Sunday, February 27, 2011
Next to Normal: Is Bipolar a Dysphemism for Life?
If you thought this Broadway musical was just about Bipolar Disorder, I won't spoil the surprise. It is a tribute to the strength and resilience of patients and families who must cope as best they can with serious mental illness on top of everything else life can throw at us. And with less help from psychiatry than we would like to offer.
I found the view of modern psychiatry balanced and accurate. Broadway has finally moved past it's obsession with psychoanalysis, but still seems stuck on individual psychotherapy. How might this story have unfolded with a family psychotherapist? There was one glaring omission: How might this story have unfolded under managed care?
Take heart psychiatrists. As Diana tells her Dr. Madden, "You're not a scary rock star anymore."
Next to Normal
Monday, February 21, 2011
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."
"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."
Sunday, February 20, 2011
Wisconsin Docs Provide Sick Notes
Is this OK? Wisconsin doctors (or say this man claims) provide notes on request so workers can get paid leave. The man interviewed implies that stress or almost any other reason justifies a sick day. Are "mental health" days OK? Is it ethical for a physician to support this?
Tuesday, February 15, 2011
Should Employers Ban Smokers?
This recent New York Times article raises some interesting questions about the extent to which the law should dictate whether employers can discriminate on the basis of behavior outside the workplace. The article focuses on health care facilities that have banned smokers, but opponents argue that smoking differs little from other legal off site behaviors like engaging in risky sports, eating unhealthy food, drinking, and (by implication) unsafe sex. According to the article even one anti-smoking organization opposes this form of discrimination citing apparent socioeconomic differences between smokers and nonsmokers.
Employers apparently want to reduce absenteeism and health costs. Health care institutions also want to present an image of their employees as healthy, perhaps to enhance their image and set an example. The ban would also present an incentive for smokers to quit.
Employers could go further by banning fast food eaters, sky divers, drinkers, and people who don't use condoms. But eliminate enough categories of risk takers and you will not find sufficient qualified workers. Furthermore, employers will have to decide whether the costs of discovering such behaviors and firing high risk workers only to have to find low risk workers and train them makes business sense.
As for secondary discrimination by association, remember you're providing an incentive to better health, and continuing to smoke is a free choice.
I say let the employers decide. What do you think?
Employers apparently want to reduce absenteeism and health costs. Health care institutions also want to present an image of their employees as healthy, perhaps to enhance their image and set an example. The ban would also present an incentive for smokers to quit.
Employers could go further by banning fast food eaters, sky divers, drinkers, and people who don't use condoms. But eliminate enough categories of risk takers and you will not find sufficient qualified workers. Furthermore, employers will have to decide whether the costs of discovering such behaviors and firing high risk workers only to have to find low risk workers and train them makes business sense.
As for secondary discrimination by association, remember you're providing an incentive to better health, and continuing to smoke is a free choice.
I say let the employers decide. What do you think?
Sunday, February 13, 2011
Are Drug Reps Going to the Dogs?
Is it unethical for my dog to accept treats from a pharmaceutical representative?
Reps can't influence my prescribing with free pens and sticky notes, or by taking me out to lunch, but where there's a will there's a way. Last week a drug rep brought treats for my dog who always comes to the office with me. (Even if they were FDA approved, I'm sure this is an off-label use.) At least the drug name doesn't appear on the treats.
Now every time I write a prescription for the rep's drug my dog rolls over, and when I write for a competing drug he growls!
Thursday, February 10, 2011
Letting Your Giftedness Out of the Closet
I recently became acquainted with Lisa Erickson, a local (you know, the old fashioned geographic way) counselor who has specialized in helping people who designate themselves or have been designated by others as "gifted." She told me about the publication of her article, Coming Out Gifted. I suspect I, as a psychiatrist, have lots of company in struggling with the idea that what might be wrong with someone is that there is too much right with them. How can one have trouble with superiority to the rest of us schmucks?
Lisa admits that her analogy falls short of perfection and lists a few ways in which "coming out" as gay differs from coming out or facing the ugly fact that one's intelligence or other capacities exceed those of others. I'll add a few, while admitting that I consider myself straight as an arrow, so what do I know? Gay doesn't come by degree. Giftedness probably does. You either have a sexual attraction to the same sex or you do not. Even bisexuality seems pretty black and white. (Speaking of black and white, perhaps race might serve up a better analogy in the sense that one can be of or from any of a number of races to a differing degrees depending on ancestry.)
But not only does giftedness occur on a continuum, but where it starts is arbitrary, a judgment call. Even if you can substantiate your claim with results of an intelligence test or star status, there will always be the question of where to draw the line. However, by the very act of "coming out" as gifted, one would seem to be drawing a bright line, saying, "I am different from you." which others may hear as, "I am better than you." And unlike gay, there exists no moral or religious condemnation of smart or talented, no matter the degree.
Of most interest to me as a psychiatrist is the notion that we might mistake attributes of giftedness as evidence of a mental disorder like attention deficit disorder or bipolar disorder. While I accept the notion that individuals with extraordinary talent or intelligence may benefit from help in adjusting to their differences, we should arguably never view their superior abilities as illness. This is where the concept of "over-excitability" starts to excite me. I'm still looking for a rigorous definition, but what I've seen makes me think psychiatrists might easily confuse gifted individuals with those who have ADD or bipolar disorder. Not that we should think giftedness renders immunity to any mental illness. But most of the attributes associated with giftedness, even over-excitability(?), can occur in individuals who are not gifted.
Help!
Lisa admits that her analogy falls short of perfection and lists a few ways in which "coming out" as gay differs from coming out or facing the ugly fact that one's intelligence or other capacities exceed those of others. I'll add a few, while admitting that I consider myself straight as an arrow, so what do I know? Gay doesn't come by degree. Giftedness probably does. You either have a sexual attraction to the same sex or you do not. Even bisexuality seems pretty black and white. (Speaking of black and white, perhaps race might serve up a better analogy in the sense that one can be of or from any of a number of races to a differing degrees depending on ancestry.)
But not only does giftedness occur on a continuum, but where it starts is arbitrary, a judgment call. Even if you can substantiate your claim with results of an intelligence test or star status, there will always be the question of where to draw the line. However, by the very act of "coming out" as gifted, one would seem to be drawing a bright line, saying, "I am different from you." which others may hear as, "I am better than you." And unlike gay, there exists no moral or religious condemnation of smart or talented, no matter the degree.
Of most interest to me as a psychiatrist is the notion that we might mistake attributes of giftedness as evidence of a mental disorder like attention deficit disorder or bipolar disorder. While I accept the notion that individuals with extraordinary talent or intelligence may benefit from help in adjusting to their differences, we should arguably never view their superior abilities as illness. This is where the concept of "over-excitability" starts to excite me. I'm still looking for a rigorous definition, but what I've seen makes me think psychiatrists might easily confuse gifted individuals with those who have ADD or bipolar disorder. Not that we should think giftedness renders immunity to any mental illness. But most of the attributes associated with giftedness, even over-excitability(?), can occur in individuals who are not gifted.
Help!
Tuesday, February 8, 2011
My DEA Buprenorphine Audit: My "Violations"
I fully expected retaliation from DEA for my open criticism of their disruptive practices and policies in auditing buprenorphine addiction treatment practices. Here's how they nailed me. You can judge for yourself whether DEA should penalize me.
To recap briefly, last fall two DEA agents appeared in my office without an appointment, despite my written requests to schedule their "routine" obligatory audit of my buprenorphine opiate addiction treatment practice. When I told them they would need to obtain a warrant they left. The following week five DEA agents invaded my office, copied some files from one of my computers, asked some questions, and left with a copy of my prescribing record. Days later two agents appeared in the office with no appointment or warning to discuss their determination. After I made it clear that I was not interested in chatting with them they left my waiting room, and I wrote a letter demanding a written enumeration of their findings.
Inexplicably it took DEA approximately 2 1/2 months, but finally, a couple weeks ago, I received a letter (return receipt requested) citing me for two "recordkeeping [sic] violations." (In fact both related to transmission of prescription orders rather than record keeping.)
- "Failure to include your "X" DEA Registration number on prescriptions for Schedule III narcotic drugs approved for detoxification and/or maintenance treatment.
- "Failure to use an application that meets the requirements to electronically sign and transmit controlled substance prescriptions.
"The purpose of this letter is to afford you the opportunity to come into compliance with the requirements of the Controlled Substances Act. Please ensure that these are corrected. This is a serious matter which, if continued, can lead to sanctions, finds, or the possibility of the suspension of your DEA registration."
You might consider item number one to be technically correct but for the fact that the statutes permit me to order such prescriptions by telephone with no written communication whatever. In order to minimize the risk that my DEA number might fall into the wrong hands I always communicated it to the pharmacy by telephone.
Item number two reveals the ineptness of those who draft and interpret these statutes. Literally it cites me for failure to use an "application" that does not exist. But we apparently cannot expect DEA to compose a sentence that reads as intended (even with 2.5 months to prepare!). I believe they meant to cite me for, "use of an application that fails to meet the requirements..." referring to statutes regulating eprescribing. As of yet no eprescribing "application" (service) meets DEA requirements. In fact I used a service that allows me to fax a prescription that exists as a word processing document file to the pharmacy. I did not use a digital or "electronic" signature. I used a stylus to produce a manual signature with digital "ink" on a tablet computer. Like any other fax device now in use this sends a copy of the signed document to the pharmacy. When the pharmacy views or prints this transmitted document the pharmacist cannot distinguish it from a paper document signed with a pen or pencil except that the signatures on successive transmission do not differ.
Our federal government must find this kind of efficiency threatening. Perhaps I am naive, but it seems to me that DEA should concern itself with preventing diversion and fraudulent prescribing. I contend that my procedures minimize the risk of both. Furthermore, the statutes failed to anticipate the technology I use, and DEA, rather than assessing the risk it poses, chose to trump up a charge based on technicalities. In other words, they didn't think. Today I believe all faxes are electronic, if not digital, and in all case in which the image of a manual signature arrives via fax the pharmacist sees only a copy of that signature. I also wonder why DEA has not cited the pharmacies for dispensing based on inadequate prescriptions since none of these was a "paper" prescription. After all no harm is done in transmitting the prescription. The harm occurs only when the pharmacist dispenses the drug to the wrong person. Of course the pharmacist cannot differentiate between a facsimile transmission of a computer file and of a scanned paper document except perhaps by the inferior quality of the latter.
Here is an applicable federal statute:
(a) A pharmacist may dispense directly a controlled substance listed
in Schedule III, IV, or V that is a prescription drug as determined
under section 503(b) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 353(b)) only pursuant to either a paper prescription signed by a
practitioner, a facsimile of a signed paper prescription transmitted by
the practitioner or the practitioner's agent to the pharmacy, an
electronic prescription that meets the requirements of this part and
part 1311 of this chapter, or an oral prescription made by an individual
practitioner and promptly reduced to writing by the pharmacist..."
My plan, which I have already communicated to DEA and which I implemented on receiving the letter, consists of providing signed paper prescriptions displaying my DEA numbers when the patient appears in the office or, when the patient does not appear, authorizing refills or ordering new prescriptions by telephone. Incidentally -- and not surprisingly -- only one pharmacist has asked me to provide my DEA number.
So what is your verdict, reader? Should DEA revoke my registration? fine me? send me to Club Fed (where I will be entitled to free health care)?
Wednesday, February 2, 2011
Pain Practice Invaded by Agents
According to stories in Washington's Peninsula Daily News and Port Townsend Leader on December 21, agents from a variety of federal, state and local law enforcement agencies invaded the home and office of physician James Kimber Rotchford, MD, disrupting his practice, which subsequently reopened. Rotchford is immediate past president of Washington Society of Addiction Medicine and supported my own campaign against unscheduled buprenorphine practice audits by DEA. He appears below in a brief interview about his pain treatment practice.
This appears to be yet another example of disregard for patients and physicians when inept and ham-fisted law enforcement authorities invade medical practices. In their defense of course we must acknowledge that real fraud happens and must be stopped. Is the only way out of this mess for all medical providers to work as employees for a single entity (not the patient)?
I susepct Dr. Rotchford is guilty of nothing more than a minor technical error in attempting to recover a small portion of the cost of practicing from Medicaid. His experience bolsters my own conviction that I have done the smart thing by opting out of Medicare and refusing to accept Medicaid at all. More here.
I have read neither of these books, but both would appear to address the problem of "criminalization of almost everything."
This appears to be yet another example of disregard for patients and physicians when inept and ham-fisted law enforcement authorities invade medical practices. In their defense of course we must acknowledge that real fraud happens and must be stopped. Is the only way out of this mess for all medical providers to work as employees for a single entity (not the patient)?
I susepct Dr. Rotchford is guilty of nothing more than a minor technical error in attempting to recover a small portion of the cost of practicing from Medicaid. His experience bolsters my own conviction that I have done the smart thing by opting out of Medicare and refusing to accept Medicaid at all. More here.
I have read neither of these books, but both would appear to address the problem of "criminalization of almost everything."
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