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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.

11 Questions for Ron Goetzel on Wellness

We thank Ron Goetzel, representing Truven Health and Johns Hopkins, for posting on Insurance Thought Leadership a rebuttal to our viral November posting, “Workplace Wellness Shows No Savings.” Paradoxically, while he conceived and produced the posting, we are happy to publicize it for him. If you’ve heard that song before, think Mike Dukakis’s tank ride during his disastrous 1988 presidential campaign.

Goetzel’s rebuttal, “The Value of Workplace Wellness Programs,” raises at least 11 questions that he has been declining to answer. We hope he will respond here on ITL. And, of course, we are happy to answer any specific questions he would ask us, as we think we are already doing in the case of the point he raises about wellness-sensitive medical events. (We offer, for the third time, to have a straight-up debate and hope that he reconsiders his previous refusals.)


(1)    How can you say you are not familiar with measuring wellness-sensitive medical events (WSMEs), like heart attacks? Your exact words are: “What are these events? Where have they been published? Who has peer-reviewed them?” Didn’t you yourself just review an article on that very topic, a study that we ourselves had hyperlinked as an example of peer-reviewed WSMEs in the exact article of ours that you are rebutting now? WSMEs are the events that should decline because of a wellness program. Example: If you institute a wellness program aimed at avoiding heart attacks, you’d measure the change in the number of heart attacks across your population as a “plausibility test” to see if the program worked, just like you’d measure the impact of a campaign to avoid teenage pregnancies by observing the change in the rate of teenage pregnancies. We’re not sure why you think that simple concept of testing plausibility using WSMEs needs peer review. Indeed, we don’t know how else one would measure impact of either program, which is why the esteemed Validation Institute recognizes only that methodology. (In any event, you did already review WMSEs in your own article.) We certainly concur with your related view that randomized controlled trials are impractical in workplace settings (and can’t blame you for avoiding them, given that your colleague Michael O’Donnell’s journal published a meta-analysis showing RCTs have negative ROIs).

(2)    How do you reconcile your role as Highmark’s consultant for the notoriously humiliating, unpopular and counterproductive Penn State wellness program with your current position that employees need to be treated with “respect and dignity”? Exactly what about Penn State’s required monthly testicle check and $1,200 fine on female employees for not disclosing their pregnancy plans respected the dignity of employees?

(3)    Which of your programs adhere to U.S. Preventive Services Task Force (USPSTF) screening guidelines and intervals that you now claim to embrace? Once again, we cite the Penn State example, because it is in the public domain — almost nothing about that program was USPSTF-compliant, starting with the aforementioned testicle checks.

(4)    Your posting mentions “peer review” nine times. If peer review is so important to wellness true believers,  how come none of your colleagues editing the three wellness promotional journals (JOEM, AJPM and AJHP) has ever asked either of us to peer-review a single article, despite the fact that we’ve amply demonstrated our prowess at peer review by exposing two dozen fraudulent claims on They Said What?, including exposés of four companies represented on your Koop Award committee (Staywell, Mercer, Milliman and Wellsteps) along with three fraudulent claims in Koop Award-winning programs?

(5)    Perhaps the most popular slide used in support of wellness-industry ROI actually shows the reverse — that motivation, rather than the wellness programs themselves, drives the health spending differential between participants and non-participants. How do we know that? Because on that Eastman Chemical-Health Fitness Corp. slide (reproduced below), significant savings accrued and were counted for 2005 – the year before the wellness program was implemented. Now you say 2005 was “unfortunately mislabeled” on that slide. Unless this mislabeling was an act of God, please use the active voice: Who mislabeled this slide for five years; where is the person’s apology; and why didn’t any of the analytical luminaries on your committee disclose this mislabeling even after they knew it was mislabeled? The problem was noted in both Surviving Workplace Wellness and the trade-bestselling, award-winning Why Nobody Believes the Numbers, which we know you’ve read because you copied pages from it before Wiley & Sons demanded you stop? Was it because HFC sponsors your committee, or was it because Koop Committee members lack the basic error identification skills taught in courses on outcomes analysis that no committee member has ever passed?


(6)    Why doesn’t anyone on the Koop Committee notice any of these “unfortunate mislabelings” until several years after we point out that they are in plain view?

(7)    Why is it that every time HFC admits lying, the penalty that you assess — as president of the Koop Award Committee — is to anoint their programs as “best practices” in health promotion? (See Eastman Chemical and Nebraska in the list below.) Doesn’t that send a signal that Dr. Koop might have objected to?

(8)    Whenever HFC publishes lengthy press releases announcing that its customers received the “prestigious” Koop Award, it always forgets to mention that it sponsors the awards. With your post’s emphasis on “the spirit of full disclosure” and “transparency,” why haven’t you insisted HFC disclose that it finances the award (sort of like when Nero used to win the Olympics because he ran them)?

(9)    Speaking of “best practices” and Koop Award winners, HFC’s admitted lies about saving the lives of 514 cancer victims in its award-winning Nebraska program are technically a violation of the state’s anti-fraud statute, because HFC accepted state money and then misrepresented outcomes. Which is it: Is HFC a best practice, or should it be prosecuted for fraud?

(10)    RAND Corp.’s wellness guru Soeren Mattke, who also disputes wellness ROIs, has observed that every time one of the wellness industry’s unsupportable claims gets disproven, wellness defenders say they didn’t really mean it, and they really meant something else altogether. Isn’t this exactly what you are doing here, with the “mislabeled” slide, with your sudden epiphany about following USPSTF guidelines and respecting employee dignity and with your new position that ROI doesn’t matter any more, now that most ROI claims have been invalidated?

(11)    Why are you still quoting Katherine Baicker’s five-year-old meta-analysis claiming 3.27-to-1 savings from wellness in (roughly) 16-year-old studies, even though you must be fully aware that she herself has repeatedly disowned it and now says: “There are very few studies that have reliable data on the costs and benefits”? We have offered to compliment wellness defenders for telling the truth in every instance in which they acknowledge all her backpedaling whenever they cite her study. We look forward to being able to compliment you on truthfulness when you admit this. This offer, if you accept it, is an improvement over our current Groundhog Day-type cycle where you cite her study, we point out that she’s walked it back four times, and you somehow never notice her recantations and then continue to cite the meta-analysis as though it’s beyond reproach.

To end on a positive note, while we see many differences between your words and your deeds, let us give you the benefit of the doubt and assume you mean what you say and not what you do. In that case, we invite you to join us in writing an open letter to Penn State, the Business Roundtable, Honeywell, Highmark and every other organization (including Vik Khanna’s wife’s employer) that forces employees to choose between forfeiting large sums of money and maintaining their dignity and privacy. We could collectively advise them to do exactly what you now say: Instead of playing doctor with “pry, poke, prod and punish” programs, we would encourage employers to adhere to USPSTF screening guidelines and frequencies and otherwise stay out of employees’ personal medical affairs unless they ask for help, because overdoctoring produces neither positive ROIs nor even healthier employers. And we need to emphasize that it’s OK if there is no ROI because ROI doesn’t matter.

As a gesture to mend fences, we will offer a 50% discount to all Koop Committee members for the Critical Outcomes Report Analysis course and certification, which is also recognized by the Validation Institute. This course will help your committee members learn how to avoid the embarrassing mistakes they consistently otherwise make and (assuming you institute conflict-of-interest rules as well to require disclosure of sponsorships) ensure that worthy candidates win your awards.

TRIA Non-Renewal: Effect on P&C?

Losses stemming from the destruction of the World Trade Center and other buildings by terrorists on Sept. 11, 2001, totaled about $31.6 billion, including commercial liability and group life insurance claims — not adjusted for inflation — or $42.1 billion in 2012 dollars. About two-thirds of these losses were paid for by reinsurers, companies that provide insurance for insurers.

Concerned about the limited availability of terrorism coverage in high-risk areas and its impact on the economy, Congress passed the Terrorism Risk Insurance Act (TRIA). The act provides a temporary program that, in the event of major terrorist attack, allows the insurance industry and federal government to share losses according to a specific formula. TRIA was signed into law on Nov. 26, 2002, and renewed for two years in December 2005. Passage of TRIA enabled a market for terrorism insurance to begin to develop because the federal backstop effectively limits insurers’ losses, greatly simplifying the underwriting process. TRIA was extended for seven years to 2014 in December 2007. The new law is known as the Terrorism Risk Insurance Program Reauthorization Act (TRIPRA) of 2007.

This week, Congress failed to reauthorize TRIA before members adjourned for the holiday recess. Now, with the expiration of the law on Dec. 31, some businesses may be left without insurance coverage in the event of a terrorist attack on the U.S. Both houses of Congress have been discussing legislation that would set out the federal government’s involvement in funding potential terrorism losses, but bills proposed by the two houses earlier this year differed, and no extension was passed.

A report from the Wharton Risk Management and Decision Processes Center found that, under the current TRIA program, some insurers have already reached a level of exposure to losses from a terrorist attack that could jeopardize their ability to pay claims, based on a critical measure of solvency: the ratio of an insurer’s TRIA deductible amount in relation to its surplus. The report, “TRIA After 2014: Examining Risk Sharing Under Current and Alternative Designs,” found that as the deductible percentage rises, as it does under the Senate bill and proposals put forward in the House, more insurers have a deductible-to-surplus ratio that is above an acceptable level. The report also sets out in detail the amount the American taxpayer and federal government would have to pay under differing scenarios.

A RAND Corp. study published in April 2014 found that in a terrorist attack with losses of as much as $50 billion, the federal government would spend more dealing with the losses than if it had continued to support a national terrorism risk insurance program, because it would likely pay out more in disaster assistance.

A report by the President’s Working Group on Financial Markets made public in April 2014 generally supports the insurance industry’s view that the expiration of TRIA would make terrorism coverage more expensive and difficult to obtain.

The insurance broker Marsh released its annual study of the market, “2014 Terrorism Risk Insurance Report,” in April. Among its many findings is that uncertainty surrounding the potential expiration of TRIA significantly affected the property/casualty insurance market. Some employers with large concentrations of workers and companies with property exposures in major U.S. cities found that terrorism insurance capacity was limited and prices higher, and some could not obtain coverage at all. If the law is allowed to expire or is significantly changed, the market is likely to become more volatile with higher prices and limited coverage, the study concludes.

Before Sept. 11, 2001, insurers provided terrorism coverage to their commercial insurance customers essentially free of charge because the chance of property damage from terrorist acts was considered remote. After Sept. 11, insurers began to reassess the risk. For a while, terrorism coverage was scarce. Reinsurers were unwilling to reinsure policies in urban areas perceived to be vulnerable to attack. Primary insurers filed requests with their state insurance departments for permission to exclude terrorism coverage from their commercial policies.

From an insurance viewpoint, terrorism risk is very different from the kind of risks typically insured. To be readily insurable, risks have to have certain characteristics.

The risk must be measurable. Insurers must be able to determine the possible or probable number of events (frequency) likely to result in claims and the maximum size or cost (severity) of these events. For example, insurers know from experience about how many car crashes to expect per 100,000 miles driven for any geographic area and what these crashes are likely to cost. As a result, they can charge a premium equal to the risk they are assuming in issuing an auto insurance policy.

A large number of people or businesses must be exposed to the risk of loss, but only a few must actually experience one, so that the premiums of those that do not file claims can fund the losses of those who do.

Losses must be random as regards time, location and magnitude.

Insofar as acts of terrorism are intentional, terrorism risk doesn’t have these characteristics. In addition, no one knows what the worst-case scenario might be. There have been few terrorist attacks, so there is little data on which to base estimates of future losses, either in terms of frequency or severity. Terrorism losses are also likely to be concentrated geographically, since terrorism is usually targeted to produce a significant economic or psychological impact. This leads to a situation known in the insurance industry as adverse selection, where only the people most at risk purchase coverage, the same people who are likely to file claims. Moreover, terrorism losses are never random. They are carefully planned and often coordinated.

To underwrite terrorism insurance — to decide whether to offer coverage and what price to charge — insurers must be able to quantify the risk: the likelihood of an event and the amount of damage it would cause. Increasingly, they are using sophisticated modeling tools to assess this risk. According to the modeling firm AIR Worldwide, the way terrorism risk is measured is not much different from assessments of natural disaster risk, except that the data used for terrorism are more subject to uncertainty. It is easier to project the risk of damage in a particular location from an earthquake of a given intensity or a Category 5 hurricane than a terrorist attack because insurers have had so much more experience with natural disasters than with terrorist attacks, and therefore the data to incorporate into models are readily available.

One problem insurers face is the accumulation of risk. They need to know not only the likelihood and extent of damage to a particular building but also the company’s accumulated risk from insuring multiple buildings within a given geographical area, including the implications of fire following a terrorist attack. In addition, in the U.S., workers’ compensation insurers face concentrations of risk from injuries to workers caused by terrorism attacks. Workers’ compensation policies provide coverage for loss of income and medical and rehabilitation treatment from “first dollar,” that is, without deductibles.

Extending the Terrorism Risk Insurance Act (TRIA):

There is general agreement that TRIA has helped insurance companies provide terrorism coverage because the federal government’s involvement offers a measure of certainty as to the maximum size of losses insurers would have to pay and allows them to plan for the future. However, when the act came up for renewal in 2005 and in 2007, there were some who believed that market forces should be allowed to deal with the problem. Both the U.S. Government Accountability Office and the President’s Working Group on Financial Markets published reports on terrorism insurance in September 2006. The two reports essentially supported the insurance industry in its evaluation of nuclear, biological, chemical and radiological (NBCR) risk — that it is uninsurable — but the President’s Working Group said that the existence of TRIA had inhibited the development of a more robust market for terrorism insurance, a point on which the industry disagrees. TRIA is the reason that coverage is available, insurers say. The structure of the program has encouraged the development of reinsurance for the layers of risk that insurers must bear themselves — deductible amounts and coinsurance — which in turn allows primary insurers to provide coverage. Without TRIA, there would be no private market for terrorism insurance.

Studies by various organizations have supported a temporary continuation of the program in some form, including the University of Pennsylvania’s Wharton School, the RAND Corp. and the Organization of Economic Cooperation and Development (OECD), an organization of 30 member countries, many of which have addressed the risk of terrorism through a public/private partnership. The OECD said in an analysis that financial markets have shown very little appetite for terrorism risk because of the enormousness and unpredictability of the exposure. RAND argued not only that TRIA should be extended but also that Congress should act to increase the business community’s purchase of terrorism insurance and lower its price. RAND also advocated mandatory coverage for some “vital systems,” establishing an oversight board and increasing efforts to mitigate the risks.

For the full report from which this is excerpted, click here.