OIG offers five keys to unlocking advisory opinions
October 18, 1999 3 minutes read
OIG offers five keys to unlocking advisory opinions
Over 100 providers have requested advisory opinions from the Department of Health and Human Services (HHS) Office of Inspector General (OIG) since Congress enacted the statute two years ago. OIG Senior Counsel Vicki Robinson recently weighed in on the risks and benefits of requesting an advisory opinion, and a blueprint for optimizing that process.
"The bar for achieving a favorable opinion is fairly high," Robinson told attorneys at the Practising Law Institute's recent Health Care Fraud and Abuse conference in Washington, DC. "But the significant guidance benefits outweigh the risks associated with filing a request."
Assuming that all regulatory requirements for submitting a request are satisfied, Robinson says the OIG's framework for analyzing an arrangement under the antikickback statute is generally broken down into several parts. She says providers should focus on five key areas — fact, reimbursement, risk, safeguards, and benefits — to maximize the value of advisory opinions.
I. Facts. According to Robinson, two factual aspects — possible referrals and possible remuneration — dominate the OIG's analysis of advisory opinions. The bottom line is that requesters must provide detailed and specific factual descriptions of their arrangements, she says. "We want to know what is really going on," she warns. "Our opinions turn on very specific factual issues."
She adds that most requesters are asked for additional information, but says those questions often enable providers to restructure their arrangements and develop additional safeguards. "If you hear our concerns, you may be able to improve what you are doing," she explains. "You should not take that as a sign that you have done a bad job in submitting your request."
II. Reimbursement. Understanding the ever-changing federal program reimbursement is often key to identifying the financial incentives that may be driving a deal. "Reimbursement is an aspect of kickback analysis that parties sometimes overlook when they are advocating for their arrangements in advisory opinion requests," she warns.
Robinson points to the advent of prospective payment systems that are rapidly altering financial incentives, as well as items and services that are separately reimbursable under a global or consolidated rate as two prime examples.
She advises potential requesters to look at several recent opinions — 99-2, 99-3, and 99-6 — as examples that demonstrate the importance of reimbursement as an issue in kickback analysis. "We do consult with HCFA in appropriate circumstances," she adds.
III & IV. Risks and safeguards. Risks and benefits many times can be viewed in tandem, according to Robinson. "We identify the possible risks of a particular arrangement and look to see if the arrangement contains sufficient safeguards to protect against those risks," she explains.
When considering risks, she says the OIG often begins with its own prior guidance, and potential requesters should do the same. She also recommends that potential requesters review the preamble to the safe harbor regulations.
According to Robinson, the OIG zeroes in on four key risk areas — increased utilization, increased program costs, inappropriate steering of patients, and unfair competition.
Having assessed the risks, her office looks to see what safeguards are present that might minimize those risks, she says. "Here, there is a good opportunity for good and thoughtful lawyering," she contends. "Safeguards should be specific, not vague generalizations and they are best if they are clear, enforceable, objective, and verifiable."
Many opinions deal with the issue of safeguards, says Robinson. But she tells potential requesters to begin with 90-75, 98-10, and 98-96.
V. Benefits. The OIG's final consideration is benefits, Robinson says. "If taking into account all of the risks and safeguards, [and] the arrangement poses relatively little risk of harm, then we look at the benefits such as increased access to care and expanded patient choice," she says. "But again, we are looking for evidence of real benefits, not speculative and theoretical ones.
"There is one element missing from this list and that is intent," concludes Robinson. "We do not make determinations of intent for the purposes of an advisory opinion." As a result, a negative opinion is not a determination of an actual violation, but rather a determination that there "may be a violation if the requisite intent is present."
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