Health Highlights: Feb. 29, 2012

Here are some of the latest health and medical news developments, compiled by the editors of HealthDay:

Feds Uncover Record-Breaking Medicare Scam

A Texas doctor allegedly recruited homeless people as fake patients in a wide-ranging, $375 million Medicare home health-care scam, the largest ever uncovered, investigators say.

Dr. Jacques Roy, 54, was arrested Wednesday and charged with falsifying hundreds of Medicare claims and taking millions of dollars for unneeded or undelivered services. He could be sent to prison for life, ABC News reported.

"According to the indictment, Dr. Roy and his co-conspirators, for years, ran a well-oiled fraudulent enterprise in the Dallas area, making millions by recruiting thousands of patients for unnecessary services, and billing Medicare for those services," said Assistant Attorney General Lanny Breuer.

The indictment alleges that Roy certified more Medicare beneficiaries for home health services and claimed more patients than any other U.S. doctor in the years 2006 to 2011, ABC said.

To obtain reimbursement from Medicare, doctors must certify that the medical services were needed and performed. Roy's operation, Medistat Group and Associates, allegedly certified false claims involving nearly 500 home health care companies in Texas. The companies were reimbursed for the bogus or unnecessary services and provided Roy with a portion of the "refund." All told, they billed Medicare for more than $350 million and Medicaid for more than $24 million, the news report said.

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Counterfeit Avastin Lacks Any Real Drug

Counterfeit vials of Avastin, a commonly used cancer drug, are probably not harmful, but do not contain the active ingredient in the real drug, according to Roche, the Swiss drug maker.

Regulators in Europe said traces of salt, starch and acetone, a solvent found in paint thinner, were found in an analysis of the fake drug's contents, the Associated Press reported. Roche said in a statement that "the counterfeit product is not safe or effective and should not be used."

Dr. Miguel Fernandez of the South Texas Poison Center in San Antonio said a low dose probably would not be toxic. "They're not great to have in your system, but depending on the concentration your body can probably handle them pretty well," Fernandez said.

The counterfeit Avastin was imported from Europe and apparently distributed by a U.S. wholesaler to doctors in the United States. Of 41 vials shipped, 36 are still unaccounted for, the AP said.

Doctors infuse Avastin to treat colon, lung, kidney and brain cancer. According to the news agency, worldwide reports of drug counterfeiting have increased over the past 10 years.

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Artificial Hips a Bigger Problem Than Breast Implants: Study

Hundreds of thousands of people who received artificial metal-on-metal hips made by Johnson & Johnson, among others, may face serious health threats, including long-term disability, British health experts report.

The BMJ and BBC researchers said more people are at risk from the metal artificial hips than are affected by faulty breast implants made in France, the subject of another recent European medical device scare.

Their investigation found that toxic cobalt and chromium ions in the artificial hips can penetrate tissue and enter the bloodstream, spreading to major organs and killing bone and muscle, according to Bloomberg News.

Dr. Carl Heneghan, director of the University of Oxford's Centre for Evidence-Based Medicine, said in a BMJ statement that a uniform, international system to assess and monitor implantable medical devices would help safeguard patients around the globe.

"Creating an independent system for post-marketing analysis for implantable medical devices that is robust and increasing international coordination around device alerts and withdrawals should go some way to sorting out the current mess," Heneghan said, according to Bloomberg.

In December, reports that breast implants made by Poly Implants Protheses SA were leaking industrial silicone led French and German officials to recommend that thousands of women have the implants removed.

The hips the researchers studied included those made by New Jersey-based J&J; Zimmer Holdings of Indiana, and a London company, Smith & Nephew Plc (SN).

Because medical devices don't need the same type of clinical testing in Europe required of new drugs, the hips were implanted in patients without adequate safety studies, the researchers said. Potentially risky design changes made over the past 10 years weren't flagged by regulators and brought to the attention of doctors and patients.

Heneghan said procedures for medical device approval in Europe are less stringent than in the United States. In the United States, tests of medical devices are government-run under the Food and Drug Administration, and manufacturers must provide proof of safety and effectiveness. In the EU, however, manufacturers need only prove the devices are safe, and they can choose from about 70 private firms, called "notified bodies," to test their products, the Bloomberg report stated. Approval from one firms enables the manufacturer to market the device throughout the 27 EU nations.

Study co-author Nick Freemantle, professor of clinical epidemiology and biostatistics at University College London, said the current approval standards are dated. "The methods of device regulation seem to be more from the 1950s than the 21st century," he wrote in the study, Bloomberg reported.

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Posted: February 2012


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