Physician Assistant Convicted of Fraud for Administering Unapproved Injections

Physician Assistant Convicted of Fraud for Administering Unapproved Injections

In a shocking case of medical fraud, a Texas physician assistant has been found guilty of giving patients unapproved injections of amniotic fluid for pain relief and illegally billing Medicare for the treatments. Ray Anthony Shoulders, PA, who worked at a Fort Worth pain management clinic, now faces up to 240 years in federal prison for his crimes. This article delves into the details of the case and highlights the dangers of unapproved medical treatments.

Shoulders administered injections of an amniotic fluid product called Cell Genuity to patients, despite the fact that it is not approved by the FDA for any indication. Initially, some patients paid out of pocket for the shots, which cost over $800 each. However, the high price deterred many patients. To overcome this obstacle, Shoulders connected with a sales representative for another amniotic product called Fluid Flow, which had a unique code for reimbursement known as a “Q code.”

Although Shoulders never purchased any Fluid Flow, he used its reimbursement code, Q4206, to bill Medicare for the Cell Genuity shots. By doing so, he increased the number of patients willing to receive the injections since they would be covered by insurance. This fraudulent scheme allowed Shoulders to make a significant profit, earning $1,200 per cc of Cell Genuity compared to the $400 per cc for Fluid Flow.

From August to October 2020, Shoulders’ clinic submitted over 100 claims for reimbursement of Fluid Flow to Medicare, receiving approximately $400,000 in fraudulent payments. However, after becoming cautious about potential investigations, Shoulders temporarily halted the scheme. When he observed no consequences after 10 months, he resumed the fraudulent activity in October 2021 and continued until December of that year.

The case involving Shoulders serves as a catalyst for broader investigations into fraudulent billing practices related to “birth tissue” claims. Several U.S. regional Medicare Administrative Contractors announced in February 2022 that they would seek to recover losses from these claims dating back more than two years. Such claims involve amniotic, placental, and umbilical cord injectables – products that have received Q codes from CMS and were marketed to doctors as reimbursable. The involvement of the Department of Justice indicates the potential for criminal prosecutions in these cases.

Medical professionals, such as Chris Centeno, MD, have long criticized the promotion of birth tissue products for unapproved orthopedic indications. Centeno anticipates further fraud cases involving U.S. clinics fraudulently billing Medicare for these products to treat pain. While some clinics may face clawbacks of their payments, Centeno believes that others could also face trial and potential conviction.

The FDA has warned about the widespread marketing of unapproved regenerative medicine therapies, including amniotic fluid and other birth tissue products. To combat the issue, the FDA issued guidance on regenerative medicine products in 2017, with full compliance required by November 2020. The deadline was delayed due to the pandemic but ultimately went into effect in June 2021. Manufacturers now need to meet FDA’s premarket approval or IND requirements before promoting these products to patients. Additionally, companies cannot advertise these products for uses outside of the IND.

The case of Ray Anthony Shoulders highlights the grave consequences of medical fraud. Patients are put at risk when unapproved treatments are administered, and Medicare suffers financial losses due to fraudulent billing. As investigations continue into birth tissue product claims, it is crucial for healthcare professionals to adhere to regulatory standards and prioritize patient safety over financial gain.

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