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UrduWe at the Association for Diagnostics & Laboratory Medicine were disappointed to see the U.S. Food & Drug Administration’s (FDA’s) attempt to circumvent Congress with its new proposed rule to duplicate the regulation of laboratory developed tests by placing these tests under FDA authority, in addition to their current regulation under the Centers for Medicare and Medicaid Services.
Tag: Healthcare Policy
AACC Statement on Excluding VALID from End of Year Legislative Package
AACC applauds the decision of the United States Congress to exclude the Verifying Accurate Leading-edge IVCT Development (VALID) Act from its end of year omnibus bill.
Medical and Patient Communities Unite to Urge Congress to Stop Bill That Would Impede Patient Access to Essential Diagnostic Tests
AACC joins more than 100 other medical and patient organizations that have expressed concerns about the Senate HELP committee rushing to pass the VALID Act, a bill that would limit patient access to vital laboratory developed tests and the lifesaving diagnoses these tests enable. Specifically, the medical and patient communities urge Congress to remove the VALID Act from the FDASLA Act, a piece of must-pass legislation that the Senate is on the cusp of ratifying.
AACC Calls on Congress to Halt Legislation That Would Hinder Patient Access to Essential Medical Tests
AACC has sent comments to the U.S. Senate Health, Education, Labor & Pensions (HELP) Committee urging the committee not to include the VALID Act in its omnibus Food and Drug Administration (FDA) user fee legislation. VALID would limit the availability of vital laboratory-developed tests, decreasing patient access to life-saving diagnostic tools.
Researchers Reveal Moral Distress Impact, Actions to Support Doctors During Pandemic
During the COVID-19 pandemic, healthcare organizations, leaders, researchers, and practitioners have attempted on the fly to deal with the inherent stresses, strains, and struggles related to an unprecedented healthcare crisis in modern times.
The Importance of Laboratory Developed Tests in Diagnosing COVID-19
Laboratory developed tests play a vital role in getting patients accurate diagnoses and effective care, and at no time has their importance been clearer than during the current pandemic. In this briefing, AACC’s leading experts in laboratory medicine will discuss why laboratory developed tests are crucial to fighting the coronavirus, as well as the regulatory barriers that nearly prevented labs from developing and introducing these tests for the virus.
Maryland Smith’s Conference on Health IT & Analytics Goes Virtual Oct. 8-10
Researchers, clinical executives and policymakers will share and discuss the latest findings and practices connected to the design, implementation and use of information technology and artificial intelligence in healthcare in this 11th annual event.
ASCO 2020: First National-Scale Study on the Impact of Medicaid Expansion on Cancer Mortality Rates Highlighted in Press Program
New data from researchers at Memorial Sloan Kettering Cancer Center (MSK) revealed the effects of Medicaid expansion on cancer death rates on a national scale. The landmark study found that states that adopted Medicaid expansion following the passage of the Affordable Care Act (ACA) in 2010 saw greater decreases in cancer mortality rates than states that did not. The findings were presented as part of the press program for this year’s virtual annual meeting of the American Society of Clinical Oncology (ASCO).
Families First Coronavirus Response Act Would Prohibit Insurers from Paying for Some COVID-19 Tests
AACC greatly values the work that the U.S. House of Representatives has done to support American families in the midst of the coronavirus outbreak and is supportive of the goals of H.R. 6201, the Families First Coronavirus Response Act. However, we are concerned that the language as currently drafted does not provide coverage for COVID-19 tests performed prior to those tests receiving Emergency Use Authorization (EUA) from the Food & Drug Administration (FDA).