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Defense to Demo Lab Developed Test Evaluations
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| The US Department of Defense (DoD) announced its intention to evaluate laboratory-developed tests for possible coverage under the TRICARE military health system. The demonstration project aims to determine the feasibility for the DoD to review laboratory developed tests approved by the Centers for Medicare and Medicaid Services, but not yet examined by the Food and Drug Administration. DoD would use the demonstration to determine if the tests meet TRICARE safety and effectiveness requirements. Laboratory-developed tests that meet the criteria may be covered as a benefit under the TRICARE program.
Under the demonstration, only laboratory-developed tests that are considered of significant importance in clinical decision making, whether for surveillance, surgical intervention, chemotherapy, or radiation therapy for cancer, may be enrolled.
Laboratories and laboratory-developed test manufacturers holding proprietary tests with a CMS national coverage determination or a local coverage determination may request their tests be considered for coverage under TRICARE. The demonstration project will begin January 27, 2012 and remain in effect for three years. Additional details for the TRICARE laboratory-developed tests demonstration projectare available here.
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| National Report Examines Potential Health Effects of Uranium Mining |
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In December 2011, the National Research Council released a report on health and environmental issues as well as avenues for mitigating certain risks, if Virginia lifts its 30-year ban on uranium mining. The National Research Council’s Committee on Uranium Mining in Virginia, chaired by Paul Locke, Associate Professor in the Department of Environmental Health Sciences at the Johns Hopkins Bloomberg School of Public Health, assessed the potential impact of uranium mining on public health, among other issues. The Committee was asked not to recommend whether uranium mining should be permitted.
In consideration of potential health impact, the report found that uranium mining and processing opens a “wide range” of adverse human health effects. While health risks are more relevant to occupational exposure, “associated risks” may extend to the general population through environmental pathways. The greatest radiation health risks from uranium mining and processing are represented through protracted exposure to radon decay products, which have strong and causal linkages to lung cancer.
Questions for the Committee were posed by the Commonwealth of Virginia. The study was funded under a contract between the National Research Council and Virginia Tech. Virginia Uranium, Inc. provided funding to the university.
To view the report on Uranium Mining in Virginia in its entirety, please visit the Auburn Health Strategies website.
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New CLIAC Chair Named
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A new chairperson has been designated to helm the Clinical Laboratory Improvement Advisory Committee (CLIAC). Paula Santrach, MD, Director of the Autotransfusion Team and Co-Director of Point of Care Testing at the Mayo Clinic, has been appointed Chair for a term ending June 30, 2013.
Dr. Santrach succeeds Elissa Passiment, EdM, CLS(NCA), Executive Vice President of the American Society for Clinical Laboratory Science, in this position.
Also, for the first time in the panel’s history, a nursing professor was named to CLIAC. Linda D. Ward, PhD, ARNP, will serve through June 30, 2015.
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OIG Wants Your Proposals Addressing Fraud
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The Office of the Inspector General (OIG) to the US Department of Health and Human Services issued its annual notice soliciting suggestions for the development of new safe harbor provisions. The OIG is also seeking ideas for the development of special fraud alerts and modifications to existing safe harbors.
“Safe harbors” are regulatory provisions that specify various payment and business practices that will not be treated as criminal offenses under the anti-kickback law, even though the arrangements may have the potential to induce referrals reimbursable by federal health care programs.
Special Fraud Alerts are issued on occasion by the OIG to explain practices that may be considered potentially fraudulent or abusive. They are intended to provide guidance to health care providers.
The OIG will accept proposals and recommendations through February 27, 2012.
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