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
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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.
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 âDisaster Tax Relief and Airport and Airway Extension Act of 2017â (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.
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.
Form CMS-10518 Applicatin to Participate in the IVIG Demonstration
CMS-10518.Emergency Justification (signed).pdf
CMS-10518 Supporting Statement PRA 10-2-17.docx
Applicatin to Participate in the IVIG Demonstration