Fraud, Waste, and Abuse Update – Foot Baths and Prescription Anti-Infective Agents

Last update: October 2, 2020

The Centers for Medicare & Medicaid Services (CMS) has identified likely medically unnecessary use of drugs, such as antibiotics and antifungals1, that are being prescribed for topical use to be administered as a foot bath. Often large quantities of the medications are prescribed as an oral or injectable form. The prescription recipients are often instructed to dilute the prescription products by mixing them with water, and soak their feet in the solution. Potential reasons for use include ingrown toenails, cellulitis, athlete’s foot and diabetic ulcers. There are no published treatment guidelines indicating the use of multiple anti-infection agents for administration by a foot bath, and there is little or no evidence supporting their use for these indications. This treatment regimen is not in accordance with a medically accepted indication, and the prescription products have limited efficacy when used topically in a diluted footbath solution.

The prescribing and dispensing of these drugs may occur in the absence of a valid patient-prescriber relationship. Prescribers may be approached by sale representatives, pharmacies or patients requesting large quantities of these products for off-label indications, potentially contributing to fraud, waste and abuse. Potentially fraudulent use of these prescriptions has resulted in millions of dollars of paid claims and a financial loss to the health care system due to medications not needed. Negative clinical impact includes potential adverse reactions from improper use of medications, confusion regarding the route of medication administration and risk of increased antibiotic and antifungal resistance.   

1Drugs may include:

  • Ciprofloxacin
  • Clindamycin
  • Gentamicin
  • Ketoconazole
  • Mupirocin
  • Tobramycin
  • Vancomycin

References:

Blue Peak Advisors. CMS Fraud Conference – Working Together to Combat Fraud. bluepeakadvisors.com/cms-fraud-conference-working-together-to-combat-fraud/. Aug. 2, 2019. Accessed July 28, 2020.