WAY BACK WHEN we walked uphill both ways in the snow to nursing school, we were taught team nursing. I did my clinical in a county teaching hospital on a medical floor staffed with RNs, LPNs, CNAs, and lots of medical interns and residents. It fascinated me how knowledgeable and assertive the nurses were. I dreamt that one day I too would be giving information to doctors. The RNs cared for their patients with the help and collaboration of the other members of their team, which consisted of LPNs and CNAs, radiology techs, respiratory techs, and other unlicensed assistive personnel. Their synchronicity in delivering patient care was a wonder to behold.

After a year as an RN in this setting, I began nursing at a private psychiatric hospital where once again we were involved in team nursing. This time my team consisted of mental health workers I, II, and IIIs, and an LPN who gave medications to the entire floor of 27 adolescent psychiatric patients. Although I was a relatively new nurse, I was hired as a supervising RN and I was accountable to nursing administration, medical staff, and of course, most importantly, the patients for all that transpired on my unit during my three, 12-hour shifts per week. All that I had learned in nursing school was put to the test in the supervision and delegation of the care provided to our patients. In this setting, it was crucial that we as staff were of one accord, the proverbial “surrogate parents” who could and would not be split.

In 1993, I moved to Nevada. I spent the first two years finishing my masters in nursing and working as the Director of Clinical Services at a well-known residential center for adolescents and children. Again, we strove to provide a culture of collaboration, utilizing each staff member-licensed and unlicensed-based on his or her scope of practice, skill level, competence, and expertise.

I began working for the NSBN in November, 1996. My first experience with Board meetings was during the Board’s attempt to pass regulations regarding delegation. I was surprised there was such controversy over a concept I believed was so basic to nursing. What we learned from this experience was that Nevada nurses needed education on what our current regulations said regarding delegation. The Board’s executive director at that time, Kathy Apple, and some of us staff traveled across the state giving presentations wherever we were invited. In my communications with Nevada nurses in 2004, I’ve found we still are not only ill informed, but also fearful of the concept of “delegation.”

Earlier this year, the American Nurses Association (ANA) asked for input to a draft of their Principles of Delegation. I responded with,

“Thank you for addressing this controversial issue in such a well-thought out and understandable document.”

ANA’s draft defined “delegation” as:

The transfer of responsibility for the performance of an activity from one individual to another while retaining accountability for the outcome. Example: The nurse, in delegating an activity to an unlicensed individual, transfers the responsibility for the performance of the activity but retains professional accountability for the overall care.

The Nevada Administrative Code defines delegation as:

NAC 632.047 “Delegation” defined. (NRS 632.120) “Delegation” means entrusting the performance of a delegable nursing duty to a person who is qualified and competent to perform the duty.

ANA did a better job of defining “delegation.” (I learned in high school English class that you don’t use the word you’re defining with another form of that word.)

Not only did they give us an excellent definition, but they gave some noteworthy recommendations for nurses who were interested in utilizing delegation in their practice.

I was ecstatic! In its draft, ANA had provided an outline for me to follow in giving Nevada nurses simple, understandable information about what has been a very controversial topic.

ANA’s first recommendation involved getting answers from your state nursing board. I decided, I can help. I was given the opportunity during a panel presentation at the Nevada Nurses Association workshop in Carson City. ANA suggested nurses get the following questions answered by their nursing board.

Don’t stop reading now. Find your Nurse Practice Act or go to the Board’s website and bring up NAC Chapter 632, the Board’s rules and regulations for nursing practice. The questions are answered for you, but you have to find the why and wherefore in our law, the Nurse Practice Act.

QUESTION #1

Does it permit delegation?

YES. NAC 632.222 Delegation and supervision of nursing care. 1. A registered nurse may delegate nursing care to other nurses and supervise other personnel in the provision of care if those persons are qualified to provide that care.

QUESTION #2

What is the definition of delegation in your state?

NAC 632.047 “Delegation” defined. “Delegation” means entrusting the performance of a delegable nursing duty to a person who is qualified and competent to perform the duty.

The President. Thank you all for coming. Thank you all for being here. Go ahead and have a seat. Thank you. Nice to be in the part of the world where the cowboy hats outnumber the ties. Thanks for coming. Gosh, it’s wonderful to be back in Montana. What a fabulous State, full of really decent, honorable people.

Conrad, thanks for introducing me. I’m glad you didn’t auction me off. [Laughter] Doing a fine job in the United States Senate, and I’m proud to call you friend. Thank you very much, sir.

And I want to thank Max Baucus for being here. We have worked a lot together in 4 years. You know, we’ve confronted a lot of things in this country. We’ve confronted a recession and confronted the need to get this economy growing. And Max worked hard with the administration to cut taxes and open up markets. And I appreciate working with you, Max. It’s been a lot of fun. We got more work to do.

We’re here to talk about an issue, after a while, that’s going to remind us we got a lot of work to do if we’re going to do our duties as public servants. But Max, thank you. Denny Rehberg, thank you, friend, for coming. I’m honored you’re here–proud of the United States Congressman from the great State of Montana–and Jan.

The Governor met me at the airport. The Governor is here. Governor, thank you for coming. I’m proud you’re here. One of these days you’re going to join the same club as me and Judy and Marc Racicot–that’s the ex-Governors club. But right now, you may have the best job in America, being the Governor of a great State. So I’m proud you’re here. Lieutenant Governor is with us today. We got a lot of other officials–secretary of State–thanks for coming.

You know, we’re flying over on Air Force One, and guess what Burns and Rehberg–all they wanted to talk about was cattle–[laughter]–Montana beef. And that’s an important subject because it’s part of how to make sure our economy continues to grow. They kept asking, “Are you talking to markets overseas to get the Montana beef into those markets?” I said, “You bet I am.” And we’ll continue to do so.

One of the reasons I worked with Max on free trade is because I believe when we open up markets for products, U.S. products, Montana products, people are going to more likely be able to find a job. We want to be selling stuff you grow here and stuff you produce here all around the world. And so I want to tell Max and Denny and Conrad, we’re going to still be opening up markets.

They also had a few other things on their mind. They wanted to talk about energy. Last night I said to the United States Congress- I said we have been debating energy long enough. It is time to get a sound energy plan to my desk so we can become less dependent on foreign sources of energy. People in Montana know something about energy. I know that.

They said also, “Make sure you keep in mind the needs of the rural health–hospitals and docs.” You’ve got some rural issues here in Montana because you’ve got a lot of land–[laughter]–and not a lot of people. [Laughter] That’s the way a lot of folks probably want to keep it too, I suspect.

If you want to have health care available and affordable, we’ve got to do something about these lawsuits that are running good doctors out of practice. We’ve got a problem in that these lawsuits are making it costly for docs to stay in business and are hurting the Federal budget too. When you’re afraid of getting sued, you practice defensive medicine. In other words, you prescribe more than you need to, just in case you have to go to a court of law. And that runs up the cost of Medicare, Medicaid, veterans benefits. So I’ve come to the conclusion that the medical liability issue is a national problem that requires a national solution, and I call upon Congress to pass real, meaningful medical liability reform.

Before we talk about Social Security, I do want to talk a little bit about the amazing times we’re living in. Just think about what has happened in the last 4 months. There was an election in Afghanistan. Millions–millions–of people voted for a leader, voted for a President for the first time in 5,000 years. I don’t know who’s counting, but that’s a lot, you know. I mean, it’s an amazing story, when you think about it. It wasn’t all that long ago that the Taliban was providing safe haven to Al Qaida in Afghanistan, and that’s where they plotted and trained. That’s why we went in, to rout them out.

We said if you harbor a terrorist, you’re equally as guilty as a terrorist. The doctrine still stands. And the reason the doctrine still stands is because there’s an enemy that still hates what we stand for. We will stay on the offense. No matter where they hide, where they run, the United States of America and coalition forces will be after them to keep us safe.

That is our duty. That’s the responsibility of the Federal Government. And I want to thank those who wear our uniform for serving this great country of ours. But the lesson of Afghanistan should remind us we’ve got a greater force at our disposal than just our military, and that is our belief in the ability of freedom to change societies.

Nancy Moshier, R.N., is an award-winning culinary expert and author of the best-selling low-carb cookbooks Eat Yourself Thin Like I Did and Eat Yourself Thin With Fabulous Desserts. Nancy has lost 131 pounds living the low-carb lifestyle!

In each issue, she answers your questions about food preparation, medical issues and living low-carb.

Q: Can whole-wheat flour or soy flour be used as a thickening agent for soups or roux? What is LC friendly?

A: Actually, I recommend using xanthan gum and guar gum for thickening. They work very well and are all fiber, so they are essentially carb-free. For making roux, I’ve found that soy flour just doesn’t make the grade. It was too soupy, and the flavor wasn’t acceptable. Whole-wheat flour works much better and tastes pretty good, although I don’t care much for the mouth feel. The carb count for roux is pretty high because of the preparation method. I recommend trying a lower-carb version of roux only after you are in the maintenance phase.

Q: Do you lose the “good” oils from nuts when you toast them?

A: Great question! After an exhaustive search for information on this topic, I have come to the conclusion that it has not been addressed–so I am going to give you an educated guess. I usually toast nuts in the microwave because it is quick and convenient. I use a paper plate and have noticed tiny oily spots after toasting nuts. The oil loss is so minimal, however, that I believe you are losing only a miniscule amount of the nut oil. I don’t think it is significant enough to really make a difference.

Q: I just began my low-carb lifestyle this week. Is it normal to feel so tired? I eat at least three main meals and three snacks a day.

A: The first week on a low-carb regimen is always the toughest. Your body is in carb withdrawal. Plus, if you are following the Atkins plan and are induction, you are also giving up caffeine–so you’re getting a double whammy. It also depends on whether or not you went on a carb binge just before starting your low-carb regimen. If you did, then your withdrawal will be much worse and last longer. My husband Ron did exactly that and paid dearly for it. To me, this says how toxic sugar is to our bodies. The good news is, once you get past the first week or two, your energy level is likely to shoot through the roof!

NANCY’S TIPS:

To keep that clumsy, hard-to-wash food processor top clean, place a sheet of plastic wrap over the food processor bowl after you’ve added the ingredients to be processed. Replace the lid on top of the plastic wrap, lock into place and process. The plastic barrier keeps the contents from coming in contact with the food processor lid. For foods with a sharp edge, just double the plastic wrap before using. My husband is glad I came up with this idea because it makes his job of cleaning up much easier!

Imagine that you urgently need a life-saving medical device. What questions would you ask your physician? Would you want to know what your available options are? Would you ask if the model that your doctor selected has ever been reported to fail? Would you ask how thoroughly the Food and Drug Administration (”FDA”) investigated the selected device before approving it for sale in the United States? Most Americans are unaware of the importance of asking any or all of these questions.1 Most of us would simply trust the choice of our physician, believing that he or she is sufficiently informed about the device’s safety profile to make the best choice.2 In addition, most Americans assume that the FDA would not permit a manufacturer to market a device that was unsafe or negligently designed.3 However, like any other administrative agency, the FDA has limited financial and human resources. Sometimes, despite the most thorough evaluation possible, a device poses risks that were not evident during the FDA approval process.4 Tragically, those risks can result in serious injury or even death to the patient.

Imagine further that because of a defect undetected by both the manufacturer and the FDA you have been seriously injured by the very device that was meant to restore your health. Yet, you are told that you have no recourse in the American legal system because the FDA’s approval of the device bars your claims against the manufacturer via the legal doctrine of preemption. This is precisely what happened in the recent Third Circuit case, Horn v. Thoratec Corp.

In January 1998, Daniel Horn suffered a heart attack.6 A week later, a medical device, known as the HeartMate, was implanted into his body to aid blood circulation through his heart.7 Because of a defect in the device, air entered the closed system and an air embolus traveled to Mr. Horn’s brain, ultimately causing his death.8 Mrs. Horn, as executor of Mr. Horn’s estate, brought common law tort claims against the manufacturer in the United States District Court for the Middle District of Pennsylvania.9 The district court dismissed the case, finding Mrs. Horn’s state claims preempted because they would impose requirements on the manufacturer that were different from, or in addition to, the requirements imposed by the FDA’s approval process.10 On appeal, the Court of Appeals for the Third Circuit affirmed the district court’s ruling.11

This Comment proposes that the Third Circuit was too hasty in finding that Mrs. Horn’s state tort claims were preempted by the Medical Device Amendments to the Food, Drug and Cosmetic Act (”MDA”). Part I will explain the background of the MDA and the preemption defense, and will describe the Horn decision. Part II will demonstrate that the presumption against preemption, as informed by the legislative intent and the statutory structure of the MDA, supports the conclusion that Mrs. Horn’s state tort claims should not have been deemed preempted. Part III will discuss the importance of the FDA’s view of preemption and will show that FDA regulations require a court to evaluate a plaintiffs tort claims individually before finding preemption. Part IV will illustrate that the Horn court did not adequately evaluate the nature of each of Mrs. Horn’s tort claims to determine whether they would impose requirements different from or in addition to those imposed by the FDA. Finally, a more exhaustive analysis of Mrs. Horn’s claims will show that some-but not necessarily all-of the claims should have survived preemption.

I. MDA PREEMPTION OF STATE CLAIMS IN HORN v. THORATEC

A. Background of the Preemption Defense and the Medical Device Amendments

The American tort system has two major functions. First, it is a “vehicle of legal redress” for victims who have been injured at the hands of another.12 second, it deters wrongful or negligent conduct with the threat of large damage awards.13 Within this system, every manufacturer is under a common law duty to use due care to avoid foreseeable dangers in the products that it sells.14 However, where the product at issue is federally regulated, manufacturers often argue that state common law tort claims must be preempted by the federal regulation.

Preemption is the doctrine under which federal law supersedes state law by operation of the Supremacy Clause of Article VI of the United States Constitution.16 When a court upholds the preemption defense in a products liability controversy, the injured party is often left with no legal recourse.17 Therefore, it is imperative that a court evaluate Congress’ intended scope of preemption,18 each of the plaintiffs claims, and the applicable federal requirement before deciding that a conflict exists.

Congress enacted the MDA in 1976 in response to injuries caused by a contraceptive device known as the Dalkon Shield.19 With new, more complicated devices entering the market, Congress sought to protect the public health by “assuring] the reasonable safety and effectiveness of medical devices intended for human use.”20 Although Congress also noted its intention to encourage the development of new medical devices by instituting a uniform regulatory scheme, commentators have recognized that the chief goal of the MDA was the protection of public health.

It is common knowledge … that the failure of schools to achieve educational objectives has reached massive proportions. It is widely recognizes [sic] that, as a result, not only are many persons deprived of the learning that both materially and spiritually enhances life, but also that society as a whole is beset by social and moral problems. These changed circumstances mandate a change in the common law.

Over the last thirty years, frustrated parents have increasingly brought claims within the legal system for educational misconduct. Finding that administrative remedies do not adequately compensate such injuries as illiteracy, misdiagnoses of learning disabilities, and failure to educate in appropriate environments, plaintiffs have tried to hold educators accountable through malpractice suits similar to legal or medical malpractice suits.2 The legal theory of malpractice holds professionals who injure others liable for their negligence if the injury was proximately caused by a failure to exercise the accepted standard of care of their profession.

Despite compelling tales of injury from negligent educators, there have been only two educational malpractice cases that have survived summary judgment since the cause of action first surfaced in the 1970s.4 In fact, alleging “educational malpractice” in the pleadings invariably leads to a dismissal of the claim because courts almost uniformly refuse to recognize this tort.5 While the number of medical and legal malpractice cases have soared, only one state-Montana-has included education among the professions liable for malpractice. In short, educational malpractice has become “a tort theory beloved of commentators, but not of courts.”

The bases upon which courts decline to recognize educational malpractice claims revolve around several factors that courts have held are relevant to determining whether a judicial recognition of a duty of care on the part of an educator is sound public policy. The factors relevant to determining that an educator owes a duty of care towards a student, as a matter of sound public policy, fall into four general categories: preventative concerns (including establishing a standard of care, causation, and injury); moral concerns; economic issues; and administrative considerations.8 Courts have repeatedly held that these factors preclude an educational malpractice action despite a severe crisis in the field of education and a growing consensus among commentators that malpractice claims should be allowed as a means to reform the system.9 One consideration under the “preventative concerns” factor has surfaced in most court opinions as a major obstacle to educational malpractice liability.10 This is the proximate cause element of the tort of negligence.

After it has been determined that the defendant’s actions are in fact12 one cause of the plaintiff’s injury, the question becomes whether the defendant should be held legally liable for the injury.13 This issue of proximate cause is framed by the question, “was the defendant under a duty to protect the plaintiff against the event which did in fact occur?”14 As applied to educational malpractice, the relevant question is whether an educator is under a duty to protect a student against illiteracy, misdiagnosis, or other educational injury. On the issue of meeting the proximate cause element of educational malpractice, one court has stated:

The “injury” claimed here is plaintiffs inability to read and write. Substantial professional authority attests that the achievement of literacy in the schools, or its failure, are influenced by a host of factors which affect the pupil subjectively, from outside the formal teaching process .. . . They may be physical, neurological, emotional, cultural, environmental; they may be present but not perceived, recognized but not identified …. We find in this situation no conceivable . . . “connection between the defendant’s conduct and the injury suffered,” as alleged, which would establish a causal link between them within the same meaning.

Extracurricular factors that underlie an educational injury, however, should not preclude an award for injuries that are proximately caused by the educator. In medical malpractice cases, there are several situations where the plaintiff will not be able to meet the burden of showing the doctor’s conduct more likely than not proximately caused an injury. One of these situations is where a patient has a preexisting medical condition. The loss of chance doctrine has evolved before a number of courts as a means to assist plaintiffs in cases in which a doctor’s negligence injures a patient with a preexisting condition by reducing the patient’s likelihood of recovering from that preexisting condition. Likewise, courts could adopt the loss of chance doctrine to help educational malpractice plaintiffs in cases for which it cannot be shown that the educator more likely than not caused an injury by reducing the chance that a student will “recover” from or overcome a preexisting physical, neurological, emotional, or environmental condition. This Note argues for the expansion of the lost chance doctrine to educational malpractice claims in order to overcome causation and damages obstacles that make courts reluctant to recognize the cause of action.

BOSTON — There are several ways physicians can offer support to parents after a fetal death, Ruth C. Fretts, M.D., said at a meeting cosponsored by Harvard Medical School and Brigham and Women’s Hospital.

She offered several suggestions on how to counsel parents after a stillbirth, including use of a decision support worksheet and a kind of parental bill of rights. (See box.)

The worksheet takes a question-and-answer format and provides space for parents to list their own thoughts and questions. Although answers to the questions may vary by hospital, the questions address general concerns of grieving parents.

The worksheet was originally designed by a social worker in Chicago who had a stillbirth. “When a bad thing happens, all hell breaks loose. It’s hard to even think. This is a checklist for the patient to hold, to look at, and to go through. When your mind is thinking of all of these millions of things, it’s helpful for the patient, and it’s helpful for the providers. And it has a thoughtful approach to the value of an autopsy,” said Dr. Fretts, assistant professor of obstetrics and gynecology, Harvard Medical School, Boston.

Some questions included on the worksheet:

* What are my options for burial or cremation?

* Should we see and/or hold our baby?

* Will pictures of my baby be taken?

* Will my baby have an autopsy or other tests?

* Can we have our baby blessed?

* Will my milk still come in after delivery?

* We have other children. Should we let them see the baby? What should we tell them?

In Australia, a perinatologist or fetal pathologist usually introduces himself or herself to the parents, expresses condolences, and explains that an autopsy may find out exactly why the baby died. The parents are told their baby will be returned to them and that great care will always be taken. The parents are more likely in this scenario to consent to an autopsy, she said.

“When you have a two-page pathology report of all the things that happened before and after, it makes such a difference in counseling that patient,” Dr. Fretts noted. She did acknowledge that not every hospital has a perinatologist or fetal pathologist available, but she still advocated encouraging parents to seek an autopsy while reassuring them great care will still be taken.

The parental bill of rights she discussed was adapted from guidelines by Share Pregnancy and Infant Loss Support Inc., a group created to offer support to individuals who have experienced the loss of a baby through stillbirth, miscarriage, or newborn death.

The term “bill of rights” is something of a misnomer, however. According to a statement from Cathi Lammert, R.N., the group’s executive director, “The term ‘rights’ is not used as a mandate for the bereaved nor as a militant statement of demands. It is an affirmation for parents who wish to be involved with their baby, to make decisions based on informed consent, and to assume the parenting role in meaningful ways despite the tragic circumstances.”

RELATED ARTICLE: Rights of a Parent When a Baby Dies

The following is an abbreviated version of the rights in the Share guidelines, which should be tailored to fit state, local, and hospital polices:

* To be given the opportunity to see, hold, and touch their baby at any time before and/or after death, within reason.

* To have photographs of their baby taken and made available to the parents, or held in security until the parents want to see them.

* To be given as many mementos as possible.

* To name their child and bond with him or her.

* To observe cultural and religious practices.

* To be cared for by an empathetic staff who will respect their feelings, thoughts, beliefs, and individual requests.

* To be with each other throughout hospitalization as much as possible.

* To be given time alone with their baby, allowing for individual needs.

* To be given information about the grieving process and support organizations.

* To have a discussion with the appropriate medical staff on options for an autopsy and other testing procedures.

* To plan a farewell ritual, burial, or cremation in compliance with local and state regulations and according to their personal beliefs, religion, or cultural tradition.

With financial ties to nearly two dozen drug and biotech companies, Dr. Charles B. Nemeroff may hold some sort of record among academic clinicians for the most conflicts of interest. A psychiatrist, a prominent researcher, and chairman of the department of psychiatry and behavioral science at Emory University in Atlanta, Nemeroff receives funding for his academic research from Eli Lilly, AstraZeneca, Pfizer, Wyeth-Ayerst–indeed from virtually every pharmaceutical house that manufactures a drug to treat mental illness. He also serves as a consultant to drug and biotech companies, owns their stocks, and is a member of several speakers’ bureaus, delivering talks–for a fee–to other physicians on behalf of the companies’ products.

But it was just three of Nemeroff’s many financial entanglements that caught the eye of Dr. Bernard J. Carroll last spring while reading a paper by the Emory doctor in the prominent scientific journal, Nature Neuroscience. In that article, Nemeroff and a co-author reviewed roughly two dozen experimental treatments for psychiatric disorders, opining that some of the new treatments were disappointing, while others showed great promise in relieving symptoms. What struck Carroll, a psychiatrist in Carmel, Calif., was that three of the experimental treatments praised in the article were ones that Nemeroff stood to profit from–including a transdermal patch for the drug lithium, for which Nemeroff holds the patent.

Carroll and a colleague, Dr. Robert T. Rubin, wrote to the editor of Nature Neuroscience, which is just one of a family of journals owned by the British firm, Nature Publishing Group, pointing out the journal’s failure to disclose Nemeroff’s interests in the products he praised. They asked the editor to publish their letter, so that readers could decide for themselves whether or not the author’s financial relationships might have tainted his opinion. After waiting five months for their letter to appear, the doctors went to The New York Times with their story–a move that sparked a furor in academic circles, and offered the public yet another glimpse into conflict of interest, one of the most contentious and bitter debates in medicine.

In his defense, Nemeroff told the Times he would have been happy to list his (many) relationships with private industry–if only the journal had asked. “If there is a fault here,” he said, “it is with the journal’s policy,” which did not require authors of review articles to disclose their conflicts of interest.

And that is pretty much where the debate over conflict of interest in medical journals stands: Should research scientists who have financial stakes in the products they are writing about be forced to disclose those ties? To which the average person might reasonably respond, of course they should. But the more pertinent question is why scientists with financial stakes in the outcome of scientific studies are allowed anywhere near those studies, much less reviewing them in elite journals.

The answer to that question is at once both predictable and shocking: For the past two decades, medical research has been quietly corrupted by cash from private industry. Most doctors and academic researchers aren’t corrupt in the sense of intending to defraud the public or harm patients, but rather, more insidiously, guilty of allowing the pharmaceutical and biotech industries to manipulate medical science through financial relationships, in effect tainting the system that is supposed to further the understanding of disease and protect patients from ineffective or dangerous drugs. More than 60 percent of clinical studies–those involving human subjects–are now funded not by the federal government, but by the pharmaceutical and biotech industries. That means that the studies published in scientific journals like Nature and The New England Journal of Medicine–those critical reference points for thousands of clinicians deciding what drugs to prescribe patients, as well as for individuals trying to educate themselves about conditions and science reporters from the popular media who will publicize the findings–are increasingly likely to be designed, controlled, and sometimes even ghost-written by marketing departments, rather than academic scientists. Companies routinely delay or prevent the publication of data that show their drugs are ineffective. The majority of studies that found such popular antidepressants as Prozac and Zoloft to be no better than placebos, for instance, never saw print in medical journals, a fact that is coming to light only now that the Food and Drug Administration has launched a reexamination of those drugs.

Today, private industry has unprecedented leverage to dictate what doctors and patients know–and don’t know–about the $160 billion worth of pharmaceuticals Americans consume each year. This is an unsettling charge that many (if not a majority) of doctors and academic researchers don’t want to acknowledge. Once grasped, however, the full scope and consequences of medical conflict of interest beget grave doubts about the veracity of wide swaths of medical science. As Dr. Drummond Rennie, deputy editor of The Journal of the American Medical Association (JAMA), puts it, “This is all about bypassing science. Medicine is becoming a sort of Cloud Cuckoo Land, where doctors don’t know what papers they can trust in the journals, and the public doesn’t know what to believe.”

Clinical Quiz questions are based on selected articles in this issue. Answers appear in this issue.

American Family Physician has been approved by the American Academy of Family Physicians as having educational content acceptable for Prescribed credit hours. Term of approval covers issues published within one year from the beginning distribution date of January 2003. This issue has been reviewed and is acceptable for up to 4 Prescribed credit hours. Thirty minutes of these credit hours conform to AAFP criteria for evidence-based CME content. When reporting CME credit hours, AAFP members should report total Prescribed credit hours earned for this activity. It is not necessary for members to label credit hours as evidence-based or Prescribed for CME reporting purposes.

The American Academy of Family Physicians is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education for physicians.

The AAFP designates this educational activity for a maximum of 4 hours in Category 1 credit toward the American Medical Association Physician’s Recognition Award. Each physician should claim only those hours of credit that he or she actually spent in the educational activity.

AAFP Credit

Each copy of AFP contains a Clinical Quiz answer card. AAFP members may use this card to obtain the designated number of Prescribed credit hours for the year in which the card is postmarked.

AAFP members who satisfy the Academy’s continuing medical education requirements are automatically eligible for the AMA/PRA.

Physicians who are not members of the AAFP are eligible to receive the designated number of credit hours in Category 1 of the AMA/PRA on completion and return of the Clinical Quiz answer card. AFP keeps a record of AMA/PRA Category 1 credit hours for nonmember physicians. This record will be provided on request; however, nonmembers are responsible for reporting their own Category 1 CME credits when applying for the AMA/PRA or other certificates or credentials.

For health care professionals who are not physicians and are AFP subscribers, a record of CME credit is kept by AAFP and will be provided to you on written request. You are responsible for reporting CME hours to your professional organization.

NOTE: The full text of AFP is available online (www.aafp.org/afp), including each issue’s Clinical Quiz. The table of contents for each online issue will link you to the Clinical Quiz. Just follow the online directions to take the quiz and, if you’re an AAFP member, you can submit your answers for CME credit.

Instructions

Read each article, answer all questions on the quiz pages, and transfer your answers to the Clinical Quiz answer card (bound into your copy of AFP). This will help you avoid errors and permit you to check your answers against the correct answers.

Mail the Clinical Quiz answer card within one year (by October 31, 2004). The bar code on the answer card contains your identification for CME credit hours.

Before beginning the test, please note:

Each Clinical Quiz includes two types of questions: Type A and Type X.

Type A questions have only one correct answer and may have four or five choices. Here is a typical Type A question:

Q1. Most allergic reactions to foods are:

[ ] A. Due to IgA deficiency.

[ ] B. Due to IgG and IgM antibodies.

4 [ ] C. IgE-mediated.

[ ] D. Due to enzyme deficiencies.

[ ] E. Due to toxins.

Type X questions may have one or more correct answers. They are multiple true-false questions with four options. Here is a typical Type X question:

Q2. Causes of varicosities in pregnancy
include:

4 [ ] A. Hormonal changes.

4 [ ] B. Venous compression.

4 [ ] C. Familial tendency.

4 [ ] D. Prolonged sitting and standing.

Clinical Quiz questions are written by the associate and assistant editors of AFP.

Type A Questions

Each question has only one correct answer.

Articles

Management of Gastroesophageal Reflux Disease (p. 1311)

Q1. Which one of the following statements about surgery for gastroesophageal reflux disease is correct?

[ ] A. By five years after surgery, fewer than 2 percent of patients require antireflux medications.

[ ] B. Surgery is more effective for alleviating extraesophageal symptoms than for alleviating heartburn.

[ ] C. Between 2 and 3 percent of patients have permanent symptoms of solid food dysphagia after antireflux surgery.

[ ] D. Antireflux surgery is significantly more effective than antacid therapy in patients with erosive esophagitis.

A Practical Guide to Anaphylaxis (p. 1325)

Q2. Which one of the following is the most common set of symptoms of anaphylaxis?

[ ] A. Angioedema and urticaria.

[ ] B. Pruritus without rash.

[ ] C. Dizziness and hypotension.

[ ] D. Dyspnea and wheezing.

[ ] E. Nausea and vomiting.

Q3. Patients with latex allergy also may be sensitive to which one of the following?

[ ] A. Shellfish.

[ ] B. Wheat products.

[ ] C. Potatoes.

[ ] D. Bananas.

The saying, “If you want something done right, do it yourself,” doesn’t apply when it comes to ensuring clean claims.

One person-even one department-is hard pressed to take on this challenge in today’s environment, where the task of coding and billing claims gets more difficult every quarter, possibly every month. That’s how often payers update the rules that govern coding and compliance.

To keep up with ever-changing regulations, patient financial services departments are reaching out to other departments and experts within the hospital to ensure claims are sent correctly the first time. Today, each functional department along the revenue cycle is sharing in the responsibility for reducing the number of days a claim remains in accounts receivable-a difficult task, to say the least.

Reducing Back-End Fixes and Rework

To come up with new ways to reduce the number of claim denials and the amount of time that staff spend fixing claims after the fact, PFS professionals are looking not only at the benefits of front-end medical necessity compliance, but also the value of improving processes before bills hit a claims scrubber.

To drop a clean claim, PFS departments often must undertake the time-consuming process of consulting with multiple departments in order to confirm that the appropriate documentation exists to support adding modifiers or changing current procedural terminology or Healthcare Common Procedure Coding System codes. Worse yet, if the claim scrubber triggers an edit, a decision may be made to simply write off the charge assuming that its value is not worth the trouble of rework to fix the problem. Or the claim will be submitted knowing that it will be denied and will need to be corrected later by denials management staff.

Back-end fixes and rework require that billing or coding staff:

> Manage a worklist of unresolved edits

> Pull charts

> Compare diagnosis and procedure code pairs manually against local fiscal intermediary rules

> Communicate with physicians or departments to check for additional documentation

> Ensure the appropriate use of modifiers

> Relay their findings and fixes back through the abstracting process, returning the claim to the billing department to rescrub

The end result may be cleaner claims, but back-end fixes and rework require a significant investment of time and labor, resulting in lost productivity and increased accounts receivable days.

An alternative approach would be to create a proactive integrated team made up of representatives from PFS, medical records coding, patient access, ancillary and clinical staff, and compliance, with responsibility for:

> Performing retrospective review of claim errors that occur throughout the revenue cycle

> Assigning responsibility for fixing the source of the identified problems

> Determining accountability for error resolution

> Reviewing new and upcoming regulations to determine financial impact and implementation implications

> Approving new services to be added to the chargemaster

This team of experts would review all hard- and soft-coded CPTs, revenue codes, and ambulatory payment classifications for editing, making it possible to track errors and pinpoint problems that occur repeatedly. After defining the impact of various problems, the task force could then address issues that have a significant financial impact or compliance exposure, as well as those that are simply easy to fix.

Although this approach involves a substantial process change for most facilities, it can have far-reaching benefits. Staff resources would be used more efficiently as PFS, ancillary, and coding staff members become more knowledgeable about each other’s area of expertise and how they can best work together to effect change.

Taking the Detective Work Out of Coding

There are numerous variables that can have an impact on coding compliance. The Centers for Medicare and Medicaid Services has issued national coverage determinations that affect countless procedures. Local carriers contribute to the maze of information with their own local medical review policies (now known as local coverage determinations). Correct coding edits that regulate which pairs of codes can and cannot be billed together are added and modified frequently. Often the detective work involved in discovering potential problems and avoiding coding errors is overwhelming.

New software and web-based technologies are making this task more manageable. Many electronic or online solutions are designed to quickly and automatically identify specific edits that will derail a claim, thus allowing coders to incorporate this information early in the initial coding session. For example, technology can immediately identify situations in which application of modifier-CA would be appropriate. This modifier, indicating that a procedure payable only in the inpatient setting was performed in the emergency department on an outpatient who died prior to admission, allows the hospital to be paid for the encounter. Without the modifier, the entire claim would be denied.

Officers violate the 14th Amendment when they deny adequate medical care to an individual in custody.

Here, three Cincinnati officers stopped Roger Owensby. They suspected that he had previously fled in a drug-related incident.

At the scene, Owensby again attempted to slip the officers who forced him to the ground, handcuffed and maced him.

Several officers appeared in support and simply observed the scene with the exception of a sergeant who discovered Owensby had stopped breathing and summoned medical aid.

The victim was pronounced dead at hospital, and his estate sued.

Because district court denied qualified immunity to the officers, they appealed to the 6th Circuit Court.

The court applied the deliberate indifference standard. During the six minutes police denied medical care to Owensby, the officers had time to do such things as greet each other, prepare for the arrival of superiors, pick up dropped items and tidy uniforms.

Under these circumstances, “there is no question that the officers had time to fully consider the potential consequences of their conduct.”

Moreover, each officer viewed Owensby in significant physical distress, yet made no attempt to summon or provide any medical care until several minutes later, when the sergeant checked on Owensby and discovered he was unconscious.

A need for medical care was so obvious that even a layperson would easily recognize the necessity for a doctor’s attention, the court said.