Foot Bath Prescriptions – MedImpact is Now the Fifth PBM Investigating

PAAS National® has alerted members through several Newsline articles of an increase in audits with Prime Therapeutics®, Caremark®, OptumRx® and Express Scripts® investigating foot bath prescriptions. MedImpact® has now jumped on the wagon as well. Topical products and injectables are commonly flagged for high quantities and dollar amounts. PBMs speculate these items are being used off-label due to the large quantities dispensed; and commonly seen in foot bath treatments.

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Prime Therapeutics® sent out a 2019 Newsletter stating the dilution of drug products in a foot bath changes the concentration and is thereby considered off-label as this has not been studied or supported to be effective. They require pharmacies to obtain clinical evidence to support the efficacy and safety of dispensing these products in foot baths.

Caremark® sent out provider manual updates for 2020 prohibiting the dispensing of high quantities or high volumes of drugs within a certain category (e.g. topical or dermatological products). Caremark® will monitor claims monthly and if a pharmacy bills 25% or more (in number of claims or dollars) of items on the aberrant product list, the pharmacy will be in a breach of contract. This list can be found on the Caremark Pharmacy Portal.

OptumRx® will mark foot bath prescriptions with a discrepancy code of CLN = no documentation to denote clinical appropriateness was validated.

Express Scripts® has sent out investigative letters referencing section 7.1 of the provider agreement. The pharmacy must respond by completing responses to questions in a letter.

Now, MedImpact® is issuing results with full recoupments on medications used in a foot bath. Their comments are: “Quantity and directions for use of drug appear to be for use in a foot bath. No clinical documentation or evidence exists to substantiate the clinical appropriateness of using this drug in a foot bath. CMS, in collaboration with the I-MEDIC, indicates Topical products are not the standard of care in treatment of foot infections such as diabetic ulcers, and could be actively harmful to the healing process. Further, the purported indications of use of these combinations used in this manner, may not be medically accepted indications (MAIs) and are, at best, investigative and experimental treatments.”

PAAS Tips:

  • Be aware that many PBMs are flagging high quantities of topical and injectable medications
  • Medicare Part D does not pay for off-label use
  • A claim for medication used in a foot bath may seem like a clean claim at adjudication, but it does not guarantee payment
  • PAAS advises against billing for topical or injectable products used in a foot bath without sufficient clinical evidence
Jennifer Ottman, CPhT