Data collection for Medicare Beneficiaries Receiving FDG Positron Emission Tomography (PET) for Brain, Cervical, Ovarian, Pancreatic, Small Cell Lung, and All Other Cancers

Forms and Documents

Document Name	Status
Form CMS-10152 Collection for Medicare Bene#s Receiving FDG Positron Emissions Tomography for Brain, Cervical, Ovarian, Small Cell Lung, and Testicular Cancers Form	Modified
Comment posted for CMS-10152 Data Collections for Medicare Beneficiaries Receiving NaF-PET .msg Supplementary Document	2013-03-15
Supporting Statement - Part A (2).pdf Supporting Statement A	2013-03-15

IC Document Collections

IC ID	Document Title	Status
8828	Collection for Medicare Bene#s Receiving FDG Positron Emissions Tomography for Brain, Cervical, Ovarian, Small Cell Lung, and Testicular Cancers Form	Modified

ICR Details

OMB Control No: 0938-0968	ICR Reference No: 201303-0938-013
Status: Historical Active	Previous ICR Reference No: 200811-0938-006
Agency/Subagency: HHS/CMS	Agency Tracking No: 19156
Title: Data collection for Medicare Beneficiaries Receiving FDG Positron Emission Tomography (PET) for Brain, Cervical, Ovarian, Pancreatic, Small Cell Lung, and All Other Cancers
Type of Information Collection: Reinstatement without change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/22/2013
	Date Received in OIRA: 03/20/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2016	36 Months From Approved
Responses	50,000	0	0
Time Burden (Hours)	4,167	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: In the Decision Memo #CAG-00181N issued on January 27, 2005, CMS determined that the evidence is sufficient to conclude that for Medicare beneficiaries receiving FDG positron emission tomography (PET) for brain, cervical, ovarian, pancreatic, small cell lung, and testicular cancers is reasonable and necessary only when the provider is participating in and patients are enrolled in a systematic data collection project. CMS will consider prospective data collection systems to be qualified if they provide assurance that specific hypotheses are addressed and they collect appropriate data elements. The data collection should include baseline patient characteristics; indications for the PET scan; PET scan type and characteristics; FDG PET results; results of all other imaging studies; facility and provider characteristics; cancer type, grade, and stage; long-term patient outcomes; disease management changes; and anti-cancer treatment received.

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Authorizing Statute(s): None

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:
	77 FR 47852	08/10/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 16270	03/14/2013
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Collection for Medicare Bene#s Receiving FDG Positron Emissions Tomography for Brain, Cervical, Ovarian, Small Cell Lung, and Testicular Cancers	CMS-10152, CMS-10152, CMS-10152, CMS-10152, CMS-10152, CMS-10152, CMS-10152, CMS-10152, CMS-10152, CMS-10152, CMS-10152	PET Facility Registration Form ,   NOPR referring_md_sheet ,   Case Registration Form ,   Pre-PET Form ,   PET Completion Form ,   Report Submission Form ,   Interpreting Physician Scan Assessment Form ,   Diagnosis of Suspected Osseous Mestasis Form-Post Scan ,   Initial Staging Form ,   Treatment Monitoring Form-Post Scan ,   Restaging Form Post-Scan

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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	50,000	0	0	0	0	50,000
Annual Time Burden (Hours)	4,167	0	0	0	0	4,167
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: $0

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

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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: 03/20/2013

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