Deeper Than the Headlines: Compliance Considerations for Amniotic Fluid Injections

Amniotic fluid injections have recently come under scrutiny - and two recent cases highlight the potential compliance pitfalls and risks of using this treatment.
Some healthcare providers have promoted the use of amniotic fluid injections for pain management, particularly in treating joint issues like arthritis and tendonitis. However, the U.S. Food and Drug Administration (FDA) has not approved amniotic fluid injections for these uses. Instead, they are primarily authorized for wound care.
The key issue is that using amniotic fluid injections for pain management remains off-label, meaning there’s limited clinical evidence to support its effectiveness in this area. As a result, Medicare and most insurance providers do not cover these treatments for joint pain or other orthopedic conditions.
The Pain Center of Virginia, PLLC, along with Waheed Baksh, M.D., entered into an Integrity Agreement (IA) with the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS). This agreement mandates that the Pain Center implement a compliance program that includes rigorous employee training, independent audits, and strict reporting of any violations or overpayments.
The recent indictment of a physician’s assistant at a Fort Worth pain clinic sheds light on how amniotic fluid injections can be misused. The PA allegedly administered amniotic fluid injections to patients, falsely claiming they were effective for pain relief and covered by Medicare. In reality, the product he used was not approved for pain management, and he billed Medicare using codes meant for different treatments.
You can find the Current LCD from CMS here and the Proposed LCD here.
FDA: www.fda.gov/va...
DOJ Enforcement 2024: www.justice.go...
OIG CIA for Enforcement 2024: oig.hhs.gov/fr...
DOJ Enforcement 2023: www.justice.go...
Current LCD example: www.cms.gov/me...
Proposed LCD example: www.cms.gov/me...