OMB is withholding approval at this time. Prior to publication of the final rule, the agency should provide a summary of any comments related to the information collection and their response, including any changes made to the ICR as a result of comments. In addition, the agency must enter the correct burden estimates.
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To encourage evidence-based use of advanced imaging services, CMS is proposing specific requirements for the development of appropriate use criteria (AUC) that can be recognized under §414.94 as part of the Medicare program. Organizations that use processes meeting these requirements and want to be recognized as qualified provider-led entities for the purpose of this section may apply to CMS. Expected respondents include national medical professional specialty societies, health systems and any other entity that meets the regulation definition.
Applications must be submitted electronically and demonstrate how the organization's process meets the requirements in §414.94(c)(1) which include: a systematic literature review of the clinical topic and relevant imaging studies; AUC development led by at least one multidisciplinary team with autonomous governance; a process for identifying team members' conflicts of interest; publication of individual AUC on each organizations website; identification of key decision points for individual criterion as evidence-based or consensus-based and strength of evidence grading per a formal, published, and widely recognized methodology; a transparent process for the timely and continual updating of each criterion; and a process for developing, modifying or endorsing AUC publicly posted on the entity's website.
To be identified as a qualified provider-led entity by CMS, organizations must demonstrate adherence to the requirements in their application and use the application process identified in §414.94(c)(2) which includes: only entities meeting the definition of provider-led entity are eligible to submit applications documenting adherence to each AUC development requirement; applications may be accepted annually by January 1; all approved entities will be posted to our website by June 30; and all qualified provider-led entities must re-apply every 6 years and applications must be submitted by January 1 during the 5th year of approval.
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
CMS-10570 - Supporting Statement A [rev 07-15-2015 by OSORA PRA].doc
Re-Application to be Recognized as a Qualified Provider-led Entity (sec. 414.94)