TV And Computer Screen Time May Be Associated With High Blood Pressure In Young Children

Sedentary behaviors such as TV viewing and "screen time" involving computer use, videos and video games appear to be associated with elevated blood pressure in children, independent of body composition, according to a report in the August issue of

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The recent trend in obesity is a major public health concern and its effect on blood pressure is of particular concern, according to background information in the article. "The clustering of cardiovascular disease risk factors in overweight youth suggests that risks may be immediate and not just indicative of potential future problems," the authors write. Although elevated blood pressure is associated with genetic factors, healthy physical, dietary and sleep habits seem to be relevant contributors to blood pressure levels in children. However, there have not been any clear links between sedentary behavior and elevated blood pressure in children younger than age 9.

David Martinez-Gomez, B.Sc., of Iowa State University, Ames, and the Spanish National Research Council, Madrid, Spain, and colleagues examined associations between sedentary behavior and elevated blood pressure in 111 young children (57 boys and 54 girls ages 3 to 8). Sedentary behavior was determined by an accelerometer generally worn over the right hip and by parental reports stating the average time the children spent watching TV, playing video games, painting, sitting or taking part in other activities with low levels of physical activity each day for seven days. Time watching TV was defined as time spent watching TV, videotapes or DVDs. Computer use was defined as the time spent using a home computer or video game. Researchers defined screen time as the total amount of time each child spent using a TV, video, computer or video game. The children's height, weight, fat mass and systolic (top number) and diastolic (bottom number) blood pressure were also measured.

The children's average sedentary time and screen time per day were five hours and 1.5 hours, respectively. Boys spent more time using computers than girls, but there were no significant differences in time spent on other sedentary behaviors. "Sedentary activity was not significantly related to systolic blood pressure or diastolic blood pressure after controlling for age, sex, height and percentage of body fat. However, TV viewing and screen time, but not computer use, were positively associated with both systolic blood pressure and diastolic blood pressure after adjusting for potential confounders," the authors write. "Participants in the lowest tertile [one-third] of TV and screen time had significantly lower levels of systolic and diastolic blood pressure than participants in the upper tertile."

"In conclusion, the results of this study showed that TV viewing and screen time were associated with elevated blood pressure independent of body composition in children," the authors write. "Given that total objective sedentary time was not associated with elevated blood pressure, it appears that other factors, which occur during excessive screen time, should also be considered in the context of sedentary behavior and elevated blood pressure development in children."

This work was supported in part by a York University Faculty of Arts Research Grant, American Heart Association Beginning-Grant-in-Aid, a University of Nebraska at Kearney Grant and a scholarship from the Spanish Ministry of Education and Science.

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Journal reference:

1. David Martinez-Gomez, BSc; Jared Tucker, MSc; Kate A. Heelan, PhD; Gregory J. Welk, PhD; Joey C. Eisenmann, PhD. Associations Between Sedentary Behavior and Blood Pressure in Young Children. Archives of Pediatrics & Adolescent Medicine, 2009;163(8):724-730 [link]

Source : http://www.sciencedaily.com/releases/2009/08/090803173127.htm

Electronic Tracking System Can Help Diabetes Patient Care

An electronic system with personalized patient information shared by diabetes patients and their primary care providers improved diabetes care and clinical outcomes, found a new study in CMAJ (Canadian Medical Association Journal).

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The study involved 511 patients and 46 family physicians and nurse-practitioners and offered web-based tools integrated with 5 different types of electronic health records, an automated telephone reminder system and a mailing of colour-coded materials to half the study sample. Sixty two per cent of patients improved with the intervention compared with 42.6% in the control group and intervention patients reported greater satisfaction with their diabetes care.

Diabetes affects approximately 7% of the populations of Canada and the US – about 23 million people – and costs $105 billion in direct annual healthcare costs. Most diabetes care is community-based, largely managed by primary care physicians.

The study is one of the first randomized trials to show success in community-based primary care and the first such trial in Canada.

"Despite the technical challenges for both patients and physicians, we have demonstrated that the care of a complex chronic disease can be improved with electronic tracking and decision support shared by family physician and patient," write Dr. Anne Marie Holbrook of McMaster University and coauthors.

The results of the study "provide strong evidence that complex research interventions can and should be implemented in community-based practices," say Dr. Richard Grant and Dr. Blackford Middleton of Harvard Medical School in a related commentary. The next steps are to create patient-centred rather than disease-focused systems to address a wide range of patient concerns and help clinical management of complex diseases outside of a visit to a doctor or nurse.

Source : http://www.sciencedaily.com/releases/2009/07/090706171456.htm

Changes in Medicare Pay Rules Could Have a Redistributive Effect

Two days before the July 4 weekend, the Centers for Medicare & Medicaid Services (CMS) announced a series of proposed changes to the 2010 physician fee schedule. In so doing, the agency stirred a controversy that has been bubbling politely below the surface of the physician community for some time now.

For years, primary care physicians (PCPs) have grumbled, sometimes publicly and certainly among themselves, that Medicare's policies and payments favor proceduralists at the expense of PCPs. The effect, family physicians, general internists, and others argued, was to decenter primary care, resulting in less coordinated care and less preventive care and discouraging a generation of students from entering the profession.

For their part, specialists steadfastly supported calls to restore primary care, including proposals for CMS to boost the relative value units for evaluation and management (E/M) and other cognitive services. However, they were not in favor of this restoration if it resulted in a corresponding devaluing of their services. To make primary care "whole" again, specialists said at the American Medical Association (AMA) House of Delegates meeting last month, real savings needed to be wrung from an inefficient and often wasteful system. This could take a variety of forms, including fewer hospitalizations, fewer inpatient readmissions, lower prescription drug costs, and so on.

What prevented these differences from breaking out into open warfare — PCPs on one side, proceduralists on the other — was not simply physicians' traditional bonhomie, although that was certainly a big factor. It was also the 2 groups' united opposition on another front — the complex, and many would say flawed, methodology that CMS uses each year to update the physician fee schedule. In short, if PCPs and specialists were not always on the same page on some matters, neither side has ever had a good word to say about the Sustainable Growth Rate formula, which, as CMS itself points out, "has yielded negative updates every year beginning in...2002."

Changes May Correct Imbalance

The proposed payment and policy changes do nothing to fix the Sustainable Growth Rate formula, which would take congressional action to accomplish — action that may, in fact, be forthcoming as healthcare reform makes its way through both the House and Senate — but, according to some experts, they do address, if not fully correct, the economic imbalance that PCPs have chafed under for years.

"This is an attempt to make primary care whole again in order to get it back to its rightful position at the center of our healthcare system," Ted Epperly, MD, FAAFP, president of the American Academy of Family Physicians and a family physician in Boise, Idaho, told Medscape Medical News. Dr. Epperly is emphatic, however, that the proposed changes should not be seen as an instance of robbing Peter to pay Paul. "The idea is not to increase one type of physician and decrease another type," he said.

Still, in its report to Congress in March, the Medicare Payment Advisory Commission (MedPAC) noted that any increase in payments for primary care, a step it fully endorsed, "would be budget neutral within the fee schedule." For specialists, this could not have come as welcome news: If the Medicare pie, as MedPAC said, was not getting bigger, then any plans to cut a somewhat larger slice for one group would necessarily mean a reduction for other groups.

Redistributing the Medicare Pie

In fact, this is precisely the effect of the proposed changes announced by CMS on July 1. Through these changes, the agency has taken steps to redistribute the Medicare pie, cutting back on what specialists have traditionally received to give a somewhat bigger slice — 6% to 8% bigger, before the annual update and other changes — to physicians in primary care.

The agency has proposed to do this in 3 major ways.

First, it has taken a harder look at the practice expense component of physician fees, using a new survey designed and conducted by the AMA. The upshot is that, if the proposed rule stands, some groups will see their practice expenses for certain services go down, with a corresponding decrease in fees, and some will see expenses go up, with a corresponding increase in fees. As a result of these changes (and others in the cost of professional liability insurance), for instance, radiologists could see an 11% dip in their fees.

"There are huge radiology expenses not captured in the AMA survey that CMS is using," Bibb Allen, MD, chair of the American College of Radiology Economics Commission, told Medscape Medical News. Among other things, Dr. Allen recommends that CMS "blend" the AMA results with data from the American College of Radiology's own expense surveys, which he says are more representative.

Second, CMS has proposed eliminating payments for consultation codes that, the agency says, are typically billed by specialists at higher rates than the equivalent E/M services. In a trade-off that could end up increasing the value of E/M services provided by PCPs, specialists billing for consultations would be required to use current E/M service codes. The resulting savings from this proposal, CMS says, would be redistributed to boost payments for existing E/M services, a boon for PCPs.

Third, CMS has proposed a change in the way that the Medicare fee schedule "recognizes the cost of professional liability insurance." In much the same way that proposed changes in the expense component would affect physicians' fees, physicians with lower liability insurance costs would see a slight reduction in their fees, and physicians who pay higher professional liability premiums — obstetricians, for example — would see a slight increase in their fees. "While these changes would have a modest impact," CMS says, "they will promote payment equity."

One other proposed change should also be noted. Concerned about what it calls the "rapid growth in high cost imaging services," CMS has proposed reducing payments for such services and redistributing "the resulting savings to increase payments for other services, including primary care services."

The rationale for this proposed action rests on a series of revised assumptions. Currently, CMS assumes, and the fee schedule reflects the fact, that physicians who own the equipment to provide these high-cost services will use it 25 hours a week, or roughly 50% of their weekly office time. In fact, says CMS, surveys show that such equipment is being used much more often, resulting in economies of scale that push per treatment costs lower, "making a reduction in payment appropriate." Following a MedPAC recommendation, CMS proposes that for equipment priced at more than $1 million, it will now assume a 45 hour/week or 90% utilization rate, with a corresponding reduction in fees for such services.

The American College of Radiology, for one, has estimated that that change alone would reduce the technical component fee for computed tomography imaging, magnetic resonance imaging, and intensity-modulated radiation therapy by as much as 40% for 2010.

Source : http://www.medscape.com/viewarticle/705551?src=mpnews&spon=34&uac=133298AG

RU Healthy? Public Health Efforts Take on Text Messaging: Campaigns Adapting to New Technology

With a few quick thumb swipes, San Francisco youth literally have health information at their fingertips. They can receive the information anywhere, anytime without having to log into a computer, make a phone call or pick up a pamphlet. For Bay area youth, getting the "411" on sexual health is as easy as hitting "send" on their cell phones.

Thanks to today's texting trend, the youth are getting answers from SexInfo, a public health text messaging service that was launched in 2006. The service received 4,500 sexual health inquiries in just its first 25 weeks of service, with broken condoms, pregnancy and sexually transmitted diseases topping the subject list. The effort came after local health officials spotted rising rates of gonorrhea and chlamydia among black teens in one of the city's low-income neighborhoods, according to Deb Levine, MA, executive director and founder of Internet Sexuality Information Services Inc., which developed SexInfo in partnership with the San Francisco Department of Public Health. While the initial idea was to create a new Web site, both Levine and colleague Jacqueline McCright, MPH, a community-based STD services manager at the public health department, decided it was time to think outside the box. While visiting high schools for inspiration, the new idea walked right in front of their faces: After the school bell rang, students filed out with cell phones in hand. But they weren't talking -- they were typing.

"That's when we knew we were on to something," Levine told The Nation's Health.

While San Francisco's health workers could be considered pioneers in text messaging, public health has been taking advantage of mobile communication devices to improve surveillance and the delivery of health interventions for some time, said Jay Bernhardt, PhD, MPH, director of the National Center for Health Marketing at the Centers for Disease Control and Prevention. But because text messaging is "multidirectional" -- in other words, because users can send and receive information in real time -- it can be a "real game-changer in public health both domestically and especially globally," said Bernhardt, who added that CDC took a "big step" last year when it co-sponsored the first Texting4Health conference at Stanford University. Mobile communication platforms, he said, are "the next wave of public health communication and surveillance."

While new communication technologies offer great opportunities for public health, Bernhardt noted, lack of access to tools such as the Internet can be a significant barrier, particularly on the global front. Cell phones, however, are the first interactive communication devices cutting across economic, educational and social divides, he said. In turn, text messaging can be used on a number of health fronts, from delivering information to managing chronic diseases to treatment adherence.

"Today, effective public health requires us to provide our information and interventions to our communities where, when and how they need them," Bernhardt told The Nation's Health. "Our communities are using social media and mobile technology as an important part of their lives and if we want to reach them and help them, then we need to communicate with them the way they communicate with each other."

In San Francisco, Levine, McCright and colleagues knew young people were texting each other, but were unsure if youth wanted to receive text messages from their local health department. Fortunately, in focus groups of young black men and women, participants liked the text messaging idea. However, they were insistent that they be the ones initiating the process, Levine said. The resulting SexInfo service allows youth -- or anyone interested -- to text the word "SexInfo" to a five-digit number to receive a message back with codes telling them to text, for example, "B2 if u think ur pregnant," "D4 to find out about HIV" or "F8 if ur not sure u want to have sex." Participants are then texted back basic health information or referrals for in-person visits. According to a SexInfo study published in the March 2008 issue of APHA's American Journal of Public Health, 2,500 of the first 4,500 text inquiries led to access to more information and referrals for testing and screening.

"Things are changing rapidly and we have to do things differently to reach different people," McCright told The Nation's Health. "We can't keep doing the same old things and expecting different results. We have to be creative."

Of course, SexInfo's success depends on smart marketing and continually checking in with young people about cell phone trends, Levine said. To spread the word about SexInfo, health workers passed out cards, put up posters, bought billboards, created public service announcements and ran ads on local television and radio shows, according to McCright. The same aggressive marketing is working for the Kaiser Family Foundation's "KnowIt" text messaging campaign, which allows users to find HIV testing sites in their area. First promoted with the help of an ongoing partnership with MTV in the summer of 2007, the service received 15,000 text requests in its first month alone and more than 200,000 text inquiries in 2008, according to Tina Hoff, vice president and director of the foundation's entertainment-media partnerships. To use the service, cell phone users send a text message with their ZIP codes to KnowIt and within seconds, receive back a text message with information on nearby HIV testing sites. The service relies on a CDC database of HIV testing sites organized by ZIP codes, and in turn, CDC uses the texting service for its own HIV outreach as well, Hoff said.

"Clearly, it's a format for communicating that (young people) are comfortable with," Hoff said. "One of the nice things about new media technologies is that they're really very accessible and not exceedingly costly to implement. But for a campaign like ours to work, it's incumbent to have effective promotion strategies. The resource is only as good as the promotions you can do."

Getting the word out is the focus for Lauren Weber, a community health educator with Arizona's Mohave Department of Public Health, whose insights led to the launch of the department's Stop Smoking Over Mobile Phone, or STOMP, program in fall 2008. The youngest member of the department's Tobacco Use Prevention Program, the 23-year-old joined the team in 2007 and began visiting schools to teach students about tobacco use. Weber said she noticed that there was no educational component for students caught on campus with tobacco. When searching online for a tobacco intervention method that would appeal to students, Weber hit upon the company Healthphone Solutions and its text messaging smoking cessation service. Now, Mohave County is the first to use the Healthphone product in the United States.

Today, Mohave County students caught with tobacco can avoid suspension from school by signing up for the smoking text service. The 26-week program creates a personalized smoking cessation service based on a participant's demographics and quit date. The text messaging service guides users through the preparations for quitting, sends encouraging messages on the quit date, and begins sending multiple texts per day after the quit date. The program is open to anyone interested and about 40 people have taken part so far, said Weber, noting that some participants couple the text messaging program with traditional in-person cessation classes.

"I know I'd rather text than talk," Weber told The Nation's Health. "What better way to reach people than to get them on the phones that they're already using."

For more information on text messaging and public health, visit www.texting4health.org or www.cdc.gov/mobilehealth. For more news from The Nation's Health, visit www.thenationshealth.org.

Source : http://www.medscape.com/viewarticle/704350?src=mp&spon=34&uac=133298AG

CT-Angiography-Identified Vulnerable Plaque Associated With Higher Risk of ACS

Vulnerable plaques identified visually by computed-tomography (CT) angiography are more likely to result in a subsequent acute coronary syndrome during follow-up, a new study has shown [1]. Identifying these unstable coronary plaques, which have areas of low attenuation and have undergone positive remodeling, could be used to aggressively treat patients who are at higher risk for future events, according to researchers.

"Our data suggest that once a patient is identified to be at risk of having an adverse event on the basis of traditional clinical, biochemical, and biomarker risk profiles, imaging may help identify those at greater risk of acute coronary events," write lead investigator Dr Sadako Motoyama (Fujita Health University School of Medicine, Toyoake, Japan) and colleagues in the June 30, 2009 issue of the Journal of the American College of Cardiology.

Speaking with heartwire , Dr Renu Virmani (Cardiovascular Pathology Institute, Gaithersburg, MD), one of the study investigators, said the results show for the first time that high-risk, vulnerable lesions, characterized previously in pathologic studies, are able to identify patients with future symptoms, and this moves the field forward by a "big step."

"This is just the beginning, but it is a good beginning," she said. "It is the first study we have showing us that we can actually identify these lesions and that these are the lesions that are going to produce symptoms in patients. Before that, it's all been a theory. We were able to say these are vulnerable plaques, and we should watch and worry about them, but we had no way of showing these were the ones that would go on to produce symptoms."

More Than 1000 Patients Assessed by CTA

To determine whether the characteristics of atherosclerotic lesions were associated with future acute coronary syndromes, the researchers analyzed the lesions based on the presence of positive vessel remodeling and low-attenuation plaques. Virmani explained that these two characteristics, along with a necrotic core, are thought to be associated with subsequent plaque rupture.

Among the 1059 patients who underwent CT angiography, 45 patients had coronary plaques that had undergone positive remodeling and were classified as low attenuation. After more than two years of follow-up, 10 patients, 22.2%, with both characteristics of vulnerable plaque developed an acute coronary syndrome. On the other hand, just one of the 27 patients with only one feature, either low attenuation or positive remodeling, developed symptoms, while only 0.5% of the 820 patients without any features of vulnerable plaque developed an acute coronary syndrome.

In a multivariable regression analysis, the presence of low-attenuation plaque or positive remodeling was associated with a 23-fold increase in the risk of an acute coronary syndrome (hazard ratio 22.8; 95% CI 6.9-75.2; p<0.001).

Virmani told heartwire that it is not always easy to identify low-attenuation plaque and that there are those who doubt whether visualizing these softer plaques can be done reliably, although the technology is improving. On the horizon are better imaging modalities, including 320-detector-row CT scanners that improve resolution, as well as machines that limit the amount of radiation exposure.

Systemic vs Focal Disease

Commenting on the results of the study for heartwire , Dr Steven Nissen (Cleveland Clinic, OH) said he was skeptical of the results and the vulnerable-plaque hypothesis, in general. In a recent editorial in the Journal of the American College of Cardiology: Cardiovascular Imaging, Nissen said that many diagnostic techniques designed to detect vulnerable plaques, including thermography, virtual histology, and optical coherence tomography, among others, have promised much but delivered little [2].

Last week, noted Nissen, a CT-angiography study, reported by heartwire , showed that the technology was unable to reliably identify the functional significance of coronary lesions in patients with stable angina and atypical chest pain. To now suggest that CT angiography can identify plaques at risk for rupture is "asking an awful lot from this technology." Also, he said the investigators did not show that the lesion of the coronary artery identified by CT angiography as vulnerable is responsible for the acute coronary syndrome.

"They don't close the loop," said Nissen. "We don't find out that the site that had positive remodeling and low attenuation is the site where the plaque ruptured. Without that, this becomes much more speculative."

In general, Nissen said that he believes the vulnerable-plaque approach is the wrong approach because atherosclerosis is a systemic disease, and if anything is likely to predict outcomes, it's a systemic, not focal, marker. Virmani, on the other hand, strenuously disagrees, telling heartwire that Nissen is "missing the boat" regarding these high-risk focal lesions because evidence shows that patients with coronary events have a focal thrombus formation.

"If you look at acute-myocardial-infarction patients, it occurs in one vessel, in the proximal areas," said Virmani. "Why? Those are the most prone areas. That's where we need to concentrate. His [Nissen's] idea of concentrating on systemic factors, such as LDL cholesterol, diabetes--yes, absolutely, but those are the patients that then have focal lesions. I don't deny that you need hypercholesterolemia for a patient to have focal lesions, but in the patients that are high risk, they do develop them at focal spots."

Did Anybody See My Stolen Horse?

In an editorial accompanying the published study, Dr Eugene Braunwald (Harvard Medical School, Boston, MA) adopts the middle road, hailing the study by Motoyama and colleagues as a landmark trial, while acknowledging the current limitations in the detection of vulnerable plaque [3].

Braunwald notes that widespread clinical application of CT angiography to characterize coronary lesions at risk for future rupture, which he aptly describes as "locking the barn before the horse is stolen," will require more potent measures for the prevention of plaque rupture than are currently available. Dual antiplatelet therapy, possible stenting, or more potent anti-inflammatory drugs are just some of the possibilities, writes Braunwald.

"Nobody is saying we need to start treating these patients," adds Virmani. "Start treating them systemically, just as Dr Braunwald points out in his editorial. Right now, we don't know how to treat these patients. We might need to think of different therapies. Some patients might need anti-inflammatory drugs, or some might need stents, but we won't know until we learn how these lesions behave prospectively."

Dr Mario Garcia (Mount Sinai School of Medicine, New York) told heartwire that low-attenuation plaques with positive remodeling are features identified as characteristics of thin-cap, lipid-rich plaques in intravascular ultrasound (IVUS) correlative studies. He added that while the present study identifies a novel imaging biomarker as a powerful predictor of future ACS, there remain unanswered questions, particularly whether the predictive accuracy of CT is superior to established serum biomarkers such as high-sensitivity C-reactive protein (CRP) and whether the same predictive utility could be extrapolated to asymptomatic subjects at risk.

In addition, like Braunwald and Nissen, Garcia says trials are needed to determine the optimal treatment strategy to follow--for example, intensive medical therapy vs prophylactic PCI--once these "high-risk features" are identified in a patient.

Source : http://www.medscape.com/viewarticle/705017?src=mpnews

Watch Out for This Growing Malpractice Trend

Introduction

Physicians who have created legal entities, such as LLCs (limited liability companies) and professional associations, to limit their liability may mistakenly believe that they are well protected against medical negligence lawsuits.

Although this legal structure does protect physicians in areas ranging from contractual obligations to "slip-and-fall" type claims, new litigation trends suggest that this can now increase liability in medical negligence cases.

Here's why: In many nonphysician business settings, creating legal entities transfers liability and insulates individual actions. Plaintiffs will typically sue corporations rather than individuals, and corporations can buy insurance to protect all of their owners and employees.

Medicine is different. Plaintiffs generally sue the individual physician rather than the entity, as by law in many states doctors cannot avoid exposure by working through a corporate entity. Therefore, physicians generally buy medical malpractice policies in their own name, rather than in the name of the practice.

However, because medical malpractice premiums have become more expensive, physicians began buying policies with lower limits of insurance. Previously, individual doctors carried as much as $12 million of insurance per claim; now the majority of physicians carry no more than $1 million per claim.

In response, plaintiff lawyers began to seek larger awards by dragging medical entities into lawsuits. Now more than previously, lawyers sue the individual physician and the corporation. That's true even for solo practitioners.

In the past, plaintiff attorneys may have named entities for a variety of reasons, but mainly to ensure that there was underlying coverage. Once coverage was established, entities were commonly dropped from a lawsuit. Now when lawyers sue an entity, they are less likely to let it out of a case, not only because it may provide potential leverage in settlement negotiations, but also because a number of legal theories can render them an effective source of independent recovery.

Be Aware of Everyone Involved

Lawyers often use a vicarious liability theory known as respondeat superior, which translates literally to "let the master answer," to hold entities liable. Under respondeat superior, the master is the corporation or other legal entity that a physician's group may practice under.

"Agency" principles are used to establish all the parties for which the master is responsible. Agency refers to an individual acting or appearing to act on behalf of another, and thus can make a medical practice liable for the acts of its entire professional and nonprofessional staff.

This causes trouble when the individual doctor responsible for an act of negligence does not have enough insurance to cover a claim. The corporation can become jointly and severally liable for paying the remainder of the judgment.

Even if physicians have insurance coverage for themselves and their entities, they must still be aware of the "vicarious" liability that can emerge from using independent contractors, sharing office space, or even using "covering doctors."

Still another negative is that when a practice is sued, it may need to hire its own lawyers to represent it. Legal fees associated with defending an entity can quickly mount, giving plaintiffs' attorneys yet additional leverage to facilitate a settlement. This "double jeopardy" -- suing both the physician and the entity -- can have a devastating effect on medical practices.

How Can Physicians Lessen This Risk?

Buying additional insurance for the entity can reduce the risk for personal liability. However, the cost may be prohibitive. Worse, high insurance limits often result in higher settlements. The more money available, the more money plaintiffs' attorneys may demand.

To lower both cost and exposure, physicians should develop an overall coverage strategy. Four options follow.

First, use 1 policy limit to cover multiple entities, if applicable.

Second, have physicians "share" their respective limits with the corporate limits to avoid bringing additional insurance policies into a lawsuit and largely eliminate a plaintiff's leverage.

Be careful when constructing this, because it can create significant exposure if coverage is not coordinated for every agent of the corporation. Shared coverage will only respond on behalf of the corporation if the claim is related to a physician that is a "named insured" on the underlying policy.

Third, look into creative solutions for insurance. Although state laws and credentialing requirements often govern insurance policy limits for physicians, there is often no similar framework for healthcare entities. As a result, insurers can offer unique solutions, such as high deductibles, aggregate limits, or even policies that only cover legal expenses, but do not insure against losses (settlements or awards).

Fourth, check with your broker before renewing your insurance coverage. Also consider consulting with experts in accounting, healthcare, and insurance law to coordinate your insurance needs with a comprehensive asset protection plan.

If you have a malpractice question that you'd like this column to address, please send your questions to BusOfMedEditor@medscape.net.

Source : http://www.medscape.com/viewarticle/703170

From Agency for Healthcare Research and Quality (AHRQ) Cases from AHRQ WebM&M: Medication Reconciliation Victory After an Avoidable Error

The Case

A 91-year-old woman, previously active and independent, recently developed weight loss, confusion, and falls without injury. She lived alone. Late one night, her family visited and found her on the floor of her home. She was lethargic and incontinent, and her speech was slurred. She did not appear to recognize her family members. She was taken to the hospital and admitted for altered mental status and dehydration. Upon arrival to the ward, the admitting nurse attempted to reconcile her home medications with those ordered on admission. However, the patient was unable to tell the nurse which medications she was taking. A family member was asked to return to the patient's home, gather all of her medications, and bring them to the hospital so that medication reconciliation could be performed. In all, seven prescription medications were returned, including Flexeril 10 mg TID, glipizide 10 mg daily, Neurontin 200 mg TID, lisinopril 10 mg daily, gabapentin 200 mg TID, cyclobenzaprine 10 mg TID, and Lortab 5 mg as needed for pain. Some medications had been filled at a local pharmacy, while others were filled by a mail-order pharmacy. The admitting physician recognized that several of the medications were duplicates (Flexeril is the brand name of cyclobenzaprine; Neurontin the brand name of gabapentin), and he adjusted the medication regimen accordingly.

The day after admission, the patient was more alert and responsive to questions. Her medications were reviewed, and she reported that she was taking all of the medications, as prescribed, from the bottles that were retrieved from her home. Unaware that any of the medications were duplicates, she thought she was taking exactly what her physician had intended.

The Commentary

The direct costs of drug-related morbidity and mortality were estimated to exceed $177 billion in 2000, of which 70% ($121 billion) was attributed to hospital admissions.^[1] The Institute of Medicine reports that up to 1.5 million preventable adverse drug events occur in the United States annually.^[2] Furthermore, potentially inappropriate medication (PIM) use is a significant problem in community-dwelling elders, accounting for an estimated $7.2 billion in health expenditures in 2001.^[3] As a result of continued medication misadventures in the United States, the Joint Commission has established specific National Patient Safety Goals (NPSG) to reduce the impact of medication errors on patient safety.^[4] This case identifies two important aspects in the safe and effective use of medications in the elderly. First, the continued use of PIM in older adults remains a problem and dramatically increases the likelihood of developing a drug-related problem.^[5] Second, medication reconciliation can identify potential and actual drug-related problems when performed across the continuum of care as outlined by the Joint Commission.^[6]

Criteria for PIM in the elderly were first developed by Mark Beers in 1997 and are commonly referred to as "Beers criteria" or the "Beers list."^[7] The Beers criteria were updated in 2003 using a literature review and expert consensus.^[8] The updated Beers list includes drugs to be avoided regardless of disease state or condition and a list of drugs to be avoided in patients with certain diagnoses or conditions. Muscle relaxants like cyclobenzaprine are included on the Beers list of PIM (see Table for a partial list of medications to be avoided in older adults) regardless of condition. Although the case above highlights the potential dangers of therapy duplication, it also illustrates the importance of minimizing use of medications that should be avoided in the elderly population. Studies indicate that 23%-40% of community-dwelling elderly patients use PIM, and that 2.6% of elderly patients take medications that should always be avoided.^[3,9] A study evaluating medication use in older adults identified a threefold increase in the incidence of documented drug-related problems when at least one PIM was used in older adults.^[5] Prescribers and other health care providers must work together to minimize the use of PIM in older adults. It is possible that this medication error could have been avoided if this patient was not taking cyclobenzaprine in the first place.

Table. Selected Potentially Inappropriate Medications to Avoid in Older Adults: Independent of Diagnosis or Conditions.

Generic Drug Name	Concerns
Indomethacin	High risk of developing central nervous system adverse events.
Cyclobenzaprine, methocarbamol, carisoprodol, other muscle relaxants	High risk of anticholinergic adverse events, sedation, and weakness and generally poorly tolerated by the elderly with questionable efficacy.
Amitriptyline, doxepin	High risk of anticholinergic adverse events, sedation, and weakness.
Diazepam, flurazepam, chlordiazepoxide, other long-acting benzodiazepines	Older adults have a higher sensitivity to benzodiazepines, causing sedation, weakness, and increased risk of falls especially when benzodiazepines with a long half-life are used.
Dicyclomine, hyoscyamine, other gastrointestinal antispasmodic drugs	High risk of anticholinergic adverse events, questionable efficacy.
Diphenhydramine, chlorpheniramine, hydroxyzine, other anticholinergic antihistamines	High risk of anticholinergic adverse events, confusion, sedation, risk of falls; nonanticholinergic antihistamines preferred.
Phenobarbital, other barbiturates	Highly addictive, high risk of adverse events including sedation, risk of falls.
Meperidine	Increased risk of confusion, accumulation, neurotoxic active metabolite that may accumulate in older adults.
Fluoxetine	Long half-life that may accumulate causing central nervous system stimulation, sleep disturbances, and agitation.
Mineral oil	Potential for aspiration, safer alternatives available.
Desiccated thyroid	Concerns about cardiac effects, safer alternatives available.

Adapted with permission from American Medication Association. Original table © 2003 American Medical Association. In: Fick DM, Cooper JW, Wade WE, et al. Updating the Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. Arch Intern Med. 2003;163:2716-2725.

The 2008 and 2009 NPSG from the Joint Commission highlight medication reconciliation as a requirement for hospitals. The Joint Commission recognizes that patients are most at risk for medication errors when transitioning across different levels or between different providers of care. The process of medication reconciliation was established to reduce adverse medication events that may occur as a result of this transition.

In the case described above, the medication reconciliation process identified the cause of the admission and resulted in prompt treatment of the patient (in this case, discontinuation of duplicate therapies) as opposed to reducing future medication errors. Communication among health care providers continues to be a focus of the NPSG and the Joint Commission. There appears to have been a breakdown in communication among health care providers and the patient in the case described above. In this situation, the patient should have received counseling and educational material from the pharmacies describing the medication, including the brand and generic name, as well as drug information from a pharmacist that included the purpose and side effects of the prescribed treatment. Furthermore, the use of multiple prescribers and multiple pharmacies could have contributed to the use of duplicate therapies. Using a single pharmacy for medications or a national electronic prescription registry also could have reduced the chance of this error occurring.

Interestingly, the use of technology -- often cited as a primary process to help reduce medication reconciliation errors -- may not be sufficient without further inquiry by a health care provider. A small study determined that 57% of electronic medical record medication histories did not match those obtained telephonically by a nurse.^[10] Furthermore, obtaining medication information from the patient alone may not be enough. Glintborg and colleagues found that patients admitted to a hospital in Denmark failed to report 27% of prescription medications filled in the last month when compared to actual prescriptions identified in the national electronic prescription file.^[11] The same study evaluated self-reported medication use during a home visit and found that 18% of medications filled in the last month were not reported. Although no studies or guidelines describe the best approach to medication reconciliation, a process that uses both electronically available medication records as well as data from direct interviews of patients and/or families appears to be the most logical and accurate approach.

With the increased use of electronic prescribing and real-time data feeds/decision support from third-party organizations, the medication reconciliation process and identification of PIM in the elderly can be enhanced not only upon hospital admission but also in ambulatory care and pharmacy settings. In the case above, it is unclear if the duplicate medications used by the patient were current and recently filled by the patient. If so, a pharmacist or physician with access to the complete medical record and prescription fill history could have identified the duplicate therapy and possibly prevented this hospital admission. Furthermore, a clinician recognizing the importance of avoiding PIM in the elderly might have prevented or mitigated the impact of this error. The focus of medication reconciliation in the hospital has reduced medication errors; however, more emphasis should be placed on accurate medication histories and appropriate prescribing practices in ambulatory care settings.

Take-Home Points

• All health care providers should be aware of medications that are best avoided in general or in specific populations such as the elderly. The Beers list is a useful resource.
• More emphasis should be placed on the implementation of medication reconciliation processes in ambulatory care settings.
• When performing medication reconciliation, multiple sources of information should be used to obtain accurate and complete medication histories (e.g., electronic medical records, pharmacy records, and patient/family history).

Reprint Information

Reprinted with permission of AHRQ WebM&M. Original citation: Cutler TW, Medication Reconciliation Victory after an Avoidable Error: AHRQ WebM&M [online journal]. March 2009. Available at: http://webmm.ahrq.gov/ is produced for the Agency for Healthcare Research and Quality by a team of editors at the University of California, San Francisco. The AHRQ WebM&M site was designed and implemented by Silverchair.

Source : http://cme.medscape.com/viewarticle/704150

Food Safety & Defense

One of the most thorough and effective food safety and defense systems in the world is the U.S. government, which performs the following chief functions:

• Establishment of Safety Standards
• Monitoring and Inspection
• Enforcement
• Tracking Food Safety Problems
• Protecting the Food Supply

Federal Regulation

The federal system of regulation consists of numerous laws and involves various agencies, each with important roles in carrying out food safety, defense, and quality activities. This segmentation of responsibility requires extensive efforts to coordinate various agency activities. Federal laws mandate how each federal agency approaches its role in food safety. In 2005, there were more than 70 interagency agreements delineating respective responsibilities between agencies with food safety and defense authority.¹ These agreements help avoid wasteful duplication of effort, conflicting actions, and gaps in coverage.

Yet, from time to time, legislators explore the feasibility of a single food agency. Critics charge that overlapping jurisdictions and duplication of efforts waste taxpayers’ money and may result in a fragmented system that prevents an effective focus of resources on areas where the risks are greatest. Federal officials argue that, by working cooperatively and through formal understandings among the agencies, federal agencies can avoid duplicating efforts while more effectively achieving the common goal of protecting public health and the nation’s food supply.

Department of Health and Human Services (DHHS)

The following agencies are under the Department of Health and Human Services (DHHS) and play a role in ensuring food safety and promoting diet and health.

Food and Drug Administration (FDA): The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health. FDA also ensures that these products are honestly, accurately and informatively represented to the public. With regard to food, the FDA is responsible for the regulation of about 80 percent of the U.S. food supply.²

Food Safety. The FDA develops standards for foods including food ingredients and color additives. It conducts research to improve detection and prevention of contamination, and collects and interprets data on nutrition, food additives, and pesticide residues. The agency also inspects food processing plants, imported products, and some animal food facilities. The FDA also regulates packaging, irradiation, other microbial reduction
technologies, and microwave ovens.

Food Defense. FDA works with other government agencies and private sector organizations to protect consumers and help reduce the risk to consumers of tampering or other malicious, criminal, or terrorist actions on the food and cosmetic supply.

Pesticides. The FDA enforces pesticide tolerances established by the Environmental Protection Agency (EPA) for products within their jurisdiction.

Seafood. The FDA operates an oversight compliance program for fishery products under which responsibility for the product’s safety, wholesomeness, identity and economic integrity rests with the processor or importer, who must comply with regulations. In addition, FDA operates the Low-Acid Canned Food (LACF) program which is based on the Hazard Analysis Critical Control Point (HACCP) concept, and is focused on thermally processed, commercially sterile foods, including seafood such as canned tuna and salmon. The FDA also provides consumption guidelines pertaining to various environmental contaminants that may be in seafood.

Animal Health Products. The FDA’s Center for Veterinary Medicine (CVM) is responsible for assuring that animal drugs and medicated feeds are safe and effective and that food from treated animals is safe to eat. The responsibilities of CVM have a direct effect on the safety of the human food supply and on the safety to animals of veterinary products.

Centers for Disease Control and Prevention (CDC): The mission of CDC is to promote health and quality of life by preventing and controlling disease, injury, and disability.

The Foodborne Diseases Active Surveillance Network (FoodNet) is the principal foodborne disease component of CDC’s Emerging Infections Program (EIP). FoodNet provides a network for responding to new and emerging foodborne diseases of national importance, monitoring the burden of and identifying the sources of specific foodborne diseases.

PulseNet is a national network of state and local public health departments and food regulatory agency laboratories coordinated by the CDC. This network of public health laboratories “fingerprints” various strains of foodborne disease-causing bacteria and compares results through an electronic database to help facilitate early detection of outbreaks.

The Laboratory Response Network (LRN) became operational in August 1999 and is charged with the task of maintaining an integrated network of state and local public health, federal, military, and international laboratories that can respond to bioterrorism, chemical terrorism, and other public health emergencies.

U.S. Department of Agriculture (USDA)

The USDA’s Food Safety and Inspection Service (FSIS) is the public health agency responsible for ensuring that the nation’s commercial supply of meat, poultry, and egg products is safe, wholesome, and correctly labeled and packaged. FSIS monitors domestic and imported meat and poultry products and certain egg products for bacterial contamination and for residues of pesticides, drugs, and other chemicals.

The USDA’s Animal and Plant Health Protection Service (APHIS) provides leadership in ensuring the health and care of animals and plants, improving agricultural productivity and competitiveness, and contributing to the national economy and the public health.

USDA’s National Residue Program protects consumers from adulterated meat and poultry products and ensures that pesticide residues do not exceed tolerances set by the EPA.

Environmental Protection Agency (EPA)

The mission of the Environmental Protection Agency (EPA) is to protect human health and the environment. Among its many activities, a priority for the EPA is to regulate the development, distribution, promotion, handling, storage, use, and disposal of pesticides used in the growing and production of food.

The EPA also sets tolerances or limits for the amount of pesticide residues that lawfully may remain in or on food marketed in the United States. EPA-established tolerances also apply to all imported foods and commodities. The agency works with state and tribal governments to establish permissible levels of contaminants for seafood harvesting waters.

Department of Commerce, National Oceanic and Atmospheric Administration

Responsibility for protecting the seafood supply is shared by federal and state agencies. The National Oceanic and Atmospheric Administration (NOAA) oversees fisheries management in the United States, NOAA’s National Marine Fisheries Service (NOAA Fisheries Service) is dedicated to the stewardship of living marine resources through science-based conservation and management and the promotion of healthy ecosystems. Additionally, NOAA Fisheries Service has an obligation to help make information about seafood products more accessible to the general public. FDA ensures the safety of fish and seafood products for consumers.

Department of Homeland Security (DHS)

The Department of Homeland Security was established to coordinate and maintain an increased level of security among domestic agencies. Homeland Security leverages resources within federal, state, and local governments, coordinating the transition of multiple agencies and programs into a single, integrated agency focused on protecting the American people and their homeland. The DHS coordinates partnerships among federal agencies and state and local leadership, the private sector, and the academic community with the common goal to strengthen the security of our nation’s food supply through awareness, prevention, protection, response and recovery. For example, the National Center for Food Protection and Defense (NCFPD) is a University-based partnership addressing security issues related to post-harvest food production. The Center is a national consortium of academic, public sector, and industry partners, formed through a federal grant, led by the University of Minnesota.

Non-Federal Organizations

National Academies

The National Academies perform a public service by bringing together committees of experts in all areas of scientific and technological endeavor. These experts serve pro bono to address critical national issues and give advice to the federal government and the public. Four organizations comprise the Academies: the National Academy of Sciences, the National Academy of Engineering, the Institute of Medicine, and the National Research Council.

Reports and studies related to food safety are primarily conducted by the Institute of Medicine’s Food and Nutrition Board (FNB) and the National Research Council’s Board on Agriculture and the Board on Environmental Sciences and Toxicology.

State Regulation

Several agricultural agencies are responsible for food safety on the state level. The laws and standards they enforce generally coincide with either federal laws or uniform model codes such as those created by the Association of Food and Drug Officials. State departments of agriculture spend significant portions of their budgets each year on food safety programs. The National Association of State Departments of Agriculture (NASDA) also provides guidance to states on food safety matters.

Food and Agriculture Industry

All sectors of the food and agriculture industry are responsible for safeguarding the food supply. Their roles include:

• Research and development: Companies are continually looking for ways to develop and improve food products to meet consumer demands.
• Adhering to government regulations: All sectors must abide by strict regulations regarding the processing, packaging, and transportation of foods.
• Working with government extension agents: Government extension agents and land-grant universities stay abreast of state-of-the-art production and safety practices, and work to incorporate them into production and processing operations.
• Working with veterinarians and consultants: These food professionals provide their expertise to improve the safety and security of the food supply
• Instituting quality control programs: Virtually all food companies have instituted a Hazard Analysis Critical Control Point (HACCP) system, which is a systematic approach to the identification, evaluation, and control of food safety hazards.
• Private testing: Many producers and some retailers have set up their own private testing systems to ensure the safety and quality of their products.
• Education: As consumer interest in food safety has increased, so too have the educational efforts by the food industry.

Consumers

Consumers also have important food safety responsibilities. Once food is purchased from the supermarket, handling, storage, and cooking practices can have an enormous impact on its safety. They must also have ready access to food safety information. Consumers should use a credible source on food safety to make informed decisions about their eating habits.

Foodborne Illness

Foodborne illness generally refers to illnesses caused by microorganisms consumed through food or beverages. When people complain of “food poisoning,” they may actually have been exposed to the microorganisms that cause foodborne illness. Microbes, bacteria, and pathogens are other terms used to describe the microorganisms that cause foodborne illness.

The effects of foodborne illness can range from relatively minor discomfort to more serious symptoms and manifestations such as fever, diarrhea, vomiting, dehydration, and even death. The acute illnesses posed by foodborne organisms, coupled with the ease and swiftness with which some develop, present food safety challenges for the entire food distribution chain.

Foodborne Illness Estimates

Government estimates vary widely as to the prevalence of foodborne illnesses. Cases of foodborne illness tend to be underreported because many people mistake foodborne illness for another illness, such as the flu, and simply do not visit a physician. The CDC, the federal agency that collects and disseminates information on foodborne illnesses, estimates that 5,000 Americans die each year from foodborne illnesses, 76 million people get sick, and more than 325,000 are hospitalized. These estimates are extrapolated from surveillance data of reported cases.

Symptoms of Foodborne Illness

The most common symptoms of foodborne illness include mild to severe abdominal cramps, diarrhea (often bloody), nausea, vomiting, dry mouth, double vision, difficulty swallowing, and flu-like symptoms (fever, chills, headache, and backache). Other symptoms associated with certain bacteria or viruses include breathing problems, blood infections, infection of the brain or nervous system, and kidney problems. Symptoms may appear from six hours up to ten days after exposure. Since foodborne illness can potentially cause severe illness or death, people who suspect they have become sick from food should see a doctor.

What Causes Foodborne Illness?

Foodborne illness is caused by microorganisms that are found widely throughout nature and the environment. The five basic categories of foodborne illness agents or contaminants include bacteria, viruses, parasites, food toxins, and unknown sources. The most common causes of foodborne illness are bacteria and the toxins produced by certain bacteria.

Generally, bacteria can spread easily and rapidly, requiring only nourishment, moisture, a favorable temperature, and time to multiply. Animal protein foods—meat, eggs, poultry, and fish—can be common hosts of foodborne bacteria. However, bacteria can be readily spread from a non-food item—such as a knife, crate, cutting board, or human hands—to food.

Contaminants causing foodborne illness can originate within the food (meat or fish), on the food (egg shell or produce), from unsafe water, or from human or animal feces. Favorite bacteria hiding places in the home include sponges, dish towels, aprons, cutting boards, sinks, counter tops, and wooden utensils.

Major Foodborne Illnesses Caused by Bacteria or Viruses

It is important to emphasize that since there are literally thousands of different strains of bacteria that can cause foodborne disease, it is difficult to generalize their characteristics and effects. The following types of bacteria are associated with most reported cases of foodborne illness in the United States:

• Bacillus cereus
• Botulism
• Campylobacter jejuni
• Clostridium perfringens.
• Escherichia coli (E.coli)
• Listeria monocytogenes
• Salmonella species
• Shigella
• Staphylococcus
• Vibrio parahaemolyticus
• Yersinia enterocolitica

Viruses also can cause foodborne illness. In these illnesses, food and water serve as vehicles for person-to-person spread of a virus.

• Norovirus
• Hepatitis A
• Rotavirus

Who’s At Risk?

Anyone can be afflicted with foodborne illness. However, certain segments of the population face greater risks and have a higher incidence of foodborne illness. They are:

• Older people
• Pregnant women, infants, and children
• People with weakened immune systems

Prevention of Foodborne Illness

Collectively, government, consumer groups, and the food industry are expanding food safety education efforts.

Public health experts believe unsanitary food preparation practices are major contributors to outbreaks. If foods are prepared a day or more before consumption and food handlers are careless, the chance of illness can increase because bacteria have more time to multiply.

The Partnership for Food Safety Education—a coalition of government, consumer and industry groups—launched its Fight BAC!™ consumer education campaign in 1997 to promote safe food handling practices and encourage behavior change among consumers.³

Advances in Food Safety Technology

Through various incidences of foodborne illness, interest in analytical technologies to identify harmful bacteria in food has grown tremendously. Additionally, there have been vast advancements in technologies, such as the irradiation of food and new anti-microbial washes and bacterial sprays to eliminate harmful bacteria from food products during processing.

Methods for Microbial Testing and Elimination

Analyzing food products for the presence of impurities, harmful bacteria, or other organisms presents many difficulties. The complexity of food and its many components make developing assessment tools a challenge over those for use with simple substances like water.

Once limited to time-consuming laboratory tests, many newer technologies in place today enable the rapid identification of harmful components in food so that items can be efficiently removed from the food supply system.

There are two major types of rapid assays—antibody-based and nucleic acid-based assays. Antibody-based assays rely on specific interactions between antigen and antibody. An antibody assay links a familiar characteristic on the bacteria’s surface (an antigen) to a substance known as an antibody. This connection is as specific as a key to a lock. When this connection is made, the test registers “success” by producing a visible reaction such as the appearance of a colored band, a measurable electrical signal or a sand-like precipitate.

Nucleic acid-based assays use the genetic material or “fingerprint” of an organism or impurity to identify “who” it is and “what” it does. Because there is abundant DNA or rRNA in most cells, it is the most accurate way to characterize and identify a bacterium or virus that could cause foodborne illness. The highly specific nature of these tests enables identification of not only the organism, but also the source (the farm, processing facility or human contact) of the foodborne pathogen. These tests will help food manufacturers and government regulators trace harmful bacteria to the exact source of the contamination before it has a chance to get to consumers. These tests can also identify the source of an outbreak of foodborne illness to a human source, food preparation location, or an initial food item.

Emerging Methods to Control or Eliminate Pathogens

Food irradiation is a food safety tool that serves as a complement to other food safety technologies. It is the process of exposing food products to radiant energy. This process produces various preservation effects, from delaying spoilage to killing harmful bacteria. Foods are irradiated by using ionizing energy (gamma rays, electron beams, or x rays) for a specified length of time. Food irradiation is best applied to foods at the end of food processing, as close to moving into the consumer marketplace as possible. This process can be referred to as “cold pasteurization,” because it eliminates harmful bacteria without the use of heat.

Under federal regulations, irradiated food must be identified on product labels with the international symbol for irradiation (the Radura), simple green petals in a broken circle. This symbol must be accompanied by the words, “treated by irradiation” or “treated with radiation.” Both the FDA and USDA allow for use of additional statements of public health benefit on labels of irradiated food products, such as, “to eliminate harmful bacteria.”

Other Food Safety Technologies

Lactoferrin, a protein found in cows milk and beef, has been developed as an anti-microbial spray to fight E. coli. The lactoferrin spray is applied to uncooked beef carcasses prior to processing and its use has been approved by the FDA.

Sodium lactate and sodium diacetate are two additional ingredients used to enhance the safety of meat and poultry, and have been found to be particularly effective as antimicrobial agents in the control of Listeria monocytogenes in ready-to-eat lunchmeats and hot dogs. They are generally recognized as safe (GRAS) by FDA and are permitted for use in these products by USDA.

The use of ozone in food processing as a food safety technique is being adapted from its use in water treatment and sanitation. Ozone has been used in water treatment for over 100 years, and is used with 98 percent of all bottled water sold in the United States. For food processing applications, ozone may cover a broader range of microorganisms than chlorine.

Unfamiliar Compounds in Foods

Improved detection methodology and instrumentation can lead to further understanding of the components found in food products. Although some of these compounds may, by themselves, be toxic, it is the dose that makes the poison with regards to human toxicology.

There is a great deal of play between the interaction of detection capability, perceived risks, true toxicological effects, and public health. Definition and resolution of the public health impact often requires extensive toxicological research and risk assessments. Interim information is frequently inconclusive and provides incomplete science on which to base solid dietary guidance outside of those recommended for general health.

Some contaminants, ubiquitous in the environment, make their way into the food supply via water uptake in plants that are consumed by fish and animals, and are present at detectable levels in animal feed and human foods.

Acrylamide: In April 2002, a group of Swedish scientists presented research that detected trace levels of a probable human carcinogen and neurotoxicant—acrylamide—in some baked and fried foods.

Research indicates that acrylamide occurs in certain foods when they are prepared using traditional cooking methods like frying, baking, and toasting, whether in a food production plant, in a restaurant, or at home.

Thus, acrylamide probably has been present at some level in foods ever since humans began cooking. In the United States, the FDA and the scientific community will continue to evaluate the accumulated data and testing protocols, and will determine appropriate recommendations as necessary. From the robust body of research conducted over the past several years, there is currently not sufficient information to draw firm conclusions about health risks to humans.

Benzene is a known carcinogen found in some foods, both naturally occurring and due to environmental contamination.

In the 1990s, scientists determined that under some conditions, benzene could be formed in some beverages when both ascorbic acid and benzoate are present under specific storage conditions and beverage companies implemented programs to address the issue. In 2005, the FDA received reports that low levels of benzene had been detected in soft drinks; and initiated a survey of benzene levels in some soft drinks. FDA has concluded that the results of their survey indicate that the levels of benzene found in soft drinks do not pose a public health safety concern. FDA will continue to collect and analyze samples and to work with industry to better understand the nature of benzene formation in these beverages and the sources of variability.

Bisphenol A, also referred to as BPA, is a chemical used in the manufacture of some food packaging materials. Products using BPA include reusable plastic containers for food and beverages, baby bottles, and the linings of cans used for food products.

Some have alleged that high exposure to BPA can cause cancer, tumors, and even developmental and hormonal changes in humans. However, expert studies consistently find no such effects given the low level of BPA exposure consumers receive. It is virtually impossible to come in contact with an unsafe amount of BPA through our day-today living activities.

Dioxin and dioxin-like compounds are colorless, odorless organic compounds containing carbon, hydrogen, oxygen and chlorine. They are produced naturally from fires, and from traditional human activities such as manufacturing, incineration, and exhaust emissions. Many of the emissions from these human activities have been reduced.

Dioxins can be deposited on plants and taken up by animals and fish as they feed and thus, may enter the food chain. Dioxins have a high affinity for fatty substances and are found in fat tissue. This human exposure to dioxins comes from the diet through food and human breast milk. Typical dietary exposure, even over the course of many years, is still far below that which might occur in accidental occupational exposures. Recent reports indicate that there are no known established health effects in people resulting from typical dioxin exposure through diet and environment.

Methylmercury: Mercury finds its way into the food chain when naturally occurring mercury or mercury from air pollutants is deposited into rivers and lakes. Once in the water, bacteria transform the air-borne mercury into methylmercury. Nearly all fish and shellfish contain traces of mercury; therefore people can be exposed to methylmercury by eating fish. Larger, predatory species of fish absorb methylmercury from the water and ingest it when eating algae and other smaller species of fish. The amount of methylmercury, measured in parts per million (ppm), vary greatly, largely based upon the species, size and age of the fish.

In a few species, methylmercury levels can reach 1 ppm, which is the limit allowed by the FDA in fish intended for human consumption. This level is found most often in large predator fish, including shark and swordfish, pike and walleye, especially, if they swim in waters polluted with high mercury levels.

While most people’s fish consumption does not cause a health concern, high levels of mercury in the blood stream can have an effect on the developing nervous system of young children and unborn babies. Therefore, women of childbearing age and those who might become pregnant and young children should follow the advice of the 2004 FDA/EPA consumer advisory on methylmercury in fish, pregnant women, and nursing mothers.

Perchlorate

Perchlorate is a major component of rocket fuel and can get into plants when they are irrigated with perchlorate containing water or when plants are grown in soil that has been previously exposed to perchlorate-containing water or fertilizer.

Federal agencies are investigating the ways that plants take up perchlorate. Until more is known about the health effects of perchlorate and its occurrence in foods, FDA continues to recommend that consumers eat a balanced diet, and does not recommend that consumers should alter their infants’ and children’s diets and eating habits to avoid exposure to perchlorate.

Food Defense

Food defense can be defined broadly as protecting the food supply from deliberate contamination. Although always considered by regulators and processors in food safety procedures, the threat of an intentional attack on the U.S. food and water supply has become an even more important issue in recent years. The centralized nature of food production and processing and the wide distribution of foods, both domestic and imported, make the food sector a target. Food or water could be compromised by being a primary vector to deliver a biologic or chemical weapon, or a secondary target, where the amount of food or water becomes inadequate to feed the population. In addition to the physical and nutritional consequences of inedible or insufficient food and water, a compromised food supply also could have significant psychological, political, and economic consequences. Any link in the food production chain is potentially susceptible and an attack could cause an erosion of public confidence in the food supply with the potential economic ruin for certain food producers.

Food contaminated by biologic, chemical, or radiological agents may be difficult to handle by traditional methods of product testing and recall involving contaminant identification and destruction. In addition, control and disposal of contaminated food could seriously disrupt the flow of safe food to consumers. Research into rapid test methodologies and product traceability systems generates new products and procedures employed throughout the food sector. Because the intentional use of one of these agents could be mistaken for a normal episode of foodborne illness, food producers, manufacturers, distributors, retailers, in addition to federal, state, and local authorities, have preparedness, planning, rapid communication, and central analysis measures in place to identify the early phase of a hostile act, and work quickly to minimize the impact on the food supply and public health.

Summary

The quest for the safest food supply in the world continues. Food processors and government regulators are working together to prevent foodborne illness. These partnerships, through HACCP regulations and expanded research, surveillance, detection, and education programs, will strengthen mechanisms to identify, control, or respond to outbreaks of foodborne illness or deliberate acts against the food supply. Continued partnerships between the public and private sector, with broad, cooperative, and integrated efforts, serve to protect and preserve the safety of the nation’s food supply.

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¹United States Government Accountability Office Oversight of Food Safety Activities,
March 2005 available at: http://www.gao.gov/highlights/d05213high.pdf

²United States Government Accountability Office, report number GAO-05-549T, May 2005 available at: http://www.gao.gov/new.items/d05549t.pdf

³As of early 2006, the Partnership's membership comprises 20 associations and nonprofit organizations in addition to Federal Government Liaisons and International Affiliates. Members represent the country's leading food industry associations, commodity groups, and professional associations in the food sciences and nutrition.

Originally printed in the 2007-2009 IFIC Foundation Media Guide on Food Safety and Nutrition

Source : http://www.ific.org/food/safety/index.cfm

New AMA Policies Address Medical Student Debt, Health Care Reform

Physicians at the American Medical Association's (AMA) annual policy-making meeting held this week in Chicago adopted a political and legislative agenda to address health reform alternatives, new approaches to Medicare payment reform, and strategies to address ballooning medical student debt.

According to their new policy, the "AMA supports health system reform alternatives consistent with principles of pluralism, freedom of choice, freedom of practice, and universal access for patients." They offered a number of approaches to improve patient care while reducing health care costs.

According to AMA president Dr. J. James Rohack, "Medicare payment methods should incentivize better care coordination and disease management." Potential strategies to meet that goal include better teamwork among health care providers and hospitals to reduce hospital readmissions, and patient-centered medical home care, without restriction of access to specialty care.

Furthermore, Dr. Rohack said, "Government action is needed with anti-trust relief, repeal of the fatally flawed Medicare physician payment formula, and medical liability protections."

Finally, the organization is calling for strategies to ease the cost of medical school education, which is leaving graduates with debts of $155,000 or more.

To that end, the AMA has committed itself to working for increases in federal and state scholarships for medical school, as well as loan repayment programs.

"We must look for novel ways to help medical students afford their education so that we have enough physicians to care or our nation's growing population," said AMA board member Dr. William Hazel.

Source : http://www.medscape.com/viewarticle/704601?sssdmh=dm1.488649&src=nldne

U.S. Doctors' Group Waffles on "Public Option"

The American Medical Association, the leading U.S. doctors' group, pronounced itself open to reform of the healthcare system on Wednesday, but said it does not want private insurers to be crowded out of the marketplace by a government-run system.

In a back-and-forth series of votes on the wording of a one-sentence resolution, the American Medical Association's House of Delegates decided to drop language that could be construed as explicit support of a "public option" -- some form of government-operated health insurance.

Instead, the phrase "public option alternatives" was watered down and replaced by the more general "health system reform alternatives."

The AMA statement went on to say reform must be "consistent with AMA principles of pluralism, freedom of choice, freedom of practice and universal access for patients."

"It was very clear people did not want to close the door on alternatives, particularly closing the door by putting a label on alternatives that meant different things to different people," outgoing AMA President Dr. Nancy Nielsen told reporters.

She referred to the public insurance option favored by President Barack Obama -- who lobbied the group that represents 250,000 physicians in a speech to the delegates on Monday -- as the best way to cover the 46 million Americans who lack health insurance.

How to pay for insuring the uninsured that advocates say will cost upwards of $1.2 trillion over the next decade may fall in part to doctors.

Initially, the 500 doctor-delegates passed a resolution that included the words "support public option," but Nielsen intervened, telling the group she was concerned the resolution would be interpreted in Congress as doctors backing government-run health insurance.

"I have avoided that word (public option)," Nielsen told the group. "Because... we can't support something we haven't seen, also we can't oppose something we haven't seen. I think it goes both ways."

Later, Nielsen tried to clarify the AMA's position.

"We want private insurers to remain. We are not in favor of a single payer (government-operated) system. So there's no question that a healthy competitive market for private insurers is in Americans' best interest," she said.

"We want them to have choice. We also know there need to be market reforms in order to make some of those market alternatives more affordable."

Source : http://www.medscape.com/viewarticle/704543?src=mpnews&spon=34&uac=133298AG

COBRA Laws and EMTALA

Introduction

The Emergency Medical Treatment and Active Labor Act (EMTALA) was created out of concern that patients were being denied emergency medical treatment because of their inability to pay. The initial intent of EMTALA was to address the allegation that some hospitals were transferring, discharging, or refusing to treat patients who did not have insurance. EMTALA was signed into law in 1986, as part of the Consolidated Omnibus Budget Reconciliation Act (COBRA). The Centers for Medicare and Medicaid (CMS) issued revisions to EMTALA in 2003, which can be found in the Federal Register on September 9, 2003.

EMTALA contains 2 basic requirements:

1. For any person who comes to a hospital emergency department, "the hospital must provide for an appropriate medical screening examination . . . to determine whether or not an emergency medical condition exists" (see 42 USC § 1395dd[a]).¹
2. If the screening examination reveals an emergency medical condition, the hospital must "stabilize the medical condition" before transferring or discharging the patient.

The definitions of "medical screening exam" and "emergency medical condition" are discussed in more detail later in this article.

The authority supporting the statute is the taxing and spending clause of the Constitution. In essence, Congress has the right to demand certain services from vendors receiving federal tax dollars. In the EMTALA statute, obligations are tied to hospitals' participation in Medicare. A hospital could relieve itself entirely of EMTALA obligations by dropping out of the Medicare program; however, Medicare is a major funding source for most nonfederally run hospitals.

EMTALA compliance is regulated by the CMS, a division of the Department of Health and Human Services (HHS). There are significant financial consequences for violating EMTALA rules. A hospital and/or the responsible physician may face individual fines imposed by the government as well as civil damages claims. Additionally, the hospital can be excluded from participating in the Medicare program, which may be financially devastating. It is imperative that ED physicians be fully aware of their obligations under EMTALA regulations.

EMTALA Obligations

EMTALA outlines specific obligations for the referring hospital, the treating or transferring physician, and the receiving physician and hospital. The main points are as follows:

Medical screening exam

• Any person requesting emergency services, who presents to a facility that provides emergency services, must receive a medical screening exam (MSE). The purpose of the MSE is to identify whether an emergency medical condition (EMC) exists.
• This request can come from the patient, someone accompanying the patient, a law enforcement officer bringing someone to the ED, or someone walking into the ED requesting a blood pressure check.
• If the MSE reveals an emergency medical condition, it is the obligation of the treating hospital to stabilize the patient prior to discharge or transfer.

Persons covered by the "250-yard rule"

• In addition to persons who come to the ED requesting treatment, EMTALA rules also apply to any person who presents on the hospital campus and requests or requires emergency services. Known as the "250-yard rule," the hospital campus is defined below² :
  • Campus means the physical area immediately adjacent to the provider's main buildings, other areas and structures that are not strictly contiguous to the main buildings but are located within 250 yards of the main buildings, and any other areas determined on an individual case basis by the HCFA regional office, to be part of the provider's campus" (42 CFR 413.65).
  • The "250-yard rule" obligates hospital staff to recognize when a visitor, another employee, or anyone on the hospital campus, is in need of a medical screening examination. This includes, "Anyone whom a layperson would believe, based on the individual's appearance and behavior, that the individual needs examination or treatment."
  • Campus typically includes the parking lot, sidewalks, driveways, and inpatient and outpatient areas.
  • The campus does not include nonmedical businesses such as retail business, private physicians' offices, or other medical entities that have a separate Medicare identity.

Patient transfer

• The treating physician may transfer the patient in the following scenarios:
  • The emergency medical condition has been stabilized and the patient requires a higher level of care.
  • The emergency medical condition has not been stabilized, but the treating physician certifies that the benefit of transfer outweighs the risk.
  • The patient or health care proxy requests transfer regardless of whether the emergency medical condition has been stabilized.
  • The on-call physician fails or refuses to appear within a reasonable period of time, and without the services of the on-call physician, the benefit of transfer outweighs the risk.
• When transferring, the treating physician must document the name of the accepting individual and facility. The treating physician must also send pertinent documents, imaging studies, and test results relating to the emergency condition to the receiving facility.
• The receiving hospital must accept the transfer as long as they have the capacity and space to do so. It is the obligation of the receiving hospital or physician to report any transfer received in violation of EMTALA. The receiving hospital may be penalized for failure to report an EMTALA violation.
• The transferring hospital must provide all medical treatment within its capacity, which minimizes the risk to the individual's health. Qualified personnel, with the appropriate medical equipment, must accompany the patient during transfer.

On-call physician duty

• Hospitals must maintain an on-call list of physicians "in a manner that best meets the needs of the hospital's patients." Note that there is no requirement under EMTALA for full-time, on-call coverage by all specialties. However, the hospital is required to adopt a plan of action for situations where the needed on-call specialist is unavailable.
• On-call physicians may be on call for multiple hospitals simultaneously and may schedule elective procedures during on-call hours.
• On-call physicians are required to respond in a reasonable time period to assist in the stabilization of a patient with an emergency medical condition.
• The ED physician's judgment should be deferred to by the specialist in situations where the ED physician requests the presence of the specialist, but the specialist does not believe that his presence is necessary.

EMTALA obligations are fulfilled when:

• An appropriate MSE identifies no emergency medical condition.
• The patient refuses to consent to treatment offered or refuses to consent to transfer offered.
• The emergency medical condition is stabilized.
• A patient with an EMC is stabilized, admitted, and develops a new EMC.
• EMTALA obligations do not apply when an individual who is on the hospital campus for outpatient, nonemergency services develops an emergency medical condition after beginning the outpatient treatment (these situations are covered under CMS's "Conditions of Participation" rules).

Enforcement

EMTALA legislation is enforced by CMS. A hospital that has more than 100 beds may be fined up to $50,000 per violation, and a hospital with fewer than 100 beds may be fined up to $25,000 per violation. Individual physicians may be fined as well, including on-call physicians who fail to appear. On-call physicians who request that an unstable patient be transferred when the risk of transfer outweighs the benefit may also be fined. Ultimately, a hospital may have its Medicare provider agreement revoked in response to EMTALA violation.

Patients Covered Under EMTALA

EMTALA regulations apply to all hospitals that participate in the federal Medicare program and apply to all patients (not just Medicare beneficiaries). Federal and military hospitals do not receive funds from Medicare and are thereby excluded from EMTALA; however, most abide by the regulations. EMATLA rules protect "any individual who comes to the Emergency Department" as well as those covered by the "250-yard rule." EMTALA defines an "Emergency Department" as follows:

• Licensed by the state as an emergency department (this applies to states that license ED's separately from hospitals), or
• Held out to the public as an emergency department or urgent care center, or
• Have provided at least 1/3 of its visits on an urgent basis without requiring a previously scheduled appointment in the previous year

Once a patient is inside an ambulance, the ambulance may be diverted en route without violating EMTALA, since the patient has not physically "come to the Emergency Department." If the ambulance is owned by the hospital, yet is being utilized as part of the community EMS system, then those patients are not covered by EMTALA as long as the ambulance is being directed by EMS and not the hospital that owns it.

Medical Screening Examination

The term medical screening examination (MSE) may lead physicians to misinterpret their responsibilities under EMTALA. It is important to understand that the MSE is not equivalent to a triage assessment. The definition of the MSE is "an evaluation reasonably calculated to identify emergency medical conditions suggested by presenting signs and symptoms." By definition, this evaluation may require the use of any diagnostic aids and/or specialty consultations normally available in the ED. For example, a patient presenting with chest pain, dyspnea, and diaphoresis may require an ECG, chest radiograph, and cardiac enzyme levels as part of the medical screening examination.

The MSE must be performed by a qualified medical provider (QMP). Although the statute does not preclude a nurse or mid-level provider from performing the MSE, compliance generally is ensured if a physician evaluates the patient. In the case of a nurse or mid-level provider, the QMP must have a job description for this role, qualifications and competencies must be established, and a formal designation for approved individuals must be in their personnel file.

Emergency Medical Condition

Emergency medical condition is defined as the following:

"A medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain) such that the absence of immediate medical attention could reasonably be expected to result in placing the health of the individual in serious jeopardy, or serious impairment to any bodily functions or serious dysfunction of any bodily part or organ."

The physician and hospital do not violate EMTALA by failing to treat an unidentified emergency medical condition despite a good faith evaluation. For example, assuming an appropriate evaluation was provided, no EMTALA violation will be found if an emergency physician discharges a patient with an acute pulmonary embolism after erroneously concluding the patient's symptoms were attributable to costochondritis. Once a physician diagnoses the patient's condition, however, appropriate treatment must be provided if the patient's health is at risk.

Emergency medical conditions also include psychiatric emergencies (substance abuse, withdrawal syndromes). These patients must receive a medical screening examination calculated to identify underlying medical problems causing or contributing to their psychiatric condition.

Stabilization

Stabilization is defined as the treatment of the emergency medical condition to reasonably ensure that no deterioration would result from the patient's transfer or discharge. An EMTALA violation is not automatically found simply because a patient's condition deteriorated following discharge or transfer from the ED. Rather, the reviewing body (either the local peer review organization or a court) examines the facts known to the emergency physician at the time of the stability determination.

Unfortunately, no clear formula exists, in either the legal profession or the medical profession, to determine whether a patient's condition can be considered stable. For example, emergency physicians may disagree on whether a patient with a diagnosis of new-onset angina is stable enough for transfer, even though vital signs are normal and no ongoing chest pain is present. The intent of the legislation is to promote cautious and conservative judgments before patient transfer or discharge.

EMTALA requires that a patient be stabilized within the hospital's "capabilities." This becomes especially relevant in the case of an adult visitor who develops an emergency medical condition while in a pediatric hospital. In this situation, the pediatric ED staff would be required to attempt stabilization of the adult patient to the best of their capabilities and not simply call EMS and wait for their arrival. In the case of an adult who develops chest pain, this may include establishing intravenous access and providing supplemental oxygen therapy.

Transfers

Once a patient's emergency medical condition has been stabilized, the patient may be transferred to receive a higher level of care at another hospital. A patient with an incompletely stabilized emergency medical condition may still be transferred without violating EMTALA rules under any one of the following circumstances:

• The patient, while understanding the risks and benefits of transfer, provides a written request for transfer despite being informed of the hospital's EMTALA obligations to provide treatment.
• The treating physician certifies that the benefits of transfer outweigh the risks.
• The on-call physician fails or refuses to appear within a reasonable period of time and without the services of the on-call physician the benefit of transfer outweighs the risk.

Additionally, a patient with an emergency medical condition may be discharged with a plan to have subsequent treatment provided as an outpatient if such a plan is consistent with medical routine and does not jeopardize the patient's health. For example, a closed supracondylar fracture may be "stabilized" in the ED by providing an examination, splinting, and pain control and by arranging for subsequent outpatient surgical repair.

Women in Labor

As defined previously, EMTALA stands for the "Emergency Medical Treatment and Labor Act." Although EMTALA principles apply similarly to emergency medicine patients and women in labor, the definitions of "emergency medical condition" and "stabilization" are more clearly defined. The definitions below apply to women in labor.

• All laboring patients are considered unstable and are thereby deemed to have an emergency medical condition.
• Stabilization may be achieved an any one of the following 3 ways:
  • The physician declares the labor to be false.
  • Labor ceases.
  • The infant and placenta are delivered.
• Transfer rules apply equally to women in labor. Therefore, a women in labor who has not been stabilized (achieved delivery of infant and placenta) may be transferred if the benefits of transfer outweigh the risks.

EMTALA Special Circumstances

EMTALA waivers

Sanctions for noncompliance with EMTALA rules may be waived under certain special circumstances such as severe storms or disease pandemics. A temporary EMTALA waiver is issued by the Secretary of the US Department of Health and Human Services (HHS) under section 1135 of the Social Security Act. Interestingly, the HHS Secretary may also waive The Health Insurance Portability and Accountability Act (HIPPA) under section 1135(b) of the Social Security Act. This waiver is designed to allow an ED, affected directly by a declared disaster, to maximize its delivery of care to the greatest number of people.³

An ED operating under an EMTALA waiver may be protected against sanctions stemming from lack of medical screening examination or transferring an unstable patient. However, if the ED withholds treatment or transfers a patient due to his inability to pay, they will receive sanctions regardless of the temporary waiver. Examples of recent EMTALA waivers occurred during the following disasters: Hurricane Katrina, New Orleans (2005); Hurricane Dean, Texas (2007); Indiana and Iowa Storms (2008).

Blood alcohol testing

In many states, law enforcement officers may bring patients to the ED and request blood alcohol testing. This is not technically viewed as requiring an MSE; however, if the patient requests an MSE, or the staff becomes aware of information suggesting that an MSE is appropriate, then EMTALA obligations must be met.

Sexual assault nurse examiner cases

Many ED's employ sexual assault nurse examiners (SANE) to identify injuries and collect forensic evidence for patients who present with a chief complaint of sexual assault. It must be remembered that these patients are also covered under EMTALA, and the SANE examiner must offer the patient an MSE.

Summary

EMTALA was enacted as a remedial statute intended to remove economic considerations from important medical decisions in the ED. Since the inception of EMTALA, most legal cases brought about by this legislation have dealt with insured patients rather than the uninsured patients EMTALA was designed to protect. Despite the high number of EMTALA violations cited since its inception, studies have shown wide gaps in EMTALA understanding among both ED and on-call physicians. It is incumbent upon us, as emergency physicians to familiarize ourselves with and abide by, the EMTALA regulations or face the aforementioned penalties.

Keywords

COBRA, EMTALA, anti-dumping, emergency, active labor, COBRA laws, Consolidated Omnibus Budget Reconciliation Act, COBRA, Emergency Medical Treatment and Active Labor Act, patient anti-dumping law, section 1867(a) of the Social Security Act, CMS, Centers for Medicare and Medicaid Services, Health Care Financing Administration, HCFA, paying for emergency medical treatment, patients with no insurance, medical treatment, transfer of patients, transferring patients

References

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Source : http://emedicine.medscape.com/article/790053-overview?src=emed_whatnew_nl_0#EMTALA