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 and Instruction	Modified
CMS-10152 Response_to_Public_Comments.doc Supplementary Document	2008-11-17
0938-0968.Supporting Statement - Part A-5-08-09.doc Supporting Statement A	2009-05-08

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 and Instruction	Modified

ICR Details

OMB Control No: 0938-0968	ICR Reference No: 200811-0938-006
Status: Historical Active	Previous ICR Reference No: 200508-0938-005
Agency/Subagency: HHS/CMS	Agency Tracking No:
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: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 05/11/2009
	Date Received in OIRA: 11/25/2008
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2012	36 Months From Approved	05/31/2009
Responses	50,000	0	50,000
Time Burden (Hours)	4,167	0	4,167
Cost Burden (Dollars)	0	0	0

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Abstract: To qualify for payment, providers must prescribe FDG PETs for beneficiaries with a set of clinical criteria specific to each cancer type and stage. CMS is requiring stakeholders including specialty societies, industry, health plans and hospital associations to create systematic clinical data bases or registries to be reimbursed for FDG PETs for beneficiaries. Data elements collected electronically on the associated instrument will be transmitted to CMS for evaluation of the short and long term benefits of FDG PETs to beneficiaries and for use in future clinical decision making.

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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:
	73 FR 51820	09/05/2008
30-day Notice:	Federal Register Citation:	Citation Date:
	73 FR 67520	11/14/2008
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	NOPR case_registration ,   NOPR pre_PET_form ,   NOPR referring_md_sheet ,   NOPR_PET_complete_form ,   NOPR_PET_report_submission_form ,   NOPR_post_PET__form

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

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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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

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: 11/25/2008

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