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by Bryan Morben, UMN Law Student, MJLST Managing Editor
A major criticism about the Patient Protection and Affordable Care Act of 2010 ("Affordable Care Act" or "ACA") is that it will lead to a premium "death spiral." Because the Affordable Care Act proscribes health insurance companies from discriminating against individuals with preexisting health conditions, some believe that people might just wait until they're sick before signing up for coverage. If that happens, everyone else's premiums will rise, causing healthy people to drop their coverage. With only sick individuals left paying premiums, the rates go up even more. And so on . . .
On the other hand, supporters of the ACA cite its other provisions to safeguard against this scenario, specifically, the subsidy/cost sharing and "individual mandate" sections. The former helps certain individuals reduce the amount of their premiums. The latter requires individuals who forego buying minimal health insurance to pay a tax penalty. The penalty generally "is capped at an amount equal to the national average premium for qualified health plans which have a bronze level of coverage available through the state Exchange." Therefore, the idea is that enough young, healthy individuals will sign up if they would have to pay a similar amount anyway.
States that have guaranteed coverage for everyone with preexisting conditions before have seen mixed results. New York now has some of the highest individual health insurance premiums in the country. Massachusetts, which also has an individual mandate, has claimed more success. But it still leaves some residents wondering whether breaking the law might make more sense.
There are notable differences between the ACA and the Massachusetts law as well. For example, the subsidies are larger in Massachusetts than they are with the ACA, so there's less of an incentive for healthy people to sign up for the federal version. In addition, the ACA's individual mandate seems to have less of a "bite" for those who elect to go without insurance. The penalty is enforced by the Treasury, and individuals who fail to pay the penalty will not be subject to any criminal penalties, liens, or levies.
Finally, the unveiling of the HealthCare.gov website, a health insurance exchange where individuals will learn about insurance plans, has been a catastrophe so far. There is also some concern that "only the sickest, most motivated individuals will persevere through enrollment process." Since high enrollment of young, healthy participants is crucial to the success of the marketplace, the website problem, and any negative effect it has on enrollment, are just the latest contributor to the possible looming spiral.
In all, it remains to be seen whether the Affordable Care Act will succeed in bringing about a positive health care reform in the United States. For an excellent discussion on the ACA's "right to health care" and additional challenges the law will face, see Erin C. Fuse Brown's article Developing a Durable Right to Health Care in Volume 14, Issue 1 of the Minnesota Journal of Law, Science & Technology.
by Katelyn DeRuyter, UMN Law Student, MJLST Note and Comment Editor
The fact that many Americans are obese is hardly news. Obesity in America has been a source of news reports, social commentaries and literature for well over a decade. In her book review of "The Omnivore's Dilemma: A Natural History of Four Meals" by Michael Pollan, published in Issue 8.1 of the Minnesota Journal of Law, Science & Technology, Morgan Holcomb discusses how obesity rates in America were part of Pollan's motivation to write "The Omnivore's Dilemma." More recently, American obesity has been described as an epidemic, and the health risks associated with obesity are gradually becoming common knowledge. Obesity is even compared, by some, to smoking and alcoholism. A recent LawSci blog post, "Is Food the New Tobacco: Science, Advertising, and the War against Obesity?" looks at Roseann Termini's article, "Food Advertising and Childhood Obesity: A Call for Action for Proactive Solutions," and draws parallels between the role of advertising in the rise of cigarette addiction and the current obesity epidemic.
A question that is overlooked in this dialogue is whether obesity is, in fact, a disease. Whether obesity is considered a disease has real consequences including altering social stigmas, increasing funds allocated for research and expanding treatment accessibility. The debate over whether obesity should be considered a disease is not new. However, new life has been breathed into the debate following the American Medical Association's (AMA) official recognition of obesity as a disease. The New York Times quoted Dr. Harris, a member of the AMA's board, as stating that "[r]ecognizing obesity as a disease will help change the way the medical community tackles this complex issue that affects approximately one in three Americans." A recent Forbes article, "Declaring Obesity a Disease: the Good, the Bad, the Ugly," provides a closer look at how the AMA reached its decision.
In reaching the conclusion that obesity is a disease, the AMA overruled its own council's recommendation. The AMA's Council on Science and Public Health (Counsel on Science) had been tasked with studying this issue over the past year. The Council on Science's recommendation against categorizing obesity as a disease rested, in part, on the concern that body mass index (BMI) is a simplistic and inaccurate tool; BMI is the tool generally used to define obesity. The Council on Science was also concerned that recognizing obesity as a disease might increase reliance on drugs and procedures and decrease the emphasis on lifestyle changes.
From a legal perspective, this classification raises interesting questions regarding future interpretation of Congressional intent when "disease" is used without a specific definition. While only time will be able to tell the actual effects of this classification, this is certainly a "must watch" area for health law attorneys.
by Alison Key, UMN Law Student, MJLST Staff
In May 2013, the Minnesota Supreme Court recognized a new cause of action against healthcare providers for medical malpractice. In Dickhoff ex rel. Dickhoff v. Green, A11-0402, 2013 WL 2363550 (Minn. May 31, 2013), Minnesota joined a growing group of states that permit medical malpractice claims for "loss of chance."
Under traditional principles of tort law, the elements of a tort include existence of a duty, breach of the duty, causation, and injury, all of which a plaintiff must prove to the standard of "more likely than not." This standard of proof has posed problems for plaintiffs in medical malpractice suits where the patient had less than a 50% chance of survival before the alleged negligence occurred. If the patient is already "more likely than not" going to suffer the injury of death from a condition before the negligence of a physician, it is impossible to argue that any physician conduct, even if negligent, was the but-for cause of the patient's ultimate death.
Courts across the country have long grappled with this issue, but have struggled to find a solution. From a patients' rights perspective, states are uncomfortable with the notion that there is virtual immunity from malpractice liability for physicians who begin treating patients after they are already terminally ill. At the same time, courts have been unwilling to hastily depart from traditional principles of tort causation and standards of proof that require a physician to be the but-for cause of the patient's injury.
States have confronted this issue in a few ways. One is to adhere to traditional principles of tort causation and not recognize a cause of action for a patient who brings a claim of medical malpractice (generally failure to timely diagnose) after an illness was already "more likely than not" the cause of death. This would not necessarily preclude a patient from bringing an action if she had a greater than 50% chance of survival (whose condition will not "more likely than not" cause death) but due to a physician's negligence, her chance of survival was reduced to below 50%. In such a case, the physician can be said to have caused by his negligence the injury that is "more likely than not" going to cause the patient's death. This is the approach Minnesota took before Dickhoff.
Another "solution" is the relaxed causation/substantial factor approach. Similar to the way that tort law deals with concurrent causation, some jurisdictions have held that if the physician's negligence and the patient's condition are concurrent causes of death, a jury will determine whether the physician was a "substantial factor" in the injury, and award damages accordingly. This acknowledges, but "relaxes," the causation requirements in malpractice claims with terminally ill patients, permitting recovery for the whole injury.
A final approach is the doctrine of "loss of chance." Rather than address the causation problems when a patient is already "more likely than not" going to suffer death, the loss of chance doctrine changes the nature of the compensable injury. Instead of regarding the injury as death, the court acknowledges that any loss of chance of survival is a compensable injury itself for which the physician must be held accountable. Under this doctrine, a patient who sees a physician when her illness is already terminal, let's say 40% chance of survival, would be permitted to recover if the physician's negligent failure to timely diagnose her injury reduced her likelihood to 30% before treatment was administered. Under the traditional approach, there would be no way to prove that the physician "more likely than not" caused death, because the illness was always 60% likely to cause death. But under the "loss of chance" doctrine, her 10% loss of opportunity to recover is itself the injury for which the patient can recover. This is the position that the Minnesota Supreme Court took in Dickhoff, permitting patients to recover for a "loss of chance" at life.
While this doctrine has intuitive appeal, it is not without its criticisms. While the Anderson opinion rightly champions patients' rights, physicians in "loss of chance" jurisdictions raise legitimate concerns. Subjecting physicians to liability under this standard is an imposition that no other professional organization subject to malpractice faces, payment for a loss in the likelihood of success. Such a departure from professional malpractice norms should be seriously considered before imposed. Particularly as physicians are faced with limitless options for testing and treatment, all of which may be reasonable, and for all of which another physician is willing to testify that he would have taken a different course of action. Further, many raise concerns about how loss of chance can be measured, and whether juries will be able to evaluate "likelihood" claims from experts to arrive at reasonable conclusions. There is also the effect of rising healthcare costs that often comes with an increase in liability expenses for healthcare providers.
But the Minnesota Supreme Court assures that these concerns are outweighed by adopting the loss of chance doctrine, which "will advance, not undermine, the fundamental purposes of tort law: deterrence and compensation." There is an argument that these two justifications will not outweigh the concerns of the medical community. Aside from being offended at the notion that a physician needs a lawsuit as deterrence to responsibly treat a terminally ill patient, the issue with a deterrence justification is that most medical malpractice cases claim negligence in diagnosis. In such cases, the physician is unaware the patient is terminally ill and he has "immunity" to liability. Therefore, physicians argue that the deterrence mechanism is insufficient to warrant such an imposition and uncertainty on health law and the practice of medicine as a whole. Further, the "compensation" rationale does not sit well with many physicians who claim that compensating patients for injury and treatment that was likely to occur anyway will be a windfall for the patient at the expense of the healthcare system (the treatment and outcome for 40% likelihood of success is often the same as the treatment and outcome for 30% likelihood of success). The Dickhoff case was remanded back to the district court for further proceedings after determining that "loss of chance" was a legitimate cause of action. Further cases will show how the patients' rights issues and the physicians concerns with this system will play out.
For further discussion of the "loss of chance" doctrine, see Tory A. Weigand, Loss of Chance in Medical Malpractice: The Need for Caution, 87 Mass. L. Rev. 3 (2002), reprinted here.
by Maya Suresh, UMN Law Student, MJLST Staff
Bringing new drugs to the market has turned into a time consuming and costly process. Resulting in a process that takes roughly 12 years and 1.2 billion dollars to develop a single new drug and move it through the approval process, the current laws administered by the FDA have the potential to stifle potential economic growth. Current laws and FDA regulations require new drugs to go through three phases of clinical trials focusing on safety, optimal dosage, and effectiveness. It is in the prolonged third phase (where effectiveness is tested through extensive clinical trials) that many manufacturers decide to pull the drug from the program as the clinical trials threaten the firm's financial viability. Ultimately, it is consumers that are hurt by the process, as they are unable to benefit from the drugs.
by Eric Nielson, UMN Law Student, MJLST Staff
This entry discusses some of the challenges identified in Grout et al.'s article Mistake-Proofing Medicine: Legal Considerations and Healthcare Quality Implications from Volume 14.1 of the Minnesota Journal of Law, Science, and Technology. If you don't have any health problems, have family with health problems, or pay taxes then the problem probably doesn't impact you. The rest of this paragraph is about me establishing my credentials on the subject, if you don't care, feel free to skip ahead. I have worked as an R&D engineer developing medical devices for more than 15 years. I have a Masters in Medical Engineering from the University of Washington. I am an inventor on several medical device patents. I have worked for a very large company and for several startups. I have conducted market research, physician training, product design, FDA filing preparation, process development, product development, and implementation, etc. I have worked at nearly every stage of medical device development. Devices I have worked on are in literally millions of people in the United States.
by Johanna Smith, UMN Law Student, MJLSTStaff
A new study published online on February 20, 2013 in the Journal of the American Medical Informatics Association found that when hospitals used electronic prescribing, it prevented 17 million drug errors--and if implemented more widely and consistently, it could prevent more than 50 million drug errors. But as of 2008, only about one in three acute care hospitals used electronic prescribing. Although there are various methods suggested to improve healthcare quality, one of the simplest is to make medical errors public. If hospitals, and the general public, were more aware of the safety benefits of electronic prescribing, this could lead to increased use and standardization. Another option to increase the use of electronic prescribing is to connect funding or reimbursement to the use of electronic prescribing.