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Beneficiaries Advisory Opinions

Sheppard Mullin Richter & Hampton LLP

District Court Elucidates the Meaning of “to Induce” Under the Federal Health Care Program Anti-Kickback Statute

The United States District Court for the Eastern District of Virginia recently dismissed an appeal by the Pharmaceutical Coalition for Patient Access (“PCPA”) that challenged a negative opinion issued by the U.S. Department...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

Bass, Berry & Sims PLC

OIG Approves DME Manufacturer Loan Program in Latest Advisory Opinion

Bass, Berry & Sims PLC on

On June 23, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services published Advisory Opinion 22-13, approving an arrangement under which a durable medical equipment (DME) manufacturer...more

Bass, Berry & Sims PLC

OIG Approves Arrangement that Provides Cash Equivalents to Patients in Latest Advisory Opinion

On March 2, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services published Advisory Opinion 22-04, approving a program under which the requestor provides digital contingency management...more

Mintz - Health Care Viewpoints

OIG Says Proposed MCO Incentive Program Protected by AKS Safe Harbor

In its favorable Advisory Opinion 18-11, the OIG explains how a managed care organization’s proposed incentive program to pay network providers to increase the amount of Early and Periodic Screening, Diagnostic, and Treatment...more

Proskauer Rose LLP

Payment by MCOs to Encourage Preventive Screenings Not a Kickback

Proskauer Rose LLP on

On October 11, 2018, the Office of the Inspector General ("OIG") for the Department of Health and Human Services ("HHS") issued an advisory opinion clarifying that an arrangement between a managed care organization and its...more

Sheppard Mullin Richter & Hampton LLP

How Broad is the Managed Care Safe Harbor?

In Advisory Opinion No. 18-11, the Department of Health and Human Services Office of the Inspector General (the “OIG”) addressed a Medicaid managed care organization’s (“MCO”) proposal to pay its contracted providers and...more

Holland & Knight LLP

Healthcare Law Update: May 2018

Holland & Knight LLP on

Enforcement - OIG Issues Advisory Opinion on Provision of Samples by a Device Distributor - On April 30, 2018, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a...more

King & Spalding

OIG Issues Advisory Opinion Regarding Pharmaceutical Manufacturers’ Program to Provide Free Limited Drugs to Beneficiaries When...

King & Spalding on

On August 12, 2015, the Department of Health and Human Services Office of Inspector General (OIG) posted Advisory Opinion No. 15-11, finding that a program to supply a limited amount of free cancer drugs to federal health...more

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