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CMS created modifiers Q0 and Q1 to be used solely to differentiate between routine and investigational clinical services: Q0(zero) – 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.
CMS has outlined guidelines on which services within a clinical trial are payable by Medicare and Modifiers Q0 and Q1 for use when billing services for beneficiaries who are registered in clinical trials qualified for coverage.
Modifier Q0
- When performing an investigational clinical service through a permitted clinical research study, the Modifier Q0 is attached to the Category B Investigational Device Exemption (IDE) code in conjunction with the IDE number on the claim.
Modifier Q1
- Modifier Q1 appliesonly to daily clinical services performed within the scope of a clinical trial. Throughout the period in which a beneficiary is registered in such a trial, he/she may also have other services that are unconnected to the trial. Examples of these may include routine preventive screening services (e.g., annual mammography) or diagnostic services for an issue unrelated to the determination or scope of the trial (e.g., ankle X-ray for a traumatic injury, unrelated to the trial). Use of the Modifier Q1 on these unconnected services is unfitting and may cause incorrect payments.
The Modifier Q1 is added to the service to indicate that the service is being performed as part of clinical management relative to the research study and not measured investigational and may be done to prevent, diagnose or treat adverse events related to the research study.
When attaching a Q1 modifier during the control arm of a research study, the following information is also necessary on the claim: Condition code 30 (non-research services provided to all patients, including managed care enrollees, enrolled in a Qualified Clinical Trial)
- And either of the following:
- ICD-9 diagnosis code V70.7 (examination of participant in clinical trial)
- ICD-10 diagnosis code Z00.6 (examination for participant or control in clinical research program).
- Modifier Q1 is used for routine clinical services during both the experimental arm and the control arm of the approved trial. The beneficiary’s medical record must include the trial name, sponsor and sponsor-assigned protocol number. The IDE number is required on the claim, if the routine services are associated with a clinical trial involving a Category A or B IDE device. Charges for a Category A IDE device itself are not covered, and charges for a Category B IDE device may be considered for coverage.
Clinical Service Billing May Include:
- An investigational item or service that has qualified as a Category B IDE device, and which is reimbursable under the Medicare Part A or Medicare Part B DME benefit.
- An item or service that is required in order to provide or administer the investigational item or service. Some examples: An administration service for provision of an investigational or noncovered drug; monitoring that is necessary to track a patient’s response to an investigational device or drug; items or services required for the prevention, diagnosis or treatment of research related adverse effects (e.g., lab testing to monitor renal function related to blood levels of various parameters to measure kidney function)
- Claims for clinical trial services provided to Medicare Advantage (MA) enrollees are processed by the Medicare Administrative Contractor (MAC) in the jurisdiction in which the provider is located. A provider who intends to provide and bill for such services for MA-enrolled beneficiaries must enroll as a Fee-for-Service (FFS) provider with the appropriate MAC in order to submit such claims. MACs will consider these claims within all the applicable FFS rules, except for a waiver of beneficiary liability for any applicable Part A or Part B deductible. Coinsurance amounts on these claims remain as the beneficiary’s responsibility. Clinical trial coding rules for MA claims are the same as those for FFS claims. When both related and unrelated services are provided to a beneficiary on the same day/stay, the institutional provider must split bill the services. Covered outpatient services, unrelated to the clinical trial, are billed to the MA plan; covered outpatient services related to the clinical trial are submitted to the MAC.
Clinical Service Billing May Not Include:
- An investigational item or service that is not a qualifying Category B IDE device.
- Items and services that are not used for direct clinical management of the beneficiary. These would include data collection and analysis performed only for purposes of the study (e.g., bi-monthly positron emission tomography (PET) scans for a beneficiary whose clinical condition would only support a bi-annual PET scan).
- Items and services that the research sponsors are providing free of charge for beneficiaries who are enrolled in the clinical trial.
Billing
- Paper claim submitters: Submit the IDE number in Item 23 of the CMS-1500 claim form.
- Electronic claim submitters: Submit the IDE number in Loop 2300 REF02 (REF01=LX).
- When an IDE number is identified on claims with Modifier Q1, that IDE number is validated by MAC. When the IDE number is identified as invalid, the claim will be returned to the provider with remark code MA130, meaning that the claim is not processable. Such claims must be corrected by the billing provider and resubmitted as new claims.
The clinical trial registry number should go before the two alpha characters of “CT” and placed in Field 19 of the paper CMS-1500 claim form and for electronic claims, it should be entered without the “CT” prefix in Loop 2300 REF02 (REF01=P4).
Why is this important for #medtech?
Some of our clients are conducting clinical trials that meet the criteria for Medicare coverage.
The GIRS InContact Reimbursement Hotline® assists our clients with medical technology hotline services that supports the clinical trial sites to submit clean claims so that they get paid for qualified services. If you need to support your account for clinical trials coding and billing, email us at info@girsinc.com or call us at 901-834-9119.
Disclaimer: The information in this blog is based on payer information which is dynamic. It is accurate at the time of posting but should not be construed to be reimbursement or legal advice. CPT® is the trademark of the American Medical Association (AMA).
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About GIRS For more than 17 years, GIRS has been assisting medical technology manufacturers with their market uptake and reimbursement strategies so that patients can have access to the care that they need. To implement successful market access strategies, the GIRS Value Discovery Landscape Assessments® team and the Payer Advocacy Compass® team work together to develop and implement foundation reimbursement landscape and payer advocacy strategies to obtain positive coverage, appropriate payment, and innovative payer contracting arrangements to improve market uptake. For more information, email us at info@girsinc.com or call us at 901-834-9119.