Compliance Risks in Ambulatory Surgery Centers
Let’s examine a few cases that demonstrate some of the compliance risks that ASCs might face.?
Ambulatory Surgery Centers (ASC) are found throughout the country. Physicians often like them because they hold potential for increased efficiencies over a traditional hospital-based operating room. Patients often like them because they are in and out within a day, which makes scheduling and completion of procedures more convenient. However, ASCs are not immune to compliance issues.??
Potential for Kickback Situations
A Georgia physician who was the founder, owner, and medical director of a surgical center and a medical device company agreed to pay a combined amount of $4.2 million to resolve allegations of violating the Anti-Kickback Statute (AKS).?
The surgical center employed approximately 12-18 physicians and was led by the founding physician who acted in a CEO capacity. The government alleged that this CEO controlled the employed physicians in his role as CEO and directed them to utilize sinuplasty-related medical devices exclusively from the medical device company, as well as to order toxicology and genetic testing from another entity in exchange for kickbacks.?
The government alleged that the medical device company provided the CEO with many forms of remuneration, including cash payments and all-expense paid trips, in return for the CEO requiring the center’s physicians to exclusively use the device company’s sinuplasty medical devices and increase the number of sinuplasty procedures conducted on the surgical center’s patients.?
The other alleged scheme involved toxicology and genetic tests. It was reported that the CEO entered into a kickback arrangement with a medical testing laboratory. The CEO directed the center’s physicians to order toxicology and genetic tests from the laboratory, despite physician objections that the tests were not medically necessary. In return, the laboratory paid the CEO 50% of the revenue generated from such tests as “commissions.”?
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False Claims Act and Lack of Medical Necessity
An outpatient surgical center in Florida agreed to pay the government $3.4 million to resolve allegations of violating the False Claims Act by submitting claims for kidney stone procedures that were not medically necessary.?
A whistleblower first brought this information to the government’s attention. The whistleblower alleged that one of the physicians who was a urologist performed extracorporeal shock wave lithotripsy, a procedure used to break up kidney stones on patients when it was not medically necessary because the procedures were not medically indicated or because the patients did not have kidney stones.?
Overbilling Risks
In a third case, a Texas ASC and affiliated pain clinic agreed to pay $836,700.00 to resolve allegations that they overbilled for procedures, thus violating the False Claims Act.?
The alleged false claims involved procedures for back and spine pain treatments, including facet joint injections, transforaminal injections, and radiofrequency ablation procedures. The government contended that the clinic and ASC billed for more units or levels of these spine procedures than they actually performed. For example, a patient may have only received a single injection, but the ASC and clinic would submit billing claims as though the patient had received two or three injections, thereby increasing the amount paid for the procedure.?
Conclusion
Clearly, ASCs are not immune to compliance risks. These cases highlight at least three risk areas that have affected ASCs in the past. These risks include the Anti-Kickback Statute, billing for medically unnecessary services and overbilling for services. ASC compliance programs should consider these risks and monitor them accordingly.?
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