Earlier this month, we represented a podiatry practice in a Medicare Part B overpayment appeal before an Administrative Law Judge. The appeal involved the use of amniotic fluid injections used on patients in 2021. Medicare demanded an overpayment over $95K plus interest based on their position that the off-label use of the amniotic injections to treat inflammation and pain associated with tenosynovitis and plantar fasciitis was experimental/investigational, and therefore, not covered. While the ALJ agreed with Medicare’s position on coverage, the ALJ found that our client was without fault, and therefore liability was limited. Specifically, the ALJ found that our client neither knew, nor could have been reasonably expected to know, Medicare would deny coverage for the amniotic injections because CMS did not relay its position on amniotic products until AFTER the dates of service involving our client. The ALJ has directed Medicare to return the entire $95K plus interest to our client!

Amniotic fluid injections continue to be the focus of CMS’ investigational and enforcement efforts into Medicare billing fraud. Prior to 2023, CMS did not issue any guidance regarding coverage of amniotic fluid injections. Despite its silence, CMS has taken the position that amniotic products used for pain management are non-reimbursable under Medicare regulations. Thus, providers that used amniotic injections prior to 2023 are at an increased risk of being the target of a Medicare billing fraud investigation. 

Healthcare fraud defense attorneys at Chilivis Grubman are essential to protect providers like our client. Please reach out to Christina Essex for any healthcare regulatory needs or questions.