ABSTRACT
This chapter focuses on Medicare coverage and payment policy. Innovations that incrementally improve upon previous technologies and are billed under some of Medicare's payment schemes-such as the inpatient and outpatient prospective payment systems. The importance of coverage, coding, and reimbursement is underscored by the company Organogenesis' experience in the early-2000s. According to an article on the Organogenesis' bankruptcy filing, the Centers for Medicare & Medicaid Services (CMS) was partially to blame for the bankruptcy with its "stringent limitations, restricting reimbursement for the products for use on only the most severe wounds and for a limited number of units per patient". Although Food and Drug Administration (FDA) approval is imperative for manufacturers to gain access to US markets, securing favorable Medicare coverage from CMS, coding, and reimbursement is critical for strong market performance. The FDA and CMS use separate criteria and request different types of clinical evidence when making their respective decisions.
