Another Doc's Buprenorphine Audit

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."