Initial sales of Entresto (the combination of sacubitril and valsartan, formerly known as LCZ696) have been slow. In the first few months after its approval in July the drug only had $16 million in sales, the drug’s manufacturer, Novartis, reported last week during its quarterly earnings report. The novel heart failure drug is widely expected to be…
Doctor: You’re Going To Have A Heart Attack! Patient: Your Tests Results Are Giving Me A Heart Attack!
October 17, 2014 by Leave a Comment
Last month I wrote a series of articles (starting here) about HDL, a laboratory company under investigation by the DOJ for giving kickbacks to physicians who use their tests. I reported additional allegations of serious misconduct based on questionable sales, marketing, and billing practices involving unnecessary testing. In response to those articles I’ve received emails from several individuals,…
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…
Embattled HDL Laboratory CEO Resigns Amid Federal Investigation
September 23, 2014 by Leave a Comment
Tonya Mallory, the embattled President and CEO of troubled Health Diagnostics Laboratory, has resigned her positions, the company announced today. Mallory said she was leaving to help her brother start a new business. Dr. Joe McConnell, a co-founder of the company and its Chief Laboratory Officer, will succeed her. Mallory will remain on the HDL Board of Directors. As previously reported (by…
Way Beyond Kickbacks: More Serious Misconduct Alleged Against Medical Testing Company
September 18, 2014 by Leave a Comment
The problems go way beyond kickbacks. As previously reported (here and in the Wall Street Journal) the US government is conducting an investigation into Health Diagnostic Laboratory, a medical laboratory testing company that has enjoyed explosive growth since its founding in 2008. Previous reports centered on kickbacks given to physicians by the company to encourage greater use of the company’s…
FDA Once Again Reaches Conclusions At Odds With Its Own Staff
July 14, 2014 by Leave a Comment
Once again the FDA has reached a conclusion that is directly opposed by some of its own scientists. Last month the FDA affirmed the safety of olmesartan, a popular blood pressure lowering drug (sold as Benicar and other names). But that reassuring view is not shared by the FDA scientists who performed the study that provided…
Hospital Quality Helps Explain Some Of The Racial Disparities In Outcomes After CABG
January 8, 2014 by Leave a Comment
It has long been known that racial disparities exist in health care. A large body of research has found that nonwhite patients have worse outcomes than whites. But it has been difficult to understand the underlying reasons for these disparities. Now a new study offers evidence that, at least in the case of bypass surgery,…
New York Area Cardiologist Admits $19 Million Fraud
April 11, 2013 by Leave a Comment
Jose Katz, a 68-year-old cardiologist with offices in New York and New Jersey, has pleaded guilty to charges that he committed health care fraud, the US Attorney for New Jersey announced yesterday. Katz admitted that he billed Medicare Part B, Medicaid, and numerous private insurers “for unnecessary tests and unnecessary procedures based on false diagnoses…
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…
Ohio Hospital And Cardiology Group Pay $4.4 Million To Settle Charges Over Unnecessary PCIs
January 4, 2013 by 2 Comments
In 2006, Reed Abelson in the New York Times reported that the PCI rate in Elyria, Ohio was four times the national average. Now, six-and-a-half years later, the local hospital and cardiology group have agreed to pay $4.4 million to settle US allegations “that the hospital and the physicians “performed angioplasty and stent placement procedures on patients who had heart disease…
Guest Post: Feds Turn Corner in ICD Investigation; Hospital Liability Divided into Categories
August 7, 2012 by Leave a Comment
Editor’s Note: The following article is reprinted with permission from Report on Medicare Compliance, an independent publication not affiliated with hospitals, government agencies, consultants or associations and published by Atlantic Information Services, Inc. The Department of Justice is apparently about to take a big step forward in its national false claims investigation of Medicare billing for implantable…
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