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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. 
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Latest From Sue Darcey

No Pay Incentives Needed For Non-Opioid Pain Control Devices, CMS Says; Industry Disagrees

Medtech firms couldn’t convince the US Medicare agency to propose additional temporary payments under Medicare for non-opioid pain management device alternatives in its proposed rule for outpatient hospitals and ambulatory surgical centers. In response, industry advocacy group AdvaMed plans to gather more data in support of payment incentives before a mid-September deadline comes for comments on the rule.

Reimbursement Medicare

T2Bacteria Panel Wins CMS Approval For New Tech Add-On Payment

The US Medicare agency approved a new technology add-on payment (NTAP) for T2 Biosystems’ blood test, the T2Bacteria panel, for the fiscal year that will begin on 1 October.

Reimbursement Medicare

CMS Clarifies Criterion To Evaluate New Tech Add-On Payments In Inpatient Rule

The US Medicare agency revised and clarified its policies on how it evaluates new technology add-on payments and highlighted its new policy on payments for FDA-approved breakthrough devices, in a final 2020 Inpatient Prospective Payment System (IPPS) rule released on 5 August.

Reimbursement Medicare

CMS Weighs Merits Of New Pass-Through Payments For Aquabeam System, Eluvia Stents In OPPS Proposal

The US Medicare agency has been scrutinizing two new devices that have generated some buzz within the industry for pass-through payment status under its proposed 2020 Outpatient Prospective Payment System (OPPS) rules. The devices are Procept BioRobotic’s AquaBeam System for removal of prostate tissue in men with urinary tract symptoms, and Boston Scientific’s Eluvia drug-eluting stent for treatment of peripheral artery disease.

Reimbursement Medicare

Medicare Telehealth Models Would Be Tested Under House Bill

A new US House bill would require the Centers for Medicare and Medicaid Services’ innovation center to test some telehealth service models to enhance access to care for beneficiaries in remote areas of the country.

Legislation Reimbursement

Device-Related Procedure Costs To Be Revealed Under CMS Proposed Payment Rule

US hospitals would have to reveal on a public website their standard charges and insurer-negotiated prices for a long list of device-related procedures, advanced imaging scans, and lab tests under a proposed Centers for Medicare and Medicaid Services rule released on 29 July.

Reimbursement Regulation
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