CMS Proposed Rule: Providing National Medicare Coverage for Approved Breakthrough Devices & Defining “Reasonable and Necessary”

Medical device companies face many economic and regulatory challenges with successfully bringing a new device to market. Two of those challenges include obtaining regulatory authorization to market a device and…

With History as Our Guide, Expanding Telemedicine in Response to the Pandemic Will Likely Result in a Hotbed of Enforcement

Telemedicine has been around well before the covid-19 public health crisis, but regulatory impediments and economic realities have stifled its widespread adoption. However, in response to the pandemic, many regulatory…


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