FEDERAL HEALTH UPDATE
Jan 15, 2010Produced 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
The agreement reportedly clears one of the last major obstacles toward final passage of comprehensive health care legislation. The deal would temporarily exempt union health plans from a significant surtax on unusually generous health policies plans, giving union leaders time to negotiate new contracts. Additional details of the agreement were not immediately available. The “Cadillac tax” is a key source of financing for a proposal to dramatically expand health coverage to the uninsured. But it is also considered to be an important tool for reining in skyrocketing health care costs, and President Obama has insisted that it be included in the package. Labor leaders had threatened to campaign against any health care bill that included the tax. By one analysis, as many as one in four union members could have been affected by the version of the tax approved by the Senate. Under that proposal, family plans that cost more than $23,000 and individual policies that cost more than $8,500 would be subject to a 40 percent surtax. The tax would be imposed on the insurance company, but economists believe it would be passed on to workers. For years, a number of unions have negotiated more generous health benefits in lieu of higher wages. Last year, the average family policy in America cost $13,375, according to a survey by the Kaiser Family Foundation. The Senate bill would affect that tax threshold for people in high-cost states and for workers in high-risk professions. Union leaders argued that the proposed tax could affect small businesses and older workers. They also complained that the tax, which would raise nearly $150 billion over the next decade, was designed to strike an ever-growing number of health policies. Advocates argued that few people would pay the tax, because they would be more likely to choose less costly health insurance policies, a choice that would help drive overall health costs lower. Instead, much of the revenue is projected to come from higher income tax collections as employers shifted resources away from health care and into wages. But skeptics argued that workers might never see the extra money, and insisted on adjustments. Military Health Care News
The Navy is staffing the nearly 900-foot ship with hundreds of doctors, nurses and technicians from the National Naval Medical Center in Bethesda. The Comfort has 12 operating rooms and space for 1,000 hospital beds. The floating hospital will be on an open-ended humanitarian mission. The Comfort visited Haiti in April
as part of a four-month mission to the Caribbean and Latin America.
It also responded to the Sept. 11, 2001, terrorist attacks in New York
and to hurricanes Katrina and Rita in 2005.
The team, which includes U.S. military engineers, operational planners, and a command and control group and communication specialists, will arrive in Haiti on two C-130 Hercules aircraft. The team will work with U.S. embassy personnel as well as Haitian, United Nations and international officials to assess the situation and facilitate follow-on U.S. military support. SOUTHCOM is closely monitoring the situation and is working with the U.S. State Department, United States Agency for International Development and the Office of U.S. Foreign Disaster Assistance and other national and international agencies to determine how to best respond to this crisis. For more information about U.S. Southern
Command visit www.southcom.mil.
Subscribers can customize their accounts by choosing to receive as many or as few items as they like based on their beneficiary category or topics of interest. They can also decide whether they want to receive immediate notifications or daily, weekly or monthly summaries. Beneficiaries can create an account at www.tricare.mil/subscriptions, and choose their beneficiary category and the topics that appeal to them. Once registered, beneficiaries will receive the latest TRICARE news releases, benefit changes, podcasts, healthy lifestyle tips and pharmacy updates from TRICARE Communications. The subscription service also allows
users to subscribe to other Military Health System Web sites and other
health-related federal Web sites. Some of the Web sites currently available
include those from the Centers for Disease Control and Prevention and
Food and Drug Administration.
Dr. Kussman recently served as the undersecretary of health for the Veterans Health Administration (VHA) after a nearly 40-year career that includes military service, private practice in medicine and health care administration. Aetna created the Military Health Care Advisory Committee in 2007 to help guide its business relationships with the federal government, including its new contract with the Department of Defense’s TRICARE organization, providing health care for active duty service members, retirees and their families. Aetna’s Military Health Care Advisory Committee, which is comprised of former military officials, military physicians and others familiar with the health care needs of military personnel, wounded warriors and their families, has six additional external members:
As undersecretary of health for the
VA, Dr. Kussman led the nation’s largest integrated health care system,
which serves more than 5.5 million veterans and 7.7 million enrollees
throughout the United States. Dr. Kussman, who also served as a commander
of the Europe Regional Medical Command, command surgeon for the U.S.
Army Europe and TRICARE lead agent for Europe, will join the committee
immediately.
The objective of the event is to create a national, large-scale military medical event where healthcare professionals (all military branches, TRICARE and non-military) come to learn about new developments in a range of disciplines as well as gain insights and transparency into the continuum of care. Specific conference topics will include continuum of care panels and individual sessions on important issues such as pre-deployment care, golden hour care, assessment of and treatment for Traumatic Brain Injury (TBI) and Post Traumatic Stress Disorder (PTSD). MHCC is the culmination of the latest tactics, strategies, technologies, systems, treatments, processes and services for patient care. It is the only national, joint service, non-DoD convention and conference that provides in-depth, firsthand accounts from experts in each stage of the continuum. Targeting best practices and new developments in military healthcare, MHCC will deliver a multidisciplinary approach to combating the health issues of all warriors and their families. For more information on speaking,
exhibiting or attending IDGA’s Military Healthcare Convention &
Conference, please visit http://www.
The $13.6 million
is made up of two orders, under which Dynamics Research will perform
program evaluations and administrative and clinical services support
for TRICARE’s Defense Center of Excellence and Military Medical Support
Office over a three-year period. For the Defense Center of Excellence,
Dynamics Research will provide clinical and management analysis to help
conduct psychological health and traumatic brain injury program evaluations
and site visits. For the Military Medical Support Office, Dynamics Research
will provide clinical and administrative task support for the nurse
consultant and patient administration sections.
This study, Deployment and the Use of Mental Health Services among U.S. Army Wives, is the the largest study ever done on the emotional impact of war on Army wives. Those rates were higher among wives whose husband deployed longer than 11 months. Previous studies show considerable mental health problems in a large proportion of U.S. soldiers and Marines returning from Iraq and Afghanistan. The psychosocial burden on families of deployed military personnel is less well understood and perhaps not comparable to that of previous deployments, given current service conditions. Besides fear for the safety of their loved ones, spouses of deployed personnel often face challenges of maintaining a household, coping as a single parent, and experiencing marital strain due to a deployment-induced separation of an uncertain duration. Increased stress among military family members before, during and after deployment is a potential mechanism for the development of mental health problems. The association between stressful life events and the subsequent onset or recurrence of mental disorders, including depression, substance use and abuse, and bipolar disorder, is well documented, though not well studied in military families. Researchers examined electronic medical-record data for all outpatient medical visits between Jan. 1, 2003, and Dec.31, 2006, by wives of active-duty Army personnel who either received outpatient care at a U.S. military treatment facility or used military medical insurance for an outpatient medical visit at a nonmilitary health care facility. These patients were 18 to 48 years of age. The sample included close to 6.6 million outpatient visits by 250,626 wives, of whom almost 35 percent had at least one mental health diagnosis during the study period. Among women whose husbands were deployed during the study period, nearly 37 percent had at least one mental health diagnosis, as compared with 31 percent of women whose husbands were not deployed. Depression, anxiety, sleep disorder, and acute stress reaction and adjustment disorder were the most common diagnoses in both groups, but the percentage of spouses with one or more diagnoses in these categories during the study period was lower among spouses of non-deployed personnel. More than two thirds of the Army service members were deployed during this time, to Iraq only (55 percent), Afghanistan only (almost 7 percent), or both (7 percent). The remaining soldiers (31 percent) were not deployed. Veterans Health Care News
Secretary Shinseki’s award came amid the department’s massive payout of educational benefits to veterans under the Post-9/11 GI Bill. To date, more than 162,000 beneficiaries have received payments and over $1.3 billion dollars have been paid out. That program, along with plans to expand health benefits to an addition quarter-million Veterans previously not eligible, are part of Secretary Shinseki’s transformation of the VA into a more people-centric and results-driven organization. Past recipients of the Gold Good
Citizenship Medal include Presidents Truman, Ford and Carter.
Preliminary data from the Department of Veterans Affairs (VA) found that the suicide rate for these veterans went up 26 percent from 2005 to 2007. It's assumed that most of the veterans in this age group served in Iraq or Afghanistan. The data also showed that while this group of veterans was more likely to commit suicide in 2005 if they were using VA health care, they were less likely to do so two years later. Last year, the Army saw a record number of suicides. The VA calculated the numbers using
Centers of Disease Control and Prevention numbers from 16 states.
In the study, Morphine and PTSD Risk in Injured Combat Veterans, researchers explored whether morphine given during resuscitation or trauma care to injured U.S. military personnel affects the subsequent development of PTSD. Medical encounter forms and clinical records concerning 696 injured soldiers without serious traumatic brain injury were linked with assessments for PTSD made at military or private treatment facilities. These assessments occurred from 1 to 24 months after the injury; 243 soldiers received new PTSD diagnoses. After controlling for injury severity, amputation, mild traumatic brain injury and Glasgow Coma Scale score, the researchers found that receipt of morphine protected against the development of PTSD. Depending on the model used, odds ratios ranged from 0.49 to 0.67. The effects were not dependent on morphine dose. The study’s findings,
published in Jan. 13, 2010, edition of Journal Watch Psychiatry, are consistent with prior studies’
findings: that opiates interfere with or prevent memory consolidation
in animal models of conditioned fear.
The new coordinators will be added to the following locations, with the total number of coordinators in each location indicated in parenthesis:
The Federal Recovery Coordinators program was created in 2007 to assist service members, veterans and their families with access to care, services and benefits provided by the Department of Veterans Affairs (VA), Department of Defense (DoD), other federal agencies, states and the private sector. Currently, the coordinators work with 419 of the most seriously injured service members and veterans. The program is administered by VA and operated jointly with DoD. The program's clients include service members and veterans who are receiving acute care at military treatment facilities; diagnosed with specific injuries or conditions; considered at risk for psychological complication; or likely to benefit from a recovery plan. Health Care News
During an online presentation, the chair of the FDA’s Transparency Task Force, Principal Deputy FDA Commissioner Joshua Sharfstein, described a Web-based curriculum called “FDA Basics,” aimed at helping the public better understand what the agency does. The curriculum is accessible via a link on the FDA Web site. The curriculum includes:
In addition, senior officials from FDA product centers and offices will answer questions on various topics during future online sessions. Each of these sessions will be announced on the FDA Web site. In one of her first acts after assuming the office last spring, FDA Commissioner Margaret A. Hamburg, M.D., announced the formation of an internal task force to develop recommendations for enhancing the transparency of the FDA’s operations and decisionmaking processes. The Transparency Initiative was launched in response to the Obama administration’s commitment to an unprecedented level of openness in government and with the strong support of the Department of Health and Human Services. The task force will develop its recommendations in three phases. FDA Basics represents the result of the initial phase, to be followed by two additional phases. In phase two of the initiative, the task force intends to make recommendations to the commissioner regarding how to make information about agency activities more transparent, useful, and understandable to the public, in a manner compatible with the agency’s goal of protecting confidential information, as appropriate. In the final phase of the initiative, the task force intends to make recommendations to the commissioner regarding FDA’s transparency to regulated industries. For more information, please visit http://www.fda.gov/
Reports filed by hospitals, health care professionals and industry account for much of information that the FDA relies on regarding medical product safety. For a variety of reasons, these reports may be incomplete or not filed in a timely manner. The Sentinel System, once operational, is expected to bolster the FDA’s efforts in monitoring product safety. Sentinel will provide FDA with the ability to analyze information collected during the course of routine health care, such as data from electronic health record systems, administrative and insurance claims databases and medical registries. The one-year contract with Harvard Pilgrim, based in Wellesley, Mass., includes four renewable years for a total of $72 million. Under the terms of the contract, Harvard Pilgrim will establish a coordinating center that will operate as a scaled down version of the Sentinel System. This center, or “mini-Sentinel,” will identify appropriate databases, develop a scientific framework for obtaining real-time data, and ensure data quality. To protect personal information, only summary results will be sent to the coordinating center. The data itself will remain within its database. The Sentinel System fulfills some requirements of the Food and Drug Administration Amendments Act of 2007 (FDAAA), which include provisions calling for the development of such a system. The Harvard Pilgrim contract is one
of the many activities contributing to building the Sentinel System.
The FDA already has awarded 10 small contracts addressing scientific
operations, data and infrastructure, privacy, and stakeholder engagement.
In addition, the FDA has awarded a cooperative agreement with the Brookings
Institution to convene meetings and workshops on active medical product
surveillance issues.
NIDA grantees Dr. Bruce J. Hinds III and Dr. Gonzalo E. Torres will receive their awards during a ceremony at the Commerce Building in Washington, DC. Bruce J. Hinds III, Ph.D., associate professor of chemical and materials engineering at the University of Kentucky, is being recognized for his work to improve the delivery of drugs that treat nicotine dependence through a novel skin patch. Gonzalo E. Torres, Ph.D., assistant professor of neurobiology at the University of Pittsburgh School of Medicine, is being cited for his research on cellular and molecular regulation in the brain and its relationship to psychiatric disorders and drug addiction. The Presidential Award for Early Career Scientists and Engineers was established in 1996 and is the highest honor bestowed by the U.S. government on outstanding scientists and engineers beginning their independent careers. Awardees are selected on the basis of two criteria: pursuit of innovative research at the frontiers of science and technology, and a commitment to community service as demonstrated through scientific leadership, public education or community outreach. Winning scientists are awarded a research grant for up to five years to further their studies in support of critical government missions. This year, eleven
federal departments and agencies nominated 100 young scientists and
engineers who showed exceptional promise for leadership in science and
technology. Drs. Hinds and Torres are 2 of 12 NIH grantees to receive
the prestigious PECASE award.
Publication of the rules starts the clock for the public comment period, with both rules having a March 15 deadline. The proposed rule from the Centers for Medicare and Medicaid Services defines "meaningful use" of electronic health records to qualify for Medicare and Medicaid incentive payments. It lays out a series of measures to collect and report data to government agencies. The rule is 169 pages long in a PDF format. An interim final rule from the Office of the National Coordinator for Health Information Technology sets initial standards, implementation specifications and certification criteria for EHR technology.
The rules are available
at gpoaccess.gov/fr/index.html
This collaborative research initiative between NIH and the D.C. Department of Health is designed to decrease the rate of new HIV infections in the city, improve the health of district residents living with HIV infection, and strengthen the city’s response to the HIV/AIDS epidemic. The partnership is being co-led by the National Institute of Allergy and Infectious Diseases (NIAID), part of NIH, and the D.C. Department of Health. NIH has allocated $26.4 million for the first two years of the partnership through funding from NIAID and the NIH Office of AIDS Research. African-Americans represent the overwhelming majority—76 percent—of the district’s HIV/AIDS cases. To better understand the risk factors for HIV infection and develop effective interventions for reducing risk, NIAID is conducting two observational studies through its HIV Prevention Trials Network (HPTN). Both local studies are being conducted through a HPTN clinical site at The George Washington University School of Public Health and Health Services. The new D.C. Partnership will help track HIV-associated health issues and outcomes by linking information from 13 of the city’s largest health care providers covering roughly 12,000 district residents living with HIV. By establishing this system, the partnership aims to better assess the clinical and treatment status of individual HIV-infected patients, evaluate outcomes of specific clinics and health programs and measure the impact of HIV testing and treatment initiatives within the city. The partnership will benefit providers by helping develop data-driven public health strategies. Non–AIDS defining illnesses and HIV co-infections, such as cardiovascular disease, diabetes and hepatitis, are significant causes of illness and death for many HIV-infected patients. In the district, however, few medical providers can provide targeted, specialized medical services that address these issues in underinsured residents. To address this gap, NIH and the D.C. Department of Health are working with Washington medical providers to establish clinics designed to provide HIV-related subspecialty care to underinsured patients in district communities most in need. The partnership also will provide a real-world examination of the test-and-treat hypothesis—the model published by World Health Organization scientists in early 2009 that proposed that the HIV epidemic can be significantly curtailed through annual, voluntary HIV testing and immediate antiretroviral treatment for individuals who test positive for HIV infection. Specifically, the test-and-treat pilot study will compare current community standards for HIV testing and treatment with accelerated expansion of routine testing services to identify HIV-infected people and evaluate enhanced methods for rapidly linking those patients to care and successful treatment. The results of the project will be analyzed to determine the cost-effectiveness of the test-and-treat approach. NIAID and CDC also plan to conduct
a pilot study in the Bronx, New York. The overall study plan is being
finalized and, once initiated, is expected to last for three years.
The assessments, from the Centers for Disease Control and Prevention (CDC), suggest that earlier findings were not aberrations but that Americans may truly have turned a corner. Figures from the National Center for Health Statistics show that 34 percent of American adults age 20 and older were obese in 2007-08 while 68 percent were considered overweight or obese. In children ages 2 through 19, 17 percent were considered obese while 32 percent were considered overweight. These numbers were compared to ones collected from 1999 to 2006 in a similar sample. The rapid increases in obesity rates seen during the 1980s and 1990s are slowing for most groups. Among women, obesity statistics remained fairly flat throughout the period encompassed by the two studies. Obesity rates among men rose slightly during the decade, but leveled off in the later years. Researchers did find an increase in the number of boys who are considered the "very heaviest," or those who are above the 97th percentile on a growth chart. Cynthia Ogden, an epidemiologist for the CDC's National Center for Health Statistics and lead author of the children's report, said the findings track with other reports, such as the Youth Risk Behavior Surveillance System, which saw a plateau among students in grades nine through 12 from 2005 to 2007. Just as many factors contribute to making people fatter — sedentary lifestyles; availability of inexpensive, fattening foods; and fewer walkable communities — a comparable number could explain why our weight is now holding steady. Researchers believe that an increasing consciousness of the crisis, coupled with copious public health messages and policies, may have contributed. The findings were published online
in the Journal
of the American Medical Association.
COPD is a serious and chronic lung disease that restricts air flow in the lungs resulting in shortness of breath. In the United States, COPD includes two main conditions — emphysema and chronic bronchitis. Spiriva HandiHaler consists of capsules and an inhalation device approved for once daily use in COPD. A March 2008 FDA Early Communication had described data submitted by the manufacturer of Spiriva HandiHaler as suggesting a small increased risk of stroke in patients treated with tiotropium, the medicine’s active ingredient. In October 2008, an Updated Early Communication highlighted two additional publications suggesting an increased risk of stroke, heart attack, and death in patients using tiotropium. This update of those communications is based on an FDA review of the Understanding the Potential Long-Term Impacts on Function with Tiotropium (UPLIFT) study that compared Spiriva HandiHaler with a placebo in 5,992 COPD patients. In November 2009, the FDA Pulmonary–Allergy Drugs Advisory Committee also reviewed the data and voted that findings from the UPLIFT study resolved the potential safety concerns for Spiriva Handihaler. For more information,
please visit Follow-Up
to the October 2008 Updated Early Communication about an Ongoing Safety
Review of Tiotropium .
Actemra’s recommended use is limited to patients who have failed other approved therapies because of serious safety concerns that were noted in clinical studies. These safety concerns include elevated liver enzymes, elevated low-density lipoprotein (LDL) or bad cholesterol, hypertension, and gastrointestinal perforations. The FDA is requiring the sponsor to conduct a post-marketing clinical trial to further evaluate the long-term safety of Actemra. Specifically, the FDA wants to evaluate the impact of elevated LDL cholesterol and blood pressure seen in some patients in shorter-term trials on the cardiovascular health of patients treated with Actemra. In addition, a Risk Evaluation and Mitigation Strategy (REMS) will require the drug sponsor to implement a communication plan for physicians informing them how to appropriately monitor their patients for liver and/or gastrointestinal side effects. The REMS will include a medication guide to ensure that patients are informed of the benefits and risks of Actemra. Actemra, marketed by San Francisco-based Genentech Inc., works by blocking the action of interleukin-6, an immune system protein that is overabundant in people with rheumatoid arthritis. The effectiveness and safety of Actemra was determined in five clinical trials in adult patients with active rheumatoid arthritis. In all of the trials, patients treated with Actemra experienced greater improvement in their tender or swollen joints than patients treated with a placebo. Reserve/Guard
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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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