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OMB Control No: 0938-1246	ICR Reference No: 201710-0938-003
Status: Historical Active	Previous ICR Reference No: 201603-0938-015
Agency/Subagency: HHS/CMS	Agency Tracking No:
Title: (CMS-10518) Application for Participation in the Intravenous Immune Globulin (IVIG) Demonstration
Type of Information Collection: Reinstatement without change of a previously approved collection	Common Form ICR: No
Type of Review Request: Emergency	Approval Requested By: 10/06/2017
OIRA Conclusion Action: Approved without change	Conclusion Date: 10/05/2017
	Date Received in OIRA: 10/05/2017
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2018	6 Months From Approved
Responses	1,500	0	0
Time Burden (Hours)	375	0	0
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.

Emergency Justfication: The IVIG Demonstration Beneficiary Application (OMB No. 0938-1246; Form CMS-10518) was approved for use through August 31, 2017, allowing CMS to continue to use the application for the period needed to implement the original demonstration period. On September 29, 2017, the “Disaster Tax Relief and Airport and Airway Extension Act of 2017” (Pub. L. 115-63) was signed into law. Section 302 of this legislation extends the Medicare IVIG Demonstration through December 31, 2020. In accordance with the implementing regulations of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) at 5 CFR 1320.13(a)(2)(i), we are requesting emergency review and approval because we believe public harm is reasonably likely to ensue if the standard normal approval process is followed. While existing beneficiaries enrolled in the demonstration as of September 30, 2017, will be automatically re-enrolled, in order to continue to enroll new beneficiaries into the demonstration, an application is required. In order to minimize the burden and potential delays for new enrollees, we are requesting an emergency extension to continue to use the IVIG Demonstration application form. Once approved, CMS will then submit a routine request to renew the use of the application for an additional 3 years, thereby allowing use of the 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
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	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	1,500	-2,500	4,000
Annual Time Burden (Hours)	375	-625	1,000
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: The respondents have decreased from 4,000 to 1,500. The burden hours have dereased from 1,000 to 375.

Annual Cost to Federal Government: $9,776,903

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? Uncollected

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

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