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OMB Control No: 0938-1246	ICR Reference No: 201603-0938-015
Status: Historical Active	Previous ICR Reference No: 201406-0938-001
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: (CMS-10518) Application for Participation in the Intravenous Immune Globulin (IVIG) Demonstration
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 08/03/2016
	Date Received in OIRA: 03/24/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2017	07/31/2017	07/31/2017
Responses	4,000	0	4,000
Time Burden (Hours)	1,000	0	1,000
Cost Burden (Dollars)	0	0	0

Abstract: Traditional fee-for-service (FFS) Medicare covers some or all components of home infusion services depending on the circumstances. By special statutory provision, Medicare Part B covers intravenous immune globulin (IVIG) for persons with primary immune deficiency disease (PIDD) who wish to receive the drug at home. However, Medicare does not separately pay for any services or supplies to administer it if the person is not homebound and otherwise receiving services under a Medicare Home Health episode of care. As a result, many beneficiaries have chosen to receive the drug at their doctor's office or in an outpatient hospital setting. Alternatively, some beneficiaries have elected to self-administer the drug subcutaneously. The "Medicare IVIG Access and Strengthening Medicare and Repaying Taxpayers Act of 2012" authorizes a 3 year demonstration under Part B of Title XVIII of the Social Security Act to evaluate the benefits of providing payment for items and services needed for the in-home administration of intravenous immune globulin (IVIG) for the treatment of primary immune deficiency disease (PIDD). The demonstration is limited to 4,000 beneficiaries and $45 million, including administrative expenses for implementation and evaluation as well as benefit costs. Participation is voluntary and may be terminated by the beneficiary at any time. PAPERWORK REDUCTION ACT SUBMISSION WORKSHEET Part I: Information Collection Request 2 CMS has designed the IVIG demonstration to pay a bundled payment for all medically necessary supplies and related nursing services to administer the drug. In processing all services and supplies needed for the administration of IVIG, CMS is not making any changes to existing coverage determinations to receive the IVIG drug in the home or for services and supplies that are otherwise not covered under the traditional FFS Medicare Part B benefit. Moreover, the demonstration only applies to situations where the beneficiary is receiving the immune globulin intravenously. This demonstration does not apply if the immune globulin is administered subcutaneously. Only those beneficiaries with PIDD who are eligible to receive IVIG under the current Medicare benefit (e.g. have PIDD, have Part B, and have traditional fee-for-service Medicare) will be eligible to enroll in the demonstration and have the new demonstration services paid for. Participation in the demonstration is voluntary. Beneficiaries who choose not to participate will continue to be eligible to receive all benefits under the traditional Medicare fee for service program. In order to be eligible for the demonstration, a beneficiary must complete an application form and be enrolled in the demonstration. The purpose of this PRA submission is to gain input and approval for the application form that beneficiaries will need to complete in order to participate in the demonstration. The demonstration is expected to begin paying for services no sooner than October 1, 2014 although the exact start date for the demonstration will depend upon when this application for participation is approved for use. The demonstration will last three years.

Authorizing Statute(s): PL: Pub.L. 112 - 242 101 Name of Law: Medicare IVIG Access

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:
	79 FR 13058	03/07/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 31335	06/02/2014
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Applicatin to Participate in the IVIG Demonstration	CMS-10518, CMS-10518	,

ICR Summary of Burden

	Total Approved	Previously Approved
Annual Number of Responses	4,000	4,000
Annual Time Burden (Hours)	1,000	1,000
Annual Cost Burden (Dollars)	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:

Annual Cost to Federal Government: $2,143,460

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

Agency Contact: Denise King 410 786-1013 Denise.King@cms.hhs.gov

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