The American Psychiatric Association recently published a long overdue compilation of opinions on the Principles of Medical Ethics with Annotations Especially Applicable to Psychiatry (2009 edition). While some opinions may reflect some needed reality testing and updating the committee has regrettably retained many archaic opinions (some more than 30 years old), and has omitted at least a few that might have added to the document.
The Opinions of the Ethics Committee on The Principles of Medical Ethics
Getting off on the wrong foot, the Forward explains that the document includes responses to questions about the seven Principles where I count nine "sections." I think we might do well to jettison the last two anyway. More on that later.
The ethics committee seems to have missed two facts about psychiatry and psychotherapy: First, many psychiatrists no longer do psychotherapy. Second, many of those who do psychotherapy do not claim to do psychoanalytic psychotherapy or to believe in psychoanalytic theory (Oh, sacrilege). This makes references to psychoanalytic terms like "counter-transference" and "transference" (I counted 6) quaint but archaic and inappropriate. These concepts serve no purpose in medication management, magnetic stimulation, or even CBT, becoming little more than euphemisms. Any attempt to impose an ethical principle based on these unproven constructs upon a psychiatrist outside the context of analytic/dynamic psychotherapy would itself be unethical and must be avoided. Psychiatrists should only be subjected to ethical principles relating to psychiatric practice in general.
Let me attempt to translate some of these references to transference. Take the answer to A.1.a. (page 5) for example: "procedures do not activate transference distortions that preclude effective treatment" appears in a 1989 opinion about whether a psychiatrist can ethically perform vaginal exams or "lead" his (We were all men back then.) patients into sexual fantasies. I would like to advance the theory that transference distortions will not likely make olanzapine or paroxetine any less effective. But could it be that by "treatment" the committee really meant psychotherapy? And I must admit I would not know a transference distortion if one bit me in the superego.
Can we not address this question without invoking mythical concepts like transference? A psychiatrist who routinely attends to the general medical needs of her patients can ethically, with the patient's consent, perform any aspect of a physical examination indicated. However, regardless of whether treatment includes psychotherapy and regardless of the type of psychotherapy, if the psychiatrist uses genital examination for his or her own sexual gratification, we should consider it unethical. We need not refer to or even believe in the existence of "transference distortions."
A.1.e.
On page 6 we see a question about the ethical implications of a psychiatrist dating a former patient. The opinion refers to the possibility the patient has developed a "positive transference" in arguing such a relationship would not be ethical. "Positive transference" here, I believe, means not just that the patient likes the psychiatrist, but also that the "liking" is just an illusion, an artifact of treatment, that it is not real. Once again, we need not invoke psychoanalytic hokus pokus. It behooves us as a profession for our patients to know they are entitled to expect that we will provide treatment we believe to be in their best interest, free of any concern that we may want something other than money from them in return.
A.2.C.
On page 8 the question is whether the role of the psychiatrist (really as psychotherapist -- no question of medication here) can ethically switch from that of treater to that of psychotherapy supervisor. Once again the initial opinion (circa 1988) "probably not" is spot on, but then from the fog of psychoanalytic theory emerges a possible exception: "unless there is consultation for both you and the social worker that indicates no transference-countertransference issues that might harm the patient or lead you to misuse the supervisory role." I see one analyst passing a consultation form to another. At the top it reads, "Rule out transference-counter... etc". How would one do this? How many months on the couch(es)? But aside from the "issues" issue this opinion raises the question of the extent to which the problem might be specific to the particular method of psychotherapy provided. If the treatment had involved CBT or systemic psychotherapy, might the answer be different? Does the committee really expect that the psychiatrist and social worker might consult a psychoanalyst on such a matter when the treatment and supervision involve family systems psychotherapy?
A.2.e. (page 11):
I am doubly interested in this question since it also touches on media use of patient information by the psychiatrist as author. The answer seems to contain a contradiction: "Their consent while "freely" given is likely to be heavily influenced by their transference feelings, the need to please you." How can consent be "freely" given when it is also "heavily influenced?" This case may not even involve psychotherapy, much less psychoanalytically oriented psychotherapy. How can the committee invoke "transference" in formulating the response? Fortunately, even in 1989, someone got to the real point which is that the whole project smacks of exploitation of patient by psychiatrist for the personal gain of the psychiatrist and is therefor probably unethical.
K.2.h. (page 49):
A quarter century ago, analytic theory, misapplied, obfuscates a straight forward problem. The financially challenged patient pays only part of the fee; unbeknownst to her, Mom pays the rest. According to the Principles, "A physician shall deal honestly with patients...", but this will only be considered dishonest from a psychoanalytic perspective if a "consultation" reveals that the associated "transference distortions [are] significant enough."
R.2.a. (page 78)
22 years ago the committee invoked psychoanalytic concepts to probe the ethical depths when a male resident accepted a ride from a female patient. Not just any patient, mind you, but one with "an eroticized transference toward him." Perhaps there would be no need to question the ethics here but for that nasty transference problem. The recommendation might have been (but was not): If a patient offers you a ride, only accept if you have previously determined the transference (assuming there is one) is not eroticized. Once again it is not clear whether the psychiatrist was providing psychoanalytic treatment.
We could debate whether evidence supports use of any psychotherapy based on psychoanalytic theory for treatment of any mental disorder, but my point here is that we should no longer consider psychoanalytic theory to be at the core of psychiatry. It is only one of many treatment modalities that psychiatrists and other professionals may elect to provide. Despite their age the opinions cited above remain instructive and deserve inclusion in the document, but the ethics committee should have either removed references to peculiarly psychoanalytic concepts or added an explanation with an updated basis or translation into non-analytic terminology. Furthermore, and perhaps of greatest concern, inclusion of analytic concepts raises suspicion that some committee members might be unable to fairly consider ethics questions or complaints where the case involves no psychoanalytic treatment. The committee should no longer assume that all treatment involves psychotherapy of any kind. Opinions should not contain obscure and often ambiguous jargon, like "transference distortion," unless accompanied by a definition. When we refer to a patient's feelings as transference we also imply, at least to some degree, as noted in at least one example above, that the feelings are an unreal artifact of treatment. Even in the context of psychoanalytic treatment this notion risks conflict with Section 1 of the Principles to the extent that it fails to provide for "respect for human dignity" in the patient-physician relationship.
Commentary on Opinions of APA Ethics Committee II
Wednesday, December 30, 2009
Saturday, December 19, 2009
Determining Competence to Suicide When Facing Imminently Terminal Illness
Recently the State of Washington enacted a "death with dignity" statute (Chapter 70.245 RCW: The Washington death with dignity act) closely modeled on the Oregon statute (Death with Dignity ORS Chapter 127) passed years ago. This euphemism for assisted suicide probably evolved not only from the stigma associated with suicide but also, for example, from the importance of preventing denial of insurance benefits to survivors. (“Actions taken in accordance with this chapter do not, for any purpose, constitute suicide, assisted suicide, mercy killing, or homicide, under the law.”)
I do find it interesting that we tend to strongly associate suicide with mental illness in spite of the fact the fact that so many (if not most) suicides, such as those we reported in the media are associated with terrorism, and if you look at the Behavenet suicide page, you will see a long list of films, and a few books, in which reference to suicide rarely relates to mental illness.
My interest in this topic lies in the question of how qualified mental health professionals might wish to respond if asked to evaluate a terminally ill patient who wants to die, in order to determine "compliance" with requirements of the law, particularly because this kind of evaluation seems to demand the clinician assume a new role unlike that of treatment provider or forensic examiner.
I hasten to point out that I pretend to have no expertise in this area, have not followed evolution of policy or law in this area closely, and hold no strong opinions for or against assisted suicide in principal. I am aware that many physicians believe that it is a rare case today in which a patient cannot “die with dignity” with previously available palliative care. Also, I approach this discussion in complete ignorance of how the practice has played out in Oregon. I have not even attempted to discover how psychiatrists or psychologists have conducted such evaluations in that state, choosing instead to approach the subject afresh.
The statute stipulates a procedure that starts with diagnosis of an imminently terminal illness. If the patient initiates the process two physicians must give a prognosis of death within six months. Only if one of the physicians questions whether the patient’s wish to die might result from a mental disorder must she request assessment by a psychiatrist or psychologist. After meeting all requirements the physician orders a lethal dose of a barbiturate such as sodium pentothal. After procuring the drug the patient has the option to use it at her discretion. Completion requires active conduct on the part of the patient. The decision to move forward is necessary, not sufficient. Even barring interference the patient or some other actor must take active steps or only nature may take its course. (A problem may arise in cases where the patient loses the physical capacity to self-administer life-ending medication. This is clearly beyond the scope of a test of competence or impaired judgment.)
Counseling Referral
The wording of the statutes differs slightly from that on the forms, but I suspect we will ultimately consider the forms definitive: A “licensed psychiatrist,” or a licensed psychologist, acting as a "consultant" must perform an evaluation to determine a) whether the patient suffers from a mental disorder or b) depression, and whether "impaired judgment" has resulted from either. RCW 70.245.060 requires a “counseling referral.” Maybe the author of the statute erroneously equated "counseling" with any of that mysterious stuff psychiatrists and psychologists do, but while such a professional might choose to counsel the patient about almost anything the statute seems to require evaluation rather than counseling. Counseling implies treatment service provided to the patient. In this setting the professional might also attempt to influence the patient. Was that intended?
Problems arise from ambiguity and questionable use of terminology. (I may have missed a few.):
States do license psychologists, but there is no "licensed psychiatrist" in Washington state, nor likely in Oregon. While statutes spell out the definition of a psychologist, nothing prevents any physician from claiming to be a psychiatrist. The state licenses physicians (or “physicians and surgeons”) but not psychiatrists. Neither the forms nor the statutes relating to assisted suicide provides for a definition of psychiatrist. Neither mentions completion of a psychiatric residency, board certification, or even the mythical "board eligibility."
Forms
Both states' forms (OR Form; WA Form) and statutes require evaluation for "psychiatric or psychological disorder or depression." This would seem to imply that mood depression -- the symptom rather than the disorder -- might produce sufficient impaired judgment to disallow assisted suicide. This might include sub-syndromal depression. But would it not be just as likely that some other sub-syndromal disorder might produce the same degree of impaired judgment? The inclusion of both terms psychiatric and psychological would seem to imply that the two categories might differ in some way. More likely, I think, the author intended to use language that might not depend on a particular system of classification, just in case we abandon the official diagnostic manual of the American Psychiatric Association, or perhaps to assure against omission of any such condition.
Furthermore, as Washington attorney Margaret Dore points out, the evaluation occurs relatively early in the process. The evaluation might find a patient competent before proceeding, but with no guarantee that her mental state will not deteriorate before the time comes to take the life-ending drug. However, the down side risk might be minimal. At worst the patient might, for example, because of impaired judgment at the time, fail to take the drug in a lethal manner. This might result in further injury, a compression syndrome or further brain injury for example. This could happen if the patient were to lose consciousness before ingesting the entire lethal dose.
Choice of Evaluator
The law does not stipulate who chooses the evaluator, but likely both physician and patient would participate. If a psychiatrist or psychologist has treated the patient before would his prior familiarity with the patient put him in a better position to make such a determination because of greater knowledge? Emotional connection with the patient might make it more difficult to maintain objectivity, especially if the professional holds a strong opinion about assisted suicide. Perhaps he should suggest that a new professional conduct the examination. Patient and physician will likely choose a "counselor" believed unlikely to oppose to accept the practice of assisted suicide. Perhaps the physician requesting the examination should ask whether the potential examiner holds any strong bias for or against.
Compensation of Evaluator
Who pays the examiner? I believe the patient should compensate the examiner. Third party payers might or might not provide reimbursement. This could conceivably hinge on whether the evaluation leads to treatment of a psychiatric disorder. This raises the question of whether an examiner should ever take on continuing treatment or refer to a new professional.
Documentation
The space provided on the evaluation form allows for very little documentation. This may reflect ignorance of the typical length of such an evaluation. It might betray the fact that the author did not intend the professional to conduct a comprehensive diagnostic examination. Or the author may have assumed that the professional would attach a complete document.
Duty
To whom does the evaluator owe a duty? the terminal patient? the attending physician?
Patient's Perspective
We should also consider assisted suicide from the patient’s point of view: "I have to convince this psychiatrist/psychologist my desire to die this way is not because I'm depressed or crazy." That is, the evaluator may be perceived as an adversary, a fact the examiner must keep in mind. The patient will have an incentive to "fake well." On the other hand the patient might fail to cooperate with evaluation. In this case the professional would probably not declare the patient competent, and the process might be halted. In the face of an adverse determination for any reason, either the patient or the attending physician might challenge the finding and request a second examination. If two evaluations disagree, a tie breaker could be ordered, but the statute seems to require only one permissive opinion to allow the process to go forward.
Administration of Lethal Medication
For the suicide to proceed to successful completion requires more from the patient than mental competence to choose death. Self administration of a lethal dose of the chosen barbiturate requires the patient to find, prepare and consume a large number of capsules or tablets over a short period of time. Some patients might require assistance at the time because of the physical demands aside from the mental demands.
Criteria for Competence
Under the Washington definition the patient must be found competent, but we can only guess that this might mean competent to want to die or competent to decide to die. The definition adds another criterion: absence of “impaired judgment,” a term that covers a lot of territory. Neither the forms nor the statutes stipulate the degree to which judgment must remain intact in order to allow assisted suicide. Some examiners might consider a wish to die as evidence of impaired judgment. What criteria should be used? Does this compare to a forensic competence assessment like testamentary capacity or competence to stand trial?
Should the examiner presume competence or incompetence? This could depend on whether the examiner has a bias against, or in favor of, assisted suicide. But it seems unlikely that evaluators opposed to assisted suicide would participate. Judging from the brevity of the form and the lack of attention to qualifications of the examiner, might we assume the authors of the law intended a presumption of competence?
I favor modeling the competence or impaired judgment test on other tests of capacity or competence. The examiner should focus the evaluation on the judgments directly related to the act of assisted suicide. For example, the patient might provide an inappropriate answer to the frequently used questions about what one should do when she discovers fire while in a crowded theater or what to do with an addressed, stamped envelope found on the street. The fact the patient meets criteria for any particular mental disorder should not in itself be assumed to render them incompetent. However history might be relevant, particularly if the patient has attempted suicide in the past, particularly if the suicide appeared related to a mental disorder.
In making this determination the examiner should elicit evidence of the degree to which the patient
1) appreciates the diagnosed illness, its effects, and the natural process of death from the illness
2) appreciates the available alternatives to assisted suicide, including palliative care
3) appreciates the irreversible nature of assisted suicide, including the process of death from the life-ending medication
4) appreciates how to administer life-ending medication to achieve the desired effect, including the ability to discriminate among life-ending medication, other medication, food, and drink.
Should we include assessment of appreciation of the impact of assisted suicide on individuals or organizations? Should there be evidence that the patient wants to die to avoid the loss of dignity associated with the terminal illness rather than to avoid psychic "pain" associated with a mental disorder. The examiner should not attempt to influence the patient, or should he?
Psychologists, who lack medical training, may not be qualified to adequately assess elements of the examination requiring knowledge of terminal physical illness and treatment, especially palliative measures. Few of these elements is straightforward or simple. Each involves judgment of the degree of understanding, taking into account the patient’s cultural and educational background.
Immunity
According to the Washington statute, "A professional organization or association, or health care provider, may not subject a person to censure, discipline, suspension, loss of license, loss of privileges, loss of membership, or other penalty for participating or refusing to participate in good faith compliance with this chapter." This seems to provide a degree of immunity, but only related to whether one participates or refuses. It would be safest to assume that one must still comply with all other aspects of law and meet the profession's standard of care. Furthermore, it is not clear that the State of Washington for example has authority over the American Psychiatric Association with regard to ethics questions. If APA censured a member for participation what legal recourse would the State have?
Those psychiatrists or psychologists who embark on these evaluations will enter uncharted territory. I hope this will at least help them ask the necessary questions about how to proceed. It will be important for the pioneers to share their experience with those who follow.
I do find it interesting that we tend to strongly associate suicide with mental illness in spite of the fact the fact that so many (if not most) suicides, such as those we reported in the media are associated with terrorism, and if you look at the Behavenet suicide page, you will see a long list of films, and a few books, in which reference to suicide rarely relates to mental illness.
My interest in this topic lies in the question of how qualified mental health professionals might wish to respond if asked to evaluate a terminally ill patient who wants to die, in order to determine "compliance" with requirements of the law, particularly because this kind of evaluation seems to demand the clinician assume a new role unlike that of treatment provider or forensic examiner.
I hasten to point out that I pretend to have no expertise in this area, have not followed evolution of policy or law in this area closely, and hold no strong opinions for or against assisted suicide in principal. I am aware that many physicians believe that it is a rare case today in which a patient cannot “die with dignity” with previously available palliative care. Also, I approach this discussion in complete ignorance of how the practice has played out in Oregon. I have not even attempted to discover how psychiatrists or psychologists have conducted such evaluations in that state, choosing instead to approach the subject afresh.
The statute stipulates a procedure that starts with diagnosis of an imminently terminal illness. If the patient initiates the process two physicians must give a prognosis of death within six months. Only if one of the physicians questions whether the patient’s wish to die might result from a mental disorder must she request assessment by a psychiatrist or psychologist. After meeting all requirements the physician orders a lethal dose of a barbiturate such as sodium pentothal. After procuring the drug the patient has the option to use it at her discretion. Completion requires active conduct on the part of the patient. The decision to move forward is necessary, not sufficient. Even barring interference the patient or some other actor must take active steps or only nature may take its course. (A problem may arise in cases where the patient loses the physical capacity to self-administer life-ending medication. This is clearly beyond the scope of a test of competence or impaired judgment.)
Counseling Referral
The wording of the statutes differs slightly from that on the forms, but I suspect we will ultimately consider the forms definitive: A “licensed psychiatrist,” or a licensed psychologist, acting as a "consultant" must perform an evaluation to determine a) whether the patient suffers from a mental disorder or b) depression, and whether "impaired judgment" has resulted from either. RCW 70.245.060 requires a “counseling referral.” Maybe the author of the statute erroneously equated "counseling" with any of that mysterious stuff psychiatrists and psychologists do, but while such a professional might choose to counsel the patient about almost anything the statute seems to require evaluation rather than counseling. Counseling implies treatment service provided to the patient. In this setting the professional might also attempt to influence the patient. Was that intended?
Problems arise from ambiguity and questionable use of terminology. (I may have missed a few.):
States do license psychologists, but there is no "licensed psychiatrist" in Washington state, nor likely in Oregon. While statutes spell out the definition of a psychologist, nothing prevents any physician from claiming to be a psychiatrist. The state licenses physicians (or “physicians and surgeons”) but not psychiatrists. Neither the forms nor the statutes relating to assisted suicide provides for a definition of psychiatrist. Neither mentions completion of a psychiatric residency, board certification, or even the mythical "board eligibility."
Forms
Both states' forms (OR Form; WA Form) and statutes require evaluation for "psychiatric or psychological disorder or depression." This would seem to imply that mood depression -- the symptom rather than the disorder -- might produce sufficient impaired judgment to disallow assisted suicide. This might include sub-syndromal depression. But would it not be just as likely that some other sub-syndromal disorder might produce the same degree of impaired judgment? The inclusion of both terms psychiatric and psychological would seem to imply that the two categories might differ in some way. More likely, I think, the author intended to use language that might not depend on a particular system of classification, just in case we abandon the official diagnostic manual of the American Psychiatric Association, or perhaps to assure against omission of any such condition.
Furthermore, as Washington attorney Margaret Dore points out, the evaluation occurs relatively early in the process. The evaluation might find a patient competent before proceeding, but with no guarantee that her mental state will not deteriorate before the time comes to take the life-ending drug. However, the down side risk might be minimal. At worst the patient might, for example, because of impaired judgment at the time, fail to take the drug in a lethal manner. This might result in further injury, a compression syndrome or further brain injury for example. This could happen if the patient were to lose consciousness before ingesting the entire lethal dose.
Choice of Evaluator
The law does not stipulate who chooses the evaluator, but likely both physician and patient would participate. If a psychiatrist or psychologist has treated the patient before would his prior familiarity with the patient put him in a better position to make such a determination because of greater knowledge? Emotional connection with the patient might make it more difficult to maintain objectivity, especially if the professional holds a strong opinion about assisted suicide. Perhaps he should suggest that a new professional conduct the examination. Patient and physician will likely choose a "counselor" believed unlikely to oppose to accept the practice of assisted suicide. Perhaps the physician requesting the examination should ask whether the potential examiner holds any strong bias for or against.
Compensation of Evaluator
Who pays the examiner? I believe the patient should compensate the examiner. Third party payers might or might not provide reimbursement. This could conceivably hinge on whether the evaluation leads to treatment of a psychiatric disorder. This raises the question of whether an examiner should ever take on continuing treatment or refer to a new professional.
Documentation
The space provided on the evaluation form allows for very little documentation. This may reflect ignorance of the typical length of such an evaluation. It might betray the fact that the author did not intend the professional to conduct a comprehensive diagnostic examination. Or the author may have assumed that the professional would attach a complete document.
Duty
To whom does the evaluator owe a duty? the terminal patient? the attending physician?
Patient's Perspective
We should also consider assisted suicide from the patient’s point of view: "I have to convince this psychiatrist/psychologist my desire to die this way is not because I'm depressed or crazy." That is, the evaluator may be perceived as an adversary, a fact the examiner must keep in mind. The patient will have an incentive to "fake well." On the other hand the patient might fail to cooperate with evaluation. In this case the professional would probably not declare the patient competent, and the process might be halted. In the face of an adverse determination for any reason, either the patient or the attending physician might challenge the finding and request a second examination. If two evaluations disagree, a tie breaker could be ordered, but the statute seems to require only one permissive opinion to allow the process to go forward.
Administration of Lethal Medication
For the suicide to proceed to successful completion requires more from the patient than mental competence to choose death. Self administration of a lethal dose of the chosen barbiturate requires the patient to find, prepare and consume a large number of capsules or tablets over a short period of time. Some patients might require assistance at the time because of the physical demands aside from the mental demands.
Criteria for Competence
Under the Washington definition the patient must be found competent, but we can only guess that this might mean competent to want to die or competent to decide to die. The definition adds another criterion: absence of “impaired judgment,” a term that covers a lot of territory. Neither the forms nor the statutes stipulate the degree to which judgment must remain intact in order to allow assisted suicide. Some examiners might consider a wish to die as evidence of impaired judgment. What criteria should be used? Does this compare to a forensic competence assessment like testamentary capacity or competence to stand trial?
Should the examiner presume competence or incompetence? This could depend on whether the examiner has a bias against, or in favor of, assisted suicide. But it seems unlikely that evaluators opposed to assisted suicide would participate. Judging from the brevity of the form and the lack of attention to qualifications of the examiner, might we assume the authors of the law intended a presumption of competence?
I favor modeling the competence or impaired judgment test on other tests of capacity or competence. The examiner should focus the evaluation on the judgments directly related to the act of assisted suicide. For example, the patient might provide an inappropriate answer to the frequently used questions about what one should do when she discovers fire while in a crowded theater or what to do with an addressed, stamped envelope found on the street. The fact the patient meets criteria for any particular mental disorder should not in itself be assumed to render them incompetent. However history might be relevant, particularly if the patient has attempted suicide in the past, particularly if the suicide appeared related to a mental disorder.
In making this determination the examiner should elicit evidence of the degree to which the patient
1) appreciates the diagnosed illness, its effects, and the natural process of death from the illness
2) appreciates the available alternatives to assisted suicide, including palliative care
3) appreciates the irreversible nature of assisted suicide, including the process of death from the life-ending medication
4) appreciates how to administer life-ending medication to achieve the desired effect, including the ability to discriminate among life-ending medication, other medication, food, and drink.
Should we include assessment of appreciation of the impact of assisted suicide on individuals or organizations? Should there be evidence that the patient wants to die to avoid the loss of dignity associated with the terminal illness rather than to avoid psychic "pain" associated with a mental disorder. The examiner should not attempt to influence the patient, or should he?
Psychologists, who lack medical training, may not be qualified to adequately assess elements of the examination requiring knowledge of terminal physical illness and treatment, especially palliative measures. Few of these elements is straightforward or simple. Each involves judgment of the degree of understanding, taking into account the patient’s cultural and educational background.
Immunity
According to the Washington statute, "A professional organization or association, or health care provider, may not subject a person to censure, discipline, suspension, loss of license, loss of privileges, loss of membership, or other penalty for participating or refusing to participate in good faith compliance with this chapter." This seems to provide a degree of immunity, but only related to whether one participates or refuses. It would be safest to assume that one must still comply with all other aspects of law and meet the profession's standard of care. Furthermore, it is not clear that the State of Washington for example has authority over the American Psychiatric Association with regard to ethics questions. If APA censured a member for participation what legal recourse would the State have?
Those psychiatrists or psychologists who embark on these evaluations will enter uncharted territory. I hope this will at least help them ask the necessary questions about how to proceed. It will be important for the pioneers to share their experience with those who follow.
Wednesday, December 9, 2009
DEA Suboxone Audit Update VI
Continued from: DEA Suboxone Audit Update V
Today I learned that DEA field offices in FL, MA, and NY sent letters, some in October, to OBOT physicians alerting them to unscheduled audits. At least some of the letters (I have not yet seen a copy) apparently included language that suggested physicians who were issued special credentials for prescribing buprenorphine, but who do not currently prescribe the drug, could avoid the hassle of the audits by relinquishing their credentials. This apparently alarmed some physicians, but a second letter from some or all of the field offices attempted to clarify and reassure physicians.
I also obtained confirmation by telephone that the NW field office did not send letters, which of course explains why I did not receive one. It is not clear whether that office will send a letter eventually, but at least one physician in the area reported that he was audited.
DEA Suboxone Audit: Worst Experience of My Career as a Physician
Today I learned that DEA field offices in FL, MA, and NY sent letters, some in October, to OBOT physicians alerting them to unscheduled audits. At least some of the letters (I have not yet seen a copy) apparently included language that suggested physicians who were issued special credentials for prescribing buprenorphine, but who do not currently prescribe the drug, could avoid the hassle of the audits by relinquishing their credentials. This apparently alarmed some physicians, but a second letter from some or all of the field offices attempted to clarify and reassure physicians.
I also obtained confirmation by telephone that the NW field office did not send letters, which of course explains why I did not receive one. It is not clear whether that office will send a letter eventually, but at least one physician in the area reported that he was audited.
DEA Suboxone Audit: Worst Experience of My Career as a Physician
Saturday, December 5, 2009
DEA Suboxone Audit Form
I have obtained and hereby make available for review and comment DEA Form 82: Notice of Inspection of Controlled Premises. I understand, but cannot be sure, that DEA agents will require OBOT physicians to sign a copy of this agreement before initiating audit of records. OBOT physicians may want to ask an attorney to review the form now so as to be prepared when audited.
I was glad to see the form includes a statement of rights. I notice, too, that the form includes no reference whatsoever to questioning or interrogation. There is a stipulation that the agent will be allowed to inventory stock of controlled substances.
DEA should make a copy of this form available on the agency Web site. Until it does you can make do with this copy.
I was glad to see the form includes a statement of rights. I notice, too, that the form includes no reference whatsoever to questioning or interrogation. There is a stipulation that the agent will be allowed to inventory stock of controlled substances.
DEA should make a copy of this form available on the agency Web site. Until it does you can make do with this copy.
Thursday, December 3, 2009
DEA Suboxone Audit Update V
Continued from: DEA Suboxone Audit Update IV
The Government Relations Department of the American Psychiatric Association has issued a helpful document providing more details regarding the OBOT audits. My local DEA office still has not provided me with a copy of the “Notice of Inspection” (DEA form 82?) I was promised. Not surprisingly they also refused my offer of an appointment for my audit. In fact there was no response to my letter at all.
The document states that DEA sent each physician to be audited a letter. I do not recall receiving such a letter, but according to APA this may yet come from the local office, but audits have already started in my area.
According to the document agents will "verify" that the physician treats no more than the 30/100 limit. It would seem that agents cannot verify this without some independent source, such as pharmacy records. They must simply take the physician's word.
The only suggestion APA could offer as to why the audits cannot be scheduled is that this is standard practice. Well, that does sound like the federal government: standard practice prevails even if it involves waste.
DEA Suboxone Audit Update VI
The Government Relations Department of the American Psychiatric Association has issued a helpful document providing more details regarding the OBOT audits. My local DEA office still has not provided me with a copy of the “Notice of Inspection” (DEA form 82?) I was promised. Not surprisingly they also refused my offer of an appointment for my audit. In fact there was no response to my letter at all.
The document states that DEA sent each physician to be audited a letter. I do not recall receiving such a letter, but according to APA this may yet come from the local office, but audits have already started in my area.
According to the document agents will "verify" that the physician treats no more than the 30/100 limit. It would seem that agents cannot verify this without some independent source, such as pharmacy records. They must simply take the physician's word.
The only suggestion APA could offer as to why the audits cannot be scheduled is that this is standard practice. Well, that does sound like the federal government: standard practice prevails even if it involves waste.
DEA Suboxone Audit Update VI
Tuesday, December 1, 2009
Telepsychiatry and Liability
These actual questions posed to me when I asked my professional liability (malpractice) carrier to cover me for conducting medication management sessions via audio/video connection using the Web, serve to illustrate some of the misconceptions about telemedicine and the extent to which state law and the courts irrationally interfere with progress, in some cases likely increasing risk.
· [In] Which states will you practice telemedicine? If multiple states, do you have licenses to practice in each state?
Most states apparently regulate medical activity where the patient is rather than where the physician is or where either resides. If my patient travels there, California law may govern treatment I provide from my home state. Unless I am licensed in CA I risk running afoul of the law there. Patients and physicians should not have to worry about care provided during travel by either party or both. A national license could solve this problem, but don't hold your breath.
For now I plan to only treat patients who normally reside in my state. If I or the patient travel to other states, I plan to contact the licensing board of the other state before (temporarily) managing the patient's care there. I already do this before contacts using the telephone only.
· Number of Patients/hours per week devoted to telemedicine?
The word "hours" in this context implies psychotherapy to me. I plan to do neither psychotherapy nor initial evaluation via telemedicine. I intend to examine every patient at least once in the office before considering telemedicine visits.
I want to use this technology for as many patients as want to use it.
· Ages & types of conditions/treatment for telemedicine?
I only treat adults and have opted out of Medicare, but I see no justification for discriminating on the basis of age. I treat patients with most psychiatric diagnoses. I see no reason why diagnosis should determine whether to apply this technology. I hope someone will comment on whether there might be certain types of cases that should not be managed via Skype.
· Previous telemedicine experience?
Lots of experience on the phone, which emphasizes the fact that insurers, and maybe the courts, see this as a limiting technology when in fact it is less limiting than the telephone if only because you can see the patient. The differences of course are not addressed in the question: I have never charged a fee for telephone contacts, and telemedicine contacts would replace at least some in person contacts.
· Equipment used? Who supplies the telemedicine equipment?
Another vague question. Both physician and patient need a computer, a video camera, and an Internet connection. Funny that they never ask this question if you propose telephone contact. Who supplies that cell phone? Who supplies that battery? Who supplies those telephone poles? Let me propose an office visit: Wait, who supplies the car? the furniture? the roof? the light bulbs?
· Is informed consent signed?
How does one sign consent? OK, this refers to yet another form. Actually, I am putting together an agreement which will include informed consent. But should I not have a separate consent form or agreement for telephone contact or office visit as well?
Phone: "I understand that doctor and patient may not be able to see each other when talking on the phone and that this leads to risk of misidentification or that each party may be unable to see the other party making rude gestures during conversation."
"I understand that if I talk to my psychiatrist on the telephone she may not be able to see holding a knife to my wrist."
Office: "I understand that meeting the physician in the office entails risk of unwanted touching that cannot happen via telephone or Skype. I understand that by traveling to the doctor's office I expose myself to risk of traffic accident, being mugged or murdered, or having my boss, who is also a patient there, see me walking into the waiting room."
Can patients decline treatment?
No! Absolutely not! All patients must submit to treatment on penalty of death!
Seriously, maybe they mean to ask whether the patient can choose to conduct visits in person. Of course they can. By telephone? Not with me.
· Will a psychiatrist or mental health professional be available if immediate attention is needed by the patient?
This is my favorite. Where do I start?
I try to picture a patient in my office for an appointment scheduled two weeks ago needing "immediate attention." I'm a doctor. It is not my job to give people attention. I diagnose and treat mental disorders. What are they talking about here? I would be available. If a patient seems at risk of suicide or some emergent medical problem we call 911 or send them to an emergency room. Doesn't matter whether the patient is in my office, at home, or on vacation in San Francisco.
This question seems to suggest that this mythical patient with this mythical need for immediate attention should have a psychiatrist or "mental health professional" (whatever that is) assigned to be present with the patient when the telemedicine contact is initiated. Why? And what exactly is this person supposed to do? Emergency psychotherapy? Hand them a tissue? Most patients probably wait weeks for an appointment with a psychiatrist. One local ER here has probably not enjoyed a visit from an on-call psychiatrist in 20 years. And if the patient is at risk of violence they need immediate attention from a SWAT team, not a mental health professional.
· Will you be obtaining the patients medical history?
What perplexes me about this question is that it could refer to almost any element in the initial evaluation, assuming that is what they refer to here. Why not ask about the psychiatric history, family history, developmental history?
If so, how will you obtain the medical history?
I like to start with general anesthesia. Then I make a 3 inch incision over the right supra-numerary fossa and dissect through the soft tissue to the hard tissue. If it's even there.
Seriously -- but not very seriously -- I ask.
· Is there a backup plan in the event of an equipment failure?
Absolutely. If the furnace goes out, I put on warm clothes. If the car breaks down, they take a cab. Or reschedule for later in the week. Hay, that just happened today. With no telemedicine involved. If the cell phone battery goes dead, we recharge it.
Oh, you mean if the computer, or the video cam, or the Internet connection fails. This really is not rocket science. You use a different computer, make do with the telephone, reschedule, or play Neanderthal and schedule an office visit. Does this really need a plan? (Maybe if you left your common sense under the pillow.)
That's all for the underwriter's questions, but here are a few more thoughts.
Using telemedicine a patient cannot physically assault a physician, office staff or another patient. Neither can they transmit infectious diseases to other patients over the Web, like they can in a waiting room.
Telemedicine markedly increases privacy for obvious reasons, some of which I hint at above. Vulnerability to hacking is a real risk, but we must weigh it against risks associated with office visits.
Skype is arguably superior to telephone but does not require waiting for business hours or availability of an office. It can also increase continuity since better-than-telephone contacts can occur when either or both parties are traveling or unable to reach the office due to illness, disaster, transportation or weather problems.
True, I will not be able to smell alcohol on the breath of an intoxicated patient, but neither will that patient kill someone while driving to my office under the influence.
Nothing in medicine is perfect, but, used sensibly, this technology offers clear advantages and deserves a place in the armamentarium of some if not all physicians, that is despite one undeniable disadvantage: My patients won't be able to enjoy petting my dog, which is why I think most pay to see me anyway.
· [In] Which states will you practice telemedicine? If multiple states, do you have licenses to practice in each state?
Most states apparently regulate medical activity where the patient is rather than where the physician is or where either resides. If my patient travels there, California law may govern treatment I provide from my home state. Unless I am licensed in CA I risk running afoul of the law there. Patients and physicians should not have to worry about care provided during travel by either party or both. A national license could solve this problem, but don't hold your breath.
For now I plan to only treat patients who normally reside in my state. If I or the patient travel to other states, I plan to contact the licensing board of the other state before (temporarily) managing the patient's care there. I already do this before contacts using the telephone only.
· Number of Patients/hours per week devoted to telemedicine?
The word "hours" in this context implies psychotherapy to me. I plan to do neither psychotherapy nor initial evaluation via telemedicine. I intend to examine every patient at least once in the office before considering telemedicine visits.
I want to use this technology for as many patients as want to use it.
· Ages & types of conditions/treatment for telemedicine?
I only treat adults and have opted out of Medicare, but I see no justification for discriminating on the basis of age. I treat patients with most psychiatric diagnoses. I see no reason why diagnosis should determine whether to apply this technology. I hope someone will comment on whether there might be certain types of cases that should not be managed via Skype.
· Previous telemedicine experience?
Lots of experience on the phone, which emphasizes the fact that insurers, and maybe the courts, see this as a limiting technology when in fact it is less limiting than the telephone if only because you can see the patient. The differences of course are not addressed in the question: I have never charged a fee for telephone contacts, and telemedicine contacts would replace at least some in person contacts.
· Equipment used? Who supplies the telemedicine equipment?
Another vague question. Both physician and patient need a computer, a video camera, and an Internet connection. Funny that they never ask this question if you propose telephone contact. Who supplies that cell phone? Who supplies that battery? Who supplies those telephone poles? Let me propose an office visit: Wait, who supplies the car? the furniture? the roof? the light bulbs?
· Is informed consent signed?
How does one sign consent? OK, this refers to yet another form. Actually, I am putting together an agreement which will include informed consent. But should I not have a separate consent form or agreement for telephone contact or office visit as well?
Phone: "I understand that doctor and patient may not be able to see each other when talking on the phone and that this leads to risk of misidentification or that each party may be unable to see the other party making rude gestures during conversation."
"I understand that if I talk to my psychiatrist on the telephone she may not be able to see holding a knife to my wrist."
Office: "I understand that meeting the physician in the office entails risk of unwanted touching that cannot happen via telephone or Skype. I understand that by traveling to the doctor's office I expose myself to risk of traffic accident, being mugged or murdered, or having my boss, who is also a patient there, see me walking into the waiting room."
Can patients decline treatment?
No! Absolutely not! All patients must submit to treatment on penalty of death!
Seriously, maybe they mean to ask whether the patient can choose to conduct visits in person. Of course they can. By telephone? Not with me.
· Will a psychiatrist or mental health professional be available if immediate attention is needed by the patient?
This is my favorite. Where do I start?
I try to picture a patient in my office for an appointment scheduled two weeks ago needing "immediate attention." I'm a doctor. It is not my job to give people attention. I diagnose and treat mental disorders. What are they talking about here? I would be available. If a patient seems at risk of suicide or some emergent medical problem we call 911 or send them to an emergency room. Doesn't matter whether the patient is in my office, at home, or on vacation in San Francisco.
This question seems to suggest that this mythical patient with this mythical need for immediate attention should have a psychiatrist or "mental health professional" (whatever that is) assigned to be present with the patient when the telemedicine contact is initiated. Why? And what exactly is this person supposed to do? Emergency psychotherapy? Hand them a tissue? Most patients probably wait weeks for an appointment with a psychiatrist. One local ER here has probably not enjoyed a visit from an on-call psychiatrist in 20 years. And if the patient is at risk of violence they need immediate attention from a SWAT team, not a mental health professional.
· Will you be obtaining the patients medical history?
What perplexes me about this question is that it could refer to almost any element in the initial evaluation, assuming that is what they refer to here. Why not ask about the psychiatric history, family history, developmental history?
If so, how will you obtain the medical history?
I like to start with general anesthesia. Then I make a 3 inch incision over the right supra-numerary fossa and dissect through the soft tissue to the hard tissue. If it's even there.
Seriously -- but not very seriously -- I ask.
· Is there a backup plan in the event of an equipment failure?
Absolutely. If the furnace goes out, I put on warm clothes. If the car breaks down, they take a cab. Or reschedule for later in the week. Hay, that just happened today. With no telemedicine involved. If the cell phone battery goes dead, we recharge it.
Oh, you mean if the computer, or the video cam, or the Internet connection fails. This really is not rocket science. You use a different computer, make do with the telephone, reschedule, or play Neanderthal and schedule an office visit. Does this really need a plan? (Maybe if you left your common sense under the pillow.)
That's all for the underwriter's questions, but here are a few more thoughts.
Using telemedicine a patient cannot physically assault a physician, office staff or another patient. Neither can they transmit infectious diseases to other patients over the Web, like they can in a waiting room.
Telemedicine markedly increases privacy for obvious reasons, some of which I hint at above. Vulnerability to hacking is a real risk, but we must weigh it against risks associated with office visits.
Skype is arguably superior to telephone but does not require waiting for business hours or availability of an office. It can also increase continuity since better-than-telephone contacts can occur when either or both parties are traveling or unable to reach the office due to illness, disaster, transportation or weather problems.
True, I will not be able to smell alcohol on the breath of an intoxicated patient, but neither will that patient kill someone while driving to my office under the influence.
Nothing in medicine is perfect, but, used sensibly, this technology offers clear advantages and deserves a place in the armamentarium of some if not all physicians, that is despite one undeniable disadvantage: My patients won't be able to enjoy petting my dog, which is why I think most pay to see me anyway.
Monday, November 30, 2009
Iscribe Down, Up Again
All you throwbacks still writing prescriptions on paper can stop laughing now.
Iscribe (iscribe.com) has announced that it's running correctly again. I hope it really is. Prescription renewals I authorized days ago failed to go through when ordered, but according to a recent email Iscribe should have transmitted them to pharmacies (via surescripts.com) by now.
Patients keep ignoring me when I tell them to call the pharmacy before trying to pick up prescriptions, one thing no one had to worry about when I wrote them on paper. With all the advantages and disadvantages eprescribing I plan to stick with Iscribe for the time being.
Iscribe (iscribe.com) has announced that it's running correctly again. I hope it really is. Prescription renewals I authorized days ago failed to go through when ordered, but according to a recent email Iscribe should have transmitted them to pharmacies (via surescripts.com) by now.
Patients keep ignoring me when I tell them to call the pharmacy before trying to pick up prescriptions, one thing no one had to worry about when I wrote them on paper. With all the advantages and disadvantages eprescribing I plan to stick with Iscribe for the time being.
Sunday, November 29, 2009
How We Should Treat the Homeless Mentally Ill
On this week's Vinyl Cafe Stuart McLean's Morley tells us how to treat the homeless mentally ill Emil.
Podcast
Podcast
Friday, November 27, 2009
Does the American Psychiatric Association Need a New Ethics Compass?
When you think of ethics and psychiatry what comes to mind? Probably physicians' financial relationships with drug companies and sexual relationships with patients. While I do not deny the importance of either I believe APA's handling of many other ethical matters warrants improvement, and I hope to address these in more detail in subsequent posts. A list of planned topics follows:
Last time I looked APA had not revised its online Opinions of the Ethics Committee on The Principles of Medical Ethics With Annotations Especially Applicable to Psychiatry since 2001. I know the ethics committee has issued opinions since then. Only those members who can access them can benefit from those opinions.
Psychiatrists have published online or in print case histories sufficiently detailed that the patient or those who know the patient could identify them. In many of these cases if they are fiction this fact was not mentioned. It is possible that patients consented to publication, but the patient may have felt pressure to consent, and there is little likelihood that the patient might benefit from the publication. APA has not dealt adequately with this problem.
APA published Questions & Answers About Procedures for Handling Complaints of Unethical Conduct as an addendum to the Code, but the most recent answer I could find was published in 2003.
Section 9 of the Code states: "A physician shall support access to medical care for all people." There is no associated "Annotation Especially Applicable to Psychiatry" except this: "New section recently adopted by the AMA." As far as I can determine recently means 2001. This feel good "principle" has clear political implications but only questionable applicability in the context of the physician patient relationship. Do we need a test case?
APA has addressed ethical considerations related to availability for patient emergencies, but the opinion (at least the only one with which I have been provided) seems to ignore realities and refers to factors which seem extraneous or indeterminable.
Third parties regularly exploit treating psychiatrists for cheap or free opinions related to obtaining benefits for patients or to return to work. APA seems unwilling to take a firm stance regarding the ethical implications.
For many years psychiatry and psychodynamic psychotherapy have been inseparable. Ethics opinions still occasionally refer to dynamic/analytic concepts like transference. Today many psychiatrists either provide psychotherapy using other methods such as CBT or provide no psychotherapy at all. Published psychiatric ethics principles and determinations should refer only to principles related to all psychiatrists and should scrupulously avoid imposition of psychoanalytic principles to psychiatrists outside the context of that method of treatment.
I will devote an extended series of posts to an ethical question I posed over three years ago which has never been addressed definitively despite referral to a number of district branches and state associations. Even when initiated at the local level APA should ultimately address ethics questions with national applicability at the national level. What is unethical in Nebraska is unethical in Florida.
Commentary on Opinions of APA Ethics Committee I
Last time I looked APA had not revised its online Opinions of the Ethics Committee on The Principles of Medical Ethics With Annotations Especially Applicable to Psychiatry since 2001. I know the ethics committee has issued opinions since then. Only those members who can access them can benefit from those opinions.
Psychiatrists have published online or in print case histories sufficiently detailed that the patient or those who know the patient could identify them. In many of these cases if they are fiction this fact was not mentioned. It is possible that patients consented to publication, but the patient may have felt pressure to consent, and there is little likelihood that the patient might benefit from the publication. APA has not dealt adequately with this problem.
APA published Questions & Answers About Procedures for Handling Complaints of Unethical Conduct as an addendum to the Code, but the most recent answer I could find was published in 2003.
Section 9 of the Code states: "A physician shall support access to medical care for all people." There is no associated "Annotation Especially Applicable to Psychiatry" except this: "New section recently adopted by the AMA." As far as I can determine recently means 2001. This feel good "principle" has clear political implications but only questionable applicability in the context of the physician patient relationship. Do we need a test case?
APA has addressed ethical considerations related to availability for patient emergencies, but the opinion (at least the only one with which I have been provided) seems to ignore realities and refers to factors which seem extraneous or indeterminable.
Third parties regularly exploit treating psychiatrists for cheap or free opinions related to obtaining benefits for patients or to return to work. APA seems unwilling to take a firm stance regarding the ethical implications.
For many years psychiatry and psychodynamic psychotherapy have been inseparable. Ethics opinions still occasionally refer to dynamic/analytic concepts like transference. Today many psychiatrists either provide psychotherapy using other methods such as CBT or provide no psychotherapy at all. Published psychiatric ethics principles and determinations should refer only to principles related to all psychiatrists and should scrupulously avoid imposition of psychoanalytic principles to psychiatrists outside the context of that method of treatment.
I will devote an extended series of posts to an ethical question I posed over three years ago which has never been addressed definitively despite referral to a number of district branches and state associations. Even when initiated at the local level APA should ultimately address ethics questions with national applicability at the national level. What is unethical in Nebraska is unethical in Florida.
Commentary on Opinions of APA Ethics Committee I
Thursday, November 26, 2009
Remote Referral: Serendipity and Anonymity on the Web
I harbor no illusion that a reader could not discover my true identity with sufficient effort, but I prefer not to use BehaveNet to promote my practice, and I don't want my patients to have "in their face" everything I write.
(Names have been changed to protect the innocent.)
I need to refer a patient to a psychiatrist or psychotherapist in a distant part of the country where I know none personally. I put the word out to some friends and family, but I don't expect much. So I resorted to the directories on the Web. When I looked at the brief profile of one professional a piece of information, along with prior suspicions about the geographical location of this individual, made me suspect I had read some of his work and liked what I read. Furthermore I thought this might make for a good match between patient and provider. I emailed the provider, dropped a few hints, and believe there has been confirmation of my suspicion.
Here's my dilemma:
I firmly believe in the Golden Rule. I don't want to reveal the professional's identity to the patient, and hope he won't tell the patient about my own presence on the Web. On the other hand I certainly will not deceive the patient by claiming more knowledge than I possess about this professional.
My idea of a solution:
I tell the patient only that my knowledge of this professional is limited to what I have read on the Web. I leave it to the professional to decide whether to reveal his Web identity to the patient. And I send a link to this post to the professional.
Happy Thanksgiving
(Names have been changed to protect the innocent.)
I need to refer a patient to a psychiatrist or psychotherapist in a distant part of the country where I know none personally. I put the word out to some friends and family, but I don't expect much. So I resorted to the directories on the Web. When I looked at the brief profile of one professional a piece of information, along with prior suspicions about the geographical location of this individual, made me suspect I had read some of his work and liked what I read. Furthermore I thought this might make for a good match between patient and provider. I emailed the provider, dropped a few hints, and believe there has been confirmation of my suspicion.
Here's my dilemma:
I firmly believe in the Golden Rule. I don't want to reveal the professional's identity to the patient, and hope he won't tell the patient about my own presence on the Web. On the other hand I certainly will not deceive the patient by claiming more knowledge than I possess about this professional.
My idea of a solution:
I tell the patient only that my knowledge of this professional is limited to what I have read on the Web. I leave it to the professional to decide whether to reveal his Web identity to the patient. And I send a link to this post to the professional.
Happy Thanksgiving
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
Friday, November 20, 2009
No, I Really Am from DEA
The imminent on-site inspections by DEA agents of offices of doctors prescribing buprenorphine creates a perfect opportunity for imposters posing as DEA agents to help themselves to stocks of any drugs on hand. Here's how it could work: A couple of people dressed in business attire arrive unannounced at your office and show you forged but convincing identification. They tell you or your staff that they have been sent by DEA to audit your office based opioid treatment operation and demand to see your records and your stock of Suboxone and Subutex. They will tell you that because you are out of compliance they must confiscate your supply.
According to one doctor who prescribes buprenorphine for opioid addiction, DEA agents, true to the policy of insisting on surprise visits, showed up at his office when he was out. The agents found a Halloween costume party in progress. How could he be certain they were not just wearing DEA agent costumes? If only I had the skills to draw a cartoon: Picture staff dressed as a vampire, a witch, and a mummy standing in the waiting room of a doctor's office with a sign that says "Suboxone Treatment Provided Here." They face a couple of people wearing jackets with DEA emblazoned on their backs, one of whom says, "No. I really AM a DEA agent.!"
I wonder how much it costs taxpayers for two civil servants to crash a party. Sounds to me like a good place for the President to start in his freeze on government spending.
According to one doctor who prescribes buprenorphine for opioid addiction, DEA agents, true to the policy of insisting on surprise visits, showed up at his office when he was out. The agents found a Halloween costume party in progress. How could he be certain they were not just wearing DEA agent costumes? If only I had the skills to draw a cartoon: Picture staff dressed as a vampire, a witch, and a mummy standing in the waiting room of a doctor's office with a sign that says "Suboxone Treatment Provided Here." They face a couple of people wearing jackets with DEA emblazoned on their backs, one of whom says, "No. I really AM a DEA agent.!"
I wonder how much it costs taxpayers for two civil servants to crash a party. Sounds to me like a good place for the President to start in his freeze on government spending.
Wednesday, November 18, 2009
Ethics and the Courts
As I read Howard Zonana's article in the last issue of the AAPL Newsletter (When Ethics and Law Clash 9/2009 34:1) in which he reviewed a NC Supreme Court opinion which seems to override the AMA Code of Ethics in a case addressing physician involvement in executions I found my indignation rising at the thought that any court might presume to proffer judgments regarding the ethics of a profession. Is that not the sole province of the relevant professional association?
Then I recalled that psychologists have often cited the American Psychological Association's Code of Ethics in refusing to provide what they call "raw data" from psychological tests to psychiatric expert witnesses whom they deem unqualified to interpret the results. I believe psychologists' use of this ploy to gain an upper hand in litigation has no real ethical validity, particularly in view of the fact that the Code (below) states only that the psychologist "may refrain" from releasing data. I have occasionally found myself hoping a judge would overrule psychologists and order release of the so-called raw data along with the rest of the records. (It is also noteworthy that the psychologists' ethics code provides for situations where the code conflicts with law.)
Although I cannot have my cake and eat it too, perhaps there is a distinction here. Participation in an execution involves actual professional practice. The court should not be able to force a physician (or a psychologist) to work against his will, regardless of the reasons. Of course the professional does have the option of resigning or waiting to be fired.
In the case of record release (including raw data), however, no real work is involved, and both case law and statutes, including HIPAA, would seem to support the principle that the patient or subject, not the professional, owns the right to determine what happens to the records .
From the American Psychological Association Ethics Code (accessed 11.18.2009):
"1.02 Conflicts Between Ethics and Law, Regulations, or Other Governing Legal Authority
If psychologists' ethical responsibilities conflict with law, regulations, or other governing legal authority, psychologists make known their commitment to the Ethics Code and take steps to resolve the conflict. If the conflict is unresolvable via such means, psychologists may adhere to the requirements of the law, regulations, or other governing legal authority.
9.04 Release of Test Data
(a) The term test data refers to raw and scaled scores, client/patient responses to test questions or stimuli, and psychologists' notes and recordings concerning client/patient statements and behavior during an examination. Those portions of test materials that include client/patient responses are included in the definition of test data. Pursuant to a client/patient release, psychologists provide test data to the client/patient or other persons identified in the release. Psychologists may refrain from releasing test data to protect a client/patient or others from substantial harm or misuse or misrepresentation of the data or the test, recognizing that in many instances release of confidential information under these circumstances is regulated by law. (See also Standard 9.11, Maintaining Test Security.)
(b) In the absence of a client/patient release, psychologists provide test data only as required by law or court order."
Then I recalled that psychologists have often cited the American Psychological Association's Code of Ethics in refusing to provide what they call "raw data" from psychological tests to psychiatric expert witnesses whom they deem unqualified to interpret the results. I believe psychologists' use of this ploy to gain an upper hand in litigation has no real ethical validity, particularly in view of the fact that the Code (below) states only that the psychologist "may refrain" from releasing data. I have occasionally found myself hoping a judge would overrule psychologists and order release of the so-called raw data along with the rest of the records. (It is also noteworthy that the psychologists' ethics code provides for situations where the code conflicts with law.)
Although I cannot have my cake and eat it too, perhaps there is a distinction here. Participation in an execution involves actual professional practice. The court should not be able to force a physician (or a psychologist) to work against his will, regardless of the reasons. Of course the professional does have the option of resigning or waiting to be fired.
In the case of record release (including raw data), however, no real work is involved, and both case law and statutes, including HIPAA, would seem to support the principle that the patient or subject, not the professional, owns the right to determine what happens to the records .
From the American Psychological Association Ethics Code (accessed 11.18.2009):
"1.02 Conflicts Between Ethics and Law, Regulations, or Other Governing Legal Authority
If psychologists' ethical responsibilities conflict with law, regulations, or other governing legal authority, psychologists make known their commitment to the Ethics Code and take steps to resolve the conflict. If the conflict is unresolvable via such means, psychologists may adhere to the requirements of the law, regulations, or other governing legal authority.
9.04 Release of Test Data
(a) The term test data refers to raw and scaled scores, client/patient responses to test questions or stimuli, and psychologists' notes and recordings concerning client/patient statements and behavior during an examination. Those portions of test materials that include client/patient responses are included in the definition of test data. Pursuant to a client/patient release, psychologists provide test data to the client/patient or other persons identified in the release. Psychologists may refrain from releasing test data to protect a client/patient or others from substantial harm or misuse or misrepresentation of the data or the test, recognizing that in many instances release of confidential information under these circumstances is regulated by law. (See also Standard 9.11, Maintaining Test Security.)
(b) In the absence of a client/patient release, psychologists provide test data only as required by law or court order."
Thursday, November 12, 2009
Suboxone DEA Audit Update III
Continued from: DEA Suboxone Audit Update
Since my last post I started telling all buprenorphine patients that DEA might demand to audit my treatment records. Reactions have ranged from resignation to curiosity to indignation. Although I had planned to mail letters to all my buprenorphine patients, since further contact with the local DEA has convinced me my audit will not happen soon, and will not likely require that I identify patients, and because I see these patients at least monthly, face-to-face, discussion seems preferable. If you choose to use a letter instead of or in addition to discussion, a model appears below. Feel free to use it as is or modify it. You will also find below a model letter to send to your local DEA office asking to schedule an appointment for the audit.
It occurred to me as well that the psychotherapists with whom I share my office might want to know about the audits. I sent them messages or letters suggesting what they might do if people claiming to be DEA agents appear when I am not in the office. I also left a message with a local agent said to be connected with the project asking whether agents might attempt to enter my office or access my records when I am not present. An agent returning my call the next day assured me they would not and that agents would not have authority to access patient identity without a court order. The agent (who was aware of my blog) also promised to provide me with a copy of the agreement agents ask physicians to sign at the start of each audit.
According to my local Reckitt-Benckiser representative the one physician whose office I have contacted to discuss the audit experience was reluctant to provide further information or even to be identified. This is despite the fact that DEA also confirmed his identity.
Interest in the audit seems to have waned at the CSAT buprenorphine forum. In particular there has been little interest in my suggestion that data be collected to determine whether the audits have discouraged patients or physicians from participating in OBOT. Many physicians seem to believe that any doctor who worries about the audits must have something to hide and that all law enforcement personnel and activities are always conducted properly and with complete respect for patients' rights. I wish.
In contrast I attended a meeting hosted by the state medical association. Those in attendance seemed to support further action to ensure that DEA conducts such audits respecting patients' rights and avoiding disruption of physician practices.
I should point out that I believe DEA has authority to conduct these audits. I have also heard many stories from patients previously treated by physicians whose OBOT practices were suspect. I hope the audit will lead to improvement, and I hope to learn something that will allow me to improve my own practice. I hope too that my patients, knowing of this scrutiny, will feel less inclined to engage in diversion.
I am left with the impression that agents most want to review policies and procedures of physicians who actually dispense drugs. For physicians who do not dispense I believe they will want to verify compliance with prescribing practices and adherence to the 30/100 patient limit. I plan to prepare a de-identified record of prescriptions with that in mind.
It is unfortunate that DEA persists in refusing to schedule audits at a time that allows for minimal disruption of physician practice. Given the widespread knowledge that the audits will take place it seems unlikely that agents will catch physicians "red-handed."
Letter to patients to inform them of imminent audit
Dear [Patient]:
I am writing to inform you of my expectation that the U.S. DEA intends to audit the records of all doctors and patients involved in treatment with buprenorphine (Suboxone, Subutex). DEA has not provided written notice of this plan but has confirmed it to me by telephone. I understand that DEA may have authority to require me to provide access to your records; however DEA may not have authority to discover your identity. In fact DEA has thus far refused to schedule the audit in advance or to provide me with further information as to how the audit will be conducted in advance, however I will continue to attempt to schedule the audit at a time when patients will not be present. Please be assured that I will do whatever I can to protect your privacy.
Please let me know if you would like to be present during the audit. If you wish to object to the audit of your records, I suggest you do so through an attorney by contacting the local office of DEA:
Agent
DEA
Address
Feel free to contact me with further questions.
Thank you.
Sincerely,
Letter to local DEA office to schedule audit
Since my last post I started telling all buprenorphine patients that DEA might demand to audit my treatment records. Reactions have ranged from resignation to curiosity to indignation. Although I had planned to mail letters to all my buprenorphine patients, since further contact with the local DEA has convinced me my audit will not happen soon, and will not likely require that I identify patients, and because I see these patients at least monthly, face-to-face, discussion seems preferable. If you choose to use a letter instead of or in addition to discussion, a model appears below. Feel free to use it as is or modify it. You will also find below a model letter to send to your local DEA office asking to schedule an appointment for the audit.
It occurred to me as well that the psychotherapists with whom I share my office might want to know about the audits. I sent them messages or letters suggesting what they might do if people claiming to be DEA agents appear when I am not in the office. I also left a message with a local agent said to be connected with the project asking whether agents might attempt to enter my office or access my records when I am not present. An agent returning my call the next day assured me they would not and that agents would not have authority to access patient identity without a court order. The agent (who was aware of my blog) also promised to provide me with a copy of the agreement agents ask physicians to sign at the start of each audit.
According to my local Reckitt-Benckiser representative the one physician whose office I have contacted to discuss the audit experience was reluctant to provide further information or even to be identified. This is despite the fact that DEA also confirmed his identity.
Interest in the audit seems to have waned at the CSAT buprenorphine forum. In particular there has been little interest in my suggestion that data be collected to determine whether the audits have discouraged patients or physicians from participating in OBOT. Many physicians seem to believe that any doctor who worries about the audits must have something to hide and that all law enforcement personnel and activities are always conducted properly and with complete respect for patients' rights. I wish.
In contrast I attended a meeting hosted by the state medical association. Those in attendance seemed to support further action to ensure that DEA conducts such audits respecting patients' rights and avoiding disruption of physician practices.
I should point out that I believe DEA has authority to conduct these audits. I have also heard many stories from patients previously treated by physicians whose OBOT practices were suspect. I hope the audit will lead to improvement, and I hope to learn something that will allow me to improve my own practice. I hope too that my patients, knowing of this scrutiny, will feel less inclined to engage in diversion.
I am left with the impression that agents most want to review policies and procedures of physicians who actually dispense drugs. For physicians who do not dispense I believe they will want to verify compliance with prescribing practices and adherence to the 30/100 patient limit. I plan to prepare a de-identified record of prescriptions with that in mind.
It is unfortunate that DEA persists in refusing to schedule audits at a time that allows for minimal disruption of physician practice. Given the widespread knowledge that the audits will take place it seems unlikely that agents will catch physicians "red-handed."
Letter to patients to inform them of imminent audit
Dear [Patient]:
I am writing to inform you of my expectation that the U.S. DEA intends to audit the records of all doctors and patients involved in treatment with buprenorphine (Suboxone, Subutex). DEA has not provided written notice of this plan but has confirmed it to me by telephone. I understand that DEA may have authority to require me to provide access to your records; however DEA may not have authority to discover your identity. In fact DEA has thus far refused to schedule the audit in advance or to provide me with further information as to how the audit will be conducted in advance, however I will continue to attempt to schedule the audit at a time when patients will not be present. Please be assured that I will do whatever I can to protect your privacy.
Please let me know if you would like to be present during the audit. If you wish to object to the audit of your records, I suggest you do so through an attorney by contacting the local office of DEA:
Agent
DEA
Address
Feel free to contact me with further questions.
Thank you.
Sincerely,
Letter to local DEA office to schedule audit
Dear Agent ______:
I understand that your agency plans to audit my records of treatment activities under the DATA 2000 waiver, office based opioid treatment (OBOT).
I have scheduled one hour at ...... on November 00, 2009 when your agents may visit the office with minimal disruption to the office routine and conduct the audit with respect for may patient's rights. Please confirm by telephone or letter. I have notified all my OBOT patients of the audit as well. They may contact you, and they may be present during the audit.
Please provide me with a copy of any agreements you will want me to sign in connection with the audit by return mail so I can obtain advice of legal counsel. Please also provide a list of documents or information you want to access, indicating in particular whether you intend to discover the identity of patients.
In the event your agents appear unannounced, please be advised that I will take precautions to assure myself they are not impostors: I will attempt to contact your office and ask for specific information to identify the agents, such as names or badge numbers which must match identification the agents provide me. Failing this I will conclude that the individuals may be posing as DEA agents, and I will contact local law enforcement via 911.
If you anticipate needing more than one hour, or if you wish to reschedule for a different date or time, please contact my office.
Thank you.
Sincerely,
DEA Suboxone Audit Update IV
I understand that your agency plans to audit my records of treatment activities under the DATA 2000 waiver, office based opioid treatment (OBOT).
I have scheduled one hour at ...... on November 00, 2009 when your agents may visit the office with minimal disruption to the office routine and conduct the audit with respect for may patient's rights. Please confirm by telephone or letter. I have notified all my OBOT patients of the audit as well. They may contact you, and they may be present during the audit.
Please provide me with a copy of any agreements you will want me to sign in connection with the audit by return mail so I can obtain advice of legal counsel. Please also provide a list of documents or information you want to access, indicating in particular whether you intend to discover the identity of patients.
In the event your agents appear unannounced, please be advised that I will take precautions to assure myself they are not impostors: I will attempt to contact your office and ask for specific information to identify the agents, such as names or badge numbers which must match identification the agents provide me. Failing this I will conclude that the individuals may be posing as DEA agents, and I will contact local law enforcement via 911.
If you anticipate needing more than one hour, or if you wish to reschedule for a different date or time, please contact my office.
Thank you.
Sincerely,
DEA Suboxone Audit Update IV
Sunday, November 8, 2009
AARP: My Letter to the Editor
Editor:
A presentation at a medical association meeting I attended yesterday suggested many, if not most, physicians accepting reimbursement under Medicare might be submitting fraudulent claims.
I thanked him for confirming my good instinct in opting out of Medicare years ago.
A physician friend told me today how he has spent hours preparing a 20+ page response to a Medicare audit.
I told him what I knew about how to opt out of Medicare.
God help me when I reach Medicare age and need a doctor myself.
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
Monday, November 2, 2009
DEA Audits: insensitivity and disrespect
Continued from: DEA On-Site Investigation of Suboxone Prescribing Physicians
Imagine you have lost almost everything because of addiction to OxyContin. You finally mustered the strength and nerve, overcoming fear and shame, and sat down in the waiting room of a physician who promises to treat you with buprenorphine to wrest you from withdrawal and clobber the cravings.
In walk two DEA agents.
DEA would have us believe they must surprise us with these audits, and yet I learned today that one physician asked that his audit be scheduled at his convenience, and now we all know to expect an audit. This situation could have been avoided.
An agent at the Seattle DEA office today refused to provide me a copy of the agreement I must sign at the start of the audit. But he told me I can get one from a colleague who has been audited already. And my tax money pays for this agency. He also told me these audits started in 2005 but ramped up more recently.
Is this the DEA's idea of a way to encourage more physicians to prescribe an effective treatment for opiate addiction?
Another scenario:
Into your office walk two people who claim to be DEA agents, present convincing (forged) credentials, and demand to inspect your supply of buprenorphine (and any other controlled substances you happen to stock). They claim because you are not in compliance they must confiscate the drugs. An hour later they have sold your drugs on the street.
By insisting on conducting these audits unannounced DEA has unwittingly set the stage for impostors to obtain more drugs illegally. What were they thinking? Were they thinking?
I discovered today that the American Psychiatric Association has contacted the ONDCP and the DEA. The American Society of Addiction Medicine is considering whether to take action.
DEA should stop these audits until they can propose a manner in which to conduct them that respects patient rights and is sensitive to medical practice.
Because of the risk of impostors, if someone appears in your office claiming to be a DEA agent, call your local DEA office, and ask for names or other information to verify they really do represent DEA. If you cannot reach DEA, consider contacting local police for assistance.
Call your local DEA office to request a copies of any agreements they may ask you to sign during an audit so you can review them with an attorney or colleague in advance. When I obtain a copy I will post it here.
If you are or have been audited, please share your experience with a comment.
DEA Suboxone Audit Update
Imagine you have lost almost everything because of addiction to OxyContin. You finally mustered the strength and nerve, overcoming fear and shame, and sat down in the waiting room of a physician who promises to treat you with buprenorphine to wrest you from withdrawal and clobber the cravings.
In walk two DEA agents.
DEA would have us believe they must surprise us with these audits, and yet I learned today that one physician asked that his audit be scheduled at his convenience, and now we all know to expect an audit. This situation could have been avoided.
An agent at the Seattle DEA office today refused to provide me a copy of the agreement I must sign at the start of the audit. But he told me I can get one from a colleague who has been audited already. And my tax money pays for this agency. He also told me these audits started in 2005 but ramped up more recently.
Is this the DEA's idea of a way to encourage more physicians to prescribe an effective treatment for opiate addiction?
Another scenario:
Into your office walk two people who claim to be DEA agents, present convincing (forged) credentials, and demand to inspect your supply of buprenorphine (and any other controlled substances you happen to stock). They claim because you are not in compliance they must confiscate the drugs. An hour later they have sold your drugs on the street.
By insisting on conducting these audits unannounced DEA has unwittingly set the stage for impostors to obtain more drugs illegally. What were they thinking? Were they thinking?
I discovered today that the American Psychiatric Association has contacted the ONDCP and the DEA. The American Society of Addiction Medicine is considering whether to take action.
DEA should stop these audits until they can propose a manner in which to conduct them that respects patient rights and is sensitive to medical practice.
Because of the risk of impostors, if someone appears in your office claiming to be a DEA agent, call your local DEA office, and ask for names or other information to verify they really do represent DEA. If you cannot reach DEA, consider contacting local police for assistance.
Call your local DEA office to request a copies of any agreements they may ask you to sign during an audit so you can review them with an attorney or colleague in advance. When I obtain a copy I will post it here.
If you are or have been audited, please share your experience with a comment.
DEA Suboxone Audit Update
Friday, October 30, 2009
DEA On-Site Investigation of Suboxone Prescribing Physicians
I just got off the phone with a pleasant representative of DEA who fielded some of my questions about the (apparently) imminent site visits by DEA agents to... Actually, she never told me the purpose, but I suspect they intend to monitor compliance of doctors prescribing Suboxone and Subutex for opiate withdrawal and maintenance with the law: DATA 2000.
DEA may have started these visits, but I have found no reports. If anyone has experienced an on-site investigation, please describe the experience by commenting here.
Not knowing how such a visit will proceed my fantasies run wild, and I still have numerous questions about this potentially disruptive plan. Mostly the DEA representative referred me to the law which lists requirements regarding record keeping and the 30/100 patient limits. She told me the visit will be unannounced, and that if I am not there when the investigators arrive, they will probably return later. She said they would try to maintain a low profile, but did not directly address many of my questions:
Should we notify patients now to give them an opportunity to object? How long will it take? Suppose I have to leave before they finish? Will we be allowed to de-identify the records? If the investigators demand access to electronic records, do we have to let them use or access computers or hard drives? (She said they just need access.) What if my digital media contain records of patients not prescribed buprenorphine? (She said they will not want to see records of patients not prescribed buprenorphine.) What questions will be asked? If I refuse to answer questions or provide access when demanded, what will happen?
I did not ask why the DEA would want to investigate doctors like me who are treating opiate addiction rather than doctors who are prescribing the drugs that are killing our patients, like OxyContin and methadone. I admit to a cynical drift here, but could it be that we threaten their livelihood? Lots of addicts equals job security for DEA employees. And if we legalize pot...
DEA Audits: insensitivity and disrespect
DEA may have started these visits, but I have found no reports. If anyone has experienced an on-site investigation, please describe the experience by commenting here.
Not knowing how such a visit will proceed my fantasies run wild, and I still have numerous questions about this potentially disruptive plan. Mostly the DEA representative referred me to the law which lists requirements regarding record keeping and the 30/100 patient limits. She told me the visit will be unannounced, and that if I am not there when the investigators arrive, they will probably return later. She said they would try to maintain a low profile, but did not directly address many of my questions:
Should we notify patients now to give them an opportunity to object? How long will it take? Suppose I have to leave before they finish? Will we be allowed to de-identify the records? If the investigators demand access to electronic records, do we have to let them use or access computers or hard drives? (She said they just need access.) What if my digital media contain records of patients not prescribed buprenorphine? (She said they will not want to see records of patients not prescribed buprenorphine.) What questions will be asked? If I refuse to answer questions or provide access when demanded, what will happen?
I did not ask why the DEA would want to investigate doctors like me who are treating opiate addiction rather than doctors who are prescribing the drugs that are killing our patients, like OxyContin and methadone. I admit to a cynical drift here, but could it be that we threaten their livelihood? Lots of addicts equals job security for DEA employees. And if we legalize pot...
DEA Audits: insensitivity and disrespect
Thursday, October 29, 2009
Is Generic Buprenorphine Approval Another FDA Blunder?
Suboxone maintenance patients will likely rejoice almost as much as third party payers over the imminent availability of a generic, but the FDA should not make buprenorphine available until after the combination buprenorphine/naloxone (Suboxone).
The idea of combining naloxone, an opiate antagonist that can only act when injected, with the mu opioid partial agonist buprenorphine for treatment of opiate addiction is to discourage addicts from injecting the drug to get high. Standard practice calls for use of buprenorphine alone (Subutex) only during pregnancy and a few other situations where it is possible that the naloxone contributes to rare adverse effects. Although I cannot claim to have priced these drugs on the street I suspect buprenorphine brings a higher price, and many of my patients have attempted to get me to prescribe it for dubious reasons.
Given the high price of Suboxone and Subutex in the pharmacies we have all eagerly awaited the arrival of cheaper alternatives. While I am glad more patients will be able to afford treatment with adequate doses, I believe many will want to switch from Suboxone to generic buprenorphine, and that this will lead to more abuse and diversion. Delay in release of the buprenorphine until after release of the combination could have prevented this. What could the FDA have been thinking?
Increase in buprenorphine availability accompanied by lower price on the street may also lead more addicts to attempt to treat themselves rather than incurring the expense of medical supervision. And since many patients (and even a few docs) seem to wrongly assume that precipitated withdrawal results from the naloxone, we may see an increase in that phenomenon when naive addicts use the drug too soon after stopping whichever full agonist they were dependent upon.
Let us hope the FDA approves a generic buprenorphine/naloxone product post haste and that its price makes it just as much of a bargain as buprenorphine alone for saving lives. And do not switch from the combination to the new generic for financial reasons alone.
The idea of combining naloxone, an opiate antagonist that can only act when injected, with the mu opioid partial agonist buprenorphine for treatment of opiate addiction is to discourage addicts from injecting the drug to get high. Standard practice calls for use of buprenorphine alone (Subutex) only during pregnancy and a few other situations where it is possible that the naloxone contributes to rare adverse effects. Although I cannot claim to have priced these drugs on the street I suspect buprenorphine brings a higher price, and many of my patients have attempted to get me to prescribe it for dubious reasons.
Given the high price of Suboxone and Subutex in the pharmacies we have all eagerly awaited the arrival of cheaper alternatives. While I am glad more patients will be able to afford treatment with adequate doses, I believe many will want to switch from Suboxone to generic buprenorphine, and that this will lead to more abuse and diversion. Delay in release of the buprenorphine until after release of the combination could have prevented this. What could the FDA have been thinking?
Increase in buprenorphine availability accompanied by lower price on the street may also lead more addicts to attempt to treat themselves rather than incurring the expense of medical supervision. And since many patients (and even a few docs) seem to wrongly assume that precipitated withdrawal results from the naloxone, we may see an increase in that phenomenon when naive addicts use the drug too soon after stopping whichever full agonist they were dependent upon.
Let us hope the FDA approves a generic buprenorphine/naloxone product post haste and that its price makes it just as much of a bargain as buprenorphine alone for saving lives. And do not switch from the combination to the new generic for financial reasons alone.
Wednesday, October 21, 2009
Paying for Interpreters is Just the Beginning
When a New Jersey court decided the case of Gerena v. Fogari just over a year ago many hailed the verdict as a win for disabled people arguing that it would send a message to doctors and others that they must provide, and in many cases pay for, sign language interpreters for hearing impaired patients (clients). But I believe the fact that the physician might actually lose money for the privilege of treating the hearing impaired patient will result in physicians looking for ways to avoid treating them at all. This unfunded mandate from the US government will lead to more rather than fewer problems for people with disabilities.
The AMA reported on the case here. Briefly, Dr. Fogari, who, if he's the same Dr. Fogari reported on here, seems to have more than his share of problems, elected not to hire a sign language interpreter to assist in communicating with his hearing impaired patient Gerena. She sued for discrimination, not malpractice, and was award substantial punitive damages. Because Medicare limits what he can collect Dr. Fogari would have had to pay an interpreter (whose fee is not limited) as much as 3-4 times as much, for a net loss of $100 - $150 for each of Ms. Gerena's visits. (This may be another good reason to opt out of Medicare, or just refuse to treat patients covered by Medicare.) Apparently judge and jury thought Dr. Fogari enjoyed enough income to spread the cost among among his entire patient load without hardship.
Whether Dr. Fogari could afford to lose money in caring for Ms. Gerena is beside the point. The essence of any professional relationship is that a service is provided for a fee, and medical ethics has always held that a physician, except perhaps in an emergency, must be able to choose whom to treat. My understanding of the rationale for this is that both physician and patient can suffer when the relationship is forced, regardless of whether the source of dislike for the patient is financial or otherwise. Even providing free treatment can raise questions about the physician's motivation in providing the care, and the patient should wonder whether she really wants care from a physician who might resent providing that care. There must be a give and take.
But suppose the physician elects to take on such a case. Now he may feel stuck with the patient and may resent it. It seems likely that the courts will assume that discharging constitutes unlawful discrimination, and punish the physician accordingly. Suppose the patient demands a prescription for Oxycontin, fails to keep appointments, or otherwise makes a nuisance of herself. The physician may feel pressured to give in to avoid getting in trouble. This threat gives the patient too much power to manipulate the physician.
Let us say you, the physician, get a call from a family member to schedule an initial office visit for their hearing impaired relative. I suggest you make the appointment at least several weeks out, because you will have a lot of preparation ahead of you. First you must decide whether to hire a professional interpreter or to use a family member. I would argue that, although probably free of charge, you cannot accept a family member. You will not know the family member's level of competence, and if a misunderstanding leads to a bad outcome, you may be liable. Furthermore, the patient may not want to share personal information with a family member. The patient may authorize release of information, but the physician has no way of knowing whether the patient has been candid, not too mention that the family member can censor what the patient "says" unbeknownst to the physician.
Having decide to use a professional sign language interpreter, now you must choose one. Although you may want to consider the recommendation of the patient, remember that you will likely be held responsible for the outcome. Consider interviewing several candidates and obtaining references before choosing.
And now comes the disclaimer: I am not an attorney. This does not constitute legal (or medical) advice. Maybe the first thing to do when that patient calls you is for you to contact an attorney to advise you on these issues and any others I may have overlooked.
Having selected an interpreter you must now negotiate the terms of the contract. Expect to pay for travel time and expense as well as waiting time. Expect also to pay even if the patient does not show up. If you like to take risks you might try demanding that the patient pay the no show fee. Of course you will need to decide how to handle the situation in which the patient appears but the interpreter does not. You will probably want to reschedule. Some interpreters may work via Internet video feed, but will this meet standard of care? Is this telemedicine? Will it increase your liability?
You must attend to some other matters. According to the Department of Labor and Industries in my state (WA), if a contractor like your interpreter gets hurt while working for you and has not purchased worker's compensation coverage, you must pay his medical expenses and possibly time loss compensation. Just like when hiring a contractor to work on your home you should require the interpreter to provide written proof of coverage.
Remember that your patient and you will reveal protected health information to the interpreter during the visit. You should consider obtaining written authorization from the patient for you to release information to the interpreter. Here you will face a Catch 22: You should have signed authorization before the interpreter gets involved in the conversation, but you will not be able to communicate with the patient (except in writing) about the authorization until the interpreter is present. Furthermore, if you meet the criteria for a covered entity, HIPAA probably requires that you have a business associate agreement with the interpreter.
Finally, consider the outcome if the interpreter negligently misinterprets resulting directly in injury to your patient. I do not know whether interpreter's can even purchase malpractice insurance. Even if the interpreter has insurance the patient will likely name you in a malpractice suit because you have the deep pocket. Consider requiring the interpreter to sign an agreement to indemnify you in such a situation. You may also want to require the interpreter to provide you with written evidence of current professional liability coverage, and the limits of liability.
Physicians should also consider how to handle contacts outside of office hours. Do you know how to use TTY? Will a physician covering your practice in your absence know how to manage?
All this probably really makes you eager to take care of hearing impaired patients. But do not expect any of this to go smoothly. A few months ago I contacted the local office of Interpreter Network to inquire about some of the issues above. After several attempts by phone and email I received a curt message from Robbi Crocett, the Executive Director, who seemed to have no grasp of the need for worker's compensation coverage for contractors ("... we are not under the L&I contract so this would be billed directly to your office..") and was unaware of the HIPAA requirement for a business associate agreement ("... we are familiar with HIPPA regulation and this is a clause that was listed in the Terms and Conditions...").
As I believe is true of most health care related legislation, neglect of reality by lawmakers leads to opportunity for attorneys and more problems for others. Misguided judges and juries compound the problems. This legislation should have provided reimbursement for interpreters by payers, including private insurers (as I understand may now be required now in California). The verdict in Gerena v. Fogari likewise may have helped Gerena and her attorney but will likely hurt rather than help hearing impaired people, like my own father, and others with disabilities. I believe Dr. Fogari should have argued that it would be unethical for him to operate at a financial loss in caring for Ms. Gerena. I hope he will appeal.
Sign language interpreters serving in medical settings should be subjected to certification and licensure requirements just like health care professionals. And when the physician's fee is restricted, so should the interpreter's.
Physicians often effectively advocate for people with disabilities. Many of you are our patients. Attacking them will turn them from friends into enemies.We should all share in costs associated with accommodation of disabilities, and all disabled patients, not just those whose physicians can afford it, should be accommodated. Physicians are not the financial "bailout" for a failing health care system or for those with disabilities.
The AMA reported on the case here. Briefly, Dr. Fogari, who, if he's the same Dr. Fogari reported on here, seems to have more than his share of problems, elected not to hire a sign language interpreter to assist in communicating with his hearing impaired patient Gerena. She sued for discrimination, not malpractice, and was award substantial punitive damages. Because Medicare limits what he can collect Dr. Fogari would have had to pay an interpreter (whose fee is not limited) as much as 3-4 times as much, for a net loss of $100 - $150 for each of Ms. Gerena's visits. (This may be another good reason to opt out of Medicare, or just refuse to treat patients covered by Medicare.) Apparently judge and jury thought Dr. Fogari enjoyed enough income to spread the cost among among his entire patient load without hardship.
Whether Dr. Fogari could afford to lose money in caring for Ms. Gerena is beside the point. The essence of any professional relationship is that a service is provided for a fee, and medical ethics has always held that a physician, except perhaps in an emergency, must be able to choose whom to treat. My understanding of the rationale for this is that both physician and patient can suffer when the relationship is forced, regardless of whether the source of dislike for the patient is financial or otherwise. Even providing free treatment can raise questions about the physician's motivation in providing the care, and the patient should wonder whether she really wants care from a physician who might resent providing that care. There must be a give and take.
But suppose the physician elects to take on such a case. Now he may feel stuck with the patient and may resent it. It seems likely that the courts will assume that discharging constitutes unlawful discrimination, and punish the physician accordingly. Suppose the patient demands a prescription for Oxycontin, fails to keep appointments, or otherwise makes a nuisance of herself. The physician may feel pressured to give in to avoid getting in trouble. This threat gives the patient too much power to manipulate the physician.
Let us say you, the physician, get a call from a family member to schedule an initial office visit for their hearing impaired relative. I suggest you make the appointment at least several weeks out, because you will have a lot of preparation ahead of you. First you must decide whether to hire a professional interpreter or to use a family member. I would argue that, although probably free of charge, you cannot accept a family member. You will not know the family member's level of competence, and if a misunderstanding leads to a bad outcome, you may be liable. Furthermore, the patient may not want to share personal information with a family member. The patient may authorize release of information, but the physician has no way of knowing whether the patient has been candid, not too mention that the family member can censor what the patient "says" unbeknownst to the physician.
Having decide to use a professional sign language interpreter, now you must choose one. Although you may want to consider the recommendation of the patient, remember that you will likely be held responsible for the outcome. Consider interviewing several candidates and obtaining references before choosing.
And now comes the disclaimer: I am not an attorney. This does not constitute legal (or medical) advice. Maybe the first thing to do when that patient calls you is for you to contact an attorney to advise you on these issues and any others I may have overlooked.
Having selected an interpreter you must now negotiate the terms of the contract. Expect to pay for travel time and expense as well as waiting time. Expect also to pay even if the patient does not show up. If you like to take risks you might try demanding that the patient pay the no show fee. Of course you will need to decide how to handle the situation in which the patient appears but the interpreter does not. You will probably want to reschedule. Some interpreters may work via Internet video feed, but will this meet standard of care? Is this telemedicine? Will it increase your liability?
You must attend to some other matters. According to the Department of Labor and Industries in my state (WA), if a contractor like your interpreter gets hurt while working for you and has not purchased worker's compensation coverage, you must pay his medical expenses and possibly time loss compensation. Just like when hiring a contractor to work on your home you should require the interpreter to provide written proof of coverage.
Remember that your patient and you will reveal protected health information to the interpreter during the visit. You should consider obtaining written authorization from the patient for you to release information to the interpreter. Here you will face a Catch 22: You should have signed authorization before the interpreter gets involved in the conversation, but you will not be able to communicate with the patient (except in writing) about the authorization until the interpreter is present. Furthermore, if you meet the criteria for a covered entity, HIPAA probably requires that you have a business associate agreement with the interpreter.
Finally, consider the outcome if the interpreter negligently misinterprets resulting directly in injury to your patient. I do not know whether interpreter's can even purchase malpractice insurance. Even if the interpreter has insurance the patient will likely name you in a malpractice suit because you have the deep pocket. Consider requiring the interpreter to sign an agreement to indemnify you in such a situation. You may also want to require the interpreter to provide you with written evidence of current professional liability coverage, and the limits of liability.
Physicians should also consider how to handle contacts outside of office hours. Do you know how to use TTY? Will a physician covering your practice in your absence know how to manage?
All this probably really makes you eager to take care of hearing impaired patients. But do not expect any of this to go smoothly. A few months ago I contacted the local office of Interpreter Network to inquire about some of the issues above. After several attempts by phone and email I received a curt message from Robbi Crocett, the Executive Director, who seemed to have no grasp of the need for worker's compensation coverage for contractors ("... we are not under the L&I contract so this would be billed directly to your office..") and was unaware of the HIPAA requirement for a business associate agreement ("... we are familiar with HIPPA regulation and this is a clause that was listed in the Terms and Conditions...").
As I believe is true of most health care related legislation, neglect of reality by lawmakers leads to opportunity for attorneys and more problems for others. Misguided judges and juries compound the problems. This legislation should have provided reimbursement for interpreters by payers, including private insurers (as I understand may now be required now in California). The verdict in Gerena v. Fogari likewise may have helped Gerena and her attorney but will likely hurt rather than help hearing impaired people, like my own father, and others with disabilities. I believe Dr. Fogari should have argued that it would be unethical for him to operate at a financial loss in caring for Ms. Gerena. I hope he will appeal.
Sign language interpreters serving in medical settings should be subjected to certification and licensure requirements just like health care professionals. And when the physician's fee is restricted, so should the interpreter's.
Physicians often effectively advocate for people with disabilities. Many of you are our patients. Attacking them will turn them from friends into enemies.We should all share in costs associated with accommodation of disabilities, and all disabled patients, not just those whose physicians can afford it, should be accommodated. Physicians are not the financial "bailout" for a failing health care system or for those with disabilities.
Thursday, October 8, 2009
The Mystery of the Denied Refill Requests
Voicemail: "Hello doctor. This is Mr. Smith. The pharmacist said you denied my refill for Suboxone."
That's odd. Mr. Smith never called to ask me to order a refill from the pharmacy. The pharmacy never contacted me to ask me to authorize a refill for Mr. Smith. Why would they think I denied it?
This mystery has haunted my practice for a year. Come to think of it, that pretty much coincides with how long I have been ordering most prescriptions (all but controlled substances) online. I signed up with both Iscribe.com and Allscripts.com about a year ago, hoping to gain enough experience to decide which I like better and maybe write an article comparing the two. But as I found myself preparing for a two-week absence from the office for vacation I realized I needed to simplify, so I quit using Allscripts and have been using Iscribe exclusively ever since. In a phone call to the customer service line at Iscribe yesterday I may have heard the solution to the mystery.
Generally when these mystery denials have taken place the pharmacists have offered no explanation, however a few months ago a pharmacist told me that a message had appeared either on the pharmacy computer or the pharmacy fax machine, and agreed to fax me a copy. Sure enough, there was a message indicating the request had been rejected. The patient's name, my name, and the drug were printed thereon, but there was no indication whatsoever of the source of the message.
I began to ask other pharmacists and to talk to my patients about the problem. One pharmacist suggested that an automated telephone prescription refill system might have generated the mystery messages, but some of my patients said they talked directly with pharmacists when they requested refills. Another pharmacist suggested the problem might be with an e-prescribing service. Regulations still prevent ordering controlled substances using Iscribe, and I understood that only renewal requests for non-controlled substances could be communicated to me using Iscribe.
A couple weeks ago, however, I was pleasantly surprised to receive some electronic requests for refills for Suboxone on Iscribe for the first time. This has become my favorite way to recieve refill requests. Typically an email message notifies me that a renewal request has arrived. I log in to my Iscribe account. A couple clicks, and it's done. Of course I was not able to authorize these Suboxone refills online. This is still not allowed. I could print a paper prescription, but since the patient is not present that does not help. Instead, I fax the prescription to the pharmacy as I would routinely. This brings me to the phone call to Iscribe. I asked the representative whether there might be a way to remove the renewal request from the inbox without printing it. In responding he mentioned that Iscribe had changed the system because of unwanted denials.
We may never know the truth, but it appears to me that, either through an automated phone system or initiated by a pharmacist, Iscribe generated the denials unbeknownst to me and with no indication of where the denials originated. It has been my understanding that e-prescribing services such as Iscribe and Allscripts use a clearinghouse, possibly surescripts.com, as an intermediary with pharmacies. My best guess now is that, after the patient asked the pharmacist for a refill, the pharmacist, rather than contacting me by fax, entered the request through the clearinghouse which identified me as participating with Iscribe. At that point either the clearinghouse or Iscribe rejected the request automatically because the drug is a control substance, without notifying me. The pharmacist thought I had generated the rejection.
E-prescribing promises many advantages over paper, phone and fax orders, but designers need to correct potential stumbling blocks quickly when identified. We will see whether the mystery denials stop.
That's odd. Mr. Smith never called to ask me to order a refill from the pharmacy. The pharmacy never contacted me to ask me to authorize a refill for Mr. Smith. Why would they think I denied it?
This mystery has haunted my practice for a year. Come to think of it, that pretty much coincides with how long I have been ordering most prescriptions (all but controlled substances) online. I signed up with both Iscribe.com and Allscripts.com about a year ago, hoping to gain enough experience to decide which I like better and maybe write an article comparing the two. But as I found myself preparing for a two-week absence from the office for vacation I realized I needed to simplify, so I quit using Allscripts and have been using Iscribe exclusively ever since. In a phone call to the customer service line at Iscribe yesterday I may have heard the solution to the mystery.
Generally when these mystery denials have taken place the pharmacists have offered no explanation, however a few months ago a pharmacist told me that a message had appeared either on the pharmacy computer or the pharmacy fax machine, and agreed to fax me a copy. Sure enough, there was a message indicating the request had been rejected. The patient's name, my name, and the drug were printed thereon, but there was no indication whatsoever of the source of the message.
I began to ask other pharmacists and to talk to my patients about the problem. One pharmacist suggested that an automated telephone prescription refill system might have generated the mystery messages, but some of my patients said they talked directly with pharmacists when they requested refills. Another pharmacist suggested the problem might be with an e-prescribing service. Regulations still prevent ordering controlled substances using Iscribe, and I understood that only renewal requests for non-controlled substances could be communicated to me using Iscribe.
A couple weeks ago, however, I was pleasantly surprised to receive some electronic requests for refills for Suboxone on Iscribe for the first time. This has become my favorite way to recieve refill requests. Typically an email message notifies me that a renewal request has arrived. I log in to my Iscribe account. A couple clicks, and it's done. Of course I was not able to authorize these Suboxone refills online. This is still not allowed. I could print a paper prescription, but since the patient is not present that does not help. Instead, I fax the prescription to the pharmacy as I would routinely. This brings me to the phone call to Iscribe. I asked the representative whether there might be a way to remove the renewal request from the inbox without printing it. In responding he mentioned that Iscribe had changed the system because of unwanted denials.
We may never know the truth, but it appears to me that, either through an automated phone system or initiated by a pharmacist, Iscribe generated the denials unbeknownst to me and with no indication of where the denials originated. It has been my understanding that e-prescribing services such as Iscribe and Allscripts use a clearinghouse, possibly surescripts.com, as an intermediary with pharmacies. My best guess now is that, after the patient asked the pharmacist for a refill, the pharmacist, rather than contacting me by fax, entered the request through the clearinghouse which identified me as participating with Iscribe. At that point either the clearinghouse or Iscribe rejected the request automatically because the drug is a control substance, without notifying me. The pharmacist thought I had generated the rejection.
E-prescribing promises many advantages over paper, phone and fax orders, but designers need to correct potential stumbling blocks quickly when identified. We will see whether the mystery denials stop.
Tuesday, September 29, 2009
What is a REfill?
You’ve gotta love iscribe.com.
It always seemed clear to me:
“Do NOT refill.” at the bottom of my prescriptions.
For years it must have been clear to pharmacists. Then, inexplicably, at a pharmacy in a small town where I had placed the same order for the same patient every month for years, a pharmacist who otherwise seems to speak and understand the English language (unlike too many pharmacists), decided that I must have faxed the prescription order, complete with number of pills to dispense, just to tell them not to fill it.
Like I would waste my time doing that when I could be blogging or tweeting.
I had to look at the prescription again. It did not say, “Do not fill.” It said do not REfill. By telephone I assured the pharmacist that I did in fact want the drug dispensed to the patient. Once.
Then it happened again at a different pharmacy.
I contacted the state pharmacy board. Confirming my belief, a gentleman there told me that indeed fill or order means dispense while REfill means dispense again at a later time. When the patient contacts the pharmacy. Without contacting the doctor again.
Just to avoid further wasted time I changed the prescription form for these language-challenged pharmacies to:
“Refills: zero”
So far it seems to work.
William Safire must be turning over in his grave.
It seems I am not alone. For almost a year now when iscribe.com, the e-prescribing service I use most, contacted me via the Web with a refill authorization request, the form demanded that I specify the number of REfills. Alas, iscribe, too, has cried “uncle” in the face of prescribing illiteracy, apparently dumbing down in an attempt to avoid confusion. Today the iscribe refill authorization form reads:
“Total # of dispensings:”
Let’s hope we can all agree on what that means.
It always seemed clear to me:
“Do NOT refill.” at the bottom of my prescriptions.
For years it must have been clear to pharmacists. Then, inexplicably, at a pharmacy in a small town where I had placed the same order for the same patient every month for years, a pharmacist who otherwise seems to speak and understand the English language (unlike too many pharmacists), decided that I must have faxed the prescription order, complete with number of pills to dispense, just to tell them not to fill it.
Like I would waste my time doing that when I could be blogging or tweeting.
I had to look at the prescription again. It did not say, “Do not fill.” It said do not REfill. By telephone I assured the pharmacist that I did in fact want the drug dispensed to the patient. Once.
Then it happened again at a different pharmacy.
I contacted the state pharmacy board. Confirming my belief, a gentleman there told me that indeed fill or order means dispense while REfill means dispense again at a later time. When the patient contacts the pharmacy. Without contacting the doctor again.
Just to avoid further wasted time I changed the prescription form for these language-challenged pharmacies to:
“Refills: zero”
So far it seems to work.
William Safire must be turning over in his grave.
It seems I am not alone. For almost a year now when iscribe.com, the e-prescribing service I use most, contacted me via the Web with a refill authorization request, the form demanded that I specify the number of REfills. Alas, iscribe, too, has cried “uncle” in the face of prescribing illiteracy, apparently dumbing down in an attempt to avoid confusion. Today the iscribe refill authorization form reads:
“Total # of dispensings:”
Let’s hope we can all agree on what that means.
Wednesday, September 23, 2009
Benzodiazepine Backlash
In the July/August, 2009 issue of the Bulletin of the King County (Washington) Medical Society psychiatrist August Piper, MD asks, “Has the Time Come to Cease Thinking of Benzodiazepines as Routinely Addictive Drugs?” My response appears in the September/October issue and below with minor modification:
Regardless of the answer to Dr. Piper's question I would like to present some arguments against prescribing benzodiazepines routinely.Benzodiazepines are not bad drugs and have many indications. Many patients do take them without becoming addicted to them. We use them for anesthesia and to manage withdrawal from alcohol, opiates, and other central nervous system depressants, including benzodiazepines. We use them to treat epilepsy and to manage status epilepticus. They are safer than the drugs they replaced: acetylcarbromal, chloral hydrate, chlormethiazole, Doriden, ethchlorvynol, ethinamate, Equanil, glutethimide, meprobamate, methaqualone, methyprylon, Miltown, Noctec, Noludar, paraldehyde, Paxarel, Placidyl, Quaalude, Sopor, thalidomide, Thalomid, Valmid, mostly names we do not hear any more, and others.The risk of addiction to benzodiazepines is very real. Patients addicted to them and other drugs seek them from physicians and will lie to obtain them. Use of benzodiazepines can produce a “high” or euphoric effect. Other risks include dangerous interactions with drugs like buprenorphine, alcohol, and other central nervous system depressants. Use of these drugs can lead to disinhibition, impaired judgment, and amnesia. Impairment of motor coordination may not be accompanied by awareness of impairment.
Benzodiazepines can help build a thriving practice. Most patients like to take them and do not like to skip a dose. What I do not like about this is that eventually I am unable to determine whether the patient continues to take them because they really need them or because they like them.
For treatment of insomnia and anxiety many other classes of drug offer substantial advantages, but both conditions often respond to behavioral intervention alone. Most antidepressants effectively treat anxiety and gabapentin and pregabalin may offer advantages as well.
Grand mal seizures can result from abrupt discontinuation of benzodiazepines. Dr. Piper argues that abrupt discontinuation of other “drugs” not usually considered addictive can produce symptoms, but none of these drugs or classes is typically used to get high or can be purchased on the street (except that the class “anticonvulsant” includes barbiturates and benzodiazepines), and in my experience patients almost always find discontinuation of benzodiazepines more unpleasant. To say discontinuation of insulin can lead to symptoms is like saying discontinuation of oxygen can lead to symptoms.
Whether we should consider benzodiazepines “routinely addictive” (whatever that means) or not, Dr. Piper has failed to convince me to prescribe them for anxiety or insomnia.
Regardless of the answer to Dr. Piper's question I would like to present some arguments against prescribing benzodiazepines routinely.Benzodiazepines are not bad drugs and have many indications. Many patients do take them without becoming addicted to them. We use them for anesthesia and to manage withdrawal from alcohol, opiates, and other central nervous system depressants, including benzodiazepines. We use them to treat epilepsy and to manage status epilepticus. They are safer than the drugs they replaced: acetylcarbromal, chloral hydrate, chlormethiazole, Doriden, ethchlorvynol, ethinamate, Equanil, glutethimide, meprobamate, methaqualone, methyprylon, Miltown, Noctec, Noludar, paraldehyde, Paxarel, Placidyl, Quaalude, Sopor, thalidomide, Thalomid, Valmid, mostly names we do not hear any more, and others.The risk of addiction to benzodiazepines is very real. Patients addicted to them and other drugs seek them from physicians and will lie to obtain them. Use of benzodiazepines can produce a “high” or euphoric effect. Other risks include dangerous interactions with drugs like buprenorphine, alcohol, and other central nervous system depressants. Use of these drugs can lead to disinhibition, impaired judgment, and amnesia. Impairment of motor coordination may not be accompanied by awareness of impairment.
Benzodiazepines can help build a thriving practice. Most patients like to take them and do not like to skip a dose. What I do not like about this is that eventually I am unable to determine whether the patient continues to take them because they really need them or because they like them.
For treatment of insomnia and anxiety many other classes of drug offer substantial advantages, but both conditions often respond to behavioral intervention alone. Most antidepressants effectively treat anxiety and gabapentin and pregabalin may offer advantages as well.
Grand mal seizures can result from abrupt discontinuation of benzodiazepines. Dr. Piper argues that abrupt discontinuation of other “drugs” not usually considered addictive can produce symptoms, but none of these drugs or classes is typically used to get high or can be purchased on the street (except that the class “anticonvulsant” includes barbiturates and benzodiazepines), and in my experience patients almost always find discontinuation of benzodiazepines more unpleasant. To say discontinuation of insulin can lead to symptoms is like saying discontinuation of oxygen can lead to symptoms.
Whether we should consider benzodiazepines “routinely addictive” (whatever that means) or not, Dr. Piper has failed to convince me to prescribe them for anxiety or insomnia.
Wednesday, August 26, 2009
Need a Loan? See Your Doctor!
Need cash for a new car? to put a new roof on the house? Forget about the credit union and the bank. Don't pawn the wedding ring. Just make an appointment with your doctor. No collateral needed. No application. The FTC has recently confirmed what we should have known all along: Doctors routinely "lend" large sums of money to their patients, much of it interest free.
When I asked a patient (not a real case) how he was going to pay for his visit recently, he said he was starting a new business and wondered whether he could pay me at his next visit. I said no. Sounds like a worthy cause, but for all I know he may really plan to use the money to buy a new home theater system, or some cocaine. I do not want my patients to incur hardship, but this starts to sound like I am in the loan business. What's more I do not know the patient's credit rating; I have no collateral; and I do not charge interest on unpaid balances.
If all the money owed health care providers in this country constitutes loans, we must be collectively one of the largest lenders in the US. Such "loans" must total in the billions.
The Federal Trade Commission intends to implement the "Red Flag Rule," well, someday. According to this rule any business that functions as a lender must implement policies and procedures to fight identity theft. If you think this will only apply to banks, savings and loans, mortgage companies and pawn shops, think again. The FTC apparently defines as lending the practice of delaying collecting of the balance due until after the explanation of benefits has been received. Allowing patients to slowly pay their medical bills over time, regardless of whether interest accrues, may also constitute lending in the eyes of the FTC, making doctors and other health care providers subject to its provisions when it goes into effect November 1. This makes at least the second time the FTC has pushed back the implementation date, perhaps in response to pressure from the likes of the AMA, which wants the FTC to exempt doctors from the rule. Read more from the AMA. I often disagree with the AMA, but not in this case. Health care providers dislike identity theft as much as anyone, but doctors are not lenders, and the federal government should not conscript us into law enforcement.
If you are a health care provider and want to concentrate on what you do best, treating your patients, you may be able to sidestep the Red Flag Rule by collecting your fee at the time of service. You will not be alone: Anna Mathews reported in the August 5, 2009 Wall Street Journal that American physicians increasingly require payment of their full fee, not just the co-payment, at the time of service rather than waiting for the patient's insurer to determine what the balance should be after considering deductibles and other factors. Most physicians seem to cite the fact that they collect little on such balances, but I am moving my psychiatric practice in that direction for a few other reasons as well:
1) I do not trust health insurance companies to pay. I have opted out of Medicare. I do not contract with any insurer.
2) Patients building large balances owed also build an incentive to leave my practice. After one or two missed payments I am hooked: If I continue to treat them without requiring payment, the balance increases. If I threaten discharge for non-payment, the patient can seek treatment elsewhere and may never pay me. And my growing resentment could adversely affect their treatment.
3) Under federal law and at least some state law (including Washington State where I practice: RCW 48.43.600) insurers who determine they have reimbursed providers by mistake can demand repayment from doctors months or years after the fact, leaving it to the doctor to collect from the patient what amounts to another involuntary "loan" (or, by that time, more likely a gift). As I understand the law, however, if the patient pays the physician directly and the insurer reimburses the patient, the insurer has no recourse but to collect from the patient directly.
4) Insured patients as a group, precisely because they spend less out of pocket for medical care, deserve less of a financial break than uninsured patients, who traditionally must pay up front. It would not be fair to my patients who pay cash for me to increase their fees to cover losses related to balance billing of insured patients. If anything insured patients can better afford to pay at the time of service.
But I have gone even further: I require patients I treat with Suboxone to make monthly visits once the transition from whatever opiates they were addicted to. When a new patient starts treatment I require payment for the first three visits and the last visit ever, like when you rent an apartment and pay for the first month and the last month. This discourages patients from disappearing right after I order their next month prescription. If they stop treatment the right way by informing me directly either I refund that advance payment or, if the patient tells me they do not plan to return, I do not need to collect payment for that visit.
I am heartened to hear how many physicians now demand payment at the time of service. We are not lenders. We are not police. And we are not the bailout for the health care crisis. By failing to require payment we only enable a broken system. I feel for patients who cannot afford either insurance or medical care, but only patients, not providers, experiencing the adverse consequences of delays and denials in reimbursement, have the power to force change.
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