CMS hosted an Open Door Forum call on November 22, 2013 to allow providers, suppliers, beneficiary advocacy groups, and other interested parties to provide input into the design and implementation of this demonstration. Mandated by the “Medicare IVIG Access and Strengthening Medicare and Repaying Taxpayers Act of 2012 (P.L. 112-242)”, the purpose of this demonstration is to evaluate the impact of providing payment for items and services needed for the in-home administration of IVIG for the treatment of primary immune deficiency disease (PIDD). The demonstration will provide these benefits for up to 4,000 Medicare beneficiaries for a period of three years. - - - CMS Innovations http://innovations.cms.gov We accept comments in the spirit of our comment policy: http://newmedia.hhs.gov/standards/comment_policy.html CMS Privacy Policy http://cms.gov/About-CMS/Agency-Information/Aboutwebsite/Privacy-Policy.html

1. Medicare Intravenous Immune
Globulin Demonstration
Open Door Forum
November 2013
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2. Today’s Goal
• Get input from key stakeholders on questions related to
demonstration design and implementation
• Respond to questions
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3. Legislative Summary
• Mandated by the Medicare Intravenous Immune Globulin
Access and Strengthening Medicare and Repaying Taxpayers
Act of 2012
• Provides payment for items and services needed for in-home
administration of intravenous immune globulin (IVIG) for the
treatment of primary immune deficiency disease (PIDD)
• 3-year demonstration period
• $45 million authorized to conduct and evaluate the
demonstration (benefit costs and administrative costs )
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4. Legislative Summary
• Limited to 4,000 beneficiaries who have been diagnosed with
PIDD and voluntarily enroll to participate
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Must be enrolled in Medicare Part B
Must be covered under Traditional Medicare FFS (not Medicare
Advantage)
Not in a home health episode
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5. Evaluation
Reports to Congress
• Interim evaluation
• Final Evaluation
 Impact on beneficiary access
 Appropriateness of implementing a new payment methodology
 Update of report : “Analysis of Supply, Distribution, Demand, and
Access Issues Associated with Immune Globulin Intravenous (IGIV),”
(ASPE 2007)
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6. Questions for Discussion
Provider/Supplier Issues
• Should billing for demonstration covered nursing services &
supplies be permitted by organizations that are not supplying
the drug?
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Would there be situations where two different providers would be
billing: one for the drug and one for the administration?
Is it reasonable to require the claim for the demonstration service
be billed on the same claim as the drug?
• What types of organizations should be eligible to participate
in the demonstration?

Should eligible organizations have to apply to participate in the
demonstration?
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7. Questions for Discussion
Beneficiary Related Issues
• Who should CMS reach out to/ inform about this
demonstration?
 How likely are beneficiaries currently receiving IVIG in other sites or
SCIG likely to switch to in-home IVIG?
• How can CMS best reach out to beneficiaries and their
providers?
• Should CMS have an open enrollment period during which
applications would be submitted on an equal basis for
consideration, rolling enrollment, or some combination ?
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8. Questions for Discussion
Beneficiary Related Issues
• Should a patient’s physician be required to sign a beneficiary’s
application to confirm the diagnosis and awareness of the
demonstration and locus of service?
• Should the beneficiary’s application specify a particular drug
or supplier?
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9. Questions for Discussion
Other Issues
• Is the demonstration likely to impact the supply of IVIG?
• Are there other factors Medicare should consider in designing
this demonstration?
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10. For More Information
• CMS Web Site
 http://innovation.cms.gov/initiatives/IVIG/
 Announcements and new information posted
 Sign up for List Serve
• CMS email box
 IVIGdemo@cms.hhs.gov
• Project Officer:
 Jody Blatt ((410)-786-6921)
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