The US Attorney for the Western District of Michigan Mark Totten announced on May 23, 2023, that a physician and his practice had agreed to pay $135,871.84 to resolve allegations that they violated the False Claims Act by using foreign, unapproved Botox to treat Medicare beneficiaries and then billing Medicare for those services.
The United States alleged that the physician treated patients with Botox (onabotulinumtoxinA), a drug administered by injection that the US Food and Drug Administration (FDA) has approved for a variety of treatments. However, beginning in August 2018, the physician began to purchase and use foreign, unapproved onabotulinumtoxinA for these treatments in order to cut costs. Government officials seized numerous packages of the foreign, unapproved drugs en route to the physician’s practice, and they warned the practice that it was importing adulterated and misbranded drugs. Despite these warnings and Medicare rules that the program denies coverage of drugs that have not received approval from the FDA, the physician knowingly used these foreign, unapproved drugs to treat Medicare beneficiaries and billed Medicare for those services.
“Providers can place patients at risk of harm through the importation and use of unapproved drugs,” said Mario M. Pinto, Special Agent in Charge at the Department of Health and Human Services, Office of Inspector General (HHS-OIG). “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.”
Compliance Perspective
Issue
US consumers rely on FDA oversight to ensure that the drugs they receive are safe and effective. Title II of the Drug Supply Chain Security Act (DSCSA) outlines steps to achieve interoperable, electronic tracing of products at the package level to identify and trace certain prescription drugs as they are distributed in the United States. This enhances the FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. Medications obtained from unlicensed sources may present safety issues since they have been manufactured or held outside of the jurisdiction of the FDA’s oversight. These medications may not be safe and effective for their intended uses and must be avoided in healthcare settings, where medications may only be obtained from authorized sources. Billing federal healthcare programs for a more expensive medication than what was used constitutes a false claim. Failure to promptly report a false claim can result in lawsuits, fines, and other sanctions.
Discussion Points
- Review your medication management policies to ensure they include the requirement for purchasing all medications administered to residents from licensed pharmacies in the United States. Also review policies and procedures for preventing and reporting a false claim. Update as needed.
- Train appropriate staff about F755 Pharmacy Services requirements for obtaining medications only from US licensed pharmacies and their responsibility to ensure this is followed as they provide medications to residents. Offer education to residents and resident representatives at the time of admission and through Resident Council on approved pharmacies used by the facility for acquiring medications, including that medications from unauthorized sources may not be brought to the facility for resident safety purposes. Document that this training occurred and place a signed copy of the training record in the employee’s education file, in resident records, or in Resident Council meeting minutes. Also train all staff on the False Claims Act and what can be considered a false claim. Include information on how to report concerns and suspected violations, and that prompt reporting is mandatory. Ensure that those who live or work in all levels of care in your settings are aware of the dangers of purchasing pharmaceuticals from unapproved sources.
- Audit to ensure that all medications administered to residents are obtained from a licensed pharmacy in the US and properly labeled. If concerns are identified that residents, their representatives, or visitors are providing counterfeit or other non-FDA approved medications from unauthorized sources, immediately secure the suspect medications and notify the administrator, director of nursing, compliance and ethics officer, or call the Hotline. Also periodically audit staff understanding to ensure that they are aware of what should be done if they suspect a false claim has occurred.
*This news alert has been prepared by Med-Net Concepts, LLC for informational purposes only and is not intended to provide legal advice.*
