(CMS-10600) Evaluation of the Medicare Patient Intravenous Immunoglobulin Demonstration

Forms and Documents

Document Name	Status
Form CMS-10600 Title Data Collection for the Evaluation of the Medicare Patient Intravenous Immunoglobulin Demonstration Project Form and Instruction	New
CMS-10600.Supporting Statement B -FINAL.docx Supporting Statement B	2016-10-21
CMS-10600.Supporting Statement A - FINAL.docx Supporting Statement A	2016-10-21

IC Document Collections

IC ID	Document Title	Status
221301	Title Data Collection for the Evaluation of the Medicare Patient Intravenous Immunoglobulin Demonstration Project Form and Instruction	New

ICR Details

OMB Control No: 0938-1316	ICR Reference No: 201604-0938-015
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: (CMS-10600) Evaluation of the Medicare Patient Intravenous Immunoglobulin Demonstration
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: 10/24/2016
	Date Received in OIRA: 05/03/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	10/31/2019	36 Months From Approved
Responses	2,941	0	0
Time Burden (Hours)	1,711	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: Section 101 of H.R. 1845 Medicare IVIG Access and Strengthening Medicare and Repaying Taxpayers Act of 2012, Public Law 112-242, mandates the establishment, implementation, and evaluation of a three-year Medicare Patient Intravenous Immunoglobulin (IVIG) Access Demonstration Project under Part B of title XVIII of the Social Security Act. The demonstration project will voluntarily enroll up to 4,000 Medicare beneficiaries who have been diagnosed with Primary Immunodeficiency Diseases. The statute also requires providing a report to Congress that will include an evaluation of the impact of the demonstration project on access for Medicare beneficiaries to items and services needed for the in-home administration of intravenous immunoglobulin (IVIG); an analysis of the appropriateness of implementing a new methodology for payment for IVIG in all care settings under part B of title XVIII of the Social Security Act (42 U.S.C. 1395k et seq.); and an update to the report entitled ‘Analysis of Supply, Distribution, Demand, and Access Issues Associated with Immune Globulin Intravenous’, issued in February 2007 by the Office of the Assistant Secretary for Planning and Evaluation (ASPE).

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Authorizing Statute(s): PL: Pub.L. 112 - 242 101 Name of Law: Medeicare IVIG Access and Strengthening Medicare and Repaying Taxpayers Act of 2012
  

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 7124	02/10/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 23704	04/22/2016
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
Title Data Collection for the Evaluation of the Medicare Patient Intravenous Immunoglobulin Demonstration Project	CMS-10600, CMS-10600, CMS-10600	Screener and Interview Guide ,   Draft Survey Form A ,   Spanish Draft Survey Form B

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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	2,941	0	0	2,941	0	0
Annual Time Burden (Hours)	1,711	0	0	1,711	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.

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Annual Cost to Federal Government: $116,860

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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: 05/03/2016

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