Tag Archives: c. everett koop

Noncompliance: a $290 Billion Problem

Noncompliance is one of the greatest challenges and opportunities for savings and improved medical outcomes.

One reason noncompliance has been such a difficult issue is its complexity. Patients don’t take their medications for a multitude of reasons. Reasons for noncompliance vary from patient to patient. That rules out a one-size-fits-all solution.

Noncompliance can be more of a challenge for workers’ compensation claims, potentially because of perceived HIPAA privacy rules. Because of an approach that appears to mirror “don’t ask, don’t tell,” little is known by many of the workers’ compensation physicians about the drugs that are being prescribed for chronic or underlying conditions to their industrially injured patients. Or, if doctors do discuss such issues with the patients, few if any include such information in their reports to the insurance companies.  Claims examiners also do not want to know about underlying medical conditions because of their fear of being roped into paying for this kind of treatment even if it may facilitate a faster recovery from an industrial injury. (Not knowing about underlying conditions, they are also limiting their ability to identify potential catastrophic claims early in the age of the claim.)

Here are some of my thoughts and commentary on noncompliance:

  • Compliance problems are one of the many reasons that the medications are doled out in a plastic weekly (with individual days) dispensing device.
  • There are many new “apps” being developed for phones and computers that are designed to insure compliance.
  • There are also new technologies being developed that will insure compliance for many of the chronic drugs. For instance, Proteus (http://www.proteus.com/) has a chip that is attached to the pill. It gives out a signal when the pill is taken. I was particularly impressed with these folks.
  • Noncompliance is also tied to pharmacy fraud. This is particularly true for physicians who are allowed to dispense out of their offices as well as for those who are involved in prescribing and dispensing opiates.
  • Compliance is significantly different for pain drugs vs. chronic drugs (such as heart medications or statins for cholesterol maintenance). We generally prefer that patients not use pain drugs unless those drugs are needed to maximize the recovery of the patient. Yet we want every patient to take the right medications at the right times to help them maintain appropriate blood pressure, sugar blood levels or anti-convulsive drugs needed to maintain a productive and healthy worker.
  • Noncompliance is one of the problems that has helped fuel the opioid epidemic. A result of the reluctance of many to take all of the pain medication that was prescribed is the filling of medicine cabinets with dangerous pain pills (which are easily accessed by children and visiting friends). One interesting comment from a good friend: “Every time I have a party, my medicine cabinet is completely cleaned out.”
  • I believe that many physicians are unable to keep up with the variety and nature of all the new drugs brought to market. This can result in poorer-quality drugs or poorly targeted drugs being prescribed, with no one the wiser. Education can be problematic with pharmacy, because there is really no independent body providing the education on the drugs.
  • In Canada, some pharmacists are allowed to prescribe as well as dispense certain drugs. There are no studies on the impact of this in prescribing or dispensing patterns. But studies in the U.S. have shown that, if there is a potential financial incentive, then more drugs are prescribed. As more baby boom doctors retire, and they are not replaced through our teaching system, more of the medical care will responsibility will be demanded of pharmacists, PAs and NPs. With more prescriptions being written by the pharmacists, compliance can be even more problematic because far less time is spent with the patients by pharmacists than by the doctors.
  • Off-label use of pharmacy is more problematic with regard to compliance because of the lack of evidence-based medicine (or any research at all) supporting the new uses of the existing drugs.
  • Blood, urine or oral swab testing for compliance is expensive and problematic but can be useful.
  • One of my favorite stories of noncompliance was the case where the prescribing physician was confronted with a blood test that demonstrated that the patient was not taking any of the prescribed (and dispensed) opiates. The doctor’s response was that the blood test proved that the patient was not abusing the drugs, and he continued to prescribe the same dose and volume for the next three months. (I believe that the patient was selling the drugs.)
  • The advent and expansion of universal medical records will assist treating physicians overcome the siloed medical approach that has existed in WC for years.
  • Some of the reasons for noncompliance are also the same reasons that we find it so hard to help injured workers recover.
  • I did not see any statistics, but I am willing to bet that noncompliance is higher with the 20% subset of population who have had ACEs (Adverse Childhood Experiences) and are the ones we have designated as at risk for delayed recovery in the workers’ compensation system.

Here is an article from Doug Benner, which is worth the read for good insight into this very complex issue:

The number of patients who are noncompliant with regard to their pharmacy usage has reached epidemic proportions, and doctors’ inability to provide optimal care as a result has mushroomed into one of the most pressing problems in healthcare today.

  • In the U.S., some 3.8 billion prescriptions are written every year, yet more than 50% of them are taken incorrectly or not at all.
  • In a survey of 1,000 patients, nearly 75% admitted to not always taking their medications as directed. A study of more than 75,000 commercially insured patients found that 30% failed to fill a new prescription, and new prescriptions for chronic conditions such as high blood pressure, diabetes and high cholesterol were not filled 20% to 22% of the time.
  • Even among chronically ill patients who regularly fill their prescriptions, only about half the doses taken are taken as their physicians intend.
  • Poor compliance accounts for 33%  to 69% of drug-related adverse events that result in hospital admissions.
  • Poor compliance with medication regimens is associated with as much as 40% of nursing home admissions.
  • In a study of more than 8,400 senior health plan enrollees, only one in three of those who began treatment with concurrent antihypertensive and lipid-lowering drugs were taking both medications as directed or at all at six months.
  • In a study of more than 240,000 patients who were given a new prescription for an antidepressant, less than 30% were still taking the medication six months later.
  • Compared with patients who follow instructions, patients who don’t take their medications as intended have a risk for hospitalization, re-hospitalization and premature death that is 5.4 times higher if they have hypertension, 2.8 times higher if they have dyslipidemia and 1.5 times higher if they have heart disease.
  • The number of patients with serious cardiac conditions who don’t take their medications is especially baffling and problematic. In a study of 34,501 patients age 65 or older, only 26% of those who began a statin regimen to reduce the risk of coronary heart disease maintained a high level of use five years later; the greatest decline occurred during the first six months of treatment.
  • Even after a life-threatening event, compliance with medication regimens remains surprisingly poor. Within two years of initiating therapy, only half of patients hospitalized for acute myocardial infarction (MI) were still taking their prescribed statins, beta-blockers, angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs).

One upshot: Poor medication compliance is implicated in more than 125,000 U.S. deaths per year.

Yet compliance — which is used interchangeably with the term “adherence,” although the latter term is gaining ground — has been exhaustively studied. More than 40,000 peer-reviewed papers on the subject have been published, “yet the rates of poor adherence have not changed significantly over the past several decades and continue to remain at an unacceptable level,” observes URAC, a healthcare accreditation organization, in a white paper prepared for industry leaders.

Or, as former Surgeon General C. Everett Koop once put it with his customary forthrightness, “Drugs don’t work in people who don’t take them.”

The $290 billion question — $290 billion being how much poor compliance is estimated to cost the U.S. healthcare system each year — is: Why?

See also: How to Pick a Health Plan (Carefully)  

An unbelievably complicated problem

One reason noncompliance has been such a tough nut to crack is its daunting complexity. Patients don’t take their medications for a multitude of reasons, many of them emanating from the murky depths of human psychology and many of which the patients (not to mention medical researchers) may not fully understand.

To complicate matters, these reasons vary from patient to patient. That rules out a one-size-fits-all solution. Internist William Shrank, MD, MSHS, chief scientific officer and chief medical officer of Provider Innovation and Analytics at CVS Caremark, has served as lead author or coauthor in more than 100 studies on patient compliance with medication. His conclusion: “There is no silver bullet.”

Researchers have analyzed the steps involved in compliance to better understand where the process breaks down. First, the patient must receive the right prescription from a doctor or another provider. The new prescription must then be filled, a seemingly simple act that can be a major barrier to compliance. The patient must then make it through the first six months on the medication, when the risk for noncompliance is highest. If the medication is for a chronic condition, it must then be taken as intended — indefinitely.

“Adherence is the result of getting through these four steps successfully,” notes the RAND Corporation, a nonprofit research organization, in a report aimed at policymakers in Washington, “and a single policy option is not going to address each of these challenges to adherence.”

To thicken the plot, a patient’s unique cluster of reasons for not complying at any given time isn’t stable. With the loss of a job, for example, medications may become unaffordable, so the patient stops taking them, cuts the pills in half to make them last longer or skips some doses.

After a divorce, job loss or any traumatic event, depression may set in; taking medication as directed may then be the last thing on the patient’s mind.

Or, a compliant patient may suffer a medication-related adverse event. As a result, she may stop taking her pills, as up to 20% of patients do because of perceived side effects.

Does the patient tell the doctor? Probably not. Why? The doctor is so busy; she doesn’t want to be a bother. Or, she doesn’t like the doctor, so this is how she retaliates. Or, she decides that her ill effects are a sign that she’s taking too many drugs, so she goes off-regimen. Or, she consults with a friend on a social networking website for patients with similar chronic conditions, and the friend advises her to try alternative medicine instead.

“Is it widely known that adherence is a cluster of behaviors and not a single construct?” asks internist John F. Steiner, MD, MPH, research director at Kaiser Permanente’s Institute for Health Research in Denver and a thought leader on medication compliance issues. “No, that’s actually a radical claim.”

It may be radical, but researchers are putting patients, doctors and the healthcare system itself under a microscope to better understand this ever-shifting cluster of behaviors and why it so often results in noncompliance. While many questions remain unanswered, here’s what has been learned to date.

Patient beliefs and behaviors are often barriers

Patients with chronic conditions may spend only a few hours a year in your office, but they spend roughly 5,000 waking hours each year living the rest of their lives. During that time, out of touch with their doctors and generally unmonitored by the healthcare system, many are allowed to quietly, invisibly slip off their regimens.

In 2009, a team of researchers at Kaiser Permanente combed through much of the vast literature on compliance and distilled the sea of data down to several important patient-related barriers. They include forgetfulness; lack of knowledge about the medication and its use; cultural, health and religious beliefs about the medication; denial or ambivalence regarding the state of their health; financial challenges; lack of health literacy; and lack of social support.

Forgetfulness is the No. 1 barrier to compliance, experts believe, although a survey of 10,000 patients found that only 24% ascribed noncompliance to forgetfulness. Up to 20% failed to take medications because of perceived side effects, 17% had cost issues and 14% didn’t feel the need to take medication because they believed it would have little to no effect on their disease.

Among patients with chronic conditions (such as high blood pressure and high cholesterol), noncompliance tends to be highest if symptoms aren’t experienced.

Myopic? Perhaps. But when doctors are patients, they tend to act just like everyone else. Steiner likes to ask an audience of physicians for a show of hands of who has ever taken an antibiotic. Many hands are raised. He then asks how many doctors took the full course of antibiotics even after their symptoms abated. Many hands go down.

Even the Sickest Patients May Not Take Their Drugs

Noncompliance is plentiful in patients who exhibit symptoms, too — even for life-threatening conditions. Not even a brush with death is enough to get some patients to stick to their regimens. According to one study, after hospitalization for acute MI, about 24% of patients still hadn’t filled their cardiac medication prescription a week after being discharged.

In another study, among patients discharged with prescriptions for aspirin, statins and beta-blockers after an episode of acute MI, about 34% stopped at least one medication and 12% stopped all three medications within a month.

A third study found that only about 40% of patients were still taking statins two years after hospitalization for acute coronary syndrome. Compliance was even lower for patients taking statins for chronic coronary artery disease.

A major reason why many patients go off-regimen is the cost of drugs. But even when patients are given drugs gratis, compliance improves only slightly. One much-discussed study looked at 2,845 Aetna health plan members discharged from the hospital after an acute MI episode who were given all of their drugs — statins, beta-blockers, ACE inhibitors, ARBs — for free. That was then compared with 3,020 Aetna enrollees who had the usual prescription coverage. In the usual-coverage group, compliance rates were 36% 49%. But without the cost barrier, the rates were only 4% to 6% higher.

What could account for this underwhelming result? Could depression play a role? Although the investigators noted cardiac-related comorbidities of patients at baseline, they didn’t ask about depression. Yet a meta-analysis of 31 studies that collectively included 18,000 people found that depressed patients with a variety of chronic illnesses, including diabetes and heart disease, had 76% greater odds of being noncompliant compared with patients who weren’t depressed.

At least you can understand why depressed patients may lack the motivation to stay on regimen, but, confoundingly, so do many patients who aren’t depressed. As Shrank and cardiologist Lisa Rosenbaum, MD, noted in a 2013 paper:

“Though patients may be forthcoming about the more practical challenges (to adherence), the psychological barriers are tougher to identify and articulate. Patients don’t generally tell their physicians, ‘Every time I look at that pill bottle, it reminds me that I’m ill,’ or ‘I tend to discount future benefits as long as I feel well today.’ Such underlying psychological mechanisms probably contribute to nonadherence far more than we realize and help explain why existing interventions have brought only modest improvements.”

In reality, however, the teamwork concept isn’t working out too well. One reason is a chronic lack of time. The mean duration of a primary care visit ranges from 7.6-17.6 minutes. To be efficient, the doctor must control the conversation, with less time for listening and discussing topics such as medication reviews and preventive care.

Even if more time were available, it’s not what every patient wants. In one study of doctor-patient relationships, behavioral economists used game-theory techniques to identify the factors affecting treatment decisions in patients with a life-threatening disease — in this case, breast cancer — who were considering adjuvant therapy. They found that when patients disregarded their doctor’s treatment recommendations, the doctors responded by telling them in more detail about the benefits of treatment. However, this produced a perplexing result: The more information the patients received, the less likely they were to be compliant.

The researchers conceded that, “Patients want more specific disease and treatment information,” but “the provision of this information might lead to therapy decisions which diverge from the physicians’ recommendations.”

But the larger problem is that too little information is offered to patients who want — and need — more. The average time that a doctor spends discussing all aspects of a newly prescribed medication is a mere 49 seconds. Surveys show that no medication instructions are given by physicians in 19% to 39% of prescriptions; in observational studies, 17% to 25% of prescriptions are not accompanied by instructions from the doctor. For a new prescription, doctors discuss dosing directions in fewer than 60% of cases and review potential adverse events — a major reason why patients quit taking their drugs — only 33% of the time.

Nor do busy doctors typically have the time or skill to sit down with a patient and tease out his or her unique personal barriers to compliance, which is why so much of their advice goes in one ear and out the other, contends behavioral psychologist Kim Lavoie, PhD, associate professor at the University of Quebec at Montreal, co-director of the Montreal Behavioral Medicine Centre and an expert on motivating patients to stick to their regimens.

“Health is not necessarily the patient’s main priority,” Lavoie observes. “If you have a 40-year-old woman who smokes, and you want to get her to quit, what’s likely to be her No. 1 concern? The answer,” she says, “is weight gain. If the conversation doesn’t address that obstacle, my prediction is that she’s not going to quit.”

The authors of a paper that analyzes the doctor-patient interaction note, “Doctors’ communication style can positively influence (patient) beliefs and therefore lead to better adherence to recommendations. However, they are often unable to understand differences in patient preferences regarding information and participation during consultations. They often fail to listen to patients and explore their views on their disease and medication.”

Explore their views? Who has the time for that? But doctors’ failure to listen may not be just a function of time. Doctors, after all, are also psychological beings, who may, at times, act irrationally in counterproductive ways.

“The doctor, just as the patient, also experiences feelings during the consultation such as anxiety or anger, which have been shown to decrease the overall satisfaction of both parties with the consultation and also the patient’s adherence to recommendations,” researchers have discovered.

See also: Is the ACA Repeal Taking Shape?  

Conflicting perspectives on compliance

When you prescribe drugs for patients with chronic conditions or advise them to go on a diet, it’s natural to assume that because patients come to you as their medical expert you share the same goal: the patients’ long-term health.

But this may not be the case. In fact, doctors and patients tend to have conflicting perspectives on the burden of adhering to the medication and lifestyle regimens the doctors prescribe. Doctors “want to maximize patients’ health outcomes in the future and are less interested in patients’ anticipatory feelings in the present,” one paper points out.  Patients “put more weight on leading an easier life now rather than thinking of the consequences of their future health status.”

It might be easier to bridge this gap if the doctor-patient relationship still had the influence it once did, but with many patients switching health plans — and, often, doctors — on a yearly basis as premiums are raised, the relationship now is often perfunctory. The more patients you are forced to see to pay the bills, the less time you have to explore and address patient barriers to compliance.

Too-brief visits with doctors and leaving with more questions than answers may be a reason why many patients seek medical advice elsewhere. The prospect of patients visiting healthcare websites (where the quality of information can be highly variable) rather than trusting doctors to know what they’re doing may make smoke come out of your ears. But now patients are visiting social networking sites, specifically for patients with chronic diseases, where they compare notes. They discuss their medications, dosages and adverse events with each other, give each other advice and often take that advice.

One study found that 55% of patients rely entirely on their physician to make treatment decisions. That means 45% are seeking advice elsewhere. In another study, 68% of patients turned to other sources to validate information received from their doctors. These other sources, needless to say, aren’t other physicians.

Even when doctors take the time to explain things to patients, many patients have little or no idea of what the doctors are talking about. Nearly half of all adults in the U.S. — 90 million people — have trouble understanding what the doctor tells them about why they are sick and about how to adhere to medication regimens, according to the Institute of Medicine.

“Each patient, in reality, has his or her own unique barriers, which can vary by disease and medication,” a team of RAND researchers concluded. “Programs for improving adherence must find a balance between ‘customized’ interventions and effective programs that work for large groups or classes of patients.

“This is not to say that society needs thousands of different programs for each barrier,” the researchers continued, “but it needs programs that can identify these barriers and take the diversity of individuals and barriers into account.”

We are not there yet.

Medication regimens can be too complicated

It’s easy to lose sight of the fact that, especially when doctors are dashing off prescriptions every 15 minutes, the drug regimens being prescribed — even though they may be evidence-based — may not be easy for patients to follow, even if they wanted to.

In a 2012 paper, Kaiser Permanente’s John Steiner calculated how many behaviors per year are required of a hypothetical 67-year-old patient with well-controlled hypertension, diabetes and hyperlipidemia. It came to more than 3,000 behaviors. “And that’s a conservative estimate,” he says.

Writing in the New York Times, internist Danielle Ofri, MD, associate professor of medicine at New York University School of Medicine, told of a small experiment she conducted with a group of medical students. They wrote up prescriptions for several common medications: metformin, furosemide, albuterol, lisinopril and rantidine. Each student received two prescriptions and two boxes of Tic Tacs and was instructed to take the “medicines” for a week.

“When we met for our next session, I asked them how they did, and they all had abashed expressions on their faces,” Ofri writes. “Not one was able to take every single pill as directed for seven days.”

Compliance, it turns out, is inversely proportional to the number of times a patient must take medication each day. For medication taken only once daily, the average compliance rate is nearly 80%; for medication that must be taken four times a day, the average rate drops to about 50%.

See also: Potential Key to Tackling Opioid Issues  

One study found that the average patient who takes a statin for dyslipidemia currently takes a total of 11 medications, makes five pharmacy visits over a three-month period and synchronizes — that is, picks up multiple prescriptions at the same time — just half of his or her refills. However, 10% of statin users take 23 or more medications, make 11 or more pharmacy visits to two or more pharmacies over 90 days, have four or more prescribers and only synchronize 10% of their refills.

Picture a Medicare patient whose memory may not be what it once was and who may lack the social support to get to the pharmacy regularly trying to adhere to all of this.

“We’re asking patients to adopt obsessive-compulsive behavior,” admits internist Edmund Pezalla, MD, MPH, national medical director of Pharmacy Policy and Strategy for the health insurer Aetna. “Taking medication every day is hard to do. We’re asking people to deal with the same boring situation over and over again. We’re not programmed to do that. Machines do that. Humans don’t do it very well.”

Fragmented care is a culprit

Even if doctors had more time to spend with patients and if patients were more willing to take their doctors’ advice, the healthcare system creates numerous obstacles to subvert their efforts. A major obstacle is fragmented care.

“In decades past, community-based physicians not only authorized a patient’s admission to the hospital, they performed regular hospital rounds, supervised overall patient care and authorized the patient’s discharge,” notes a report by the New England Health Policy Institute (NEHI). “In theory, medication management was seamless because the admitting physician, the discharging physician and the ‘receiving’ physician in the community were the same individual.”

That’s not the situation today. Patients with chronic conditions now see primary doctors, who, in turn, refer them to specialists. If the patients are hospitalized, a hospitalist likely as not will take over their care. Many patients are discharged, not to their homes, but to long-term acute care hospitals, inpatient rehabilitation hospitals or skilled nursing facilities, where more doctors will prescribe medications for them.

“Transferring patients from short-term acute care hospitals to post-acute providers increases the number of times information needs to be passed between providers and increases the opportunity for errors and medication errors in particular,” the NEHI report points out.

Other systemic barriers to compliance include lack of access to healthcare, inconvenience in obtaining prescription refills, wide variations in the cost of the same drugs from one health plan to another and pharmacy policies that limit prescription size and require frequent refills.

Access to pharmacy data is a problem

Even in accountable care organizations and integrated delivery systems, with resources far beyond those of the average doctor, care teams typically lack access to pharmacy data, such as the rate at which a prescription is filled and refilled by a given patient. If you knew which of your patients weren’t picking up their drugs, you would know who needs help with medication compliance.

“For patients with coexisting conditions who take multiple medications prescribed by multiple physicians, there is a vital need to reconcile the prescribed regimen with what a patient is actually taking and to understand why there is a difference between the two,” note David M. Cutler, PhD, and Wendy Everett, ScD, in a 2010 paper. “But optimizing and reconciling medications require substantial investments of time by a skilled healthcare practitioner, as well as electronic data sharing among practitioners — neither of which is widely available in today’s model of healthcare delivery.”

Even if time, skill and electronic-data-sharing were widely available, the complexity of each patient’s barriers and the ever-shifting nature of those barriers would probably still thwart many efforts to improve medication compliance.

“Although the multifactorial nature of nonadherence means there will never be a one-size-fits-all solution, interventions ranging from education to elimination of selected copayments to telephone-based counseling have achieved modest improvements in clinical trials,” Rosenbaum and Shrank point out. “But even if we had more robust interventions,” they write, “we’d lack simple, cost-effective ways of targeting the right intervention to the right patient.”

Why research hasn’t been more helpful

Advances in medicine generally stem from peer-reviewed studies that produce statistically compelling, evidence-based data for doing one thing or another. The more studies, the better and more refined the evidence — or so one would think.

This hasn’t, by and large, been the case with compliance. The ocean of data on the subject has stubbornly resisted attempts at synthesis into a statistically compelling, evidence-based, systematized plan or plans of action for overcoming barriers to compliance across a range of patients, drugs and diseases.

A 2007 Cochrane review of interventions for enhancing medication compliance didn’t mince words: “With the astonishing advances in medical therapeutics during the past two decades, one would think that studies of the nature of non-adherence and the effectiveness of strategies to help patients overcome it would flourish,” the authors wrote. “On the contrary, the literature concerning interventions to improve adherence with medications remains surprisingly weak.”

“There probably is a set of general principles that might emerge from the literature,” suspects Kaiser Permanente’s John Steiner, “but they’re not intuitively evident because of the way the studies are designed and carried out.”

Even the definition of compliance is subject to debate. Is compliance mainly taking one’s medications as instructed — a narrow definition adopted by most researchers because it simplifies research to study only one variable at a time, even if it sacrifices environmental complexity? Or should the definition be broader: “The extent to which a person’s behavior — taking medication, following a diet or executing lifestyle changes — corresponds with the agreed recommendations from a healthcare provider,” as WHO maintains?

Steiner tells of his 93-year-old father, who embodies this definitional dilemma: “He discovered to his great delight that, as long as he took his statin, he could eat anything he wanted,” Steiner says. “By being adherent with his medication, he didn’t need to be adherent with his diet. Those are different adherence behaviors, but, in his case, one trumps the other.”

“The problem is with the way the scientific literature evolves,” Steiner reflects. “It’s reductionistic. You want to do a study on adherence with antihypertensive drugs, for example, and you disregard the six other drugs that the patient is taking.

“That can make the literature seem fragmented,” he says. “We don’t tackle the adherence problem at the patient level. We tackle it at the drug or disease level. It’s easier to study at that level. Measurements are easier. Costs are lower.”

How much compliance is enough?

The Centers for Medicare and Medicaid Services has introduced uniform standards for compliance outcomes with its five-star rating system for Medicare Advantage plans. The top rating is awarded to plans that achieve 70% to 80% compliance in hyperlipidemia, hypertension and cholesterol management in their members.

But this raises another niggling issue: From a population-based perspective, how much compliance is enough? Setting optimal compliance rates across the board at 80% is arbitrary and potentially counterproductive, Steiner believes.

“There’s almost no evidence that can allow us to set those sorts of thresholds in a scientific way,” he asserts. “For example, for first-generation antiretroviral drugs, studies showed that you needed adherence of 95% or greater to knock out the virus. An 80% adherence threshold would not have been stringent enough for those old drugs.

See also: EpiPen and the Prescription Crisis  

“The converse is also true. Years ago, when rheumatic fever was common, doctors prescribed penicillin to knock out strep throat, because that triggered rheumatic fever. However, studies showed that you only probably needed to take a third of the doses to knock out all the strep. So for that kind of situation, 30% to 40% adherence was probably just fine. If it were 80%, you would increase the risk for side effects, as well as the cost, without increasing the clinical benefit.”

In the Annals of Internal Medicine in 2012, Steiner writes, “If lower levels of adherence are sufficient to achieve clinical goals, pursuit of higher adherence is wasteful. And if higher levels are required, even these adherence targets will not suffice.”

Moderate progress on compliance issues

Despite a tsunami of unanswered questions, the enormous amount of research that has gone into compliance has not been a waste of time. On the contrary, it has produced some valuable insights. The second article in this series looks at the healthcare industry’s initiatives to improve compliance on the basis of this research.

With more than 40,000 peer-reviewed studies on the subject conducted over several decades, you’d think we’d at least be at Compliance 2.0 by now in the state of our knowledge. In reality, it’s more like Compliance 1.5. We aren’t on the verge of solving this immensely complex problem. The outlines of what is, at best, a partial solution are only just starting to emerge.

Despite moderate progress, “The heterogeneity in how adherence is assessed, measured and defined is a major limitation to the data on barriers of adherence,” investigators at RAND concluded in 2009.

That continues to be the case.

A Proposed Code of Conduct on Wellness

So many wellness industry misdeeds to expose, so little room on the internet.

This posting will start out as one of my typical shock-and-awe postings featuring a wellness vendor raising the bar for dishonesty and employee harms. Uniquely, though, we will close with a surprisingly uplifting slam-bang conclusion that could change the wellness industry forever…but only with your help.

The Bad News

It’s that time of year again, when traditionally the C. Everett Koop Award Committee bestows an award upon a fellow committee member or award sponsor, in recognition of doing the best job of fabricating dramatic savings while making only trivial improvements in employee health. That’s par for the course, and isn’t even news any more.

See also: The Yuuuuge Hidden Costs of Wellness

However, this year, the Koop Award Committee apparently decided that actually improving employee health was too high a bar for a wellness program to clear, so the committee gave the award to a committee colleague, Wellsteps, for a program in which the health status of Boise School District employees deteriorated. We’ve done the arithmetic so you don’t have to. The award application below shows that 5,293 employee biomarkers improved, while 6,397 got worse.

Screen Shot 2016-08-14 at 7.46.59 PM

In addition to the objective failure of the program, consider employee self-reported health. The single most important question to ask to gauge the state of someone’s health is: “How is your health?” Wellsteps buried the answer to that question at the end of a long list, but squint hard enough and you can see that Boise employee self-reported health status declined, by a small but statistically significant (p=0.0007) amount:

Screen Shot 2016-08-14 at 7.48.39 PM

There are many other problems with this program, too. Wellsteps is shaming even the lightest drinkers, attributing massive savings to improved health despite the deterioration in health, suppressing data showing increased health spending and flouting clinical guidelines. All that is covered in this Linkedin Pulse.

In all fairness, here is the response from Wellsteps’ Troy Adams (best known in the wellness industry for posting that ”It’s fun to get fat, and it’s fun to be lazy”) to my initial observations that Wellsteps is harming employees and fabricating savings. Surprisingly, I agree with both points:

  1. Yes, the Wellsteps data is “rock solid;” and,
  2. Yes, having just walked into from 92-degree heat, I am at least temporarily full of “hot air.”

The Good News

Fabricating savings is part of the Koop Award DNA, but bestowing an award on a vendor that actually harmed employees crosses a bright red line. Rather than complaining about it (or more accurately, in addition to complaining about it), I thought it might be time to take steps to prevent this type of performance from being considered acceptable, let alone prizeworthy.

So I convened a group, including WELCOA‘s respected and forward-thinking new CEO, Ryan Piccarella, and leading wellness gurus Jon Robison and Rosie Ward of Salveo Partners. Together, we crafted a very simple and minimalist Code of Conduct. (I don’t want to take more than my share of the credit. This was a joint effort. I just happened to be the one who initiated the email chain.) In full, it appears below. It is definitely “minimalist,” a Code of the first-do-no-harm variety. And yet, as low a threshold as it is, many vendors – including Wellsteps and many previous Koop Award winners – would not be able to meet it.

What we would ask of ITL’s readership is:

  1. Circulate this posting/the Code widely;
  2. As brokers or customers, insist that your vendor(s) follow the Code of Conduct…and add it as an actual contractual term;
  3. As brokers or vendors, announce that you will be following the Code. (While this blog is my own effort, I am also affiliated with Quizzify. Quizzify will be announcing this week that it intends to make this Code of Conduct a contractual term, meaning that failing to adhere to it would constitute a breach of our obligations under the contract.)

The Employee Health Program Code of Conduct

Our organization resolves that its program should do no harm to employee health, corporate integrity or employee/employer finances. Instead, we will endeavor to support employee well-being for our customers, their employees and all program constituents.

Employee Benefits and Harm Avoidance

Our organization will recommend doing programs with/for employees rather than to them, and will focus on promoting well-being and avoiding bad health outcomes. Our choices and frequencies of screenings are consistent with U.S. Preventive Services Task Force (USPSTF) and CDC guidelines and Choosing Wisely.

See also: Wellness Promoters Agree: It Doesn’t Work  

Our relevant staff will understand USPSTF guidelines, employee harm avoidance, wellness-sensitive medical event measurement and outcomes analysis.

Employees will not be singled out, fined or embarrassed for their health status.

Respect for Corporate Integrity and Employee Privacy

We will not share employee-identifiable data with employers and will ensure that all protected health information (PHI) adheres to HIPAA regulations and any other applicable laws.

Commitment to Valid Outcomes Measurement

Our contractual language and outcomes reporting will be transparent and plausible. All research limitations (e.g., “participants vs. non-participants” or the “natural flow of risk” or ignoring dropouts) and methodology will be fully disclosed, sourced and readily available.

Are Obamacare Wellness Programs Soon to Be Outlawed?

The Equal Employment Opportunity Commission (EEOC) filed suit Aug. 20 against a Wisconsin company, Orion Energy Systems, which severely penalized and then fired an employee who refused to participate in the type of wellness program now encouraged by the Affordable Care Act. The EEOC is arguing that there was “no business necessity” for this program and that the exam and other intrusive screening were “not job-related.”

If the EEOC were to prove that the standards it cites (part of the Americans with Disabilities Act) apply to wellness programs, this has strong implications for the Insurance Thought Leadership community. This could spell the end of workplace wellness generally, and specifically could expose your clients with penalty-based or mandatory medical wellness programs to similar lawsuits.

Although the White House is probably hoping the EEOC loses, winning this suit should be a layup. It can easily be shown that medical wellness programs are not job-related and have no business necessity. Quite the contrary, the three most basic provisions of “medicalizing” the workplace with wellness — health risk assessments (HRAs), biometric screens and enforced doctor visits — are more likely to harm employees than benefit them.

HRAs makes employees disclose things like whether they routinely examine their testicles (which men are not supposed to do) or whether women intend to become pregnant. These HRAs then also give feedback with no basis in medicine, such as recommending a prostate cancer test that the federal government strongly advises against and perpetuating the myth that all women under 50 should get regular mammograms.

Biometric screens pose an even greater risk to health than HRAs. Although medical societies are urging fewer screenings to avoid overdiagnosis and overtreatment, employer human resource departments can’t get enough of them, thanks to incentives created by Obamacare. The inevitable consequence: More people identified for “early intervention” to treat clinically insignificant conditions. For instance, an overzealous Nebraska colonoscopy screen caused the state’s vendor to trumpet that it saved the lives of 514 state employees who never had cancer in the first place. Yet instead of calling for an investigation, the state promoted this and other equally fallacious results successfully enough to win their program  the C. Everett Koop wellness award.

Biometric screens usually include weigh-ins and penalties for refusing to participate (or, sometimes, for not losing weight). Shaming people into losing weight is unhealthy and unproductive, and body image issues reinforced by workplace “biggest loser contests” affect 20 million women and can be fatal.  Meanwhile, weight has only a slight effect on health spending during the working years, and, if economic incentives could generate sustained weight loss, Oprah Winfrey would have kept her weight off instead of giving up her lucrative Optifast endorsement contract. Medical science has no clue what causes obesity. Some novel theories are being proposed, but, whatever the cause, Obamacare-inspired fines are not the cure.

Forcing employees to go to the doctor when they aren’t sick is perhaps the most curious and expensive wellness requirement. The clinical literature is quite clear about the futility of this custom, which may do more harm than good. Obviously checkups can’t save money if all they do is increase diagnoses and treatments with no offsetting benefit to actual health. Perhaps employee checkups are job-related in a few fields – public safety, airlines, sports, adventure travel – but otherwise it’s hard to see how worthless checkups improve an employee’s ability to answer the phone or do most other typical job-related tasks.

The ADA standard is “business necessity,” meaning these hazards and punishment might be acceptable if money was being saved or morale was being improved, but – as the book Surviving Workplace Wellness shows, quite the opposite is true. No wellness vendor has ever shown savings that weren’t obviously made up, and most won’t defend their own claims. Even Nebraska somehow “found” huge savings despite all these unnecessary cancer treatments and no meaningful change in employee health, savings claims that their vendor now refuses to defend. Further, the wellness industry’s own recently published analysis shows no savings.

Likewise, morale impacts are so negative that CVS and Penn State employees rose up in revolt against them. Increasing employee resistance also explains why employers have needed to almost triple fines since 2009 (now averaging $594) against employees who refuse to allow their companies to pry, poke and prod them.

Perhaps Orion Energy’s defense could be that trying to control employee health behaviors and fining employees who eat too many Twinkies is a “business necessity” because it shows employees who’s the boss. There is, after all, no provision in employment law that requires employers to be nice.

That defense might win the suit but also generate some headlines worthy of late-night talk shows.  Still it’s hard to imagine any other defense succeeding.

Insurance brokers and consultants need to follow developments closely. If the suit succeeds, you’ll need to caution your clients to scale back on “playing doctor” with employees, and certainly on penalties for non-compliance. Orion’s penalty was draconian – a few hundred dollars in fines is probably still OK. Focusing wellness efforts on less sexy issues like serving healthy food and getting employees to exercise more should also keep your clients out of trouble.

The worst development would be a flood of these lawsuits, but we at ITL will follow up with what you can do to avoid being one of the targets.

The Wellness Industry Pleads the Fifth

The wellness industry’s latest string of stumbles and misdeeds are on the verge of overwhelming the cloud’s capacity to keep track of them.

First, as readers of my column may recall, is the C. Everett Koop Award Committee’s refusal to rescind Health Fitness Corp.’s (HFC’s) award even after HFC admitted having lied about saving the lives of 514 cancer victims. (As luck would have it, the “victims” never had cancer in the first place.) Curiously, HFC’s customers have won an amazing number of these Koop awards, which are given for “population health promotion and improvement programs.” Why so many, you might ask? Is HFC that good? Well, HFC is not just a winner of the Koop Award. HFC is also a major sponsor. Perhaps it was an oversight that HFC omitted this detail from its announcement that both Koop Awards were won by its customers for 2012.

Second, the American Heart Association (AHA) recently announced its guidelines for workplace screenings. They call for much more screening than the U.S. Preventive Services Task Force does. As it happens, the AHA guidelines were co-written by a senior executive from Staywell, a screening vendor. Not just any vendor, but one that had already been caught making up outcomes.

Third, although the American Journal of Health Promotion published a meta-analysis that showed a degree of integrity rare for the wellness industry, it then hedged the conclusion. The analysis showed that high-quality studies on wellness outcomes demonstrated “a negative ROI in randomly controlled trials.” But the journal then added that invalid studies (generally comparing active, motivated participants to non-motivated non-participants) showed a positive return. The journal said that if you averaged the results of the invalid and the valid studies you got an ROI greater than break-even. However, the averaging logic leading to that conclusion is a bit like “averaging” Ptolemy and Copernicus to conclude that the earth revolves halfway around the sun.

How does the wellness industry respond to criticisms like these three? It doesn’t. The industry basically pleads the Fifth.

The industry knows better than to draw attention to itself when it doesn’t control the agenda. The players know a response creates a news cycle, which they will lose — and that absent a news cycle no one other than people like you are going to read my columns and notice these misdeeds.

One co-author of the AHA guidelines wrote to my Surviving Workplace Wellness co-author, Vik Khanna, and said the AHA would respond to our “accusation” but apparently thought better of it when the lay media didn’t pick up the original story.  (As a sidebar, I replied that saying a screening vendor was writing the screening policy was an “observation,” not an “accusation,” and recommended the editors check www.dictionary.com to see the difference.)

Similarly, in the past, I have made accusations and observations about the wellness industry both in this column and on the Health Care Blog…and gotten no response. So to make things extra easy for these folks, I dispensed with statements that needed to be rebutted. Instead, I asked some simple questions. I said I would publish companies’ responses, which would create a great marketing opportunity for them…if, indeed, their responses appealed to readers.

I posted the questions on a new website called www.theysaidwhat.net.  I got only one response, from the Vitality Group. The other wellness companies allowed the questions to stand on their own, on that site.

To ferret out responses, I then did something that has probably never been done before: I offered wellness companies a bribe…to tell the truth. I said I’d pay them $1,000 to simply answer the questions I posted about their public materials, which would take about 15 minutes.( If someone makes me that offer, I ask, “Where do I sign?” but I’m not a wellness vendor.)

Here’s how easy the questions are: Recall from a previous ITL posting that Wellsteps has an ROI model on its website that says it saves $1,358.85 per employee, adjusted for inflation, by 2019 no matter what you input into the model as assumptions for obesity, smoking and spending on healthcare. The company claims this $1,358.85 savings is based on “every ROI study ever published.” Compiling all those citations would require time, so I merely asked the company to name one little ROI study that supports this $1,358.85 figure. Silence.

I asked similar questions (which you can view on the click-throughs) to Aetna, Castlight, Cigna, Healthstat, Keas (which wins style points for the most creative way to misreport survey data), Pharos, Propeller Health, ShapeUp, US Corporate Wellness and Wellnet, as well as their enablers and validators, Mercer and Milliman. Propeller and Healthstat responded — but didn’t actually answer the questions. Healthstat seems to say that rules of real math don’t apply to it because it prefers its own rules of math. Propeller – having released the completely mystifying interim results of a study long before it was completed – said it looks forward to the study’s completion and didn’t even acknowledge that questions were asked.

In all fairness, one medical home vendor sent a response expressing a seemingly genuine desire to understand or clarify issues with its outcomes figures and to possibly improve their validity (if, indeed, they are invalid). As a result, I am not adding the vendor to this site; the idea is not to highlight honest and well-intentioned vendors. (The company would like its name undisclosed for now, but if anyone wants to contact it, just send me an email, and I will pass it along to the company for response.)

Likewise, there are good guys – Towers Watson and Redbrick, despite their high profiles, managed to stay off the list by keeping their hands clean (or at least washing them right before inspection). Allone, owned by Blue Cross of Northeastern Pennsylvania, even had its outcomes validated and indemnified. I will announce more validated and indemnified vendors in a followup posting.

As for the others, well, I am not saying that their historic and continuing strategy of pleading the Fifth when asked to explain themselves means that they know their statements are wrong. Nor am I saying that they are liars, idiots or anything of the sort. Something like that would be an “accusation.” Instead, I am merely making an “observation.”

It isn’t even my observation. It is credited to Confucius:  “A man who makes a mistake and does not correct it, is committing another mistake.”