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Access to immunoglobulin therapies through public and private payers tops IDF's advocacy priorities:

  • Enact a permanent Medicare benefit for home access to intravenous immunoglobulin (IVIG) treatments that covers all necessary supplies and services, as well as the medication itself.
  • Work to address barriers that prevent skilled nursing facilities (SNF) from administering Ig therapy, resulting in rejection of patients who need Ig therapy, or patients skipping needed Ig treatments while in a facility.
  • Ensure access to the Ig therapy that works best for each patient through private payers.

Why Covering Immunoglobulin (Ig) Replacement Therapy Matters

Many people with PI rely on lifelong immunoglobulin (Ig) replacement therapy to protect them from life-threatening infections because they were born without a properly functioning immune system. Ig is a blood plasma product that helps prevent frequent and/or severe infections and is administered intravenously (IVIG) or subcutaneously (SCIG). The decision to use IVIG versus SCIG is individually determined by the patient and their physician and involves considerations such as venous access, dosing schedules, adverse reactions, and convenience of use based on their lifestyle. According to IDF's 2018 Treatment Survey, 39% of people with PI who require Ig treatment receive IVIG.

Medicare Benefit for Home Access to IVIG

 

History of the Medicare IVIG Access Demonstration Project

In 2003, Congress enacted the Medicare Modernization and Prescription Drug Act that included a provision that allows Medicare to cover home infusion of intravenous immunoglobulin replacement therapy (IVIG) for primary immunodeficiency diseases (PI). The provision, however, only permitted reimbursement of the immunoglobulin (Ig) and not the supplies and other services necessary to administer the treatment—essentially making this a benefit on paper only.

IDF worked for years to have legislation passed that would allow Medicare beneficiaries with PI coverage for IVIG home infusions. In January 2013, the Medicare IVIG Access Act (HR 1845) become law, and in October 2014 the Centers for Medicare and Medicaid Services (CMS) began implementing the three-year demonstration project allowing for the payment of home infusion supplies and services for 4,000 Medicare beneficiaries with PI.

The demonstration project has been extended twice, and the most recent extension pushed the enrollment cap to 6,500 individuals with PI. It also included a provision requiring that CMS report their findings on the effectiveness of the project by the end of 2022. This helps avoid a potential gap in coverage by giving time for Congress to analyze the findings and pass legislation for a permanent benefit before the demonstration expires in 2023.

Advocating for a Permanent Benefit

With Medicare coverage for home IVIG infusion under the current demonstration project scheduled to end at the end of 2023, the IDF advocacy team is working to ensure that a permanent benefit is created to cover the medication, services, and supplies required for home IVIG therapy. As has been highlighted during the COVID-19 pandemic, it is essential that individuals with PI, who are immunocompromised, have an option to receive infusions at home.

Additional Information and Resources

Barriers Preventing Skilled Nursing Facilities from Administering Ig Therapy

IDF is also working to understand and address barriers that prevent skilled nursing facilities (SNF) from accepting patients who need Ig therapy, or refusing to administer Ig therapy to admitted patients. This includes the role played by Medicare and private payer reimbursement for services. IDF is working with the American Health Care Association (AHCA), a group that represents skilled nursing facilities, to develop a strategy for overcoming this challenge. 

Access to the Ig Therapy That Works Best through Private Payers

Advocacy efforts with private payers relate to ensuring that PI patients who need Ig therapy have access to the specific treatment they require using the mode of administration and site of care that they and their doctor have determined they need. As biologics, Ig therapy is not interchangeable. Access to the product that works best for each patient is essential because of side effects and varying tolerability levels.

In July 2021, the IDF Medical Advisory Committee (MAC) approved the Model Coverage Policy for Immunoglobulin Replacement Therapy for Primary and Secondary Immunodeficiency Diseases with Impaired Antibody Response. This document was developed to support proactive advocacy so that payers adopt medically appropriate policies around Ig therapy for the treatment of PI. IDF is also working to educate payers and address specific patient challenges related to access to specific Ig therapies.


Make a difference by advocating for Ig therapy access through IDF's Action Alerts! Action Alerts let you easily sign on to letters or send templated emails to your legislators, letting them know how policies affect the PI community.

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