The OIG established new requirements for the Self-Disclosure Protocol in what experts believe is an attempt to clear smaller cases from the OIG's plate. But legal experts say providers might find their own plates are filling up with violations they cannot disclose.
The OIG released an open letter to providers that put new limitations on the types of violations that could be reported using the Self-Disclosure Protocol. The OIG will no longer accept Stark Law violations that do not implicate the anti-kickback statute, and it also established a minimum settlement amount of $50,000.
"It's shocking" said Robert A. Wade, Esq., partner at Baker & Daniels, LLP, in South Bend, IN.
Wade said the new guidance seems to contradict the message the OIG originally sent when it established the Self-Disclosure Protocol in 2006. The Self-Disclosure Protocol was designed to create a means for providers to voluntarily bring violations to the government's attention without fear of further litigation.
The OIG not only allowed, but used to encourage providers to use the Self-Disclosure Protocol for Stark Law violations, according to Wade, but now the OIG has said it will not accept straight Stark violations.
That means a provider could potentially discover a multi-million dollar Stark violation, but if it doesn't also include "colorable violations of the anti-kickback statute" the provider cannot come clean to the government using the Self-Disclosure Protocol.
These changes have left some providers scratching their heads. Wade said he and a client were preparing to disclose a violation via the Self-Disclosure Protocol, but that violation no longer meets the OIG's new requirements.
However, Wade said providers have two options for violations that do not meet the new self-disclosure requirements—neither of which provide the same closure as the self-disclosure protocol.
The first option is to treat the violations like overpayments, and attempt to return the money through a Medicare carrier/fiscal intermediary.
Wade points out that carriers/fiscal intermediaries are not equipped to perform the duties necessary to ensure that the provider did its due diligences. This includes making sure the audit that discovered the violation was thorough, complete, and within an acceptable time frame. Wade said carriers/fiscal intermediaries must address this issue.
The second option providers have is to disclose the violation to the Department of Justice. This option also does not guarantee no further action, and Wade said this option is "not one you prefer to use."
Until further guidance comes advising providers what to do with theses lesser violations, they will need to either choose between these two options, or choose to do nothing and hope for the best.