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Teaching Hospital Update – September 8-12, 2008

 
 
By Leah Voigt Romano*

On-Duty Hours May Not Be the Only Factor in Resident Fatigue

According to a recent study published in the September 10 issue of JAMA, cutting shift lengths will not reduce fatigue-related errors by first-year medical residents if the same workload is simply packed into fewer hours. Increased work intensity was associated with reduced sleep and lower participation in educational activities among fifty-six interns followed during one-month general medicine rotations, reported the study's authors. They also found that interns with heavy workloads were also more likely to overstay their scheduled shifts.

Simply cutting the duty-hour maximum for trainees was unlikely to alleviate fatigue and other problems associated with long shifts if the actual workload is not also reduced. "While people have been focusing a lot on the number of hours and resident fatigue, it's also important to focus on workload [and] on handoff errors and communication around shift change," the study's lead author said.

V. Arora et al., Association of Workload of On-call Medical Interns With On-Call Sleep Duration, Shift Duration, and Participation in Educational Activities, 300 JAMA 1146 (Sept. 10, 2008).

John Gever, On-Duty Hours Not the Only Factor in Medical Resident Fatigue, MedPage Today (Sept 9, 2008).

AHA Advocates Standardized Wristband Colors

An American Hospital Association (AHA) advisory requested all hospitals to start using three standardized colors for alert wristbands to improve patient safety. The colors, which have already been adopted in numerous states, include red for patient allergies, yellow for a fall risk, and purple for "do not resuscitate" patient preferences.

To date, more than twenty-five state hospital associations have provided their hospitals with voluntary guidelines on standardized patient wristband colors. Caregivers working in states that have adopted the wristband colors have welcomed the standardization and have reported reduced confusion caused by the numerous previous variations, according to the AHA.

In its advisory, the AHA cautioned that the wristbands "are merely an alert, and patients' status always should be verified with their charts." The association invited all hospitals to participate in a series of informational calls on the topic scheduled for September 19 and September 23.

Jennifer Lubell, AHA Pushes Standardized Wristband Colors, Modern Healthcare's Daily Dose (Sept. 8, 2008) (note: registration is required to view this content).

Supreme Court to Consider Whether to Bar Liability Suits Against Drug Makers

According to an article this week in the Los Angeles Times, the U.S. Supreme Court in November will consider whether to shield the makers of prescription and over-the-counter drugs from liability lawsuits. According to the Times, "the right to a civil jury trial has been a historic protection for consumers," but a recent series of lawsuits "has limited lawsuits against businesses," including a Supreme Court ruling in February that shields the manufacturers of government-approved medical devices from liability claims. In the past, "FDA maintained that regulatory laws passed by Congress did not bar such lawsuits," but the agency "changed course" under the Bush administration and said that its oversight of drugs and medical devices barred most lawsuits regarding those products, the Times reports.

According to the Times, the Bush administration and the pharmaceutical industry now "stand on the verge of shutting down tens of thousands of lawsuits that have cost the industry billions of dollars in jury verdicts and settlements." After the Bush administration failed to persuade states or Congress to limit liability suits, it had federal agencies "reinterpret" laws to conclude that jury verdicts "would conflict with federal policy," and "[n]owhere is this approach having more effect than in the area of drugs and medical devices," the Times reports.

The case before the Supreme Court in November involves Diana Levine, who was awarded $6.7 million in damages from Wyeth after an anti-nausea drug was improperly injected into an artery and caused gangrene, which resulted in the amputation of her lower right arm and hand. Although the warning label urges extreme caution when administering Phenergan via injection, Levine sued the drug maker, claiming that the company should have warned against injecting the drug under any circumstance.

Kaiser Daily Health Policy Report, Supreme Court to Consider Whether to Bar Liability Lawsuits Against Pharmaceutical Companies, Henry J. Kaiser Fam. Fdn. (Sept. 8, 2008).

Obesity Surgery Cost-Effective

According to an article published this week in The Wall Street Journal, the cost of the most common type of weight-loss surgery, which typically runs between $17,000 and $26,000, is offset within two to four years by medical cost savings. These findings, published in the September issue of the American Journal of Managed Care, may increase pressure on health insurance companies to cover gastric bypass surgery. Some insurance plans specifically exclude weight-loss surgery—despite medical evidence of its effectiveness as a treatment not just for obesity but also for related conditions including diabetes, high blood pressure, and sleep apnea.

"The most cost-effective treatment for obesity is bariatric surgery. If you do that, within two to four years, you will get your money back," said the study's lead author. "We have identified the break-even point for insurers," he added.

Some policy makers and analysts are likely to question the findings because the study was paid for by Johnson & Johnson's Ethicon Endo-Surgery unit, a maker of surgical devices and instruments used in weight-loss surgery. The study's author said he stands by the study's integrity and added that the company "has been totally hands off."

Each of 3,651 severely obese patients in a large claims database who underwent surgery was matched to a control subject who did not have the surgery. The patients were matched for age, gender, geography, health status, and baseline costs. The patients were predominantly female with an average age of forty-four years. More than one-third of the patients had hypertension and many had high cholesterol, diabetes, and other conditions.

The analysis covered six months of presurgical evaluation and care; the surgery itself; and, on average, about eighteen months of postsurgical care, including costs incurred from surgical complications. Some patients' postsurgical claims were tracked for up to five years. Costs included payments for prescription drugs, physician visits, and hospital services. Claims were monitored for obese patients who did not have surgery over the same period.

The study showed that insurers fully recovered the costs of laparoscopic surgery after twenty-five months. Laparoscopic surgery is a less-invasive version of gastric bypass with an average cost of $17,000. Between 2003 and 2005, the break-even point was reached in forty-nine months for traditional bariatric surgery, which carries an average cost of $26,000. The study did not address gastric banding, an alternative procedure.

Rhonda L. Rundle, Obesity Surgery is Called Cost-Effective, WALL ST. J. (Sept. 8, 2008).

Study Shows White Students Benefit from Medical School Diversity

According to another study published in the September 10 issue of JAMA, white medical students were more likely to say they are better equipped to care for patients of different backgrounds if they attended racially and ethnically diverse medical schools. The study also found that students are more likely to believe that access to adequate healthcare is a right rather than a privilege and that lack of access to care is a major problem in the U.S.

On the other hand, researchers found that attending a medical school with a diverse student body had no effect on white students' plans to work with underserved populations.

These findings lend support to the U.S. Supreme Court's 1978 ruling that "student body racial diversity is associated with measurable, positive student outcomes," the researchers said. The Court struck down the University of California Davis School of Medicine's admission policy of reserving spots for minority students, but said medical schools could consider race in admissions, arguing that a diverse environment enhanced education. Although studies of undergraduate schools have suggested the court was correct, there has been little empirical evidence that the same is true in medical schools.

To help fill this gap, the researchers used data collected on the 2003 and 2004 Graduation Questionnaires administered by the Association of American Medical Colleges. The data set included responses from 20,112 graduating medical students (64% of all graduates in 2003 and 2004) from 118 allopathic medical schools. Historically black and Puerto Rican medical schools were excluded.

S. Saha et al., Student Body Racial and Ethnic Composition and Diversity-Related Outcomes in U.S. Medical Schools, 300 JAMA 1135 (Sept. 10, 2008).

Michael Smith, White Students Benefit from Medical School Diversity, MedPage Today (Sept. 9, 2008).

Genome Scanning Device Drops its Price

The personal DNA scanning service 23andme was scheduled to announce this week that it is lowering the price of its gene-mapping service from $999 to $399 in order to attract more customers and expand its database of individual genetic profiles to bolster medical research. The price cut is made possible by a new gene-scanning computer chip made by Illumina. The discount makes the firm the least costly among competitors, whose prices range from about $1,000 to $2,500.

These firms analyze a sampling of genes to find variations that could indicate an individual's increased risk for certain diseases or behavioral traits. 23andMe also offers social networking features that allow customers to share their results with family and friends. The company compiles the genetic information into databases, to which researchers can gain access.

23andMe co-founder Anne Wojcicki said, "We're really focusing on the democratization of genetic information." The firm hopes the price cut will provide an influx of genetic information and "hasten the day when a full genetic screening becomes routine medical practice."

However, some have raised concerns about the technology. Public health officials have said knowledge of the relationships between genes and most diseases is not sufficient to be used in making serious medical decisions. Many have urged physicians, most of whom are not trained in interpreting results of gene tests, to encourage patients to be skeptical of such direct-to-consumer tests. New York and California regulators have ordered that gene scanning companies stop advertising to consumers until the businesses obtain a license to offer medical tests. The states also have required that physicians order the tests.

Kaiser Daily Health Policy Report, Genome Scanning Service 23andMe Drops Price to $399, Hopes to Promote "Democratization of Genetic Information", Henry J. Kaiser Fam. Fdn. (Sept. 9, 2008).

Physicians Support Gainsharing Exception, But Stark Says Proposal Risks Fraud and Abuse

Physician groups, in comment letters to the Centers for Medicare & Medicaid Services (CMS), overwhelmingly supported a proposal that would make it easier for hospitals to pay cash incentives to doctors for quality improvement and cost savings initiatives. However, U.S. Representative Fortney (Pete) Stark (D-CA), who authored the physician self-referral laws, said that giving broad approval to so-called gainsharing or shared savings arrangements was ill-advised.

CMS proposed, in the calendar year 2009 physician fee schedule, the creation of an exception to physician self-referral rules (known as the Stark rules) that would allow for shared savings programs. Comments were due to CMS by August 29. The final physician payment rule is due from CMS by November 1.

Shared saving programs—commonly referred to as gainsharing programs—generally involve hospitals paying physicians a portion of cost savings that are achieved from quality or other improvement initiatives. The American Medical Association said, in its comments to CMS on the proposed rule, that shared savings programs could improve the healthcare delivery system by encouraging collaboration between physicians and hospitals, improving efficiency in hospital operations, and funding quality initiatives. Nevertheless, the AMA said that gainsharing arrangements could be risky because they could implicate fraud and abuse laws and, for that reason, the group said CMS should be cautious about encouraging shared savings programs.

It was the risk of fraud and abuse to the Medicare program and its beneficiaries that Stark said concerned him most. "The overall goal of the self-referral statute is to guard against inappropriate financial incentives that could encourage physicians to make medical decisions based on their ability to profit rather than what is the most appropriate care and treatment for their patients," Stark said in his letter to CMS.

"Exempting gainsharing arrangements from the self-referral laws runs counter to this goal," he continued. "By definition, gainsharing programs create financial incentives for physicians to refer patients to particular hospitals, not necessarily because it is in the best interest of patients, but because physicians stand to gain financially from doing so." Rather than create a broad exemption to self-referral rules, Stark said CMS should wait to make any changes until after the completion of three gainsharing demonstration projects authorized by Congress.

Kendra Casey Plank, Physicians Support Gainsharing Exemption; Stark Says Proposal Risks Fraud, Abuse, BNA HEALTH L. REP. (Sept. 11, 2008) (note: registration is required to view this content).

*We would like to thank Leah Voigt Romano, Esquire (Hall Render Killian Heath & Lyman PLLC, Troy, MI) for providing this week's Teaching Hospital Update.

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