AlignMap

My post, It’s Time To Stop The Damage Caused By Today’s Patient Compliance Paradigm, went online at the eyeforpharma.com site today.

While fundamentally a summary of the preceding posts on this blog, ¹ It’s Time To Stop The Damage Caused By Today’s Patient Compliance Paradigm can claim an original introduction, which, I think, is worth sharing here:

Imagine that, say,  a well known Fortune 500 manufacturer of state of the art medical devices and the Feds co-funded a $14.2 million multi–center  study at four prestigious universities to determine the  effectiveness of a newly designed stereotactic laser bloodletting* machine (with optional Facebook connection)  in treating diabetes.

Doesn’t it seem likely that a whistle-blower – or, failing that, a Senator coming up for re-election, an investigative reporter desperate for a story, a publicity-seeking Attorney General of one state or another, a gadfly shareholder, a do-gooder looking for a cause, or a Ralph Nader wannabe – would be loudly decrying the use of public and shareholder monies on a clinical trial of a treatment never shown to be of benefit to patients with this disease despite many, many years of use? One would, in fact, think that  congressional committees would be convened, newspaper stories written, blog posts posted, accusations leveled and denied, indictments brought, damage control instituted, scapegoats designated, and heads rolled.

At the least, the medical device company,  the Federal agency that handed over the bucks, and the academic institutions involved would be called upon to justify their choice of investments, i.e., explain why the limited amount of money and skilled researchers were designated to be expended on this project instead of a potentially effective therapy – or at least one that has not already proven useless.

I contend that  the now dominant  paradigm of adherence to treatment, has,  like bloodletting,  been so unsuccessful for so long (see previous posts: The Tragedy Of Patient Compliance and Patient Compliance – So Wrong For So Long)  that continuing to explore the same familiar primrose paths  of the patient compliance model  entails an intellectual responsibility to provide an explicit rationale for taking this tack.

Next: Alternatives To the Current Patient Compliance Model

The posts in this sequence have thus far focused on the why the treatment adherence paradigm is ineffective and the danger of its continued use.

As noted already, the next entries will begin a discussion of possible alternatives to the current model.

1. See Why The Treatment Adherence Paradigm Must Be Destroyed:  Part 1 and Part 2↩

This is the second post in this series on the inadequacy of the current treatment adherence paradigm. The link to the first post in this series follows: Why Today’s Treatment Adherence Paradigm Must Be Destroyed – Part 1.

The photo atop this post, “Instant Of Impact,” was taken by Jeff Lowe

Patient Compliance – The Concept That Wouldn’t Die

The status of Patient Compliance (AKA Treatment Adherence, AKA Concordance, … ) as an organized field of study is baffling.

On one hand,I find no convincing arguments refuting, entirely, in part, or in degree, the assessment of the effectiveness of patient compliance I published over three years ago:¹

After almost 2500 years of pondering, healthcare’s consensus is that compliance problems are complex, and the most promising solutions are also complex, as well as impractical and diverse, with no sure means of determining which interventions are most likely to work for a specific patient. And, few reviewers confidently endorse any specific tactic without extensive hedging.

Heck, the only reason I haven’t submitted Patient Compliance to one of those web sites that collect urban legends, online hoaxes, and the like is my inability to find folks who believe that the efforts expended in the name of treatment adherence have contributed much in the way of useful information or tactics. It’s not a legend, urban or otherwise, if no one believes in it.

On the other hand, I notice that  Pfizer Canada, AstraZeneca, and Merck Frosst Canada have each kicked in $400,000 and the Canadian  provincial government has contributed $500,000 to  fund a new Research Chair in Patient Adherence to Drug Therapy at the University of Saskatchewan,² leading one to assume somebody in those companies and in the Canadian government either has faith in the concept or too much money left in the budget at the end of the fiscal year.

This morning, I was excited to find, in a recently published (23 June 2009) article, Group kicks off effort to improve medication compliance, the information that

… a new initiative by the New England Healthcare Institute hopes to determine which strategies are most likely to control this problem. The Institute is forming work groups composed of key healthcare stakeholders, including payers, patients, providers, caregivers, health IT execs and employers, to examine strategies for combatting non-compliance with med regiments [sic].³

The next paragraph, however, transformed my excitement into discouragement:

Strategies under consideration include patient education, dosing schedules, packaging and financial incentives to comply with physicians’ recommendations.

The piece I originally found turned out to be a rewrite of another article, Initiative aiming for better medication adherence,⁴ which is no more forthcoming on this point:

The institute will establish work groups out of its participating stakeholders to identify strategies to combat nonadherence, including patient education, dose schedules, packaging and financial incentives.

After the most promising strategies are selected,

… the institute will create demonstration projects to test those strategies.

Let’s recapitulate:  The New England Healthcare Institute, an organization considered well grounded and admirably innovated  by some folks,⁵ is working with “key healthcare stakeholders, including payers, patients, providers, caregivers, health IT execs and employers,” many or most of whom are, one assumes, knowledgeable about patient compliance, to select strategies from candidates such as “patient education, dosing schedules, packaging and financial incentives” to for demonstration projects to “improve patients’ adherence to their medication.”

My question is:

What is the rationale for pursuing compliance enhancement within the framework of a system that has yet to show substantial results after decades of attempts, especially given that all of the strategies named have been subjected to a significant number of  clinical  trials already?

As follow-up, I also have the following  rhetorical questions which are, of course, no more than thinly disguised elements of my ongoing rant:

• Do they think they will generate different results from implementing the same methodologies?
• Do they think the problem is that the research groups who performed the previous studies didn’t do a good job?
• Are they going to implement these previously tested strategies in a unique way, and, if so, what do they have in mind?
• Are they going to consider only previously tested, mainstream approaches?
• How does one get in on a gig like this? Do they need a consultant with a moderately varying point of view?

Patient Compliance Accomplishments

Another dichotomy contributes to the befuddlement: my jeremiads on the the near absence of  effective compliance enhancements contrast with my astonishment over the amount of material produced under the aegis of treatment adherence.

Workers in the field have, for example, generated all manner of books, graduate theses, articles in the medical and sociological literature, newspapers, and periodicals from Parade to Tallahassee Magazine, government grants, marketing projects by pharmaceutical firms, books, medication reminder appliances that range from novelty items to sophisticated, state of the art electronics, salaried positions, workshops, panels, international conferences, and other boondoggles.

The presumption of improved adherence is also, of course, the rationale that launched a thousand new drug applications.

How many industries or scientific fields⁶ remain viable after spending 30-40 years producing libraries of  research papers, handbooks, and published articles, battalions  of machines and devices, and a plethora of PowerPoint presentations with only a handful of  achievements that actually produce the desired effect?

I Believe For Every Drop Of Rain That Falls, …

Notwithstanding the massive investments of money, time, and effort, when it comes to empirical results, the relative impotency of patient compliance enhancements  ranks among the worst kept secrets in healthcare.

Oh,  we try to be polite about  it.  For example, David E. Williams, in his recent  post,  The last lever for big pharma, noted

Meanwhile there is one other major lever: medication adherence. If big pharma can find a way to encourage existing patients to sustain their therapy, there is also a significant growth opportunity. That’s easier said than done, however, and pharma companies are still struggling to find cost effective approaches to this challenge. [emphasis mine]

I don’t know Mr. Williams, but I’ll bet he’s a nice guy – because instead of writing “… pharma companies are still struggling to find cost effective approaches to this challenge,” he could have, with equal accuracy, written “… pharma companies have repeatedly failed to find cost effective, comprehensive approaches to this catastrophic problem.”

Moreover, he could have, again with equal accuracy (and more thoroughness),  written,  “… pharma companies, academic researchers, healthcare organizations, clinicians, health insurers, governmental agencies, and other third party payors have repeatedly failed to find cost effective, comprehensive approaches to this catastrophic problem.”

The smart money, in fact, is on Diogenes finally stumbling across that honest man before a stakeholder in treatment adherence (who isn’t hawking the latest and greatest compliance enhancement product) championing the historical accomplishments of and future prospects for the field turns up.

Exceptions and Outliers

To save folks the trouble of emailing protestations that their program, gizmo, or incantation does so  improve patient compliance and, in fact,  returns $22,655  in health savings for every $1 investment in said program/gizmo/incantation, I am willing to stipulate that islands of success may indeed exist somewhere in the vast, uncharted seas of patient compliance enhancement failure.

The supposed examples of success I’ve examined thus far, however, have turned out to involve complex, labor-intensive sets of multiple interventions, special circumstances (e.g., self-selected populations of clients likely to be compliant with or without enhancements),  inaccessible, unvalidated evidence (e.g., favorable results from proprietary studies, the data of which are kept secret), or other magical assumptions (e.g., defining the removal of a medication from a dispenser as equivalent to appropriate ingestion of that medication).  This is a bit like a government agency charged with improving mine safety claiming success based on  a single, unpublished study, the data for which was gathered from the miners’ recall of accidents over the past year, showing a “low rate of significant preventable injuries directly attributable to mine engineering” in a single model mine in Idaho. I can’t determine what the so-called evidence means – other than I won’t be strolling through that mine.

So, If Patient Compliance Is Useless, Why Do We Keep Using It

Well, it sounds a bit like a shared delusion, but a delusion is an unshakable belief in something untrue. That “unshakable belief” criterion pretty much rules out this diagnosis since there exist  few hard-core supporters of the concept of patient compliance.  Perhaps that makes it the first case of  pseudo-folie à plusieurs (”false madness of many”).

Or maybe it’s a discipline-wide repetition compulsion.

Or, maybe there isn’t a name for the problem but I do know a joke that covers it:

A passerby walking home late at night sees a drunk on his knees under a streetlight, searching for something. The passerby asks the drunk, “What are you doing?” “Looking for my apartment key,” says the drunk. The passerby, trying to be helpful, walks to the area near the drunk and begins  looking for the key.  After 15 minutes, it becomes clear that the key is not in the vicinity.  The newcomer asks, “Are You sure you lost your key here?” “No, actually I first noticed it was missing when I was walking over there,” the drunk says, pointing to an area a half block away. The passerby, a bit perplexed, asks, “Then, why are  you looking here if you lost your key over there?” Responds the drunk, “Because the light is better here, under the streetlight.”

It’s time to do the merciful thing and pull the plug on this flat-lined concept.

Next Post: Alternatives To The Patient Compliance Paradigm

1. The Verdict From Patient Compliance Research↩
2. U of S adds research chair, Heanette Stewart, The Star Phoenix. June 16, 2009↩
3. Actually, I was a tad miffed as well since this is an idea I’ve been pushing for years with no success, but I suppose I should deal with that on my own time.↩
4. Initiative aiming for better medication adherence , by Jean DerGurahian. ModernHealthcare.com. Posted: June 22, 2009↩
5. Yes, including me.↩
6. To avoid unseemly arguments and bloodshed, let’s exclude faith-based areas of endeavor and activities taking place before 1900↩

Because The Survival Of The Current Patient Compliance Concept Endangers Patients

But more about that later.

Understanding both the catastrophic risk and the seemingly inexplicable persistence of the patient compliance model¹ is facilitated by first considering a parallel case of another incorrect medical hypothesis.

There Will Be Blood: Bloodletting As A Model For Adherence

While mistaken beliefs in many fields of knowledge can impair or imperil  individuals, the calculus of  the danger represented by erroneous medical concepts can be especially evident. Prescribing an ineffective  treatment, for example, can be a death sentence to a patient with a serious disorder. Some  treatments that were once widely accepted, in fact, are now known to be toxic  even to  otherwise healthy individuals.

Nonetheless, detecting and rooting out such errors has frequently proved to  be an  extraordinarily arduous and prolonged task.

Medical theories and practices that now appear blatantly  fallacious and even ludicrous were often founded on logical premises, were seemingly congruent with the available evidence, and were supported and used by competent, careful, and conscientious practitioners.  Many treatments that we now know were disastrous wrong were not the work of quacks, greedy producers and sellers of worthless or poisonous potions, charismatic charlatans, sociopaths, or religious fanatics. In fact, the most widespread and enduring – and therefore the most dangerous – mistaken medical methodologies were those formed and held by clinicians acting thoughtfully and in good faith.

Consider bloodletting, as described in Wikipedia:²

Bloodletting (or blood-letting) is the withdrawal of often considerable quantities of blood from a patient in the belief that this would cure or prevent a great many illnesses and diseases. It was a tremendously popular medical practice from antiquity up to the late 19th century, a time span of almost 2,000 years. The practice has been abandoned for all except a few very specific conditions. It is conceivable that historically, in the absence of other treatments for hypertension, bloodletting could sometimes have had a beneficial effect in temporarily reducing blood pressure by a reduction in blood volume. However, since hypertension is very often asymptomatic and thus undiagnosable without modern methods, this effect was unintentional. In the overwhelming majority of cases, the historical use of bloodletting was harmful to patients.

Bloodletting was founded on a logical, albeit inaccurate, notion:

“Bleeding” a patient to health was modeled on the process of menstruation. Hippocrates believed that menstruation functioned to “purge women of bad humors”. Galen of Rome, a student of Hippocrates, began physician-initiated bloodletting.³

And, scientific discoveries supported it.

The popularity of bloodletting in Greece was reinforced by the ideas of Galen, after he discovered that veins and arteries were filled with blood, not air as was commonly believed at the time.

Bloodletting was not cavalierly formulated. Rather the associated theoretical explanations became increasingly sophisticated.

Galen created a complex system of how much blood should be removed based on the patient’s age, constitution, the season, the weather and the place. Symptoms of plethora were believed to include fever, apoplexy, and headache. The blood to be let was of a specific nature determined by the disease: either arterial or venous, and distant or close to the area of the body affected. He linked different blood vessels with different organs, according to their supposed drainage. For example, the vein in the right hand would be let for liver problems and the vein in the left hand for problems with the spleen. The more severe the disease, the more blood would be let. Fevers required copious amounts of bloodletting.

Bloodletting was widespread, and became one of of those principles so obviously true that it was integrated into common sense.

The Talmud recommended a specific day of the week and days of the month for bloodletting, and similar rules, though less codified, can be found among Christian writings advising which saints’ days were favourable for bloodletting. Islamic medical authors too advised bloodletting, particularly for fevers. The practice was probably passed to them by the Greeks; when Islamic theories became known in the Latin-speaking countries of Europe, bloodletting became more widespread. Together with cautery, it was central to Arabic surgery; the key texts Kitab al-Qanun and especially Al-Tasrif li-man ‘ajaza ‘an al-ta’lif both recommended it. It was also known in Ayurvedic medicine, described in the Susruta Samhita.

Bloodletting Machine Mechanism

Not everyone, however, bought into the idea. Some, in fact, began demonstrating that, at least in some classes of cases, bloodletting was valueless.

William Harvey disproved the basis of the practice in 1628, and the introduction of scientific medicine, la méthode numérique, allowed Pierre Charles Alexandre Louis to demonstrate that phlebotomy was entirely ineffective in the treatment of pneumonia and various fevers in the 1830s.

By the mid-1800s, there was substantial empirical evidence this method didn’t work in a number of specific cases. These findings not only  failed to stop the practice but likewise failed to slow its growth.  Indeed, bloodletting enjoyed a surge of popularity during this period with it being touted as a potential treatment for almost every imaginable ailment.

…  in 1840, a lecturer at the Royal College of Physicians would still state that “blood-letting is a remedy which, when judiciously employed, it is hardly possible to estimate too highly”, and Louis was dogged by the sanguinary Broussais, who could recommend leeches fifty at a time.

Bloodletting was used to treat almost every disease. One British medical text recommended bloodletting for acne, asthma, cancer, cholera, coma, convulsions, diabetes, epilepsy, gangrene, gout, herpes, indigestion, insanity, jaundice, leprosy, ophthalmia, plague, pneumonia, scurvy, smallpox, stroke, tetanus, tuberculosis, and for some one hundred other diseases. Bloodletting was even used to treat most forms of hemorrhaging such as nosebleed, excessive menstruation, or hemorrhoidal bleeding. Before surgery or at the onset of childbirth, blood was removed to prevent inflammation. Before amputation, it was customary to remove a quantity of blood equal to the amount believed to circulate in the limb that was to be removed.

Leeches became especially popular in the early nineteenth century. In the 1830s, the French imported about forty million leeches a year for medical purposes, and in the next decade, England imported six million leeches a year from France alone. Through the early decades of the century, hundreds of millions of leeches were used by physicians throughout Europe.

Bloodletting persisted into the 20th century and was even recommended by Sir William Osler in the 1923 edition of his textbook The Principles and Practice of Medicine

The question becomes, why did bloodletting  persist for 2,000 years even though for all but a handful of cases it provided no physiological advantage in the fight against disease? As it turns out, one need not invoke conspiracy theories about nefarious plots carried out by the Leech-sellers Guild and the physicians to fool the public to explain the longevity of bloodletting.

One reason for the continued popularity of bloodletting (and purging) was that, while anatomical knowledge, surgical and diagnostic skills increased tremendously in Europe from the 17th century, the key to curing disease remained elusive, and the underlying belief was that it was better to give any treatment than nothing at all. The psychological benefit of bloodletting to the patient (a placebo effect) may sometimes have outweighed the physiological problems it caused. Bloodletting slowly lost favour during the 19th century, but a number of other ineffective or harmful treatments were available as placebos—mesmerism, various processes involving the new technology of electricity, many potions, tonics, and elixirs. [Emphasis mine]

And, there are a limited number of cases in which bloodletting is helpful:

In the absence of other treatments, bloodletting actually is beneficial in some circumstances, including the fluid overload of heart failure, and possibly simply to reduce blood pressure. In other cases, such as those involving agitation, the reduction in blood pressure might appear beneficial due to the sedative effect.

Summary: Comparing Bloodletting And Patient Compliance

Let’s review:

Bloodletting is a practice dating back to Hippocrates which was, until 200 years ago when it began to fall out of favor, the standard of care for a wide scope of disorders throughout the civilized world. A multitude of explanatory theories and methodologies of implementation were devised. Skilled physicians, surgeons, and barbers, aided by cleverly designed mechanical devices and leeches (biological machines), became ever more efficient in performing the procedure. That the process could not be shown to result in positive outcomes in the overwhelming majority of cases was explained away or ignored, as was the scientific evidence that the process was therapeutically ineffective in given disorders, perhaps in the belief that it was better to give any treatment than nothing at all.

Treatment adherence is a model dating back to Hippocrates which continues to be the standard of care throughout the civilized world. A multitude of explanatory theories and methodologies of implementation have been devised. Skilled physicians, other clinicians, and researchers, aided by cleverly designed mechanical devices, have become ever more efficient in performing a set of compliance enhancement procedures (such as reminding the patient to take a pill, educating the patient, packaging all of a patient’s medication in dose packs, etc.). That the process has not been shown to result in significant improvements in the overwhelming majority of cases has been explained away or ignored, as has the scientific evidence that certain specific procedures are ineffective, perhaps in the belief that it is better to try to improve compliance by any means available than do nothing at all.

On the other hand, I can find no evidence that anyone has suggested that patient compliance can be enhanced by the use of leeches.

The Potential Risk Of Bloodletting And Patient Compliance

The danger of bloodletting was not, except in a small number of cases, death by exsanguination. Instead, the harm done to centuries of patients was in the form of what economists call opportunity cost.  If, for example, one purchases a car for $30,000, the opportunity to invest that  $30,000 in ones next best choice, say starting ones own business, is lost.

During the time that bloodletting was in favor, it was the dominant investment target for available intellectual, financial, and medical professional capital. Consequently, the opportunity to use those resources to develop and implement other, perhaps more effective, therapies was lost. Every day that the practice of bloodletting slowed the development of more effective therapies was a day treatment outcomes were worse than they could have been – that means some patients died, suffered incapacities, recovered more slowly, and, at best, endured the pain and cost of treatment needlessly.

Similarly, as long as intellectual, financial, and medical professional capital are devoted to the current patient compliance paradigm, developing and implementing other, perhaps more effective, alternatives is unlikely. And, every day that the current patient compliance paradigm slows the development of more effective enhancement of treatment implementation is a day treatment outcomes are  worse than they could have been – that means some patients die, suffer incapacities, recover more slowly, and, at best, endure the discomfort, inconvenience, and cost of treatment needlessly.

Incorrect, ineffective patient compliance theory is not  trivial  – it is literally a matter of life and death.

And that is why I  resort to posts like this with accurate but  admittedly sensationalist titles like “Why Today’s Treatment Adherence Paradigm Must Be Destroyed.”

Coming In Part 2

• A brief exposition on my contention that the patient compliance paradigm is ineffective and wastes resources yet doesn’t have the good grace to die on its own.
• The  lack of enthusiasm for the contemporary concept of patient compliance  paradoxically coupled with continuing use of that system as a basis for research and interventions.
• The Showdown: My dismissal of treatment adherence compliance as a system capable of generating effective compliance enhancements could be wrong, but I’ve found almost no support for the opposing view. I maintain that, at this point, those continuing to pursue research, offer programs, invest in a Chair in Patient Adherence to Drug Therapy, … have the intellectual responsibility to present their arguments for staying the course or indicate the changes they  intend to institute.
• Possible alternatives to patient compliance.

Credit Due Department:
The photo atop this post, ”4 Seasons Hotel Implosion,” was taken by Mozambique – Moments.

1. For the purposes of this post, “patient compliance model,” “treatment adherence paradigm,” and similar terms refer to any  ideas explicitly set forth by or implicit to patient compliance as  a system of thought rather than a simple statistic.  For example, the calculation of number of doses taken as prescribed divided by the total number of doses prescribed is a patient compliance statistic; the idea that noncompliance is an entity that causes patients to fail to take their medications as prescribed (not unlike miasma was thought to cause the Black Death) and that can be addressed by a simple response such as patient education is part of the “treatment adherence paradigm.”↩
2. All references, unless otherwise specified, are from Wikipedia↩
3. Those who scoff at the “logic” employed by  Hippocrates and his followers to derive this premise are urged to consider that in 2009, many and perhaps most adults still believe in the disproved idea that sweat rids the body of toxins.↩

Flag of the Surgeon General Of The U.S.

Why President Obama Should Appoint Me Surgeon General

1. It would make my mother feel better if I had a salaried job with the government.
2. I would have the opportunity to give back something to medicine and society, improve public health, embrace humanity, end world hunger, save the whales, be all that I can be, reach out and touch someone, get ‘er done, boldly go where no man has gone before, bla bla bla bla … .
3. I could really use that Federal health insurance.
4. My campaign to transform patient Compliance into a useful concept producing effective results is the only means of fulfilling President Obama’s promise to  improve the medical system and extend coverage  to significantly more people while decreasing healthcare costs other than paying doctors and hospitals in Confederate money.
5. Chicks dig a guy in uniform.

Surgeon General J.K. Barnes - Appointed by President Lincoln

It’s Magic! “Resolution 710 – Identifying Abusive, Hostile Or Non-Compliant Patients” Changed To Procedural Code Issue

OK – Resolution 710, proposed at the 2009 Annual Meeting of the American Medical Association,¹ was always technically a procedural coding issue. Heck, it’s not even an unusual sort of procedural coding issue.

The Non-Compliant Patient Coding Resolution Isn’t Quite As Bad As Some Folks Are Making  It Out To Be

The Resolution would have caused certain data to be collected in order to formulate new modifier and/or add-on  Current Procedural Terminology codes² to identify services provided for “Abusive, Hostile Or Non-Compliant Patients.”

Those modifier and/or add-on CPT codes could have two possible consequences:

1. Clinicians could use the new codes to modify their usual charges for a treatment because of the special circumstances (i.e., that the patients being served are “Abusive, Hostile Or Non-Compliant”).

This is nothing new or nefarious. Psychiatrists, for example, may charge different rates for 30 minutes of psychotherapy, depending on the setting and whether medical evaluations are included:

• Psychotherapy, 20-30 minutes; office/outpatient setting (CPT 90804)
• Psychotherapy, 20-30 minutes; office/outpatient setting with medical evaluations and management services (CPT 90805)
• Psychotherapy, 20-30 minutes; inpatient hospital, partial hospitalization or residential care setting (CPT 90816)
• Psychotherapy, inpatient hospital, partial hospitalization or residential care setting with medical evaluations and management services (CPT 90817).³
  

And, surgeons may legitimately charge more for an operation if there factors present which require substantially more work.

For example, because no CPT code exists for a revision of an arthroscopic anterior cruciate ligament (ACL) reconstruction, a physician may report CPT code 29888 (arthroscopically aided anterior cruciate ligament repair/augmentation or reconstruction) with a modifier 22. The documentation must support substantially greater work for the revision, such as increased time and technical difficulty associated with approach through adhesions/scar tissue, removal of hardware, or tendon grafting. In box 19 on the claim form, add a note that the modifier 22 supports a revision ACL with increased complexity.⁴

Resolution 710 could conceivably have led to modifier codes associated with higher compensation based on the altogether credible notion that providing some direct clinical services for “Abusive, Hostile Or Non-Compliant Patients” is more difficult than providing those same services for patients who are cooperative.⁵

It’s a bit like United Airlines charging extra for passengers too overweight to fit comfortably into an airplane seat. It may not be compassionate or humanitarian, but it can be justified on an economic basis. (It’s also worth noting that the existence of a CPT code or modifier does not mean an insurer, government agency, or individual patient will automatically honor it by paying higher fees.)

2. The new codes could lessen the impact of negative outomes on a clinician’s performance record.

Even more important than the money, however, is the concern that patients in these categories could make their physicians look bad.  This is, at least from my own hypervigilant perspective, an understandable concern. With everyone from the government to third party payors to consumer groups to rate-your-doc web sites collecting data on clinical performance, it’s easy to see how someone in the healing professions would worry about a treatment failure showing up on his or her record, not because of an error in prescribing treatment but because the patient didn’t follow instructions.

But The Non-Compliant Patient Coding Resolution Is Still Pretty Bad

First, I would have lots of questions about how “Non-Compliant Patient” would be defined, given that I have yet to find an acceptable all-encompassing definition of the term. Is anyone who misses an appointment non-compliant?  How about missing six of the last eleven appointments?⁶

Come to think of it, I’m not sure I can come up with a functional definition of “Abusive Patient” or “Hostile Patient” either.

But even as fundamental an issue as how one identifies these patients is, I suggest, secondary to the real problem.

The Real Problem – Nasty, Insulting Language

The real problem is the language and tone of the Resolution. The significant text of Resolution 710 begins

Whereas, Many patients are becoming more abusive and hostile toward physicians for many reasons not limited to the economy, increasing co-pays and deductibles, unreasonable expectations and demands, a lack of instantaneous cure, arrogance and/or the belief that they “own” their physicians;

As I noted in an earlier post, it really doesn’t get much better after that.

While I did not expect a ringing denunciation of this insulting-to-patients, embarrassing-to-doctors Resolution, I had thought it possible that a delegate would comment on the implicit message (you know, the one about “we hate patients”) conveyed by the document as presented, perhaps using filtering the criticism through the classic code so that it becomes, “The way it’s written now, it could be misinterpreted by others as insulting to patients even though I am sure Dr. Jones, who authored this Resolution, cares deeply for all his patients.”

Nope, Reference Committee G opted to mumble something about “concerns in labeling patients” and then  pass the problem to somebody else by implementing the classic technicality ploy – This isn’t my problem – this is his problem.

Here’s what happened, as excerpted from Report of Reference Committee G

RESOLUTION 710 – IDENTIFYING ABUSIVE, HOSTILE OR NON-COMPLIANT PATIENTS

Mr. Speaker, your Reference Committee recommends that Resolutions 710 not be adopted.

Resolution 710 asks that our AMA ask its CPT Editorial Panel to investigate for data collection and report back at Annual 2010 meeting:

1) developing a modifier for the E&M codes to identify non-compliant patients and/or
2) develop an add-on code to E&M codes to identify non-compliant patients.

Your Reference Committee heard limited supportive testimony on Resolution 710. The author stated that the intent of this resolution is to identify non-compliant patients, especially as there is an increasing focus on physician performance and releasing of physician data. Testimony was empathetic to the difficulty in working with non-compliant patients, but expressed concerns in labeling patients and acknowledged a desire to be sensitive to the possible mental health issues of non-compliant patients.

Testimony provided by the CPT Editorial Board stated that the appropriate forum for addressing CPT issues is through the CPT Editorial Panel process, not the House of Delegates. In addition, while there are no codes that exist to identify someone as specifically non-compliant, there are existing modifiers to identify patients who do not comply. For example, Modifier 2P (Performance Measure Exclusion Modifier Due to Patient Reasons) is available to report non-compliant patients. The list of reasons for Modifier 2P include (1) “patient declined”, (2) “economic, social, or religious reasons”, and (3) “other patient reasons”. This modifier is intended to be used with performance measure Category II codes. CPT Category II Performance Measurement codes are intended to facilitate data collection about the quality of care rendered by coding certain services and test results that support nationally established performance measures and that have an evidence base as contributing to quality patient care. These codes describe clinical components that may be typically included in evaluation and management services or clinical services and, therefore, do not have a relative value associated with them. Given that there exists an appropriate avenue to code for non-compliant patients and that this issue should be directly addressed through the CPT Editorial Panel, your Reference Committee recommends that Resolution 710 not be adopted.

Got that?  My unofficial translation follows:

Everybody knows that there are some patients so difficult that they make their doctors (and nurses and physician assistants and respiratory therapists and … ) miserable and they are capable of screwing up their own treatment. Everybody sane knows you can’t go around calling these patients nasty names. Besides, some of them have psychiatric problems, and no one wants to open that bag of worms.

Besides, the Resolution is a CPT issue.  This is the House of Delegates, not  the CPT committee. We aren’t the ones to deal with new CPT codes. In any case, there are already some codes that address these issues; they just don’t use the term, “Non-Compliant Patient,” thank goodness.

So, let’s put an end to this foolishness right now.  If the people pushing this loser want to pursue it, they can take it up with the CPT Editorial Panel.

I think I understand why this went down as it did, and I’m sympathetic to the internal  political demands the AMA and most such institutions face.

And, the Resolution was, happily, not adopted, so that’s good.

I believe, however, the AMA missed an opportunity to make it clear that the language of Resolution 710 is aberrant and does not reflect the medical community’s characterization of patients.

1. For background, see AMA Resolution On Non-Compliant Patients – What’s Up With That?↩
2. CPT codes “describes medical, surgical, and diagnostic services and is designed to communicate uniform information about medical services and procedures among physicians, coders, patients, accreditation organizations, and payers for administrative, financial, and analytical purposes.” From Wikipedia↩
3. From Answers to Common Questions About New CPT Psychotherapy Codes↩
4. From Modifier changes for 2008↩
5. Of course, I suspect I could make an equally persuasive economic case for patients paying reduced rates if they have to deal with an abusive, hostile, or noncooperative doctor.↩
6. See  Patient Compliance – So Wrong For So Long for a list of hair-splitting examples that illustrate the problem of defining noncompliance.↩

AlignMap In Cites, the tumblelog companion to this blog, offers succinctly annotated links to web sites and online material pertinent to treatment adherence.

Typically, these are brief news stories, videos of compliance enhancement devices, and summaries of treatment studies that require little explication.  In addition, AlignMap In Cites posts frequently include information sources from outside the healthcare sciences mainstream.

Some of the most recent AlignMap In Cites posts follow:

• Poison information specialists concerned about callers who don’t adhere to their advice
• A new Research Chair in Patient Adherence to Drug Therapy at the University of Saskatchewan
• A discussion of the legal and ethical aspects of withholding state of the art AIDS drugs from non-compliant patients
• An educational and behavioral change focused game promoting Adherence

Excerpts from and links to the most recent AlignMap In Cites posts are listed in the right sidebar.

In the preceding AlignMap post, AMA Resolution On Non-Compliant Patients – What’s Up With That?, I was critical of a proposed Resolution coming before the American Medical Association House Of Delegates bearing the subject line, “Identifying Abusive, Hostile or Non-Compliant Patients” and beginning

Whereas, Many patients are becoming more abusive and hostile toward physicians for many reasons not limited to the economy, increasing co-pays and deductibles, unreasonable expectations and demands, a lack of instantaneous cure, arrogance and/or the belief that they “own” their physicians;¹

And, it really doesn’t get much better after that.²

Seized this morning by an altogether atypical compulsion to be fair to the AMA,³ I found A Responsible Patient,⁴ an article by Swathi Arekapudi published in Virtual Mentor, which is published by the American Medical Association Journal Of Ethics.

This thoughtful piece addresses the term “non-compliant” in language parallel to that I used in Compliance Versus Adherence and Beyond – The War Of The Words, definitively establishing the wisdom of the author:⁵

The move from overt paternalism towards increased patient autonomy is illustrated by the change in the adjectives used by medical authorities over the course of a century to describe patients who do not follow medical advice. The terms evolved from the “vicious” and “ignorant” TB patients of the early 1900s, the “recalcitrant” after World War II, to the “non-compliant” patient that emerged in the 1970s. Ironically the term non-compliant, which was developed specifically to be a non-judgmental phrase, has been criticized for its implication that patients should necessarily follow physician recommendations. “Non-adherent” is suggested as a better term because its lacks the implication that patients must necessarily follow their physicians’ advice. No doubt this new term will face a slew of criticisms in time.

Even more pertinent to the AMA Resolution is the concluding section:

The modern patient-physician relationship is grounded in the autonomy of the patient and the need for the patient to make informed decisions. As we move away from the paternalism that formerly characterized patient-physician relationship, we see that active communication between the physician and the patient is invaluable in the patient’s informed decision making. The goal of a physician, namely to improve or maintain the health of his or her patients when possible, can be accomplished by increasing the number of patients who adhere to recommended therapy. Though collaboration and cooperation are necessary they do not necessarily put the physician and the patient on equal footing in terms of medical knowledge. But through a patient-physician relationship built on a mutual understanding of what is expected of the other, patients will be able to understand their role in their own health care. Though physicians can no longer “order” patients to follow medical instructions they must now educate patients about the medical consequences of accepting or refusing treatment. The best method for achieving the goal of patient health is open communication between physician and patient. Labeling a patient “difficult” or “non-compliant” will weaken the bond of communication between doctor and patient.

Being Fair

Despite the risk of losing my credibility as a blogger, I must admit that, while the language used and the ideas set forth in A Responsible Patient are especially well-constructed, they are otherwise far more representative of the professional literature, symposia, and AMA publications dealing with noncompliance I’ve read over the past 30-40 years than is the “Identifying Abusive, Hostile or Non-Compliant Patients” Resolution.

Further, all I know for certain about the AMA’s stance on this issue is that somebody in the Michigan delegation to the American Medical Association House Of Delegates thought this was a good idea and managed to get it to a vote of the House.

Even if, however, this embarrassment is voted down, I fear the publicity it has churned up will have negated much of the work the medical community has done in improving doctor-patient communication, the tone of which is reflected in A Responsible Patient.

This short article, well worth reading by clinicians and non-clinicians alike, is available without charge at A Responsible Patient.

1. The entire Resolution can be found at AMA Resolution On Non-Compliant Patients – What’s Up With That?↩
2. I was hoping the final paragraph would be something along the lines of “Fooled you. You’ve been punk’d.”↩
3. Full disclosure: I once belonged to the AMA. I can’t find my records, but my most recent payment of AMA dues was at least 10 years and probably closer to 20 years ago.↩
4. A Responsible Patient by Swathi Arekapudi. Virtual Mentor. April 2003, Volume 5, Number 4.↩
5. I’ve omitted references from the following  excerpts. Those footnotes are, of course, available in the original article that is available online.↩

In one of those instances of serendipity about which one hears so much, the AMA and I have each been independently engaged in changing the current perspective and policies on management of non-compliant patients.

Our proposals, it turns out, are not identical.

The result of my efforts today can be found in the preceding post, Beyond Patient Compliance: Patients Who Lie, in which I hold that

optimal treatment is most efficaciously pursued by aligning the doctor, the patient, and other stakeholders to maximize mutual trust, a strategy which takes priority over the percentage of prescribed pills taken by the patient.

The AMA Resolution

After hitting the “publish” button for that post, I checked  the patient compliance news alerts I  follow, only to discover that the American Medical Association House Of Delegates was considering Resolution 710, “Identifying Abusive, Hostile or Non-Compliant Patients,” which comes up for a vote tomorrow (June 16, 2009). The text of the resolution, taken from http://www.ama-assn.org/ama1/pub/upload/mm/475/refcomg.pdf, follows:

Resolution: 710 (A-09)
Introduced by: Michigan Delegation
Subject: Identifying Abusive, Hostile or Non-Compliant Patients
Referred to: Reference Committee G, (J. Leonard Lichtenfeld, MD, Chair)

_____________________________________

Whereas, Many patients are becoming more abusive and hostile toward physicians for many reasons not limited to the economy, increasing co-pays and deductibles, unreasonable expectations and demands, a lack of instantaneous cure, arrogance and/or the belief that they “own” their physicians; and

Whereas, There are decreasing numbers of physicians both in primary care and specialties especially in terms of access; and

Whereas, Increasing noncompliance with treatment can reflect negatively on physicians during black box audits by insurance companies and oversight governmental agencies; and

Whereas, Abusive, hostile, and noncompliant patients result in increasing office resources, adding to office overhead and added stress on all of the office personnel, which can lead to potential ill health; and

Whereas, The stress of dealing with ungrateful patients is adding to the stress of physicians leading to decreased physician satisfaction; and

Whereas, Any complaint to any oversight investigative regulatory body leads to uncompensated expenditure of time, resources, and monies to defend physicians or the “guilty until proven innocent” principal; and

Whereas, Physicians need to own the data to simplify patient collection and identification to defend themselves as well as alert outside investigating agencies to the potential nature of the patient’s records; therefore be it

RESOLVED: That our American Medical Association ask its CPT Editorial Panel to investigate for data collection and report back at Annual 2010 meeting: 1) developing a modifier for the E&M codes to identify non-compliant patients and/or 2) develop an add-on code to E&M codes to identify non-compliant patients. (Directive to Take Action)

Fiscal Note: Staff cost estimated at less than $500 to implement.
Received: 05/06/09

The Implications

I have little to say about the AMA’s Resolution, which seems all too straightforward. From others, however, there has been an  (understandably)  vehement  response to the AMA resolution.  Googling “AMA non-compliant patients” displays a  batch of these venomous criticisms of arrogant doctors.

I, of course, believe my ideas on non-compliance are far superior to  those implicit in this Resolution the AMA is considering. I’ll be publishing further posts in the near future outlining this  new vision that goes beyond Patient Compliance.

Meanwhile, I’m desperately hoping that there is an explanation for the AMA even considering a resolution that threatens, by its very language, to alienate doctors and patients, exacerbating rather than alleviating non-compliance.

Keep a watch also on the faults of the patients, which often make them lie about the taking of things prescribed.
- Hippocrates¹

Launching A Guerrilla Attack On Patient Compliance – The Battle Of Patients With Pants On Fire

The publication of  Lots Of Patients Fib, Sometimes By Accident, a  nicely done article by Karen Ravn in the June 8, 2009 LA Times about patients who  lie to their physicians  provides a circumscribed clinical scenario that  demonstrates  both the problems with the current patient compliance paradigm and the rationale for the kinds of changes necessary to transform it into a useful concept.

An excerpt from the Lots Of Patients Fib, Sometimes By Accident follows:

It’s well-known that patients don’t always do a perfect job of following — or “adhering to” — the treatment plans their doctors lay out for them. A paper published in 2004 in the journal Medical Care analyzed more than 500 studies on that matter and found that, on average, about 75% of patients met the adherence standards researchers had set.

But these figures may overestimate adherence because some patients are probably fudging. “Patients who say they always take their meds may not be,” says Dr. Steven Hahn, professor of clinical medicine at Albert Einstein College and an internist at Jacobi Medical Center in New York City.

“Patients who say they don’t always take them are likely to be missing significant amounts.”

One indication of how much people fib is how things change when they know they’re being watched.

In a 2001 study in the Journal of Hypertension, scientists followed 41 patients who had been unsuccessful in lowering their blood pressure with three prescribed drugs. Patients continued taking the same three drugs during the study, but they now knew they were being monitored electronically: The drugs came in special packages that recorded the date and time whenever they were opened.

After two months of being monitored, about one-third of the patients had lowered their blood pressure to the normal range. Chances were good, the researchers concluded, that those patients had not been taking the drugs properly before.

A number of other studies have found that patients in clinical trials sometimes “dump” their medication — i.e., simply dispose of it — so it will look as if they’ve been using it as prescribed even though they haven’t.

Also, in the above-mentioned 2000 study published in Chest, 236 patients used inhalers to take medication intended to help them breathe. The inhalers were fitted with electronic monitors that could record the date and time whenever patients used them. Not all of the patients knew about the monitoring feature.

During one year of the study, 30 of the 101 patients who did not know they were being monitored — about 30% — dumped at least once. (Dumping was defined as activating the inhaler more than 100 times within a three-hour period.)

Of the 135 patients who did know they were being monitored, only one dumped.

Most of the dumping incidents occurred just before a clinic visit, and researchers concluded that patients dumped in order to give the impression that they had used their inhalers more often than they had.

No experienced clinicians, I suspect, will be surprised by this information. And, I’ve found few non-clinicians, who, on reflection, fail to recognize that misleading a doctor about treatment adherence, whether by omission or commission, is common.

The potential consequences, however, may be less apparent.

I examined the difficulties created by patients misleading their doctors about their compliance with the prescribed treatment in an earlier post, Treatment Adherent Refusal Of Prescribed Medications.  There I pointed out the risk that the patient would undergo unnecessarily aggressive treatment:

Clinicians cannot efficaciously deal with treatment failure caused by noncompliance if they do not know that the patient did not follow the treatment plan. At best, physicians will be less efficient in providing appropriate care; at worst, they may modify the treatment with disastrous results.

Moreover, the dangers to the patient’s health and the financial cost to the patient and society can increase exponentially. Consider this example from Noncompliance Costs of a nonadherent patient who hides the noncompliance from his doctor:

A Case Of Routine & Tragic Patient Noncompliance

A patient with an respiratory infection does not complete the full course of the antibiotic prescribed by his physician. When symptoms persist, the patient returns to his doctor but fails to report the noncompliance. The physician consequently believes that the original medication was somehow inadequate (e.g., the pathogen was resistant to the medication or not covered within the therapeutic range of the medication) and prescribes a different agent, one that is more costly and more prone to side-effects.

Already in this scenario, noncompliance has resulted in

• At least one unnecessary clinic visit
• Two medications in a situation in which one might have sufficed
• A potentially erroneous shift in ongoing treatment
• An increased risk of adverse medication effects, both because the second drug causes more side-effects than the first and because the patient is exposed to two medications instead of one
• A deviation, based on misinformation, from the initial treatment plan which, by design, should provide the optimal combination of safety, affordability, and effectiveness for that patient. At best, the new treatment plan will be similar to but somehow less advantageous than the original therapy. At worst, the noncompliance-caused treatment failure will cause the clinician to mistakenly alter the diagnosis and treatment such that the actual problem is not addressed.

This example is, admittedly, oversimplified. Some disorders improve despite noncompliance with treatment. Some clinicians might have suspected noncompliance when the patient did not improve. Some patients do confess their failure to follow the treatment plan. Nonetheless, a plethora of evidence demonstrates that noncompliance clearly increases the risk of treatment failure, that clinicians rarely recognize or even suspect noncompliance, and that patients even more rarely reveal nonadherence to treatment. This example is, in fact, statistically condensed but conceptually accurate, and countless analogous cases occur every day throughout the healthcare system. …²

Because of the complexity and interdependent nature of the contemporary healthcare system, the impact of patient noncompliance is rarely limited to wasting one medical treatment that would have been successful if implemented. Instead, any treatment failure caused by noncompliance is subject to an array of multipliers, some obvious and some invisible, that can easily increase the potential fiscal, physiological, and social cost exponentially and connections, both direct and indirect, that distribute a similar range of losses to others. Moreover, the extraordinarily high value western culture places on both the individual and health heightens the stakes and further drives the process.

Not only is this a common problem and one with serious consequences but it is also one nurtured by the contemporary patient compliance model.

Patient Compliance Is A Self Defeating  Strategy

In Treatment Adherent Refusal Of Prescribed Medications, I also pointed out that the conflict between patient and clinician that is part and parcel of our perspective on patient compliance motivates the patient to lie to the doctor:

The currently prevalent models of noncompliance management have a final common pathway: their objective, their only measure of success, is the patient following the medication regimen as prescribed – whether this goal is attained by coercion, persuasion, incentives, moral appeals to responsibility or concern for ones family, patient education, or other methods. Even so-called “patient empowerment” can be accurately translated in this context as “the patient is empowered to choose to take the medication as prescribed.” Consequently, patients who do not take their medications as prescribed are powerfully but covertly encouraged to actively or passively mislead clinicians about the noncompliance, perpetuating this vicious cycle.

This realization led to what I then modestly called …

The Incredibly Revolutionary Idea

1. We quit pretending that noncompliance will disappear if patients are properly educated, persuaded, empowered, informed, motivated, coerced, bribed, threatened, influenced, or reminded. We acknowledge the obvious – that except in a few cases,³ the patient makes the final choice about following a prescribed treatment.

2. Rather than continue the unrequited efforts to eradicate noncompliance, we try, as a first step in breaking the vicious cycle, fixing that part of the healthcare system that multiplies the damage caused by noncompliance: the miscommunication between clinician and patient about noncompliance.

I went on to suggest how the reader might address this issue directly with his or her clinician, but precise tactics are, in this case, less important than the big picture, i.e., the afore mentioned Incredibly Revolutionary Idea.

Storming The Bastille

The New Order Of Things – Replacing Patient Compliance

While only one aspect of the healthcare process, the problem of patients lying about adherence does spotlight the need for and the type of change in patient compliance I am promoting.

Continuing to emphasize the requirement of adhering to a prescribed treatment regimen also continues the conflict between patient and clinician, which, in turn, encourages the patient to lie to the doctor about following treatment. Because every doctor has had the experience of patients lying to him or her, the mistrust has become pervasive. Wary doctors may well mistrust all patients since discerning who is and isn’t telling the truth is difficult and often impossible.   Consequently the entire system has become corrupted.

My contentions are (1) the goal is not good compliance by a specific patient but instead optimal treatment for each patient and (2) optimal treatment is most efficaciously pursued by aligning the doctor, the patient, and other stakeholders to maximize mutual trust, a strategy which takes priority over the percentage of prescribed pills taken by the patient.

To dismantle the patient compliance apparatus that has hindered improvements in treatment outcomes, a systemic shift in perspective is necessary.

As an integral element of that shift, the doctor must convincingly transmit to the patient that valid and reliable communication between them supersedes a compliance scorecard.

Or, I suppose we can invest in electronic compliance monitoring devices, lie detectors, and a spy network.

One option for managing patients who may be lying

By the way, we might want to consider changing the name from “lie detector” to something like “trust enhancement processor.”

1. I know – I’m tired of seeing this quotation too. It just fit so well, I felt compelled to use it.↩
2. This scene is extended beyond this point in the original example at Noncompliance Costs, . I recommend reading it in its entirety to gain a perspective on how  impressively simple it is to conjure up plausible scenarios in which initial noncompliance which is compounded by lying  about it leads to severe incapacity or death and, by extrapolation, how likely it is that this sort of thing happens with some frequency.↩
3. E.g., cases involving children or adult patients incompetent to handle their own healthcare and cases in which forced compliance with treatment is legally sanctioned and is pragmatically feasible↩

If the same principles currently prevalent in the field of patient compliance were applied to the study and management of side-effects, …

Intercosmic Journal Of Treatment Side-Effectology

Searching for the cause  of treatment side-effects & its cure

Articles

Patients  equipped with new  side-effect reduction device report  disappearance of  rashes caused by medication

Patient shown operating  Visual
Side-effect Detection Modulator

An AlignMap.com Publication – Allan Showalter, MD, Editor

I’ve published a second post, Patient Compliance – So Wrong For So Long, at the eyeforpharma.com site.

For ongoing AlignMap readers, this will be a new perspective on an old theme – the failure of the concept of patient compliance to provide reliable or valid information about a patient’s response to treatment recommendations.

Specifically, I compare the meager accomplishments in treatment adherence to the civilization-changing benefits produced in the field of epidemiology.

I also offer examples in which minor situational variations may – or may not – change ones assessment whether a given patient is compliant or noncompliant. The implicit question, of course, is how useful can the concept of compliance itself be if the significance of a patient being identified as compliant or noncompliant is nebulous.

About That Fish, The Barrel, And The Smoking Guns

Yeah, I know it seems like overkill, and it is, I admit,  a tad too easy to be enjoyable as a sport, but, after all, the current ideas about patient compliance have so far  been able to dodge bullets for decades and still survive.

More to the point,  this elaboration of the problems with patient compliance is necessary as explanation of and motivation for the changes essential for creating a functional alternative to the current thinking.

In the meantime, take a look at Patient Compliance – So Wrong For So Long if for no other reason than garnering inspiration from epidemiology’s successes and imagine what could be accomplished if we could make similar advances in patient compliance.