Ray Anthony Shoulders, a physician's assistant at a Fort Worth pain management clinic, has been charged with healthcare fraud for allegedly injecting amniotic fluid into patients' joints in a deceptive attempt at pain management. The charges were announced in a news release, and the case is being investigated by the Department of Health and Human Services' Office of Inspector General with the assistance of the Federal Bureau of Investigation's Dallas Field Office.
“This defendant allegedly claimed that amniotic fluid – a product that has never been approved to treat pain – would alleviate his patients’ suffering. He allegedly told patients that the treatment was covered by Medicare, kindling false hopes. To add insult to injury, he allegedly scammed Medicare out of more than half a million dollars,” Leigha Simonton, U.S. Attorney for the Northern District of Texas, said in the release.
Shoulders was charged with conspiracy to commit healthcare fraud and 11 counts of healthcare fraud, the release reported. He first appeared before U.S. Magistrate Judge Jeffrey Cureton July 19. Amniotic fluid, the liquid that surrounds a developing fetus during pregnancy, was allegedly fraudulently claimed for payment by Medicare in excess of $614,000 by Shoulders and others, according to the indictment, for the off-label treatment of joint pain in patients.
The U.S. Food and Drug Administration approved several amniotic products for use in treating wounds, but not in treating pain, according to the release. The FDA has repeatedly issued consumer alerts informing the public 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," as well as for "chronic pain or fatigue."
Medicare deems amniotic injections used to treat pain to be medically unnecessary and does not reimburse them since amniotic products have not been approved to treat pain. They do pay for certain, but not all, amniotic fluid injections used to lessen swelling in injured tissue, according to the release.
Shoulders' main medication was "Cell Genuity," an amniotic product Medicare would not cover, either for pain relief or wound treatment. Initially, Shoulders allegedly demanded patients pay more than $800 out of pocket for each injection because the substance was not covered by insurance, but many patients reportedly turned them down because of their expensive price and dubious efficacy, the release reported.
Shoulders allegedly discovered "Fluid Flow," an amniotic substance for wound care Medicare would pay for, the release said. He discussed the Fluid Flow reimbursement rates and billing procedures with a sales representative, but he chose not to buy any Fluid Flow because it was substantially more expensive than Cell Genuity.
Instead, the release alleges Shoulder continued injecting patients with Cell Genuity while billing Medicare under the specific Fluid Flow code, Q4206. More patients agreed to the procedure because they were assured their insurance would pay for the injections.
