Gene Therapy Group Seeks OIG ‘Safe Harbor’ For Patient Assistance

By Maaisha Osman / February 26, 2024 at 3:26 PM
An industry group representing companies developing cell and gene therapies is pushing the HHS Office of Inspector General (OIG) to adopt safe harbor provisions under the Federal Anti-Kickback Statute (AKS) that would allow companies to provide more assistance to patients, while a bill before the House Energy & Commerce Committee would legally establish a similar policy. Alliance for Regenerative Medicine (ARM) sent a letter to OIG on Feb. 2 asking the office to establish safe harbor provisions that would give...

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