On December 7, 2016, the Office of the Inspector General (OIG) published a new “safe harbor” regulation under the anti-kickback statute (AKS). Since it's 1976 establishment, OIG has been at the forefront of the nations efforts to fight waste, fraud, and abuse and Medicare Medicaid. On December 7, 2016, the Office of Inspector General of the US Department of Health and Human Services (OIG) published a final rule containing revisions to both the federal Anti-Kickback Statute (AKS) safe harbors and the beneficiary inducement prohibition in the civil monetary penalty rules (CMP Law) (Final Rule). What is the office of Inspector General The federal agencies mission is to protect the integrity of the participants as well as health and welfare a program beneficiaries. The proposed amendments include an. Safe Harbors to the Anti-Kickback Statute Value-Based Enterprise Arrangements. Six of these contain guidance specific to hospitals, surgery centers and other providers. HHS' Office of Inspector General issued 22 advisory opinions in 2012. SUMMARY: In this proposed rule, the Department of Health and Human Services (Department or HHS) proposes to amend the safe harbor regulation concerning discounts, which are defined as certain conduct that is protected … do not qualify for protection under the Discounts Safe Harbor. The Health and Human Services Office of Inspector General (OIG) has taken a step toward easing this bottleneck by amending the local transportation safe harbor to the Anti-Kickback Statute. In the same rule, the OIG created two new related Safe Harbors – the Point-of-Sale Reductions in Price for Prescription Pharmaceutical Products Safe Harbor, and the PBM Service Fees Safe Harbor, both of which become effective January 29, 2021. Section 2 specifically provided new authority to the Office of Inspector General (OIG) to exclude an individual or entity from participation in the Medicare and State health care programs if it is determined that the party has engaged in a prohibited remuneration scheme. The first three advisory opinions closely address … The regulations will become effective in 30 days. The OIG finalizes, with a number of modifications, its proposals to establish three new safe harbors under the AKS for certain remunerative arrangements between eligible participants in a "value-based enterprise" (VBE), which is a network of individuals and entities that collaborate to … ACTION: Proposed rule. 9 The OIG also clarified that the safe harbor protects only payments related to FQHCs treating MA plan enrollees, not arrangements unrelated to the treatment of MA plan enrollees at FQHCs. Arrangements that do not fit in a safe harbor are analyzed on a case-by-case basis, including ... HHS Office of Inspector General Fact Sheet Notice of Proposed Rulemaking OIG -0936-AA10-P . On November 19, 1999, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) published eight new safe harbor regulations to the Anti-Kickback Statute. Start Preamble Start Printed Page 2340 AGENCY: Office of Inspector General (OIG), Department of Health and Human Services (HHS). The amendment expands the mileage allowance for patients residing in rural areas and eliminates the mileage limitation for patients being discharged home. Under the safe harbor, government-owned/operated ambulance providers and suppliers can receive protection under the AKS if they choose to waive the collection of beneficiary cost … These are briefly described below. update to the provision under which electronic health records software is deemed … The Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS) issued a proposed rule to create a new safe harbor under the federal Anti-Kickback Statute for electronic health records items and services. HHS has identified the broad reach of the Federal anti-kickback statute, 42 U.S.C. In addition, the OIG clarified six of the original eleven safe harbors.