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10.3390/bioengineering7010026 22 BalkeJ.VolzP.NeumannF.BrodwolfR.WolfA.PischonH.et al (2018)

This area of research is nascent and requires significant further validation

and Does not contain services described by a HCPCS code to which we have assigned status indicator J1. The assignment of status indicator J2 to a specific set of services performed in combination with each other allows for all other OPPS payable services and items reported on the claim (excluding services that are not covered OPD services or that cannot by statute be paid for under the OPPS) to be deemed adjunctive services representing components of a comprehensive service and resulting in a single prospective payment for the comprehensive service based on the costs of all reported services on the claim (80 FR 70333 through 70336)

After confirming all entry criteria, the investigator or a designated team member will formally enroll the participant, obtaining written informed consent prior to any randomization or trial-related procedures