Claims sent to Medicare for routine costs in a qualifying study require special coding. Clear documentation on the billing plan and in the patient’s chart is important to ensure correct claims coding.
Medicare Research Claim Codes
- Z00.6 Diagnosis Code – Identifies the patient as a participant in a qualifying study.
- Q1 Modifier – Identifies that the item or service meets the definition of a routine cost.
- Q0 Modifier – Identifies investigational items or services that are being investigated as an objective within a qualifying study.
Document Modifiers on Billing Grid
- Once the Principal Investigator has determined that the study is a qualifying study, each billable routine cost in the study must be pre-identified as needing either the Q0 or Q1 modifier by using “M0” or “M1” billing designations on the billing grid.
Perform Epic Charge Reviews
- Any UF study involves protocol-required items or services that generate a patient-based charge in Epic will be uploaded into Epic. Study teams are responsible for performing Epic Charge Reviews on these studies; this includes identifying any routine costs that require the Z00.6 diagnosis and Q0/Q1 modifiers.
In addition, the Investigators (or their designees) are responsible for providing the billing offices with necessary information so that these offices can code the correct information on claims submitted to Medicare for services rendered in a qualifying clinical study as follows:
- Each claim for an outpatient technical service must include the diagnosis code Z00.6 as the secondary diagnosis (primary for healthy controls) with either Q0 or Q1 modifier attached.
- Each claim for inpatient technical service or must include the diagnosis code Z00.6 as the second or higher diagnosis (modifiers are not needed).
- Each claim for a professional service (both inpatient and outpatient) must include the diagnosis code Z00.6 as the secondary diagnosis (primary for healthy controls) with either Q0 or Q1 modifier attached.
The use of the QO and Q1 modifiers and Z00.6 diagnosis codes is the Principal Investigator’s attestation that the services are provided in a study that meets all criteria of a Medicare qualifying study.
Note: For non-Medicare subjects, if these extra codes are not required by the subject’s insurance plan, the codes are “scrubbed” off of the claims.
ClinicalTrials.gov NCT Number
- As of January 1, 2014, it is mandatory to report a clinical trial number on claims for routine costs in a qualifying study.
- The clinical trial number is assigned by ClinicalTrials.gov when a new study is submitted to the ClinicalTrials.gov Protocol Registration System.
- This number is listed prominently on each specific study’s page and is always preceded by the letters ‘NCT’.
- The Centers for Medicare & Medicaid Services (CMS) uses this number to identify all items and services provided to beneficiaries during their participation in a qualifying 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.
Medicare Medical Record Requirements
When billing out routine costs in a qualifying study, clear documentation must be provided in the patient’s chart. The following information must be placed in the beneficiary’s medical record:
- Study name
- Sponsor’s name
- Sponsor-assigned protocol number
If Medicare initiates a medical review, a copy of the signed informed consent must be readily supplied upon request. Additionally, the billing provider must submit a detailed itemization of items and services billed as routine costs in the study.
IND & IND-Exempt Study Sponsor Identification
Sponsors of IND and IND-exempt studies that will bill routine costs must identify themselves to Medicare via email at firstname.lastname@example.org and include the following information in the notification:
- Study sponsor’s name and contact information
- Information on drug under study (name, route of administration, etc.)
- Disease being investigated
- Expected enrollment and length of study
Study teams should obtain verification from the sponsor that the above notification has been sent to Medicare.