Clinical Research BillingOverview

Gina Vuocolo-Branch, DirectorCalendar Review & Analysis OfficeFall 2011

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

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Medicare Billing Requirements

Effective January 1, 2008, routine costs are reported to Medicare with modifiersQ0 - 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

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 volunteerThe 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.

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