Article Detail - JF Part B
Clinical Trials and Claim Submission
As a reminder, the following is required for a claim to be processed:
- Clinical trial number - Item 19, or electronic equivalent
- Modifier - Q0 and/or Q1
- ICD-10 code Z00.6
Note: Information included is for billing and coding purposes only and is not meant to imply guarantee of coverage and/or payment.
As of 2014, per CMS Change Request (CR) 8401, a clinical trial number is mandatory on all claims. At that time, CMS required contractors to require an eight-digit clinical trial number. More information can be found at the CMS Internet Only Manual (IOM), Publication 100-04, Claims Processing Manual, Chapter 32, Section 69.
This aligns with the CMS Clinical Trial Policy outlined in CAG-00071R2. Noridian is recommending that the current hard-coded edits be revised to better align with published guidance.
Sub-regulatory guidance on billing and payment for qualifying clinical trial services was posted in 2014, and entities billing for these services are thoroughly acquainted with the terms required for Medicare reimbursement.
Thus, the revision to the edits should not pose an extra burden to suppliers or providers.
Note: This is a reminder that clinical trials that are also investigational device exemption (IDE) trials must continue to report the associated IDE number on the claim form as well.
