Fear of lawsuits may drive doctors to overuse antibiotics

Posted on Thu, Dec. 31, 2009

As she waited for back surgery at Cooper University Hospital last week, Betty Lindley got a nice surprise.

Instead of the flimsy gown patients have groused about for years, she was given a new type of gown Cooper has been using for the last six months. A machine blows warm air between layers of paper – actually a DuPont fabric made of wood fibers, polypropylene, and polyester – in the gown to keep patients toasty before, during, and after surgery. The look isn’t slimming, but Lindley didn’t mind. As anyone who has ever visited an operating room knows, surgeons like it a lot colder than their half-dressed patients.

Lindley, who has had surgery before, liked how she felt under the puffy, purple gown. “I’ve been freezing cold before,” she said. “I am warm, and I love it.”

The new gowns, which are made by Minnesota-based Arizant Inc. and cost about $15 each, not only make patients feel better – doctors say they also help them heal better.

Plus, there is money at stake. As Medicare expands efforts to tie medical pay to performance, the government is requiring hospitals to report on their efforts to maintain normal body temperatures during surgery, starting tomorrow. Two percent of pay is connected to reporting on this and other measures known to improve patient results.

About 1,700 facilities, including several in this region, are now using the gowns, known as Bair Paws (http://www.arizant.com/us/bairpawssystem), compared with about 1,300 a year ago, said Jami Collins, a senior product manager at Arizant. The company and several competitors also make forced-air blankets most hospitals use in their ORs.

“We’ve been contacted by a number of facilities who say ‘We need this now.’ . . . It’s obviously a driver for our business,” said Troy Bergstrom, marketing communications manager for Arizant.

Locally, Thomas Jefferson University Hospital and Main Line Health hospitals began using the gowns in the last year. Abington Memorial Hospital has been using them for three years, and Fox Chase Cancer Center for four. The design was recently modified so the gowns can be used during surgery.

Temperatures in operating rooms typically are in the low 60s to keep surgeons, who wear multiple layers of clothing, comfortable.

Daniel Sessler, an anesthesiologist who is chairman of the department of outcomes research at the Cleveland Clinic, said doctors once took it for granted that surgical patients would be cold.

“Patients,” he said, “were not actively warmed because people didn’t think it made a difference.”

It does. Sessler began studying the effect of lowered body temperature in the mid ’90s. Allowing a patient’s temperature to fall by just two degrees – this can happen easily during surgery – triples the risk of heart problems and wound infections, increases blood loss, and prolongs time in the recovery room 40 percent and in the hospital 20 percent, Sessler said. He has done research on patient warming with and without financial support from Arizant.

This is partly because the rooms are cold, but mostly because anesthesia changes the body’s ability to retain and generate heat. Anesthesia makes it impossible for people to shiver, said Michael Goldberg, chief of anesthesiology at Cooper. Shivering is how we warm ourselves up when we are cold. After surgery, shivering is bad, because it saps energy and oxygen that could be better spent on recovery.

A tiny fraction of heart and brain operations go better when the body is cool, Sessler said.

Over the last decade, anesthesiologists, who are responsible for monitoring patient temperatures, have paid increasing attention to this issue. Sessler said he thought all hospitals warmed some patients now, usually with a combination of heated cotton blankets, the warmed air covers, and heated intravenous fluids. But, “there are probably a lot of hospitals who warm only a fraction of the patients who should be warmed,” he said.

The government is requiring reporting of temperature control in procedures that take an hour or more, but some hospitals now use some kind of active warming in shorter operations as well.

The advantage of the gowns, which are loaded with Velcro, is that they can go easily from waiting areas to the OR. During a procedure, they can be opened in various ways so surgeons have access to the parts they need to cut while others are covered.

Sessler said there was plenty of evidence that warming patients before surgery was helpful, but no studies that showed whether the gowns led to better patient outcomes than the forced-air blankets, which cost less. Cleveland Clinic does not use the gowns.

Richard Webster, vice president for perioperative services at Jefferson, remains somewhat skeptical about the gowns, although his hospital now uses them for most cases. He estimates they cost an extra $150,000 a year. “It’s not insignificant at a time when we’re not being reimbursed more,” he said.

“I think the jury’s still out on how effective this is or how important it is.”

The Virtua health system studied the problem, said Carol Mullin, vice president of clinical outcomes and quality management. What the staff found is that patient temperatures were fine in presurgery holding areas, but they dropped rapidly after patients got to the OR. Virtua is now making a big effort to start warming with the blankets and head coverings quickly in the OR. It is not using the gowns.

Patrick Breen, an anesthesiologist at Abington Memorial, said he thought the gowns made temperature control easier. When he arrived at the hospital 31/2 years ago, he was struck by how many patients spent a long time in the recovery room warming up after surgery. The hospital had warming blankets in its ORs, but they were not being used until most of the presurgical prep was finished. That took about 20 minutes. By then, it was hard to catch up.

The advantage of the gowns, he said, is that patients go into the OR warm and the staff immediately hooks their gowns to another warming unit.

He estimates that the gowns cost $3 to $4 more per case than the warmed-air blankets, and he thinks they are worth it.

Doctors also said that warm patients were happier patients. Surgical patients with the gowns are less likely to fuss about being cold, always a big complaint.

“We want them to feel well and feel comfortable before they have this very stressful thing happen,” Goldberg said.

Doctors said some patients, especially large ones, did not want extra warming, but many do.

“All the little old ladies coming in having their hips and knees done, they love these things,” Breen said.

Patients often ask, “Can I get this at home?” The answer is “No.”

“We’re focusing on getting surgical patients warm first,” Bergstrom said.

December 31, 2009

By MICHAEL MOSS

Eight years ago, federal officials were struggling to remove potentially deadly E. coli from hamburgers when an entrepreneurial company from South Dakota came up with a novel idea: injecting beef with ammonia.

The company, Beef Products Inc., had been looking to expand into the hamburger business with a product made from beef that included fatty trimmings the industry once relegated to pet food and cooking oil. The trimmings were particularly susceptible to contamination, but a study commissioned by the company showed that the ammonia process would kill E. coli as well as salmonella.

Officials at the United States Department of Agriculture endorsed the company’s ammonia treatment, and have said it destroys E. coli “to an undetectable level.” They decided it was so effective that in 2007, when the department began routine testing of meat used in hamburger sold to the general public, they exempted Beef Products.

With the U.S.D.A.’s stamp of approval, the company’s processed beef has become a mainstay in America’s hamburgers. McDonald’s, Burger King and other fast-food giants use it as a component in ground beef, as do grocery chains. The federal school lunch program used an estimated 5.5 million pounds of the processed beef last year alone.

But government and industry records obtained by The New York Times show that in testing for the school lunch program, E. coli and salmonella pathogens have been found dozens of times in Beef Products meat, challenging claims by the company and the U.S.D.A. about the effectiveness of the treatment. Since 2005, E. coli has been found 3 times and salmonella 48 times, including back-to-back incidents in August in which two 27,000-pound batches were found to be contaminated. The meat was caught before reaching lunch-rooms trays.

In July, school lunch officials temporarily banned their hamburger makers from using meat from a Beef Products facility in Kansas because of salmonella — the third suspension in three years, records show. Yet the facility remained approved by the U.S.D.A. for other customers.

Presented by The Times with the school lunch test results, top department officials said they were not aware of what their colleagues in the lunch program had been finding for years.

In response, the agriculture department said it was revoking Beef Products’ exemption from routine testing and conducting a review of the company’s operations and research. The department said it was also reversing its policy for handling Beef Products during pathogen outbreaks. Since it was seen as pathogen-free, the processed beef was excluded from recalls, even when it was an ingredient in hamburgers found to be contaminated.

The Beef Products case reveals a schism between the main Department of Agriculture and its division that oversees the school lunch program, a divide that underscores the government’s faltering effort to make hamburger safe. The U.S.D.A. banned the sale of meat found to be contaminated with the O157:H7 strain of E. coli 15 years ago, after a deadly outbreak was traced to Jack in the Box restaurants. Meat tainted with salmonella is also a hazard. But while the school lunch program will not buy meat contaminated with salmonella, the agriculture department does not ban its sale to the general public.

Even so, E. coli outbreaks nationwide have increased in recent years. And this summer, two outbreaks of particularly virulent strains of salmonella in hamburger prompted large recalls of ground beef across several states.

Although no outbreak has been tied to Beef Products, officials said they would thoroughly scrutinize any future industry innovations for fighting contamination “to ensure that they are scientifically sound and protect public health,” and that they were examining the government’s overall meat safety policies.

The founder and owner of Beef Products, Eldon N. Roth, declined requests for interviews or access to the company’s production facilities. Responding to written questions, Beef Products said it had a deep commitment to hamburger safety and was continually refining its operation to provide the safest product possible. “B.P.I.’s track record demonstrates the progress B.P.I. has made compared to the industry norm,” the company said. “Like any responsible member of the meat industry, we are not perfect.”

Beef Products maintains that its ammonia process remains effective. It said it tests samples of each batch it ships to customers and has found E. coli in only 0.06 percent of the samples this year.

The company says its processed beef, a mashlike substance frozen into blocks or chips, is used in a majority of the hamburger sold nationwide. But it has remained little known outside industry and government circles. Federal officials agreed to the company’s request that the ammonia be classified as a “processing agent” and not an ingredient that would be listed on labels.

Within the U.S.D.A., the treated beef has been a source of friction for years. The department accepted the company’s own study as evidence that the treatment was effective. School lunch officials, who had some doubts about its effectiveness, required that Beef Products meat be tested, as they do all beef used by the program.

School lunch officials said that in some years Beef Products testing results were worse than many of the program’s two dozen other suppliers, which use traditional meat processing methods. From 2005 to 2009, Beef Products had a rate of 36 positive results for salmonella per 1,000 tests, compared to a rate of nine positive results per 1,000 tests for the other suppliers, according to statistics from the program. Beef Products said its testing regime was more likely to detect contamination.

Despite some misgivings, school lunch officials say they use Beef Products because its price is substantially lower than ordinary meat trimmings, saving about $1 million a year.

Another snapshot of processed beef’s performance emerges from confidential records of tests in 2007 by the food giant Cargill. In the preceding year and a half, Cargill, which used more than 50 vendors, suspended three facilities for excessive salmonella; two were Beef Products plants, records show.

Since introducing the treated meat, Beef Products has faced the challenge of balancing safety with taste, records and interviews show.

Pathogens died when enough ammonia was used to raise the alkalinity of the beef to a high level, company research found. But early on, school lunch officials and other customers complained about the taste and smell of the beef. Samples of the processed beef obtained by The Times revealed lower levels of alkalinity, suggesting less ammonia was used.

Beef Products acknowledged lowering the alkalinity, and the U.S.D.A. said it had determined that “at least some of B.P.I.’s product was no longer receiving the full lethality treatment.”

Beef Products said it had submitted new research to the agriculture department showing that its treatment remained effective with lower alkalinity. Agriculture officials said Beef Products’ latest study is under review.

A Safety Solution

Headstrong and self-assured, Eldon N. Roth had the good fortune of being in the right place at the right time.

Mr. Roth spent the 1990s looking to give Beef Products a competitive edge by turning fatty slaughterhouse trimmings into usable lean beef.

Mr. Roth and others in the industry had discovered that liquefying the fat and extracting the protein from the trimmings in a centrifuge resulted in a lean product that was desirable to hamburger-makers.

The greater challenge was eliminating E. coli and salmonella, which are more prevalent in fatty trimmings than in higher grades of beef. According to a 2003 study financed by Beef Products, the trimmings “typically includes most of the material from the outer surfaces of the carcass” and contains “larger microbiological populations.” Beef Products said it also used trimmings from inside cuts of meat.

Mr. Roth was well suited to tackle the problem, friends say. Though lacking a science background, he had a knack for machinery and obtained patents for over two dozen pieces of equipment and methods used in processing beef.

“He looked and looked at stuff and always wondered, why can’t it be done this way?” said Dr. David M. Theno, a food safety consultant and friend of Mr. Roth. “He is like a lot of inventors. Not everyone sees Eldon’s vision.”

One of Mr. Roth’s early trials involved running electricity through the trimmings to kill bacteria, Dr. Theno and others said. Mr. Roth eventually settled on ammonia, which had been shown to suppress spoilage. Meat is sent through pipes where it is exposed to ammonia gas, and then flash frozen and compressed — all steps that help kill pathogens, company research found.

The treated beef landed in Washington in 2001, when federal officials were searching for ways to eliminate E. coli. Beef Products already had one study showing its treatment would do that; another company-sponsored study by an Iowa State University professor that was published in a professional journal seconded that finding.

Mr. Roth asserted that his product would kill pathogens in untreated meat when it was used as an ingredient in ground beef — raising the prospect of a risk-free burger. “Given the technology, we firmly believe that the two pathogens of major concern in raw ground beef — E. coli O157:H7 and salmonella — are on the verge of elimination,” Mr. Roth wrote to the department.

The Food and Drug Administration signed off on the use of ammonia, concluding it was safe when used as a processing agent in foods. This year, a top official with the U.S.D.A.’s Food Safety and Inspection Service said, “It eliminates E. coli to the same degree as if you cooked the product.”

Carl S. Custer, a former U.S.D.A. microbiologist, said he and other scientists were concerned that the department had approved the treated beef for sale without obtaining independent validation of the potential safety risk. Another department microbiologist, Gerald Zirnstein, called the processed beef “pink slime” in a 2002 e-mail message to colleagues and said, “I do not consider the stuff to be ground beef, and I consider allowing it in ground beef to be a form of fraudulent labeling.”

One of the toughest hurdles for Beef Products was the Agricultural Marketing Service, the U.S.D.A. division that buys food for school lunches. Officials cited complaints about the odor, and wrote in a 2002 memorandum that they had “to determine if the addition of ammonia to the product is in the best interest to A.M.S. from a quality standpoint.”

“It is our contention,” the memo added, “that product should be labeled accordingly.”

Represented by Dennis R. Johnson, a top lawyer and lobbyist for the meat industry, Beef Products prevailed on the question of whether ammonia should be listed as an ingredient, arguing that the government had just decided against requiring another company to list a chemical used in treating poultry.

School lunch officials said they ultimately agreed to use the treated meat because it shaved about 3 cents off the cost of making a pound of ground beef.“Several packers have unofficially raised concern regarding the use of the product since the perception of quality is inferior,” the 2002 memo said. “But will use product to obtain lower bid.”

In 2004, lunch officials increased the amount of Beef Products meat allowed in its hamburgers to 15 percent, from 10 percent, to increase savings. In a taste test at the time, some school children favored burgers with higher amounts of processed beef.

Beef Products does not disclose its earnings, but its reported production of seven million pounds a week would generate about $440 million in annual revenue, according to industry records.

Dr. Theno, the food safety consultant, applauds Mr. Roth for figuring out how to convert high-fat trimmings “with no functional value.”

“There were some issues with that,” Dr. Theno said. “But he, and God bless him, amassed a tidy fortune for it.”

As sales took off, Mr. Roth started offering a buy-back guarantee: If any of the most virulent E. coli was found in ground beef containing Beef Products meat, the company would buy the tainted meat.

This was based on Mr. Roth’s initial prediction that his treated beef could kill E. coli in any meat it was mixed with. The company acknowledges that its subsequent study found no evidence to back that up, although it says it is now trying with an enhanced treatment. The guarantee remains on the company Web site: “Contact a B.P.I. sales representative today to take the challenge!”

Odor and Alkalinity

As suppliers of national restaurant chains and government-financed programs were buying Beef Product meat to use in ground beef, complaints about its pungent odor began to emerge.

In early 2003, officials in Georgia returned nearly 7,000 pounds to Beef Products after cooks who were making meatloaf for state prisoners detected a “very strong odor of ammonia” in 60-pound blocks of the trimmings, state records show.

“It was frozen, but you could still smell ammonia,” said Dr. Charles Tant, a Georgia agriculture department official. “I’ve never seen anything like it.”

Unaware that the meat was treated with ammonia — since it was not on the label — Georgia officials assumed it was accidentally contaminated and alerted the agriculture department. In their complaint, the officials noted that the level of ammonia in the beef was similar to levels found in contamination incidents involving chicken and milk that had sickened schoolchildren.

Beef Products said the ammonia did not pose a danger and would be diluted when its beef was mixed with other meat. The U.S.D.A. accepted Beef Product’s conclusion, but other customers had also complained about the smell.

Untreated beef naturally contains ammonia and is typically about 6 on the pH scale, near that of rain water and milk. The Beef Products’ study that won U.S.D.A. approval used an ammonia treatment that raised the pH of the meat to as high as 10, an alkalinity well beyond the range of most foods. The company’s 2003 study cited the “potential issues surrounding the palatability of a pH-9.5 product.”

Soon after getting initial approval from the agriculture department, the company devised a plan to make a less alkaline version of the beef, internal company documents show. Beef Products acknowledged in an e-mail exchange that it was making a lower pH version, but did not specify the level or when it began selling it.

In 2008, after the school lunch program temporarily suspended a Beef Products plant for salmonella contamination, the company wrote in a letter that its effort to combat ammonia “aroma” might have reduced the alkalinity below the initial target levels. It said it was taking steps to ensure that the alkalinity remained elevated.

Samples of the treated beef obtained by The Times this month showed a pH as low as 7.75, according to an analysis by two laboratories. Dr. Michael P. Doyle, a food industry consultant and director of the Center for Food Safety at the University of Georgia, said one point on the exponential pH scale was a considerable difference, and “could have a significant effect on the antimicrobial effectiveness of the ammonia.”

This month, Beef Products provided The Times with new research that the company said showed that E. coli and salmonella were undetectable at a pH level of 8.5. The agriculture department said it did not learn that Beef Products was using lower levels until October, after inquiries by The Times, and that it was studying the company’s research.

McDonald’s, whose hamburgers have contained Beef Products meat since 2004, declined to say if it monitored it for pH. But Danya Proud, a chain spokeswoman, said, “We expect the pH level to meet the specifications that are approved by the U.S.D.A.”

Contagion and Notification

At 6:36 a.m. on Aug. 10, the Beef Products plant in South Sioux City, Neb., started up its production line for the school lunch program. In 60 minutes, the plant produced a batch of 26,880 pounds of processed beef that tested positive for E. coli.

Six days later at the same plant, another 26,880-pound lot was found to have salmonella, government records and interviews show.

Within hours of confirming the contamination, the school lunch division of the Agriculture Department in Washington began investigating.

Just down the hall at department headquarters, the division that oversees meat for the general public did not conduct its own inquiry for another month and half, after receiving questions from The Times.

The problems in South Sioux City came shortly after school lunch officials had suspended a Beef Products plant in Holcomb, Kan., for excessive salmonella. The main U.S.D.A. was not notified of the suspension by school lunch officials, and the plant continued to supply other customers.

Agriculture Secretary Tom Vilsack has since directed school lunch officials to share information about their suspensions with the department’s meat safety division.

In addressing the latest contamination cases in Nebraska, Beef Products said it suspected a glitch in its treatment operations, referring to ammonia gas by its chemical name, NH3, according to an e-mail message to school lunch officials.

“The system was stopped for two minutes in order to install a new valve,” the company said. “When the system was restarted, there was product flow for approximately one minute without NH3 flow.”

After the school lunch officials replied that the glitch might explain only one of the two episodes, Beef Products shifted focus to its suppliers, saying it would more closely scrutinize them for contamination.

Under the U.S.D.A.’s new policy for Beef Products, the company itself is also likely to get more scrutiny.

Cargill, one of the nation’s largest hamburger makers, is a big buyer of Beef Products’ ammoniated trimmings for its patties. Company records show that Beef Products, like other suppliers, has periodically exceeded Cargill’s limits on acceptable bacteria levels. That led Cargill to stop buying meat from two Beef Products plants for several months in 2006 after company tests showed excessive levels of salmonella.

But the following year, when Cargill faced an E. coli outbreak, it ruled out Beef Products as a possible culprit, citing the U.S.D.A.’s view that the ammonia treatment provided a “lethality step” for the pathogen. In addition, Cargill officials said recently, they suspect that another supplier, not Beef Products, was the problem. As a result, Beef Products did not face as wide a recall as other Cargill suppliers.

Recently, another E. coli outbreak was traced to a hamburger maker in upstate New York that also used multiple suppliers, including Beef Products. This time, the agriculture department said Beef Products was being recalled with other suppliers, although a source of the contamination had not been identified.

“This will continue to be our approach going forward,” the department said.

When the World Health Organization declared a “public health emergency of international concern” on April 25, 2009, after the emergence in Mexico of pandemic influenza A (H1N1) virus, Australia activated its well-rehearsed plan for response to pandemic influenza.¹ The Australian Health Management Plan for Pandemic Influenza is a strategic outline, based on evidence and international best practices, of actions and interventions that the health care community should consider taking during a pandemic. It describes the planning assumptions, the phases of a response, and the key actions that minimize a pandemic’s effects on the population and the health care community. Over the subsequent 6 weeks, the implementation of border-control measures — including requirements that travelers entering Australia declare whether they have symptoms of influenza or have been in contact with someone with severe respiratory illness and that contacts of persons with known influenza be traced — gave the health care community time to learn more about the natural history of the new influenza strain.² The groups that had been identified worldwide as the most vulnerable to poor outcomes were pregnant women, indigenous populations, and persons with gross obesity or serious underlying medical conditions. Australia pursued a modified version of its national plan for pandemic influenza, under which such persons and those with rapidly progressing influenza and respiratory distress were targeted for early outpatient-based treatment with antiviral medication and careful follow-up by primary care physicians and hospitals. Additional public health mitigation measures included opening the national stockpile of antiviral medication, providing personal protective equipment to general practitioners, issuing public messages recommending self-quarantine at home for persons with influenza-like illness, and launching public-awareness campaigns aimed at reducing droplet spread of the disease.

This first wave of 2009 pandemic influenza A (H1N1) virus infection lasted about 18 weeks in Australia, from mid-May to late September 2009 (see graph).³ Consultations for influenza-like illness in general practices and emergency departments peaked at 34 and 38 per 1000 consultations, respectively. The percentage of clinical isolates that tested positive for influenza A peaked at 38 to 65% in the various states and territories, and the 2009 H1N1 virus accounted for 90% of influenza A isolates by week 8 (see maps). Rates of absenteeism from work and school were similar to those seen in 2007, the year in which Australia had its worst recent influenza season. The rate of hospitalizations was 23 per 100,000 population, with indigenous Australians overrepresented (16%) and about 13% of all patients who were hospitalized being admitted to intensive care units (ICUs). The highest rate of hospitalization occurred among children under 5 years of age. Boys younger than 5 years of age were hospitalized at rate of 67.9 per 100,000 population, and girls in that age group at a rate of 54.1 per 100,000 population, as compared with 51.1 per 100,000 population in this age group during previous influenza seasons. The median length of stay was 3 days, with 19% of patients being hospitalized for more than 7 days.

Intensive care specialists identified some patients with confirmed 2009 influenza A (H1N1) virus infection and “lung-only” single-organ failure whose lung function could not be sustained with the use of ventilators. Among these patients, extracorporeal membrane oxygenation (ECMO) was used extensively.⁴ Approximately 2.1 patients per million population were treated with ECMO, and two thirds of these patients survived. A distinguishing feature of the epidemic was the number of people who were hospitalized in ICUs with confirmed cases of pandemic H1N1 influenza (3.5 per 100,000) and their young age (median, 42 years). According to data from influenza reports and from the Australian government, a total of 387 adults (over 20 years of age) were admitted with viral pneumonitis resulting from influenza A, as compared with a median of only 57 adults per year admitted with viral pneumonitis from any cause between 2005 and 2008. The peak of the epidemic in Australia lasted about 3 weeks, and although the Australian health system was stressed, there was spare capacity of ECMO equipment, hospital beds, and ICU beds.

Before the 2009 H1N1 virus reached Australia, there were dire predictions that the country would see many thousands of deaths from infection with this virus. In reality, 190 deaths associated with the virus have been confirmed to date, although some additional cases may not have been documented. A broader measure of all Australian deaths resulting from influenza or pneumonia currently indicates that there have been fewer such deaths than in other influenza or winter seasons.³ However, this year the median age of the patients who died was 53 years, as compared with 83 years in previous seasons. The lower-than-expected number of deaths could reflect the success of public health mitigation measures, the use of early antiviral therapy against a sensitive virus, and the natural history of this illness, which tends to be moderate in most people rather than severe.

A national vaccination program was begun in Australia on September 30, 2009, using a monovalent, unadjuvanted 2009 influenza A (H1N1) vaccine (Panvax, CSL Biotherapies).⁵ In clinical trials of this vaccine, Australian participants had higher than expected levels of protective cross-reactive antibodies, although the implications of this finding are uncertain. It is possible that more asymptomatic infections had already occurred. This vaccination program should provide a higher level of protection for the Australian population against an anticipated second wave of infection with the virus.

Key lessons so far from this experience in an unprotected population suggest that important elements of the response were a national coordination of efforts and the use and modification of the national pandemic plan framework, focusing on persons who were most at risk. The spread of the epidemic occurred earlier in some geographic locations than in others, which created challenges (such as implementing the school closure policy) in terms of maintaining a coordinated national approach to the epidemic. This challenge was addressed in part by holding regular meetings of the cross-jurisdictional Australian Health Protection Committee. Public messages regarding the public health response used the names of the phases of the pandemic plan, including “Delay,” “Contain,” and “Protect,” which may have helped the public to take appropriate personal action and reduce the impact of the virus on our population.

 

Financial and other disclosures provided by the authors are available with the full text of this article at NEJM.org.
Source Information

 

From the Department of Health and Ageing, Canberra, ACT, Australia.

This article (10.1056/NEJMp0910445) was published on November 25, 2009, at NEJM.org.

References

 

1. Australian health management plan for pandemic influenza. Canberra: Australian Government Department of Health and Ageing, 2008. 
2. Shinde V, Bridges CB, Uyeki TM, et al. Triple-reassortant swine influenza A (H1) in humans in the United States, 2005-2009. N Engl J Med 2009;360:2616-2625. [Erratum, N Engl J Med 2009;361:102.] [Free Full Text]
3. Australian Government Department of Health and Ageing. Australian influenza surveillance report no. 21: reporting period 26 September–2 October 2009. (Accessed November 20, 2009, at http://www.healthemergency.gov.au.)
4. The ANZIC Influenza Investigators. Critical care services and 2009 H1N1 influenza in Australia and New Zealand. N Engl J Med 2009;361:1925-1934. [Free Full Text]
5. Greenberg ME, Lai MH, Hartel GF, et al. Response to a monovalent 2009 influenza A (H1N1) vaccine. N Engl J Med 2009;361:2405-2413. [Free Full Text]

Posted by NEJM • December 2nd, 2009 • Printer-friendly

George J. Annas, J.D., M.P.H.

President Barack Obama has made it clear that he does not want abortion politics to sabotage health care reform. In his September 10 speech about health care to a joint session of Congress, he said, “Under our plan, no federal dollars will be used to fund abortions.” Nonetheless, the centrality of abortion in U.S. politics makes it likely that abortion funding will play a major role in determining whether there is any health care reform law at all. The current abortion controversy concerns the Stupak amendment, whose presence or absence from the final bill may determine the votes of enough members of Congress to determine the outcome. This makes it critical to understand both this amendment and the current state of the law on federal funding for abortion.

The Stupak amendment provides that “No funds authorized or appropriated by this Act . . . may be used to pay for any abortion or to cover any part of the costs of any health plan that includes coverage of abortion, except in the case where a woman suffers from a physical disorder, physical injury, or physical illness that would, as certified by a physician, place the woman in danger of death unless an abortion is performed, including a life-endangering physical condition caused by or arising from the pregnancy itself, or unless the pregnancy is the result of rape or incest” (italics added).

The House passed this amendment by a vote of 240 to 194, with 64 Democrats voting in favor (the House health care bill itself passed 220 to 215). Many have blamed the Catholic bishops who lobbied fervently for passage of the Stupak amendment. More influential, however, has been the previously secret fundamentalist Christian political leadership group known variously as the Family or the Fellowship, which includes among its members both of the amendment’s main sponsors, Bart Stupak (D-MI) and Joe Pitts (R-PA).¹

The Stupak amendment has been defended as merely continuing the practice created by the Hyde amendment. That amendment, named after the late Congressman Henry Hyde (R-IL), which has been attached to every Health and Human Services Appropriations Act passed since 1976 (and has been added to appropriations legislation for the Defense Department, the Indian Health Service, and federal employees’ health insurance plans) prohibits the use of federal funding for “any abortion” or for any “health benefits coverage that includes abortion,” unless the pregnancy is the result of “rape or incest” or “would, as certified by a physician, place the woman in danger of death unless an abortion is performed.” Under the Hyde amendment, states may use their own funds to finance abortion services through their Medicaid programs, and 17 states currently do so.

The U.S. Supreme Court has ruled on the government funding question twice. The first case, in 1977, involved a Connecticut regulation that limited state Medicaid funding to “medically necessary” abortions, thus excluding those not necessary to preserve a woman’s life or health. The Court ruled that women have a constitutional right to choose to have an abortion, but the state has no obligation to pay for the exercise of this right and may constitutionally encourage women to continue their pregnancies to term by providing funding for childbirth and not abortion. The state may not constitutionally create obstacles to abortion, but it has no obligation to remove obstacles, such as poverty, that are not of its own making.²

Three years after the Connecticut decision, the Court upheld the Hyde amendment, which prohibited federal funding for medically necessary abortions.³ Under this ruling, even low-income women who would have devastating health outcomes if they continued a pregnancy could not have an abortion paid for by Medicaid. In both cases, the Court ruled that the government could make “a value judgment favoring childbirth over abortion and [implement] that judgment by the allocation of public funds.” There is no constitutional requirement for the federal government to fund any abortion. Federal funding is a political question to be addressed by Congress.

The current version of the U.S. Senate bill on health care reform, which Majority Leader Harry Reid (D-NV) created by blending bills from two committees, does not contain the Stupak amendment but specifically excludes federal funding for abortions as prohibited by any federal law (including the Hyde amendment) that was in effect “6 months before the beginning of the plan year involved.” States must also ensure that “no federal funds pay or defray the cost” of abortion services in new health plans that cover abortion. Moreover, states are required to offer at least two plans in the proposed health insurance exchanges (where most people who currently lack coverage will purchase insurance): one that covers abortion services and one that does not. Nonfederal funds for abortion coverage in any plan must be segregated, and payment must be made separately, in an amount estimated by the secretary of health and human services, to cover this benefit.

The primary promoters of the Stupak amendment in the Senate, Orrin Hatch (R-UT) and Sam Brownback (R-KS), who is also a member of the Family,¹ would not vote for a health care reform bill even if it outlawed federal payments for all abortions because both men object to more government involvement in health care. Since 51 votes would be required for the Senate to adopt the amendment, it seems unlikely that it will be added to the Senate bill.

Three major questions have been raised about the House and Senate approaches: Do they fulfill Obama’s no-federal-funding promise? Do they follow the Hyde amendment “tradition”? And do they represent good health insurance policy?

As for the first question, the Senate version fulfills the President’s promise by requiring abortion funding to come from sources other than federal tax dollars. This aspect of the provision has been denigrated as a “bookkeeping trick,” but all payments involve bookkeeping. Even federal employees who pay for abortions with their government salaries are using funds that came from federal tax dollars. As for the second question, the Stupak amendment goes far beyond the Hyde amendment by prohibiting the use of federal tax dollars not only for abortion itself but also for any health plan available on the proposed exchanges that covers abortion. The goal is to limit access to abortion, even when no federal funds are being used for it.

The third question relates to public health policy. The Hyde amendment institutionalizes the moral view of some members of Congress that even medically necessary abortions should not be considered health care. This view, for example, led Congress to criminalize an abortion procedure without an exception for the health of the pregnant woman.⁴ These are the types of federal government intrusions into health care that opponents of public insurance plans usually decry.

President Obama is nonetheless on solid political ground in leaving for another day the toxic issue of federal funding for abortions. Should the current Senate bill get to conference committee, the Senate conferees should insist that their abortion-funding–neutral language be adopted in the final bill. The House conferees are unlikely to object. The Stupak amendment cannot be fairly termed a health care bill because it further restricts funding, and voting against it seems to me a reasonable response from senators and representatives who support social justice and equality between the sexes.

Financial and other disclosures provided by the author are available with the full text of this article at NEJM.org.

Source Information

From the Boston University School of Public Health, Boston.

This article (10.1056/NEJMp0911513) was published on December 2, 2009, at NEJM.org.

References

 
1. Sharlet J. The Family: the secret fundamentalism at the heart of American power. New York: HarperCollins, 2008.
2. Maher v Roe, 432 U.S. 464 (1977).
3. Harris v. McRae, 448 U.S. 297 (1980).
4. Annas GJ. The Supreme Court and abortion rights. N Engl J Med 2007;356:2201-2207. [Free Full Text]

Posted by NEJM • December 30th, 2009 • Printer-friendly

Harald Schmidt, M.A., Kristin Voigt, D.Phil., and Daniel Wikler, Ph.D.

Chronic conditions, especially those associated with overweight, are on the rise in the United States (as elsewhere). Employers have used both carrots and sticks to encourage healthier behavior. The current health care reform bills seek to expand the role of incentives, which promise a win–win bargain: employees enjoy better health, while employers reduce health care costs and profit from a healthier workforce.  

However, these provisions cannot be given an ethical free pass. In some cases, the incentives are really sticks dressed up as carrots. There is a risk of inequity that would further disadvantage the people most in need of health improvements, and doctors might be assigned watchdog roles that might harm the therapeutic relationship. We believe that some changes must be made to reconcile incentive use with ethical norms.

Under the 1996 Health Insurance Portability and Accountability Act (HIPAA), a group health plan may not discriminate among individuals on the basis of health factors by varying their premiums. But HIPAA does not prevent insurers from offering reimbursements through “wellness programs.” These include what could be called participation incentives, which offer a premium discount or other reimbursement simply for participating in a health-promotion program, and attainment incentives, which provide reimbursements only for meeting targets — for example, a particular body-mass index or cholesterol level. Subsequent regulations specified that attainment incentives must not exceed 20% of the total cost of an employee’s coverage (i.e., the combination of the employer’s and employee’s contributions).¹

The health care reform measures currently before Congress would substantially expand these provisions (see box). However, ethical analysis and empirical research suggest that the current protections are inadequate to ensure fairness.

Attainment incentives provide welcome rewards for employees who manage to comply but may be unfair for those who struggle, particularly if they fail. The law demands the provision of alternative standards for those who cannot or should not participate because of medical conditions, but those categories are narrowly defined. For all others, the implicit assumption is that they can achieve targets if they try. This assumption is hard to reconcile with what we know about lifestyle change. Most diets, for example, do not result in long-lasting weight reduction, even though participants want and try to lose weight. Attainment-incentive programs make no distinction between those who try but fail and those who do not try.

Proponents of attainment incentives typically do not view this situation as inequitable. Steven Burd, the chief executive officer of Safeway, whose “Healthy Measures” program offers reimbursements for meeting weight, blood-pressure, cholesterol, and tobacco-use targets, compared his company’s program to automobile insurance, in which for decades “driving behavior has been correlated with accident risk and has therefore translated into premium differences among drivers.” In other words, says Burd, “the auto-insurance industry has long recognized the role of personal responsibility. As a result, bad behaviors (like speeding, tickets for failure to follow the rules of the road, and frequency of accidents) are considered when establishing insurance premiums. Bad driver premiums are not subsidized by the good driver premiums.”²

If people could lose weight, stop smoking, or reduce cholesterol simply by deciding to do so, the analogy might be appropriate. But in that case, few would have had weight, smoking, or cholesterol problems in the first place. Moreover, there is a social gradient. A law school graduate from a wealthy family who has a gym on the top floor of his condominium block is more likely to succeed in losing weight if he tries than is a teenage mother who grew up and continues to live and work odd jobs in a poor neighborhood with limited access to healthy food and exercise opportunities. And he is more likely to try. In Germany, where both participation and attainment incentives have been offered since 2004, participation rates among people in the top socioeconomic quintile are nearly double the rates among those in the poorest quintile.³

Incentive schemes are defended on the grounds of personal responsibility, but as Kant observed, “ought” implies “can.” Although alternative standards must be offered to employees for whom specific targets are medically inappropriate, disadvantaged people with multiple coexisting conditions may refrain from making such petitions, seeing them as degrading or humiliating. These potential problems are important in view of the proposed increases in reimbursement levels.

The reform proposals prohibit cost shifting, but provisions in the Senate bill could result in a substantial increase in financial burden on employees who do not meet targets (or alternative standards). On the basis of the average cost of $4700 for employee-only coverage, a 20% incentive amounts to $940; 30% would equal $1410 and 50%, $2350. In practice, insurers may stay below the maximum levels. Some may elect to absorb the full cost of reimbursements, in part because some or all of these costs may be offset by future savings from a healthier workforce. Alternatively, however, insurers might recoup some or all of the costs by increasing insurance contributions from insurance holders. In the extreme case, the incentive might then simply consist of being able to return to the previous level of contributions. Similar effects can be achieved by varying applicable copayments or deductibles.⁴ Direct and indirect increases would disproportionately hurt lower-paid workers, who are generally less healthy than their higher-paid counterparts and thus in greater need of health care, less likely to meet the targets, and least likely to be able to afford higher costs. Some employees might decide to opt out of employer-based health insurance — and indeed, one wellness consulting firm, Benicomp, implies in its prospectus that such a result might be desirable, pointing out that employees who do not comply might be “motivated to consider other coverage options” and highlighting the savings that would result for employers.⁴

Proponents emphasize that wellness incentives are voluntary. But the scenarios above show that voluntariness can become dubious for lower-income employees, if the only way to obtain affordable insurance is to meet the targets. To them, programs that are offered as carrots may feel more like sticks. It is worth noting that countries such as Germany generally use far lower reimbursements ($45 to $130 per year, or a maximum of 6% of an employee’s contribution) and often use in-kind incentives (such as exercise equipment, heart-rate monitors, or vouchers contributing to the cost of a “wellness holiday”) rather than cash.³

There are also questions about the effect on the therapeutic relationship. When the German Parliament passed a law making lower copayments conditional on patients’ undergoing certain cancer screenings and complying with therapy, medical professionals rejected it, partly out of concern about being put in a policing position.³ American physicians expressed concern when West Virginia’s Medicaid program charged participating doctors with monitoring patients’ adherence to the requirements set out in the member agreement.⁵ Requiring physicians to certify an employee’s medical unsuitability for an incentive scheme or to attest to their achievement of a target might similarly introduce an adversarial element into the doctor–patient relationship.

Incentives for healthy behavior may be part of an effective national response to risk factors for chronic disease. Wrongly implemented, however, they can introduce substantial inequity into the health insurance system. It is a problem if the people who are less likely to benefit from the programs are those who may need them more. The proposed increases in reimbursement levels threaten to further exacerbate inequities. Reform legislation should therefore not raise the incentive cap. Attainment incentives that primarily benefit the well-off and healthy should be phased out, and the focus should shift to participation-incentive schemes tailored to the abilities and needs of lower-paid employees. Moreover, it is crucial that the evaluation of pilots include an assessment of the socioeconomic and ethnic backgrounds of both users and nonusers to ascertain the equitability of programs.

Financial and other disclosures provided by the authors are available with the full text of this article at NEJM.org.

Source Information

From the Harvard School of Public Health and the Harvard University Program in Ethics and Health, Boston.

This article (10.1056/NEJMp0911552) was published on December 30, 2009, at NEJM.org.

References

 
1. Mello MM, Rosenthal MB. Wellness programs and lifestyle discrimination — the legal limits. N Engl J Med 2008;359:192-199. [Free Full Text]
2. Burd SA. How Safeway is cutting health-care costs. Wall Street Journal. June 12, 2009.
3. Schmidt H, Stock S, Gerber A. What can we learn from German health incentive schemes? BMJ 2009;339:b3504-b3504. [Free Full Text]
4. Detailed overview, 2009. Ft. Wayne, IN: BeniComp Advantage. (Accessed December 22, 2009, at http://www.benicompadvantage.com/products/overview.htm.)
5. Bishop G, Brodkey A. Personal responsibility and physician responsibility — West Virginia’s Medicaid plan. N Engl J Med 2006;355:756-758. [Free Full Text]

Posted by NEJM • December 30th, 2009 • Printer-friendly

Timothy S. Jost, J.D.

Health care reform lurches forward. The House and Senate have both passed reform bills. How well reform works in practice, however, will depend on one key difference between the two bills that has received far too little attention — how their provisions will be implemented and enforced.

The essential frameworks of the House and Senate bills are quite similar: both include health insurance and underwriting reforms, insurance exchanges, subsidies to make insurance affordable, individual mandates, and penalties for large employers who fail to insure their employees. Yet their approaches to oversight and enforcement, and in particular to the respective roles of the federal and state governments, differ substantially. As we look back a decade from now, whether we see the vast majority of Americans benefiting from ready access to uniformly fair and affordable health insurance or a national patchwork, with some states ensuring access to affordable health insurance for most residents while other states leave many uncovered, will depend largely on whether the final legislation is closer to the House or the Senate approach.

In sum, the House bill creates a new federal program implemented and enforced consistently throughout the country by a new federal agency, the Health Choices Administration (HCA), in cooperation with the states. The Senate bill takes a bifurcated approach. Primarily, it depends on the states to adopt the federal insurance reforms as their own law, establish their own exchanges, and under federal supervision but without ongoing federal financial support, implement and enforce the law themselves. But alternatively, the Senate lets the states opt out of national reform altogether, creating their own reform programs.

The House’s HCA would have primary responsibility for administering the regulatory and subsidy programs established under the bill. The House bill would establish a national insurance exchange, which would be responsible for negotiating and enforcing agreements with insurers. It would also create a national public insurance plan.

Recognizing the important ongoing regulatory role of the states, however, the House bill would not supersede state laws that do not conflict with it. The states would be primarily responsible for insurer licensure and solvency and would continue to enforce their own laws as to marketing, claims practices, consumer protection, and most other functions that they now regulate, except insofar as state laws came in conflict with new federal requirements. The federal government would conduct audits of health plans in cooperation with the states, and state attorneys general could enforce the federal law. State-law remedies against health insurers would be preserved. States would have input into the secretary of health and human services’ definition of the essential benefits package and could decide whether to enter into interstate insurance compacts.

The House bill would even permit a state to operate its own insurance exchange, but only if the HCA determined that it met specific requirements. If a state opted out of the national exchange, the HCA could retain enforcement authority and could terminate the state exchange if it ceased to meet federal requirements. A state that opted out would have to provide matching funding to establish its own exchange; otherwise, the federal government would pay the full cost of operating the national exchange in the state.

The basic model under the Senate bill, by contrast, would establish a hierarchy between the federal and state governments. The primary responsibility of the federal government would be to draft regulations and then to monitor state compliance. The states would have to enforce the federal law as well as their own laws. Only if the federal government determined that a state would fail to implement the insurance reforms by 2014, or at the state’s request, could the federal government implement the reforms directly or set up a federal exchange in that state. Under the Senate approach, some states might choose to allow federal implementation of the law, but the expectation would be that the states would enforce the law themselves. If a state turned over implementation to the federal government, that implementation would be further delayed.

The Senate bill also incorporates an alternative model. It gives the states opportunities to opt out of the national reform program. A state would be allowed to create its own basic plan for residents with incomes from 133 to 200% of the federal poverty level, if it were willing to cover eligible persons for only 85% of the amount that the federal government would otherwise have paid for coverage (in the form of tax credits for premiums and cost-sharing–reduction payments, or “affordability credits”). Furthermore, after 2017, with federal permission, states could opt out of most of the remaining requirements of the legislation (including the individual and employer mandates and the provisions regarding affordability credits) to pursue their own reform programs. If this option were widely followed, of course, it would destroy the national scope of the reform program.

Perhaps most important to the states, these enforcement and exchange responsibilities are an unfunded mandate. The Senate legislation would provide the states with start-up funding for the exchanges, consumer assistance, and premium review, but once the legislation was implemented, states would be on their own. Moreover, the federal government would administer the affordability credits, which would not pass through the states (except in states with waivers). The states would not, in any event, have access to this money for carrying out their responsibilities.

The Senate bill is no doubt intended to show deference to the states, but the House bill is in fact more in line with the traditional relationship of cosovereignty between the federal and state governments. The House bill recognizes the states as partners, not as either underlings or wholly independent sovereigns. In my view, the House approach would result in effective, uniform, national implementation of the reform legislation, whereas the Senate bill is likely to get mired in state political battles. Each state would have to enact the federal laws as its own — and thus would begin 50 state reenactments of the battle we have witnessed all year in Congress.

We have tried state implementation of federal health care reforms before, and the results have often been discouraging. The Senate approach is precisely that taken by the Health Insurance Portability and Accountability Act (HIPAA) insurance reforms of the 1990s, and though HIPAA’s reforms to group insurance were successfully implemented, implementation of the individual insurance reforms was faltering and incomplete.¹ Although Medicaid, another joint federal–state effort, has proved successful in extending coverage to poor Americans, it has also resulted in a continual tug-of-war between the federal government and the states over funding and control.²

Moreover, there is every reason to believe that state implementation of federal reforms would be even more difficult this time around. Arizona has already placed on its ballot for next year a constitutional amendment opposing implementation of health care reform on its soil, and 11 other states are considering following suit.³ Finally, most states are in desperate financial straits and in no position to take on major new obligations for implementation and enforcement.

In the end, it is not just the reforms we adopt but how we choose to implement them that will matter. The Senate bill undoubtedly reflects the Senate’s reading of the political landscape, but I believe that the House bill is much more likely to result in more effective and consistent implementation of national health care reform.

Financial and other disclosures provided by the author are available with the full text of this article at NEJM.org.

Source Information

From the Washington and Lee University School of Law, Lexington, VA.

This article (10.1056/NEJMp0911636) was published on December 30, 2009, at NEJM.org.

References

 
1. Pollitz K, Tapay N, Hadley E, Specht J. Early experience with `new federalism’ in health insurance regulation. Health Aff (Millwood) 2000;19:7-22. [Abstract]
2. Jost TS. Disentitlement? The threats facing our public health-care programs and a right-based response. New York: Oxford University Press, 2003:172-8.
3. Cauchi R. State legislation opposing certain health reforms, 2009-2010. Denver: National Conference of State Legislatures, December 2009. (Accessed December 17, 2009, at http://www.ncsl.org/IssuesResearch/Health/StateLegislationOpposingCertainHealthReforms/tabid/18906/Default.aspx.)