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Medication Assisted Therapy, SBIRT & Other SA
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Federal privacy regulations and primary care? (exemplar topic) 0 N. Serrano Good morning everyone! This is both an FYI and a request for interpretive help. It looks like SAMHSA has finalized its rules for entities managing substance use data. My quick review seems to be that essentially they added some elements to the standard consent form which allow the patient to agree to release of SA data specifically. Beyond that, I'm not sure what substantive changes there are (my eyes glazed over quickly). What was encouraging were the multiple references to integrated care and the benefits to patients with substance use disorders as a primary motivating factor for revising the rules. Anyone with thoughts or guidance on the issue from their institutions? ------------------------------- I've spent a lot of time studying and consulting regarding this topic. Here's a summary of my best understanding. 42 CFR part 2 is the section of federal law that regulates addiction treatment records. They are meant to govern practices that "hold themselves out" as addiction treatment centers. Primary care clinics by nature care for folks who are struggling with a variety of chronic conditions, including addiction. We have a federally accepted process for physicians (and now APCs as well) to obtain a Drug Addiction Treatment Act (DATA) waiver (commonly referred to as an "x" license) that is explicitly designed to allow primary care providers to prescribe buprenorphine for the treatment of opioid addiction within the context of comprehensive primary care. So... as long as treatment for addiction is being provided as part of comprehensive primary care, the records of such care are not subject to 42 CFR part 2. Having language in the standard consent form as you describe below is a good idea to make sure all bases are covered. Now, if you have an addiction sub-specialty service that is co-located within primary care (such as an addiction medicine doc whose sole role is to care for folks struggling with addiction and handles referrals from primary care to care for addiction, the rules of 42 CFR part 2 would apply. That is my essential understanding of the rule. I would be curious to hear if others have similar or differing interpretations. -------------------------------- James, I have the same thinking on the rules for 42 CFR Part 2. In primary care, we are not held to the same rules/regulations as addiction medicine or treatment facilities whose sole purpose is substance abuse treatment. However, if provision of services as you stated include an addiction medicine specialist co-located and receive referrals from primary care, they are then bound to the special rules set forth in 42 CFR Pt 2 and require a special consent form to release or share information. In integrated primary care settings, whole person care includes mental/behavioral health and substance use/misuse/abuse screening and treatment and is treated as a chronic care management therefore one generalized consent form (which includes mental health and substance abuse) is signed at initiation of primary care. I have overseen integrated behavioral health in FQHCs for the past 13 years and the only time we have had a special consent form is when we operated an MAT program within our primary care setting. I think now that the rules have changed and there is a heavy emphasis on incorporating the use of buprenorphine and naloxone into primary care, I am not sure that it is even necessary to have a separate consent form any longer even in this case. ----------------------------------- We have extensively reviewed this issue and believe the key provision is that a program must "hold itself out" to the community as providing SUD services to be bound by 42 CFR Part 2. We are an FQHC with a thoroughly integrated Behavioral Medicine department, including MAT (for our patients only) and do not believe 42 CFR applies to us as we do not advertise or in any other way represent ourselves to the community as an SUD program.
by N. Serrano
Monday, August 28, 2017

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