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.
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.
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