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.

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

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

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

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, 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.

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."

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

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

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.

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

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