Raising the Patient Limit on Buprenorphine Physicians: HHS’s New Proposed Rule

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Last month, the Health and Human Services (HHS) department of the U.S. government posted new proposed regulations for doctors who prescribe buprenorphine (better known as Suboxone, Subutex, or Zubsolv) from office-based practices. This rule proposes to raise the number of patients that physicians can treat in their office practice from one hundred to two hundred. They did this to make more treatment available for people with opioid addiction, to combat opioid overdose deaths in our country,

This new proposed rule is now posted online at: https://www.federalregister.gov/articles/2016/03/30/2016-07128/medication-assisted-treatment-for-opioid-use-disorders#h-63

Anyone can submit a comment about this proposed rule, until May 31, 2016.

I studied this proposed rule at length, and thought I’d give my blog readers my interpretation and my opinion of it.

First of all, I approve of the idea behind the proposed regulation. Too many people with opioid use disorder want treatment and can’t get it. Many doctors are at their one hundred patient limit and have been for some time.

I haven’t taken a new patient in months. And as I’ve grumbled about in previous posts, several practitioners in my area already have well over one hundred buprenorphine office patients. Rogue doctors are going to do what they do no matter what, but us law-abiding doctors would like permission to treat more patients.

This new proposed rule would allow physicians who have had a one hundred patient limit for at least one year to request permission to treat up to two hundred patients at one time.

However, this proposed rule is a little more complicated than it would appear on the surface. Medical practitioners have to meet certain criteria to get approval to treat up to two hundred patients.

First of all, as the regulation is written now, some physicians believe that physicians who are board-certified by the American Board of Addiction Medicine won’t qualify for approval to treat up to two hundred patients. The proposed new regulation says the physician must have “subspecialty board certification.” Apparently, some physicians feel that an exact interpretation of this means only psychiatrists with subspecialty certification in addiction medicine would qualify. I read on the American Society of Addiction Medicine’s website that they want members to protest this wording to allow ABAM-certified doctors to qualify too. Thirty-six hundred doctors, including me, are board certified by ABAM, while only about a thousand psychiatrists have subspecialty board certification in Addiction Psychiatry in this country.

I read the entire DHHS document online, but the way I read it, I thought ABAM certified doctors would definitely qualify, but then maybe I’m a little fuzzy about what, exactly, “subspecialty” means. I think HHS’s intention was to include ASAM/ABAM doctors.

Practitioners seeking approval to treat up to two hundred patients must meet other criteria. In simplified terms, they need to, among other things:

  1. Have professional coverage for after-hours emergencies.
  2. Provide case management services
  3. Have electronic medical records
  4. Use that practitioner’s state prescription monitoring program
  5. Accept third-party insurance
  6. Have a plan to address possible diversion of prescribed buprenorphine medication
  7. Re-apply for permission to treat up to two hundred patients every three years
  8. Supply yearly reports about their practice and their buprenorphine patients

Several of these requirements are fairly obvious and should be standard of care anyway. For example, coverage after hours should be provided no matter if the practitioner has one patient, two-hundred, or a thousand. And I can’t imagine any doctor would prescribe buprenorphine for a patient with opioid use disorder without checking the state prescription monitoring program.

Personally, every night before I see my office-based patients, I look at their data on the prescription monitoring program. That way, if I get any surprises, I can discuss this with my patient at their visit.

All practices should have a plan to detect diversion. In my patient agreement, patients understand they may be asked to do a pill count at any time. I’ve lost some patients who failed pill counts.

Yearly reporting requirements seem reasonable, depending on what the government intends to do with this data. I assume DHH intends to monitor the quality of the care that a buprenorphine physician is delivering, and monitor the results of this care. Such monitoring is to include: average monthly case load of the physician, percentage of patients who are receiving either psychosocial counseling or case management services; number of patients being checked on the state prescription monitoring program; sending year-end reports about the number of patients who have completed treatment, number who have been referred elsewhere, and the number of patients who no longer want this form of treatment.

Physicians can collect that data without too much problem, I think.

However, I worry about how this information could be misinterpreted. For example, if the people who will review these reports expect patients to “complete” treatment for a chronic disease such as opioid addiction, they may mistakenly conclude that doctors with higher numbers of patients who complete treatment provide better care than doctors with lower numbers of patients who complete treatment. In reality, the opposite may well be true, since the standard of care with medication-assisted treatment is maintenance, not detox.

I’m also concerned about submitting the number of patients getting counseling. For maintenance patients, how long should they receive counseling? To me, the answer should be “as long as they need it.” This should be highly individualized.

If patients have been stable on buprenorphine for more than three years, with relapse-free recovery, do they still need counseling? Some of my patients are in relapse-free recovery for longer than that, and they have productive jobs, happy home lives, and no mental health issues. Should I still insist they still go to counseling? I don’t think so, unless counseling can improve the quality of their lives.

I’m not talking about new patients, fresh into treatment. Nearly all of those patients need counseling. But what if they have no insurance, and can’t afford “official” counseling? Is 12-step attendance good enough to meet counseling requirements?

There’s no way to know how people evaluating yearly physician reports will view such topics.

Now let’s talk about some of the requirements which may be deal-breakers for me.

When I read about practitioners having to accept third-party payers, I thought nope, not gonna do it.

My practice is bare-bones. I have three employees: me, my fiancé, and a man who works my front desk for about six hours per week. It’s kind of a mom-and-pop practice. Patients pay me, and I give them receipts with the needed codes to fill with their insurance company so they can be paid back. Since I don’t mess with insurance, I can keep my office costs down, because I don’t have to pay for another person to file insurance. Technically it is not a cash-only practice, since I’m set up to take credit and debit cards, but I am cautious about accepting checks. I have learned the hard way not to accept a check from a new patient.

My fiancé, who is a licensed professional counselor and also a licensed clinical addiction specialist, does the counseling for some of my office patients. He also answers the 24-hour phone, and since we are together most of the time, it’s easy for him to talk to me about whatever is going on. He screens new patients and does scheduling. He also handles most of the prior authorizations for buprenorphine medications (since I tend to get angry and swear).

My other employee, Daniel, works in my office on the one day per week that I’m open. He is terribly overqualified for his job, since he is just finishing his Master’s degree in addiction counseling. He checks patients in, performs drug screens, records the results, checks patients out and takes their money, and schedules their next visit. Besides being smart and savvy, he also knows my patients are sick people getting well.

I have few expenses. My fiancé does all the computer work that I need, and the only bills I have are rent, electricity, and various office expenses.

If I decided to accept third party insurance, I’d have to add another employee. I’ve seen the nightmares that come with billing insurance, having worked in primary care for ten years. Insurance companies deny claims for frivolous and stupid reasons, and take their time paying doctors. I heard this year from a few colleagues that BlueCross/BlueShield, the primary payer in my state, in some cases waits longer than six months to pay doctors, and still denies many claims. I’d have to raise my rates to make up for this, making it more difficult for my patients with no insurance.

Right now I charge $85 to $100 per 20-minute visit. I feel strongly that people with addiction shouldn’t have to pay more to see their doctor than people with other chronic illnesses, so I keep my rates low, relative to other providers. About half of my patients are the working poor, who don’t qualify for Medicaid in my state, and also don’t qualify for Obamacare. They can still afford treatment, because I’m also willing to prescribe generic buprenorphine/naloxone, which is quite a bit cheaper than name brand medication.

Am I willing to take on the headache of accepting insurance in order to be able to treat a hundred more patients? I don’t know if I am. I plan to investigate it further, maybe talk to some other doctors who take insurance currently, to see how big a hassle it is to get paid.

Next let’s talk about electronic medical records (EMRs). EMRs sound better in theory than they work in practice. My doctor friends complain that they cost much money, are not designed to be physician-friendly, and take up more time than they save. They aren’t interoperable, so each practice has a different electronic record. To coordinate care with a provider outside of one specific system means the record still has to be printed out on paper to be faxed or mailed.

Do electronic records provide better care? I have my doubts. I’ve bitched about EMRs in prior blogs, describing how I’ve requested records on my patients from the local hospital. Those records show on the front page, without fail, that the patient has been screened for Ebola. But I have to look at many pages to try to find a final diagnosis and treatment plan from the emergency department physician. Sometimes I find it… and sometimes not.

Privacy is a big issue to some of my patients. I treat several people, prominent in their communities, who see me specifically because I don’t have electronic medical records. They are willing to travel more than an hour one-way to see me, both because they know their records aren’t computerized, and because my office is very private, in the back on a non-descript realty building. Some of these patients may be a little paranoid about their records, but maybe not.

If I worked in an office owned by a big hospital system, how many people could get access to read my records? We all know stigma against substance use disorders and mental health diagnoses exist. It could cause damage to patients with substance abuse issues if details about addiction treatment were leaked. Ironically, my patients who work in healthcare are the ones most concerned about their privacy, and maybe for good reason.

Besides, EMRs are expensive, and probably I couldn’t afford one for my small practice.

Those are my specific objections to the proposed rule. I understand why the authors of the rule included these requirements. HHS doesn’t want bad doctors, running buprenorphine pill-mills, to be able to qualify to treat more patients. But as I’ve complained about at length and repeatedly in my blog…those doctors already thumb their nose at patient limits. So this proposed rule is likely to be followed only by the doctors who are already conscientious about following rules and guidelines.

I’m glad and grateful the HHS proposed this new rule. But I’m not yet sure I will want to increase my patient limit, for the reasons described.

13 responses to this post.

  1. There are several EHRs that are free for the basic programs, such as Kareo and Practice Fusion. They are all you need. They make their money on the add-ons and billing services.
    But the insurance requirement would be a deal breaker for us.


  2. Posted by SP on May 11, 2016 at 2:06 pm

    It is interesting to me that you ask the question if a patient that has been stable for three years still requires counseling, because in the OTP setting we must always provide counseling to all patients. If I have a patient in treatment for twenty years, they must still participate in counseling. Since the inception of office based buprenorphine treatment there has been a double standard that creates a two-tier treatment system, which gives patients the false sense that if they are being treated in a doctor’s office, they are somehow “better” than those being treated in OTPs. That mentality is also seen throughout society and within the medical community. This idea contributes to the stigmatization patients within the OTP treatment system face. Many OTPs now utilize buprenorphine as well as methadone and we continue to be required to apply the majority of the same regulations and accreditation standards to all patients regardless of what medication is used to treat them. So, is a patient stable twenty years in a highly regulated and intensive treatment facility any more in need of counseling than a patient being treated in an office based practice who has been stable three years?


    • You raise excellent points.
      I dare say a patient stable for twenty years probably knows more about addiction, recovery, and methadone treatment than the average new OTP counselor. At that point, who is counseling whom?
      I feel office-based programs should be for very stable patients, but that’s not the way it has worked out. Many stable patients have no option other than OTPs, and many office-based programs attempt to treat patients who are unstable, probably to the patient’s detriment.


  3. It’s absurd that bup doctors cannot prescribe methadone. I’ve been a methadone client for over 30 years clean for over 20. I am stable on 20mg a day (I get monthlies in 10mg tablets). Methadone is as cheap as aspirin but I’m forced to pay over $400 a month. As a compliant patient I only go once a month and if doctors were allowed to prescribe methadone it would cost me around $20 at the local pharmacy. But my only alternative (other than stopping) is bup which I did try 10 years ago with no success. 20mg/day clean for 20+ years and A doctor is not allowed to help me. At least Florida allows the pills instead of liquid and 27 day take homes.


    • I don’t disagree with you. There are methadone patients who would do just fine in an office-based setting. But on the other hand, this nation has many methadone overdose deaths about eight or so years ago, which kind of made it difficult for doctors to advocate for methadone patients to be allowed to be seen in offices instead of OTPs.


  4. I agree with comment about Methadone, but with the DATA 2000 waiver in order to prescribe. The Feds figure Methadone is more dangerous, and it may be. But a licensed provider can prescribe Methadone for “pain” outside of an OTP. Logic? That’s the government for you.


  5. Posted by William Taylor, MD on May 23, 2016 at 5:21 pm

    There’s probably some turf-protecting reflected in the proposed rules. Suboxone expansion threatens both traditional OTP’s and abstinence based treatment programs. The AATOD came out against expanding suboxone limits, claiming without any solid evidence that counseling would be inadequate in office based practices.

    The net result is that politicians can appear to be doing something, but the expanded limits are hedged with so many restrictions that there will be no practical effect.

    I’ll believe the gov’t is serious when:
    1. Any doc can prescribe buprenorphine
    2. Insurance companies are required to cover MAT at realistic payment levels, without prior authorizations, pre-approvals, and the usual red tape.
    3. Abstinence based rehab programs get one shot at treatment. If a patient relapses after release, the only insurance coverage is for MAT.
    4. The FDA throws out the silly Belbuca and approves buprenorphine as FIRST-LINE treatment for chronic pain.

    Don’t hold your breath


    • Well, the Belbuca doses are so much lower than what we use to treat addiction – I think the max dose of Belbuca, 900mcg twice per day, equals1.8 milligrams, if I’ve got my decimal in the right place. I wonder how much it does for pain…


  6. Posted by William Taylor, MD on May 30, 2016 at 5:13 pm

    The decimal points you cite are exactly correct. Here’s some other numbers: Good rx price for 1 month of Belbuca 0.9 bid is about $650. 2 mg daily of generic buprenorphine goes for about $90.

    With all the hand-wringing about doctors prescribing too much opioid agonist for chronic pain, why is there not more enthusiasm (and research) for a much safer, FDA approved alternative analgesic, that can even be affordable with a little creative prescribing?


  7. Posted by Lois L. on July 23, 2016 at 12:23 pm

    Belbuca is certainly more costly for a cash only patient compared to any of the buprenorphine formulations approved for treatment of addiction. However, insurance cost is often the same.

    Relative to dosing, I have not seen any bioavailability comparison data or comparative serum buprenorphine levels for belbuca and butrans and other buprenorphine formulations. Remember that 8mg of suboxone is supposed to be equivalent to 5.7mg of zubsolve and 4.2mg bunavail based on varying bioavailability of the different formulations.

    In my experience, opioid experienced patients on 8mg of suboxone require 80-160mg of morphine sulfate a day to stop withdrawal and over 160mg a day to get pain relief superior to 8mg of suboxone. Patients (without current physical dependence on opioids, with or without a history of addiction) do get significant pain relief on 2mg of suboxone a day, especially when this dose is divided up and taken 3-4 times a day.


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