Z00.6 — Encounter for examination for normal comparison and control in clinical research program
ICD-10-CM
Prior Authorization
No Prior Auth Required
No active coverage policies found for this code (low confidence)
Documentation Required
- Claims for investigational chemotherapy drugs administered in outpatient clinical trials must include condition code 30, modifier Q0, and diagnosis code Z00.6 on the Medicare claim.
- Billing and coverage must follow CMS guidance for qualifying clinical trials (CMS IOM Pub 100-04, Medicare Claims Processing Manual, Ch.32 §69.5 and CMS IOM Pub 100-03, NCD Manual, Ch.1 Pt.4 §310.1).
- Providers should document that the drug use is investigational and that the trial is qualifying per CMS definitions when submitting claims or when retaining records (follow CMS manual requirements).
- For patients meeting B2–B5, a formal shared decision-making encounter using an evidence‑based decision tool must occur with a physician or qualified non‑physician practitioner prior to initial ICD implantation; this encounter may be a separate visit and must be documented.
Key Coverage Criteria
- Medicare covers routine costs of qualifying clinical trials as described in CMS guidance.
- Medicare covers reasonable and necessary items and services used to diagnose and treat complications arising from participation in any clinical trial.
- Patients with a personal history of sustained ventricular tachyarrhythmia (sustained VT) or cardiac arrest due to ventricular fibrillation (VF) not associated with an acute myocardial infarction and not due to a transient or reversible cause are covered for ICD implantation.
- Patients with prior myocardial infarction and measured left ventricular ejection fraction (LVEF) ≤ 0.30 are covered for ICD implantation provided they do not have NYHA class IV heart failure, have not had CABG or PCI within the past 3 months, have not had an MI within the past 40 days, and are not clinical candidates for coronary revascularization.
- Patients with severe ischemic dilated cardiomyopathy without a personal history of sustained VT or cardiac arrest, who have NYHA class II or III heart failure and LVEF ≤ 35% are covered for ICD implantation provided they have not had CABG/PCI within 3 months, have not had an MI within 40 days, and are not candidates for coronary revascularization.
- Patients with severe non-ischemic dilated cardiomyopathy without prior cardiac arrest or sustained VT who have NYHA class II or III heart failure, LVEF ≤ 35%, and have been on optimal medical therapy for at least 3 months are covered for ICD implantation provided they have not had CABG/PCI within 3 months, have not had an MI within 40 days, and are not candidates for coronary revascularization.
9 Active Policies
A56391 — Billing and Coding: Implantable Automatic Defibrillators
J05
A56326 — Billing and Coding: Implantable Automatic Defibrillators
J06
A53784 — Billing and Coding: The Routine Costs of Investigational Chemotherapy Drugs Studied In a Qualifying Clinical Trial
A56340 — Billing and Coding: Implantable Automatic Defibrillators
A56343
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