OIG lays out seven pillars of advisory opinion wisdom’
The Health and Human Services (HHS) Office of Inspector General (OIG) has released a "preliminary checklist for advisory opinion requests" that outlines what must be included in advisory opinion requests.
But to fully understand the real costs and benefits of getting an advisory opinion, it’s important to look beyond the guidelines to understand how the OIG itself views the advisory opinion process.
Here is an exclusive look at "the seven pillars of advisory opinion wisdom," according to OIG Senior Counsel Vicki Robinson:
I. Almost everything implicates the anti-kickback statute. "Simply put," says Robinson, "the anti-kickback statute is broad enough to encompass almost any arrangement between parties that do business together and get federal health care program reimbursement." She warns that if such an arrangement exists, her office will likely construe that it implicates the statute. "But that does not mean you will get an unfavorable opinion," she adds.
Many opinions, including the recent opinion on St. Jude’s Children’s Hospital, have concluded that while there was a potential violation, if there were adequate safeguards and benefits OIG would not impose sanctions. "That determination is binding on the parties that requested the opinion," she adds, "unless there was a failure to disclose material information in which case all bets are off.
II. If it increases costs, forget about it. According to Robinson, there are at least four evils addressed by the anti-kickback statute — increased program costs, increased utilization, improper steering of patients, and unfair competition. "If an arrangement increases costs either through increased charges or increased utilization, the probability that we are going to issue a favorable opinion is low," she warns. However, if the arrangement will implicate the statue without increasing costs, the OIG will be more amenable to looking at its potential benefits. According to Robinson, the best example of this is Opinion 98-3, which involves the donation of an ambulance to a municipality.
III. Don’t blow smoke. "If the arrangement has safeguards against increased costs and utilization or provides offsetting benefits," says Robinson, "then show us." She urges providers to be specific and be detailed. "Conclusory statements [about] your arrangement will result in better quality of care, or that the parties have good intent carry very little weight because everybody tells us they have good intent," she says. "We can hypothesize about risks and kick-backs but when it comes to benefits we want proof."
IV. Sometimes, you have to wait until the fat lady sings. The ultimate determination to the potential for fraud and abuse will turn on what happens after the arrangement is implemented, Robinson warns, no matter how much information the OIG receives beforehand about a proposed arrangement. In other words, she says, don’t expect the OIG’s opinion to immunize you from sanction. For example, a joint venture that doesn’t meet the small entity joint venture safe harbor may have safeguards that appear to provide equivalent protection, but final determination will turn largely on whether the referral source investors actually contribute to operation of the success of the joint venture or simply make referrals and cash their dividend checks. "Sometimes you simply cannot predict how an arrangement will work in practice even if the contract and documents look very good," she warns.
V. A negative can be a positive. "There can be a lot of very good guidance in a negative opinion," says Robinson. "It is generally easier for us to generalize if we are saying what we don’t like." By contrast, she adds, when the OIG approves an arrangement, it is very careful to do so narrowly that the opinion can not be misconstrued or misapplied.
VI. Beware of the dog that doesn’t bark. Robinson warns providers to be very cautious in comparing arrangements they may be working on with the arrangements in published opinions.
"You may think your arrangement is very close to what is in the published opinion; but remember that you have not seen the things that have not been approved, and you certainly have not seen our view about the hundreds and thousands of arrangements that we are not asked about," she says. "Differences in the facts of similar arrangements will often lead to a different result. You must be very careful not to generalize too much from the advisory opinion."
VII. Remember, you have been warned. The final tenet, according to Robinson, is that the OIG believes that in many substantive areas advisory opinions are filling gaps in guidance and setting up benchmarks. "To the extent that advisory opinions address an area or practice that subsequently becomes the subject of an investigation, we will expect providers to have read the opinion and have taken it to heart," she concludes.
[Editor’s note: An upcoming issue of Compliance Hotline will outline the dangers that Robinson says are associated with the advisory opinion process and how to minimize those risks.]