If the same medical device is loaned to three different teaching hospitals for a period of 30 days each is that considered one loan subject to the short term loan exclusion? If three identical devices are loaned to three different teaching hospitals is that considered three separate loans subject to the short term exclusion?
The short term loan exclusion to permit evaluation of the device or medical supply by the covered recipient applies on a per-covered recipient basis. Therefore, if a manufacturer loans a medical device (whether the same device or not) to different teaching hospital recipients, each for a period of 90 days or less, each loan would be eligible for the exclusion in 42 C.F.R. 403.904(i)(5).Key words: Open Payments, Sunshine Act