Clinical laboratory
Healthcare issues related to clinical laboratories; H.R. 4128/S. 2209, the Verifying Accurate Leading-edge IVCT Development (VALID) Act, provisions relating to FDA oversight of laboratory-developed tests; Federal policy related to implementation of the Families First Coronavirus Response Act, Pub. L. 116-127, provisions relating to coverage of and funding for COVID-19 diagnostic tests; Federal policy related to implementation of the Coronavirus Aid, Relief, and Economic Security (CARES) Act, Pub. L. 116-136, provisions relating to coverage and reimbursement of COVID-19 diagnostic tests and Medicare reimbursement for clinical laboratory tests; S. 3799, the PREVENT Pandemics Act, and a draft of the Improving DATA in Public Health Act, provisions relating to demographic data reporting obligations for laboratories; Federal policy related to the National Correct Coding Initiative and manual instructions inconsistent with American Medical Association guidelines for Current Procedural Terminology (CPT) coding; H.R. 5030/S. 2706, the DIVERSE Trials Act, provisions relating to enhancing diversity in clinical trials and data collection and reporting by clinical laboratories; Federal policy relating to reform of Medicare reimbursement for clinical laboratory services under Section 216 of the Protecting Access to Medicare Act, Pub. L. 113-93; H.R. 6000, the Cures 2.0 Act, provisions relating to pandemic preparedness, improvements in clinical research processes, and advancement of genetic and genomic testing;
HCR - Health Issues
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