Emergency Justification Memo

DEPARTMENT OF HEALTH & HUMAN SERVICES
Centers for Medicare & Medicaid Services
7500 Security Boulevard

Baltimore, Maryland 21244-1850

crvrs

CENTTRS FOR MEDICARE

DATE:

October 4,2017

TO:

Dominic Mancini
Acting Director, OIRA

FROM

Seema

& MTDICAID SIRVICI!

v.r,n.t'ü"

Administrator

SUBJECT:

Request for Emergency Clearance of the Paperwork Reduction Act Package
Related to the Intravenous Immunoglobulin (IVIG) Demonstration Beneficiary Application
(OMB no. 0938-1246; CMS-105 I 8)

Background
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 selÊadminister the drug subcutaneously.
The "Medicare IVIG Access and Strengthening Medicare and Repaying Taxpayers Act of 2012"
authorized a3 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 began October 1,2014 and, in accordance with
the statutory limitation, was scheduled to end September 30, 2017.
CMS 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 did 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) are eligible to enroll in the demonstration and have the new demonstration services

paid for. Participation in the demonstration is voluntary but a beneficiary must complete an
application form and be enrolled in the demonstration.
On July 25,2014, in accordance with the Paperwork Reduction Act, OMB approved the
"Application for Participation in the lntravenous Immune Globulin (IVIG) Demonstration"
(CMS - 10518; OMB CONTROL NUMBER:0938-1246). The form was approved for use for
three years and was given an expiration date of July 31,2017. Since applications could be
submitted through August 15,2017 in order to have coverage in September 2017 (which would
have been the last month of the demonstration), a request to extend the use of the application for
one month was submitted to OMB. In August, 2017, OMB approved a one month emergency
extension for the use of this application through August 31,2017.

F.tension Request
The IVIG Demonstration Beneficiary Application (OMB No.0938-1246;Form CMS-l05lS)
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. I l5-63) was
signed into law. Section 302 of this legislation extends the Medicare IVIG Demonstration
through December 31,2020. ln 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. ln 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.

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Supporting Statement
Application for Participation in the Intravenous Immune Globulin (IVIG) Demonstration

A

Background

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 ímmune 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 doctofs office or in an outpatient hospital setting.
On January 3,2012, the President signed into law the "Medicare IVIG Access and Strengthening
Medicare and Repaying Taxpayers Act of 2012" . Title I of the act states:
"The Secretaty shall establish and implement a denonstration project under part
B of title XVIII of the Social Security Act to evaluate the benefits of providíng
payn ent for itents and seruices needed Jbr the in-hone administralion of
intt'avenous inntune globulin þr the treatnrent oJ' primary intmune deJìciency
disease. "
B.

The statute limited the demonstration to 4,000 beneficiaries and $45 million, including
administrative expenses for implementation and evaluation as well as benefit costs. The statute
also required that an evaluation of the demonstration be conducted.
On September 28,2017, Congress passed the "Disaster Tax Relief and Airport and Airway
Extensioþ Act_o_f ?Qtl:', $q"!igl l0_2_o_f_t[is_ l_egi¡lgt_io_n_e¡1e4{s_tþe_ $_e{igqrg IYI_G_
Demonstration through December 31,2020. 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. The original
enrollment and financial limits remain and CMS will continue to monitor both to assure that
statutory limitations are not exceeded.
Under this demonstration, Medicare pays under Part B a bundled payment for all medically
necessary supplies and services to administer IVIG in the home to enrolled beneficiaries who are
not otherwise homebound and receiving home health care benefits. The exact payment amount is
updated annually in January.

In order to implement the demonstration and ensure that statutory limits are not exceeded, it is
necessary to positively enroll beneficiaries in the demonstration. The collection of information
referenced under this submission is for the application to participate in the demonstration. With
this submission, CMS is seeking OMB approval for the reinstatement of the Application for
Participation in the Intravenous Immune Cloblulin ([VIG) Demonstration under OMB control
number 0938- 1246.

1

Commented

þB1l:

when President signed.

May need to update date for

Participation is voluntary and may be terminated by the beneficiary at any time. Beneficiaries
who do not participate will continue to be eligible to receive all of the regular Medicare Part B
benefits that they are would be eligible for in the absence of the demonstration.

Part B. Justification

1.

Need and Legal Basis
As noted above, this demonstration was originally Congressionally mandated under Title I
of the "Medicare IVIC Access and Strengthening Medicare and Repaying Taxpayers Act of
2012. The "Disaster Tax Relief and Airport and Airway Extension Act of 2017" exrends
the demonstration through December 31,2020.
In order to implement the demonstration and ensure that statuto¡y enrollment and cost limits
it is necessary to positively enroll beneficiaries in the demonstration. The
collection of information referenced under this submission is for the application to participate
in the demonstration. The application is not changing from that originally approved for use
through August 3 I , 20 I 7, (CMS- 105 l8) Application for Participation in the Intravenous
Immune Globulin (IVIG) Demonstrationnsert. Participation is voluntary and may be
terminated by the beneficiary at any time. Beneficiaries who do not participate will continue
to be eligible to receive all of the regular Medicare Part B benefits that they are would be
eligible for in the absence of the demonstration.
are not exceeded,

This data collection only applies to the application form that will be used to enroll eligible
beneficiaries and provide some baseline data that is being used to facilitate the evaluation.
Any additional data collection that is required for the evaluation will have a separate PRA
application.

2.

Purpose and Use of the lnformation Collection
The Medicare IVIC Demonstration application requests basic demographic information
necessary to determine eligibility for participation in the demonshation. It also includes some
questions about how and where the beneficiary is currently receiving immunoglobulin and
related services. This application was previously approved for use through August 3 I , 20 I 7
(OMB no. 0938-1246 (CMS- I 05 I 84). The application is not changing with this new request.

3.

Use of lmproved lnformation Technology and Burden Reduction
CMS has hired an implementation support contractor to assist in the processing of new
applications as well as to respond to any provider, supplier or beneficiary inquiries.
Applications will be able to be downloaded from the demonstration web site or, upon
request, may be mailed to a beneficiary by the CMS implementation support contractor
Completed applications may be returned by mail or fax.

2

Because the application requires the signature of the beneficiary as well as hiVher provider,
is not practical, given the limited size of the demonstration and the desire to re-stat the
demonshation quickly, to have a fully automated on-line application submission process.

4.

it

Efforts to ldentify Duplication and Use of Similar lnformation
This is the only way for beneficiaries to apply to pârticipâte in this demonstration. There is
no other collection of similar information being done.

5.

lmpact on Small Businesses or Other Small Entities
Beneficiaries will be required to have their doctor's co-sign the application. This ensures that
there is communication between the beneficiary and the provider regarding the
appropriateness of receiving this drug at home. It also allows the provider to confirm that the
beneficiary has primary immune deficiency disease @IDD) which is a requirement for
participation.
Some of the doctors who will be asked to co-sign applications for their patients will work for
or own small businesses (i.e., physicians' offices). However, the impact of this data
collection on small businesses over and above what would be done during a routine patient
visit will be minimal and will insure better communication between patient and provider.
Beyond their signature confirming that the patient has the required diagnosis of PIDD, no
other information is being requested from the provider.

6.

Gonsequences of Collecting the lnformation Less Frequently
This is a one-time request for data. It could not be requested less frequently and still enable
CMS to conduct the demonstration.

7.

Special Circumstances Relat¡ng to the Guidelines of 5 CFR 1320.5
CMS shall list the OMB control number on the frónt page of the application. We do not
anticipate any special circumstances that would require the need for other means to inform
potential respondents of the OMB control number associated with this application.

8.

Gomments in Response to the Federal Register Notice and Efforts to Consult
Outside the Agency

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CMS is requesting to renew the use of a previously approved form. No changes to the form
are being proposed.

9.

Explanation of Any Payment or G¡ft to Respondents
The benefit to beneficiary respondents will be the potential ofbeing selected to participate in
the demonstration and receiving the additional demonstration services for the administration
of IVIG in the home. There will be no other payments or incentives to respondents or their
providers.

l0.Assurance of Confidentiality Provided to Respondents
Confidentiality of patient-specific data will be maintained as provided by the Privacy Act of
1974 (5 U.S.C.552a). The implementation support contractor will be a DME-MAC that
currently processes Medicare claims. This contractor currently meets all requirements for
handling personally identifiable data in a secure and confidential manner. All personnel who
will have access to data collected through this application will be trained on the significance
and protection of confidentiality and respondent information will be maintained in a
confidential manner to the fullest extent possible. The application database will be stored on
a secured server with access-limiting firewall protections, including encryption and password
requirements. Data collected through this application will be retained only long enough to
perform analyses associated with CMS's implementation and evaluation of the IVIG
Demonstration, and

will then be destroyed.

These data collection activities are covered under a Centers for Medicare & Medicaid
Services System of Records: "Master Demonstration, Evaluation, and Research Studies
the Office of Research, Development and Information" (System No. 09-70-0591). The

System of Records Notice was published in the Federal Register on
72, page 19705).

11.

for

April 19,2007 (Volume

Justification for Sensitive Questions
The proposed application asks for information necessary to confirm the identity ofthe
Medicare beneficiary and validate their eligibility for the demonstration. Additional non
demographic information that will be collected will be related to how they are currently
receiving immune globulin and their perceived benefit from participating in the
demonstration and will be used to conduct the statutorily mandated demonstration evaluation.

Neither CMS nor its contraclors will identiff any individual beneficiary or provider in any
published reports or presentations.

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12.

Estimates of Annualized Burden Hours and Costs
Estimates of survey burden in terms of hours and annualized costs for this one-time
application are shown in the table below. The estimated total number of respondents is based
on the most recent enrollment trends during the last year ofthe demonstration and the
statutorily mandated limit on enrollment. Each beneficiary will only need tô complete the
application once and it is expected to take no more than 15 minutes to do so. Thus the total
projected hours required will be no more than 375 (40 respondents per month x 37.5
additional months (October l, 2017 - November 15, 2020, the last date applications can be
accepted) x .25 hour per response). The cost per hour ofbeneficiary response time is based
on the median Medicare income level as provided by The Henry J. Kaiser Family

Foundation, "Income and Assets of Medicare Beneficiaries, 2016-2035".1

TOTAL

1500

I

0.25 hß. (15 min.)

375

s 3.15'

ö 4,125

I 3. Capital costs.
There are no capital costs.

14.Annualized Gost to the Federal Government
The demonshation is limited to $45 million, including benefit and administrative costs. As of
October l, CMS has allocated approximately $3.7 million for the evaluation and implementation
support. Through September 22, 2017 , S 6,076,903 has been expended to pay for claims under
the demonshation. The Disaster Tax Relief and Airport and Airway Extension Act of 2017 does
not provide additional funding. While additional fr.rnding will be needed to support the continued
implementation support for and evaluation of the demonstration, we will continue to monitor
enrollment and total expenditures closely in order to stay within the statutory limits.

I Taken fron the ntedian Medicare incone level as provided in The Henry J. Raßer Family Foundation,
http:/Avww.klf.org/ntedicare/issue-brief/incon e-and-assets-of-nedicare-beneJiciaries-20 I 6-2035/ : $(826,200
nedian annuol incone / (2080 hours/year)= 12.60/hourt.25=$3.1 5 per response.

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In addition, it is estimated that .35 FTE GS- l5 senior project officer will be required to
implement and monitor the demonstration. Based on the mid-range salary for this staff, CMS
annual salary expenses for implementation will be approximately $53,037.1

15.

Explanation for Program Changes or Adjustments
No changes in the application form from that previously approved are being requested.

16. Plans

for Tabulation and Publication and Project Time Schedule

The stâtute originally authorizing this demonstration requires an interim Report to Congress
on the impact of the demonstration on access for Medicare beneficiaries to items and services
needed for the in-home administration of IVIG . This interim report was published in March
2016 and is on CMMI's web site (https://innovation.cnts.gov/initiatives/ivig/). A,final
evaluation is due to Congress not later than one year after the date ofcompletion ofthe
demonstration project. Nothing in the legislation extending the demonstration changes these
requirements.

Although summary level data on applications submitted and beneficiaries enrolled in the
demonstration may be included in these reports, any additional data collection necessary to
support this demonstration will be covered under a separate PRA application.
No personally identifiable beneficiary or provider level data will be published in any ofthe
evaluation reports.

lT.Reason(s) Display of OMB Expiration Date is lnappropriate
Not applicable. The OMB expiration date will be displayed on all applications.

I

Solaries based on DC/Boltinore 2017 GS wage rutes, The nrìdt'angc v,as defined os mid-wa¡, bcnwen sreps 5 and
6. For GS- I 5 this is I 5 1,534/FTE.

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