Quality Update for June 9, 2005

AHRQ, AMA, AHA Join Forces in Campaign for Patient Safety CMS Administrator Proposes Using Medicare Part D Data to Monitor Drug Safety First Prototype for EHR Exchange Network Launched in MA, CA, and IN New Proposed Rule Aims to Improve Hospice Care Study: Only Half of High Risk Patients Prescribed Statins Commission to Identify Characteristics of High Performing Health System JCAHO Announces 2006 National Patient Safety Goals AHRQ, AMA, AHA Join Forces in Campaign for Patient Safety The Agency for Healthcare Research and Quality, the American Medical Association, and the American Hospital Association announced a public education campaign, 5 Steps to Safer Health Care, to help health care providers and the public learn about improving patient safety. The campaign includes a fact sheet in English and Spanish that offers evidence-based, practical tips on the role patients can play to help avoid errors related to prescription medicines, laboratory tests, procedures, and surgery. The tips are also included in the Medicare & You handbook mailed to Medicare beneficiaries each year. The 5 steps include: Ask questions if you have doubts or concerns. Keep and bring a list of ALL the medicines you take. Get the results of any test or procedure. Talk to your doctor about which hospital is best for your health needs. Make sure you understand what will happen if you need surgery. In addition, the groups recently worked with actress Laura Innes, who plays Dr. Kerry Weaver on the hit NBC show ER, to record a 30-second public service announcement that is airing on TV stations nationwide. To view the PSA, fact sheet, and other patient safety materials online, visit: http://www.ahrq.gov/qual/5stepspsa.htm Print copies of the fact sheet also are available by calling AHRQ's Publications Clearinghouse at 1-800-358-9295 or by sending an e-mail to ahrqpubs@ahrq.gov Back to top CMS Administrator Proposes Using Medicare Part D Data to Monitor Drug Safety The Los Angeles Times reported on June 5, 2005 that Mark McClellan, MD, Centers for Medicare & Medicaid Services Administrator and former head of the FDA, proposed using billing data from the new Medicare prescription drug benefit to track the safety and effectiveness of prescription medications. The proposal was one of several ideas discussed at a recent FDA drug safety advisory committee meeting. McClellan’s proposal includes combining billing data from prescriptions covered by Medicare with Medicare beneficiary claims data already being collected and cross-referencing the information to spot signs of trouble. The large data poll from the 43 million people covered by Medicare would serve as a “warning network” to detect problems easier and faster. In August, UnitedHealth Group Inc., a large private insurer will start using a monitoring system similar to the one McClellan has proposed. That system will track the four new drugs: Cialis, Spiriva, Ketek, and Cymbalta. It will compare health outcomes of patients taking each new drug with patients using the current leading drug for the same medical condition. Currently, the FDA approves drugs based on trials which may be too short or too limited to spot dangerous side effects. When more people use the drug on the open market over long periods of time, problems become apparent. McClellan told the Times, “One of the main frustrations with Vioxx was that it was on the market for a number of years and used by millions of people, and only later was there a possible association with problems.” The FDA already has a safety surveillance network called the Adverse Event Reporting System (AERS) that accumulates about 400,000 reports a year. Although drug companies are required to submit data, reporting for physicians and hospitals is voluntary. AERS is considered effective for identifying rare side effects but can miss common medical problems and those caused by long-term use. The system also does not provide a total number of patients taking a drug, a key element in calculating prevalence. The Medicare proposal by McClellan would address these problems. McClellan’s proposal would also be relatively inexpensive to implement because it would take advantage of systems that are already in place and funded by tax payer dollars. AHQA EVP David Schulke observed, “If CMS follows through on the staff level with Dr. McClellan’s thinking, it will signal the government is moving beyond the passive monitoring role of the FDA and is now preparing to proactively and promptly identify drug safety threats. Medicare data, and those who know how to work with it, will be at the center of this important new public health policy initiative. QIOs that already have --or act now to aggressively develop-- expertise in working with drug claims data are going to be well-positioned to contribute to this new more active form of post-market surveillance, but it will be a competitive field with many other qualified entrants.” According to the Times, some medical and pharmaceutical experts are excited about using Medicare data to monitor drug safety, but that the FDA remains “noncommittal.” A spokesperson for the FDA told the Times that “It really is too early. The agencies are exploring this possibility.” Back to top First Prototype for EHR Exchange Network Launched in MA, CA, and IN The first prototype of an electronic national health information exchange or “health information-sharing environment,” based on common, open standards was recently announced. The project was initiated by Connecting for Health, a public-private collaborative of more than 100 diverse organizations that is managed by the Markle Foundation and funded by both Markle and the Robert Wood Johnson Foundation. The prototype allows authorized users of three very different health information networks located in California, Massachusetts, and Indiana to share health information both within and among these local regions and communities. The experiment is based on a common framework developed by Connecting for Health in 2004 that offers a set of policy principles, guidelines, and technical specifications to facilitate the electronic sharing of medical information among authorized individuals and institutions, while protecting privacy and securing personal information. Two Connecting for Health working groups, consisting of experts in health policy, clinical medicine, and information technology, developed the framework through a yearlong collaborative effort. The common framework provides that any prototype must: guarantee that patients and their authorized health professionals jointly make decisions regarding the sharing of health information; store information about individual patients in the electronic files of the health professionals and institutions responsible for patient care, as well as in each individual patient's own records, and not in centralized national or regional databases; create nationwide capability for health information exchange using the Internet, not a new network; facilitate communication among numerous, disparate information networks and diverse communities; and allow for diversity in software and hardware that can participate in the system. It is expected that development of additional tools and techniques for sending, receiving, and viewing medical data by authorized participants will result, providing important information for policymakers, local communities, and vendors. For more information, visit www.connectingforhealth.org. Back to top New Proposed Rule Aims to Improve Hospice Care The Centers for Medicare & Medicaid Services (CMS) recently announced a new proposed rule the agency hopes will improve the quality of care provided to more than 700,000 Medicare beneficiaries receiving hospice care each year. The proposed conditions of participation (CoP) for hospices would ease the regulatory burden for hospice providers and improve the quality of care for hospice patients. Under the proposed rule, hospice providers would pay more attention to meeting the specific needs of individual patients. Changes and additions to the current rule, originally published in 1983, would include: Adding a patient assessment requirement to ensure that all patient needs are identified on a timely basis; Replacing the quality assurance requirement with a more comprehensive quality assessment and performance improvement (QAPI) CoP that enables hospices to take tailored proactive steps to ensure quality care; Allowing hospices to contract for core services in certain situations; Removing the requirement that a registered nurse provide patient care in an inpatient facility on a 24-hour basis, as recommended by the Secretary’s Advisory Committee on Regulatory Reform. CMS is proposing to remove this prescriptive, process-oriented requirement, contained in the current hospice conditions of participation, and replace it with an alternative outcome-oriented requirement that focuses on the results of care provided to patients and their families; and Adding guidance for hospices that care for residents of nursing facilities. The proposed was published in the May 27, 2005 Federal Register available at: http://a257.g.akamaitech.net/7/257/2422/01jan20051800/ edocket.access.gpo.gov/2005/pdf/05-9935.pdf Public comments will be accepted until July 27, 2005. AHQA intends to comment on the proposed rule; those QIOs that would like to offer their input should contact dadler@ahqa.org Back to top Study: Only Half of High Risk Patients Prescribed Statins Stanford School of Medicine researchers conclude that cholesterol-lowering statins are prescribed to only 50% of patients at high risk for heart disease. The findings are published in the May online journal, Public Library of Science Medicine. Using annual data from 1992 to 2002 in the National Ambulatory Medical Care Survey (NAMCS) and the outpatient department component of the National Hospital Ambulatory Medical Care Survey (NHAMCS), researchers examined outpatient visits to hospitals and physicians and the medications prescribed or renewed during the visits. Although use of statins increased from 1992 to 2002, researchers found that the drugs were not recommended for about half of the patients with high cholesterol in moderate and high-risk groups for heart disease. Lower statin use was independently associated with younger patient age, female gender, African American race (versus non-Hispanic white), and non-cardiologist care. The authors conclude, “ Despite notable improvements in the past decade, clinical practice fails to institute recommended statin therapy during many ambulatory visits of patients at moderate-to-high cardiovascular risk.” They also note that “Information technology and broader national policy around quality measurement and reporting are just two potential strategies that could be used to improve current practice. Patient-centered interventions should strengthen patient education and improve patient access to different treatment options.” Read the full study at: http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0020123 Back to top Commission to Identify Characteristics of High Performing Health System The Commonwealth Fund announced the creation of a Commission on a High Performance Health System aimed at moving the U.S. toward a health care system that achieves better access, improved quality, and greater efficiency, with particular focus on the most vulnerable due to income, race/ethnicity, health, or age. The panel is charged with defining the characteristics of high-performance health systems; identifying the policy changes that will facilitate achieving such a system; setting realistic targets for what the U.S. could achieve in higher system performance; recommending concrete steps, including policies and practices, private and public, that would lead to achievement of these goals; issuing an annual “scorecard” documenting progress in achieving the goals; and issuing an annual report outlining key policy issues related to achieving a high-performance health system. The Commission is chaired by James J. Mongan, M.D., President and CEO of Partners HealthCare. The 18 commissioners represent broad interests in health care and a commitment to each of the elements of a high-performance health system—coverage, quality, and efficiency. The commission is scheduled to have its first meeting in July 2005. A list of the commissioners is available at: http://www.cmwf.org/usr_doc/Commission_members.pdf Back to top JCAHO Announces 2006 National Patient Safety Goals The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has released the 2006 National Patient Safety Goals and associated requirements for each accredited program and the disease-specific care certification program. The total number of requirements for each accreditation program remains unchanged. A major addition to the 2006 goals includes a requirement that “hand-offs” of patients between caregivers be standardized, with particular attention to assuring the opportunity for asking and responding to questions. This requirement is part of the goal to “Improve the effectiveness of communication among caregivers.” Another new requirement addressing medication safety applies to all accredited organizations that provide surgical or other invasive services. It specifies that all medications, medication containers, and other solutions used in perioperative settings are to be labeled. New goals in other selected programs address the prevention of pressure ulcers and encourage the active involvement of patients and their families in the patient's care as a patient safety strategy. To read the full text of goals and requirements in the 2006 National Patient Safety Goals, visit: http://www.jcaho.org/accredited+organizations/patient+safety/npsg.htm Back to top

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