Appropriate Use Criteria for Advanced Diagnostic Imaging Services (CMS-10570)
Reinstatement with change of a previously approved collection
No
Regular
10/29/2020
Requested
Previously Approved
36 Months From Approved
10
0
150
0
0
0
To encourage evidence-based use of advanced imaging services, CMS established 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 that want to be recognized as qualified provider-led entities (PLEs) 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 organizationâs 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 membersâ conflicts of interest; publication of individual AUC on each organizations website; identification of AUC that are relevant to priority clinical areas; 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 entityâs website; disclosure of external parties involved in the AUC development process.
To be identified as a qualified PLE 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 PLE are eligible to submit applications documenting adherence to each AUC development requirement; applications will be accepted annually by January 1; all approved PLEs from each year of submissions will be posted to the CMS website by June 30; and all qualified PLEs must re-apply every 5 years and applications must be submitted by January 1 during the 5th year of after the PLEâs most recent approval date.
The changes to burden consist of the following:
1) Reduction of the number of respondents based on the number of actual responses received in year 1 (2016), which decreases the total annual hours and total cost. Removal of the one- time burden calculation for new applications, since we have received less than ten applications each year since 2017.
2) Updated the wage estimates using the most currently available U.S. Bureau of Labor Statisticsâ May 2019 National Occupational Employment and Wage Estimates for all salary estimates. The broad category 29-1060 which included all physicians and surgeons was deleted from the BLS wage estimates for 2019, replaced with several more detailed categories. We chose 29-1228 (Physicians, All Other; and Ophthalmologists, Except Pediatric) as the most appropriate category that would include radiologists.
3) Reflecting the burden associated with re-applications as a one-time cost, instead of an annualized cost spread over 5 years, due to the number of applications received and approved each year.
The changes result in a net decrease in respondents, total annual burden hours and total cost.
In summary, the total burden hours decreased from 1,350 hours to 150 hours and the total cost decreased from $84,984 to $14,980.
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 CLEAN 06.16.20.doc.docx
Re-Application to be Recognized as a Qualified Provider-led Entity (sec. 414.94)