CMS Pub. 100-04, ch. 32, § 69.6

Routine Costs Submitted by Practitioners/Suppliers

Claims with dates of service on or after January 1, 2008:

• HCPCS modifier ‘Q1’ (numeral 1 instead of the letter i); and,

• ICD-10 diagnosis code Z00.6 (in either the primary or secondary positions)

CMS covers the cost of healthy volunteers in a qualified clinical trial if it meets the following

conditions:

• The trial is not designed exclusively to test toxicity or disease pathophysiology.

• The trial must have therapeutic intent.

• If the trial has therapeutic interventions, it must enroll patients with a diagnosed disease

rather than healthy volunteers.

• If the trial is studying diagnostic interventions, it may enroll healthy patients to have a

proper control group.

Claims submitted with modifier Q1 shall be returned as unprocessable if ICD-10-CM code Z00.6

is not submitted on the claim.

Contractors shall return the following messages:

Claims Adjustment Reason Code (CARC) 16: “Claim/service lacks information which is needed

for adjudication. As least one Remark Code must be provided (may be comprised of either the

Remittance Advice Code or NCPDP Reject Reason Code).”

Remittance Advice Remark Code (RARC) M76: “Missing/incomplete/invalid diagnosis or

condition.”

Effective for claims with dates of service on or after January 1, 2014, it is mandatory to report a

clinical trial number on claims for items/services provided in clinical trials/studies/registries, or

under Coverage with Evidence Development (CED.) Providers must report the 8-digit number on

clinical trial number on the following claims locators:

• 837 professional claim format Loop 2300 REF02 (REF01=P4) (do not use ‘CT’ on the

electronic claim); or

• CMS-1500 paper form place in Field 19 (preceded by ‘CT’).

In addition to the clinical trial number, claims should also include:

• ICD-10 diagnosis code Z00.6 (in either the primary or secondary positions)

• HCPCS modifier Q0 or Q1 as appropriate

Practitioner claims submitted without a clinical trial number shall be returned as unprocessable

using the following messages:

CARC 16: “Claim/service lacks information which is needed for adjudication. At least one

Remark Code must be provided (may be comprised of either NCPDP Reject Reason Code, or

Remittance Advice Remark Code 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)

Routine Costs Submitted by Institutional Providers

All Institutional Clinical Trial Claims

Regardless of the date of service, clinical trial claims received after April

1, 2008, providers must report the 8-digit clinical trial number. To bill

the 8-digit clinical trial number, institutional providers shall use value

code ‘D4’where the value code amount equals the 8-digit clinical trial

number. Below are the claim locators in which to bill the 8-digit clinical

trial number:

• 837 institutional claim format Loop 2300 REF02 (REF01=P4)

• Paper CMS-1450 value code ‘D4’

NOTE: Value code ‘D4’/amount data from the internal claims

processing is mapped/populated to the 837 institutional claim formats

for a coordination of benefits 837 institutional claim

NOTE: It is mandatory to report a clinical trial number on claims for

items or services provided in clinical trials, studies or registries.

Institutional claims submitted without a clinical trial number shall be

returned to providers.

NOTE: Modifier Q0 is used for services defined as an investigational

clinical service provided in an approved clinical research study. Append

this modifier on a Category B Investigational Device Exemption (IDE)

code along with IDE number on the claim.

The modifier Q1 is a line item specific and must be used to identify

items and services that constitute medically necessary routine patient

care or treatment of complications arising from a Medicare beneficiary’s

participation in a Medicare covered clinical trial. Items and services that

are provided solely to:

• Satisfy data collection and analysis needs; and

• That are not used in the clinical management of the patient

are not covered and may not be billed using modifier Q1. Items and

services that are not covered by Medicare by virtue of a statutory

exclusion or lack of a benefit category also may not be billed using

modifier Q1. When billed in conjunction with the Z00.6 diagnosis

code, modifier Q1 will serve as the provider’s attestation that the service

meets the Medicare coverage criteria (i.e., was furnished to a

beneficiary who is participating in a Medicare qualifying clinical trial

and represents routine patient care, including complications associated

with qualifying clinical trial participation).

Inpatient Clinical Trial Claims

Institutional providers billing clinical trial service(s) must report ICD-10

diagnosis code Z00.6 in either the primary or secondary position and

condition code 30 regardless of whether all services are related to the

clinical trial or not.

NOTE: HCPCS codes are not reported on inpatient claims. Therefore,

the HCPCS modifier requirements (i.e., Q0/Q1) as outlined in the

outpatient clinical trial section below, are not applicable to inpatient

clinical trial claims.

Outpatient Clinical Trial Claims

On all outpatient clinical trial claims, providers must do the following:

• Report condition code 30,

• Report ICD-10 diagnosis code Z00.6, in the primary or secondary position; and

• The 8-digit clinical trial identifier number in the 837I Loop 2300

REF02 (REF01=P4) or as value code ‘D4’ on paper only CMS-

1450.

• Identify all lines that contain an investigational item/service with

HCPCS modifier Q0 for dates of services on or after 01/01/08.

• Identify all lines that contain a routine service with HCPCS

modifier Q1 for dates of service on or after 1/1/08.

For clinical trial billing requirements for patients enrolled in a managed

care plan/MAO, please refer to Section 69.9 of this chapter.