1. Clinical Research Billing Overview Gina Vuocolo-Branch, Director Calendar Review & Analysis Office Fall 2011

2. Executive Memorandum President Clinton signed an executive memorandum on June 7, 2000 directing the Secretary of Health and Human Services to “explicitly authorize (Medicare) payment for routine patient care costs...and costs due to medical complications associated with participation in clinical trials”. Source: CMS Transmittal AB-00-89 2

3. 3 Medicare Billing Requirements  Effective January 1, 2008, routine costs are reported to Medicare with modifiers  Q0 - Investigational clinical service provided in a clinical research study that is in an approved qualified trial  Q1 - Routine clinical service provided in a clinical research study that is in an approved qualified trial

4. Medicare Billing Requirements- cont’d  Diagnosis code V70.7 is required as a primary diagnosis for Inpatient (IP) and Outpatient (OP) clinical trials when the patient is a healthy control group volunteer  The study has diagnostic intent  Diagnosis code V70.7 is required as a secondary diagnosis for IP & OP clinical trials  The study has therapeutic intent  Failure to bill Medicare appropriately may result in fraud investigation and/or treble damages. 4