Democratized Diagnostics: Why Medical Artificial Intelligence Needs Vetting

Originally published on September 22, 2017, on the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics Bill of Health blog.

Pancreatic cancer is one of the deadliest illnesses out there.  The five-year survival rate of patients with the disease is only about 7%.  This is, in part, because few observable symptoms appear early enough for effective treatment.  As a result, by the time many patients are diagnosed the prognosis is poor.  There is an app, however, that is attempting to change that.  BiliScreen was developed by researchers at the University of Washington, and it is designed to help users identify pancreatic cancer early with an algorithm that analyzes selfies.  Users take photos of themselves, and the app’s artificially intelligent algorithm detects slight discolorations in the skin and eyes associated with early pancreatic cancer.

Diagnostic apps like BiliScreen represent a huge step forward for preventive health care.  Imagine a world in which the vast majority of chronic diseases are caught early because each of us has the power to screen ourselves on a regular basis.  One of the big challenges for the modern primary care physician is convincing patients to get screened regularly for diseases that have relatively good prognoses when caught early.

I’ve written before about the possible impacts of artificial intelligence and algorithmic medicine, arguing that both medicine and law will have to adapt as machine-learning algorithms surpass physicians in their ability to diagnose and treat disease.  These pieces, however, primarily consider artificially intelligent algorithms licensed to and used by medical professionals in hospital or outpatient settings.  They are about the relationship between a doctor and the sophisticated tools in her diagnostic toolbox — and about how relying on algorithms could decrease the pressure physicians feel to order unnecessary tests and procedures to avoid malpractice liability.  There was an underlying assumption that these algorithms had already been evaluated and approved for use by the physician’s institution, and that the physician had experience using them.  BiliScreen does not fit this mold — the algorithm is not a piece of medical equipment used by hospitals, but rather part of an app that could be downloaded and used by anyone with a smartphone.  Accordingly, apps like BiliScreen fall into a category of “democratized” diagnostic algorithms. While this democratization has the potential to drastically improve preventive care, it also has the potential to undermine the financial sustainability of the U.S. health care system.

Democratized diagnostic algorithms should be a source of financial concern for the health care system because of the malpractice risks they will create for physicians who disagree with them. A study published in JAMA Oncology in 2015 found that patients demand specific medical interventions in 8.7% of encounters.  As democratized diagnostic apps proliferate in app stores, patients with “diagnoses” may begin to appear in doctors’ offices — smartphones in hand — demanding tests and procedures more frequently. These apps will likely be wrapped in legal language disclaiming all diagnostic accuracy — telling users to consult a physician for an actual evaluation — but a jury may find a “diagnosis” from such an app sufficient to establish that a physician who failed to pursue further testing or treatment was negligent.  Thus, if a patient presents with a cancer warning from an app, a physician may feel obligated to run a barrage of tests to confirm or refute the algorithm’s determination — even if the patient exhibits none of the symptoms typically associated with the diagnosis.

The potential influx of patients will be exacerbated by the liability concerns faced by the apps themselves.  It’s a common joke that patient information websites like WebMD will identify any set of symptoms as a potential indicator of a terminal illness.   But this makes sense given the liability landscape.  WebMD does not want to risk discouraging patients from seeking medical attention — or pursuing more traditional preventive screenings — because of assurances received on the website.  Diagnostic apps will want to avoid similar liability, and as a result they may be designed to either over-diagnose or tell patients to consult a physician regardless of the algorithm’s analysis.

The systemic harm of this perfect storm will be its impact on defensive medicine.  As previously mentioned, defensive medicine is when a physician orders more diagnostic tests and procedures than a patient’s condition warrants, and it puts an immense burden on the U.S. health care system.  In a 2013 survey of private-sector physicians, 75 percent admitted to using defensive medicine to avoid lawsuits, resulting in an estimated $650 billion spent annually on unnecessary care.  As democratized diagnostic apps proliferate, it is easy to see how defensive medicine will increase commensurately.  Regardless of a patient’s symptoms, no physician will want to disregard an app diagnosis only find herself in front of a jury trying to explain why she ignored the algorithm’s warning.

The underlying issue here is fundamentally one of quality control.  If these artificially intelligent algorithms were universally superior to physicians in their diagnostic capabilities, they could decrease defensive medicine by limiting expensive testing to cases where the likelihood of a positive finding is very high.  However, when any coder can spin up a “diagnostic” algorithm and throw it on an app store, it will be difficult for physicians to determine which apps to trust and which to ignore.  Some of these apps, including BiliScreen, may be able to diagnose diseases earlier and more accurately than physicians with decades of experience, but it’s unlikely that all medical apps available from an app store for $0.99 will be so good.  Indeed a 2014 study published in Translational Behavioral Medicine reported an “enormous range of quality among [mobile health] apps.” While accuracy rate could be a helpful metric, physicians will still face the difficulty of determining how low the accuracy rate must be for an app’s diagnosis to be safely ignored.  Would a jury find that disregarding an algorithm with 75% accuracy constitutes negligence?  What about 60% or 45% accuracy?  This will be almost impossible for any individual physician to predict.  As a result, medical providers may feel pressure to order confirmatory tests in cases involving all but the least accurate apps.

One possible solution is vetting of diagnostic algorithms by a trusted third party. Having a curated set of accurate democratized diagnostic apps would serve two functions critical for reaping the benefits of these innovative technologies while avoiding their pitfalls.  First, it would give physicians — and juries — guidelines for determining which algorithms warrant diagnostic deference.  A physician could point to a poor rating by a vetting organization as a justification for her decision not to pursue additional testing for a patient with no clinically relevant symptoms.  Second, a curated set of reliable apps would help guide patients to the most accurate diagnostic algorithms available, decreasing the likelihood of erroneous diagnoses and expensive physician-ordered tests to refute them.  This quality control would maximize the ability of democratized diagnostic apps to serve both individual patients and the health care system as a whole — accurately identifying diseases early and decreasing the prevalence of defensive medicine by taking some diagnostic liability away from health care providers.

There are many ways this vetting could be accomplished.  It could be done by a non-profit or university that reviews the evidence supporting diagnostic algorithms and rates them according to their accuracy, or it could be taken on by the platforms purveying these apps to users, such as the iOS App Store or the Google Play store.  These tech companies already serve as gatekeepers, vetting both code and content before an app will be offered for download, so it would not be outlandish for them to require a certain degree of diagnostic accuracy prior to allowing a medical app on their platforms.

The promise of democratized diagnostic algorithms is immense — but as with all technological advancements, where there is promise there is also peril.  If not vetted and implemented properly, each $0.99 app has the potential burden the health care system with additional unnecessary diagnostic testing.  Empowering patients to conduct their own preventive screening could save countless lives — so long as it doesn’t cause the already bloated health care system to collapse under its own weight.

Maybe For-Profit Hospitals Aren’t So Bad

Originally published on the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics Bill of Health blog.

For-profit hospitals have taken their fair share of flack over the years. Much maligned by many in the medical community, they are seen as money-hungry corporate machines that pervert the medical profession by putting the bottom line before patient care. This skepticism of profit-driven hospitals feels right. Medicine has long been the purview of charitable organizations and religious institutions. It’s supposed to be a calling — a public service to which practitioners are drawn — not a check to cash at the bank.

As for-profit hospitals proliferated, there was research done suggesting they had quality and cost issues stemming from their profit motives. For-profit hospitals had higher mortality rates, employed fewer trained professionals per bed, and were more expensive than their non-profit and government counterparts. Researchers speculated that this was the result of duties owned to shareholders by corporate leaders or compensation incentives for executives based on profitability rather than quality of care. These studies seemed to confirm what many thought they already knew: medicine and money don’t mix well.

More recent studies, however, suggest that for-profit hospitals may have turned over a new leaf. Since 2010, for-profit hospitals have out-performed non-profits in the “Top Performer” evaluation carried out by The Joint Commission — an organization that accredits hospitals in the US — with a higher percentage of for-profit hospitals qualifying for the honor than non-profits. A study published in JAMA from the Harvard T.H. Chan School of Public Health found that hospitals that converted from non-profit to for-profit improved their financial position by increasing their total margins and experienced no change in mortality rates.

The same researchers from Harvard reported a preliminary analysis comparing non-profit and for-profit hospitals in 2012, showing that — across a number of metrics associated with quality — for-profit hospitals were comparable to non-profit ones. Interestingly, the analysis also showed that the most dangerous hospitals for patients by far were government hospitals, which underperformed in almost every quality metric when compared with both non-profit and for-profit private medical facilities. The basic takeaway from the analysis was that there is variation in quality from hospital to hospital, but that variation it is not correlated with for-profit status.

Given the strides for-profit hospitals have made, why does the perception persist that they crank out profit at the expense of patient care?

Perhaps this negative perception endures because some continue to critique for-profit hospitals by focusing on the ways in which the predominantly private health care system in the United States lags behind government-run programs in other developed countries. It’s well established that the United States has higher costs and poorer outcomes compared to its peer nations. The U.S. spends far more of its gross domestic product on health care than any other industrialized country, and is 37th in the World Health Organization’s health system ranking. The U.S. strategy of having competing insurers individually negotiate with hospitals — which are gaining market power as they consolidate — simply doesn’t make economic sense. But while the health care system in the United States has some substantial issues, that’s an indictment of the private system as a whole — not of the for-profit hospitals within that system. Conflating criticism of a non-governmental health care system with that of for-profit hospitals within it is unfair to those hospitals which — at least as of late — have been performing just as well as their non-profit counterparts, but this confusion may explain why many still harbor negative feelings towards for-profit medical facilities.

Another reason for the continued skepticism of for-profit hospitals may be connected to concern over fiduciary duties owed by directors and officers to shareholders. As previously mentioned, some critiques of for-profit hospitals have posited that the fiduciary duty of care could force directors and executives to maximize profits at patients’ expense. This critique, however, doesn’t accurately reflect the obligations imposed on corporate directors and officers by the duty of care. When evaluating whether corporate management has satisfied the duty of care, courts have turned to a surprisingly deferential standard known as the business judgment rule. See, e.g.Kamin v. American Express Co., 383 N.Y.S.2d 807 (Sup. Ct. 1976). If a decision satisfies the requirements of the business judgment rule, courts will generally defer and not second-guess directors. According to the American Bar Association, a decision is a business judgment when it is made by disinterested directors who have been reasonably informed, and who are acting in good faith to advance the corporation’s interest. See Am. Bar Ass’n, Corporate Director’s Guidebook (2d ed. 1994). In other words, provided the board isn’t conflicted, uninformed, or acting in bad faith, the decision will be upheld even if it ends up having detrimental impacts on the corporation or its shareholders. Thus, it’s highly unlikely that shareholders could successfully use the duty of care to prevent measures designed to put patients over short-term profits.

This is by no means a comprehensive account or analysis of the criticisms of for-profit hospitals. It is simply meant to point out that some common concerns may not be entirely fair or accurate. To be sure, the jury is still out on for-profit hospitals. They have made impressive strides over the past few years, but still have a history tainted by poor quality of care and — at times — outright fraud. The intuition against them is appealing — I can sympathize with the discomfort some feel towards injecting profit motives into an area traditionally conceived of as a public service. But we should not let our biases impact our assessment of these institutions. If for-profit hospitals are delivering better or less expensive care than non-profit ones, they should get credit for that. At the end of the day, quality and cost of patient care should be the priority — wherever it’s given.

Will Medicare Reform be a Republican Obamacare?

Originally published on the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics Bill of Health blog.

As the health care community waits with bated breath to see what will become of the Affordable Care Act under the Trump administration, Republicans in Congress have set their sites on another health-related initiative that has been on their wish list for years: reforming Medicare. While Trump promised throughout his campaign not to change the fundamental ways in which Medicare works — in part to appeal to older voters, who overwhelming would like the program to stay as it is — shortly after the election, “modernizing Medicare”appeared as a priority on the transition website for the new administration.

The reform many Republicans are pushing for — championed by Speaker of the House Paul Ryan (R-WI) — is privatization along the lines of Medicare Advantage. Instead of providing for full insurance coverage through the government, as traditional Medicare currently does, Ryan’s proposal would have eligible patients purchase insurance from private companies with financial assistance from the government. The theory is that by having private insurers provide coverage, Medicare will capture efficiencies of the private market, while simultaneously offering consumers more choice in the coverage they receive.

After Paul Ryan first unveiled this plan in 2011, the Kaiser Family Foundation released a report detailing the significant fiscal problems with this “modernized” vision of Medicare. According to the Foundation’s analysis, the average out-of-pocket expense for beneficiaries increase from $5,630 under the current system to $12,500. The reason for this increase, according to the Congressional Budget Office, is that providing coverage is actually more expensive for a private insurerthan it is for the government.  The proposal faces other economic challenges as well, and ironically, some of them stem from its close resemblance to Obamacare.

Under the Affordable Care Act, exchanges were created through which individuals can buy insurance plans that meet specific coverage standards with the assistance of government subsidies. Insurers cannot discriminate against patients on the basis of preexisting conditions, but can discriminate to some extent based on age. Interestingly, all of these attributes are shared by the Republican plan for Medicare. The proposal would create what are ostensibly “Medicare exchanges,” through which eligible consumers would purchase private insurance with financial assistance from the government. The GOP Medicare plan would also prohibit discrimination based on preexisting conditions, but would permit it on the basis of age.

The similarity to Obamacare is more than just an amusing irony. The Affordable Care Act made huge strides to increase coverage for previously uninsured individuals by prohibiting discrimination on the basis of preexisting conditions, by providing financial assistance for those struggling to purchase insurance, and by expanding Medicaid. However, as insurance companies have revised their premiums for 2017, it’s become clear that insuring sicker individuals — those who would previously have been denied coverage due to a preexisting condition — is taking an economic toll on insurance company risk pools. The Obama administration announced in October that premiums for 2017 will increase by an average of 25 percent — but for some they could increase by as much as 110 percent.

The GOP Medicare plan could have a similar effect, making affordable premiums short-lived. As with Obamacare, the plan would introduce a large number of older, sicker patients into insurers’ risk pools without adding any younger, healthier patients to offset them. As a result, it’s possible that the GOP plan would have the very same sustainability issues that Republicans are currently decrying in their criticism of the Affordable Care Act.

Proponents of the GOP proposal point to Medicare Advantage as an indication that all of Medicare can successfully and sustainably be privatized. But evidence from Medicare Advantage suggests that as people age and become sicker, they transition back to traditional Medicare, taking themselves out of the Medicare Advantage risk pools. Thus, the stability of Medicare Advantage premiums is not reliable evidence that privatizing all of Medicare would be similarly feasible. Furthermore, Medicare Advantage reaps financial benefits from the low prices negotiated by the traditional Medicare program, which private insurers simply don’t have the necessary bargaining power to secure.

It’s unclear whether the GOP will be successful in its quest to overhaul Medicare. To be sure, the program does have some sustainability issues — the 2016 Medicare trustees report estimates that Medicare as it currently exists will only be able to pay all its bills until 2028. But given how unpopular Medicare privatization is with elderly, conservative voters — and the uncertainty that the GOP plan will be sustainable and affordable — Republicans could face serious political backlash if they continue to pursue Ryan’s proposal. While admitting the similarities between Obamacare and the GOP plan for Medicare may be difficult for some congressional Republicans, acknowledging that the Medicare proposal could have similarly detrimental effects on private insurance risk pools will help avoid some of the sustainability issues starting to arise under the Affordable Care Act.

The Affordable Care Act was an incredibly important step towards ensuring that every American receives the health care they need — but it isn’t perfect. Let’s hope Republicans don’t make the same mistakes as they try to revamp Medicare.

Health Insurance, Veterinary Care, and the Not-So-Secret Benefits of Pets

Originally published on the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics Bill of Health blog.

Pet ownership is incredibly popular in the United States. There are almost 70 million companion dogs spread across 43 million American households.   This isn’t particularly surprising, given that study after study has shown that companion animals promote healthier, happier, longer lives for their owners. Despite pet popularity and prevalence, though, many pet owners don’t fully understand how expensive their four-legged family members can be — especially if they end up needing extensive veterinary care. Every year, millions of companion animals are euthanized because their owners lack the financial resources to pay for necessary veterinary services. Unlike in human medicine, pets in the hospital with readily curable ailments often go untreated for financial reasons.

How can we help people keep and care for their pets — capturing companion animal health benefits while also ensuring those pets receive the veterinary care they need? The answer might be found in the synergies between animal and human health — and the benefits they entail for health insurance providers.

The health benefits of companion animals have been extensively documented in both the scientific literature and the mainstream media. Pet owners have, inter alia, decreased risk of cardiovascular diseasedecreased risk of anxiety and depressiondecreased incidence of allergies, and increased immune system function. Some insurance companies even have materials for their customers promoting pet ownership because of these benefits. The health conditions ameliorated by animal companionship are often otherwise treated with doctor’s visits, medications, and other expensive interventions paid for in large part by insurance providers. In other words, pet ownership produces positive externalities on insurance providers by decreasing the amount they pay in traditional medical services for these ailments — and insurance companies have an interest in incentivizing animal companionship.

Insurance companies should consider covering or subsidizing companion animal health care as part of their insurance plans. This is potentially a win-win-win. Pets get the care they need, more people can have access to the benefits of animal companionship, and insurance companies could save money on medications and doctors that would otherwise be necessary for treating the chronic illnesses that pets have been shown to help combat.

To establish conclusively that bundling pet insurance as part of human health insurance would result in financial gains for insurance companies would require a fairly extensive economic analysis, which is beyond the scope of the present post, but the numbers suggest the potential is there. Veterinary care expenditures in the United States currently total to an annual $14.37 billion. While that number seems large, it’s dwarfed by the amount we spend annually on chronic diseases. The United States currently spends about $48.6 billion on high blood pressure every year, as well as $16.5 billion on anti-depressants, $17.5 billion on nasal allergies, and billions more on the other, more serious issues that these chronic illnesses can exacerbate, including $110 billion on cardiovascular disease. Thus, even relatively small reductions in the prevalence of these diseases — and the complications to which they lead — could result in savings that well exceed total veterinary care spending.

Now, of course, there is a moral hazard issue here. Covering medical expenses for companion animals could result in owners seeking far more veterinary care for their pets than they currently do or than is necessary. Indeed, given the number of animals that are euthanized each year for lack of funds, it’s likely that health insurance providers covering costs would increase demand for veterinary services. There are reasons to believe, though, that the increase may not be as pronounced as we might fear. For one, the insurance company need not foot the entire bill to capture the beneficial effects of incentivizing pet ownership. Subsidies for veterinary care could involve some cost sharing, which would disincentive seeking excess, unnecessary care. Furthermore, as in human medicine, financial assistance with veterinary care costs could increase preventive measures to combat companion animal diseases, which could end up reducing demand for more extreme, expensive measures down the road. By covering veterinary care, insurance companies could even decrease the overall cost of care, because veterinary hospitals would no longer have to budget for the free procedures they often perform for clients who cannot pay.

This wouldn’t be the first time health insurers cover costs to incentivize healthier living. Many insurance providers cover or subsidize, gym memberships, weight-loss programs, acupuncture therapy, massages, and more in hopes of encouraging behaviors that have been shown to decrease the incidence of chronic diseases. Not only does this decrease their long-term expenditures on their patient populations, it also serves as a mechanism through which they can compete with other providers. It’s possible that covering or subsidizing veterinary care could serve largely the same ends.

Companion animal health hasn’t traditionally been considered among the levers insurance providers have at their disposal to promote the health of the people they cover, but maybe it should be. More quantitative research is needed to flesh out exactly how the coverage or subsidies would work, but this is certainly worthy of exploration. By encouraging and enabling people to have healthy companion animals, health insurance providers could save money, make their customers healthier and happier, and help millions of animals receive veterinary care to which they may not otherwise have access. It could be a win for everyone — those of us with two legs and those of us with four.

Voluntary Firearm Waiting Periods Could Save Thousands of Lives

Originally published on the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics Bill of Health blog.

Suicide is one of today’s most pressing public health issues. It’s the second most common cause of death for those ages 15-34, and claims over 40,000 lives every year. Of those, a staggering 20,000 are the result of firearms. To put that in perspective, there are about 30,000 gun deaths overall in the United States each year, which means that self-inflicted fatalities make up over 60% of total domestic gun deaths. Of the most prevalent means of attempting suicide, firearms are by far the most lethal. Firearm suicide attempts end in death more than 85% of the time, whereas attempts by drug overdose — the most common method — are only fatal 3% of the time.

While suicides by firearm have been on the rise in recent years, there may be an easy way to substantially reduce their incidence. A new study out of the University of Alabama Birmingham by Vars, et al., suggests that allowing individuals at risk of suicide to put themselves on a voluntary “Do-Not-Sell’ list, which would result in a waiting period before they could acquire a firearm, could be effective in preventing suicide attempts. The researchers surveyed 200 patients at both in- and out-patient psychiatric facilities who had disorders associated with anxiety and depression, and found that nearly half of them would put themselves on a list which would preclude them from quickly accessing firearms in the event that they were contemplating suicide. This is particularly notable given that these were all Alabama residents — a state that ranks in the top 10 of Guns and Ammo’s list of the best states for gun owners. In other states with more robust gun control and fewer gun enthusiasts, the Do-Not-Sell rate could very well be higher.

The theory behind the potential efficacy of such a list is that, for many, serious suicidal contemplation is a temporary experience which passes. Research suggests that a majority of those who attempt firearm suicide only contemplate it for less than a day. One study found that almost 50% of those who attempt firearm suicide wait less than 20 minutes between deciding to take their own life and attempting to do so. The majority of those who survive don’t end up dying of self-inflicted injuries. Thus, if a Do-Not-Sell list can prevent potential suicide victims from acquiring firearms immediately, there is a significant chance those suicides will never happen. While there is some evidence to suggest that decreasing access to firearms for those at risk of suicide could lead to increases in other forms of self-harm, the comparatively low success rates of other suicide methods suggest that lives would be saved simply by taking guns out of the short-term equation.

If actual Do-Not-Sell signup rates were to be consistent with what Vars and his colleagues found, the number of lives saved by such a list would be substantial. Vars, et al., found a signup rate of about 46% in the at-risk pool they surveyed. Assuming a similar rate among those who would attempt suicide by firearm nationwide — which, granted, may be a self-selecting pool less likely to register for such a list — a voluntary Do-Not-Sell list would prevent over 9,800 potential suicide victims from obtaining firearms when suicidal thoughts arise. Given that 90% of those who unsuccessfully attempt to commit suicide end up not committing suicide later, allowing people to delay their acquisition of firearms could save nearly 9,000 lives every year. That means 30% of all gun-related deaths that happen in the United States each year would never have the chance to occur.

While the potential efficacy of a Do-Not-Sell list shouldn’t be particularly surprising — people have been self-binding since Odysseus tied himself to the mast of his boat to avoid heeding the sirens call as he passed their island — its potential impact on the number of gun deaths each year is remarkable. Those of us in favor of stronger gun-control laws would likely advocate for a federal mandatory waiting period for all gun purchases, but we shouldn’t let the perfect be the enemy of the good. The voluntary Do-Not-Sell list has shown that it has the potential to substantially decreases the number of needless deaths a year that result from readily accessible firearms, and it likely represents a far less politically polarizing step than further-reaching gun-control measures.

When talking about suicide, it’s easy to get lost in the statistics, but the human cost of even one life lost to suicide is unimaginable. Given the ease with which it could be implemented, if the Do-Not-Sell list could save even one life, I would say it was a no-brainer. But the fact that it could save thousands of lives makes it one of the most promising avenues for reducing suicide and gun-related violence currently available — and makes it too important for policymakers to ignore. Hopefully, as the Do-Not-Sell idea receives increasing attention, states will seriously consider implementing it. For some, it could literally make the difference between life and death.

Religious Hospitals Should Fully Fund Their Employees’ Pensions

Originally published on the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics Bill of Health blog.

In July, the Ninth Circuit held that Dignity Health, a faith-based hospital system in the southwest United States, was not exempt from the employee pension requirements of the Employee Retirement Income Security Act (ERISA). The hospital system decided in 1992 that it would consider itself a church for the purposes of ERISA, and therefore would qualify for ERISA’s church exemption and not have to provide fully funded or insured pensions for its employees. As a result of this decision, it underfunded its employees’ pensions to the tune of $1.2 billion.

The Ninth Circuit was the second to make such a ruling after the Seventh Circuit issued a similar decision against Advocate Health Care in March. Many thought these rulings would lead the Supreme Court to leave the issue alone, but that may not be what SCOTUS has in mind. Associate Justice Anthony Kennedy recently granted Dignity reprieve from complying with the Ninth Circuit decision while he and the other justices decide whether to hear the case. Hopefully, this signals that the Court is planning to extend the Ninth Circuit’s decision, ensuring that hospital systems with religious affiliations across the country fulfill their responsibilities to their employees and provide them with the pensions they deserve.

Dignity Health is not a church. While it did have an official relationship with the Catholic Church until 2012, at the end of the day Dignity Health is a medical services juggernaut. It is the fifth-largest hospital system in the country, with 39 acute care hospitals and over 250 ancillary facilities spread across Arizona, Nevada, and California. Its annual revenue is approximately $10.5 billion. It’s so big that in 2012 it was included in an antitrust investigation by the California Attorney General’s Office to assess the impact of hospital consolidation on health care pricing in California.

The arguments in court centered on Dignity’s relationship with the Catholic Church. Dignity argued that because it is a non-profit with a religious affiliation, its pension plans should be regarded as church plans. The plaintiffs countered by arguing that Dignity is a hospital system — not a church — and that it has acquired many non-religious hospitals which perform procedures that go against catholic teachings. Both sides are trying to make sense of an opaque statute. ERISA provides that an organization qualifies for the church plan exemption if it is “associated with a church..[and] shares common religious bonds and convictions,” but it also notes that plans are not church plans if they are for the benefit of employees “who are employed in connection with…unrelated trades or businesses.”

While these arguments make sense from a legal perspective, on a policy level they appear to miss the point. Whether or not Dignity Health has a strong association with the Catholic Church seems irrelevant to whether it should be able to underfund the pensions of its estimated 56,000 employees. The purpose of ERISA is to protect employees, and it’s unclear why a nurse who works for a non-religious hospital is entitled to more protection than a nurse who works for Dignity Health simply because its board shares a set of religious beliefs.

Furthermore, under the provision of ERISA on which Dignity relies, there is no requirement that the organization be a non-profit. Thus, taking Dignity’s argument to the extreme, for-profit companies could avoid complying with ERISA’s pension funding and disclosure requirements by establishing a relationship with a religious organization. In other words, Google could stop adequately funding the pensions of its 57,000 employees — saving billions of dollars — simply by finding religion.

Fortunately, the federal courts that have heard the case have recognized the absurdity of this argument. The U.S. District Court for the District of Northern California noted in its rejection of Dignity’s position that “to maintain a church plan, an organization must not only be associated with the church, but it must have [as] its ‘principle purpose or function . . . the administration or funding of a [benefits] plan or program . . . for the employees of a church.’” Given that Dignity is not a church, the court found that it should have to comply with ERISA like all the other hospital conglomerates that don’t have spiritual proclivities.

It seems as though the courts are getting this one right, but those decisions fail to reach many hospitals and medical centers across the country that continue to underfund pensions for their employees because of religious affiliations. We’re talking hundreds of thousands of doctors, nurses, technicians, orderlies, and other staff members that don’t have ERISA protection for their pensions because the hospitals for which these people work think their religious connections exempt them from fulfilling their obligations as large-scale employers. Hopefully, the Supreme Court’s decision to consider taking this case signals that this practice will soon come to an end.

The church exemption to ERISA exists for good reason. Faith-based organizations without avenues for generating revenue likely can’t fund and insure pensions for their employees in the way multi-national companies can, and they shouldn’t be held to the same standards. But that doesn’t mean a health care conglomerate with over $10 billion in annual revenue should be able to shirk its responsibilities to its employees because it has a spiritual affiliation.  ERISA exists to protect employees, regardless of their employers’ religious leanings, and it’s time for that protection to be afforded to employees of religiously affiliated health care systems.

The Federal Government Should Consider Medical Marijuana a Potential Ally in the Fight Against Opioid Addiction

Originally published on the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics Bill of Health blog.

The United States is in the midst of what many are calling an opioid epidemic. According to the American Society of Addiction Medicine, more than 1.9 million people in the U.S. have a substance use disorders involving prescription pain medications, and another 580,000 have substance abuse issues with heroin. The human costs of these rates of addiction are staggering.   Of the approximately 50,000 lethal drug overdoses that happen each year, almost 20,000 are the result of prescription opioids, and another 10,000 are the result of heroin. While prescription painkillers traditionally aren’t as dangerous as heroin, the connection between the two is well established. According to a 2013 survey, about 80% of heroin users started out abusing opioid painkillers.

Despite continued efforts at nearly every level of government, the rates of opioid addiction and overdose have continued to climb. However, researchers have identified an unlikely ally that may have quietly been slowing the rise of opioid use in certain states: medical marijuana.

study recently released by Columbia University’s Mailman School of Public Health suggests that medical marijuana availability is linked to decreases in opioid usage. The study looked at opioid prevalence in autopsy reports from fatal car accidents over 14 years, and found that states that passed medical marijuana laws in that period saw a relative decrease in opioid prevalence compared to states that didn’t. While this study is making a splash, it’s just the most recent piece in a long line of research into the connection between medical marijuana availability and opioid use. One study published in Health Affairs in July showed that states which implemented medical marijuana laws between 2010-2013 saw a significant decrease in Medicare Part D prescriptions filled for medications for which marijuana is a possible alternative therapy — including opioids. Another study from 2014 showed a 25% decrease in deaths from prescription pain medication overdoses in states that implemented medical marijuana laws.

Unfortunately, as these medical marijuana success stories roll in, the federal government has been characteristically slow to adapt. While many were hopeful that the Drug Enforcement Agency (DEA) would reclassify marijuana as a Schedule II drug — opening up the possibility for more research and for medical availability in all 50 states — the DEA confirmed in August that it would be maintaining its Schedule I classification for marijuana. This means marijuana will remain classified with the most dangerous drugs including heroin, ecstasy, and MDMA — subject to more stringent regulation than cocaine, which is a Schedule II drug.

Whether or not one supports full marijuana legalization, the evidence for the positive effects of medical marijuana in combating the opioid crisis is at the point where the federal government should start taking it seriously.  The DEA’s position is that the science to support marijuana as a medical therapy isn’t yet sufficient to warrant reclassification, pointing to the fact that the FDA has not yet authorized its use for medical purposes, which is understandable. But it’s not clear that argument withstands a cost-benefit analysis in light of recent research. As previously noted, states that implement medical marijuana laws see a decrease of 25% in prescription pain medication overdose fatalities. Given that the U.S. has about 30,000 overdose deaths a year from heroin and prescription opioids, every year the federal government waits to seriously consider nation-wide medical marijuana potentially raises the opioid fatality count by 7,500. So while the instinct to wait for more research is understandable — and one that I would support in many contexts — waiting is not a costless decision.

It’s also not clear there is much to be gained by waiting on the FDA. To get through the FDA approval process, medical marijuana would potentially go through clinical trials, but those only require the drug be tested on about 1000 people for a limited time. This makes a lot of sense as a barrier to market entry for brand new chemical compounds that have previously only been administered to animals, but it’s unclear that it would add significant insight in the context of medical marijuana — a substance used by an estimated 22 million Americans in 2014.

The opioid epidemic isn’t going anywhere any time soon, and the impact it’s having on our communities is absolutely devastating. Despite years of public attention and many initiatives at every level of government, there has yet to be a solution implemented to effectively combat opioid addiction on a national scale. Congress passed an attempt at a solution over the summer, but only allocated about half of the requested funds to the endeavor, which doesn’t bode well for its long-term chances of success. It’s time to think outside the box. The substantial costs of inaction and the possible benefits of medical marijuana are such that its potential should no longer be ignored. Helping to pave the way for medical marijuana across the country is not something the federal government should do lightly — but neither is failing to recognize an ally in the fight against the opioid epidemic as its death toll continues to rise.

Hospitals Should Think Before Performing Searches for Law Enforcement

Originally published on the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics Bill of Health blog.

In 2012, a Jane Doe suspected of transporting drugs was detained by U.S. Customs and Border Protection (CBP) agents without a warrant, and brought to University Medical Center in El Paso, Texas. Medical Center personnel — under the direction of the law enforcement agents — performed an X-ray, CT scan, and cavity search before determining that the woman was not in fact carrying any controlled substances. A few months after suffering this traumatic — and possibly illegal — event, the woman received a $5400 bill from the Medical Center for the services rendered as part of the search.

While the woman was compensated to some extent — she settled lawsuits with University Medical Center and the CBP to the tune of $1.1 million and $475,000, respectively — her story, and stories like hers, raise important questions about the ways in which hospitals should (or shouldn’t) work with law enforcement to perform invasive searches.

It’s understandable why hospitals and medical professionals are inclined to cooperate with law enforcement requests for invasive procedures and cavity searches — law-abiding citizens often don’t want to obstruct law enforcement agents from doing their jobs. But in the course of bringing suit against University Medical Center, Edgar Saldivar of the ACLU of Texas noted that the hospital and many of its personnel didn’t know where the obligation to assist the CBP stopped. Many medical professional don’t know that — according to the CBP’s own Personal Search Handbook — they are under absolutely no obligation to comply with requests by law enforcement to perform cavity searches with or without a warrant.

Not only are hospitals and medical professionals not required to assist with invasive searches, but as the case of Jane Doe demonstrates, they can be liable if they help in instances where they shouldn’t. They aren’t agents of the state, and therefore are neither compelled to perform any actions pursuant to a law enforcement request or search warrant nor legally protected if they violate someone’s rights while assisting in the execution of such a request or warrant.

The potential for substantial liability alone should give hospitals pause when deciding whether to assist with a cavity search. But putting that aside, is this something that hospitals should be having their physicians and medical professionals do at all?

Medical professionals occupy a unique ethical space. We leave our lives in their hands, in part because we trust that they will act in our best interest as patients. We believe that their responsibilities to patients trump those to bottom lines or government agencies, and that’s why we dutifully consent to procedures when our dentists say we need cavities filled or our doctors say we need colonoscopies. The trust that physicians receive entails an ethical obligation to live up to those expectations. This is not to say there aren’t limits on the lengths to which doctors should go for their patients — I’ve written before on some of these limitations — but it’s not clear hospitals should be putting doctors in situations where they feel pressure to actively subvert the interests of those for whom they are caring.

This is not to say that physicians should never assist law enforcement with searches. There may be situations in which a hospital or medical professional could reasonably conclude that the suspect is better off at a medical facility under professional care than undergoing whatever alternative method of cavity searching the officers have in mind. At the end of the day, though, the person being searched is a patient, and hospitals and physicians should be sure that the procedures being performed are indeed in that patient’s interest, and not just a means to law enforcement’s ends. While cavity searches are not particularly dangerous procedures, all medical procedures come with risk, and subjecting a patient to that risk for the sole purpose of assisting with a law enforcement investigation may very well violate the “do no harm” ideals embodied in the Hippocratic Oath.

There are no black and white answers here, but one thing is clear: hospitals and medical professionals need to give this issue significantly more thought and attention. The ACLU’s experience with University Medical Center showed that its personnel were caught off guard — not knowing what their duties were to law enforcement or to the individual being searched, and not thinking about the possible ramifications of cooperation. As a result, they subjected an innocent woman in their care to a traumatic, violating experience and cost the hospital $1.1 million. Hospitals should be training their personnel for these situations. Doctors should know they have no obligation to assist with law enforcement searches, and both physicians and institutions should have carefully thought out their responses to such a situation before one presents itself.

No patient should ever have to worry about a physician in charge of her care violating her rights, and no physician should ever feel pressured to violate a patient’s rights in the name of law enforcement. There is a lot that hospitals can do to help prevent these situations from arising, protecting both their personnel and their patients. The millions of dollars they’ll also save avoiding lawsuits is just the icing on the cake.

Ambulances are Monopolies — and They Should Be Regulated Accordingly

Originally published on August 29, 2016, on the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics Bill of Health blog.

You go to your local urgent care with a headache and a fever, and the doctor suggests a trip to the hospital for further evaluation — just to make sure there isn’t anything serious causing your symptoms. She offers an ambulance, and you accept. You could probably walk or Uber, but you’re not feeling well, and the doctor has offered to arrange the ride. Why not?

This was the story of Joanne Freedman. She didn’t think too much about it, until she received a $900 bill for the two-block ambulance ride she took to the hospital. While Joanne’s experience was particularly egregious, it is not wholly uncommon. Ambulance pricing is one of the most variable and least transparentcomponents of health care costs, with rides ranging from tens to thousands of dollars. This is in part because there are many ambulance providers, and they all have different relationships with different insurance companies. It’s also in part because ambulance rates are generally set according to the services the ambulance is equipped to provide, not necessarily the services actually provided. Some ambulance companies have contracts with municipalities that make them the only game in town, while others are in more diverse markets with multiple providers competing for patients. All this combines to create an incredibly complex industry with very little consistency from ambulance to ambulance.

But is this disjointed, free-market system the best way to structure emergency transportation? The arguments underlying the justification of a free, unregulated market hinge on the ability of consumers to police the industry through choice. If the seller of a good sets the price too high, consumers will buy from a different seller until she brings the price down to what consumers are willing to pay.  This is, in theory, what allows markets to find the right prices for goods and services more efficiently than any government agency or regulator ever could.

These arguments may hold up in certain markets — if a company sells a stick of gum for $500, chances are it’ll find its gum sales drop precipitously. However, when applied to the emergency transportation industry, they just don’t pan out. This is in large part because, to any one individual consumer, ambulances are essentially monopolies. Not only do consumers have no means of price comparison on the spot — as they usually require ambulances in high-stress, time-sensitive situations — they often have no control over their ambulance service provider. When a patient calls 911 or when a physician orders an ambulance, the patient have no agency in determining which ambulance comes to get him or her. As a result, the patient faces a market with exactly one option. While the ambulance industry is actually quite diverse, with many providers ranging from small municipal divisions to large private companies, to any one consumer, the market is functionally a monopoly.

Not only are consumers faced with a single ambulance provider, they are often in no position to make a rational cost-benefit analysis for accepting or rejecting these services. Consumers have little to no information about the cost of ambulance services at the time they are required to accept them, and they may not even know whether their situations constitute emergencies — which impacts how much their insurance companies will pay for rides. Can we really expect patients in this position to make rational decisions about whether or not to get in the ambulance?

All of this suggests that the ambulance market is in need of more robust regulation.  While it’s something of an economic boogeyman, we actually have a pretty good way of regulating industries where monopoly power is part of an efficient market: price control.

The most prominent examples of price-controlled monopoly markets are those for utilities.  As electric grids were built up across the country to bring power to people’s homes, it became clear that the most efficient means of purveying electricity was to have a single provider wire houses. This avoided the redundant investment of multiple companies trying to build their own wiring networks to every residence. This posed municipalities with a dilemma. Do they try to encourage the inefficiency of redundant wiring to enable competition between power providers, or do they allow a monopolist to control the market for electricity in a given area?  The “Goldilocks” solution on which many municipalities settled was price-regulated, government-sanctioned monopolies. A single provider got the entire market, but was largely unable to exploit that dominance to squeeze money out of consumers.

While the market for ambulance services isn’t exactly like that for utilities, the two share an important attribute: a monopoly is the optimal market structure. We want the ambulance market to be a monopoly on an individual level. We don’t want 911 calls to trigger ambulance races to the most lucrative patients, and we don’t want patients to have to weigh the costs and benefits of various providers while reeling from a car crash or having a heart attack. The market actually works best — in terms of getting patients to the hospital as quickly as possible with as little red tape as possible — when patients only have one option. The market has evolved to capture this kind of efficiency, but the regulation hasn’t kept pace. This is why stories of patients like Joanne Freedman being blindsided by bills for ambulances they had no hand in selecting are now commonplace. It’s time the regulation caught up, and started treating ambulances like the situational monopolies they are (and should be).

Price controls for the ambulance market would have to be nuanced. Different ambulances are more expensive to operate than others based on the services they are equipped to provide, and the set prices should reflect that. There should also be analogous requirements on how much insurance companies must pay for both emergency and non-emergency ambulance rides, and those should balance out so insured patients aren’t unwittingly on the hook for the difference between the cost of a ride to the hospital and what insurers are willing to pay.

Regulating prices isn’t the only possible solution for the wild west of ambulance pricing. Municipalities could go back to operating ambulances as a public service, as they did in the mid-20th century. But however we choose to rein in the market, one thing is for sure: the status quo is not acceptable. Even the staunchest libertarians concede that there is occasionally a role for government regulation in instances of true market failure. For patients calling 911 for an ambulance, traditional market forces are powerless to save them from unknowingly incurring substantial costs. The government has both the means and responsibility to intervene, and price controls are a tried and true method of protecting consumers from monopolists — be they ambulances or utilities. Going to the hospital in an ambulance is scary enough. Patients shouldn’t have to worry about going bankrupt on the way.

Is Gaming the Transplant List an Ethical Dilemma?

Originally published on June 28, 2016, on the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics Bill of Health blog.

NPR recently published a thought-provoking piece discussing an ethical dilemma doctors face when treating patients in need of organ transplants. Transplant list priority is designed to depend upon the relative sickness of patients, allocating organs to those who need them most. However, instead of lab results or other direct measures, the list uses the treatment a patient is receiving as a proxy for her condition. As a result, doctors have the ability to move their patients up the list by prescribing — or over-prescribing — more extreme and invasive treatments.

It’s understandable why this temptation exists — doctors go into medicine to heal, and I imagine it’s difficult to refrain from taking an action which could very well save a patient’s life. But should this be an ethical dilemma?

Bumping a patient up the transplant list could certainly save a life, but that life could come at the expense of another’s. The problem is that organ transplants are inherently zero-sum — if one patient goes up on the list, another must come down. If one person gets an organ, that means another doesn’t. Furthermore, over-treating to influence transplant priority has consequences that reach beyond any individual patient, potentially furthering inequality in the transplant system and contributing to unsustainable health care spending.

Influencing transplant priority by prescribing unnecessary, intensive treatment may exacerbate the inequality already baked into the transplant system. Transplant lists are localized, and organs donated in particular areas are made available to local medical centers before being offered to hospitals elsewhere. This means that transplant lists in some regions move faster than those in others. Patients are allowed to register for more than one list, but doing so is expensive, requiring the ability to travel quickly around the country and pay the tens of thousands of dollars it costs to receive the necessary tests for multiple transplant list approvals. A Columbia University study published last year found that patients on multiple lists tended to be wealthier and get transplants faster than their single-list counterparts.

The patients that can be moved up the transplant list through over-treatment will tend to be those with more robust insurance, who have better access to treatment facilities with more intensive care capabilities. In other words, they’ll tend to be wealthier than patients without access to the same coverage or treatment options. Wealthier patients can already get transplants more quickly  — and over-treatment allows them to ascend those lists even faster. While it’s true that some over-treated patients will not be in the pool of those wealthy enough to afford multiple transplant listings, the practice still furthers the distribution of organs away from the under-insured who can’t afford or access the extra care.

Even if the benefits of ascending the transplant list through over-treatment were distributed equitably, it still puts unnecessary burden on a health care system struggling under its own weight. It’s no secret that health care spending in the United States is out of control, and one of the main drivers of spending growth is over-utilization. From emergency room visits for non-emergency care to defensivediagnostic testing, many unnecessary medical services are ordered and paid for every day. There are many reasons for this, and it has garnered significant attention in the fight to control health care spending. Normalizing the practice of over-treating patients to move them up the transplant list piles unnecessary costs onto an already strained system, and because the treatment needed to bump a patient up the list is intensive and often invasive — sometimes requiring stints in the ICU — it’s also incredibly expensive.

New rules further specifying the treatment needed to advance on the transplant list are being considered in order to reduce this practice, but they still rely on treatment as a proxy for need, and thus may only lead to increasingly extreme over-treatment. At the end of the day, no system will be tamper proof. There will always be a way to influence a patient’s chances of receiving a transplant. So what do we do?

Instead of trying to foolproof the transplant list, perhaps we should push for a cultural shift in which the possibility of increasing transplant priority through over-prescription isn’t seen as a moral dilemma, because providers and patients recognize an obligation to the health care system as a whole. Certainly physicians should be zealous advocates for their patients, and there should be avenues through which a physician can make appeals on behalf of her patients if she feels the current priority criteria don’t fully capture their needs. However, when viewed in light of the negative impact it can have on the entire health care system — not to mention the immense cost it has on the patients that will inevitably be bumped down the list as others are bumped up — maybe the decision not to increase a patient’s transplant priority through over-treatment shouldn’t be such a hard one.

More broadly, this holistic perspective would help in many areas of health care currently plagued by misaligned incentives. Antibiotics, for example, are over-prescribed to appease individual patients at the risk of contributing to antibiotic resistance, and the practice of defensive medicine continues to proliferate, undermining efforts to reduce overall health care spending. The more health care providers, administrators, and patients factor these broader externalities into everyday decisions, the better off the entire system will be.

Medicine is an art — the individualized craft of healing. But health care is a system — an interconnected web in which actions have consequences far beyond any one patient. Zealous advocacy on behalf of individual patients is a critical component of effective care, but perhaps it shouldn’t come at the expense of other patients or the system as a whole. As newly minted physicians recite in the Hippocratic Oath, “I will remember that I remain a member of society, with special obligations to all my fellow human beings, those sound of mind and body as well as the infirm.” Over-treating for transplant priority seems out of sync with this commitment to those beyond the exam room. It’s understandable why this feels like a moral dilemma, but maybe it shouldn’t feel like one. The decisions made in the health care system impact all of us, and we need to remember that, even when — especially when — it’s difficult.