News & Analysis as of

Office of the Inspector General Clinical Trials Medical Devices

Morgan Lewis - Health Law Scan

Manufacturers Should Carefully Evaluate OIG’s Approval of Medicare Cost Sharing Subsidies in Clinical Trials

At the end of last year, the US Department of Health and Human Services Office of Inspector General (OIG) issued an Advisory Opinion (AO 23-11, the Opinion) in which OIG approved an arrangement where a medical device...more

Sheppard Mullin Richter & Hampton LLP

OIG Permits Medical Device Manufacturer’s Cost-Sharing Subsidies for Medicare Beneficiaries in Clinical Trial

Last month, in the last advisory opinion issued by the Office of Inspector General (“OIG”) in 2023 – Advisory Opinion No. 23-11 (the “Opinion”) – OIG “blessed” an arrangement involving a medical device manufacturer (the...more

King & Spalding

OIG Issues Favorable Advisory Opinion Regarding the Subsidization of Certain Medicare Cost-Sharing Obligations in the Context of a...

King & Spalding on

On December 21, 2023, the OIG issued a favorable advisory opinion (Advisory Opinion 23-11) regarding the proposed subsidization of certain Medicare cost-sharing obligations in the context of a clinical trial. The...more

King & Spalding

OIG Declines to Impose Sanctions Against Device Manufacturer’s Medicare Cost-Sharing Subsidy in Clinical Trial

King & Spalding on

On March 11, 2022, OIG issued Advisory Opinion No. 22-05 in which it responded to a request for an advisory opinion regarding a proposed subsidization of certain cost-sharing obligations in the context of a clinical trial...more

Robinson+Cole Health Law Diagnosis

Advisory Opinion 22-05: OIG Declines to Impose Sanctions Against Device Manufacturer’s Medicare Cost-Sharing Subsidy in Clinical...

On March 16, 2022, the Office of Inspector General (OIG) published Advisory Opinion 22-05 (Advisory Opinion) in which it declined to impose sanctions against a medical device manufacturer (Requestor) that proposes to pay...more

Sheppard Mullin Richter & Hampton LLP

OIG Advisory Opinion Alert: Yet Another Favorable Decision for Medical Device Manufacturers

On Thursday, March 16, the Office of the Inspector General for the Department of Health and Human Services (“OIG”) issued OIG Advisory Opinion (“AO”) No. 22-05, relating to subsidization of certain Medicare cost-sharing...more

Baker Donelson

OIG Approves Subsidies to Medicare Beneficiaries Provided by a Clinical Research Study

Baker Donelson on

On May 28, 2015, the U.S. Department of Health & Human Services, Office of Inspector General (OIG) issued an advisory opinion approving a medical device manufacturer’s proposed arrangement to provide subsidies to certain...more

King & Spalding

OIG Advisory Opinion Approves Patient Subsidies For Clinical Study

King & Spalding on

On June 4, 2015, OIG published an advisory opinion (No. 15-07) stating that it will not impose administrative sanctions on a medical device manufacturer that planned to pay for copayments and certain other costs for Medicare...more

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