December 2006

FDA works to improve postmarket program for medical devices

The U.S. Food and Drug Administration (FDA) announced its action plan for strengthening the way it monitors the safety of medical devices after they reach the marketplace. "Many of today’s medical devices are smaller and more complex than ever, offering new medical opportunities that have benefited literally millions of people," said Scott Gottlieb, M.D., Deputy Commissioner for Medical and Scientific Affairs, FDA. "But this technical sophistication sometimes means that the margin for error with device manufacturing shrinks and so we need to be working even harder, after devices and engineering changes are approved, to monitor for potential safety problems." FDA’s Center for Devices and Radiological Health (CDRH) last year completed a comprehensive assessment of the tools used to monitor the safety of medical devices after the agency approves them for marketing. In January, the agency formed a Postmarket Transformation Leadership Team to develop an action plan focusing on four main areas: enhancing the center’s culture of collaboration; developing world class data systems; enhancing risk/benefit communication efforts; and collaborating on improved enforcement strategies and outcomes.

The action items include the following: creating a cross-cutting organizational structure within CDRH to better integrate premarket, postmarket and enforcement efforts; developing internal performance measurements to track the center’s handling of postmarket issues, such as recalls; pursuing the development of a unique identifier system to identify a device and the information associated with that device throughout its lifetime; proposing mandatory use of electronic reporting for required adverse event reports and revising the current system that records reported adverse events for devices (the Manufacturer and User Facility Device Experience Database or MAUDE system); increasing the use of Medical Product Safety Device Network (MedSun) programs, a network comprised of more than 350 hospitals that have been recruited and specifically trained to identify and report device problems, and help provide "real time" data on signals and safety problems; enhancing risk/benefit communication efforts so health practitioners, patients and consumers receive clearer and more timely information on public health news; and increasing the coordination among the agency’s compliance and enforcement programs.

AHA, AHRMM call for medical device identification system

The AHA and its Association for Healthcare Resource & Materials Management urged the Food & Drug Administration to develop a mandatory unique device identifier (UDI) system for medical devices, similar to the National Drug Code that is used for pharmaceuticals. A UDI system would improve patient safety and reduce medical errors while increasing efficiency, the associations said, adding that a UDI system would facilitate the management of the roughly 600 device recalls the FDA issues each year. Currently, device recalls require manual searches of inventory and medical records. With a UDI, searches could be conducted electronically, and hospitals could more quickly and accurately notify and, if necessary, treat patients who have received a recalled device, the groups said. In addition to safety benefits, a UDI would allow hospitals and others to realize efficiencies in the inventory, tracking and purchasing of devices and could make it more difficult to counterfeit medical supplies. The AHA encourages individual hospitals to send their own comments to the FDA.

HIPAA security rule compliance remains low

Most "covered entities" have complied to some extent with most of the Health Insurance Portability and Accountability Act (HIPAA) regulations, but Security Rule compliance remains low among healthcare providers. Though the deadline for compliance with the HIPAA Security Rule passed over a year ago, 80% of payers and only 56% of providers who responded to the US Healthcare Industry HIPAA Summer 2006 Survey have implemented the Security standards. Of those claiming full compliance with the Security Rule, gaps remain; many "compliant" Providers and Payers could not confirm that they had implemented all key Security standards. Sponsored by Phoenix Health Systems and the Healthcare Information and Management Systems Society (HIMSS), the twice-yearly survey is in its seventh consecutive year of tracking and reporting on the status of HIPAA compliance within the healthcare industry. Given the significantly poor results among Providers, the survey drilled down into individual Provider groups to identify the most obvious trouble spots. "Though we have no direct data explaining why small hospitals/large practices have made so much progress in the last six months in Security, the fact that larger hospitals have more complex systems/processes infrastructures has been a key factor in their slower compliance," said D’Arcy Guerin Gue, Executive Vice President of Phoenix Health Systems. "By inference, it is possible that the simpler infrastructures of smaller organizations have contributed to their greater compliance levels." On a positive note, healthcare Providers are taking the necessary steps to convert to the National Provider Identifier (NPI), a move required by May 23, 2007. Almost 67% of participating Providers have already applied for their NPI, and 77% have identified the internal changes needed for the conversion.

The survey also found that implementation of the Transactions and Code Sets (TCS) standards across the industry appears to be stalled. Providers reporting full compliance with TCS actually dropped from 84% in Winter 2006 to 72%. Seventy-three percent (73%) of Payers reported compliance both in this survey and in the Winter 2006 Survey. About 42% of Providers and 45% of Payers are conducting all HIPAA-required transactions. Both groups cite the other’s lack of readiness as the primary reason for not conducting more standard transactions. Less than half of participants have measured direct return on investment (ROI) from their investment in standard Transactions and Code Sets, but 4% of both Providers and Payers indicated that they have achieved "significant" ROI. Both Provider and Payer Survey participants agree that HIPAA implementation has resulted in greater attention to patient privacy and data security by their workforces, as well as increased consumer confidence. Close to 30% of Provider and Payer participants are currently participating in health information networks, such as a Regional Health Information Organization (RHIO), and about 20% are planning to do so. The majority of participants agreed that HIPAA standards have facilitated the execution of such networks.

Public Citizen reports on pacemaker pricing case

The pacemaker manufacturer Guidant must make public judicial records from a case involving the pricing of its products in response to a Public Citizen motion to unseal the documents, according to a federal judge’s ruling. The sealed summary judgment records were from the recently settled Cardiac Pacemakers v. Aspen II Holding Co., in which two subsidiaries of Guidant that produce and sell controversial cardiac rhythm management devices sued the health care consulting company Aspen Health Care Metrics for publishing information about the prices of Guidant’s pacemakers. Guidant had defended the filing of the papers supporting summary judgment under seal but provided no documentation of a need for secrecy. Paul Alan Levy, an attorney for Public Citizen, argued before Judge Donovan Frank of the U.S. District Court for the District of Minnesota that the information was highly important to the public interest and should be unsealed. Frank ruled that Guidant must release all of the summary judgment briefs and most of the supporting affidavits, while allowing most of the supporting exhibits to remain sealed for reasons that he did not sufficiently explain. In its motion, Public Citizen asserted that Guidant’s efforts to suppress publication of its products’ prices hinders efforts at maintaining price transparency and threatens to foster the artificial elevation of prices, possibly limiting public access to affordable health care. Guidant’s attempts to keep court records secret also deny other hospitals, purchasing organizations and health care industry actors who are subject to Guidant’s lawsuit threats access to vital information to better prepare their own defense. "This is a partial win for healthcare consumers over corporate secrecy," said Levy. "Unfortunately, although Judge Frank has ordered the release of a significant amount of material, the methods he has used, extensive in chambers review without requiring Guidant to make a public showing of evidence of its need for confidentiality, sets a poor precedent for future cases. An appeal may be necessary to ensure that future cases are handled correctly."

Hospital costs for children with flu higher than suspected

Going into another flu season, a new study reports that hospitalizing children for influenza may cost up to three or four times the previously accepted estimates. Pediatric researchers from The Children’s Hospital of Philadelphia say their finding strengthens the economic justification for broadly vaccinating children against flu. "We found the cost of influenza-related hospitalizations in children was about $13,000 each, compared to most prior studies that estimated the cost at three to four thousand dollars," said study leader Ron Keren, M.D., M.P.H., a pediatrician at The Children’s Hospital of Philadelphia. "This suggests that annual influenza vaccinations for children, especially for those with certain high-risk conditions, may be more cost-effective than previously thought." The study appears in the November issue of Pediatrics. The researchers analyzed billing data for 727 patients up to age 21 who were admitted to Children’s Hospital with laboratory-confirmed influenza over four consecutive flu seasons, from 2000 to 2004. "We found a broad range of hospital costs in the study, from approximately $7,000 each for patients treated only on the ward, to nearly $40,000 each for children cared for in the intensive care unit," said Dr. Keren. Children with low-risk conditions had hospital costs averaging $9,000 each, compared to those with high-risk conditions, whose costs averaged $15,000 each.

November 2006
 

ECRI chooses successor for clinical equipment management system

FDA seeks injunction against orthopedic implant device manufacturer

HIDA releases acute care market report

Lack of standards, reimbursement issues contribute to errors in breast cancer diagnosis

ECRI (www.ecri.org) an independent, nonprofit health services research agency, announces immediate plans to phase out the future development and support of its HECS4 computerized maintenance management system (CMMS). Because of the need for Internet-based software and other technological advancements, ECRI has aligned with an established CMMS software company, Phoenix Data Systems Inc. ECRI’s commitment to HECS4 customers and to quality products was paramount in its choice of Phoenix and its AIMS.NET software. Phoenix has nearly 25 years of experience as a CMMS software developer and has continually supported and enhanced the AIMS Equipment Maintenance Management software, culminating in AIMS.NET, an established and complete Internet-based software application. The collaboration of ECRI and Phoenix allows both organizations to focus on their strengths and capitalize on their respective relationships with hospitals throughout North America and worldwide. As part of the terms of the new contract, ECRI and Phoenix will collaborate on marketing AIMS.NET to North American users of HECS4. In addition, Phoenix has appointed ECRI as the exclusive international distributor for the AIMS.NET product and services. ECRI will cease further development of the HECS4 product and will phase out support over a two-year period. ECRI negotiated special pricing accommodations to assist with the transition from HECS4 to AIMS.NET and recommends that existing HECS4 users contact Phoenix Data Systems for formal price quotations.

FDA seeks injunction against orthopedic implant device manufacturer

On Oct 6, the US FDA announced that it is seeking a permanent injunction against Endotec Inc (Orlando FL), and Michael J. Pappas PhD, President; Frederick F. Buechel MD, Medical Director; and Jared Pappas, Director of Regulatory Affairs, to stop the alleged illegal distribution of unapproved, total joint replacement devices. The government’s complaint, filed by the US Dept of Justice in US District Court for the Middle District of Florida, charges Endotec with violating the federal Food, Drug, & Cosmetic Act, by allegedly distributing total joint replacement devices without an approved premarket application, or without an approved clinical study. FDA officials said the complaint states that the company has carried out the illegal distribution of unapproved total joint replacement devices since March 15 2002, despite the FDA’s warnings that these actions were illegal. The FDA advised consumers who have one of the Endotec replacement joints, to continue with standard medical care and report any adverse events or problems to their physicians. If patients are unsure if they have an Endotec device, they should check with their physician. These alleged actions violate federal law, because data establishing the safety and effectiveness of the devices has not been reviewed by FDA, officials said. The FDA also requested that physicians report any adverse events to the FDA MedWatch Adverse Event Reporting program at the following link: CLICK HERE.

HIDA releases acute care market report

The Health Industry Distributors Association (HIDA) recently released the 2006 Acute Care Market Report. This new report presents the latest information about the market for medical-surgical supplies and equipment among acute care facilities and hospital systems. It is one in a series of three annual Market Reports produced by HIDA for healthcare distributors, manufacturers and other organizations tracking medical-surgical supply and equipment markets. Key trends discussed in the Market Report include: Increasing hospital margins and profits, with margins nearly doubling to 5.3% between 2000 and 2004, and profits rising more than 148% during the same period; High costs of uncompensated care, with the uninsured accumulating nearly $125 billion in treatment expenses—33% of which is not compensated to hospitals; Increased use of emergency departments, with a 26% increase in utilization over the past decade occurring despite a 12% decline in the number of emergency departments nationwide; and Growth in small hospitals, with the number of 6 to 24-bed hospitals growing 22% between 2000 and 2004, double the rate of any other size category. HIDA’s Market Reports collect a variety of open source data and information to present a unique view of key markets for healthcare distribution, enabling business owners, business intelligence staff, sales executives, and industry analysts to identify trends and opportunities. The reports, can be ordered on the HIDA Web site, www.HIDA.org, for purchase by HIDA Members and HIDA Educational Foundation Associates ($40 per copy) and by non-members ($595 per copy). For more information contact HIDA at (703) 549-4432 or go to www.hida.org.

Lack of standards, reimbursement issues contribute to errors in breast cancer diagnosis

The Susan G. Komen Breast Cancer Foundation, recognized as the global leader in the fight against breast cancer, issued a white paper calling for the review of gaps in current breast cancer pathology guidelines and procedures. The white paper, Why Current Breast Pathology Practices Must Be Evaluated, developed by the Komen Foundation with a panel of leading experts in oncology, breast pathology, surgery and radiology, identifies a lack of uniform national standards in pathology practices, tissue handling, preservation and access, and current reimbursement policies as key issues that need to be addressed. While it is difficult to determine the incidence of errors in breast cancer diagnosis, the white paper estimates that the error rate could be as high as two to four percent. Based on this estimate, approximately 5,000 to 10,000 women diagnosed each year (invasive and in-situ disease) may have an inaccurate diagnosis, and more than 90,000 women currently living with breast cancer may also have diagnoses that are not entirely accurate. This could include mistaking benign and malignant disease, non-invasive and invasive disease, as well as estrogen receptor (ER) and HER2 status, two important predictive and prognostic markers that require specific treatment. A number of factors impede the ability to obtain a completely accurate breast cancer diagnosis. To address these issues, the white paper outlines the following possible solutions: Improving standards for training in breast cancer pathology and specialization, and mandating compliance; Encouraging or mandating second pathology opinions for appropriate cases; and integrating pathology into the clinical care team for greater consensus diagnosis, especially between pathologists and radiologists. Compounding these issues are reimbursement policies that often dictate which pathology services will be used or deny payment for second opinions. More pressing, however, is the concern that reimbursement rates are not in line with the workload required to accurately diagnosis specific types of breast cancer, creating a disincentive for more thorough review when clinically appropriate. In addition to inaccurate breast pathology diagnostics and issues with health insurance and reimbursement practices, the white paper also discusses the related issue of tissue handling, the impact on research of falling participation in tissue banking and the appropriate roles for organizations, medical societies and government in promoting standards for tissue handling, preservation and access for the patient as well as for research. For the full report, visit www.komen.org/

AHRMM announces 2007 Board of Directors election results

The Association for Healthcare Resource & Materials Management (AHRMM) has announced the winners of its 2007 Board of Directors elections. Newly elected officials include: President-Elect Mary Ann Michalski, CMRP, FAHRMM; Region 2 Representative James Smoker, CMRP; Region 7 Representative Becky Daniel; and Region 8 Representative Liz Veazey, RN, MBA, CMRP. President-Elect Michalski is the national account manager for Supply Chain Operations for HealthSouth in Birmingham, AL. She has been a member of AHRMM for over 24 years, during which she has served as the Region 5 Board Representative, Chair of the AHRMM Membership & Chapter Committee and president of her local chapter. She brings over 26 years of experience to the president-elect position where her main responsibilities will include: serving on both the AHRMM Executive and Nominating Committees, developing the Association’s strategic plan and budget, and in the absence of the president, assuming the duties of that office. The new Regional Representatives, Smoker, Daniel, and Veazey, are responsible for representing their constituents by conveying regional issues to the Board. In Region 2, Smoker, director of material resource services, WellSpan Health in York, PA, brings over 16 years of experience as both an AHRMM member and a professional in the field. In Region 7, Daniel, regional director of supply chain management, Texas Health Systems in Arlington, TX, brings 29 years of field experience and three years of membership experience to the Board. Finally, in Region 8, Veazey, clinical supply chain analyst, Scottsdale Healthcare in Scottsdale, AZ, brings over four years of both membership and materials management experience to AHRMM’s leadership. AHRMM elections are held each year via the Association’s web site. All newly elected officials begin their terms on January 1, 2007.

Large number of adverse drug events occur outside the hospital and lead to E.R. visits

Each year, an estimated 700,000 persons experience adverse drug events that lead to emergency department visits, according to a study in the October 18 issue of JAMA. Outpatient use of drug therapies in the United States is common. In 2004, 82 percent of the U.S. population reported using at least 1 prescription medication, over-the-counter medication, or dietary supplement in the previous week and 30 percent reported using 5 or more of these drugs, according to background information in the article. While these medications may offer substantial benefits, there also may be risks. Information on outpatient adverse drug events (ADEs) has been difficult to collect, but the problem is large and can be expected to increase. 

Daniel S. Budnitz, M.D., M.P.H., of the Centers for Disease Control and Prevention, Atlanta, and colleagues analyzed data from the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance project (NEISS-CADES) to determine the frequency and characteristics of ADEs in the U.S. that have led to emergency department visits. The study included data from Jan. 2004 through Dec. 2005. Over the 2-year study period, 21,298 adverse drug event cases were reported. "Based on data from a nationally representative surveillance system, we estimate that more than 700,000 patients were treated for ADEs in U.S. emergency departments annually in 2004 and 2005, and 1 of every 6 required subsequent hospital admission, transfer to another health care facility, or emergency department observation admission. Individuals aged 65 years or older were more than twice as likely to be treated in emergency departments for an ADE and nearly 7 times as likely to require hospitalization as individuals younger than 65 years. Among all patients who were hospitalized, most ADEs were due to unintentional overdoses and two-thirds of these were due to toxicity from a relatively small set of drugs for which regular monitoring is commonly required to prevent acute toxicity. Sixteen of the 18 drugs most commonly causing ADEs have been in clinical use for more than 20 years," the authors write. Adverse drug events accounted for 2.5 percent of estimated emergency department visits for all unintentional injuries and 6.7 percent of those leading to hospitalization, and also accounted for 0.6 percent of estimated emergency department visits for all causes. Insulins or warfarin, drugs that typically require ongoing monitoring to prevent overdose or toxicity, were implicated in 1 in every 7 estimated ADEs treated in emergency departments. "The finding that individuals aged 65 years or older (12 percent of the U.S. population) accounted for one-quarter of ADEs overall and half of adverse events requiring hospitalization highlights the importance of directing ADE prevention efforts to this vulnerable population. Emergency department visits for ADEs in this age group were nearly as common as those for motor vehicle occupant injuries," the authors write. "Efforts to reduce the burden of outpatient ADEs have been hampered by sparse data, except in selected health care systems or settings. Ongoing data collection in NEISS-CADES will enable more detailed examination of the epidemiology of emergency department-treated outpatient ADEs, focusing on specific patient populations, drug classes, conditions, and circumstances. Identifying appropriate measures of drug exposure and evaluating drug risks in relation to drug benefits remain important challenges in improving the quality of outpatient drug therapy," the researchers write.

OCTOber 2006

Program supports physician-hospital collaboratons to improve quality of care

Drug-eluting stent safety triggers special FDA advisory panel

The Centers for Medicare & Medicaid Services (CMS) has announced a three-year demonstration program to examine whether allowing hospitals to provide financial incentives for physicians to support better care can improve patient outcomes without increasing costs. In the demonstration program, the hospital would be paid its usual inpatient rate for the patient’s care, but would pay to the physician a portion of the savings resulting from quality improvement and efficiency initiatives taken by the physician. Such incentive payments would only be allowed for documented, significant improvements in quality of care and savings in the overall costs of care. The program is known as the Physician-Hospital Collaboration Demonstration (PHCD). The program is intended to focus on the entire scope of health care for a surgical episode or other episode of illness involving hospital care. It will encompass physician groups and up to 72 hospitals in a limited number of geographic areas across the country, and will test whether financial incentives from hospital payments to their physicians for quality and efficiency improvement can increase quality while reducing hospitals’ and Medicare costs. For example, incentive payments to surgeons for achieving lower infection rates and fewer readmissions with complications could both improve patient outcomes and lower overall hospital and Medicare costs. The demonstration requires tracking patients for an entire episode of care, which generally extends well beyond a hospitalization, to determine the impact of hospital-physician collaborations on preventing short and longer-term complications, duplication of services, coordination of care across settings, and other quality improvements that hold great promise for eliminating preventable complications and unnecessary costs. This demonstration will examine the effects of the incentive payments system-wide, as hospitals and physicians within a geographic area collaborate on similar quality improvement initiatives and work together to assure that appropriate longer-term outcomes and other quality measures can be tracked appropriately. "We will give preference to proposals submitted by a healthcare group consortium, composed of healthcare groups and affiliated hospitals, because we need a sufficiently large demonstration size to reliably measure impacts on longer-term patient results and overall Medicare costs," CMS Administrator Dr. Mark McClellan said. "This is very different from traditional ‘gainsharing’ with its short-term focus. We are aiming to support the best efforts of physicians and hospitals to improve quality and efficiency in the overall care for their patients." CLICK HERE.

GAO reports on health IT  

The United States Government Accountability Office (GAO) released a report on health information technology, saying that Health and Human Services (HHS) is continuing efforts to define its national strategy. The use of information technology (IT) has enormous potential to improve the quality of healthcare and is critical to improving the performance of the U.S. healthcare system. Given the federal government’s role in providing healthcare in the U.S., it has been urged to take a leadership role in driving change to improve the quality and effectiveness of health care, including the adoption of IT. GAO was asked to identify progress made by HHS toward the development and implementation of a national health IT strategy. In late 2005, to help define the future direction of a national strategy, HHS awarded several health IT contracts and formed the American Health Information Community, a federal advisory committee made up of healthcare stakeholders from both the public and private sectors. Through the work of the these contracts and the community, HHS and its Office of the National Coordinator for Health IT have made progress in five major areas associated with the President’s goal of nationwide implementation of health IT. The five areas of progress and their supporting activities include: 1.) Advancing use of electronic health records: Defined initial certification criteria for certain electronic health records and certified 22 vendors’ products; Presented functional requirements for inclusion of patient information into electronic health records; Initiated work to advance the use of electronic health records to rebuild medical records following disasters. 2.) Establishing interoperability standards for a health information exchange: American National Standards Institute Health IT Standards Panel selected 90 interoperability standards for areas such as electronic health records and public health detection and reporting; Coordinated with the National Institute for Standards and Technology to align federal and private sector standards for interoperable health IT. 3.) Developing prototypes of a nationwide health information network: Awarded contracts for developing prototypes for a national network to four contractors. 4.) Addressing privacy and security issues associated with the nationwide exchange of health information: Contracted with 34 states and territories to perform assessments of the impact of policies and laws on security and privacy practices; Selected standards to help ensure privacy and confidentiality; Formed a new workgroup to specifically address privacy and security policy issues; Made recommendations covering topics that are central to challenges for protecting health information privacy in a national health information exchange environment. 5.) Integrating public health systems into a national network: Made recommendations to help support sharing of clinical care data with local, state, and federal biosurveillance programs, including the development of materials for public education on benefits to public health and national security, and the protection of patient confidentiality; Selected information exchange standards for sharing clinical health information with public health. Although HHS agreed with GAO’s prior recommendations and has made progress in these areas, it still lacks detailed plans, milestones, and performance measures for meeting the President’s goals. For more information, CLICK HERE.

Physician burnout associated with increase in perceived medical errors  

Physicians who believe they have committed a major medical error in the previous three months are more likely to report symptoms of burnout and depression, which may also increase the risk of a future error, according to findings of a Mayo Clinic study published in the current issue of Journal of the American Medical Association (JAMA). Since the Institute of Medicine’s 1999 report that as many as 100,000 patients die each year because of preventable medical errors, several studies of physicians in medical and surgical residency programs have found that a significant proportion of medical trainees make medical errors. "In addition to the obvious negative effects of errors on patients, studies have shown that the physicians involved often experience guilt, shame, distress and depression," said Tait Shanafelt, M.D., the Mayo Clinic physician who led the current study. "Better understanding these effects on physicians, and how they may affect the care future patients receive, is the goal of our research." Previous studies asking residents about errors either had taken a single snapshot in time or asked residents to look back on their entire residency and recollect whether they had made a serious error. The Mayo study is the first to follow a group of residents prospectively, enabling researchers to examine the relationship between physician distress and the future likelihood of an error. "We knew from previous studies some of the effects on physicians of making an error," explains Dr. Shanafelt. "This new study takes it a step further, enabling us to see the time relationship between errors and burnout, and vice versa." On average, 14.7 percent of the participants reported making an error in the previous three months on each quarterly survey. Those who reported an error experienced substantially higher levels of burnout and were more than three times more likely to have a screening test indicate possible depression. The connection between errors and various measures of distress also operated in reverse; those who scored high on burnout measures were twice as likely to report an error in the next three months as those with low burnout. The study also found a trend toward increased future errors for physicians with symptoms of depression. "Not only are physicians who perceive they have made errors more likely to experience burnout and symptoms of depression, but those who are distressed appear more likely to make an error in the next three months," said Dr. Shanafelt. The researchers say additional study is needed to identify effective approaches to assist physicians who have made medical errors, and that residency programs, HMOs, and hospital administrators should also establish efforts to prevent, identify and treat burnout in physicians, for the benefit of their patients.

MedPAC reports on physician-owned heart hospitals

The Medicare Payment Advisory Commission (MedPAC) has released a report to Congress regarding their investigation of physician-owned cardiac hospitals. The report updates MedPAC’s March 2005 specialty hospital report that found that among other things, physician-owned specialty hospitals did not have lower costs per severity-adjusted discharge than competitor community hospitals in their markets, although their patients had shorter lengths of stay. The new findings were similar to the earlier report, however the statistical significance of some findings has increased due to having a larger number of specialty hospitals to examine, MedPAC reported. Specifically, MedPAC found: The number of physician-owned specialty hospitals roughly doubled from 2002 to 2004. Specialty hospitals continue to locate in areas that lack certificate-of-need laws and have above average population growth. The median heart hospital has 56 beds and a strong focus on Medicare inpatient services. The median orthopedic/surgical hospital has 14 beds, focuses on outpatient services, and receives a majority of its revenue from private payers. Both types of physician-owned hospitals tend to have lower shares of Medicaid patients than local competitors and nonlocal peer hospitals that specialize in cardiac or orthopedic care. As previously found, specialty hospitals’ inpatient services are not less costly than community hospitals’ services. But they do have some competitive advantages such as shorter lengths of stay. Physician-owned heart hospitals were associated with a statistically significant increase in the rate of cardiac surgeries in the market area. For a typical market, MedPAC estimates that entrance of a physician-owned cardiac hospital was associated with a 6 percent increase in the number of cardiac surgeries per 1,000 Medicare beneficiaries. The typical heart hospital had 26 percent of the cardiac surgery market in 2004 and obtained most of its market share by diverting patients from competitor community hospitals. MedPAC concluded that as physician-owned entities capture more profitable service lines, the effect on community hospitals may increase. However, MedPAC found that community hospitals’ profit margins appeared stable through 2004, even in markets where physician-owned hospitals captured more than 10 percent of all admissions. CLICK HERE.

Drug-eluting stent safety triggers special FDA advisory panel

The FDA said it will hold a special meeting of a device advisory committee to assess new data about "small but significant" increases in the rates of death and myocardial infarction among patients treated with drug-eluting coronary stents. The agency said that its Circulatory System Devices Advisory Panel will meet before the end of the year to consider the implications of a meta-analysis reported in Spain and earlier data that suggested late-stenosis safety concerns with the devices. The agency added that it has already discussed safety concerns with the makers of the two FDA-approved drug-eluting stents-Cypher, a sirolimus-eluting stent sold by Cordis, a Johnson & Johnson company, and Taxus, the paclitaxel-eluting stent sold by Boston Scientific. The FDA cited two recent studies, BASKET, first reported in March at the American College of Cardiology meeting, and the Camenzind metanalysis reported last month in Barcelona at the European Society of Cardiology meeting. The BASKET study found that at 18 months, the rate of death or myocardial infarction was 8.4% for patients treated with drug-eluting stents and 7.5% for bare-metal stents, but that difference was not statistically significant. By contrast, the Camenzind meta-analysis, which included three-year data, found a 2.4% increase in the incidence of death or MI in patients who received Cypher stents compared with patients treated with bare-metal stents. The FDA also signaled that it is seeking more information about the possible mechanism of the excess mortality and MI in patients with drug-eluting stents. The hypothesis is that the events are caused by late stent thrombosis due to a failure of the stent to re-endothelialize, but that has yet to be proven. The FDA statement said the agency is continuing to evaluate information related to the duration of dual antiplatelet therapy with aspirin and Plavix. The FDA said it "believes that coronary [drug-eluting stents] remain safe and effective when used in patients having clinical and coronary anatomic features similar to those treated in the pivotal trials conducted by the manufacturers for FDA approval." (MedPage Today)

September 2006

FCC begins rulemaking to establish a new "MedRadio" service for medical devices

The FCC has initiated a proceeding to establish a new service for advanced medical radio communication ("MedRadio") devices in the 401-406 MHz band. The FCC noted that an ever-increasing number of medical devices are coming to rely upon radio transmissions for critical aspects of their functionality. In this Notice of Proposed Rule Making, the FCC proposed designating an additional two-megahertz of spectrum for these devices, at 401-402 MHz and 405-406 MHz, adjacent to the existing Medical Implant Communications Service (MICS) band at 402-405 MHz, for a total of 5 megahertz specifically designated for medical device radiocommunica-tions. Underscoring the flexibility and scope of potential uses under this new service, the FCC proposed to revise its nomenclature and designate the entire 401-406 MHz band as MedRadio service. To accommodate a wider variety of devices than the current MICS service, which is limited to use of implant devices, the FCC proposed allowing the use of body-worn transmitting devices in the MedRadio service.

Five nationally renowned speakers at ASHES 21st Annual Conference

The 21st Annual Conference and Healthcare Marketplace of the American Society for Healthcare Environmental Services (ASHES), September 24 – 28, 2006 in Nashville, TN, features well-known best selling authors, a famous broadcaster and nationally-renowned motivational speakers. Dr. Jerry Punch, Physician and Broadcaster, ABC’s Wide World of Sports and ESPN is the opening keynote speaker of the conference. His session is titled, "eXceeding eXpectations Through Teamwork!" Mac Fulfer Author, Amazing Face Reading, shows how this art/science of face reading can be a means to a deeper communication with every person you meet. Greg Blake, Chief Encouragement Officer (CEO), PepWorks International, presents a best-in-class, high-energy motivational session entitled "How to THRIVE and Not Just Survive in Turbulent Times! An eXtreme Personal & Professional Environmental Makeover". Ron Rosenberg, President, Quality Talk, will hold an interactive and entertaining session entitled, "The Hidden Secrets to Double Your Memory". Fred Lee, President of Fred Lee and Associates Inc., and author of If Disney Ran Your Hospital – 9 ½ Things You Would Do Differently, is the closing keynote speaker. For more information about the ASHES Conference, www.ashes.org

BC/BS plans unveil Blue Health Intelligence

Blue Cross and Blue Shield Plans announced the creation of Blue Health Intelligence (BHI), a resource designed to help improve healthcare quality through opportunities to share critical health information initially with employers, and in the future, with consumers and providers. BHI as a health intelligence resource will strengthen the movement to greater healthcare transparency by ultimately providing unmatched detail about healthcare trends and best practices. The secure, HIPAA-compliant database is comprised of claims information (with no personal identifiers) from 79 million lives, significantly larger than existing healthcare databases. Twenty Blue Cross and Blue Shield Plans currently are participating in BHI. Access to the aggregate data will be available only to the participating Plans. The development of BHI over the last several years responds to the demands of employers, consumers, and providers who are calling for credible and actionable data to drive informed, evidence-based decision making. BHI is currently being pilot-tested and will be operational by 2007. As BHI evolves, the resource will provide a number of benefits to employers, consumers, providers and other stakeholders, such as: Sharper insight into healthcare trends and best clinical practices; information about the efficacy of certain treatments and new medical technologies as well as emerging trends in healthcare practice and delivery; benchmarking data to assist in conducting comparative analyses across a number of healthcare components; and opportunities for health services research.

CDC researchers develop new way to assess pandemic potential of influenza viruses

Researchers at the Centers for Disease Control and Prevention (CDC) have developed a new research method that may help identify the types of genetic changes necessary for the avian influenza virus (H5N1) to be more easily transmitted among people. After developing the research method, CDC scientists used it to investigate the ability of a lab-engineered combination of the avian influenza virus and a more common human virus to spread in lab animals. Efficient and sustained human-to-human transmission is the remaining property that H5N1 avian influenza viruses do not yet have that is needed to cause a pandemic. In this series of experiments, published in the July 31 issue of the journal Proceedings of the National Academy of Sciences, genes from a human H3N2 influenza virus were added to genes from an H5N1 avian influenza virus to create new hybrid viruses. The new viruses were tested in ferrets because their susceptibility to flu viruses is similar to that of humans. The animals were then placed in close proximity, to see if infected ferrets passed the new virus to uninfected animals and whether they transmitted it more easily than the original H5N1 virus. In this model, human H3N2 viruses transmitted efficiently between the ferrets, but avian H5N1 viruses did not. When the hybrid viruses were tested it was found that these viruses also did not pass easily between ferrets. "This important science has established a new research method to help us learn more, in advance, about the genetic changes that enable new influenza viruses to spread efficiently and in a continuous manner among people," said CDC Director Dr. Julie Gerberding. "H5N1 viruses continue to spread among birds worldwide and their genetic properties are constantly changing. There is an urgent need to better understand how these viruses could acquire the ability to spread efficiently between people." The first characteristic that scientists believe is needed to cause a pandemic is being a new virus to which humans have little or no immunity. The second characteristic is the ability to infect people and cause illness. The CDC studies were designed to help researchers learn what genetic changes would be needed for the virus to gain the remaining trait necessary to cause a pandemic: the ability to spread easily from person to person in a sustained manner within the population. Dr. Taronna Maines and her CDC colleagues designed and tested a research method that involved three elements: ferrets; a caging system that enabled researchers to put healthy and infected animals in close proximity; and reverse genetics, a tool for combining the genes from human and avian influenza viruses. The studies showed that the H3N2 virus passed easily by droplets but the H5N1 virus did not, reflecting what is seen with these viruses in humans. Researchers then swapped genes from a 1997 H5N1 avian flu virus with genes from an H3N2 virus, in a process called reassortment. When tested using the ferret model, these "hybrid" viruses did not pass easily between ferrets and, in fact, caused less severe disease than the original H5N1 virus. The reassortment work was designed to mirror the phenomenon that occurs in nature when two flu viruses combine to form a new virus, a process that led to the 1957 and 1968 pandemics. It is still unknown whether the H5N1 virus could reassort with a human influenza virus in nature.

Webcast offers free CE credit for clinicians: Balancing skin health and medical adhesives

A new Webcast informing health care professionals about skin health and medical adhesives is available from 3M. This 55-minute program addresses and helps clinicians give recommendations on issues such as: Why irritation seems to be increasing with use of adhesive products; alternatives when products do not stick to patients’ skin; the common mistakes and correct procedures for applying and removing adhesive products; why adhesive products occasionally leave residue on patients’ skin after removal; and treating patients who are allergic to certain dressing types. The webcast is presented by Laura Rutledge, MSN, RN, CRNI, 3M Clinical Research Specialist. Rutledge is a seasoned professional with experience in infusion therapy, critical care, risk management and cardiology. Visit www.3M.com/Tegaderm to view the Webcast at your convenience. The program’s learning objectives include: Refresh knowledge of general skin anatomy and adhesive properties; Define S.P.A.R.E. and list the considerations related to each letter of the S.P.A.R.E. acronym; Demonstrate the appropriate techniques for applying and removing adhesive film dressings. One free CE credit is available to US participants who view the entire Webcast and complete the survey at the end.

GAO surveys nonprofit hospital systems on executive compensation policies

As a part of Congress’s continuing efforts to oversee the activities of the nonprofit sector, the Committee on Ways and Means, House of Representatives, asked the Government Accountability Office (GAO) to review executive compensation issues at selected private, nonprofit hospital systems to gain an understanding of the policies and practices related to the salaries, benefits, travel, gifts, and entertainment expenses paid by these hospital systems. The study’s key questions were as follows: What corporate governance structure do selected hospital systems report as having in place over executive compensation? What is the basis for the compensation and benefits earned by, awarded to, or paid to the executives as reported by selected hospital systems? What internal controls do selected hospital systems report as having in place over the approval, payment, and monitoring of executive travel and entertainment expenses, gifts, and other perquisites? In answering the questions, GAO used the American Hospital Association’s AHA Guide (2005) to identify private, nonprofit hospital systems according to the number of staffed beds reported. The hospital systems reported similarities in certain governance and compensation policies and practices. For example, hospital systems commonly reported policies and practices such as: Having an executive compensation committee or entire board with primary responsibility for approving executives’ base salary, bonuses, and perquisites; having a conflict of interest policy that covers members of the executive compensation committee and compensation consultants; and relying upon comparable market data of total compensation and benefits prior to making compensation determinations. With respect to perquisites, entertainment and travel expenses and related internal control for their executives, the 65 hospital systems reported a range of practices. For example, hospital systems commonly reported that they provide for payment of automobile-related expenses as a perquisite to executives. They also commonly reported having written policies that cover business travel and entertainment expenses. However, hospital systems reported a mix of practices related to payment for other perquisites, such as memberships in recreational and social clubs and audits of perquisites and entertainment expenses.