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Last Modified: 7/29/2020 Location: FL, PR, USVI Business: Part A, Part B

Billing/coding of routine costs in clinical trials

Medicare covers routine costs of qualifying clinical trials. Routine costs of a clinical trial include all items and services that are otherwise generally available to Medicare beneficiaries and services that are provided in either the experimental or the control arms of a clinical trial.

Routine costs DO include (and therefore are covered):

Items or services that are typically provided absent a clinical trial (e.g., conventional care)
Items or services required solely for the provision of the investigational item or service (e.g., administration of a non-covered chemotherapeutic agent), the clinically appropriate monitoring of the effects of the item or service, or the prevention of complications
Items or services needed for reasonable and necessary care arising from the provision of an investigational item or service – in particular, for the diagnosis or treatment of complications

Routine costs DO NOT include (and therefore are NOT covered):

The investigational item or service itself unless otherwise covered outside of the clinical trial
Items and services provided solely to satisfy data collection and analysis needs and that are not used in the direct clinical management of the patient (e.g., monthly CT scans for a condition usually requiring only a single scan); and items and services customarily provided by the research sponsors free of charge for any enrollee in the trial
In addition, reasonable and necessary items that are used to diagnose and treat complications arising from participation in clinical trials are also covered. Applicable deductibles and coinsurance rules apply to clinical trial items and services.
If clinical trial and non-clinical trial services are submitted on the same claim, then separate line items must be used for each type of service. Items and services provided free of charge by research sponsors may not be billed to Medicare.
Note: If it is necessary for a provider to show the items and services that are provided free of charge in order to receive payment for the covered routine costs (e.g., administration of a non-covered chemotherapeutic agent), providers are instructed to submit such charges as non-covered.

Reporting requirements for institutional providers

The eight-digit Clinical Trial Number (NCT99999999) needs to be added on claim form 1500 paper and electronic and claim form UB-04 paper and electronic. See MLN Matters article SE1344 external link and MLN Matters article 8401 external link for more details.
Note: For professional claims, the eight-digit clinical trial number should be preceded by the two alpha characters of "CT.”

Institutional paper claim or Direct Data Entry (DDE)

For form UB-04 (Part A), add the value amount for "paper only" value code D4/DDE claim UB-04 and place the 8-digit number in field locators (FL) 39-41 when a clinical trial includes:
Condition code 30
ICD-10 code Z00.6 (in either the primary or secondary positions) and
Modifier Q0 and/or Q1, as appropriate (outpatient claims only)

Institutional electronic claim

For form UB-04 (Part A), for institutional claims that are submitted on the "Electronic Claim 837I", the eight-digit number should be placed in Loop 2300 REF02 (REF01=P4) when a clinical trial claim includes:
Condition code 30
ICD-10 code Z00.6 (in either the primary or secondary positions) and
Modifier Q0 and/or Q1, as appropriate (outpatient claims only)

Reporting requirements for practitioners/suppliers

The eight-digit Clinical Trial Number (NCT99999999) needs to be added on claim form 1500 paper and electronic and claim form UB-04 paper and electronic. See MLN Matters article SE1344 external link or MLN Matters article 8401 external link for more details.
Note: For professional claims, the eight-digit clinical trial number should be preceded by the two alpha characters of "CT.”
For Part B CMS-1500 claim form (paper), add to field locator (FL) 19 and for the "Electronic equivalent 837P" add the eight-digit number in Loop 2300 REF02(REF01=P4) when a clinical trial includes:
ICD-10 code Z00.6 (in either the primary or secondary positions) and
Modifier Q0 and/or Q1, as appropriate (outpatient claims only).
Note: Services furnished to Medicare beneficiaries who are control group volunteers who are participating in a qualified clinical trial may also be submitted for reimbursement. The claim submission requirements for these claims depend upon the source of the submission – institutional providers or practitioners/suppliers.

Modifier definitions

Q0: Investigational clinical service provided in a clinical research study that is in an approved clinical research study.
Q1: Routine clinical service provided in a clinical research study that is in an approved clinical research study.
Please note: Medicare Part B clinical trial/registry/study claims with dates of service on and after January 1, 2014, not containing an eight-digit clinical trial number, will be returned as unprocessable.

IDE number

All clinical trials and investigational device exemption (IDE) trials must continue to report the associated IDE number on the claim form as well.
First Coast Service Options (First Coast) strives to ensure that the information available on our provider website is accurate, detailed, and current. Therefore, this is a dynamic site and its content changes daily. It is best to access the site to ensure you have the most current information rather than printing articles or forms that may become obsolete without notice.