The Health Insurer Nudge – Article by Wendy Netter Epstein

From Volume 91, Number 4 (May 2018)
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The Health Insurer Nudge

Wendy Netter Epstein[*]

Lawmakers are looking for Affordable Care Act savings in the wrong place. Removing sick people from risk pools or reducing health plan benefits—the focus of lawmakers’ attention—would harm vulnerable populations. Instead, reform should target the $210 billion worth of unnecessary care prescribed by doctors, consented to by patients, and paid for by insurers.

 This Article unravels the mystery of why the insurance market has failed to excise this waste on its own. A toxic combination of mismatched legal incentives, market failures, and industry norms means that the insurance market cannot solve the problem absent intervention.

But this intervention could be a simple nudge: steering decisionmakers away from unnecessary care, while protecting the autonomy of doctors and patients. Insurers should require, by contract, that providers receive an automated warning before ordering commonly overused interventions. Such computer-driven nudges have been effective in other contexts and would reduce premiums without harming those most in need of help. Because insurers lack appropriate incentives to nudge, the law must mandate them.

TABLE OF CONTENTS

Introduction

I. The Problem: High Rates of Unnecessary and Ineffective Health Care

A. Rising Premium Rates in Health Care and the Unnecessary Care Cause

B. High Rates of Unnecessary Care Increases Premiums and Harms Patients

1. Overutilization

2. Misconsumption

3. The Harm of Unnecessary Care

C. The Actors That Contribute to High Rates of Unnecessary Care

1. Doctors

2. Patients

II. Rational Insurers Should Screen for Unnecessary Care, But Laws, Markets, and Norms Get in
the Way

A. History of Insurer Approaches to Coverage Decisions

1. Deference to Physicians (Early Years–1970s)

2. A Move to Insurer-Driven Reimbursement Decisions (1970s–1990s)

3. The Pendulum Swings (Mostly) Back to Physician-Driven Reimbursement (1990s–Present)

B. Why Payors Often Reimburse for Unnecessary Care

1. Difficulty and Administrative Cost in Identifying
Unnecessary Care

2. Legal Constraints and Desire to Avoid Negative Publicity

3. Insurers Just Raise Premiums Instead

4. Physician and Patient Autonomy

III. Between Autonomy and Death Panels: The Need for a Nudge

A. The Autonomy Value is Important but Dangerous if Unalloyed

B. The Promise of Nudge

1. Types of Nudges

2. Criticism of Nudges

IV. Nudging Away Unnecessary Care

A. The Proposed Solution: A Warning Nudge

1. The Data on Which to Base Warnings

2. Why Warning Nudges Would Be Effective

B. The Need to Mandate This Nudge

C. Addressing Challenges and Suggestions for Further
Study

1. A Paternalistic Approach

2. Concerns About Data

3. Obtaining Buy-In from Providers

4. IT Resistance and Alert Fatigue

5. Cost of Compliance

6. Patients Ultimately Make Care Decisions

Conclusion

 

Introduction

In the current health reform debate, policymakers are looking for ways to lower both premiums and overall health insurance costs. Discussions have largely centered on options like reducing coverage or removing sick people from risk pools.[1] These approaches, however, would severely harm vulnerable segments of the population.[2] Policymakers should instead focus on ways to reduce unnecessary care.

Health care spending in the United States is bloated by payments for expensive treatments that are unnecessary and ineffective.[3] Arthroscopic knee surgery for osteoarthritis works no better than a placebo surgery, and yet it continues to be routinely performed.[4] Pre-operative chest X-rays are often ordered for patients with no symptoms of heart or lung disease, even though they are unlikely to yield useful information.[5] MRI’s for uncomplicated headaches are on the rise, despite guidelines recommending they not be used.[6] And the list goes on.[7]

The United States significantly outspends all other industrialized nations in health care, yet does worse in most measures of quality.[8] Unnecessary care is a big part of the problem.[9] By some estimates, spending on unnecessary care accounts for as much as 30% of total health care spending—on the order of $750 billion per year, with $210 billion of that spent on unnecessary services.[10] An Institute of Medicine report made the sobering analogy that if the price of milk had grown as quickly since 1945 as the cost of unnecessary health care, a gallon of milk would [now] cost $48.[11] Spending on unnecessary care raises systemic costs, ultimately raising insurance premiums and pricing some patients out of the market. It can also harm patients who are exposed to unnecessary radiation, complications, infections, and emotional harm.[12]

Unnecessary care is consumed because doctors prescribe it, patients consent to it, and payors pay for it. The role of doctors and patients in creating this problem has received considerable attention in the literature.[13] Economic incentives, cultural norms, and legal incentives stemming from the medical malpractice system cause doctors to over-test, over-prescribe, and over-treat.[14] Patient decision-making is also subject to informational deficits and cognitive biases that lead many to err on the side of more treatment—doing something feels better than doing nothing.[15] Furthermore, moral hazard makes patients inefficiently price sensitive,[16] and lack of price transparency impedes patient ability to take cost into account in making decisions.[17] Significant efforts are underway to address these patient and physician-centric problems, although they are not without challenges.[18]

But what is particularly perplexing is why insurance companies and government payors are reimbursing for high-cost, unnecessary care. Of all the actors in the complicated web that is health care, insurance companies would seem best situated to act as a check on patients and doctors. A rational, profit-maximizing insurance company—or even a nonprofit one—should be motivated to refuse reimbursement for unnecessary care that fails to improve patient health and might even harm it. Insurers able to reduce claims costs would increase profit margins or at least be able to reduce premiums. But while insurers occasionally refuse coverage, particularly for so-called “experimental” procedures, the vast majority of the time, they defer decisions on the medical necessity of treatment to physicians.[19]

There are reasons that insurers do so, grounded in norms, imperfect markets, and laws.[20] For one, it can be hard to identify with requisite certainty which expensive procedures are likely to be ineffective.[21] And the possibility of error in these determinations could have dire consequences. Consider, for example, the insurer that refuses to pay for a certain cancer treatment that, it later learns, would have saved the patient’s life. Private insurers, for a variety of reasons, tend to follow the lead of Medicare in coverage decisions.[22] Insurers also might lack adequate incentives to incur the administrative costs of a stricter medical necessity review, particularly when insurers can instead raise premiums in an imperfectly competitive market.[23] And in some cases, state statutes and common law require insurers to defer to doctors on the medical necessity of care.[24]

But perhaps the biggest hurdle is the norm of patient and physician autonomy. Health Maintenance Organizations (HMOs) were strongly criticized when their utilization reviews were said to infringe on patient and physician autonomy in making medical decisions.[25] The predominant arguments were that each patient is different, medicine is more of an art than a science, and doctors employed by insurance companies should not be able to override the decision of a doctor who has actually examined the patient.[26] The autonomy argument is still commonly made today—often in the form that a patient’s right to self-determination is particularly strong in health care where patients are charged with making very personal decisions that affect their own bodies.[27]

But while patient and physician autonomy are important, patients and physicians do not operate in a vacuum. When patients and physicians choose unnecessary care, and that care is reimbursed by a private or government payor, the decision has repercussions beyond the patient’s individual well-being.  Other members of the risk pool bear the reimbursement cost.[28]

And there are other considerations. Since the original outcry against HMO utilization reviews, data has improved. While there are circumstances in which the individual patient’s knowledge is particularly important, much can be learned from the data that apply across broad categories. We can now identify some common tests and procedures that are over-used and the circumstances in which such overuse is particularly likely. Over time, we will be able to identify more circumstances and make these determinations more personalized.[29] There are many organizations—private and governmental—gathering this data.[30] And while there is still a tremendous amount of work to be done, all indications are that progress will continue.

Also, the challenge of addressing overuse of health services by changing patient and doctor behavior persists. De-biasing decisionmakers is difficult, transparency is slow in the making, and changing payment incentives can have perverse effects.[31] Consider, as well, that we now better appreciate how slow medical practice is to adapt to new evidence. One study found that it takes, on average, seventeen years for custom and practice in medicine to catch up with the evidence, meaning that the majority of doctors continue to adhere to outofdate practices long after the evidence mandates change.[32] Custom and practice-based medical malpractice law, therefore, also does little to stem the tide of unnecessary care.[33]

The time has therefore come to revisit the role of payors in addressing the unnecessary care problem. Payors cannot be tasked with making reimbursement decisions absent input from physicians. There are too many land mines, including that insurer financial motivations can prompt denial of reimbursement for profit maximization reasons, rather than for the betterment of patient health.[34] Yet individual circumstances and doctor intuition still matter. Political headwinds against “death panels” are too strong to contemplate payor power absent a role for doctors and patients. Neither can unabated physician and patient autonomy in decision-making carry the day. Payment decisions not only affect individuals, but impose costs on society writ large.

The problem begs for a middle path—a way to steer decisionmakers away from unnecessary care while still protecting the right to choose.[35] Insurers motivated by reducing claims costs should require the implementation of a nudge: an automated warning to providers when they try to order a test that is known to be overused or a treatment that evidence suggests will be ineffective. Essentially, the insurer should require the provider’s ordering system prompt the doctor with a warning saying, “are you sure you want to prescribe this test?” There is preliminary evidence that such nudges can move the needle in significant ways.

There are hurdles to consider. Caution should be exercised about the quality of the data on which nudges are based. Building the necessary information technology (“IT”) capacity would be costly. Providers might become conditioned to these warnings and begin to ignore them or might resent the additional administrative step of having to click through another screen. But perhaps the most important hurdle is that payors are inadequately incentivized to implement these nudges on their own. Regulators therefore need to mandate such a system.

Part I of this Article starts by describing the problem of unnecessary care, the actors who cause it, even if inadvertently, and its consequences. Attempts to address the problem by changing patient and physician behaviors are well-intended but so far have not yielded enough positive change. Notably, far too little attention has been paid to payors’ roles in the unnecessary care problem.

Part II takes up the issue of payors specifically and addresses why they now do little to screen for unnecessary care. It explores the evolution in payor approaches to coverage determinations, from complete respect for physician autonomy to more active insurer decision-making and back again, and concludes by exploring payor incentives. A combination of imperfect markets, laws backing physician autonomy, and industry norms explain why the market has not corrected the unnecessary care problem on its own.

Part III makes the normative argument that unalloyed respect for physician and patient autonomy is dangerous. On the other hand, failure to guard autonomy entirely is equally problematic. Such situations are ripe for nudges. In order to move decision-making away from the problematic poles between which the industry has vacillated over its history, and given the imperfect functioning of insurance markets, this Part suggests that a nudge may be required.

Finally, Part IV sets out the proposed solution—an automated warning to providers when they try to order care that is likely to be unnecessary. Studies of warning-type nudges give reason for optimism that this transparent and autonomy-respecting regime can be successful, although Part IV also explores the challenges to its success.

I.  The Problem: High Rates of Unnecessary and Ineffective Health Care

The Affordable Care Act (“ACA”) has been shrouded in controversy—both political and legal—since its passage in 2010. Heated debates about the individual mandate,[36] Medicaid expansion,[37] and religious objections to coverage of contraceptives[38] have dominated the conversation. Although these debates continue, the rhetoric on repealing and replacing the ACA has centered of late on a very practical problem: high premium rates.

A.  Rising Premium Rates in Health Care and the Unnecessary Care Cause

Premiums rates have risen significantly over the past decade.[39] Rising premiums were an important theme in the 2016 presidential election. Then-candidate Donald Trump pressed his case for doing away with the ACA with particular fervor following the release of a government report in October 2016 that detailed rate hikes. In one of the presidential debates, he stated: “[O]ne thing we have to do, repeal and replace the disaster known as Obamacare. [I]t’s destroying our country . . . . [T]he premiums are going up 60, 70, 80%.”[40] The issue of high premium rates was, by many accounts, salient with voters.[41]

After the election, President Trump and other Republican leaders continued to press the point, emphasizing the need to lower premiums as a key reason to repeal and replace the ACA.[42] In fact, premiums do generally seem to be on the rise, although increases have been highly variable nationwide.[43] On average, premiums for individual policies purchased on the Exchanges rose about 25% in 2017.[44] For those who obtain their policies through employers, premiums increased by a more modest amount, but still went up faster than wages.[45]

There is some debate about just how problematic increasing premium rates are. The premium increases largely track the 2009 Congressional Budget Office estimates for premium rates at the time the ACA was passed.[46] And despite increasing premiums, about 85% of enrollees through the Exchanges receive premium tax credits, which lower their premiums to 10% of their income.[47] Even so, someone has to pay when premium rates go up.[48] For the most part, that health care costs are too high and that health reform should focus on bringing down costs generally and premiums specifically are rare points on which liberals and conservatives in the health care debate agree—even if they disagree on how to go about it.[49]

There are many reasons why health insurance premiums have gone up under the ACA.[50] Recent attention, particularly among Republicans, has focused on two such reasons: the requirement of more robust coverage and the expense in covering sicker insureds.[51] The ACA requires that plans cover “essential health benefits,” which include ten core categories of health care services.[52] Plans providing broader coverage are raising premiums to cover the additional claims costs.[53] The ACA also prevents plans from experience rating, which means charging sicker patients higher rates. Because plans are prohibited from excluding patients with pre-existing conditions and cannot charge them more, premiums have also gone up.[54]

But fixing either of these problems is difficult and requires making troubling trade-offs. For instance, Republican plans to replace the ACA have contemplated allowing insurers to offer skimpier coverage or permitting insurers to charge sicker people higher premiums.[55] Whether these results are palatable turns on difficult value judgments, but for many, these approaches are inscrutable and impossible to justify because of their negative impact on vulnerable populations like the sick and the poor.[56]

Yet there is another important contributor to high premium rates that is well-documented, but has largely eluded policymaker focus in the repeal and replace debate: the fact that premiums are hugely bloated by unnecessary care.[57] Fixing this problem would implicate far fewer value judgments. If it were possible to reduce premiums by cutting back on unnecessary care, it would be hard to imagine many objections.[58] And policymakers might not have to submit to skimping on benefits or failing to cover sick people to decrease premiums. The next section describes the problem of unnecessary care and how it impacts insurance rates.

B.  High Rates of Unnecessary Care Increases Premiums and Harms Patients

The term “unnecessary health care”[59] describes the provision of “services which show no demonstrable benefit to patients.”[60] Unnecessary care includes both “overutilization”—too much care that does not improve patient health[61]—and “misconsumption”—the wrong choice of care when a different choice (or even doing nothing) would lead to better outcomes.[62] Taken together, overutilization and misconsumption have dire consequences for both the cost of health care and patient well-being.

1.  Overutilization

There are many examples of overutilization of care, but perhaps the most prominent are the overuse of imaging, diagnostic tests, and antimicrobials (including antibiotics).[63]

Imaging studies, such as magnetic resonance imaging (MRI), ultrasound imaging, computed tomography (CT) scans, and conventional X-rays, create visual representations of the body’s inside for clinical analysis.[64] Advances in imaging techniques have greatly enhanced the ability of physicians to diagnose a wide variety of ailments.[65] But imaging can be both expensive[66] and harmful to patients, and many studies have now determined imaging to be markedly overused.[67] For instance, X-rays for uncomplicated lower back pain, CT scans for sinusitis, and MRI scans for uncomplicated headaches, are all commonly performed but often not clinically indicated.[68] A 2016 University of Michigan study found that nearly 60% of the advanced imaging “performed for more than 29,000 Michigan women diagnosed with early breast cancer between 2008 and 2014 could not be medically justified based on retrospective record review.[69] One report estimates that 2050% of all high-tech imaging is unnecessary.[70]

Laboratory tests are similarly overused—by some estimates on the order of 6070% more than necessary.[71] These tests do not contribute towards management of patients.[72] Consider as a particularly illuminating example the documented overuse of BRCA-1 genetic tests in patients for whom such testing was not clinically indicated.[73] Although the BRCA-1 tests have come down in price following the Supreme Court’s holding in Association for Molecular Pathology v. Myriad Genetics that isolated DNA sequences are not patentable,[74] the Myriad test at one point cost $3,000.[75]

Finally, the prescription of antimicrobials (which includes antibiotics and antifungals) when medically inappropriate is an important example of overutilization.[76] In 2016, the Centers for Disease Control and Prevention released a study in collaboration with other medical experts that found that at least 30% of antibiotics prescribed in the United States are unnecessary.[77] Overuse includes the prescription of antibiotics for conditions caused by viruses that do not respond to antibiotics.[78]

2.  Misconsumption

In addition to overutilization, much care is also misconsumed in the United States. Misconsumption is essentially inappropriate treatment that medical guidelines do not support, but that doctors nonetheless perform.[79] Misconsumption often comes from treatments that became popular absent evidence of efficacy—and maybe even became the standard of care—but were later determined to generally not be effective. While some misconsumption naturally ends over time once evidence of ineffectiveness becomes widely known, much still persists. Often misconsumption continues for many years after dispositive evidence that the procedure is ineffective.[80] In other words, the standard of care is very slow to conform to evidence.[81]

Consider the case of knee arthroscopy for osteoarthritis, where a fiberoptic endoscope and surgical instruments are inserted into the knee to smooth rough surfaces and repair tears in the cartilage and meniscus.[82] A review of past gold standard studies clearly shows that the procedure is not beneficial to osteoarthritis patients, yet doctors continue to perform it.[83]

There are many other procedures that fall in a similar category: spinal fusion surgeries for low back pain on worn out discs,[84] vertebroplasty for osteoporotic vertebral fractures,[85] placement of coronary stents in patients with nonacute indications,[86] laparoscopic uterine nerve ablation for chronic pelvic pain,[87] and removal of healthy ovaries during a hysterectomy.[88] Radical mastectomy was the standard of care for breast cancer for decades and continues to be in wide use even after a randomized trial revealed that it was no better at protecting women from cancer than more conservative techniques.[89]

3.  The Harm of Unnecessary Care

Rates of both overutilization and misconsumption in the United States are disturbingly high. The United States spends approximately 17% of gross domestic product (GDP) on health care services—the highest percentage by a wide margin of any industrialized nation.[90] According to the Institute of Medicine, the provision of unnecessary care accounted for more than 8% of health care spending in the United States in 2009 ($210 billion out of $2.6 trillion).[91] The Congressional Budget Office warns that the costs associated with unnecessary care are significant and growing.[92] Studies of Medicare specifically have led to similar conclusions. One well-known study of Medicare claims found large regional variations in Medicare spending, with enrollees in higherspending regions receiving more care than those in lowerspending regions.[93] Yet health outcomes and satisfaction with care were no greater in the higher utilization regions than in the low utilization regions.[94]

As National Institutes of Health bioethicist Ezekiel Emanuel and Stanford economist Victor Fuchs concluded in their 2008 article, The Perfect Storm of Overutilization, unnecessary care[95] is the most important contributor to high health care costs in the United States.[96] This cost is problematic both because of the financial impact and the potential harm unnecessary care causes patients.

First, consider basic economics. When insured patients receive unnecessary care, they generate claims costs that must be paid by the insurer. Insurers, and the actuaries that work for them, analyze claims costs in setting premium rates. When claims costs increase, insurers respond by raising premiums to cover the costs.[97] As premiums increase, poorer insureds in the individual market who pay premiums out of pocket become uninsured as they can no longer afford the premiums.[98] Poor, uninsured individuals who do not qualify for Medicaid cannot access care except through charity and in emergency rooms.[99] That care becomes more costly than before the care became emergent.[100] And it likely results in debt, which is recovered only through government funds or hospitals raising overall rates.[101] The bottom line is that increasing premiums has a domino effect that not only negatively impacts individuals who have to pay more to cover insurance premiums, but also increases the number of uninsureds with all of the consequences that follow.

The Affordable Care Act attempted to address the problem by subsidizing premiums for poorer individuals through tax credits.[102] As premiums increase, individuals receive larger subsidies so that the percentage of their income they must pay to cover premiums is fixed. But while the tax credits may indeed prevent people from becoming uninsured, rising premium rates means the government must pay ever-increasing rates to subsidize insurance for these individuals.[103]

High rates of unnecessary care also result in premium increases for employer group insurance plans.[104] In response to increasing premiums, employers must either pass a higher percentage of costs onto employees[105] or they must make other sacrifices to try to reduce costs, such as by narrowing networks, increasing deductibles and copays, or choosing less robust coverage plans. Alternately, employers may pay employees less to account for larger employer shares of health insurance premiums.[106]

And it is not just private insurance that is affected. High rates of unnecessary care increase government spending under Medicare and Medicaid, too. The Congressional Budget Office has found that higher per beneficiary spending spurred by unnecessary testing and procedures is a clear driver of rising Medicare expenses.[107]

Second, patients are harmed in non-economic ways by unnecessary care. The delivery of care inherently involves risk and may lead to complications. Patients who needlessly receive medical interventions are subject to health care-associated infections, . . . post-operative complications such as blood clots, and other harms.[108] A recent report suggests that medical errors might be the third most common cause of death in the United States.[109] Unnecessary care increases a patient’s risk of being subject to medical errors.

Further, exposure to excess radiation from unnecessary imaging can be dangerous. One study estimates that excess radiation from overuse of CT and MRI scans causes 1.5%–2% of all cancers.[110] Unnecessary diagnostic testing can also lead to overdiagnosisthat is, the diagnosis of a person with a condition that will not cause harm or would otherwise have remained irrelevant.[111]

Problems from overuse of antimicrobials are also significant, putting patients at needless risk for allergic reactions and other side effects. The overuse of antibiotics drives antibiotic resistance, endangering patients who actually require antibiotics to treat bacterial infections.[112]

Given this parade of horribles, the logical question is how we have ended up with such tremendous levels of unnecessary care being consumed in American health care.

C.  The Actors That Contribute to High Rates of Unnecessary Care

High rates of unnecessary care are not attributable to a single actor. Most of the scholarly focus to date has been on the contribution of patients and doctors to the problem. In their famous 2008 article, Drs. Emanuel and Fuchs described how doctor and patient incentives lead to the “perfect storm of ‘more’” care.[113]

1.  Doctors

Doctors’ contributions to unnecessary care are well-documented in the literature and therefore only briefly described here. They include the fee-for-service reimbursement system, the perceived need to practice defensive medicine, and the training and culture of physician-delivered care.

First, doctors are typically paid based on the services they provide. The more tests and procedures ordered and performed, the higher their compensation.[114] A doctor therefore has a financial incentive to do more, not less.

Second, the medical malpractice liability regime encourages doctors to practice “defensive medicine,” where doctors order more diagnostic tests and perform more medical procedures to protect them from later being sued for not doing enough.[115] In a Pennsylvania study, 92% of the 824 physicians surveyed reported ordering imaging tests and diagnostic measures for assurance against malpractice liability.[116]

Finally, cultural norms spur unnecessary care. Doctors are instilled with a commitment to leave no stone unturned on behalf of their patients and to put patient health above financial considerations.[117] At the same time, there are no approved standards of care. What physicians learn in medical school becomes their standard practice, and it can be difficult to uproot learned practices despite new evidence.[118] It can also be difficult for physicians to keep abreast of new evidence.[119] Further, incentive to conduct high quality studies of effectiveness is lacking given that payment is based on standard practice, not evidence, and there is typically little opportunity to monetize research findings.[120]

Given how slow medical practice is to adapt to new evidence,[121] custom and practice-based medical malpractice law also does little to stem the tide of unnecessary care. The FDA regulates pharmaceuticals for efficacy, if imperfectly,[122] but only the laws of medical malpractice and informed consentand the market if it were properly functioningserve as a check on the provision of ineffective medical services.

Attempts have been made, and continue to be made, to mitigate these problems. Payment reforms attempt to encourage doctors to reduce costs while maintaining quality—to give doctors an incentive to avoid low-value care.[123] And tort reform attempts to lessen the perceived need to practice defensive medicine.[124] But these solutions, at least as of yet, have not significantly stemmed the tide of unnecessary care.[125]

2.  Patients

Doctors are not alone in contributing to the unnecessary care problem. Patients must consent to the care they receive.[126] While some patients are merely susceptible to their physician’s suggestions, others drive the provision of unnecessary care, convincing their doctors to agree to their desired care.[127]

For one, patients are subject to a number of cognitive biases that cause them to insist on extra tests or prescriptions.[128] There is a cultural preference for “more,” particularly when it comes to technological solutions.[129]

Adding to this, the nature of insurance creates moral hazard, where patients lack adequate financial incentive to refuse unnecessary care.[130] Patients’ monthly premiums are a sunk cost, and they spend little out-of-pocket (at least historically) for the care they consume.[131]

Lack of price transparency further exacerbates the situation.[132] Patients who might be deterred from overuse by the cost of tests and procedures are not motivated to turn down care because they do not have insight into cost at the time of decision-making.

As with physician incentives, efforts have been made to address patient incentives—to improve patient decision-making so that it does not contribute to waste of health care resources. For instance, there has been a big push in the last decade to de-bias patient decision-making and encourage rational choice.[133] Efforts have been made to address moral hazard by giving patients more skin in the game through consumer-driven health care. As a supplement to these efforts, policymakers have tried to make costs more transparent. These policy initiatives attempt to stem the tide of unnecessary care.[134] But just as with efforts to address physician biases, these patient-centric efforts have, so far, not made a big impact.

What is obviously missing from this story is a discussion of payors who currently reimburse the unnecessary care that is being consumed. The next Part explores why payors tend to be complicit in the storm of unnecessary care, despite what would appear to be contrary incentives.

II.  Rational Insurers Should Screen for Unnecessary Care, But Laws, Markets, and Norms Get in the Way

While physician and patient incentives to increase unnecessary care are well-documented, it is perplexing why insurance companies[135] are paying for high-cost, unnecessary care. Of all of the actors in the complicated health care web, insurance companies seem best situated to act as a check on patients and doctors. A rational, profit-maximizing insurance company—or even a nonprofit one[136]—should be motivated to refuse reimbursement for unnecessary care to lower claims costs.

This Part details how insurance companies have approached coverage determinations over time. It then addresses the various counterintuitive reasons—grounded in market failures, legal incentives, and industry norms—that insurers today often reimburse for unnecessary care.

A.  History of Insurer Approaches to Coverage Decisions

Private health insurance is governed by what essentially amounts to a three-party contract. Patients agree to pay insurance companies fixed monthly premiums, and these premiums entitle patients to coverage, which means the insurer makes payments to cover the patient’s care. Providers are reimbursed for the care they provide (either directly or indirectly) by these insurer payments.[137]

Insurance contracts are necessarily incomplete.[138] With perfect information, an insurer could specify by contract what it is agreeing to reimburse for. But typically, the parties do not know at the time of contracting what type of care the patient will need or what an appropriate treatment for the patient will be.[139] Insurance contracts address this problem in two general ways. First, they define broad categories of care that are either covered or excluded.[140] For instance, emergency room visits might be covered, but experimental treatments or cosmetic procedures excluded. Second, within those categories for which a policy provides coverage, the insurer agrees to reimburse only for tests and procedures deemed “medically necessary.”[141] This approach to defining coverage is intended as a work-around for the incomplete contracts problem.[142]

Over time, approaches to determining the bounds of reimbursement have evolved, from an early period marked by deference to physician decision-making on matters of medical necessity, to insurer attempts to more actively manage the reimbursement process, and then back again to a mostly physician-centered approach.[143]

1.  Deference to Physicians (Early Years–1970s)

Although the term “medically necessary” is vague, it initially mattered little. Prior to the mid-twentieth century, medicine was dominated by physician paternalism.[144] Physicians made medical decisions on behalf of patients, and insurance companies reimbursed for the care provided without question.[145] Use of the term “medical necessity” in contracts was really a delegation to one party—the doctor—to make decisions about what care was required.

The few court cases that emerged from this period are consistent with the norm of deference to physician decision-making. For instance, in the 1966 case Mount Sinai Hospital v. Zorek, a patient’s physician sought to hospitalize a patient to treat her obesity.[146] In a move that was rare for the time, the insurer objected to paying for the hospitalization.[147] The court concluded that the insurer must defer to the treating physician and pay for the treatment prescribed.[148] The court reasoned that “[o]nly the treating physician can determine what the appropriate treatment should be for any given condition. Any other standard would involve intolerable second-guessing . . . .[149]

However, by the early 1970s, the tide started to turn, as the United States faced the first real crisis of rapidly expanding health care costs.[150] With doctors paid on a fee-for-service basis, and patients largely insulated from cost by their insurers, demand and reimbursement for services rose quickly.[151] In response, policymakers turned to managed care to contain costs.[152] With it came new approaches to insurer reimbursement that were less deferential to physicians.

2.  A Move to Insurer-Driven Reimbursement Decisions (1970s–1990s)

Although managed care was first introduced after World War I, it gained popularity as a delivery model in the 1970s and 1980s. Managed care organizations (MCOs) were designed primarily to manage cost and utilization.[153] Their ascendancy eroded physician power in driving reimbursement decisions.[154]

One of the key ways that MCOs attempted to rein in costs was by more stringently reviewing utilization of health care resources—by both prospective and retrospective review of claims.[155] Prospective review required physicians to justify the medical necessity of the prescribed service or procedure to the insurer before the service was delivered.[156] It usually took the form of requiring pre-approval or prior authorization.[157] The idea was to weed out unnecessary care before it occurred.

With retrospective review of claims, insurers reviewed requests for reimbursement after care had already been delivered, refusing requests the insurer deemed unnecessary.[158] The purpose of retrospective review was to uncover provider practice problems and deter physicians from delivering high-cost, unnecessary care.[159]

The overall result was that insurers during this period routinely refused to reimburse for care they deemed unnecessary. Particularly for patients covered by MCOs, the provision of health care services was heavily influenced by insurer decisions, not just clinical decisions.[160]

Physicians and patients did not accept this new reality without resistance. Physicians abhorred the administrative burdens MCOs imposed.[161] And they argued that insurers should not be able to substitute their judgment for a physician’s expertise. They noted that each patient has individual needs and circumstances that cannot be properly appreciated by an insurance company.[162] Much of medicine is based on intuition, not hard science, hence there was often no legitimate basis on which insurers could make decisions.[163] Physicians also criticized utilization review because it lacked transparency.[164] Patients were similarly angered, primarily by their inability to obtain the care that their doctors told them they needed.[165]

But perhaps the strongest argument against insurer-driven reimbursement decisions was that insurers had a perverse incentive to ration care.[166] Motivated by controlling costs and generating profits, insurers’ reasons for declining coverage, commonly believed to be based on cost containment and not medical appropriateness, were inherently suspect.[167]

Courts prevented insurers from entirely taking the reins in decision-making during this period, continuing in many cases to define medical necessity with reference to physician judgment.[168] But by most accounts, it was the political failure of insurer-driven reimbursement decisions that doomed the approach.[169] By the late 1990s, the pendulum had swung back, at least mostly, to deference to physician decision-making.

3.  The Pendulum Swings (Mostly) Back to Physician-Driven Reimbursement (1990s–Present)

Today, private (and public) insurers are mostly punting to doctors on questions of medical necessity.[170] Insurers do still have processes for deciding whether to cover new technologies.[171] And most readers have probably had some experience with insurers refusing to pay or requiring that certain steps be taken before reimbursing for treatment. But it is not common for insurers (or the government) to evaluate the effectiveness of interventions that are already in common use—even if sound evidence suggests that the intervention is ineffective.[172] Without overwhelming evidence of harm, it is uncommon for an insurer to refuse reimbursement.[173]

The reasons for this are complicated. In response to the backlash against utilization review, laws have made it more difficult for insurers to take on physician decision-making, administrative processes have been put in place to make it easier to challenge insurer decision-making, and other realities have resulted in insurers taking a back seat to physicians and patients in assessing the necessity of care for reimbursement purposes.

B.  Why Payors Often Reimburse for Unnecessary Care

Rational insurers should be motivated to screen and refuse to pay for unnecessary care. Why don’t they? This section explores the legal, cultural, and market-based reasons.

1.  Difficulty and Administrative Cost in Identifying Unnecessary Care

It can be difficult and therefore costly for insurers to administratively identify unnecessary care. Unlike with pharmaceuticals,[174] no agency approves the effectiveness of medical procedures before they become the standard of care. Nor does any agency review continued effectiveness.[175] One of the major arguments against evidence-based medicine has always been that much of medical practice is not based strictly in science.[176]

Relatedly, differences in individual patients, detectable by the treating physician, can be hard for an insurance company to identify. These differences may make care necessary for one patient, but not another.

For these reasons, “putting a great deal of effort into identifying and eliminating unnecessary care is likely to increase rather than decrease administrative costs.”[177] If administrative costs in identifying unnecessary care are higher than insurers’ savings in rejecting reimbursement for unnecessary care, that would explain why insurers now mostly defer to physician decision-making.[178]

Given this background, perhaps it is not surprising that there is a strong industry norm of private insurers simply following Medicare’s coverage decisions.[179] The advantage is that Medicare bears the administrative cost of determining when care should be reimbursed and when it should not.[180] The disadvantage—which is a significant one—is that Medicare’s process is flawed and not designed to identify unnecessary care.[181] Rather, Medicare tends to consider whether to cover new technologies and procedures, infrequently revisiting decisions already made, despite developments in the evidence of effectiveness. Or at least, Medicare is very slow to update its coverage decisions.[182]

Following Medicare decisions, however, also has the advantage—at least perceived to be so by private insurers—of insulating them from liability.[183] The next Section discusses the legal regime that deters insurers from more actively policing unnecessary care.

2.  Legal Constraints and Desire to Avoid Negative Publicity

There are a number of legal constraints that insurers face in reviewing patient and physician decision-making about care. First, states responded to the political failure of utilization review by building up a large statutory and regulatory apparatus to monitor the actions of insurance companies. Some states require plans to use a specified definition of medical necessity and require insurers to defer to the judgment of physicians.[184] For example, in Louisiana, medical necessity is defined to include “health care services . . . that are considered by most physicians . . . to be the standard of care.”[185] In states that do not mandate a definition of medical necessity, many still require plans to submit their proposed definitions to state regulators for approval.[186]

Other restrictions on insurers are also in common use. The majority of states restrict insurer use of pre-authorization procedures[187] and the time that plans take when making prospective medical necessity determinations[188] and dictate the information that must be provided in denial letters.[189]

Perhaps the most impactful change, though, has been the increase in legislatively-mandated review processes, both internal and external, for medical necessity denials. These processes are intended to give insureds better recourse.[190] Internal reviews generally involve review by a plan physician who was not involved in the initial denial and then review by an internal committee.[191] Once internal processes are exhausted, insureds may be entitled to external review.[192]

This growth in regulation was based on the need to address real abuses of the utilization review process, as described above. But it also impacts insurers’ abilities to screen for unnecessary care and adds significant cost to insurers that refuse reimbursement for unnecessary care if their decisions are challenged.

Second, insurers are also deterred from more aggressively screening for unnecessary care by the cost of litigation. When an insurer rejects a reimbursement request on the basis that the care is not medically necessary, it can be sued for breach of contract. Then, in subsequent litigation, insurers face hurdles. Many courts still interpret “medical necessity” to be congruent with physician judgment and standard of care (and not necessarily evidence).[193] Also, ambiguities in insurance contracts are construed in favor of the insured.[194] The conventional wisdom is that courts tend to be sympathetic to plaintiffs seeking access to care they would not be able to afford absent coverage.[195] Indeed, there have been a number of high profile cases where insurers have been ordered to pay for care even where evidence of effectiveness was lacking.[196]

More recently, some scholars have expressed skepticism that medical necessity litigation is as one-sided in favor of insureds as previously thought.[197] But regardless of insurer success in these lawsuits, they provide an additional cost that deters insurers from attempting to screen for unnecessary care.

Insurers may face other liability, as well. In addition to contract suits, insurers can be sued in tort for bad faith performance of their duties to insureds.[198] And insurers have been sued—and held liable—under state insurance law.[199]

Even if insurers win when they are sued, they incur costs—both financial and often reputational, as well. “[I]nsurers are acutely aware that a well-publicized dispute over an inappropriately denied claim might cause them to lose the next renewal of their contract.”[200]

For all of these reasons, insurers are deterred from a more aggressive review of unnecessary care. But there is yet another consideration, which is that insurers have other, more foolproof ways of generating profits.

3.  Insurers Just Raise Premiums Instead

Maximizing profits[201] requires either reducing costs or increasing revenues (or even better, doing both). Where reducing costs is difficult, insurers may turn to the other option. Notably, they can increase revenues by raising premiums. Insurers frequently choose this option. Premiums have been steadily increasing over the last decade, while costs for unnecessary care have been on the rise.[202]

There should be both regulatory and market-driven checks on insurers’ abilities to raise premiums. Neither, however, seem to have significantly stemmed the tide of rate increases.

First, a competitive market should constrain insurer ability to raise premiums. Theoretically, if insurers raise rates higher than competitors, consumers would purchase plans from the competitors and revenues might actually decrease rather than increase.[203] Although advocates of the private health insurance system often assume that competition will drive down prices, empirical evidence supporting this theory is scant.[204] Rather, there is a growing body of evidence that health insurance markets are not perfectly—or even adequately—competitive.[205] Insurers wield their market power, permitting them to raise premiums without significant competitive consequence.[206]

Market concentration has exacerbated these problems.[207] Studies evaluating the effect of consolidation on pricing have found that consolidation leads to premium increases.[208] By recent measure, the top five largest insurers hold 83% of the market.[209] It seemed the so-called “big five” might even further consolidate down to three before antitrust challenges ultimately ended Aetna’s attempt to acquire Humana[210] and Anthem’s purchase of Cigna.[211] But even with five, market competition has not served as a strong check on insurers’ abilities to raise premiums.

Second, regulation might limit premium increases. Depending on the state, an insurer might need to obtain prior approval of rates from the department of insurance.[212] But in other states, insurers might only be subject to “file and use” requirements, meaning they must file their rates, but the rates need not be approved,[213] or the requirement of providing an actuarial certificate attesting that their rates are in compliance with state law.[214] The ACA has brought some increased regulatory scrutiny to insurer premiums,[215] requiring that large rate increases be evaluated to ensure they are based on valid cost assumptions.[216]

But regardless of these constraints, it is a job of regulators to keep insurance companies solvent. So if costs increase, premium increases are typically considered justified and are approved.[217] Nothing about the rate approval process scrutinizes whether insurers have made efforts to contain costs.[218] Therefore, while there is considerable regulation governing rate increases, it has not significantly impacted insurers’ abilities to raise rates.[219]

And where raising prices is prohibitive, insurers have made other business decisions to protect profits that are also viewed as more desirable than policing unnecessary care. For instance, insurers have simply withdrawn from non-profitable individual markets.[220] They have increased focus on administering employer ERISA plans where the employer bears the risk and the insurer is just paid a fee.[221] Or insurers have moved into other areas entirely, such as providing direct medical services.[222]

The final reason why insurers seem loathe to screen for unnecessary care involves the strong norms of physician and patient autonomy.

4.  Physician and Patient Autonomy

Particularly in matters concerning health, autonomy or self-rule is considered to be of great importance[223]—both to patients and physicians.[224] One physician describes, in a commonly held view, how autonomy in health care would ideally function:Everyone in society should have access to needed health care . . . . Only the physician and the patient should decide how to respond to a given medical condition. And someone should reimburse providers of health care at reasonable rates.[225]

Patient autonomy and physician autonomy mean different things and have different justifications. Patient autonomy means the right to self-determination—to make personal decisions about what happens to one’s own body.[226] It is specifically to be valued for deontological reasons.[227] Even if patients choose poorly, pure autonomy dictates that they should nonetheless be permitted to make the choice.[228]

Respecting patient autonomy is also said to further individual well-being.[229] Only the patient truly understands her goals and preferences; therefore, the patient is best-suited to make health care decisions.[230] And a patient is deserving of autonomy, so the argument goes, because the decisions are highly personal, affecting only the individual.

The theoretical basis for physician autonomy differs. Physician autonomy is a type of professional autonomy. A professional—someone who has “special power and prestige”[231]—develops a special competence.[232] In medicine specifically, physician autonomy means the freedom to make decisions on the basis of professional judgment and specialized knowledge.[233] Physician autonomy is colloquially synonymous with clinical freedom[234] and is highly valued by physicians.[235]

Both patients and physicians have been vocal about how insurers should defer to their autonomy.[236] Indeed the need to respect patient and physician autonomy was made particularly clear following the backlash against HMOs.

But even now, insurers face pressure from patients, physicians, and the organizations that represent their interests when they refuse to reimburse for care insurers deem unnecessary.[237] Take, for example, the story of Blue Cross and Blue Shield of North Carolina’s 2010 attempt to limit reimbursement for spinal fusion surgery under specific circumstances. Its proposal was backed by significant research indicating that spinal fusion surgery was ineffective in the circumstances under which it intended to refuse reimbursement,[238] but the American Association of Neurological Surgeons and the North Carolina Spine Society complained loudly. While they argued about the well-being of their patients, perhaps most importantly, they called the insurer’s decision an “intrusion into the physician-patient relationship . . . .”[239] Unsurprisingly, the insurer backed down.[240]

This is just one example to highlight the power, politically and culturally, that professional and personal autonomy arguments have.[241] These strong norms deter insurers from actively screening for unnecessary care. The autonomy value has a special moral importance in health care.[242]

Therefore, although it might seem that a rational insurer should serve as a check on patient and physician decision-making to screen out unnecessary care, important impediments exist to insurers fulfilling that role.[243] The normative question of whether or not insurers’ failure to play the part is the right result remains unanswered. The next Part argues that although insurers cannot topple autonomy rights, there is a role for them to play.

III.  Between Autonomy and Death Panels: The Need for a Nudge

Policymakers and industry experts agree that reducing unnecessary care is highly desirable. This care does not help patients—and may even harm them—and adds huge, unnecessary cost to the delivery of health care. Although the goal is uncontroversial, there is little consensus on what role, if any, insurers (and regulators) might play in effectuating change. The next Sections argue that while the importance of protecting patient and physician autonomy forecloses insurer-driven decision-making, patient and physician autonomy should not be unfettered. There is a crucial role for insurers (and ultimately providers) to play in cabining unnecessary care. These are precisely the circumstances—where autonomy must be respected, but decision-making is problematic—that call for a nudge.

A.  The Autonomy Value is Important but Dangerous if Unalloyed

There are many reasons to value patient autonomy, including both deontological and welfarist reasons. Patients should have the right to make very personal decisions concerning their own bodies.

And there are equally good reasons to respect providers’ professional autonomy, not the least of which is that professional autonomy is a key component of physician career satisfaction, which in turn is significantly associated with quality of patient care.[244] Professional autonomy motivates physicians and ensures that their expertise can be brought to bear on offering the best patient care.[245]

But arguments that this autonomy should be unfettered—an ideal of complete clinical autonomy for physicians and decision-making autonomy for patients, without concern for resources—are highly flawed.[246] The importance of autonomy cannot mean that there is no role for insurers or regulators in care decisions.[247]

First, when left entirely to their own devices, patients and physicians do not always make decisions that ultimately result in the best care.[248] Both patients and physicians suffer from a number of systematic decision-making biases that often prevent them from choosing treatment options that most improve well-being.[249] For instance, patients suffer from affective forecasting errors that lead to systematic mispredictions about how they will adapt to certain medical conditions, and they can be prone to commission bias, where doing something seems to be a better choice than doing nothing.[250] These biases and others likely contribute to the overtreatment and mistreatment problems discussed in Part I.[251]

Physician decision-making, too, is subject to biases and likely exacerbates these patient problems. Perhaps most prominently, physicians tend to be overly optimistic, believing that negative events are less likely to occur at their hands than those of others.[252] Physician financial incentives further skew care choices away from the ones that would be best for patients.[253]

Second, the autonomy value is predicated on the assumption that individual decisions do not negatively impact other members of society. That assumption is wrong.[254] Rather, the decision to consume unnecessary care ultimately increases premiums.[255] The evidence is convincing: spending is at least 30% higher than it should be—raising rates for all insureds.[256] Where an individual’s exercise of autonomy negatively impacts the rights of others in the community to exercise their own autonomy rights, the case for unalloyed autonomy is significantly weakened.[257]

The importance of autonomy does not dictate the system currently in place, where physician and patient demands for medical treatment are answered largely without question.[258] At the same time, physician and patient autonomy cannot be ignored and replaced with insurer decision-making motivated by reducing cost.[259] This was the failed experiment of the 1980s and 1990s.

Given these constraints, nudges bear consideration. A nudge holds the potential to steer decisionmakers, while still protecting autonomy.

B.  The Promise of Nudge

When it is important to protect decisional autonomy, but the exercise of autonomy alone results in suboptimal decision-making, the situation may be ripe for a nudge. “Libertarian paternalism”[260] refers to a regulatory system that “steer[s] people’s choices in directions that will improve the choosers’ own welfare” without choosing for them.[261]Nudges” are the methods implemented to steer people toward better decision-making.[262]

In Richard Thaler and Cass Sunstein’s original conception, a nudge was defined as that which “alters people’s behavior in a predictable way without . . . significantly changing their economic incentives.”[263] Nudges encourage people to choose in one way, but leave open the possibility of making a different choice—like a GPS that steers you in one direction, but lets you go a different way.[264]

Lawmakers and policymakers[265] are increasingly focusing on nudges because they can be effective without being coercive.[266] For instance, Great Britain changed the default on corporate pension plans to automatically enroll employees, while allowing opt-out.[267] The change resulted in significantly increased savings for retirement. [268] In many studies, nudges compare favorably to more traditional interventions like financial incentives, sometimes having a larger desired impact than more expensive and coercive tools.[269]

The term “nudge” describes a diverse set of potential interventions. The next section discusses the different forms that nudges can take.

1.  Types of Nudges

Perhaps the most well-known nudge is changing a default rule.[270] For instance, changing a regime from one that requires opting in to one of automatic enrollment with the right to opt out encourages enrollment, while protecting autonomy.[271] Policy defaults have been employed to encourage individuals with large mortgages to escrow funds for their taxes and insurance[272] and to nudge voters to vote by automatically registering citizens, but providing information on how to decline registration.[273]

Nudges, however, are not just changes to default rules. Other examples include moving healthy snacks to higher shelves than unhealthy ones,[274] redesigning a physician’s electronic prescribing pad to make it easier for the physician to prescribe generic medication and more onerous to prescribe a brand name drug,[275] and informing customers about their neighbor’s lower electricity usage to encourage energy conservation.[276] A vast literature has developed in the last two decades that explores nudges intended “to make people healthier, wealthier, and happier.”[277]

A warning is another particular type of nudge.[278] Consider, for example, the surgeon general’s warnings that are mandated to appear on cigarette packages, informing individuals that smoking causes lung cancer.[279] Credit card bills warn about the dangers in only making the minimum payment.[280] In general, warnings are intended to trigger an individual’s attention. As Sunstein has noted, “attention is a scarce resource, and warnings are attentive to that fact.”[281]

Warnings serve a number of purposes. In the most basic sense, they are informational.[282] They might inform a consumer of information necessary to make a decision that the consumer did not previously possess.

Warnings also serve to remind. Even if a decisionmaker might have previously known the information, she might not draw on the information in the moment of making the decision. Or because decisionmakers use judgment heuristics—essentially mental shortcuts—in making decisions, warnings can counteract incorrect or inaccurate recall.[283] For instance, warnings can work to counteract human tendency to be overly optimistic, in addition to other biases.[284]

Ultimately, the purpose of a warning is to influence behavior.[285] However, warnings have the advantage of being fully transparent,[286] and they do not impact personal autonomy. People are entirely free to ignore the warning if they choose.[287] Perhaps for this reason, warnings have been popular with both policymakers and with the individuals that they impact.[288]

Although warnings are not foolproof, there is ample empirical support for their effectiveness.[289] For example, consider a study of a warning nudge used to encourage students to make healthier selections in their school lunches. There, a computerized ordering system based on the U.S. Department of Agriculture MyPlate recommendations was used to encourage students to make healthier lunch choices. The study found that the treatment group subject to the nudge made significantly healthier food selections than the students who were not nudged.[290]

Not all warnings are successful, but a large and growing body of literature has explored the conditions under which warnings are most likely to result in the desired behavior. The next Section explores this literature and the challenges to the use of nudges more generally.

2.  Criticism of Nudges

There are some general criticisms of the use of nudges.[291] While less paternalistic than flat out regulation, nudges can still be coercive. If one believes that government should never intervene in an individual’s sovereign life,[292] then nudging is an unwanted intrusion. One critic of nudging has described nudges as “state incursions into the sphere of liberty.”[293]

For instance, the government might want to try to reduce obesity by drawing attention to the calories in fast food.[294] If one believes that the choice to be obese is one that a free individual in a free society should be able to make—and that an individual should not be forced to know how many calories they are consuming—then mandatory calorie labeling may be an unwanted governmental intrusion.

Nudging is also criticized when the goals behind its use are controversial. Put another way, the choice architect that puts in place the nudge is making certain decisions about what behavior is desirable. That choice might reflect a value judgment about which people disagree. Or it might be based on data that is imperfect or subject to interpretation.

Finally, not all nudges actually work, in the sense of accomplishing the behavior change that they intend. And although nudges are intended to be low cost, they are often not costless. There is the risk that nudging’s costs exceed its benefits in some circumstances.

Although these objections bear consideration, they are not insurmountable. Nudges do involve a degree of manipulation, but then so do essentially all decisions. It is difficult to avoid all aspects of paternalism in presenting choices. As to concerns about deciding which way to nudge, these are valid, but less problematic when the nudge is transparent.[295] If the government is the choice architect and people do not like the direction the government is nudging, they can make their opinions known by voting. If done right, nudges are transparent and preserve autonomy, muting concerns about infringement on liberty.[296] However, nudges are problematic if they are costly or do not work, which is why the gathering of good empirical data is crucial.

The use of warnings to nudge raises some additional concerns. Because warning nudges are perhaps the least coercive of all nudges, the biggest question is whether or not they work to influence choice.[297] On this question, the literature is robust. Scholars have identified the following crucial factors in determining the success of warning nudges: (i) noticeability, (ii) temporal and spatial proximity, (iii) the requirement of physical interaction with the warning, (iv) the use of concrete directions, (v) and the cost associated with warning compliance.[298]

First, warnings are likely to be most effective where they are conspicuous and brief.[299] Few people actively look for warnings. If the warning is not read by the decisionmaker, it cannot have the desired effect.[300]

Second, temporal and spatial proximity are important to warning compliance. For instance, in one study, a warning that a file cabinet would tip if the top cabinet were filled before the bottom cabinet was placed on the packing box and in various places inside the top cabinet.[301] When the warning was just on the packing box, it was viewed, read, and complied with at significantly lower rates than when it was placed inside the cabinet. Further, when the warning was placed on a cardboard bridge that had to be physically removed to fill the top drawer, compliance levels were even higher than when the warning was simply placed inside the cabinet.[302] Results from other studies are consistent: compliance is highest when the warning is delivered in both physical and temporal proximity to the task and when the decisionmaker must physically interact with it in some way.[303] Given these parameters, technology provides particularly good opportunities to deliver effective warnings at a low cost.[304]

Third, warnings are more likely to be effective if accompanied by concrete directions for the individual reading it, such as you can do X and Y to lower your risk.[305] In one study, people who used water-repellent sealer were given different labels to determine whether compliance is dependent upon the explicitness of warnings and instructions.[306] The results indicated that “procedurally explicit precautions included in the directions substantially increased reading rates from 4% to 78% and compliance rates from 10% to 65%.”[307]

Lastly, to the extent that decisionmakers view the decision of whether or not to comply with a warning through the lens of a cost-benefit analysis, then the cost of complying with a warning is particularly important and can influence warning effectiveness.[308] Compliance cost may take many forms. There may be financial costs associated with warning compliance, or there may be costs in terms of time, convenience, or emotional toll.[309] For instance, a smoker may choose to ignore the surgeon general’s warning because the costs of recovering from addiction are higher than the cost of good health—at least in that individual’s estimation. Biases can skew cost-benefit analyses.[310] In particular, the optimism bias, which causes people to discount the risk of experiencing a negative event, can be impactful. But in general, studies confirm that the lower the costs of complying with the warning, the more likely that the warning will be effective.[311]

Warnings are not perfect. Users can choose to ignore them. Plenty of people still smoke despite surgeon general’s warnings. And many still only make the minimum payment on their credit card bills. Warnings cannot always counteract other, potentially stronger forces motivating decisions. But nonetheless, there is reason to be optimistic that a properly designed warning that accounts for these challenges could effectively reduce unnecessary care. The next Part presents the proposal.

IV.  Nudging Away Unnecessary Care

The fundamental challenge with reducing unnecessary care is that there is a spectrum from patient and physician autonomy on one end to insurer decision-making on the other, where both poles are problematic, and no path to a middle ground has been identified. Complete autonomy for patients and doctors results in health care decisions being made by those with no real incentive to stop harmful overuse. But too much control by insurers means that both non-beneficial and beneficial care may be rationed.

In Crossing the Quality Chasm, the Institute of Medicine delivered the directive that, “IT must play a central role in the redesign of the health care system if a substantial improvement in health care quality is to be achieved during the coming decade.”[312] In keeping with that sentiment, the way to reduce unnecessary care, but protect patient and physician autonomy, is by employing a computerized nudge. Providers should receive an automated warning before their orders for commonly overused interventions are placed, dissuading unnecessary care without the use of inflexible, autonomy-reducing methods. In a perfect world, insurers would require this nudge in their contracts with providers. However, because a toxic combination of mismatched legal incentives, market failures, and industry norms prevents that from happening, the government will have to mandate it.

A.  The Proposed Solution: A Warning Nudge

The health care industry is notoriously behind in its adoption of technology.[313] Yet recent years have been marked by a digital transformation of medicine.[314] Use of health IT systems and electronic health records is now widespread and growing.[315] By the end of 2017, approximately 90% of office-based physicians nationwide will be using electronic health records.[316] The vast majority of hospitals and most outpatient practices now use some form of Computerized Provider Order Entry (CPOE) system, which allows providers to order tests, procedures, consultations, and prescribe medications electronically.[317] Most communications between providers and insurers now also occur electronically, with use of electronic prior authorization procedures notably on the rise. These systems are far from perfect, often scoring low on usability and interoperability.[318] Lawmakers and policymakers are continuing to explore ways to improve the state of health IT.[319] But this technology proliferation can be deployed to effectively nudge.

Systems could be programmed so that a computerized warning pops up when a provider places an order (or submits a pre-authorization) for a test or procedure that is likely to be unnecessary.[320] The warning would prompt the provider with a question that essentially asks if she is sure about the order given evidence that the test or procedure is often overutilized or misconsumed. The warning should link to additional sources of information that supply the warning’s scientific basis to the provider. And where appropriate, the warning should also suggest an alternate intervention.

For instance, when a provider enters an order for an X-ray for uncomplicated lower back pain, a CT scan for sinusitis, or an MRI for an uncomplicated headache—all of which have been identified as commonly overused tests[321]—the warning would pop up. Similarly, to address misconsumption, a warning could pop up when a provider tries to schedule (or seeks pre-authorization for) a spinal fusion surgery for a worn out disc or laparoscopic uterine nerve ablation for chronic pelvic pain.[322] The provider could proceed as planned if the provider believes that it is in the best interests of the patient to do so, but this nudge requires the provider to click “Yes, I’m sure” for the order to process.[323] Although the warning would not deter all unnecessary care, there is reason to believe it could be effective.

There is precedent for such a system already in place. Clinical decision support systems (CDSSs) are designed to help providers make care recommendations to their patients.  Early CDSS systems were used in prescribing medications, attempting to prevent medication errors by screening for drug doses, allergies, and drug interactions. CDSSs now go beyond a focus on medications and often employ alerts and warnings relevant to broader issues of patient care.[324] Some insurer systems are also screening for red flags of unnecessary care, typically as a part of their electronic pre-authorization practices[325]—although the purpose of these reviews is ultimately to decide whether or not to grant pre-authorization. Providers cannot override denials.[326]

CDSSs, however, are not yet in widespread use[327] and, as currently implemented, are both overinclusive and under-inclusive. CDSSs, particularly as employed for e-prescribing, have been criticized for the abundance of alerts that pop up when providers try to enter orders, many of which are not useful.[328] And even where CDSSs are deployed, they are still mostly used for prescribing and not for other types of orders and interventions. There is also concern about the quality of the data on which these systems are programmed.[329] The next Section takes up the data issue specifically.

1.  The Data on Which to Base Warnings

Perhaps one of the biggest questions about any computerized warning system concerns the underlying data. Who decides which orders draw warnings and how?[330] This Section makes a suggestion, but also provides alternatives worth considering.

The first, and probably best option, is to tie the warnings to the already established Choosing Wisely campaign. In 2012, the American Board of Internal Medicine Foundation, Consumer Reports, and nine medical specialty societies launched the campaign.[331] Its purpose was to promote quality, evidence-based care that was “truly necessary.”[332] Specifically, it tasked medical societies with preparing lists of five tests or procedures in their clinical domains that are performed too often.[333] The initial set of lists was well-received, and the campaign has grown from there, with more than seventy societies now involved.[334] The Robert Wood Johnson Foundation has provided considerable funding to aid its efforts, awarding grants in 2013 and 2015.[335]

To give an example of how the campaign works, the American College of Radiology (“ACR”)a nonprofit, professional medical society whose members are radiologists, nuclear medicine physicians, and medical physicists[336]generated its list of five recommendations to reduce unnecessary care in radiology, one of which states simply: “Don’t do imaging for uncomplicated headache.”[337] To support the recommendation, ACR provides citation to a list of academic sources.[338] This guidance could easily be converted to a computerized warning, such that a provider entering an order for imaging for an uncomplicated headache would get a pop-up discouraging (but not preventing) the order.

The Choosing Wisely lists have been well-received, but on their own have not had a particularly robust effect on unnecessary care. One study found that following the release of the guidelines, use of imaging for headaches and cardiology both declined, but other services on the “unnecessary” lists actually saw increases in use.[339] Merely establishing guidelines does not seem to be enough to effect practice patterns.

Using professional societies more generally—and the Choosing Wisely lists specifically—as the basis for computerized warnings, however, offers a number of advantages. The lists are driven by the providers practicing in their respective specialties. They are simple to translate to warnings and are not so numerous as to overwhelm. They do not contain “close calls,” but rather focus on the big-ticket sources of overuse. They also establish a national standard, which might even be helpful to physicians in malpractice litigation[340] and could promote uniformity in approach.[341]

In terms of challenges, however, the Choosing Wisely lists may reflect and perpetuate physician biases in care given that it is the providers themselves generating the lists. If the project gets into more controversial territory, it might be hard to reach consensus. There would need to be a structure for updating the lists over time, and the project’s funding is driven by private grants, which may not sustain it over the long term.

There are other options for sourcing the data. Government-driven processes have the advantage of solving the funding problem and ensuring a singular national approach. Any government process would need to win the buyin of the provider community, though, and would need to overcome the traditional hurdles of bureaucracy and difficulty in ensuring quick responses to changes in evidence. A government-driven process would likely meet great resistance from the current Congress and administration.[342]

Another option is a government-private partnership. The Advancing Clinical Decision Support project, led by the RAND Corporation, Massachusetts-based Partners HealthCare, and Harvard Medical School and funded by the U.S. Office of the National Coordinator for Health Information Technology is an example already underway. The overall goal of the project is to address barriers to adopting CDSSs. Partnerships such as this could be tasked with vetting data for the warning nudges.[343]

Finally, there are a number of dispersed private endeavors engaged in evaluating scientific evidence, typically with a focus on new medical technologies.[344] These endeavors are driven by health plans, but usually include representation from a wider community of industry actors, such as academics, physicians, and representatives from medical associations.[345]

Ultimately, the goal would be to use sound scientific data that is consensus-driven, with significant buy-in from the providers that the data seeks to influence. Where clear data is lacking, a warning would not be used. There are plenty of areas, however, where unnecessary care data is robust; efforts should start there. Over time, the warnings should be personalized as effectively as possible to individual patient circumstances. Although there is much work to be done, the trend is moving strongly in that direction.[346]

2.  Why Warning Nudges Would Be Effective

Warning messages based on Choosing Wisely lists or other comparable data could effectively reduce unnecessary care. The warnings utilize most, if not all, of the best practices scholars have identified for securing warning compliance and do not significantly impact physician autonomy, which is perhaps the biggest concern in any effort to reduce unnecessary care.

First, the warnings would disseminate valuable, targeted information. The timing and mode of delivery ensures that providers will draw on relevant information at the time of deciding on care. The warnings would be designed to force physical interaction because the provider will have to click to “answer” it.[347] Where possible, the warnings would also provide a concrete suggestion of what the provider should do instead of the original order.[348]  Importantly, the warnings would be limited and targeted because the Choosing Wisely lists are limited and targeted, addressing a major source of provider ire with current CDSS systems that over-warn and prompt warning fatigue.

Second, although designed to prompt compliance, the warnings would not impact professional autonomy. Ultimately, providers still decide whether or not to place the order. Providers often fight the use of evidence-based medicine to the extent it impacts their abilities to take account of differences between individual patients and does not respect their professional intuition.[349] The warning system addresses those arguments by nudging providers away from care that is likely unnecessary, while avoiding a more coercive approach.

Early studies provide further basis for optimism that unnecessary care warnings can be effective. Los Angeles-based Cedars-Sinai Health System built 180 Choosing Wisely recommendations into its electronic health records . . . .”[350] For instance, because sedative drugs are not supposed to be used by the elderly, it built in a warning for new orders of benzodiazepine for patients over age 65. The health system saw a 40% decrease in use after implementing the warning message.[351] New York-based Crystal Run Healthcare experimented with something similar, programming into its system pop-up alerts based on four of the Choosing Wisely recommendations from the American Academy of Family Physicians. It led to decreases in annual EKGs, MRIs for low back pain, and bone density screening. [352]

More generally, there is ample evidence that warnings built into computerized provider order entry systems can improve the quality and efficiency of care. In Scotland, the addition of computerized, educational reminder messages was associated with a reduction of more than 20% in test ordering.[353] Another study found increased adherence to radiology test guidelines and a decrease in radiology utilization.[354] There are also many studies of medication alerts that have been shown to be effective in reducing unnecessary and even harmful prescriptions.[355] For instance, in one study, physicians who received computerized alerts about a drug’s potential adverse effects were significantly less likely to prescribe the medication.[356] Many other systematic reviews have found that computerized decision support tools in general can deter low-value care.[357]

Given the promising nature of this approach, it might be surprising that it has not gained significant traction. The next Section explains why the government will need to mandate the nudge.

B.  The Need to Mandate This Nudge

Insurers would be best situated to require unnecessary care warnings because providers lack sufficient incentive to adopt such technology. While some health systems have experimented with implementing these warnings unprompted by insurers, it is unlikely that these systems will proliferate if left to providers. After all, despite the beginning of payment reform, providers are still largely paid on a fee-for-service basis, giving them the financial incentive to order more care, not less. Providers must pay to implement the technology, and while providers may have incentive to improve quality—which should mean reducing harmful unnecessary care—it is hard to see much effort originating from health systems or provider groups absent other forces at play.[358]

Insurers, however, could require by contract an unnecessary care warning system. Private insurers and providers routinely enter into contracts that govern provider “in network” status and dictate reimbursement rates, among other provisions. There is nothing that prevents insurers—especially because most possess a dominant negotiating position over providers[359]—from simply requiring by contract that providerordering systems include warnings of unnecessary care.

Flaws in decision-making caused by market failures and counterproductive legal incentives have, however, gotten in the way.[360] The most prominent flaw being that it is easier to raise premiums in an imperfectly competitive, ineffectively regulated market, than to undertake systematic efforts to reduce unnecessary care that involve incurring transaction costs.[361] For this reason, the nudge will not happen unless it is mandated.

It is not uncommon for nudges to require regulation.[362] For instance, in an effort to reduce obesity, lawmakers required the labeling of nutrition information on restaurant menus.[363] Other so-called “informational nudges” have also been regulated,[364] such as laws pertaining to credit card disclosures, insurance choice, and fuel economy, to name a few.[365]

And insurance contracts are already subject to a host of other mandates.[366] In the name of consumer protection and public health, laws require coverage of essential health benefits, among other services or benefits for which insurers must provide coverage, including coverage for particular types of providers and coverage for certain groups like adopted children and domestic partners.[367]

Mandates generally are not without controversy. They infringe on the parties’ freedom of contract.[368] And there is concern that insurance mandates increase premiums,[369] but if the system works as designed, a mandate requiring unnecessary warnings should actually decrease premiums by reducing costly unnecessary care. Any additional cost that the specific mandate contemplated in this Article provokes should be covered by the anticipated savings.[370]

Lawmakers might also avoid the insurance contract and instead go directly to the source by requiring that providers implement these warning systems. This direct regulation might be conducted through amendments to HIPAA or perhaps through the meaningful use requirements. But insurers are still the actors most motivated to reduce unnecessary care, despite the challenges, and it makes the most sense to give them a crucial role to play, particularly in monitoring for compliance. Although insurers might not have the incentives to require a warning nudge system in the first place, once it is in place, they will have an incentive to see it work effectively.

C.  Addressing Challenges and Suggestions for Further Study

Although the warning nudge has the potential to substantially reduce unnecessary care and drive down insurance premiums, it is not without its challenges.

1.  A Paternalistic Approach

The most commonly levied argument against nudging is that it is paternalistic and manipulative, even if it might be less overtly coercive than other forms of regulation.[371] The argument against automated warnings, then, is perhaps obvious—they are an attempt to change behavior and do not respect the autonomy of doctor and patient decision-making.

It is true that the whole purpose of the warning system would be to influence decision-making and change behaviors. But while there is a degree of paternalism, any coercion is minimal. After all, doctors and patients are ultimately free to make their own decisions absent repercussion. Common alternatives, such as tying compensation to the likely effectiveness of treatment, are far more coercive.

In general, health care interactions already contain all sorts of attempts to influence. Doctor treatment recommendations in particular have been shown to highly influence the choices that patients make about their care.[372] Framing effects in health care are, to a large degree, unavoidable. And if that is the case, the arguments for at least framing in the “right” direction are strong.

2.  Concerns About Data

But what is the “right” direction? Perhaps the biggest stumbling block to the nudge solution is still the data. As scholars have noted, “[d]espite widespread concerns that many patients receive biomedical interventions that have little or no evidence about their safety and therapeutic effectiveness, what ‘effective’ means and how to measure it are contested questions.”[373] Indeed much of medical practice is the result of tradition and collective experience, not the rigorous and systematic study of medical interventions.[374] And the individual skill of a provider or individual patient characteristics can often be highly relevant to outcomes.[375]

Yet while it is undoubtedly true that definitive clinical information about effectiveness is often lacking and individual circumstances may often be important, this need not be paralyzing. More studies need to be done, but additional resources are being directed at learning more about the effectiveness of a wide-range of treatments. And scholars and policymakers have good ideas about how to incentivize more useful clinical research.[376]

It is clear that evidence of overuse and misuse currently exists. It would be short-sighted to ignore that data—that campaigns like Choosing Wisely have studied—and take no action while waiting for more comprehensive data to emerge. Even if data is imperfect, the warning nudge accounts for personalized decision-making by not requiring compliance. Providers may still disagree. This is a key advantage over other proposed solutions. For instance, one idea that has started to gain traction is for insurers to tier reimbursement or cost-sharing rates to evidence of effectiveness. This is promising, but the concern about infringement on physician judgment is an important stumbling block to this more aggressive nudge.[377]

The fact that evidence of effectiveness (or ineffectiveness) is lacking for many interventions is not necessarily a bad thing for a nascent alert system. From a cognitive perspective, it may be beneficial to focus on a smaller number of (high impact) warnings. Too many warnings may be counterproductive.

3.  Obtaining Buy-In from Providers

Another challenge concerns potential provider resistance to a warning system. Providers as a group are fiercely protective of their professional autonomy. This has translated into some general resistance to the concept of evidence-based medicine, which is perceived as a slight to professional judgment and intuition.[378]

But there is evidence that physicians can be influenced by computerized warning systems,[379] and a number of reasons exist to believe that provider buy-in can be obtained in this context. First, if the warnings are driven by the work of professional associations, of which providers are members, they are more likely to credit the warnings and pay attention. Second, warnings are much less coercive and have a far less serious impact on professional autonomy than other methods of reducing unnecessary care, like utilization reviews or even value-based insurance design.[380] Third, physicians desiring to limit their practice of defensive medicine might feel empowered by the national standards.[381] A good warning system should actually reduce liability that stems from unnecessary care that causes harm.

4.  IT Resistance and Alert Fatigue

A related challenge to obtaining provider buy in concerns provider resistance to IT. One survey found that doctors in the United States were less likely to believe that health IT can improve care than in other countries.[382] Physicians are often suspicious that technology will lead to the industrialization of medicine and complain that IT adoption has increased their administrative burdens, giving them less time to focus on important patient care.[383] Studies indicate that physicians are reluctant to support an IT that interferes with their traditional work routines.”[384] Notably, for this alert to be effective, it must be communicated at a time when it can influence the doctor’s care recommendations, which may involve changes to work routines. Many doctors currently don’t access an order entry system until after a course of care has been agreed to with the patient.[385]

Alert fatigue—the idea that with too many (unhelpful) alerts, providers will stop paying attention—is also a concern.[386] Some particularly troubling reviews have found very high alert override rates, particularly where alerts are pervasive and important alerts are buried in a sea of unimportant ones.[387]

It is therefore particularly important to design a warning system that does not overwhelm. Better to use discrete lists, like the ones from Choosing Wisely’s campaign, that might under-deter unnecessary care than to risk undermining the entire enterprise by adding too many unwieldy alerts.

It is also important to test for unintended consequences. For instance, it is possible that physicians might react negatively to the alerts and increase unnecessary care rather than reduce it. This reaction seems unlikely, particularly when coupled with payment reform and the fact that these alerts would be driven by peers. But with any new nudges, experimentation is prudent to test for any potentially negative consequences.[388]

On the other hand, if the nudge is not strong enough, insurers can be utilized to encourage compliance—another advantage of involving insurers. For instance, an insurer could either tier reimbursement rates such that the care it wishes to deter is reimbursed at a lower rate or could tier co-pays to try to directly impact patient decision-making.[389] There are downsides to this, particularly that this more coercive use of financial incentives requires an even higher confidence in the data and more negatively impacts patient and physician autonomy.[390] But it is an option that could be deployed if provider resistance to the warnings proves too strong.

5.  Cost of Compliance

Another crucial consideration is the cost of provider compliance.[391] The administrative burden discussed in the prior Section is one such cost. Presumably that cost could be minimized by systemic efficiencies and targeted use of warnings. But there is another relevant provider cost—the revenue providers will lose from delivering less care (or care with lower rates of reimbursement) in a fee-for-service system.

This is an important cost. One could imagine a rational physician who is warned that a spinal fusion surgery is likely unnecessary, but discounts that warning because he stands to earn a significant amount from performing the surgery. In a world where the warnings are easily ignored and the reimbursement rates from unnecessary care are substantial, warnings may not be particularly effective.

Here, there are at least two answers. First, the payment reform movement might be helpful. If providers are paid based on patient outcomes and cost savings, rather than on a fee-for-service basis, this problem becomes much less significant.[392] Although there has been a big trend away from fee-for-service, a few politicians have expressed skepticism of payment reform.  The future is unclear.

Second, cultural forces (and pressures) are not to be underestimated and might play a more important role in physician decision-making than rote financial concerns. If these warnings are generated by professional associations of which the provider is a member and effectively change the standard of care, it might override reimbursement concerns. This is particularly true if the warnings cause the standard of care to more quickly align with the evidence.

6.  Patients Ultimately Make Care Decisions

Finally, although the nudge is directed at physician practices, it is actually patients who ultimately make care decisions. Informed consent doctrine requires that a physician explain treatment options and attendant risks and benefits, so that the patient can properly decide on care.[393] Therefore, reducing unnecessary care will not be accomplished by directing efforts at providers alone.

That being said, if the care is truly unnecessary, the physician is not legally required to give the patient the option to choose it.[394] And as a practical matter, physicians are highly influential in care decisions and often hold the ability to align patient perceptions about appropriate care with their own.[395] Most patients are not as medically literate as their doctors. Some patients would actually prefer to have the physician decide their care, or at least strongly steer them in the right direction.[396] To the extent that physicians today acquiesce to patient demands for unnecessary care more often than they should, the warning system might give the physician more confidence to persuade the patient otherwise.

At bottom, all of these potential challenges could be better assessed with more empirical testing of the concept. Responses to nudges are notoriously unpredictable. But given the magnitude of the unnecessary care problem and the fundamental flaws in the other approaches, now is the time to try.[397]

Conclusion

High premiums have become the central focus of recent debates over the U.S. healthcare system’s future. Solutions like reducing benefits or kicking sick people out of risk pools would have dire consequences. There is a better target—the unnecessary care that accounts for 30% of health care costs.

The problem is well-documented. Patients and providers lack adequate incentive to address it. Insurers would seem best situated to act as a check because a rational insurer should want to reduce claims costs. But insurer experiments with refusing to reimburse for unnecessary care were political failures. And because of problematic legal incentives, market failures, and cultural norms, insurers have taken a back seat to patients and physicians in recent years.

The problem calls for a nudge—a way to respect patient and physician autonomy, but to discourage unnecessary care. A computerized warning, based on the professional consensus of medical associations, could be particularly impactful and should be implemented and tested. In a perfect world, insurers would just require providers they contract with to implement the warnings. But in this case, the government will likely have to intervene.

 


[*] *. Visiting Associate Professor, University of Chicago Law School; Professor, DePaul University College of Law; Faculty Director, Mary and Michael Jaharis Health Law Institute. I would like to thank John Bronsteen, Christopher Buccafusco, Anthony Casey, Emily Cauble, I. Glenn Cohen, Max Helveston, Andrew Gold, Gregory Mark, Jonathan Masur, Frank Pasquale, Govind Persad, Nicholson Price, Jessica Roberts, Christopher Robertson, Zoë Robinson, Rachel Sachs, Ana Santos Rutschman, Ameet Sarpatwari, Nadia Sawicki, and Nicolas Terry. I also thank the attendees and listeners of the University of Chicago Faculty Workshop, the DePaul University Faculty Workshop, the Chicago Health Law Professors Workshop, and the Week in Health Law Podcast for insightful comments.

 [1]. See Gisele Grayson, Alyson Hurt & Alison Kodjak, CHART: Who Wins, Who Loses with Senate Health Care Bill, NPR: Policy-ish (June 22, 2017, 3:59 PM), http://www.npr.org/sections/health-shots/2017/06/22/533942041/who-wins-who-loses-with-senate-health-care-bill.

 [2]. Dylan Matthews, These Are All the People the Senate Health Care Bill Will Hurt, Vox (June 26, 2017, 5:11 PM), https://www.vox.com/2017/6/22/15855262/senate-health-bill-victims-hurts-medicaid-poor (discussing effect of Senate health care bill on vulnerable parties).

 [3]. The Cost of Health Care: How Much is Waste?, Nat’l Acad. Press, http://resources.nationalacademies.org/widgets/vsrt/healthcare-waste.html (last visited May 6, 2018). See also Carrie H. Colla et al., Choosing Wisely: Prevalence and Correlates of Low-Value Health Care Services in the United States, 30 J. Gen. Internal Med. 221, 221–22 (2015) (“Elimination of low-value services as a cost control strategy has much economic appeal because it would improve quality while reducing costs.”).

 [4]. J. Bruce Moseley et al., A Controlled Trial of Arthroscopic Surgery for Osteoarthritis of the Knee, 347 New Eng. J. Med. 81, 85 (2002).

 [5]. Tanner J. Caverly et al., Editorial, Too Much Medicine Happens Too Often: The Teachable Moment and a Call for Manuscripts from Clinical Trainees, 174 JAMA Internal Med. 8, 9 (2014); Meredith A. Niess & Allan Prochazka, Preoperative Chest X-Rays: A Teachable Moment, 174 JAMA Internal Med. 12, 12 (2014) (“Exposing a patient to multiple, additional studies prolongs surgical delay, increases exposure to radiation, prolongs and exacerbates underlying anxiety, and increases the likelihood of additional incidentalomas.”); Chest X-Rays Before Surgery, Choosing Wisely, http://www.choosingwisely.org/patient-resources/chest-x-rays-before-surgery (last visited May 6, 2018).

 [6]. Brian C. Callaghan et al., Headaches and Neuroimaging: High Utilization and Costs Despite Guidelines, 174 JAMA Internal Med. 819, 820 (2014) (explaining that neuroimaging for headaches generates nearly $1 billion in annual costs despite recommendations against the practice).

 [7]. See infra Section I.B. Tremendous amounts of ineffective drugs are also prescribed and reimbursed. This problem raises considerations beyond the scope of this Article, which focuses on unnecessary medical services and largely brackets, for now, the issue of pharmaceuticals. For a discussion of the pharmaceutical over-prescription issue, see Rebecca S. Eisenberg & W. Nicholson Price, II, Promoting Healthcare Innovation on the Demand Side, 4 J.L. & Biosci. 3, 3–7 (2017) and Rachel E. Sachs, Commentary, Promoting Demand-Side Innovation: Prizes for Payers, 4 J.L. & Biosci. 391, 391–93 (2017).

 [8]. 155 Cong. Rec. S11,132 (daily ed. Nov. 5, 2009) (statement of Sen. Hagan) (noting that the United States spends “the most per capita of all industrialized nations,” but has “higher infant mortality and lower life expectancy”); David Squires & Chloe Anderson, U.S. Health Care from a Global Perspective: Spending, Use of Services, Prices, and Health in 13 Countries, Commonwealth Fund: Issue Briefs (Oct. 8, 2015), http://www.commonwealthfund.org/publications/issue-briefs/2015/oct/ushealthcarefromaglobalperspective. See also Adam Candeub, Contract, Warranty, and the Patient Protection and Affordable Care Act, 46 Wake Forest L. Rev. 45, 51 (2011) (“There is little to no data linking total health care expenditures with positive health care outcomes . . . .”).

 [9]. Ezekiel J. Emanuel & Victor R. Fuchs, Commentary, The Perfect Storm of Overutilization, 299 JAMA 2789, 2789 (2008) (“The most important contributor to the high cost of US health care, however, is overutilization.”).

 [10]. See Grayson, supra note 1 and accompanying text.

 [11]. Comm. on the Learning Health Care System in Am., Inst. of Med., Best Care at Lower Cost: The Path to Continuously Learning Health Care in America 99–100 (Mark Smith et al. eds., 2013) (ebook).

 [12]. See Diane Armao, Richard C. Semelka & Jorge Elias, Jr., Radiology’s Ethical Responsibility for Healthcare Reform: Tempering the Overutilization of Medical Imaging and Trimming Down a Heavyweight, 35 J. Magnetic Resonance Imaging 512, 516 (2012); Najlla Nassery et al., Opinion, Systematic Overuse of Healthcare Services: A Conceptual Model, 13 Applied Health Econ. & Health Pol’y 1, 1–2 (2015).

 [13]. See infra Sections I.C.1–2.

 [14]. David A. Hyman & Charles Silver, You Get What You Pay For: Result-Based Compensation for Health Care, 58 Wash. & Lee. L. Rev. 1427, 1443 (2001); Jessica Mantel, Spending Medicare’s Dollars Wisely: Taking Aim at Hospitals’ Cultures of Overtreatment, 49 U. Mich. J.L. Reform 121, 132–33 (2015) (explaining that fee-for-service encourages doctors to recommend costly interventions); Richard S. Saver, Health Care Reform’s Wild Card: The Uncertain Effectiveness of Comparative Effectiveness Research, 159 U. Pa. L. Rev. 2147, 2174 (2011) (“Financial incentives powerfully guide physician behavior . . . above and beyond technical appeals to clinical judgment.”). See also Arnold S. Relman, Commentary, Doctors as the Key to Health Care Reform, 361 New Eng. J. Med. 1225, 1225–27 (2009) (arguing for physician compensation independent of medical decisions).

 [15]. Timothy Stoltzfus Jost, The American Difference in Health Care Costs: Is There a Problem? Is Medical Necessity the Solution?, 43 St. Louis. U. L.J. 1, 15 (1999); Shannon Brownlee, Vikas Saini & Christine Cassel, When Less Is More: Issues of Overuse in Health Care, Health Aff. Blog (Apr. 25, 2014), https://www.healthaffairs.org/do/10.1377/hblog20140425.038647/full (“Patients often believe implicitly that there’s always one more test, one more treatment to try, and that their doctor would never recommend a procedure or a stay in the ICU that was not in their best interest.”).

 [16]. Jerry L. Mashaw & Theodore R. Marmor, Conceptualizing, Estimating, and Reforming Fraud, Waste, and Abuse in Healthcare Spending, 11 Yale J. on Reg. 455, 458 (1994) (“The reliance on third-party payments to finance medical care strengthens patients’ own bias towards using whatever methods are available when their health is at stake.”).

 [17]. Wendy Netter Epstein, Price Transparency and Incomplete Contracts in Health Care, 67 Emory L.J. 1, 3 (2017) [hereinafter Epstein, Price Transparency] (“Patients suffer from both an imbalance of information and an imbalance of power.”); Erin C. Fuse Brown, Irrational Hospital Pricing, 14 Hous. J. Health L. & Pol’y 11, 16 (2014); Mark A. Hall & Carl E. Schneider, Patients as Consumers: Courts, Contracts, and the New Medical Marketplace, 106 Mich. L. Rev. 643, 653–56 (2008) (discussing physicians’ failure to disclose prices).

 [18]. See Epstein, Price Transparency, supra note 17, at 51–58; Erin C. Fuse Brown, Resurrecting Health Care Rate Regulation, 67 Hastings L.J. 85, 104–06 (2015) (discussing price transparency shortcomings in solving market failure). See generally Wendy Netter Epstein, Revisiting Incentive-Based Contracts, 17 Yale J. Health Pol’y L. & Ethics 1 (2017) (discussing challenges with value-based compensation for providers).

 [19]. Katherine Baicker, Amitabh Chandra & Jonathan S. Skinner, Saving Money or Just Saving Lives? Improving the Productivity of US Health Care Spending, 4 Ann. Rev. Econ. 33, 38 (2012) (discussing why insurers pay for services deemed medically necessary by physicians); Mark A. Hall & Gerard F. Anderson, Health Insurers’ Assessment of Medical Necessity, 140 U. Pa. L. Rev. 1637, 1644–51 (1992) (discussing case law that led private insurers to defer to physicians’ decisions).

 [20]. See generally Elisabeth Rosenthal, An American Sickness: How Healthcare Became Big Business and How You Can Take It Back (2017) (discussing factors causing American healthcare system to become expensive and inefficient).

 [21]. See discussion infra at Section II.B.1.

 [22].               See generally Jeffrey Clemens & Joshua D. Gottlieb, In the Shadow of a Giant: Medicare’s Influence on Private Physician Payments (Nat’l Bureau of Econ. Research, Working Paper No. 19503, 2013) (showing private medical care pricing tracks Medicare pricing and discussing factors that contribute to Medicare’s influence in certain markets).

 [23]. See infra Section II.B.3 (discussing that imperfect markets and ineffective regulatory efforts permit insurers to raise premiums).

 [24]. See infra Section II.B.2.

 [25]. Suzanne M. Grosso, Rethinking Malpractice Liability and ERISA Preemption in the Age of Managed Care, 9 Stan. L. & Pol’y Rev. 433, 435 (1998) (describing how utilization review violates provider autonomy).

 [26]. Id.

 [27]. See, e.g., Nadia N. Sawicki, Modernizing Informed Consent: Expanding the Boundaries of Materiality, 2016 U. Ill. L. Rev. 821, 827 (2016) (“The doctrine of informed consent is grounded in the ethical principle of patient autonomy.”); Peter H. Schuck, Rethinking Informed Consent, 103 Yale L.J. 899, 924 (1994); Erin Sheley, Rethinking Injury: The Case of Informed Consent, 2015 BYU L. Rev. 63, 68 (2015).

 [28]. See infra Section I.B.3.

 [29]. See, e.g., Alexander M. Capron & Donna Spruijt-Metz, Behavioral Economics in the Physician-Patient Relationship: A Possible Role for Mobile Devices and Small Data, in Nudging Health: Health Law and Behavioral Economics 233, 234 (I. Glenn Cohen, Holly Fernandez Lynch & Christopher T. Robertson eds., 2016).

 [30]. See infra Section IV.A.1.

 [31]. See supra notes 1415 and accompanying text.

 [32]. E. Andrew Balas & Suzanne A. Boren, Managing Clinical Knowledge for Health Care Improvement, in 2000 Yearbook of Med. Informatics 65, 66.

 [33]. See Sara Rosenbaum et al., Commentary, Who Should Determine When Health Care Is Medically Necessary?, 340 New Eng. J. Med. 229, 230 (1999) (“[F]or more than 200 years, the courts in malpractice cases have turned to clinical practices for evidence of when and under what circumstances medical care should be considered medically necessary, and insurers therefore have relied on the prevailing clinical standards of care.”).

 [34]. See Christopher Robertson, The Split Benefit: The Painless Way to Put Skin Back in the Health Care Game, 98 Cornell L. Rev. 921, 937 (2013).

 [35]. Richard H. Thaler & Cass R. Sunstein, Libertarian Paternalism, 93 Am. Econ. Rev. 175, 178–79 (2003). See also Cass R. Sunstein & Richard H. Thaler, Libertarian Paternalism Is Not an Oxymoron, 70 U. Chi. L. Rev. 1159, 1161–62 (2003).

 [36]. See Nat’l Fed’n of Indep. Bus. v. Sebelius, 567 U.S. 519, 548–61, 570 (2012) (finding the individual mandate to be a constitutional exercise of congressional taxing authority, but not a proper use of Congress’s Commerce Clause or Necessary and Proper Clause powers); Akhil Reed Amar, Opinion, Constitutional Objections to Obamacare Don’t Hold Up, L.A. Times (Jan. 20, 2010), http://articles.latimes.com/2010/jan/20/opinion/la-oe-amar20-2010jan20. The individual mandate, however, was subsequently repealed as a part of tax reform efforts. Louise Radnofsky, The New Tax Law: The Individual Health-Insurance Mandate, Wall St. J. (Feb. 13, 2018, 12:09 PM), https://www.wsj.com/articles/the-new-tax-law-the-individual-health-insurance-mandate-1518541795.

 [37]. See Nat’l Fed’n of Indep. Bus., 567 U.S. at 585 (mandatory Medicaid expansion violated Congress’s Spending Clause authority); Sara Rosenbaum, Commentary, Medicaid and National Health Care Reform, 361 New Eng. J. Med. 2009, 2009–12 (2009) (discussing the controversy over Medicaid expansion).

 [38]. Burwell v. Hobby Lobby Stores, Inc., 134 S. Ct. 2751, 2759 (2014); Douglas Nejaime & Reva B. Siegel, Conscience Wars: Complicity-Based Conscience Claims in Religion and Politics, 124 Yale L.J. 2516, 2518 (2015).

 [39]. See Health Care and the 2008 Elections, Henry J. Kaiser Fam. Found. 2 (Oct. 2008), https://kaiserfamilyfoundation.files.wordpress.com/2013/01/7828.pdf; Henry J. Kaiser Fam. Found. & Health Res. Educ. Trust, Employer Health Benefits Survey: 2016 Annual Survey, 24–25 (Sept. 2016).

 [40]. The Third Presidential Debate: Hillary Clinton and Donald Trump, YouTube (Oct. 19, 2016), https://youtu.be/smkyorC5qwc. See also Rachana Pradhan, Trump Misleads on Obamacare Premiums Increases, Politico (Oct. 19, 2016, 10:53 PM), http://www.politico.com/blogs/2016-presidential-debate-fact-check/2016/10/trump-misleads-on-obamacare-premium-increases-230052.

 [41]. In one survey, between 57–62% of voters in the 2016 Presidential Election said that “the cost of health insurance premiums” was “very important” to their vote for President. Ashley Kirzinger et al., Kaiser Health Tracking Poll: September 2016, Henry J. Kaiser Fam. Found. (Sept. 29, 2016), https://kaiserf.am/2j7E3Px. See also Olga Khazan, How Obamacare Helped Trump, Atlantic (Nov. 9, 2016), https://www.theatlantic.com/health/archive/2016/11/how-obamacare-helped-trump/507113/. Other prominent Republicans adopted the same focus. See, e.g., Abby Goodnough, Increase in Health Act Premiums May Affect Arizona Vote, N.Y. Times (Oct. 29, 2016), https://nyti.ms/2jOFiou (discussing Senator McCain’s opposition to Obamacare on basis of increasing premiums); Jon Greenberg, Sen. Ted Cruz Says Premiums Have Gone “Up and Up and Up” for “Virtually Every Person”, Politifact (Oct. 17, 2013, 5:19 PM), http://www.politifact.com/truth-o-meter/statements/2013/oct/17/ted-cruz/sen-ted-cruz-says-premiums-have-gone-virtually-eve.

 [42]. Drew Altman, Obamacare Debate: Where GOP Governors Stand on Repeal and Replace, Henry J. Kaiser Fam. Found. (Jan. 10, 2017), http://www.kff.org/health-reform
/perspective/obamacare-debate-where-gop-governors-stand-on-repeal-and-replace; Margot Sanger-Katz, No Magic in How G.O.P. Plan Lowers Premiums: It Pushes Out Older People, N.Y. Times: The Upshot (Mar. 14, 2017), https://nyti.ms/2nj1Xf5; President Donald Trump (@realDonaldTrump) (Apr. 24, 2017, 10:18 AM), https://twitter.com/realDonaldTrump/status/856557986474491904 (“If our healthcare plan is approved, you will see . . . premiums will start tumbling down.”).

 [43]. See Cynthia Cox et al., 2017 Premium Changes and Insurer Participation in the Affordable Care Act’s Health Insurance Marketplaces, Henry J. Kaiser Fam. Found. (Nov. 1, 2016), https://kaiserf.am/2zIR5wW; Reed Abelson & Margo Sanger-Katz, A Quick Guide to Rising Obamacare Rates, N.Y. Times: The Upshot (Oct. 25, 2016), https://nyti.ms/2k4Jr4r.

 [44]. Brad Tuttle, 8 States Where Obamacare Rates Are Rising by at Least 30%, Money (Oct. 18, 2016), http://time.com/money/4535394/obamacare-plan-premium-price-increases-2017-states; Off. of the Assistant Sec’y for Planning and Evaluation, ASPE Research Brief: Health Plan Choice and Premiums in the 2017 Health Insurance Marketplace 5 (2016).

 [45]. See Sy Mukherjee, Here’s How Much Your Health Insurance Premiums Could Go Up Next Year, Fortune (Aug. 10, 2016), http://fortune.com/2016/08/10/employer-health-premiums-rise.

 [46]. Larry Levitt et al., How ACA Marketplace Premiums Measure Up to Expectations, Henry J. Kaiser Fam. Found. (Aug. 1, 2016), https://kaiserf.am/2GY4ULB; Editorial, Affordable Care Act Premium Increases Are a Fixable Problem, N.Y. Times (Oct. 25, 2016), https://nyti.ms/2jE1t0m.

 [47]. Dan Mangan, Obamacare Deductibles Are on the Rise for 2017, Along with Monthly Premiums, CNBC (Oct. 26, 2016, 3:19 PM), https://cnb.cx/2GgHn4F.

 [48]. Abelson & Sanger-Katz, supra note 43.

 [49]. Barack Obama, United States Health Care Reform Progress to Date and Next Steps, 316 JAMA 525, 529 (2016) (conceding that ACA adjustments will be needed in light of premiums); Alan Rappeport & Margot Sanger-Katz, Hillary Clinton Takes a Step to the Left on Health Care, N.Y. Times (May 10, 2016), https://nyti.ms/2nnv268 (describing Clinton’s preference for a public option). See also Altman, supra note 42; Goodnough, supra note 41; Greenberg, supra note 41; Khazan, supra note 41; Kirzinger, supra note 41; Trump, supra note 42.

 [50]. See, e.g., Abelson & Sanger-Katz, supra note 43.

 [51]. Id.

 [52]. 42 U.S.C. § 18022(b) (2012) (essential health benefits include “(A) Ambulatory patient services. (B) Emergency services. (C) Hospitalization. (D) Maternity and newborn care. (E) Mental health and substance use disorder services, including behavioral health treatment. (F) Prescription drugs. (G) Rehabilitative and habilitative services and devices. (H) Laboratory services. (I) Preventive and wellness services and chronic disease management. (J) Pediatric services, including oral and vision care.”).

 [53]. Cong. Budget Off., Pub. No. 3102, Key Issues in Analyzing Major Health Insurance Proposals 59 (Dec. 2008), https://www.cbo.gov/sites/default/files/110th-congress-2007-2008/reports
/12-18-keyissues.pdf (“The more comprehensive the insurance coverage, the higher the premium would be.”). This claim is not without controversy. Some mandates have been shown to lower premiums. See, e.g., Tracey A. LaPierre et al., Estimating the Impact of State Health Insurance Mandates on Premium Costs in the Individual Market, J. Ins. Reg. 3, 31 (Mar. 1, 2009) (noting that if patients forego care, they can require more expensive care later).

 [54]. The individual mandate was supposed to account for this by drawing healthier people into the risk pool. The mandate, however, has been repealed. Radnofsky, supra note 36.

 [55]. Alison Kodjak, New GOP Health Proposal Could Ditch Protections for People Who Are Sick, NPR (Apr. 20, 2017), http://www.npr.org/sections/health-shots/2017/04/20/524881039/new-gop-health-proposal-could-ditch-protections-for-people-who-are-sick.

 [56]. See Julia Zorthian, Just 21% of Voters Approve of the New GOP Health Care Plan, TIME (May 11, 2017), http://time.com/4775979/ahca-health-care-republican-support-quinnipiac-poll. These methods are also unlikely to succeed in lowering premiums for some segments of the population. See Cong. Budget Off. Cost Estimate: American Health Care Act 3 (Mar. 13, 2017), https://www.cbo.gov/system/files/115th-congress-2017-2018/costestimate/americanhealthcareact.pdf.

 [57]. Aaron L. Schwartz et. al, Measuring Low-Value Care in Medicare, 174 JAMA Internal Med. 1067, 1068 (2014) (explaining why Medicare paying for unnecessary care).

 [58]. See Agnès Couffinhal & Karolina Socha-Dietrich, Ineffective Spending and Waste in Health Care Systems: Framework and Findings, in Tackling Wasteful Spending on Health 17, 19 (2017) (“In other words, cutting ineffective spending and waste can produce significant savings–a strategic move for policy makers.”); Donald M. Berwick & Andrew D. Hackbarth, Eliminating Waste in US Health Care, 307 JAMA 1513, 1513–16 (2012). Although most scholars agree that reducing unnecessary care will drive down premiums, one concern is that volume reduction may be offset with higher prices. See, e.g., Jost, supra note 15, at 17. Insurer market power, however, mutes this concern.

 [59]. The term “wasteful care” is also used in the literature, although it typically also includes administrative waste and fraud and abuse. See, e.g., Jules Delaune & Wendy Everett, Waste and Inefficiency in the U.S. Health Care System: Clinical Care: A Comprehensive Analysis in Support of System-Wide Improvements, New Eng. Healthcare Inst. (Feb. 2008), http://media.washingtonpost.com/wp-srv/nation/pdf/healthreport_092909.pdf.

 [60]. Einer Elhauge, The Limited Regulatory Potential of Medical Technology Assessment, 82 Va. L. Rev. 1525, 1531 (1996) (describing care as “harmful if it provides a lower benefit to the individual patient than other care options (including no care) and unnecessary if it provides no benefit improvement over less (or no) care”). For purposes of this Article, unnecessary care describes only care that does not improve health outcomes. The term does not mean to include care that is inefficient in an economic sense because another intervention might be more cost effective. Whereas unnecessary care does not provide clinical benefit to the patient, “low-value” care might provide some clinical benefit, just at a higher cost than other options. It would be worthwhile to consider how to reduce low value care in future work, but this Article does not take up that question.

 [61]. See, e.g., Emanuel & Fuchs, supra note 9; Ezekiel J. Emanuel & Victor R. Fuchs, Response, Health Care Overutilization in the United States, 300 JAMA 2250, 2251 (2008).

 [62]. Martin Hensher et al., “Too Much Medicine:” Insights and Explanations from Economic Theory and Research, 176 Soc. Sci. & Med. 77, 82 (2017).

 [63]. Berwick & Hackbarth, supra note 58, at 1513–16. See Elizabeth McGlynn et al., The Quality of Health Care Delivered to Adults in the United States, 348 N. Eng. J. Med. 2635 (2003) (finding that, on average, patients receive the recommended treatment for their conditions only slightly more than 50% of the time).

 [64]. Medical Imaging Modalities, Med. Imaging & Tech. Alliance, http://www.medicalimaging.org/about-mita/medical-imaging-primer/ (last visited May 7, 2018).

 [65]. See John K. Iglehart, The New Era of Medical Imaging—Progress and Pitfalls, 354 N. Eng. J. Med. 2822, 2822–23 (2006).

 [66]. See Jost, supra note 15, at 9.

 [67]. Vijay M. Rao & David C. Levin, The Overuse of Diagnostic Imaging and the Choosing Wisely Initiative, 157 Annals Internal Med. 574, 574–75 (2012) (“[I]nappropriate imaging unnecessarily exposes patients to excessive radiation, inconvenience, and actual harms . . . .”).

 [68]. B. Rehani, Commentary, Imaging Overutilisation: Is Enough Being Done Globally?, 7 Biomed. Imaging & Intervention J., Jan.–Mar. 2011, at 1–2 (discussing overuse of diagnostic imaging, such as X-rays and CT scans); Bryn Nelson, Medical Care Overuse Causes Waste, Harm in Healthcare, Hospitalist (June 2015), https://www.the-hospitalist.org/hospitalist/article/122392
/medical-care-overuse-causes-waste-harm-healthcare; Peter Ubel, Who Received More Wasteful Care: Medicaid Enrollees or People with Private Insurance, Forbes (May 31, 2017, 7:37 AM), https://www.forbes.com/sites/peterubel/2017/05/31/who-receives-more-wasteful-care-medicaid-enrollees-or-people-with-private-insurance.

 [69]. Press Release, Univ. of Mich. Rogel Cancer Ctr., Study Suggests Many Women with Early Breast Cancer Receive Unnecessary Imaging Test, (Feb. 23, 2016), http://www.mcancer.org
/news/archive/study-suggests-many-women-early-breast-cancer-receive-unnecessary-imaging-tests.

 [70]. Rao & Levin, supra note 67, at 574 (“20% to 50% of all ‘high-tech’ imaging provide[s] no useful information and may be unnecessary.”).

 [71]. E.g., Martina Montagnana & Giuseppe Lippi, Editorial, Overusing Laboratory Tests: More Advantages or Drawbacks, J. Laboratory & Precision Med. (July 12, 2017), http://jlpm.amegroups.com/article/view/3701/4403.

 [72]. Id.

 [73]. Della Brown White et al., Too Many Referrals of Low-Risk Women for BRCA1/2 Genetic Services by Family Physicians, 17 Cancer Epidemiology Biomarkers & Prevention 2980, 2980 (2008).

 [74]. See Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2111 (2013).

 [75]. White, supra note 73, at 2980.

 [76]. Although this Article mostly focuses on the overuse of medical services, largely bracketing the issue of pharmaceutical overuse, see supra notes 46, the over-prescription of antimicrobials bears consideration and could be stemmed by the nudge suggested in Part IV, see infra Part IV. See also C. Lee Ventola, The Antibiotic Resistance Crisis: Part 1: Causes and Threats, 40 Pharmacy & Therapeutics 277, 277–83 (2015) (describing that although most commonly considered overutilization, antibiotic overuse could just as easily be seen as an example of misconsumption).

 [77]. Katherine E. Fleming-Dutra et al., Prevalence of Inappropriate Antibiotic Prescriptions Among U.S. Ambulatory Care Visits, 2010–2011, 315 JAMA 1864, 1869 (2016).

 [78]. See Antibiotic Prescribing and Use in Doctor’s Offices, Ctrs. For Disease Control and Prevention, https://www.cdc.gov/antibiotic-use/community/about/should-know.html (last updated Jan. 9, 2018).

 [79]. See Christina J. Charlesworth et al., Comparison of Low-Value Care in Medicaid vs Commercially Insured Populations, 176 JAMA Internal Med. 998, 999 (2016) (examining the pervasiveness of low-value, unnecessary care).

 [80]. E.g., Aaron E. Carroll, Heart Stents Are Useless for Most Stable Patients. They’re Still Widely Used., N.Y. Times (Feb. 12, 2018), https://nyti.ms/2BoJ0h6; Eric Patashnik, Why American Doctors Keep Doing Expensive Procedures that Don’t Work, Vox (Feb. 14, 2018, 10:06 AM), https://www.vox.com/the-big-idea/2017/12/28/16823266/medical-treatments-evidence-based-expensive
-cost-stents.

 [81]. E. Andrew Balas, Editorial, Information Systems Can Prevent Errors and Improve Quality, 8 J. Am. Med. Informatics Ass’n 398, 399 (2001) (“Studies show that it takes an average of 17 years to implement clinical research results in daily practice, a remarkably slow and inefficient process.”).

 [82]. David T. Felson, Arthroscopy as a Treatment for Knee Osteoarthritis, 24 Best Pract. & Res. Clinical Rheumatology 47, 47–48 (2010).

 [83]. See Jeffrey Katz et al., The Role of Arthroscopy in the Management of Knee Osteoarthritis, 28 Best Pract. & Res. Clinical Rheumatology 143, 151–55 (2014); Anne Mounsey & Bernard Ewigman, Arthroscopic Surgery for Knee Osteoarthritis? Just Say No, 58 J. Fam. Pract. 143, 143–45 (2009).

 [84]. See Roger Chou et al., Interventional Therapies, Surgery and Interdisciplinary Rehabilitation for Low Back Pain: An Evidence-Based Clinical Practice Guideline from the American Pain Society, 34 Spine, 1066, 1066–77 (2009); Robert Langreth, Why You Should Never Get Fusion Surgery for Plain Back Pain, Forbes (Jan. 10, 2011, 8:44 AM), https://www.forbes.com/sites/robertlangreth
/2011/01/10/why-you-should-never-get-fusion-surgery-for-plain-back-pain.

 [85]. Rachelle Buchbinder et al., Percutaneous Vertebroplasty for Osteoporotic Vertebral Compression Fractures, Cochrane Database of Systematic Revs. (Apr. 4, 2018).

 [86]. Rasha Al-Lamee, Percutaneous Coronary Intervention in Stable Angina (ORBITA): A Double-Blind, Randomised Controlled Trial, 391 Lancet 31, 31 (2018); Anahad O’Connor, Heart Stents Still Overused, Experts Say, N.Y. Times: Well (Aug. 15. 2013, 6:00 AM), http://well.blogs.nytimes.com
/2013/08/15/heart-stents-continue-to-be-overused.

 [87]. See Jane Daniels et al., Laparoscopic Uterosacral Nerve Ablation for Alleviating Chronic Pelvic Pain: A Randomized Controlled Trial, 302 JAMA 955, 959–60 (2009).

 [88]. See Stephen J. Duckett et al., Identifying and Acting on Potentially Inappropriate Care, 203 Med. J. Aust. 183, 183 (2015); C.A. Larson, Prophylactic Bilateral Ophorectomy at Time of Hysterectomy for Women at Low Risk: ACOG Revises Practice Guidelines for Ovarian Cancer Screening in Low-Risk Women, 21 Current Oncology, 9, 9–12 (2014).

 [89]. A fair amount of medical care that is the standard of care may in fact be ineffective. See Lindi H. VanderWalde & Stephen B. Edge, Decisions Shared or Otherwise: The Ongoing Evolution of Local Therapy for Breast Cancer, 32 J. Clinical Oncology 873, 873­–74 (2014).

 [90]. See Bradley Sawyer & Cynthia Cox, How Does Health Spending in the U.S. Compare to Other Countries?, Peterson-Kaiser: Health System Tracker (Feb. 13, 2018), https://www.healthsystemtracker.org/chart-collection/health-spending-u-s-compare-countries/#item-start. By comparison, Germany spends 11.2% of its GDP on health, Canada spends 10.4%, and Japan spends 10.2%. Id.

 [91]. See Sarah Kliff, We Spend $750 Billion on Unnecessary Health Care. Two Charts Explain Why., Wash. Post: Wonkblog (Sept. 7, 2012), https://www.washingtonpost.com/news/wonk/wp/2012
/09/07/we-spend-750-billion-on-unnecessary-health-care-two-charts-explain-why; Annie Lowrey, Study of U.S. Health Care System Finds Both Waste and Opportunity to Improve, N.Y. Times (Sept. 11, 2012), https://nyti.ms/2tR4FY4.

 [92]. Cong. Budget Off., Pub. No. 4933, The 2014 Long-Term Budget Outlook 35–36 (2014), http://www.cbo.gov/sites/default/files/cbofiles/attachments/45471-Long-TermBudgetOutlook_7-29.pdf.

 [93]. See Elliott S. Fisher et al., The Implications of Regional Variations in Medicare Spending. Part 2: Health Outcomes and Satisfaction with Care, 138 Annals Internal Med. 288, 288 (2003).

 [94]. Id. (“Medicare enrollees in higher-spending regions receive more care than those in lower-spending regions but do not have better health outcomes or satisfaction with care.”). See also Aaron L. Schwartz et al., Measuring Low-Value Care in Medicare, 174 JAMA Internal Med. 1067, 1071–73 (2014).

 [95]. Emanuel and Fuchs use the term “overutilization,” but they employ it in a broader sense than this Article. Emanuel & Fuchs, supra note 9, at 2789 (“Overutilization can take 2 forms: higher volumes, such as more office visits, hospitalizations, tests, procedures, and prescriptions than are appropriate or more costly specialists, tests, procedures, and prescriptions than are appropriate.”).

 [96]. Id.

 [97]. See M.S., Are Health Insurers Making Huge Profits?, Economist: Democracy in America (May 5, 2010), http://www.economist.com/blogs/democracyinamerica/2010/03/insurance_costs_and
_health-care_reform.

 [98]. The Affordable Care Act’s premium tax credits are intended to address this problem by lowering monthly premiums for those whose income falls between 100–400% of the Federal Poverty Level. Internal Revenue Serv., Eligibility for the Premium Tax Credit, https://www.irs.gov
/affordable-care-act/individuals-and-families/eligibility-for-the-premium-tax-credit (last updated Feb. 8, 2018).

 [99]. See Rachel Garfield & Anthony Damico, The Coverage Gap: Uninsured Poor Adults in States that Do Not Expand Medicaid, Henry J. Kaiser Fam. Found. (Nov. 1, 2017), http://www.kff.org
/uninsured/issue-brief/the-coverage-gap-uninsured-poor-adults-in-states-that-do-not-expand-medicaid.

 [100]. See Key Facts about the Uninsured Population, Henry J. Kaiser Fam. Found. (Nov. 29, 2017), http://www.kff.org/uninsured/fact-sheet/key-facts-about-the-uninsured-population.

 [101]. See Spending on Health Care For Uninsured Americans: How Much, and Who Pays?, in Comm. on Consequences of Unins., Hidden Costs, Value Lost: Uninsurance in America 38–61 (2003) (ebook).

 [102]. See 26 U.S.C. § 36B(b) (2016). The ACA also provides for cost-sharing reduction subsidies. See, e.g., 42 U.S.C. §§ 18051(d)(3)(A)(i) (2016); id. § 18071(c)(3)(B); id. § 18082(c)(3); Press Release, Ctrs. for Medicare & Medicaid Servs., March 31, 2016 Effectuated Enrollment Snapshot (June 30, 2016), https://www.cms.gov/newsroom/mediareleasedatabase/fact-sheets/2016-fact-sheets-items/2016-06-30.html (noting that in 2016, 85% of people who purchased insurance through the Health Insurance Marketplace received a tax credit).

 [103]. See Abelson & Sanger-Katz, supra note 43.

 [104]. Rachel Dolan, Health Policy Brief: High-Deductible Health Plans, Health Aff. (Feb. 4, 2016), http://healthaffairs.org/healthpolicybriefs/brief_pdfs/healthpolicybrief_152.pdf.

 [105]. See Katherine Baicker & Jonathan Skinner, Health Care Spending Growth and the Future of U.S. Tax Rates, in 25 Tax Pol’y & Econ. 39, 42–43 (Jeffrey Brown ed., 2011) (most evidence suggests that in the long run workers bear the costs of the higher premiums).

 [106]. Baicker et al., supra note 19, at 37 n.4.

 [107]. See Cong. Budget Off., Pub. No. 3085, The Long-Term Outlook for Health Care Spending 15 (Nov. 2007), https://www.cbo.gov/sites/default/files/110th-congress-2007-2008/reports
/11-13-lt-health.pdf (finding the majority of rising Medicare expenditures can be attributed to higher spending per beneficiary).

 [108]. Couffinhal & Socha-Dietrich, supra note 58, at 22.

 [109]. Martin A. Makary & Michael Daniel, Medical Error—The Third Leading Cause of Death in the US, 353 British Med. J. 2139, 2139 (2016).

 [110]. David J. Brenner & Eric J. Hall, Computed Tomography—An Increasing Source of Radiation Exposure, 357 New Eng. J. Med. 2277, 2282 (2007).

 [111]. E.L.M. Ho, Editorial, Overuse, Overdose, Overdiagnosis . . . Overreaction?, 6 Biomed. Imaging & Intervention J., July–Sept. 2010, at 1; To Screen or Not to Screen: The Risks of Over-Imaging and Testing, Univ. of Mich. Inst. for Healthcare Pol’y & Innovation (Oct. 13, 2016), http://ihpi.umich.edu/news/screen-or-not-screen-risks-over-imaging-testing.

 [112]. Press Release, Ctrs. for Disease Control and Prevention, CDC: 1 in 3 Antibiotic Prescriptions Unnecessary (May 3, 2016), https://www.cdc.gov/media/releases/2016/p0503-unnecessary-prescriptions
.html.

 [113]. Emanuel & Fuchs, supra note 9, at 2789–91.

 [114]. See Gardiner Harris, Doctor Faces Suits Over Cardiac Stents, N.Y. Times (Dec. 5, 2010), http://www.nytimes.com/2010/12/06/health/06stent.html.

 [115]. Couffinhal & Socha-Dietrich, supra note 58, at 24 (“The rise of defensive medicine, driven mainly by fear of missing a low-probability diagnosis and fear of litigation, can also fuel overtreatment, notably the ordering of unnecessary tests.”).

 [116]. David Studdert et al., Defensive Medicine Among High-Risk Specialist Physicians in a Volatile Malpractice Environment, 293 JAMA 2609, 2609 (2005). See also Benjamin R. Roman et al., Association of Attitudes Regarding Overuse of Inpatient Laboratory Testing with Health Care Provider Type, 177 JAMA Internal Med. 1205, 1205 (2017); M. Sonal Sekhar, Letter to Editor, Defensive Medicine: A Bane to Healthcare, 3 Annals Med. & Health Sci. Res. 295, 295 (2013). But see Baicker et al., supra note 19, at 50 (discussing a study finding the magnitude of defensive medicine is low).

 [117]. See generally Atul Gawande, The Cost Conundrum—What a Texas Town Can Teach Us About Health Care, New Yorker (June 1, 2009), http://www.newyorker.com/magazine/2009/06/01 (noting that McAllen, Texas provided a chief example of the overuse of medical services).

 [118]. Patashnik, supra note 80. See also Elhauge, supra note 60, at 1537 (noting that professional groups do not effectively police unnecessary medical practices).

 [119]. Lynda Chin & Greg Satell, How Physicians Can Keep Up with the Knowledge Explosion in Medicine, Harv. Bus. Rev. (Dec. 19, 2016), https://hbr.org/2016/12/how-physicians-can-keep-up-with-the-knowledge-explosion-in-medicine; Patashnik, supra note 80.

 [120]. Eisenberg & Price, supra note 7, at 1–7. See also Couffinhal & Socha-Dietrich, supra note 58, at 24 (“Discrepancies between how care should be delivered as prescribed by guidelines and how care is delivered in practice can be driven by knowledge deficits, cognitive bias, or resistance to changing traditional practice, despite evidence that an old practice is outdated.”).

 [121]. See Balas & Boren, supra note 32, at 65–66.

 [122]. There is a prevalence of drugs prescribed for off-label uses not approved by the FDA. Randall S. Stafford, Regulating Off-Label Drug Use—Rethinking the Role of the FDA, 358 New Eng. J. Med 1427, 1427–29 (2008).

 [123]. Couffinhal & Socha-Dietrich, supra note 58, at 26 (noting that traditional fee-for-service payment drives the prevalence of low-value care).

 [124]. But it is not clear that it has the desired effect. See, e.g., Hal Scherz & Wayne Oliver, Commentary, Defensive Medicine: A Cure Worse Than the Disease, Forbes: Capital Flows (Aug. 27, 2013, 10:52 AM), https://www.forbes.com/sites/realspin/2013/08/27/defensive-medicine-a-cure-worse-than-the-disease (noting that where tort reform has been enacted, no decline in the amount of defensive medicine has been found).

 [125]. See Alan Rosenberg et al., Early Trends Among Seven Recommendations from the Choosing Wisely Campaign, 175 JAMA Internal Med. 1913, 1914 (2015) (examining an alternative solution to reducing overuse and waste in the U.S. health care system in light of past solutions failure to mitigate the issue).

 [126]. E.g., Canterbury v. Spence, 464 F.2d 772, 782 (D.C. Cir. 1972).

 [127]. Eric G. Campbell et al., Professionalism in Medicine: Results of a National Survey of Physicians, 147 Annals Internal Med. 795, 799–800 (2007) (finding 36% of the physicians surveyed would accommodate a patient who badly wanted a test, even if the physician knew it was unnecessary).

 [128]. Couffinhal & Socha-Dietrich, supra note 58, at 24–26 (“Patients’ requests for additional treatments are another important driver of low-value care. In the patient’s mind, ‘doing nothing’ ordoing less’ may be indistinguishable from doing harm.”).

 [129]. See Katherine Hobson, Cost of Medicine: Are High-Tech Medical Devices and Treatments Always Worth It?, U.S. News (July 10, 2009, 8:00 AM), http://health.usnews.com/health-news/best-hospitals/articles/2009/07/10/cost-of-medicine-are-high-tech-medical-devices-and-treatments-always-worth-it.

 [130]. Robertson, supra note 34, at 939 (describing moral hazard).

 [131]. See id. at 939–40.

 [132]. See generally Epstein, Price Transparency, supra note 17 (exploring the problems that lack of price transparency cause in the health care marketplace and providing a potential solution to this problem).

 [133]. See Wendy Netter Epstein, Nudging Patient Decision-Making, 92 Wash. L. Rev. 1255, 1288–92 (2017) [hereinafter Epstein, Nudging Patient] (discussing limitations of efforts to de-bias patient decision-making).

 [134]. See, e.g., John C. Robinson & Paul B. Ginsburg, Consumer-Driven Health Care: Promise and Performance, 28 Health Aff. 272, 272, 278­–79 (2009).

 [135]. Although most of this Article’s analysis focuses on private insurers, many of the same arguments can be made about government payors, which have similar motivation to reduce claims costs.

 [136]. For-profit insurers enhance shareholder value by maximizing profit, but even nonprofit insurers must be concerned about claims costs relative to revenue. See, e.g., Robert Weisman, Health Insurers Make Less in 2013, Boston Globe (Feb. 28, 2014), https://www.bostonglobe.com/business
/2014/02/28/compensation-net-income-down-largest-massachusetts-health-insurance-companies
/xHIc03wLzB50zKxmBYvr7K/story.html (noting total compensation of $1.9 million for the chief executive at the nonprofit insurer Harvard Pilgrim Health Care).

 [137]. Aaron E. Carroll, Medicaid Gives the Poor a Reason to Say No Thanks, N.Y. Times: The Upshot (Sept. 22, 2014), https://nyti.ms/2lMGw26. Government programs like Medicare and Medicaid are similar, with the exception that the government is the payor rather than the insurance company, and some patients may not pay monthly premiums. Id.

 [138]. John V. Jacobi, Tara Adams Ragone & Kate Greenwood, Health Insurer Market Behavior After the Affordable Care Act: Assessing the Need for Monitoring, Targeted Enforcement, and Regulatory Reform, 120 Penn St. L. Rev. 109, 130 (2015) [hereinafter Jacobi et al., Health Insurer Market Behavior] (explaining that “the infinite complexity of human medical conditions” make it impossible to contractually cover every possible procedure); Rosenbaum, supra note 33, at 231 (noting that “no amount of effort could produce a contract that specified all [covered procedures]”).

 [139]. See Russell Korobkin, The Efficiency of Managed Care “Patient Protection” Laws: Incomplete Contracts, Bounded Rationality, and Market Failure, 85 Cornell L. Rev. 1, 29 (1999) (noting contracts are incomplete in part because of “the fast pace of change in medical technology and knowledge”).

 [140]. See Alan M. Garber, Evidence-Based Coverage Policy, 20 Health Aff. 62, 64 (2001).

 [141]. Id. at 65 (describing medical necessity provision in federal employees’ health plan). Private insurance plans have similar provisions. Id. Medicare is also bound by a similar provision in the Social Security Act. Id. at 64.

 [142]. Linda A. Bergthold, Medical Necessity: Do We Need It? 14 Health Aff. 180, 181–82 (1995) (describing the emergence of medical necessity provisions in the 1940s to ensure payment for providers).

 [143]. Id. at 181–83.

 [144]. See Marsha Garrison & Carl E. Schneider, The Law of Bioethics: Individual Autonomy and Social Regulation 41 (2003).

 [145]. Bergthold, supra note 142, at 182 (“[I]nsurers accepted the decisions of physicians about what was medically necessary without much question.”); Jost, supra note 15, at 1; Jessica Mantel, A Defense of Physicians’ Gatekeeping Role: Balancing Patients’ Needs with Society’s Interests, 42 Pepp. L. Rev. 633, 636–38 (2015); Rosenbaum, supra note 33, at 229 (“From the 1950s through the late 1970s, physicians’ medical opinions largely dictated coverage and were rarely challenged by insurers.”).

 [146]. Mt. Sinai Hosp. v. Zorek, 271 N.Y.S.2d 1012, 1014 (Civ. Ct. 1966).

 [147]. Id.

 [148]. Id. at 1016, 1019.

 [149]. Id. at 1016.

 [150]. See Aaron C. Catlin & Cathy A. Cowan, History of Health Spending in the United States, 1960–2013, 11–14 (2015), https://www.cms.gov/Research-Statistics-Data-and-Systems
/Statistics-Trends-and-Reports/NationalHealthExpendData/Downloads/HistoricalNHEPaper.pdf.

 [151]. See Catlin & Cowan, supra note 150, at 11–14; Baicker, supra note 19, at 38; Peter D. Jacobson et al., Defining and Implementing Medical Necessity in Washington State and Oregon, 34 Inquiry 143, 152 (1997).

 [152]. See Health Maintenance Organization Act of 1973, 42 U.S.C. § 300e (2012).

 [153]. David Villar Patton, Note, Achieving Managed Care Accountability by Ending the ERISA Preemption Defense, 59 Ohio St. L.J. 1423, 1426 (1998) (describing MCO mechanisms to reduce healthcare costs and discourage unnecessary care).

 [154]. Id. at 1428. See also Mantel, supra note 145, at 638.

 [155]. See Michael A. Dowell, Avoiding HMO Liability for Utilization Review, 23 U. Tol. L. Rev. 117, 117 (1991) (describing purpose of utilization review as assuring payment is made only for medically necessary services); John V. Jacobi, Tara Adams Ragone & Kate Greenwood, The Sentinel Project: The ACA’s Marketplace Reforms and Access to Care, Seton Hall L. Ctr. for Health & Pharm. L. & Pol’y, Sept. 8, 2014, at 1, 24 [hereinafter Jacobi et al., Sentinel Project] (defining prospective and retrospective review).

 [156]. See Jacobi et al., Sentinel Project, supra note 155, at 24.

 [157]. See id.

 [158]. Id.

 [159]. See Robertson, supra note 34, at 935–36.

 [160]. Rosenbaum, supra note 33, at 229 (“The line between clinical decisions about necessary medical care and decisions about insurance coverage is particularly blurred in managed-care plans.”).

 [161]. See Meghan O’Rourke, Doctors Tell All—and It’s Bad, Atlantic (Nov. 2014), https://www.theatlantic.com/magazine/archive/2014/11/doctors-tell-all-and-its-bad/380785.

 [162]. Rosenbaum, supra note 33, at 230 (explaining the importance of accounting for individual variation).

 [163]. See Richard A. Epstein, The Erosion of Individual Autonomy in Medical Decisionmaking: Of the FDA and IRBs, 96 Geo L.J. 559, 572 (2008) [hereinafter Epstein, Erosion of Individual Autonomy] (“[W]hat physicians do daily is to extrapolate from known to unknown situations by making intelligent guesses.”); Rosenbaum, supra note 33, at 231.

 [164]. Rosenbaum, supra note 33, at 231 (noting utilization reviews are often based on “unpublished, proprietary, and unreviewed data”). Another concern is that the burden caused by utilization review might deter some beneficial care. See Jost, supra note 15, at 16.

 [165]. See Alain Enthoven, The Donald C. Ozmun and Donald B. Ozmun and Family Lecture in Management at the Mayo Clinic: Managed Care: What Went Wrong? Can It Be Fixed? (Nov. 1, 1999), in Insights by Stan. Bus., http://stanford.io/1mb4jHf.

 [166]. See Robertson, supra note 34, at 937.

 [167]. Elhauge, supra note 60, at 1550 (“Worse, insurers have a financial incentive to deny care even when the benefits exceed the costs.”); Robertson, supra note 34, at 936 (“Still, the insurer’s ability to ration is, and should be, severely limited.”).

 [168]. See, e.g., Adams v. Blue Cross/Blue Shield of Md., 757 F. Supp. 661, 669 (D. Md. 1991) (defining “accepted medical practice” as standards adopted by the Maryland oncological community); Sarchett v. Blue Shield of Cal., 729 P.2d 267, 270–71 (Cal. 1987) (defining “medical necessity” with reference to physician judgment on treatment of illness or injury); Hall & Anderson, supra note 19, at 1645. But, this is not true for all cases. See Bergthold, supra note 142, at 185 (noting courts’ inconsistency in deferring to physician authority).

 [169]. Managed care and utilization reviews still exist today, but in a less impactful way than during insurer-driven reimbursement years. Kathryn E. Flynn, Maureen A. Smith & Margaret K. Davis, From Physician to Consumer: The Effectiveness of Strategies to Manage Health Care Utilization, 59 Med. Care Res. & Rev. 455, 455 (2002) (noting utilization reviews are unpopular).

 [170]. See, e.g., Christopher T. Robertson, The Presumption Against Expensive Health Care Consumption, 49 Tulsa L. Rev. 627, 628 (2014) (“These public and private insurers have largely punted on the rationing imperative, and now pay for all sorts of high-cost treatments with little or no proven efficacy, and without any serious concern for cost-effectiveness as such.”); William M. Sage, Managed Care’s Crimea: Medical Necessity, Therapeutic Benefit, and the Goals of Administrative Process in Health Insurance, 53 Duke L.J. 597, 606–07 (2003) (“Recently, many health plans have beaten a hasty and well-publicized retreat from preauthorization, and have even offered relatively generous support for care in clinical trials that was previously excluded as ‘investigational.’”).

 [171]. Am. Acad. of Actuaries, Issue Brief: Health Insurance Coverage and Reimbursement Decisions 2 (Sept. 2008), http://www.actuary.org/pdf/health/comparative.pdf (describing the services of technology assessment organizations, in-house insurer assessments, and federally funded assessment centers typically housed at universities).

 [172]. See, e.g., Eisenberg & Price, supra note 7, at 17–18.

 [173]. See Austin Frakt, Blue Shield of California Just Did Something Unusual, Incidental Economist (Aug. 29, 2013, 4:08 PM), http://theincidentaleconomist.com/wordpress/blue-shield-of-california-just-did-something-unusual (quoting Steven Pearson, president of the Institute for Clinical and Economic Review, that “[i]t is exceedingly rare for health plans to remove coverage for any service that they have previously covered unless there is striking new evidence of safety problems or other unanticipated harms.”). But see Austin Frakt, JAMA Forum: Pushback Against Covering Proton Beam Therapy, news@JAMA (Sept. 4, 2013) [hereinafter Frakt, Pushback], https://newsatjama
.jama.com/2013/09/04/jama-forum-pushback-against-covering-proton-beam-therapy (describing how several insurers have stopped covering proton beam therapy for early stage prostate cancer).

 [174]. Although even for pharmaceuticals that have supposedly been approved by the FDA as safe and effective, it can be difficult to identify unnecessary care, particularly because the FDA approves drugs on imperfect information and the prescription of drugs for off-label uses—by definition not approved by the FDA—is prevalent. See Stafford, supra note 122, at 1427–29.

 [175]. Professional regulation and the tort liability system are intended to ensure that safe and effective care is being delivered, but do an insufficient job, particularly given their grounding in custom, not evidence.

 [176]. See Epstein, Erosion of Individual Autonomy, supra note 163, at 571–72. Further, there is insufficient incentive for this evidence to be developed because agency approval is not required and there is no carrot of patent exclusivity.

 [177]. Jost, supra note 15, at 17.

 [178]. But rates of unnecessary care are so high, it is doubtful that administrative expenses in identifying it could be higher. See Part IV for a suggestion of a low-cost nudge to deter unnecessary care.

 [179]. Baicker, supra note 19, at 48 (“[P]rivate insurance coverage is heavily influenced by the norms driven by Medicare coverage . . . .”). It is important to note that Medicare’s coverage decisions cannot take the cost of care into account. Sean R. Tunis, Editorial, Why Medicare Has not Established Criteria for Coverage Decisions, 350 New Eng. J. Med. 2196, 2197 (2004).

 [180]. And by following Medicare’s decisions, insurers might insulate themselves from potential liability. See infra Section II.B.2.

 [181]. See Katharine Cooper Wulff, Franklin G. Miller & Steven D. Pearson, Can Coverage Be Rescinded When Negative Trial Results Threaten a Popular Procedure? The Ongoing Saga of Vertebroplasty, 30 Health Aff. 2269, 2273 (2011) (describing how, despite evidence, private insurers wait for Medicare decisions).

 [182]. See Medicare Program; Revised Process for Making Medicare National Coverage Determinations, 68 Fed. Reg. 55,634 (Sept. 26, 2003) (detailing Medicare procedures for making National Coverage Determinations).

 [183]. See Baicker, supra note 19, at 41 (noting that private insurers following Medicare decisions “avoid litigation in which their patients claim that insurers are withholding valuable care”).

 [184]. Ctr. for Health Pol’y, Stan. Univ., State-by-State Compendium of Medical Necessity Regulation: Survey of State Managed Care Regulators 8 (2001), http://www.hcfo.org/files/hcfo/stanford.pdf (noting that, as of 2001, 11 states had laws specifying a standard definition of medical necessity that plans are required to use). See also Baicker, supra note 18, at 38; Nat’l Acad. for State Health Pol’y, Medical Necessity (Dec. 18, 2013), http://www.nashp.org/medical-necessity (state-by-state list of legislation regarding medical necessity).

 [185]. La. Admin. Code tit. 50, § 1101(A) (2017). For an example of another state’s similar definition, see Ariz. Admin. Code § R9-22-101 (2017). Not only are insurers required to reimburse for care when custom deviates from the evidence, but also physicians are insulated from tort liability when they adhere to the standard of care. Rosenbaum, supra note 33, at 230.

 [186]. See Ctr. for Health Pol’y, Stan. Univ., supra note 184, at 12; Elhauge, supra note 60, at 1555–56 (describing power of state insurance commissioners). See also Med. Doctor Provider Class Plan Determination Report, No. 90-11109-BC (Mich. Dep’t of Licensing & Reg., Ins. Bureau Aug. 5, 1991) (appeal) (mandating Blue Cross Blue Shield of Michigan yield determination of medical necessity to the treating physician). There is other pressure to accept physician decisions about standard of care. See, e.g., Sage, supra note 170, at 597–98 (describing case law “allowing individual plaintiffs to sue managed care health plans in state court alleging that faulty decision making caused physical harm”).

 [187]. See Ctr. for Health Pol’y, Stan. Univ., supra note 184, at 37.

 [188]. Id. at 40.

 [189]. Id. at 9. Mandates also require insurers to cover certain categories of care. See infra notes 366–70 and accompanying text. See also Robertson, supra note 34, at 938 (“State and federal governments have imposed over two thousand mandates on insurance providers, requiring them to cover particular treatments.”).

 [190]. See Jacobi et al., Health Insurer Market Behavior, supra note 138, at 132–33.

 [191]. Id.

 [192]. Id. See also Sage, supra note 170, at 597 (noting that ERISA plans are not exempt).

 [193]. See Jacobi et al., Health Insurer Market Behavior, supra note 138, at 130; Robertson, supra note 34, at 937.

 [194]. Robertson, supra note 34, at 937–38; Elhauge, supra note 60, at 1553–54 (noting that courts construe any contractual ambiguity against the insurer, applying also to ERISA plans).

 [195]. Robertson, supra note 34, at 937–38 (noting that insurers consistently lose these cases in court); Sage, supra note 170, at 610–11 (“The conventional wisdom about medical necessity litigation is that judges disregard contractual language in order to allow sympathetic plaintiffs access to potentially lifesaving therapies . . . .”).

 [196]. See Bailey v. Blue Cross & Blue Shield of Va., 67 F.3d 53, 55 (4th Cir. 1995) (affirming summary judgment for the plaintiff despite insurance policy specifically excluding coverage); Elhauge, supra note 60, at 1554; Sage, supra note 170, at 610–11. These denials were based on the experimental nature of the procedure, not its medical necessity, but the analysis was similar.

 [197]. See, e.g., Peter D. Jacobson, Elizabeth Selvin & Scott D. Pomfret, The Role of the Courts in Shaping Health Policy: An Empirical Analysis, 29 J.L. Med. & Ethics 278, 285 (2001). See also Sage, supra note 170, at 612 (noting that ERISA also keeps many disputes out of court because plaintiffs’ lawyers can’t make money on the suits).

 [198]. Robert H. Jerry, II & Douglas R. Richmond, Understanding Insurance Law 156 (5th ed. 2012) (“[I]nsurers can be held liable in tort for bad faith performance of their duties to insureds.”).

 [199]. Elhauge, supra note 60, at 1549–51. The corporate practice of medicine doctrine also prevents insurers from directing the practice of medicine. See Ani B. Satz, Fragmentation After Health Care Reform, 15 Hous. J. Health L. & Pol’y 173, 203 (2015).

 [200]. Hall & Anderson, supra note 19, at 1672.

 [201]. For discussion of implication for nonprofit insurers, see supra note 136.

 [202]. Robert Harrow, Why Health Insurance Prices Will Continue to Rise in 2016 and Beyond, Forbes (Jan. 14, 2016, 9:52 AM), https://www.forbes.com/sites/robertharrow/2016/01/14/why-health-insurance-prices-will-continue-to-rise-in-2016-and-beyond (“The knee-jerk reaction to increased operating costs has been to ‘adjust premiums’—in other words, increasing prices.”); Ctr. For Consumer Info. & Ins. Oversight, Fighting Unreasonable Health Insurance Premium Increases, Ctrs. for Medicare & Medicaid Servs., https://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs
/ratereview05192011a.html (last updated Nov. 16, 2011) (noting rapid rise of premiums).

 [203]. Ctr. For Consumer Info. & Ins. Oversight, supra note 202.

 [204]. See, e.g., Leemore S. Dafny, Are Health Insurance Markets Competitive?, 100 Am. Econ. Rev. 1399, 1400, 1426 (2010) (noting minimal empirical evidence for competitive private insurance market).

 [205]. Id. (finding that local health insurance markets are not perfectly competitive).

 [206]. Id. at 1427 (finding that “health insurers are exercising market power in an increasing number of geographic markets”).

 [207]. Id.

 [208]. See, e.g., Leemore S. Dafny, Evaluating the Impact of Health Insurance Industry Consolidation: Learning from Experience, 33 Commonwealth Fund: Issue Brief, Nov. 2015, at 5 (collecting evidence).

 [209]. Health Insurance Industry Consolidation: What Do We Know from the Past, Is It Relevant in Light of the ACA, and What Should We Ask: Before the Subcomm. on Antitrust, Competition Policy & Consumer Rights of the S. Comm. on the Judiciary, 114th Cong. 5 (2015) (testimony of Leemore S. Dafny, Ph.D., Director of Health Enterprise Management, Kellogg School of Management, Northwestern University).

 [210]. Rebecca Hersher, Aetna and Humana Call off Merger After Court Decision, NPR (Feb. 14, 2017, 11:41 AM), http://www.npr.org/sections/thetwo-way/2017/02/14/515167491/aetna-and-humana-call-off-merger-after-court-decision.

 [211]. Mara Lee, Anthem Terminates Cigna Merger Agreement, Mod. Healthcare (May 12, 2017), http://www.modernhealthcare.com/article/20170512/NEWS/170519940.

 [212]. Rate Review Processes in the Individual and Small Group Markets, Henry J. Kaiser Fam. Found., https://www.kff.org/health-reform/state-indicator/rate-review-program-effectiveness (last updated Apr. 8, 2016) (state-by-state requirements).

 [213]. Henry J. Kaiser Family Found., Rate Review: Spotlight on State Efforts to Make Health Insurance More Affordable 4 (2010), https://kaiserfamilyfoundation.files.wordpress.com
/2013/01/8122.pdf.

 [214]. Id.

 [215]. Ctr. For Consumer Info. & Ins. Oversight, Review of Insurance Rates, Ctrs. for Medicare & Medicaid Servs., https://www.cms.gov/CCIIO/Programs-and-Initiatives/Health-Insurance-Market-Reforms/Review-of-Insurance-Rates.html (last visited May 8, 2018).

 [216]. Health Insurance Issuer Rate Increase: Disclosure and Review Requirements, 45 C.F.R. § 154.200–.230 (2018) (describing the criteria CMS will use when evaluating whether a rate increase is unreasonable). See also Dafny, supra note 204, at 6–7 (describing the ACA provision on medical loss ratios).

 [217]. State Approval of Health Insurance Rate Increases, Nat’l Conf. St. Legislatures (Sept. 18, 2016), http://www.ncsl.org/research/health/health-insurance-rate-approval-disapproval.aspx (describing that to be approved, rate increases must be proportional to benefits offered and not arbitrary).

 [218]. See generally Scott E. Harrington & Janet Weiner, Deciphering the Data: Health Insurance Rates and Rate Review 1–5 (2014), https://ldi.upenn.edu/sites/default/files/pdf
/health%20insurance%20rate%20and%20review.pdf.

 [219]. Ctr. For Consumer Info. & Ins. Oversight, supra note 215 (“Many times, insurance companies have been able to raise rates without explaining their actions to regulators or the public or justifying the reasons for their high premiums.”).

 [220]. Harrow, supra note 202 (Aetna pulling out of some state exchanges).

 [221]. See J. Craig Anderson, More Companies Self-Insure Workers to Avoid Rising Health Care Premiums, Portland Press Herald (Aug. 8, 2017), https://www.pressherald.com/2017/08/08/more-companies-self-insure-workers-to-avoid-rising-health-care-premiums.

 [222]. For example, in January 2017, UnitedHealth Group announced its purchase of Surgical Care Affiliates, an outpatient surgery chain, to begin providing direct medical services. Jeff Sommer, Gripes About Obamacare Aside, Health Insurers Are in a Profit Spiral, N.Y. Times (Mar. 18, 2017), https://nyti.ms/2me4jeX.

 [223]. See Tom L. Beauchamp & James F. Childress, Principles of Biomedical Ethics 12–13 (6th ed. 2009); John Stuart Mill, On Liberty 52 (Edward Alexander ed., Broadview Press 1999) (1859); Edmund D. Pellegrino, Patient and Physician Autonomy: Conflicting Rights and Obligations in the Physician-Patient Relationship, 10 J. Contemp. Health L. & Pol’y 47, 47 (1994); Schuck, supra note 27, at 924.

 [224]. Gillian Matthews, Clinical Freedom, 8 J. Med. Ethics 150, 150 (1982) (“[F]rom earliest days [medicine] has been concerned with the protection of freedom—both of the patient and the physician.”).

 [225]. Uwe E. Reinhardt, U.S. Health Care Costs Part VI: At What Price Physician Autonomy?, N.Y. Times: Economix (Dec. 26, 2008, 10:07 AM), https://economix.blogs.nytimes.com/2008/12/26
/us-healthcare-costs-part-vi-at-what-price-physician-autonomy.

 [226]. See Sawicki, supra note 27, at 827.

 [227]. See Barbara Secker, The Appearance of Kant’s Deontology in Contemporary Kantianism: Concepts of Patient Autonomy in Bioethics, 24 J. Med. & Phil. 43, 44 (1999).

 [228]. Schuck, supra note 27, at 924–26. This same argument is made in support of the medical marijuana and right-to-try movements. See, e.g., Julie Turkewitz, Patients Seek ‘Right to Try’ New Drugs, N.Y. Times (Jan. 10, 2015), https://nyti.ms/2jYDo43.

 [229]. Evanthia Sakellari, Patient’s Autonomy and Informed Consent, ICUs & Nursing Web J. Jan.–Mar. 2003, at 2.

 [230]. Id. at 4–5. See also Lawrence O. Gostin, Informed Consent, Cultural Sensitivity, and Respect for Persons, 274 JAMA 844, 844–45 (1995). But see Epstein, Nudging Patient, supra note 133, at 1274–88 (discussing flaws in patient decision-making).

 [231]. Magali Sarfatti Larson, The Rise of Professionalism: A Sociological Analysis x (1977).

 [232]. Id. at 208–10. See also Matthews, supra note 224, at 151 (describing the characteristics that define a professional).

 [233]. See Anne-Marie Barry & Chris Yuill, Understanding the Sociology of Health: An Introduction 35 (2nd ed. 2008); Zhiping Walter & Melissa Succi Lopez, Physician Acceptance of Information Technologies: Role of Perceived Threat to Professional Autonomy, 46 Decision Support Sys. 206, 207 (2008).

 [234]. Although paternalism once dominated health care, the law of informed consent makes a physician’s clinical autonomy subject to patient consent. See supra notes 126, 133, 225.

 [235]. “A survey of physicians found that 68% agreed or strongly agreed that clinical freedom was essential to the practice of medicine and physicians should fight against any constraints upon it.” Walter & Lopez, supra note 233, at 208. See also L. Cooke & M. Hutchinson, Doctors’ Professional Values: Results from a Cohort Study of United Kingdom Medical Graduates, 35 Med. Educ. 735, 735–40 (2001).

 [236]. See Matthews, supra note 224, at 152–53.

 [237]. See Frakt, Pushback, supra note 174.

 [238]. Donald H. Taylor, Jr., Balancing the Budget Is A Progressive Priority 53–55 (2012); Donald H. Taylor, Jr., Will BCBS of California’s Proton Beam Therapy Decision Stick?, freeforall (Aug. 29, 2013), https://donaldhtaylorjr.wordpress.com/2013/08/29/will-bcbs-of-californias-proton-beam-therapy-decision-stick.

 [239]. Taylor, supra note 238, at 54 (quoting Dr. John Wilson, a neurosurgeon at Wake Forest University).

 [240]. Id. at 55 (noting that the policy was revoked only six weeks after announcing it).

 [241]. David C. Beyer & Najeeb Mohideen, The Role of Physicians and Medical Organizations in the Development, Analysis, and Implementation of Health Care Policy, 18 Seminars Radiation Oncology 186, 187–88 (2008) (discussing the role of the AMA and physician specialty associations in influencing health policy).

 [242]. See Mantel, supra note 145, at 637–38; William M. Sage, Should the Patient Conquer?, 45 Wake Forest L. Rev. 1505, 1505 (2010) (“[N]early all progressive impulses among American health lawyers and policy makers over the past half century have sought to liberate and empower the patient.”).

 [243]. Robertson, supra note 34, at 939 (“Due to these pressures, ‘insurers have largely abandoned direct attempts to limit coverage for most medical procedures and instead have adopted a pass-through attitude toward medical spending.’”).

 [244]. Jeffrey J. Stoddard et al., Managed Care, Professional Autonomy, and Income: Effects on Physician Career Satisfaction, 16 J. Gen. Internal Med. 675, 675, 680–82 (2001).

 [245]. The use of the term “autonomy” might be confusing in that physicians cannot make decisions absent patient informed consent. And to be sure, physician and patient autonomy may conflict, which is the subject of much scholarly discussion. See, e.g., Pellegrino, supra note 223, at 58. The relevant issue for current purposes, however, is how patient and physician autonomy should interact with the role of insurers.

 [246]. See Reinhardt, supra note 225 (doubting that physician autonomy serves society well).

 [247]. See id. (arguing against complete autonomy for physicians and patients).

 [248]. See Epstein, Nudging Patient, supra note 133, at 1256, 1268–69.

 [249]. See George Loewenstein, Projection Bias in Medical Decision Making, 25 Med. Decision Making 96, 100, 103–04 (2005); Michael L. Kelly, Commentary, Ethics Case: Risk Perception, Bias, and the Role of the Patient-Doctor Relationship in Decision Making about Cerebral Aneurysm Surgery, 17 AMA J. Ethics 6, 7 (2015) (“[C]ognitive biases and decision-making heuristics strongly influence decision making for both patients and physicians.”) (footnotes omitted).

 [250]. Epstein, Nudging Patient, supra note 133, at 1283–85.

 [251]. See id.

 [252]. See Prognosis in Advanced Cancer 25–26 (Paul Glare & Nicholas A. Christakis eds., 2008).

 [253]. Sita Slavov, How Your Doctor Is Driving Up Health Care Costs, U.S. News (Aug. 22, 2013, 9:00 AM), https://www.usnews.com/opinion/blogs/economic-intelligence/2013/08/22/how-financial-incentives-for-doctors-drive-up-health-care-costs.

 [254]. See Mantel, supra note 145, at 664 (noting that the exercise of autonomy crowds out other goods and services).

 [255]. See supra Section I.B.3.

 [256]. Reflections on Variations, Dartmouth Atlas of Health Care, http://www.dartmouthatlas.org/keyissues/issue.aspx?con=1338 (last visited May 8, 2018). See also Reinhardt, supra note 225 (“[O]verall per-capita Medicare spending could probably be reduced by at least 30[%] without harming patients . . . .”).

 [257]. See Mantel, supra note 145, at 663–64.

 [258]. See id.; Elhauge, supra note 60, at 1531–33.

 [259]. It is tempting to argue that laws entirely deferring to physician decision-making are flawed and must be replaced, but they exist as a response to the negative impact of insurer-driven decision-making. Because the right answer is neither complete patient/physician autonomy nor complete insurer-power, getting rid of the laws would not fix the problem. See infra Part IV (proposing a nudge solution).

 [260]. Richard H. Thaler & Cass R. Sunstein, Libertarian Paternalism, 93 Am. Econ. Rev. 175, 175 (2003) (coining the term “Libertarian Paternalism”).

 [261]. Cass R. Sunstein & Richard H. Thaler, Libertarian Paternalism Is Not an Oxymoron, 70 U. Chi. L. Rev. 1159, 1161–62 (2003).

 [262]. Richard H. Thaler & Cass R. Sunstein, Nudge: Improving Decisions About Health, Wealth and Happiness 4–6 (2008) [hereinafter Thaler & Sunstein, Nudge: Improving Decisions].

 [263]. Id. See also Daniel M. Hausman & Brynn Welch, Debate: To Nudge or Not to Nudge, 18 J. Pol. Phil. 123, 126 (2010).

 [264]. Thaler & Sunstein, Nudge: Improving Decisions, supra note 262, at 4–6; Hausman & Welch, supra note 263, at 126; Cass R. Sunstein, Nudging: A Very Short Guide, 37 J. Consumer Pol’y 583, 584 (2014) [hereinafter Sunstein, Nudging: A Very Short Guide] (discussing the GPS analogy). See also Christopher T. Robertson, I. Glenn Cohen & Holly Fernandez Lynch, Introduction, in Nudging Health, supra note 29, at 7.

 [265]. See generally Shlomo Benartzi et al., Should Governments Invest More in Nudging?, 28 Psychol. Sci. 1041 (2017) (arguing for the greater use of nudges).

 [266]. Sunstein, Nudging: A Very Short Guide, supra note 264, at 584 (discussing the United Kingdom’s Behavioural Insights Team and the United States’ White House Social and Behavioral Sciences Team).

 [267]. See Nudge Nudge, Think Think. The Use of Behavioural Economics in Public Policy Shows Promise, Economist: Free Exchange (Mar. 24, 2012), http://www.economist.com/node/21551032.

 [268]. See William G. Gale & David C. John, State Sponsored Retirement Savings Plans: New Approaches to Boost Retirement Plan Coverage 16–17 (Pension Research Council, Wharton School, Working Paper No. WP2017-12, 2017), https://pensionresearchcouncil.wharton.upenn.edu/wp-content
/uploads/2017/09/WP-2017-12-John-Gale.pdf.

 [269]. See Benartzi, supra note 265, at 1051.

 [270]. Thaler & Sunstein, Nudge: Improving Decisions, supra note 262, at 108–09.

 [271]. Richard H. Thaler & Shlomo Benartzi, The Behavioral Economics of Retirement Savings Behavior 2 (AARP Pub. Pol’y Inst., Issue Paper No. 2007-02, 2007), https://assets.aarp.org
/rgcenter/econ/2007_02_savings.pdf.

 [272]. See 12 C.F.R. § 226.35(b)(3) (2017).

 [273]. See Or. Rev. Stat. § 247.017 (2017); Cass R. Sunstein, The Ethics of Influence: Government in the Age of Behavioral Science 14 (2016) (discussing Oregon’s automatic voter registration system).

 [274]. See, e.g., Ellen van Kleef, Kai Otten & Hans C.M. van Trijp, Healthy Snacks at the Checkout Counter: A Lab and Field Study on the Impact of Shelf Arrangement and Assortment Structure on Consumer Choices, 12 BMC Pub. Health 1071, 1071 (2012).

 [275]. See Christopher T. Robertson, I. Glenn Cohen & Holly Fernandez Lynch, Introduction, in Nudging Health, supra note 29, at 6.

 [276]. P. Wesley Schultz et al., The Constructive, Destructive, and Reconstructive Power of Social Norms, 18 Psychol. Sci. 429, 432–33 (2007).

 [277]. Cass R. Sunstein, Simpler: The Future of Government 9 (2013). See generally Thaler & Sunstein, Nudge: Improving Decisions, supra note 262 (discussing how “choice architecture” can nudge people in beneficial directions).

 [278]. Cass R. Sunstein, Do People Like Nudges? 1 (Dig. Access to Scholarship at Harvard, Working Paper No. 16147874, 2015), http://nrs.harvard.edu/urn-3:HUL.InstRepos:16147874 [hereinafter Sunstein, Do People Like Nudges?].

 [279]. See generally Family Smoking Prevention and Tobacco Control Act, Pub. L. 111–31, 123 Stat. 1776 (codified as amended in scattered sections of 21 U.S.C.).

 [280]. See Cass R. Sunstein, The Ethics of Nudging, 32 Yale J. Reg. 413, 415 (2015).

 [281]. Sunstein, Nudging: A Very Short Guide, supra note 264, at 586. See also Behavioural Insights Team, Behaviour Change and Energy Use 18–22 (2011), https://www.gov.uk
/government/uploads/system/uploads/attachment_data/file/60536/behaviour-change-and-energy-use.pdf (describing ways of influencing consumers’ energy usage patterns by influencing their behavior through disclosure of personalized comparative usage information). There is some disagreement about whether warnings are properly categorized as nudges. If the goal of a warning is to stimulate conscious decision-making, it should be contrasted with nudges that influence decision-making by “exploiting [individuals’] cognitive and emotional limitations” and aim to make decisions more automatic. Robert Baldwin, From Regulation to Behaviour Change: Giving Nudge the Third Degree, 77 Mod. L. Rev. 831, 834–35 (2014) (describing the argument but noting that many policy-makers have followed Thaler and Sunstein’s broader definition of nudge to include warnings).

 [282]. See Lawrence O. Gostin, Daniel Hougendobler & Anna E. Roberts, American Public Health Law, in Oxford Handbook of U.S. Health Law 943 (I. Glenn Cohen et al. eds., 2017); Sunstein, Do People Like Nudges?, supra note 278, at 1.

 [283]. Thaler & Sunstein, Nudge: Improving Decisions, supra note 262, at 23.

 [284]. Id; Sunstein, Do People Like Nudges?, supra note 278, at 8.

 [285]. Warnings can have an emotional effect on decisionmakers. See, e.g., Cass R. Sunstein, Why Nudge? The Politics of Libertarian Paternalism 59 (2014) (ebook) [hereinafter Sunstein, Why Nudge?]. See also Robert Lepenies & Magdalena Malecka, The Institutional Consequences of Nudging—Nudges, Politics, and the Law, 6 Rev. Phil. & Psychol. 427, 430 n.9 (2015) (describing how consumers “do not react to laws, but—non-cognitively—to a nudge”).

 [286]. See Sunstein, Do People Like Nudges?, supra note 278, at 15.

 [287]. Cass R. Sunstein, Opinion, There’s a Backlash Against Nudging—but It Was Never Meant to Solve Every Problem, Guardian (Apr. 24, 2014, 2:30 PM), https://www.theguardian.com
/commentisfree/2014/apr/24/nudge-backlash-free-society-dignity-coercion.

 [288]. See, e.g., Sunstein, Do People Like Nudges?, supra note 278, at 4 (finding strong support for various warning nudges in studies).

 [289]. See, e.g., Kenneth R. Laughery & Michael S. Wogalter, Designing Effective Warnings, 2 Revs. Human Factors & Ergonomics 241, 241–42 (2006) (surveying literature). But see James Nonnemaker et al., Experimental Study of Graphic Cigarette Warning Labels 4-1–4-3 (2010) (finding limited impact, if any, from cigarette warnings).

 [290]. Gabrielle F. Miller et al., The Effects of Pre-Ordering and Behavioral Nudges on National School Lunch Program Participants’ Food Item Selection, 55 J. Econ. Psychol. 4, 13 (2016) (finding that nudged students selected significantly more fruits, vegetables and low-fat milk than non-nudged groups).

 [291]. Lepenies & Magdalena, supra note 285, at 428 (discussing critiques of nudges for being intrusive and exploiting human weakness).

 [292]. See Mill, supra note 223, at 112–13.

 [293]. Heidi M. Hurd, Fudging Nudging: Why “Libertarian Paternalism” is the Contradiction It Claims It’s Not, 14 Geo. J.L. & Pub. Pol’y 703, 703 (2016).

 [294]. See, e.g., Kamila M. Kiszko et al., The Influence of Calorie Labeling on Food Orders and Consumption: A Review of the Literature, 39 J. Community Health 1248, 1248 (2014).

 [295]. It is possible that transparency might decrease the effectiveness of the nudge, which is yet another reason for experimentation. But there is at least some evidence that nudges can be both transparent and effective. See, e.g., Hendrik Bruns et al., Can Nudges Be Transparent and Yet Effective?, 69 J. Econ. Psychol. (forthcoming Dec. 2018).

 [296]. Cass R. Sunstein, Nudges Do Not Undermine Human Agency, 38 J. Consumer Pol’y 207, 210 (2015) (noting that desirable nudges can promote both autonomy and welfare). See Sunstein, Why Nudge, supra note 285, at 143 (objections to paternalistic approaches are muted if they “impose small costs, or no material costs, on those who seek to go their own way”).

 [297]. Laughery & Wogalter, supra note 289, at 242.

 [298]. Id. at 249–58.

 [299]. Id. at 242 (“Generally, a warning must capture attention; that is, it must be noticed and encoded.”).

 [300]. Id. at 253.

 [301]. Judy Edworthy & Austin Adams, Warning Design: A Research Perspective 42–43 (1996).

 [302]. Id.

 [303]. See generally J. Paul Frantz & Timothy P. Rhoades, A Task-Analytic Approach to the Temporal and Spatial Placement of Product Warnings, 35 Human Factors 719 (1993) (discussing how to create effective warnings that consider a person’s cognitive and behavioral activities during product use).

 [304]. Laughery & Wogalter, supra note 289, at 260.

 [305]. Barbara Sattler, Bruce Lippy & Tyrone G Jordan, Hazard Communications: A Review of the Science Underpinning the Art of Communication for Health and Safety 8 (1997), https://www.osha.gov/dsg/hazcom/hc2inf2.html.

 [306]. J. Paul Frantz, Effect of Location and Procedural Explicitness on User Processing of and Compliance with Product Warnings, 36 Human Factors 532, 532 (1994).

 [307]. Id.

 [308]. David M. DeJoy, Attitudes and Beliefs, in Warnings and Risk Communication 197–98 (Michael S. Wogalter et al., eds., 2005) (ebook).

 [309]. Id.

 [310]. Although cost-benefit analysis may also suffer from “incommensurability” in this context. See, e.g., Matthew Adler, Incommensurability and Cost-Benefit Analysis, 146 U. Pa. L. Rev. 1371, 1376 (1998); Cass R. Sunstein, Incommensurability and Valuation in Law, 92 Mich. L. Rev. 779, 796 (1994) (“Incommensurability occurs when the relevant goods cannot be aligned along a single metric without doing violence to our considered judgments about how these goods are best characterized.”) (emphasis omitted).

 [311]. Dejoy, supra note 308, at 197–98; Laughery & Wogalter, supra note 289, at 257–58.

 [312]. Comm. on Quality of Health Care in Am., Inst. of Med., Crossing the Quality Chasm: A New Health System for the 21st Century 165 (2001). See also Nicolas P. Terry, Meaningful Adoption: What We Know or Think We Know About the Financing, Effectiveness, Quality, and Safety of Electronic Medical Records, 34 J.L. Med. 7, 10 (2013).

 [313]. Robert Pearl, 5 Things Preventing Technology Adoption in Health Care, Forbes, (Sept. 11, 2014, 1:25 PM) https://www.forbes.com/sites/robertpearl/2014/09/11/5-things-preventing-technology-adoption-in-health-care.

 [314]. See generally Robert Wachter, The Digital Doctor: Hope, Hype, and Harm at the Dawn of Medicine’s Computer Age (2015) (exploring how technology has changed the practice of medicine). The regulations responsible, at least in part, for spurring this transformation are Title IV of Division B and Title XIII of Division A, known together as the Health Information Technology for Economic and Clinical Health Act (“HITECH Act”). 42 U.S.C. §§ 300jj–300jj-52 (2016); id. §§ 17921–17953.

 [315]. EHR Adoption Rates: 20 Must-See Stats, Practice Fusion (Mar. 1, 2017) [hereinafter EHR Adoption Rates: 20 Must-See Stats], http://www.practicefusion.com/blog/ehr-adoption-rates; Off. of the Nat’l Coordinator for Health Info. Tech., Office-based Physician Electronic Health Record Adoption, HealthIT.gov (Dec. 2016), https://dashboard.healthit.gov/quickstats/pages/physician-ehr-adoption-trends.php; Data and Program Reports: EHR Incentive Programs, Ctrs. for Medicare & Medicaid Servs., https://www.cms.gov/Regulations-and-Guidance/Legislation/EHRIncentivePrograms/DataAnd
Reports.html (last modified Apr. 25, 2018, 10:59 AM). But see Stephanie O. Zandieh et al., Challenges to EHR Implementation in Electronic-Versus Paper-Based Office Practices, 23 J. Gen. Internal Med. 755, 755 (2008).

 [316]. EHR Adoption Rates: 20 Must-See Stats, supra note 315.

 [317]. Agency for Healthcare Res. & Quality, Patient Safety Primer: Computerized Provider Order Entry, Patient Safety Network, https://psnet.ahrq.gov/primers/primer/6/computerized-provider-order-entry (last updated June 2017); Jason M. Baron & Anand S. Dighe, Computerized Provider Order Entry in the Clinical Laboratory, 2 J. Pathology Informatics, Aug. 2011, http://www.jpathinformatics.org/text.asp?2011/2/1/35/83740.

 [318]. See, e.g., Bryan Cleveland, Using the Law to Correct the Market: The Electronic Health Record (EHR) Incentives Program, 29 Harv. J.L. & Tech. 291, 307 (2015).

 [319]. See id. at 307–08.

 [320]. Computerized warnings require adoption of health IT systems. While there are still providers using paper-based systems, adoption of health IT systems is widespread. Stephen T. Mennemeyer et al., Impact of the HITECH Act on Physicians’ Adoption of Electronic Health Records, 23 J. Am. Med. Informatics Ass’n 375, 375 (2016).

 [321]. See supra Section I.B.

 [322]. Id.

 [323]. A provider might even be asked to justify overriding the warning, but given the strength of the autonomy value and the administrative burden, it does not seem prudent for the nudge to be taken that far.

 [324]. Agency for Healthcare Res. & Quality, Glossary: Clinical Decision Support System (CDSS), Patient Safety Network, https://psnet.ahrq.gov/glossary/clinicaldecisionsupportsystem (last visited May 8, 2018).

 [325]. Traditional Medicare does not utilize pre-authorization procedures. Its use by private insurers depends on the particular plan.

 [326]. These systems that reject coverage based on certain data, rather than simply warning the physician are highly criticized by physicians (and patients) for failing to account for individual patient circumstances and overriding physician professional judgment.

 [327]. Colene Byrne et al., Advancing Clinical Decision Support: Key Lessons in Clinical Decision Support Implementation 1 (2011), https://www.healthit.gov/sites/default/files
/acds-lessons-in-cds-implementation-deliverablev2.pdf.

 [328]. Ben-Tzion Karsh, Agency for Healthcare Res. & Quality, AHRQ Pub. No. 09-0054-EF, Clinical Practice Improvement and Redesign: How Change in Workflow Can Be Supported by Clinical Decision Support (2009), https://healthit.ahrq.gov/key-topics/clinical-decision-support/clinical-practice-improvement-and-redesign-how-change-workflow-can-be-supported-clinical-decision.

 [329]. Byrne et al., supra note 327, at 1–2 (documenting challenges facing CDSS).

 [330]. Garber, supra note 140, at 67 (“The most crucial—and controversial—question for evidence-based coverage policy concerns the adequacy of evidence. What standards must the body of evidence meet to support a decision to offer coverage?”).

 [331]. Daniel Wolfson et al., Engaging Physicians and Consumers in Conversations About Treatment Overuse and Waste: A Short History of the Choosing Wisely Campaign, 89 Acad. Med. 990, 990 (2014). See also Choosing Wisely, http://www.choosingwisely.org (last visited May 8, 2018).

 [332]. Wolfson et al., supra note 331, at 991.

 [333]. Id. at 990.

 [334]. See Choosing Wisely: Partnering with Patients to Make Better Choices on Using Health Care Services, Me. Health Mgmt. Coalition (Oct. 10, 2013), https://www.mainequalitycounts.org
/image_upload/Choosing%20Wisely%20Presentation%20from%20Kellie_Kathy_Betty.pdf; Special Society Partners, Choosing Wisely, http://www.choosingwisely.org/our-mission/specialty-society-partners (last visited May 8, 2018).

 [335]. Wolfson et al., supra note 331, at 994; Press Release, Robert Wood Johnson Found., $4.2 Million Grant Program to Support Health Care Organization Implementation of Choosing Wisely Recommendations (Jan. 8, 2015), https://www.rwjf.org/en/library/articles-and-news/2015/01/new–4-2-million-grant-program-to-support-health-care-organizati.html.

 [336]. See About ACR, Am. C. of Radiology, https://www.acr.org/About-ACR (last visited May 8, 2018).

 [337]. Am. Coll. of Radiology, Don’t Do Imaging for Uncomplicated Headache, Choosing Wisely (Apr. 4, 2012), http://www.choosingwisely.org/clinician-lists/american-college-radiology-imaging-for-uncomplicated-headache.

 [338]. Id.

 [339]. See Rosenberg et al., supra note 125, at 1913.

 [340]. See M. Susan Ridgely & Michael D. Greenberg, Too Many Alerts, Too Much Liability: Sorting Through the Malpractice Implications of Drug-Drug Interaction Clinical Decision Support, 5 St. Louis U. J. Health L. & Pol’y 257, 280 (2012) (“Given that the law in most states now recognizes a national (as opposed to local) standard of care, having a group of appropriate national professional societies involved in ratifying a national DDI list should have the effect of ‘moving the goal posts’ even faster. Malpractice liability will continue to be judged based on negligence, and by comparison with professional standards of care, so moving the goal posts in terms of the standard of care seems like a reasonable strategy to employ.”).

 [341]. See id. at 279–80 (noting that use of professional organizations has the benefit of creating a single nationwide standard and engaging relevant expertise).

 [342]. Although other countries do have government-funded national panels. See Ross Koppel, The Marginal Utility of Marginal Guidance: Commentary on Too Many Alerts, Too Much Liability: Sorting Through the Malpractice Implications of Drug-Drug Interaction Clinical Decision Support by M. Susan Ridgely and Michael D. Greenberg, 5 St. Louis U. J. Health L. & Pol’y 311, 316 (2012).

 [343]. See Advancing Clinical Decision Support, Rand Corp., https://www.rand.org/health/projects
/clinical-decision-support.html, (last visited May 8, 2018); Ridgely & Greenberg, supra note 340, at 280.

 [344]. See, e.g., Press Release, Blue Cross Blue Shield Ass’n, Blue Cross and Blue Shield Association Releases ‘Investing in America’s Health’ (Jan. 29, 2014), https://www.bcbs.com/news/press-releases
/blue-cross-and-blue-shield-association-releases-investing-americas-health (describing the Technology Evaluation Center).

 [345]. There are also groups involved in what is termed “academic detailing”—university-based or non-commercial groups without ties to industry that educate providers with a goal of encouraging adherence to medical evidence from randomized controlled trials. These groups might also be a source of relevant data. See Michael A. Fischer & Jerry Avorn, Academic Detailing Can Play a Key Role in Assessing and Implementing Comparative Effectiveness Research Findings, 31 Health Aff. 2206, 2206–10 (2012). See also Garber, supra note 140, at 65–66 (describing the Canadian Task Force on the Periodic Health Examination, the U.S. Preventive Services Task Force, and the U.S. Agency for Healthcare Research and Quality).

 [346]. Paul Keckley, Medical Necessity and Unnecessary Care, Health Care Blog (Jan. 29, 2015), http://thehealthcareblog.com/blog/2015/01/29/medical-necessity-and-unnecessary-care (“The data and sophisticated analytic tools upon which determinations of medical necessity and unnecessary care are increasingly available. Defaults that ‘my patients are different’ and ‘we don’t have the data’ will fall on deaf ears.”).

 [347]. A concern remains, however, of automatic click through rather than processing of information.

 [348]. See, e.g., Peter Davey et al., Interventions to Improve Antibiotic Prescribing Practices for Hospital Inpatients, Cochrane Database of Systematic Revs., Apr. 30, 2013, at 1, 2, http://onlinelibrary.wiley.com/enhanced/exportCitation/doi/10.1002/14651858.CD003543.pub3; Linda Court Salisbury, Minimum Payment Warnings and Information Disclosure Effects on Consumer Debt Repayment Decisions, 3 J. Pub. Pol’y & Mktg. 49, 57–62 (2014) (finding that an information nudge greatly increased proportion of consumers choosing three-year payment amount).

 [349]. Howard I. Kushner, Evidence-Based Medicine and the Physician-Patient Dyad, 14 Permanente J. 64, 64 (2010).

 [350]. Mary Brophy Marcus, Do You Really Need That MRI?, CBS News (Dec. 16, 2015, 12:44 PM), http://www.cbsnews.com/news/do-you-really-need-that-mri.

 [351]. Id.

 [352]. Choosing Wisely at Crystal Run Healthcare, Choosing Wisely (Aug. 7, 2014), http://www.choosingwisely.org/resources/updates-from-the-field/choosing-wisely-at-crystal-run-healthcare.

 [353]. Ruth E. Thomas et al., Effect of Enhanced Feedback and Brief Educational Reminder Messages on Laboratory Test Requesting in Primary Care: A Cluster Randomised Trial, 367 Lancet 1990, 1990–96 (2006).

 [354]. Andrew Georgiou et al., The Impact of Computerized Provider Order Entry Systems on Medical-Imaging Services: A Systematic Review, 18 J. Am. Med. Informatics Ass’n 335, 339 (2011) (reporting that electronic reminders promoted adherence to ordering guidelines and can reduce unnecessary and inappropriate testing).

 [355]. See, e.g., Davey et al., supra note 348, at 2 (“[I]nterventions to increase effective prescribing can improve clinical outcome.”).

 [356]. Kevin M. Terrell et al., Computerized Decision Support to Reduce Potentially Inappropriate Prescribing to Older Emergency Department Patients: A Randomized, Controlled Trial, 57 J. Am. Geriatric Soc’y 1388, 1390–91, 1393 (2009) (finding that the electronic decision support system reduced the amount of emergency room discharges that resulted in a potentially inappropriate prescription). But see Section IV.C.3 for a discussion of how such systems can also be ineffective.

 [357]. See, e.g., Andrew Georgiou et al., The Impact of Computerized Physician Order Entry Systems on Pathology Services: A Systematic Review, 76 Int’l J. Med. Informatics 514, 523 (2007) (reviewing four studies that found CPOE use resulted in improved compliance with guidelines); David F. Lobach, Electronically Distributed, Computer-Generated, Individualized Feedback Enhances the Use of a Computerized Practice Guideline, J. Am. Med. Informatics Ass’n Ann. Fall Symp. 1996, at 493, 496 (1996) (finding increased compliance with guidelines without high maintenance expenses).

 [358]. See supra Section I.C.1 for a discussion of provider incentives.

 [359]. See Roger Fontes, Negotiating Contracts with Insurance Companies, MD Mag. (Aug. 16, 2013), http://www.mdmag.com/physicians-money-digest/practice-management/negotiating-contracts-with-insurance-companies-fontes (“[I]nsurance companies have the more dominant negotiating position in most circumstances.”).

 [360]. See supra Section II.B.

 [361]. See id.

 [362]. See Donald Marron, Obama’s Nudge Brigade: White House Embraces Behavioral Sciences to Improve Government, Forbes: Business in the Beltway (Sept. 16, 2015, 3:32 PM), https://www.forbes.com/sites/beltway/2015/09/16/obama-nudge-government. See generally Behav. Insights Team, http://www.behaviouralinsights.co.uk (last visited May 8, 2018).

 [363]. See Saurabh Bhargava & George Loewenstein, Behavioral Economics and Public Policy 102: Beyond Nudging, 105 Am. Econ. Rev.: Papers & Proc. 396, 397 (2015).

 [364]. See Brigitte C. Madrian, Applying Insights from Behavioral Economics to Policy Design, 6 Ann. Rev. Econ. 663, 664–68 (2014) (discussing various policy tools that have been used to influence consumer behavior).

 [365]. See Bhargava & Loewenstein, supra note 363, at 397.

 [366]. See Jacobi et al., Health Insurer Market Behavior, supra note 138, at 114–28 (discussing federal and state efforts to regulate insurance contracts and how these efforts have shifted after the ACA).

 [367]. See id. Most of the conditions that government currently places on insurer contracts are related to coverage decisions that are exclusively within the control of the insurer. This type of legal mandate would therefore be somewhat of a departure from other requirements.

 [368]. Jacobi et al., Sentinel Project, supra note 155, at 11.

 [369]. Id.

 [370]. A mandate does make the “nudge” a requirement, which is a bit of an odd formulation. Despite a heavy hand in requiring the warning system, however, the providers themselves are still more nudged than shoved because they may opt out of the warning’s advice.

 [371]. See, e.g., Hurd, supra note 293, at 703, 734.

 [372].                                                                       See, e.g., Terrie R. Fried, Shared Decision Making—Finding the Sweet Spot, 374 New Eng. J. Med. 104, 104 (2016).

 [373]. Karen J. Maschke & Michael K. Gusmano, Evidence and Access to Biomedical Interventions: The Case of Stem Cell Treatments, 41 J. Health Pol., Pol’y & L. 917, 918 (2016). See also Mantel, supra note 145, at 694 (“Like government regulators, insurers simply cannot develop timely, detailed rules for the full range of treatment decisions given the breadth of the medical landscape, the lack of definitive clinical information, and constantly evolving medical knowledge.”).

 [374]. See Ridgely & Greenberg, supra note 340, at 258 (discussing the challenge of “developing clinical practice guidelines that can be readily and unambiguously translated into a computable form”).

 [375]. See Koppel, supra note 342, at 314–15.

 [376]. See, e.g., Eisenberg & Price, supra note 7, at 39–48 (discussing current regulatory efforts and areas for improved regulation to spur clinical research); Sachs, supra note 7, at 392–96 (discussing additional areas to incentivize insurers to participate in clinical research). See also Baicker et al., supra note 19, at 51 (suggesting government subsidization of clinical effectiveness research).

 [377]. See Clark C. Havighurst, Health Care Choices: Private Contracts as Instruments of Health Reform 117–37 (1995); Michael E. Chernew et al., Value-Based Insurance Design, 26 Health Aff. 195, 198 (2007); Austin Frakt, Health Plans that Nudge Patients to do the Right Thing, N.Y. Times: The Upshot (July 10, 2017), https://nyti.ms/2u03ARI (explaining that a value-based insurance design is an option currently being explored).

 [378]. E.g., Marshall B. Kapp, Getting Physicians and Patients to Choose Wisely: Does the Law Help or Hurt?, 46 U. Tol. L. Rev. 529, 533–34 (2015).

 [379]. See Davey et al., supra note 348, at 2–4 (finding that stewardship programs can decrease antibiotic prescription rates); Gilad J. Kuperman et al., Medication-Related Clinical Decision Support in Computerized Order Entry Systems: A Review, 14 J. Am. Med. Informatics Ass’n 29, 29 (2007).

 [380]. See Baicker et al., supra note 19, at 49–50; Eisenberg & Price, supra note 7, at 29. Indeed, it is possible to make the nudge even stronger by, for instance, requiring that providers justify to insurers their decisions to ignore a warning prompt. A more coercive approach seems likely to hinder provider buy-in, but different regimes merit testing for effectiveness.

 [381]. A malpractice “safe harbor” might also be employed for providers who change their practices based on the warnings. See Ridgely & Greenberg, supra note 340, at 262 (suggesting a “safe harbor” to aid adoption of drug-drug interaction protocols).

 [382]. Press Release, Accenture, Doctors Agree on Top Healthcare IT Benefits, But Generational Divide Exists, According to Accenture Eight-Country Survey (Jan. 10, 2012), https://newsroom.accenture.com/subjects/research-surveys/doctors-agree-on-top-healthcare-it-benefits-but-generational-divide-exists-according-to-accenture-eight-country-survey.htm.

 [383]. See Terry, supra note 312, at 12–13; Walter & Lopez, supra note 233, at 208, 212–13.

 [384]. Walter & Lopez, supra note 233, at 207.

 [385]. Even if a doctor may not be timely influenced by an alert of unnecessary care for a current patient, at the very least, the alert may influence the care of future patients.

 [386]. See Ridgely & Greenberg, supra note 340, at 258.

 [387]. Koppel, supra note 342, at 314 (“[P]roviders quickly become enraged at the constant (but irrelevant) reminders associated with many of the medication orders they enter.”); Ridgely & Greenberg, supra note 340, at 258, 261 (“CDS systems ‘generate excessive number[s] of alerts, many of which are clinically unhelpful.’”); Sarah Patricia Slight et al., A Cross-Sectional Observational Study of High Override Rates of Drug Allergy Alerts in Inpatient and Outpatient Settings, and Opportunities for Improvement, 26 BMJ Quality & Safety 217, 223–24 (2017).

 [388]. For this reason, it might even be worth considering state-level regulation (or even more localized implementation), first, to allow experimentation on a smaller-scale.

 [389]. See Eisenberg & Price, supra note 7, at 29.

 [390]. Id. at 48.

 [391]. This assumes a cost already born to implement the IT-based warning system in the first place.

 [392]. See Epstein, Price Transparency, supra note 17, at 24–29 (discussing the promise of incentive-based compensation, but encouraging targeted implementation that takes account of the need to innovate and motivate).

 [393]. See Epstein, Nudging Patient, supra note 133, at 1266–74 (describing informed consent doctrine).

 [394]. Id. at 1271.

 [395]. Id. at 1305. See also Katherine Berry et al., Influence of Information Framing on Patient Decisions to Treat Actinic Keratosis, 153 JAMA Dermatology 421, 421, 424–25 (2017) (finding patient decisions significantly affected by physician wording).

 [396]. See Cass R. Sunstein, Choosing Not to Choose: Understanding the Value of Choice 107 (2015).

 [397]. See Austin B. Frakt & Nicolas Bagley, Why It’s So Hard for Insurers to Compete Over Technology, news@JAMA: JAMA Forum (July 5, 2017), https://newsatjama.jama.com/2017/07/05
/jama-forum-why-its-so-hard-for-insurers-to-compete-over-technology (discussing other options and hurdles to success).

Should Statistical Sampling Be Used to Prove Liability Under the False Claims Act in Healthcare Fraud? – Note by Milene Vega

From Volume 91, Number 3 (March 2018)
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Should Statistical Sampling Be Used to Prove Liability Under the False Claims Act in Healthcare Fraud?

Milene Vega, R.N.[*]

TABLE OF CONTENTS

INTRODUCTION

I. BACKGROUND

A. Proving Liability Under the FCA

B. Damages Under the FCA

C. Statistical Sampling and the FCA

1. How Statistical Sampling Would Establish Liability

2. How Statistical Sampling Would Establish Damages

D. Legal Precedent for the Use of Statistical Sampling

1. Daubert Generally Permits Use of Statistical Methods

2. Wal-Mart Stores, Inc. v. Dukes: Individualized Determination Cannot Be Replaced by “Trial by Formula”

3. Tyson Foods: Admissibility of Statistical Sampling Turns on Reliability

E. Sampling in Other Types of Litigation

II. ANALYSIS

A. Cases Allowing the Use of Statistical Sampling

B. Cases Not Allowing the Use of Statistical Sampling

C. Courts That Likely Would Have Allowed Statistical Sampling if Data Had Been Reliable or Timing Was
Proper

D. Courts That Did Not Decide the Issue Determinatively

E. United States ex rel. Michaels v. Agape Senior
Community, Inc.

1. The District Court Case

2. The Circuit Court Case

III. IMPACT

A. Consequences of Rejecting Statistical Sampling for Liability

B. Consequences of Permitting Statistical Sampling for Liability

IV. A SOLUTION and a SUGGESTED OUTCOME

A. Criticisms and Potential Flaws in Judicial Reasoning

1. Courts Conflate the Use of Statistical Sampling in Proving Liability and Establishing Damages

2. Evidentiary Burden

3. Many Medical Decisions Are Subjective, and Medical Opinions Can Differ

4. Is Justice Being Served?

B. A More Reasonable Approach

CONCLUSION

 

INTRODUCTION

In recent years the False Claims Act (FCA)[1] has become the Department of Justice’s (“DOJ”) favorite tool to combat large-scale fraud—particularly healthcare fraud. In fact, from 2009 to 2016 alone, the DOJ recovered over $19.3 billion in health care fraud[2]more than half the health care fraud dollars recovered since the 1986 amendments to the False Claims Act.”[3] In general, the statute prohibits (1) knowingly submitting false claims to the federal government or causing another to submit a false claim, (2) knowingly creating a false record or statement to get a false claim paid by the federal government, and (3) retaining funds improperly received from the federal government.[4]

Although the FCA originated during the Civil War, Congress has periodically strengthened the FCA through amendments, which have converted it into a “modern weapon” that the DOJ and whistleblowers use to punish providers who knowingly submit false claims or false records or retain funds improperly received from the government.[5] The amendments have permitted larger damages, which in turn have incentivized whistleblowers and the DOJ to use whatever means available to prove liability in as many false claims as possible. During the last five years in particular, that has meant turning away from proving liability for each individual claim and instead using statistical sampling as proof of liability for a much larger number of claims.[6]

While many courts have consistently approved statistical sampling to calculate damages, they have not resolved whether statistical sampling is sufficient to establish liability under the FCA.[7] Some district courts have held that plaintiffs must prove the falsity of each individual claim, while others have held that falsity and liability may be established for thousands of Medicare and Medicaid claims from only a relatively small sampling.[8] This controversy has recently come to the fore in United States ex rel. Michaels v. Agape Senior Community, Inc.,[9] the first instance in which a circuit court has considered this issue. Notably, the government, despite refusing to intervene in the underlying action, filed a brief concerning the use of statistical sampling once the case was appealed,[10] suggesting its intent to continue using statistical sampling to prove liability.

Ultimately, the combination of the FCA’s trebling of damages and the civil penalties it imposes per false claim means that billions of dollars in potential damages hinge on how courts use statistical sampling.[11] This paper will (1) consider how district courts have treated the use of statistical sampling to prove liability in FCA cases concerning healthcare fraud, (2) analyze the outcome of Michaels, and (3) consider the effect of the courts’ decisions on future FCA and qui tam litigation. This paper will then criticize the courts’ decisions and propose that a more reasonable approach would be to use a bellwether trial to determine whether there is sufficient evidence to prove a generalized fraudulent practice and the likelihood of commonality between the claims. Only after preliminary liability has been established in such a way through a bellwether trial could statistical sampling then be used to establish liability for the remainder of claims, when it would otherwise be infeasible to prove the elements of liability for each individual claim.

I.  BACKGROUND

The FCA originated in 1863, as a way to deter fraud against the government during the Civil War.[12] It targeted Union suppliers who were defrauding the United States, incentivizing private citizens to bring actions against suppliers at a time when the government lacked resources to investigate and prosecute such fraud.[13] Since then, the FCA has undergone several revisions, most recently in 2010 as part of the Patient Protection and Affordable Care Act (ACA).[14] Despite its 155year history, the FCA is certainly not a war relic; today it remains more relevant than ever, with some scholars calling it a “modern nightmare for the health care industry.”[15] The FCA continues to serve as the federal government’s safeguard against being overcharged or provided “shoddy goods or services.”[16] In fact, FCA actions have significantly increased since 2009, with the DOJ recovering more than $3.5 billion in fiscal year 2015,[17] more than $4.7 billion in 2016,[18] and $3.7 billion in 2018—the eight consecutive year in which over $2 billion of yearly recoveries were from the healthcare industry[19]and there are no signs of a slowdown. Indeed, the former head of the Justice Department’s Civil Division has called the FCA the “government’s most effective civil tool to ferret out fraud.”[20]

Today, most FCA litigation is originated by whistleblowers (called “relators”) under the statute’s qui tam provisions.[21] A typical claim at issue in healthcare fraud cases under the FCA is a request by a provider for reimbursement of services or items, submitted to the Centers for Medicaid & Medicare Services (CMS) or a state Medicaid agency.[22] A claim may be submitted individually or as part of annual cost reports presented to CMS or a state agency.[23] However, because the healthcare industry is so highly regulated, there are “an innumerable variety of issues [that] can cause claims to be false or fraudulent.”[24]

Generally, the issues can be categorized into claims that are factually false and claims that are legally false.[25] Factually false claims include misrepresentations of services provided, such as (1) when a service occurred in a different location than the one stated (for example, a service was provided at a physician’s office but is billed as having been provided at an ambulatory care center); (2) when service was not performed at all or a different service was performed; and (3) when a claim indicates that a physician performed a service, but in reality it was performed by unlicensed personnel.[26] Another type of factually false claim is for a service that CMS deems not medically necessary for a specific patient.[27] If a claim indicates that a service was medically necessary, but according to CMS it was not, the claim is false even if the services were provided and the treating physician is of the opinion that the service was necessary.[28]

On the other hand, legally false claims are those that, despite being factually accurate (for example, the services were provided as stated in the claim), have failed to meet a condition for payment under a “federal healthcare program.[29] Such claims can be as simple as a patient failing to qualify under specific eligibility criteria or failing to meet a requirement under one of the federal government’s complicated payment rules.[30] Legally false claims also include claims resulting from a violation of the Anti-Kickback Statute or the Stark Law.[31] Further, under the implied false certification theory upheld by the Supreme Court in 2016, a claim for payment “impliedly certifies compliance with all conditions of payment.[32] Therefore, if such a claim fails to disclose a violation of “material statutory, regulatory, or contractual requirement . . . it has made a misrepresentation that renders the claim ‘false or fraudulent’” under the FCA.[33] Regardless of whether it is a legally or factually false claim, plaintiffs must first prove liability and then, separately, damages.

A.  Proving Liability Under the FCA

An individual or entity is liable under the FCA for (1) submitting a “false or fraudulent claim for payment or approval” or causing another person or entity to submit a false claim for payment or approval; (2) submitting a “false record or statement material to a false or fraudulent claim;” or (3) possessing or controlling funds improperly received.[34] Thus, not only does the statute prohibit actively submitting fraudulent claims or information, it also prohibits failing to pay back an overpayment within a specified timeframe, in what is sometimes referred to as the reverse false claims provision.[35]

One of the most important aspects of the FCA from a liability perspective is that a plaintiff must prove scienter.[36] To prove scienter, the government or a relator must prove either “actual knowledge,” “deliberate ignorance,” or “reckless disregard.[37] However, specific intent to defraud is not required.[38] In other words, for there to be liability based on actual knowledge, an individual or entity must have known at the time that they were submitting a claim or statement that it was false or, in the case of improper retention of money, that they were not entitled to those funds.[39] Nonetheless, scienter can also be proved if the violator acted with “reckless disregard or deliberate ignorance.[40] As such, to avoid liability an individual or entity must still establish reasonable safeguards to protect against filing inaccurate claims.[41]

B.  Damages Under the FCA

While the stakes are already extremely high for providers, who risk being excluded from federally funded programs such as Medicare and Medicaid for losing at trial on just one FCA claim,[42] once liability is established, FCA damages are particularly large.[43] The FCA not only issues a civil penalty between $5,000 and $10,000 per false claim but also awards treble damages to a successful plaintiff-relator.[44] To put this in perspective, in United States v. Krizek, despite having only $245,392 in actual damages, the government sought $81 million in total damages as a result of treble damages and civil penalties of $10,000 for each of the 8,002 separate claims.[45] Additionally, violators are liable for the legal costs incurred by the government or plaintiff-relator.[46]

The FCA does, however, permit reduced damages if certain conditions are met. First, the violating party must provide the investigating officials with “all information known to such person about the violation within 30 days of obtaining the information.[47] Second, the violating party must fully cooperate with the investigation.[48] Third, when the violating party provides the information, there must be no actions regarding the violation (criminal, civil, or administrative) commenced against them under the FCA, and the violating party must “not have actual knowledge of the existence of an investigation into such violation.”[49] Even the reduced damages, however, are to be assessed at no less than two times the amount sustained by the government.[50] Because the damages at stake are so incredibly high, the method by which plaintiff-relators can prove liability for each claim is a major point of contention in FCA cases: the lower the burden to prove liability, the higher the number of claims and subsequent damages.

C.  Statistical Sampling and the FCA

Statistical sampling is one of the methods that ultimately reduces the burden of proving liability in FCA cases. While the FCA does not statutorily authorize statistical sampling, it also does not prohibit it.[51] FCA cases, as courts have acknowledged, present a particular challenge, because for especially large fraud schemes it becomes prohibitively expensive and impractical for qui tam relators and the government to pursue and prove each individual claim.[52] As a result, starting in 1991 with Chaves County Home Health Service, Inc. v. Sullivan,[53] courts have allowed statistical sampling and extrapolation to be used to establish damages once liability has already been proven.[54]

Despite its past use, until recently[55] statistical sampling was generally limited to establishing damages.[56] In other words, plaintiffs had to prove liability through other evidence, as courts recognized that “establish[ing] damages when liability has been proven is different than using extrapolation to establish liability.”[57] In recent years, though, district courts have taken different approaches in determining whether statistical sampling can be used to establish liability.[58] However, no circuit court has yet resolved the issue, and the one time the issue has been certified for appeal, the court declined to decide it.[59] As such, the question remains whether statistical sampling is sufficient evidence to establish liability under the FCA. Additionally, as will be discussed in greater detail, courts frequently conflate statistical sampling for liability and damages, even when they claim to only be using statistical sampling to calculate damages. Thus, it is important to understand how statistical sampling can be used in practice to establish liability and to determine damages, clearly highlighting the differences between the two uses.

1.  How Statistical Sampling Would Establish Liability

The following example demonstrates how statistical sampling would typically be used to establish liability in an FCA case. Assume that the government brings suit against a healthcare provider for allegedly false claims submitted to Medicare between 2012 and 2015. During that period, the healthcare provider submitted 100,000 claims. It would be highly impractical for the government to carefully review each of the 100,000 claims and bring suit on every single claim found to be false. Instead, the government reviews a statistically valid random sample of 500 claims. Upon completing its review, the government has proof that of these 500 claims, 250 (50 percent) are false under the FCA. Accordingly, based on this statistical sampling, the government claims that 50 percent of the total number of claims, or 50,000, are false. If the court were to allow statistical sampling to establish liability, the healthcare provider could be held liable for 50,000 claims, even though the government definitively proved the falsity and knowledge elements of only 250 claims.

Using statistical sampling to establish liability would require using statistical sampling to establish damages almost by default. In the example above, liability for 50,000 claims means little without corresponding damages. However, since the government could only establish the exact amount of damages for 250 claims, the government would have no choice but to rely on statistical sampling to also calculate damages for the remaining 49,750 claims.

2.  How Statistical Sampling Would Establish Damages

In theory, it is possible to use statistical sampling only to calculate damages (and not to establish liability in any way). For example, a defendant healthcare provider could admit that every single time they submitted certain types of claims to Medicare, they knew the claims were false. The government could then determine that 3,000 of these types of claims were submitted and decide that it would be impractical to determine the exact amount of damages for each one. Instead, the government could review a statistically valid sample of 300 of these 3,000 claims. If based on its review the government calculates an average damage amount of $250 per false claim, then the government could be awarded $750,000 in damages (or $2,250,000 after trebling) for the 3,000 false claims, despite having only reviewed 300 of them.

In practice, however, such situations are exceedingly rare in FCA litigation. Given the FCA’s trebling of damages and how its civil penalties are levied on each individual claim, defendants have virtually no incentive to admit liability on claims the government is unable or unwilling to thoroughly review, and they have a strong incentive to challenge the alleged falsity of such claims. Accordingly, even when a court claims that it is using statistical sampling solely to determine damages, unless liability has already been proven for every single claim, the court is actually using statistical sampling to establish liability.[60]

Having discussed how statistical sampling could feasibly be used to establish liability and damages separately, this Note turns now to an overview of the legal precedent surrounding the use of statistical sampling.

D.  Legal Precedent for the Use of Statistical Sampling

1.  Daubert Generally Permits Use of Statistical Methods

Statistical sampling evidence is typically introduced through expert testimony. Generally, the Federal Rules of Evidence allow for the admission of an expert’s testimony if certain requirements are met.[61] Those requirements, provided in Rule 702, are that (1) the expert’s knowledge will help the trier of fact to better understand evidence in the case or make a factual determination; (2) the testimony is sufficiently based on facts or data; and (3) the testimony both results from, and properly applies to, the facts of the case and reliable principles and methods.[62] Accordingly, a court must first determine that an expert is testifying as to specialized knowledge and that this knowledge will be helpful to the trier of fact.[63]

Under Daubert v. Merrell Dow Pharmaceuticals, Inc., a court must determine not only if evidence is relevant but also whether it is reliable.[64] The court, acting as gatekeeper, must consider the following factors, commonly known as the “Daubert factors”:

1) whether the expert’s scientific technique or theory can be, or has been, tested; 2) whether the technique or theory has been subject to peer review and publication; 3) the known or potential rate of error of the technique or theory when applied; 4) the existence and maintenance of standards and controls; and 5) whether the technique or theory has been generally accepted in the scientific community.[65]

It follows then, under Daubert, that an expert can testify as to extrapolated data so long as the methodology is appropriate and the data is randomly selected and representative of the whole.[66] However, the Daubert factors are not exclusive,[67] and the court is ultimately given considerable leeway in determining whether evidence is admissible.[68] Additionally, the proponent of the expert testimony must establish by a preponderance of the evidence that the testimony satisfies the admissibility requirements.[69]

2.  Wal-Mart Stores, Inc. v. Dukes: Individualized Determination Cannot Be Replaced by “Trial by Formula”

One of the main legal precedents for the use of statistical sampling comes from the landmark case Wal-Mart Stores, Inc. v. Dukes, in which the Supreme Court refused to allow trial by statistics.[70] However, the Court did not close the door to the use of statistical sampling during the damages phase.[71] In Wal-Mart, respondents attempted to certify a class of 1.5 million female employees by alleging that local managers pervasively discriminated against women in the workplace, favoring male employees for promotions and higher pay, and that Wal-Mart had refused to restrain the managers’ discretion in these decisions.[72] To certify the class,[73] respondents had to prove that “‘questions of law or fact [were] common to all the women of Wal-Mart.”[74] To satisfy this requirement, they attempted to use anecdotal testimony of 120 women, the expert testimony of a sociologist, and statistical evidence showing pay and promotion disparities between male and female employees.[75]

The Court disregarded the expert testimony, finding that the anecdotal evidence was too weak.[76] The statistical evidence consisted of a regression analysis showing a disparity between the number of women promoted to management positions and the total number of available employees.[77] The Court found that the evidence did not raise an inference of a company-wide discriminatory policy, and “merely proving that the discretionary system has produced a racial or sexual disparity is not enough.”[78] The Court noted that a defendant is entitled to litigate its statutory defenses to individual claims”[79] and has “a right to contest the fact of its liability to each claimant, including the fact of the claimant’s injury.”[80] The Court reversed the Ninth Circuit, holding that “individualized determinations of each employee’s eligibility for backpaycould not be replaced by Trial by Formula.”[81]

In the postWal-Mart period, courts have typically allowed statistical sampling to prove damages but not aspects such as liability or commonality of issues.[82] For example, in Dailey v. Sears, Roebuck & Co., the court held that plaintiffs in a class action could not use statistical sampling to show commonality of issues for class certification.[83]

3.  Tyson Foods: Admissibility of Statistical Sampling Turns on Reliability

In 2016, the Supreme Court revisited the use of statistical sampling evidence in Tyson Foods, Inc. v. Bouaphakeo.[84] Here, the Court rejected brightline rules regarding statistical sampling, instead preferring a case-by-case approach.[85] In Tyson Foods, a class action suit was filed against an employer. The suit alleged that the employer failed to compensate employees for the time it took to put on and take off protective gear, resulting in unpaid overtime wages in violation of the Fair Labor Standards Act (FLSA).[86] To establish the amount of unpaid time, the plaintiffs relied on an expert study that reviewed evidence concerning only a sample of class members, such as videotaped observations of the time it took some employees to put on and take off the protective gear.[87] Based on the review of the sample, the expert determined that one category of employees averaged eighteen minutes a day putting on and taking off the gear, while another averaged twenty-one minutes and fifteen seconds.[88] Since the employer did not maintain records tracking this time for each individual, the plaintiffs calculated the damages for each affected member of the class based on the averages from the sample.[89] The employer did not move for a hearing to determine the validity of the study under Daubert or attempt to discredit the expert’s testimony with a rebuttal expert, but rather argued that the study overstated the average times and that the actual differing times it would take each individual to put on and take off the protective gear made the lawsuit too speculative for classwide recovery.[90] In affirming the damages awarded, the Court recognized that statistical sampling is just another piece of evidence that can “establish or defend against liability”[91] and is at times “the only practicable” approach to prove liability, and thus under the circumstances of the instant case sampling could be used.[92]

Despite both parties and their respective amici urging the Court to establish “broad and categorical rules governing the use of representative and statistical evidence,” the Court refused to do so.[93] The Court instead concluded that whether statistical sampling is appropriate depends on “the degree to which the evidence is reliable in proving or disproving the elements of the relevant cause of action”[94] and the “facts and circumstances particular” to each case.[95] The opinion in Tyson extends well beyond the FLSA and class actions and has been hailed by some legal practitioners as the new roadmap to FCA claims.[96]

E.  Sampling in Other Types of Litigation

Statistical sampling is also used in other types of litigation, and the breadth of its use as appears to be expanding. For example, statistical sampling is frequently used in antitrust, equal employment opportunity, discrimination, voting rights, product liability, trademark, fairness in sentencing, and mass tort cases (including environmental cases such as toxic torts).[97] In 2010, statistical sampling was also permitted in MBIA Insurance Corp. v. Countrywide Home Loans, Inc., a notable mortgage securities case.[98]

II.  ANALYSIS

As Tyson Foods indicates, courts, including the Supreme Court, are reluctant to establish clear, general rules regarding the use of statistical sampling in litigation, and this is no different in cases involving the FCA. As such, parties involved in FCA litigation and courts deciding FCA claims must rely on the sometimesconflicting reasoning of previous decisions regarding the use of statistical sampling. Accordingly, an overview of frequently cited and reliedupon cases addressing the use of statistical sampling in FCA claims is necessary in order to fully understand the legal arguments made for and against their use. Having already reviewed the background of the FCA and established the legal precedents for the use of statistical sampling evidence, this Note will now analyze how district courts have approached the use of statistical sampling to prove liability in FCA cases pertaining to healthcare fraud.

The following is an overview and survey of the sixteen most cited and relevant cases. This Part of the Note extracts their fundamental legal principles concerning statistical sampling and categorizes and discusses them as follows: Section A, courts allowing the use of statistical sampling to prove liability; Section B, courts not allowing the use of statistical sampling to prove liability; Section C, courts that likely would have allowed statistical sampling if data had been reliable or the timing was proper; and Section D, courts that did not decide the issue determinatively. Section E provides an in-depth discussion of Michaels v. Agape Senior Community, Inc., given the magnitude of its importance as the only case concerning statistical sampling and FCA liability to reach an appellate court.

 

Table 1.  Healthcare Fraud Cases with Statistical Sampling for Liability

Case

Venue

Year

Statistical Sampling Allowed for Liability?

Notes

United States ex rel. Martin v. Life Care Centers. of America, Inc.[i]

E.D. Tenn.

2014

Y

 

United States v. Robinson[ii]

E.D. Ky.

2015

Y

 

United States v. Aseracare Inc [iii]

N.D. Ala.

2014

Y

 

United States ex rel. Ruckh v. Genoa Healthcare, LLC[iv]

M.D. Fla.

2015

Y

 

United States ex rel. Loughren v. UnumProvident
Corp. [v]

D. Mass.

2009

Y

 

United States ex rel. Wall v. Vista Hospice Care, Inc. [vi]

N.D. Tex.

2016

N

 

United States v. Medco Physicians Unlimited[vii]

N.D. Ill.

2000

N

 

United States ex rel. Trim v. McKean[viii]

W.D. Okla.

1998

N*

*Denied based on “tainted” data.

United States ex rel. El-Amin v. George Washington University [ix]

D.D.C.

2008

N*

*Denied because of inappropriate timing, and relators failed to define parameters of sample size.

United States ex rel. Guardiola v. Renown Health[x]

D. Nev.

2014

Y*

*Only allowed statistical sampling in discovery; did not rule as to trial phase.

United States v. Cabrera-Diaz[xi]

D.P.R.

2000

Y*

*Granted on a motion for default summary judgment.

United States v. Krizek[xii]

D.D.C.

1994

Y*

*Defendants agreed to use of a small sample to determine liability.

United States v. Fadul[xiii]

D. Md.

2013

Y*

*Addressed statistical sampling only with regard to common law claim, not FCA claim.

United States v. Friedman[xiv]

D. Mass.

1993

N*

*Acknowledged validity in general of statistical sampling but only referred to statistical sampling regarding damages.

 

United States ex rel. Michaels v. Agape Senior Community, Inc. [xv]

D.S.C.

2015

N

 

United States ex rel. Michaels v. Agape Senior Community, Inc. [xvi]

4th Cir.

2017

N*

*Held that it was inappropriate to review issue through an interlocutory appeal.

A.  Cases Allowing the Use of Statistical Sampling

The following are cases in which the court allowed the use of statistical sampling to prove liability in FCA litigation. These summaries demonstrate that courts arrive at this decision primarily based on (1) the FCA’s purpose of combating large scale fraud, (2) the impracticability of the government or a relator proving each one of thousands of claims, and (3) the lack of authority that would disallow the use of statistical sampling.

First, in United States ex rel. Martin v. Life Care Centers of America, Inc., the defendants argued that “the Government cannot satisfy its burden of proof through evidence based on statistical sampling and extrapolation.”[99] The court, finding that no legal precedent was determinative,[100] held that statistical sampling could be used by a plaintiff to attempt to prove liability in FCA litigation.[101] The court reasoned that the purpose of the FCA—to fight large-scale fraud against the government—would be undermined were it not to allow statistical sampling, because it would be impractical to review individual claims on a large scale.[102] Notably, however, the court ruled that the fact finder must determine how much weight is given to the statistical evidence.[103]

Similarly, in United States v. Robinson, the court denied the defendant’s motion for summary judgment, finding the defendant had not proven that the use of extrapolated data was inappropriate.[104] Agreeing with Martin, it held that, with “over 25,000 claims at issue,” it would be impracticable to require a plaintiff to present evidence of each claim individually and that it would defeat the purpose of the FCA.[105]

Additionally, the court in United States v. Aseracare Inc., found that “statistical evidence is evidence” and deferred to the fact finder as to the weight such evidence should receive.[106] Notably, the court did not distinguish between the use of statistical sampling at the damages stage and at the liability stage, although it did ask the plaintiffs whether they were using sampling to establish liability or damages.[107]

In another example, United States ex rel. Ruckh v. Genoa Healthcare, LLC, the relator moved to admit expert testimony on statistical sampling before any sampling had been done.[108] The defendant argued that the expert testimony was inadmissible, citing United States v. Friedman (discussed infra in Part II.D).[109] The court was not persuaded by the defendant’s arguments and, quoting Martin, explained that even though Friedman did not allow statistical sampling for the case at hand, it did “not stand for the proposition that statistical sampling cannot be used” at all.[110] Instead, the court “recognized the validity of statistical sampling” in general[111] and held that no testimony was excludable solely because it was statistical sampling.[112]

Finally, in United States ex rel. Loughren v. UnumProvident Corp., the court concluded that statistical sampling was adequate to determine the number of false claims.[113] Notably, however, it only did so after a bellwether trial, during which testimony was presented that the defendant had a generalized policy of coercing its insureds to file for Social Security disability benefits when it “knew or should have known that these insureds did not meet the statutory definition of disability required to qualify.”[114] While the court ultimately granted the motion to exclude the expert’s testimony, it did so only because it found the statistical sampling and expert testimony to be unreliable.[115]

B.  Cases Not Allowing the Use of Statistical Sampling

The following two cases are examples of courts disallowing statistical sampling in FCA litigation and the typical reasoning behind that decision. Courts arrive at this decision primarily based on (1) the claims at issue involving subjective medical judgment, (2) the plaintiff’s burden in establishing falsity and scienter for each claim, and (3) the lack of authority that would allow the use of statistical sampling.

In United States ex rel. Wall v. Vista Hospice Care, Inc., a case involving patient eligibility for hospice care, the court struck expert statistical sampling testimony.[116] The court reasoned that statistical sampling was insufficient to prove liability in an FCA claim when the “underlying determination of eligibility for hospice is inherently subjective, patient-specific, and dependent on the judgment of involved physicians.”[117] While the court recognized the general validity of statistical sampling, it noted that it is not always permissible and instead turns on the degree to which the evidence is reliable in proving or disproving the elements of the relevant cause of action.”[118] In fact, the court argued that any ruling that extrapolation and sampling are always reliable, no matter the “nature of the data and the nature of the claim,” is incorrect in light of Wal-Mart, which requires “a particularized analysis of . . . whether extrapolation from a particular data set can reliably prove the elements of the specific claim.”[119]

In arriving at its decision the court also noted how the facts were analogous to those in Michaels v. Agape Senior Community, Inc., in that each claim involved subjective decisionmaking based on the facts and circumstances surrounding each individual patient.[120] The court then differentiated the case at hand from several decisions that did permit sampling, because those cases did not involve a physician’s necessary “subjective clinical judgment” in predicting an individual’s life expectancy.[121] Further, one of the cases, Robinson, dealt with only a single optometrist, as opposed to Vista Hospice Care, which involved many physicians at different locations.[122] These points were particularly important because even if there were sufficient proof in one particular claim requiring subjective judgment, such a finding could not impact the burden of proof for a different claim requiring subjective judgment involving “different patients, different medical conditions, different caregivers, different facilities, different time periods, and different physicians.”[123]

Ultimately, the court determined that an FCA claim based on the exercise of a physician’s subjective clinical judgment “must be predicated on the presence of an objectively verifiable fact at odds with the exercise of that judgment,” and not simply question the subjective judgment.[124] An example of such a claim involving an “objectively verifiable fact” would be a physician not actually exercising clinical judgment where he neither reviewed a patient’s medical condition nor saw the patient.[125] Accordingly, an FCA claim cannot rely solely on an expert’s disagreement with a certifying physician’s subjective conclusion.[126]

Separately, the court emphasized that the FCA’s scienter requirement is independent of the requirement to show the falsity of records or claims.[127] In other words, showing that a defendant operated with reckless disregard for falsity does not in itself prove actual falsity under the FCA.

In an older case, United States v. Medco Physicians Unlimited, the plaintiff asked the court to extrapolate from an expert review of sixteen of the defendant’s patients that the defendant had fraudulently billed for all of its patients.[128] The court declined because the plaintiff had failed to cite any authority supporting extrapolation, or even to provide evidence sufficient to prove fraudulent billing for the sixteen reviewed patients, let alone the rest.[129]

C.  Courts That Likely Would Have Allowed Statistical Sampling if Data Had Been Reliable or Timing Was Proper

FCA cases sometimes discuss the issue of statistical sampling but refuse to allow it for reasons specific to the case at hand. However, if these casespecific issues had been corrected, statistical sampling would likely have been allowed. As demonstrated in the summaries that follow, courts have refused to permit the use of statistical sampling to prove liability when (1) the data or methodology used in conducting the sample was flawed, (2) the plaintiff raised the issue of statistical sampling after an unreasonable delay, or (3) the plaintiff failed to properly establish the parameters of the sample.

In United States ex rel. Trim v. McKean, the court rejected the use of audits as statistical data for extrapolation because the data was “tainted.”[130] The court appeared to take issue with the method and factual circumstances surrounding the performance of the audit and not necessarily the use of extrapolated statistical data in FCA claims generally.[131] In fact, it found that the audit was “persuasive evidence of false claims.”[132]

In United States ex rel. El-Amin v. George Washington University, the court denied the relators’ motion for “trial by representative sample because the litigation had been pending for eleven years, and at no point had the relators raised the issue of statistical sampling.[133] In addition to the practical inconveniences presented by this lastminute argument, the relators were unprepared to even define the universe of claims, instead merely providing an estimate of somewhere between 5,000 to 15,000 claims.[134] It seems very likely, however, that the court would have allowed statistical sampling had the issue been raised by the relators in a timely matter, given the court’s emphasis on the injustice of allowing the case to be converted to a trial by representative sample so late into the litigation and its mention that the “[r]elators [had not] taken the preparatory steps that would give them the proper foundation to try this case by statistical sample.”[135]

D.  Courts That Did Not Decide the Issue Determinatively

Finally, some courts discuss the issue of statistical sampling but refuse to rule on the matter. As demonstrated by the following summaries, courts have failed to decide the issue of statistical sampling when they (1) deferred the decision to a later stage of the litigation that never occurred; (2) decided the matter on a motion for default judgment or the defendants agreed to the use of a sample; (3) addressed statistical sampling outside of the FCA context, even though the opinion also addressed FCA claims; and (4) recognized the general validity of statistical sampling but opted to award damages only on claims the court was able to actually examine. It is worth noting, however, that each of these cases, in some way, acknowledges the validity of statistical sampling.

In United States ex rel. Guardiola v. Renown Health, the court allowed statistical sampling in the discovery phase but did not make a ruling on admissibility of statistical sampling, reserving it instead for the “pre-trial stage.”[136] While the case settled before trial, the judge’s willingness to allow statistical sampling at the discovery phase suggests that he would likely have permitted it in pre-trial motions.

In another case, United States v. Cabrera-Diaz, the court granted the plaintiff’s motion for default judgment, finding—based on statistical sampling—that the defendants had violated the FCA by knowingly “caus[ing] to be presented false or fraudulent claims to the United States”[137] However, Cabrera-Diaz is exceptional, as the Martin court argued, in that it was decided on a motion for default judgment.[138] Because the physician was not present to oppose the motion, liability was proven not by the use of statistical sampling but instead as a result of the defendant’s failure to answer.[139] As such, given that the outcome was determined by a “procedural mechanism,” the court’s reasoning should not be viewed as determinatively binding.[140] While one cannot say with certainty what the outcome would have been had the defendants responded to the motion, the opinion still reflects a willingness to accept statistical sampling to prove liability.

A similarly unique case is United States v. Krizek, in which the court conducted a trial based on seven patients and 200 claims “that the government believed to be representative” of 8,002 reimbursement claims.[141] This decision resulted from the defendants’ motion to quash a subpoena seeking office records, on the grounds of patient confidentiality.[142] Apparently for the purposes of protecting such confidentiality, the court decided to move forward with a smaller sample trial based on the seven patients’ records that the government already possessed.[143] The opinion noted, however, that the defendants had agreed “that a determination of liability” on the smaller trial would then extend the liability to the remaining 8,002 claims.[144] Because the defendants had agreed, the court did not explain its rationale or the legal precedent for using a sample to establish liability; therefore this opinion cannot be used as binding precedent for the use of statistical sampling to prove liability in FCA claims.

Another case, United States v. Fadul,[145] is often cited by defendants and courts to reject the use of statistical sampling to prove liability in FCA claims. Nonetheless, while Fadul technically addressed statistical sampling, it did not address statistical sampling in the context of an FCA claim.[146] In Fadul, the government moved for summary judgment on both the FCA and common law claims.[147] The court determined, however, that summary judgment on the FCA claim was inappropriate because there were discrepancies in the record regarding scienter and because of the “general preference for allowing the issue of scienter to be decided by a fact finder.”[148] Thus, the court never addressed statistical sampling in the context of the government’s FCA claim.

Rather, statistical sampling came up only when determining damages for the common law claim based on payment by mistake of fact relating to improper Medicare and Medicaid coding.[149] The court made clear that, “[n]otably, ‘[k]nowledge of falsity is not a requisite for recovery under the mistake doctrine.’ . . . Thus, even where it cannot establish that a defendant acted knowingly for purposes of the False Claims Act, the Government may be entitled to recovery under the alternative theory of payment by mistake of fact.”[150] Accordingly, Fadul provides no insight as to whether statistical sampling is appropriate in FCA claims.

Another case frequently cited as precedent for rejecting statistical sampling to prove liability[151] is United States v. Friedman.[152] There, however, the court did not outright reject statistical sampling to prove liability. Instead, it “recognize[d] the validity of the mathematical and statistical projections based on a review of a smaller number of claims” but noted that it was “reluctant to accept a statistical sampling” in that particular case because it had the opportunity to scrutinize discrete claims and wanted the opportunity to do the same for the remaining claims.[153] The court referred to the use of statistical sampling in calculating damages but did not delve into its admissibility for purposes of proving liability.[154]

E.  United States ex rel. Michaels v. Agape Senior Community, Inc.

All of the cases summarized above are district court cases. Michaels is the only case involving statistical sampling in FCA litigation to reach a circuit court. For this reason, a thorough summary of the district court opinion and the arguments made to the Fourth Circuit is appropriate, as the arguments may serve as a guide for future litigants.

1.  The District Court Case

In Michaels, the plaintiff-relators alleged that their former employer, an entity owning twenty-four nursing homes, had engaged in a widespread fraud by submitting false claims for reimbursement of home healthcare services.[155] The number of claims at issue was approximately between 53,280 and 61,643.[156]

During discovery, the court ruled that statistical sampling could not be used to determine damages.[157] The case later settled before trial, but the government objected to the settlement, believing that it represented only 10 percent of the potential damages of the case, which it estimated to be around $25 million.[158] As a result, the defendants filed a motion to enforce the settlement.[159] During oral argument it was revealed that the government had relied on statistical sampling in arriving at its estimated damages, despite the previous order from presiding Judge Joseph F. Anderson, Jr. rejecting such use in the instant case.[160] Given the voluminous number of claims, and the great expense and time involved were the case to continue to trial, Judge Anderson detailed his reasoning for denying the use of statistical sampling for the purpose of certifying the issue for interlocutory appeal.[161]

Judge Anderson affirmed the reasoning of the court in Friedman,[162] denying the use of statistical sampling because the claims at issue were distinct and based on evidence that should be subject to individual examination in court.[163] He made a distinction between the case at hand, in which all relevant medical records were available to the parties, and cases in which evidence was no longer available and thus statistical sampling was the only way that the case could be tried.[164] Denying the use of statistical sampling in those cases would “allow widespread fraud to go unpunished.”[165] Here, however, because the claims at issue concerned medical records and patient information that varied from patient to patient, the case was not conducive to statistical sampling.[166] The court carefully noted numerous cases cited for and against the use of statistical sampling before certifying the decision for interlocutory appeal.[167]

It is worth noting that the court seemed to conflate the use of statistical sampling in proving liability and in establishing damages. At no point did the court distinguish between the two.[168]

2.  The Circuit Court Case

On appeal, the government relied heavily on Martin and argued that statistical sampling was essential to these types of cases.[169] In turn, the defendants argued that as hospice eligibility is subjective and individualized, statistical sampling would not be an appropriate method for establishing liability.[170] The defendants also emphasized that statistical sampling is typically used to calculate damages once liability has been conceded or is indisputable.[171] Additionally, they argued that scienter could not be proved through statistical sampling, making an analogy to Fadul, in which the court found that collective knowledge of employees/agents was insufficient to prove scienter.[172] Thus, Agape posited that aggregate data from sampling is not sufficient to prove scienter.[173]

Amicus briefs were also filed in support of the defendants-appellees by Savaseniorcare Administrative Services, LLC (Savaseniorcare); the American Hospital Association (“AHA”) and the Catholic Health Association of the United States (“CHA); and the American Health Care Association (AHCA).[174] These amici provide a glimpse into what the arguments against statistical sampling could look like should this issue reach the Supreme Court in the futureas some practitioners have suggested it might[175]and thus are worthy of detailed review.

Savaseniorcare argued that whether a treatment is reasonable or necessary, and thus appropriately reimbursable, cannot be decided by a mathematical formula. These decisions are necessarily subjective, involving complex circumstances that require individualized medical judgment.[176] Additionally, it noted that “reasonable disagreement of professional opinion” is insufficient to establish liability under the FCA;[177] the conduct must instead be objectively false.[178] As such, it would be inappropriate to conduct a trial by formula when the relevant conduct consisted of subjective medical decisions concerning whether a patient should be admitted to hospice care.[179] Further, it emphasized that FCA liability does not attach to an “underlying fraudulent scheme” but rather only attaches when there is an actual claim for payment.[180] Therefore, trial by formula would be insufficient, since it would not provide proof that each individual claim was false.[181]

Savaseniorcare also noted that the government had been trying to avoid appellate review in both the case at hand and Martin because the government is accustomed to using the threat of statistical sampling to obtain large settlements from providers.[182] It urged the court to recognize the government’s assertion that the inability to use statistical sampling would allow large-scale fraud to run rampant and unpunished is nothing more than a scare tactic.[183] It then argued that the court should not sidestep the decision, given how often the issue arises in healthcare fraud litigation and FCA cases in general, and that it is a controlling question of law.[184]

The AHA and CHA made similar arguments, but they also focused heavily on the plaintiff’s burden of proof, arguing that it would be illogical and counter to the purpose of the FCA to shift the burden to defendants.[185] Doing so would essentially make way for “financially motivated relators to attempt to collect large judgments . . . by second guessing doctors’ medical judgments.”[186] They also relied heavily on United States ex rel. Nathan v. Takeda Pharmaceuticals North America, Inc. to assert that if “statistical allegations” are insufficient to plead a cause of action, they should be insufficient to find liability.[187]

AHA and CHA also contended that arguments regarding whether statistical sampling is appropriately conducted under the Daubert standard have no bearing as to whether statistical sampling should be used to establish liability in the first place.[188] In other words, it is ultimately irrelevant whether the statistical sampling is reliable under Daubert because statistical sampling should not be used to establish liability, even if it is reliable. Further, they suggested that since relators can recuperate reasonable fees under the FCA, including expert fees, it is particularly unjustified that liability standards should be relaxed: if what the relators allege is true, and they prove each claim, then they will be able to recuperate the expenses incurred in satisfying their burden of proof.[189] They also argued that the district court cases that the relators and the government relied upon only address the issue of proving damages, not the issue of proving liability.[190] Finally, they argued that the approval of statistical sampling to establish liability would prove catastrophic to the healthcare industry, ultimately resulting in increased healthcare costs.[191]

Similar to the AHA and CHA, the AHCA espoused concern over the burden of proof.[192] It also argued, however, that the use of statistical sampling to prove liability would violate the Due Process Clause.[193] Given the FCA’s treble damages allowance, amounting to “essentially punitive damages,” due process rights would be violated if defendants were not permitted to defend their liability for each specific claim.[194] Finally, it emphasized the practical effects of allowing statistical sampling to prove FCA liability, namely, continued pressure for providers to settle meritless cases.[195]

During oral argument, the Fourth Circuit judges seemed uninterested in the statistical sampling arguments, commenting that the district court had the ability to decide whether statistical sampling was appropriate for each individual case given the factual context.[196] Instead, the court was more interested in the government’s veto power over the settlement.[197]

Ultimately, the Fourth Circuit dismissed the statistical sampling portion of the relators’ appeal as improvidently granted, finding that it was not a pure question of law and, as such, was not appropriate for interlocutory review under 28 U.S.C. § 1292(b).[198] The court noted that the relators themselves presented the issue as whether the statistical sampling was properly conducted under the Daubert standard, not whether it could be used at all.[199] Thus, the question at issue was whether the district court had discretion to allow the relators to “use statistical sampling to prove [the] case.[200] The court emphasized that there was a difference “between a question of law, which will satisfy § 1292(b), and a question of fact or matter for the discretion of the trial court,” concluding that the statistical sampling issue in Michaels was a factual matter subject to the abuse of discretion standard and thus inappropriate for interlocutory appeal.[201] Through its emphasis that the issue as presented was a factual one, the circuit court was careful to avoid comment as to whether the use of statistical sampling is appropriate for proving liability as a matter of law. Despite passing on the issue for the moment, the decision in practice allows district courts to continue to use discretion in determining whether statistical sampling is appropriate for a particular case.[202]

With the resolution of the interlocutory appeals, Michaels settled and was dismissed in August 2017.[203] While Michaels did not ultimately provide the answer practitioners were looking for, other circuits will likely have to determine in the near future whether statistical sampling can be used to prove liability. As such, this Note turns now to the impact a more definitive ruling would have.

III.  IMPACT

A.  Consequences of Rejecting Statistical Sampling for Liability

Should a circuit court decide to reject the use of statistical sampling to prove liability, FCA discovery would become significantly more burdensome given the increase in the number of claims that must be proven.[204] Whistleblowers also argue that the costs would be so significant that “combat[ing] large scale fraud through whistleblower litigation” would become much harder,[205] potentially defeating the very purpose of the FCA. They argue that attorney’s fees would increase insurmountably, and cases would take much longer to settle. A rejection of statistical sampling would also reduce the potential recovery of damages, since litigants would have to prove each individual claim and would be unable to collect damages from as many claims as they would if statistical sampling was allowed. Ultimately, this would greatly reduce the incentive for whistleblowers to file suit. Arguably more importantly, it would also reduce the incentiveand possibly make it prohibitively expensivefor attorneys to take on contingent whistleblower litigation cases.

Additionally, some may argue that this significantly increased discovery would also burden courts through an increase in pre-trial motions.[206] However, this argument fails to recognize that the burden would also be borne by prosecutors and whistleblowers who, as a result, could only pursue claims that they could individually prove, likely decreasing in the number of actions filed. Further, the number of claims would also decrease because of the reduced financial incentive for attorneys and whistleblowers, as discussed above, thereby negating the increased burden on courts.

B.  Consequences of Permitting Statistical Sampling for Liability

On the other hand, a circuit court allowing the use of statistical sampling to prove liability would have its own significant consequences. First, such a result would significantly increase the pressure providers feel to settle FCA actions—even in instances where they did little or nothing wrong. Defendants could risk going bankrupt if they do not settle, due to the potentially devastating financial effects that the FCA’s civil penalties and treble damages[207] could have if only a small sample of false claims were to establish wide liability

Additionally, since the use of statistical sampling would significantly increase the financial risk to any provider receiving reimbursements from the federal government (such as providers accepting Medicare and Medicaid), the use of statistical sampling would reduce the number of providers accepting patients covered by federal programs. There is already a shortage of primary care providers willing to accept Medicare and Medicaid, and the population eligible for these programs has significantly increased under the Affordable Care Act.[208] Allowing statistical sampling to establish liability would, therefore, exacerbate the shortage problem. Ultimately, this decision would negatively affect access to care for those who are most needy and ill. Without access to preventative care through a primary care doctor, a large portion of this population will develop serious illnesses that could have otherwise been prevented or managedand taxpayers will have to foot the hospital bills.

IV.  A SOLUTION and a SUGGESTED OUTCOME

To provide a workable solution regarding the use of statistical analysis to establish liability in FCA cases, the problems with previous court decisions must be addressed and corrected. In this Part, Section A highlights and describes common problems and potential flaws in the judicial reasoning regarding the use of statistical liability in FCA litigation. Section B takes these criticisms into consideration as it recommends a general framework for the proper use of statistical sampling in such cases, helping litigants and courts to balance the negative consequences of always either allowing or disallowing the use of statistical sampling to establish liability.

A.  Criticisms and Potential Flaws in Judicial Reasoning

1.  Courts Conflate the Use of Statistical Sampling in Proving Liability and Establishing Damages

As briefly described above, a common problem in statistical sampling cases is conflation of the use of statistical sampling to prove liability with use to establish damages. Take, for example, Michaels.[209] At first, the court discussed the matter as a damages issue (that is, whether statistical sampling could be used to prove damages).[210] Later, in the same opinion, the court said it is a liability and damages issue.[211] At no point did the court distinguish between the elements to prove liability versus the requirements for damages. Under the FCA, however, plaintiffs must prove several elements: falsity, scienter, material conduct, and actual damages.[212]

The court in Robinson did the same. It began by discussing the defendant’s claim that it is inappropriate to use statistical sampling to extrapolate liability and damages.[213] The court then proceeded to rule that the results of the statistical sampling, per the evidence submitted, could be submitted to a jury, primarily because such methods “have been accepted in the Sixth Circuit and in other jurisdictions as reliable and acceptable evidence in determining facts related to FCA claims.”[214] The court did not go into detail about whether the results of the statistical sampling could be used for the purpose of determining damages, establishing liability, or both, and instead ruled that “[t]he weight to be given to such statistical evidence is necessarily one which must be considered by the fact finder in light of the practical difficulties in obtaining a claim-by-claim review.”[215] Thus, by permitting the statistical sampling without providing any guidance for the fact finder (or future cases) as to its permissible uses, the court either confused or ignored the difference between use to establish damages and use to establish liability.

The danger of purportedly using statistical sampling only for damages, without establishing liability, can be illustrated by looking instead at a Medicaid overpayment case, which parties have cited in FCA cases to support the validity of statistical sampling for purposes of proving damages.[216] In Goldstar Medical Services, Inc. v. Department of Social Services, the government conducted an audit of a sample of ninety-three out of 3,496 relevant claims.[217] Based on the ninety-three sample claims, the government determined that sixty-nine, or 74%, contained errors resulting in an excess reimbursement from Medicaid.[218] The government then extrapolated that from the entire universe of 3,496 claims, the defendant’s excess reimbursements totaled $261,303.45.[219] The court recognized that “[i]t is well established that proof of damages through the use of statistics and statistical sampling has been endorsed in numerous cases involving Medicare and Medicaid overpayments” and upheld the government’s use of statistical extrapolation.[220] Since this was an appeal from an administrative judge’s ruling on a post-payment Medicaid audit,[221] it is not subject to the elements of an FCA claim. However, assume instead that the claims were FCA claims and the court was alleging that the statistical sampling was only being used to establish damages. In that situation, the court would implicitly be using the sampling to establish both liability and damages. While definitive proof was found regarding the sixty-nine claims, no such proof was found or presented for any claims outside of the ninety-threeclaim sample. Accordingly, to extrapolate damages regarding claims outside of the sample, the court would have to accept that the defendant was liable for errors that the government established solely through statistical data.

Instead, courts should recognize that the analysis as to whether statistical sampling is appropriate for establishing liability requires looking at the individual elements of liability under the FCA. That analysis differs fromand requires a different legal foundation thanthe analysis regarding statistical sampling for damages. First, the scienter element of the FCA must be proved. If scienter is being proved through actual knowledge, it must be proven that the defendant knowingly submitted a false claim. Establishing through statistical sampling that a certain number of false claims were likely submitted does not address scienter here. Furthermore, even if relators were able to prove an “underlying fraudulent scheme” to satisfy scienter through deliberate ignorance or reckless disregard, this, although likely evidence of fraud and liability, is not alone sufficient.[222] This is because a defendant could maintain fraudulent records, and even prepare fraudulent claims, but never actually submit a false claim to the government. Thus, it would still be necessary to establish that a false claim was actually presented for payment to satisfy the falsity element of the FCA.

Additionally, muddling the requirements for establishing liability and for calculating damages would effectively remove one of the few protections that the FCA provides defendants. The FCA’s requirement that the falsity and scienter of each specific claim be proved safeguards against abuse by potential plaintiffs.[223] This is of particular importance because the FCA allows for treble damages, which could be devastating in cases where thousands of claims are at issue.

2.  Evidentiary Burden

Another problem with using statistical sampling to prove liability is the plaintiff or government’s “evidentiary burden to establish the elements of a FCA claim.”[224] While the government often argues that forbidding the use of statistical sampling would allow large-scale fraud to go unpunished, this ignores a critical point: permitting the use of statistical sampling to establish liability creates a perverse incentive for relatorswho already have a significant pecuniary incentive to bring suitto allege large-scale fraud with little or no proof.[225] In this instance, the larger the fraud that one alleges, the lower the burden of actually having to prove the fraud; as long as the plaintiff can use statistical sampling, the government no longer has the burden of establishing proof of falsity and scienter for each individual claim. Instead, the government or plaintiff can establish proof of falsity and scienter for only a subset of cases and claim that they have satisfied their burden for hundreds, if not thousands, of other unexamined claims. Defendants would effectively have the burden of discrediting the statistical evidence or proving that each claim in the claims universe was actually valid.

Courts, like those in Martin and Aseracare, that take the approach that due process is satisfied so long as defendants can rebut the evidence at trial and through cross-examination fail to recognize that this approach shifts the burden of proof. Although these courts state that statistical sampling is the only practical way for the government and relators to logistically and cost-effectively try large FCA claims, they ask defendants to bear the very cost that they are shielding plaintiffs from. In effect, the courts require defendants to individually sift through thousands of claims to combat statistical evidence obtained cost-effectively by plaintiffs. As a result, wise defendants are likely to perform a cost-benefit analysis to determine whether the costs of document review for thousands of claims and the associated legal fees are worth combating the litigation, or whether it is more costeffective to settle. It is also worth noting that some defendants who are single practitioners may not have the means to hire a law firm or expert to conduct such an analysis. Thus, this shifting of the burden creates the opportunity for the government to impose (or extort) settlement from providers. This outcome is not true to the statutory purpose of the FCA, and it contradicts Congress’s express desire to place the burden of proof on the government.

3.  Many Medical Decisions Are Subjective, and Medical Opinions Can Differ

One of the issues plaguing the use of statistical sampling in FCA cases involving the healthcare industry is that many of the claims being reviewed for fraud result from a treating physician’s clinical judgment—a subjective decision. These decisions are made on a “patient-by-patient basis” and are not an exact science.[226] Thus, it would be inappropriate to draw conclusions from a small sampling for claims based on clinical judgments because the samples could not possibly account for the subjective nature of such decisions for the entire universe of claims.

For example, in Vista Hospice Care, the relator claimed that the defendants had submitted fraudulent claims to the government when it admitted patients who were ineligible for hospice into hospice care and then submitted claims for reimbursement.[227] Determining whether a patient is eligible for hospice care, however, is a subjective clinical decision.[228] Under Medicare regulations, “terminally ill” patients are eligible for hospice care,[229] and a “terminally ill” person is one whose life expectancy is “[six] months or less if the illness runs its normal course.”[230] A bystander without clinical or medical experience might assume that determining whether a person has six months to live is a simple process, based on some sort of scientific clinical criteria. The truth is far from that. While Medicare has published guidelines for hospice admissions,[231] these “guidelines are not necessarily accurate in predicting death within six months.”[232]

To make a prediction concerning life expectancy, a provider must first determine what exactly qualifies as a terminal condition and then assess, using subjective and objective symptomatology, whether that specific patient has less than six months to live. And while providers may look to Medicare’s guidelines to assist them with their decisions, these guidelines are not necessarily accurate in determining life expectancy, and the decision is ultimately subjective. It stands to reason, then, that if doctors must make an individualized and subjective clinical judgment, reasonable medical minds can differ as to whether the person could qualify for hospice care.[233]

Therefore, if we had a case involving 50,000 claims concerning hospice eligibility, it would be inappropriate to use statistical sampling of, say, 1,000 claims to prove liability for a percentage of all 50,000 claims. To do so would be making not only the assertion that a proportionate number of claims in the universe of claims were false, but also that the provider’s clinical judgment was incorrect in all of those cases—a highly illogical conclusion considering the subjectivity of the field of medicine as a whole and the subjective determinations that a provider has to make in forming clinical judgments. In other words, it would be inappropriate to use a sample in this context because it would be almost impossible to establish a truly representative sample given the unique circumstances surrounding each and every claim.

As illustrated above, it is particularly difficult to justify the argument that scienter and falsity can be proved via statistical sampling for FCA claims concerning subjective clinical decisions. In essence, we would be saying that a provider knew that thousands of clinical judgments were false and such clinical judgments actually were false simply because a small sample of those judgments were incorrect (or in many instances, just inconsistent with an expert witness’s clinical judgment). While this may seem practical, it also seems starkly unjust in light of the significant consequences of the FCA and the nature of the decisions involved. After all, reasonable minds can differ.

4.  Is Justice Being Served?

Part of the issue also centers on justice—it is not fair to determine knowledge as to thousands of claims from a small sampling. This is especially so in the realm of healthcare, not only because decisions are often times subjective, but also because they pertain to different patients and circumstances. Unlike in cases dealing with uniform products, healthcare providers frequently deal with many different patient scenarios, and because no two patients are alike, neither are two claims. Further, it seems particularly unjust to assume liability from just a small sampling when the corresponding damages are trebled.

On the other hand, not allowing statistical sampling to prove liability could lead to abuse by providers who know of the disallowance, which is also not in the interest of justice. However, it seems ultimately more unjust that some providers should suffer such severe consequences as treble damages and civil penalties for thousands of claims, potentially bankrupting their practice, just because there is the potential for abuse.

Additionally, while many would say that not allowing statistical sampling would frustrate the government’s ability to sue,[234] this is simply not the case. The government would still be able to sue, but it would have to focus its efforts on the claims it can actually prove. It would accordingly focus on the meritorious cases, instead of attempting to sue for as many claims as possible by bundling them and seeking to bypass its evidentiary burden. Limiting the government’s ability to use statistical sampling to establish liability would therefore not frustrate its ability to sue under the FCA, but it would protect defendants from potential governmental abuse. This is because if statistical sampling is generally permitted to establish liability, the government can pressure defendants to settle for arguably unjustifiably large amounts, due to the prospect of their being held liable for even greater amounts on top of the costs of defending against the statistical sampling.[235]

B.  A More Reasonable Approach

An approach more reasonable than broadly allowing or disallowing statistical sampling to establish FCA liability in the healthcare industry would be to limit its use to cases where there is sufficient evidence of a company-wide policy that results in the submission of false claims. This could be accomplished through a bellwether trial[236] to determine whether there is sufficient evidence of a generalized policy of fraud.[237] If there are sufficient findings following the bellwether trial, then the court could proceed to use statistical sampling to extrapolate and establish liability for the universe of claims.

A model case is UnumProvident, in which there was sufficient evidence of liability in the eyes of the fact finder before using statistical sampling.[238] This was accomplished through a bellwether trial that uncovered a generalized fraudulent policy.[239] Another model case is Fadul, in which the court did not rely solely on statistical evidence to prove falsity and scienter.[240] The court in Fadul relied on significant evidence, including expert reports, employee testimony, and an audit to establish liability.[241] Only after liability was properly established was statistical sampling used to establish liability for a universe of claims and to determine the total amount of damages.[242]

 However, the approach used in UnumProvident and Fadul would still be insufficient in my suggested framework. Similar to the approach used in those cases, evidence of liability would need to be provided prior to the use of statistical sampling. Unlike those cases, though, I suggest that the use of statistical sampling to extrapolate liability in FCA cases concerning healthcare fraud should be limited to cases where evidence is presented (again prior to the use of statistical sampling) indicating a known company-wide procedure or policy that results in the systematic submission of false claims. For example, the government or plaintiff might submit evidence of a standard policy or procedure that any time an abdominal scan was performed on a Medicare or Medicaid patient, a claim would instead be submitted for a full-body scan, generating a larger reimbursement. Statistical sampling to establish liability in such an arrangement would therefore be appropriate because the government or plaintiff could approximate the total number of incorrectly submitted scans in a given timeframe based on a representative sample of claims, and there would be an acceptably high level of certainty that the defendant should be held liable forand pay damages onevery single one of the extrapolated number of claims. This outcome would be a just and reasonable middle ground.

 Furthermore, these cases would not be subject to the criticisms surrounding the subjective nature of most healthcare decisions. For example, this framework would not apply to the situation in Vista Hospice Care, in which the issue centered around a particularly subjective matter, hospice-care eligibility.               Additionally, this proposed outcome would accommodate the government’s reasonable assertion that in cases involving tens of thousands of claims, statistical sampling is the only efficient way to avoid wasting judicial resources. However, it would subject only defendants who violate the FCA in a particularly egregious manner to the burdens of statistical sampling to establish liability. This would result in plaintiffs being able to more easily collect large amounts of damages in cases involving such violations, thereby deterring egregiousness, while also protecting the vast majority of defendants from potential abuse by the government. In turn, this could help increase the number of healthcare providers who accept Medicare or Medicaid.

While opponents may point to judicial economy to argue against this proposed approach, given the additional resources required to conduct bellwether trials, we must weigh judicial economy against the interests of justice. When billions of dollars per year in damages are potentially at stake, it is the courts’ responsibility to make sure they justly establish liability for those damages. Fulfilling this responsibility requires a certain amount of time and resources. Here, such additional resources are warranted. In any event, it is difficult to judge if these concerns are even valid, given that limiting the use of statistical sampling will likely lead to an overall decrease in the number of claims filed.

CONCLUSION

 Statistical sampling and its use in FCA cases remains a “hotly contested issue” and one that may eventually have to be decided by the Supreme Court, should circuits split on its use for establishing liability.[243] Despite the Fourth Circuit’s refusal to rule on whether statistical sampling could be used to prove liability in qui tam litigation,[244] circuit courts will inevitably be faced with the decision—likely in the near futureas the government continues to combat large-scale fraud. Given the subjective nature of the medical field and the negative effects a decision may have on the healthcare system as a whole, however, courts considering whether statistical sampling should be used to establish FCA liability in healthcare cases should carefully weigh the interests of justice and judicial efficiency.

 

 


[*] *. Executive Online Editor, Southern California Law Review, Volume 91. J.D. Candidate 2018, University of Southern California Gould School of Law; B.A. Nursing 2015, Florida International University; A.S. Nursing 2014, Miami-Dade College. I would like to thank my note advisor, Professor Alexander Capron. I would also like to thank to my husband, Austin Stack, and my parents, Rafael and Leticia Vega, whose sacrifices and unending support have made this possible. Finally, I owe an immense debt of gratitude to the editors of Volume 91 of the Southern California Law Review for their outstanding editing and feedback, especially Eli Tarlow, Justin Bongco, and James Salzmann.

 [1]. See 31 U.S.C. §§ 3729–3733 (2012).

 [2]. Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, Justice Department Recovers Over $4.7 Billion from False Claims Act Cases in Fiscal Year 2016 (Dec. 14, 2016), https://www.justice.gov/
opa/pr/justice-department-recovers-over-47-billion-false-claims-act-cases-fiscal-year-2016 [hereinafter U.S. Dep’t of Justice 2016].

 [3]. Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, Justice Department Recovers Over $3.5 Billion from False Claims Act Cases in Fiscal Year 2015 (Dec. 3, 2015), https://www.justice.gov/
opa/pr/justice-department-recovers-over-35-billion-false-claims-act-cases-fiscal-year-2015 [hereinafter U.S. Dep’t of Justice 2015].

 [4]. 31 U.S.C. § 3729(a)(1)(A)–(B), (D) (2012); Laura Laemmle-Weidenfeld, Litigation Under the Civil False Claims Act, in An Introduction to Health Law Litigation Based on Contract and Government Claims 133, 133–34 (Aaron Krauss ed., 2016).

 [5]. Patricia Meador & Elizabeth S. Warren, The False Claims Act: A Civil War Relic Evolves into a Modern Weapon, 65 Tenn. L. Rev. 455, 455–56, 459–61 (1998).

 [6]. See Jeanne A. Markey & Raymond M. Sarola, 4th Circ. FCA Statistical Sampling Case Is One to Watch, Law360 (Oct. 8, 2015, 10:33 AM), https://www.law360.com/aerospace/articles/712001.

 [7]. Eric Topor, Appellate Review of Medicare Statistical Sampling Anticipated, Bloomberg BNA: Health L. Rep., Apr. 13, 2016, at 1.

 [8]. See infra Part II.

 [9]. See United States ex rel. Michaels v. Agape Senior Cmty., Inc., 848 F.3d 330, 340–41 (4th Cir. 2017).

 [10]. See Matthew M. Curley, FCA at the 4th Circ.: Contemplating 2 Key Issues, Law360 (Oct. 27, 2016, 5:20 PM), https://www.law360.com/appellate/articles/855918.

 [11]. See, e.g., U.S. Dep’t of Justice 2016, supra note 2 (providing examples of recent settlements that range from $125 million to $784.6 million).

 [12]. See United States ex rel. Martin v. Life Care Ctrs. of Am., Inc., 114 F. Supp. 3d 549, 557 (E.D. Tenn. 2014); Charles Doyle, Cong. Research Serv., R40785, Qui Tam: The False Claims Act and Related Federal Statutes 5 (2009).

 [13]. Robin Page West, Advising the Qui Tam Whistleblower: From Identifying a Case to Filing Under the False Claims Act 2 (2d ed. 2009).

 [14]. Laemmle-Weidenfeld, supra note 4, at 133.

 [15]. Meador & Warren, supra note 5, at 456.

 [16]. See A Roadmap for New Physicians: Fraud & Abuse Laws, Off. Inspector Gen., https://oig.hhs.gov/compliance/physician-education/01laws.asp (last visited Apr. 7, 2018).

 [17]. U.S. Dep’t of Justice 2015, supra note 3.

 [18]. U.S. Dep’t of Justice 2016, supra note 2.

 [19]. Press Release, Office of Pub. Affairs, U.S. Dep’t of Justice, Justice Department Recovers Over $3.7 Billion from False Claims Act Cases in Fiscal Year 2017 (Dec. 21, 2017), https://www.justice.gov/
opa/pr/justice-department-recovers-over-37-billion-false-claims-act-cases-fiscal-year-2017.

 [20]. U.S. Dep’t of Justice 2015, supra note 3.

 [21]. Laemmle-Weidenfeld, supra note 4, at 136.

 [22]. Id. at 146–47.

 [23]. Id. at 147.

 [24]. Id.

 [25]. See id. at 147–48.

 [26]. Id. at 147.

 [27]. Id. (“Medicare has issued significant amounts of guidance in the form of regulations, national coverage decisions, and other less formal means indicating what criteria must be met in order for particular items and services to be medically necessary.”).

 [28]. See id.

 [29]. See id. at 148.

 [30]. Id.

 [31]. Id. at 148–51. See also 42 U.S.C. §§ 1320a–7b(b), 1395nn (2012).

 [32]. Universal Health Servs., Inc. v. United States ex rel. Escobar, 136 S. Ct. 1989, 1995 (2016).

 [33]. Id.

 [34]. 31 U.S.C. § 3729(a)(1)(A)–(B), (D). See also Laemmle-Weidenfeld, supra note 4, at 133–34.

 [35]. Laemmle-Weidenfeld, supra note 4, at 134, 147–48. See also 42 U.S.C. § 1320a-7k(d).

 [36]. See Laemmle-Weidenfeld, supra note 4, at 135.

 [37]. 31 U.S.C. § 3729(b)(1)(A) (“the terms “knowing” and “knowingly”—(A) mean that a person, with respect to information—(i) has actual knowledge of the information; (ii) acts in deliberate ignorance of the truth or falsity of the information; or (iii) acts in reckless disregard of the truth or falsity of the information”).

 [38]. Id. § 3729(b)(1)(B)).

 [39]. See id. § 3729(b)(1)(A); Laemmle-Weidenfeld, supra note 4, at 135.

 [40]. Id.

 [41]. See United States v. United Healthcare Ins. Co., 848 F.3d 1161, 1169 (9th Cir. 2016).

 [42]. See Laemmle-Weidenfeld, supra note 4, at 135–36 (citing 42 U.S.C. §§ 1320a-7(b)(7), 
-7a(a)(1)(B)) (explaining that the Department of Health and Human Services can exclude providers from participating in federal healthcare programs if the providers submit false claims).

 [43]. Id. at 135.

 [44]. 31 U.S.C. § 3729(a)(1).

 [45]. United States v. Krizek, 111 F.3d 934, 936 (D.C. Cir. 1997).

 [46]. 31 U.S.C. § 3729 (a)(3); Laemmle-Weidenfeld, supra note 4, at 146.

 [47]. Id. § 3729 (a)(2)(A).

 [48]. Id. § 3729 (a)(2)(B).

 [49]. Id. § 3729 (a)(2)(C).

 [50]. Id. § 3729 (a)(2).

 [51]. See Michael Koon & Savannah Wiseman, What Are the Odds?: Proving Liability in False Claims Act Cases Through Statistical Sampling, ABA Health eSource (June 2015), http://www.americanbar.org/publications/aba_health_esource/2014-2015/June/fca.html.

 [52]. See, e.g., Ill. Physicians Union v. Miller, 675 F.2d 151, 157 (7th Cir. 1982); United States ex rel. Martin v. Life Care Ctrs. of Am., Inc., 114 F. Supp. 3d 549, 565 (E.D. Tenn. 2014); United States v. Fadul, No. DKC 11-0385, 2013 U.S. Dist. LEXIS 27909, at *47 (D. Md. Feb. 28, 2013).

 [53]. Chaves Cty. Home Health Serv., Inc. v. Sullivan, 931 F.2d 914, 922–23 (D.C. Cir. 1991).

 [54]. See United States v. Cabrera-Diaz, 106 F. Supp. 2d 234, 240–42 (D.P.R. 2000) (outlining cases that have allowed statistical sampling to establish damages).

 [55]. Markey & Sarola, supra note 6.

 [56]. Martin, 114 F. Supp. 3d at 560.

 [57]. Id. at 563.

 [58]. See United States ex rel. Wall v. Vista Hospice Care, Inc., No. 3:07-cv-00604-M, 2016 U.S. Dist. LEXIS 80160, at *37 (N.D. Tex. June 20, 2016) (“No circuit has resolved whether statistical sampling and extrapolation can be used to establish liability in an FCA case where falsity depends on individual physicians’ judgment regarding individual patients.”).

 [59]. United States ex rel. Michaels v. Agape Senior Cmty., Inc., 848 F.3d 330, 341 (4th Cir. 2017). See infra text accompanying notes 198202.

 [60]. See infra Part I.C.1.

 [61]. See Vista Hospice Care, 2016 U.S. Dist. LEXIS 80160, at *42 & n.108.

 [62]. Id. (citing Fed. R. Evid. 702).

 [63]. Id.

 [64]. Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 589–90 (1993).

 [65]. United States v. Beverly, 369 F.3d 516, 528 (6th Cir. 2004) (citing Daubert, 509 U.S. at 592–95). See also United States ex rel. Martin v. Life Care Ctrs. of Am., No. 1:08-cv-251, 2014 U.S. Dist. LEXIS 142657, at *5–9 (E.D. Tenn. Sept. 29, 2014).

 [66]. United States ex rel. Wall v. Vista Hospice Care, Inc., No. 3:07-cv-00604-M, 2016 U.S. Dist. LEXIS 80160, at *42 (N.D. Tex. June 20, 2016) (citing United States v. Pena, 532 Fed. App’x 517, 520–21 (5th Cir. 2013).

 [67]. Martin, 2014 U.S. Dist. LEXIS 142657, at *7–8.

 [68]. Id. at *8 (citing Baker v. Chevron U.S.A. Inc., 533 F. App’x 509, 520 (6th Cir. 2013)).

 [69]. Vista Hospice Care, 2016 U.S. Dist. LEXIS 80160, at *42 & n.108.

 [70]. See Wal-Mart Stores, Inc. v. Dukes, 564 U.S. 338, 355–60, 367 (2011).

 [71]. See Jay Tidmarsh, Resurrecting Trial by Statistics, 99 Minn. L. Rev. 1459, 1474–75 (2015).

 [72]. Wal-Mart, 564 U.S. at 343–45.

 [73]. See Fed. R. Civ. P. 23(a) (listing class certification requirements).

 [74]. Wal-Mart, 564 U.S. at 346 (quoting Fed. R. Civ. P. 23(a)(2)).

 [75]. Id.

 [76]. See id. at 353–55, 358.

 [77]. Id. at 356.

 [78]. Id. at 356–57. “Information about disparities at the regional and national level does not establish the existence of disparities at individual stores.” Id. (quoting Dukes v. Wal-Mart Stores, Inc., 603 F.3d 571, 637 (9th Cir. 2010) (Ikuta, J., dissenting)).

 [79]. Id. at 367.

 [80]. Tidmarsh, supra note 71, at 1474 (emphasis omitted).

 [81]. Wal-Mart, 564 U.S. at 366–67. The Court explained the proposed trial by formula: “A sample set of the class members would be selected, as to whom liability for sex discrimination and the backpay owing as a result would be determined in depositions supervised by a master. The percentage of claims determined to be valid would then be applied to the entire remaining class, and the number of (presumptively) valid claims thus derived would be multiplied by the average backpay award in the sample set to arrive at the entire class recovery—without further individualized proceedings.” Id. at 367. See also United States ex rel. Wall v. Vista Hospice Care, Inc., No. 3:07-cv-00604-M, 2016 U.S. Dist. LEXIS 80160, at *36–37 (N.D. Tex. June 20, 2016).

 [82]. See Tidmarsh, supra note 71, at 1459–77 (discussing Wal-Mart’s effects on statistical sampling).

 [83]. Dailey v. Sears, Roebuck & Co., 154 Cal. Rptr. 3d 480, 500–02 (Ct. App. 2013). See also Elizabeth J. Cabraser et al., California Class Actions and Coordinated Proceedings § 19.01 (2d ed. 2017), LexisNexis.

 [84]. Tyson Foods, Inc. v. Bouaphakeo, 136 S. Ct. 1036, 1040, 1044–45 (2016).

 [85]. See id. at 1049; David L. Scher & R. Scott Oswald, Biggest Test Yet for Statistical Sampling in FCA Cases, Law360 (Oct. 18, 2016, 12:16 PM), https://www.law360.com/articles/851303/biggest-test-yet-for-statistical-sampling-in-fca-cases.

 [86]. Tyson Foods, 136 S. Ct. at 1042.

 [87]. Id. at 1042–44

 [88]. Id. at 1043–44.

 [89]. Id.

 [90]. Id. at 1044.

 [91]. Id. at 1046.

 [92]. Id. (emphasis added) (quoting Manual for Complex Litigation (Fourth) § 11.493 (2004)).

 [93]. Id. at 1049.

 [94]. Id. at 1046.

 [95]. Id. at 1049.

 [96]. See Scher & Oswald, supra note 85. See also United States ex rel. Wall v. Vista Hospice Care, Inc., No. 3:07-cv-00604-M, 2016 U.S. Dist. LEXIS 80160, at *36–41 (N.D. Tex. June 20, 2016); Scott D. Stein & Brenna E. Jenny, Tyson Provides Road Map for Use of Sampling in FCA Cases, Law360 (Mar. 31, 2016, 11:13 AM), https://www.law360.com/articles/777949/tyson-provides-road-map-for-use-of-sampling-in-fca-cases.

 [97]. See generally David H. Kaye & David A. Freedman, Reference Guide on Statistics, in Reference Manual on Scientific Evidence 211 (3d ed. 2011); Statistical Science in the Courtroom (Joseph L. Gastwirth ed., 2000) (explaining how statistical analysis is used in differing aspects of the law); Laurens Walker & John Monahan, Sampling Evidence at the Crossroads, 80 S. Cal. L. Rev. 969 (2007) (providing a brief history of statistical sampling in the law and the rise of statistical sampling in mass tort cases).

 [98]. See MBIA Ins. Corp. v. Countrywide Home Loans, Inc., No. 602825/08, slip op. at 3–7 (N.Y. Sup. Ct. Dec. 22, 2010). See also George Bundy Smith & Thomas J. Hall, The Use of Statistical Sampling as Evidence, N.Y. L.J., Feb. 18, 2011, at 3, 3.

 [99]. United States ex rel. Martin v. Life Care Ctrs. of Am., Inc, 114 F. Supp. 3d 549, 557 (E.D. Tenn. 2014).

 [100]. Id. at 564.

 [101]. Id. at 570–71.

 [102]. Id. at 571. See generally Recent Case, United States ex rel. Martin v. Life Care Centers of America, Inc., Nos. 1:08-cv-251, 1:12-cv-64, 2014 U.S. Dist. LEXIS 142660 (E.D. Tenn. Sept. 29, 2014), 128 Harv. L. Rev. 2074 (2015) (providing an in-depth discussion of the opinion).

 [103]. Martin, 114 F. Supp. 3d at 572.

 [104]. United States v. Robinson, No. 13-cv-27-GFVT, 2015 U.S. Dist. LEXIS 41123, at *33–34 (E.D. Ky. Mar. 31, 2015).

 [105]. See id. at *17, 29 (citing Martin, 114 F. Supp. 3d at 554 and Mich. Dep’t of Educ. v. U.S. Dep’t of Educ., 875 F.2d 1196, 1205 (6th Cir. 1989)).

 [106]. United States v. Aseracare Inc., No. 2:12-CV-245-KOB, 2014 U.S. Dist. LEXIS 167970, at *25–26 (N.D. Ala. Dec. 4, 2014) (citing Bazemore v. Friday, 478 U.S. 385, 400 (1986)), substituted by 2014 U.S. Dist. LEXIS 191636 (N.D. Ala. Dec. 19, 2014), vacated by 2014 U.S. Dist. LEXIS 191640 (N.D. Ala. Dec. 19, 2014). 

 [107]. Reporter’s Official Transcript of Motion Hearing at 223–26, Aseracare, 2014 U.S. Dist. LEXIS 167970 (No. 305). See also infra Part IV.A (discussing how some courts do not seem to distinguish between liability and damages and their respective requirements when analyzing the use of statistical sampling).

 [108]. United States ex rel. Ruckh v. Genoa Healthcare, LLC, No. 8:11-cv-1303-T-23TBM, 2015 U.S. Dist. LEXIS 55384, at *7 (M.D. Fla. Apr. 28, 2015).

 [109]. Id. at *8–9.

 [110]. See id. at *9–10 (quoting Martin, 114 F. Supp. 3d at 561).

 [111]. Id. at *9 (quoting Martin, 114 F. Supp. 3d at 561).

 [112]. Id. at *12–13.

 [113]. United States ex rel. Loughren v. UnumProvident Corp., 604 F. Supp. 2d 259, 261 (D. Mass. 2009).

 [114]. Id. at 260–61.

 [115]. See id. at 269.

 [116]. United States ex rel. Wall v. Vista Hospice Care, Inc., No. 3:07-cv-00604-M, 2016 U.S. Dist. LEXIS 80160, at *31–32, 89 (N.D. Tex. June 20, 2016).

 [117]. See id. at *35.

 [118]. Id. at *36 (quoting Tyson Foods, Inc. v. Bouaphakeo, 136 S. Ct. 1036, 1046 (2016).

 [119]. Id. at *40.

 [120]. See id. at *37–38.

 [121]. Id. at *40 (emphasis omitted).

 [122]. Id.

 [123]. Id. at *41–42.

 [124]. Id. at *54.

 [125]. Id. at *55–56.

 [126]. See id. at *56–57.

 [127]. Id. at *64.

 [128]. United States v. Medco Physicians Unlimited, No. 98 C 1622, 2000 U.S. Dist. LEXIS 5843, at *23 (N.D. Ill. Mar. 15, 2000).

 [129]. Id. at *23–24.

 [130]. United States ex rel. Trim v. McKean, 31 F. Supp. 2d 1308, 1314 (W.D. Okla. 1998).

 [131]. See id.

 [132]. Id.

 [133]. United States ex rel. El-Amin v. George Washington Univ., 533 F. Supp. 2d 12, 49–51 (D.D.C. 2008).

 [134]. Id.

 [135]. Id. at 50–51 (“In short, the Relators’ failure to take even the most basic steps in preparing for a trial by representative sample proves fatal to the instant motion because, as the Defendant convincingly argues, the time for trial preparation is over. . . . It would be unfair to the Defendant at this stage of the litigation and on the eve of trial to permit the Relators to convert this case to a trial by representative sample. The Defendant, like the Relators, has not consulted an expert statistician and, like both the Relators and this Court, cannot even identify the universe of allegedly fraudulent claims. In light of these practical considerations, the motion is denied.”).

 [136]. United States ex rel. Guardiola v. Renown Health, No. 3:12-CV-0295-LRH (VPC), 2014 U.S. Dist. LEXIS 157410, at *5 (D. Nev. Nov. 5, 2014).

 [137]. United States v. Cabrera-Diaz, 106 F. Supp. 2d 234, 243 (D.P.R. 2000).

 [138]. United States ex rel. Martin v. Life Care Ctrs. of Am., Inc, 114 F. Supp. 3d 549, 563–64 (E.D. Tenn. 2014).

 [139]. See id.

 [140]. See Martin, 114 F. Supp. 3d at 564 (“Without evidence and argument opposing the government’s position, the Court cannot view the result in Cabrera-Diaz as anything other than an unopposed remedy suggested by the government, which was granted through a procedural mechanism to obtain judgment from unresponsive parties.”).

 [141]. United States v. Krizek, 859 F. Supp. 5, 7 (D.D.C. 1994).

 [142]. United States v. Krizek, No. 93-54, 1994 U.S. Dist. LEXIS 21095, at *1–2 (D.D.C. Mar. 9, 1994).

 [143]. See id. at *3.

 [144]. Krizek, 859 F. Supp. at 7.

 [145]. United States v. Fadul, No. DKC 11-0385, 2013 U.S. Dist. LEXIS 27909 (D. Md. Feb. 28, 2013).

 [146]. See id. at *23–39.

 [147]. Id. at *21.

 [148]. Id. at *37–38.

 [149]. Id. at *44–45.

 [150]. Id. at *39–40 (second alteration in original) (emphasis added) (footnote omitted) (quoting United States v. Mead, 426 F.2d 118, 125 n.6 (9th Cir. 1970)).

 [151]. See, e.g., Brief of Defendants-Appellees Agape Senior Community Inc., et al. Regarding Statistical Sampling at 24–25, United States ex rel. Michaels v. Agape Senior Cmty., Inc., 848 F.3d 330 (4th Cir. 2017) (Nos. 15-2145, 15-2147) [hereinafter Defendants-Appellees Brief] (citing Friedman as precedent that courts do not allow statistical sampling for liability).

 [152]. United States v. Friedman, No. 86-0610-MA, 1993 U.S. Dist. LEXIS 21496, at *9 n.1 (D. Mass. July 23, 1993).

 [153]. Id. (noting that at trial specific claims “were analyzed and discussed and subjected to cross examination”).

 [154]. See generally id.

 [155]. United States ex rel. Michaels v. Agape Senior Cmty., Inc., No. 0:12-3466-JFA, 2015 U.S. Dist. LEXIS 82379, at *2 (D.S.C. June 25, 2015), aff’d in part and dismissed in part, 848 F.3d 330 (4th Cir. 2017).

 [156]. Id. at *3 (discussing the disagreement between the plaintiff-relators and defendants about the number of patients and claims at issue).

 [157]. Id. at *4.

 [158]. Id. at *6–7.

 [159]. Id. at *7.

 [160]. Id. at *1, *7–8.

 [161]. Id.

 [162]. United States v. Friedman, No. 86-0610-MA, 1993 U.S. Dist. LEXIS 21496, at *9 n.1 (D. Mass. July 23, 1993).

 [163]. Michaels, 2015 U.S. Dist. LEXIS 82379 at *19–20.

 [164]. Id. at *18–19.

 [165]. Id. at *19.

 [166]. Id. at *24.

 [167]. See id. at *20–22, *26–27.

 [168]. See infra Part IV.

 [169]. See Public Brief for the United States as Intervenor-Appellee at 37–42, Michaels, 848 F.3d 330 (Nos. 15-2145, 15-2147).

 [170]. Defendants-Appellees Brief, supra note 151, at 7, 19–21.

 [171]. Id. at 26–29.

 [172]. See id. at 29–30.

 [173]. Id. at 30.

 [174]. Brief of Savaseniorcare Administrative Services, LLC as Amicus Curiae Supporting Defendants-Appellees Seeking Affirmance, Michaels, 848 F.3d 330 (Nos. 15-2145, 15-2147) [hereinafter Savaseniorcare Brief]; Brief for Amici Curiae the American Hospital Association and the Catholic Health Association of the United States in Support of Defendants-Appellees, Michaels, 848 F.3d 330 (Nos. 15-2145, 15-2147) [hereinafter AHA/CHA Brief]; Brief of American Health Care Association as Amicus Curiae in Support of Defendants-Appellees, Michaels, 848 F.3d 330 (Nos. 15-2145, 15-2147) [hereinafter AHCA Brief].

 [175]. See Topor, supra note 7.

 [176]. See Savaseniorcare Brief, supra note 174, at 5.

 [177]. Id. at 10 (quoting 42 C.F.R. § 483.20(j)(2) (2017)) (“Clinical disagreement does not constitute a material and false statement.”).

 [178]. Id. (citing United States ex rel. Wilson v. Kellogg Brown & Root Servs., Inc., 525 F.3d 370, 376 (4th Cir. 2008)).

 [179]. Id. at 5–7, 10.

 [180]. Id. at 11–12 (quoting United States ex rel. Nathan v. Takeda Pharm. N. Am., Inc., 707 F.3d 451, 456 (4th Cir. 2013)).

 [181]. See id.

 [182]. See id. at 23–25.

 [183]. Id. at 4, 20–21.

 [184]. Id. at 24–25.

 [185]. See AHA/CHA Brief, supra note 174, at 7–8. The burden of proof would shift to defendants if statistical sampling were allowed: plaintiff-relators would not have to prove the falsity of each individual claim, but defendants potentially would have to sift through each claim to disprove allegations of falsity. See id.

 [186]. Id.

 [187]. Id. at 13–14 (citing United States ex rel. Nathan v. Takeda Pharm. N. Am., Inc., 707 F.3d 451, 459 (4th Cir. 2013)).

 [188]. Id. at 19.

 [189]. Id. at 20.

 [190]. Id. at 21.

 [191]. Id. at 22–25.

 [192]. AHCA Brief, supra note 174, at 6–14.

 [193]. Id. at 15.

 [194]. Id. at 15–18 (internal quotation marks omitted) (quoting Vermont Agency of Nat. Res. v. U.S. ex rel. Stevens, 529 U.S. 765, 784 (2000)).

 [195]. Id. at 26–30.

 [196]. Oral Argument at 2:24–9:40, United States ex rel. Michaels v. Agape Senior Cmty., Inc., 848 F.3d 330 (4th Cir. 2017) (Nos. 15-2145, 15-2147), http://coop.ca4.uscourts.gov/OAarchive/mp3/15-2145-20161026.mp3.

 [197]. See id.

 [198]. Michaels, 848 F.3d at 341.

 [199]. Id.

 [200]. Id.

 [201]. Id. (quoting McFarlin v. Conseco Servs., LLC, 381 F.3d 1251, 1258 (11th Cir. 2004)).

 [202]. See Eric Topor, Ruling on Statistical Sampling in Fraud Cases Left for Another Day, BNA (Feb. 24, 2017), https://www.bna.com/ruling-statistical-sampling-n57982084379.

 [203]. See Order, United States ex rel. Michaels v. Agape Senior Cmty., Inc., No. 0:12-03466-JFA, 2015 U.S. Dist. LEXIS 82379 (D.S.C. June 25, 2015), aff’d in part and dismissed in part, 848 F.3d 330 (4th Cir. 2017) (No. 345).

 [204]. Topor, supra note 7.

 [205]. Id.

 [206]. See, e.g., id.

 [207]. See supra text accompanying note 44.

 [208]. See Kevin Murphy, Advanced Practice Nurses: Prime Candidates to Become Primary Caregivers in Relation to Increasing Physician Shortages Due to Health Care Reform, 14 J. Nursing L. 117, 117–19 (2011).

 [209]. See United States ex rel. Michaels v. Agape Senior Cmty., Inc., No. 0:12-3466-JFA, 2015 U.S. Dist. LEXIS 82379, at *4, *17–18, *20 (D.S.C. June 25, 2015), aff’d in part and dismissed in part, 848 F.3d 330 (4th Cir. 2017).

 [210]. Id.

 [211]. See id. at *20–24.

 [212]. United States v. Fadul, No. DKC 11-0385, 2013 U.S. Dist. LEXIS 27909, at *23–24 (D. Md. Feb. 28, 2013) (citing United States ex rel. Harrison v. Westinghouse Savannah River Co., 352 F.3d 908, 913 (4th Cir. 2003)). See also supra Part I.A (discussing in detail the requirements under the FCA).

 [213]. United States v. Robinson, No. 13-cv-27-GFVT, 2015 U.S. Dist. LEXIS 41123, at *28 (E.D. Ky. Mar. 31, 2015).

 [214]. Id. at *28–29.

 [215]. Id. at *32 (quoting Mich. Dep’t of Educ. v. U.S. Dep’t of Educ., 875 F.2d 1196, 1205 (6th Cir. 1989)).

 [216]. See, e.g., Opening Brief of Appellants at 12, United States ex rel. Michaels v. Agape Senior Cmty., Inc., 848 F.3d 330 (4th Cir. 2017) (Nos. 15-2145, 15-2147); Defendants-Appellees Brief, supra note 151, at 7, 26.

 [217]. Goldstar Med. Servs., Inc. v. Dep’t of Soc. Servs., 955 A.2d 15, 21 (Conn. 2008).

 [218]. Id.

 [219]. Id. at 31.

 [220]. Id.

              [221].              Id. at 22­­–23; see, Anna Grizzle & Julia Tamulis, Medicare and Medicaid Audits, in An Introduction to Health Law Litigation Based on Contract and Government Claims 84, 99, 102­–05 (Aaron Krauss ed., 2016).

 [222]. See United States ex rel. Nathan v. Takeda Pharm. N. Am., Inc., 707 F.3d 451, 456 (4th Cir. 2013) (citing United States ex rel. Harrison v. Westinghouse Savannah River Co., 176 F.3d 776, 785 (4th Cir. 1999)).

 [223]. See AHA/CHA Brief, supra note 174, at 6.

 [224]. United States ex rel. Martin v. Life Care Ctrs. of Am., Inc., 114 F. Supp. 3d 549, 563 (E.D. Tenn. 2014).

 [225]. See supra text accompanying note 44.

 [226]. See United States v. Robinson, No. 13-cv-27-GFVT, 2015 U.S. Dist. LEXIS 41123, at *13 (E.D. Ky. Mar. 31, 2015).

 [227]. See United States ex rel. Wall v. Vista Hospice Care, Inc., No. 3:07-cv-00604-M, 2016 U.S. Dist. LEXIS 80160, at *17–20 (N.D. Tex. June 20, 2016).

 [228]. Id. at *8–9.

 [229]. 42 C.F.R. § 418.20 (2017).

 [230]. Id. § 418.3.

 [231]. See Ctrs. for Medicare & Medicaid Servs., Medicare Hospice Benefits 7 (2017), https://www.medicare.gov/Pubs/pdf/02154-Medicare-Hospice-Benefits.PDF.

 [232]. Medical Criteria for Hospice Eligibility, Stanf. Sch. Med., https://palliative.stanford.edu/home-hospice-home-care-of-the-dying-patient/medical-criteria-for-hospice-eligibility (last visited Apr. 9, 2018). See Amanda Jacobowski, Note, Calculating Death: Implications of the Six-Month Prognosis Certification Requirement for the Medicare Hospice Benefit, 19 Elder L.J. 187, 213–16 (2011) (explaining the deficiencies and problems of the “six-month prognosis” requirement and discussing what happens to patients who have outlived the six-month prognosis).

 [233]. See, e.g., United States v. Aseracare, Inc., No. 2:12-CV-245-KOB, 2014 U.S. Dist. LEXIS 167970, at *23 (N.D. Ala. Dec. 4, 2014), substituted by 2014 U.S. Dist. LEXIS 191635 (N.D. Ala. Dec. 19, 2014), vacated by 2014 U.S. Dist. LEXIS 191640 (N.D. Ala. Dec. 19, 2014).

 [234]. See, e.g., United States v. Robinson, No. 13-cv-27-GFVT, 2015 U.S. Dist. LEXIS 41123, at *32–33 (E.D. Ky. Mar. 31, 2015).

 [235]. See, e.g., U.S. Dep’t of Justice 2015, supra note 3 (listing several examples of recent large settlements). See also Laemmle-Weidenfeld, supra note 4, at 146 (“As a practical matter, the vast majority of FCA cases settle . . . .”).

 [236]. A bellwether trial used by a judge to try a smaller number of cases that are representative of the sample. Alexandra D. Lahav, Bellwether Trials, 76 Geo. Wash. L. Rev. 576, 577 (2008). The verdicts are then used “as a basis for resolving the remaining cases.” Id. These types of trials are commonly used to value cases in mass tort litigation and have been used to resolve human rights class actions. Id. at 577–78.

 [237]. Alternatively, should sufficient evidence be presented at summary judgment, the permissibility of statistical sampling could be decided at that point.

 [238]. See United States ex rel. Loughren v. UnumProvident Corp., 604 F. Supp. 2d 259, 26061 (D. Mass. 2009).

 [239]. Id.

 [240]. See United States v. Fadul, No. DKC 11-0385, 2013 U.S. Dist. LEXIS 27909, at *27–28 (D. Md. Feb. 28, 2013); supra text accompanying notes 145–50.

 [241]. Fadul, 2013 U.S. Dist. LEXIS 27909 at *27–28.

 [242]. Id.

 [243]. James Swann & Eric Topor, Outlook 2017: New Year May Bring Stark Reform, ACA Repeal, Heavy Dose of Uncertainty, BNA’s Health Care Fraud Rep., Jan. 6, 2017.

 [244]. United States ex rel. Michaels v. Agape Senior Cmty., Inc., 848 F.3d 330, 341 (4th Cir. 2017).


[i].                              United States ex rel. Martin v. Life Care Ctrs. of Am., Inc, 114 F. Supp. 3d 549, 572 (E.D. Tenn. 2014).

[ii].  United States v. Robinson, No. 13-cv-27-GFVT, 2015 U.S. Dist. LEXIS 41123, at *29–33 (E.D. Ky. Mar. 31, 2015).

[iii].                             United States v. Aseracare Inc., No. 2:12-CV-245-KOB, 2014 U.S. Dist. LEXIS 167970, at *25 (N.D. Ala. Dec. 4, 2014), substituted by 2014 U.S. Dist. LEXIS 191635 (N.D. Ala. Dec. 19, 2014), vacated by 2014 U.S. Dist. LEXIS 191640 (N.D. Ala. Dec. 19, 2014).

[iv].               United States ex rel. Ruckh v. Genoa Healthcare, LLC, No. 8:11-cv-1303-T-23TBM, 2015 U.S. Dist. LEXIS 55384, at *10–13 (M.D. Fla. Apr. 28, 2015).

[v].                United States ex rel. Loughren v. UnumProvident Corp., 604 F. Supp. 2d 259, 261 (D. Mass. 2009).

[vi].               United States ex rel. Wall v. Vista Hospice Care, Inc., No. 3:07-cv-00604-M, 2016 U.S. Dist. LEXIS 80160, at *41–47 (N.D. Tex. June 20, 2016).

[vii].                United States v. Medco Physicians Unlimited, No. 98 C 1622, 2000 U.S. Dist. LEXIS 5843, at *23 (N.D. Ill. Mar. 15, 2000).

[viii].                United States ex rel. Trim v. McKean, 31 F. Supp. 2d 1308, 1314 (W.D. Okla. 1998).

[ix].                United States ex rel. El-Amin v. George Washington Univ., 533 F. Supp. 2d 12, 49–51 (D.D.C. 2008).

[x].   United States ex rel. Guardiola v. Renown Health, No. 3:12-CV-0295-LRH (VPC), 2014 U.S. Dist. LEXIS 157410, at *5 (D. Nev. Nov. 5, 2014).

[xi].                             United States v. Cabrera-Diaz, 106 F. Supp. 2d 234, 240–41, 243 (D.P.R. 2000).

[xii].                United States v. Krizek, 859 F. Supp. 5, 7 (D.D.C. 1994).

[xiii].                United States v. Fadul, No. DKC 11-0385, 2013 U.S. Dist. LEXIS 27909, at *45–47 (D. Md. Feb. 28, 2013).

[xiv].               United States v. Friedman, No. 86-0610-MA, 1993 U.S. Dist. LEXIS 21496, at *9 n.1 (D. Mass. July 23, 1993).

[xv].               United States ex rel. Michaels v. Agape Senior Cmty., Inc., No. 0:12-3466-JFA, 2015 U.S. Dist. LEXIS 82379, at *4 (D.S.C. June 25, 2015), aff’d in part and dismissed in part, 848 F.3d 330 (4th Cir. 2017).

[xvi].                Michaels, 848 F.3d at 341.

Statutory Millennialism: Establishment and Free Exercise Concerns Arising from the Health Care Sharing Ministry Exemption’s 1999 Cutoff Date – Note by James R. Salzmann

From Volume 91, Number 2 (January 2018)
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STATUTORY MILLENNIALISM:
ESTABLISHMENT AND FREE EXERCISE CONCERNS ARISING FROM THE HeaLth Care SHARING MINISTRY EXEMPTION’S 1999 CUTOFF DATE

JAMES R. SALZMANN[*]

INTRODUCTION

For nearly a decade, health care reform has been at the center of American politics. The development, enactment, and reform of the Patient Protection and Affordable Care Act (PPACA)—Obamacare,” in the parlance of both opposition and advocates—dominated the election cycles of 2010, 2012, 2014, and 2016, and continued policy changes and market instabilities are all but certain to remain in the spotlight through 2018 and 2020. The endurance of this debate should come as no surprise: national attempts to expand access to affordable medical services have a long history, beginning not with Barack Obama, Mitt Romney, Bill Clinton, or even Lyndon Johnson, but with Teddy Roosevelt and the Progressive Party in 1912.[1] Along the way, while employer-provided insurance came to form the cornerstone of American health care coverage, a wide range of proposals sought to extend benefits to the uninsured, including efforts to create tax subsidies, to introduce single-payer government care, and to impose employer and individual mandates.[2] Of course, it was that final optionthe individual mandate, requiring that taxpayers either carry insurance or pay for their failure to do so—that featured in the law finally passed by Congress in 2010. Of “critical importance,” the mandate was “the price for the [insurance] industry’s cooperation.”[3] However, “perhaps because prominent Republicans had [originally] endorsed the idea, Democrats underestimated the problems it would cause.”[4] While the mandate still survives in full through 2018, it will continue only nominally thereafter: shortly before this Note went to press, the narrow Republican majorities in Congress—following years of promises to “repeal and replace”[5]reduced the mandate’s penalty to $0 for 2019 and beyond, although procedural limitations required them to leave intact the theoretical command.[6]

The mandate has been the subject and survivor of substantial litigation, as well as of considerable scholarship.[7] Underexplored, however, is a provision within the mandate giving special consideration and accommodation to those who obtain membership in a type of medical collective known as a health care sharing ministry: such members are entirely exempt from the PPACA’s requirements.[8] This provision is unique in federal law. Unlike traditional conscientious-objector exemptions (which the PPACA also grants), the sharing ministry exemption demands no showing of a religious burden: to avoid the demands of the individual mandate, one need only join a club structured around shared ethical principles.[9] And as a nation, join we have: sharing ministry membership has expanded dramatically since 2010, so dramatically that the exemption may have helped to accelerate the destabilization of the very risk pools that the Act was meant to supply.[10] But the ability to join is not universal to people of all faiths and creeds, for the exemption contains a cutoff-date clause that not only forecloses the formation of new sharing ministries, but also limits the benefit of an exemption to members of just those sharing ministries which were in operation ten years before the PPACA’s passage.[11] Whether by accident or design, the effect of this limitation is to enshrine in law an accommodation for only five ministries—each one explicitly Christian in its tenets and joining requirements.[12]

This Note explores the sharing ministry exemption from several angles. Part I traces the history of the exemption’s creation, looking at the passage of the PPACA and attacks on Obamacare before turning to the rise of sharing ministries and their incorporation into the text of the law. Part II reviews a prior court challenge to the legality of the exemption, looking at why a suit brought on Establishment Clause grounds failed and how better probing of the legislative history might have warranted a different result. Finally, Part III examines unaddressed Free Exercise Clause concerns, including the burden on religious practice that the exemption creates (rather than alleviates); its inequitable effect on Muslim Americans, who are excluded from sharing ministry participation; and how these concerns fit within the framework established by the Religious Freedom Restoration Act. The Note concludes with a look ahead: whether or not the mandate’s 2017 defanging survives future elections, individual claims for faith-based exemptions to government mandates in other realms will continue to stand in tension with equality concerns. Such concerns simultaneously compel both the granting of and withholding of accommodation, but the sensible balanc[ing]” test for resolving these conflicts, as provided by Congress, remains underused.[13] The sharing ministry exemption is a window into the usefulness of the test, and how in some cases it is possible to preserve legislative purpose only through the abrogation of legislative exemptions.

I.  CREATING A SOLUTION AND A PROBLEM

A.  The PPACA

On March 23, 2010, following protracted battles in Congress and in the court of public opinion, President Obama signed the PPACA into law.[14] The PPACA significantly expanded Medicaid, required insurers to cover pre-existing conditions, insured policyholders’ children into adulthood, gave insurance subsidies to lower-income households, and created marketplaces for the purchase of private health care policies.[15] To create a risk pool deep enough to ensure the affordability of such policies, the PPACA also included an “individual mandate,” requiring most Americans to carry a compliant form of health insurance from 2014 forward, regardless of their health or employment status.[16]

In pitching this version of health care reform to the country, Obama made a series of public promises to those who already had health coverage, promises which he reiterated at the bill’s signing:

If you like your current insurance, you will keep your current insurance. No Government takeover, nobody is changing what you’ve got if you’re happy with it. . . . [W]hat works in our system won’t change. And a lot of people are happy with the health care that they’ve got, and that won’t change because of this legislation.[17]

While the degree to which this commitment could ever have been generally met is debatable,[18] the PPACA does, in fact, contain a little-noticed provision guaranteeing exactly such rights to members of the then-obscure form of alternative risk distribution known as health care sharing ministries.[19]

That sharing ministries obtained a statutory accommodation for their members is remarkable: any exemptions from the individual insurance mandate had to be carefully limited by Congress if the wider program was to succeed, because the guarantee of preexisting-condition coverage hinged on the simultaneous enrollment of millions of healthy policyholders.[20] The list of exemptions was therefore short, with only two touching upon personal beliefs.[21] The first such exemption acknowledges that some Americans have a conscientious objection to insurance programs of any sort, and so “member[s] of a recognized religious sect or division . . . ,[22] whose faith has also entitled them to absent themselves from participating in Social Security, face no penalty for failure to comply with the individual mandate.[23]the very term d exeeption, 016) (requiring objectorstwo touch upon personal belief. The first, dful both of the threats 11111111 This “[r]eligious conscience exemption”[24] thereby carries over precisely from the exemption already in place for a preexisting social welfare scheme, fulfilling, rather literally, the president’s promise that objectors may keep “the health care that they’ve got”: the care given internally by their sect, which their faith obliges them to take in preference to government assistance.[25]

But with the second belief exemption—for health care sharing ministries—the very concept was appearing in the federal code for the first time.[26] As defined by the PPACA, sharing ministries must be audited 501(c)(3) organizations, which have been “in existence at all times since December 31, 1999” and have spread the costs of members’ medical expenses “continuously and without interruption” since that date.[27] So long as a ministry’s members (1) “share a common set of ethical or religious beliefs and share medical expenses among members in accordance with those beliefs” and (2) can “retain membership even after they develop a medical condition,”[28] the members are entirely exempt from the command to maintain coverage meeting PPACA standards.

Of course, the 2016 election of President Trump called the future of the entire PPACA into serious question.[29] A cornerstone of Trump’s campaign was a pledge “to immediately deliver a full repeal of Obamacare,” including the “eliminat[ion of] the individual mandate.”[30] Such action would obviate the need for special treatment of any insurance alternatives. Yet Trump took office espousing neither a clear nor a consistent vision of his administration’s health care policy, variously expressing a desire to keep some aspects of the PPACA intact,[31] to destroy Obamacare through inaction,[32] or to spend enough federal funds to expand health care coverage even further.[33] Through much of Trump’s first year in the White House, the mandate survived close calls. Early signs that Trump’s IRS would cease to enforce the individual mandate flagged,[34] and although the agency agreed to process tax returns which do not answer the question of whether health coverage was maintained during the year—a change from Obama-era policies—the tax authority stated that “barring a legislative change, it w[ould] continue enforcing the Affordable Care Act, while ‘taxpayers remain required to follow the law and pay what they may owe.’”[35]

That legislative action finally appeared at the end of 2017, a late addition to the tax reform bill advanced in Congress after the failure of attempts to more fully repeal the PPACA[36]:

Remarkably, after the millions of words written by lawyers to attack and defend the mandate in court, the tax bill wipes it out with just two sentences. The penalty is either a flat dollar amount, $695 for an adult, or 2.5 percent of household income above a certain threshold, whichever is greater. The tax bill slices the penalty to “$0” and “zero percent,” starting in 2019, relieving taxpayers of $43 billion in penalties they would otherwise pay through 2027, the budget office says.[37]

This tax legislation, signed into law in late December 2017, obviously represents a near-total neutering of the mandate’s power from 2019 forward.[38] But while the old maxim holds that there is no penalty without a law, the inverse is not quite true: there is still law without a penalty. With the structure of the mandate still enshrined in the code, restoration of the tax penalty is hardly unimaginable in a different political environment. This Note will therefore address the sharing ministry exemption as it stands through the 2018 tax year, mindful that even if the penalty’s abrogation is permanent, a rigorous examination of potential challenges to the law may prove useful in future debates over the nuances of both health care reform and belief-based exemptions.[39]

B.  The Exemption

Taken at face value, the PPACA’s belief exemptions appear reasonable: if the purpose of the law is to expand the number of Americans with health insurance while allowing those who liked their existing plans to keep their coverage intact, then why not permit people of shared belief, with a communal commitment to one another, to continue to meet their obligations outside of the confines of a commercial insurance product? Several objections apply to the sharing ministries, however, which do not impact the legitimacy of the religious conscience objector exemption. First, the sharing ministries are not simply unregulated. Unlike religious conscience communities, the organizations themselves do not assume ultimate responsibility for care or claims. Each ministry serves as a clearinghouse for the sharing of costs amongst its membership; the costs are those billed by unaffiliated medical providers beyond the community, and there is no recourse if individual financial obligations go unmet.[40] Second, the sharing ministry exemption language avoids entirely the traditional underpinnings of faith-based exemptions.[41] While the religious conscience exemption applies to “an adherent of established tenets or teachings of such sect or division by reason of which he is conscientiously opposed to acceptance of the benefits of . . . insurance,”[42] sharing ministry members need simply “share a common set of ethical or religious beliefs” and “share medical expenses . . . in accordance with those beliefs.”[43] The religious conscience exemption is thus aimed at those whose religious beliefs require active opposition to a program, but sharing ministry members need only have a belief; whether that belief is sincere, or central to their faith, or even in any way burdened by the government is immaterial. It is especially noteworthy that the belief need not be religious: ethics alone suffice, even though the ethical difference between a secularized cost-sharing program and an insurance policy is nearly impossible to discern.[44] Third, and relatedly, there is potential for abuse: again unlike a religious conscience objector, a sharing ministry member expresses no belief barring participation in traditional insurance at a later date. While shared faith—especially regarding an opposition to contraceptive coverage—is undeniably important to some, economic incentives are also in play,[45] with non-comprehensive coverage, unsurprisingly, costing less than insurance which meets the federal mandate.[46] The door nevertheless remains open to the public market should a ministry member require treatment for a preexisting or otherwise-uncovered condition.[47]

There is also a fourth complication, critical yet largely unprobed, to be found within the cutoff date set by the PPACA. Because December 31, 1999 was chosen—when drafting the law a decade later—as the last possible date of establishment for qualified sharing ministries (though enrollment of new members therein is unrestricted), only five sharing ministries are eligible to extend an exemption to their memberships of “well over 625,000”[48]: Medi-Share, Samaritan Ministries, Christian Healthcare Ministries, Liberty HealthShare, and Altrua HealthShare.[49] This would not necessarily be a problem in and of itself if the range of pre-2000 ministries covered the full spectrum of ethical and religious beliefs within which medical costs might be shared.[50] But the sharing ministries began only in the 1990s, and at the end of the decade they remained a niche product, with perhaps 130,000 members across a handful of providers, some managing as few as forty families and all the subject of considerable skepticism from state insurance commissions.[51] As written, then, the PPACA’s 1999 cutoff enshrines in law an exemption that is open, both in practice and actuality, to only a handful of first-moving companies—all of which limit membership to a single sect.[52]

Each of the exemption-compliant ministries has a detailed set of joining requirements. Medi-Share, Samaritan, and Christian Healthcare each demand that members explicitly profess their faith, including testimony of “a personal relationship with the Lord Jesus Christ” confirmable by the member’s church.[53] Members must also “attend church regularly,”[54] and “embrace[] and follow[] the teaching of the New Testament in its entirety.”[55] The criteria used by Liberty and Altrua are somewhat broader, but they too remain deeply rooted in the Christian tradition.[56] At Liberty, in lieu of a statement of faith, members instead agree to “[o]bserve Christian [s]tandards” by following the teachings of the Bible and praying or worshipping regularly; to accept the community’s shared beliefs, including a fundamental “right to worship the God of the Bible;” and to live a “[g]odly [l]ifestyle” according to “Jesus Christ’s mandates.”[57] Altrua, originally marketed to Latter-Day Saints,[58] has a somewhat more liberal policy, requiring that members “share in . . . standards” based upon “biblical beliefs,” including prohibitions on alcohol, premarital or same-sex relationships, most abortions, and abuse.[59] Yet Altrua still makes clear that it is an organization for Christians, heading its membership guide with the exhortation of Galatians 6:2: “[c]arry each others burdens, and in this way you will fulfill the law of Christ.”[60] In short, while the PPACA created an exception nominally available to followers of any “common set of ethical or religious beliefs” so long as they had a collective agreement to share one another’s health care costs,[61] the only such organizations actually eligible to accept members are, to varying degrees, affiliates of a single religious tradition.

The law thus appears to give a clear benefit only to those willing to profess allegiance to Jesus Christ: an act of statutory millennialism, both in the literal fact of the cutoff date and in the practical implications for Christians. What, though, of persons sharing beliefs regarding mutual support and actively practicing such who, while similarly-situated, lie beyond the protection of the exemption scheme? When Congress backdated the sharing ministry exemption to 1999, it did not simply grandfather existing plans while precluding the formation of new sharing ministries, a permissible distinction.[62] Instead, Congress made it functionally impossible for ministries established between January 1, 2000 and the passage of the PPACA in 2010 to serve customers who otherwise met the criteria for a legislative exemption, customers whose ethics had also led them to seek to share their medical costs within a community of fellow-believers, but whose beliefs neither conformed to the standards of the grandfathered sharing ministries nor entitled them to the status of religious conscience objectors.[63]

II.  CHALLENGES TO THE LAW

A.  Liberty University and the Establishment Clause

To date, only one constitutional challenge to the sharing ministry exemption has advanced through the courts. In Liberty University, Inc. v. Geithner, a non-profit Christian college argued that both the religious conscience and the sharing ministry exemptions violated the Establishment Clause, discriminating against the university’s beliefs by granting accommodation only to sects which, respectively, qualified for the Social Security exemption or ran sharing ministries before 2000.[64] Their suit was dismissed by the trial court; on appeal, the Fourth Circuit found that the law did not explicitly discriminate amongst religions.[65] While the 1999 cutoff for sharing ministries might be “arbitrary, . . . neither the cutoff’s text nor its history suggests any deliberate attempt to distinguish between particular religious groups.”[66] Like the district court before them, it found the date cutoff to be similar in form to a 1950 cutoff date within the religious conscience exemption, a drawn line which had already survived Supreme Court challenges.[67] In the absence of a “‘proposed accommodation singl[ing] out a particular religious sect for special treatment’”[68] which “‘makes explicit and deliberate distinctions between different religious organizations,’”[69] the court would not subject the sharing ministry exemption to strict scrutiny, but instead reviewed for Establishment Clause violations under the “less rigorous” Lemon test.[70]

Applying Lemon, the court “require[d] ‘a secular legislative purpose,’ a ‘principal or primary effect . . . that neither advances nor inhibits religion,’ and no ‘excessive government entanglement with religion.’”[71] The Liberty University court suggested that the PPACA’s 1999 cutoff date advanced two secular purposes: ensuring the reliability of sharing ministries, and keeping closed “floodgates for any group to establish a new ministry to circumvent the Act.”[72] Without conducting further analysis, the court also determined that religion was neither advanced nor inhibited, and that the cutoff carried no entanglement risks for the government because “it applies only secular criteria”—in this case, a calendar date.[73]

B.  Liberty University Revisited

Two factors suggest that a different plaintiff might have reached a different result on the sharing ministry question. First, Liberty University’s chief complaint was rooted, fatally, in the random nature of the cutoff date[74]: “Liberty alleges that the health care sharing ministries exemption discriminates against Liberty University’s religious beliefs by implementing an arbitrary date of December 31, 1999 for participation in a healthcare sharing plan.”[75] By asserting that the date was simply chosen at random, the plaintiff effectively foreclosed further inquiry into the legislative intent behind the exemption history. Both the trial and appeals courts simply proceeded on the assumption that the date was arbitrary, making no attempt to assess why the December 31, 1999 date was selected or what the consequences of such a cutoff might have been. While it is true that “[i]f Congress allowed any and all groups to form healthcare sharing 501(c)(3) organizations, it could effect an end-run around the mandatory coverage provisions,” the conclusion that the purpose was sect-neutral stands only if one accepts that the 1999 date was indeed arbitrary.[76]

At first glance, the date appears to be a classic example of legislative grandfathering. Grandfathering is a widespread practice throughout the federal code, enabling, in essence, time-tested and functional alternatives to new laws to continue status quo ante: “[t]hat grandfathering should be a common feature of the law is, of course, what one would expect . . . and . . . . the type of grandfathering that we see is what one would predict, in the sense that it focuses on durable forms of compliance . . . .”[77] Such concessions go to the very heart of Obama’s promise that “nobody is changing what you’ve got if you’re happy with it.”[78] This view of sharing-ministries as standard grandfathering was echoed by Representative Tom Perriello, Democrat of Virginia, a staunch advocate for the provision: “A major touchstone of our efforts toward comprehensive health care reform has been consumer choice . . . . [t]o that end, individuals who choose to receive their health care coverage through health sharing ministries instead of traditional health plans should not be penalized . . . .”[79]

But the question must be asked: why create a ten-year gap between the cutoff date and the passage of the PPACA? Tax-related grandfathering, although common, typically impacts decisions made “after the date on which the change is enacted or after some later date,” not a decade prior.[80] While backdating can be efficient where a “transition is being considered by Congress but before it has been enacted,” to prevent taxpayers from benefitting from action taken especially for the avoidance of consequences on the visible horizon,[81] efficiency and fairness demand only that this extend to “the date when the government first seriously considered the reform.”[82] That is very different from the sharing ministry situation. Obama’s first comprehensive health care reform policy address was obviously not delivered in December of 1999, but nearly a full decade later, on June 15, 2009.[83]

The closest statutory comparison, and the one made by the Fourth Circuit,[84] is to the 1965 act which enshrined in law the Social Security exemption for objecting “sect[s] or division[s] . . . in existence at all times since December 31, 1950,” incorporated into the PPACA for religious conscience.[85] As with the sharing ministry exemption, this cutoff date was set by Congress long after the year in question: in fact, eleven years following the Social Security Act first encompassed the self-employed.[86] Crucially, however, the December 31, 1950 date—even though much later imposed—represents a clear attempt to harmonize an exemption with the calendar and consequences of the original bill: “As originally enacted, the Self-Employment Contributions Act imposed a tax for each taxable year beginning after December 31, 1950, upon the self-employment income of every individual.”[87] The same date is used several times in the original 1954 act.[88] Although the 1965 accommodation may well have been tailored to meet the needs of Old Order Amish taxpayers,[89] it ultimately requires only that a sect have been in existence longer than the period affected by self-employment contribution legislation.[90] Accordingly, a sect cannot be created for purposes of avoiding the tax, but any sect that predates the tax remains eligible for consideration. The PPACA, on the other hand, pegs no other requirement, penalty, or privilege to the December 31, 1999 date: it appears ex nihilo.

If the choice of cutoff date reflects neither the conventions of tax-related grandfathering nor an attempt to harmonize with related provisions, then the process by which the date was chosen deserves further scrutiny. It may be that the date truly is purely arbitrary, as the Liberty University plaintiff alleged.[91] But the legislative history and statements from sharing ministry lobbyists suggest that there may have been a purpose behind it. According to a senior advisor to the Senate Committee on Health, Education, Labor, and Pensions (HELP), which drafted the sharing ministry exemption:

The Christian Care Ministry [CCM]—which runs . . . ‘Medi-Share’—reached out to Senate staffers and convinced us it was a legitimate, albeit unorthodox, coverage alternative for people of faith that would otherwise be forced out of business by the mandate. The exemption got into the original HELP bill markup in June 2009, got tightened along the way so that new entities could not use it as a loophole, and stayed.[92]

The untightened language was likely that of Senator Jim DeMint, Republican of South Carolina, introduced in his own health care measure (to rival that of President Obama) on June 23, 2009: “For purposes of this paragraph, the term ‘health care sharing ministry’ means any health care cost sharing arrangement among persons of similar beliefs that is not in the trade or business of providing health insurance,” full stop.[93] Four months later, though, when Senator Max Baucus, Democrat of Montana, introduced his version of the bill, the December 31, 1999 cutoff had been added to the definition.[94]

One possible explanation for the evolution is that CCM successfully lobbied for a particular date in a targeted effort to restrict competition. Publicly, the group’s lobbying motivations were rooted in a desire to expand sharing ministry access generally, and shortly after the first draft of an exemption appeared in the Senate bill, CCM issued a position paper explaining its rationale[95]:

[R]eform as it is being packaged right now will adversely affect our ability to serve the Christian community . . . . Religious freedom is in jeopardy. It starts with taking away the right to voluntarily share medical bills with other believers based on what CCM believes is a biblical mandate to care for one another. As Christians, CCM is concerned about any effort that limits the personal choice to help other Christians with dollars and prayers.[96]

But the Senate’s “tightening” of the window grandfathered Medi-Share and the other evangelical Christian sharing ministries while excluding, by the very narrowest of margins, their principal competitor, Altrua HealthShare—founded in March 2000.[97] By itself, this could have simply been a ruthless business practice, of no constitutional concern. However, Altrua was not just a competitor: run by Latter-Day Saints, it was also the only organization open to non-evangelicals while calling itself a sharing ministry.

Of course, “the Constitution allows the State to accommodate religious needs by alleviating special burdens,”[98] and in granting such an accommodation, the “government may (and sometimes must) accommodate religious practices and . . . may do so without violating the Establishment Clause.”[99] And CCM may fairly lobby for such accommodations in an attempt to safeguard its client base and business model. What is less clear, however, is whether the Senate’s response to the lobbying created not a lawful accommodation for religion generally, but instead constituted an “‘accommodation singl[ing] out a particular religious sect for special treatment.’”[100] A cutoff date engineered to favor evangelical sharing ministries while excluding a Mormon competitor would be an “explicit and deliberate distinction[] between different religious organizations”—or in other words, exactly what the Fourth Circuit claimed the exemption was not.[101] A single religious group asked for and received the accommodation they required. Consciously or not, Congress aided them in writing their similarly-situated competitors of a different faith out of a safe harbor, a devastating blow to Altrua’s business prospects which Altrua avoided only through a just-in-time 2014 merger with Blessed Assurance Bulletin, a hitherto-obscure Texas provider.[102]

With further evidence that the date was not arbitrary but was a knowing attempt to exclude Latter-Day Saints,[103] the inquiry might proceed along different, more rigorous lines. Under the precedent of Larson v. Valente, though “the Lemon v. Kurtzman ‘tests’ . . . . [may] reflect the same concerns that warrant[] the application of strict scrutiny” to a law discriminating amongst, rather than against, religions,[104] it is strict scrutiny that controls in the testing: with . . . a denominational preference, our precedents demand that we treat the law as suspect and that we apply strict scrutiny in adjudging its constitutionality.”[105] In Larson, Minnesota had granted an exemption only to religious organizations receiving more than half of their contributions from non-members, and the legislative history indicated that this threshold was specifically meant to distinguish among sects, favoring the Roman Catholic archdiocese while discriminating against the Unification Church.[106] The Court found faciaorig ty argument, as discusve such scrutiny. lth coverage for the widest number of people, but vorig ty argument, as discusfacial neutrality lacking not by looking to the plain language of the statute, but to the process of choosing its terms. The law having been constructed to preference certain denominations, “that rule must be invalidated unless it is justified by a compelling governmental interest and unless it is closely fitted to further that interest.”[107]

The sharing ministry exemption might not survive such scrutiny. Even assuming arguendo that President Obama’s promise—citizens with some form of health insurance can keep their existing coverage—represents a compelling government interest, the 1999 cutoff date is not “closely fitted” to that purpose. Sharing ministries created a mere three months after the deadline, ten years earlier, were providing customers with existing coverage of a type identical to that covered by the exemption. Additionally, consumers of traditional (commercial) insurance had been permitted to keep other non-compliant grandfathered plans so long as they held the policy on the date of the PPACA’s passage.[108] The sharing ministry exemption thus appears closely fitted only to the purpose of closing the door on a Mormon sharing ministry of ten years standing, while preserving identical programs run for evangelical Protestants. If a cutoff date predating Congressional consideration of the bill was necessary at all it would surely be to ensure that surviving ministries be able to demonstrate a degree of financial stability and reliability, so that consumers could rely on it in the absence of regular insurance; those ends could easily be met through less restrictive regulatory requirements,[109] including rigorous auditing standards and disclosure to the public of the percentage of claims covered in full and in part.[110]

As in Larson, therefore, a challenger equipped to aggressively argue a discriminatory legislative intent might well succeed in defeating the exemption on Establishment Clause grounds—although as in Larson, the likely remedy is not necessarily invalidation of the policy generally, but invalidation of the denominationally-discriminatory criteria.

III.  AN ALTERNATIVE INQUIRY: THE FREE EXERCISE CONCERN

As Kathleen Brady has explained, “respect for conscience requires a judicially enforceable right of exemption under the Free Exercise Clause. . . . [and a]ccommodations by legislatures and administrators still play a critical role in protecting conscience . . . . where the Free Exercise Clause does not mandate relief.”[111] That ability to accommodate is not absolute, however; while the legislature may act to expand Free Exercise even when the judiciary would not be compelled to do so, it can and should be constrained by certain limits, rooted in Establishment Clause concerns and traceable through judicial precedent:

[T]he Court’s decisions have identified . . . limits [to legislative exemptions] that make sense in light of First Amendment values. First, religious exemptions and other forms of accommodation designed to meet the needs of religious believers in conflicts with the state must address genuine burdens on religious exercise. These exemptions cannot be used as a means to advance religion. . . . accommodations must [also] take account of the value of religious equality. . . . [and] sometimes the burdens that legislative and administrative accommodations place on others will be impermissibly high.[112]

These limitations are a useful rubric for evaluating actual and potential Free Exercise claims stemming from the sharing ministry accommodation, both in terms of the appropriateness of the original legislative action and of the shape of a legal challenge thereto.

A.  Genuine Burdens on Religious Exercise

In addition to its Establishment Clause claims, Liberty University had also argued that the PPACA’s mandate constituted a violation of the Free Exercise Clause, on the grounds that it compelled Liberty to fund abortifacient contraceptives; and the Fifth Amendment, on the grounds that the granting of religious conscience and sharing ministry exemptions to other select groups denied equal protection to the school.[113] But while the university did offer alternative (non-compliant) insurance to its employees,[114] it never made a Free Exercise argument relating to that coverage. Instead, it argued that the existence of religious accommodations for some should simply invalidate the applicability of the PPACA for others. It is of course well-settled that legislative exemptions on religious grounds are in fact permissible,[115] part of the “room for play in the joints productive of a benevolent neutrality which will permit religious exercise to exist without sponsorship and without interference.[116] The Fourth Circuit’s dismissal of the claim was thus unsurprising.[117] However, a plaintiff whose practices were identical to those of actual sharing ministry members—rather than one claiming a different sort of religious exemption altogether—would bring a much stronger Free Exercise Clause argument.[118] Altrua’s Mormon members might have been these plaintiffs save for the company’s merger,[119] but another class of potential plaintiffs also exists: not the Latter-Day Saints whom the law so nearly excluded, but a subset of American Muslims.[120]

Most Muslims in this country participate in both Social Security and regulated health care programs.[121] But “in the strictest sense of the religion, believers of Islam consider health insurance, and, for that matter, any form of risk insurance, to be forbidden or haraam.”[122] In 2008, in response to the problems conventional insurance causes such Muslims, the insurance giant AIG began to offer Lexington Takaful Solutions, a Sharia-compliant comprehensive insurance program, through which members contributed to a “pooling system” for the compensation of fellow participants.[123] The product line opened with homeowner’s coverage as a gateway to a full “range of Takaful products, including accident and health . . . .”[124] Such a pooling arrangement for health care would appear to fulfill not only the requirements of the faith, but also the requirements of a sharing ministry.[125]

This domestic takaful launch did not go unnoticed.[126] Within days, members of Congress joined voices with constituents critical of a Sharia-compliant product being sold by a AIG, the beneficiary of a federal bailout; in a scathing letter to the company’s chairman, Representatives Sue Myrick, Republican of North Carolina, and Frank Wolf, Republican of Virginia, declared that “Shariah law is radical and fanatic . . . . Islamists use Shariah finance to become legitimate and mainstream, and slowly change the legal system to suit their ideology . . . . We would hate to see the FBI visit you one day, look into your books . . . .”[127] Although Lexington Takaful Solutions later removed its product from the market, it first sold a small number of policies, accounting for 0.0006% of Lexington’s 2009 revenues.[128] However, the 1999 cutoff date meant that even if the Lexington policy suite expanded to include the planned health coverage before its withdrawal, it could not qualify as a sharing ministry under the PPACA—and no other provider has attempted to offer a health insurance product in the United States satisfying Sharia law as well as either the individual mandate or its permitted exceptions.[129] In its absence, currently-willing takaful participants, whether or not former holders of a takaful product which failed to satisfy the sharing ministry exemption because of the PPACA’s cutoff date, but whose participation in conventional insurance runs contrary to their religious practice, might bring a Free Exercise claim.[130] And thanks to the Religious Freedom Restoration Act of 1993 (RFRA), such suits are substantially easier to litigate than Establishment Clause claims.

Under RFRA, a federal law cannot “substantially burden a person’s exercise of religion even if the burden results from a rule of general applicability [unless] . . . . it demonstrates that application of the burden to the person . . . (1) is in furtherance of a compelling governmental interest; and (2) is the least restrictive means of furthering that compelling governmental interest.”[131] This statutory test repudiated the Supreme Court’s holding in Employment Division v. Smith that Free Exercise claims alone were generally insufficient grounds for the granting of exemptions from neutral laws of general applicability,[132] instead reinstituting (at least nominally) the strict scrutiny of the Sherbert test devised by Justice Brennan.[133] In RFRA analysis, the intent of the legislature is irrelevant, and “[l]aws valid under Smith would fall under RFRA without regard to whether they had the object of stifling or punishing free exercise.”[134]

The PPACA has already faced substantial and nearly-crippling challenges under RFRA, including, most famously, Burwell v. Hobby Lobby Stores, Inc.[135] In Hobby Lobby, a corporation’s owners objected (in the vein of Liberty University, though more successfully) to insuring the provision of contraceptives which they believed caused abortions, a newly-required element of PPACA-compliant employee health insurance plans.[136] The corporation sought refuge within an already-existing exemption from the so-called “contraceptive mandate,” created by Congress for the benefit of non-profit religious organizations. The Court found this accommodation expandable to for-profit, closely-held corporations whose owners asserted similar moral objections.[137] As “HHS [Health and Human Services] itself has demonstrated that it has at its disposal an approach that is less restrictive than requiring employers to fund contraceptive methods that violate their religious beliefs,” the Hobby Lobby owners should be given the same alternative.[138] The Court’s willingness to open wider the doors of an exemption to accommodate additional objectors, once the government has created it for the benefit of some subset, strongly suggests that a challenge to the sharing ministry exemption would receive a sympathetic hearing.

Even so, the question cannot be adjudicated unless the burden is substantial: “[a]s RFRA’s language makes explicit, strict scrutiny is triggered only by substantial burdens on religion, not by all burdens on religion.”[139] The definition of substantiality and the methods by which courts might assess that factor—including theological or civil measures—have long been debated: as Michael Dorf wrote not long after RFRA’s passage, “[n]either the text nor the legislative history of RFRA provides any clear indication of how courts ought to determine whether an incidental burden on religion is in fact substantial,” and the cases to which Congress specifically draws the court’s attention are “equally unilluminating” in resolving the question.[140] Even whether the substantiality is a measure of the pressure brought to bear by the government in its imposing of the burden, or instead a measure of the impact that compliance would bring upon the individual, is not a wholly settled question,[141] although Hobby Lobby was merely the latest in a long series of cases suggesting that the courts give the claimant significant latitude in this regard.[142] But however courts do the measuring, at some point they must “determine when the burden has crossed the line from being insubstantial to substantial.”[143] In other words, a law’s burden falls along a spectrum, impacting the faithful somewhere between their mere preferences and their sacred duties. Until the burden crosses a substantiality threshold, there is no need to even consider the government’s interest in determining whether RFRA demands accommodation.

Dorf has suggested a tripartite approach to answering the substantiality question.[144] First, is there a “bona fide religious belief that [the plaintiff] should engage in the burdened practice?”[145] Second, the courts should take a flexible approach to the consideration of alternative means of satisfying both the law and the belief.[146] Finally, “[b]y asking whether the burden imposed by a particular law on an adherent of a minority faith greatly exceeds the law’s effect on the majority—whose religious preferences the law reflects—we can give the substantiality test some concrete substance.”[147]

The theoretical faithful-Muslim plaintiff easily satisfies both the first and third prongs of this test.[148] As to the second, the alternative means of satisfaction are limited to three potential choices: (1) acquisition of a PPACA-compliant insurance policy, administered by a non-religious entity and structured so as to violate some interpretations of Sharia law; (2) membership in a PPACA-compliant sharing ministry, similar in structure to a takaful plan but requiring either a profession of Christian faith or a willingness to participate in a Christian mission of shared responsibility; or (3) surrender of the “individual shared responsibility payment” imposed for failure to carry such insurance, capped for 2018 at the higher of (a) 2.5% of household income or the national average price of minimally-compliant insurance, or (b) $695 per adult and $2,085 per household (though of course now falling to $0 in 2019).[149]

For a takaful adherent, the first option is a substantial burden by essentially any standard. In her Hobby Lobby dissent challenging the Court’s deference to substantiality claims,[150] even Justice Ginsberg appeared to consider a command [to] purchase or provide [what] they find objectionable,” as would here be required, to be obviously substantial.[151] The second option, joining an existing sharing ministry, demands the equally untenable concession of subscribing to a Christian belief statement in order to satisfy a command of Islam. The third option, paying the shared responsibility payment tax for failure to carry insurance, is economically quantifiable—but a closer question. Willingness to pay the tax rather than purchase alternative insurance is by one measure itself confirmation of the substantiality of the first two burdens.[152] But while a “law [which] simply regulates a secular activity and . . . operates so as to make the practice of [] religious beliefs more expensive” is permissible,[153] the Court has recently recognized the “severe burden that taxation . . . can impose.”[154] And in And in vant United Stated Seantoed the “ust two options, nsberg ion Requests to the offices of the relevant United Stated SeantoHobby Lobby, the Court declined to follow the argument of amici that the substantial burden of providing religiously-objectionable insurance coverage could be eliminated if the employer instead provided no insurance and paid the tax for so doing.[155] Because some sort of insurance is itself a valuable commodity for workers, it was not possible to state that the cost of the penalty and the lost benefit together were not higher than the cost of compliant insurance.[156] By the same logic, then, to say that no burden arises in paying a tax ignores the fact that an unaccommodated takaful adherent must (through this year) pay a penalty in addition to internalizing the out-of-pocket costs of health care, there being no acceptable insurance substitute to acquire. In short, a Muslim plaintiff should be able to demonstrate the substantiality of the burden through 2018.

B.  The Burden’s Inequitable Effect

In creating the sharing ministry exemption, it is by no means certain that Congress was responding to what it perceived as a substantial Free Exercise burden on evangelical Christians. While other PPACA exemptions require takers to be “conscientiously opposed to acceptance of the benefits of . . . insurance,”[157] in the case of religious conscience, or to “oppose[] providing coverage . . . on account of religious objections,”[158] for religious employers, no oppositional requirement attaches to the sharing ministries. This absence reflects the theological problem faced by the exemption’s original advocates: the consumption of commercial health insurance does not burden the exercise of most Protestant faiths. (Despite funds cial insurance7, 2017) es have claimed, erroneously, that ACA-marketplace insurance funds abortions. vernment interests mithe claims of some sharing ministry advocates that PPACA-marketplace insurance plans fund abortion, every state offers at least one plan which excludes abortion services.[159]) The sharing ministry accommodation, then, is not motivated by a religious burden in the traditional sense.

However, including the sharing ministry exemption within the PPACA shifts the analysis radically. When the “religious preferences the law reflects” are those of Christian ministry members, an entirely different group of minority faiths bears the burden, and the burden for some Muslims, if forced to buy secular commercial policies in a world in which Christian counterparts do not, is not insubstantial. Indeed, their burden may well be as great as that felt by a Christian religious-conscience objector, even though the terms of that particular clause exclude Muslims by virtue of their sect’s broad ability to participate in Social Security.[160] This goes straight to the heart of Brady’s argument for applying an equality test to legislative accommodations:

Accommodations that entail substantial expense for a discrete segment of the community raise issues of religious equality. The accommodated faith is afforded protection with costs only some incur. When the costs of accommodation are not shared by the community at large, we worry that more popular or powerful faiths are being advantaged at the expense of those with less communal support. Unequal burdens raise concerns of religious favoritism.[161]

Regardless of the original legislative intentions, the imbalance in the degree of burden between accommodated and unaccommodated parties should therefore be a cause for concern.

C.  The Burden Shifted: Legislative and Administrative Hindrance

In Hobby Lobby, the Court found it unnecessary to examine whether the provision of a variety of contraceptives represented a compelling interest of the government, and instead focused on whether the mandate that employer-sponsored health insurance cover such contraceptives was, in fact, the least restrictive means of achieving such an interest.[162] Assessing the latter question requires asking, in the Court’s language, whether “the fundamental point would still be that there simply is no less restrictive alternative to the categorical requirement.”[163] And as previously discussed, the creation of an exemption for some does a great deal to undermine the argument that an extension of such an exemption would be fatal to the broader interest. Where “the record . . . shows that there is an existing, recognized, workable, and already-implemented framework to provide coverage. . . . [it appears that it] equally furthers the Government’s interest but does not impinge on the plaintiffs’ religious beliefs.”[164] By allowing some sharing ministries, therefore, the government makes it extremely difficult to tighten the spigot for similarly-situated—yet excluded—groups.

A Free Exercise challenge to the sharing ministry exemption would presumably not balance the believer’s burden against the compelling interest behind the exemption, but rather against that behind the wider law. Here, the interest (at least until 2019) is to make health insurance coverage both more robust, through improvements in the minimum standards of saleable policies, and more affordable,[165] through the requirement that Americans either spread risk by purchasing insurance or else offset the government’s health care spending via the shared responsibility payment.[166] But RFRA’s focus on the implications of a law “‘to the person’—the particular claimant whose sincere exercise of religion is being substantially burdened”—makes it difficult to defend the compelling interests inherent in a system which requires mass participation against any single defection.[167] The government has, in essence, conceded via the original exemption that the least restrictive means of achieving its wider ends do not require total consistency.

 As with the contraceptive exception in Hobby Lobby, the existence of individual-mandate exemptions thus does nothing to help the government’s case, and Congress may have underestimated their potential to threaten the PPACA’s efficacy. Continuing criticism argues that “the law is poorly designed . . . . [and t]he penalties attached to the individual mandate are too weak,”[168] leading to a withdrawal of insurers from the marketplace and escalating costs for those who remain. The porousness of the sharing ministry exemption has appeared at least partly to blame,[169] though the anti-PPACA rhetoric and policy certainly had an effect, as well[170] and anticipation of the 2019 penalty-elimination is likely to further accelerate the spiral.[171] In 2011, however, shortly after the establishment of the exemption’s enshrinement but well before either Altrua’s qualification as an exempted sharing ministry or the individual mandate’s imposition date, membership amongst all ministries amounted to about 100,000—lower even than a decade earlier.[172] Six years later, though, enrollment had jumped tenfold, to more than a million.[173] While it is possible that some members may pay the mandate’s penalties inadvertently,[174] the plans are often marketed as a way to avoid having to do so,[175] and members often tout that avoidance as a key benefit.[176] Together, they represent more than 3% of the twenty-nine million Americans without health insurance;[177] if members had instead purchased marketplace insurance, they would have increased the size of the commercial pool by 8%.[178] The exempted population thus constitutes a non-inconsiderable threat to the pool’s stability, especially given that ministry members—who typically pledge to abstain from risky behaviors including extramarital sex and the use of tobacco, alcohol, and other drugsmay be relatively healthy, and therefore especially important for maintaining a lower cost-per-patient average.[179] How, then, could this impermissibly-narrow exemption be widened without further undermining the very purpose of the law?[180] Though perhaps a moot question after 2019, once the mandate’s penalty evaporates, the theoretical answer may nevertheless lie within RFRA’s resurrection of Sherbert, which contains the underpinnings of a solution for laws that risk being swallowed up by exceptions. “[A]dministrative inconvenience alone does not negate the feasibility of an otherwise less restrictive means—unless the administrative problem would be ‘of such magnitude’ that it would render ‘the entire statutory scheme unworkable.’”[181] To strip away the cutoff date and allow new sharing ministries of all faiths—or ethically-grounded ministries of no faith at all—risks exactly such a destruction of statutory purpose. And as Justice Ginsburg observed in her Hobby Lobby dissent, “[a]ccommodations to religious beliefs or observances, the Court has clarified, must not significantly impinge on the interests of third parties.”[182] Here the statutory accommodation impinges on the interests of non-Christian sharing ministry participants, while the most obvious remedy—expansion—impinges on those of the millions of American who participate in the health insurance marketplace.[183]

The theoretical Muslim plaintiff’s argument for the expansion of the exemption to include takaful participants thus runs aground. The legislature intended to accommodate sharing ministry members, but one unforeseen effect of the PPACA was to foreclose the offering of a sharing ministry equivalent catering to Muslims, forcing those same Muslims into a now-mandatory commercial insurance market, with Free Exercise concerns attendant. While an expanded exemption might restart American takaful programs, such an easy fix—via judicial elimination of the cutoff date—would undermine the legislature’s original purpose in passing the wider law and impose potentially dramatic third-party burdens as more and more consumers leave the secular marketplace. The harder fix, then, is to eliminate the exemption altogether.

Although politically complicated, such a remedy is constitutionally sound, and there is precedent for a court’s striking of accommodations. In Texas Monthly, Inc. v. Bullock, the Court found that a state sales-tax waiver for religious publications was unconstitutional, giving an effective grant-in-aid to religion in violation of the Establishment Clause:

[W]hen government directs a subsidy exclusively to religious organizations that is not required by the Free Exercise Clause and that either burdens nonbeneficiaries markedly or cannot reasonably be seen as removing a significant state-imposed deterrent to the free exercise of religion, as Texas has done, it “provide[s] unjustifiable awards of assistance to religious organizations” and cannot but “conve[y] a message of endorsement” to slighted members of the community.[184]

Similarly, and running in even closer parallel to the sharing ministry question, in Boone v. Boozman, the court examined the legislative exemption from vaccine laws granted to Arkansans whose “recognized church or religious denomination” forbade inoculations, in light of a religious plaintiff who had no denominational affiliation.[185] Faced with the construction of an exemption that excluded believers simply because they lack a recognized church, the court found it “difficult to imagine how the State would have a compelling interest in limiting the religious exemption to some religious sects . . . over others,” noting that “[w]here the State elects to accommodate religion on a particular issue like immunization, it is simply not constitutionally permissible for it to indulge the free exercise rights of some individuals and inhibit the free exercise rights of others on an arbitrary basis.”[186] But having found that the exemption cannot stand as written, the court did not expand its applicability. Instead, it focused on the legislative purpose of the vaccination law as a whole:

[T]he General Assembly sought to establish a comprehensive immunization program for school children, and the statute is complete in itself and capable of execution in accordance with that intent without the . . . religious exemption. [That exemption] must be stricken as unconstitutional, but the remaining portions of the statute remain in full force and effect. In other words, there now exists no statutory religious exemption to immunization in the State of Arkansas.[187]

The vaccine analogy is especially apt when considering the insurance problem, for just as it is epidemiologically demonstrable that an immunization scheme fails unless a critical level of coverage can be maintained, so is it also with insurance risk pools.

 Here, as with health insurance, substantive Free Exercise concerns were already handled by the religious conscience exemption.[188] Like the religious-publication tax grant at issue in Texas Monthly, the additional accommodation for sharing ministries appears to have been conceived not as an attempt to alleviate a substantial burden on religion but rather to answer a political demand—with the result that it created a larger problem than the one it ostensibly solved.

Of course, President Trump and the 115th Congress were never likely to amend the PPACA in such a way as to strengthen the individual mandate through the elimination of faith-based exemptions; now, removing the mandate’s penalty will take the question of burdens off the table entirely come 2019. But so long as the mechanism of the mandate survives, there remains the potential for the legislature to restore the penalty—and with it, to restore exemption issues. A vigorous challenge, effectively litigated, would provide an opportunity not to extend the sharing ministry exemption to new groups, but to close it permanently, guiding consumers back into the regulated market, eliminating free-rider dangers, enhancing coverage, and helping to guarantee the efficacy of the mandate upon which the PPACA is built.

CONCLUSION

Regardless of the survival of the PPACA and the individual mandate, the need to measure a right to personal religious liberty against the rights of third parties, represented through compelling government interests—the very core of RFRA—will remain at the heart of how courts examine Free Exercise claims. In passing RFRA, Congress wrote its intentions into the statute, stating that “governments should not substantially burden religious exercise without compelling justification,” and “the compelling interest test as set forth in [pre-Smith] court rulings is a workable test for striking sensible balances between religious liberty and competing prior governmental interests.”[189] Yet more than two decades after RFRA’s bipartisan passage,[190] the “competing prior governmental interests” are too often ignored in discussions of religious freedom. In its 2016 platform, for example, the Republican Party argued not for “sensible balances,” but instead argued that:

The Free Exercise Clause is both an individual and a collective liberty protecting a right to worship God according to the dictates of conscience. Therefore, we strongly support the freedom of Americans to act in accordance with their religious beliefs, not only in their houses of worship, but also in their everyday lives. We support the right of the people to conduct their businesses in accordance with their religious beliefs and condemn public officials who have proposed boycotts against businesses that support traditional marriage. . . . We support the public display of the Ten Commandments as a reflection of our history and our country’s Judeo-Christian heritage and further affirm the rights of religious students to engage in voluntary prayer at public school events and to have equal access to school facilities. We assert the First Amendment right of freedom of association for religious, private, service, and youth organizations to set their own membership standards.[191]

The call for liberty is clear, but there is no acknowledgment of either the need to measure the substantiality of burdens upon that liberty, or the degree to which legitimate and compelling government interests might warrant imposition thereupon—unless the party in power hopes to elevate the “country’s Judeo-Christian heritage” itself to the status of such an interest.

The issues raised by the sharing ministry exemption deserve special consideration in an age of considerable deference to the individual belief-based claim. An object lesson in the complicated dynamics of religion-clause balancing tests, this exemption illustrates how the legislative process can give rise to Establishment Clause concerns, and how genuine desires to accommodate the needs of diverse faiths can both create new forms of discrimination and undermine the wider purposes of public laws. While sharing ministry litigation has been extremely limited, even in the era of the defanged mandate its persistence in the code will remain a potential landmine should the penalty be revived or the exemption’s structure be imported wholesale into new health care legislation. How the issue is eventually defused may have implications not just for the Christians who participate in ministries today, the Muslims who seek Sharia-compliant financial products, and the Americans of all faiths who rely on robust risk pools, but also for the larger challenge of how any administration must interpret and implement belief exemptions from social-cooperation laws. Though little noticed amidst a wider national debate, the choice here presented—whether to maintain a limited exemption, to open the floodgates to all claimants, or to excise the exemption for the sake of wider purposeis thus one of fundamental importance.


[*] *. Editor-in-Chief, Southern California Law Review, Volume 91; J.D. Candidate 2018, University of Southern California Gould School of Law; M.A. Fine and Decorative Art 2008, Sotheby’s Institute of Art; A.B. History and Literature 2002, Harvard University. I am indebted to my wife, Dehn W.H. Gilmore, and to my son, Jack, for their boundless patience and loving support; to Professor Nomi Stolzenberg, for her encouragement, enthusiasm, and invaluable assistance; and to the superb attorneys and old friends who inspired me to pursue this new career and gave sound advice along the way, including Frances Cohen, Elizabeth N. Dewar, Judith G.H. Edington, John A.D. Gilmore, Patricia G. Hambrecht, Wheatly A. MacNamara, and James W. Lawson.

 [1]. See Dan Balz, Introduction to Staff of the Wash. Post, Landmark: The Inside Story of America’s New Health-Care Law and What It Means for Us All 4 (2010) (“The [1912] party platform . . . call[ed] for ‘the protection of home life against the hazards of sickness, irregular employment and old age through the adoption of a system of social insurance adapted to American use.’”).

 [2]. See Paul Starr, Remedy and Reaction: The Peculiar American Struggle over Health Care Reform 19–21 (2011).

 [3]. Id. at 187.

 [4]. Id. at 21. Cf. Stuart M. Butler, Assuring Affordable Health Care for All Americans, Address at Meharry Medical College (Oct. 2, 1989), in 218 Heritage Lectures 6 (1989) (addressing problems with the American health care system and proposing an insurance mandate as part of a conservative solution).

 [5]. See, e.g., Editorial, Ding Dong. Repeal and Replace Is Dead. (For Now), L.A. Times (July 28, 2017, 9:15 AM), http://www.latimes.com/opinion/editorials/la-ed-healthcare-skinny-repeal-20170728-story.html. Cf., e.g., Alex Pappas, Trump: ‘Repeal and Replace Is Not Dead!,Fox News (July 29, 2017), http://www.foxnews.com/politics/2017/07/29/trump-repeal-replace-is-not-dead.html.

 [6]. Act to Provide for Reconciliation Pursuant to Titles II and V of the Concurrent Resolution on the Budget for Fiscal Year 2018, Pub. L. No. 115-97, § 11801, 131 Stat. 2054, 2092 (2017) (to be codified at 26 U.S.C. §5000A(c)).

 [7]. See Douglas A. Bass, Annotation, Validity of the Minimum Essential Medical Insurance Coverage, or “Individual Mandate,” Provision of § 1501 of the Patient Protection and Affordable Care Act of 2010, Pub. L. No. 111-148, 124 Stat. 119, 60 A.L.R. Fed. 2d 1 (2011).

 [8]. See I.R.C. § 5000A(d)(2)(B) (2012).

 [9]. See id. (“The term ‘health care sharing ministry’ means an organization . . . members of which share a common set of ethical or religious beliefs and share medical expenses among members in accordance with those beliefs . . . .”).

 [10]. See, e.g., Tracy Seipel, Obamacare: ‘Health Care Sharing Ministries’ Increase Membership in Wake of New Law, Mercury News (July 26, 2014, 10:33 AM), http://www.mercurynews.com/ 2014/07/26/obamacare-health-care-sharing-ministries-increase-membership-in-wake-of-new-law.

 [11]. See I.R.C. § 5000A(d)(2)(B)(ii)(IV).

 [12]. See infra note 49 and accompanying text.

 [13]. 42 U.S.C. § 2000bb (emphasis added). See, e.g., Martin S. Lederman, Reconstructing RFRA: The Contested Legacy of Religious Freedom Restoration, 125 Yale L.J.F. 416, 419–20 (2016).

 [14]. See Sheryl Gay Stolberg & Robert Pear, Obama Signs Health Care Bill into Law, with a Flourish, N.Y. Times (Mar. 23, 2010), https://nyti.ms/2jDDkXM.

 [15]. See Shailagh Murray & Lori Montgomery, House Passes Health-Care Reform Bill Without Republican Votes, Wash. Post (Mar. 22, 2010), http://www.washingtonpost.com/wp-dyn/content/article/2010/03/21/AR2010032100943.html.

 [16]. See I.R.C. § 5000A(a); Casey B. Mulligan, The Power of the Individual Mandate, N.Y. Times: Economix (Oct. 23, 2013, 12:01 AM), https://economix.blogs.nytimes.com/2013/10/23/the-power-of-the-individual-mandate. (“[T]he individual mandate can be enforced and thereby help discourage millions of people from going without health insurance.”).

 [17]. Remarks on the Patient Protection and Affordable Care Act, 1 Pub. Papers 402, 404 (Mar. 23, 2010) [hereinafter Remarks].

 [18]. See, e.g., Donald J. Trump (@realDonaldTrump), Twitter (Jan. 5, 2017, 4:01 AM), https://twitter.com/realDonaldTrump/status/816977937731878912 (“The fact is ObamaCare was a lie from the beginning. ‘Keep you [sic] doctor, keep your plan!’”).

 [19]. I.R.C. § 5000A(d)(2)(A)(i).

 [20]. See Allison K. Hoffman, Oil and Water: Mixing Individual Mandates, Fragmented Markets, and Health Reform, 36 Am. J.L. & Med. 7, 64 (2010) (“With an individual mandate, the government creates a requirement that all Americans obtain insurance. Yet it leaves implementation for the most part in the hands of private insurers, who, to whatever degree permitted, design, price, and issue the plans that Americans must buy. This power over design, in essence, imbues insurers with a tremendous amount of delegated state power to determine the contours of how the mandate is put in place and effects Americans. Regulations, thus, may be seen as a way to ensure insurers implement the mandate consistent with intended legislative objectives, including health redistribution.”).

 [21]. Both come under the heading “[r]eligious exemptions,” even though the sharing ministry may theoretically be organized along purely ethical lines. I.R.C. § 5000A(d)(2).

 [22]. Id. § 5000A(d)(2)(A)(i).

 [23]. Congress defined this group by direct reference to the longstanding conscientious objector exemption within the Social Security Act: to be exempt, a sect must have been in existence since 1950, it must teach adherents not to participate in insurance plans, and it must have an independent system for ensuring the well-being of members. See id. § 1402(g)(1) (requiring objectors to be conscientiously opposed to acceptance of the benefits of any private or public insurance . . . [for] death, disability, old-age, or retirement or . . . medical care.”).

 [24]. Id. § 5000A(d)(2)(A).

 [25]. A sect that made no care provision for its adherents would not fulfill the terms of the exemption.

 [26]. See Edward A. Zelinsky, Do Religious Tax Exemptions Entangle in Violation of the Establishment Clause? The Constitutionality of the Parsonage Allowance Exclusion and the Religious Exemptions of the Individual Health Care Mandate and the FICA and Self-Employment Taxes, 33 Cardozo L. Rev. 1633, 1671 (2012).

 [27]. I.R.C. § 5000A(d)(2)(B)(ii)(IV)–(V).

 [28]. Id. § 5000A(d)(2)(B).

 [29]. See Jeffrey Toobin, The Highest Court, New Yorker, Nov. 21, 2016, at 58.

 [30]. Healthcare Reform to Make America Great Again, Donald J. Trump for President, https://web.archive.org/web/20170207063426/https://www.donaldjtrump.com/positions/healthcare-reform (last visited Jan. 3, 2018).

 [31]. See Reed Abelson, Donald Trump Says He May Keep Parts of Obama Health Care Act, N.Y. Times (Nov. 11, 2016), https://nyti.ms/2eIXqcX.

 [32]. See Thomas Kaplan, ‘Let Obamacare Fail,’ Trump Says as G.O.P. Health Bill Collapses, N.Y. Times (July 18, 2017), https://nyti.ms/2vyCGgZ.

 [33]. See Damian Paletta, Trump Calls for More Spending on Health Care so It’s ‘The Best Anywhere,’ but He Just Proposed Big Cuts, Wash. Post (May 28, 2017), http://wapo.st/2r2UFNm.

 [34]. See Peter Sullivan, IRS Loosening Enforcement of ObamaCare Mandate, Hill (Feb. 15, 2017, 12:41 PM), http://thehill.com/policy/healthcare/319672-irs-takes-step-against-obamacare-mandate.

 [35]. Brianna Ehley & Aaron Lorenzo, Trump Still Enforcing Obamacare Mandate, Politico (May 3, 2017, 2:14 PM), http://politi.co/2pFTUqW.

 [36]. Mike DeBonis & Damian Paletta, Senate GOP Changes Tax Bill to Add Obamacare Mandate Repeal, Make Individual Income Cuts Expire, Wash. Post (Nov. 14, 2017), http://wapo.st/2hsekQS.

 [37]. See Robert Pear, Without the Insurance Mandate, Health Care’s Future May Be in Doubt, N.Y. Times (Dec. 18, 2017), https://nyti.ms/2CZJngA.

 [38]. See Eileen Sullivan & Michael Tackett, In Signing Sweeping Tax Bill, Trump Questions Whether He Is Getting Enough Credit, N.Y. Times (Dec. 22, 2017), https://nyti.ms/2DyfGmW.

 [39]. Although the PPACA is the only federal law to contain a sharing ministry exemption at present, Congress has considered adding the exception to existing legislation governing Health Savings Accounts (HSAs). E.g., H.R. 1752, 114th Cong. (2015). Additionally, although beyond the scope of this paper, it should be noted that a number of states recognize sharing ministries and accord them special consideration, in some cases following exactly the language of the federal exemption. See, e.g., N.H. Rev. Stat. Ann. § 126-V:1 (LexisNexis 2016).

 [40]. See Benjamin Boyd, Health Care Sharing Ministries: Scam or Solution?, 26 J.L. & Health 219, 236–238 (2013) (discussing the dissent in Commonwealth v. Reinhold, 325 S.W.3d 272, 280–82 (Ky. 2010)). See also Ehren K. Wade, Comment, Just What the Doctor Ordered? Health Care Reform, the IRS, and Negotiated Rulemaking, 66 Admin. L. Rev. 199, 221 (2014) (“[M]inistries . . . may refuse to cover certain treatments on religious grounds and are largely unregulated, such that they may not have reserves to cover large expenses and are not required to carry such reserves.”).

 [41]. Kent Greenawalt has identified three typical justifications for exemptions: necessity of avoiding offense to a religious belief; necessity of avoiding “grave practical difficulties” arising from noncompliance, as when a draftee refuses to fire on a battlefield; and necessity of allowing noncompliance from a law which compels morally abhorrent action or inaction. Kent Greenawalt, Exemptions 5–6 (2016).IdIdring ministries are arguably an exemption of the latter type, but the moral abhorraent, and witness must be avaialble 111111

 [42]. I.R.C. § 1402(g)(1) (2012).

 [43]. Id. § 5000A(d)(2)(B)(ii)(II).

 [44]. See Charlene Galarneau, Health Care Sharing Ministries and Their Exemption from the Individual Mandate of the Affordable Care Act, 12 J. Bioethical Inquiry 269, 280 (2015) (“Notably, a commitment to share medical expenses is also the core ethical principle underlying secular health insurance. . . . [W]hat does it mean to share medical expenses in accordance with those beliefs?”). Cf. Wisconsin v. Yoder, 406 U.S. 205, 215 (1972) (“A way of life, however virtuous and admirable, may not be interposed as a barrier to reasonable state regulation . . . if it is based on purely secular considerations; to have the protection of the Religion Clauses, the claims must be rooted in religious belief.”).

 [45]. See Kimberly Leonard, Christians Find Their Own Way to Replace Obamacare, U.S. News & World Rep. (Feb. 23, 2016, 1:12 PM), http://www.usnews.com/news/articles/2016-02-23/
membership-for-health-sharing-ministries-soars-under-obamacare (“People say they join health sharing ministries for a variety of reasons—whether they’ve found exchange plans to be prohibitively expensive or because they prefer sharing medical costs with others who hold their faith and will pray for their medical hardships. Some say they don’t want to pay into a plan that violates their religious objections, such as those that cover abortions or emergency contraception, the latter of which is obligated under Obamacare for all private plans.”).

 [46]. See, e.g., Holly Johnson, Why We’re Joining a Healthcare Sharing Ministry, Club Thrifty (Dec. 10, 2014), http://clubthrifty.com/joining-healthcare-sharing-ministry (“[T]he fact is, when we shopped around for health insurance this year, we discovered that healthcare sharing ministries simply offered the best value out there.”).

 [47]. See Galarneau, supra note 44, at 278–79.

 [48]. Kate Shellnutt, Bearing Burdens After Obamacare: The Future of Christian Healthcare Sharing, Christianity Today (Feb. 2, 2017), http://www.christianitytoday.com/ct/2017/february-web-only/future-of-christian-healthcare-ministries-after-obamacare.html.

 [49]. See Sean Parnell, Make That Five Sharing Ministries (Dec. 13, 2013), Self-Pay Patient, http://selfpaypatient.com/2013/12/13/make-that-five-sharing-ministries. The PPACA precludes members of later-established ministries from circumventing the mandate, regardless of the sincerity of belief or the actual ability of the ministry to satisfy claims. An alternative form of non-compliant ministry also exists, in which membership fees are redistributed to offset tax penalties charged for failure to carry insurance, but this curious subset is beyond the scope of this paper. See No Penalties for M.C.S. Members, M.C.S. Medical Cost Sharing, http://www.medicalcostsharing.com/penalties-m-c-s-members (last visited Jan. 3, 2018).

 [50]. See Hillary Rosner, Opinion, Should I Lie About My Beliefs to Get Health Insurance?, N.Y. Times (Dec. 10, 2016), http://nyti.ms/2xXmpVr.

 [51]. See Chuck Fager, Bearing (Some but Not All) Burdens, Christianity Today (Oct. 2, 2000), http://www.christianitytoday.com/ct/2000/october2/17.24.html.

 [52]. Health Care Sharing Ministry Exemptions, Obamacare Facts, http://obamacarefacts.com/
healthcare-sharing-ministry-exemptions (last visited Jan. 3, 2018) (“If you don’t share the Biblical faith of a HCSM, then strongly consider another health coverage type. If you do, you may have just found a potentially cost effective health care option.”). Cf. Christen Varley, Comment to Ask a Zenefits Advisor: Are Health Care Sharing Ministries Exempt from ACA Penalties?, Zenefits, https://www.zenefits.com/blog/ask-bud-health-care-sharing-ministries/#comment-2402353068 (last visited Jan. 3, 2018) (“I am obligated to point out Liberty HealthShare does not inquire of it’s [sic] members religious affiliation and or church/temple membership, support, or attendance. . . . We expect members to care for their bodies as creations of God and to respect the rights of all to worship the God of the bible. We made the conscious decision to broaden the availability of HCS to more Americans.”).

 [53]. E.g., Medi-Share, Program Guidelines & Frequently Asked Questions 12 (2017), https://mychristiancare.org/globalassets/media/medi-share/medi-share-guidelines.pdf. The Medi-Share Guidelines require that:

All adult Members age 18 and older must attest to a personal relationship with the Lord Jesus Christ. A church leader may be interviewed to verify their testimony. Adult Members profess the following Statement of Faith to qualify for Medi-Share membership: I believe that there is only one God (Deuteronomy 6:4) eternally existing in three Persons: the Father, Jesus Christ the Son, and the Holy Spirit (Matthew 28:19). I believe Jesus is God, in equal standing with the Father and the Holy Spirit (Colossians 1:15-20, 2:9). I believe the Bible is God’s written revelation to man and is verbally inspired, authoritative and without error (2 Timothy 3:16-17). . . . All Members agree to the following: Live by biblical standards[; b]elievers are to bear one another’s burdens[; a]ttend and actively support a fellowship of believers regularly.

Id. at 12–13.

 [54]. E.g., Samaritan Ministries, Guidelines for Health Care Sharing 14–15 (2017), https://samaritanministries.org/uploads/documents/2017-02-guidelines.pdf. Samaritan requires that members:

A. Be a professing Christian according to Biblical principles. . . .

B. Be in agreement with the following member statement of faith:

I believe in the triune God of the Bible. He is one God Who is revealed in three distinct Persons—God the Father, God the Son, and God the Holy Spirit. I believe Jesus Christ was God in the flesh—fully God and fully man. . . .

C. Attend a Christian church regularly (at least three out of four weeks per month that your health or weather permits). . . .

D. Believe that you are to bear one another’s burdens as taught in the Bible. . . .

L. Have your pastor or church leader sign a statement confirming that you meet the above requirements.

Id.

 [55]. E.g., Christian Healthcare Ministries, Christian Healthcare Ministries Guidelines 4 (2016), http://www.chministries.org/downloads/CHM_Guidelines_2016_V2.pdf. The Christian Healthcare Ministries membership requirements state that:

If you are a Christian, you can be a member of Christian Healthcare Ministries. A Christian is a person who embraces and follows the teaching of the New Testament in its entirety. Additionally, you must: abstain from the use of tobacco and the illegal use of drugs (I Corinthians 6:19-20)[;] follow biblical principles regarding the use of alcohol[;] attend group worship regularly as health permits (Hebrews 10:25) . . . .

Id.

 [56]. Altrua was founded in 2000, but its post-PPACA acquisition of Blessed Assurance Bulletin, a small Texas sharing ministry in business since 1997, made the “December 31, 1999 date, chosen by the drafters . . . no longer an issue.” Sean Parnell, Altrua Qualifies for Obamacare Exemption, Plus More on CMF Curo, Self-Pay Patient (Oct. 15, 2014), http://selfpaypatient.com/2014/10/15/ altrua-qualifies-for-obamacare-exemption-plus-more-on-cmf-curo. Altrua’s narrow escape via this acquisition is discussed in more detail infra at note 102 and accompanying text.

 [57]. Liberty HealthShare Sharing Guidelines, Liberty HealthShare 5 (2017), https://www.libertyhealthshare.org/Content/Sharing-Guidelines.pdf. The guidelines provide that:

In order to become and remain a Sharing Member, a person must . . . : A. Observe Christian Standards. The modern medical cost sharing movement was begun by a small band of Christians to practically demonstrate how to fulfill the command by Christ to ‘bear one another’s burdens’. In accordance with that practice, every member of Liberty HealthShare is expected to: 11111111111111111111111111111111standards in my daily life and will continue to do so.”11111111111111111111111111111111111111111Strive to live in accordance with biblical principles. Honor the biblical teaching to ‘share one another’s burdens’ (Gal. 6:2). Participate regularly in worship or prayer. B. Accept Our Shared Beliefs. . . . It is our spiritual duty to God and our ethical responsibility to ourselves and the other members of our cost-sharing ministry to care for our bodies and maintain our health. . . . At the core of what we do, and how we relate to and engage with one another as a community of people, is a set of common beliefs. Our Statement of Shared Beliefs is as follows: 1. We believe that our personal rights and liberties originate from God and are bestowed on us by God, and are not concessions granted to us by governments or men. 2. We believe every individual has a fundamental religious right to worship the God of the Bible in his or her own way. 3. We believe it is our biblical and ethical obligation to assist our fellow man when they are in need according to our available resources and opportunity. 4. We believe it is our spiritual duty to God and our ethical duty to others to maintain a healthy lifestyle and avoid foods, behaviors or habits that produce sickness or disease to ourselves or others. 5. We believe it is our fundamental right of conscience to direct our own healthcare, in consultation with physicians, family or other valued advisors, free from government dictates, restraints and oversight. These beliefs form the religious and ethical basis for our interaction and relationship as a community. . . . C. Maintain a Godly Lifestyle. Members highly value the spiritual principle that our bodies are gifts from God and we must respect and care for our physical bodies. Further, we have an ethical obligation to our fellow members to live healthy and make wise choices so as not to place any unnecessary burdens on those who are sharing with us. As a community of people we try our best to live out Jesus Christ’s mandates.

Id. at 5–6.

 [58]. Randall Sluder, Comment to What Do You Know About Christian Healthcare Ministries as a Solution to the Health Insurance Problem? (January 2015 Update), Junior Ganymede (Jan. 29, 2015), http://www.jrganymede.com/2013/12/30.

 [59]. Altrua HealthShare, Application 7, http://www.pohealthcare.com/application_
packet.pdf. Altrua requires a pledge, in full, that:

Because of the biblical beliefs listed in the Statement of Standards, I chose to live a clean and wholesome life, and share in the following standards and convictions with members of Altrua HealthShare: I believe in keeping my body clean with proper nutrition and consuming foods in moderation. I believe that the use of tobacco, illicit drugs, and excessive alcohol consumption is harmful to body and soul. I do not currently use and have not used tobacco or illegal drugs in the past 12 months. According to the word of God sexual relations outside the bond of marriage between a man and a woman are morally wrong. I believe that abortion is wrong, except in special circumstances such as rape or serious injury to the mother, and then, only after careful consideration by all concerned. I believe that I am obligated to provide and care for my family and that abuse of any kind of a family member or anyone else is wrong. I currently meet each of these standards in my daily life and will continue to do so.

Id. (emphasis added).

 [60]. Altrua HealthShare, Membership Guidelines 2 (2017), https://altruahealthshare.org/ pdfs/ahs_membership_guidelines_2017-2.pdf.

 [61]. I.R.C. § 5000A(d)(2)(B)(ii)(II) (2012).

 [62]. For a full discussion of the grandfathering issue, see infra Part II.B.

 [63]. A review of groups which have obtained Social Security exemptions—thereby making their members eligible for the religious conscience exemption—found that only Anabaptists and the Amish have qualified. See Jeffrey R. Mullen, Note, Religion and the PPACA: An Analysis of Non-Secular Line Drawing Within the Health Insurance Mandate, 14 Rutgers J.L. & Religion 149, 178–80 (2012). This aligns with the intent of Congress in creating a very narrow exemption. See Wisconsin v. Yoder, 406 U.S. 205, 222–23 n.11 (1972) (“The history of the exemption shows it was enacted with the situation of the Old Order Amish specifically in view.”).

 [64]. See Liberty Univ., Inc. v. Geithner, 753 F. Supp. 2d 611, 641 (W.D. Va. 2010), vacated, 671 F.3d 391 (4th Cir. 2011).

 [65]. See Liberty Univ., Inc. v. Lew, 733 F.3d 72, 101–03 (4th Cir. 2013).

 [66]. Id. at 102.

 [67]. See id. at 101 (citing United States v. Lee, 455 U.S. 252, 260–61 (1982)); Liberty Univ., 753 F. Supp. 2d at 641.

 [68]. Liberty Univ., 733 F.3d at 101 (citing Bd. of Educ. of Kiryas Joel Vill. Sch. Dist. v. Grumet, 512 U.S. 687, 706–07 (1994)).

 [69]. Id. (citing Larson v. Valente, 456 U.S. 228, 246–47 & n. 23 (1982)).

 [70]. Id.

 [71]. Id. at 101–02 (citing Lemon v. Kurtzman, 403 U.S. 602, 612–13 (1971)).

 [72]. Id. at 102.

 [73]. Id. Relying on Justice O’Connor’s suggestion that primary effect and entanglement inquiries could be dealt with as one, the court also found that the religious conscience objector exemption was constitutional, as the secular purpose and primary effect of the PPACA were each to guarantee health coverage of some sort. See id. at 101–02 (citing Zelman v. Simmons-Harris, 536 U.S. 639, 668 (2002) (O’Connor, J., concurring)).

 [74]. See id. at 102.

 [75]. Liberty Univ., Inc. v. Geithner, 753 F. Supp. 2d 611, 641 (W.D. Va. 2010) (internal quotation marks omitted).

 [76]. Id.

 [77]. Steven Shavell, On Optimal Legal Change, Past Behavior, and Grandfathering, 37 J. Legal Stud. 37, 38­–39, 69–70 (2008).

 [78]. Remarks, supra note 17.

 [79]. Janelle Rucker, Health Care Ministries Keep Close Eye on Legislation, Roanoke Times (Apr. 7, 2010), at A12.

 [80]. Kyle D. Logue, Tax Transitions, Opportunistic Retroactivity, and the Benefits of Government Precommitment, 94 Mich. L. Rev. 1129, 1134 (1996).

 [81]. Id. at 1179.

 [82]. Louis Kaplow, An Economic Analysis of Legal Transitions, 99 Harv. L. Rev. 509, 607 (1986).

 [83]. See President Barack Obama, Remarks by the President to the Annual Conference of the American Medical Association (June 15, 2009), https://obamawhitehouse.archives.gov/the-press-office/remarks-president-annual-conference-american-medical-association.

 [84]. See Liberty Univ., Inc. v. Lew, 733 F.3d 72, 101 (4th. Cir. 2013).

 [85]. Social Security Amendments of 1965, Pub. L. No. 89-97, § 319, 79 Stat. 286, 391 (codified as amended at I.R.C. § 1402(g)(1)(E) (2012)). See also I.R.C. § 5000A(d)(2).

 [86]. See Social Security Amendments of 1954, Pub. L. No. 83-761, 68 Stat. 1052 (codified as amended at 42 U.S.C. §§ 402–405, 408–411, 413–418, 420–422).

 [87]. Rev. Rul. 68-498, 1968-2 C.B. 377, 1968 IRB LEXIS 256.

 [88]. See Social Security Amendments of 1954 passim.

 [89]. Amish resistance to Social Security was the driving force behind the 1965 religious conscience objection. Believing that “to pay social security tax . . . is to admit that the government has a responsibility for aged Amish members, and to admit this is to deny the faith,” a resistance movement arose; the I.R.S.’s 1961 seizure and sale of farm animals to compensate for unpaid taxes drew such opprobrium that enforcement was curtailed and a legislative accommodation developed. John. A. Hostetler, The Amish and the Law: A Religious Minority and Its Legal Encounters, 41 Wash. & Lee L. Rev. 33, 44–45 (1984).

 [90]. Cf. W. Wesley Hill, Thou Shalt Opt Out: Reforming the Religious Conscience Exemption from Social Security and the Affordable Care Act Based on State Experience, 43 U. Mem. L. Rev. 659, 661 (2013) (“Among the conditions of the exemption is that the individual belong to a religious sect that has a support system in place for dependent members similar to Social Security. Because of this and a host of other requirements, the exemption is foreclosed to the overwhelming majority of the public.”).

 [91]. See supra text accompanying note 75.

 [92]. John E. McDonough, Inside National Health Reform 122 (2011).

 [93]. S. 1324, 111th Cong. (2009).

 [94]. See S. 1796, 111th Cong. (2009). The committee report for Senator Baucus’s bill suggests that a sincerity test was intended to be inherent. See S. Rep. 111-89, at 52 (2009) (“Exemptions from the penalty are also allowed for . . . individuals with sincerely held beliefs who participate in health arrangements provided by established religious organizations (e.g., those participating in Health Sharing Ministries) . . . .”).

 [95]. Robert Y. Baldwin, Healthcare Sharing and Healthcare Reform—A Position Statement from Christian Care Ministry, Inc. (CCM) in Response to Filing of Senate Bill on Healthcare, PRWeb (Sept. 21, 2009), http://www.prweb.com/releases/Medi/share/prweb2903324.htm.

 [96]. Id.

 [97]. See Sluder, supra note 58. See also The Kirtland Sharing Alliance, Utah Division Corporations & Com. Code, https://secure.utah.gov/bes/details.html?entity=4756607-0141 (last visited Jan. 3, 2018) (listing the corporate establishment date of The Kirtland Sharing Alliance, another Altrua predecessor corporation, as June 1, 2000).

 [98]. Bd. of Educ. of Kiryas Joel Vill. Sch. Dist. v. Grumet, 512 U.S. 687, 705 (1994).

 [99]. Id. at 705–06 (quoting Hobbie v. Unemp’t Appeals Comm’n of Fla., 480 U.S. 136, 144–45 (1987)).

 [100]. Liberty Univ., Inc. v. Lew, 733 F.3d 72, 101 (4th Cir. 2013) (citing Kiryas Joel, 512 U.S. at 706–07).

 [101]. Id. at 101.

 [102]. See Sluder, supra note 58. Blessed Assurance Bulletin had served as few as forty families, but it had done so since before 2000; Altrua’s acquisition of it thereby enabled its own members to qualify for a PPACA exemption. See Fager, supra note 51.

 [103]. Although this Note will argue infra in Section III.A that Muslims, and not Mormons, may be most disadvantaged by the cutoff date, there is no evidence to suggest that Muslim insurance alternatives were intended to be either included or excluded by Congress or the CCM; commentators appear to have realized that some Muslim insurance programs might count as sharing ministries only at the time the PPACA was passing, in March 2010. See Steve Gilbert, Islam Q&A: Health Insurance is “Haraam, Sweetness & Light (Mar. 22, 2010), https://web.archive.org/web/20170630110718/ http://sweetness-light.com/archive/health-insurance-is-forbidden-under-islam; WordWayze, Amish, Muslims to Be Excused from Obamacare Mandate?, Am. Thinker (Mar. 24, 2010), http://www.americanthinker.com/ blog/2010/03/amish_muslims_to_be_excused_fr.html.

 [104]. Larson v. Valente, 456 U.S. 228, 252 (1982).

 [105]. Id. at 246.

 [106]. Id. at 253–55.

 [107]. Id. at 247 (citations omitted).

 [108]. See 42 U.S.C. § 18011(a)(2) (2012) (“[W]ith respect to a group health plan or health insurance coverage in which an individual was enrolled on March 23, 2010, this subtitle and subtitle A (and the amendments made by such subtitles) shall not apply to such plan or coverage, regardless of whether the individual renews such coverage after March 23, 2010.”).

 [109]. See Robin Fretwell Wilson, The Calculus of Accommodation: Contraception, Abortion, Same-Sex Marriage, and Other Clashes Between Religion and the State, 53 B.C. L. Rev. 1417, 1501–02 (2012).

 [110]. See Samuel T. Grover, Religious Exemptions to the PPACA’s Health Insurance Mandate, 37 Am. J.L. & Med. 624, 648–49 (2011).

 [111]. Kathleen A. Brady, The Distinctiveness of Religion in American Law: Rethinking Religion Clause Jurisprudence 258–59 (2015).

 [112]. Id. at 260.

 [113]. See Liberty Univ., Inc. v. Lew, 733 F.3d 72, 99–102 (4th Cir. 2013).

 [114]. See id. at 86.

 [115]. See, e.g., Corp. of the Presiding Bishop of the Church of Jesus Christ of Latter-Day Saints v. Amos, 483 U.S. 327, 334 (1987).

 [116]. Walz v. Tax Comm’n of N.Y., 397 U.S. 664, 669 (1970).

 [117]. Liberty Univ., 733 F.3d at 100, 103. See also Sherbert v. Verner, 374 U.S. 398, 409–10 (1963) (“Nor do we, by our decision today, declare the existence of a constitutional right to unemployment benefits on the part of all persons whose religious convictions are the cause of their unemployment.”).

 [118]. See Grover, supra note 110, at 644 (“A court will likely question why [a] group [claiming a Free Exercise violation] now needs a health care sharing ministry when it did not have one, or a predecessor to one, in existence prior to January 1, 2000. If indeed there is a religious group in existence that can convincingly answer these questions, then it is within the court’s power to strike down the grandfather clause . . . which is certainly severable from the rest of the exemption and from the rest of the PPACA.”).

 [119]. See supra Part II.B.

 [120]. This proposition has been advanced before, but on the assumption that some PPACA-compliant sharing ministries would be open to followers of Islam. See Mullen, supra note 63, at 174. See also Gilbert, supra note 103; WordWayze, supra note 103.

 [121]. Even the most conservative of commentators appear to concede this point. See Eric Burns, Muslims Exempt from Obamacare? Separating Rumor from Reality, Frontpage Mag. (Oct. 13, 2011), https://www.frontpagemag.com/fpm/108489/muslims-exempt-obamacare-eric-burns. It is nevertheless critical to note that the existence of a “Muslim exemption” within the PPACA is a persistent rumor, and a falsehood. The Act contains no such exemption in either fact or practice but rather, as this paper seeks to demonstrate, it may instead actually unconstitutionally discriminate against Muslims. See David Mikkelson, Muslims Exempt from Obamacare Requirements, Snopes (Apr. 13, 2016), http://www.snopes.com/politics/medical/exemptions.asp.

 [122]. Mullen, supra note 63, at 174.

 [123]. AIG Offers First Takaful Homeowners Insurance Product for U.S., Ins. J. (Dec. 2, 2008), http://www.insurancejournal.com/news/national/2008/12/02/95930.htm.

 [124]. Risk Specialists Companies Announces First Takaful Homeowners Product for U.S., BusinessWire (Dec. 1, 2008, 10:24 AM), http://www.businesswire.com/news/home/20081201005672/
en/Risk-Specialists-Companies-Announces-Takaful-Homeowners-Product.

 [125]. See Mullen, supra note 63, at 180 (“Muslims seeking to be exempt from the PPACA’s individual mandate for religious purposes will have to qualify under the health care sharing ministries exemption. This is the very premise of takaful, a type of Islamic insurance where members contribute money into a pooling system to guarantee each other against loss or damage.”).s policies, but without a health compoenent. rican i catered to Muslims, while the wider law opened their ability to ated Seanto.

 [126]. See, e.g., Jeffrey Imm, Exclusive: AIG Defies U.S. Taxpayers by Promoting Sharia in America, Fam. Security Matters (Dec. 5, 2008), http://www.familysecuritymatters.org/ publications/detail/exclusive-aig-defies-us-taxpayers-by-promoting-sharia-in-america.

 [128]. See Murray v. Geithner, 763 F. Supp. 2d 860, 870 (E.D. Mich. 2011), aff’d on separate basis sub nom. Murray v. U.S. Dep’t of Treasury, 681 F.3d 744 (6th Cir. 2012). The date of Lexington’s withdrawal from the takaful market is unclear, but this foray into Sharia-compliant insurance formed the heart of an extensively-litigated post-PPACA Establishment Clause challenge to the Treasury Department’s bailout of AIG under the Emergency Economic Stabilization Act of 2008. See generally id.

 [129]. One company does now offer homeowner’s policies, but without a health component. See Homeowner’s Takaful, Zayan Takaful, http://www.zayantakaful.com/products.php (last visited Jan. 3, 2018).

 [130]. One Christian commentator, former pastor Drew Zahn, realized the exemption’s potential limitations for Muslim takaful adherents almost immediately after the PPACA’s passage. See Drew Zahn, Does Your Faith Free You from Forced Obamacare?: Why Amish Won’t Have to Purchase Insurance, but Muslims Will Cry Foul, WorldNetDaily (Apr. 6, 2010, 8:34 PM), http://www.wnd.com/2010/04/137221. Contra Gilbert, supra note 103; WordWayze, supra note 103 (raising the possibility that Muslims would be exempt).

 [131]. 42 U.S.C. § 2000bb-1 (2016).

 [132]. See Emp’t Div. v. Smith. 494 U.S. 872, 878–81 (1990). See also United States v. Lee, 455 U.S. 252, 263 n.3 (1982) (Stevens, J., concurring).

 [133]. See Burwell v. Hobby Lobby Stores, Inc., 134 S. Ct. 2751, 2791 (2014) (Kennedy, J., concurring). See also Sherbert v. Verner, 374 U.S. 398, 403–04 (1963).

 [134]. City of Boerne v. Flores, 521 U.S. 507, 534 (1997).

 [135]. Hobby Lobby, 134 S. Ct. at 2751.

 [136]. See id. at 2762–63.

 [137]. Id. at 2785.

 [138]. Id. at 2782.

 [139]. Caroline Mala Corbin, Deference to Claims of Substantial Religious Burden, 2016 U. Ill. L. Rev. Online 10, 13.

 [140]. Michael C. Dorf, Incidental Burdens on Fundamental Rights, 109 Harv. L. Rev. 1175, 1213–14 (1996).

 [141]. See, e.g., Chad Flanders, Substantial Confusion About “Substantial Burdens, 2016 U. Ill. L. Rev. Online 27, 28–29.

 [142]. See Hobby Lobby, 134 S. Ct. at 2778–79 (“[I]n these cases, the [plaintiffs] sincerely believe that providing the insurance coverage demanded by the HHS regulations lies on the forbidden side of the line, and it is not for us to say that their religious beliefs are mistaken or substantial.”).

 [143]. Michael A. Helfand, Identifying Substantial Burdens, 16 U. Ill. L. Rev. 1771, 1790 (2016).

 [144]. See Dorf, supra note 140, at 1216–17.

 [145]. Id. at 1216.

 [146]. See id. at 1217.

 [147]. Id.

 [148]. For discussion of the disparate impact on the minority faith, see infra beginning at Part III.B.

 [149]. Individual Shared Responsibility Payment—Reporting and Calculating the Payment, IRS (last updated Dec. 22, 2017), https://www.irs.gov/affordable-care-act/individuals-and-families/aca-individual-shared-responsibility-provision-calculating-the-payment. See also supra text accompanying note 37.

 [150]. Burwell v. Hobby Lobby Stores, Inc., 134 S. Ct. 2751, 2799 (2014) (Ginsberg, J., dissenting) (“[T]oday’s decision elides entirely the distinction between the sincerity of a challenger’s religious belief and the substantiality of the burden placed on the challenger.”).

 [151]. Id.

 [152]. See Amy J. Sepinwall, Conscience and Complicity: Assessing Pleas for Religious Exemptions in Hobby Lobby’s Wake, 82 U. Chi. L. Rev. 1897, 1924 (2015) (“A mild preference to abstain will not do; instead, it must be the case that contributing would cause the objector to experience a deep rift in his self, so much so that he would be willing to incur some penalty to avoid betraying his convictions.”).

 [153]. Braunfeld v. Brown, 366 U.S. 599, 605 (1961).

 [154]. Nat’l Fed’n of Indep. Bus. v. Sebelius, 567 U.S. 519, 574 (2012).

 [155]. See Hobby Lobby, 134 S. Ct. at 2778–79.

 [156]. See id.

 [157]. I.R.C. § 1402(g)(1) (2012) (emphasis added).

 [158]. 45 C.F.R. § 147.131(b)(1) (2016) (emphasis added).

 [159]. Compare 45 C.F.R. § 800.602(a) (“OPM will ensure that at least one of the MSP issuers on each Exchange in each State offers at least one MSP option that does not provide coverage of services described in section 1303(b)(1)(B)(i) of the Affordable Care Act.”), with Obamacare Abortion Resources, Abortion Obamacare, http://www.obamacareabortion.com/resources (last visited Jan. 3, 2018) (“If you are dissatisfied with your state insurance choices, you may consider a healthcare sharing ministry. While healthcare sharing does not fix the problem of abortion funding in Obamacare, it does provide an option that respects conscience and moral values.”).

 [160]. See Hania Masud, Comment, Takaful: An Innovative Approach to Insurance and Islamic Finance, 32 U. Pa. J. Int’l L. 1133, 1140 (2011) (“Because insurance typically involves risk, uncertainty, and interest, it poses a unique challenge to Islamic law. Under traditional Islamic law, the game-oriented risk profiles of insurance would not meet the requirements of a legally-valid contract between parties.”).

 [161]. Brady, supra note 111, at 269.

 [162]. See Burwell v. Hobby Lobby Stores, Inc., 134 S. Ct. 2751, 2780 (2014). See also supra text accompanying notes 136–38.

 [163]. Hobby Lobby, 134 S. Ct. at 2758.

 [164]. Id. at 2786 (Kennedy, J., concurring).

 [165]. See Statement by the President on the Anniversary of the Affordable Care Act, 2013 Daily Comp. Pres. Doc. 180 (Mar. 23, 2013) (“Because of the Affordable Care Act, insurance companies will no longer have unchecked power to cancel your policy, deny you coverage, or charge women more than men. And soon, no American will ever again be denied care or charged more due to a pre-existing condition, like cancer or even asthma. . . . [and] private plans will compete to save middle class families money.”).

 [166]. The shared responsibility payment was designed to ensure that individuals could not simply wait until they were unhealthy to purchase the coverage which, by law, would now have to be sold inclusive of pre-existing conditions. Congress expected that millions of “citizens may lawfully choose to pay [it] in lieu of buying health insurance.” Nat’l Fed’n of Indep. Bus. v. Sebelius, 567 U.S. 519, 568 (2012).

 [167]. Gonzales v. O Centro Espirita Beneficente Uniao do Vegetal, 546 U.S. 418, 430–31 (2006).

 [168]. David Brooks, Opinion, The Incredible Shrinking Obamacare, N.Y. Times (Sept. 6, 2016), https://nyti.ms/2cg1WTk.

 [169]. Early commentary appears to have expected exempted groups to be both static and small. See, e.g., Jessica Donoghue, New Development, PeopleV.US v. Obama, 12 Rutgers J.L. & Religion, 202, 207 (2010) (“The second religious exemption under the PPACA is for individuals who belong to a ‘Health Care Sharing Ministry.’ . . . A limited group of individuals qualify for this exemption.”).E-mail from er, lries 14-15 (Aug. 015).y and Culturetion,”ion and Affordable Care Actin exemption that is open, practically and E-mail from er, lries 14-15 (Aug. 015).y and Culturetion,”ion and Affordable Care Actin exemption that is open, practically and

 [170]. See, e.g., Paul Demko & Rachana Pradhan, Trump’s War of Attrition Against Obamacare, Politico (July 21, 2017, 5:19 AM), http://www.politico.com/story/2017/07/21/trumps-war-of-attrition-against-obamacare-240777; Haeyoun Park, We’re Tracking the Ways Trump Is Scaling Back Obamacare. Here Are 12., N.Y. Times (Oct. 12, 2017), https://nyti.ms/2kIb9sO; Margot Sanger-Katz, Drop in Late Obamacare Enrollment Appears to Be a Trump Effect, N.Y. Times: Upshot (Feb. 3, 2017), https://nyti.ms/2k5jvGa.

 [171]. Shelby Livingston, Insurers Brace for Repeal of Individual Mandate, Mod. Healthcare (Dec. 18, 2017), http://www.modernhealthcare.com/article/20171218/NEWS/171219884.

 [172]. Compare Timothy Stoltzfus Jost, Loopholes in the Affordable Care Act: Regulatory Gaps and Border Crossing Techniques and How to Address Them, 5 St. Louis U. J. Health L. & Pol’y 27, 43 (2011), with Fager, supra note 51 (estimating roughly 130,000 members in 2000).

 [173]. See History, Alliance Health Care Sharing Ministries, http://www.healthcaresharing.org/about-us/#history (last visited Jan. 3, 2018).

 [174]. See Dan Mangan, IRS: More Paid Obamacare Fine than Expected, CNBC (July 20, 2015, 5:29 PM), http://www.cnbc.com/2015/07/20/irs-more-paid-obamacare-fine-than-expected.html (estimating that about 4% of those who paid penalties in 2015 were, in fact, entitled to an exemption of some sort).

 [175]. See, e.g., Healthcare Reform, Christian Care Ministry, https://mychristiancare.org/medi-share/what-is-medishare/healthcare-reform (last visited Jan. 3, 2018) (“Medi-Share members are exempt from the mandate to purchase insurance or face financial penalties.”).

 [176]. See, e.g., Leonard, supra note 45 (“Jennifer, whose family’s membership in the ministry means they won’t incur the $2,085 maximum fine families have to pay for going uninsured in 2016, estimates that members have shared $30,000 of her family’s medical bills.”).

 [177]. See Jessica C. Barnett & Marina Vornovitsky, Health Insurance Coverage in the United States: 2015, U.S. Census Bureau 7 (2016), https://www.census.gov/content/dam/Census/library/
publications/2016/demo/p60-257.pdf. Although the government does not report the subset of uninsured Americans who claim exemption from the individual mandate—such as through sharing ministry membership—TurboTax estimates that 70 percent of uninsured filers pay no penalty because of their exempt status. See Sarah Ferris, TurboTax: Most Uninsured Escaped ObamaCare Penalty (Feb. 23, 2016, 9:38 AM), Hill, http://thehill.com/policy/healthcare/270385-turbotax-most-uninsured-people-exempt-from-obamacare-penalty-in-2015.

 [178]. About 12.2 million Americans purchased marketplace coverage in 2017. See Health Insurance Marketplaces 2017 Open Enrollment Period Final Enrollment Report: November 1, 2016– January 31, 2017, Centers for Medicare & Medicaid Services (Mar. 15, 2017), https://www.cms.gov/Newsroom/MediaReleaseDatabase/Fact-sheets/2017-Fact-Sheet-items/2017-03-15.html [hereinafter 2017 Enrollment Report].

 [179]. See Leonard, supra note 45. See also Stephanie Armour, Fewer Uninsured Face Fines as Health Law’s Exemptions Swell, Wall St. J. (Aug. 6, 2014, 10:30 PM), https://www.wsj.com/
articles/fewer-uninsured-face-fines-as-health-laws-exemptions-swell-1407378602 (estimating that 90 percent of uninsured Americans will qualify for an exemption from the mandate’s penalty).

 [180]. Cf. Remarks at a Listening Session with Health Insurance Industry Leaders, 2017 Daily Comp. Pres. Doc. 144 (Feb. 27, 2017) (“Since Obamacare went into effect, nearly half of the insurers are stopped and have stopped from participating in the Obamacare exchanges. It has gotten so bad that nearly 20 million Americans have chosen to pay the penalty, or received an exemption rather than buy insurance. That’s something that nobody has ever heard of or thought could happen, and they’re actually doing that rather than being forced to buy insurance.”).

 [181]. Priests for Life v. U.S. Dep’t of Health & Human Servs., 808 F.3d 1, 24 (D.C. Cir. 2015) (Kavanaugh, J., dissenting) (quoting Sherbert v. Verner, 374 U.S. 398, 408–09 (1963)). See also Cutter v. Wilkinson, 544 U.S. 709, 720 (2005) (citation omitted) (“Properly applying [the Religious Land Use and Institutionalized Persons Act of 2000], courts must take adequate account of the burdens a requested accommodation may impose on nonbeneficiaries . . . .”).

 [182]. Burwell v. Hobby Lobby Stores, Inc., 134 S. Ct. 2751, 2790 (2014) (Ginsburg, J., dissenting).

 [183]. See 2017 Enrollment Report, supra note 178.

 [184]. Tex. Monthly, Inc. v. Bullock, 489 U.S. 1, 15 (1989) (Brennan, J., plurality opinion) (quoting Corp. of the Presiding Bishop of the Church of Jesus Christ of Latter-Day Saints v. Amos, 483 U.S. 327, 348 (1987) (O’Connor, J., concurring)).

 [185]. Boone v. Boozman, 217 F. Supp. 2d 938, 941–43 (E.D. Ark. 2002).

 [186]. Id. at 951 (citing Sherr v. Northport-East Northport Union Free Sch. Dist., 672 F. Supp. 81, 90–91 (E.D.N.Y. 1987)).

 [187]. Id. at 952.

 [188]. But see Grover, supra note 110, at 643–44 (arguing that the religious conscience exemption should be subsumed within that granted to sharing ministries).

 [189]. 42 U.S.C. § 2000bb (2012) (emphasis added).

 [190]. See Peter Steinfels, Clinton Signs Law Protecting Religious Practices, N.Y. Times (Nov. 17, 1993), http://www.nytimes.com/1993/11/17/us/clinton-signs-law-protecting-religious-practices.html (noting bipartisan sponsorship and the Senate’s vote of 97-3).

 [191]. Platform Comm., Republican Platform 2016, at 12 (2016).

 

Is California Committed?: Why California Should Take Action to Address the Shortcomings of its Assisted Outpatient Commitment Statute – Note by Andrea Reynoso

From Volume 88, Number 4 (May 2015)
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The history of the treatment of mental illness in the United States is anything but simple. While both social and scientific understanding of mental illness have developed tremendously in recent decades, there remain significant barriers to implementing effective treatment and rehabilitation programs for people with mental illness. Inherent in this intersection of law and mental health is the delicate balance between preserving liberty and autonomy interests on the one hand, and providing for individual and societal safety on the other. This balance is not easily achieved and remains the core debate surrounding much of today’s mental health legislation.


 

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Runaway Preemption: The Reckless Doctrine of Pliva and Mutual Pharmaceutical – Note by Michael E. Bowlus

From Volume 88, Number 4 (May 2015)
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In March 2014, Gordon Johnston issued an urgent warning to members of Congress: the Food and Drug Administration was “[d]isregarding decades of regulatory stability” by proposing a new regulation that “raises patient safety concerns and threatens the system that created thousands of affordable options for consumers.” Johnston, himself a former deputy director at the FDA, was joined at a press briefing by economist Alex Brill, who estimated that the proposed regulation, if approved, would raise annual U.S. health care costs by $4 billion. 

Just what, exactly, was the FDA proposing to do? In the Agency’s words, it sought to “clarify procedures” allowing drug manufacturers “to change . . . product labeling to reflect certain types of newly acquired information.” In plain English, the ultimate consequence of the rule would be explicitly to permit generic drug manufacturers to update their labels with new safety warnings on a temporary basis, pending subsequent agency approval. Under current regulations, brand-name drug manufacturers are already able to update their warning labels in a similar fashion. However, the Agency has taken different positions over the years regarding whether generic drug manufacturers may update their labels. The proposed rule, announced in November 2013, would eliminate the ambiguity by establishing parity between both types of drug manufacturers with respect to label updates.


 

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“The Dustbin of Quackery”? Senate Bill 1172 and the Legal Implications of Banning Reparative Therapy for Homosexual Minors – Note by Marlena McMurchie

From Volume 87, Number 6 (September 2014)
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On September 30, 2012, California became the first state in the nation to place restrictions on the practice of attempting to change an individual’s sexual orientation. The passage of this landmark legislation, known as Senate Bill (“SB”) 1172, set off a firestorm of protest, with multiple lawsuits being filed within twenty-four hours of the bill’s passage. Though the issue of SB 1172’s validity has been decided by the Ninth Circuit, which upheld the law in August 2013, other states are considering passage of similar measures, and many issues were debated minimally or not at all in the California cases. Thus, this Note seeks to examine the potential claims that may be brought on behalf of parents and children against these laws and how such challenges may be overcome. As it is thus far the only law of its kind, SB 1172 is treated as a case study and model in many parts of this Note, and some time is spent discussing the law itself in detail. For the purposes of analysis and simplicity, it is assumed that future laws will be substantively similar to SB 1172.


 

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The Defibrillation of NOTA: How Establishing Federal Regulation of Waitlist Eligibility May Save Organ Transplant Patients with Disabilities from Flat-Lining – Note by Danielle Richards

From Volume 87, Number 1 (September 2013)
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Imagine this: thirty-five-year-old identical twin males are admitted into a hospital for congestive heart failure. Neither twin smokes nor drinks. Neither has other underlying medical conditions. There is, however, one distinct difference between them: at birth, twin “A,” Alex, was delivered normally, but twin “B,” Brian, had his umbilical cord wrapped around his neck, causing oxygen deprivation and resulting in moderate mental disability. As adults, Alex is completely independent, but Brian is not, as he lives with his elderly parents. Both twins are stubborn, but a few times, Brian has reacted especially negatively when placed in new and stressful situations.

The twins have the same doctor who determines that both are equally sick, concluding that each will survive only with a heart transplant. Although it seems Alex can comply with postoperative treatment—first, with help from family and later, alone—Brian may not be able to comply by himself. His parents and his sister, however, are willing to provide Brian with the additional support he needs to comply, such as ensuring he takes his medication, follows other medical restrictions, and attends regular follow-up appointments. If Brian can comply with the postoperative treatment with or without help from his family, the doctor predicts Brian’s long-term prospects for life-prolongation will be the same as Alex’s prospects.

After evaluating the twins, the doctor has to decide independently whether to place each on the national heart transplant waitlist. Knowing the above, what should the doctor decide? Should Alex be placed on the heart transplant waitlist? Should Brian? Should the doctor consider Brian’s mental disability when making his decision? Should it matter that Brian’s parents and sisters have agreed to provide him with additional support?


 

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Gerontology and the Law: A Selected Annotated Bibliography: 2009-2011 Update – Bibliography by Judy K. Davis & Karen Skinner

From Volume 86, Number 6 (September 2013)
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This bibliography serves as the 2009–2011 update to Gerontology and the Law: A Selected Annotated Bibliography. First published in 1980 by Law Library Journal the bibliography has since been updated nine times between 1982 and 2010 in the Southern California Law Review. The original bibliography and the first five updates provided citations to a variety of books, articles, and other law related materials on various aspects of the law and gerontology. Starting with the sixth update, the style and content of the bibliography was changed in two ways: first, the bibliographers took a more selective approach in choosing resources to include and second, the bibliographers added annotations briefly describing the source after each citation.

For this update, the bibliographers chose a selection of scholarly books and articles discussing legal issues related to gerontology, aging, and the elderly in the United States published between the years 2009–2011. This bibliography does not include sources that are directed toward the general public, such as popular literature and self-help guides, and sources that do not deal with both law and gerontology. Other sources not included, some of which have been included in prior updates, are book reviews, newspaper articles, government documents, Congressional documents, conference proceedings, dissertations, and sources written in a language other than English. Although the focus of this 2009–2011 update is on the United States, a limited number of sources with an international or foreign perspective are included if deemed useful to researchers in the United States. Newer editions of older works are included if they were published between 2009–2011; however, if more than one edition was published between these dates, only the latest edition is included.

To locate sources to include in this bibliography, the bibliographers searched the following databases periodically from February 2013 to April 2013:

Ageline (produced by the American Association of Retired Person; searched via OvidSP or EBSCO) Journals and Law Reviews (Westlaw Classic database) Legal Resource Index (produced by the Information Access Company; searched via Westlaw Classic) Medline (produced by the National Library of Medicine; searched via OvidSP) Social Sciences Citation Index (produced by Thomson Reuters; searched via ISI Web of Knowledge) WorldCat (produced by OCLC Online Computer Library Center, Inc.; searched via OCLC FirstSearch) As with prior updates, the citations in the bibliography do not conform to The Bluebook: A Uniform System of Citation or to The Chicago Manual of Style. Instead, the citation format is a combination of the two styles and is consistent with previous updates of the bibliography.


 

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