The Z00.6 (ICD-10) diagnosis code reports that the service involved “examination of participant in clinical trial”. The Z00.6 (ICD-10) diagnosis code must be used for all services provided as part of a Qualified Clinical Trial or approved study, even if it would otherwise be standard of care for the patient absent the trial.
The Z00.6 (ICD-10) diagnosis code goes in a visible secondary diagnosis position on the hospital and professional claim when billing for items/services related to a Qualified Clinical Trial or approved study regardless of whether all services on the claim are related to the study or not. If the patient is a healthy volunteer it is placed in the primary position.
The Q0/Q1 HCPCS modifiers are used to characterize the line-item service as investigational or a routine cost in a Qualified Clinical Trial when billing for items/services related to a Qualified Clinical Trial or approved study regardless of whether all services on the claim are related to the clinical trial or not. Billing Medicare, Medi-Cal and most private payers for outpatient items/services that are routine costs of a Qualified Clinical Trial, approved device study, or other study/registry approved under CED requires line-item application of HCPCS modifier Q0 for investigational item/services, and line-item application of HCPCS modifier Q1 for routine services.
CMS and possibly other payors pay more for the service performed in a non-hospital licensed clinic to help the physician covered the overhead costs of running the office. The physician does not have this same expense when the services are performed on a hospital licensed clinic.
Healthy control group volunteers participating in a clinical research study, by definition, do not have any underlying medical conditions. Therefore, placing the Z00.6 diagnosis code in the secondary position and a disease diagnosis in the primary position on the claim may affect the patient’s medical history and possibly the future medical treatment the patient will receive.
Effective January 1, 2014, the Centers for Medicare & Medicaid Services is mandating the reporting of the clinical trial number assigned to the study on www.clinicaltrials.gov on all claims for items/services provided to beneficiaries participating in all clinical trials qualified for coverage (i.e. clinical trials, clinical studies, CMS-approved Category A and B Device trials, or registries resulting from studies covered under Coverage with Evidence Development).
The number to be reported on the claim is the number assigned by the National Library of Medicine ClinicalTrials.govwebsite when a new study is entered in the NLM Clinical Trials data base.
Medicare, Medi-Cal, and many private payers require the following codes be properly applied on claims for items/services related to all Qualified Clinical Trials, approved Device Studies, and approved clinical studies or Registries under a CED:
NCT# (required for all as of January 1, 2014)
Z00.6 (ICD-10) diagnosis code
Condition Code 30
Revenue Code 624 for study devices, with the FB modifier and nominal $1.01 charge if the device is provided free by the sponsor
(See <ahref="http: www.cms.gov="" manuals="" downloads="" clm104c32.pdf"="">http://www.cms.gov/manuals/downloads/clm104c32.pdf)
Condition Code 30 means “qualified clinical trial” and it must appear on the hospital inpatient or outpatient claim when billing for items/services related to a Qualified Clinical Trial or approved study regardless of whether all services on the claim are related to the clinical trial or not.
When billed with the Z00.6 (ICD-10) diagnosis code, the Q1 HCPCS modifier serves as the provider’s attestation that the service is a routine cost of a qualified clinical trial. This is required under Medicare special billing rules.
Yes. When scheduling a study protocol visit encounter in CareConnect, it is critical to select the location where the services will actually be performed. Otherwise, claims may report an incorrect place of service code. Claims for billable study protocol items/services, just as any other claim, must accurately reflect the service location. Reimbursement may differ depending on the place of service (e.g., 11=doctor’s office vs. 22=hospital out-patient). Reporting an incorrect place of service code can result in an overpayment or underpayment.
Billing Medicare for outpatient items/services that are routine costs of a Qualified Clinical Trial requires the following codes/modifiers. (These should also be used for commercial insurers.)
Z00.6 (ICD-10) diagnosis code in the secondary position unless the patient is a healthy volunteer for which it is placed in the primary position
Condition Code 30
Line-item application of HCPCS modifier Q0 for investigational item/service
Line-item application of HCPCS modifier Q1 for routine service
NCT# (as of January 1, 2014)
(When billed with the Z00.6 (ICD-10) diagnosis code, the Q1 HCPCS modifier serves as the provider’s attestation that the service is a routine cost of a qualified clinical trial. This is required by Medicare.)
Yes. When submitting a claim for routine clinical research study-related services to a federal payer, reporting a disease diagnosis on the claim, when no such medical condition exists, may be construed as a false claim, as the patient’s medical condition is being inaccurately represented. Submitting a false claim may result in significant fines of up to three times the amount of damages sustained by the government payer, plus up to $11,000 per false claim submitted.