Press Release for U.S. Attorney’s Office, Northern District of Texas:
Certain amniotic products have been approved by the U.S. Food and Drug Administration for wound care, but not for pain management. (In fact, the FDA has issued repeated consumer alerts warning that biologics like amniotic fluid “have not been approved for the treatment of any orthopedic condition, such as osteoarthritis, tendonitis, disc disease, tennis elbow, back pain, hip pain, knee pain, neck pain, or shoulder pain,” nor for “chronic pain or fatigue.”) Because amniotic products have not been approved to treat pain, Medicare considers amniotic injections administered to treat pain medically unnecessary and does not reimburse for them. They do reimburse for some – but not all – amniotic injections administered to reduce inflammation of damaged tissue, as in a wound.
These types of injections happen all the time under the umbrella of “Regenerative Medicine.” The idea is that the amniotic fluid contains stem cells which can help regenerate cartilage in the joints.
Clearly, the U.S. Attorney’s Office was dubious about the efficacy of the injections. But what got the PA in hot water is the submission of the charges to Medicare for reimbursement.