By Leah Voigt Romano*
December 19, 2008
Baucus Outlines Health Reform Objectives
Senate Finance Committee Chairman Max Baucus (D-MT) said this week that he expects a healthcare reform bill to be ready early in 2009 but that some healthcare priorities may be included in an economic stimulus package first. Baucus said in a briefing with reporters that he supports the inclusion of health information technology and a short-term reauthorization of the State Children's Health Insurance Program (SCHIP) in the stimulus package.
The SCHIP reauthorization would last for a "sufficient duration"—long enough to allow the question of children's health to be included in comprehensive reform efforts, he said. Baucus said he expects reform legislation to be ready near the beginning of next year, and that he is waiting for the Congressional Budget Office to score the plan. In addition, Baucus said he considers health information technology necessary infrastructure spending that should be included in the stimulus package, mentioning grants and Medicare incentives as possible ways to spur health information technology. Baucus also said that healthcare reform will require significant upfront investment, and that it may be easier to include some of those costs in the stimulus because pay-as-you-go rules will be loosened.
Baucus's comments echo those of President-Elect Barack Obama, who called for health information technology investments in a December 6 radio and web address.
Baucus Outlines Health Reform Objectives, Says Some Provisions Should Be in Stimulus, BNA HEALTH L. REP., Dec. 18, 2008 (note: registration is required to view this content).
Quality-Improvement Program Enhances Stroke Care
According to researchers, a quality-improvement program increased compliance with guidelines for stroke treatment issued by the American Heart Association and American Stroke Association at nearly 800 hospitals.
The percentage of available interventions that were performed for eligible patients admitted for acute stroke or transient ischemic attack increased from 83.52% in the first year after implementation of the program to 93.97% in the fifth year. Hospitals were 18% more likely to provide guidelines-based care for each year of participation in the quality-improvement program, the researchers reported online in Circulation: Journal of the American Heart Association.
However, there is still room for improvement, said Dr. Schwamm, who is a member of the steering committee for the quality-improvement program. "We shouldn't rest until we're at 100 percent for all measures," he said.
The program—Get With The Guidelines–Stroke—was designed to improve adherence to guidelines for evidence-based stroke care. The program evaluates seven measures to enhance stroke care and decrease the risk of subsequent stroke or myocardial infarction. It provides an online interactive assessment and reporting tool, resources, quarterly workshops, training, and feedback to participating hospitals.
Dr. Schwamm and colleagues assessed the program's effectiveness at 790 academic and community hospitals nationwide that volunteered to participate. Overall, they looked at data from 322,847 patients (median age 74; 75.1% white; 46.1% male) admitted from 2003 through 2007.
About three-quarters of the patients (73.2%) presented with acute ischemic stroke and the rest (26.8%) with transient ischemic attack. Median bed size among the hospitals was 300. About half (51.7%) were teaching hospitals.
L. Schwamm et al., Get With the Guidelines–Stroke is Associated with Sustained Improvement in Care for Patients Hospitalized with Acute Stroke or Transient Ischemic Attack, CIRCULATION 2008, DOI: 10.1161/CIRCULATIONAHA.108.783688.
Todd Neale, Quality Improvement Program Enhances Stroke Care, MedPage Today, Dec. 15, 2008.
OIG Issues Two Studies on Reporting of Adverse Events at National, State Levels
In two separate reports issued this week, the Department of Health and Human Services Office of Inspector General (OIG) identified key issues in reporting adverse events at hospitals and reviewed how some states already are gathering data about such incidents, and how the data are being used. In particular, the OIG described seven issues it said were critical to understanding adverse events, also called "never events," in hospitals.
Adverse events are described as any harm to a patient that results from medical care, the OIG explained. Congress required in the Tax Relief and Health Care Act of 2006 that the OIG conduct the reviews.
Among its findings, the OIG said that measuring the incidence of adverse events in hospitals is difficult because there is "no optimal method" for measuring how often adverse events occur. But the OIG noted that there are indications that elderly patients are more vulnerable to adverse events than other patient populations. The OIG further observed that nonpayment policies for adverse events were increasingly popular among payors and are considered "a powerful incentive" to cutting the number of adverse events in hospitals. However, the OIG also found that such policies to deny payment have drawbacks. For example, nonpayment might limit access to care, increase hospital costs, and reduce hospital revenues, according to the report, Adverse Events in Hospitals: Overview of Key Issues (OEI-06-07-00470).
The OIG also said that public disclosure by hospitals of adverse events could benefit patients, but such reporting raised legal concerns for providers and patients. Those legal concerns could discourage full disclosure of events and lead to underreporting of adverse events. In its report, the OIG also said there is widely available information on ways hospitals can prevent adverse events, but that hospitals and clinicians may be slow to adopt changes. In addition, the OIG noted strategies that could speed the process in reducing adverse events in hospitals.
In a second report, Adverse Events in Hospitals: State Reporting Systems (OEI-06-07-00471), the OIG reviewed existing state requirements for reporting adverse events at hospitals, finding broad differences in how states collect such data. As of January 2008, twenty-seven states had either developed adverse-event reporting systems or were working toward development of a reporting system.
OIG Issues Two Studies on Reporting of Adverse Events at National, State Levels, BNA HEALTH L. REP., Dec. 18, 2008 (note: registration is required to view this content).
Journal Articles on Drug Trials Often Offer Limited Information for Doctors
According to a study in the current issue of PLoS Medicine, medical journal articles on drug trials often do not provide doctors with complete information necessary to evaluate the potential benefits and risks of new drugs.
To obtain approval for a new drug, companies must present FDA with results from various clinical trials. After gaining FDA approval, the companies typically fund written accounts of such trials to appear in medical journals. The firms can employ third parties to prepare journal articles on newly approved drugs. Such articles can carry the names of doctors who participated in the trials and can be written by drug company doctors who helped develop the drug. Many doctors use the articles to determine whether and how they will use the drugs.
Researchers examined 164 drug trials involving as many as 1,500 patients over a two-year span. They looked at write-ups of these trials as they appeared in medical journals, as well as trials whose results remained unpublished. They found that not all trial results submitted to FDA as part of drug approval bids were published in medical journals, and those that were written up often contained discrepancies between the results sent to FDA and the published data.
According to the study, drug trials showing "favorable" results were more than five times as likely to be published than those showing "unfavorable results." Results from one-quarter of the trials remained unpublished five years after FDA had approved the drugs, the study shows. In addition, the team found that new drug information available to doctors in medical journals is often "incomplete and potentially biased."
A senior vice president of Pharmaceutical Research and Manufacturers of America said that doctors can make "appropriate prescribing decisions" on new drugs using FDA-approved drug labels, which contain information based on every study the drug has been subject to. A policy statement from the industry said that drugmakers "have a long-standing commitment to ensure that physicians and patients have access to all relevant information about the medicines we discover, consistent with regulatory requirements, so that our products can be used safely and effectively."
The study is available online:
Kristin Rising et al., Reporting Bias in Drug Trials Submitted to the Food and Drug Administration: Review of Publication and Presentation, PLOS MEDICINE.
Kaiser Daily Health Policy Report, Journal Articles on Drug Trials Often Offer Limited Information for Doctors, Study Says, Henry J. Kaiser Fam. Fdn (Dec. 15, 2008).
Mutation Linked to Lower Lipid Levels in Some Amish
According to a recent study of how Old Order Amish in Pennsylvania handle high-calorie milkshakes, about 5% have a genetic mutation that may fend off heart disease.
In the December 12 issue of Science, researchers reported that carriers of the mutation had a more than 50% reduction in apoC-III protein levels compared with non-carriers, indicating a significant reduction in serum triglycerides.
They were also less likely to have detectable coronary artery calcification, "which suggests that lifelong deficiency of apoC-III has a cardioprotective effect," the researchers said. Even though this specific mutation has not been found outside the Amish community, the findings raise "the possibility that therapies aimed specifically at down-regulating apoC-III expression will be clinically efficacious and safe in reducing the morbidity and mortality associated with coronary heart disease," researchers added.
The study's lead researcher said that long-term studies to assess whether the mutation carriers actually have better cardiovascular outcomes are in the planning stages. In addition, she and her colleagues will conduct more studies to better understand the physiology of apoC-III and related pathways.
The researchers fed 809 Old Order Amish volunteers a milkshake containing 782 kcal/m2 of body surface area and measured triglyceride levels almost every hour for six hours afterward as part of the Heredity and Phenotype Intervention Heart Study.
T. Pollin et al., A Null Mutation in Human APOC3 Confers a Favorable Plasma Lipid Profile and Apparent Cardioprotection, 322 SCIENCE 1702 (2008).
Todd Neale, Mutation Linked to Lower Lipid Levels in Some Amish, MedPage Today, Dec. 12, 2008.
Los Angeles Times Examines HHS Secretary-Nominee Daschle's Approach to U.S. Healthcare System Overhaul
President-Elect Barack Obama's HHS secretary nominee—former Senate Majority Leader Tom Daschle (D-SD), who Obama also named as director of a new White House Office of Health Reform—"has put a premium on cooperation between the White House, Congress and major health care interest groups" in the overhaul of the U.S. healthcare system, the Los Angeles Times reports. The Times examines Daschle's book on healthcare called "Critical," and his specific and "potentially controversial" plans for healthcare reform.
Daschle has proposed to establish a Federal Health Board modeled after the Federal Reserve to determine the medications, medical devices, and other treatments that federal healthcare programs should cover based on cost effectiveness. According to the Times, Daschle also has proposed a requirement that all U.S. residents obtain health insurance and the establishment of a public health plan to provide coverage for those who do not obtain private coverage. The Times also looks at Daschle's "virtual road map for the kind of campaign the Obama White House and its allies will probably pursue in their effort to avoid the pitfalls that doomed" healthcare reform efforts by former President Bill Clinton in the 1990s.
Kaiser Daily Health Policy Report, Los Angeles Times Examines HHS Secretary-Nominee Daschle's Approach to U.S. Health Care System Overhaul, Henry J. Kaiser Fam. Fdn. (Dec. 15, 2008).
*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.