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Allison Kvien, MJLST Staff Member
Have you seen the "flu shots today" signs outside your local grocery stores yet? Looked at any maps tracking where in the United States flu outbreaks are occurring? Gotten a flu shot? This year's flu season is quickly approaching, and with it may come many implications for the future of health care in this country. This year marks the first year with the Patient Protection and Affordable Care Act (ACA) in full effect, so thousands of people in the country will get their first taste of the ACA's health care benefits in the upcoming months. The L.A. Times reported that nearly 10 million previously uninsured people now have coverage under the ACA. Though there might still be debate between opponents and proponents of the ACA, the ACA has already survived a Supreme Court challenge and is well on its way to becoming a durable feature of the American healthcare system. Will the upcoming flu season prove to be any more of a challenge?
In a recent article entitled, "Developing a Durable Right to Health Care" in Volume 14, Issue 1 of the Minnesota Journal of Law, Science, and Technology, Erin Brown examined the durability of the ACA going forward. Brown explained, "[a]mong its many provisions, the ACA's most significant is one that creates a right to health care in this country for the uninsured." Another provision of the ACA is an "essential benefits package," in which Congress included "preventative and wellness services," presumably including flu shots. For those that will be relying on the healthcare provided by the ACA in the upcoming flu season, it may also be important to understand where the ACA's vulnerabilities lie. Brown posited that the vulnerabilities are concentrated mostly in the early years of the statute, and the federal right to health care may strengthen as the benefits take hold. How will the end of the ACA's first year go? This is a very important question for many Americans, and Brown's article examines several other questions that might be on the minds of millions in the upcoming months.
Roma Patel, Note and Comment Editor
The Supreme Court's decision in Hobby Lobby took the health law spotlight this summer. As the Court's opinion was dissected every which way in the weeks following its release, something else was brewing at the Court of Appeals for the D.C. Circuit in Halbig v. Burwell.
On its face, the Halbig case challenges the federal tax credits, which are available to qualified individuals, enrolled in the health insurance exchange programs. The provision, established by the Patient Protection and Affordable Care Act, references the payment of credits to individuals who enroll through an Exchange established by the state. The legal challenge claims these credits are not available to the 36 states that chose to let the federal government manage their exchanges.
With millions of Americans relying on these tax credits in order to afford health insurance under the mandate, the case's outcome could be devastating. One concern few are addressing is whether Halbig presents a legitimate legal question in the first place. While the plaintiff, senior policy advisor to the Department of Health and Human Services under President George W. Bush, paints this as a matter of statutory language and intent. Advocates for the ACA feel opponents are making a last ditch effort to invalidate the entire law based on imperfect legislative wording. The incessant politicization of health care reform has left most Americans frustrated and disillusioned. Regardless of the outcome, perhaps Halbig represents an opportunity to shine a light on the rhetoric surrounding the healthcare debate itself.
Mayura Iyer, MJLST Staff
When we feel unwell, or have an injury, or are battling a serious condition, we turn to doctors and hospitals to take care of us and return us to health. But what if these professionals are actually adding to the harm? A recent study in the Journal of Patient Safety stated that between 210,000 and 440,000 patients each year suffer some type of preventable harm that contributes to their death. These numbers are staggering and make medical errors the third leading cause of death in America. With statistics like that, you would expect the problem to be the topic of every major headline, however, these facts are not well documented or disseminated.
John Grout, John Hill, and Arlen Langvardt discussed the prevalence and causes of medical errors and how to mistake-proof the healthcare industry in their article in Volume 14, Issue 1 of the Minnesota Journal of Law, Science & Technology. Their article stated that medical errors stem from the multi-factorial, complex nature of medical procedures and from the subjective component of providing medical care. However, the article goes on to suggest several ways in which medical errors can be minimized through "mistake-proofing" measures that have had great success in other industries. The article gives examples of a variety of mistake-proofing methods, from using devices to monitor staff hygiene to using computers to aid the process of prescribing medication.
So why, when there are ways to tackle the issue, are the rates of medical errors not improving? Part of the problem is the institutionalized culture of healthcare. There has historically been a pass of sorts for the errors of doctors, granting them a pardon for reasonable human error. Furthermore, there is a culture of overlooking the mistakes of colleagues - partly because of a fear of retaliation and partly because there is an unspoken rule of maintaining and protecting professional reputations. However, when the cost of error is equal to the value of human life, it is necessary to break down harmful practices and implement policies that will adequately address the problem of fatal medical errors.
Academics, administrators, and doctors themselves have recognized this issue and even suggested easily to implement methods of error reduction. Dr. Marty Makary, a surgeon at Johns Hopkins Hospital, has suggested simple ideas like using cameras to record medical procedures and electronically-published reviews and ratings to make healthcare providers more accountable and thus minimize errors. With the problem only increasing, it will soon be impossible for healthcare providers to ignore. But recognizing the problem is only the first step; the more complicated task will be implementing policies that address the issue and ensuring adequate compliance. However, with the insight offered by practitioners and academics alike, the solution to this problem seems within reach.
Ke M. Huang, MJLST Staff
Once upon a time, a farmer and his new wife, who had no means to support the farmer's first wife's children, decided to abandon the children in the woods. These children--Hansel and Gretel--found in the woods a charming little house made of sweets. A wicked witch lived in that house.
Earlier this month, President Obama signed into law the Farm Bill of 2014. According to a New York Times article, the President called the Farm Bill a "jobs bill," and "innovation bill," a "research bill," and a "conservation bill." Yet, amid the provisions of the Farm Bill that addressed topics such as crop insurance, conservation, and trade, there were also provisions that touched on the issue of healthy nutrition of families.
Senator Stabenow (D-MI), chairwoman of the Senate Agriculture Committee and the author of the Farm Bill, emphasized that part of the Bill's purpose was to improve nutrition choices in families. Changes such as doubling SNAP benefits (formerly called food stamps) for buying healthier foods and financing new grocery stores in underserved areas reflect that purpose.
A question remains whether the Farm Bill of 2014 will be effective in achieving that purpose. Especially for nutrition among the children, the article by Termini et al. in the Volume 12, Issue 2 of the Minnesota Journal of Law, Science & Technology offers some answers. In other words, the article addresses the predicament of modern day Hansel and Gretel who are lured by sugared snacks, french fries, and company.
In Food Advertising and Childhood Obesity (2011), Termini et al. (1) provide some alarming data about nutrition-related health complications among American children, (2) discuss the relationship between the health complications and food advertising, and (3) propose several solutions to address these health complications. While Termini et al. mention advocates of consumer choice, the authors primarily propose measures for the food industry, the government, and parents. For example, akin to the SNAP benefits for buying healthier foods, Termini et al. propose tax incentives for buying healthy food.
In final analysis, even if the often-regarded villain in the story of Hansel and Gretel is the witch, at least the government was partly responsible for the predicament of the children. Had the government funded a SNAP benefit program for the children's family, or even subsidized the family farm through a crop insurance program, the parents would not have to leave the children alone in the woods. Just some food for thought.
Roma Patel, MJLST Staff
The Affordable Care Act is making its way back to the Supreme Court, this time with a different mandate under judicial scrutiny. In November the Court announced it would hear Sebelius v. Hobby Lobby Stores, Inc., regarding the comprehensive, yet controversial, health care law. Unlike National Federation of Independent Business v. Sebelius, where the Court upheld the ACA's individual mandate to buy health insurance as a constitutional exercise of Congress's taxing power, the Hobby Lobby case involves a religious liberty challenge against the ACA's requirement that employers provide insurance coverage for contraception and some drugs that some believe cause abortions.
Hobby Lobby is a private corporation that owns arts-and-crafts stores throughout the country. The company is owned by the Green family, Evangelical Christians who believe that life begins at fertilization. Because Hobby Lobby is a for-profit employer of more than 50 people, the ACA will require it to provide insurance coverage of a full range contraception.
In June 2013 the U.S. Court of Appeals for the 10th Circuit ruled in favor of Hobby Lobby, stating that corporate entities are entitled to religious freedom. The 3rd and 6th Circuits split from the 10th Circuit and held that for-profit corporations do not have religious rights on two other cases challenging the ACA. On September 19, both Hobby Lobby and the 3rd Circuit case, Conestoga Wood Specialties Corp. v. Sebelius, were appealed to the Supreme Court.
Commentary on the Hobby Lobby case can best be described as dicey. Conservative and religious bloggers have hurled phrases such as, "atheist bullies" and "an attack on First Amendment rights" while the left cry, "war on women" and "crazed bible thumpers." The broader issues at stake here are understandably divisive and extremely personal.
Amidst the often-exacerbated discussion of the case and the issues surrounding it is a desperate need to set the record straight: this is not a First Amendment issue, per se. What the Supreme Court will decide is Whether the Religious Freedom Restoration Act of 1993 (RFRA), 42 U.S.C. §§ 2000bb et seq., which provides that the government "shall not substantially burden a person's exercise of religion" unless that burden is the least restrictive means to further a compelling governmental interest, allows a for-profit corporation to deny its employees the health coverage of contraceptives to which the employees are otherwise entitled by federal law, based on the religious objections of the corporation's owners.
Hobby Lobby argues the provision forces it to pay for methods of contraception which the owners find religiously immoral; namely the Plan B morning-after pill, an emergency contraceptive called Ella, and two different kinds of intrauterine devices (IUDs) that may sometimes work by preventing a fertilized egg from implanting into the uterus.
Counsel for the government argues that rights to religious freedoms do not apply to for-profit corporations and that health decisions should be between a woman and her physician, there is no place to an employer to impose his or her personal beliefs on someone else's.
Amicus briefs have been flooding the Supreme Court's doors defending both sides of the issue. Questions of corporate personhood and whether the Court's decision could open a huge hole in the longstanding history of religion and the practice of medicine remain relevant. For example, some religions don't believe in blood transfusions, so does that mean business owners with such beliefs can refuse to provide insurance coverage for an employee's transfusion? Religious beliefs are personal and deeply subjective, how can health policy makers expand on patient coverage without being at odds with subjective beliefs?
The ultimate question is whether the ACA unduly infringes on the right to religious expression or if it pursues the least restrictive means of enforcing its provision on contraception with regard to the First Amendment. The result of Hobby Lobby will be close and the case will be one to watch.
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.