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

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...