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2013, and FDA's December 2024 review lists the same trial set

Strinic, D., et al

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HCPCS J3380 Biologics (IL-23 inhibitor): Risankizumab (Skyrizi, J7999) newer biologic for moderate-to-severe CD

In the CY 2020 OPPS/ASC final rule with comment period, we finalized that beginning in CY 2020, payment for services assigned to a New Technology APC would be excluded from being packaged into the payment for comprehensive observation services assigned status indicator J2 when they are included on a claim with a J2 service (84 FR 61167)

The number of units for 250 mcg depends on your peptide concentration after mixing