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Bringing Regenerative Medicine to Patients: The Coverage, Coding, and Reimbursement Processes
Book chapter

Bringing Regenerative Medicine to Patients: The Coverage, Coding, and Reimbursement Processes

Khin-Kyemon Aung, Scott Levy and Sujata K. Bhatia
Engineering 3D Tissue Test Systems, pp 381-400
2018
DOI: https://doi.org/10.1201/9781315118260-21

Abstract

Tissue Test Systems OPPS NIH 3T3 Myelodysplastic Syndrome Perineuronal Nets FDA Approval Current Procedural Terminology Codes Medicare Physician Fee Schedule Coverage Decision NIH 3T3 Mouse Fibroblast Myeloid Differentiation Primary Response Gene-88 MyD88 Allogeneic Hematopoietic Stem Cell Transplants Coverage Determination Medicare Payment Advisory Commission Cross-linked Ultra-high Molecular Weight Polyethylene ACOs DNA Screening Cpt Code Skin Substitute HCPCS Code Alternative Payment Models National Coverage Determinations ICD-10 Cm Code
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.

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