AUSTIN, TEX. (FRONTLINE MEDICAL NEWS) – Using the federal government’s voluntary self-disclosure protocol to report potential program violations offers advantages and disadvantages.

On one hand, the protocol allows health providers to get in front of possible offenses and retain some control, according to Miami health law attorney Stephen H. Siegel . On the other hand, launching the process could draw increased government scrutiny to a practice.

However, it can pay to be safe, rather than sorry later, Mr. Siegel said at an American Health Lawyers Association meeting.

“You are far better [off] and in a much better position, being proactive than reactive,” Mr. Siegel said in an interview. “Being proactive is an indication that your intention is to do the right thing. Whereas reactive, certainly the government doesn’t view [your intention] that way.”

Several federal agencies offer voluntary disclosure protocols. The HHS Office of Inspector General (OIG) self-disclosure protocol was created in 1998 to enable the self-disclosure of potential health care fraud. The Centers for Medicare & Medicaid Services provides the voluntary self-disclosure protocol, which is limited to potential violations of the physician-self referral statute, also called the Stark Law . Self-disclosures can also be made to the Department of Justice, although the agency has no formal protocol.

Voluntary self-disclosure can limit the possibility of an external investigation and reduce criminal and civil liability, according to Mr. Siegel. In a self-disclosure case, doctors can typically expect to pay back 1.5 times the amount that was improperly paid by the government. Whereas, in a false claims act case, for example, physicians can wind up paying back treble damages, plus a fine of between $5,500 and $11,000. Other advantages to voluntary self-disclosure include an expedited resolution, better control over adverse publicity, and the neutralizing of whistle-blower threats and lawsuits.

Disadvantages include financial loss, potential reputation harm, no immunity from liability or prior commitments by government, and possible penalties for conduct that may have remained undiscovered and thus undisclosed.

“For the most part, doctors are not aware of [voluntary self-disclosure],” Mr. Siegel said in an interview. “They’re not using it. [However], I think voluntary disclosure is going to become more widely used as people realize the ability to control the risk associated with the process.”

A number of issues warrant voluntary self-disclosure in a practice setting: possible government overpayments, potential improper arrangements with service providers, demonstrable patient harm, falsification of medical records, medical directorship issues, inadequate staffing, or the practice of medicine without a license, among others.

Regardless of which agency handles the self-disclosure, the admission will likely make its way to other agencies.

“Be assured that the agencies are going to talk to each other,” Mr. Siegel said. “If you submit it to DOJ [Department of Justice], chances are, it’s going to go to OIG.”

After choosing which agency to direct the self-disclosure, submit a timely, complete, and transparent disclosure, he advised. Each disclosure protocol is specific. For example, the OIG requires the disclosing party to acknowledge that the conduct is a potential violation and explicitly identify the laws that were potentially violated. The disclosing party also must agree ensure that corrective actions are implemented and that potential misconduct has stopped by the time of disclosure or, for improper kickback arrangements, within 90 days of submission.

The process of voluntary self-disclosure can be slow, usually taking more than a year. The OIG and CMS also reserve the right to reject a voluntary disclosure, Mr. Siegel said. If the government has already initiated an investigation for instance, an agency may reject the self-disclosure.

The government considers a host of factors when choosing how to resolve a self-disclosure case including the effectiveness of preexisting compliance programs; the nature of the conduct and its financial impact; the doctor’s ability to repay; whether the discloser is a first‐time offender; whether the incident is isolated; efforts to correct the problem; the period of alleged conduct; how the matter was discovered; and the party’s level of cooperation.

Mr. Siegel stressed there are no guarantees about how a voluntary self-disclosure case may be settled and that the matter will depend on the circumstances.

“There is no one-size-fits-all approach to voluntary self‐disclosure,” he said. “These decisions should be made with the assistance of competent and experienced counsel.”

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