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We proposed to revise the section heading at 425.510 to Application of the APM Performance Pathway (APP) quality measure set or the APP Plus quality measure set (as applicable) to Shared Savings Program ACOs for performance years beginning on or after January 1, 2021. We proposed to sunset the requirement that ACOs must report quality data on the APP quality measure set according to the method of submission established by CMS and to revise 425.510(b)

Comment: Some commenters requested that we allow a broader scope of qualifying practitioners to be able to bill for HCPCS code G0545 in order to ensure nurses and other qualified practitioners can bill for the expert care they provide in treating infectious diseases

Medicines and their components cannot be substituted on a one-to-one basis without going through R&D, legal and regulatory approval processes. SEAC questioned the assumption in the dossier that diagnostic laboratory testing including in vitro diagnostic medical devices and calibration of measurement instruments and as analytical reference materials were fully covered under a scientific research & development (SR&D) exemption

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