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Grand Rapids physician pays settlement, accused of using foreign, unapproved Botox

Botox
Posted at 4:02 PM, May 23, 2023
and last updated 2023-05-23 18:04:14-04

GRAND RAPIDS, Mich. — A Grand Rapids physician agreed to pay more than $135,000 to resolve allegations against him and his practice, Elite Medical Spine & Musculoskeletal Center PLLC (Elite).

U.S. Attorney for the Western District of Michigan Mark Totten announced Tuesday that Derek Lado, D.C. agreed to pay $135,871.84.

Dr. Lado and his practice are accused of violating the False Claims Act by using foreign, unapproved Botox to treat Medicare beneficiaries and then billing Medicare for those services.

“Patients deserve the confidence that their medical practitioners are following the rules to keep them safe,” Totten said. “If you cut corners by using foreign drugs that have not been approved by the FDA as safe and effective to treat our Medicare population, there will be consequences.”

Federal officials say Dr. Lado and Elite treated patients with Botox (onabotulinumtoxinA), a drug administered by injection that the U.S. Food and Drug Administration (FDA) has approved for different treatments.

However, the United States alleges that Dr. Lado and Elite started buying and using foreign, unapproved onabotulinumtoxinA for treatments in August 2018, to cut costs.

Government officials seized several packages of the foreign, unapproved drugs en route to Elite.

They say they also warned the practice that it was importing adulterated and misbranded drugs.

Additionally, Medicare rules state that the program denies coverage of drugs that have not received FDA approval.

Despite the warnings, the federal government says Dr. Lado knowingly used the drugs for treatment and billed Medicare.

“Providers can place patients at risk of harm through the importation and use of unapproved drugs,” Mario M. Pinto, Special Agent in Charge at the Department of Health and Human Services, Office of Inspector General (HHS-OIG), said. “Protecting the safety of Medicare and Medicaid patients is crucial and HHS-OIG is committed to ensuring that taxpayer dollars are not used for unapproved, potentially dangerous medical substances that put patients at risk.”

The federal government says the claims resolved by the settlement are allegations only and there has been no determination of liability.

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