Orthopedic Applications of Stem Cell Therapy — Policy Summary

Scope

Overview of policy positions related to orthopedic uses of stem cell–based procedures and products. Summarizes coverage perspectives and cites sources referenced in the policy.

Regulatory Considerations

• FDA HCT/P (21 CFR 1271) framework: minimal manipulation and homologous use criteria vs biologics pathways (IND/BLA).
• Notes on investigational designations in certain indications and plan-specific coverage variation.

Notes

Policy documents summarize payer positions and may change; they are not clinical practice guidelines. Patients should confirm current coverage with their carrier.