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Therefore, status indicator E1 was an appropriate assignment for a service involving a non-FDA approved device

Similarly, in the CY 2015 OPPS/ASC final rule with comment period (79 FR 66933 through 66934), we finalized our proposal that payment for certain diagnostic test codes within the medical range of CPT codes for which separate payment is allowed under the OPPS will be at the lower of the PFS nonfacility PE RVU-based (or technical component) amount or the rate calculated according to the standard ASC ratesetting methodology when provided integral to covered ASC surgical procedures

Reconstitution AOD 9604 typically comes as lyophilized powder requiring reconstitution with bacteriostatic water

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