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Office of the Inspector General refines provider self-disclosure protocol
Physicians note: Enforcement agencies can open investigations into any self-disclosed conduct.
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In an “Open Letter to Health Care Providers,” Department of Health and Human Services Inspector General Daniel Levinson advised Medicare providers that the Office of Inspector General “generally” will not require a Corporate Integrity Agreement from providers who resolve kickback and fraud allegations under the Self-Disclosure Protocol.
The Office of Inspector General (OIG) established the Self-Disclosure Protocol (SDP) in 1998 to promote a shared commitment to compliance and program integrity between the OIG and health care providers. Physicians who self-police compliance matters within their practices and voluntarily self-disclose instances of potential fraud under the SDP significantly minimize the risk they will be subject to an OIG-directed investigation. In addition to the increased financial cost and disruption to a practice associated with an OIG investigation, SDP disclosures often result in reduced damages and a general assurance from the OIG not to exclude the self-disclosing provider from the Medicare and Medicaid programs.|
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CIA changes
The open letter, issued on April 15, builds on a 2006 letter to the provider community in which the OIG sought to encourage providers to self-disclosure potential Stark Law violations by committing to resolve cases, generally, for an amount near the lower end of the range of recoverable monetary damages. Whereas, the OIG’s 2006 letter expressly states Corporate Integrity Agreement (CIA) decisions will continue to be made under traditional guidelines, the recent pronouncement further encourages providers to participate in the SDP by removing the threat of a CIA for most self-disclosure cases.
The OIG explains 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.” Accordingly, the OIG makes it clear that the benefits of participating in the SDP apply only to providers who furnish complete and informative disclosures, respond timely to OIG requests for additional information and perform accurate audits, all of which serve as indications that “the provider has adopted effective compliance measures.”
Refined requirements
The open letter also refines the criteria physicians and other providers must meet in order to participate in the SDP process. Specifically, in addition to the basic information previously outlined in the SDP the initial self-disclosure to the OIG also must contain the following:
- a complete description of the conduct being disclosed;
- a description of the provider’s internal investigation or a commitment regarding when it will be completed;
- an estimate of the damages to the federal health care programs and the methodology used to calculate that figure or a commitment regarding when the provider will complete such estimate; and
- a statement of the laws potentially violated by the conduct.
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Once the OIG determines an initial submission complies with these rules and accepts the physician into the SDP, the physician will have 3 months to complete an internal investigation and damages assessment.
Physicians also should be aware that the OIG expects their “full cooperation” while the self-disclosed matter is under review. The OIG emphasized in the open letter that it will remove providers from participation in the SDP unless they “disclose in good faith and timely respond to OIG's requests for additional information.”
Physicians electing to self-disclose should make sure to include all information required under the SDP, even if certain facts could make the potential violation appear worse. Self-disclosures that omit or obscure relevant information in bad faith may place physicians at greater risk than had they never disclosed the incident at all. In addition, physicians should be prepared to respond to follow-up questions and provide additional information as requested by the OIG.
Other agencies pose risk
Given the current enforcement environment and recent trends in the investigation of physician financial relationships within the health care industry, orthopedic surgeons should proceed cautiously with regard to self-disclosure and settlement with the OIG. Although the OIG’s open letter offers providers the additional incentive of avoiding a CIA through participation in the SDP, physicians should be aware that a disclosure made under the SDP does not necessarily mean that other federal and state enforcement agencies could not open their own investigation into the self-disclosed conduct.
For instance, as previously reported in Orthopedics Today (“Orthopedists liable under federal kickback statute,” March), federal and state enforcement agencies have become keenly interested in the propriety of payments made by medical device companies to physicians.
Accordingly, self-disclosures related to payments received by a physician from a device manufacturer may draw attention from the Department of Justice as well as states’ Attorneys General. Although disclosure of potential fraud under the SDP may be the prudent course of action in many cases, self-disclosing physicians would be wise to raise this issue with the OIG and, if appropriate, seek assurances or releases from other enforcement agencies that have independent authority to prosecute the reported conduct.
For more information:
- Richard S. Liner, JD, MPH, can be contacted at Arent Fox LLP, 1050 Connecticut Avenue, NW, Washington, DC 20036; 202-857-8972; e-mail: liner.richard@arentfox.com.
References:
- An Open Letter to Health Care Providers, Office Inspector General, Apr. 15, 2008.
- Integrity Agreements No Longer Required In Most Cases of Self-Reported Fraud, IG Says. Health Care Fraud Reporter. April 23, 2008:364.