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Mandatory Reporting of Clinical Trial Number

Effective January 1, 2014, it will be mandatory to report a clinical trial 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 number is an eight digit number and is always preceded by the letters ‘NCT’ is assigned by the National Library of Medicine (NLM) http://clinicaltrials.gov/ website when a new study appears in the NLM Clinical Trials Database.

The Centers for Medicare & Medicaid Services (CMS) uses this number to identify all items and services provided to beneficiaries during their participation in a clinical trial, clinical study, or registry. Furthermore, this identifier permits CMS to better track Medicare payments, ensure that the information gained from the research is used to inform coverage decisions, and make certain that the research focuses on issues of importance to the Medicare population.

For professional claims, the 8-digit clinical trial number preceded by the 2 alpha characters of CT must be placed in Filed 19 of the paper claim Form CMS-1500 (e.g., CT12345678) or the electronic equivalent 837P in Loop 2300 REF02(REF01=P4) when a clinical trial claim includes:

• ICD-9 code of V70.7/ICD-10 code Z00.6 (in either the primary or secondary positions) and

• Modifier Q0 and/or Q1, as appropriate (outpatient claims only).

Reference: http://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNMattersArticles/Downloads/MM8401.pdf

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