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:
- The trial must evaluate an item or service that falls within a Medicare benefit category and is not statutorily excluded from coverage.
- It must have therapeutic intent.
- 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.