Tennessee’s New Guidelines for Office-Based Buprenorphine Prescribing

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I’ve spent a great deal of time puzzling through a document titled “Tennessee Nonresidential Buprenorphine Treatment Guide,” released early this year. This document was created, as it says on page 2 of the document, because of the “growing prevalence of individuals who have an opioid use disorder, an increased number of individuals using medication-assisted treatment with buprenorphine, and diversion issues associated with buprenorphine.”

I’ll give my readers a warning – this blog entry is dense with the finer points of Tennessee’s document, and it’s not light reading.

This document outlines the standards of care that Tennessee’s office-based buprenorphine prescribers will be asked to follow. The physicians’ licensing board, the Tennessee Board of Medicine, will use this document to assess the quality of care OBOT physicians provide.

It was written with the help of many experts: doctors from Tennessee’s psychological and psychiatric associations, doctors from the Board of Pharmacy, from Tennessee’s Department of Mental Health and Substance Abuse Services, from Tennessee Department of Public Health, from drug courts, law enforcement personnel, specialists from Vanderbilt University, the state medical association, nurses’ associations, physicians from the medical society and physicians actively practicing addiction medicine. The document is fifty pages long, probably because more than forty people helped write it.

This document acknowledges that buprenorphine can be a valuable tool to treat patients with opioid use disorder, when used appropriately. The guideline describes the consolidated opinion of these experts as to what constitutes appropriate use.

Moving on to the actual guidelines, the document first outlines what must be done before the patient enters treatment.

The physician must:

  • Make sure the patient has opioid use disorder, and determine the length, severity, and consequences of use, including all prior treatments, if any, and the results of those treatments
  • Must document other substances used, and the extent they are used, and how treatment for these substances will be incorporated into the treatment plan
  • Must assess “process” addictions and decide how they can affect substance use disorders. This means assessing the patient for compulsive gambling, sexual practices, spending, or other impulsive and out of control behaviors.
  • Must assess the patient’s other mental health and physical health conditions, and determine how, when, where these problems will be treated
  • Must assess the patient’s social supports, employment status, housing situation, financial status and legal issues
  • Determine the patient’s readiness for treatment
  • Determine the patient’s wishes regarding pregnancy, if she is capable to becoming pregnant. She should be referred for long-acting birth control if she does not wish to become pregnant.
  • The physician must check the state’s prescription monitoring website before initial prescription and before each office visit
  • Must obtain an observed drug screen and document the results, prior to the start of treatment
  • Must do proper patient selection, which means the patent is told about all options for treatment, the patient is willing to start this treatment, and that there are no reasons not to start the patient in treatment
  • Signed agreement to start treatment must be obtained
  • The physician must complete required elements about consent to treatment dealing specifically with pregnancy and NAS prevention

I say physician and not provider, because Tennessee won’t allow physician extenders like nurse practitioners and physician assistants prescribe buprenorphine, despite the changed federal rule that does allow extenders to prescribe. In other states, extenders first need to take a 24-hour course about opioid use disorder and its treatment with buprenorphine, compared to the 8-hr course physicians take. But Tennessee prohibits extenders from prescribing buprenorphine.

Anyway, Tennessee is recommending a thorough assessment of the patient prior to office-based treatment with buprenorphine. In fact, what they describe above is much like what’s called a diagnostic assessment in the substance abuse treatment world. It’s a full evaluation of the patient’s bio-psycho-social needs.

I don’t do this in my office-based practice. Right now, I schedule an hour’s visit with a new patient, enough time for me to do a standard history and physical exam, as I would for any other new primary care patients. I certainly do get a full history of the opioid use disorder, and other substance use, along with psychiatric and medical issues. I get a drug screen prior to treatment, and I always check the prescription monitoring program. But I don’t delve into process addictions, support systems, or figure out how all other issues will be treated. All of this can’t be done in an hour. But as I get to know my patients over the next few weeks, we talk about all of this, albeit in a more casual way.

However, this data doesn’t necessarily need to be collected by a physician. A trained and licensed therapist could go through much of the background information gathering, and pass this along to the physician prescribing buprenorphine. Plus, physician extenders can help the physician gather information about the patient; they just can’t prescribe the buprenorphine.

At the opioid treatment program where I work, counselors gather the data and compose a bio-psycho-social evaluation or diagnostic assessment. This is built into the system, and it’s done before the patient sees me. This whole intake process takes us about two to three hours, but is required at OTPs.

Next comes a section on how to provide care after the patient enters treatment:

  • Women of childbearing age must do an observed urine screen for pregnancy upon admission, and then once per month. The woman must be asked about the possibility of pregnancy at each visit.
  • All patients should be prescribed the combination product buprenorphine/naloxone, unless the patient is pregnant, nursing, or has a documented adverse reaction to naloxone. A physician can prescribe the buprenorphine monoproduct to no more than 5% of his total patients. Going over this limit will subject the prescriber to scrutiny by Tennessee’s medical board, the guidelines say.
  • Under a section titled, “General dosing guidelines,” there is the statement, “Target buprenorphine dose range should be 6-12mg (or equivalent) per day.”

That requirement of monthly pregnancy screens sounds a bit…twitchy…to me. Of course, we want to know when a woman is pregnant as soon as possible, to get prenatal care started. But other medications, some of which actually cause birth defects during pregnancy, carry no requirements of monthly pregnancy testing (ACE inhibitors come to mind).

I worry Tennessee is allowing some of that “criminally pregnant” mindset into their guidelines. It feels like authorities in Tennessee strongly disapprove of women on medication-assisted treatments becoming pregnant. All things being equal, I think it would be best if they could delay pregnancy until off medication, but often that’s unrealistic. It should be the woman’s choice when she wants to start a family, and she shouldn’t be judged for getting pregnant while on medication-assisted treatment.

As for the prohibition of the buprenorphine monoproduct: the authors of this guideline appear to doubt the truthfulness of the many patients who say they feel better on the monoproduct buprenorphine than on the combination product buprenorphine/naloxone. I remain convinced that some patients do absorb some of the naloxone, leading to unpleasant symptoms of nausea, headache, and muscle aches.

Clearly, I hold a minority opinion. However, I’ve found some interesting data about the urine drug screens of patients on the combination product, all testing positive for naloxone. But I digress. That could be a whole other blog.

Why do these dosing guidelines say the target dose should beget dose of 6-12mg per day? The FDA has approved doses up to 24mg per day.

Again, it’s that “less is better” mindset. It’s as if Tennessee health officials have been forced to recognize medication-assisted treatment is necessary, but to show their underlying disapproval, they want physicians to be stingy with dosing.

We saw that same attitude with methadone in the past, too, before we had conclusive data showing better outcomes with adequate dosing.

Tennessee state law already says that any physician who prescribes more than 16mg per day for more than 30 days must document in the record why that dose is needed. I don’t know how that law is helpful, since the only reason to go above 16mg per day is that a lower dose didn’t suppress withdrawal signs and symptoms.

A buprenorphine prescriber who has a patient on more than 16mg per day for more than 30 days must either obtain consultation from an addiction medicine specialist or turn that patient over to such a specialist.

Next, this document gave very specific guidelines about benzodiazepine prescribing in patients on buprenorphine:

  • Benzodiazepines should not be initiated in a patient with opioid use disorder if that patient has never been on them before, or if that patient has misused them in the past.
  • Patients with a longstanding benzodiazepine prescription for a legitimate medical condition may be prescribed buprenorphine, but only with careful coordination of care with the prescriber, which must be documented
  • The buprenorphine provider may take over prescribing the benzodiazepine if the patient is willing to start a taper
  • If the patient with opioid use disorder also has a clear history of benzodiazepine use disorder, the duration and extent of that use must be clearly documented, and the patient may be switched to a long-acting benzodiazepine like clonazepam to taper the dose.
  • Doses of benzodiazepines that are at, or higher, than the equivalent of clonazepam 2mg per day are considered to be on a “high dose.” Reasons for such a high dose must be documented, and these patients should be tapered as rapidly as possible to below that benzo equivalence.
  • Patients on high dose benzodiazepine therapy for more than six weeks shall be managed by a physician who is board-certified in addiction medicine, or by a physician who has obtained a formal consult from such a specialist.

I’m going to refrain from commenting on this section, since I’m more rabidly opposed to benzodiazepines than many physicians.

OK, one comment.

Benzos are not first-line medications for anxiety disorders, and there are few indications for long-term (more than three months) benzo prescriptions, except possibly for end-of-life care. Besides, benzos have long-term side effects like increased incidence of dementia, falls, and the like.

Then the document shifts again to tasks that need to be completed upon admission:

  • Each patient must get a mandatory infectious disease screening, to include, at a minimum, HIV and Hepatitis B and C, tuberculosis, and sexually transmitted diseases. This doesn’t have to be done in the physicians’ office; patients may be referred to the local health department.
  • Each patient must be screened for the need for trauma-informed care, including an ACE (Adverse Childhood Event) score.
  • Before initiating treatment, the patient must sign an individualized treatment plan, to be documented in the patient’s record.

Tennessee’s Health Department must be able to do all this infectious disease testing, which is great. In North Carolina, Health Departments do all except Hepatitis C testing, due to its expense.

After patients needing trauma-informed care are identified, does Tennessee have enough counselors trained to provide Trauma-focused therapy?

At our opioid treatment program, more than 70% of the females entering treatment need this care, but there are few places that provide it, and long wait times to get it. Is Tennessee better equipped? Where are these patients going to get this treatment?

After this section, we get down to the nitty gritty of actual treatment. The guidelines divide treatment into three phases: induction, stabilization, and maintenance. Here are the guidelines:

  • During induction and stabilization phases, patients should have weekly office visits, one observed drug screen per week, counseling sessions every two weeks, at a minimum, and receive weekly case management services
  • For patients in the maintenance phase for less than one year, they must have office visits every 2-4 weeks, counseling sessions at least monthly, have 12 random and observed drug screens per year, and receive case management at least monthly
  • For patients on maintenance for more than one year, they must have office visits at least every two months, receive counseling monthly, get 8 random observed drug screens per year, and receive at least monthly case management services.
  • The prescriber needs to document which stage of treatment the patient is in.

Finally, I think these guidelines, for the most part, are good. There’s nothing wrong with establishing a mandatory minimum of services to be given to patients with opioid use disorder. It’s just that in so many aspects, this guideline for office-based care is almost exactly what is required of care given at opioid treatment programs, even down to the number of required counseling sessions for each patient.

That’s kind of ironic, considering how viciously Tennessee fought to keep OTPs out of their state. After all, the first OTP in Eastern Tennessee, an area with one of the highest overdose death rates in the world, just got their first OTP in August of 2017.

Now, almost comically, we have Tennessee advocating for the type of care OTPs have been providing for decades.

We need to consider the intent of the DATA 2000 law. It was enacted to give patients with opioid use disorder a different treatment option with less restrictive requirements than those found at OTPs. Tennessee’s new guidelines don’t provide a less restrictive option for patients and their physicians in Tennessee.

I worked in primary care for about a decade before switching to addiction medicine. Primary care doctors, faced with Tennessee’s guidelines, well-intentioned as they are, won’t want the headache and responsibility of trying to meet this standard of care. Buprenorphine treatment will remain in the hands of specialists. I’m not saying this is good or bad – just that it may not be Tennessee’s intention. Time will tell.

Perhaps DATA 2000 was overly hopeful. Maybe all patients, or at least patients new to treatment, need tighter guidelines like Tennessee’s.

Or maybe (as I have come to believe) all these patients need to start treatment at an OTP, then transfer to office-based setting after they are stable for a year or so, where they can be treated with fewer restrictions and more flexibility, as DATA 2000 physicians could to do before these new guidelines were passed.

Here’s another important consideration: who will pay for this treatment? Who pays for the therapists, counselors, observed drug screening and pregnancy testing? Who pays for the complete bio-psycho-social work up and the treatment plan development and updates? There was no mention of this in the guidelines.

I know it sounds like I’m critical of Tennessee’s efforts, and I am, a little. But it’s an exceptional accomplishment to get all the people and organizations together who are interested in this problem, get them talking, and get them to agree on a set of guidelines. All participants are to be commended, because that’s not easy work.

Hopefully, the experts can be flexible enough to try something, re-assess, change things that don’t work well, and keep things that do work well.

Concerned people in North Carolina also will be watching and hopefully learning from Tennessee’s efforts.

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14 responses to this post.

  1. Posted by Icecutter on February 11, 2018 at 9:31 pm

    Tennessee is , oh, I don’t know, how does “draconian” sound? They don’t trust patients or doctors to know what is best. I’d like to see some of these authors go down in the trenches at a MAT clinic and try to implement this on 10 patients in one day.

    Reply

  2. Posted by Craig on February 11, 2018 at 9:53 pm

    Tennessee has without a doubt the dumbest and most ignorant people in the world that are making up these stupid rules,it will without a doubt cause some people to not seek mat treatment and will ultimately cause overdose deaths,how dand dumb can you be,idiots,let the prescribing dr have a little say as to how to treat the patients,this is the craziest dumbest rules I have seen yet on mat treatment,and even more ignorant is tenn not allowing nurse practitioners and physician assistants to prescribe mat treatment,just line the addicts up and put a bullit in their head already,so stupid and this needs to be changed,if I lived in Tennessee I would lead a consortium to make sure all setting representatives and other are not relected to office and that new people are elected in their place,can’t beli this nonsense

    Reply

  3. Posted by Neil G on February 11, 2018 at 11:50 pm

    Whatever the current level of opiod crisis is in Tennessee, expect a parabolic rise. The guidelines are designed for physician reprimand, sanction, license revocation and ultimately prosecution. Treating patients with substance issues is exciting and rewarding: but not under this inane, regressive scrutiny. Tennesse makes Canada, where opiod dispensing machines will soon become available to users, seemenlightened. I wish the masochists treating substance use problems in Tennessee the best of luck.

    Reply

  4. Posted by Obsteve on February 12, 2018 at 12:26 am

    I think I see what Tennessee was trying to do. Their attempts to make OBOT immune to a ‘pill mill’ redux will prob create more problems than it prevents. The most glaring mandate is the dosing cap and the methadone experience should have been looked at, and I suspect wasn’t. Probably because the “blue ribbon” panel of advisors have little to no OTP experience.

    Reply

  5. Posted by Mark Essex on February 12, 2018 at 11:25 am

    Thank you for the detailed analysis of the new guidelines. Was very informative.

    Reply

  6. Posted by Rob on February 12, 2018 at 9:30 pm

    The OBOT licensing is for “… a service entity that includes, but is not limited to, stand-alone clinics, treatment resources, individual physical locations occupied as the professional practice of a prescriber or prescribers licensed pursuant to Title 63, or other entities prescribing products containing buprenorphine, or products containing any other controlled substance designed to treat opioid use disorder by preventing symptoms of withdrawal to fifty percent (50%) or more of its patients and to one hundred fifty (150) or more patients.”

    It is not for the use of buprenorphine as a therapeutic tool in a primary care setting, as needed or on occasion.

    I was not involved in the creation of the rules, but can imagine some of the committee conversations revolved around:

    1) diverted buprenorphine from high volume clinics that have historically been subject to minor regulation, especially as it compares to OTPs that dispense methadone. Also, as Obsteve observes above, the pill mill proliferation earlier in the decade is still fresh on everyone’s minds.

    2) the lack of any real rubric for quality when it comes to the treatment of patients at an OBOT. There are many excellent docs at such clinics, and probably a few bad ones. How do you know which is which? Licensing high volume OBOTs might really help.

    3) the perception that benzos have been overprescribed at some clinics as a means to keep “market share” in what is occasionally a crowded market for addiction medicine providers. In one state analysis, at least one NE TN county was identified as having 1000% more buprenorphine prescribers (from the SAMHSA data) than it needs. But about half of TN counties have far fewer than they need.

    4) neonatal abstinence syndrome rates that have soared in TN, and have captured much public and policy maker attention. NAS has been reportable in TN since 2012 and the greatest source of the delivering mom’s opioid has. for several years, been listed as “Medication Assisted Treatment” about 2/3 of the time (google TN NAS for a lot of govt data on the topic).

    I very much enjoy this blog and normally, I would just read it and then go on about my day. However, in this case, its important that the readers know that the licensed OBOT, which could be very large with many providers and almost exclusively focused on OUD, is distinct from the primary care buprenorphine provider for which the DATA 2000 waiver was intended. The entities should not be conflated.

    Reply

    • No, these guidelines are for all buprenorphine prescribers.
      You cited a 2017 law that requires prescribers with more than 150 patients at one location to be licensed with Tennessee’s Department of Mental Health and Substance Abuse. Then lawmakers were concerned there was no way to monitor all of the other prescribers, so they created these new guidelines, which apply to all buprenorphine prescribers, no matter how many patients they treat. These guidelines apply even if providers don’t need licensure because they treat fewer than 150 patients at one site.

      Reply

  7. Posted by Margo on February 20, 2018 at 4:47 am

    Hello, I am currently caught up in the “new laws and regs” as a patient, would it be possible to speak (email) with you to get some clarity and possibly direction concerning my current situation. I am terrified.

    Reply

  8. Posted by dbbetter on February 22, 2018 at 9:53 pm

    The providers did this to themselves by setting up profit-oriented clinics and giving out buprenorphine (Suboxone, Subutex, Bunavail, etc..) like candy. The fact of the matter is that buprenorphine is a narcotic. Sure, it can substantially reduce harm and do a lot for opiod detox, but do you really want to spend your life on it? (The answer is absolutely not!). Worse is the concurrent administration of clonazepam. Long-term benzodiazepine use will destroy your cognitive function and result in very protracted withdrawals. I’ve now been clean from Suboxone and clonazepam+other benzos for 4 months and am just now recovering proper cognitive function. I spent 15 years on Suboxone, one of the first batch of patients prescribed it, and can tell you now that it substantially blunted proper psychoscial and emotional development.

    Reply

    • I think blunting of psychosocial and emotional development might much more likely be caused by clonazepam, a benzodiazepine. But I’m glad you are doing better!
      Oh, and all doctors set up “profit-oriented clinics.” That’s our system of medicine – it’s for-profit. If you think we need nationalized healthcare, vote for politicians who support it.

      Reply

  9. Posted by almckean on March 11, 2018 at 6:39 pm

    I very much hope that other states don’t adopt this platform, which is unnecessarily draconian and regimented. Rather than lowering the threshold for addicts, these rules will make accessing treatment more difficult. I notice that the one group of people who were not consulted in the process of designing new restrictions were opioid addicts in recovery with MAT. If Tennessee officials were actually concerned with reaching the opioid addicts who are overdosing and dying every day, they would have asked the recovering addicts who have first hand knowledge of what works and what doesn’t.

    Reply

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