Sunday, July 31, 2016

CPT Modifier Q0 and Q1 - Definition and usage.

Modifier Q0

Definition


Investigational clinical service provided in a clinical research study that is in an approved clinical research study.

Appropriate Usage


    When a service is performed as part of an approved clinical research study     When the investigative in nature

Inappropriate Usage


    When the service is not part of an approved clinical research study
    When the service is not investigative in nature

CMS issued in which it deleted modifier -QR and replaced it with modifier -Q0. A specific list of diagnosis codes for which modifier –Q0 does not have to be reported to Medicare.

Submit Q0 modifier for Clinical Trial Services for Medicare Beneficiaries, Clinical Trials that Qualify for coverage under a specific NCD, The instruction to be follow for coding and submitting claims n Change Request associated with the NCD


CMS is discontinuing the QA, QR, and QV modifiers as of December 31, 2007, and creating the following two new modifiers that will be used solely to differentiate between routine and investigational clinical services. These new modifiers will be included in the 2008 Annual HCPCS Update and are effective for dates of service on and after January 1, 2008:


• Q0 - Investigational clinical service provided in a clinical research study that is in an approved clinical research study.

** Investigational clinical services are defined as those items and services that are being investigated as an objective within the study. Investigational clinical services may include items  or services that are approved, unapproved, or otherwise covered (or not covered) under
Medicare.


• Q1 - Routine clinical service provided in a clinical research study that is in an approved clinical research study.

** Routine clinical services are defined as those items and services that are covered for Medicare beneficiaries outside of the clinical research study; are used for the direct patient management within the study; and, do not meet the definition of investigational clinical services. Routine clinical services may include items or services required solely for the provision of the investigational clinical services (e.g., administration of a chemotherapeutic agent); clinically appropriate monitoring, whether or not required by the investigational clinical service (e.g., blood tests to measure tumor markers); and items or services required for the prevention,  diagnosis, or treatment of research related adverse events (e.g., blood levels of various parameters to measure kidney function). 

Contractors are to update their edits as follows:

• The Q0 modifier replaces QA and QR. 

• The Q1 modifier replaces QV. 


How to Use the Modifiers:

Use the Q0 and Q1 modifiers on outpatient provider claims for items/services provided in Medicare qualified clinical trials/studies. These include trials that fall under the 2007 Medicare Clinical Trial Policy, trials that are required by a specific National Coverage Determination (NCD), and IDE trials.

• Use Q0 to designate the item under investigation in the trial/study


• Use Q1 to identify routine services provided in the trial/study


Billing Requirements for Providers Billing Routine Costs of Clinical Trials Involving a Category B IDE

GENERAL INFORMATION

A. Background: The current, 2007 Annual HCPCS Update contains the following three modifiers to bill for patient care when beneficiaries are enrolled in clinical research studies (formerly referred to as clinical trials):

• QA - FDA Investigational Device Exemption.

• QR - Item or Service Provided in a Medicare Specified Study.

• QV - Item or Service Provided as Routine Care in a Medicare Qualifying Clinical Trial.

It has come to our attention that these modifiers are not being used as intended as the long descriptors are vague and overlapping. As a result, the Centers for Medicare and Medicaid Services (CMS) is revising its modifiercoding policy.

B. Policy: CMS is discontinuing the QA, QR, and QV modifiers as of December 31, 2007, and creating the following two new modifiers that will be used solely to differentiate between routine and investigational clinical services. These new modifiers will be included in the 2008 Annual HCPCS Update and are effective for dates of service on and after January 1, 2008:

• Q0 - Investigational clinical service provided in a clinical research study that is in an approved clinical research study.

o Investigational clinical services are defined as those items and services that are being investigated as an objective within the study. Investigational clinical services may include items or services that are approved, unapproved, or otherwise covered (or not covered) under Medicare.

• Q1 - Routine clinical service provided in a clinical research study that is in an approved clinical research study.

o Routine clinical services are defined as those items and services that are covered for Medicare beneficiaries outside of the clinical research study; are used for the direct patient management within the study; and, do not meet the definition of investigational clinical services. Routine clinical services may include items or services required solely for the provision of the investigational clinical services (e.g., administration of a chemotherapeutic agent); clinically appropriate monitoring, whether or not required by the investigational clinical service (e.g., blood tests to measure tumor markers); and items or services required for the prevention, diagnosis, or treatment of research related adverse events (e.g., blood levels of various parameters to measure kidney function). 

Contractors are to update their edits as follows:

• The Q0 modifier replaces QA and QR. 

• The Q1 modifier replaces QV.

All claims submitted for patient care in clinical research studies must use the two new modifiers for routine and investigational clinical services. This includes studies that are certified under the Medicare Clinical Research Policy, Investigational Device Exemption (IDE) trials, and studies required under a coverage with evidence development (CED) national coverage determination (NCD). Effective for dates of service on and after January 1, 2008, claims submitted with the discontinued modifiers will be processed as return-to-provider/return as  unprocessable.


Billing Requirements for Providers Billing Routine Costs of Clinical Trials Involving a Category A IDE 


Providers shall notify their contractor of the Category A IDE device trial before billing routine costs of clinical trials involving a Category A device, as listed in Section 68.2 above. Upon receiving the required information for the trial, the contractor will determine if the Category A device, as used in the trial, is intended for the diagnosis, monitoring, or treatment of an immediately life-threatening disease/condition. If the contractor determines that the device does, in fact, meet the requirements of coverage, then the provider may begin billing the routine costs of a clinical trial involving a Category A device. Providers shall submit claims for the routine costs of a clinical trial involving a Category A IDE by billing according to the clinical trial billing instructions found in Section 69.6 (Qualifying Clinical Trials) of this chapter.

In addition to billing the routine costs, providers must identify the line for which the Category A IDE device is being billed.

Institutional Billing

Institutional providers must bill the device involved with the clinical trial by placing the Category A IDE Number on a 0624 (IDE) revenue code line, with the charges for the device placed in the “Non-covered” charges field. The 0624 revenue code and the Q0 modifier alert contractors that the Category A IDE is billed on that line.

Practitioner/Supplier Billing

Effective for dates of service on or before December 31, 2007, providers must place a QV modifier (Item or service provided as routine care in a Medicare qualifying clinical trial) on the line for the device along with the IDE number. 

Effective for dates of service on or after January 1, 2008,   practitioner/suppliers will no longer bill a QV modifier to identify the device. Instead, practitioner/suppliers will bill a Q0 modifier (Investigational clinical service provided in a clinical research study that is in an approved clinical research study) along with the IDE number. 



Billing Requirements for Providers Billing Routine Costs of Clinical Trials Involving a Category B IDE

As noted above in section 68.2, of this chapter, providers shall first notify their contractor of the IDE device trial before submitting claims for Category B IDEs. Once the contractor notifies the provider that all required information for the IDE has been furnished, the provider may bill claims for the particular Category B IDE.

When billing for Category B IDEs, providers shall bill for the device and all related procedures. The Category B IDE and the routine costs associated with its use are eligible for payment under Medicare. (Reimbursement for the device may not exceed the Medicare-approved amount for a comparable device that has been already FDA approved).

Institutional Billing

Institutional providers must bill the Category B IDE Number on a 0624 revenue code line with charges in the covered charges field (providers receiving the device free of charge must bill the IDE charges as non-covered).

Practitioner/Supplier Billing

Effective for dates of service on or before December 31, 2007, practitioners/suppliers must bill the Category B IDE on a line with a QA modifier (FDA IDE) along with the  IDE number. However, effective for dates of service on or after January 1, 2008, practitioner/suppliers will no longer bill a QA modifier to identify a Category B device.

Instead, practitioners/suppliers will bill a Q0 modifier (Investigational clinical service provided in a clinical research study that is in an approved clinical research study) along with the IDE number.

The following table shows the designated field locations to report the IDE Number on institutional and practitioner claims:


Data             CMS-1450                   CMS-1500            837i and 837p

IDE # FL 43 Item 23 Segment 2300,

REF02(REF01=LX)

Contractors will validate the IDE number for either a Category A or B device when modifier Q0 is submitted on the claim along with the IDE number. Claims containing an invalid IDE number will be returned to the provider. (Remark code MA50 is used,  Missing/incomplete/invalid Investigational Device Exemption Number for FDA approved clinical trial services), along with Reason Code 16 (Claim/service lacks information which is needed for adjudication). 

Additional billing requirement:

The following modifier and condition code shall be reported when billing for PRP services only in the context of an approved clinical study:

• Q0 modifier

• Condition code 30 (for institutional claims only)


• Value Code D4 with an 8-digit clinical trial number. NOTE: This is optional and only applies to Institutional claims.

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