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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

US Midterms: Industry Loses Some Supporters In Congress, But Retains Many

With most of the Nov. 6 election tally completed, it’s clear there will be many new faces for the device industry to engage with in the halls of Congress, but the sector still appears to have a significant group of supporters on Capitol Hill. Also, several medtech-relevant measures were on the ballot.

Elections Legislation

Medicare Allows Use Of Hospital Outreach Lab Pay Data; Industry Applauds, But Still Sues

The clinical laboratory industry praised the US Centers for Medicare and Medicaid Services for making changes in its final Clinical Laboratory Fee Schedule rule to allow more data from hospital outreach labs to be considered in setting laboratory test pay rates. But lab advocates are still pursuing a lawsuit and pushing for legislative reforms.

Reimbursement Regulation

Twenty-Four Congressional Midterm Races To Watch In US Medtech-Heavy Regions

Medtech firms are accustomed to rooting for House and Senate candidates they have backed in traditionally medtech-facility heavy regions of the US including Minnesota, Indiana and Massachusetts. As the sector grows in new regions, there are a broader set of important races for the industry, including in California, Texas, and New Jersey, this election season.

Elections Legislation

Remote Monitoring, Virtual Care Get More Support In Medicare Rules

Remote patient monitoring costs can be reported by home health agencies as allowable Medicare costs starting in 2020 under a new regulation. And, in a separate rule, Medicare has established new reimbursement categories for "virtual" health care.

Reimbursement Regulation

Industry Requests Three Additional Safe Harbors Under Anti-Kickback Statutes

AdvaMed is asking for three new safe harbors from potential Anti-Kickback Statute (AKS) violations to shelter value-based pricing, warranty, and risk-sharing arrangements formed among hospitals, physicians and device manufacturers.

Reimbursement Compliance

Device Week, Oct. 26, 2018 – New Opioids Law, And 510(k) Pilots

On this week's podcast, David Filmore talks to Sue Darcey about the US opioids bill enacted this week, including its expansion of "sunshine" payment reporting requirements for device-makers. And Elizabeth Orr discusses some recently launched 510(k)-process pilot programs and questions from industry.

Legislation Device Week
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