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ICD Trial/Registry Requirements

Christine Posted Fri 05th of September, 2014 12:33:47 PM

We have questions re: claim submissions for Pts enrolled in ICD Registry/Trial,(NCT01999140,"ICD implant/Primary Prevention"). We have a good understanding of the requirements and reporting procedures for the initial implant/claim submission. Where we are troubled, is in finding "reporting requirements" for claims submission during the Post OP period and throughout the duration of the Pt's participation in this Trial.
Are we required to identify these Pts as "trial participants" for ALL Post OP visits with the Physician plus ALL or ANY other services related to the ICD/device, such as: "in person" device interrogations and/or programming, and all "remote" device evaluations? If so, how do we "note" these claims? Do we follow the same criteria for Dx/s, Q0 Mod, and append the claim/s with the Registry number as we did on the initial implant claim?
We are seeing recent CMS news flashes/alerts, upcoming for 2015. The alerts speak to "tightening up" mandatory reporting requirements particular to this Trial, reiterating requirements for the initial claim submission, but really nothing about post OP/lifetime participation/reporting. Can you help us sort this out, or get us onto the right track?
Thanks so much for your assistance,
Christine Brooks, RN, Biller/Coder

SuperCoder Answered Wed 10th of September, 2014 08:47:08 AM

Hi Christine-
This question requires some research. Please allow us additional time to research this.
Thank you.

SuperCoder Answered Wed 10th of September, 2014 08:47:30 AM


SuperCoder Answered Wed 10th of September, 2014 08:47:30 AM
SuperCoder Answered Thu 11th of September, 2014 08:54:56 AM

Thank you for allowing additional time to research. After researching this study extensively using all of our resources, we are unable to locate any additional information on the submission of Post Op or Lifetime care in regards to this clinical trial. Appending with the correct DX, the QO modifier and yes, including the registry number would be the best route to take for Post Op and Lifetime care.

Christine Posted Fri 12th of September, 2014 10:50:58 AM

Yes, I found the same, after MUCH research. There really is nothing to be found R/T requirements for Post OP reporting. I agree, until instructed otherwise, we will amend all Post OP claims with all info regarding the trial; Dx, Q0 Mod and Registry number. Now, to formulate a process in which to identify all Pts in Trial Registry throughout "lifetime" of Pt/trial :). Thank you so much for your extensive research.

Christine Brooks

SuperCoder Answered Fri 12th of September, 2014 13:03:20 PM

You are welcome.

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