By Reesa N. Benkoff*
AHRQ Issues Interim Patient Safety Guidance Signaling
Desire to Begin Certifying Patient Safety Organizations
The Department of Health and Human Services (HHS) Agency for Healthcare Research and Quality (AHRQ) has issued interim guidance that provides some degree of regulatory certainty for entities seeking to become patient safety organizations (PSOs). The interim guidance, published in the Federal Register October 14 (73 Fed. Reg. 60705), outlines how entities may become certified as PSOs and how patient safety work product (PSWP) will be treated pending completion of rulemaking that began with a notice of proposed rulemaking in February. Although AHRQ said it expects to issue final rules before the end of the year, the guidance allows prospective PSOs to apply for certification now based on AHRQ's statement that it will treat much of what it proposed then as "binding" in the interim.
The guidance allows AHRQ to begin receiving applications from qualified entities that wish to become PSOs, which were authorized by Congress in 2005 to improve safety through the collection and analysis of data on patient safety events under the Patient Safety and Quality Improvement Act (Patient Safety Act). The guidance specifically explains how AHRQ intends to handle the listing and delisting of PSOs and how it will apply the Patient Safety Act's enforcement provisions. It also clarifies how information disclosed in the PSO listing and delisting process will be handled for enforcement purposes.
The sections of the interim guidance that the agency designated "binding" will remain in effect until HHS issues a final rule for PSOs, which will then supersede the interim guidance, AHRQ said. All sections of the proposed rule that are not designated as binding, as well as the preamble to the proposed rule, are not binding, the agency stated. "In regard to the material that is not binding, individuals and entities may follow alternative approaches, provided that the alternative approach is consistent with, and satisfies the requirements of the Patient Safety Act. Such alternative approaches would not apply after the interim period unless permitted by the final rule." The guidance largely tracks the language contained in the proposed rule on PSOs that was issued by AHRQ Feb. 12 (73 Fed. Reg. 8112).
Access the interim guidance.
AHRQ Issues Interim Patient Safety Guidance Signaling Desire to Begin Certifying PSOs, BNA'S HEALTH L. REP. (Oct. 16, 2008) (note: registration is required to view this content).
Physicians More Likely to Diagnose Coronary Artery Disease in Men than Women with Same Complaints
According to a recent study, a stressed out man who sees a primary care physician with symptoms of coronary artery disease (CAD) is more likely to be diagnosed with the condition than a woman with the same complaints. According to researchers, primary care physicians interpret chest pain or other coronary artery disease symptoms as psychogenic when the patient is an anxious woman. The finding emerged from a survey of general internists who were asked to "make the diagnosis" based on detailed clinical scenarios.
The scenarios were designed so as to elicit a diagnosis of coronary artery disease, researchers said. The variables were the addition of life stressors such as divorce or job loss and the gender of the patients. The researchers asked eighty-seven general internists to make a diagnosis based on vignettes that described a 47-year-old man and a 56-year-old woman, each of whom had many cardiovascular disease (CVD) symptoms and risk factors. Half of the vignettes indicated that the patient had recently experienced a life stressor "and they appeared anxious."
Gender bias was observed only when symptoms were presented in the context of stress, where fewer women received a CAD diagnosis. When stress was a confounder, women were also less likely to be referred to a cardiologist and were less likely to be prescribed CV medications than men with the same symptoms and same life stressors. According to researchers, although stress factors made it more likely that women's symptoms would be considered psychogenic, men's symptoms were considered organic regardless of stress; in fact, a life-stress scenario actually increased the likelihood that men would be diagnosed with CVD. The study may suggest that physicians need to be especially careful when assessing patients to be sure that they rule out CAD before attributing symptoms to anxiety.
Peggy Peck, Primary Care Physicians Think Zebras When Chest Pain Patient is Anxious Woman, MedPage Today (Oct. 13, 2008).
Davies Award Winners Honored for Health IT Use
Eastern Maine Medical Center, Bangor (EMMC) earned top honors from the Healthcare Information and Management Systems Society for its use of health information technology to improve patient care and quality. The Davies Awards honor excellence in the implementation of electronic health records (EHRs). "EMMC represents a shining example of how to implement and utilize the electronic health record along with other technologies in enhancing the delivery of high quality, evidence-based healthcare," reported Brian Jacobs, chairman of the HIMSS Davies Award Organizational Committee and chief medical information officer, Center for Pediatric Informatics at Children's National Medical Center in Washington, in a written statement. Seven other organizations also received awards under the society's 2008 Nicholas E. Davies Awards for organizational, ambulatory and community health categories.
Additionally, three practice groups earned awards for ambulatory care, and four more won for best community health or member organization. Davies winners for ambulatory care are: Palm Beach (Florida) Obstetrics and Gynecology; Oklahoma Arthritis Center, Edmond; and Cardiology Consultants of Philadelphia. Community health winners are: Columbia Basin Health Association, Othello, Washington; White River Rural Health Center, Augusta, Arkansas; New York Children's Health Project, New York City; and Community Health Access Network and Member CHC's, New Hampshire. Winners of the Davies Public Health Award, Cherokee Indian Hospital Authority and the New Jersey Health and Senior Services Department, were announced in August.
Matthew DoBias, Davies award winners honored for health IT use, Modern Healthcare's Daily Dose (Oct. 10, 2008).
Growing Number of U.S. Residents Delay Medical Care
as Economy Worsens
The number of people who have gone without a prescription, used retirement savings to pay for health services, or skipped a doctor's appointment for themselves or a child has increased since last year, according to a study released this summer by the Rockefeller and Time Magazine. The study found that 25% of 2000 respondents said that in 2008 they skipped a doctor's visit because of cost, up from 18% in 2007, and 10% said they decided to forgo a visit to the doctor for their child for the same reason.
In addition, this summer, IMS Health recorded the first decline in U.S. prescription drug spending after double-digit increases for almost a decade. Another survey by the Center for Studying Health System Change found that almost 20% of U.S. residents say they have trouble paying medical bills.
Many physicians have raised concerns that actions taken to save money in the short term could result in more severe—and costly—long-term health problems.
Kaiser Daily Health Policy Report, Growing Number of U.S. Residents Delay Medical Care as Economy Worsens, Henry J. Kaiser Fam. Fdn. (Oct. 16, 2008).
Health Systems to Buy Emageon for $62 Million
Health Systems Solutions has signed a definitive agreement to acquire Emageon in a cash deal worth about $62 million. Health Systems will pay $2.85 per share for all outstanding shares in the Birmingham, Alabama-based health imaging company, representing a 37% increase over Emageon's share price as of market close October 13. Stanford International Bank, Health Systems' principal shareholder, is providing $85 million for the deal, with the extra money to be used for working capital and future acquisition efforts, the company disclosed in a news release.
The transaction, subject to stockholder approval and customary closing conditions, is expected to close within 120 days, according to a Health Systems spokesman. The new company will have 400 employees, and Emageon's management will continue to operate the business as a unit of Health Systems. The purchaser, Tampa, FL-based Health Systems develops information technology for the industry.
Jean DerGurahian, Health Systems to buy Emageon for $62 million, Modern Healthcare's Daily Dose (Oct. 14, 2008) (note: registration is required to view this content).
Government Guidelines Urge Americans to Rev Up Exercise
According to recent HHS Guidelines, moderate exercise for two-and-a-half hours a week has been recommended by new federal guidelines for all adults ages 18 through 64 to better their health. Children benefit from an hour or more of physical activity a day, the HHS guidelines noted.
The recommendations came from an analysis by the thirteen-member Physical Activities Guidelines Committee, commissioned in April 2007 by HHS Secretary Mike Leavitt to investigate scientific literature on the health benefits of exercise. The committee, chaired by William L. Haskell, PhD, of Stanford, concluded that exercise reduces the risk of early death, coronary heart disease, stroke, high blood pressure, type 2 diabetes, colon and breast cancer, and depression—and can even improve thinking ability in older adults. The committee found that inactivity among children, adolescents, and adults in the U.S. is high, putting Americans at unnecessary risk.
Efforts to stimulate more exercise have not done well. Therefore, HHS created the guidelines with recommendations for children, adolescents, adults, older adults, pregnant women, and those with disabilities. Adults gain "substantial health benefits" from two-and-a-half hours a week of moderate-intensity exercise, or seventy-five minutes of vigorous-intensity exercise per week, the guidelines asserted. Moderate exercise was defined as walking briskly, ballroom dancing, and gardening—and vigorous exercise as race walking, jogging, running, or swimming laps. All activity should be done in at least 10-minute sessions spread throughout the week, the guidelines said. Increasing moderate exercise to five hours a week provides "additional health benefits" for adults, the guidelines added, as does muscle-strengthening activity at least two days a week. This includes weight training, push-ups, and sit-ups.
Children and adolescents need at least an hour of exercise a day, with vigorous activity at least three days a week, according to the guidelines. Hiking and skateboarding count for moderate exercise, and bike riding and sports such as soccer and hockey classify as intense. Muscle- and bone-strengthening activities are recommended for children three days a week.
Older adults, the guidelines said, should follow the regular adult guidelines if physically possible. If not, they should be "as physically active as their abilities and conditions allow." The same recommendation was for adults with disabilities. If older adults are at risk of falling, they should do exercises that maintain or improve balance.
Pregnant women should get the adult-recommended two-and-a-half hours of moderate exercise per week, and those who already engage in vigorous exercise can continue to do so, so long as they talk about their activity level with their physician throughout pregnancy.
Prior to the new guidelines, the 1995 Dietary Guidelines for Americans included advice on physical activity. In 2006, the HHS and the Institute of Medicine convened a workshop that found "advances in the science of physical activity and health justified the creation of separate physical activity guidelines."
Kristina Fiore, Government Guidelines Urge Americans to Rev Up Exercise, MedPage Today (Oct. 10, 2008).
*We would like to thank Reesa N. Benkoff, Esquire (Hall Render Killian Heath & Lyman PLLC, Troy, MI) for providing this week's Teaching Hospital Update.