Federal privacy regulations and primary care? (exemplar topic)
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.
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.
Neftali Serrano, PsyD
Executive Director, CFHA &
Fan of All Things Integrated Care