Policy and Reimbursement Considerations in Early Clinical Development

Each year, one out of every six United States healthcare dollars is spent on cardiovascular (CV) disease. Not surprisingly, CV conditions and procedures are subject to reimbursement and setting of care and quality measure policies, all of which can greatly affect a hospital's reimbursement. The treatment of heart failure (HF) is the ultimate example of a condition hospitals struggle to manage both clinically and financially. This white paper discusses the current policies and common challenges that U.S. providers face with reimbursement. It also addresses several considerations for designing a robust clinical trial that not only meets the needs of regulators but also accounts for the future needs of practitioners and payers in a real-world setting.