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.

Prescription Preauthorization: The New Medical Emergency

It’s 5 PM Friday, and you’re closing the office for the weekend when you receive a fax from a local pharmacy informing you that you must call an 800 number or complete a form for your patient’s health insurance company or there will be no reimbursement for the drug you prescribed earlier in the day. The patient, who may still be waiting in the pharmacy, needs a 3 month supply to take on a trip to England leaving early Saturday morning. Emergency!

The insurer is placing you in the awkward position of choosing between compliance with the demands of an entity with which you may have no direct relationship, possibly compromising your relationship with your patient, or leaving your patient with no access to needed medication for three months unless the patient elects to pay cash for what insurance might – or might not – pay for if you jump through enough hoops. Your patient will also likely expect you to say whatever it takes to get reimbursement.

When the pharmacist provides you with an 800 number you must call for preauthorization she probably thinks she is helping you. I think it’s rude and presumptuous, and a waste of time for the pharmacist. The pharmacist should ask the patient or the insurer to contact the physician. Most insurers seem to offer a choice of telephone contact or completion of a form to be returned to the insurer.

Let’s do some reality testing. As physician your duty is to the patient, to diagnose and treat, not to obtain reimbursement or to help an insurance company make a decision about reimbursement. You do have a duty to provide a copy of the medical record to whomever your patient wishes. The high cost of prescription drugs is a product of our free market economy. Don’t accept responsibility for that. Neither should you feel responsible for knowing the prices of every drug available. (I admit, though, that I do tell my patients they can get fluoxetine, paroxetine and citalopram for only $4 a month at some pharmacies!) You as physician have no duty to expend your time in order to help the payer complete a process that will enable them to deny reimbursement and improve their bottom line. You certainly should not distort the facts (lie) to get the insurer to pay for the medication. A written contract governs the patient’s relationship with the payer. The patient has agreed to the terms of that contract, and the patient, not the physician, is responsible for knowing whether the payer can demand preauthorization.

Potential for negative health consequences, not financial consequences, makes for medical emergency. Request for preauthorization does not qualify. Preauthorization, like other reimbursement related matters, should assume low priority in your practice compared to clinical matters. Accomplishing it during the next business week should suffice. If we refuse to treat these requests as emergencies, payers can develop more reasonable approaches, for example by paying for the first prescription without preauthorization but notifying the patient that future orders will require review. Furthermore, regardless of how pharmacist, physician and patient respond, the preauthorization process may lead to costly delays, even threat to the health of the patient, and may lead to necessity of another contact between physician and patient to discuss an alternative, affordable, treatment.

Before you engage in providing preauthorization information to a payer your patient should understand that, assuming you provide correct information, reimbursement may still be denied, and that this is not the physician’s responsibility. The patient should pay the physician for this service. You should offer to simply provide a copy of your record to the payer in lieu of answering questions on a form or by telephone. Let the payer decide whether to reimburse based on the entire record instead of your answers to a few questions. Since this involves providing more – or at least different – information, with different implications, than what you routinely provide with a claim form, you should obtain from the patient separate informed consent for release.

In my practice I contract with no payers. My initial application and policy statement informs patients that I charge a $50 fee for preauthorization, payable in advance, and that the patient must first agree to the terms outlined in my preauthorization form, which states that I will provide a copy of the record at no charge instead and that the payer may still deny reimbursement. I also tell my patients to call the pharmacy to make sure the prescription is ready before going to pick it up.

Third party payers will respond to complaints from subscribers, not from physicians or pharmacists. By caving in to escalating demands from payers providers validate and enable policies that only transfer costs from insurers to patient, pharmacist and physician. The role of a physician is to diagnose and treat illness, not to obtain reimbursement. Don’t enable insurers to manipulate you or to redefine medical emergency. We must also honor patient requests to provide records to insurance companies, but by engaging in the preauthorization process without being paid by the patient we may transgress ethical boundaries. Patients should pay a nominal fee for physician participation in any review process with full understanding that the physician accepts no responsibility for the outcome. Only when physicians take control of this process will our patients demand reasonable behavior from insurance companies. And this is another good reason to avoid contracting with them.

It’s Nice to be N.a.C.E (Not a Covered Entity)

From soon after HIPAA, and its subsequent Privacy Rule took effect, I tried hard to comply in my psychiatric practice, handing out notices of my "privacy policy" to patients (who rarely, if ever, read them) and informing forensic clients and examinees of what I could only guess my duties, and their rights, might be. Who would have thought a complaint by a disgruntled forensic examinee to the Office of Civil Rights (OCR) would free me, at least for now, from the mysterious Privacy Rule?

I also understood from the beginning that the Privacy Rule might only apply to those meeting the criteria to be considered a “covered entity”. At the beginning it seemed less than clear how these criteria might be applied. Indeed it seemed at first glance that I might not meet these criteria, but my risk management advisors, arguing that the Privacy Rule would become a national standard regardless, and apparently thinking they were playing it safe, always encouraged me to assume that I was a covered entity and comply with the rule as well as I might.

Denial of Access

It seemed at first that forensic evaluations would be exempt from some of the many requirements of the Privacy Rule, one of which addresses limitation of right of access to the medical record. Indeed according to 45 CFR Subtitle A, Subchapter C, § 164.524 (a) (1) (ii):

“Except as otherwise provided in paragraph (a)(2) or (a)(3) of this section, an individual has a right of access to inspect and obtain a copy of protected health information about the individual in a designated record set, for as long as the protected health information is maintained in the designated record set, except for: …

“(ii) Information compiled in reasonable anticipation of, or for use in, a civil, criminal, or administrative action or proceeding;... ”

It seemed to me that "civil" and "criminal" probably referred to lawsuits and trials, and that “administrative action or proceeding” might include termination of employment, disability determination, and the like. If this was true, I reasoned that the Privacy Rule might not entitle examinees to a copy of records of forensic examination.

But then a case summary or “guidance” published at the OCR Web site described a case in which the covered entity had denied access in what sounded to me like a case of “administrative action.” OCR draws attention to the “payment source” (presumably the insurance company rather than the examinee) as a critical factor. (I find no reference to payment source in the regulation.):

“Private Practice Revises Process to Provide Access to Records
Covered Entity: Private Practices
Issue: Access

“At the direction of an insurance company that had requested an independent medical exam of an individual, a private medical practice denied the individual a copy of the medical records. OCR determined that the private practice denied the individual access to records to which she was entitled by the Privacy Rule. Among other corrective actions to resolve the specific issues in the case, OCR required that the private practice revise its policies and procedures regarding access requests to reflect the individual's right of access regardless of payment source.”

(http://www.hhs.gov/ocr/privacy/hipaa/enforcement/examples/allcases.html#case10)

Because of this interpretation of the regulation, and in spite of the fact that medical records law in my state seems to specifically exclude right of access to such records, I dutifully began to inform examinees of this apparent right to a copy of my report. I also began to inform my forensic clients that I might have to allow access even against the client’s wishes.

I even cancelled two scheduled forensic examinations when the client, an insurance company, refused to withdraw their requirement that I deny the examinee access to my report. The letter requesting the examinations included a statement I had not seen before:

“By accepting this engagement, you agree that information provided by us and your report shall not become part of or constitute a ‘designated record set’ as that term is defined in the HIPAA Privacy Rule. In addition, this information and your report shall not be subject to an individual’s rights of access or amendment under the Privacy Rule.”

Again, my risk management consultants, taking what they probably thought was the safest path, and having failed to inform me that I was N.a.C.E, advised me not to agree to that condition because it might set me up for a violation of the Privacy Rule. I cancelled the evaluations.

The Complaint

In 2008 I examined a worker at the request of the employer. The examinee requested a copy of my report at the time of the examination. I probably would have complied with this request, but my client, the examinee’s employer, asked me not to. I was caught in the middle. After the examinee threatened to file a complaint with OCR, I convinced the employer to release a copy of my report to the treating psychotherapist. That did not satisfy the examinee. Ultimately I convinced the client to release a copy of my report directly to the examinee. That did not satisfy the examinee.

I expected a visit from an FBI agent, or at least a certified letter, but instead someone identified as a representative of OCR left a message on my voice mail that a complaint had been filed. My professional liability carrier assigned (and paid for) an attorney to represent me.

My attorney, after contacting the attorney from OCR, asked me, “Do you bill electronically?” I asked her what that meant. She said she did not know. But she said that if I could answer that I do not bill electronically, OCR might not investigate further. She also confirmed my suspicions about the source of the complaint, but she said OCR had not described the allegations.

For someone who thrives on conflict, that disappointed me. I had envisioned a real investigation. I would have an opportunity to tell of my valiant efforts to do the right thing. I would show OCR the examinee's written acknowledgement of receipt of my report. (I assumed there would be an allegation that I had refused to provide it. Which was true. The employer, not I, provided it to the examinee, but only after I exerted pressure.) I would learn something about how OCR interprets and enforces the Privacy Rule. Maybe the case would even help establish legal precedent which might clarify the regulation for other forensic examiners. After all, what’s so bad about a $100 fine or a couple years in Club Fed (where I would be entitled to free medical care). Best of all: I could write about the experience.

My attorney did not agree with this approach.

My attorney asked again, “Do you bill electronically?” I said, “Tell them I don’t know, and we will see what they do.” I started a list of questions for OCR.

My attorney advised against it. “Let sleeping dogs lie,” she might have said. I might have said, “Make sleeping dogs tell the truth.”

In the end I relented: I print bills and claim forms with a computer and mail them. Apparently OCR does not consider that electronic. I fax prescriptions for controlled substances directly from my computer. I order prescriptions for non controlled substance drugs using a Web-based service. I keep patient records on three computers. I keep my office schedule on the computers and my smart phone. I take notes during patient visits and forensic evaluations on a tablet PC and dictate progress notes with voice recognition software. I dictate evaluations (free of identifying information) using audio recording software, encrypt them and ftp (upload) them to New Delhi for transcription. Sometimes I feel like my whole professional life is electronic. However, I do not communicate with my patients via email, and I do not, and perhaps never have, submit(ted) bills via the Internet. I described all this to my attorney.

My attorney wrote the attorney at OCR describing how I bill. OCR wrote back promptly. OCR did not question the veracity of my statement, did not require me to prove that I do not bill electronically, did not ask me whether I ever billed electronically, and did not ask whether I might start billing electronically tomorrow. The letter to myself and the complainant was unequivocal: [the doctor] “… does not meet the definition of a covered entity as he does not bill electronically for his services. Therefore, the requirements of the Privacy Rule do not apply to him.”

It’s official. I am Not a Covered Entity.

“N.a.C.E”

Nice!

What does this get me? In theory at least:

• I do not have to pass out the never-to-be-read and comprehensively hedged Notice of Privacy Policies.

• I do not have to provide forensic examinees a copy of my report.

• I do not have to try to get “business associates” who might see protected health information to sign a “business associates” agreement.

• I do not have to worry about what “minimum necessary” might mean.

• I do not have to tell anyone how to file a complaint with OCR.

I am not a covered entity. I can just try to practice ethically and comply with state medical records law, and Tarasoff, and specific authorization for sexually transmitted diseases and substance abuse records. (Did I miss any?)

Nice!

How can you be N.a.C.E? (Consult an attorney and…) Do not bill electronically, and if you were thinking about starting, put those thought stopping techniques to work right now.

The attorney who handled the complaint at my local OCR answered most of my questions, apparently to the best of her ability. She explained that my status as a covered entity could change. If I start to bill electronically, I become a covered entity, and, if the examinee alluded to previously finds out that I am not N.a.C.E. and again demands access to my report, I will be obligated to provide it subject to the Privacy Rule. If I stop billing electronically, I will once more be N.a.C.E.

If you were the examinee in a forensic evaluation and you believe you were mistreated, do not lose heart. Even if the examiner is N.a.C.E. you can still retaliate by filing a complaint. Who knows? With the vicissitudes of federal bureaucracy all of this could change at moment’s notice – or more likely without any notice – and you will have a chance to really annoy the examiner and give those OCR workers some added job security. But be warned: You risk doing the examiner the same favor my examinee did me: providing the examiner with written proof that they are N.a.C.E.

You might wonder what could ever induce me to give up my N.a.C.E status. I have no desire to start billing for my services electronically. The Electronic Medical Record? My last flirtation with EMR resulted in an enormous waste of time and money. Opt back in with Medicare? No way. Contract with health plans? Not if I can help it. But as this case was unfolding, and as dealing with pharmacies has reached the point of pain, a company that sets up physicians to dispense medications from their offices approached me, and the attorney at OCR advised me that use of the electronic pharmacy benefit billing system that goes along with it would render me no longer N.a.C.E.

But that’s another story.

Enforcement of the Privacy Rule represents yet another nail in the coffin of private practice of medicine, including forensic medicine, and it acts as an unwanted and unnecessary disincentive to movement of health care into the digital age. With the escalating cost of health care none of us can afford to waste resources in a futile attempt to understand how to comply with an ill-defined regulation. Enforcement of this regulation appears to contradict the exclusion in paragraph ii. Regardless of whether you believe an examinee should be denied access to the record of a forensic examination, enforcement should parallel to some degree the wording of the regulation. I recently interviewed two OCR representatives in the hope of finding a clearer interpretation of what "civil," "criminal," and "administrative" might mean to OCR. Neither could provide a clear or credible explanation. When the very agency charged with enforcement is incapable of clearly stating where the regulation applies and where it does not our government has failed us. With respect to this particular regulation at least, enforcement appears to be arbitrary, and OCR has failed miserably to clearly and adequately inform "covered entities," or anyone else for that matter, of what is required of them to comply with the regulation. OCR should immediately take steps to clarify paragraph ii. Furthermore, for such a law to hinge on whether a provider "bills electronically" seems to fly in the face of the equal protection clause of the Fourteenth Amendment. This regulation should apply to everyone or no one

The Best Treatment or Just the Most Expensive?

$600 an Hour for Treatment

No, $600 for a 45 minute psychotherapy session.

On July 7, 2008 The New York Times published an article (Age of Riches: Challenges of $600-a-Session Patients by Eric Konigsberg) describing the psychotherapy practices of psychiatrists Michael Stone and Byram Karasu.

At first read this looks like another story about the wealthy getting the best treatment. Not necessarily. This article tells us a little about what is probably a very unrepresentative sample of the rich and famous but raises many questions about the practice of psychiatry, or at least the practice of some forms of psychotherapy.

The article begins with an example in which Dr. Karasu criticizes a “therapist” for encouraging a patient to go ahead with an expensive purchase despite his misgivings rather than “explore” the patient’s anxiety. He labels the purchase as a manifestation of an “addiction” involving “excesses and consumption.”

The average psychiatrist today may charge more than $100 for a medication management visit that may last five minutes. Cram 12 of those into an hour and you easily exceed Dr. Karasu’s fee. Of course it takes many more patients to fill your practice. Or fewer psychiatrists can treat the same number of patients, depending on your perspective. The $600 fee is exorbitant, and indeed few can afford it, especially twice a week, but the economic law of supply and demand determines how high a fee such a professional can command.

Regardless of fees much of importance is conspicuous by its absence. There are references to treatment, neurosis, patients, doctors, and psychoanalysis, but there is no mention of illness, of mental disorder. The rich “patients” described in the article seem to want only help for life problems, for “unhappiness or emotional anguish,” or just someone to talk to.

If this is not just an example of the richest patients buying the best doctors, we need to look further for an explanation. Perhaps it is the rare wealthy narcissist (Narcissism also afflicts the poor and can lead to failure.) who gravitates to a treatment that is expensive, if easily afforded, and makes him feel special. Perhaps these doctors are no better than the next “therapist” at helping them, but they may become skilled in attracting them to and keeping them in “therapy” even when they fail to “make progress.”

Sometimes many of us like to think all that money and success would not have made us happier anyway, and indeed the wealthy suffer from many of the same mental disorders as the rest of us. Antidepressants and other medications, and psychotherapy methods like cognitive behavior therapy, effectively treat most mental disorders today. The notion of “neurosis” was long ago abandoned by the diagnostic manual of the American Psychiatric Association, but psychoanalysts, Freudian and otherwise, cling to it stubbornly. The few who seek psychoanalytic psychotherapy from the likes of Drs. Stone and Karasu may be less ill and more in search of someone to listen. They may even like the idea of a “treatment” that can go on for years, regardless of whether it is effective.

Ambivalence about whether to bid $8 million for a painting is not likely a manifestation of a mental disorder, nor is the success of “treatment” likely to hinge on whether to give the patient permission to buy rather than force him to explore his anxiety. The mentally ill, wealthy or not, deserve effective treatment. The worried well are all too happy to pay someone with lofty status to listen to their complaints. Psychoanalysts like Drs. Stone and Karasu need only a few such patients to fill their practices.

If you are wealthy and need treatment that works, find a family or cognitive behavioral psychotherapist, or take psychiatric medication. They work just as well for the wealthy as for the rest of us.

Psychological Testing and Firearm Permits

The article, “An Empirical Survey of Psychological Testing and the Use of the Term Psychological: Turf Battles or Clinical Necessity?” (Dattilio, Frank M.; Tresco, Katy E.; Siegel, Alex Professional Psychology: Research and Practice. 2007 Dec Vol 38(6) 682-689) includes the apparently erroneous statement:

“Most states in the United States will only issue a permit to carry a firearm to individuals who undergo psychological testing by a licensed psychologist and are approved.”

When I asked Dr. Datillio via email to cite a statute supporting this statement, he provided only a Pennsylvania statute requiring the applicant to undergo such an evaluation in order to obtain a permit to carry a concealed handgun for (non law enforcement) work. According to the National Rifle Association 48 states issue permits for concealed carry of handguns to ordinary citizens, and none of them requires psychological evaluation. An Internet search appeared to confirm this. Official documents, including statutes, application forms, and other listings of requirements of 35 states revealed not a single one requiring psychological evaluation. Almost all the states in some way restrict issuance of permits, purchase or possession of firearms for individuals with a putative history of substance use disorder or other mental illness.

The laws of at least two states provide for restoration of the right to be issued a concealed carry permit after it has been revoked. The state of Massachusetts allows a physician (not a psychologist) to restore the right of permit. The permit may be restored when the individual

“(ii) has been confined to any hospital or institution for mental illness, unless the applicant submits with his application an affidavit of a registered physician attesting that such physician is familiar with the applicant’s mental illness and that in such physician’s opinion the applicant is not disabled by such an illness in a manner that should prevent such applicant from possessing a firearm;
“(iii) is or has been under treatment for or confinement for drug addiction or habitual drunkenness, unless such applicant is deemed to be cured of such condition by a licensed physician, and such applicant may make application for such license after the expiration of five years from the date of such confinement or treatment and upon presentment of an affidavit issued by such physician stating that such physician knows the applicant’s history of treatment and that in such physician’s opinion the applicant is deemed cured;…”

The state of Mississippi allows a psychiatrist (not a psychologist) to restore the right of permit when the individual

“Has not been voluntarily or involuntarily committed to a mental institution or mental health treatment facility unless he possesses a certificate from a psychiatrist licensed in this state that he has not suffered from disability for a period of five (5) years;…”

In no state’s materials was there any basis for concluding that evaluation by a psychologist might suffice. But even the two laws quoted above presume the physician or psychiatrist is qualified to make this determination in the absence of generally accepted criteria and with assumption of considerable liability for a bad outcome.

Does Flumazenil Contribute to Treatment for Alcohol Dependence?

Raymond Anton, MD, et al presented a poster* at a recent meeting of the Research Society on Alcoholism describing a placebo controlled, randomized study of flumazenil/hydroxyzine/gabapentin for alcohol dependence. Available as the Prometa protocol, this off label use of off patent drugs has been touted as a treatment for alcoholism and addictions to methamphetamine and cocaine.

In this study the flumazenil, a benzodiazepine antagonist, was administered intravenously on two consecutive days. Hydroxyzine, an antihistamine, was administered before the flumazenil infusions and at bedtime as needed for six days. Participants, including some with "mild/moderate alcohol withdrawal," took increasing doses of gabapentin for 39 days and attended counseling. Whether the protocol in this study “cured” any of the subjects of alcoholism has apparently not yet been determined. That might presumably take many years and begs the question of whether this cure would simply consist of successful abstinence or actual ability to drink “normally.” Participants were reported to tolerate intravenous administration of flumazenil.

The other question that remains is whether the flumazenil (or the hydroxyzine) adds anything to the effectiveness of gabapentin alone. Gabapentin, an unscheduled anticonvulsant drug also used off label to treat anxiety, is an obvious candidate for treating alcohol withdrawal. Flumazenil on the other hand can precipitate seizures (at least in some patients who have recently used benzodiazepines or other sedative-hypnotics), something for which alcoholics in withdrawal are already at increased risk. We need a study comparing flumazenil/hydroxyzine/gabapentin to gabapentin alone as well as to placebo to settle that question. In the meantime, if you are thinking of trying this combination on your patients, be warned that the protocol is protected by a “use” patent (7,348,321) owned by Hythiam, Inc. If this corporation is looking after its licensees and their considerable financial investment in the license, Hythiam might sue you for patent infringement. But if the gabapentin works just as well by itself, Hythiam might not have much worth licensing.

*R.F. Anton, H. Myrick, P. Latham, A. Baros, T. Wright, S. Stewart, R. Malcolm, R. Wald, P. Randall “Double Blind Controlled Trial of Flumazenil and Gabapentin for the Treatment of Alcohol Dependence”

Them that has gets. Gets what?

It can be hard to avoid considering the wealth (or poverty) and income of a patient. Do they deserve sliding scale or no fee at all? Will the fee be a hardship? Can the patient afford weekly visits, a newly released medication? Will they pay my bill? Will I have to send them to collection?

When we consider the patient’s financial well-being in the context of professional liability, we might wonder whether the patient or their survivors would more likely sue for purely financial reasons, and we like to think that another good thing about wealthy patients is that they already have so much money they probably would not bother. In most cases it seems that wealthy (whether by virtue of assets or income) patients might be preferred, all other things being equal.

The John Ritter malpractice case raises questions about this assumption. According to media accounts of his wrongful death suit plaintiffs demanded approximately $40 million in damages based at least in part on an estimate of Ritter’s future income potential. This makes the usual $1 million/$3 million professional liability coverage look pretty inadequate.

Of course plaintiffs who win lawsuits do not always get what they demand. Had they prevailed in the Ritter case the award might have come from the policies of more than one physician. And maybe other factors would have protected the defendant physicians’ assets. Still it makes me wonder whether the risk attendant to treating patients with high earned income might be greater in a way I had not previously considered. Maybe we should not be so eager to have them as patients.

Presumably already wealthy patients who no longer earn might not qualify for so great a judgment. Maybe “them who has gets” a doctor, but not necessarily a bigger damage award. And maybe there is a small advantage in not making too much money.

No, Dr. Moffic, That Is Not the... Answer!

In his article “To Drive or Not to Drive? That Is the…” (The Ethical Way, Clinical Psychiatry News, Volume 35, Issue 10, Page 41 (October, 2007), Dr. H. Steven Moffic has established a new duty of treating psychiatrists to evaluate the “fitness to drive” of each patient, and a new exception to physician patient privilege “…when you are reasonably sure of potential danger” arising from psychiatrically impaired ability to drive.

Dr. Moffic has paid scant attention to the damage such a conflict of role or interest might have on the treatment relationship. He also failed to reference any ethical precept, including the most relevant: “A psychiatrist who regularly practices outside his or her area of professional competence should be considered unethical.” (American Psychiatric Association, The Principles of Medical Ethics With Annotations Especially Applicable to Psychiatry, 2006 Edition http://psych.org/psych_pract/ethics/ppaethics.cfm; accessed November 5, 2007). Instead, he takes the position that the treating psychiatrist should perform even a questionably competent evaluation because “practically speaking, such information usually is difficult to obtain.” He described this difficulty in one case as arising only from the fact that the patient “lived alone.” Regardless of whether a patient lives alone, a forensic psychiatrist can answer questions about disability, competence or capacity, and fitness with little or no conflict of role or interest, leaving your relationship with your patient unharmed.

The duty of a clinical psychiatrist is to diagnose and treat mental illness. The only well-accepted exceptions are the Tarasoff duty to protect, the duty to report physician misconduct, and the duty to notify authorities of child abuse. There is no duty to “fill out forms.” There is no duty to ensure that a patient can obtain a license to drive a motor vehicle, to practice medicine or to fly an airplane. There is no duty to obtain insurance money for a patient. If a duty to protect the public from drivers impaired by their medications or mental disorders has been established, Dr. Moffic should cite applicable statutory or case law.

Treating psychiatrists are no more qualified to perform "clinical assessments" of fitness for driving than to determine whether their patients should or should not be permitted to own or use firearms, return to work, be considered disabled, be considered competent to make a will, or to stand trial. They are not qualified to determine whether a patient is fit to procreate, raise children, or ride a bicycle. All such assessments result in a conflict of role, if not a conflict of interest, which will probably interfere with the physician’s care of the patient.

Dr. Moffic recommends that we “Do receive informed consent” but fails to specify to what the patient must consent. The need to obtain authorization to release information is obvious. The clinician who follows this recommendation should also, however, advise the patient of the limitations of the psychiatrist’s ability to perform a “clinical assessment of the patient’s driving” and the potential adverse effect on the treatment relationship. He should also warn the patient before undertaking a psychiatric evaluation that he might determine that the patient is unfit to drive and that he might report this to “authorities” whether the patient wants him to or not.

As long as psychiatrists like Dr. Moffic find it more expedient to “just sign the form,” attorneys, insurers, bureaucrats, and a host of other third parties will exploit this free and easy alternative to forensic evaluation with no regard for the resulting damage to the doctor-patient relationship or for the quality of the assessment.

Dr. Moffic asks, “What is the clinician to do?” when your patient asks you to “fill out a form.” The answer: Focus on treating the patient to the best of your ability and to follow your instincts and the admonition of Nancy Reagan and, “Just say no.”

FDA Warns About Sleeping Pills and Sleep Driving

The March 14, 2007 FDA warning about the dangers of "sedative-hypnotics" may do more to create confusion than it does to increase patient safety, but it certainly reveals flaws in the agency's categorization of drugs as well as evidence of how little FDA approval really means. The FDA Press Release lists the following drugs (Comments in parentheses are mine.):

• Ambien and Ambien CR (already carry the warning!)
• Butisol sodium (Does anyone still prescribe this dinosaur?!)
• Carbrital (pentobarbital and carbromal) (Do they really still manufacture this stuff?!)
• Dalmane (a benzodiazepine)
• Doral (a benzodiazepine)
• Halcion (a benzodiazepine)
• Lunesta
• Placidyl (Does anyone still prescribe this dinosaur?!)
• Prosom (a benzodiazepine)
• Restoril (a benzodiazepine)
• Rozerem (probably acts like melatonin, a hormone)
• Seconal (Does anyone still prescribe this dinosaur?!)
• Sonata

What do these drugs have in common? Apparently they have all been approved by the FDA for treatment of insomnia. (Just try to find a copy of the official label to confirm this!) Although the warning refers to "sedative-hypnotics," drugs used to combat insomnia are usually categorized as soporifics or hypnotics. The "sedative" in "sedative-hypnotics" addresses the fact that most drugs so classified produce sedation or calming as well as assist in falling asleep or staying asleep. Although it might be considered a hypnotic, Rozerem would not be classified or used as a sedative. In the past benzodiazepines like Dalmane and diazepam have been separated from other sedative-hypnotic drugs, like Placidyl and pentobarbital (a barbiturate) because of the different chemical structure, different properties, and relatively better safety record of the benzodiazepines. Not surprisingly drugs like Ambien and Dalmane are included along with several other central nervous system depressants. It is surprising, however, that they have also included Rozerem, the only drug on the list that is neither a central nervous system depressant nor a controlled substance, and is thought to act on the melatonin receptor. While one might expect all of the central nervous system depressant drugs to share the adverse effect that prompted the warning, one might not expect Rozerem to cause this phenomenon. Unless there is clear evidence that it does this might unfortunately discourage physicians from prescribing what might be one of the few drugs, if not the only drug, that might be safer.
Even more confusing and potentially dangerous than the inclusion of Rozerem is the exclusion of a number of other central nervous system depressants and other sedating drugs which are often used to aid sleep. Of greatest concern is the omission of all the other benzodiazepines, sedative hypnotics, including even barbiturates, that are not explicitly approved for treating insomnia, despite the fact that these might be the drugs one would most likely expect to be associated with this phenomenon. Drugs frequently prescribed for insomnia such as quetiapine, mirtazapine, trazodone, and sedating antihistamines, such as diphenhydramine are conspicuously absent. Of course melatonin is omitted even though ramelteon is included, despite the fact that they probably share the same mechanism of action, presumably because melatonin, a hormone, is regulated by the FDA as a dietary supplement while Rozerem is regulated as a prescription pharmaceutical. The omission of sodium oxybate might be related to the tight control over its use.
The FDA overvalues its approval designations to the extent that they appear to consider approved indication to determine clinical class. This approach risks creation of increased confusion and potential for ill advised switching to drugs that might be even less safe. For example, a physician might switch a patient from Ambien to diazepam despite the drug's similarity to Halcion, eschewing Rozerem, which might not be associated with this effect, simply because Rozerem is included in the warning.
The FDA should adopt a more rational application of categories that does not depend solely on approved indication. Drug categories frequently overlap and may be based on different properties. The class of "benzodiazepines" is based on the similarities in chemical structure among the drugs in the class. The class of "hypnotics" is based on the drugs' effectiveness in induction of sleep. The class of serotonin reuptake inhibitors is based on the drugs' common mechanism of action. Approval is driven by the marketing choices of the company that holds the patent on the drug. Obtaining approval for a spcific indication requires evidence of safety and effectiveness, and the process costs the company millions of dollars with no guarantee of ultimate approval. The FDA should develop a more uniform and rational approach to approval as well as categorization. All drugs effective for treating insomnia should be approved for that indication and classified as hypnotics regardless of the business goals of the company that markets the entity, but only the drugs for which there is compelling evidence of a given adverse effect should carry the appropriate warning.