Response to Proposed Rule Comments

We received 103 public comments on our proposals for Appropriate Use Criteria (AUC)
for Advanced Diagnostic Imaging Services. Commenters included mostly medical specialty
societies and professional organizations, radiology benefit management companies, insurers,
health systems and hospitals, medical technology organizations and experts, and medical
professionals. Below are the comments related to the application process for provider-led
entities (PLEs) to become qualified and the process for re-qualification. We have considered the
comments and are adopting the proposed provisions specific to the PLE application and qualified
PLE re-qualification processes with minimal changes.
Comment: Some commenters disagreed with our proposal to require qualified PLEs to
reapply for qualification every 6 years, and were instead in favor of a shorter time frame for
review.
Response: We carefully reviewed the timeline for reapplication and have determined that
an application submitted by January of the fifth year of approval will receive a determination
prior to the start of the qualified PLE’s sixth year. Therefore, the cycle of approval for qualified
PLEs is every 5 years. This is different than what was proposed as we had originally proposed a
cycle that was every 6 years. As finalized, a PLE that becomes qualified for the first 5-year
cycle beginning July 2016 would be required to submit an application for requalification by
January 2021. A determination would be made by June 2021 and, if approved, the second 5-year
cycle would begin in July 2021. For example:
Year 1 = July 2016 to June 2017
Year 2 = July 2017 to June 2018
Year 3 = July 2018 to June 2019
Year 4 = July 2019 to June 2020

Year 5 = July 2020 to June 2021 (reapplication is due by January 1, 2021).
We believe the reapplication timeline is appropriate and allows for PLEs, CDS
mechanism developers and ordering practitioners to enter into longer term agreements without
the constant concern that the PLE will lose its qualified status. We will assess whether a
qualified PLE consistently has developed evidence-based AUC and met our other requirements
at the time of requalification. We note, however, that if it appears that qualified PLEs are not
maintaining compliance with our requirements for AUC development, we may terminate their
qualified status.
Comment: One commenter recommended that CMS create a concise list of AUC
development requirements or create a template for entities to use for their application and post
the list or template to the CMS website.
Response: At least for the first round of applications for qualified PLEs, we will not be
making available templates or applications. CMS might consider developing such templates or
applications in the future if we find it would be useful, efficient or necessary.