Billing Requirements for Clinical Trials

Effective Date: October 14, 2019

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 shall deny any clinical trial procedure billed with modifier -Q0 (Investigational clinical service provided in a clinical research study that is in an approved clinical research study), or -Q1 (Routine clinical service provided in a clinical research study that is in an approved clinical research study) if the required diagnosis, Z00.6, to indicate participation in a clinical trial or research study, is not present.

Limitations and Exclusions:
While reimbursement is considered, payment determination is subject to, but not limited to:

  • 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.

References:

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

cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/clm104c32.pdf

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