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Sue Darcey

Senior Reporter

Washington, D.C.
Sue Darcey is a senior reporter covering the medical device and diagnostics industry. Her current fields of expertise and interest include monitoring medical device post market performance and safety, development of new genomic and laboratory developed tests, the influence of industry lobbying and campaign contributions over Senators’ and Representatives’ voting practices and lawmaking on devices, and FDA approvals of diagnostics for emerging diseases, including tests for Ebola and Zika viruses. A Washington, D.C.-based trade journalist with over 30 years’ experience covering Capitol Hill and regulatory agencies including FDA, CMS and the Environmental Protection Agency, Sue is constantly on the look-out for any problems or safety issues connected to device use, ways that firms resolve those issues, and any new regulations that arise from the challenges. 

Latest From Sue Darcey

Coverage Decisions For AlloMap Molecular Testing To Detect Cardiac Allograft Rejections Left Up To MACs

The US CMS has proposed that due to low Medicare use, it will not nationally cover AlloMap molecular tests to detect cardiac allograft rejections.

Policy Reimbursement

GAO To Investigate Trump Admin Attacks On Scientific Integrity At FDA, CDC

The US watchdog agency accedes to three senators’ request to look into political pressures placed on the FDA and the CDC to alter the science behind their COVID-19 responses.

Policy Legislation

CMS Proposes Coverage For Colorectal Cancer Blood-Based Tests – Except For Epigenomics’ Screen

The US Medicare agency coupled its proposed coverage memo on colorectal cancer screens based on blood-based biomarker tests with a note that the Epi proColon assay does not meet its criteria.

Policy Reimbursement

Seating Of Barrett On Supreme Court Could Be Death Knell For ACA’s Chronic Illness Coverage

During her confirmation hearings, Judge Amy Coney Barrett denied it’s her goal to end all Affordable Care Act coverage, but some senators and legal experts disagree. And if the ACA is struck down, coverage for chronic disease treated with medical devices – including cancer, heart disease and diabetes – could fall by the wayside.

Policy Legal Issues

US Election 2020: Here’s Who Industry’s Donating To

US senatorial friends of the device industry running competitive races in 2020 are being aided by medtech PAC dollars this fall.

Policy Elections

11 New Telehealth Services Will Be Payable By CMS During Pandemic, Agency Says

The US Medicare agency will allow reimbursements for a bevy of new telemedicine services during the COVID-19 public health emergency, it announced on 14 October.

Policy Medicare
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