Healthcare

Oops! They Did It Again . . .

February 4, 2014
First Amendment, Healthcare, Healthcare Reform

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.

The Affordable Care Act “Death Spiral”: Fact or Fiction?

November 10, 2013
Healthcare, Healthcare Reform

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.

Is Obesity a Disease?

October 4, 2013
Healthcare, Public Health

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.

The “Loss of Chance” Doctrine after Dickhoff

September 19, 2013
Healthcare, Litigation

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.

Reviving GRAS(E): Bringing Reform to the Drug Approval Process

April 3, 2013
Food and Agriculture, Healthcare, Healthcare Reform, Pharmaceuticals, Public Health

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.

The negative effect on consumers is what Emily Puchalski hopes to eliminate with the recommendation detailed in her note published in Issue 14.1 of the Minnesota Journal of Law, Science & Technology. In “Bringing Dormant GRAS(E) to Bloom: Reviving The GRASE Concept for Drugs,” Puchalski suggests that a revival of the Food and Drug Administration’s (FDA) “generally recognized as safe and effective” laws and regulations, commonly reffered to as “GRASE”, could minimize the negative effects on consumers. Many drugs, once discovered, have formulations found in earlier drugs that have already been established as safe for consumer use. The GRASE law is grounded in this understanding, and provides a way for these “already established as safe” drugs to get to the market quicker without having to go through extensive clinical trials.

The problem with GRASE however, is that it is very difficult for a drug to achieve GRASE status. Due to this difficulty, GRASE has fallen out of use as manufacturers have stopped trying to achieve the status. Puchalski suggests that if the FDA were to revive GRASE, it could convince manufacturers to apply for GRASE status, allowing already established safe and effective drugs to come to market more quickly, thus benefiting consumers.

It would appear that Puchalski’s recommendation is being heard. In late February Micropharma Limited was able to obtain GRASE status for their new heart health probiotic. Ryan Jones, CEO of Micropharma Limited, echoed Puchalski when he spoke of the benefits the company has been able to reap with the highly coveted status. GRASE status will allow the company to accelerate development of the drug within both the United States and international markets. Further, it provides strong reputational benefits for the company, as it makes clear to the public that Micropharma is committed to investing a significant amount of time and energy into providing safe and effective drugs to the market.

The ability for Micropharma to obtain GRASE status could serve as evidence of a potentially reformed drug approval process. However, the full benefits realized by consumers and the market will only become clear with time.

New Medicine Into Old Bottles, Quality and the US Medical System

March 12, 2013
Healthcare, Healthcare Reform, Public Health

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.

The medical delivery system in the United States is fundamentally unchanged in its approach to quality management since the sixties, with the notable exception of anesthesiology (consider how, malpractice pressure forced reform of anesthesiology in the 80s). The public sector of our economy had to make major revisions when foreign competition in the eighties meant that domestic manufacturing could not compete with other countries. American automotive manufacturers took it in the chops because they could not effectively compete with Japanese and Korean companies. Only in the last decade have the automotive manufactures achieved economic efficiencies similar to their competitors (and finally shed some of their legacy costs). Hospitals and private practices never had this wave of foreign competition and so have never had to reinvent themselves to stay in business. Hospitals are heavily subsidized both directly by the taxpayer and through the federal system. The result has been local monopolies with limited real competition, just like the big three automakers before the Japanese entered the picture.

Japan did not invent quality manufacturing. Japanese industry was known for cheap, poor quality goods well into the sixties. What changed is that Japan got serious about producing quality products as a way to compete internationally and move up the value chain. To do this they relied on the work of several notable Americans: Demming, Juran (University of Minnesota graduate), and Crosby. These three together with Taguchi constitute the key founders of the discipline of Quality Management. There are some key concepts that I want to explore in relation to medical providers.

1) “Quality is free.” It is inherently cheaper to do it right the first time than to have to fix it. It is cheaper to spend more on the process to make it so reliable that you don’t have to continue to monitor the output. Your current business is probably externalizing the costs or hiding them and thus minimizes the real cost of defects in the products you make. Time and money are spent to prevent customers from knowing what the actual quality of health care provided by hospitals.

2) Nobody understands the problem better than all of us together. To find the best solution, you need to understand the system from the point of view of everyone who interacts with it. This requires that line personal have the ability to discuss problems and solutions without fear of negative job impact. This does not exist in modern hospitals. Nurses and staff doing the work are not free to identify problems or concerns with physicians. Decisions are not made with consensus but are top down, command and control by people with very limited information. This prevents identification of effective, realistic solutions and instead encourages ineffective window dressing committees.

3) Quality improvement depends on good information and systematic effort. Bluntly Medical providers have systematically hidden outcomes information in an effort to prevent the consuming public from being aware of how bad a job they’ve done. This includes not gathering the information, not publishing information they have, and playing malpractice claims to keep quiet. Take a typical medical procedure and go find the published complication rate. Then take those numbers and talk with specialists in that field about those numbers. What you’ll find is that the published data invariably understates the prevalence of complications at top flight institutions. This is generally a result of selection bias, where only data sets with exceptional outcomes are submitted for publication (so as not to reflect poorly upon the institution). In the absence of good information, these Potemkin village studies underestimate the scope and cost of the problem and encourage administrators and staff to ignore the problem. Nobody ever says Institution X published a study with only a 3% complication rate for procedure Y, we need to get our numbers to that level. They instead say, I wonder what their real rate is or I wonder how they selected their patients for that study.

4) Management needs to lead or it will not happen. This is a system problem. This is not a problem of people not doing their jobs. It is not about people not trying to do their best. The highly complex medical delivery system does not hold anyone responsible for the error rate. It doesn’t not impact salaries, reputation, or stock price the way it does at private companies. Look at the response from hospitals that are killing people every day compared with Toyota’s response to the “sudden acceleration” fiasco. Is the executive team involved? Are resources focused on the problem? Etc. FDA holds management personally, legally responsible for failures of the quality systems at medical device companies. The same standard hasn’t been applied to medical delivery systems. Maybe it’s time to apply this principle outside of Anesthesiology.

Improving Healthcare Quality: Electronic Prescribing

February 26, 2013
Healthcare, Healthcare Reform, Pharmaceuticals

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.

An article in the January 23, 2013 Journal of the American Medical Association reported that once Medicare and Medicaid stopped reimbursing costs due to certain medical errors, the number of times a foreign item was left in a surgical patient dropped by half. The authors note that this number may not be truly accurate, since the hospitals would have financial incentives to hide the errors. Currently, reporting relies mainly on self-reporting by the hospitals, which is not always accurate. A new article in the Minnesota Journal of Law, Science, and Technology (MJLST) by John R. Grout, John W. Hill, and Arlen W. Langvart entitled “Mistake-Proofing Medicine: Legal Considerations and Healthcare Quality Implications,” discusses how to mistake-proof medicine and looks at healthcare quality on a broader level, including electronic prescribing. The MJLST article highlights that many hospital administrators are concerned more with the finances of the hospital than with patient safety. Connecting these two items increases the probability that patient safety will become a priority for hospitals. Although electronic prescribing is not a complete fix for incorrect prescriptions, it is an important part of improving the process. Compared to the cost of medical errors–including incorrect prescriptions–mistake-proofing is generally less expensive.

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