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 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 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 entity’s 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 PLE’s 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 Statistics’ 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)