Office of Inspector General 2023 – Federal Register Recent Federal Regulation Documents
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Action to Delay Effective Date Consistent With Congressionally Enacted Moratorium
This action stays certain amendments to the safe harbors to the Federal anti-kickback statute that were promulgated in a final rule (``Fraud And Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees'') published in the Federal Register on November 30, 2020 (the 2020 Final Rule). In response to a moratorium enacted by Congress on implementation of the 2020 Final Rule, most recently in section 11301 of the Inflation Reduction Act of 2022, which extended previous moratoria on implementation, administration, or enforcement of the 2020 Final Rule until January 1, 2032, the new effective date for the amendments set forth in the 2020 Final Rule is January 1, 2032.
Solicitation of Proposals for New and Modified Safe Harbors and Special Fraud Alerts
In accordance with section 205 of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), this annual notification solicits proposals and recommendations for developing new, or modifying existing, safe harbor provisions under section 1128B(b) of the Social Security Act (the Act), the Federal anti-kickback statute, as well as developing new OIG Special Fraud Alerts.
Grants, Contracts, and Other Agreements: Fraud and Abuse; Information Blocking; Office of Inspector General's Civil Money Penalty Rules
This final rule amends the civil money penalty (CMP) regulations of the Department of Health and Human Services (HHS) Office of Inspector General (OIG) to: incorporate new CMP authority for information blocking; incorporate new authorities for CMPs, assessments, and exclusions related to HHS grants, contracts, other agreements; and increase the maximum penalties for certain CMP violations.
Modernization of Compliance Program Guidance Documents
This Federal Register notice sets forth upcoming procedures for issuing compliance program guidance documents from HHS-OIG.
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