FEDERAL HEALTH UPDATE
August 8, 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
Every four years, DoD commissions complete a review of compensation principles and concepts for members of the armed forces. The 10th QRMC began in 2006. The second part of the QRMC reviewed non-cash and deferred compensation, focusing on the following four topics: retirement, TRICARE, recruiting and retention incentives for health care professionals, and quality of life. Recommendations include:
DoD will study the recommendations for potential implementation and send selected proposals to Congress as proposed legislation. This is the second volume of the study, covering non-cash and deferred compensation. The first volume was released in March and focused on the following cash compensation areas: pay comparability, special and incentive pays, pay for performance and housing. Full recommendations, in greater detail, can be viewed on the Web at http://www.defenselink.mil/news/QRMCreport.pdf .
More than 1.5 million troops have deployed to Iraq and Afghanistan since 2001. The DoD estimates that up to 15-20 percent of returning troops have problems after returning home. Irritability, depression, increased stress, and relationship difficulties are the typical concerns faced by service members and their families following a deployment. Multiple reports have highlighted the need for Web-based behavioral health tools to reach the many service members who do not seek out face-to-face care. In addition to barriers to care, such as scheduling appointments or getting time off from work, or transportation costs, many service members fear the stigma that talking to a counselor will damage a career or be seen as a sign of weakness. In recent months, DoD has taken steps to combat the stigma associated with obtaining necessary mental health treatment. In May 2008, DoD officials announced that applicants for government security clearances would not have to report mental health treatment for their combat-related injuries on their applications. The Web site offers self-care tools for the entire military community 24/7 anywhere an internet connection is available. The materials can be used anonymously. Additionally, military leadership and health care providers can tap the site’s materials to learn about common problems and change strategies and to obtain useful contact information concerning local resources. AD’s twelve programs focus on: Adjusting to War Memories; Dealing with Depression; Handling Stress; Improving Relationships; Succeeding at Work; Overcoming Anger; Sleeping Better; Controlling Alcohol and Drugs; Helping Kids Deal with Deployment; Seeking Spiritual Fitness; Living with Physical Injuries; and Balancing Your Life. Self-assessments provide tailored feedback and recommendations. AD’s intended outreach includes active duty service members, veterans, and their families. The site offers particular advantages for National Guard and Reserve units, who may be distant from a Military Treatment Facility or otherwise located in areas lacking providers who are knowledgeable concerning military-related adjustment concerns. In addition to AD’s initial public release on Aug. 5, 2008, the fully functional site is expected to be released late-September 2008. Phase 3 project development will commence in October 2008. http://www.health.mil/Press/Release.aspx?ID=301
Cognitive rehabilitation is proven to improve brain function following traumatic brain injuries, which can negatively affect concentration, memory and problem-solving and decisionmaking abilities. As many as 320,000 troops returning from Iraq and Afghanistan may be affected by TBI. Without a change in the current TRICARE policy, these service members will not have access to cognitive rehabilitation therapy to treat their injuries. Along with McCaskill, Senators Evan Bayh (D-Ind.), Barack Obama (D-Ill.), Hillary Clinton (D-N.Y.), Ken Salazar (D-Colo.), Ted Kennedy (D-Mass.), Joe Lieberman (I-Conn.), Jeff Bingaman (D-N.M.), John Kerry (D-Mass.), and Blanche Lincoln (D-Ark.) signed the letter. http://mccaskill.senate.gov/newsroom/record.cfm?id=301821
The money — the most spent in one year on military medical research since a $210 million breast cancer study in 1993 — will fund 171 research projects on two of the most prevalent injuries of the Iraq and Afghanistan wars. By contrast, the National Institutes of Health spends about $80 million per year on TBI research. According to Gregory O'Shanick, national medical director for the Brain Injury Association of America, the research will not only help service members but also help civilian victims. An estimated 1.4 million Americans suffer TBI each year, leaving 235,000 hospitalized and 50,000 dead, according to the Centers for Disease Control and Prevention. The majority are mild cases that can often lead to recovery. Many others suffer lasting damage to their short-term memory and problem-solving abilities, researchers say. The new research focuses considerable attention on mild TBI, says Navy Capt. E. Melissa Kaime, head of the Congressionally Directed Medical Research Programs office, which is distributing the funds. The studies should be completed in 18 months to five years. Projects range from the development of an eyeglasses-like device that can detect brain injury through eye movement to coordinated studies of troops and veterans at locations across the country. The Pentagon also will target new ways of delivering therapy to PTSD victims living in remote areas of the U.S. and reducing the stigma that can keep victims from seeking help. In addition, funding will go toward evaluating up to 20 different medications for TBI and studying ways of regenerating damaged brain cells. Half of the $300 million in Pentagon funds has been distributed and all will be paid out by Sept. 30. Congress has provided an additional $273.8 million this year to study battlefield injuries, some of which will also go toward researching PTSD and TBI.
Prior to his arrival at Martin, Blanck, Mr. Moore served in several senior positions in the Department of Homeland Security’s Transportation Security Administration. Mr. Moore brings extensive experience in homeland security policy, aviation transportation programs, regulatory policies, staffing solutions, industry stakeholder relationship management and networking, government relations, and project management. Mr. Moore holds a J.D. in law from New England School of Law in Boston, Mass., and has a B.A. in Economics from Villanova University.
The purpose of FLITE is to standardize business practices and modernize information technology that supports financial and asset management. The program has two components — Strategic Asset Management (SAM) and Integrated Financial Accounting System (IFAS). Both components are Web-based and will automate many manual procedures. The RFPs released are for the SAM component. One is for the SAM pilot implementation at the Milwaukee VA Medical Center; the other is for hardware to support the SAM application. The SAM project will use the VA-owned Maximo software application to manage all classes of physical assets, supply inventories and work management activities. The release of the SAM RFPs moves the FLITE Program from the planning phase to the development phase and begins a multi-year process to consolidate asset management and improve access to data for decisionmaking, evaluation and action. VA expects to release RFPs for hosting and implementing the pilot for the IFAS project and program management support services in the near future. http://www1.va.gov/opa/pressrel/pressrelease.cfm?id=1546
The Office of the Inspector General of the Department of Veterans Affairs (VA) released its findings in a report on human subject protection violations at the Central Arkansas Veterans Healthcare System in Little Rock. The studies involved thousands of veterans who had volunteered for behavioral and drug experiments. The investigation, which began last August, reviewed more than a half-dozen human experiments including studies of colon, breast and prostate cancer, which had been conducted since 2006. It found that entire consent forms were missing, signatures were missing from consent forms, HIV testing was conducted without documented consent and research officials failed to obtain witness signatures in a study involving patients with dementia. Additionally, the investigation found that researchers had failed to report “serious adverse events” during the experiments, including the deaths of 105 veterans. The researchers were required to report such events, regardless of whether they were accidental or linked to the experiments, to the Institutional Review Board. The board, which conducted oversight of the experiments, had been implemented and operated by the University of Arkansas for Medical Sciences but was transferred to the VA after the investigation began. The VA created a review board and halted all new experiments involving human subjects. http://www.washingtontimes.com/news/2008/aug/05/violations-rife-in-hospitals-studies-on-veterans/
The findings, which appear online in the journal Cancer, are the first to link the herbicide with this form of cancer. The research is also the first to utilize a large population of men in their 60s and the prostate-specific antigen (PSA) test to screen for the disease. The patients in the current study were entering their prime years for developing prostate cancer. There was also the added factor that it was conducted entirely during the era of PSA screening, providing a powerful tool for early diagnosis and tracking of prostate cancer. More than 13,000 Vietnam veterans enrolled in the VA Northern California Health Care System were stratified into two groups — exposed or not exposed to Agent Orange between 1962 and 1971. Based on medical evaluations conducted between 1998 and 2006, the study revealed that twice as many men exposed to Agent Orange were identified with prostate cancer. In addition, Agent Orange-exposed men were diagnosed two-and-a-half years younger and were nearly four times more likely to present with metastatic disease. Other prostate cancer risk factors — race, body-mass index and smoking — were not statistically different between the two groups. Now a banned chemical, Agent Orange is a combination of two synthetic compounds known to be contaminated with the dioxin tetrachlorodibenzo-para-dioxin (TCDD) during the manufacturing process. Named for the color of the barrel in which it was stored, Agent Orange was one of many broad-leaf defoliants used in Vietnam to destroy dense forests in order to better visualize enemy activity. It is estimated that more than 20 million gallons of the chemicals, also known as "rainbow herbicides," were sprayed between 1962 and 1971, contaminating both ground cover and ground troops. Most of the rainbow herbicide used during this time was Agent Orange. In 1997, the International Agency for Research on Cancer reclassified TCDD as a group 1 carcinogen, a classification that includes arsenic, asbestos and gamma radiation. Prostate cancer is the second most common malignancy and the second leading cause of cancer death in American men. It is estimated that there will be about 186,320 new cases of prostate cancer in the United States in 2008 and about 28,660 men will die of the disease this year. http://www.sciencedaily.com/releases/2008/08/080805092016.htm#
The policies and procedures are described in four final guidance documents, and proposed changes in policies are described in a draft guidance. The FDA announced the availability of the guidance documents in Aug. 5, 2008 Federal Register; copies of all of the guidances are available on FDA’s Web site. Most of the changes in the final guidance documents will go into effect immediately, and all are expected to be fully implemented within 120 days. FDA advisory committees are panels of independent, outside experts who advise agency officials as they consider regulatory decisions involving complex medical and scientific issues. Last year, FDA convened 48 meetings of advisory committees on topics ranging from the safety of diabetes medications to the evaluation of new anticancer drugs for use in children. Two of the guidance documents address FDA's processes for evaluating and disclosing information about potential conflicts of interest and FDA waivers allowing participation in advisory committee meetings. Prior to each meeting, advisory committee members are screened by FDA staff to determine whether they have a potential financial conflict of interest, such as grants, stock holdings and contracts with a company that would be affected by the committee’s recommendations. FDA is instituting a cap of $50,000 as the maximum personal financial interest an advisor may have in all companies that may be affected by a particular meeting. If an advisor’s personal financial interest is greater than $50,000, he or she will not be allowed to participate in that meeting. If less than $50,000, FDA officials may, in certain situations, grant a waiver, but will do so only if they determine that there is an essential need for the advisor’s particular expertise. Waivers, which include a description of the advisor’s personal financial interest and why the need for the expertise was essential, will be posted on the FDA’s Web site in advance of the meeting. FDA intends to use new templates for waivers and financial interest disclosure that will make them clearer and more consistent. Another change addresses the public availability of briefing materials, the background information provided to advisory committee members in advance of a meeting. All advisory committee briefing materials will be posted prior to a meeting on the FDA’s Web site at least 48 hours before the meeting is scheduled to occur. The agency also issued recommendations addressing the way that advisory committees will vote on questions, so as to avoid even the perception of any manipulation of votes. It is recommended that advisory committees use a process of simultaneous voting, in which all members vote at once. The agency also recommends that the results of votes be announced immediately in the meeting, and FDA intends to post on the FDA Web site a list indicating how each member voted. Any posted list will be part of the permanent record of the meeting. FDA also proposed new criteria to clarify when the agency should refer a matter to an advisory committee. In some instances FDA is required by law to refer a matter to an advisory committee. In other instances, FDA would consider these new criteria when deciding whether to refer a matter to an advisory committee. The draft guidance being published for public comment is designed to make FDA’s advisory committee process more predictable and transparent. The agency also has made improvements to the advisory committee Web site to make it easier for users to access news on advisory committee meeting dates, agendas, financial disclosures and briefing materials. http://www.fda.gov/bbs/topics/NEWS/2008/NEW01871.html
The Task Force found evidence that screening for prostate cancer provided few health benefits but led to substantial physical harm and some psychological harm in men age 75 and older. In men younger than 75, the Task Force concluded that current evidence is insufficient to assess the balance of benefits and harm of prostate cancer screening. An estimated 218,890 U.S. men were diagnosed with prostate cancer in 2007. and one in six men will be diagnosed in his lifetime. Screening for prostate cancer is most often performed using PSA tests and digital rectal exams. The PSA test is more likely to detect prostate cancer than the digital rectal exam. However, prostate cancers that are found with a PSA test take years to affect health; most prostate cancers that grow serious enough to cause death take more than 10 years to do so. Since a 75-year-old man has an average life expectancy of about 10 years and is more likely to die from other causes such as heart disease or stroke, prostate cancer screening is unlikely to help men over 75 live longer. For the same reasons, men younger than 75 with chronic medical problems and a life expectancy of fewer than 10 years are also unlikely to benefit from screening. There is also harm associated with prostate cancer screening, which includes biopsies, unnecessary treatment and false-positive results that may lead to anxiety. Complications often result from treating prostate cancer and may include urinary incontinence and impotence. These slow-growing cancers may never have affected a patient's health or well-being had they not been detected by screening. Current data show that one-third of all men in the United States over 75 are receiving PSA testing. Although most major medical organizations suggest that prostate cancer screening may be discontinued in men with a life expectancy of fewer than 10 years, the Task Force is the first group to define an explicit age cutoff above which screening is likely to be ineffective or harmful. The results of two ongoing clinical trials—the National Cancer Institute's Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial and the European Study of Screening for Prostate Cancer—should help to clarify the potential benefits of screening in men under the age of 75. http://www.ahrq.gov/news/press/pr2008/tfproscanpr.htm
Twenty-eight new Nurse Education Practice and Retention Program grants worth $8.5 million were awarded to 25 academic institutions and three hospital organizations. These grants support initiatives to address the nursing shortage by strengthening capacity for nurse education, practice and retention. Two new grants totaling almost $600,000 for “Faculty Development: Integrated Technology into Nursing Education and Practice Initiative” went to Drexel University in Philadelphia for $299,834 and the University of Washington, Seattle, Wash., for $299,633. These grant funds support nursing collaboratives — partnerships among collegiate schools of nursing, academic health centers, accredited public or private institutions and other organizations — to help nursing faculty integrate technologies related to simulated learning, informatics and tele-health into the nursing curriculum. Nine new Nursing Workforce Diversity Program awards totaling $2.8 million were made to seven universities and two community colleges. Among other things, funds help educate and support pre-nursing and nursing students from disadvantaged backgrounds, including racial and ethnic minorities underrepresented among registered nurses. In addition, several grant projects have identified students at the middle school or high school level to take part in summer enrichment programs on nursing school campuses or participate in job-shadowing in a clinical nursing setting. During the school year, the program helps enrolled youngsters establish Future Nurses Clubs, attend career fairs and weekend “nursing academies,” or receive tutoring to pass exams for college entry. To view the list of awardees, please visit: http://newsroom.hrsa.gov/releases/2008/nursingfacility.htm
The study, A National Study of Chronic Disease Prevalence and Access to Care in Uninsured U.S. Adults, was led by Andrew Wilper of the University of Washington-Seattle. He and his colleagues analyzed health surveys of adults ages 18 to 64 conducted by the federal government. The researchers found that about 11 million people out of the 36 million people who reported having no health insurance in 2004 — the latest data examined by the study — had been diagnosed with a chronic condition. However, researchers noted the estimate likely is low because it does not factor in uninsured U.S. residents who have a chronic condition with which they have not yet been diagnosed. The study also found that fewer than 25 percent of the uninsured with a chronic condition reported seeing a physician within the previous year and that about seven percent said they would visit the emergency department if they needed care. The study's authors said, “For some of the 11.4 million uninsured Americans with serious chronic conditions, access to care seems to be unobtainable; many may face early disability and death as a result.”
The six vaccines and their manufacturers are: CSL Limited, Afluria; GlaxoSmithKline Biologicals, Fluarix; ID Biomedical Corporation of Quebec, FluLaval; MedImmune Vaccines Inc., FluMist; Novartis Vaccines and Diagnostics Limited, Fluvirin; and Sanofi Pasteur Inc., Fluzone. Approval information and specific indications can be found at http://www.fda.gov/cber/flu/flu2008.htm. This season's vaccines contain three strains of the influenza virus that disease experts expect to be the most likely cause of the flu in the United States. Each season's vaccines are modified to reflect the virus strains most likely to be circulating—the closer the match between the circulating strains and the strains in the vaccines, the better the protection. The FDA changed all three strains for this year's influenza vaccine—an unusual occurrence, as usually only one or two strains are updated from year to year. Two of the three strains recommended for the U.S. this year are now in use for the Southern Hemisphere's 2008 influenza season, which is currently underway. Each year, experts from the FDA, World Health Organization, U.S. Centers for Disease Control and Prevention (CDC) and other institutions study virus samples and patterns collected throughout the year from around the world in an effort to identify strains that may cause the most illness in the upcoming season. Based on those forecasts and on the recommendations of its Advisory Committee, the FDA each February decides on the three strains that manufacturers should include in their vaccines for the U.S. population. The FDA makes this decision early in the year so that manufacturers have enough time to produce the new vaccines. Vaccination remains the cornerstone of preventing influenza, a contagious respiratory illness caused by influenza viruses. According to the CDC, every year an average of 5 to 20 percent of the U.S. population gets the flu, more than 200,000 are hospitalized from flu complications and there are about 36,000 flu-related deaths. http://www.fda.gov/bbs/topics/NEWS/2008/NEW01872.html
Epilepsy affects an estimated 2.7 million people in the United States and costs about $15.5 billion in medical costs and lost or reduced earnings and productivity each year. The study found that nearly half (44 percent) of adults with active epilepsy reported having recent seizures. Of those, 65 percent said they had more than one seizure in the past three months. Inadequate medical treatment for epilepsy greatly increases a person’s risk for subsequent seizures, disability, injuries sustained during a seizure, and, in rare cases, death. However, many people with epilepsy lead normal productive lives. The study, which is based on state-specific data from the 2005 Behavioral Risk Factor Surveillance System, collected data from more than 120,000 adults 18 and older. Epilepsy is a chronic neurological condition that occurs when recurrent abnormal electrical activity in the brain causes involuntary changes involving body movement or function, sensation, awareness, or behavior. http://www.cdc.gov/media/pressrel/2008/r080807a.htm
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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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