FEDERAL HEALTH UPDATE
June 20, 2008Produced by Kate Connelly Theroux in collaboration with the Institute of Federal Health Care (IFHC) To subscribe, please visit http://fedhealthinst.org/subscriber.cfm. Sponsored by
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Congressional Schedule
These organizational changes were announced on June 2, 2008. DHIMS, led by Program Manager Army Col. Claude Hines, Jr. and Deputy Program Manager Army Col. Bruce Brehm, supports the AHLTA family of products and will continue working toward a longitudinal electronic health record that bridges the information gaps between theater, garrison and beyond. DHSS, led by Program Manager Dr. Dan Magee and Principal Deputy Program Manager Mr. Mike Veasey, supports more than 30 products used throughout the MHS supporting three major functions: clinical support, medical logistics and resources. http://www.tricare.mil/pressroom/news.aspx?fid=418
Ellen Embrey, deputy assistant secretary of Defense for force health protection and readiness, announced that Lois Kellett, director of integration and communications at DoD’s TRICARE Management Activity, has been named acting director of the new office, and Cliff Freeman, director of the VA/DoD Health Information Technology Sharing Program, is acting deputy director. The posts will be filled on a permanent basis after they are officially created and the recruitment process has been followed. The office is located within the Military Health System for now but will have its own space later this year. Dr. Michael Kussman, VA’s undersecretary for health, said a national health information network is needed because VA patients also receive care at DoD facilities and from TRICARE and private providers, sometimes paid for by Medicare. http://www.govhealthit.com/online/news/350423-1.html
LSAT features a ventilator, suction, oxygen system, infusion pump, physiological monitor, clinical blood analyzer, and defibrillator. These medical devices are complemented with a fully network-capable on-board computer monitoring system and standalone power system all packaged together in the NATO litter form factor. The U.S. Army and the Defense Advanced Research and Projects Agency (DARPA) selected Integrated Medical Systems, Inc. (IMS), owned in part by Northrop Grumman, to develop the LSTAT system under the guidance of the U.S. Army's Walter Reed Army Institute for Research (WRAIR), based upon defined mission needs. The FDA-cleared LSTAT is currently being evaluated at various military and civilian locations across the globe. LSTAT can play a critical role in saving lives during military operations like Kosovo, FEMA response to chemical-biological terrorism and accidents, and U.S. support after global natural disasters. The LSTAT Lite "suitcase ICU" will be on display for discussion and demonstration for members of Congress, the Administration, Department of Defense and the public on Thursday, June 26, from 9:30 a.m. to 1:00 p.m. in Cannon House Office Building Room 340.
Serving on the committee are Gulf War and other veterans, veterans service organizations’ representatives, medical experts, and the surviving spouse of a Gulf War veteran. The first meeting is designed to give committee members an overview of VA, as well as the benefits and services provided to Gulf War veterans. Members will receive briefings on health care, education, home loan guaranty, disability compensation, veterans’ legal and appeal rights and other benefits. For a list of the committee members, please visit: http://www1.va.gov/opa/pressrel/pressrelease.cfm?id=1517
Among the report’s findings:
Although screening for breast and cervical cancer for women in VA facilities exceeds screening in private-sector facilities, women veterans lag their male counterparts in some quality measurements, the report noted. VA has already launched an aggressive program to ensure women veterans receive the highest quality of care, including placement of women advocates in every outpatient clinic and medical center. Health care will be a major topic at VA’s National Summit on Women Veterans Issues scheduled for June 20-22 in Washington. The report also found minority veterans are generally less satisfied with inpatient and outpatient care than white veterans. That disparity will be the focus of an in-depth study, based upon input from veterans, which will be completed this summer. http://www1.va.gov/opa/pressrel/pressrelease.cfm?id=1515
The Manteno home grant of $570,545 will pay for the replacement of an emergency generator. At the Quincy home, the $690,533 grant will cover the cost of a mold remediation project. The two VA grants will pay 65 percent of the estimated $1.9 million cost of the projects. The two facilities, along with state-run veterans homes in Anna and LaSalle. are open to veterans who served in the military during wartime. To be eligible, veterans must have entered the military in Illinois or have been a state resident for a year before applying. This year, VA expects to spend nearly $3 billion in Illinois to serve the state’s 840,000 veterans. VA operates five major medical centers in Illinois, plus more than 20 community-based outpatient clinics, five nursing homes and nine Vet Centers. http://www1.va.gov/opa/pressrel/pressrelease.cfm?id=1516
The grant will pay for renovations to the fire alarms, oxygen storage, sprinklers and electrical system. The VA grant equals 65 percent of the estimated $1.7 million cost of the project. The facility is open to veterans who served in the military during wartime. To be eligible, veterans must have been a state resident for three years before applying. http://www1.va.gov/opa/pressrel/pressrelease.cfm?id=1520
“Reports in the news media today that the Department of Veterans Affairs (VA) is testing drugs on war veterans are inaccurate and misleading. VA conducts extensive and often groundbreaking, evidence-based research nationwide to discover better health care methods for our veterans. In our PTSD and smoking cessation study, our research is to learn if it is easier to stop smoking when smoking cessation treatment is combined with PTSD therapy, or whether the two therapies are more effective if they are provided separately. In either case, patients are receiving treatment recommended by their own doctors using counseling with or without FDA approved medication that includes Varenicline (Chantix). Participation in this program is voluntary, and all participants are closely monitored clinically by mental health professionals who provide smoking cessation methods patients agree to use.” To read the full statement, please visit: http://www1.va.gov/opa/pressrel/pressrelease.cfm?id=1518.
This is the first time that FDA and EMEA have allowed submission of a single application by a drug company to the two agencies. The new biomarkers are KIM-1, Albumin, Total Protein, â2-microglobulin, Cystatin C, Clusterin, and Trefoil Factor-3. For decades, both FDA and EMEA have required drug companies to submit the results of two blood tests, called blood urea nitrogen (BUN) and serum creatinine, to evaluate renal toxicity. In addition to those tests, the FDA and EMEA will now consider results from the seven new tests as part of their respective drug review processes. Although a decision by the sponsor to collect information using the new tests is voluntary, if collected, it must be submitted to FDA. Development of the new biomarkers was led by the Predictive Safety Testing Consortium (PSTC), whose members include scientists from 16 pharmaceutical companies. The PSTC was organized and led by the Critical Path Institute, a nonprofit organization that works to support FDA research collaborations that improve the development of medical products. Researchers from Merck & Co., Whitehouse Station, N.J., and Novartis AG, Basel, Switzerland, identified the new biomarkers, tested them to prove their accuracy and usefulness, and then shared their findings with the other consortium members for further study. The consortium then submitted applications for use of the biomarkers to FDA and EMEA. The project is the first in which a group of drug companies has worked together to propose and qualify new safety tests and then present them jointly to the FDA and EMEA for consideration. The FDA and EMEA laid the groundwork for these specific joint-agency biomarker reviews in 2004 when they developed a framework called the Voluntary Exploratory Data Submission review process. The new process allowed the PSTC to submit a single biomarker data application to both regulatory agencies and then to meet jointly with scientists from both agencies to discuss it in detail and to address additional scientific questions posed by the regulators. Each regulatory agency then reviewed the application separately and made independent decisions on use of the new biomarkers. FDA scientists believe that the seven new tests may provide important advantages over the BUN and creatinine tests. The new tests are more sensitive and can detect cellular damage within hours. And while BUN and serum creatinine show that damage has occurred somewhere in the kidneys, the new tests can pinpoint which parts of the kidney have been affected. http://www.fda.gov/bbs/topics/NEWS/2008/NEW01850.html
The signing marks the opening of a two-day traditional Chinese medicine Research Roundtable at the National Institutes of Health (NIH). The roundtable features scientific presentations by researchers from China and the United States. Topics include the synthesis of Western medicine and traditional Chinese medicine; criteria for evaluating traditional Chinese medicine practices; and the application of modern scientific tools such as proteomics (the study of proteins) to the study of traditional Chinese medicine. The MOU and the establishment of the international collaboration will aid in furthering scientific research on traditional Chinese medicine. Participants in the roundtable include a delegation from the Chinese State Administration on Traditional Chinese Medicine, academics from U.S. universities and scientists and researchers from NIH, Indian Health Service and the Food and Drug Administration (FDA). Thirty-six percent of Americans use some form of complementary and alternative medicine (CAM), according to the 2002 National Health Interview Survey. In the United States, traditional Chinese medicine is an alternative medical system that is considered a part of complementary and alternative medicine. Integrative medicine combines mainstream medical practices with alternative medical practices. Traditional Chinese medicine involves numerous practices including acupuncture, tai chi, and herbal therapies. In 2007, NIH’s National Center for Complementary and Alternative Medicine (NCCAM) supported nearly $20 million in research on traditional Chinese medicine practices. http://www.hhs.gov/news/press/2008pres/06/20080616b.html
The demonstration was designed to test new payment systems under Medicare that would improve the safety, quality and efficiency of care delivered in the nation’s hospitals. Given the series of reports issued over the past decade – starting with the Institute of Medicine’s 1999 landmark report “To Err is Human” – there is a growing awareness and well-documented need for Medicare to change the way it pays for health care services. The outcomes from the third year of this demonstration provide even more evidence that paying for performance in health care with innovative Value-Based Purchasing (VBP) initiatives can dramatically improve the quality of health care delivered to hospital patients. In November 2007, CMS submitted a proposal to Congress to implement Medicare VBP. Within that proposal, a percentage of a hospital’s payment for each discharge would be contingent on the hospital’s actual performance on a specific set of measures. Currently, Medicare pays a set amount for each discharge, whereas under VBP, amounts would be linked to quality of services provided, not just quantity of service. Changing Medicare’s hospital payment methodology to reflect CMS’ implementation plan for VBP requires new legislation. Hospitals participating in HQID have volunteered to report their quality data for the following five high-volume inpatient conditions using national measures of quality care: acute myocardial infarction (AMI/heart attack); coronary artery bypass graft; heart failure; pneumonia; hip and knee replacement. More than 30 nationally defined, standardized, risk-adjusted measures representing process of care and patient outcomes are being tracked to evaluate whether the care provided consistently meets accepted evidence-based practice standards. Individual hospital improvements are striking. Fifteen hospitals moved from “worst to first” rankings, moving from the bottom to the top fifth of hospitals in one or more clinical areas. These hospitals improved by an average 32.6 percentage points in quality scores over three years. The quality measures were developed by government and private organizations, such as the National Quality Forum, the American Hospital Association and the Leapfrog Group. In addition, they have been tested by CMS, the Joint Commission on Accreditation of Healthcare Organizations and the Agency for Health Research Quality. The total increment in average composite quality scores CQS over HQID’s first three years is 15.8 percentage points. Between HQID’s second and third years, the average CQS increase is 4.4 percentage points. The top-performing 112 hospitals earned a total of $7.0 million in incentive payments for substantial and continual advancement in quality of care. For the third year of HQID, Sacred Heart Medical Center, in Spokane, WA, received the highest quality incentive payment of $385,342 for achieving top performance in four of the five clinical areas. CMS has awarded more than $24.5 million over the first three years of the project. The HQID project was extended by CMS for an additional three years through September 2009. For complete information about the HQID project and to view a list of those hospitals ranking in the top 50 percent in each focus area, visit www.cms.hhs.gov/HospitalQualityInits.
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If you need further information on any of the items in the Federal Health Update, please contact Kate Connelly Theroux at (703) 447-3257 or by e-mail at katetheroux@fedhealthinst.org. To subscribe, please visit http://fedhealthinst.org/subscriber.cfm. To unsubscribe, please send an email to newsletter@fedhealthinst.org with UNSUBSCRIBE as the subject. Back issues availiable at Federal Health Update Archives. |
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