Thursday, November 12, 2009

Suboxone DEA Audit Update III

Continued from: DEA Suboxone Audit Update

Since my last post I started telling all buprenorphine patients that DEA might demand to audit my treatment records. Reactions have ranged from resignation to curiosity to indignation. Although I had planned to mail letters to all my buprenorphine patients, since further contact with the local DEA has convinced me my audit will not happen soon, and will not likely require that I identify patients, and because I see these patients at least monthly, face-to-face, discussion seems preferable. If you choose to use a letter instead of or in addition to discussion, a model appears below. Feel free to use it as is or modify it. You will also find below a model letter to send to your local DEA office asking to schedule an appointment for the audit.

It occurred to me as well that the psychotherapists with whom I share my office might want to know about the audits. I sent them messages or letters suggesting what they might do if people claiming to be DEA agents appear when I am not in the office. I also left a message with a local agent said to be connected with the project asking whether agents might attempt to enter my office or access my records when I am not present. An agent returning my call the next day assured me they would not and that agents would not have authority to access patient identity without a court order. The agent (who was aware of my blog) also promised to provide me with a copy of the agreement agents ask physicians to sign at the start of each audit.

According to my local Reckitt-Benckiser representative the one physician whose office I have contacted to discuss the audit experience was reluctant to provide further information or even to be identified. This is despite the fact that DEA also confirmed his identity.

Interest in the audit seems to have waned at the CSAT buprenorphine forum. In particular there has been little interest in my suggestion that data be collected to determine whether the audits have discouraged patients or physicians from participating in OBOT. Many physicians seem to believe that any doctor who worries about the audits must have something to hide and that all law enforcement personnel and activities are always conducted properly and with complete respect for patients' rights. I wish.

In contrast I attended a meeting hosted by the state medical association. Those in attendance seemed to support further action to ensure that DEA conducts such audits respecting patients' rights and avoiding disruption of physician practices.

I should point out that I believe DEA has authority to conduct these audits. I have also heard many stories from patients previously treated by physicians whose OBOT practices were suspect. I hope the audit will lead to improvement, and I hope to learn something that will allow me to improve my own practice. I hope too that my patients, knowing of this scrutiny, will feel less inclined to engage in diversion.

I am left with the impression that agents most want to review policies and procedures of physicians who actually dispense drugs. For physicians who do not dispense I believe they will want to verify compliance with prescribing practices and adherence to the 30/100 patient limit. I plan to prepare a de-identified record of prescriptions with that in mind.

It is unfortunate that DEA persists in refusing to schedule audits at a time that allows for minimal disruption of physician practice. Given the widespread knowledge that the audits will take place it seems unlikely that agents will catch physicians "red-handed."

Letter to patients to inform them of imminent audit

Dear [Patient]:

I am writing to inform you of my expectation that the U.S. DEA intends to audit the records of all doctors and patients involved in treatment with buprenorphine (Suboxone, Subutex). DEA has not provided written notice of this plan but has confirmed it to me by telephone. I understand that DEA may have authority to require me to provide access to your records; however DEA may not have authority to discover your identity. In fact DEA has thus far refused to schedule the audit in advance or to provide me with further information as to how the audit will be conducted in advance, however I will continue to attempt to schedule the audit at a time when patients will not be present. Please be assured that I will do whatever I can to protect your privacy.

Please let me know if you would like to be present during the audit. If you wish to object to the audit of your records, I suggest you do so through an attorney by contacting the local office of DEA:


Feel free to contact me with further questions.

Thank you.


Letter to local DEA office to schedule audit

Dear Agent ______:

I understand that your agency plans to audit my records of treatment activities under the DATA 2000 waiver, office based opioid treatment (OBOT).

I have scheduled one hour at ...... on November 00, 2009 when your agents may visit the office with minimal disruption to the office routine and conduct the audit with respect for may patient's rights. Please confirm by telephone or letter. I have notified all my OBOT patients of the audit as well. They may contact you, and they may be present during the audit.

Please provide me with a copy of any agreements you will want me to sign in connection with the audit by return mail so I can obtain advice of legal counsel. Please also provide a list of documents or information you want to access, indicating in particular whether you intend to discover the identity of patients.

In the event your agents appear unannounced, please be advised that I will take precautions to assure myself they are not impostors: I will attempt to contact your office and ask for specific information to identify the agents, such as names or badge numbers which must match identification the agents provide me. Failing this I will conclude that the individuals may be posing as DEA agents, and I will contact local law enforcement via 911.

If you anticipate needing more than one hour, or if you wish to reschedule for a different date or time, please contact my office.

Thank you.


DEA Suboxone Audit Update IV


  1. suboxone providerMarch 10, 2010 at 4:34 PM

    Have you received a copy of the agreement agents ask physicians to sign at the start of each audit? It would be valuable if you'd share it. Thx

  2. Here is the form along with statutes:

    DEA Form 82:

    The question remains what will happen if you decline to sign and the agents return with an Administrative Inspection Warrant. I should hear back from DEA on this in a couple of weeks and will post soon after.

  3. Anyone know any lawyer who deals with DEA related cases. Just in case, if the DEA agents are inappropriate, he or she can used. Basically, I feel, they are DEA agents and they should be dealt as legal entity, who best can address legal issues other than a lawyer.

  4. I am not an MD but an RPh. Do these types of audit problems occur only with "prescribers" who've completed the 8 hour course and are using Suboxone as a "maintenance tx"? It is my definite understanding (I can look up the CFR Code reference if needed) that any "provider" can prescribe Suboxone for the "off-label" use of pain, in which case the 8 hrs. of education and additional 10 digit identifier are not necessary. Is it professionally unwise to use Suboxone on a pain patient because the DEA is going to scrutinize the heck out of you? To me it would seem to make some degree of sense to use Suboxone especially in a recovering narcotic addict that needs more pain relief than Toradol (or the NSAID du jour) can provide. We just had someone relapse back to heroin use after getting a Vicoprofen Rx. I realize that could happen even with Suboxone, but the euporia by taking extra should be blunted to a fair degree and the relapse "potential" not as great. Just wondering and giving my "thoughts."
    A "shirt tail inlaw" of mine is a former DEA agent. He said there were two "camps" of agents: those who realized some people may eventually require huge doses of narcotics for pain relief, and those who were "unaware" of the no ceiling-effect (or didn't believe it) and thought anyone getting more than XXmg was abusing. Seems like the later camp has won--too bad for those with severe pain. JMO.

  5. Anon, I believe you are correct that DEA requires no special qualification for treatment of pain with buprenorphine and only audits practices of docs with special DEA numbers, but I don't treat pain, I have not heard of DEA "scrutinizing the heck" out of docs treating pain.

    I'm not surprised at the idea of the two camps of agents. Even non-addicts can develop tolerance and require higher doses. DEA should stick to law enforcement. Agents are not qualified to make judgments about whether someone is abusing a drug. If they want to focus on docs prescribing -codones inappropriately, it's OK by me.

  6. moviedoc,
    1. My question about Suboxone/pain was: does anyone know if using Suboxone for pain is a flag for the DEA; nothing to do with practice type only presenting problem (pain).
    2.I am in total agreement with the DEA sticking to law enforcement. Tolerance occurs to desired effect-legit or illegit (analgesia or euphoria). The two "camps" my DEA inlaw referenced comes from a lack of consistent understanding/knowledge in the DEA about such things as tolerance (regardless of use intent). What I find unfortunate is (according to former agent) many in the DEA do just look at the number of mg/day and make abuse/addiction vs. legit. use and appropriate/inappropriate prescribing decisions and many of them apparently make them badly with repurcussions for patients and doctors. I think that's too bad. Hope I was clearer??

  7. Anon, I guess I really can't answer your question about DEA "red flags." Anyone else? How would DEA see that red flag? I know they look at pharmacy records, so maybe they would see a Rx written by a physician without the special number. But would that be enough to trigger an investigation? Don't know. They might want to make sure the drug was prescribed for pain, but patients with pain can become addicts, and addicts can develop conditions that necessitate use of narcotic analgesics, so it get murky.

    If what your inlaw says is true it is indeed unfortunate. One would hope DEA would get medical input before even demanding access to review records in these ambiguous cases.

    It's bad enough that DEA might have two camps, but to me it's even worse that the US government has two camps: DEA vs. all the agents that promote treatment of addiction.