(CMS-10518) Application for Participation in the Intravenous Immune Globulin (IVIG) Demonstration

ICR 201801-0938-002

OMB: 0938-1246

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Supporting Statement A
2018-05-16
IC Document Collections
ICR Details
0938-1246 201801-0938-002
Active 201710-0938-003
HHS/CMS
(CMS-10518) Application for Participation in the Intravenous Immune Globulin (IVIG) Demonstration
Extension without change of a currently approved collection   No
Regular
Approved with change 05/18/2018
Retrieve Notice of Action (NOA) 01/05/2018
  Inventory as of this Action Requested Previously Approved
05/31/2021 36 Months From Approved 05/31/2018
1,220 0 1,500
305 0 375
0 0 0

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.

PL: Pub.L. 112 - 242 101 Name of Law: Medicare IVIG Access
  
None

Not associated with rulemaking

  82 FR 49816 10/27/2017
83 FR 529 01/04/2018
No

  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 1,220 1,500 0 0 -280 0
Annual Time Burden (Hours) 305 375 0 0 -70 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The number of respondents have decreased from 1,500 to 1,220 due to a decrease in the remaining months of the demonstration that will be covered by the extension period. The total burden hours have decreased from 375 to 305.

$9,974,758
No
    No
    No
No
No
No
Uncollected
Denise King 410 786-1013 [email protected]

  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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
01/05/2018


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