Mandatory Reporting Of An 8-Digit Clinical Trial Number On Claims

Effective January 1, 2014, providers should mandatorily report clinical trial identifier number on claims for items and services provided in clinical trials that are qualified for coverage as specified in the “Medicare National Coverage Determination (NCD) Manual,” Section 310.1.

The Clinical Trial Identifier number to be reported is the same number that has been reported voluntarily since the implementation of CR 5790, dated January 18, 2008. That is the number assigned by the National Library of Medicine (NLM) http://clinicaltrials.gov/ website when a new study appears in the NLM Clinical trials data base.

CMS understands that implementing CR 8401 by January 1, 2014, would create an undue hardship on a number of its stakeholders. As a result, for physicians, providers, and suppliers who do not have the capacity at this time to report the clinical trials identifier number associated with trial-related claims, CMS is providing an option to submit a generic number in place of the actual National Clinical Trials (NCT) number.

Beginning January 1, 2014, and continuing no later than through December 31, 2014, those above-mentioned physicians, providers, and suppliers may instead report an 8-digit, generic number of 99999999 using the instructions in CR 8401. This will allow trial-related claims to process appropriately if they are prepared according to instructions in CR 8401.

Keep in mind that trial-related claims will be returned if they do not contain either the actual clinical trial identifier number or the 8-digit generic number 99999999 – you may not leave those indicated fields blank. That said, CMS encourages those affected by CR 8401 to update their internal claims processing procedures as expeditiously as possible so they can begin reporting the actual clinical trial identifier number as CR 8401 instructs.

NOTE: For clarification, the clinical trial identifier number is required for all items/services provided in relation to participation in a clinical trial, clinical study, or registry that may result from coverage with evidence development (CED), the Medicare Clinical Trial Policy, or a CMS-approved investigational device exemption (IDE) study. For IDE trials, both the IDE and the clinical trial identifier number are required. Specifically, include the clinical trial identifier number if: the beneficiary is enrolled in an approved clinical trial; AND, the claim is for the investigational item or service, AND/OR, the costs are related to the investigational item or service, AND/OR, the costs are related to routine care for the condition in the clinical trial.

Source: MLN Matters®Number: SE1344