David Blank

2 months ago | jdsupra.com | David Blank |Aaron Danzig |Gabriel Scannapieco

On February 18, 2025, in a closely watched decision, the United States Court of Appeals for the First Circuit in United States v. Regeneron Pharmaceuticals Inc., No. 23-2086, 2025 U.S. App. LEXIS 3667 (1st Cir. Feb. 18, 2025) held that an Anti-Kickback Statute (“AKS”) violation must be the “but-for” cause for submitting a claim to establish False Claims Act (“FCA”) liability.

Nov 27, 2024 | pubs.acs.org | Jacob Schaffner |David Blank |Morris Oyelowo |Towhidi Illius Jeaydi

Aug 1, 2024 | jdsupra.com | David Blank

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 Statute (“AKS”) and the beneficiary inducement prohibition of the Civil Monetary Penalties Law (“Beneficiary Inducement CMP”). The programs proposed offering financial aid to patients for treatment-related travel and fertility expenses.

Jul 11, 2024 | jdsupra.com | David Blank

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 financial risks associated with the purchase of a high-cost drug in the rare disease space.

Jun 27, 2024 | jdsupra.com | David Blank

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 assistance program providing travel-related financial support to qualifying patients and caregivers.