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Clinical trials background
What regulatory guidance addresses devices and clinical trials in the Medicare program?
Important information notifying users of the requirements for approval of transcatheter aortic valve replacement (TAVR) studies.
CAC meetings are for the purpose of discussing literature related to proposed LCDs before they are developed. CAC meetings are open for the public to attend as observers. Read more information regarding the meeting format schedule, and regi…
Medicare covers the routine costs of qualifying clinical trials, as such costs are defined in National Coverage Determination (NCD) 310.1, as well as reasonable and necessary items and services used to diagnose and treat complications arisi…
First Coast accepts information regarding new drugs, new or revised indications, or marketing materials for forthcoming drugs or medical devices. Read this article to find out how to submit this information.
First Coast identified several errors when providers bill for infectious disease panels. Read this article to learn more about billing these services correctly.
The CAC is used to supplement the MAC’s internal expertise and to ensure an unbiased and contemporary consideration of “state of the art” technology and science. Please read this fact sheet for more details.
The purpose of the open meeting is to allow interested parties the opportunity to make presentations of information and offer comments related to proposed local coverage determinations (LCDs) and/or the revised portion of a proposed LCD tha…
Previous instructions to bill Rebyota fecal microbiota, live-jslm with HCPCS G0455, expired effective June 30, 2023. Instead, providers shall bill HCPCS code J1440 on the same claim with HCPCS 0780T (fecal microbiota transplantation procedu…
Visit our Journey to LCD coverage page to find more information related to LCDs, including the LCD development process and how to become involved, as well as how local and national coverage guidelines relate to claims processing.