closed, but I read through the public comments of many different behavioral health providers and others, and all the ones I read basically concur with AMIA that the revision of Part 2 does not solve the problem.

Hazelden Betty Ford Foundation wrote that it “is very concerned about the proposed changes to the consent requirements. While in some respects the Proposed Rules seem to alleviate some of the barriers in releasing information  to treating providers, the new rules also create different consent standards based upon use and the entity/individual to which the information is to be disclosed. Instead of one consent requirement under the old rule, now SAMSHA has essentially created three different consent requirements, depending upon the relationship with the receiving entity and the use of the information. Health care providers administer consents with non-legal staff, most often the administrative or counseling staff who work closely with patients. Having such disparate consent requirements for use/entity will create unintentional mistakes by well-meaning staff. The complexity of the Proposed Rules will impose a tremendous training issue for Hazelden Betty Ford. Additionally, many changes will have to be made to the electronic health record to capture these nuanced changes — at a significant cost to providers.”

Kaiser Permanente’s letter said it supports revisions to Part 2 that will ensure substance use disorder patients can benefit from integrated care models without the risk of adverse consequences from loss of privacy. “However, we feel strongly that the changes SAMHSA proposes move in the wrong – and in a clinically dangerous – direction.  It recommends repealing Part 2, or at least substantially modifying Part 2 to conform to the HIPAA exceptions and minimum necessary standard, which would allow healthcare providers in integrated models to use and disclose substance use disorder records using electronic exchange technology under appropriate privacy safeguards and consistent with other medical care.

Instead, Kaiser wrote, “SAMHSA appears to have gone out of its way to make sharing clinical information for treatment purposes more difficult, other than nominal easing of consent form requirements for a very limited type of HIE. SAMHSA has not created a treatment exception, has not permitted patients to consent to disclosure of information to “all of my treating providers,” has made consent forms more complicated and confusing, has eliminated “management” from the definition of treatment, and has restricted use of Qualified Service Organization (“QSO”) arrangements for any treatment purpose. We again strongly urge SAMHSA to create a treatment exception to allow health care providers to share patient information for the purposes of treatment without patient consent.”

The State of Vermont’s Agency of Human Services commended the overall objective of the proposed revisions to reflect the operation of “new integrated health care models,” but it expressed concern that the revisions do not go far enough to reflect that social services programs designed to improve social determinants of health are, when appropriately integrated with publicly financed health delivery systems, every bit a part of the new integrated models of health care. 

“Several of our concerns relate to the new ‘consent’ requirements.  Overall, we believe that the revisions, when applied to social service organizations involved in providing drug and alcohol abuse evaluation, assessment and referral services, do not achieve the stated objective of making the Part 2 regulations ‘more understandable and less burdensome.’ Rather, we are concerned that the revisions may actually create disincentives to the sharing of information necessary to the identification and treatment of those in need of care and supports.” 

So it seems that although provider organizations recognize the need to change the regulation, the overall response to the initial proposal is overwhelmingly negative. How will SAMHSA respond? Go back to the drawing board? Or proceed with the changes despite the skepticism of the industry? What should they do?

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