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April 20, 2013 01:00 AM

Updated protocol

Guide clarifies self-disclosure for violations

Joe Carlson
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    Healthcare lawyers are praising a revised how-to guide from HHS' inspector general's office that clarifies the leniency and timeframe that healthcare companies can expect when they turn themselves in for potentially fraudulent financial arrangements.

    HHS has long allowed healthcare providers to turn themselves in for suspected violations of the anti-kickback law and the Stark law—more than 800 such disclosures have been made by hospitals, physician groups and healthcare product-makers since 1998.

    The new inspector general's office's Provider Self-Disclosure Protocol incorporates more than a decade of government experience with the program along with public feedback and three earlier incremental clarifications. The result is a 15-page document that people with experience navigating the process say goes a long way toward addressing criticisms that it was murky and slow.

    “This is sort of pulling together an amalgamation of all previous guidance,” said Morgan Lewis partner Howard Young, who was a deputy branch chief at the inspector general's office when the original protocol was published. “But there is some new learning that OIG is communicating in this update as well.”

    The new document discloses for the first time that companies can expect to pay about 1 ½ times the amount of Medicare proceeds involved in the suspected fraud if they reach a settlement, in most cases. However, the minimum penalty for any disclosure involving a kickback is $50,000, and $10,000 for all other matters.

    “We've determined that a 1.5 multiplier provides a financial incentive while still being reflective of the fact that we are talking about conduct that implicates a fraud statute,” said Tony Maida, deputy chief of the Administrative and Civil Remedies Branch of the Office of the Inspector General's Office of Counsel.

    The inspector general's office self-disclosure program is intended to resolve matters that implicate the anti-kickback statute. The most common types of kickback issues that hospitals disclose, according to the protocol, are false or inflated Medicare claims, employment of people whom the office has excluded from Medicare, and payments to doctors to induce referrals. The CMS has a separate disclosure protocol for violations of the Stark law.

    Most settlements take less than a year after acceptance into the program, according to the new document. To further streamline the process, the agency shortened the window for companies to submit findings of internal investigations to 90 days after the initial submission. Companies that self-disclose almost always avoid having costly and embarrassing corporate integrity agreements imposed on them—that was the case in all but one of 235 cases handled this way since 2008.

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    John Richter, a partner with King & Spaulding and a former U.S. attorney in western Oklahoma, noted that the program cannot address every concern a company might have about handing over incriminating information. It can't stop the U.S. Justice Department from targeting the hospital for the same conduct under the False Claims Act. Nor does it prevent whistle-blowers from bringing False Claims lawsuits, though public disclosure of information may mitigate some of that risk.

    “I think the upside is the clarification of the consequences,” Richter said. “The downside is the uncertainty of the collateral consequences that are outside the OIG's control.”

    Follow Joe Carlson on Twitter: @MHJCarlson

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