One aspect of the Affordable Care Act (ACA) that is not likely to be repealed is the enhancement of penalties for Medicare and Medicaid fraud and abuse. That includes the new Regulation on civil monetary penalties (CMPs) that the OIG adopted on Dec. 7. The CMP authorities allow the OIG to punish violations that include false claims; contracting with an excluded individual; beneficiary inducements; AKS misconduct; “knowing” Stark Law violations; and violations of the Emergency Medical Treatment and Labor Act (EMTALA), to name just a few. CMPs are imposed as part of a settlement when a provider or supplier follows the OIG’s self-disclosure protocol. The CMP final rule updates these regulations with the OIG’s expanded authority under the Affordable Care Act, including a new CMP for violations of the 60-day overpayment refund rule, to impose CMPs and exclusions on providers and suppliers. Labs will be at greater risk of CMPs, particularly by the new overpayment offense. Under the new rules, failure to report and return overpayments within 60 days of identifying them can result in CMPs of up to $10,000 per item or service overpaid. The “per-service” language is especially scary for labs and other diagnostics providers that submit a high volume of low-value claims. Not only will it become easier to get fined but fine amounts will be higher due to “catch-up adjustments” for inflation.