Extract to table

Taken together, these factors support the characterization of the CLARION trial as a high-complexity Phase III oncology study that requires substantial investigator and site staff time, specialized clinical expertise, and significant institutional infrastructure, all of which must be accounted for in any meaningful FMV assessment of the proposed compensation

Applicable manufacturers must submit annual reports to CMS by March 31 of each year, covering payments and transfers of value made during the preceding calendar year

Categorization of Reportable Payments Each payment and transfer of value under the MCTA must be analyzed to determine whether it is reportable under the Sunshine Act and, if so, under what payment category

Where the site institution receiving per-patient site fees is a teaching hospital (as identified on the CMS teaching hospital list), the payments must be reported as payments to a covered recipient under the "research" nature-of-payment category

Each of these items must be tracked, valued, and reported under the appropriate Sunshine Act payment category if the recipient is a covered recipient