Before initiation of a Budget Workbook, an analysis is completed of the clinical trial to determine eligibility for payment of routine costs in a clinical trial under the 2000 Medicare National Coverage Decision (NCD). Routine costs of a clinical trial include all items and services that are otherwise generally available to Medicare beneficiaries. The study must meet one of the following three criteria:

1. The trial must evaluate an item or service that falls within a Medicare benefit category and is not statutorily excluded from coverage.
2. It must have therapeutic intent.
3. The trial must enroll patients with diagnosed disease rather than healthy volunteers.

In addition, the trial must meet one of the criteria below:

• Funded by NIH, CDC, AHRQ, HCFA, DOD, and VA;
• Supported by centers or cooperative groups that are funded by the NIH, CDC, AHRQ, HCFA, DOD and VA;
• Conducted under an investigational new drug application (IND) reviewed by the FDA; and
• Be exempt from having an IND under 21 CFR 312.2(b)(1),
• The PI will be asked to delineate Routine Costs from Protocol Induced Costs.
• The Medicare Review Form will be reviewed for accuracy during the budget initiation meeting.