Archive for August, 2006

WHO issues definitions for human H5N1 cases

Aug 29, 2006 (CIDRAP News) – The World Health Organization (WHO) today released a list of case definitions for human H5N1 avian influenza infection to improve reporting and tracking of the disease. 

The WHO said the use of standard definitions will help national and international authorities report and classify human cases, promote better communication, and allow the comparison of data across time and between places. The agency worked with several partners to develop the definitions. 

Officials listed several caveats about using the terminology. The case definitions apply only to the current phase of pandemic alert (phase 3, no or very limited human-to-human transmission) and may change as new information emerges about the disease or its epidemiology. National authorities should notify the WHO only about probable or confirmed H5N1 cases. The definitions are not intended to provide complete case descriptions, but to standardize case reporting. 

Clinical decisions about the care of patients who may have H5N1 infection should be based on clinical judgment and epidemiologic reasoning, not on the case definitions, the WHO said. The agency said that although most patients with H5N1 infection have had fever and lower respiratory symptoms, the clinical spectrum is broad. 

The case definitions include: 

Person under investigation: A person whom public health authorities are investigating for possible H5N1 infection. 

Suspected H5N1 case: A patient who has unexplained acute lower respiratory illness with a fever greater than 38°C (100.4°F) and cough, shortness of breath, breathing difficulty, and one or more of the following exposures 7 days before symptom onset: 

  • Close contact within 1 meter (eg, caring for, speaking with, or touching) with a person who is a suspected, probable, or confirmed H5N1 case 

  • Exposure to (eg, handling, slaughtering, defeathering, butchering, or preparing for consumption) poultry or wild birds, their remains, or their feces where H5N1 infections in animals or humans have been suspected or confirmed in the last month 

  • Consumption of raw or undercooked poultry where H5N1 infections in animals or humans have been suspected or confirmed in the last month 

  • Close contact with a confirmed H5N1-infected animal other than poultry or wild birds (eg, cat or pig) 

  • Handling human or animal samples suspected of containing the H5N1 virus in a laboratory or other setting. 

Probable H5N1 case (notify WHO): 

  • Definition 1: A person who meets the criteria for a suspected case and has either (1) evidence of acute pneumonia on a chest radiograph plus respiratory failure (hypoxemia, severe tachypnea) or (2) laboratory confirmation of influenza A but insufficient laboratory evidence for H5N1 

  • Definition 2: A person dying of an unexplained respiratory illness who is epidemiologically linked by time, place, and exposure to a probable or confirmed H5N1 case. 

Confirmed H5N1 case (notify WHO): A patient who meets the criteria for a suspected or probable case and has had one of the following test results from a national, regional, or international influenza laboratory whose H5N1 test results are accepted by the WHO: 

  • Isolation of an H5N1 virus 

  • Positive H5 polymerase chain reaction (PCR) results from tests using two different PCR targets (eg, primers specific for influenza A and H5 hemagglutinin) 

  • A fourfold or greater rise in neutralization antibody titer for H5N1 based on testing of an acute serum specimen (collected 7 days or less after symptom onset) and a convalescent serum specimen. The convalescent neutralizing antibody titer must be 1:80 or higher 

  • A microneutralization antibody titer for H5N1 of 1:80 or greater in a single serum specimen collected at day 14 or later after symptom onset and a positive result using a different serologic assay, such as a horse red blood cell hemagglutination inhibition titer of 1:160 or more or an H5-specific Western blot positive result. 

Q Fever Resource

A concise information page for clinicians including background, epidemiology, patient education materials, references and more.

www.bt.cdc.gov/agent/qfever/clinicians/
 

Antidepressants during pregnancy may affect baby

By David Douglas Fri Aug 25, 8:01 PM ET

NEW YORK (Reuters Health) - Babies born to women who took the newer type of antidepressants called selective serotonin reuptake inhibitors or SSRIs during pregnancy appear to be at increased risk of having a low birth weight and to develop respiratory distress, Canadian researchers report.

Lead investigator Dr. Tim F. Oberlander told Reuters Health that “our study was undertaken to distinguish the effects of maternal mental illness — pregnancy-related depression — from its treatment — SSRIs — on neonatal outcomes.”

Oberlander and colleagues at the University of British Columbia, Vancouver examined population health data for almost 120,000 live births between 1998 and 2001. Fourteen percent of mothers were diagnosed with depression. The researchers compared the outcomes of babies born to 1451 depressed mothers treated with SSRIs during pregnancy and of those born to 14,234 depressed mothers who were not treated with SSRIs.

There was a significantly greater incidence of respiratory distress (13.9% vs. 7.8%) and longer hospital stays for infants born to depressed mothers on SSRIs than those born to untreated depressed mothers, the team reports in the Archives of General Psychiatry.

Birth weight and gestational age were also significantly less in SSRI-exposed infants and a significantly greater proportion was born before 37 weeks.

“These findings are contrary to an expectation that treating depressed mothers with SSRIs during pregnancy would be associated with lessening of the adverse neonatal consequences associated with maternal depression,” Oberlander said.

Summing up, he noted that, “while our study may add another cautionary note to the use of SSRI medications during pregnancy, the use of antidepressants must be weighed against the risks of untreated or undertreated disease … and thus the decision should be made by an informed patient with her physician on a case-by-case basis.”

SOURCE: Archives of General Psychiatry, August 2006.

ODH Health Alert Advisory

ODH HAN Advisory 8-24-06:  Important - Indeterminate Test Result for Botulinum Toxin in an Envelope — Pennsylvania 

 

Positive Promotions of New York mailed envelopes containing corn starch to healthcare providers, hospices, home health organizations and hospitals in Ohio, Pennsylvania and New York.  When powder was discovered in an envelope in Pennsylvania, a rapid test was indeterminate for botulinum toxin.  Preliminary testing at the Pennsylvania Department of Health Laboratory indicates that the substance is consistent with corn starch.  Confirmatory testing for botulinum toxin is underway, with preliminary results negative to date.  The company has instructed persons to discard these envelopes without opening them to avoid further confusion.  Ohio Department of Health concurs with the recommendations of the Pennsylvania Department of Health and Positive Promotions that recipients not open envelopes. 

 

For further information, please contact ODH Bureau of Infectious Disease Control at 614-466-0265. 

New AHRQ Evidence Report on Treatment Options to Repair Abdominal Aortic Aneurysm

A new AHRQ evidence report on treatment options to repair abdominal aortic aneurysm finds that more research is needed to evaluate the long-term benefits and harms of endovascular repair versus open surgical repair. In patients medically fit for surgery and with an AAA of 5.5 cm or more, endovascular repair is a less invasive procedure, requires a shorter length of stay, and is associated with lower 30-day morbidity and mortality that open surgical repair. However, studies have not shown improved quality of life beyond 3 months or survival beyond 2 years, according to the report. Endovascular repair is associated with more complications, increase need for re-intervention, more long-term radiological monitoring, and greater costs when compared with open surgical repair. A 4-year study of 166 endovascular repair patients medically unfit for surgery found that endovascular repair did not confer any survival benefit compared with no intervention. Research is needed to evaluate the cost-effectiveness of endovascular repair in the United States. Research is also needed to evaluate whether the outcomes of endovascular repair procedures are influenced by either hospital volume or the surgeon’s experience. The report, Comparison of Endovascular and Open Surgical Repairs for Abdominal Aortic Aneurysm, was requested by America’s Health Insurance Plans, and research was conducted by AHRQ’s Minnesota Evidence-based Practice Center in Minneapolis. Select to read the report. A print copy is available by sending an e-mail to AHRQPubs@ahrq.hhs.gov.pager 2 ringtone wayfree phone sprint 20 lg ringtone3g ringtone cell free phone freeverizon ringtones add phone toforce air ringtonesalltel altell ringtonesway pager free ringtone 2free trackback ringtone link 4 Map

Majority of Physicians Would Disclose Medical Errors to Patients, but Struggle with What to Say

Sixty-five percent of physicians would “definitely” disclose a harmful medical error to patients, and 29 percent would “probably” do so, according to one of two articles supported, in part, by AHRQ and published in the August 14 issue of the Archives of Internal Medicine. Four percent of doctors would disclose only if the patient asked, and 1 percent would definitely not disclose, according to the article, Choosing Your Words Carefully: How Physicians Would Disclose Harmful Medical Errors to Patients, which surveyed nearly 3,000 American and Canadian physicians. Researchers found that Canadian physicians and those who had positive attitudes or good prior experiences would be more likely to disclose more information to patients. The other article, U.S. and Canadian Physicians’ Attitudes and Experiences Regarding Disclosing Errors to Patients, based on the same survey, found that despite different malpractice climates, physicians in both the U.S. and Canada have similar attitudes toward and experiences with error disclosure. Select to read the first abstract and select to read the abstract of the latter article in PubMed®.

Hospitals Grew With Medicare Paying the Way

August 20, 2006
LIVINGSTON, N.J. — The St. Barnabas hospital system spent much of the last decade in a sprint to expand through aggressive mergers, political connections and celebrity patrons like the actor Joe Pesci, growing into New Jersey’s largest health care provider and the state’s second biggest private employer.

But the rapid rise in the prominence of St. Barnabas — which at one time had 3,200 beds in nine hospitals throughout the state — was also fueled by what federal prosecutors called one of the most lucrative Medicare fraud schemes in the nation’s history.

By systematically inflating the bills for their sickest elderly patients, the prosecutors said, the executives of the St. Barnabas Health Care System bilked the federal government of at least $630 million from 1995 to 2003. The hospital system, which is a nonprofit institution, eventually stopped the overcharging when it was publicly questioned, and in June the hospital system and its executives, who had been threatened with criminal prosecution, agreed to repay the federal government $265 million.

St. Barnabas has rejected allegations that it defrauded Medicare. In the settlement, it did not acknowledge any deliberate wrongdoing, and last week, Ellen Greene, a spokeswoman for St. Barnabas, described the situation as the result of a misinterpretation of Medicare’s complex rules. She said the company was glad to have gotten past the problem and was focusing on its health care mission.

What happened at this health care system, based largely in suburbs throughout New Jersey, is representative of how hundreds of hospitals around the country, facing pressures from cuts in reimbursements by private insurers, improperly charged the taxpayer-financed Medicare program billions of dollars.

The episode at St. Barnabas, whose legal problems are not over, is part of a wave of Medicare fraud investigations that, according to a federal report, have reached more than 450 hospitals nationwide. Experts said the money involved could exceed $6 billion.

“The way the system has operated, it’s almost irresponsible corporate governance for hospitals not to cheat Medicare,” said Patrick Burns, an analyst at Taxpayers Against Fraud, a leading watchdog organization.

The problems began a decade ago, when hospital administrators around the country —facing cuts in reimbursements from managed care companies — turned to a handful of accounting firms that promised to help them maximize their financing from Medicare, the nation’s health insurance program for the elderly.

By exploiting loopholes in the complex formula that Medicare uses to reimburse providers for their most expensive cases, known as outliers, many hospitals’ federal aid doubled, quadrupled or increased 10 times.

St. Barnabas received more federal Medicare money from the pool of outlier money than some national chains 10 times its size. In 2001, the aid accounted for more than 15 percent of St. Barnabas’s total revenue, at least five times a typical percentage, and, according to depositions from former employees, the hospital system’s bookkeepers were ordered to hide the money elsewhere in the budget to avoid arousing the suspicions of auditors.

Ms. Greene declined to comment on that allegation.

 

Fearing that a harsher fine might run the St. Barnabas health care system out of business, federal prosecutors said St. Barnabas had been required to pay back less than half of the amount it overbilled.

A few weeks after the government case against St. Barnabas was settled, Tenet Healthcare, one of the nation’s largest hospital chains, agreed to repay $788 million of the $1.9 billion it had been accused of overcharging. No one involved in either case faced criminal charges.

After their Medicare subsidies shrank, both St. Barnabas and Tenet closed hospitals, costing hundreds of employees their jobs and disrupting medical care for the communities they had served. Still, in New Jersey, where state officials are impaneling a commission to close a dozen or more hospitals, St. Barnabas finds itself in a far stronger financial position than many hospitals that were not suspected of skirting the law.

As recently as the early 1990’s, St. Barnabas — which was named after a martyr who sold his possessions to help the poor, but is not run by the Roman Catholic Church — operated with a low-key business approach usually found at institutions that are licensed as nonprofit.

Faced with pressure from managed care insurance plans and the prospect of federal health care reform, the system’s chief executive, Ronald J. Del Mauro, voiced determination to firm up St. Barnabas’s financial stability. He preached a strict devotion to the bottom line and engineered a bold set of mergers and acquisitions.

By 1996, St. Barnabas ran seven hospitals in northern and central New Jersey, with 4,000 affiliated doctors, more than 20,000 employees and a million patients. According to depositions by a St. Barnabas consultant and two former employees, which were filed in the settlement, the drive for profits soon affected the Medicare billing, and hospital administrators found a way to capitalize on a loophole in the formula Medicare used to determine reimbursements in outlier cases.

One part of the equation was based on a hospital’s retail charges: the amount paid by the small percentage of patients who do not have insurance. By rapidly increasing retail charges for procedures often covered by Medicare, St. Barnabas got a steep increase in federal aid. As a result, its Medicare payments for outlier cases jumped to $287 million in 2002 from $85 million in 1998.

A consultant hired to work with St. Barnabas said in a sworn deposition that the hospital’s top executives held meetings to plan a “corporate directive” to increase federal aid by raising the prices charged to Medicare patients. The consultant, James T. Monahan, said that St. Barnabas had routinely added hidden charges to the room-and-board fees of Medicare patients and tried to conceal the windfall profits it was receiving from Medicare, in part by overstating its debt.

Mr. Monahan, who later filed a whistle-blower complaint under which he stands to gain millions of dollars from the legal settlement, declined to be interviewed for this article.

St. Barnabas was hardly alone in that practice. Hundreds of other hospitals were using similar tactics to artificially boost their Medicare payments, and many were clients of two accounting firms that specialized in helping clients do that.

The fraud was so extensive, Medicare officials said in 2003, that to restrict the number of outlier claims, they had to raise the threshold for qualified cases in each of the previous five years: from under $10,000 in 1998, to more than $33,000 in 2003.

Despite the years-long surge in questionable Medicare payments across the country, federal auditors did not undertake a widespread investigation until October 2002, when Kenneth R. Weakley, an analyst for UBS Warburg, wrote a report warning investors that Tenet was receiving an “extraordinary” and unsustainable amount of outlier financing.

As they announced the settlements with Tenet and St. Barnabas in June, Justice Department officials said they were satisfied that they had collected a substantial sum of money without risking an uncertain outcome at trial and without endangering the viability of the two hospital systems. David Knowlton, executive director of the New Jersey Health Care Quality Institute, an advocacy group, said that even though the settlements did not recover all the fraudulently obtained funds, they would provide a strong deterrent.

Officials of St. Barnabas pointed out that they had not admitted any wrongdoing and said they were relieved to be able to focus their attention on health care without the distraction of an investigation.

“This agreement,” Michael Slusarz, a vice president and spokesman for St. Barnabas, said in a statement in June, “will allow us to focus our energy and resources on our mission of providing the highest quality of care to our patients.”

As the state begins deciding how many, and which, hospitals to close, St. Barnabas is in an enviable position by virtue of its size, its reputation for providing quality health care and its political contacts in Trenton. For instance, the state’s health commissioner, Fred Jacobs, was senior vice president of medical affairs at St. Barnabas before being appointed to his current post, and Gov. Jon S. Corzine’s deputy chief of staff, Jeaninne LaRue, was a senior vice president and lobbyist for St. Barnabas. The company has also had a long relationship with Senate President Richard J. Codey, whose district in Essex County has some St. Barnabas facilities. During Mr. Codey’s 14 months as acting governor, his administration approved St. Barnabas’s application to perform highly profitable angioplasty procedures without having a cardiac surgical backup, an arrangement that some health care advocates criticized as favoritism. Mr. Codey insists that the decision was made based on the recommendations of a committee of health care experts, and that he was not personally involved.

“I certainly try to support the hospital, because it’s important for the community and a large employer, but there’s nothing more to it than that, ” he said.

St. Barnabas continues to face legal scrutiny, however.

A class-action suit filed by two hospitals, one from Colorado and one from Maine, claims $514 million in damages because the overbilling by St. Barnabas deprived “all of the legitimate hospitals of aid they were entitled to,” said Hal Hirsch, a lawyer for the plaintiffs. Wall Street rating agencies downgraded St. Barnabas bonds after the government settlement was signed and the hospitals’ lawsuit was filed.

Hundreds of nonprofit hospitals across the country are being scrutinized by the Internal Revenue Service and examined by Congress to determine whether they are following guidelines that forbid tax-exempt entities to give executives excessive compensation.

The United States attorney’s office in New Jersey declined to comment on whether the executive pay structure at St. Barnabas was part of any inquiry. But two people who had been questioned by Justice Department investigators said they had been asked for documentation on how Mr. Del Mauro and two other top administrators at St. Barnabas are paid.

Mr. Del Mauro gets no compensation from St. Barnabas Hospital Center, according to its public filings, but he and two other senior administrators are paid officers of SBC Management, a profit-making company that does business with the hospital center. That sort of arrangement is common in the hospital industry.

In 1998, Mr. Del Mauro received $613,000 from SBC, according to documents on file with the I.R.S. His compensation was $4.7 million in 2003, the last year St. Barnabas received the huge Medicare overpayments. In 2004, it was $4.2 million.

Speaking on Mr. Del Mauro’s behalf, Ms. Greene, vice president for public relations and marketing at St. Barnabas, said that she was unable to provide details about Mr. Del Mauro’s compensation or the amount and type of business transactions between the hospital and SBC Management, but that the hospital was complying with the law and the federal tax code.

Termination of Out-of-Hospital Resuscitation Rule May Help EMTs

NEW YORK (Reuters Health) Aug 02 - A new three-item clinical prediction rule may help emergency medical personnel decide when to terminate basic life support resuscitative efforts in cases of out-of-hospital cardiac arrest.

The prediction rule recommends, in the absence of advanced cardiac life support, EMTs may consider the termination of basic life support resuscitative efforts: if there is no return of spontaneous circulation before transportation to the ED is initiated; if the patient received no shocks before transportation is initiated; and if the cardiac arrest was not witnessed by EMS personnel, clinicians report in August 3 issue of The New England Journal of Medicine.

Dr. Laurie J. Morrison of the University of Toronto and colleagues validated this rule by testing it in 24 emergency medical systems in Ontario, which included 1240 adults with presumed cardiac arrest who were treated by EMTs trained in the use of an automated external defibrillator.

Of the 776 patients for whom the prediction rule called for termination of basic life support, 4 survived (0.5%). “The rule had a specificity of 90.2 percent for recommending transport of survivors to the emergency department and had a positive predictive value for death of 99.5 percent when termination was recommended,” the authors report.

“Implementation of this rule would result in a decrease in the rate of transportation from 100 percent of patients to 37.4 percent,” they add.

Dr. Morrison and colleagues note that “substantial numbers” of out-of-hospital cardiac arrest patients with little or no potential for survival are regularly transported to emergency departments.

Guidelines to help EMTs identify which patients would truly benefit from resuscitation efforts would be “extremely useful” and economical.

N Engl J Med 2006;355:478-487.