Category: DHHS OIG

OIG Advisory Opinion Permits Refunding Device Purchase Price Under Limited Conditions

On September 17, 2018, the Office of Inspector General (“OIG”) issued Advisory Opinion No. 18-10 regarding a proposed arrangement in which a surgical device and wound care product manufacturer (“Manufacturer”) will offer its hospital customers (“Customer”) who purchase the following three products for use in a joint replacement surgery: (i) […]

OIG Seeks Comments to Anti-Kickback Statute and Beneficiary Inducements CMP Related to ‘Patient Centered Care’

The Health and Human Services (HHS) Office of Inspector General (OIG) published today a request for information (RFI) seeking ways in which it might modify or add new safe harbors to the federal Anti-Kickback Statute (AKS) and exceptions to the definition of “remuneration” in the beneficiary inducement provision of the Civil […]

OIG Releases Report Re: Open Payments Program

The Health and Human Services Office of Inspector General (OIG) recently released a report on its review of the Open Payments program, titled “OPEN PAYMENTS DATA: REVIEW OF  ACCURACY, PRECISION, AND CONSISTENCY IN REPORTING.” The OIG reviewed data from calendar year 2015 available as of June 2016. The OIG’s key takeaway […]

GAO Releases Report Analyzing HHS-OIG Integrity Agreements Since 2005

The U.S. Government Accountability Office (GAO) released a report on May 10th characterizing over 10 years of corporate integrity agreements and integrity agreements (collectively, “Agreements”) entered into by the U.S. Department of Health and Human Services Office of Inspector General (“HHS-OIG”) with entities subject to HHS-OIG’s permissive exclusion authority. The […]

OIG Advisory Opinion Approves Ostomy Supply Distributor to Provide Free Product Samples

On Monday, the Office of Inspector General (OIG) issued Advisory Opinion No. 18-02 regarding an arrangement in which the Requestor who distributes and sells, but does not manufacture, certain ostomy products (Products) provides a limited number of free Product samples to patients and contracts with a third party (Contractor) to […]

OIG Releases December Work Plan Items; Focus on Opioid Prescribing Continues

As we announced earlier this year, the Office of Inspector General (OIG) is updating its Work Plan monthly rather than its previous twice-yearly publications. The December updates include 6 new Work Plan items: Status Update on States’ Efforts on Medicaid-Provider Enrollment. OIG will follow-up on a previous review to determine the extent to […]

OIG Releases November Work Plan Items; Focus on Opioid Prescribing and Telemedicine

As we announced earlier this year, the Office of Inspector General (OIG) is updating its Work Plan monthly rather than its previous twice-yearly publications. The November updates include 4 new Work Plan items: Opioids in Medicaid: Concerns about Extreme Use and Questionable Prescribing in Selected States. Focusing on the opioid public health […]