$300 Millions Dollars Of Cardiology Sunshine

cardio_millionaires

$300 million dollars. That’s how much industry paid to cardiologists and other related healthcare professionals between August 2013 and December 2014… … Click here to read my entire story on MedPage Today….

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Embattled Lab Nears Settlement With Government Over Kickbacks

Health Diagnostic Laboratory Inc, the embattled lab company, is nearing a $50 million settlement with the Justice Department, according to a Wall Street Journal story by  John Carreyrou. As previously reported here, the federal government is investigating HDL for giving kickbacks to physicians  who use  the company’s tests. Additional allegations suggest a broader pattern of serious misconduct based on questionable sales,…

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Medicare Reimbursement for Lung Cancer Screening Provokes Debate

Although 160,000 people in the U.S. die each year from lung cancer, accounting for more than a quarter of all cancer deaths, screening for lung cancer remains controversial. Based on results from the National Lung Screening Trial (NLST) in 2011, the U.S. Preventive Services Task Force (USPSTF) issued a B recommendation in favor of low-dose…

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More Sunshine: CMS Wants Companies To Report Payments To Physicians For Medical Education

In a major reversal of policy, CMS wants industry to report payments to physicians for continuing medical education. The move would eliminate from the Physician Payment Sunshine Act the current exemption for CME. Initially CMS’s  proposal for implementation of the Sunshine Act required industry to report payments to physicians for CME programs. But after considerable debate and lobbying…

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ACC And STS Break New Ground To Test TAVR For Unapproved Uses

ACC STS TVT logo

In a startling break with tradition, the American College of Cardiology and the Society of Thoracic Surgeons will manage and run their own clinical trials testing expanded uses for transcatheter aortic valve replacement (TAVR). The two medical groups have recently been granted an investigational device exemption (IDE) by the FDA for one such trial and…

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ICD Investigation: DOJ Sends Resolution Model To Hospitals

DOJ Summary Chart

Hospitals across the country received emails from the US Department of Justice on Thursday containing a proposed “Resolution Model” that will allow the hospitals to begin to settle the long-standing and much-feared DOJ investigation into improper Medicare billing for ICDs. The action appears to confirm an article, published earlier in August in Report on Medicare…

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HRS 2012: More Clarity on DOJ ICD Investigation, “Incidental PCIs” Still Excluded

In a guest post, electrophysiologist Edward J. Schloss recounts a talk at Heart Rhythm Scientific Sessions 2012 by Suneet Mittal which provided a detailed account of his group’s experience with a Department of Justice investigation of ICD implantation outside of NCD guidelines….

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Politics and Transcatheter Aortic Valve Replacement

Scott Gottlieb, MD

From the first early stages of its development, the prospect of transcatheter aortic valve replacement (TAVR) provoked two broad and competing fears: Regulatory safeguards would kill a promising new technology, denying its life-saving benefits to many thousands of desperately sick people. The stampede to stake a claim in a promising, highly lucrative new territory would…

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CMS Issues National Coverage Decision for TAVR

The Centers for Medicare & Medicaid Services (CMS) today issued its national coverage decision (NCD) for  transcatheter aortic valve replacement (TAVR). As expected, CMS will offer reimbursement for TAVR, but only if a number of criteria are first met. The NCD was initially requested by the American College of Cardiology and the Society of Thoracic…

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CMS Releases Details Of Proposed National Coverage For TAVR

(Updated with statement from the ACC and STS) On Thursday the Centers for Medicare & Medicaid Services (CMS) released a memo containing details of its proposed Medicare coverage for TAVR (transcatheter aortic valve replacement). The memo is a response to a formal request for national coverage determination (NCD) from the Society of Thoracic Surgeons (STS) and…

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