Appropriate Use Criteria for Advanced Diagnostic Imaging Services (CMS-10570)

Forms and Documents

Document Name	Status
CMS-10570 - Supporting Statement A - Passback2 [rev 06-21-2016].doc Supporting Statement A	2016-06-21
AUC comment response 10-27-15.pdf Supplementary Document	2015-11-18

IC Document Collections

IC ID	Document Title	Status
217472	Re-Application to be Recognized as a Qualified Provider-led Entity (sec. 414.94)	Modified
217369	Application to be Recognized as a Qualified Provider-led Entity (sec. 414.94)	Unchanged

ICR Details

OMB Control No: 0938-1288	ICR Reference No: 201511-0938-007
Status: Historical Active	Previous ICR Reference No: 201507-0938-004
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: Appropriate Use Criteria for Advanced Diagnostic Imaging Services (CMS-10570)
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 06/24/2016
	Date Received in OIRA: 11/18/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2019	36 Months From Approved
Responses	60	0	0
Time Burden (Hours)	1,350	0	0
Cost Burden (Dollars)	0	0	0

---

Abstract: To encourage evidence-based use of advanced imaging services, CMS has required 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 (PLEs) may apply to CMS. Expected respondents include national medical professional specialty societies, health systems and any other entity that meets the 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.

---

Authorizing Statute(s): PL: Pub.L. 113 - 93 218(b) Name of Law: Protecting Access to Medicare Act of 2014
  

Citations for New Statutory Requirements: PL: Pub.L. 113 - 93 218(b) Name of Law: Protecting Access to Medicare Act of 2014

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0938-AS40	Final or interim final rulemaking	80 FR 41685	07/15/2015

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 41685	07/15/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 70886	11/16/2015
Did the Agency receive public comments on this ICR? Yes

---

Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Re-Application to be Recognized as a Qualified Provider-led Entity (sec. 414.94)
Application to be Recognized as a Qualified Provider-led Entity (sec. 414.94)

---

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	60	0	60	0	0	0
Annual Time Burden (Hours)	1,350	0	1,350	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: Not applicable. This is a new collection.

---

Annual Cost to Federal Government: $69,479

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

---

Common Form ICR:  No

---

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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 11/18/2015

---