June 2008
Health care providers who resolve fraud matters using the Department of Health and Human Services Office of Inspector General’s (HHS OIG) provider self-disclosure protocol generally will no longer be required to enter into corporate integrity agreements (CIAs).
In an open letter to providers released April 15, IG Daniel Levinson said that accurate and complete disclosure, timely responses to OIG requests for additional information, and accurate audits by disclosing providers all indicate "effective compliance measures" that rule out the need for CIAs or certification of compliance agreements in most cases.
"We believe that this presumption in favor of not requiring a compliance agreement appropriately recognizes the provider’s commitment to integrity and also advances our goal of expediting the resolution of self-disclosures," Levinson said in the letter, which he released at the Health Care Compliance Association’s 2008 Compliance Institute.
Levinson also said that his office seeks to speed the self-disclosure process and told providers they should "be in a position to complete an investigation and damages assessment" within three months of the OIG accepting self-reported cases of fraud.
OIG Chief Counsel Lewis Morris said his staff also has made internal improvements to streamline the self-disclosure protocol and that the new time frame not only speeds the process but discourages providers from entering the self-disclosure protocol with too little information or with no intent to actually resolve the matter.
Since its release in 1998, the OIG’s self-disclosure protocol has provided an avenue for health care providers and suppliers to report identified misconduct proactively. Assuming the written disclosure is accepted by the OIG as sufficient to meet the requirements of the protocol, the process allows resolution with the OIG, usually by means of a monetary settlement and often accompanied by a CIA.
Downsides of the protocol, says the law firm of Foley & Lardner, have included concerns by providers and suppliers about the extent of information required to secure acceptance under the protocol, the cautionary advice by the OIG that the matter may not end with the disclosure but may require referral to or involvement with the U.S. Department of Justice (DOJ), and an aversion by providers and suppliers to incur the costs and other burdens associated with a CIA.
IG Daniel Levinson, like his predecessors, has placed the protocol clearly at the center of the OIG’s compliance and fraud enforcement activities, notes Foley & Lardner in a recent legal news alert. Since 1998, 379 disclosures have been accepted into the protocol, and 165 of those were resolved with monetary settlements totaling $118 million. There were 53 disclosures submitted during calendar year 2007.
"It must be underscored that the OIG does not accept all self-disclosures for processing under the protocol," says F&L. "Among other factors, the OIG must be convinced that the disclosure is offered in good faith, and the OIG generally will not accept a matter for the protocol already under investigation by the government."
Initial Submission Requirements
The open letter also addresses the OIG’s expectations for providers’ initial submissions, saying that such submissions should include sufficient details about the conduct being disclosed, a description of the providers’ internal investigation, an estimate of damages to the federal government, and a statement of the laws violated.
In the past, a provider had two avenues for self-disclosure. First, it could disclose at the beginning of its own internal investigation by including only certain "basic information" in the submission. Second, the provider could disclose after it had completed its internal investigation and self-assessment by submitting more detailed information as part of its submission.
The 2008 open letter no longer permits providers to submit bare-bones disclosures limited to the basic information. "This heightened requirement appears to be driven by the OIG’s concerns about disclosures not being made in good faith or not containing enough information for the OIG to determine whether to admit a provider or supplier to the protocol," says F&L.
Not for Simple Overpayments
The open letter clearly restates the OIG’s long-standing policy that the self-disclosure protocol is not intended to resolve billing errors or overpayments. Such matters should be resolved directly by providers to "the appropriate claims-processing entity" such as a Medicare payment contractor, Levinson said.
According to Morris, examples of matters providers should consider self-disclosing include systemic evaluation and management upcoding, Stark law violations, and alteration of medical records. The benefits of self-disclosing include the possibility of reduced damages and, generally, assurance that the OIG would not seek to exclude a provider from federal health programs, Morris said during the compliance conference.
However, he cautioned that the OIG still would seek some damages and could not shield providers from action by private entities or the DOJ. Levinson and Morris added, though, that they believe that self-disclosing could protect providers in many instances against qui tam actions.
Morris also said that the OIG did not seek to use the self-disclosure protocol as an avenue to investigate matters unrelated to those raised by providers, but noted that if obvious cases of fraud were brought to light during a disclosure, the OIG would not ignore them.
Cautions Remain
Although the protocol may offer significant comfort given possible alternatives, the decision whether to self-disclose (and where—to the OIG, the Medicare contractor, Medicaid, or the DOJ) has always been a decision that has required careful consideration, notes Foley & Lardner. The primary concerns with the protocol have been the lack of significant incentives to those self-disclosing, inconsistent or disparate treatment of self-disclosers, and the time often required to resolve a self-disclosure with the OIG.
"It should also be noted that recent positions taken by the DOJ suggest that the protocol may not be viewed as a "public disclosure" that would bar a qui tam recovery under the False Claims Act," says F&L in its alert. "Although the 2008 open letter offers some favorable prospects to providers and suppliers to encourage use of the protocol, caution (and legal counsel) is still advised with respect to all disclosure of misconduct to avoid prejudicing future options."
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