FEDERAL HEALTH UPDATE
September 26, 2008Produced by Kate Connelly Theroux in collaboration with the Institute of Federal Health Care (IFHC) To subscribe, please visit http://fedhealthinst.org/subscriber.cfm. Sponsored by
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Congressional Schedule
Undersecretary of Veterans Affairs for Health Michael Kussman and Cliff Freeman, acting deputy director, DoD/VA Interagency Program Office (IPO), described the steps the VA has made to determine what information clinicians need and gave a demonstration of VISTA. Dr. S. Ward Casscells, assistant secretary of defense for health affairs, described DoD’s efforts and assured the committee that the DoD’s electronic health system will be legible, secure, safe from failure, and easy both to learn and to use.
Prior to the enhancement, the TRDP was only available to retirees and their families in the United States, the District of Columbia, Guam, Puerto Rico, the U.S. Virgin Islands, American Samoa, the Commonwealth of the Northern Mariana Islands and Canada. The Enhanced-Overseas TRDP now allows retirees worldwide to purchase dental coverage. Highlights of the benefits available under the Enhanced-Overseas program include:
There is no TRDP dentist network overseas. However, Enhanced-Overseas TRDP enrollees who need to locate a dentist for covered services may call the International SOS Assistance, Inc., (I-SOS) 24-hour referral service toll-free from inside the United States at 800-523-6586 or outside of the United States via collect call to 215-942-8226. In addition, an online host nation provider list of more than 500 dentists and dental clinics in nearly 50 countries is located on the TRDP Web site. For Enhanced-Overseas TRDP customer service questions, please contact Delta Dental of California via the following international toll-free number: (AT&T USADirect Access Number) + (866) 721-8737. For more information about TRDP and Enhanced-Overseas TRDP coverage visit http://www.trdp.org. http://www.tricare.mil/Pressroom/News.aspx?fid=458
According to the European Regional Medical Command (ERMC), FluMist began arriving at Army clinics in August and flu shot shipments will be arriving soon. Vaccination is mandatory for all active-duty military personnel, Department of Defense civilians designated as emergency essential and Reserve personnel on active duty. TRICARE beneficiaries will also be offered the vaccine to protect against influenza and its severe complications. Unlike some previous years when there were shortages, there is an ample supply of the vaccine available this season. For this year’s flu season — a typical season being from October to May — the Department of Defense has 3.5 million doses. Whether a patient will receive the nasal vaccine or a shot will depend on age and medical history. FluMist is approved for anyone between the ages of 2 and 49. For pregnant women, those with certain allergies, or patients over the age of 49, flu shots will be given, as will pediatric shots for children 6 to 23 months old. Anyone authorized receive a vaccination should contact their local clinic. ERMC’s reported goal is to vaccinate 95 percent of U.S. Army Europe’s active-duty population by the end of the year. http://www.stripes.com/article.asp?section=104&article=57621
The new law retroactively replaces the mid-year 2008 Medicare Physician Fee Schedule (MPFS) rate reduction of 10.6 percent with fee schedule rates (0.5 percent increase) in effect from January to June 2008. In addition, MPFS payment rates are being revised to increase the fee schedule amounts for certain mental health services. The new rates went into effect on Sept. 1, 2008. The exact terms of the incentive plans for health care providers will be outlined in Medicare’s final rule on the 2009 MPFS this fall. http://www.tricare.mil/pressroom/news.aspx?fid=457
Throughout the 2008 Pacific Partnership mission, Mercy served as an enabling platform for military and nongovernmental organizations (NGOs) to coordinate and carry out HCA efforts in the Republic of the Philippines, Vietnam, the Federated States of Micronesia, Timor-Leste and Papua New Guinea. The relationships built and sustained with multi-national partners in the Asia Pacific region through exercises and professional and military exchanges are designed to help in humanitarian efforts and preserve peace and stability in the region. During this year’s mission, more than 90,000 patients were treated by the medical teams in various locations throughout the Western Pacific, including more than 1,300 surgery patients and more than 14,000 dental patients. Medical and engineering professionals from the partner and host nations of Australia, Canada, Chile, India, Indonesia, Japan, New Zealand, Republic of Korea, Portugal, Singapore, Republic of the Philippines, Vietnam, Timor-Leste, Papua New Guinea and the Federated States of Micronesia served on the Pacific Partnership team. http://www.health.mil/Press/Release.aspx?ID=352
VA has revised the Disability Rating Schedule in light of current scientific and medical knowledge in order to provide VA employees with more detailed and up-to-date criteria for evaluating and compensating veterans with these injuries. Two groups of veterans may be affected by these changes. The first group includes veterans who will be awarded disability compensation for TBI and burn injuries in the future. The second group includes veterans already receiving compensation for these injuries whose disabilities are reevaluated under the new criteria. Blast injuries resulting from roadside improvised explosive devices have been common sources of injury in the conflicts in Iraq and Afghanistan and appear to be somewhat different from the effects of trauma seen from other sources of injury. As of September 2008, there are more than 22,000 veterans being compensated for TBI, of whom more than 5,800 are veterans of the conflicts in Iraq and Afghanistan. Traumatic brain injuries result in immediate effects such as loss or alteration of consciousness, amnesia and sometimes neurological impairments. These abnormalities may all be transient, but more prolonged or even permanent problems with a wide range of impairment in such areas as physical, mental and emotional or behavioral functioning may occur. More than 90 percent of combat-related TBIs are closed head injuries, with most service members sustaining a mild TBI or concussion. Difficulties after TBI may include headache, sleep difficulties, decreased memory and attention, slower thinking, irritability and depression. These changes will be effective Oct. 23, 2008. http://www1.va.gov/opa/pressrel/pressrelease.cfm?id=1582
The report, titled Amyotrophic Lateral Sclerosis in Veterans: Review of the Scientific Literature, analyzed numerous previous studies on the issue and concluded that “there is limited and suggestive evidence of an association between military service and later development of ALS.” ALS, also called Lou Gehrig’s disease, is a neuromuscular disease that affects about 20,000 to 30,000 people of all races and ethnicities in the United States, is often relentlessly progressive, and is almost always fatal. ALS causes degeneration of nerve cells in the brain and spinal cord that leads to muscle weakness, muscle atrophy, and spontaneous muscle activity. Currently, the cause of ALS is unknown, and there is no effective treatment. The new interim final regulation applies to all applications for benefits received by VA on or after Sept. 23, 2008, or that are pending before VA, the United States Court of Appeals for Veterans Claims, or the United States Court of Appeals for the Federal Circuit on that date. VA will work to identify and contact veterans with ALS, including those whose claims for ALS were previously denied, through direct mailings and other outreach programs. http://www1.va.gov/opa/pressrel/pressrelease.cfm?id=1583
A total of 184 funding applications were submitted by state and local health departments in a competitive application process. Eligible applicants for the awards were limited to the 62 state, local and territorial public health departments that currently receive federal funding through CDC′s Public Health Emergency Preparedness (PHEP) Cooperative Agreement. The 29 award recipients have one year to complete the projects, which begin on September 30, 2008. The projects focus on seven key areas and include:
A list of the 29 award recipients and their projects can be found at http://emergency.cdc.gov/cotper/coopagreement/07/funding-schedule-pan-flu.asp. The $24 million for the new projects is part of $600 million in PHEP supplemental funding appropriated by Congress to accelerate state and local influenza pandemic planning efforts. The focus of the funding, which was distributed in three phases beginning in 2006, was on practical, community-based procedures that could prevent or delay the spread of an influenza pandemic. http://www.cdc.gov/media/pressrel/2008/r080924.htm
The new organization is being established in cooperation with the U.S. Department of Health and Human Services (HHS), as a successor to the American Health Information Community (AHIC), a federal advisory committee that will soon be dissolving. The Board of Directors will be immediately tasked with defining the strategies by which the organization will fulfill its mission to develop a unified approach in creating an effective, interoperable nationwide health information system in the United States. The 15 members of AHIC Successor Board of Directors are:
In addition to the new Board members listed above, HHS Secretary Mike Leavitt and Veterans Affairs Secretary James Peake will serve as federal liaisons to the board. The National Coordinator for Health Information Technology, Robert Kolodner, M.D., will continue to coordinate federal input into the public-private process. The initial three signatories to the incorporation—John Glaser, Ph.D., vice president and chief information officer, Partners HealthCare System, Inc.; Jonathan Perlin, M.D., Ph.D., chief medical officer and president, Clinical Services, Hospital Corporation of America; and Dr. Tooker—will also participate as Board members for the first year, after which they will step down without replacement. The current AHIC, which is scheduled to complete its work by the end of 2008, advises HHS on how to accelerate the development and adoption of health information technology. To learn more about the AHIC successor and HHS’ health IT initiative visit http://www.hhs.gov/healthit/. More information on the AHIC Successor, Inc., including a list of its board of directors, is available at http://www.ahicsuccessor.org
The purpose of the Targeted Capacity Expansion Program for Substance Abuse Treatment and HIV/AIDS Services is to enhance and expand substance abuse treatment and/or outreach/pretreatment services in conjunction with HIV/AIDS services in traditionally underserved communities. Traditionally underserved communities include African-American, Latino/Hispanic and other racial or ethnic communities affected by substance abuse and HIV/AIDS. Grant funds will be used by community service providers to implement evidence-based treatment practices encompassing services such as case management, substance abuse counseling, HIV testing, mental health referrals and HIV risk reduction education. In addition, grant funds will be used for community outreach efforts designed to inform individuals on how they can lower their risks for substance use and HIV infection. Forty nine community programs have been selected to receive funding through these grants. Awardees providing treatment services will average about $450,000 in funding each year, while programs providing community outreach services will average about $350,000 per year. The actual award amounts may vary, depending on the availability of funds and the activities proposed by the awardees. The funds are awarded and administered by SAMHSA’s Center for Substance Abuse Treatment. To view the grant awardees and their first-year grant amounts, please visit http://www.samhsa.gov/newsroom/advisories/0809193153.aspx
An interagency agreement between CMS and the Department of Defense (DoD) will enable beneficiaries who have original Medicare and also receive TRICARE benefits to be offered the option of adding TRICARE health data to their MyPHRSC personal health records (PHRs). This data has only been available to the beneficiary through the DoD Medical Information Technology systems until this point. PHRs generally are electronic health records that individual patients maintain or control, which can include clinical, laboratory and claims data, among other types of medical data. PHRs are tools that can help consumers manage their health and health care services. Beneficiaries who elect to participate in the South Carolina initiative can also add other personal health information manually if they choose. MyPHRSC is a pilot program that enables Medicare beneficiaries in South Carolina to collect and then access information about their health and health care services electronically. Having this information available at their fingertips will help them better manage their health care needs and medical care. Currently, beneficiaries can authorize CMS to send their individual Medicare health data to the PHR. Under this expansion of the pilot, an eligible beneficiary may authorize the DoD to provide TRICARE data from the DoD systems directly to their existing MyPHRSC record. Initially, active medications will be made available. Other data may later be made available for existing MyPHRSC records, as they become available and upon request by the beneficiary. This collaboration with DoD will be the first time additional data from another electronic source other than Medicare will be available in MyPHRSC. The PHR tool selected for the MyPHRSC was created by HealthTrio, which currently offers PHRs to thousands of individuals through employer contracts. The Medicare data is provided through Palmetto GBA, a Medicare contractor serving the region that includes South Carolina. The pilot is being managed by QSSI, a company that specializes in information technology solution development and headquartered in Gaithersburg, Md. The pilot is accepting enrollment online at www.MyPHRSC.com. CMS NR 09-23-2008
While scientists at any career level can receive Pioneer Awards, only early career investigators who have not held an NIH regular research (R01) or similar NIH grant are eligible for New Innovator Awards. Both programs are key components of the NIH Roadmap for Medical Research. Now in its fifth year, the Pioneer Award program has made 63 awards, 16 of them in 2008. The New Innovator Award program, launched in 2007, supports 61 investigators — 30 selected last year and 31 more this year. Each Pioneer Award provides $2.5 million in direct costs over five years. New Innovator Awards are for $1.5 million in direct costs over the same time period. For both programs, NIH selects the recipients through special application and evaluation processes. Distinguished outside experts identify the most highly competitive applicants. The Advisory Committee to the Director, performs the second level of review and NIH Director Elias A. Zerhouni, M.D makes final decisions based on the outside evaluations and programmatic considerations. More information on the Pioneer Award, including details on the 47 scientists who received awards in the first four years of the program, is at http://nihroadmap.nih.gov/pioneer. Information on the New Innovator Award is at http://nihroadmap.nih.gov/newinnovator. Details on the research plans of the new recipients are at http://nihroadmap.nih.gov/newinnovator/Recipients08.asp.
AAHRPP-accredited organizations include community hospitals, a contract research organization, independent IRBs, teaching hospitals, universities and, now, a private, independent research facility. The newly accredited organizations include
Through the accreditation process, organizations must demonstrate that they have built extensive safeguards into every level of their research operation and that they adhere to the highest standards for research. The accreditation process typically results in system-wide improvements that enhance protections for research participants and promote high-quality research. Accreditation is available to U.S. and international organizations that conduct biomedical, behavioral or social sciences research involving human participants. Decisions on accreditation are announced quarterly and is valid for three years. http://www.aahrpp.org/www.aspx?PageID=248
Premiums rose a modest five percent this year, but they have more than doubled since 1999 when total family premiums stood at $5,791 (of which workers paid $1,543). During the same nine-year period, workers’ wages increased 34 percent and general inflation rose 29 percent. This year many workers are also facing higher deductibles in their plans, including a growing number with general plan deductibles of at least $1,000 – 18 percent of all covered workers in 2008, up from 12 percent last year. This is partly, but not entirely, driven by growth in consumer-directed plans such as those that qualify for a tax-preferred Health Savings Account. The shift has been most dramatic for workers in small businesses with three to 199 workers, where more than one in three (35 percent) covered workers must pay at least $1,000 out of pocket before their plan generally will start to pay a share of their health-care bills – rising from 21 percent last year. For workers facing deductibles in Preferred Provider Organizations, the most common type of plan, the average deductible rose to $560 in 2008, up nearly $100 from 2007. The annual Kaiser/HRET survey provides a detailed picture of how employer coverage is changing over time in terms of availability, cost and coverage. It was conducted between January and May of 2008 and included 2,832 randomly selected, non-federal public and private firms with three or more employees (1,927 of which responded to the full survey and 905 of which responded to a single question about offering coverage). The annual percentage premium increase is calculated by comparing this year’s average premium to last year’s, a change in methodology designed to be more reflective of changes across the entire market. To read the full report, please visit www.kff.org+ehbs092408.cfm
Dr. Zerhouni, a physician-scientist and world-renowned leader in radiology research, has served as NIH director since May 2002. One of the hallmarks of his tenure is the NIH Roadmap for Medical Research, launched in 2003, after extensive consultations with the scientific community. The NIH Roadmap brought together all of the NIH 27 Institutes and Centers to fund compelling research initiatives that could have a major impact on science, but that no single institute could tackle alone. Additional information about the NIH Roadmap can be found at www.nihroadmap.nih.gov. Dr. Zerhouni also launched new programs to encourage high-risk innovative research, such as the Director's Pioneer Awards and New Innovator Awards and focused especially on the need to support new investigators and foster their independence. He worked to lower barriers between disciplines of science and encourage trans-NIH collaborations. Dr. Zerhouni also led a major reform of the translational and clinical research system in the United States. He also worked to improve public access to scientific information. These efforts, along with his continual advocacy for the public's investment in the NIH, greatly contributed to Congress passing the NIH Reform Act of 2006. http://www.nih.gov/news/health/sep2008/od-24.htm
Companies must stop manufacturing unapproved BSS products on or before Nov. 24, 2008, and must stop shipping such unapproved products on or before Jan. 21, 2009. After these dates, all unapproved BSS products must have FDA approval to be manufactured or shipped in interstate commerce. Companies that continue to market unapproved BSS products after these dates may be subject to immediate FDA enforcement action, such as seizure and/or injunction against the company. The FDA’s action does not affect approved ophthalmic BSS products. Companies marketing any unapproved topical drug products containing papain must stop manufacturing them on or before Nov. 24, 2008. Companies or others engaged in shipping these products must stop shipping these products on or before Jan. 21, 2009. After these dates, all topical products containing papain must have FDA approval to be manufactured or shipped in interstate commerce. Companies that continue to market unapproved topical papain products after these dates may be subject to immediate FDA enforcement action, such as seizure and/or injunction against the company. No topical drug product containing papain has been approved by the FDA. Companies that do not comply with the designated timelines may face further FDA action, including enforcement action. If FDA takes enforcement action against a company that continues to market an unapproved product after the stated timeframes, the FDA may simultaneously take additional action regarding any other violative products that the company may be marketing, including any other unapproved drugs. To read FDA’s Compliance Policy Guide (CPG): http://www.fda.gov/cder/Guidance/6911fnl.htm.
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If you need further information on any of the items in the Federal Health Update, please contact Kate Connelly Theroux at (703) 447-3257 or by e-mail at katetheroux@fedhealthinst.org. To subscribe, please visit http://fedhealthinst.org/subscriber.cfm. To unsubscribe, please send an email to newsletter@fedhealthinst.org with UNSUBSCRIBE as the subject. Back issues availiable at Federal Health Update Archives. |
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