Donald Trump has nominated Scott Gottlieb to be the next FDA Commissioner. To his credit, Gottlieb is not certifiably crazy like several of the other candidates who were reported to be under consideration for the job. But he is is a deeply conservative ideologue who is determined to reduce the government’s role in healthcare. On two occasions in…
Dollars For Heart Docs: 2015 Edition
August 24, 2016 by 1 Comment
–Cardiologists received more than $200 million from industry in 2015. In 2015 cardiologists and other cardiovascular specialists received more than $200 million dollars from industry, according to new data released by Medicare. More than 30,000 physicians in cardiovascular medicine received industry payments in 2015, though many of these payments were relatively small amounts. But more…
The Hidden Cost Of Free Lunch
June 20, 2016 by 2 Comments
–Brand name prescribing increases when industry pays for the meals Physicians who accept free meals from a drug company are more likely to prescribe that company’s brand name drugs, according to a new study in JAMA Internal Medicine. The authors compared data from the Open Payments Database listing industry payments to physicians with Medicare prescribing…
Encouraging Results Found In Long Term TAVR Registry
November 30, 2015 by Leave a Comment
Since it’s first FDA approval in late 2011 the use of transcatheter aortic valve replacement therapy (TAVR) has grown dramatically– but not dangerously or explosively– in the US. Now accumulating data from a central national registry provides the best picture yet of the evolution and current status of TAVR. The TVT Registry, which is run by the Society of Thoracic Surgeons (STS)…
CMS Proposal Would Plug Up Watchman Reimbursement
November 11, 2015 by Leave a Comment
Medicare is proposing to put severe constraints on reimbursement for percutaneous left atrial appendage closure using the Boston Scientific Watchman device to prevent stroke in patients with nonvalvular atrial fibrillation. On Tuesday afternoon the Centers for Medicare & Medicaid Services (CMS) issued the draft of a restrictive national coverage determination (NCD) for Watchman that would almost certainly apply the…
Trick Or Treat? Hospitals, Haunted By DOJ ICD Investigation, Settle For $250 Million
October 30, 2015 by Leave a Comment
The specter of the US government investigation into hospital overuse of ICDs has now finally been dismissed. The investigation, which has haunted hospital executives and electrophysiologists since it began in 2011, was finally resolved on the day before Halloween. With a $250 million treat for the government the hospitals have now finally managed to get the unwelcome trick or treaters…
$300 Million Dollars Of Cardiology Sunshine
July 23, 2015 by 1 Comment
$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….
Embattled Lab Nears Settlement With Government Over Kickbacks
March 24, 2015 by Leave a Comment
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,…
Medicare Reimbursement for Lung Cancer Screening Provokes Debate
October 13, 2014 by 1 Comment
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…
More Sunshine: CMS Wants Companies To Report Payments To Physicians For Medical Education
July 3, 2014 by Leave a Comment
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…
ACC And STS Break New Ground To Test TAVR For Unapproved Uses
February 12, 2013 by Leave a Comment
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…
ICD Investigation: DOJ Sends Resolution Model To Hospitals
August 30, 2012 by 1 Comment
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…
HRS 2012: More Clarity on DOJ ICD Investigation, “Incidental PCIs” Still Excluded
May 12, 2012 by Leave a Comment
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….
Politics and Transcatheter Aortic Valve Replacement
May 4, 2012 by 2 Comments
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…
CMS Issues National Coverage Decision for TAVR
May 1, 2012 by 1 Comment
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…
CMS Releases Details Of Proposed National Coverage For TAVR
February 2, 2012 by 5 Comments
(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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