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.

---

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

1. CMS. EMTALA statute - 42 USC 1395dd. emtala.com. Available at http://www.emtala.com/law/index.html. Accessed April 21, 2005.

2. Code of Federal Regulations. Revised as of October 1, 2002. From the U.S. Government Printing Office via GPO Access. 42CFR413.65. [Full Text].

3. Courtney B. Waiving EMTALA sanctions in response to public health emergencies. Biosecur Bioterror. Sep 2008;6(3):213-7. [Medline].

4. Bourgeois FT, Shannon MW. Adult patient visits to children's hospital emergency departments. Pediatrics. Jun 2003;111(6 Pt 1):1268-72. [Medline].

5. CMS. Medicare Program; Clarifying Policies Related to the Responsibilities of Medicare-Participating Hospitals in Treating Individuals with Emergency Medical Conditions. September 9, 2003.

6. Derlet RW, Kinser D, Ray L, Hamilton B, McKenzie J. Prospective identification and triage of nonemergency patients out of an emergency department: a 5-year study. Ann Emerg Med. Feb 1995;25(2):215-23. [Medline].

7. Derlet RW, Ledesma A. How do prudent laypeople define an emergency medical condition?. J Emerg Med. May-Jun 1999;17(3):413-8. [Medline].

8. Diekema DS. Unwinding the COBRA: new perspectives on EMTALA. Pediatr Emerg Care. Aug 1995;11(4):243-8. [Medline].

9. Emtala. 53 Federal Register 22,513. 1988.

10. Emtala. 59 Federal Register 32,086. 1994.

11. Fosmire MS. Frequently Asked Questions about the Emergency Medical Treatment and Active Labor Act (EMTALA). 2003. emtala.com [Web site]. Available at http://emtala.com/faq.htm.

12. Glass DL, Rebstock J, Handberg E. Emergency Treatment and Labor Act (EMTALA). Avoiding the pitfalls. J Perinat Neonatal Nurs. Apr-Jun 2004;18(2):103-14; quiz 115-6. [Medline].

13. Hershey N. Comments relating to medical screening examination required by EMTALA (Emergency Medical Treatment and Labor Act). Hosp Law Newsl. Jan 1995;12(3):1-3. [Medline].

14. Himmelstein DU, Woolhandler S, Harnly M, et al. Patient transfers: medical practice as social triage. Am J Public Health. May 1984;74(5):494-7. [Medline].

15. Hyman DA. Patient dumping and EMTALA: past imperfect/future shock. Health Matrix Clevel. Winter 1998;8(1):29-56. [Medline].

16. Leibold P. The new EMTALA squeeze. Health Prog. Jan-Feb 1999;80(1):14-5, 17. [Medline].

17. Managed care in conflict with EMTALA. ED Manag. Apr 1998;10(4):41-4. [Medline].

18. Mathis T, Leach TN, LeFevre CM. Legal issues of emergency psychiatric patients: the application of EMTALA and state civil commitment laws. J Health Hosp Law. Dec 1996;29(5):257-67. [Medline].

19. McClurg AJ. Your money or your life: Interpreting the Federal act against "patient dumping". Wake Forest Law Rev. 1989;24(3):13-237.

20. McDonnell WM, Roosevelt GE, Bothner JP. Deficits in EMTALA Knowledge Among Pediatric Physicians. Pediatr Emerg Care. Aug 2006;22(8):555-61. [Medline].

21. Michael KI, McMenamin JP. What you can't afford to ignore about EMTALA. Va Med Q. Spring 1995;122(2):102-7, 111. [Medline].

22. New EMTALA guidelines hot off the press: here's what your ED needs to know. ED Manag. Sep 1998;10(9):97-102. [Medline].

23. Roeder KH, Wheeler SK. New developments define hospital obligations under EMTALA. GHA Today. Nov 1998;42(11):3, 11. [Medline].

24. Schiff RL, Ansell D. Federal anti-patient-dumping provisions: the first decade. Ann Emerg Med. Jul 1996;28(1):77-9. [Medline].

25. Schiff RL, Ansell DA, Schlosser JE, Idris AH, Morrison A, Whitman S. Transfers to a public hospital. A prospective study of 467 patients. N Engl J Med. Feb 27 1986;314(9):552-7. [Medline].

26. Selbst SM. Emergency Medical Treatment and Active Labor Act: legal concerns about private or managed care patients in the emergency department. Curr Opin Pediatr. Oct 1997;9(5):465-9. [Medline].

27. Spain DA, Bellino M, Kopelman A, Chang J, Park J, Gregg DL. Requests for 692 transfers to an academic level I trauma center: implications of the emergency medical treatment and active labor act. J Trauma. Jan 2007;62(1):63-7; discussion 67-8. [Medline].

28. Strickler J. EMTALA: the basics. JONAS Healthc Law Ethics Regul. Jul-Sep 2006;8(3):77-81; quiz 82-3. [Medline].

29. Wood JP. Emergency physicians' obligations to managed care patients under COBRA. Acad Emerg Med. Aug 1996;3(8):794-800. [Medline].

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

Discharge Against Medical Advice: Ethical Considerations and Professional Obligations

Abstract

Discharges against medical advice (AMA) account for approximately 1% of discharges for general medical patients. Patients discharged AMA have longer eventual hospital stays and worse health outcomes. These patients are also less likely to have an established relationship with a physician, tend to have poorer social supports, and are more likely to abuse alcohol and other substances. These discharges are also distressing for physicians and other health professionals. How should physicians manage their conflicted obligations to respect patients' choices and to prevent harms from befalling their patients? What are physicians' obligations to their patients who leave accepting only partial or inadequate treatment plans or no treatment at all? When should physicians question the decision-making capacity of patients who make dangerous judgments to leave the hospital? This article examines the ethical and professional implications of discharge AMA.

Background

Discharges against medical advice (AMA) account for approximately 1% of discharges for general medical patients and up to 10% and 30% for patients afflicted with HIV disease and psychiatric disorders, respectively.^[1-7] Patients discharged AMA have higher rates of readmission, longer subsequent hospital stays, and worse health outcomes.^[3,5,8-11] Not unexpectedly,discharges AMA are associated with overall health costs of up to 50% greater than usual discharges.^[2]

Patients who leave AMA are more likely to have poorer social supports, to abuse alcohol, heroin, and other substances, and often have weighty psychosocial or financial concerns.^[12-18] They are also less likely to have an established relationship with a primary care physician.^[19] Although studies have found that rates of discharge AMA are higher among some ethnic minorities, one recent study suggests that other patient variables, such as level of income and type of insurance, may be more closely related.^[7,20] Unfortunately, many patients who leave AMA have dual sources of distress: compelling personal concerns that fuel one's wish to leave and the illness that initially caused the patient to seek care.

Physicians are often distressed by the clinical and ethical challenges of discharges AMA. How should physicians manage their conflicted obligations to respect patients' choices and to prevent harms from befalling their patients? What are physicians' obligations to their patients who leave accepting only partial or inadequate treatment plans or no treatment at all? When should physicians call into question the decision-making capacity of patients' who make seemingly unwise or clearly dangerous judgments to leave the hospital? In addition to these sorts of concerns, physicians who discharge patients AMA enjoy no definitive legal protection from the consequences of their patients' choices.^[21-23] In fact, good clinical judgement and careful documentation provide the best liability protection.^[24]

Clearly, discharges AMA are problematic for patients, stressful for physicians, and resource intensive for health facilities. Therefore, efforts to understand, better manage, and ultimately decrease discharges AMA will benefit all parties. Whereas the literature on discharge AMA tends to focus on psychiatric and substance abuse patients, this review examines the professional and ethical implications of discharge AMA more generally.

Does Discharge AMA Differ From Treatment Nonadherence Elsewhere in Health Care?

Patients' nonadherence to recommended treatment is often influenced by treatment side effects,costs, inconvenience, psychosocial burden, and the quality of the patient-physician relationship. Not surprisingly, these same factors are often associated with discharge AMA.^[25-28] In fact, nonadherence in discharge AMA and nonadherence elsewhere are fundamentally similar. Differences,where they exist, are often in the degree or imminency of health risk and in the ability of physicians to monitor the patient.

Discharges AMA tend to involve health risks that are more acute and more severe compared to general nonadherence. To illustrate, Patient A is diagnosed with the metabolic syndrome during an office visit. His physician recommends medical therapy, and the patient declines, thereby incurring a high risk of a cardiovascular event within the next 10 years. Patient B presents to the hospital with an acute coronary syndrome. He declines to remain in the hospital for an evaluation of ischemic burden despite a high risk of a myocardial infarction in the next few days. Patient A is motivated by the cost of medication and chooses to purchase his wife's medications, foregoing his own. Patient B is motivated by distress over leaving his frail wife alone at home and concerns of medical bills that he can not afford to pay. The patient in each of these cases is motivated by social and financial concerns. The consequence of each patient's choice is a higher risk of a cardiovascular event. A major difference is the temporal relationship between the decision to not accept treatment and the ensuing adverse event.

Of course, high-risk situations are not exclusive to the inpatient setting. For example, a patent presents to a physician's office after having experienced substernal chest pain during the previous evening. The physician recommends hospitalization but the patient declines. Conversely, a hospitalized patient may pursue discharge AMA because the patient disagrees with the physician's stipulations for safe discharge plan including assistance at home. Yet, these concerns about custodial needs, if identified by the physician in an office setting, may not necessarily compel the physician to hospitalize the patient.

Another difference between discharge AMA and general nonadherence is that adherence is more readily and closely measured in the inpatient setting. Hospital-based occurrences of nonadherence are immediately identified and addressed. To contrast, in the outpatient setting, adherence is far poorer with a 20% nonadherence rate considered to be "good compliance".^[29-31] Regardless of the setting for nonadherence, the variance between recommended and accepted treatments often stems from the fact that patients tend to make decisions based on values and broader interests whereas physicians tend to emphasize more circumscribed medical goals.^[32,33]

Informed and Voluntary Refusal of Treatment

A patient's intention to leave AMA may trigger physicians and other hospital staff to question the patient's decision-making capacity.^[34] One's capacity to make decisions is specific to the decision at hand. For example, a patient with early dementia and an infected arterial insufficiency ulcer may not be able to fully appreciate all the consequences of premature discharge on her health, but may be able to reliably indicate her preferred health agent.

Clinicians commonly make implicit capacity determinations, and do so each time a patient's general consent for treatment is accepted. These assessments tend to be made more explicitly when the patient's decision appears to be grossly contrary to his or her welfare. Capacity to make decisions includes the ability to understand information germane to the decision, to deliberate,and to appreciate the consequences of choices.^[35] As with consent to treatment, a physician who accepts a patient's refusal for treatment has determined that the patient has adequate decision making capacity. However, physicians do not regularly document assessments of capacity in discharge AMA.^[36-38]

Writers on the subject suggest that patients who refuse low-risk but high-benefit treatments should be held to a higher standard of capacity.^[22] This notion could expose patients to incapacity determinations based on a physician's subjective assessment of net benefit or net harm. Rather, I contend that the standard itself should not vary. It should always require that the patient's level of cognitive function, insight, and deliberative abilities be appropriate to the decision at hand and sufficient for the patient to render an autonomous decision. The relative benefit of a treatment, in and of itself,is not relevant to the level of capacity required. Rather, net benefit is relevant to physicians' obligations to more carefully verify patients' understanding of the pertinent information and their perceptions of the consequences of their choices when declining high benefit/low harm treatments.

A capacitated patient's decision to leave AMA,however well informed, may nevertheless not be entirely voluntary. Voluntary decisions are those that are made with substantially free choice.^[39] Various controlling influences may impact a patient's decision to leave AMA, including social or emotional challenges such as a desperate concern about losing employment.^[9,13-15] Health professionals may view a patient's action under some controlling influences as meritorious, for example,leaving AMA to fulfill one's obligation to care for a demented spouse, whereas professionals may view acting on other controlling influences as contemptible,such as a leaving to satisfy a drug addiction. Physicians should view controlling influences, regardless of its moral valence, as affecting the voluntariness of a patient's decision. Moreover, physicians are positioned, through either support or coercion, to influence the degree to which a patient's decision about treatment is voluntary. To illustrate, physicians who support their substance abuse patients by providing adequate treatment of their withdrawal symptoms see lower rates of discharge AMA among these addicted patients.^[3,5,7] Regarding coercion, physicians of hospitalized patients may state their refusal to prescribe a beneficial but inferior outpatient treatment in order to compel their patients to accept standard inpatient treatment.

Physicians' Obligations in Discharge AMA

Broadly stated, physicians' obligations are to promote their patients' welfare and to respect their autonomy which is understood as serving the patient's self-defined best interests including maintaining dignity.^[40] When discharging a patient AMA, physicians are sometimes limited in the ways in which they can fulfill these obligations. Physicians should attempt to promote informed decision-making by discussing the likely harms of premature discharge, the likely harms and benefits of inpatient treatment, and alternatives to inpatient treatment, including medically inferior options where these exist.

Within this obligation to promote patient's welfare, physicians should render only objective and conservative assessments of harm and benefit. These assessments may directly reflect well established medical evidence (eg, use of statins in acute coronary syndromes), but may also be partly or even wholly dependent on clinical judgment(eg, interpreting and applying criteria for inpatient versus outpatient treatment of pneumonia). The process though which these clinical judgments are made is critical because it forms the basis of the medical advice that defines whether a patient's discharge is routine or AMA. Physicians, in addition to their obligation to objectively assess options for treatment, should be mindful of their fiduciary responsibilities in their position to influence patients' choices by the content,emphasis, and manner with which they communicate treatment options.^[41-44]

In addition to supporting patient autonomy through information and education, physicians can promote authenticity of choice by identifying patients' compelling reasons to leave AMA. Does the patient have a demented spouse alone at home? Does the patient have a cultural or religious requirement that they perceive cannot be met while hospitalized? Is the patient concerned about loss of employment? Does the patient have an important family obligation (eg, wedding, funeral)to fulfill? Ways in which these concerns can be mitigated should be explored, often through a multidisciplinary approach that may include social work and pastoral care.^[45]

What are physicians' obligations to patients who are willing to accept only partial or inadequate treatment plans upon discharge AMA? Should physicians be complicit in treatments that are substandard, such as the writing of a prescription for an oral antibiotic for a patient whose clinical condition meets criteria for inpatient treatment of pneumonia? Should physicians be complicit in treatments that are somewhat effective,but clearly inadequate and potentially dangerous? An example of this is the providing of a prescription for an oral anti-arrhythmic medication for a patient diagnosed in the emergency department (ED) with syncope from a tachyarrhythmia.

In considering these scenarios, physicians may need to focus primarily on their ethical obligations to not cause harms, because discharge AMA limits physicians' ability to actively promote patients' health.^[46] To illustrate, Patient C, a frequent abuser of alcohol, presents to the ED and is diagnosed with a pulmonary embolus. She want sonly analgesic medication for her chest pain and states that she plans no outpatient follow up. What options should the ED physician consider? The physician should not discharge the patient with a prescription for warfarin, the use of which requires close and careful monitoring especially in the setting of alcohol consumption, because this treatment, along with this patient's social practices and disinclination for follow up, introduces risks similar in seriousness to her medical condition.^[47] Should the ED physician give her an injection of low molecular weight heparin before the patient exits? Although a single injection of heparin is not likely to meaningfully affect her disease course,there is little direct harm in providing it. However,one must also consider possible indirect harms. For example, the offer of heparin may harm Patient C if she construes it as a bona fide treatment alternative, thereby influencing her decision to leave AMA. In another scenario, Patient D presents to the ED with an upper gastrointestinal hemorrhage and orthostatic hypotension that responds quickly to intravenous fluids. The patient unconditionally refuses to undergo an endoscopyor to accept admission into the hospital. Should the ED physician administer a dose of intravenous proton pump inhibitor (PPI), and write a prescription for high-dose oral PPI? Because the harms of PPIs are low and it may prevent rebleeding, providing such care does not violate the obligation to not cause disproportionate harms, and attends to the obligation to promote the patient's health. To summarize, physicians' obligations to provide treatment upon discharge AMA is determined by a complex evaluation of the likelihood and magnitude of each the harms and benefits associated with the outpatient treatment and the disease associated risks of morbidity and mortality. This assessment is outlined in Table 1 .

Do physicians have obligations for facilitating after-care when discharging a patient AMA? The policy of some hospitals is that there are no such obligations.^[48] Arguably, providing resources for after-care to these patients may benefit these patients with no additional medical risk, with the caveat that offering after-care does not influence the patient's decision to leave AMA. Therefore,physicians are ethically obligated to offer this care. In fact, this is the practice of many physicians and consistent with a number of authorities in medicine and ethics.^{[24,36,49,50]} There is little evidence to support the concern that providing patients with after-care resources exposes physicians or institutions to greater legal liability. In fact the opposite may be true.^[51] For patients who habitually leave AMA and who repeatedly have not sought recommended after-care, it should not be ethically obligatory for hospital staff to expend efforts to secure after-care.

A corollary to physicians' obligations is the obligations of patients as users of health resources. There is an enormous literature on patients' rights, yet a relative dearth of discourse,let alone consensus, on patients' duties and responsibilities.^[52,53] At a minimum, patients are obligated to honor commitments and to disclose relevant information in the interest of their personal health.^[54] Do patients discharged AMA have moral obligations to their fellow patients or to society in terms of responsible use of often costly and sometimes limited health resources? If so,what do these obligations require and which patients should be so obligated? These are important questions to consider, yet are beyond the scope of this discussion.

Summary and Conclusions

Clinicians caring for patients who seek discharge AMA are often faced with emotionally charged and time-pressured treatment situations. These clinicians must weigh multiple considerations for the benefit of their patients, and maintain professional standards of clinical care. Clinicians presented with these situations should (1) evaluate patients' decision-making capacity, (2) assess the degree to which their choices are influenced by controlling external influences and mitigate these factors where possible, and (3) encourage and facilitate after-care ( Table 2 ).

Although discharge AMA accounts for only a small percentage of hospital discharges, its medical,emotional, and resource utilization consequences for patients as well as for physicians and hospitals is disproportionate. The clinical impacts of discharge AMA should be further investigated and specific strategies and interventions to mitigate its health effects should be validated.

References

1. Ibrahim SA, Kwoh CK, Krishnan E. Factors associated with patients who leave acute-care hospitals against medical advice. Am J Public Health. 2007;97(12):2204-2208.
2. Aliyu ZY. Discharge against medical advice: sociodemographic, clinical and financial perspectives. Int J Clin Pract. 2002;56(5):325-327.
3. Anis AH, Sun H, Guh DP, Palepu A, Schechter MT, O'Shaughnessy MV. Leaving hospital against medical advice among HIV-positive patients. CMAJ. 2002;167(6):633-637.
4. O'Hara D, Hart W, McDonald I. Leaving hospital against medical advice. J Qual Clin Pract. 1996;16(3):157-164.
5. Pages KP, Russo JE, Wingerson DK, Ries RK, Roy-Byrne PP, Cowley DS. Predictors and outcome of discharge against medical advice from the psychiatric units of a general hospital. Psychiatr Serv. 1998;49(9):1187-1192.
6. Smith DB, Telles JL. Discharges against medical advice at regional acute care hospitals. Am J Public Health. 1991; 81(2):212-215.
7. Franks P, Meldrum S, Fiscella K. Discharges against medical advice: are race/ethnicity predictors? J Gen Intern Med. 2006;21(9):955-960.
8. Hwang SW, Li J, Gupta R, Chien V, Martin RE. What happens to patients who leave hospital against medical advice? CMAJ. 2003;168(4):417-420.
9. Baptist AP, Warrier I, Arora R, Ager J, Massanari RM. Hospitalized patients with asthma who leave against medical advice: characteristics, reasons, and outcomes. J Allergy Clin Immunol. 2007;19(4):924-929.
10. Fiscella K, Meldrum S, Franks P. Post partum discharge against medical advice: who leaves and does it matter? Matern Child Health J. 2007;11(5):431-436.
11. Ding R, Jung JJ, Kirsch TD, Levy F, McCarthy ML. Uncompleted emergency department care: patients who leave against medical advice. Acad Emerg Med. 2007;14(10): 870-876.
12. Chan AC, Palepu A, Guh DP, et al. HIV-positive injection drug users who leave the hospital against medical advice: the mitigating role of methadone and social support. J Acquir Immune Defic Syndr. 2004;35(1):56-59.
13. Cook CA, Booth BM, Blow FC, McAleenan KA, Bunn JY. Risk fctors for AMA discharge from VA inpatient alcoholism treatment programs. J Subst Abuse Treat. 1994;11(3): 239-245.
14. Endicott P, Watson B. Interventions to improve the AMAdischarge rate for opiate-addicted patients. J Psychosoc Nurs Ment Health Serv. 1994;32(8):36-40.
15. Green P, Watts D, Poole S, Dhopesh V. Why patients sign out against medical advice (AMA): factors motivating patients to sign out AMA. Am J Drug Alcohol Abuse. 2004; 30(2):489-493.
16. Jankowski CB, Drum DE. Diagnostic correlates of discharge against medical advice. Arch Gen Psychiatry. 1977;34(2): 153-155.
17. Jeremiah J, O'Sullivan P, Stein MD. Who leaves against medical advice? J Gen Intern Med. 1995;10(7):403-405.
18. Fiscella K, Meldrum S, Barnett S. Hospital discharge against medical advice after myocardial infarction: deaths and readmissions. Am J Med. 2007;120(12): 104-153.
19. Weingart SN, Davis RB, Phillips RS. Patients discharged against medical advice from a general medicine service. J Gen Intern Med. 1998;13(8):568-571.
20. Moy E, Bartman BA. Race and hospital discharge against medical advice. J Natl Med Assoc. 1996;88(10): 658-660.
21. Devitt PJ, Devitt AC, Dewan M. An examination of whether discharging patients against medical advice protects physicians from malpractice charges. Psychiatr Serv. 2000;51(7): 899-902.
22. Gerbasi JB, Simon RI. Patients' rights and psychiatrists' duties: discharging patients against medical advice. Harv Rev Psychiatry. 2003;11(6):333-343.
23. Devitt PJ, Devitt AC, Dewan M. Does identifying a discharge as "against medical advice" confer legal protection? J Fam Pract. 2000;49(3):224-227.
24. American College of Emergency Physicians Scientific Meeting. http://meetings.acep.org/NR/rdonlyres/3389C314-2395-
    4FCE-BD9A-FAABFFC0DFB6/0/WE184.pdf. Accessed November 30, 2007.
25. Shemesh E, Yehuda R, Milo O, et al. Posttraumatic stress, nonadherence, and adverse outcome in survivors of a myocardial infarction. Psychosom Med. 2004;66(4):521-526.
26. Piette JD, Heisler M, Krein S, Kerr EA. The role of patientphysician trust in moderating medication nonadherence due to cost pressures. Arch Intern Med. 2005;165(15): 1749-1755.
27. George J, Kong DC, Thoman R, Stewart K. Factors associated with medication nonadherence in patients with COPD. Chest. 2005;128(5):3198-3204.
28. Elbogen EB, Swanson JW, Swartz MS, Van Dorn R. Medication nonadherence and substance abuse in psychotic disorders: impact of depressive symptoms and social stability. J Nerv Ment Dis. 2005;193(10):673-679.
29. Monane M, Bohn RL, Gurwitz JH, Glynn RJ, Levin R, Avorn J. Compliance with antihypertensive therapy among elderly medicaid enrollees: the roles of age, gender, and race. Am J Public Health. 1996;86(12):1805-1808.
30. Wang PS, Benner JS, Glynn RJ, Winkelmayer WC, Mogun H, Avorn J. How well do patients report noncompliance with antihypertensive medications?: a comparison of selfreport versus filled prescriptions. Pharmacoepidemiol Drug Saf. 2004;13(1):11-19.
31. DiMatteo MR. Variations in patients' adherence to medical recommendations: a quantitative review of 50 years of research. Med Care. 2004;42(3):200-209.
32. van Kleffens T, van Leeuwen E. Physicians' evaluations of patients' decisions to refuse oncological treatment. J Med Ethics. 2005;31(3):131-136.
33. Donovan JL, Blake DR. Patient non-compliance: deviance or reasoned decision-making? Soc Sci Med. 1992;34(5): 507-513.
34. Ganzini L, Volicer L, Nelson WA, Fox E, Derse AR. Ten myths about decision-making capacity. J Am Med Dir Assoc. 2005;6(3 Suppl):S100-S104.
35. Grisso T, Appelbaum PS, Hill-Fotouhi C. The MacCAT-T: a clinical tool to assess patients' capacities to make treatment decisions. Psychiatr Serv. 1997;48(11):1415-1419.
36. Dubow D, Propp D, Narasimhan K. Emergency department discharges against medical advice. J Emerg Med. 1992; 10(4):513-516.
37. Seaborn MH, Osmun WE. Discharges against medical advice: a community hospital's experience. Can J Rural Med. 2004;9(3):148-153.
38. Henson VL, Vickery DS. Patient self discharge from the emergency department: who is at Risk? Emergency Med J. 2005;22(7):499-501.
39. Beauchamp JF, Childress TL. Respect for Autonomy. Principles of Biomedical Ethics. Fifth ed. New York: Oxford University Press; 2001. p. 57-112.
40. Snyder L, Leffler C. Ethics Manual: fifth edition. Ann Intern Med. 2005;142(7):560-582.
41. Mazur DJ, Hickam DH. The effect of physician's explanations on patients' treatment preferences: five-year survival data. Med Decis Making. 1994;14(3):255-258.
42. Mazur DJ, Merz JF. How the manner of presentation of data influences older patients in determining their treatment preferences. J Am Geriatr Soc. 1993;41(3):223-228.
43. Mazur DJ, Hickam DH, Mazur MD, Mazur MD. The role of doctor's opinion in shared decision making: what does shared decision making really mean when considering invasive medical procedures? Health Expect. 2005;8(2): 97-102.
44. Malloy TR, Wigton RS, Meeske J, Tape TG. The influence of treatment descriptions on advance medical directive decisions. J Am Geriatr Soc. 1992;40(12):1255-1260.
45. Holden P, Vogtsberger KN, Mohl PC, Fuller DS. Patients who leave the hospital against medical advice: the role of the psychiatric consultant. Psychosomatics. 1989;30(4): 396-404.
46. Beauchamp JF, Childress TL. Nonmaleficence. Principles of Biomedical Ethics. Fifth ed. New York: Oxford University Press; 2001:113-164.
47. Stein PD, Henry JW, Relyea B. Untreated patients with pulmonary embolism. Outcome, clinical, and laboratory assessment. Chest. 1995;107(4):931-935.
48. Memorial Hospital Pembroke, Pembroke Pines, Florida. Medical Staff Rules and Regulations. http://www.mhs.net/AboutUs/Physician_Bylaws/pdfs/
    mhp/MHP_Rules_and%20_Regs_2004.pdf. Accessed August 29, 2008.
49. Quill TE, Cassel CK. Nonabandonment: a central obligation for physicians. Ann Intern Med. 1995;122(5):368-374.
50. Swota AH. Changing policy to reflect a concern for patients who sign out against medical advice. Am J Bioethic. 2007;7(3):32-34.
51. Strinko JM, Howard CA, Schaeffer SL, Laughlin JA, Berry MA, Turner SN. Reducing risk with telephone follow-up of patients who leave against medical advice of fail to complete an ED visit. J Emerg Nurs. 2000;26(3):223-232.
52. English DC. Moral obligations of patients: a clinical view. J Med Philos. 2005;30(2):139-152.
53. Draper H, Sorell T. Patients' responsibilities in medical ethics. Bioethics. 2002;16(4):335-352.
54. Brody H. Patients' Responsibilities. In: Post SG, ed. Encyclopedia of Bioethics. Third ed. New York: Thompson Gale; 2004. p. 1990-1992.

Source : http://www.medscape.com/viewarticle/583105

Obama presses doctors to back health care overhaul

President Barack Obama bluntly told doctors Monday he is against their highest legislative priority — limiting malpractice awards — and earned a smattering of boos from an audience he was here to court for his health care overhaul plans.

Pushing anew to reshape the nation's health care delivery system and extend coverage to the millions who don't have it, Obama went before the annual meeting of the American Medical Association and took on others who take issue with parts of his plan as well.

Calling them "naysayers," "fear-mongers" and peddlers of "Trojan horse" falsehoods, Obama warned interest groups, lobbyists and others against using "fear tactics to paint any effort to achieve reform as an attempt to socialize medicine."

"There are those who will try and scuttle this opportunity no matter what," Obama said.

GOP Rep. Tom Price of Georgia — a former orthopedic surgeon — reacted preemptively to Obama's speech by accusing him of seeking a "government takeover" of health care. Speaking to reporters on a conference call organized by the Republican National Committee, Price said a committee that Obama's administration has established to study the effectiveness of various medical treatments would turn into a "rationing board" to overrule doctors and deny patients care.

And Sen. Jon Kyl, R-Ariz., and other Republicans introduced legislation to ban the rationing of care on such a basis.

The economic stimulus legislation that passed over the winter provides funding for "comparative effectiveness research," and the GOP proposal would block the government from using the results to "deny coverage of an item or service" in a federal health care program.

Addressing the doctors in Chicago, the president said for the first time publicly that health care reform, including covering the almost 50 million Americans who have no insurance, would cost about $1 trillion over 10 years.

"That's real money, even in Washington," he said. "But remember: That's less than we are projected to have spent on the war in Iraq. And also remember: Failing to reform our health care system in a way that genuinely reduces cost growth will cost us trillions of dollars more in lost economic growth and lower wages."

Aides had said previously that the administration wants to keep the cost around $1 trillion, while also acknowledging it might go higher.

Obama has taken steps in recent days to outline where money could be found.

He wants to cut federal payments to hospitals by about $200 billion and cut $313 billion from Medicare and Medicaid over 10 years. He also is proposing a $635 billion in tax increases and spending cuts in the health care system as a "down payment" for his plan.

The president traveled to Chicago to talk to the 250,000-physician group in hopes of persuading doctors not to fight him on reform. The nation's doctors, like many other groups, are divided over the president's proposals. Many are skeptical of his plan to create government-sponsored insurance as an option alongside private coverage.

They also want limits on jury awards in medical malpractice lawsuits — caps that Democrats, including Obama, have long opposed and Republicans led by former President George W. Bush long pushed for.

Obama drew hearty applause with a focus on the particular concerns of the medical profession: telling them any system that relies on them "to be bean-counters and paper-pushers" is out of whack and that his push to investigate best-practices and eliminate unnecessary procedures "is not about dictating what kind of care should be provided."

"I need your help, doctors," he said. "To most Americans, you are the health care system. The fact is, Americans — and I include myself, Michelle, and our kids in this — we just do what you tell us to do."

But the malpractice issue is the most provocative with this audience, which chafes at the heavy expense of malpractice insurance.

Obama started by sympathizing with doctors "who feel like they are constantly looking over their shoulder for fear of lawsuits" and said he recognizes any health overhaul will be hard to accomplish without changing that. The crowd burst into loud support.

"Don't get too excited yet. ... Just hold onto your horses here, guys," Obama said as he prepared to deliver what he knew would be disappointing news.

"I want to be honest with you. I'm not advocating caps on malpractice awards," the president said, greeted by a smattering of boos, a remarkable public response to a popular president accustomed to cheering audiences.

He added, without offering specifics, that "excessive defensive medicine" that is conducted out of fear of lawsuits and that increases health costs should be curbed.

Though he offered no support for limiting lawsuits, Obama raised the antennae of trial lawyers' groups just by mentioning the issue.

The Center for Justice and Democracy, which says it advocates for injured consumers, attorneys and others, released a letter to Obama signed by 64 survivors of medical malpractice saying they were "extremely concerned that the rights of medical malpractice patients may be stripped away as part of your national health care proposal."

"The notion that 'defensive medicine' is leading to higher health care costs is not supported by empirical data or academic literature," Les Weisbrod, president of the American Association for Justice, the main lobby for trial lawyers.

Obama co-sponsored legislation with Hillary Rodham Clinton when both were in the Senate in 2005 that would have created a program to allow patients to learn of medical errors and establish negotiated compensation with the offer of an apology.

The president directly took on criticism from former Republican presidential candidate Mitt Romney, though not by name. On Sunday, Romney, widely expected to consider another run at the White House in 2012, called Obama's support for public insurance a "Trojan horse" to create a single-payer system like Britain's.

"When you hear the naysayers claim that I'm trying to bring about government-run health care, know this: They are not telling the truth," Obama said.

The president repeated that he is "open" to a mandate requiring all Americans to have health insurance. But he said that any plan must address the rising costs of a system he called a "ticking time bomb" for the federal budget.

"A big part of what led General Motors and Chrysler into trouble," he said, "were the huge costs they racked up providing health care for their workers — costs that made them less profitable and less competitive with automakers around the world."

"If we do not fix our health care system," Obama said, "America may go the way of GM — paying more, getting less, and going broke."

http://news.yahoo.com/s/ap/20090616/ap_on_go_pr_wh