Advisory opinion: OIG approves EMS arrangement
Advisory opinion: OIG approves EMS arrangement
The Health and Human Services’ Office of Inspector General (OIG) last week approved the proposed lease of cardiac diagnostic equipment to emergency medical services (EMS) providers. As with several other advisory opinions on ambulance restocking, the OIG blessed the proposed arrangement because it said appropriate safeguards were in place.
"This opinion does not stretch any boundaries," says Joe Lynch, a health care attorney with Vinson Elkins in Washington, DC. "EMS is already a highly regulated area." On its face, Lynch says the program outlined in the opinion clearly presents the types of things the letter of the anti-kickback statute prohibits. "I think this is a case where the OIG takes a practical real-world’ perspective in interpreting the statute," he says.
Not only did the proposed arrangement not threaten to increase costs to the Medicare program or steer patients to a particular hospital, it was likely to have a positive impact on the quality of patient care by permitting earlier and more accurate pre-hospital screening, the OIG claimed.
Health care attorneys say that most recent OIG advisory opinions have clarified existing practices rather than breaking any new ground. But they say that should not be surprising. "The whole nature of the process does not lend itself to a lot of groundbreaking," says Lynch. For one thing, opinion requesters often are reluctant to invite scrutiny. In addition, the OIG is very precise in terms of what it will approve.
Health care attorney Bruce Shih of Latham and Watkins in Los Angeles notes several common themes among advisory opinions. First, to the extent the proposed arrangement does not meet a safe harbor, a favorable advisory opinion provides protection that the OIG will not prosecute.
Second, to the extent the proposed arrangement does not meet a safe harbor and technically violates the anti-kickback statute, a favorable advisory opinion is absolutely necessary, and the OIG has demonstrated its willingness to grant favorable opinions for such technical violations in certain cases, says Shih. He says a good example is small percentage commissions to independent contractors to accommodate a real-world approach to practices.
Finally, a requesting party may seek reassurance from the OIG that a proposed arrangement meets a safe harbor. That was the case in the OIG’s latest opinion, in which it determined that payments by vendors to a group-purchasing organization (GPO) owned by entities affiliated with various health care providers that purchase items covered by the GPO’s vendor contracts would fall within the GPO’s safe harbor.
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