By Shailin Thomas
Medicare Advantage was introduced as a mechanism for capturing some of the oft-extolled efficiencies of the private health insurance market. Instead of paying providers for services directly, as in traditional Medicare, the government pays Medicare Advantage insurers a predetermined, risk-adjusted amount of money per patient to cover all medical expenses for the year. The risk adjustment ensures that companies insuring Medicare Advantage patients with chronic diseases — who will likely need more intensive, expensive care — receive additional funds to help cover those costs. For each qualifying condition a patient has, the Medicare Advantage plan receives on average an additional $3000 annually.
While the risk adjustment of Medicare Advantage payments was well intentioned and economically rational, it appears to have opened up an avenue for significant abuse on the part of Medicare Advantage insurers. The Department of Justice recently joined a lawsuit against UnitedHealth, a large provider of Medicare Advantage plans, for allegedly defrauding the government out of hundreds of millions, if not billions, of dollars. The complaint alleges that UnitedHealth “upcoded” its risk-adjustment claims by submitting for conditions patients did not actually have and refusing to correct false claims when it discovered or should have discovered them. In essence, the company allegedly realized it could extract more money out of the government by making the patients it covers appear sicker than they actually are, and took full advantage of that.
Recently, I wrote about the rise of artificial intelligence in medical decision-making and its potential impacts on medical malpractice. I posited that, by decreasing the degree of discretion physicians exercise in diagnosis and treatment, medical algorithms could reduce the viability of negligence claims against health care providers.
It’s easy to see why artificial intelligence could impact the ways in which medical malpractice traditionally applies to physician decision-making, but it’s unclear who should be responsible when a patient is hurt by a medical decision made with an algorithm. Should the companies that create these algorithms be liable? They did, after all, produce the product that led to the patient’s injury. While intuitively appealing, traditional means of holding companies liable for their products may not fit the medical algorithm context very well.
Traditional products liability doctrine applies strict liability to most consumer products. If a can of soda explodes and injures someone, the company that produced it is liable, even if it didn’t do anything wrong in the manufacturing or distribution processes. Strict liability works well for most consumer products, but would likely prove too burdensome for medical algorithms. This is because medical algorithms are inherently imperfect. No matter how good the algorithm is — or how much better it is than a human physician — it will occasionally be wrong. Even the best algorithms will give rise to potentially substantial liability some percentage of the time under a strict liability regime.
Artificial intelligence and machine-learning algorithms are the centerpieces of many exciting technologies currently in development. From self-driving Teslas to in-home assistants such as Amazon’s Alexa or Google Home, AI is swiftly becoming the hot new focus of the tech industry. Even those outside Silicon Valley have taken notice — Harvard’s Berkman Klein Center and the MIT Media Lab are collaborating on a $27 million fund to ensure that AI develops in an ethical, socially responsible way. One area in which machine learning and artificial intelligence are poised to make a substantial impact is health care diagnosis and decision-making. As Nicholson Price notes in his piece Black Box Medicine, Medicine “already does and increasingly will use the combination of large-scale high-quality datasets with sophisticated predictive algorithms to identify and use implicit, complex connections between multiple patient characteristics.” These connections will allow doctors to increase the precision and accuracy of their diagnoses and decisions, identifying and treating illnesses better than ever before.
As it improves, the introduction of AI to medical diagnosis and decision-making has the potential to greatly reduce the number of medical errors and misdiagnoses — and allow diagnosis based on physiological relationships we don’t even know exist. As Price notes, “a large, rich dataset and machine learning techniques enable many predictions based on complex connections between patient characteristics and expected treatment results without explicitly identifying or understanding those connections.” However, by shifting pieces of the decision-making process to an algorithm, increased reliance on artificial intelligence and machine learning could complicate potential malpractice claims when doctors pursue improper treatment as the result of an algorithm error. In it’s simplest form, the medical malpractice regime in the United States is a professional tort system that holds physicians liable when the care they provide to patients deviates from accepted standards so much as to constitute negligence or recklessness. The system has evolved around the conception of the physician as the trusted expert, and presumes for the most part that the diagnosing or treating physician is entirely responsible for her decisions — and thus responsible if the care provided is negligent or reckless. Continue reading
By Shailin Thomas
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.
By Shailin Thomas
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 insurer than 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.
By Shailin Thomas
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 disease, decreased risk of anxiety and depression, decreased 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.
By Shailin Thomas
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.
By Shailin Thomas
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.
By Shailin Thomas
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.
A 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. Continue reading
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.
The Petrie-Flom Center is pleased to welcome our new 2016-2017 Student Fellows. In the coming year, each fellow will pursue independent scholarly projects related to health law policy, biotechnology, and bioethics under the mentorship of Center faculty and fellows. They will also be regular contributors here at Bill of Health on issues related to their research.
Seán Finan is an LLM candidate from Ireland at the Harvard Law School. He recently graduated from the LLB programme at Trinity College, Dublin, where he served as a Senior Editor of the Trinity College Law Review. His research interests include the ethical implications of emerging biotechnologies. For his Fellowship project, he intends to investigate the use of morality tests on patent applications as a means of indirect regulation of research.
Wendy Salkin is a Ph.D. candidate in the Department of Philosophy at Harvard University. Her primary research is in political philosophy, moral philosophy, social philosophy, and philosophy of law. She also works on questions in feminist philosophy and bioethics. She is writing a dissertation on informal political representation under the supervision of Tommie Shelby, T.M. Scanlon, Richard Moran, and Eric Beerbohm. She holds a J.D. from Stanford Law School and a B.A. in Philosophy and Africana Studies from New York University. For her Fellowship project, she will examine new directions in the debate over lifespan extension.
Brad Segal is currently a medical student at Harvard Medical School where he is enrolled in a dual MD/Master of Bioethics degree program. Brad received his BA and BS from UC San Diego where he double majored in Philosophy and Physiology/Neuroscience. In his first year at HMS Brad’s paper on the ethics of organ transplantation was awarded the Henry K. Beecher Prize in Medical Ethics. He has also studied the ethical implications of our evolving understanding of the brain, and has published on whether and when individual genetics and neurobiology should mitigate a criminal defendant’s moral culpability. During his Fellowship he will be studying what ‘harm’ means in the medical context.
Shailin Thomas is a second year law student in a joint MD/JD program between Harvard Law School and the New York University School of Medicine. He received a B.S. from Yale University, where he studied cognitive neuroscience — exploring the anatomy and physiology behind social phenomena. His interests lie at the intersection of clinical medicine and the legal forces that shape it. Prior to law school, Shailin worked on both the administrative and clinical sides of health care, and as a research associate at the Berkman Center for Internet & Society. He is currently an affiliate of the Berkman Center and Outreach Editor for the Harvard Journal of Law & Technology. A fervent proponent of privacy and freedom of expression, Shailin has also served on the Board of Directors of the American Civil Liberties Union of Connecticut. For his Fellowship project, he will focus on a tort solution for faulty eyewitness testimony procedures.