My DEA Buprenorphine Audit: My "Violations"

I fully expected retaliation from DEA for my open criticism of their disruptive practices and policies in auditing buprenorphine addiction treatment practices. Here's how they nailed me. You can judge for yourself whether DEA should penalize me.

To recap briefly, last fall two DEA agents appeared in my office without an appointment, despite my written requests to schedule their "routine" obligatory audit of my buprenorphine opiate addiction treatment practice. When I told them they would need to obtain a warrant they left. The following week five DEA agents invaded my office, copied some files from one of my computers, asked some questions, and left with a copy of my prescribing record. Days later two agents appeared in the office with no appointment or warning to discuss their determination. After I made it clear that I was not interested in chatting with them they left my waiting room, and I wrote a letter demanding a written enumeration of their findings.

Inexplicably it took DEA approximately 2 1/2 months, but finally, a couple weeks ago, I received a letter (return receipt requested) citing me for two "recordkeeping [sic] violations." (In fact both related to transmission of prescription orders rather than record keeping.)

1. "Failure to include your "X" DEA Registration number on prescriptions for Schedule III narcotic drugs approved for detoxification and/or maintenance treatment.
2. "Failure to use an application that meets the requirements to electronically sign and transmit controlled substance prescriptions.

"The purpose of this letter is to afford you the opportunity to come into compliance with the requirements of the Controlled Substances Act. Please ensure that these are corrected. This is a serious matter which, if continued, can lead to sanctions, finds, or the possibility of the suspension of your DEA registration."

You might consider item number one to be technically correct but for the fact that the statutes permit me to order such prescriptions by telephone with no written communication whatever. In order to minimize the risk that my DEA number might fall into the wrong hands I always communicated it to the pharmacy by telephone.

Item number two reveals the ineptness of those who draft and interpret these statutes. Literally it cites me for failure to use an "application" that does not exist. But we apparently cannot expect DEA to compose a sentence that reads as intended (even with 2.5 months to prepare!). I believe they meant to cite me for, "use of an application that fails to meet the requirements..." referring to statutes regulating eprescribing. As of yet no eprescribing "application" (service) meets DEA requirements. In fact I used a service that allows me to fax a prescription that exists as a word processing document file to the pharmacy. I did not use a digital or "electronic" signature. I used a stylus to produce a manual signature with digital "ink" on a tablet computer. Like any other fax device now in use this sends a copy of the signed document to the pharmacy. When the pharmacy views or prints this transmitted document the pharmacist cannot distinguish it from a paper document signed with a pen or pencil except that the signatures on successive transmission do not differ. 

Our federal government must find this kind of efficiency threatening. Perhaps I am naive, but it seems to me that DEA should concern itself with preventing diversion and fraudulent prescribing. I contend that my procedures minimize the risk of both. Furthermore, the statutes failed to anticipate the technology I use, and DEA, rather than assessing the risk it poses, chose to trump up a charge based on technicalities. In other words, they didn't think. Today I believe all faxes are electronic, if not digital, and in all case in which the image of a manual signature arrives via fax the pharmacist sees only a copy of that signature. I also wonder why DEA has not cited the pharmacies for dispensing based on inadequate prescriptions since none of these was a "paper" prescription. After all no harm is done in transmitting the prescription. The harm occurs only when the pharmacist dispenses the drug to the wrong person. Of course the pharmacist cannot differentiate between a facsimile transmission of a computer file and of a scanned paper document except perhaps by the inferior quality of the latter.

Here is an applicable federal statute:

"Sec. 1306.21  Requirement of prescription.
    (a) A pharmacist may dispense directly a controlled substance listed 
in Schedule III, IV, or V that is a prescription drug as determined 
under section 503(b) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 353(b)) only pursuant to either a paper prescription signed by a 
practitioner, a facsimile of a signed paper prescription transmitted by 
the practitioner or the practitioner's agent to the pharmacy, an 
electronic prescription that meets the requirements of this part and 
part 1311 of this chapter, or an oral prescription made by an individual 
practitioner and promptly reduced to writing by the pharmacist..."

My plan, which I have already communicated to DEA and which I implemented on receiving the letter, consists of providing signed paper prescriptions displaying my DEA numbers when the patient appears in the office or, when the patient does not appear, authorizing refills or ordering new prescriptions by telephone. Incidentally -- and not surprisingly -- only one pharmacist has asked me to provide my DEA number.

So what is your verdict, reader? Should DEA revoke my registration? fine me? send me to Club Fed (where I will be entitled to free health care)?

Pain Practice Invaded by Agents

According to stories in Washington's Peninsula Daily News and Port Townsend Leader on December 21, agents from a variety of federal, state and local law enforcement agencies invaded the home and office of physician James Kimber Rotchford, MD, disrupting his practice, which subsequently reopened. Rotchford is immediate past president of Washington Society of Addiction Medicine and supported my own campaign against unscheduled buprenorphine practice audits by DEA. He appears below in a brief interview about his pain treatment practice.



This appears to be yet another example of disregard for patients and physicians when inept and ham-fisted law enforcement authorities invade medical practices. In their defense of course we must acknowledge that real fraud happens and must be stopped. Is the only way out of this mess for all medical providers to work as employees for a single entity (not the patient)?

I susepct Dr. Rotchford is guilty of nothing more than a minor technical error in attempting to recover a small portion of the cost of practicing from Medicaid. His experience bolsters my own conviction that I have done the smart thing by opting out of Medicare and refusing to accept Medicaid at all. More here.

I have read neither of these books, but both would appear to address the problem of "criminalization of almost everything."

Why Psychiatrists Should Enter the Blogosphere

A few weeks ago Shrinkrap Dinah posted Why Shrinks Don't Blog, quoting my earlier comment:

"The fact is, though you claim your blog is for psychiatrists, my impression is that few of us participate in any blog. What stops them? Snobbery? Hubris? Ignorance? Apathy? Fear?"

Despite a lively conversation I'm not sure we ever answered the question, but it occurs to me, now that I've been doing this since August 2009, to put the hard sell on my colleagues who have not yet jumped in.

Doctor, you are in control. You do not have to start your own blog and post to it every day. Just read someone else's when you get the urge. Read a few comments, too. Most of us isolate ourselves pretty completely. We put together a pretty narrow view of psychiatry. Reading blogs will not provide a complete psychiatry world view, but it will expand your horizons.

You will discover how some of your colleagues think and practice. Once in a while you may incorporate some of these ideas in your own approach. Better yet you will discover what some of our patients think about us, especially what they may not feel free to discuss during a visit. You will become more sensitive to their concerns.

Enter the fray by posting a comment. Most blogs allow you to post anonymously, so you need not worry that your patients or colleagues will discover your innermost secrets and opinions. Your opinion matters to the rest of us, and we want to learn from your experience. You can influence psychiatric thinking. Test your own ideas by provoking disagreement from others. It is not so terrible to discover that you were wrong. I know from experience.

Starting you own blog may be easier than you thought. Decide whether you want to remain anonymous or  use your blog as a vehicle to increase exposure for your professional identity, even to market your practice. You can make a commitment or not. Write as little or as much as you want. You will not spend every waking moment screening comments.

To paraphrase, "Doctor, blog thyself." You will make psychiatry better.

Psychiatric Ethics of Publishing Cases

Publication of psychiatric cases in the media can benefit the public, patients, and psychiatry in general. It can also benefit the author and the publisher, but such publication raises the question of whether, and how, we can ethically make patient treatment information public.

Do we as psychiatrists want prospective patients to wonder whether they might end up in the same positions as Dr. Spork and his patient Barbara?:



In the past week or so two psychiatrists appear to have described real cases in national media. In neither was there any indication that the author had made up the case; in neither was there indication that the psychiatrist obtained permission from the patient; and in neither was there any indication of the extent, if  any, to which the author might have disguised the case. In both the level of detail seemed sufficient that the patient might be identified:

Depression On The Rise In College Students
In fairness to the Dayton, Ohio psychiatrist, Jerald Kay, MD, who did not author the story, I can find only one sentence in which he seems to have supplied the information. Perhaps the author obtained the story elsewhere and Kay just added to it.

When Self-Knowledge Is Only the Beginning
New York psychiatrist Richard A. Friedman, MD authored this story.

In each of these articles:

• Does potential benefit to the public outweigh risk of damage to the patient?
• What constitutes adequate disguise?
• Can a psychiatrist ethically ask a patient to allow publication without damaging the treatment relationship?

An author can attempt to disguise patient information, but what constitutes adequate disguise? In a private communication a chair of the American Psychiatric Association ethics committee pointed me to the standard used by a professional journal. The sole criterion was whether the patient herself could recognize her case. But, in my opinion the most critical piece of information in determining whether a case describes oneself is the name of the treating psychiatrist who will generally be the author. Regardless of the criteria used, the author should make note of the fact that a case has been fictionalized or disguised.

When it seems likely that any reader can identify the patient from published information, and even perhaps when there seems to be little such danger, one might consider obtaining the patient's consent to publish their case. However, this raises the additional question of whether a patient can freely consent. In most situations where it is desirable to release patient information the patient benefits directly, and often the patient initiates the request. In this case however the author, publication, and perhaps the public -- not the patient -- stand to benefit. The physician asking for consent risks placing the patient in a difficult position where he might feel pressured to consent against his will, damaging the treatment relationship. If the patient did consent to publication, the author should state this fact in the article.

Relevant sections of the APA Principles of Medical Ethics With Annotations Especially Applicable to Psychiatry:

Section 1.1 “A psychiatrist shall not gratify his or her own needs by exploiting the patient. The psychiatrist shall be ever vigilant about the impact that his or her conduct has upon the boundaries of the doctor-patient relationship, and thus upon the well-being of the patient.”

Section 4.11 “It is ethical to present a patient or former patient to … the news media only if the patient is fully informed of enduring loss of confidentiality, is competent, and consents in writing without coercion.”

From an APA Ethics Opinion:

Section 2-RR “Their consent, while ‘freely’ given, is likely to be heavily influenced by their transference feelings, the need to please you… suggests an exploitation of your patients for your personal gain that outweighs the potential benefit of public education.”

Dr. E. Fuller Torrey Unethical?

The January 10 New York Times quoted psychiatrist Torrey with regard to accused Arizona mass murderer Loughner: “I’d say the chances are 99 percent that he has schizophrenia.” (Red Flags at a College, but Tied Hands)

According to Section 7.3 of the Ethics Code of The American Psychiatric Association, "On occasion psychiatrists are asked for an opinion about an individual who is in the light of public attention or who has disclosed information about himself/herself through public media. In such circumstances, a psychiatrist may share with the public his or her expertise about psychiatric issues in general. However, it is unethical for a psychiatrist to offer a professional opinion unless he or she has conducted an examination and has been granted proper authorization for such a statement."

Are we to believe that Dr. Torrey conducted an examination and obtained authorization? Was he acting ethically when he made the statement (assuming that's what he actually said)?

The Sporkiatrist Tries to Do Psychotherapy

More New Ways to Communicate

A few weeks ago I asked, Is It Time to Give up on the Phone?, bemoaning the challenges our increasingly complicated and varied modes of communication present. Here I add alternatives that arguably increase the complexity and opportunities for dysfunction, but at the same time allow workarounds when other modalities fail.

Fax
How did I forget? I use a fax service that, for a reasonable monthly fee, assigns my own private fax number and allows me to send and receive via Internet. Received faxes appear in my email inbox as .pdf files. I can even receive a document in .pdf format, print it to a .jnt (Windows Journal) file, sign it with the stylus on my tablet pc, print back to .pdf format with CutePDF Writer (a free download), and fax it back, all without paper. One patient who had lost his phone actually did cancel his appointment via fax.

Videoconfernce
Of course videoconferencing via Skype, Google Video Chat, or other such service makes for a nice alternative to the voice only phone, but users can also send text messages. The chief limitation for me comes from the fact that I usually do not leave Skype running unless I have scheduled a patient contact. The notifications whenever someone signs distract me. Phone-based videoconferencing services like Tango depend on an operating telephone, so they do not add much.


Google Voice
This free and flexible service offers the capability of customizing an outgoing message to an identified caller. I almost tested this a couple weeks ago with the patient I mentioned in the earlier post who apparently was unable to access voicemails I had recorded. I could have recorded a message specifically for him containing more or less the same information I had left on his voicemail. The same capability used to "block" unwanted callers. Once you have identified a caller you want blocked simply so indicate through your Google Voice contacts list. The caller then encounters a message that says something to the effect that the number is no longer in service. An accommodating DEA agent actually confirmed for me that this works very nicely. (I recorded a custom outgoing message for a patient yesterday after several failed attempts to contact him by phone.)

Another more mundane feature probably available in one guise or another to many cell phone users actually allowed me to communicate with the patient mentioned above. Between Google Voice, my software-as-a-service contact management vendor, and my Android phone I am able to send unidentified callers as well as selected identify callers (usually all of my patients) directly to voicemail without ringing the phone. However, in the case of this particular patient I had not yet set his contact for immediate forwarding, so shortly before I intended to record a special outgoing message for him the phone rang identifying him, and, of all things, I actually picked up the phone and answered the old-fashioned way.

Google Wave
Google has indicated it plans to abandon the service in the near future. However, just yesterday it occurred to me that it might offer a solution to a different problem. I like to be able to hand my patients information at the end of a visit. Most commonly this would relate to a new medication I have just prescribed. However, I also like to be able to provide a business card when I refer someone to a psychotherapist or primary care physician. (I could write down the name and phone number, but the patient could never read it, and I always seem to run out of cards.) Since these kinds of information, as well as information about specific mental disorders, reside on Web pages, I would like to be able to efficiently provide the patient with a link. Google Wave appears to offer the capability of establishing a private forum for myself and the patient where I might post URL's for future reference by the patient. Since one can also leave messages or use a Wave for real-time text and even video chat, it could also serve in place of the telephone in a pinch. Furthermore, I can envision, with the patient's permission of course, inviting the patient's psychotherapist and primary care provider into the Wave.

Each of these modalities carries risks and benefits. In particular I wonder about the privacy and security of Wave. However, like with other modalities, we can always manage the content of the conversation in such a way as to maximize privacy. And as with other modalities such as e-mail, a written agreement can go a long way toward assuring that patient and physician understand rules and expectations.

After all, as far as I know it's still okay, even under HIPAA, to smile at the patient when you see him in public.