November 11 2021
The National Coverage Analysis (NCA) is a guidance tool that is provided by CTSU and is available to assist institutions in clinical trial billing compliance with federal regulations. NCA’s have been provided by CTSU since 2016 and are available for certain NCI-sponsored clinical trials. NCA’s correspond with the protocol specific Funding Sheet which outlines the reimbursement totals for research procedures & assessments.
Although the NCA is available to institutions, it’s use is not required and institutions are still responsible for any changes to the NCA, while ensuring compliance with specific institutional guidelines. It is important to know that the provided NCA’s may not be consistent with institutional policies/guidelines. There may also be Local Coverage Determinations (LCDs) applicable to your Medicare contractor’s region which may impact your site.
NCA’s are provided at the time of trial activation and are updated each time an amendment or protocol funding update occurs. To find the protocol specific NCA, look within the “Funding” tab for the study. When updates to the NCA occur, the new version is posted in CTSU with the corresponding version date. The CTSU bi-monthly broadcast includes announcements about updates to NCAs.
Locating the NCA Worksheet
- Open NRG-BN007 study folder in CTSU
- Click on the “Funding Information” tab in the header of the protocol folder
- Click on the link to “NRG-BN007 Coverage Analysis Worksheet”
Below is a snapshot of what will appear on the first page of the NRG-BN007 NCA Excel spreadsheet.
How to Navigate through an NCA (example NRG BN007):
To get started, it is recommended to compare the NCA to the NRG BN007 Funding Sheet and the model informed consent section that addresses cost. Take notice that different types of trials provide different coverages within the NCA.
By clicking on the Qualified Clinical Trial (QCT) tab of the NCA Worksheet, you can see that NRG BN007 is considered a qualifying clinical trial because it meets all four criteria requirements within the Qualifying Clinical Trial Analysis section of the worksheet. If all four questions were not answered “yes” within the Qualifying Clinical Trial Analysis section, it would not be considered a qualified trial.
The Coverage Analysis (CA) Build tab contains the actual reimbursements which are contained within the protocol assessments category.
A legend is provided at the bottom of the NCA and outlines what each letter stands for.
In this NCA, most of the worksheet contains “RC’s” since these items are routine cost for a QCT and billable to Medicare/government payer/commercial payers. The sponsor pays for the ipilimumab, nivolumab, and research testing on the patient’s tumor tissue, which is indicated by an “S” on the NCA worksheet. The reasons for assignments are included within the justification and comments column on the far right of the CA Build. The justifications and comments provide helpful information to explain the reason behind the assigned coverages.
By clicking on the “Version History” tab, you can see that NRG BN007 NCA has several versions, although there have not been any amendments to the actual study. The explanation to these updates is listed within the “NCA Update” column.
Educational Resources available within CTSU:
- CTSU National Coverage Analysis (NCA) for NCI Clinical Trials Session II Slides August 15, 2018.
- CTSU National Coverage Analysis (NCA) for NCI Clinical Trials Session II Recording August 15, 2018.
- CTSU National Coverage Analysis (NCA) for NCI Clinical Trials Session I Slides August 8, 2018.
- CTSU National Coverage Analysis (NCA) for NCI Clinical Trials Session I Recording August 8, 2018.
- CTSU National Coverage Analysis (NCA) for NCI Clinical Trials Session I Q and A from Sites August 8, 2018.
For questions related to a study specific NCA, contact the CTSU help desk at: ctsucontact@westat.com