Integration of new technology into clinical practice after FDA approval

Abstract

Development of new medical technology is a crucial part of the advancement of medicine and our ability to better treat patients and their diseases. This process of development is long and arduous and requires a significant investment of human, financial and material capital. However, technology development can be rewarded richly by its impact on patient outcomes and successful sale of the product. One of the major regulatory hurdles to technology development is the Food and Drug Administration (FDA) approval process, which is necessary before a technology can be marketed and sold in the USA. Many businesses, medical providers and consumers believe that the FDA approval process is the only hurdle prior to use of the technology in day-to-day care. In order for the technology to be adopted into clinical use, reimbursement for both the device as well as the associated work performed by physicians and medical staff must be in place. Work and coverage decisions require Current Procedural Terminology (CPT) code development and Relative Value Scale Update Committee (RUC) valuation determination. Understanding these processes is crucial to the timely availability of new technology to patients and providers. Continued and better partnerships between physicians, industry, regulatory bodies and payers will facilitate bringing technology to market sooner and ensure appropriate utilization.

Keywords: CPT; Center for Medicare and Medicaid Services; Coverage with appropriateness determination; Coverage with study participation; Current Procedural Terminology; FDA; Fixed payment; Food and Drug Administration; Health technology assessment organizations; Local coverage determination; MEDCAC; Medical devices; Medical technology; Medicare Administrative Contractors; Medicare Evidence Development and Coverage Advisory Committee; Medicare Program Integrity Manual; National coverage determination; Private payer; Public payer; RBRVS; RUC; Reimbursement; Relative Value Update Committee; Resource-based relative value scale; Specialty society; Technology development; Work value.