The Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) has published a proposed rule that would amend the health care program civil monetary penalty (CMP) regulations (Proposed Rule). Notably, the Proposed Rule would codify the OIG’s expanded statutory authority under the Affordable Care Act (ACA) to impose CMPs on providers and suppliers and would allow for significant penalties in a variety of scenarios. For example, the Proposed Rule would permit the OIG to impose $10,000 per day penalties on providers and suppliers who fail to timely report and return an identified overpayment. Furthermore, the Proposed Rule would allow the OIG to impose $10,000 per day penalties—at the 9-digit NDC level—on drug manufacturers who fail to timely report and certify drug-pricing data. Such proposals could increase the OIG’s ability to leverage substantial penalties beyond that which is permitted under current regulations. Likewise, the OIG would codify its expanded authority under the ACA to permit CMPs for conduct including:
..Failure to grant OIG timely access to records, upon reasonable request;
..Ordering or prescribing while excluded when the excluded person knows or should know that the item or service may be paid for by a federal health care program;
..Making false statements, omissions, or misrepresentations in an enrollment or similar bid or application to participate in a federal health care program; and
..Making or using a false record or statement that is material to a false or fraudulent claim.
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Topics: Affordable Care Act, Civil Monetary Penalty, Drug Manufacturers, HHS, OIG, Pharmaceutical, Prescription Drug Coverage, Prescription Drugs, Proposed Regulation
Published In: Health Updates, Science, Computers & Technology Updates
DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.
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