Use of an 8-Digit Registry Number on Clinical Trial Claims

Effective January 1, 2014, the Centers for Medicare & Medicaid Services (CMS) will require inclusion of an 8-digit clinical trial number on claims associated with clinical trial participation. Clinical trial related claims submitted to Medicare for dates of services on or after January 1, 2014, will be returned to the provider if the 8-digit clinical trial number is not present.

The 8-digit clinical trial number, also called the National Clinical Trial (NCT) Number or Clinical Trials identifier (IDE number), can be found on the ClinicalTrials.gov website.
http://clinicaltrials.gov/

This 8-digit NCT number will be added to the list of other required data:
Institutional clinical trial claims are identified through the presence of all of the following elements:
Value Code D4 and corresponding 8-digit clinical trial number (when present on the claim);
ICD-9 diagnosis code V70.7;
Condition Code 30; and
HCPCS modifier Q1: outpatient claims only. (See MM5805 related to CR5805 for more information regarding modifier Q1.)

Practitioner/DME clinical trial claims are identified through the presence of all of the following elements:

ICD-9 diagnosis code V70.7;
HCPCS modifier Q1; and
8-digit clinical trial number (when present on the claim).
On institutional claims, the 8-digit numeric clinical trial number should be placed in the value amount of value code D4 on the paper claim UB-40 (Form Locators 39-41) or in Loop 2300, HI – Value Information segment, qualifier BE on the 837I.


On professional claims, the clinical trial registry number should be preceded by the two alpha characters of “CT” and placed in Field 19 of the paper Form CMS-1500 or it should be entered WITHOUT the “CT” prefix in the electronic 837P in Loop 2300 REF02(REF01=P4).Medical record documentation of clinical trial title, sponsor name and sponsor protocol number should be kept on file with each participating facility.

1 comment:

Rohith said...

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