(CMS-10152) 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

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form CMS-10152 PET Facility log-in information	Form and Instruction	Modified	Available
Form CMS-10152 Diagnosis of Suspected Osseous Metastasis Form	Form and Instruction	Modified	Available
Form CMS-10152 Report Submission Form	Form and Instruction	Modified	Available
Form CMS-10152 PET Completion Form	Form and Instruction	Modified	Available
Form CMS-10152 Initial Staging Form	Form and Instruction	Modified	Available
Form CMS-10152 Pre-PET Form	Form and Instruction	Modified	Available
Form CMS-10152 Interpreting Physician Scan Assessment Form	Form and Instruction	Modified	Available
Form CMS-10152 Restaging Form - Post Scan	Form and Instruction	Modified	Available
Form CMS-10152 Treatment Monitoring Form	Form and Instruction	Modified	Available
Form CMS-10152 Restaging Form	Form and Instruction	Modified	Available
CMS-10152 Supporting Statement - Part A.docx	Supporting Statement A	Uploaded 2016-05-16	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
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	PET Facility log-in information
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	Diagnosis of Suspected Osseous Metastasis Form
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	Report Submission Form
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	PET Completion Form
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	Initial Staging Form
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	Pre-PET Form
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	Interpreting Physician Scan Assessment Form
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	Restaging Form - Post Scan
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	Treatment Monitoring Form
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	Restaging Form

ICR Details

OMB Control No: 0938-0968	ICR Reference No: 201605-0938-013
Status: Historical Active	Previous ICR Reference No: 201303-0938-013
Agency/Subagency: HHS/CMS	Agency Tracking No: 19156
Title: (CMS-10152) 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 without change	Conclusion Date: 03/06/2017
Retrieve Notice of Action (NOA)	Date Received in OIRA: 05/17/2016
Terms of Clearance: This information collection request is approved as an extension, consistent with CMS' categorization in ROCIS and discussion in the supporting statement. However, OMB notes that the burden change for this collection was erroneously reported in ROCIS as a program change. In future submissions of all information collection requests, CMS needs to be mindful to report burden changes associated with extensions in the adjustment category. Failure to do so can result in it being sent back to the agency as "improperly submitted." OMB further notes that CMS states it plans to display the expiration date associated with this collection. The expiration date and OMB control number must be displayed on all paper and electronic versions of the collection.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2020	36 Months From Approved	03/31/2017
Responses	25,000	0	50,000
Time Burden (Hours)	2,083	0	4,167
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): US Code: 42 USC 1395y Name of Law: Social Security Act
  

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:
	81 FR 11571	03/04/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 29269	05/11/2016
Did the Agency receive public comments on this ICR? No

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

table that charts list of burden

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	Restaging Form ,   Treatment Monitoring Form ,   Restaging Form - Post Scan ,   Interpreting Physician Scan Assessment Form ,   Pre-PET Form ,   Initial Staging Form ,   PET Completion Form ,   Report Submission Form ,   Diagnosis of Suspected Osseous Metastasis Form ,   PET Facility log-in information

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ICR Summary of Burden

table that charts list 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	25,000	50,000	0	-25,000	0	0
Annual Time Burden (Hours)	2,083	4,167	0	-2,084	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: The burden has decreased because the number of respondents decreased.

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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: 05/17/2016

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