CMS is proposing to revise § 416.195(a)(2) to require that the IOL’s FDA-approved labeling contain a claim of a specific clinical benefit based on a new lens characteristic in comparison to currently available IOLs.
CMS is also proposing to revise § 416.195(a)(4) to require that any specific clinical benefit referred to in § 416.195(a)(2) must be supported by evidence that demonstrates that the IOL results in a measurable, clinically meaningful, improved outcome.
To learn more about the proposed payment rule, click here.
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