(CMS-10583) Medicare beneficiaries receiving beta amyloid positron emission tomography (PET) for dementia and neurodegenerative disease

Forms and Documents

Document Name	Status
Form CMS10583 IDEAS forms Form and Instruction	New
CMS-10583 Final Supporting Statement.doc Supporting Statement A	2016-04-27

IC Document Collections

IC ID	Document Title	Status
219315	IDEAS forms Form and Instruction	New

ICR Details

OMB Control No: 0938-1305	ICR Reference No: 201512-0938-007
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: (CMS-10583) Medicare beneficiaries receiving beta amyloid positron emission tomography (PET) for dementia and neurodegenerative disease
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 04/28/2016
	Date Received in OIRA: 12/18/2015
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2019	36 Months From Approved
Responses	3,700	0	0
Time Burden (Hours)	6,475	0	0
Cost Burden (Dollars)	0	0	0

---

Abstract: In the Decision Memo #CAG-00431N issued on September 27, 2013, CMS determined that the evidence is sufficient to conclude that for Medicare beneficiaries receiving beta amyloid positron emission tomography (PET) in dementia and neurodegenerative disease 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 results; results of all other imaging studies; facility and provider characteristics; dementia characteristics; disease management changes; and treatment received.

---

Authorizing Statute(s): US Code: 42 USC 1395Y Name of Law: Social Security Act
  

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:
	80 FR 57826	09/25/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 76292	12/08/2015
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
IDEAS forms	CMS10583, CMS-10583, CMS-10583, CMS-10583	IDEAS Assessment ,   IDEAS Eligibility Form ,   IDEAS Post - PET form ,   IDEAS Pre-PET form

---

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	3,700	0	0	3,700	0	0
Annual Time Burden (Hours)	6,475	0	0	6,475	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: This is a new information collection.

---

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

---

Common Form ICR:  No

---

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: 12/18/2015

---