FEDERAL HEALTH UPDATE
Sep 4, 2009Produced 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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Executive and Congressional News
Military Health Care News
Beck began working for the MHS in 1999 when she transformed an existing DoD Gulf War illness Web site into the Force Health Protection and Readiness site. In 2007 Dr. S. Ward Casscells, then assistant secretary of defense for health affairs, tasked Beck to create an interactive, user-friendly site for the MHS (www.health.mil). The site, which received virtually zero visits in 2007, has averaged 190,000 hits a month this year. It incorporates Web 2.0 features such as a blog and video while also interfacing with outside applications such as Facebook and Twitter. The honor, which recognizes civilian
and government employees in the first third of their career who have
made a considerable contribution to the government information technology
community, was awarded to 28 individuals, more than half of whom are
associated with the DoD. http://www.health.mil/Press/
In a global effort to treat leishmaniasis, the DoD signed a cooperative test and evaluation project agreement with the French Republic Minister of Defense to further the development of "topical paromomycin + gentamicin cream," a new drug being developed by the U.S. Army for the treatment of simple and non-complicated cutaneous leishmaniasis. Cutaneous leishmaniasis is a neglected disease of military significance and a major public health challenge in the Middle East, Mediterranean basin and Latin America. According to the World Health Organization, leishmaniasis is endemic in 88 countries and the population at risk is more than 350 million. The disease is a vector-borne protozoal infection of the skin and mucosal tissues, and infection can result in chronic, and sometimes disfiguring, necrotic lesions. The U.S. and French militaries require a safe and simple treatment for cutaneous leishmaniasis, as there is no prophylactic pharmaceutical or vaccine available and there are no FDA-approved therapeutic drugs for cutaneous leishmaniasis. Currently, available treatment options include the use of intravenous sodium stibogluconate, a drug that has been used since 1912 as an investigational drug, and whose active ingredient is based on the metal antimony. The other option is amphotericin B, which is not FDA-approved for treating cutaneous leishmaniasis. As part of this new
agreement, the U.S. will provide the drug to the French military in
order to sponsor and conduct clinical trials with “topical paromomycin
+ gentamicin cream" in French Guiana. The U.S. and French will
share medical information and results from the clinical trials.
The congressionally directed task force will address trends and causal factors, methods to update prevention and education programs, suicide assessment by occupation, suicide incident investigations, and protective measures for confidential information derived from investigations for the department. The task force will operate within the Federal Advisory Committee Act guidelines as a subcommittee of the Defense Health Board, responsible to the Secretary of Defense, through the assistant secretary of defense for health affairs and the under secretary of defense for personnel and readiness. Membership consists of DoD and non-DoD experts, including at least one representative each from the Army, Navy, Air Force and Marine Corps and one family member with a background in working with military families. The task force will present their findings and recommendations to the secretary of defense within twelve months. Following review by the secretary, the task force’s report and recommendations will be sent to Congress. The names and biographies of the
task force members are available on the Military Health Care Web site
at http://www.health.mil/dhb/
The DMRDP Applied Research and Advanced Technology Development Award is being offered for the first time in FY10 and anticipates that approximately $97 million will be available to support both intramural and extramural applied research and advanced technology development. The goal of the DMRDP is to advance the state of medical science in those areas of most pressing need and relevance to today’s battlefield experience. The objectives of the DMRDP are to discover and explore innovative approaches to protect, support and advance the health and welfare of military personnel, families and communities; to accelerate the transition of medical technologies into deployed products; and to accelerate the translation of advances in knowledge into new standards of care for injury prevention, treatment of casualties, rehabilitation and training systems that can be applied in theater or in the clinical facilities of the Military Health System (MHS). To view the solicitation, please
visit http://www.grants.gov/search/ Veterans Health Care News
VA listed several reasons for not exercising the contract option, including UTSWMC's persistent and continuing noncompliance with contract terms and conditions and detailed documentation by the contracting officer of performance deficiencies. VA also noted that its Office of Inspector General documented severe performance deficiencies in a July 15 report and recommended that no further task orders be issued under the contract. VA will meet with UTSWMC contract staff on today to provide guidance for completing work in progress and submitting adequate documentation to allow payment. UTSWMC will be allowed to fulfill task orders already in progress if it corrects all performance deficiencies. The decision not to continue the contract means VA's research program will be able to redirect funds to support additional research into GWVI. In 2010, that research will include a genomic study to identify susceptibility factors and markers of GWVI; studies of similarities and differences with chronic fatigue syndrome and fibromyalgia; studies of new diagnostic tests; identification of sub-populations of ill Gulf War Veterans; and studies of potential new treatments. The redirected funding for these
new VA research initiatives will be in addition to the substantial support
VA already provides for GWVI research — $7 million in 2008 and $4.8
million so far in 2009.
VA employees were still trying to determine exactly how many veterans mistakenly received letters intended to inform people with ALS, or Lou Gehrig's disease, of benefits available to them or surviving spouses and children. VA officials said the department
mailed more than 1,800 letters last week and had been notified by fewer
than 10 veterans who received them in error. But the National Gulf War
Resource Center, a veterans group, said at least 1,200 veterans received
the letters by mistake.
The VA published a proposed regulation in the Aug. 24, 2009, Federal Register to make it easier for a veteran to claim service connection for PTSD by reducing the evidence needed if the stressor claimed by a veteran is related to fear of hostile military or terrorist activity. Under the new rule, VA would not require corroboration of a stressor related to fear of hostile military or terrorist activity if a VA psychiatrist or psychologist confirms that the stressful experience recalled by a veteran adequately supports a diagnosis of PTSD and the veteran's symptoms are related to the claimed stressor. Previously, claims adjudicators were required to corroborate that a non-combat veteran actually experienced a stressor related to hostile military activity. This rule would simplify the development that is required for these cases. PTSD is a recognized anxiety disorder that can follow seeing or experiencing an event that involves actual or threatened death or serious injury to which a person responds with intense fear, helplessness or horror, and is not uncommon in war. Comments on the proposed
rule will be accepted over the next 60 days. A final regulation will
be published after consideration of all comments received.
The VA has leased 2.4 acres to a private-sector medical facility in exchange for construction of a 30,000 square-foot building for the Department of Veterans Affairs (VA) at its Samuel S. Stratton VA Medical Center. The new building, to be used by VA for administrative functions and training, will free up space for veterans' clinical services elsewhere on the campus. Meanwhile, the VA-affiliated Albany Medical Center will use the leased federal land to build a needed parking garage to serve the larger community with a potential for retail use in some of the space. VA's Samuel S. Stratton
Medical Center serves veterans in 22 counties of upstate New York, western
Massachusetts and Vermont. It provides primary care, wellness and preventive
outpatient care, and the full range of inpatient medical care, including
specialty services.
The estimated total cost for the project is nearly $810,000, with VA’s grant covering 65 percent of the cost. The Wisconsin Department of Veterans Affairs agreed to enter into a contract for the improvements within 90 days of an agreement with VA. Last year, VA spent more than $1.4
billion in Wisconsin on behalf of the state's 437,000 Veterans. VA operates
major medical centers in Madison, Milwaukee and Tomah, 17 outpatient
clinics, two Vet Centers and the national cemetery in Wood.
Called Veterans Chat, the new service enables veterans, their families and friends to go online where they can anonymously chat with a trained VA counselor. If a "chatter" is determined to be in a crisis, the counselor can take immediate steps to transfer the person to the VA Suicide Prevention Hotline, where further counseling and referral services are provided and crisis intervention steps can be taken. Veterans, family members or friends
can access Veterans Chat through the suicide prevention Web site
(www. The pilot program, which has been in operation since July 3, allows veterans to retain anonymity by entering whatever names they choose once they enter the one-on-one chat. They are then joined by a counselor who is trained to provide information and respond to the requests and concerns of the caller. Both Veterans Chat and the VA's Suicide Prevention Hotline have been established under the National Suicide Prevention Lifeline, which was established through collaboration between VA and the Substance Abuse and Mental Health Services Administration (SAMHSA) of the Department of Health and Human Services. If the counselor decides the caller is in a crisis, the counselor will encourage the veteran to call the Suicide Prevention Hotline, where a trained suicide prevention counselor will determine whether crisis intervention techniques are required. Since becoming operational in July
2007, VA's Suicide Prevention Hotline has received more than 150,000
calls, resulting in 4,000 rescues.
The clinic is aimed at introducing recently injured veterans to adaptive sports and renewing their self confidence through sporting activities. Events at this rehabilitation clinic include adaptive kayaking, sailing, track and field, cycling and surfing, using venues throughout San Diego, including the U.S. Olympic Training Center. Participation is open to military veterans who are eligible for VA medical care and who have orthopedic amputations, traumatic brain injuries, burn injuries, psychological trauma, certain neurological conditions, visual impairment, spinal cord injuries and other injuries incurred in the last six years. This clinic, hosted by the VA San Diego Healthcare System, is one of VA’s six rehabilitation events held each year. For more information, visit www.summersportsclinic.va.gov. Health Care News
Pharmacia & Upjohn Company has agreed to plead guilty to a felony violation of the Food, Drug and Cosmetic Act for misbranding Bextra with the intent to defraud or mislead. Bextra is an anti-inflammatory drug that Pfizer pulled from the market in 2005. Under the provisions of the Food, Drug and Cosmetic Act, a company must specify the intended uses of a product in its new drug application to FDA. Once approved, the drug may not be marketed or promoted for so-called “off-label” uses – i.e., any use not specified in an application and approved by FDA. Pfizer promoted the sale of Bextra for several uses and dosages that the FDA specifically declined to approve due to safety concerns. The company will pay a criminal fine of $1.195 billion, the largest criminal fine ever imposed in the United States for any matter. Pharmacia & Upjohn will also forfeit $105 million, for a total criminal resolution of $1.3 billion. In addition, Pfizer has agreed to pay $1 billion to resolve allegations under the civil False Claims Act that the company illegally promoted four drugs — Bextra; Geodon, an anti-psychotic drug; Zyvox, an antibiotic; and Lyrica, an anti-epileptic drug — and caused false claims to be submitted to government health care programs for uses that were not medically accepted indications and therefore not covered by those programs. The civil settlement also resolves allegations that Pfizer paid kickbacks to health care providers to induce them to prescribe these, as well as other, drugs. The federal share of the civil settlement is $668,514,830 and the state Medicaid share of the civil settlement is $331,485,170. This is the largest civil fraud settlement in history against a pharmaceutical company. As part of the settlement, Pfizer also has agreed to enter into an expansive corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services. That agreement provides for procedures and reviews to be put in place to avoid and promptly detect conduct similar to that which gave rise to this matter. The U.S. Attorney’s offices for
the District of Massachusetts, the Eastern District of Pennsylvania,
and the Eastern District of Kentucky, and the Civil Division of the
Department of Justice handled these cases. http://www.hhs.gov/news/press/
Funded through the National Cancer Institute, the National Human Genome Research Institute, the other centers across NIH, the "Exploratory Innovations in Biomedical Computational Science and Technology" program will be coordinated by the NIH Biomedical Information Science and Technology Initiative committee. Under the program, NIH will grant up to $275,000 over two years to academic institutes, small businesses, non-profits, state governments and other groups to conduct research aimed at rapidly advancing informatics and computational biology goals in database design, querying approaches, data retrieval, visualization and integration. Areas of interest include approaches
for handling data from genomic sequencing studies, gene expression,
proteomics, pathway data, biomedical imaging and other areas.
The conference focused on the use of family history in the primary care setting for common diseases such as diabetes, stroke, cancer, and heart disease. The 16-member conference panel included experts in the fields of family medicine, population health, pediatrics, obstetrics and gynecology, health economics, epidemiology, biostatistics, genetic counseling, medical genetics, nursing, health informatics, endocrinology, behavioral science, ethics, health services and outcomes research, and a public representative. Reporting a positive history of a family disease or condition to a health care provider could prompt a range of next steps, from lifestyle changes including diet and exercise to referral to genetic services or other specialists. The panel perceived a need to approach their assessment from a balanced perspective, appreciating the potential for both benefits and harms of obtaining and acting upon family history information. The panel recognized the longstanding use and intuitive appeal of this relatively simple and noninvasive tool to try to improve health outcomes for at-risk individuals. The collection of a family history may also foster productive relationships between individuals and their clinicians. At the same time, the panel acknowledged theoretical harms, such as overtreatment and patient anxiety, should be taken into account. The panel's findings and recommendations were aimed primarily at the research and health professional communities, rather than the public at large, and intended to inform the research agenda rather than influence current clinical practice. The panel recognized that family history has an important role in the practice of medicine and may motivate positive lifestyle changes, enhance individual empowerment and influence clinical interventions. The panel found that it is unclear how this information can be effectively gathered and used in the primary care setting for common diseases. Additional research is needed to understand how the routine collection of family history will lead to improved health outcomes. To help address these gaps, the panel outlined several research recommendations in three categories: the family health information to be collected, the optimal way to collect and use it, and the outcomes of this tool for diagnosis and engagement with individuals and family members. The conference was sponsored by the NIH Office of Medical Applications of Research and the National Human Genome Research Institute along with other NIH and Department of Health and Human Services components. A complete listing of the panel members
and their institutional affiliations is included in the draft conference
statement. Additional materials, including panel bios, photos, and other
related resources, are available at http://consensus.nih.gov/ The panel released their findings
in a statement that is available at http://consensus.nih.gov.
The EUA allows the Department of Defense (DoD) to distribute the H1N1 test to its qualified laboratories that have the required equipment and trained personnel to perform the test and interpret its results. It authorizes the use of unapproved medical products or unapproved uses of approved medical products during a declared public health emergency. The U.S. Centers for Disease Control and Prevention (CDC) developed the test, which is called the CDC swH1N1 (swine) Influenza Real-Time RT-PCR. Under this new EUA, the DoD’s Joint Biological Agent Identification and Diagnostic System (JBAIDS) can be used to run the CDC’s test. The FDA previously cleared other assays for use on the JBAIDS beginning in 2005. For more information, please visit Department
of Defense Aug. 24, 2009, News Release on EUA.
The Tobacco Products Scientific Advisory Committee is tasked with providing advice, information and recommendations to the Commissioner of Food and Drugs on health and other issues relating to tobacco products. The committee will be asked to consider a variety of topics including:
The TPSAC will consist of 12 members, including the chair, to be selected by the Commissioner of Food and Drugs. The members will be experts knowledgeable in the fields of medicine, medical ethics, science or technology involving the manufacture, evaluation or use of tobacco products. There will be nine voting and three non-voting members. Of the nine voting members, seven will be health care professionals practicing in the area of oncology, pulmonology, cardiology, toxicology, pharmacology, addiction or any other relevant specialty. One member will be an officer or employee of a state or local government or the federal government, and the final member will be a representative of the general public. The three non-voting members will be identified with industry interests. These members will include one representative of the tobacco manufacturing industry, one representative of the tobacco growers and one representative of the small business manufacturing industry. The announcement was published in
the Aug. 25, 2009 Federal Register.
The Presidential Advisory Council on HIV/AIDS (PACHA) provides advice, information, and recommendations to the Secretary of Health and Human Service and the President regarding programs and policies intended to promote effective prevention of HIV disease, to advance research on HIV and AIDS, and to promote quality services to persons living with HIV and AIDS. The role of the Council is solely advisory. The Secretary provides the President with copies of all written reports provided by the Council. Helene D. Gayle is president and CEO of CARE USA and is an internationally recognized expert on health, global development and humanitarian issues. Dr. Gayle spent 20 years with the Centers for Disease Control and Prevention (CDC), focused primarily on combating HIV/AIDS, in a variety of roles involving research, programs and policy. She was appointed as the first director of the National Center for HIV, STD and TB Prevention and achieved the rank of Rear Admiral and Assistant Surgeon General in the U.S. Public Health Service. Dr. Gayle earned a B.A. in psychology
at Barnard College, an M.D. from the University of Pennsylvania and
an M.P.H. from Johns Hopkins University. She is board certified in pediatrics,
completing a residency in pediatric medicine at the Children’s Hospital
National Medical Center in Washington, DC. She has been honored with
awards from Johns Hopkins University, Columbia University, Cable Positive,
the Eleanor Roosevelt Center at Val-Kill, the Arthur Ashe Institute
for Urban Health and the U.S. Public Health Service, among others. She
holds faculty appointments at the University of Washington School of
Public Health and Emory University School of Medicine.
Overseen by the Health Resources and Services Administration (HRSA), the Health Center system served more than 17 million medically underserved people in 2008, up from 10 million patients served in 2001. Since the economic downturn began, the health center patient population has grown by another one million people — a third of them children. By law, patients are accepted regardless of their ability to pay. A total of 180 grants worth more than $21.9 million will give existing health centers the funds to add or increase mental health/substance abuse, enabling (i.e., outreach, transportation and case management services), oral health or pharmacy services. Additionally, 48 planning grants totaling more than $3.8 million will be distributed to organizations in hard hit areas that do not have health centers to help them develop new service delivery sites. New health center sites must meet federal requirements for governance, community involvement, quality of care and financial feasibility. HRSA’s Health Center Program funds a national network of more than 1,100 community, migrant, homeless and public housing health center grantees. These organizations provide health care at more than 7,500 clinical sites, ranging from large medical facilities to mobile vans. In FY 2009, more than $2.1 billion was appropriated to support the Health Center Program. For a list of grants awarded, please
visit http://www.hhs.gov/news/press/
The purpose of these cooperative centers, which collectively will receive funding up to $100 million over five years, is to characterize the human immune system under normal conditions and to understand how it changes following infection or vaccination. NIAID will launch this new research initiative in 2010, with the funding for the first year of the initiative coming from the American Recovery and Reinvestment Act. Researchers will examine various elements of the immune system — including white blood cell subsets, signaling molecules and antibodies — after exposure to either infectious agents such as viruses or bacteria or to the components of a vaccine, including vaccine boosters known as adjuvants. By doing so, immunologists can identify specific patterns of the various subsets of white blood cells and immune molecules that reflect the status and function of the immune system under different conditions. The new program will exploit research approaches that have only recently become available such as systems biology, which integrates information about an organism’s genes, proteins and metabolism with data from the host. In addition, the initiative will provide support for centralized infrastructure to collect, characterize, and store the human samples; for bioinformatic capacity to analyze the large and complex data sets that will be generated; and for the discovery and development of new immune response monitoring tools and sample-sparing assays. The activities described in this
release are supported by funds provided to NIH through the American
Recovery and Reinvestment Act (ARRA). More information about NIH’s
ARRA grant funding opportunities can be found at NIH Recovery Act Grant Information
page.
During the spring, the Sesame Workshop produced four different versions of a television PSAs featuring Sesame Street’s Elmo and Gordon explaining the importance of practicing healthy habits such as washing hands, sneezing into the bend of an arm, and avoiding contact with eyes, nose and mouth. They have now been reformatted to promote www.flu.gov, the federal government’s one-stop Web site for all the latest information on the new H1N1 virus and the seasonal flu. The PSAs will be distributed nationwide and will be supported in airtime donated by television stations. In late May, Sesame Workshop first partnered with HHS on a new PSA campaign focused on the importance of providing parents, teachers and children with accurate information about how to practice healthy habits, highlighting proper hand washing and simple everyday actions that lead to staying healthy and keeping germs away. On a global scale, Sesame Workshop was the first nonprofit to respond to the flu outbreak in Mexico, with the immediate creation of four PSAs featuring the beloved Muppets of Plaza Sésamo and several Mexican celebrities who donated their time to the cause. The flu prevention messaging has reached millions of children and their families both in Mexico and the United States. The PSAs are part of an initiative to provide practical steps recommended by the Centers for Disease Control and Prevention (CDC) to help prevent the spread of the flu virus and other infectious disease. For more information on how to take
steps to prevent the flu, visit www.flu.gov.
AHRQ will interview physicians, medical directors, IT administrators, pharmacists and others at 110 organizations over two years, the agency said in a notice in the Sept. 1 Federal Register. AHRQ will accept comments on its plans until Oct. 1. All e-prescribing systems may not have the same range of features, and physicians may have problems deploying the software, AHRQ said. Several studies have shown that IT system limitations, workflow and training issues, and real or perceived regulatory barriers can be obstacles for physician practices and pharmacies. The AHRQ study will be the first to ask questions of physician practices and pharmacies in the same communities on the same topics, which should paint a much more complete picture of e-prescribing use. For example, in addition to gaining physician and pharmacy perspectives on electronic transmission, AHRQ will explore how physicians use data about the list of accepted drugs from the patient’s health plan and how pharmacies view changes in communication with physician practices about accepted drugs with e-prescribing. A 2008 Medicare improvements law authorized incentives for physicians who use e-prescribing. And the stimulus law provides for incentives for meaningful use of electronic health records, including e-prescribing. The study will help the Health and
Human Services Department, state and local government and private health
care organizations come up with valuable approaches to promote the adoption
and effective use of e-prescribing. http://www.govhealthit.com/
A review of 1,531 open post-marketing studies indicated that more than 80 percent are proceeding according to the established timelines, have been submitted for FDA review, or have been determined by the FDA to have met their goals or are no longer needed. The study, done under a contract with Booz Allen Hamilton and supported by additional funds from Congress, examined the backlog of industry post-marketing studies for FDA-approved drugs and biologics. The review found that most companies meet their obligations in a timely manner. The study also recommended changes designed to improve the quality of the information submitted to the FDA, the timeliness of the FDA review and the accuracy of the FDA’s databases. The agency is evaluating the recommendations and already has made significant improvements based upon the study:
Under the Food and Drug Administration Amendments Act of 2007, the FDA must undertake such a review annually. The review showed that the industry has been initiating most studies on time and submitting final reports for many studies, as required. Many of these reports are pending completion of a thorough FDA review. The FDA will continue to work with Booz Allen Hamilton to complete the agency’s review of all submitted reports in a timely manner. Manufacturers of drugs and biologics
are also required to report to the FDA in a timely manner any serious
safety issues that are identified from studies or other sources. http://www.fda.gov/NewsEvents/ Reserve/Guard
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