NCD 310.1 Decision Trees: Routine vs Research
Printable decision trees for the 23 most common procedure categories in clinical trials. Use these reference guides to train analysts and ensure consistent coverage determinations.
How to Use These Decision Trees
Each decision tree guides you through the key questions for classifying a specific procedure type. Start at the top and follow the branches based on your answers. The final node gives you the classification with the NCD 310.1 rationale to document.
Decision Tree: Imaging Procedures
CT, MRI, PET, X-Ray, Ultrasound, and other diagnostic imaging.
Would this imaging be ordered for SOC diagnosis or monitoring outside the trial?
Is frequency consistent with SOC guidelines?
Rationale: Per NCD 310.1, imaging ordered for diagnosis, staging, or monitoring in accordance with standard of care guidelines is considered a routine cost. Imaging performed at protocol-specified frequencies exceeding SOC should be split: SOC portion routine, excess research.
Procedure Category Quick Reference
Summary classification guidance for all 23 procedure categories covered in the full PDF.
| Category | Common Procedures | Default | Key Question |
|---|---|---|---|
| Imaging | CT Scan, MRI, PET Scan, X-Ray, Ultrasound | Usually Routine | Would this imaging be ordered for standard of care outside the trial? |
| Laboratory | CBC, CMP, Liver Function, Tumor Markers, Pharmacokinetic Samples | Mixed | Is the test for safety monitoring (routine) or PK/PD analysis (research)? |
| Drug Administration | Study Drug Infusion, Comparator Drug, Pre-medications, Rescue Medications | Usually Research | Is this the investigational product or a standard treatment? |
| Procedures | Biopsy, Surgery, Radiation, Physical Exam, Vital Signs | Mixed | Would this procedure be performed regardless of trial participation? |
Common Edge Cases
Companion Diagnostics
Tests required for trial eligibility (e.g., biomarker testing) are typically research costs. However, if the same test would be ordered for SOC treatment decisions, it may be routine. Document the clinical necessity independent of trial participation.
Protocol-Mandated Frequency
When a protocol requires imaging every 6 weeks but SOC is every 12 weeks, the first scan in each 12-week period is routine; the additional scan is research. Track and split accordingly.
Safety Monitoring Labs
Labs ordered to monitor for known side effects of approved drugs (even when used investigationally) are typically routine. Labs specifically for PK/PD or research endpoints are research costs.
Automate these decisions
Engram Clinical applies NCD 310.1 logic automatically, generating coverage determinations with the rationale your auditors require.