By Jennifer P. Viegas*
December 31, 2008
HHS OIG Study of Adverse Events Substantiates Patient Safety Concerns
The Department of Health and Human Services Office of Inspector General (OIG) recently reported a limited study of hospitalized Medicare beneficiaries' substantiated concerns about adverse events in hospitals and the need to improve patient safety.
According to the report, the OIG found that 15% of 278 hospitalized patients in two counties experienced adverse events during their stays in August 2008. Of the forty-one patients affected by adverse events, six experienced multiple adverse events, raising the total number of incidents to fifty-one. Although the adverse events resulted in permanent harm and undesirable clinical outcomes for the patients, only one incident resulted in higher costs for the Medicare program.
In addition to the 15% of beneficiaries who experienced adverse events during their hospital stays, the OIG identified an additional 15% percent who experienced events resulting in temporary harm that required medical intervention during their hospital stays. Examples of events that the OIG defined as resulting in temporary harm were swelling at a treatment site and low-level infections. However, because these temporary events did not prolong the hospital stay or result in permanent harm, they were not included in the overall rate of adverse events. Nevertheless, the events were included in the report because they would be of interest to hospitals and other providers seeking to improve overall patient safety. Furthermore, such incidents indicate cases that could have escalated to more serious adverse events without timely intervention.
However, variations in how adverse events are defined made it difficult to determine the incidence rate of such events. The OIG defined adverse events using the National Quality Forum's list of Serious Reportable Events, the Centers for Medicare & Medicaid Services's list of hospital-acquired conditions, and the National Coordinating Council for Medication Errors' Reporting and Prevention Index for Categorizing Errors.
While the study was not nationally representative, the OIG cautioned that the findings were evidence that the incidence rate of adverse events in hospitals was a concern for Medicare beneficiaries and that there was a need to focus on safety precautions to reduce such events.
HHS OIG Study of Adverse Events Substantiates Patient Safety Concerns, BNA'S HEALTH L. REP. (Dec. 25, 2008) (note: registration is required to view this content).
UnitedHealth Settles Backdating Allegations: SEC
According to the Securities and Exchange Commission (SEC), UnitedHealth Group agreed to settle charges that it violated the reporting, books and records, and internal controls provisions of federal securities laws, without admitting or denying the allegations or paying a monetary penalty.
In a separate settlement with the SEC, David Lubben, former UnitedHealth Group general counsel, consented to an anti-fraud injunction, a $575,000 penalty and a five-year officer and director ban. Lubben also admitted to no wrongdoing as part of the agreement.
Reports stated that UnitedHealth engaged in a long-running scheme to hide over a billion dollars in executive compensation which was a breach of its duty to shareholders to accurately report its financial results. According to the complaint filed, the company overstated its net income from 1994 through 2005 by almost $1.53 billion.
The SEC did not charge UnitedHealth or Lubben with fraud, as it did its former Chief Executive Officer William McGuire in a prior case. The agency also did not seek a monetary penalty because of the company's "extraordinary cooperation" in the investigation. The SEC oversaw a $468 million settlement between McGuire and UnitedHealth Group, which was granted preliminary approval by federal and state judges last week.
UnitedHealth Group is pleased to have resolved this matter with the SEC and will continue to focus on serving its customers, growing its businesses, reinforcing its community and customer relationships, and helping people live healthier lives.
Rebecca Vesely, UnitedHealth Settles Backdating Allegations: SEC, Modern Healthcare's Daily Dose (Dec. 23, 2008) (note: registration is required to view this content).
Sleep Duration Linked to Cardiovascular Health
Skimping on sleep may increase the risk of coronary heart disease, an observational cohort study of middle-aged persons showed. Each additional hour of sleep was associated with a 33% reduced risk of coronary artery calcification, a subclinical predictor of coronary heart disease.
Researchers were unable to explain the mechanism underlying the association and said that there may be unknown factors that predict both sleep duration and calcification. Previous studies have found that sleep duration and quality are associated with risk factors for coronary artery calcification, such as glucose regulation, blood pressure, sex, age, education, and obesity, according to the researchers. But the studies were subject to various limitations, including the use of self-reported sleep measures, they said. To explore the issue using objective measures of sleep duration and quality, the researchers turned to the Coronary Artery Risk Development in Young Adults (CARDIA) study, an ongoing prospective, multicenter cohort study examining the development of cardiovascular risk factors.
They calculated the five-year incidence of coronary artery calcification in 495 participants from the Chicago study site. The participants ranged in age from thirty-five to forty-seven and were free of calcified plaques at baseline, as determined by computed tomography. Sleep duration and quality were measured using a wrist activity monitor and questionnaires assessing daytime sleepiness, overall quality, and self-reported duration. The mean sleep duration was 6.1 hours.
Through five years of follow up, 12.3% of participants showed signs of coronary artery calcification. The risk of calcified plaque accumulation decreased significantly with each additional hour of objectively measured sleep after adjusting for age, sex, race, education, smoking, and apnea risk. Additional adjustment for major cardiovascular risk factors had little effect on the results.
Based on the research, the magnitude of the observed effect was similar to sizable differences in established coronary risk factors. The main limitation of the study, they acknowledged, was the lack of a clinical diagnosis of sleep apnea for the participants. Nevertheless, if the findings are confirmed in other cohorts and sleep duration is linked to cardiovascular events, interventional studies should be conducted to help guide clinical advice.
Todd Neale, Sleep Duration Linked to Cardiovascular Health, MedPage Today (Dec. 23, 2008).
Malaria Drug May Soon Be Set for U.S. Debut
The Food and Drug Administration is expected to approve the first malaria drug in the United States to contain artemisinin, the wormwood derivative from China that is the latest and much-heralded cure for malaria in Africa and Asia. Although there are only about 1,500 cases of malaria treated in the country each year—virtually all in people who just back from the tropics—the approval would also make the drug available to the military and to Americans planning to go abroad.
The drug, Coartem, is made by the Swiss company Novartis. It combines artemether, an artemesinin derivative, with lumefantrine, a drug developed by Chinese scientists, which does not kill parasites as quickly but lingers in the blood longer. By mopping up parasites that artemisinin misses, lumefantrine helps prevent resistance that would defeat the drug, as happened with previous so-called miracle cures like chloroquine.
Novartis sells Coartem (pronounced koh-AHR-tem) to the World Health Organization and medical charities for about 80 cents per course of treatment, which it says is the production cost. It has sold nearly 200 million treatments for use in Africa and claims they have saved 500,000 lives.
Coartem was introduced in 2001; it is approved in more than eighty countries, including sixteen in Europe. Novartis had had little interest in registering it here because the market is so small and the FDA's requirements are expensive, even when the application fee, more than $1 million for a new drug, is waived, as it was for Coartem. Novartis came under pressure to register it here because so much taxpayer money was being spent on it after the $1.2 billion President's Malaria Initiative passed in 2005. Because the drug is now under review, Novartis may do nothing that smacks of salesmanship to Americans. At a conference of tropical medicine doctors in New Orleans this month, the Coartem sales booth had guards preventing any United States resident from even peeking inside.
Coartem is taken only after only a patient has malaria—not for prevention—and some have noted side effects such as sun sensitivity, abdominal pain, and nightmares.
Donald McNeil Jr., Malaria Drug May Soon be Set for U.S. Debut, N.Y. TIMES, Dec. 22, 2008.
President-Elect Obama Seeks to Create, Save Three Million Jobs in Healthcare, Other Industries with Economic Stimulus Package
As part of his proposed two-year economic stimulus package of $675 to $775 billion, President-elect Barack Obama seeks to create or save three million jobs. The types of jobs Mr. Obama would propose to create involve installation of information technology in medical facilities as well as other subsidies to train more nurses, both to create jobs now and address a looming shortage in the health professions.
In addition, with millions more Americans losing their healthcare coverage, Obama will propose major new spending to subsidize states' share of Medicaid and their children's health programs, and to expand healthcare coverage for those who lose insurance from their employers. Congressional sources have said that the package will likely include at least $100 billion for states, in large part for healthcare programs, and about $350 billion for infrastructure, which includes an expansion of electronic health records. Obama advisers are working to convince lawmakers of the wisdom of limiting the package to projects that would create a large number of jobs quickly or make a down payment on Obama's broader economic goals, such as improving the healthcare system.
Meanwhile, congressional Democrats are "'scrambling to coordinate work' on the economic stimulus package, but 'they have only a narrow window to get their House and Senate portions together to have the bill ready by Jan. 20,' when Obama takes office." "House Speaker Nancy Pelosi (D-CA) seeks to move the package to the floor by Jan. 8, and Senate Majority Leader Harry Reid (D-NV) seeks to move the package to the floor as early as Jan. 13.," according to congressional sources.
In the House, the package faces opposition from Republicans and the fiscally conservative Democratic Blue Dog Coalition because of the cost. However, the package will likely pass in the House. In the Senate, rules afford the minority plenty of routes to hold things up and shape the final outcome of the bill, potentially giving the incoming minority of forty-one or forty-two Republicans a significant say in the final form of Obama's stimulus legislation.
Additionally, the Obama transition team announced that Vice President-elect Joe Biden will head a White House Task Force on Working Families, giving the incoming vice president a defined role in the administration's domestic policy. According to Biden, the task force, which will include the HHS secretary, will recommend proposals to ensure that middle-class U.S. residents are "no longer being left behind" in healthcare and other areas. Such proposals could include legislation or executive orders.
Kaiser Daily Health Policy Report, President-Elect Obama Seeks To Create, Save Three Million Jobs in Health Care, Other Industries With Economic Stimulus Package, Henry J. Kaiser Fam. Fdn. (Dec. 22, 2008).
*We would like to thank Jennifer P. Viegas, Esquire (Hall Render Killian Heath & Lyman PLLC, Troy, MI) for providing this week's Teaching Hospital Update.
AHLA Teaching Hospital Updates are intended to provide quick summaries of cutting-edge issues of interest to teaching hospitals and their counsel. Additional information and more in-depth coverage on these topics may be available from AHLA Health Lawyers Weekly and appropriate AHLA Practice Groups.