April 18, 2024

Inquiry Into Payments by Device Maker

Gov. Brian Sandoval on Monday asked state health officials to look into whether the dealings between the doctors and a company called Biotronik had involved improper billing practices or patient safety issues, according to a spokeswoman, Mary-Sarah Kinner.

The inquiry follows a report on Sunday in The New York Times that heart device specialists at a Las Vegas practice started using Biotronik implants in nearly all their patients in 2008 after company documents showed they became consultants to the device maker, getting up to $5,000 a month in fees.

Last year, at one Las Vegas hospital where the cardiologists practiced, University Medical Center of Southern Nevada, 95 percent of the patients, or 250 of the 263 people who got a pacemaker or defibrillator, got a Biotronik device.

Before becoming Biotronik consultants, those doctors, who belong to a practice called Nevada Heart and Vascular, apparently rarely, if ever, used its devices. Several experts on medical ethics said on Tuesday that the ties between the cardiologists, Biotronik and a distributor for the device maker called Western Medical raised both ethical and legal questions.

“It is giving off a reeking aroma of conflict of interest,” said Arthur Caplan, a professor of bioethics and philosophy at the University of Pennsylvania in Philadelphia.

Ms. Kinner, the spokeswoman for Governor Sandoval, said he had asked officials of several state agencies to review the situation. A formal report has yet to be issued though no irregularities were found in a review of the services for which the doctors had billed, Ms. Kinner said.

The state’s Board of Medical Examiners, which licenses physicians, is also reviewing the issue, she added.

Under federal law, anyone who gives or receives something of value to induce the use of a drug or a medical device paid for by a taxpayer-financed program like Medicare can face criminal or civil charges. In the case of the medical device industry, kickbacks to doctors have been disguised as consulting fees or payments for other services.

Biotronik has confirmed that federal investigators were examining its sales and marketing practices, though a company lawyer has declined to elaborate, other than to say he understood the inquiry was civil in nature. He said the company paid reasonable consulting fees for legitimate services.

Nationwide, Biotronik accounts for just over 5 percent of the market for heart implants, according to industry estimates.

In a statement Monday, Dr. William H. Resh, the managing partner of Nevada Heart and Vascular, said his group had turned to Biotronik because its devices were cost-effective and less prone than those of competitors to recalls.

“When you are dealing with a person’s heart, it is important not only to know that you are using a quality product, but also a product that you have a good familiarity with,” Dr. Resh said.

Dr. Resh did not respond to written questions about why he and his partners, given his concerns about recalls, had once frequently used devices made by Guidant, a company that recalled tens of thousands of devices in 2005 and 2006.

For example, in 2007, University Medical Center data shows, over 85 percent of those patients who got a heart device there got one marketed by Boston Scientific, a company which just a short time earlier had acquired the troubled implant business of Guidant. Dr. Resh and his associates had a contract with the facility to perform those implants.

A spokeswoman for one Las Vegas-area health care facility that does not have a contract with Biotronik, St. Rose Dominican Hospitals, said in response to a reporter’s inquiry that Dr. Resh’s group did do implants there using heart devices made by either Boston Scientific or another manufacturer, Medtronic. But that spokeswoman, Jennifer McDonnell, said that the volume of implants performed by his group had declined since 2008, the time when those cardiologists became Biotronik consultants.

In a statement, University Medical Center said that Biotronik devices had performed very well and that patients had benefited since the facility adopted their use. The hospital first started using the devices in mid-2008, when it changed its contracting policies.

The Times article focused on ties between a device industry sales official in Las Vegas named Caesar Fonte and Dr. Resh and his colleagues. Prior to mid-2008, when Mr. Fonte was at Guidant and later Boston Scientific after it acquired Guidant, he worked with the Las Vegas cardiologists who were then paid consultants to those companies. At that time, they largely used the devices Mr. Fonte represented.

But in mid-2008, Mr. Fonte quit Boston Scientific to start his own company called Western Medical that distributed Biotronik implants and other medical products. Virtually overnight, Dr. Resh and his partners became Biotronik consultants and shifted much of their business to it.

Dr. Resh, his colleagues and Biotronik declined to disclose how much the physicians had received in payments since mid-2008.

For its part, Western Medical received a commission fee of 25 percent from Biotronik on each sale; in one month alone, the company sold $1 million worth of devices in Las Vegas.

Mr. Fonte declined earlier to be interviewed. Dr. Resh did not respond Tuesday to an e-mail asking if he and Mr. Fonte had entered into any business arrangements or investments together.

Speaking generally, Ann S. Brandt, an executive with HealthCare Appraisers, a firm based in Florida that evaluates physician consulting agreements, said the types of events in the Las Vegas case failed what she called the “sniff test.”

“When you see a whole lot of people making a lot of money, it has to be looked at,” said Ms. Brandt.

Article source: http://feeds.nytimes.com/click.phdo?i=1a08349e36320c7d32a7150f9b917180

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