FEDERAL HEALTH UPDATE
Oct 2, 2009

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

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Executive and Congressional News

  • The Senate passed a continuing resolution on Sept. 30, 2009, to allow government to continue operating beyond the last day of the fiscal year.

    The continuing resolution, which was attached to the conference report for the legislative branch appropriations bill (H.R. 2918), extends funding to government agencies at the levels in the 2009 appropriations bills which were set to expire on Sept. 30.

    The House approved the same measure last week. The bill was sent to the White House for President Obama’s signature.

  • On Sept. 30, 2009, President Barack Obama announced $5 billion in grant awards under the American Recovery and Reinvestment Act of 2009 (Recovery Act) to fund cutting-edge medical research in every state across America.

    The more than 12,000 grant awards are expected to create tens of thousands of jobs over the next two years and are part of an overall $100 billion Recovery Act investment in science and technology.

    Through new programs, such as Challenge Grants, Grand Opportunity grants and Signature Initiatives, the grant awards will support the full spectrum of medical research—from basic research to clinical and translational studies. The Recovery Act funded NIH grants are in several areas including heart disease, autism, HIV-AIDS, H1N1 Flu and cancer.

    Military Health Care News

  • TRICARE Management Activity (TMA) announced that TRICARE Area Office (TAO) Europe has changed its name to TRICARE Area Office Eurasia-Africa.

    The new title does not add any new territory to the area the TAO supports, but rather recognizes the office’s responsibilities extend far beyond the European continent.

    TAO Eurasia-Africa supports the European and African continents, all Middle Eastern countries, Pakistan, Russia and several former Soviet Republics including the Baltic States, Ukraine, Georgia, Kazakhstan, Kyrgyzstan and Uzbekistan. TAO Pacific also supports TRICARE beneficiaries on the Asian continent in India, China, Southeast Asia, the Korean Peninsula, Taiwan and Japan.

  • TRICARE Management Activity (TMA) announced increases to some out-of-pocket costs paid by TRICARE Standard beneficiaries at civilian hospitals for inpatient care and inpatient behavioral health services for fiscal year 2010, which runs from Oct. 1, 2009 to Sept. 30, 2010.

    For active duty family members using TRICARE Standard and TRICARE Extra, the daily cost share for inpatient admissions at civilian hospitals has increased from $15.65 to $16.30 per day or $25 per admission, whichever is greater. There is no charge for separately billed professional services.

    The daily cost share for retirees, their families and other eligible beneficiaries using TRICARE Standard for inpatient admissions at civilian hospitals has increased from $535 to $645 per day or 25 percent of the total charge, whichever is less. Additionally, these beneficiaries pay 25 percent of the TRICARE-allowable charge for separately billed professional services.

    The out-of-pocket costs for retirees, their families and other eligible beneficiaries for inpatient behavioral health services at low-volume civilian hospitals has increased from $193 to $197 per day or 25 percent of the billed charge, whichever is less.

    Every year the costs for TRICARE-covered inpatient services are reviewed and are subject to change.

    For additional information about copayments and cost-shares for TRICARE-covered services, visit the TRICARE Web site at http://www.tricare.mil/costs.

  • Spectrum Healthcare Resources Inc. in St. Louis recently won a $28.5 million contract to provide family health centers that extend the DeWitt Health Care Network in Fort Belvoir, Va.

    Spectrum Healthcare will provide all facilities, facility maintenance, staffing, supplies and equipment necessary to support an ambulatory and primary care program for the treatment and authorized military beneficiaries and their dependents.

    President George Tracy leads Spectrum Healthcare Resources, which provides physicians, clinical personnel and management services to military treatment facilities throughout the United States.

  • University of Michigan scientists have developed a combination drug that promises a safer, more precise way for medics and fellow soldiers in battle situations to give a fallen soldier both morphine and a drug that limits morphine’s dangerous side effects.

    The researchers used nanotechnology to devise ultra-small polymer particles capable of carrying the drugs into the body. The development of the combination drug makes possible a precise feedback system that can safely regulate release of the drugs aboard the nanoparticles.

    Soldiers injured in combat typically receive morphine as soon as possible to relieve pain. Morphine, however, also depresses normal breathing and blood pressure, sometimes to life-threatening levels. So medics need to give a short-acting drug that aids normal respiration and heart beat, but in doses that still allow the morphine to relieve pain effectively. Currently, achieving that balance is a challenge outside a hospital.

    The combination drug that U-M scientists have developed promises to make balanced treatment possible even in combat zones. The long-range goal of the research, funded by the U.S. Defense Advanced Research Projects Agency, is to develop a practical method that medics or soldiers themselves could administer, perhaps using an auto-injector device.

  • The Military Health System (MHS) announced the launch of a new annual "Building Stronger Female Physician Leaders in the MHS" award on Sept. 29, 2009.

    The new award honors outstanding female physicians who have made significant contributions to the practice of military medicine and serve as exemplary role models for others. It is one of many innovative initiatives designed to attract female physicians into the MHS.

    The award will honor one junior leader (03-05) per service, as well as recognize one senior (06) MHS-wide leader. Nominees must demonstrate distinctive achievement and service in their field of clinical expertise, involvement in enhancing the role of women in medicine by being a positive role model for women of all ages, and service to their communities.

    A panel comprised of a female physician leader from each service as well as one female leader from Department of Defense Health Affairs will review and score each of the nomination packages and determine the award winners based on the order of merit. Winners will have the opportunity to sit on future panels.

    Nominations are due on Oct.30, 2009. Winners will be announced formally at the MHS Conference, held in Washington, DC in January 2010.

Veterans Health Care News

  • The Department of Veterans Affairs (VA) has staffed an office to serve survivors of veterans and military personnel to serve as their advocate, with a charter that includes creating or modifying programs, benefits and services.

    The office, authorized in the Veterans Benefits Improvement Act of 2008, will serve as the primary advisor to the VA secretary on all issues affecting the survivors and dependents of deceased veterans and service members. It will monitor VA’s delivery of benefits to survivors; make appropriate referrals to VA offices for survivors seeking benefits; and explore innovative ways of reaching survivors who are not receiving the VA benefits for which they are eligible.

    VA benefits for eligible survivors include educational assistance, home loan guaranties, health care insurance and Dependency and Indemnity Compensation, a monthly payment to the survivors of some people who die on active duty and some seriously disabled Veterans.

    More than 554,000 spouses, dependents and other survivors of veterans are receiving VA benefits. That figure includes nearly 5,000 spouses of World War I Veterans, 90 spouses and 94 children of Spanish-American War Veterans and two children of Civil War veterans. http://www1.va.gov/opa/pressrel/pressrelease.cfm?id=1786

  • Secretary of Veterans Affairs Eric K. Shinseki has announced plans to replace the Bob Michel Community Based Outpatient Clinic, operated by the Department of Veterans Affairs (VA) in Peoria, with a new, larger clinic by mid-2011.

    VA has selected the JRA Development Group of Pittsburgh to build a 37,000-square-foot facility at Orange Prairie Road and American Prairie Drive. The developer will own the land and the building, leasing it to VA for about $1.6 million annually for up to 20 years.

    The current, 30-year-old clinic is part of the VA Illiana Health Care System, serving veterans in central Illinois and west central Indiana. It offers primary care, including home-based and women’s care, optometry, audiology, neurology, podiatry, laboratory and mental health services. The clinic also provides transportation for patients to VA medical centers in Danville, Ill., and Iowa City, Iowa.

    The clinic has 91 employees and sees more than 9,000 veterans, with more than 46,000 outpatient visits per year.

    Additional services the new clinic will offer include physical medicine and rehabilitation, compensation and pension eligibility exams, environmental agent exams, onsite mobile MRI screening, mammography, expanded women’s health services and other specialty services.

Health Care News

  • The Centers for Disease Control and Prevention (CDC) has awarded $4.37 million in grants to enhance health care information management and improve the detection of and response to emerging public health threats.

    The grants will fund four new Centers of Excellence in Public Health Informatics, at Harvard Pilgrim Health Care, Indiana University, the University of Pittsburgh, and the University of Utah.

    The overall purpose of the Center of Excellence initiative is to discover strategies and tools that increase the ability of health departments, physicians and other health care providers to promote health and prevent diseases, injuries or disabilities. These centers will support the CDC national priorities. A common emphasis will be translation of results into measurable public health impacts.

    Each center will conduct two new projects that support national priorities in informatics, and support real-time bio-surveillance for potential health threats through immediate access to data from hospitals and health care systems in major metropolitan areas across the nation.

  • The Food and Drug Administration has made important progress in the last two years toward creating a more effective IT infrastructure, according to a preliminary report by the FDA Science Board’s Subcommittee on Information Technology.

    The findings are notable because the panel lambasted the agency two years ago in a report that found that FDA’s computer systems could not support the agency’s main mission.

    That earlier report, titled “FDA Science and Mission at Risk,” cited a range of problems, including decentralized and aging network servers, unreliable email systems, woefully inadequate disaster recovery programs and scientific computing capabilities that did not meet basic needs of the scientific staff.

    But the most recent findings by committee strike a decidedly more positive tone. “The [agency’s] work greatly exceeded our expectations in terms of how much progress had been made putting together an IT infrastructure,” according to Dr. Sangtae Kim, head of the subcommittee, which authored the report. “We saw a budget and a realistic plan to meet the challenges of a data-driven, science-driven agency.”

    Kim said advances the FDA made in strengthening the IT infrastructure are largely due to its $2.5 billion, 10-year data center migration program. Awarded in 2008 to 10 contractors, the Information and Computer Technology for the 21st Century (ICT21) program is a comprehensive, agency-wide IT modernization project that includes data management, data warehousing, IT infrastructure and IT security.

    The subcommittee concluded that the ICT21 program was adequately funded. "Legacy costs [and] high needs for desktop support are very significant,” said Kim. “But based on accepted best practices and principles, the subcommittee felt comfortable endorsing the $2.5 billion figure."

    The final report is scheduled to be released in November.

  • The U.S. Food and Drug Administration has approved Folotyn (pralatrexate), the first treatment for a form of cancer known as Peripheral T-cell Lymphoma (PTCL), an often aggressive type of non-Hodgkins lymphoma.

    Folotyn, is manufactured by Allos Therapeutics Inc. of Westminster, Colo., was approved under the FDA's accelerated approval process, which allows earlier approval of drugs that meet unmet medical needs. It is approved for patients who have relapsed, or have not responded well to other forms of chemotherapy.

    Lymphoma is a cancer of the lymphatic system, which is part of the immune system. There are many types of lymphoma: one type is called Hodgkin's disease, and the rest are called non-Hodgkin's lymphomas. PTCL involves a type of white blood cell called T-cells. It is a relatively rare disease, occurring in less than 9,500 patients each year in the United States.

    The FDA approved the drug based on evidence that it reduces tumor size, because tumor shrinkage is considered reasonably likely to predict a clinical benefit such as extending the survival of cancer patients. Tumor shrinkage was seen on imaging scans in one study. Of 109 patients with PTCL in the trial, 27 percent had reduction in tumor size.

    To speed the drug's availability, Folotyn was granted priority review, ensuring a review within six months rather than 10 months for a standard review. The drug was also designated as an orphan drug, which provides a variety of financial incentives to manufacturers that develop drugs for a small number of patients with a rare disorder.

  • On Sept. 25, 2009, the U.S. Food and Drug Administration approved Stelara (ustekinumab), a biologic product for adults who have a moderate to severe form of psoriasis.

    Plaque psoriasis is an immune system disorder that results in the rapid overproduction of skin cells. About 6 million people in the United States have plaque psoriasis which is characterized by thickened patches of inflamed, red skin, often covered with silvery scales.

    Stelara, manufactured by Centocor Ortho Biotech Inc. of Horsham, Pa., is a monoclonal antibody, a laboratory-produced molecule that mimics the body’s own antibodies that are produced as part of the immune system. The biologic treats psoriasis by blocking the action of two proteins which contribute to the overproduction of skin cells and inflammation.

    Three studies of 2,266 patients evaluated the biologic’s safety and effectiveness.

    Since Stelara reduces the immune system’s ability to fight infections, the product poses a risk of infection. Serious infections have been reported in patients receiving the product and some of them have lead to hospitalization. These infections were caused by viruses, fungi, or bacteria that have spread throughout the body. There may also be an increased risk of developing cancer.

    The FDA is requiring a risk evaluation and mitigation strategy or REMS for Stelara that includes a communication plan targeted to healthcare providers and a medication guide for patients.

  • HHS Secretary Kathleen Sebelius announced $40 million in grants to 69 grantees in 41 states and the District of Columbia to help them find and enroll children who are uninsured but eligible for either Medicaid or the Children’s Health Insurance Program (CHIP).

    Recognizing that millions of children are eligible for Medicaid or CHIP, but remain uninsured, the Children’s Health Insurance Program Reauthorization Act of 2009 (CHIPRA) set aside $100 million for fiscal years 2009-2013 expressly to help find and enroll eligible children. Of the total outreach amount, $80 million will be given to states and other organizations, $10 million to Tribal organizations and $10 million for a national outreach effort. These awards are for a two-year period ending Dec. 31, 2011, which will then be followed by a second round of $40 million in new grants.

    The grants were awarded to applicants whose outreach, enrollment and retention efforts will target geographic areas with high rates of eligible but uninsured children, particularly those with racial and ethnic minority groups who are uninsured at higher-than-average rates.

    The vast majority of grantees will be using multiple, community-based approaches. The grant awards require that recipients be able to show actual increases in enrollment and retention of children already in the programs. Both CHIP and Medicaid state agencies are to report to the Centers for Medicare & Medicare Services (CMS) the number of new enrollees and those who retained coverage that are directly attributable to the grant activities. Grantees are also to report activities they believe were the most effective in finding, enrolling and maintaining children in these benefit programs.

  • HHS Secretary Kathleen Sebelius announced awards totaling $27.8 million to health center-controlled networks and large multi-site health centers to implement electronic health records (EHR) and other health information technology (HIT) innovations.

    The funds are part of the $2 billion allotted to HHS’ Health Resources and Services Administration (HRSA) under the American Recovery and Reinvestment Act of 2009 (ARRA) to expand health care services to low-income and uninsured individuals through its health center program.

    Eighteen grants totaling more than $22.6 million will support EHR implementation. Grants totaling more than $2.6 million will help four grantees implement a variety of HIT innovations, including the creation of health information exchanges among different providers and the incorporation of HIT at dental delivery sites. Another five grants totaling over $2.5 million will help health centers devise plans to use existing EHRs to improve patient health outcomes.

    HRSA received $2 billion through the Recovery Act to expand health care services to low-income and uninsured individuals through its health center program. To date, more than $1.3 billion of these funds have been awarded to community-based organizations across the country. HRSA-supported health centers treated 17 million patients in 2008, 40 percent of whom have no health insurance.

    In addition, HRSA received $500 million in Recovery Act workforce funds—$300 million to expand the National Health Service Corps (NHSC) and another $200 million for other health care workforce programs. The NHSC funds will pay for student loan repayments for primary care medical, dental, and mental health clinicians who will practice for a minimum of two years in NHSC sites that treat underserved and uninsured people. Recently, awards totaling $33 million—part of the $200 million total—were announced to expand the training of health care professionals.

  • The Department of Health and Human Services (HHS) released of $120 million in American Recovery and Reinvestment Act (ARRA) funds for prevention and wellness programs for U.S. states and territories.

    The $120 million in cooperative agreements will be awarded to states and territories for three components: statewide policy and environmental change, tobacco cessation through quit-lines and media campaigns, and special initiatives to create health-promoting policies and environments. For the first two components, dollar amounts awarded to each state and territory will be based on population size and number of smokers. For the third component, states will apply for special funds through a competitive process based on the potential health impact of the proposed activities. States and territories will have two years to complete their work. They will coordinate their efforts with other Communities Putting Prevention to Work initiatives in large cities, urban areas, small cities, rural areas, and tribal areas.

    Funded projects will emphasize state-level policy and environmental changes that will help communities and schools support healthy choices.

    In addition to the $373 million already released to communities and tribes around the country, the comprehensive Communities Putting Prevention to Work initiative will make $650 million available for public health efforts to address obesity, increase physical activity, improve nutrition and decrease smoking.

  • The U.S. Food and Drug Administration announced the availability of the first draft guidance for industry on Risk Evaluation and Mitigation Strategies or REMS, which are required for certain drugs or biologics.

    The Food and Drug Administration Amendments Act of 2007 (FDAAA) granted the FDA the authority to require the submission and implementation of a REMS if the FDA determines a REMS is necessary to ensure that a drug’s benefits outweigh its risks.

    REMS components include medication guides; patient package inserts; a communication plan for health care providers; elements to ensure safe use including requirements for those who prescribe, dispense, or use the drug; and a timetable for REMS submission.

    The draft guidance for industry titled “Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed REMS Modifications”:

  • On Oct. 1, 2009, MSN announced the launch of My Health Info, a new Web site for consumers that incorporates Microsoft's HealthVault profiles into a more comprehensive offering.

    The site, located on MSN's health and fitness homepage, provides tools for monitoring condition specific variables, such as high blood pressure or diabetes, as well as general health stats, such as body-mass index. Consumers can customize individual dashboards by adding or deleting widgets.

  • The United States National Cancer Institute (NCI) formalized bilateral partnerships this week with the governments of Argentina, Brazil, Mexico and Uruguay, to accelerate progress against cancer in Hispanic populations in the United States and Latin America and improve cancer research.

    John E. Niederhuber, M.D., NCI director, representing the U.S. Department of Health and Human Services, signed formal letters of intent to collaborate in cancer research efforts. These countries, along with Chile (which signed a letter of intent in June) and the United States, comprise the United States-Latin America Cancer Research Network (US-LA CRN). This partnership was created to build a comprehensive understanding of the cancer burden among Hispanic populations in Latin America and the United States and to enhance the cancer research and care infrastructures in both regions of the hemisphere.

    Spearheaded by NCI's Office of Latin American Cancer Program Development, this partnership will support the co-development of programs in three broad scientific areas: cancer research and clinical trials; multinational and multidisciplinary training programs; technology and capacity building.

    The Latin American countries and the United States will link their research efforts through the cancer Biomedical Informatics Grid, an information network enabling the US-LACRN members to share data and knowledge. The network participants will also initiate pilot projects to expand research efforts and improve the delivery of cutting-edge cancer treatments to patients in the United States and Latin America.

    In Latin America, cancer is among the top three deadliest diseases, and its incidence in these countries continues to rise. Cancer also takes a large toll on Hispanic/ Latino populations in the United States, which is estimated to climb to nearly 60 million and represent approximately 19 percent of the U.S. population by 2020. Reducing the burden of cancer in the United States and abroad will depend heavily on understanding and controlling cancer in this population.

    For the first pilot project of this collaboration, the countries identified research concepts that are intended to improve breast cancer management in Latin America. At the same time, they will provide an opportunity to enhance research training, capacity building and establishment of a sustainable clinical research infrastructure for future projects.

    For more information about NCI's Office of Latin American Cancer Program Development, please go to http://olacpd.cancer.gov.

Reserve/Guard

  • As of Sept. 29, 2009, the total number of Guard and Reserve currently on active duty has decreased by 971 to 140,757. The totals for each service are Army National Guard and Army Reserve 109,188; Navy Reserve, 6,405; Air National Guard and Air Force Reserve, 15,949; Marine Corps Reserve, 8,559; and the Coast Guard Reserve, 656. www.defenselink.mil

Reports/Policies

  • The GAO published “Medicare Physician Services: Utilization Trends Indicate Sustained Beneficiary Access with High and Growing Levels of Service in Some Areas of the Nation,” (GAO-09-559) on Sept. 28, 2009. In this report, the GAO examined whether, from 2000 through 2008, beneficiaries had problems accessing physician services; identified areas of the country in which Medicare beneficiaries are potentially over-served by physicians; and described characteristics that distinguish the potentially over-served areas from other areas in the nation. http://www.gao.gov/new.items/d09559.pdf

  • The GAO published “Nursing Homes: CMS's Special Focus Facility Methodology Should Better Target the Most Poorly Performing Homes, Which Tended to Be Chain Affiliated and For-Profit,” (GAO-09-689) Sept. 28, 2009. In this report, the GAO determined the number of most poorly performing nursing homes nationwide; how their performance compared to that of homes identified using the SFF methodology; and the characteristics of such homes. http://www.gao.gov/new.items/d09689.pdf

Legislation

  • H.R.3648 (introduced Sept. 24, 2009): To amend title VII of the Public Health Service Act to increase the number of physicians who practice in underserved rural communities was referred to the House Committee on Energy and Commerce.
    Sponsor: Representative John T. Salazar [CO-3]
  • H.R.3652 (introduced Sept. 25, 2009): To amend the Public Health Service Act and title XVIII of the Social Security Act to make the provision of technical services for medical imaging examinations and radiation therapy treatments safer, more accurate, and less costly was referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, 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 John Barrow [GA-12]
  • H.R.3656 (introduced Sept. 25, 2009): To amend the Public Health Service Act to expand and intensify programs of the National Institutes of Health and the Centers for Disease Control and Prevention with respect to translational research and related activities concerning Down syndrome, and for other purposes was referred to the House Committee on Energy and Commerce.
    Sponsor: Representative Cathy McMorris Rodgers [WA-5]
  • H.R.3657 (introduced Sept. 25, 2009): To amend title 38, United States Code, to provide for members of the United States Public Health Service and National Oceanographic and Atmospheric Administration Corps to transfer unused benefits under Post-9/11 Educational Assistance Program to family members, and for other purposes was referred to the House Committee on Veterans' Affairs.
    Sponsor: Representative Ciro D. Rodriguez [TX-23]
  • H.R.3663 (introduced Sept. 29, 2009): To amend title XVIII of the Social Security Act to delay the date on which the accreditation requirement under the Medicare Program applies to suppliers of durable medical equipment that are pharmacies was agreed to by Voice Vote.
    Sponsor: Representative Zachary T. Space [OH-18]
  • H.R.3664 (introduced Sept. 29, 2009): To direct the Secretary of Health and Human Services to establish a Healthcare Innovation Zone pilot program was referred to the Committee on Energy and Commerce, and in addition to the Committee on Ways and Means, 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 Allyson Y. Schwartz [PA-13]
  • H.R.3668 (introduced Sept. 29, 2009): To amend the Public Health Service Act to reauthorize the special diabetes programs for Type I diabetes and Indians under that Act was referred to the House Committee on Energy and Commerce.
    Sponsor: Representative Diana DeGette [CO-1]
  • H.R.3680 (introduced Sept. 30, 2009): To amend the Public Health Service Act to provide for health data regarding Native Hawaiians and other Pacific Islanders was referred to the House Committee on Energy and Commerce.
    Sponsor: Representative Madeleine Z. Bordallo [GU]
  • S.1717 (introduced Sept. 25, 2009): A bill to authorize major medical facility leases for the Department of Veterans Affairs for fiscal year 2010 and for other purposes was held at the desk.
    Sponsor: Senator Daniel K. Inouye [HI]
  • S.1720 (introduced Sept. 25, 2009): A bill to amend title VII of the Public Health Service Act to provide improved training and primary care was referred to the Committee on Health, Education, Labor, and Pensions.
    Sponsor: Senator Jack Reed [RI]
  • S.1732 (introduced Sept. 30, 2009): A bill to amend the Public Health Service Act to provide for health data regarding Native Hawaiians and other Pacific Islanders was referred to the Committee on Indian Affairs.
    Sponsor: Senator Daniel K. Inouye [HI]

Hill Hearings

  • The House Veterans Affairs Committee will hold a hearing on Oct. 7, 2009, to examine the implications of the Department of Veterans Affairs’ PTSD Rule-Making.
  • The House Veterans Affairs Committee will hold a hearing on Oct. 8, 2009, to mark up pending legislation.
  • The House Veterans Affairs Committee will hold a hearing on Oct. 14, 2009, to receive an update on the state of the Department of Veterans Affairs.
  • The House Veterans Affairs Committee will hold a hearing on Oct. 15, 2009, to identify the causes of inappropriate billing practices by the Department of Veterans Affairs.

Meetings / Conferences


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