Another physician's experience of DEA audit of his buprenorphine practice turned into considerably more and suggests the agents involved were ignorant, inadequately supervised, out of control, and unable to conduct themselves properly in a physician's office. Our tax dollars pay for this:
"On April 5th, 2010, two female agents presented their paper ID, but when I asked if they had badges, they said no. They arrived at 5pm and stayed until nearly 8pm. They interrogated me about my Suboxone patients. I have 2 on compassionate care. The patients receive their Suboxone at no charge, and I also do not charge them for their appointments. They wanted to see my bookkeeping and where I kept the Suboxone locked up. I showed them the lockbox, inside a locked cabinet; showed them the two bottles of 30 tablets each, with the patient's name on each bottle. They wanted to see my documentation, including the receiving documents that come with the bottles. They informed me that I should not keep these receiving documents in the patient's charts, but in a separate file of their own. That was an irregularity. They also said I need to segregate all my Suboxone patient files into a separate file away from my other patient files. That too, was an irregularity.
"I have listed all my Suboxone patients including my 2 compassionate care patients in a bound notebook that is locked in the cabinet next to lockbox of Suboxone. They said I should have put "0" on the first line, as that is what I started with, and that was an irregularity. They also said I should put "Suboxone" "8mg" "tablets" and my "X - DEA number" on the top of each page, and since I didn't, that was an irregularity. They had me Xerox copies of all my entries, as they stood. They had me sign an accounting record indicating that I had dispensed a total of 600 tablets to the 2 compassionate care patients, and that I had 60 tablets remaining in the lockbox.
"Then after about 2 hours, they began asking me about the medications I ordered and dispensed when I had worked at a pain clinic years ago. They informed me that since it was past the 2 years required to keep records for the DEA, re: dispensing controlled medications, they were not interested in who received them. But they asked many questions about the now defunct clinic; some questions that were very uncomfortable such as, "Why was this clinic given that name?" Although I attempted to explain to them who the person was it was named for, they would jump on my answers before I was finished saying,"So it was the doctor who owned this clinic?" Again, I tried to explain who he was, how he was one of the fathers of modern medicine who invented a new treatment back in the 15th & 16th centuries. They didn't know what the new treatment was and wanted to know if I was dispensing it at this pain clinic. I told them it was a medicine from a long time ago. They asked where this clinic was located, and as I attempted to give them the directions, they again, would jump on my answers with more questions before I could finish, also making remarks, such as "Do you turn North or South when you leave the freeway." I tried to tell them that for anyone who knows me, I have no idea about North and South directions, but that people turn right at the off-ramp and then take the first left. They asked again, "is turning left going South ?" I said I didn't know. I am not good with compass directions. They continued with this line of questions, wanting to know more about the types of treatments were offered at this clinic, who the owner was, where he was now, what my interests were there, how often I was there, how long did I stay there, etc. (I continued to wonder why they asked all these questions, if this was years ago, the clinic is now defunct, the owner is deceased, and in their own words, the documentation for the dispensing of these medications, was no longer needed since it was beyond the DEA requirement of keeping records 2 years). They wanted to know why I ordered these medications for the pain clinic. I informed them that I was there to learn from an expert, and I was asked to order them, as they were for my patients. They then informed me that I should have not used my DEA number at one of my offices, and that this was also an irregularity. I informed them that I had a DEA number at the other clinic, but there was some confusion with the ordering of medications, as they would be delivered to my other address. As I had a separate DEA number for each location, I never gave it a second thought, and attempted a number of times to correct this, but there was confusion at the ordering company with different customer numbers, and there still is as there remains on my file two customer numbers. So I kept accepting the medications at the other address. If the DEA bothered to look at some of these invoices, they could see that the medications were being ordered for other clinic, which the distributor put on the top of some invoices, or they just would put PA, but would have my Seattle address. In addition, because of this confusion, I received charges for medications and other supplies that I didn't order or receive.
"When the older agent went to the restroom, she insisted upon me staying in the hallway and not returning to my office where the other agent was left by herself. In addition, they asked me to copy my bound ledger book of all my Suboxone patients, both agents stayed in my office alone without my supervision, as the copy machine was in another room.
"When they left, they handed me copies of Web pages. They informed me that there were several irregularities and that they would have to turn everything over to their supervisor who would be in touch with me. This really started freaking me out.
'A colleague told me that much of the information the agents told me was untrue, ie, I didn't have to segregate my Suboxone patient files from my other patient files; that I didn't have to keep a separate bound journal for my regular Suboxone patients, as I wasn't dispensing anything to them but a written prescription. That there was a lot of the nit-picking with putting "Suboxone" "8mg" "tablets" and "X-DEA" at the top of two pages and putting "0" on the very first entry line, was more for harassment than anything else.
"On Thursday, April 9th, I called Supervisory Agent Ruth Carter, and left a message informing her of my distress, that since this 3 hour interrogation on last Monday night, (with the agents basically telling me I was in trouble for these irregularities but wouldn't say what kind of trouble), that I have not been sleeping or eating this past week. That I am having constant ruminating thoughts: Have I done something wrong ? Am I going to jail ? Will I lose my license and livelihood ?
"This distress is all true as I have discussed how I have been feeling with several colleagues. It was indeed an ordeal, I was very nervous having DEA in my office. My mouth was dry and I kept drinking lots of water, and I kept thinking to myself, "They're going to see this as an indication of some sort of guilt."
"Other questions and answers and comments that came to mind later:
"They asked if I ever heard from any of my patients, of any place that sells drugs. I informed them that I heard in back of a Jack-in-the-Box downtown. They asked where it was, how many Jack's there were, and I told them I only heard, "in back of a Jack-in-the-Box." They asked where on Broadway. Again, I said all I heard about is in back of a Jack-in-the-Box on Broadway. (I learned later from a colleague that this Jack-in-the-Box on Broadway was razed several years ago).
"In addition to the information on the other clinic I mentioned above, they asked a lot of other questions. How many doctors worked there (several) ; what did those doctors treat (I don't know) what kinds of treatments were provided at this clinic (pain, cancer; alternative, brief anesthesia, use pain medications, trigger point injections, prolo therapy, chelation, hormones, heart disease treatments, arthritis, fibromyalgia, thyroid, any and every kind of muscle and joint therapy); were other doctors providing pain management (I don't know); they asked if the clinic or the owner were ever under investigation (I don't know); what other kinds of medications were being used (I said I knew about liquid cocaine, but never used it, or saw it used). The older agent said it is used in eye surgery or treatment. I told them the doctor who owned the clinic died last year and it was a great loss to me personally and to the community as he was a world famous physician, author, had been on radio, TV. They asked me if I knew why he died. I said I didn't, but I speculated. I told them that he was to retire soon, had arranged for his clinic to be sold soon, but I was never formally informed of a specific reason.
"I kept thinking how odd it was to continue asking me questions about a defunct clinic, with books that have been closed years ago. And how the older agent said she was not concerned about how the medications were distributed as the times those medications were ordered and distributed were more than 2 years ago. Obviously, I had not continued to order medications since. So I didn't understand why all the harassing questions, but I was becoming more uncomfortable, and visibly shaken, feeling I had done something really wrong and I was going to be arrested or lose my license on the spot for something that happened years ago, and was never investigated then for any improprieties. In addition, they can easily pull my Schedule II records, and they can see that I am rarely writing for pain medications, as I don't want people to get the wrong idea, and have a line at the front door with people drug seeking.
"As I have said to several other colleagues, if I had known that there was so much involved in paperwork, DEA investigation ,etc with dispensing Suboxone to 2 patients under compassionate care, and it was going to be any different than giving other compassionate care medications, like Seroquel XR, Effexor XR, Pristiq, etc, I would never have done it. I still don't understand why the doctors who prescribe Suboxone are under such scrutiny for a Schedule III, which is relatively not abusable, requiring a separate DEA, and yet, the prescribers of Oxycontin, a schedule II narcotic, which appears to be the drug responsible for causing most of this opiate addiction, don't need a separate DEA number, like those of us who prescribe Suboxone. I further understand that Suboxone was originally a Schedule V med (as buprenorphine), but was moved to Schedule III for FDA approval (as buprenorphine + naloxone). It appears that the DEA is targeting those of us who are trying to provide treatment and even a cure for opiate addiction. It also appears that the DEA is trying to harass and intimidate those us from providing this treatment and that there may be some collaboration with Purdue Pharmaceuticals, to keep patients away from a cure or treatment for the addiction they have caused as it is cutting into their bottom line.
"They asked me how I induced patients on Suboxone. I told them I don't induce anyone. My patients came to me already on Suboxone from hospitals, detox clinics and other doctors who induced the patients, but already had too many Suboxone patients on their books. They asked how these patients heard of me. I told them the Internet. The older agent, said in an attacking manner, (which scared the hell out of me). "Do you advertise? Do you have a Web site that advertises you prescribe Suboxone?" She kept it up even after I stood and showed her a paper indicating it was from the Suboxone company, and that is where many of the patients come from. She asked how many patients total I have. (I said we would have to count, but they are all here, including the ones who are no longer coming to this office). They asked if I had ever prescribed Subutex. (I said I did, as one pregnant woman informed me her OB/GYN said it would be less harmful to the fetus, but that she is no longer coming here).
"I also talked about how I hope Vivitrol takes over much of the opiate addiction treatment. Neither agent heard of this medication. I informed them it was injectable naltrexone which lasts for a month. They asked what naltrexone was (and at that point I knew they had no understanding of Suboxone being a combination or buprenorphine and naloxone). I told them about the history of naltrexone (the oral medication) and injectable naltrexone (Vivitrol) and how if it is injected once a month, the patient could not sell medication, like some sell or trade Suboxone, that it works all the time, and there is no problem with forgetting a daily dose, since it is given monthly. I also gave them brochures on this medication. They asked if I have prescribed Suboxone for chronic pain. (I have). And if I wrote Chronic Pain on the prescription (I do).
"The also said that the primary point of their visit is to provide education (even tho they kept harassing me with questions about the other clinic with the younger agent writing down lots of notes). But it wasn't for education, but to discover as many violations as they could. If it was for education, they would have instructed me and had me put on top of the two pages "Suboxone" "8mg" "Tablets" "X-DEA" then and there, and not use those ploys to say I violated the CSA. The cover page on my ledger has all that, and I didn't understand why it had to be on the top of these two pages.
"They asked if I did urine tox screens (I do not because these have to be witnessed) but I have saliva tests I can use. That substance abuse treatment is not my primary activity, but I am providing a service to about 35 people, who cannot afford treatment unless covered by insurance or compassionate care. They asked if I required people to attend 12-step groups (I do not as how would I know for sure they do). That as a physician - psychiatrist, I need to be able to trust my patients to some degree, as many have lost their trust in others, and vice-versa. But my patients must come in every 30 days to get their prescription. And I have discharged patients from my practice if I discover they are misusing their medications, not keeping timely appointments, etc.
"They also said if methadone is prescribed, it can only be prescribed for pain in low doses, and not for opiate addiction. If prescribed for opiate addiction it must be in an approved clinic.
"They said that if I had an office in 3 different states I would have to have a separate DEA for each state (as well as a state license). They said that my prescriptions can be honored in any state even without being licensed in that state where the prescription is filled. If I were to work at another clinic which dispensed medications, I would need to obtain a separate DEA for that clinic. If I were to dispense Suboxone from another clinic, I would need to obtain a separate X-DEA as well.
"They asked if I had purchased my new prescription pads yet (I have not.) and then informed me that they have already investigated fraud with the use of these new prescription pads.
"They also remarked that although (in their opinion) doctors no longer make house calls (which we still do, and some of my colleagues know I do this), I would be allowed to carry all schedules of medications with me, and then when I return, I should lock up my medical bag. Apparently not taking into account that many doctors who do house calls keep their bag with them at home, as they often will make the house call from their home.
"On Monday, April 13th, Supervisor Ruth Carter, returned my phone call and said I should not be concerned with the investigation. She said these "irregularities" are actually violations, but these are easily taken care of. I told her that they asked me about a pain clinic I worked at years ago where I dispensed medications, and was told it was an "irregularity " by the agents, as I was sent medications by the pharmaceutical company to my one clinic address that were used at another clinic address where I also had a separate DEA. She said it was a violation, as I am only suppose to dispense medications from the location where they are received. (I never knew this was a problem as I had two separate DEA's and was dispensing them to my patients under the guidance of a mentor, and that's the only reason that I ordered them). I told her that there was quite a bit of confusion during the ordering of medications, as the company would send the medications to me under the name of one clinic but to my the other address. I attempted to correct this clerical error several times, but it was apparently too confusing.
"I also said that the agents told me I had to keep my Suboxone patient files separate from my other patient files. Ms Carter said this is not true. All I would have to do is to show the DEA the number of patients who are on Suboxone (which they should know as Suboxone patients are easily identifiable by our special X-DEA number). I said I was told there was another irregularity as the receipts for the Suboxone were in each of the two patient's charts, and it was supposed to be in a separate file. Ms Carter said this was not a violation. She said I would be receiving a letter about these violations, and that I would need to send a return letter stating that I had done what was asked. She also stated that if there was anything serious, her agents would have spoken to her right away but they haven't contacted her about any serious violations and her agents haven't met with her for over a week. I told her I was disturbed when the older agent asked me to wait outside the bathroom door and not return to my office, where the younger agent remained by herself. Ms Carter said I should never have left her agents in my private office unattended and I should always conduct any questioning in a conference room or some other neutral ground. (This disturbed me even more, and I began thinking that these agents are not trustworthy if they cannot be left unattended in my private office. What were they doing, downloading my personal files? Bugging my phone? Or what?). I told her that they were left alone in my office on a couple of occasions as they requested record copying, as the copier is in the other room. Since her agents were out asking me all these questions, I asked Ms Carter why her agents knew nothing about Vivitrol, the injectable naltrexone for opiate abuse. Ms Carter stated they should know about the drug they were questioning me about and any alternatives that they may want to question, (like they did with methadone). I told Ms Carter about my anxiety, how stressed I was as after 3 hours I was getting worried that I did something really wrong and was going to have my door kicked in, be arrested, lose my license, my patients who depend upon me, my livelihood, my home and everything I worked so hard to achieve. She reassured me that this was not going to happen. They have no intention of taking my license from me and no one would be kicking in any doors. Ms Carter apologized for any anxiety this investigation has caused as it was meant to only be educational and not vindictive. I asked Ms Carter why her agents continued to ask me questions about a pain clinic I worked in years ago, when the agents don't require any records that are more than 2 years old. She didn't know why her agents were asking me all these questions about events that happened more than two years ago, as they are only supposed to be discussing Suboxone prescribing, dispensing and record keeping. (I kept thinking to myself: these agents are not supposed to remain alone in my office; that several of the statements these agents made to me are false, ie, what is a violation; they are not supposed to question me about anything but Suboxone, ....are these rogue agents? Agents who do not follow directives of their supervisor? Does this violate any DEA rules, that agents are not supposed to question doctors outside the scope of their investigation? Are they trying to score extra points? Are we responsible for what we say under duress, but the DEA does not require proof of what we did greater than 2 years ago? Again, I kept wondering if these agents were real DEA, as they had no badges. And if they weren't agents, do they use contractors to do this questioning as that way they don't violate rules of conduct if they don't follow DEA rules but do as they please to get the information they want to pursue? Like a rendition?)
"I also asked Ms Carter why the DEA was going after Suboxone prescribers and not the prescribers who are causing the opiate addiction ? Why don't Oxycontin prescribers need an X-DEA? Wouldn't it be more judicious to go after those who are causing a lot of the problem and not those of us who are prescribing a treatment and cure? I told her there is rumor that the DEA is being funded by the opium industry as Suboxone interferes with their profits; ie, if people use Suboxone, they won't use and abuse opiates; that we are in Afghanistan protecting opium fields like we did in Viet Nam, Laos and the entire Golden Triangle. There is no oil in Afghanistan and pharmaceutical giants like Mallinckrodt buy 80% of the world's opium from Afghanistan (20% from Turkey). It is Afghanistan that most of the worlds heroin (93%) comes from. She said she didn't know anything about it, but she is following directives from D.C. Again, she apologized for any undue anxiety and reassured me that it is not their intention to do anything but to educate doctors on proper record keeping, and that I they have no intention of taking away my license to prescribe or practice.
"The last thought why the DEA was doing this, is to rack up as many "irregularities" (aka violations) as they can. No matter that they are clerical errors such as not putting the word "Tablet" on the top of each page. It is a violation of the DEA code. But the DEA can present these many violations to Congress and point out they have discovered all these crooked doctors who blatantly violate DEA regulations, and if they only had more money from Congress they could do a much better job.
"At the bottom of it all is money."
Showing posts with label audit. Show all posts
Showing posts with label audit. Show all posts
Monday, February 21, 2011
Tuesday, November 23, 2010
Wednesday, November 3, 2010
More Harassment from DEA
A few days after the audit I started getting voice mails (2) from a DEA auditor asking when I would like to meet to go over the "findings" growing out of The Audit. I ignored them and set Google Voice to block all numbers associated with the local DEA office. The auditor emailed me (He told me my number had been disconnected. Thanks for confirming the call blocking feature works!), this time asking if we could meet the next day (10.29). I faxed a terse letter to his boss that morning (last Friday) telling him he could send any comments or questions in writing.
That same Friday morning, as I waited for a new patient to finish her paperwork, my office manager informed me the auditor above and another male from DEA had just appeared in the waiting room.(They did not present a warrant.) Furious at this presumptuous invasion of my office I called the Seattle field office. Apparently they got the message that he was wasting his time (and our tax money). After they received a phone call they left.
I filed a formal complaint with the US Attorney. I attempted to have them charged with criminal trespass by local police, but the police refused to interfere with an ongoing "investigation." I have contacted the ACLU. I figure at a minimum DEA has violated my right to freedom from unreasonable search and seizure and the privacy rights of both myself and my patients, not to mention the patients of my office mates.
I don't recall that it was a requirement of DEA registration that I allow these thugs unrestricted access to my office, which I regard as my castle. If that's the case they can so inform me, and I will decide whether I might prefer to continue my practice without DEA registration. (Other than buprenorphine I only prescribe controlled substances to 4 patients, one with schizophrenia who takes clonazepam to prevent seizures related to clozapine, a couple of patients with ADD who take methylphenidate, and one buprenorphine patient who takes pregabalin (Has anyone heard of addiction/abuse associated with that drug?). Partly because most of my patients are usually recovering addicts/alcoholics I have convinced myself that I can handle almost any case without controlled substances. Hey, it could even help me market my practice.
I'm fed up with the harassment I apparently must endure to prescribe buprenorphine, and have allowed my buprenorphine practice to shrink since early this year anyway. I could retire. I would have time to picket in front of the local DEA office. At least one other physician I no of has said he will stop prescribing the drug because of DEA harassment.
My plan if another auditor shows up in my office without a warrant: Depending on whether patients are present I will call 911 or ignore them and maybe leave. I don't know whether my office mates have enough nerve to demand they leave if they present when I am not there.
When I spoke to the auditor at the field office while the two auditors were in my office I made her aware that I expect DEA to communicate with me in writing. She told me that's not the way they do things. Fine. If DEA wants to have a meeting, "their way," they can meet without me.
Five days have passed since I faxed my request for the findings from my audit in writing. So far I have received nothing, but this makes the third time DEA has ignored my letters. These are public servants?
That same Friday morning, as I waited for a new patient to finish her paperwork, my office manager informed me the auditor above and another male from DEA had just appeared in the waiting room.(They did not present a warrant.) Furious at this presumptuous invasion of my office I called the Seattle field office. Apparently they got the message that he was wasting his time (and our tax money). After they received a phone call they left.
I filed a formal complaint with the US Attorney. I attempted to have them charged with criminal trespass by local police, but the police refused to interfere with an ongoing "investigation." I have contacted the ACLU. I figure at a minimum DEA has violated my right to freedom from unreasonable search and seizure and the privacy rights of both myself and my patients, not to mention the patients of my office mates.
I don't recall that it was a requirement of DEA registration that I allow these thugs unrestricted access to my office, which I regard as my castle. If that's the case they can so inform me, and I will decide whether I might prefer to continue my practice without DEA registration. (Other than buprenorphine I only prescribe controlled substances to 4 patients, one with schizophrenia who takes clonazepam to prevent seizures related to clozapine, a couple of patients with ADD who take methylphenidate, and one buprenorphine patient who takes pregabalin (Has anyone heard of addiction/abuse associated with that drug?). Partly because most of my patients are usually recovering addicts/alcoholics I have convinced myself that I can handle almost any case without controlled substances. Hey, it could even help me market my practice.
I'm fed up with the harassment I apparently must endure to prescribe buprenorphine, and have allowed my buprenorphine practice to shrink since early this year anyway. I could retire. I would have time to picket in front of the local DEA office. At least one other physician I no of has said he will stop prescribing the drug because of DEA harassment.
My plan if another auditor shows up in my office without a warrant: Depending on whether patients are present I will call 911 or ignore them and maybe leave. I don't know whether my office mates have enough nerve to demand they leave if they present when I am not there.
When I spoke to the auditor at the field office while the two auditors were in my office I made her aware that I expect DEA to communicate with me in writing. She told me that's not the way they do things. Fine. If DEA wants to have a meeting, "their way," they can meet without me.
Five days have passed since I faxed my request for the findings from my audit in writing. So far I have received nothing, but this makes the third time DEA has ignored my letters. These are public servants?
Wednesday, October 20, 2010
The Audit
The big audit. At last.
In my last post I told you I expected DEA agents to return, "Administrative Warrant" in hand, to conduct the obligatory audit of my buprenorphine practice. The entourage did arrive on October 14, conducted the audit, and I'm still a free man. Nobody got hurt.
Let me recap: When I applied for the special DEA number that allows me to treat opiate addiction with buprenorphine it was clear that I might have to submit to audit of my prescribing records. However, only about a year ago I discovered DEA had embarked on a project of auditing all such physicians. I only objected to a few aspects of the plan. DEA law enforcement agents, the sort that might carry badges and guns, would conduct the audits. This I could accept, but what really galled me was DEA's refusal to schedule the audits. I guess they thought they might catch me red-handed doing something illegal. I expected this to disrupt my practice unnecessarily, and I began to protest. Professional associations such as the American Psychiatric Association, the American Association of Addiction Psychiatry, and the American Society of Addiction Medicine, to my disappointment, focused their efforts on assisting physicians in complying rather than assisting us in assuring that our rights and those of our patients would not be violated. We all learned early on to expect agents to present physicians with Form 82 on arrival. This form permits agents to enter the office and conduct the audit. We were warned that if we refused to sign Form 82 agents would return with an "Administrative Warrant." (Yikes!)
Warrants, even the administrative kind, sound pretty bad, like something to be avoided at all costs, something that will brand you a criminal for the rest of your life. But it seemed possible there might exist some advantage in going this route, and that has turned out to be true. I asked DEA to provide me with a copy of such a warrant and detailed description of how they conduct such an audit. The description proved vacuous and useless, and DEA refused to send me a copy. I figured I would have to get it the hard way.
After agents Sanchez and Carter left my office on October 8 I wondered how long I would have to wait for them to return with the dreaded administrative warrant I had the audacity to demand from them, but I decided to use the time to prepare. I would not have wanted to do the audit on the 8th anyway. Although my office manager was there to help, it had been a busy morning, and I was running behind. The buprenorphine prescription logs I wanted to show the auditors still needed hours of work to remove patient names, so that night I copied all buprenorphine prescription records of patients I deemed active going back the requisite 90 days to a single spread sheet on Google docs. Then it was just a matter of keeping it up-to-date.
When I walked back into my waiting room October 14 after lunch and a haircut, a casually dressed man introduced himself, handed me my warrant (the moment I had been waiting for -- I wonder how long he had been waiting.), and told me to read it over and get settled while he summoned the rest of the troops. He staked out the waiting room for the rest of the audit. Agent Carter took charge. A big guy with a couple suitcases turned out to be their computer "expert" (his description). There was an African-American woman who didn't do much. And remember the attractive woman I mentioned from my own unannounced visit to the DEA field office? She's their secret weapon. I call her Ms. Waterboard. She can interrogate me any day. Anytime she wants to. I'll confess to anything. Making obvious assumptions about everyone's sexual orientation and marital status, if you're 10-20 years younger than me, and have not already found the woman of your dreams (like I have), and practice in the area covered by the Seattle field office, do whatever it takes to get interrogated by Ms. Waterboard. And she loves dogs, so arrange to have one in your office for the audit.
Just to speculate on DEA strategy: Have enough agents to keep the doc so busy that he won't really notice when they do something they probably shouldn't or that he might say something he might have preferred to avoid saying. I let down my guard with the interrogation. I can only blame Ms. Waterboard so far. I did confront the agents with the fact that there was no mention on the warrant of any interrogation. However, it seems fair to me that they should be able to ask me questions directly related to my buprenorphine records.
I do believe DEA exceeded the appropriate boundaries in interrogating me. Agent Carter asked me my observations about the relative numbers of heroin addicts versus pharmaceutical opiate addicts presenting for treatment. I had no idea. I was also asked how many active patients I was currently treating. When I asked for a definition of "active" none was forthcoming. When I made a wise crack about my experience testifying in court where a definition would be damanded, the African-American woman reminded me that she knew all about my background. So I hedged and estimated between 30 and 40 patients without a real definition. Ms. Waterboard asked me about my office hours. Rather than getting into a discussion of the fact that I don't really have set office hours, I evaded the question by reporting the days and times when my office manager is usually present. No one seemed to notice that I didn't really answer the question. (This often works in court, too, by the way.)
The auditors presented me with a single page printout of prescriptions from a local pharmacy, citing it as evidence that I stocked buprenorphine in my office, which I never have. When I explained that these were simply prescriptions picked up by patients before coming to the office to have their induction the auditors made a few phone calls and dropped the issue.
The real fun was with my log. The DEA computer "expert" seemed befuddled by the notion that my log resided on a server somewhere in cyberspace. The warrant simply did not contain any language to allow for seizure of such an abstract entity. I offered to print a copy, but I think he really wanted to snoop around in my hard drive. It appeared as though he had never seen a tablet PC before. He opened a case containing an impressive array of hard drives, and connected one to a USB port, but ultimately was unable to figure out how to download the elusive file. I offered to help. He accepted, and thus began the most time-consuming part of the audit. We are dealing with computers here after all. Unfortunately, I had not yet installed Adobe Acrobat Reader on my tablet since installing Windows 7. After 15 or 20 minutes I was able to download a copy of the file to the hard drive so he could make a copy, and I was also able to print a copy on paper.
Of course the whole notion of "seizing" evidence, whether on a computer or elsewhere, implies that the evidence will be incriminating. In this situation, however, the only evidence would likely exonerate me.
Early in the audit one of the agents confronted me that this all could have been so much easier had I just cooperated by signing Form 82 the week before. Although I will never be sure, I suspect they meant to imply that they subjected me to a more intimidating or disruptive audit to punish me for forcing them to get a warrant. In fact, though, because I had time to prepare, I believe things went more smoothly, and the timing disrupted my practice much less. Only one patient appeared in the waiting room while they were doing their dirty work, and he complimented me on my handling of the situation. (One of the agents seemed to be holding the door to the waiting room open during most of the audit.)
How would I handle the audit differently if I could do it again? First, I would not have volunteered access to my computer. As far as I can tell the warrant does not require me to allow DEA to commandeer my computer for its own purposes. Instead, I would have printed out a fresh copy of the log every day so I could simply present it to the auditors. I might also refuse to answer questions unrelated to my buprenorphine practice. I would really like to know whether DEA would revoke my license just because I refuse to confabulate office hours that do not exist.
What else did the auditors do wrong? When I did resist answering questions, citing absence of reference to interrogation in the warrant, I seem to recall at least a veiled threat of admonishment or revocation of my DEA number. When I sarcastically suggested that that might not be such a bad thing, agent Carter, a little too eagerly, offered to relieve me of the burden of the audit if I would surrender my special number. This same interaction has played out before around these audits elsewhere in the US, and I have seen at least one letter from a DEA field office claiming to deny any effort to discourage physicians from treating addicts with buprenorphine. Agent Carter's offer would seem to betray DEA's real position: By treating opiate addicts we threaten DEA job security. I believe the agancy would be very happy to have us abandon our efforts.
DEA also needs to get up to speed with computers and the Internet. I had provided agent Carter with access to my log at Google docs months ago. Let's compare the costs of two or more agents showing up only to be told they need to return with the warrant and five agents showing up the next week unnecessarily versus the cost of going online and peeking at my log at your leisure while sitting in your office downtown. Think about this next time you pay federal income tax. Maybe the auditors thought they would find a meth lab in my office. If so, they did not conduct a very thorough search. The whole exercise was a waste.
If you prescribe buprenorphine to treat drug addiction, I strongly suggest you place your prescribing log online. If DEA has not yet audited your practice, plan to refuse to sign Form 82 when agents arrive unless you are completely prepared, and they have arrived at a convenient time for your office. If we all force them to obtain warrants, maybe they will back down and start scheduling.
I cannot speak from experience since I have never wanted to stock any controlled substance in my office. When the opportunity presented itself for me to stock buprenorphine, I declined. I suspect those of you who do stock that drug or others will find the audit considerably more difficult regardless of whether you sign Form 82.
I initiated a moratorium on accepting new buprenorphine patients almost a year ago with the idea that I would end the moratorium after my audit was completed. I do plan to accept a few new patients for buprenorphine induction and maintenance, but before I will want to accept significant numbers of new patients (like anywhere near my limit of 100) I would like the United States government to deal with its ambivalence. All the agencies need to get together and decide whether they want us to treat addicts or not. If not, I certainly have better things to do with my time than subject myself to this kind of harassment.
DEA can chalk up another victory in the war on drug treatment.
The saga continues.
In my last post I told you I expected DEA agents to return, "Administrative Warrant" in hand, to conduct the obligatory audit of my buprenorphine practice. The entourage did arrive on October 14, conducted the audit, and I'm still a free man. Nobody got hurt.
Let me recap: When I applied for the special DEA number that allows me to treat opiate addiction with buprenorphine it was clear that I might have to submit to audit of my prescribing records. However, only about a year ago I discovered DEA had embarked on a project of auditing all such physicians. I only objected to a few aspects of the plan. DEA law enforcement agents, the sort that might carry badges and guns, would conduct the audits. This I could accept, but what really galled me was DEA's refusal to schedule the audits. I guess they thought they might catch me red-handed doing something illegal. I expected this to disrupt my practice unnecessarily, and I began to protest. Professional associations such as the American Psychiatric Association, the American Association of Addiction Psychiatry, and the American Society of Addiction Medicine, to my disappointment, focused their efforts on assisting physicians in complying rather than assisting us in assuring that our rights and those of our patients would not be violated. We all learned early on to expect agents to present physicians with Form 82 on arrival. This form permits agents to enter the office and conduct the audit. We were warned that if we refused to sign Form 82 agents would return with an "Administrative Warrant." (Yikes!)
Warrants, even the administrative kind, sound pretty bad, like something to be avoided at all costs, something that will brand you a criminal for the rest of your life. But it seemed possible there might exist some advantage in going this route, and that has turned out to be true. I asked DEA to provide me with a copy of such a warrant and detailed description of how they conduct such an audit. The description proved vacuous and useless, and DEA refused to send me a copy. I figured I would have to get it the hard way.
After agents Sanchez and Carter left my office on October 8 I wondered how long I would have to wait for them to return with the dreaded administrative warrant I had the audacity to demand from them, but I decided to use the time to prepare. I would not have wanted to do the audit on the 8th anyway. Although my office manager was there to help, it had been a busy morning, and I was running behind. The buprenorphine prescription logs I wanted to show the auditors still needed hours of work to remove patient names, so that night I copied all buprenorphine prescription records of patients I deemed active going back the requisite 90 days to a single spread sheet on Google docs. Then it was just a matter of keeping it up-to-date.
When I walked back into my waiting room October 14 after lunch and a haircut, a casually dressed man introduced himself, handed me my warrant (the moment I had been waiting for -- I wonder how long he had been waiting.), and told me to read it over and get settled while he summoned the rest of the troops. He staked out the waiting room for the rest of the audit. Agent Carter took charge. A big guy with a couple suitcases turned out to be their computer "expert" (his description). There was an African-American woman who didn't do much. And remember the attractive woman I mentioned from my own unannounced visit to the DEA field office? She's their secret weapon. I call her Ms. Waterboard. She can interrogate me any day. Anytime she wants to. I'll confess to anything. Making obvious assumptions about everyone's sexual orientation and marital status, if you're 10-20 years younger than me, and have not already found the woman of your dreams (like I have), and practice in the area covered by the Seattle field office, do whatever it takes to get interrogated by Ms. Waterboard. And she loves dogs, so arrange to have one in your office for the audit.
Just to speculate on DEA strategy: Have enough agents to keep the doc so busy that he won't really notice when they do something they probably shouldn't or that he might say something he might have preferred to avoid saying. I let down my guard with the interrogation. I can only blame Ms. Waterboard so far. I did confront the agents with the fact that there was no mention on the warrant of any interrogation. However, it seems fair to me that they should be able to ask me questions directly related to my buprenorphine records.
I do believe DEA exceeded the appropriate boundaries in interrogating me. Agent Carter asked me my observations about the relative numbers of heroin addicts versus pharmaceutical opiate addicts presenting for treatment. I had no idea. I was also asked how many active patients I was currently treating. When I asked for a definition of "active" none was forthcoming. When I made a wise crack about my experience testifying in court where a definition would be damanded, the African-American woman reminded me that she knew all about my background. So I hedged and estimated between 30 and 40 patients without a real definition. Ms. Waterboard asked me about my office hours. Rather than getting into a discussion of the fact that I don't really have set office hours, I evaded the question by reporting the days and times when my office manager is usually present. No one seemed to notice that I didn't really answer the question. (This often works in court, too, by the way.)
The auditors presented me with a single page printout of prescriptions from a local pharmacy, citing it as evidence that I stocked buprenorphine in my office, which I never have. When I explained that these were simply prescriptions picked up by patients before coming to the office to have their induction the auditors made a few phone calls and dropped the issue.
The real fun was with my log. The DEA computer "expert" seemed befuddled by the notion that my log resided on a server somewhere in cyberspace. The warrant simply did not contain any language to allow for seizure of such an abstract entity. I offered to print a copy, but I think he really wanted to snoop around in my hard drive. It appeared as though he had never seen a tablet PC before. He opened a case containing an impressive array of hard drives, and connected one to a USB port, but ultimately was unable to figure out how to download the elusive file. I offered to help. He accepted, and thus began the most time-consuming part of the audit. We are dealing with computers here after all. Unfortunately, I had not yet installed Adobe Acrobat Reader on my tablet since installing Windows 7. After 15 or 20 minutes I was able to download a copy of the file to the hard drive so he could make a copy, and I was also able to print a copy on paper.
Of course the whole notion of "seizing" evidence, whether on a computer or elsewhere, implies that the evidence will be incriminating. In this situation, however, the only evidence would likely exonerate me.
Early in the audit one of the agents confronted me that this all could have been so much easier had I just cooperated by signing Form 82 the week before. Although I will never be sure, I suspect they meant to imply that they subjected me to a more intimidating or disruptive audit to punish me for forcing them to get a warrant. In fact, though, because I had time to prepare, I believe things went more smoothly, and the timing disrupted my practice much less. Only one patient appeared in the waiting room while they were doing their dirty work, and he complimented me on my handling of the situation. (One of the agents seemed to be holding the door to the waiting room open during most of the audit.)
How would I handle the audit differently if I could do it again? First, I would not have volunteered access to my computer. As far as I can tell the warrant does not require me to allow DEA to commandeer my computer for its own purposes. Instead, I would have printed out a fresh copy of the log every day so I could simply present it to the auditors. I might also refuse to answer questions unrelated to my buprenorphine practice. I would really like to know whether DEA would revoke my license just because I refuse to confabulate office hours that do not exist.
What else did the auditors do wrong? When I did resist answering questions, citing absence of reference to interrogation in the warrant, I seem to recall at least a veiled threat of admonishment or revocation of my DEA number. When I sarcastically suggested that that might not be such a bad thing, agent Carter, a little too eagerly, offered to relieve me of the burden of the audit if I would surrender my special number. This same interaction has played out before around these audits elsewhere in the US, and I have seen at least one letter from a DEA field office claiming to deny any effort to discourage physicians from treating addicts with buprenorphine. Agent Carter's offer would seem to betray DEA's real position: By treating opiate addicts we threaten DEA job security. I believe the agancy would be very happy to have us abandon our efforts.
DEA also needs to get up to speed with computers and the Internet. I had provided agent Carter with access to my log at Google docs months ago. Let's compare the costs of two or more agents showing up only to be told they need to return with the warrant and five agents showing up the next week unnecessarily versus the cost of going online and peeking at my log at your leisure while sitting in your office downtown. Think about this next time you pay federal income tax. Maybe the auditors thought they would find a meth lab in my office. If so, they did not conduct a very thorough search. The whole exercise was a waste.
If you prescribe buprenorphine to treat drug addiction, I strongly suggest you place your prescribing log online. If DEA has not yet audited your practice, plan to refuse to sign Form 82 when agents arrive unless you are completely prepared, and they have arrived at a convenient time for your office. If we all force them to obtain warrants, maybe they will back down and start scheduling.
I cannot speak from experience since I have never wanted to stock any controlled substance in my office. When the opportunity presented itself for me to stock buprenorphine, I declined. I suspect those of you who do stock that drug or others will find the audit considerably more difficult regardless of whether you sign Form 82.
I initiated a moratorium on accepting new buprenorphine patients almost a year ago with the idea that I would end the moratorium after my audit was completed. I do plan to accept a few new patients for buprenorphine induction and maintenance, but before I will want to accept significant numbers of new patients (like anywhere near my limit of 100) I would like the United States government to deal with its ambivalence. All the agencies need to get together and decide whether they want us to treat addicts or not. If not, I certainly have better things to do with my time than subject myself to this kind of harassment.
DEA can chalk up another victory in the war on drug treatment.
The saga continues.
Saturday, October 9, 2010
DEA Suboxone Audit: The Wait is Finally Over. Or Is It?
This story started for me almost a year ago: DEA On-Site Investigation of Suboxone Prescribing Physicians
Sometime late last year I wrote a letter to the Seattle field office asking to schedule my audit as soon as possible. I asked DEA to provide a detailed description of how they carry out the audit after serving an "administrative warrant" on a physician who refuses to sign Form 82, giving permission for the audit. After several months without a response it occurred to me to give the DEA a taste of their (it's?) own medicine. I had to be in the city early for an orchestra rehearsal anyway, so I made my own unannounced visit to the Seattle field office last spring.
When I entered the office I explained to the polite guard that I wanted to hand deliver a letter and that I wanted to dispose of some unused samples of modafinil I brought with me. He asked me whether I was carrying any explosive devices. Fortunately that day I had left my C-4, dynamite, and IED's at home. He asked whether I had an appointment. The answer of course was no. He asked whether the agents might know who I was. The answer of course was yes. Sitting in the waiting room I was struck by a wall covered by portraits of DEA agents who lost their lives in the line of duty. I trust none of the deaths occurred while auditing physicians trying to treat patients suffering from addictive diseases.
After a short wait a very attractive young woman entered the waiting room and asked me whether I might wait for agent Carter since chief agent Thomas was on vacation. When I asked agent Carter to please proceed with my audit, she explained this would not be possible and told me how to dispose of my drug samples.
Once more there was no response to my letter.
I was pleasantly surprised when, on September 29, agent Sanchez left a message on my voicemail asking me to call him back on his cell phone. I in turn left a message on his voicemail suggesting when he might reach a person by dialing my office number, but I did not hear from him until Friday, October 8. I was standing at the reception window talking to my office manager and agents Sanchez and Carter entered the waiting room, introduced themselves, and told us they were ready to perform my audit. I asked them whether they had a warrant. They said no. (If only I could have obtained a photograph of the look on their faces.) I explained to them that I wanted to know what would happen during an audit performed under administrative warrant. They asked me if I had not received a letter from the diversion office in Springfield. I explained that the letter I had received was woefully inadequate. I asked if they wanted to schedule an audit later, but they repeated the mantra that that doesn't fit with their policy. I pointed out that I had shared my buprenorphine prescribing log, which resides in Google Docs, with Agent Carter. They told me they are not allowed to access the Internet. They left. I completely forgot to ask whether they were carrying explosives.
So I'm back to waiting and wondering what will happen next. It would have been so much easier for everyone concerned if they had only honored my request for a detailed explanation of how an audit is conducted under administrative warrant. But I hope without too much further delay to be able to provide a first-hand description.
As a taxpayer I'm really OK with DEA agents having access to the Internet. Maybe we could arrange for the FBI to monitor their use. Or maybe we could establish another agency. We could subject them to unannounced visits to audit their browser histories.
Next: The Audit
Sometime late last year I wrote a letter to the Seattle field office asking to schedule my audit as soon as possible. I asked DEA to provide a detailed description of how they carry out the audit after serving an "administrative warrant" on a physician who refuses to sign Form 82, giving permission for the audit. After several months without a response it occurred to me to give the DEA a taste of their (it's?) own medicine. I had to be in the city early for an orchestra rehearsal anyway, so I made my own unannounced visit to the Seattle field office last spring.
When I entered the office I explained to the polite guard that I wanted to hand deliver a letter and that I wanted to dispose of some unused samples of modafinil I brought with me. He asked me whether I was carrying any explosive devices. Fortunately that day I had left my C-4, dynamite, and IED's at home. He asked whether I had an appointment. The answer of course was no. He asked whether the agents might know who I was. The answer of course was yes. Sitting in the waiting room I was struck by a wall covered by portraits of DEA agents who lost their lives in the line of duty. I trust none of the deaths occurred while auditing physicians trying to treat patients suffering from addictive diseases.
After a short wait a very attractive young woman entered the waiting room and asked me whether I might wait for agent Carter since chief agent Thomas was on vacation. When I asked agent Carter to please proceed with my audit, she explained this would not be possible and told me how to dispose of my drug samples.
Once more there was no response to my letter.
I was pleasantly surprised when, on September 29, agent Sanchez left a message on my voicemail asking me to call him back on his cell phone. I in turn left a message on his voicemail suggesting when he might reach a person by dialing my office number, but I did not hear from him until Friday, October 8. I was standing at the reception window talking to my office manager and agents Sanchez and Carter entered the waiting room, introduced themselves, and told us they were ready to perform my audit. I asked them whether they had a warrant. They said no. (If only I could have obtained a photograph of the look on their faces.) I explained to them that I wanted to know what would happen during an audit performed under administrative warrant. They asked me if I had not received a letter from the diversion office in Springfield. I explained that the letter I had received was woefully inadequate. I asked if they wanted to schedule an audit later, but they repeated the mantra that that doesn't fit with their policy. I pointed out that I had shared my buprenorphine prescribing log, which resides in Google Docs, with Agent Carter. They told me they are not allowed to access the Internet. They left. I completely forgot to ask whether they were carrying explosives.
So I'm back to waiting and wondering what will happen next. It would have been so much easier for everyone concerned if they had only honored my request for a detailed explanation of how an audit is conducted under administrative warrant. But I hope without too much further delay to be able to provide a first-hand description.
As a taxpayer I'm really OK with DEA agents having access to the Internet. Maybe we could arrange for the FBI to monitor their use. Or maybe we could establish another agency. We could subject them to unannounced visits to audit their browser histories.
Next: The Audit
Thursday, April 22, 2010
DEA Suboxone Audit Update VIII
Continued from: Worst Experience of My Career: a Follow Up
After numerous phone calls and broken promises, as well as assistance from my congressman, I received a letter from Mark Caverly, Chief the the Liaison and Policy Section, Office of Diversion Control, DEA, responding to my request for a description of the buprenorphine record and stock inspection process when conducted under Administrative Inspection Warrant.
Although Mr. Caverly provided no such description, he did shed some light on what a physician might expect. I am left with the overall impression that the process differs little from an inspection conducted after a physician has signed Form 82, the chief difference being that the inspection is conducted without the physician's permission.
The most egregious aspect of the inspections from the physician's (an patients' present at the office) seems unchanged from the "permitted" inspection: agents will appear unannounced, thus unnecessarily disrupting medical care under the illusion that this will prevent physicians from preparing in advance, so the agents can catch offenders red handed. Because of this I see little advantage in declining to sign Form 82 when agents appear at your office.
Mr. Caverly failed to answer most of the rest of my questions:
"Will agents force entry if the physician is not present?"
He seems to have missed the fact that this is a yes or no question. He simply cited a statute with no reference to forced entry. The statute does refer to a "right" (Shouldn't that be authority?) to "enter such premises... in a reasonable manner," whatever that means.
"Will agents serve the warrant during regular business hours?"
The cited statute also specifies that inspections should be conducted at "reasonable times," whatever that means. Again, he does not seem to recognize a yes or no question.
"If the physician is present when the agents serve the warrant, and is prepared to provide access to the required records, will the audit be conducted as it would have been with Form 82 (Notice of Inspection) consent?"
Once more he evades a yes or no question. He simply tells us that the same records must be made available rather than addressing how the inspection will be conducted.
"Will agents be more or less likely to confiscate records than they would be with Form 82 consent?"
He evades this question as well but does tell us that the physician will be provided with a receipt for any records seized pursuant to the authority of the Administrative Inspection Warrant, and that the records will be returned when the process is completed.
"To what extent does national policy govern the process, and how much latitude and discretion does DEA afford local field offices?"
Once more his answer is uninformative and completely fails to address the question. It would be wonderful to see one of these people cross examined in court where they can't get away with such evasiveness. And these are public servants?
After numerous phone calls and broken promises, as well as assistance from my congressman, I received a letter from Mark Caverly, Chief the the Liaison and Policy Section, Office of Diversion Control, DEA, responding to my request for a description of the buprenorphine record and stock inspection process when conducted under Administrative Inspection Warrant.
Although Mr. Caverly provided no such description, he did shed some light on what a physician might expect. I am left with the overall impression that the process differs little from an inspection conducted after a physician has signed Form 82, the chief difference being that the inspection is conducted without the physician's permission.
The most egregious aspect of the inspections from the physician's (an patients' present at the office) seems unchanged from the "permitted" inspection: agents will appear unannounced, thus unnecessarily disrupting medical care under the illusion that this will prevent physicians from preparing in advance, so the agents can catch offenders red handed. Because of this I see little advantage in declining to sign Form 82 when agents appear at your office.
Mr. Caverly failed to answer most of the rest of my questions:
"Will agents force entry if the physician is not present?"
He seems to have missed the fact that this is a yes or no question. He simply cited a statute with no reference to forced entry. The statute does refer to a "right" (Shouldn't that be authority?) to "enter such premises... in a reasonable manner," whatever that means.
"Will agents serve the warrant during regular business hours?"
The cited statute also specifies that inspections should be conducted at "reasonable times," whatever that means. Again, he does not seem to recognize a yes or no question.
"If the physician is present when the agents serve the warrant, and is prepared to provide access to the required records, will the audit be conducted as it would have been with Form 82 (Notice of Inspection) consent?"
Once more he evades a yes or no question. He simply tells us that the same records must be made available rather than addressing how the inspection will be conducted.
"Will agents be more or less likely to confiscate records than they would be with Form 82 consent?"
He evades this question as well but does tell us that the physician will be provided with a receipt for any records seized pursuant to the authority of the Administrative Inspection Warrant, and that the records will be returned when the process is completed.
"To what extent does national policy govern the process, and how much latitude and discretion does DEA afford local field offices?"
Once more his answer is uninformative and completely fails to address the question. It would be wonderful to see one of these people cross examined in court where they can't get away with such evasiveness. And these are public servants?
Tuesday, March 2, 2010
Worst Experience of My Career: a Follow Up
Previous post: Agents in the Waiting Room: To Warn or Not
In DEA Suboxone Audit: Worst Experience of My Career As a Physician I relayed a first hand account of an audit of an OBOT physician by DEA agents.
[I am postponing the bulk of this post indefinitely at the request of the physician, but stay tuned]
The bottom line: Because of these audits opiate addicts will find it more difficult to obtain effective treatment. They will likely continue to obtain drugs illegally, in many cases provided by those physicians DEA should target. Some of them will die. And DEA agents will have more job security.
Audits should be conducted by administrative personnel who know how to conduct themselves with respect in a physician’s office, not law enforcement personnel, who instead should pursue suspected criminals. DEA should schedule audits. If DEA wants to collect information about trends in drug use, they should look elsewhere. Patients should be informed and have an opportunity to object if agents attempt to force access to records without a court order. I might consider refusing access to identified records in the absence of a court order. Physicians should consider refusing to provide information in writing or orally that does not relate to the stated purpose of the audit.
Illinois attorney Glen Crick wrote about DEA inspections with a focus on requests to surrender registration:
http://www.cricklaw.com/docs/Request_to_Surrender_DEA_Registration.pdf
You have a right to obtain legal counsel. But according to yet another physician, Agent Nice denounced Dr. Brave for retaining an attorney. Patients in your waiting room have a right to know these are law enforcement agents. Physicians should make sure to have a witness such as an office manager present during the audit: Agents may lie about what happened during their investigation at your office. Do not trust what a DEA agent tells you during an audit.
Maybe you or another physician will qualify for one of these:
or speak out from your bumper. Better yet, send one as a gift to your favorite DEA agent. I sent one to R. Gil Kerlikowske at the Office of National Drug Control Policy:
In DEA Suboxone Audit: Worst Experience of My Career As a Physician I relayed a first hand account of an audit of an OBOT physician by DEA agents.
[I am postponing the bulk of this post indefinitely at the request of the physician, but stay tuned]
The bottom line: Because of these audits opiate addicts will find it more difficult to obtain effective treatment. They will likely continue to obtain drugs illegally, in many cases provided by those physicians DEA should target. Some of them will die. And DEA agents will have more job security.
Audits should be conducted by administrative personnel who know how to conduct themselves with respect in a physician’s office, not law enforcement personnel, who instead should pursue suspected criminals. DEA should schedule audits. If DEA wants to collect information about trends in drug use, they should look elsewhere. Patients should be informed and have an opportunity to object if agents attempt to force access to records without a court order. I might consider refusing access to identified records in the absence of a court order. Physicians should consider refusing to provide information in writing or orally that does not relate to the stated purpose of the audit.
Illinois attorney Glen Crick wrote about DEA inspections with a focus on requests to surrender registration:
http://www.cricklaw.com/docs/Request_to_Surrender_DEA_Registration.pdf
You have a right to obtain legal counsel. But according to yet another physician, Agent Nice denounced Dr. Brave for retaining an attorney. Patients in your waiting room have a right to know these are law enforcement agents. Physicians should make sure to have a witness such as an office manager present during the audit: Agents may lie about what happened during their investigation at your office. Do not trust what a DEA agent tells you during an audit.
Maybe you or another physician will qualify for one of these:
or speak out from your bumper. Better yet, send one as a gift to your favorite DEA agent. I sent one to R. Gil Kerlikowske at the Office of National Drug Control Policy:
Saturday, January 30, 2010
Proposed Additions to a PCSS Guidance
A physician associated with the Physician Clinical Support System for prescribing methadone and buprenorphine has asked me, "do you have an edit or rewrite of the proposed guidance? I would be very interested in what you would propose that would benefit our members as they are included in an audit."
My response follows:
Premises:
Questions arise even before the audit begins. If agents approach a physician outside the office, how must the physician respond? Must the agent identify himself/herself as such. Must the physician respond at all? What must agents do to properly identify themselves and demonstrate that their visit is proper. Can agents demand a physician provide identification if confronted in a hallway or parking lot?
Does the administrative order provide for more protection such that it may be preferable to unannounced audit? What does it entail? By whom must it be authorized? A judge? Must investigation under administrative order be scheduled?
How should a physician who uses electronic medical records handle the situation in which computer files cannot be accessed temporarily or permanently due to technical problems? May the physician postpone the audit until the problem can be corrected?
PCSS should offer guidance as to whether physicians can refuse to answer questions agents may ask that may not relate to buprenorphine records, for example:
Physicians need to know whether we can decline investigation at a particular time because:
Agents may use audits as a pretext to investigate further matters they believe may lead to criminal charges, possibly subverting due process protection such as Miranda laws?
Buprenorphine patient count:
What determines whether a patient should be counted toward the 30/100 limit? Is it based on:
According to a recent article in Psychiatric News "agents will ask to see three months of records." If this is true, will the want the last three months counting backward from the day of the examination, the last three full months, or any three months. Will agents want to see records of any patient for whom the physician wrote a prescription during that period or for only those patients currently active?
Suggestions for strategy:
We cannot assume that DEA will answer any of the questions above. If DEA does answer the questions, we cannot assume that individual agents will abide by any answers provided. We must find alternatives means to collect information about how agents actually conduct themselves. We need to ask anyone who is audited to debrief, perhaps by developing a questionnaire which can be completed (anonymously) online, and perhaps modified as we learn more. We need to find out whether there is any covert, implied or overt threat that might result in physicians fearing to describe the experience, especially if agents inform them of any irregularity. We need to know whether any physician has initiated disciplinary action against an agent.
Each physician not yet audited should write a letter to the local DEA field office (return receipt requested) as follows:
I am writing to formally request that you schedule my audit of buprenorphine records. [Give date and time when patients will not be present, but physician and needed staff will be present.]
Please be advised that if your agents arrive unannounced, I will only be able to allow the audit if:
If individuals appear claiming to be DEA agents but have not been previously identified to me by you, I will contact your office by telephone and give you an opportunity to confirm their legitimacy. If I am unable to positively identify the agents as legitimate, I will ask them to leave. If they do not leave, I will contact local law enforcement. Anyone appearing at or remaining at my office without proper authority will be charged with criminal trespass.
Please be advised that no information that identifies a patient will be provided.
Even though DEA will not likely schedule the audit, evidence the agency received the letter will weaken any claim that the physician did not cooperate with the audit.
More strategies:
We should establish a buddy system whereby physicians available will be notified by text (Twitter?), phone, or email when a colleague in the community faces an audit so they can travel to the office to provide support from a less threatened perspective, then gather and report on what they have observed.
We should suggest that all OBOT physicians abide by a complete or at least partial moratorium on new patients until DEA begins to schedule audits as I have done, and make sure that all concerned agencies know. This will underscore the likelihood that this policy has already discouraged many physicians from providing this treatment while preventing DEA from claiming that our protest is financially motivated. So far I have turned away 3 new potential buprenorphine patients.
I cannot imagine that this listing could cover all possibilities. Since I do not keep buprenorphine or other controlled substances in my office I have not attempted to include questions or strategies that might arise in relation to that aspect of the investigation. Perhaps someone even more paranoid than myself could add more items. Better yet, I invite comments from those physicians who have experienced audits already.
My response follows:
Premises:
- Doctors are not accustomed to audits or investigations by law enforcement and are therefor vulnerable.
- Doctors are unaware of their rights.
- Doctors are easily intimidated by implied threats of criminal prosecution or revocation of licenses.
- DEA agents are not accustomed to conducting audits or investigations of physicians.
- DEA agents are not trained in how to conduct themselves in a way that respects the rights and privacy of patients.
- DEA agents will base their conduct of audits on erroneous assumptions about medical practices.
- Patients are at a disadvantage and unlikely to protest because of stigma and fear of loss of privacy
- Patients are vulnerable to disruption of medical care.
- These audits constitute fertile ground for violation of due process.
- Unannounced and unscheduled intrusion of DEA agents will disrupt medical practice.
Questions arise even before the audit begins. If agents approach a physician outside the office, how must the physician respond? Must the agent identify himself/herself as such. Must the physician respond at all? What must agents do to properly identify themselves and demonstrate that their visit is proper. Can agents demand a physician provide identification if confronted in a hallway or parking lot?
Does the administrative order provide for more protection such that it may be preferable to unannounced audit? What does it entail? By whom must it be authorized? A judge? Must investigation under administrative order be scheduled?
How should a physician who uses electronic medical records handle the situation in which computer files cannot be accessed temporarily or permanently due to technical problems? May the physician postpone the audit until the problem can be corrected?
PCSS should offer guidance as to whether physicians can refuse to answer questions agents may ask that may not relate to buprenorphine records, for example:
- Do you prescribe other scheduled drugs?
- Any other “do you” question, not to mention Did you or Have you ever...?
- Do you dispense other scheduled drugs?
- Do you count pills?
- Do you require patients to submit to random drug tests?
- How often do you see patients?
- Are you licensed to carry a concealed firearm?
- Do you keep a weapon in your office?
- Where do you live?
- Do you have family members or colleagues who suffer from substance use disorders?
- Have you ever been diagnosed with hepatitis? Opiate addiction? AIDS?
- With whom do you live?
- Have you ever used marijuana?
Physicians need to know whether we can decline investigation at a particular time because:
- Office staff are not present
- A witness is not present
- Patients need attention
- Records cannot be readily accessed
- The witness or office staff must leave.
- Patients need attention.
- The physician believes the mission is completed and agents are extending their stay in order to intimidate.
- Physician or staff becomes ill or incapacitated.
- Copies
- Access to a copier
- Telephone
- Seating (If we do not providing seating agents may be less likely to dally.)
- Criminal record?
- Whether physician owns registered firearms?
- Whether physician is licensed to carry a concealed weapon?
- Whether physician has worked in the criminal justice system?
- Whether physician has testified as an expert witness in criminal court?
- Physician's immigration status?
Agents may use audits as a pretext to investigate further matters they believe may lead to criminal charges, possibly subverting due process protection such as Miranda laws?
Buprenorphine patient count:
What determines whether a patient should be counted toward the 30/100 limit? Is it based on:
- Date of last contact
- Date of last prescription
- Date when last prescription should have run out
- Whether patient is alive or dead
- Whether patient has been discharged
- Whether patient has disappeared
- Whether patient responds to phone calls
- Whether patient has declared intention to stop using the drug, but may still have a supply
According to a recent article in Psychiatric News "agents will ask to see three months of records." If this is true, will the want the last three months counting backward from the day of the examination, the last three full months, or any three months. Will agents want to see records of any patient for whom the physician wrote a prescription during that period or for only those patients currently active?
Suggestions for strategy:
We cannot assume that DEA will answer any of the questions above. If DEA does answer the questions, we cannot assume that individual agents will abide by any answers provided. We must find alternatives means to collect information about how agents actually conduct themselves. We need to ask anyone who is audited to debrief, perhaps by developing a questionnaire which can be completed (anonymously) online, and perhaps modified as we learn more. We need to find out whether there is any covert, implied or overt threat that might result in physicians fearing to describe the experience, especially if agents inform them of any irregularity. We need to know whether any physician has initiated disciplinary action against an agent.
Each physician not yet audited should write a letter to the local DEA field office (return receipt requested) as follows:
I am writing to formally request that you schedule my audit of buprenorphine records. [Give date and time when patients will not be present, but physician and needed staff will be present.]
Please be advised that if your agents arrive unannounced, I will only be able to allow the audit if:
- I have been able to confirm by telephone with your office that the agents are legitimate.
- I am present
- My office staff are present
- No patients are present
- There is no reason to believe that other practices sharing my office will be disrupted.
- I will expect the agents to leave when asked and will allow them to schedule another encounter to complete any unfinished business.
If individuals appear claiming to be DEA agents but have not been previously identified to me by you, I will contact your office by telephone and give you an opportunity to confirm their legitimacy. If I am unable to positively identify the agents as legitimate, I will ask them to leave. If they do not leave, I will contact local law enforcement. Anyone appearing at or remaining at my office without proper authority will be charged with criminal trespass.
Please be advised that no information that identifies a patient will be provided.
Even though DEA will not likely schedule the audit, evidence the agency received the letter will weaken any claim that the physician did not cooperate with the audit.
More strategies:
We should establish a buddy system whereby physicians available will be notified by text (Twitter?), phone, or email when a colleague in the community faces an audit so they can travel to the office to provide support from a less threatened perspective, then gather and report on what they have observed.
We should suggest that all OBOT physicians abide by a complete or at least partial moratorium on new patients until DEA begins to schedule audits as I have done, and make sure that all concerned agencies know. This will underscore the likelihood that this policy has already discouraged many physicians from providing this treatment while preventing DEA from claiming that our protest is financially motivated. So far I have turned away 3 new potential buprenorphine patients.
I cannot imagine that this listing could cover all possibilities. Since I do not keep buprenorphine or other controlled substances in my office I have not attempted to include questions or strategies that might arise in relation to that aspect of the investigation. Perhaps someone even more paranoid than myself could add more items. Better yet, I invite comments from those physicians who have experienced audits already.
Tuesday, November 24, 2009
DEA Suboxone Audit Update IV
Continued from: Suboxone DEA Audit Update III
No more developments since my last post. I sent an email to a local DEA agent but have received no acknowledgement or response. So I just faxed this letter to the local DEA office chief:
Re: Audit of OBOT physicians
Dear Mr. T:
Although I have received no official notification I understand your agents intend to audit my records of prescription of buprenorphine for treatment of opiate dependence under DATA 2000. Since I have heard evidence to suggest that some physicians might engage in inappropriate prescribing of this drug I welcome the audit and look forward to cooperating fully. I understand that your agents will not ask to see information that identifies any patient and that the audit will be restricted to records of buprenorphine prescription. (I do not dispense the drug.)
Since I am sure you want to minimize wasted time for your agents, avoid disruption of my medical practice, avoid potential for impostors, and avoid disturbing my patients I make the following requests:
I understand that at the outset of the audit I will be required to sign an agreement. Please send me a copy of the agreement now so I can have my attorney review it prior to the audit. You may send a copy via fax to __.
I have scheduled an hour at 3:00 PM on Wed. December 9, 2009 for the audit. I will not schedule patients during that time, but will be sure to be in the office. However, I will need confirmation of the time and date by December 2, 2009. If this time and date do not work for your agents, please contact my office to schedule an alternate time and/or date.
Thank you.
I'll let you know what happens.
DEA Suboxone Audit Update V
No more developments since my last post. I sent an email to a local DEA agent but have received no acknowledgement or response. So I just faxed this letter to the local DEA office chief:
Re: Audit of OBOT physicians
Dear Mr. T:
Although I have received no official notification I understand your agents intend to audit my records of prescription of buprenorphine for treatment of opiate dependence under DATA 2000. Since I have heard evidence to suggest that some physicians might engage in inappropriate prescribing of this drug I welcome the audit and look forward to cooperating fully. I understand that your agents will not ask to see information that identifies any patient and that the audit will be restricted to records of buprenorphine prescription. (I do not dispense the drug.)
Since I am sure you want to minimize wasted time for your agents, avoid disruption of my medical practice, avoid potential for impostors, and avoid disturbing my patients I make the following requests:
I understand that at the outset of the audit I will be required to sign an agreement. Please send me a copy of the agreement now so I can have my attorney review it prior to the audit. You may send a copy via fax to __.
I have scheduled an hour at 3:00 PM on Wed. December 9, 2009 for the audit. I will not schedule patients during that time, but will be sure to be in the office. However, I will need confirmation of the time and date by December 2, 2009. If this time and date do not work for your agents, please contact my office to schedule an alternate time and/or date.
Thank you.
I'll let you know what happens.
DEA Suboxone Audit Update V
Tuesday, November 3, 2009
DEA Suboxone Audit Update
Continued from: DEA Audits: insensitivity and disrespect
No great progress today but I did speak to a staff person from one office where DEA conducted an audit. I am hoping to obtain a copy of the agreement the physician signed. She told me that the entire audit lasted about 30-40' and would have been shorter but for the fact that the office took advantage of the opportunity to learn more from the agents. She said the agents focused primarily on records and procedures related to handling of free Suboxone supplied by the manufacturer to financially challenged patients. She said the meeting was not unpleasant.
I also heard from a physician who took the initiative to invite DEA to audit his practice. He said there has been no response thus far. I plan to do the same. I would like to conduct this piece of business when no patients or other professionals are present in the office.
I will keep you "posted" on further developments. Please describe your experiences as comments.
Suboxone DEA Audit Update III
No great progress today but I did speak to a staff person from one office where DEA conducted an audit. I am hoping to obtain a copy of the agreement the physician signed. She told me that the entire audit lasted about 30-40' and would have been shorter but for the fact that the office took advantage of the opportunity to learn more from the agents. She said the agents focused primarily on records and procedures related to handling of free Suboxone supplied by the manufacturer to financially challenged patients. She said the meeting was not unpleasant.
I also heard from a physician who took the initiative to invite DEA to audit his practice. He said there has been no response thus far. I plan to do the same. I would like to conduct this piece of business when no patients or other professionals are present in the office.
I will keep you "posted" on further developments. Please describe your experiences as comments.
Suboxone DEA Audit Update III
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