CMM-210: Implantable Intrathecal Drug Delivery Systems

Implantable intrathecal or epidural drug delivery systems (including pumps) are medically necessary for selected nonmalignant chronic intractable pain, severe refractory spasticity/chronic dystonia (intrathecal baclofen), and cancer-related pain when criteria are met, but are experimental/investigational for other uses (e.g., intrathecal insulin, antibiotics, heparin) and pump replacement is not covered if the existing device remains functional. Key requirements include documented pathology, failure of conservative therapy (≥6 months of provider-directed noninvasive pain management for pain or ≥6 weeks of oral antispasmodics plus PT for spasticity), required objective baseline measures and trial-response thresholds (≥50% pain reduction and functional gain for pain/cancer; ≥2-point Ashworth/Spasm Frequency improvement for spasticity), a mental-health assessment and agreement to a 50% systemic opioid reduction prior to an intrathecal opioid trial, and documentation of device end-of-life/irreparability (and no abuse) for replacement.