Medicare Coverage of Items and Services for Coverage with Evidence Development (CMS-10697)

Forms and Documents

Document Name	Status
CMS 10697 Supporting Statement A - CED protocol - Passback2_clean.docx Supporting Statement A	2020-12-01

IC Document Collections

IC ID	Document Title	Status
237613	Medicare Coverage of Items and Services for Coverage with Evidence Development	Modified

ICR Details

OMB Control No: 0938-1387	ICR Reference No: 202012-0938-002
Status: 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

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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.

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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

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

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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

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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

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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	15	0	0	0	0	15
Annual Time Burden (Hours)	1,500	0	0	0	0	1,500
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:

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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

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Common Form ICR:  No

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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: 12/01/2020

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