View Information Collection Request (ICR) Package

OMB Control No: 0938-1387	ICR Reference No: 202012-0938-002
Status: Historical Active	Previous ICR Reference No: 201908-0938-017
Agency/Subagency: HHS/CMS	Agency Tracking No: CCSQ
Title: Medicare Coverage of Items and Services for Coverage with Evidence Development (CMS-10697)
Type of Information Collection: Existing collection in use without an OMB Control Number	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 12/02/2020
	Date Received in OIRA: 12/01/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2023	36 Months From Approved
Responses	15	0	0
Time Burden (Hours)	1,500	0	0
Cost Burden (Dollars)	0	0	0

Abstract: This collection is new. CED is a paradigm whereby Medicare covers items and services on the condition that they are furnished in the context of approved clinical studies or with the collection of additional clinical data. In making coverage decisions involving CED, CMS decides after a formal review of the medical literature to cover an item or service only in the context of an approved clinical study or when additional clinical data are collected to assess the appropriateness of an item or service for use with a particular beneficiary. The legal basis of CED comes from Section1862(a)(1)(E) of the Social Security Act (42 U.S.C. 1395y), which states that “in the case of research conducted pursuant to section 1142, which is not reasonable and necessary to carry out the purposes of that section.” CMS uses the information generated from CED for the following: • Results from studies required under CED inform medical decision-making and improve patient care. • Data from CED studies that are published in the medical literature may be used by CMS to make evidence-based changes to the NCD. • Data generated from CED required registries are used by researchers to advance the field specific to the NCD. While the intent of these CED NCDs was to monitor the appropriateness of use of these items and services, we recognized that the data could also be used to generate useful clinical evidence. More recent NCDs have tended to rely on section 1862(a)(1)(E) of the Act, in which CED is used to support clinical research.

Authorizing Statute(s): US Code: 42 USC 1395y Name of Law: Social Security Act: Exclusions from Coverage and Medicare as Secondary Payer

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 25810	06/04/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 44898	08/27/2019
Did the Agency receive public comments on this ICR? No

Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Medicare Coverage of Items and Services for Coverage with Evidence Development

ICR Summary of Burden

	Total Approved	Change Due to Potential Violation of the PRA
Annual Number of Responses	15	15
Annual Time Burden (Hours)	1,500	1,500
Annual Cost Burden (Dollars)	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:

Annual Cost to Federal Government: $1,109,540

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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination. No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination. 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? No

Agency Contact: Stephan McKenzie 410 786-1943 stephan.mckenzie@cms.hhs.gov

View ICR - OIRA Conclusion