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OMB Control No: 0938-1246	ICR Reference No: 202104-0938-011
Status: Historical Active	Previous ICR Reference No: 201801-0938-002
Agency/Subagency: HHS/CMS	Agency Tracking No: CMMI
Title: Application for Participation in the Intravenous Immune Globulin (IVIG) Demonstration (CMS-10518)
Type of Information Collection: Revision of a currently approved collection	Common Form ICR: No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 03/16/2022
	Date Received in OIRA: 04/26/2021
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	03/31/2025	36 Months From Approved	03/31/2022
Responses	6,500	0	1,220
Time Burden (Hours)	1,625	0	305
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. 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. On September 28, 2017, Congress passed the ‘‘Disaster Tax Relief and Airport and Airway Extension Act of 2017’’. Section 302 of this legislation extends the Medicare IVIG Demonstration through December 31, 2020. While existing beneficiaries enrolled in the demonstration as of September 30, 2017 were automatically re-enrolled, in order to continue to enroll new beneficiaries into the demonstration, an application is required. The purpose of this renewal request is provide for the continued use of the application form through the end of the new demonstration period.

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:
	86 FR 9348	02/12/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 21739	04/23/2021
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
Applicatin to Participate in the IVIG Demonstration	CMS-10518, CMS-10518	,

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	6,500	1,220	5,280
Annual Time Burden (Hours)	1,625	305	1,320
Annual Cost Burden (Dollars)	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: Burden has increased due to the number of potential beneficiaries has increasing from 1,220 to 6,500.

Annual Cost to Federal Government: $7,600,000

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination. No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination. 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? No

Agency Contact: Stephan McKenzie 410 786-1943 stephan.mckenzie@cms.hhs.gov

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