Office of the Inspector General ("OIG")

On February 6, 2019, the Office of the Inspector General of the U.S. Department of Health and Human Services (the “OIG”) published in the Federal Register a proposed rule (the “Proposed Rule”) that, if made final in its current form, would (i) amend the Anti-kickback Statute (“AKS”) Discount Safe Harbor to explicitly exclude discounts relating to price reductions or other remuneration offered by a pharmaceutical manufacturer to a Medicare Part D plan sponsor (“Plan Sponsor”), a Medicaid managed care organization (“MCO”), and/or a pharmacy benefit manager (“PBM”) under contract with such a sponsor or organization; and (ii) add two new safe harbors: a “Discounts Offered at the Point-of-Sale” safe harbor (“Point of Sale Safe Harbor”) and a PBM Fee Arrangement Safe Harbor (“PBM Safe Harbor”).
Continue Reading HHS Proposes Rule to Eliminate Safe Harbor for PBM Drug Rebates

The U.S. Department of Health & Human Services, Office of Inspector General (OIG) recently issued Advisory Opinion No. 13-03, declining a clinical laboratory company’s proposed plan to provide various laboratory services to physician practice groups for those patients of the physician practices not covered by a federal healthcare program. Although the proposed arrangement only includes patients who are not covered by federal health care programs, the OIG opined that the physician practices would receive prohibited remuneration and that the proposed arrangement could affect the decision-making of the practices’ physicians, leading to prohibited referrals for laboratory services covered by a federal healthcare program.
Continue Reading OIG Opinion 13-03

The Office of Inspector General has published its Work Plan for the 2013 Fiscal Year. This provides health care industry players with an insight into the activities that OIG plans to initiate or continue with respect to federal health care programs and operations in the upcoming fiscal year. Some new areas that OIG plans on investigating include:
Continue Reading OIG Publishes Work Plan for 2013 Fiscal Year

By Karie Rego

The Office of the Inspector General ("OIG") recently published several reports finding that prestigious east coast hospitals incorrectly billed the Medicare program for replacement medical devices. These are not new problems.   In fact, it has been reported that providers often bill the Medicare program for replacement devices without accounting for the related credit which is refunded by the manufacturer to the provider.
 Continue Reading OIG Billing Reviews of Medical Device Replacements

By Ken Yood and Lynsey Mitchel

The mission of the Office of the Inspector General ("OIG") is to protect the integrity of the programs and operations of the Department of Health & Human Services, for example Medicare, by detecting and preventing waste, fraud and abuse, and identifying opportunities to improve program economy, efficiency and effectiveness. The Work Plan describes both the ongoing and new audits and evaluations that the OIG plans to address in fiscal year 2011.
 Continue Reading OIG Releases Fiscal Year 2011 Work Plan