self-disclosure protocol restricted
on march 24, 2009, the office of inspector general (oig) for the department of health and human services issued an open letter about its voluntary self-disclosure protocol. in the past, oig encouraged use of the protocol to self-report suspected violations of law related to the federal health care programs. in 2006, oig specifically invited disclosures about potential physician self-referral violations (i.e., stark law violations). now, however, oig stated it no longer will accept disclosures that involve only liability under the physician self-referral law unless they also are associated with colorable anti-kickback statute violations. further, oig established a minimum settlement amount of $50,000 for providers filing under the protocol. while the reason for and the outcome of the oig’s latest restrictions on the use of the protocol are unclear, it is doubtful much will change for providers deciding whether to utilize the protocol. in general, the protocol can be a trap for the unwary because it was designed to address potential violations of law, not issues that are related to mere overpayments. once locked into the protocol process, a provider likely will be required to accept a settlement amount that is at least two times the amount of the disclosed damages. and, there is the potential that the provider will be required to enter into a corporate integrity agreement (cia) or certification of compliance agreement (cca). the open question for a provider now is what to do when it detects significant stark violations because one avenue to correct the problem appears to have been taken away. to be fair, though, dealing with stark issues always has been complicated and challenging.