Doctor: You’re Going To Have A Heart Attack! Patient: Your Tests Results Are Giving Me A Heart Attack! Reply

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, including a patient and a health care provider, whose stories appear to confirm and provide additional perspective about the allegations in the earlier articles.

“Your test results are giving me a heart attack!”

Click here to read the full post on Forbes.


Medicare Reimbursement for Lung Cancer Screening Provokes Debate 1

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 CT screening for high-risk current and former smokers. Due to a provision in the Affordable Care Act, private insurance is now mandated. More recently, the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) concluded that there is only low to intermediate confidence that “there is adequate evidence to determine if the benefits outweigh the harms.” The Centers for Medicare and Medicaid Services (CMS) is expected to issue a final decision on national coverage in 2015.

Click here to read the full post on Forbes.


Embattled HDL Laboratory CEO Resigns Amid Federal Investigation Reply

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 the Wall Street Journal and 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, marketing, and billing practices regarding unnecessary testing.

Click here to read the full post on Forbes.


Tonya Mallory




Way Beyond Kickbacks: More Serious Misconduct Alleged Against Medical Testing Company Reply

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 tests. The new allegations suggest a broader pattern of serious misconduct based on questionable sales, marketing, and billing practices regarding unnecessary testing.

The main new accusation involves HDL’s sales force, who work for an independent but closely related company known as BlueWave Healthcare Consultants Inc. These salesmen persuade physicians and other healthcare providers to order a whole host of unnecessary tests from HDL and, often, from other lab companies as well, including Singulex and Innovative Diagnostic Laboratory (IDL). As the WSJ article explained, kickbacks to physicians occur when the companies give excessive process and handling (P&H) fees instead of the $3 “draw” fee generally allowed by Medicare. My sources inform me that by combining multiple tests from multiple companies these fees can climb to as much as $100 per patient. This is called “stacking.”

To prevent patients and insurers from looking too closely at these practices the company has a policy of rarely if ever requesting co-payments from patients. Therefore the physicians profited from the kickbacks and the company benefited by collecting the portion of the charges which escape scrutiny from insurance companies and Medicare. Both the promotion of unnecessary tests and the refusal to collect co-payments are illegal and unethical, say experts.

Click here to read the full post on Forbes.


FDA Once Again Reaches Conclusions At Odds With Its Own Staff Reply

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 the basis for the review. And now outside experts are also raising concerns about the drug.

Back in 2010 the FDA said that it was initiating a safety review of olmesartan due to troubling findings from 2 clinical trials that raised the possibility that patients with type 2 diabetes taking olmesartan might have an increased risk of cardiovascular death. Four years later the FDA announced  that it had completed that review.

Click here to read the full post on Forbes, including comments from Sanjay Kaul and Franz Messerli and Sripal Bangalore.

Hospital Quality Helps Explain Some Of The Racial Disparities In Outcomes After CABG Reply

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, a significant but by no means complete portion of this disparity is due to decreased access among nonwhites to high quality hospitals.

In a paper published in JAMA Surgery, Govind Rangrass and colleagues analyzed Medicare data from 173,925 CABG patients. 8.6% of the study population was nonwhite. The mortality rate was 3.6% for the entire population. Nonwhite patients had a 34% increased risk of dying.

A key finding was that the third of hospitals that had the highest proportion of nonwhite patients (more than 17.7% nonwhite) also had the highest risk-adjusted mortality for both white and nonwhite patients (3.8% and 4.8%)….

Click here to read the full post on Forbes.


New York Area Cardiologist Admits $19 Million Fraud Reply

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 and for medical services rendered by unlicensed practitioners.”

Katz spent over $6 million advertising on Spanish-language advertising. For most of his patients he performed the same battery of unnecessary diagnostic tests and falsified  records. He then gave a false diagnosis or coronary artery disease and intractable angina and prescribed EECP (enhanced external counterpulsation) to these patients. According to the government, Katz billed Medicare and Medicaid more than $15.6 million for EECP treatment from 2005 through 2012. In total, Katz billed Medicare and Medicaid more than $70 million during this period.

Some of Katz’s patients were treated by Mario Roncal, who was called “Dr. Roncal” in the office, though he did not have a valid  medical license in the United States. According to the government, “to conceal this illegal and unlicensed practice of medicine, Roncal forged Katz’s signature on paperwork associated with Roncal’s unlawful medical services, including on patient charts. During the conspiracy, Katz used his own billing numbers to bill Medicare Part B and Medicaid for the illegal services Roncal provided as though they were provided by Katz.”

Click here to read the full story on Forbes.

Jose Katz

Jose Katz



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

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 hope to gain an IDE for at least two more trials. The news was first reported by The Gray Sheet (subscription required) on February 8.

The new development represents a significant enlargement of the TVT registry, already run by the ACC and STS, which tracks all TAVR usage in the US.

Click here to read the entire post on Forbes.


Ohio Hospital And Cardiology Group Pay $4.4 Million To Settle Charges Over Unnecessary PCIs 2

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 but whose blood vessels were not sufficiently occluded to require the particular procedures at issue.”

The leader of the cardiology group defends its quality of care and says it “settled this matter so we can put it behind us and move forward.”

Read my complete story about this on Forbes.

Guest Post: Feds Turn Corner in ICD Investigation; Hospital Liability Divided into Categories Reply

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 cardiac defibrillator (ICD) procedures. After a year of debating the medical-necessity parameters of ICD implants, DOJ now has a blueprint for determining hospital liability, according to attorneys familiar with the case. Some ICD cases will be home free, while others will be the subject of repayment plus interest or triple damages, they say.

“There has been a breakthrough,” one attorney says.

As a result, DOJ will soon send letters to hospitals with instructions for resolving their potential ICD overpayments. Hospitals will be asked to self-audit ICD procedures using an audit tool the federal government developed in collaboration with defense counsel and Navigant Consulting, attorneys say. After the audits are completed, hospitals will report back to DOJ, which will spot check their findings. Then settlement talks presumably will begin, the attorneys say.

“They want to move forward and close these cases that have been pending for close to two years,” says another attorney. The U.S. Attorney’s Office for the Southern District of Florida, which is spearheading the case, had no comment.

The investigation of ICDs, which are small electronic devices that shock the heart back to a normal rhythm, focuses on hospital claims that ran afoul of Medicare’s national coverage decision (NCD 20.4). Initially, DOJ took the position that noncompliant billing for ICD implantation is within the realm of the False Claims Act, but it paused to consider that perhaps medical necessity in this area is not always black and white. “There will be cases that literally or technically are outside of the NCD but the government will not be demanding a repayment because there are just some scenarios that clearly were not contemplated by the authors of the NCD,” one attorney says.

The NCD for ICDs describes nine categories — “covered indications” — that trigger Medicare payment (RMC 10/31/11, p. 1). They are divided into indications for primary prevention, which means the patient did not experience prior episodes of an irregular heartbeat but is still at elevated risk for sudden death due to cardiac arrest, and secondary prevention, which means the patient had prior episodes of an irregular heartbeat.

Only the indications for primary prevention — three through nine — have “timing requirements.” Medicare won’t pay for a patient’s ICD implant within 40 days of an acute myocardial infarction (MI) or within three months of a coronary artery bypass graft (CABG) or percutaneous transluminal coronary angioplasty (PTCA). For example, Medicare covers ICDs for patients with non-ischemic dilated cardiomyopathy and for patients with coronary artery disease with a documented prior MI, as long as acute MI didn’t occur in the previous 40 days. The idea is to first give patients time to recover from the heart attack to determine whether the patient really is at elevated risk for cardiac arrest.

Hospitals May Not Be as Vulnerable

If hospitals billed Medicare for ICD procedures, they may be at risk in the national false claims enforcement action. But they may not take as big a hit as was feared when DOJ first sent out subpoenas and civil investigative demands, lawyers say. “There are some different categories where the hospitals and doctors have good things to say about the medical necessity of the decision to implant. And the government has now acknowledged the decision to implant and no demand for money will be made in those cases,” one attorney says.
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