Tricks and tips to getting an advisory opinion
Many health care attorneys are recommending that providers seriously consider getting an advisory opinion from OIG before engaging in any transaction. They don’t guarantee that you won't get in trouble, but OIG's blessing for a deal is as close to a guarantee as you'll get. And if the regulators do think your idea for, say, paying incentives to doctors violates the anti-kickback statute, it's better to know before you actually start handing out bonus checks. On the other hand, a negative opinion from the government might quiet that nagging business partner who's pushing you to try a scheme you think is dangerous.
Either way, here are some tips on getting the answer you want, according to Herve Gouraige, an attorney at Latham Watkins in Newark, NJ. Gouraige got his hospital client a favorable OIG ruling last summer. The Delaware hospital had sought to sign a union contract that would pay nurses a bonus depending on how many admissions the hospital received from members of a union health plan that the nurses belonged to. OIG concluded that the bonus met a safe harbor that protects compensation paid to employees for covered services, and that payments were small enough that they wouldn't bribe patients into choosing a particular hospital.
Gouraige's advice on navigating the advisory opinion process:
Make an argument. Not surprisingly, Gouraige likens asking for an opinion to writing a legal brief. The trick is to pose a question to OIG as to whether your idea is legal — and then back it up with a series of arguments as to why you think it is. For example, if a top OIG official like Lew Morris spoke at a conference and expressed concerns about the type of transaction you're proposing, then you may want to cite those statements and then explain why these concerns don't apply.
Be cooperative. OIG has 60 days to reply to an opinion, but that doesn't count time elapsed while you respond to its requests for additional documentation. And chances are that they will ask you for more information. Gouraige says his opinion took several months, partly because OIG insisted that the hospital write up the union contract and show it the bonus provision before an opinion would be rendered.
Read between the lines. Regulators will never directly tell you whether you will get a favorable opinion. But you can sense which way the wind is blowing by the follow-up questions that OIG attorneys will ask. There are several points at which you can choose to withdraw your request. "But by then, you've already divulged a lot of information," Gouraige notes.
Don't assume you'll get a cold shoulder. OIG bitterly opposed the Congressional mandate to give advisory opinions. But now that the agency has to give them, its staff is pretty cooperative, says Gouraige. In fact, the attorneys in OIG's advisory opinion section will "try to be your advocates," when draft opinions are circulated for approval from other OIG departments. "Your role is to marshal the facts that can help them," he adds.