News & Analysis as of

Life Sciences Office of the Inspector General Manufacturers

Arnall Golden Gregory LLP

OIG Issues Split Decision: Travel Assistance Approved, Fertility Support Under Scrutiny

On July 22, 2024, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued Advisory Opinion 24-05, evaluating two manufacturer-sponsored assistance programs under the federal Anti-Kickback...more

Arnall Golden Gregory LLP

OIG Issues Favorable Advisory Opinion Involving Financial Risk Mitigation Arrangements for High-Cost Rare Disease Drug

On June 20, 2024, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted Advisory Opinion 24-04, a favorable opinion analyzing a refund and discount program designed to alleviate the...more

Arnall Golden Gregory LLP

OIG Greenlights Manufacturer’s Travel-Related Financial Assistance Offering

On June 17, 2024, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) posted a favorable Advisory Opinion 24-03 (“AO 24-03”) involving a pharmaceutical manufacturer’s proposed patient...more

Arnall Golden Gregory LLP

OIG Greenlights Manufacturer’s Limited Free Drug Program

On February 28, 2023, the Office of Inspector General (“OIG”) issued Advisory Opinion No. 23-02 (“Opinion”), which favorably addresses a pharmaceutical manufacturer’s proposal to offer a free limited supply of medication for...more

King & Spalding

Congress Acts to Eliminate MDRP Misclassification

King & Spalding on

President Trump on Thursday signed into law the most extensive set of amendments to the Medicaid Drug Rebate Program statute since the Affordable Care Act in 2010. The new law addresses the perception that drug manufacturers...more

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