2018

BioTech Company Engaged in Clinical Trials Creates MMSEA Section 111 Reporting Policy

United States - California

According to Centers for Medicare & Medicaid Services (CMS), payments made by sponsors of clinical trials are considered to be payments by liability insurance and must be reported under Section 111 of the Medicare, Medicaid and SCHIP Extension Act of 2007 (MMSEA).

On behalf of a biotechnology company that sponsors clinical trials for oncology drugs, Faegre Baker Daniels drafted the policies and procedures to ensure compliance with applicable MMSEA requirements. These policies and procedures were tailored specifically to the needs of the biotech company, and they will serve as the entity’s roadmap with respect to its Section 111 reporting processes. The policies and procedures set forth a step-by-step process to ensure compliance at each stage of the clinical trial. 

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