AP NEWS
Click to copy
Click to copy

Sanford suspends use of medical devices amid investigation

July 18, 2019

SIOUX FALLS, S.D. (AP) — Sanford Health will suspend the use of some medical devices manufactured by one of its surgeons as a federal investigation into their use is underway.

Sanford’s neurosurgeon Wilson Asfora owns a company that sells devices used in spine surgeries. Two Sanford doctors in 2016 filed a lawsuit accusing Asfora of illegally profiting by using those devices in spine surgeries at the hospital in violation of anti-kickback laws. The suit describes accounts of Asfora installing unnecessary medical devices into patients. The Department of Justice has intervened to investigate the case.

Micah Aberson, Sanford’s executive vice president, said the suspension beginning Aug. 1 is not related to deficiencies or clinical outcomes. The hospital will stop using the Asfora Bullet Cage and a plate used in neck fusions, replacing them with similar devices.

“The distraction of the economics related to the device is what we want to remove from the conversation,” Aberson told the Argus Leader Wednesday.

Aberson noted the suspension will remain in effect until legal issues are resolved.

In the lawsuit, Drs. Bryan Wellman and Dustin Bechtold contend Asfora’s surgeries and use of cages and screws spiked because he had a financial incentive to implant devices owned by his company.

“One level was all that was medically necessary for this patient,” according to a summary of one patient’s fusion. “Dr. Asfora put in three additional cages, which this patient did not need, but which Dr. Asfora personally benefited from financially. Dr. Asfora never saw this patient prior to surgery. Three of these levels were off-label, medically unnecessary, and medically tainted by kickbacks.”

The 111-page suit also said Sanford and Asfora billed Medicare and other federal programs for care that was never provided.

“The government has been intermittently interviewing various members of our team over the last couple of years,” Aberson said.

Aberson maintained that the allegations against Asfora have no merit.

“We as an organization continue to stand by Dr. Wilson Asfora and his treatment of patients and his clinical outcomes,” he said.

___

Information from: Argus Leader, http://www.argusleader.com

All contents © copyright 2019 The Associated Press. All rights reserved.