Novel medical devices intended to treat diseases of the eye, such as retinitis pigmentosa and glaucoma, could greatly improve patient care and health outcomes. A number of factors influence the research and development process of these investigational therapeutics. Specifically, given the significant upfront investments required to develop new devices, reimbursement and payment policies of large payers, such as the Centers for Medicare and Medicaid Services (CMS), play an important role in product development and commercialization.
Recently, the Centers for Medicare and Medicaid Services granted the first ophthalmic device, a retinal prosthesis, an incentive payment through the New Technology Add-on Payment (NTAP) program. In our article, we consider how innovative reimbursement pathways may impact the pace of ophthalmological research and development. We argue that in light of ongoing efforts to make reimbursement decisions more efficient, CMS should leverage its influence as a large payer to promote the development of breakthrough devices such as through coordinating and expediting joint FDA-NTAP review.
(cite: Hwang TJ, Ciolino JB. Retinal implants and Medicare reimbursement policies for breakthrough treatments in ophthalmology. JAMA Ophthalmol 2015: 133(4): 373-374.)