Providers that find potential Anti-Kickback Statute violations, false claims or excluded individuals on staff can report the conduct to HHS’ Office of Inspector General through its Health Care Fraud Self-Disclosure Protocol.
A Sept. 25 client brief from Anthony Mahajan, founding partner of Health Law Alliance, lays out what a complete submission requires.
Here are nine things to know:
1. Not every billing problem qualifies. The protocol only covers conduct that may violate federal criminal, civil or administrative law and carries civil monetary penalty exposure. An ordinary overpayment or billing error with no statutory violation goes through the Medicare contractor’s or payer’s voluntary refund process instead. Conduct that raises only Stark law exposure goes to CMS’ Self-Referral Disclosure Protocol. Conduct that implicates both Stark and the Anti-Kickback Statute stays with OIG, and OIG decides which protocol applies when the line is unclear.
2. The violation must be named plainly. A submission has to identify the disclosing party by name, address, provider and tax ID numbers, and the government payers it bills. It also names a point of contact and the federal statute the conduct may violate.OIG will not accept a disclosure that fails to clearly acknowledge the conduct as a potential violation. Hedges such as “the government may think there is a violation, but we disagree” raise questions about whether a matter belongs in the protocol, OIG said.
3. The narrative needs specifics. It must name the conduct, the time period and each implicated person’s role. When the disclosure involves an excluded employee or contractor, it must also give that person’s job duties, employment dates and the screening failure that allowed the hire.
4. An authorized official must certify it. The submission reports the findings of the internal investigation and the corrective action already taken. An authorized official then certifies that it is truthful and made in good faith.
5. False-billing damages follow a set method. Damages come from reviewing every affected claim or a statistically valid random sample of at least 100 claims, projected using the mean point estimate. Underpayments found during the review cannot be netted out. OIG expects a report on the review’s objective, the claim population, the data sources and the reviewer’s qualifications. When a sample is used, the report must include the sampling plan. OIG strongly recommends drawing it with its free RAT-STATS software.
6. Kickback and Stark damages are calculated differently.Disclosures must estimate what federal healthcare programs paid for items or services tied to the arrangement. Kickback disclosures must also report the total remuneration involved, even if the provider believes part of it served a lawful purpose.
7. An open investigation does not rule a provider out. Providers under audit or government investigation, including a sealed qui tam complaint, can still use the protocol if they disclose in good faith rather than to get ahead of the inquiry. Providers already facing a government inquiry, including an investigation or audit, are not automatically barred from the protocol. The disclosure must be made in good faith and not to circumvent the inquiry.
8. Cooperation drives every benefit. OIG expects a thorough investigation, complete information, a single point of contact and prompt answers to follow-up requests. OIG rejects submissions that leave out required information, don’t conform to the protocol or aren’t a good fit for it. A provider that is rejected or stops cooperating loses the protocol’s benefits, and the conduct goes back under OIG’s civil monetary penalty authority and exclusion risk.
9. Resolution usually comes without an integrity agreement. A resolved matter ends in a settlement agreement and a release from OIG’s permissive exclusion authority. OIG has stated a presumption against imposing integrity obligations on parties that cooperate.Between 2016 and 2020, OIG resolved 330 protocol cases through settlements without requiring integrity measures, according to the protocol. A lower penalty is not guaranteed, because each settlement depends on the facts and on the provider’s cooperation.
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