October 2, 2009

HPN to spotlight "Supply Chain-Focused CEOs" in January 2010 edition

Many industries outside of healthca...
Further, under GINA and the new interim final regulations, group health plans and health insurance issuers in both the gro...
FDA Alert: New USP standards for Heparin products will result in decreased potency adjustments

The U.S. Food and Drug Adm...
the point of care. The Metro Lionville Series also allows for technology integration, while offering alternate power syste...
Until this outbreak, hospitals were not required to report to public health authorities deaths from influenza, except in c...
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October 2, 2009


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October 2, 2009

  1. 1. October 2, 2009 HPN to spotlight "Supply Chain-Focused CEOs" in January 2010 edition Many industries outside of healthcare recognize and respect the value that effective and efficient supply chain management contributes to the top and bottom lines. Among healthcare providers, such recognition and support is growing, slowly but surely, from the top post in the executive suite. That’s why Healthcare Purchasing News launched its yearly search for "supply chain focused CEOs five years ago. We wanted to locate forward-thinking men and women to share their insights with you. Since 2005, you’ve helped us do that. In fact, we’ve profiled 16 of them already since the inception of the award. Well, it’s that time of the year again – time to nominate noteworthy hospital presidents/CEOs for HPN’s 6th Annual "S.U.R.E. Award for Supply Chain Focused CEOs" award. We’re looking to recognize chief executives who support, understand, recognize and empower the materials management department to do what needs to be done to achieve bottom-line savings and top-line revenue. We ask you, our dedicated and loyal readers, to recommend worthy candidates for recognition in our January 2010 edition by e-mailing us reasons how and why your CEO deserves the spotlight – no more than a couple of paragraphs are needed for each of the four S.U.R.E. categories listed above that comprise the "SURE" acronym. Please describe how and why he or she supports, understands, recognizes and empowers the materials management department and its top executive. For your nomination to qualify, please be sure to comply with the following rules: 1. Any nomination must be original and exclusive to HPN and not have been submitted – either original or edited – to any other publication or online media outlet currently or within the previous year. 2. GPO and distributor support is commendable, but we’re looking for internally driven details beyond GPO- and distributor-driven contributions, including outsourcing operations to a GPO or distributor. 3. Any nominated executive (or nominator) must be willing to share relevant basic financial details with our readers – specifically annual revenues, annual expenses and annual purchasing volume. 4. Only administrators/CEOs are eligible for consideration – not COOs or executive/senior vice presidents. Help us share the stories of these remarkable CEOs in our January 2010 edition so that the industry may learn from them and be inspired. Thanks in advance. E-mail us your nominations by Monday, November 2, to editor@hpnonline.com. New rules protect patients’ genetic information Individuals’ genetic information will have greater protections through new regulations issued Thursday by the U.S. Departments of Health and Human Services (HHS), Labor, and the Treasury. The interim final rule will help ensure that genetic information is not used adversely in determining healthcare coverage and will encourage more individuals to participate in genetic testing, which can help better identify and prevent certain illnesses. The interim final rule with request for comments and the notice of proposed rulemaking implement Title I of the Genetic Information Nondiscrimination Act of 2008 (GINA). Under GINA, and the interim final rule, group health plans and issuers in the group market cannot: increase premiums for the group based on the results of one enrollee’s genetic information; deny enrollment; impose pre-existing condition exclusions; or do other forms of underwriting based on genetic information. In the individual health insurance market, GINA prohibits issuers from using genetic information to deny coverage, raise premiums, or impose pre-existing condition exclusions.
  2. 2. Further, under GINA and the new interim final regulations, group health plans and health insurance issuers in both the group and individual markets cannot request, require or buy genetic information for underwriting purposes or prior to and in connection with enrollment. Finally, plans and issuers are generally prohibited from asking individuals or family members to undergo a genetic test. The proposed rule published Thursday modifies the HIPAA Privacy Rule pursuant to GINA Title I to clarify that genetic information is health information and to prohibit the use and disclosure of genetic information by covered health plans for eligibility determinations, premium computations, applications of any pre-existing condition exclusions, and any other activities related to the creation, renewal, or replacement of a contract of health insurance or health benefits. In combination with the new penalties for violations of the HIPAA Privacy Rule, as provided for by the American Recovery and Reinvestment Act of 2009, a use or disclosure of genetic information in violation of the HIPAA Privacy Rule could result in a fine of $100 to $50,000 or more for each violation. Visit the Federal Register to view the new regulations and www.dol.gov/ebsa for more information about them. Less than half of medical students understand healthcare system Less than half of graduating medical students in the U.S. say they received adequate training in understanding healthcare systems and the economics of practicing medicine, according to a study conducted by the University of Michigan Medical School. The national survey of more than 58,000 medical students from 2003-2007 showed an overwhelming majority were confident about their clinical training. But when it came to understanding health economics, the healthcare system, managed care, managing a practice or medical record-keeping, 40 percent to 50 percent of students reported feeling inadequately prepared. The findings were published this month in Academic Medicine. "Our patients expect us to understand the system," says Matthew M. Davis, M.D., associate professor of pediatrics and internal medicine in the Child Health Evaluation and Research (CHEAR) Unit at the University of Michigan Medical School. "If we don't, that can result in poor patient care.” "And if we don't expect doctors to understand the healthcare system, who is going to?" asks Davis, who co-authored the research with Monica L. Lypson, M.D., assistant dean of graduate medical education at the U-M Medical School and Mitesh S. Patel, M.D., M.B.A., a U-M medical school graduate now at the University of Pennsylvania. Davis explains researchers wanted to assess what medical students are learning about healthcare systems, especially as the nation struggles with healthcare reform. It's important, Davis says, that physicians can contribute to the national dialogue. The study looked at graduates nationwide from 2003 to 2007, and also compared two top-ranked medical schools in more detail. One of those schools had a higher intensity curriculum in healthcare systems. Students who had the higher intensity curriculum were three times more likely to report that they had appropriate training in healthcare systems. The time devoted to healthcare systems training, however, did not lead to lower perceptions about their clinical or other training. Davis says he hopes the survey will prompt medical schools to stress the importance not only of physicians' ability to heal, but also to help guide their patients through a complex healthcare system. A higher-intensity curriculum in medical economics appears to work, he says. Visit here for the study. Penumbra announces worldwide voluntary field removal of the original version of 6F Neuron 070 Delivery Catheter Penumbra is initiating a voluntary field removal of the original version of Neuron 6F 070 Delivery Catheter. For these catheters, Penumbra has received feedback from some users that the catheter could kink or ovalize in certain anatomical situations. This kinking and/or ovalization of the catheter lumen can lead to difficulty in catheter advancement and/or delivery of other devices through the guide catheter. Continued usage of a kinked catheter could cause the catheter to break, which could result in a portion being retained in the patient, which could result in additional procedural time, patient injury or death. Consumers who have the older version of 6F Neuron 070 Delivery Catheter which is being recalled should stop using and return the device. If your facility is in possession of units with Lot numbers F14630 or higher, you may continue to use these units. Units with Lot numbers F14630 or higher are not affected by this Field Removal Action. Penumbra voluntarily conducted a field removal of the devices after learning about the devices potential to kink or ovalize. FDA has been apprised of this action. There are four injury reports to date, which may be potentially associated with this defect. Penumbra is notifying affected hospitals through detailed Field Removal notification letters requesting that affected product be returned to Penumbra. Replacement product will be available for all affected customers. Visit here for more information from the FDA.
  3. 3. FDA Alert: New USP standards for Heparin products will result in decreased potency adjustments The U.S. Food and Drug Administration alerted healthcare professionals Thursday, to a change in heparin manufacturing that is expected to decrease the potency of the common blood-clotting drug. To ensure the quality of heparin and to guard against potential contamination, the United States Pharmacopeia (USP), a nonprofit standards-setting organization, adopted new manufacturing controls for heparin. These changes include a modification of the reference standard for the drug’s unit dose. Manufacturers in the United States label the amount of heparin included in their products based on USP standards. The changes adopted by the USP for the heparin unit dose match the World Health Organization’s International Standard (IS) unit dose definition that has been in use in Europe for many years. The revised USP reference standard and unit definition for heparin is about 10 percent less potent than the former USP unit. Manufacturers for the U.S. market have begun to make heparin using the new USP standard. While the USP manufacturing controls take effect Oct. 1 for production, the FDA has asked that they not ship this new product to customers until Oct. 8, 2009, or later. The delay will give healthcare providers and facilities time to learn about the changes and to make adjustments to their pharmacy procedures and dosing practices, according to John Jenkins, M.D. director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research. Four companies market heparin in the United States. APP, the largest manufacturer, markets heparin in vials; Hospira markets heparin in intravenous bags, vials, and syringes; Baxter markets heparin in intravenous bags, and B. Braun markets heparin in intravenous bags. The FDA has asked that all manufacturers identify their new products to help pharmacies and healthcare professionals differentiate it from the former product. The revised standards for heparin are contained in a new USP monograph. The monograph was revised, in part, in response to a 2007-2008 incident of heparin contamination involving a manufacturing step in China. The contaminated heparin was associated with deaths and other adverse events in the U.S. The monograph was changed to include a test for the contaminant. See the FDA alert to healthcare professionals. MedAssets' Service Line Analytics drives business intelligence to control and reduce supply costs for hospitals MedAssets has launched Service Line Analytics, an on-demand business intelligence solution designed to identify and drive sustainable financial improvement in the management of high-cost medical devices, supplies, pharmaceuticals, ancillary services, length of stay, and other key hospital cost drivers. Service Line Analytics combines MedAssets' technology with the clinical utilization expertise of its Aspen Healthcare Metrics subsidiary to gather, interpret and report on actionable clinical, financial and supply cost data by clinical service line and specific patient population. Service Line Analytics helps healthcare executives significantly reduce costs while improving patient outcomes through a cohesive understanding of interlinked reimbursement, supply cost, supply utilization, clinical factors and other resource utilization by physician and MS-DRG. Opportunity areas include medical, surgical and implant supply price, utilization of those supplies, pharmacy utilization, physician preference item (PPI) pricing and length of stay (LOS) supply usage. Health systems representing more than 30 facilities have assisted in the product development through beta testing of the Software as a Service (SaaS) offering, including Atlantic Health, Baptist Health System, Carilion Clinic and Carondelet Health Network. To learn more about MedAssets' Service Line Analytics, go to www.medassets.com/servicelineanalytics. Metro launches integrated healthcare division to drive innovation, improve patient care Metro, providing technology, storage and transport solutions for healthcare facilities and other industries, has realigned its healthcare division to drive innovation and improve patient care by integrating its clinical storage products with Flo Healthcare, Lionville Systems and medDISPENSE’s market-leading mobile computing and medication management solutions. A division of Emerson, InterMetro (Metro) acquired the three companies in 2006, 2007 and 2008, respectively. Metro’s realigned healthcare division includes three groups: Clinical Products – Provides storage solutions with the latest technology for virtually every department within the hospital, including shelving systems, carts, work centers, cabinets and accessories. Metro products and services—such as Metro IQ shelving—enable hospitals to maximize space and productivity while ensuring reliable, efficient operation. The Clinical Products group also features Lifeline emergency carts and modular Starsys WorkCenters. Mobile Computing – Offers mobile workstations with configurable designs to support EMR/clinical documentation, telehealth and vital signs data capture. The Metro Flo Series of wireless mobile computing workstations seamlessly connects clinicians with real-time information at
  4. 4. the point of care. The Metro Lionville Series also allows for technology integration, while offering alternate power systems and additional options. Medication Management -- Includes products from Metro, the Metro Lionville Series and the Metro medDispense Series to offer customers a wide selection of automated dispensing cabinets, medication carts and pharmacy fixtures for acute-care and long-term-care environments. Metro’s medication management systems support pharmacists, nurses and technology professionals wherever medications are stored, dispensed, administered and recorded. For more information, visit www.Metro.com. A race in cardiology A race is on to develop the potentially next big thing in heart surgery: a replacement valve that can be implanted through thin tubes known as catheters rather than by traditional open-heart surgery. The contest pits two major companies, Edwards Lifesciences and Medtronic. Analysts estimate a market for the product that could exceed $1.5 billion within six years. But if the valves catch on, their benefits for the nation’s aging population could be substantial — even if the impact on the nation’s healthcare bill may be hard to calculate. The new valves — which make it possible to repair the heart without the rigors of chest-opening surgery — have been available in Europe for about 18 months, with sales of about $100 million split about evenly last year between the two companies. While doctors say that the early results have been promising, they add that it is too early to gauge the technology’s long-term benefits. In the U.S., the devices are currently being tested in older, critically ill patients in clinical trials. Many medical experts and financial analysts predict that if the devices live up to their makers’ claims, they could revolutionize valve replacement, a common heart operation, and extend the lives of thousands of frail patients who are not now considered candidates for surgery. The development of the new valves makes it clear that even as Congress debates ways to control the nation’s skyrocketing health costs, medical technology continues to advance in ways that may drive up healthcare spending even further with costly new procedures that can enable more people to live longer. Most heart valve replacements involve people of Medicare age. The race between Edwards and Medtronic involves one of the heart’s four valves — the aortic valve, which controls blood flow into the aorta from the heart. Aortic valves were involved in the vast majority of the estimated 95,000 open-heart surgeries in the country last year to replace a diseased valve with a new one, according to Millennium Research, a consulting group. An estimated 20,000 people die annually from valve-related disease, including those too sick to withstand surgery. The new valves from Edwards and Medtronic would be meant to enable more such patients to have life-saving valve replacements. The new units, known as percutaneous heart valves, are implanted through catheters, in much the same way that artery-opening stents are. A catheter holding a compressed replacement valve is inserted through a small incision in the groin or, if blood vessels are blocked, through an opening near the ribs. The catheter is then snaked through a vessel into the heart and the new valve is released, essentially compressing the diseased tissue and moving into its place. But the new technology would not be inexpensive. The current cost of heart valve replacement surgery is about $50,000, a sum that includes surgical fees, hospital costs and the price of a replacement valve, which sells for about $5,000. By contrast, the new valves currently sell for up to $30,000. Both Edwards and Medtronic, though, say that the higher prices for the valves would be offset by lower costs from anticipated shorter hospital stays. If the new valves prove beneficial in the sickest of patients, the next big question will be whether they should be used in patients who are now considered suitable candidates for open-heart surgery. Many heart specialists, pointing to the rapid proliferation of other expensive medical technologies, are urging caution. They point out that the success rate of conventional open-heart surgery is extremely high and that the replacement valves now in use are highly durable, lasting 10 to 15 years. Visit the New York Times for the article. CDC reports 28 flu deaths among pregnant women In a reminder that the new strain of H1N1 influenza may not be as benign as originally thought, federal health officials reported Thursday that 100 pregnant women infected with the virus were hospitalized in intensive care units in the first four months of the outbreak, and 28 have died. The 28 deaths occurred between the emergence of the strain in late April and the end of August.
  5. 5. Until this outbreak, hospitals were not required to report to public health authorities deaths from influenza, except in children. As a consequence, the "expected" mortality of pregnant women who become ill with seasonal flu strains is not known. However, pregnant women have been among the victims of the novel H1N1 swine flu strain since the first cases were found in April. "Whether this is more common or people are just noticing it because we're attending to this H1N1 virus, it's difficult to say," said Anne Schuchat, a physician at the Centers for Disease Control and Prevention in Atlanta. However, she added, anecdotal reports are that "doctors around the country…have never seen this kind of thing before." In the briefing, Schuchat said that 600,000 doses of the nasal-spray form of the vaccine will arrive in 25 states and cities by Tuesday. The shipments mark the start of the unprecedented effort to offer a pandemic flu shot to every American who wants one. The nasal vaccine is a live influenza virus that has been genetically weakened so that it can't cause illness and replicates only in the cooler temperatures of the nose. It can be taken by people ages 2 to 49, but not by pregnant women or people with chronic illnesses such as asthma, diabetes and kidney failure. About 7 million doses of nasal vaccine should be available by the end of next week. The first doses of injectable vaccine -- which is made from genetically altered virus -- will arrive soon thereafter. Use of the H1N1 nasal vaccine may be complicated by the recommendation that it should be given at least four weeks apart from the seasonal flu nasal vaccine. Those who have already gotten that vaccine would have to get the pandemic flu shot for protection against the novel H1N1 strain, unless they want to wait at least a month for the nasal spray. The need for the interval doesn't involve safety, said Anthony Fiore, a CDC physician and epidemiologist. Instead, some virologists believe the two "live" vaccines could compete with each other for the immune system's attention, resulting in sub-optimal response to one of them. At the moment, however, that problem is theoretical, as there have never been two nasal flu vaccines available in the same season. The CDC reported "widespread" flu activity in 26 states last week. Visit the Washington Post for the article.