Effective Date:

October 14, 2019

Last Updated:

June 20, 2021

Purpose:

This policy provides guidelines for appropriately billing for members who are participating in clinical trials.

Scope:

Products included:

• NJ FamilyCare/Medicaid Plan
• Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP)

Definitions:

• Q0 modifier: Investigational clinical service provided in a clinical research study that is in an approved clinical research study
• Q1 modifier: Routine clinical service provided in a clinical research study that is in an approved clinical research study
• Z00.6 diagnosis code: Encounter for examination for normal comparison and control in clinical research program

Policy:

Any service identified as part of a clinical trial must be billed with modifier -Q0 or –Q1. Additionally, the billed service must be accompanied by ICD-10 code Z00.6 (Encounter for examination for normal comparison and control in clinical research program) on the claim. These requirements are consistent with applicable CMS policy and guidance.

Procedure:

Horizon NJ Health will not consider for reimbursement any clinical trial procedure billed with modifier -Q0 or -Q1 if the required diagnosis, Z00.6, to indicate participation in a clinical trial or research study, is not present.

Limitations and Exclusions:

Notwithstanding the foregoing, all payment determinations are subject to all other, applicable limitations, including but not limited to, the following:

• Benefit Limitations
• The terms of any applicable provider participation agreement;
• Routine claim editing logic, including but not limited to incidental or mutually exclusive logic;
• Medical necessity; and
• Applicable law, regulatory guidance, government mandates, and the terms of the Managed Care Contract between Horizon NJ Health and the New Jersey Department of Human Services, Division of Medical Assistance and Health Services.

CPT Copyright 2017 American Medical Association. All rights reserved. CPT® is a registered trademark of the American Medical Association. The CPT codes and nomenclature used in this Policy are subject to revision and/or change by the American Medical Association. In the event of such changes, the Policy will continue to be in force, albeit applied to the new or amended coding so issued until such time as the Policy is reviewed and updated to reflect the new or amended coding.

References:

Medicare Claims Processing Manual, Chapter 32- Billing Requirements for Special Services, 68.1.C “General Billing Requirements”

American Medical Association, Current Procedural Terminology (CPT®) Professional Edition and associated publications and services

History: