FEDERAL HEALTH UPDATE
Jan 16, 2009

Produced by Kate Connelly Theroux in collaboration with the Institute of Federal Health Care (IFHC)

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Congressional Schedule
  • On Jan. 14, 2009, the House passed H.R. 2, the Children’s Health Insurance Program Reauthorization Act of 2009.  The legislation expands the program to cover adults, families making up to $80,000, including illegal immigrants.
  • The Senate Veterans Affairs (VA) Committee held a hearing on Jan. 14, 2009, to examine the nomination of Eric K. Shinseki, to be Secretary of Veterans Affairs. Former Senator Bob Dole and Senator Daniel K. Inouye introduced Shineki to the committee and urged his confirmation.  All of the committee members stated their intention to support Shinseki’s nomination.  During their statements, a number of them also lauded the current VA Secretary, Dr. James. B. Peake, as one of the best leadesr the VA has had.  Chairman Daniel K. Akaka said he intends to send Shinseki’s nomination directly to the Senate floor for consideration on Jan. 20, 2009.  
  • The Senate Armed Services Committee held hearings on Jan. 15, 2009, to examine the nominations of William J. Lynn III, to be Deputy Secretary, Robert F. Hale, to be Under Secretary (Comptroller) and Chief Financial Officer, Michele Flournoy, to be Under Secretary for Policy, and Jeh Charles Johnson, to be General Counsel, all of the Department of Defense. 
  • The Senate Health, Education, Labor, and Pensions Committee held a hearing on Jan. 15, 2009 to examine investing in health information technology (IT), focusing on stimulus for a healthier America.

Military Health Care News

  • The Department of Defense announced the opening of a 24-hour outreach center to provide information and referrals to military service members, veterans, their families and others with questions about psychological health and traumatic brain injury.

    The new center, which is operated by the Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury (DCoE), can be contacted around the clock, 365 days a year, by phone at (866) 966-1020 and by e-mail at resources@dcoeoutreach.org

    The center, staffed by behavioral health consultants and nurses, can address everything from routine requests for information about psychological health and traumatic brain injury, to questions about symptoms a caller is having, to helping callers find appropriate health care resources.

    In addition to answering questions, staffers refer callers to contact centers in other parts of the Department of Defense, other federal agencies, and outside organizations when appropriate.  Other contact centers also refer callers to the DCoE outreach center.

    The center serves members, leaders and healthcare providers of the Army, Navy, Air Force, Marines, Coast Guard, National Guard, Reserve and all uniformed services, along with veterans of all the services.  The families of service members and of veterans are also served by the new center.

  • The Department of Defense (DoD) is working with the Department of Veterans Affairs (VA) to expand a pilot program that simplifies the current disability evaluation process for wounded, injured and ill service members.

    The Disability Evaluation System (DES) pilot program is aimed at assisting wounded service members to obtain faster access to TRICARE and other health care and VA benefits by developing a single medical examination used by both DoD and VA, with a single-source disability evaluation done by VA and accepted by DoD.

    The pilot, implemented in November 2007 in the National Capitol Region, is slated to expand to 19 additional installations through June 1, 2009.

    Currently, a wounded warrior’s branch of service evaluates the member for conditions that may make him or her unfit for duty. This evaluation initiates the medical examination board process. Following separation or retirement from service, the member is again evaluated by the VA for disability and compensation. The pilot process streamlines and makes more transparent both processes through concurrent rather than sequential processing, more information for the member during the process, and comprehensive information regarding entitlements from both agencies at the time of the separation. 

    Under the pilot, only one evaluation is necessary after a member is referred for a service medical evaluation board. The single evaluation also helps service members get comprehensive information about their benefits, including TRICARE.

    The pilot was initially tested at three military treatment facilities in the National Capitol Region – Malcolm Grow Medical Center at Andrews Air Force Base, Md., Walter Reed Army Medical Center in Washington, D.C., and National Naval Medical Center in Bethesda, Md. 

  • On Jan. 13, 2009, TRICARE Management Activity announced that Navy Rear Adm. Elizabeth Niemyer has been named the new director of TRICARE Regional Office (TRO) – West.  As regional director, she oversees managed care support contracts and the TRICARE integrated health care delivery system in 21 states covering more than 2.7 million eligible beneficiaries.

    Niemyer previously served as executive director, TRICARE Area Office – Europe from May 2005 to June 2007 before transferring to the Navy Bureau of Medicine and Surgery, where she served as the assistant deputy chief of staff for operations. Those assignments followed a broad and varied Navy career and graduation from the Naval War College.

    Like TRICARE’s other two regional directors, Niemyer is responsible for oversight of all health care delivery activities within her region, including management of the health care support contracts. Directors are also responsible for providing support to military treatment facility commanders in the region, sustaining quality care and improving customer satisfaction across the TRICARE system. http://www.tricare.mil/pressroom/news.aspx?fid=493

  • The Department of Defense announced the following nominations:
    • Air Force Col. James J. Carroll has been nominated to the grade of brigadier general while serving as deputy assistant surgeon general, modernization, Office of the Surgeon General, Headquarters U.S. Air Force, Falls Church, Va.
    • Air Force Col. Bart O. Iddins has been nominated to the grade of brigadier general while serving as command surgeon, Headquarters Air Force Special Operations Command, Hurlburt Field, Fla.
    • Air Force Col. Michael W. Miller has been nominated to the grade of brigadier general while serving as senior executive and director of staff, Office of the Surgeon General, Headquarters U.S. Air Force, Pentagon, Washington, D.C.
  • Somatic Systems, Inc., the worldwide center for Clinical Somatics(TM), the groundbreaking drug-free, non-surgical approach to pain relief, announced that it will begin its treatment program for military veterans.

    Somatic Systems will begin providing service for US military veterans in the second half of February. The first region for the program will be the Denver area. It will operate as a part-time, limited availability program as an initial launch phase before full-time full service operations begin. Service will begin with veterans and then progress to military dependents and active personnel.

    Talks are currently underway with the Department of Veterans Affairs (VA) and TRICARE, the military health insurance plan, regarding implementation details of insurance coverage reimbursements for the services. Currently, the company expects the first phase of insurance implementation to be partial reimbursement before progressing to maximum reimbursement rates.

    TSomatic Systems obtained military contractor status in October and registration in the National Provider registry this month. The expected course is full military approval and health coverage for Somatic Systems' Clinical Somatics treatments, clinics, practitioners and treatment service programs.

    In addition to implementing services to help military veterans, the Denver program will provide opportunities to demonstrate a variety of larger implementation scenarios and range of options and benefits of the Clinical Somatics pain and injury treatment system to a broad audience of decisionmakers  to promote further growth of Somatics within the military.

  • TriServ Alliance, LLC, announced it has submitted final revisions to its bid to the U.S. Department of Defense to support delivery of health care for the third generation TRICARE South Region Contract. If awarded the contract, TriServ will begin servicing the 2.9 million active duty, retired and participating reserve and National Guard members of the uniformed services, their families and beneficiaries in April 2010.

    TriServ Alliance, LLC, is an independent, community-based company established in anticipation of providing access to health care services to TRICARE beneficiaries in the South Region. The TRICARE South Region includes Alabama, Arkansas, Florida, Georgia, Kentucky (Fort Campbell only), Louisiana, Mississippi, Oklahoma, South Carolina, Tennessee and Texas (excluding certain areas of Western Texas). Please visit www.triserv.net for more information.

     

Veterans Health Care News  

  • The Department of Veterans Affairs (VA) and National Institutes of Health (NIH) conducted a six-year study comparing deep-brain stimulation (DBS) to medication, along with speech, physical or occupational therapy, to treat Parkinson’s disease. The results of the trial, the largest of its kind to date, appear in the Jan. 7 Journal of the American Medical Association (JAMA).

    Researchers found that electrical stimulation of the brain — a treatment in which a pacemaker-like device sends pulses to electrodes implanted in the brain — is riskier than drug therapy but may hold significant benefits for those with Parkinson’s disease who no longer respond well to medication alone.

    The study included 255 Parkinson’s patients at seven VA medical centers and six university hospitals.  The VA sites were Portland, Ore., Seattle, San Francisco, Los Angeles, Houston, Richmond, Va., and Philadelphia, all members of VA’s network of Parkinson’s Disease Research, Education and Clinical Centers.

    Researchers also noted VA’s nationwide system of hospitals and specialized centers of excellence make the Department uniquely capable of conducting such large, multi-site trials of new therapies and medical devices.  VA’s patient population is especially suited for trials of treatments for chronic disease in the elderly.

    Patients who took part in the study were on medication but are no longer seeing improvements in symptoms such as tremors or stiffness.  Many were also developing side effects from drugs, such as involuntary face, arm or leg movements. 

    Researchers followed the patients for six months, finding:

    • Patients who received DBS gained an average of 4.6 hours per day of good motor control and few or no involuntary movements, compared with no gain for those on medical therapy alone;
    • 71 percent of DBS patients showed significant gains in motor function, compared with only 32 percent of drug therapy patients; and 
    • Serious adverse side effects were nearly four times more common in the DBS group, but almost all of these effects in both groups were resolved during the six-month study.  The most common side effects from DBS were infections, falls, depression, gait and balance problems, and pain.

    The trial was sponsored by VA’s Cooperative Studies Program and the National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health.

    Parkinson’s disease, a progressive neurological disorder, affects 1.5 million Americans, with 50,000 new cases diagnosed annually.  VA treats at least 40,000 veterans with the disorder each year.  Most patients are over age 50, but some forms of the disease can strike younger adults.

  • The Department of Veterans Affairs (VA) announced it is providing $21.7 million to its regional health care systems to improve services specifically designed for veterans in rural areas.

    Within the last year, VA has launched a major rural health initiative.  The Department created a 13-member committee to advise the VA secretary on issues affecting rural veterans; opened three rural health resource centers to better understand rural health issues; rolled out four new mobile health clinics to serve 24 predominately rural counties; announced the opening of 10 new rural outreach clinics in 2009; and launched a fleet of 50 new mobile counseling centers.

    The extra funding is part of a two-year VA program to improve the access and quality of health care for veterans in geographically isolated areas.  The program focuses on several areas, including access to health care, providing world-class care, the use of the latest technology, recruiting and retaining a highly educated workforce and collaborating with other organizations.  

    More specifically, the new funds will be used to increase the number of mobile clinics, establish new outpatient clinics, expand fee-based care, explore collaborations with federal and community partners, accelerate the use of telemedicine deployment and fund innovative pilot programs.  

    The new funds will be distributed according to the proportion of veterans living in rural areas within each VA regional health care system, called VISNs, for “Veterans Integrated Service Networks.”  

    VISNs with less than 3 percent of their patients in rural areas will receive $250,000.  Those with population of rural veterans between 3 percent and 6 percent will receive $1 million each.  And VISNs with more than 6 percent of their veterans population in rural areas will receive $1.5 million.

  • The Department of Veterans Affairs (VA) announced that the firm of Boyer Harlingen L.C. will construct a new 120,000-square-foot health care center in Harlingen, Texas, which VA will lease for a minimum of 20 years.

    The three-story facility, which is scheduled to open in October 2010, will be located on the campus of the University of Texas Regional Medical Education Center at Harlingen.  It will offer a full range of outpatient services, including six surgical suites, and clinics for prosthetics care, oncology and sensory aids. 

    VA estimates that once the center is completed, it will eliminate about 95 percent of the four-hour trips many veterans enrolled for VA care currently have to make to San Antonio for medical services.  In collaboration with the University of Texas Regional Academic Health Center, VA will use the new facility to provide a full range of expanded services, including specialty and diagnostic services such as pharmacy, digital x-rays, CT scans, MRIs and other services.  

    Physicians at the center will also perform outpatient surgeries, including cataract removals, diagnostic colonoscopies and prostate biopsies.  VA also plans to expand the services it provides at its health care facilities in McAllen and Corpus Christi.  Inpatient care will be provided at local South Texas private-sector hospitals under contract to VA, with certain high acuity and high-tech care at VA’s Audie L. Murphy Medical Center in San Antonio.  Plans for the new center also include parking for 750 cars in a three-story garage. http://www1.va.gov/opa/pressrel/pressrelease.cfm?id=1644

  • With motor vehicle crashes being a leading cause of deaths among combat veterans during the first years after their return home, the Department of Veterans Affairs (VA), the Department of Transportation (DOT) and the Department of Defense (DoD) are working together to reduce these accidents.

    Secretary of Veterans Affairs Dr. James B. Peake, Deputy Under Secretary of Defense for Installations and Environment Wayne Arny, and Acting Administrator of the National Highway Traffic Safety Administration David Kelly announced the creation of a new program designed to identify needed research involving recently returned veterans from Iraq and Afghanistan and to increase awareness of the importance of safe driving among newly demobilized veterans. 

    Experts in transportation safety, veterans’ health and medical care and public health are identifying gaps in current knowledge and developing a strategic plan for addressing key research questions, in fields ranging from epidemiology to psychology and biomechanics.  

    Participants in the strategic planning process include scientists and policy officials from VA, DOT, DoD and Department of Health and Human Services, as well as non-governmental experts.  The resulting strategic plan will lay out research needs and identify priorities for the initiative.

    The safe-driving initiative strives to increase awareness of motor vehicle crashes among veterans and the importance of safe driving, seatbelt and helmet usage, and other measures.  To reach out to veterans and their families, VA will create a national educational program using the Department’s network of medical centers, community clinics, drop-in counseling centers (Vet Centers), and veterans’ benefits offices. 

    The initiative will also include outreach to mobilize national veterans service organizations; the nation’s governors and state police, safety officers, and state highway safety officials; and the private sector — including employers; automobile, motorcycle and sports vehicle dealers and manufacturers; the motor vehicle insurance industry; and driving and motorcycle racing enthusiasts’ organizations.  NASCAR legend and safe driving advocate, Richard Petty, will also be an active partner in the initiative.  

    According to the Department of Transportation, motor vehicle crashes are the leading cause of death for all Americans between the ages of 8 through 34.  Men constitute about 70 percent of all traffic deaths.   Motor vehicle accidents are the greatest cause of accidental fatalities among service members and veterans.  Several studies have reported an increase in post-deployment deaths among military personnel who served in a combat zone compared to their non-deployed counterparts, who are in the military but not deployed to a war, after both the Vietnam War and the 1991 Gulf War.  Preliminary evidence also indicates this is the case with veterans from Iraq and Afghanistan.

  • One million veterans are in line to share $319.8 million in annual insurance dividends during 2009, according to the Department of Veterans Affairs (VA).

    VA operates one of the nation’s largest life insurance programs, providing more than $1 trillion in coverage to seven million service members, veterans and family members.

    The dividend payments are being sent to an estimated one million holders of VA insurance policies on the anniversary date of their policies.  Sent automatically through different payment plans, the amounts vary based on the age of the veteran, the type of insurance, and the length of time the policy has been in force.

    The dividends come from the earnings of trust funds into which veterans have paid insurance premiums over the years and are linked to returns on investments in U.S. government securities.

    Veterans eligible for the dividends have had VA life insurance policies in effect since they left the military and have received annual notifications from VA about the policies.

    Dividends are paid each year to veterans who served between 1917 and 1956 and who hold certain government life insurance policies.  The policies are known by letters that appear at the beginning of each policy’s identification number.

    World War II veterans holding National Service Life Insurance ("V") policies comprise the largest group receiving 2009 insurance dividend payments.  They are expected to receive total payments of $243.8 million.

    An additional group of World War II-era veterans, those who have Veterans Reopened Insurance ("J", "JR" and "JS") policies, will in total receive dividends of $8.1 million.

    Korean War era veterans who have maintained Veterans Special Life Insurance ("RS" and "W") policies can expect to receive dividends totaling $67.2 million.

    Dividends totaling $725,000 will be paid to veterans who served after World War I until 1940 who hold U.S. Government Life Insurance ("K") policies.

    Veterans who have questions about their policies may contact the VA insurance toll-free number at 1-800-669-8477 or send an email to VAinsurance@va.gov.  They may also visit the Internet at www.insurance.va.gov.

Health Care News

  • The Centers for Medicare and Medicaid Services (CMS) has granted three-year extensions, subject to certain conditions, for three participants in the Care Management for High Cost Beneficiaries Demonstration (CMHCB) that have demonstrated success in helping to manage the care for high cost patients. 

    Care management for high cost beneficiaries is a provider-based service to improve quality of care and reduce costs for fee-for-service beneficiaries who have one or more chronic diseases.  The services support collaboration among participants’ primary and specialist providers to enhance communication of relevant clinical information.  They are intended to help increase adherence to evidence-based care, reduce unnecessary hospital stays and emergency room visits, and help participants avoid costly and debilitating complications.

    The extensions were awarded to Key to Better Health, a division of Village Health; Massachusetts General Care Management Program; and Health Hero Network, Health Buddy Project.

  • The Key to Better Health program, a New York-based company, provides targeted disease management directed by clinical nephrologists to identify potential problems and avoid complications, coordinate early intervention plans and prevent acute hospitalization for beneficiaries identified with Chronic Kidney Disease (CKD).  
  • Massachusetts General Care Management Program, located in Boston, provides highly integrated care management services through the use of practice-based case managers, individualized plans of care, 24-hour access to care managers and electronic medical records. 
    • The Health Hero Network’s Health Buddy program is unique because of its focus on a tele-monitoring device, and it is representative of the remote health monitoring industry, a growing sector in health care.  Health Buddy provides participants with an appliance for use in their homes as a means to monitor participants’ symptoms, physical status, and condition-specific knowledge.  This program currently operates in Bend, Ore., and Wenatchee, Wash.

    All of these programs are un usual because of their defined intervention focus on the fee-for-service Medicare population.  The programs in the demonstration have had a positive impact on selected high cost Medicare beneficiaries and have met and/or exceeded the savings target required in the demonstration agreement.

    CMS hopes to use the additional three years to study the programs and determine whether they can be replicated.   

    The CMHCB demonstration was approved to provide disease management services for thousands of beneficiaries by awarding six organizations with populations in sizes from 1,800 to 15,000.  The demonstration originally approved for three years, tests provider-based intensive care management services as a way to improve quality of care and reduce costs for fee-for-service beneficiaries who have one or more chronic diseases and generally incur high Medicare costs.  The sites were chosen in different areas of the country, with the primary focus on disease states of congestive heart failure (CHF), diabetes, and/or chronic kidney disease (CKD). CMS NR 01-13-2009

  • The Los Angeles Times reports that health insurer WellPoint Inc. has been barred from adding customers to Medicare plans after it denied prescription drugs to the elderly, endangering their lives.

    The sanctions, outlined in a letter to WellPoint from the Centers for Medicare and Medicaid Services, followed a "sharp" increase in consumer complaints, the agency said. Elderly customers were stopped from receiving essential prescription drugs and some were overcharged because of computer mistakes.

    "WellPoint's conduct poses a serious threat to the health and safety of both its prospective and current Medicare beneficiaries," the agency said in the letter.

    The number of complaints jumped in the last 12 days, Medicare said.

  • The U.S. Food and Drug Administration (FDA) announced it has launched of a voluntary pilot program that would help promote the safety of drugs and active drug ingredients produced outside the United States.

    The FDA plans to select 100 applicants to participate in the Secure Supply Chain pilot program. To qualify, applicants will need to meet the pilot program's criteria, including a requirement that they maintain control over the drug products from the time of manufacture through entry into the country.

    The goal of the pilot is to allow FDA to determine the practicality of developing a secure supply chain program. Such a program would assist the agency in its efforts to prevent the importation of drugs that do not comply with applicable FDA requirements by allowing the agency to focus its resources on foreign-produced drugs that fall outside the program and that may not be compliant. It will also expedite the entry of products meeting the pilot's criteria into the United States. The pilot was developed with input from U.S. Customs and Border Protection and other stakeholders. Information about the pilot appears in a Federal Register notice that went on display January 15.

    Each applicant may designate up to five drugs for selection in the pilot program. To qualify, applicants must meet the pilot's criteria, including a requirement to maintain control over the drugs from the time of manufacture through entry into the United States. A secure supply chain will help mitigate risks such as contamination and counterfeiting. Applications for participation in the pilot program will be processed in the order received.

    Companies wishing to participate in the two year pilot program must meet certain criteria, including:

    • For finished drug products, the applicant must hold an FDA-approved drug application or must be the foreign manufacturer identified in an FDA-approved application;
    • The active pharmaceutical ingredients imported must be used only to make FDA-approved drugs;
    • Foreign drug manufacturers and U.S. establishments receiving drugs must be FDA-registered and comply with Good Manufacturing Practices; and
    • Applicants must show that their drug products use a secure supply chain.

    The pilot program is planned to run for a period of two years.

  • The U.S. Department of Health and Human Services released an updated and improved version of the Surgeon General’s Internet-based family health history tool. The new tool makes it easier for consumers to assemble and share family health history information.  It can also help practitioners make better use of health history information so they can provide more informed and personalized care for their patients.

    Key features of the new version of the Surgeon General’s My Family Health Portrait include:

    • Convenience – Consumers can access the tool easily on the Web.  Completing the family health history profile typically takes 15-20 minutes. Information is easily updated or amended.
    • Consumer control and privacy – The family health history tool gives consumers access to software that builds a family health tree. But the personal information entered during the use of the tool is not kept by a government or other site. 
    • Sharing – Because the information is in electronic form, it can be easily shared with relatives or with practitioners.  Relatives can add to the information and a special re-indexing feature helps relatives easily start their own history based on data in a history they received. Practitioners can help consumers understand and use their information.
    • EHR-ready, Decision support-ready – Because the new tool is based on commonly used standards, the information it generates is ready for use in electronic health records and personal health records.  It can be used in developing clinical decision software, which helps the practitioner understand and make the most use of family health information.
    • Personalization of care – Family history information can help alert practitioners and patients to patient-specific susceptibilities.
    • Downloadable, customizable – The code for the new tool is openly available for others to adopt.  Health organizations are invited to download and customize, using the tool under their own brand and adding features that serve their needs.  Developers may also use the code to create new risk assessment software tools.

    The first adopter of the HHS-developed tool is the National Institute of Genomic Medicine of Mexico (INMEGEN).  Dr. Gerardo Jimenez-Sanchez, director general of the institute, will release the Mexican Spanish-language version of the tool in Mexico City this month.  The Mexican family health history tool will be available on the INMEGEN Web site, http://www.inmegen.gob.mx.

    The Indian Health Service will adopt it into its care system, as well as the Lance Armstrong Foundation (LAF), a cancer advocacy organization. 

    The Surgeon General’s My Family Health Portrait was originally launched in 2004, but the first version was not standards-based.  It will be hosted by the National Cancer Institute. The Surgeon General’s new My Family Health Portrait tool is located at https://familyhistory.hhs.gov.  

  • Commissioner of Food and Drugs Andrew C. von Eschenbach, M.D., announced the appointments of Lou Valdez as associate commissioner for international programs and of Lori Davis as chief information officer.

    In 2008 the FDA opened offices in China and implemented plans for additional offices in India, Europe, Latin America and the Middle East. The agency also commenced a multi-year information technology modernization program.

    Valdez will help lead implementation of the FDA's international programs at a time of significant growth and expansion of the agency and the Department of Health and Human Services' (HHS) international presence. Valdez previously served as deputy director of the HHS Office of Global Health Affairs, where she led the development of U.S. Government policy positions on a wide range of complex international public-health issues.

    Lori Davis joined FDA as deputy chief information officer in November 2007 and has been instrumental in restructuring the Office of Information Management and centralizing Information Technology (IT) project budgets and resources. In her new position, Davis will be responsible for strengthening FDA's IT infrastructure, and for creating a robust IT foundation to enhance the interoperability of systems across the agency. Davis previously served as acting deputy director in the Office of Strategic Operations and Regulatory Affairs at HHS' Centers for Medicare & Medicaid Services (CMS), as special assistant to the CMS chief operating officer, and as deputy director of CMS' Office of Health Insurance Portability and Accountability Act Standards (now the Office of e-health Standards and Services).

  • Dr. Raynard S. Kington, acting director of the National Institutes of Health (NIH), released his first Biennial Report of the Director, a document that provides an integrated portrait of NIH research activities. The report was created to make it easier for Congress, advocates and patient groups, and the general public to understand the many programs within the agency.
    • The report contains an assessment of the state of biomedical and behavioral research organized by disease category, investigative approach or resource. To ensure that the document reflects the work of all 27 Institutes and Centers (ICs), 15 trans-NIH teams gathered, reviewed and organized information into a standardized format.

    The NIH Reform Act of 2006 replaced many of the disparate reports required by law from NIH's ICs with one comprehensive biennial account to Congress.

    The NIH Biennial Report for Fiscal Years 2006 and 2007 is the agency's first under the new mandate.

  • The U.S. Department of Health and Human Services (HHS) announced a $487 million multiple year contract with Novartis Vaccines and Diagnostics, Inc., to build the first U.S. facility to manufacture cell-based vaccine for seasonal and pandemic flu. Because cell-based influenza vaccine can be made faster and in greater quantities than traditional vaccine, the new facility is expected to increase the U.S. capacity to make pandemic influenza vaccine by at least 25 percent.

    Cell-based vaccine production could more easily meet surge capacity needs because cells could be frozen and stored in advance of an epidemic or developed rapidly in response to an epidemic. Cell-based vaccine production also dramatically reduces the possibility for contamination and promises to be more reliable, flexible, and expandable than egg-based methods. 

    Currently, influenza vaccines licensed by the U.S. Food and Drug Administration (FDA) are made in  specialized chicken eggs using a process that has changed little in over 50 years. In place of eggs, cell-based vaccine production uses laboratory-grown cells that are capable of hosting a growing virus. The virus is injected into the cells where it multiplies. The cells’ outer walls are removed, harvested, purified, and inactivated. Using this technology, a vaccine can be produced in a matter of weeks.

    New cell-based influenza vaccines provides an option for people who are allergic to eggs and, therefore, unable to receive current flu vaccines. Cell-based production avoids other problems that egg-based production has, such as a potential shortage of eggs due to poultry-based diseases.

    The cell-based vaccine technology can also be used to make vaccines for seasonal influenza and other major emerging infectious diseases.

    Under the contract, Novartis and HHS share the cost of the new cell-based influenza vaccine manufacturing facility in Holly Springs, N.C., with the HHS contract covering 40 percent of the cost and Novartis bearing 60 percent.

    Novartis also will provide two new flu vaccines for seasonal flu or for pre-pandemic use. The contract builds on progress made through a previous HHS contract award to Novartis to accelerate the development of cell-based influenza vaccine.

    In addition, the new contract will fund scientific studies, called clinical bridging studies, to compare existing Novartis vaccines to new ones—including those developed in the new facility— to show that these new ones are also safe and effective. By comparing new and existing vaccines, the company can provide information quickly to the FDA to request licenses for the new vaccines.

    If licensed by the FDA, the new cell-based vaccines made in the United States could be purchased for by the federal government for vaccine stockpiles.

  • HHS Secretary Mike Leavitt and Commissioner of the HHS Food and Drug Administration (FDA) Andrew C. von Eschenbach, M.D., marked the opening of HHS/FDA offices in New Delhi, and Mumbai, India.

    HHS/FDA will post 10 experienced officials in India to work closely with industries that ship food and medical products to the United States, to improve safety and quality, which will facilitate the smooth flow of trade.  Along with the office drector, HHS/FDA will have four inspectors and five senior technical experts who will cover food, medical devices and medicines. 

    These HHS/FDA personnel will provide technical advice, conduct inspections of facilities that export to the United States, and work with Indian government agencies and the private sector to develop certification programs to allow the efficient flow of safe HHS/FDA-regulated goods between the United States and India. 

    These offices are part of HHS/FDA’s Beyond Our Borders Initiative, which will place 35 HHS/FDA personnel in 14 locations around the world, mostly connected to U.S. Embassies, Consulates and Missions.  This initiative will expand HHS/FDA consumer-protection efforts beyond the United States to form collaborative partnerships with governments and industry on product safety. 

    India is the fourth-largest exporter by volume of drugs and biologics, especially generic pharmaceuticals, to the United States.  India is also a significant exporter of food products.  

    With the opening of these offices, HHS/FDA now has an in-country presence in China, Central America, India, and Europe.  HHS/FDA also plans to post FDA personnel to several more locations in 2009 — México, South America, Europe and the Middle East.  http://www.hhs.gov/news/press/2009pres/01/20090115a.html

  • CSC, a technology-enabled solutions and services provider, has won a $265 million contract from the North Carolina Department of Health and Human Services (NC DHHS) to replace the state's current Medicaid Management Information System (MMIS) with a new healthcare administration system that will manage other state agency health services in addition to Medicaid. The contract has a seven-and-a-half-year base period and a one-year option.

    Under the terms of the contract, CSC will develop a new enterprise MMIS solution for healthcare administration supporting multiple agencies within the NC DHHS. The solution will be enhanced by commercial off-the-shelf products designed for a multi-tiered, service-oriented architecture and aligned with the Medicaid IT Architecture (MITA) business enterprise. The new system will also provide the department with an information technology platform that promotes efficiency and information sharing across all divisions and programs. 

    In addition, CSC will be the fiscal agent for the NC DHHS and its divisions, providing operational support to manage provider and recipient call centers, prior authorization reviews, claims processing, pharmacy operations, medical policy reviews and other administrative activities. CSC also will provide similar support to other health coverage programs offered by NC DHHS. http://www.csc.com/newsroom/press_releases/19750

     
Reserve/Guard
  • The total number of Guard and Reserve currently on active duty has increased by 2,627 from the last report to 126,654.  The totals for each service are Army National Guard and Army Reserve 96,029; Navy Reserve, 5,855; Air National Guard and Air Force Reserve, 16,161; Marine Corps Reserve, 7,766; and the Coast Guard Reserve, 843.  www.defenselink.mil

Reports/Policies

  • The GAO published “Health Information Technology: Federal Agencies' Experiences Demonstrate Challenges to Successful Implementation,” (GAO-09-312T) on Jan. 15, 2009. The report http://www.gao.gov/new.items/d09312t.pdf
  • The GAO published “Medical Devices: FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process,” (GAO-09-190) on Jan. 15, 2009. http://www.gao.gov/new.items/d09190.pdf
  • The Department of Defense Inspector General released report "Report on the Assessment of Arms, Ammunition, and Explosives Accountability and Control; Security Assistance; and Logistics Sustainment for the Iraq Security Forces" (SPO-2009-002) on Dec. 19, 2008.  The report includes significant observations and recommendations for the medical aspect of DoD and interagency stability operations.  http://www.dodig.mil/SPO/reports.html

Legislation

  • H.RES.52 (introduced Jan. 13, 2009): Providing for consideration of the bill (H.R. 2) to amend title XXI of the Social Security Act to extend and improve the Children's Health Insurance Program, and for other purposes was placed on the House Calendar. 
    Sponsor: Representative Alcee L. Hastings [FL-23]
  • H.R.241 (introduced Jan. 7, 2009): To amend title 10, United States Code, to require the amounts reimbursed to institutional providers of health care services under the TRICARE program to be the same as amounts reimbursed under Medicare, and to require the Secretary of Defense to contract for health care services with at least one teaching hospital in urban areas was referred to the House Committee on Armed Services. 
    Sponsor: Representative Gene Green [TX-29]
  • H.R.270 (introduced Jan. 7, 2009): To amend title 10, United States Code, to provide for continuity of TRICARE Standard coverage for certain members of the Retired Reserve was referred to the House Committee on Armed Services. 
    Sponsor: Representative Robert E. Latta [OH-5]
  • H.R.297 (introduced Jan. 8, 2009): To amend title 38, United States Code, to provide for an increase in the amount of subsistence allowance payable by the Secretary of Veterans Affairs to veterans participating in vocational rehabilitation programs and for other purposes was referred to the House Committee on Veterans' Affairs. 
    Sponsor: Representative Steve Buyer [IN-4]
  • H.R.298 (introduced Jan. 8, 2009): To amend title XXI of the Social Security Act to require SCHIP annual reports to include information on the HEDIS measure relating to access to primary care practitioners by individuals eligible for child health assistance under such plans and on State efforts to avoid certain displacement of private health coverage, and to express the sense of Congress that such States should utilize Consumer Assessment of Healthcare Providers and Systems consumer satisfaction surveys to measure access by such individuals to physicians was referred to the House Committee on Energy and Commerce. 
    Sponsor: Representative Charles W. Boustany, Jr. [LA-7] 
  • H.R.303 (introduced Jan. 8, 2009): To amend title 10, United States Code, to permit additional retired members of the Armed Forces who have a service-connected disability to receive both disability compensation from the Department of Veterans Affairs for their disability and either retired pay by reason of their years of military service or Combat-Related Special Compensation and to eliminate the phase-in period under current law with respect to such concurrent receipt was referred to the Committee on Armed Services, and in addition to the Committee on Veterans' Affairs, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. 
    Sponsor: Representative Gus M. Bilirakis [FL-9]
  • H.R.321 (introduced Jan. 8, 2009): To amend title XXI of the Social Security Act to expand coverage options under the State Children's Health Insurance Program (SCHIP) through premium assistance was referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and Education and Labor, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. 
    Sponsor: Representative Jeff Fortenberry [NE-1]
  • H.R.323 (introduced Jan. 8, 2009): To amend title XXVII of the Public Health Service Act and title I of the Employee Retirement Income Security Act of 1974 to require that group and individual health insurance coverage and group health plans provide comprehensive coverage for childhood immunization was referred to the Committee on Energy and Commerce, and in addition to the Committee on Education and Labor, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. 
    Sponsor: Representative Gene Green [TX-29]
  • H.R.333 (introduced Jan. 8, 2009): To amend title 10, United States Code, to permit retired members of the Armed Forces who have a service-connected disability rated less than 50 percent to receive concurrent payment of both retired pay and veterans' disability compensation, to eliminate the phase-in period for concurrent receipt, to extend eligibility for concurrent receipt to chapter 61 disability retirees with less than 20 years of service, and for other purposes was referred to the Committee on Armed Services, and in addition to the Committee on Veterans' Affairs, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. 
    Sponsor: Representative Jim Marshall [GA-8]
  • H.R.341 (introduced Jan. 8, 2009): To amend the Internal Revenue Code of 1986 to suspend the running of periods of limitation for credit or refund of overpayment of Federal income tax by veterans while their service-connected compensation determinations are pending with the Secretary of Veterans Affairs was referred to the House Committee on Ways and Means. 
    Sponsor: Representative Todd Russell Platts
  • H.R.394 (introduced Jan. 9, 2009): To amend title 38, United States Code, to authorize the Secretary of Veterans Affairs to increase the amount of the Medal of Honor special pension provided under that title by up to $1,000 was referred to the House Committee on Veterans' Affairs. 
    Sponsor: Representative Henry E. Brown, Jr. [SC-1]
  • H.R.402 (introduced Jan. 9, 2009): To designate the Department of Veterans Affairs Outpatient Clinic in Knoxville, Tennessee, as the "William C. Tallent Department of Veterans Affairs Outpatient Clinic" was referred to the House Committee on Veterans' Affairs. 
    Sponsor: Representative John J. Duncan, Jr. [TN-2]
  • H.R.439 (introduced Jan. 9, 2009): To amend the Public Health Service Act regarding residential treatment programs for pregnant and parenting women, a program to reduce substance abuse among nonviolent offenders and for other purposes was referred to the House Committee on Energy and Commerce. 
    Sponsor: Representative Denny Rehberg [MT] 
  • H.R.444 (introduced Jan. 9, 2009): To amend section 340B of the Public Health Service Act to revise and expand the drug discount program under that section to improve the provision of discounts on drug purchases for certain safety net providers was referred to the House Committee on Energy and Commerce. 
    Sponsor: Representative Bobby L. Rush, [IL-1]
  • H.R.449 (introduced Jan. 9, 2009): To amend title 38, United States Code, to expand the availability of health care provided by the Secretary of Veterans Affairs by adjusting the income level for certain priority veterans was referred to the House Committee on Veterans' Affairs. 
    Sponsor: Representative Joe Sestak [PA-7]
  • H.R.462 (introduced Jan. 13, 2009): To amend titles XIX and XXI of the Social Security Act to improve dental benefits under Medicaid and the State Children's Health Insurance Program (SCHIP), and for other purposes was referred to the House Committee on Energy and Commerce. 
    Sponsor: Representative Elijah E. Cummings [MD-7]
  • H.R.463 (introduced Jan. 13, 2009): To expand access to preventive health care services that help reduce unintended pregnancy, reduce abortions, and improve access to women's health care was referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and Education and Labor, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. 
    Sponsor: Representative Louise McIntosh Slaughter [NY-28]
  • H.R.464 (introduced Jan. 13, 2009): To provide for a five-year SCHIP reauthorization for coverage of low-income children, an expansion of child health care insurance coverage through tax fairness, and a health care Federalism initiative, and for other purposes was referred to the Committee on Energy and Commerce, and in addition to the Committees on Ways and Means, and Rules, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. 
    Sponsor: Representative Tom Price [GA-6]
  • H.R.466 (introduced Jan. 13, 2009): To amend title 38, United States Code, to prohibit discrimination and acts of reprisal against persons who receive treatment for illnesses, injuries, and disabilities incurred in or aggravated by service in the uniformed services was referred to the House Committee on Veterans' Affairs. 
    Sponsor: Representative Lloyd Doggett [TX-25]
  • H.R.468 (introduced Jan. 13, 2009): To expand, train, and support all sectors of the health care workforce to care for the growing population of older individuals in the United States was referred to the Committee on Energy and Commerce, and in addition to the Committee on Education and Labor, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the committee concerned. 
    Sponsor: Representative Janice D. Schakowsky [IL-9]
  • H.R.479 (introduced Jan. 13, 2009): To amend the Public Health Service Act to provide a means for continued improvement in emergency medical services for children was referred to the House Committee on Energy and Commerce. 
    Sponsor: Representative Jim Matheson [UT-2]
  • H.R.484 (introduced Jan. 13, 2009): To require the Secretary of Defense to develop and implement a plan to provide chiropractic health care services and benefits for certain new beneficiaries as part of the TRICARE program was referred to the House Committee on Armed Services. 
    Sponsor: Representative Mike J. Rogers [MI-8]
  • S.179 (introduced Jan. 8, 2009): A bill to improve quality in health care by providing incentives for adoption of modern information technology was referred to the Committee on Finance. 
    Sponsor: Senator Debbie Stabenow [MI]
  • S.207 (introduced Jan. 13, 2009): A bill to amend the Internal Revenue Code of 1986 to allow a deduction for health insurance premiums was referred to the Committee on Finance. 
    Sponsor: Senator Barbara Boxer [CA]
  • S.214 (introduced Jan. 12, 2009): A bill to amend title XXI of the Social Security Act to permit qualifying States to use their allotments under the State Children's Health Insurance Program for any fiscal year for certain Medicaid expenditures was referred to the Committee on Finance. 
    Sponsor: Senator Jeff Bingaman [NM]
  • S.226 (introduced Jan. 13, 2009): A bill to designate the Department of Veterans Affairs outpatient clinic in Havre, Montana, as the Merril Lundman Department of Veterans Affairs Outpatient Clinic was referred to the Committee on Veterans' Affairs. 
    Sponsor: Senator Jon Tester [MT]

Hill Hearings

  • The Senate Armed Services Committee will hold a hearing on Jan. 27, 2009, to examine challenges facing the Department of Defense.  Defense Secretary Robert M. Gates is scheduled to testify.
Meetings / Conferences

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.

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