Participating in clinical trials can leave health care providers vulnerable to false claims liability if Medicare rules are not closely followed. This publication reviews settlements involving clinical trials, provides an overview of the applicable Medicare rules and offers concrete steps that organizations can take to avoid clinical trial-related False Claims Act liability.
Settlements involving clinical trials
The following settlements involving overbilling related to clinical trials illustrates how things can go awry, sometimes resulting in multi-million dollar losses:
What clinical trial-related costs does Medicare cover for its beneficiaries?
As of July 9, 2007, Medicare covers the routine costs of qualifying clinical trials, as well as reasonable and necessary items and services used to diagnose and treat complications arising from participation in clinical trials. The coverage requirements for routine costs of qualifying clinical trial services are contained in National Coverage Determination 310.1.
The following costs may be billable to the Medicare program:
The following costs may not be billed to the Medicare program:
Billing rules for Medicare beneficiaries in qualified clinical trials
The rules for billing Medicare for items and services provided to beneficiaries who are participating in qualified clinical trials are set forth in the Medicare Claims Processing Manual, chapter 32, section 69. It is important that these claims be submitted properly to ensure correct payment consistent with Medicare rules. Accurate claim submissions include the clinical trial number, proper use of condition code 30, the correct diagnosis code to signal that the beneficiary is part of a clinical trial and proper use of research modifiers Q0/Q1, when applicable.
Steps to protect your organization