Mandatory Reporting of an 8-Digit Clinical Trial Number on Claims

Effective Date:  January 1, 2014

Link from CMS: https://www.noridianmedicare.com/provider/updates/docs/mm8401_revised.pdf

CR 8401 CMS Article:

Effective January 1 2014, it will mandatory to report a clinical trial number for items and services provided in clinical trials that are qualified for converage that are qualified for coverage as specified in the Medicare National Coverage Determination Manual, SECTION 310.1.

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 institutional paper or direct data entry (DDE) claims, the 8-digit clinical trial number is to be placed in the value amount for paper only value code D4/DDE claim UB-04 (For Locators 39-41) when a clinical trial claim includes:

                        Condition code 30; encounter driven

                        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).

For institutional claims that are submitted on the electronic claim 837I, the 8-digit number should be placed in Loop 2300 REF02 (REF01=P4) when a clinical trial claim includes:

                        Condition code 30;

                        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).

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Utility/Provider/Device Exemption Number:

From F1:  complete only when the provider is part of a Clinical

Trial Study, enter the assigned Exemption Number.

Utility/Procedure/Status:

From F1:  Investigational Device: requires a /Provider 'Device Exemption

Number' when a Device Exemption number is assigned and

the Place of Service is 12, 13, 32 or 33.

For professional claims, the 8-digit clinical trial number preceded by the 2 alpha characters of CT must be placed in Field 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).

Medicare Part B clinical trial/registry/study claims with dates of service on and after January 1, 2014, not containing an 8-digit clinical trial number will be returned as unprocessable to the provider for inclusion of the trial number using the messages listed below..

                        Claim Adjustment Reason Code (CARC) 16: “Claim/service lacks information which is needed for adjudication. At least one Remark Code must be provided (may be comprised of either National Council for Prescription Drug Programs (NCPDP) Reject Reason Code, or Remittance Advice Remark Code (RARC) that is not an ALERT.)”

                        RARC MA50: “Missing/incomplete/invalid Investigational Device Exemption number for FDA-approved clinical trial services.”

                        RARC MA130: “Your claim contains incomplete and/or invalid information, and no appeal rights are afforded because the claim is unprocessable. Please submit a new claim with the complete/correct information.”

                        Group Code-Contractual Obligation (CO).

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