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Why insurance coverage of 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 biologic—that is, a medication made from a biological rather than chemical source—derived from blood plasma and is administered intravenously (IVIG) or subcutaneously (SCIG).  

According to IDF's 2018 Treatment Survey, 39% of people with PI who require Ig treatment receive IVIG, while 61% receive SCIG. The decision to use IVIG versus SCIG is individually determined by the patient and their physician. It involves considerations including vein access, dosing schedules, adverse reactions, and convenience of use based on the patient's lifestyle. As a biologic, Ig therapy is not interchangeable. Access to the product that works best for each patient is essential to avoid side effects and tolerability issues. 

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

Barriers preventing skilled nursing facilities from administering Ig therapy

IDF is working to understand and address barriers that prevent skilled nursing facilities (SNFs) from accepting patients who need Ig therapy, or refusing to administer Ig therapy to admitted patients.  

Patients are typically admitted to SNFs when they need more care than they can receive at home (e.g., extensive physical therapy, changing of bandages, IV medication) but do not need to be hospitalized. For example, someone undergoing knee replacement surgery may be discharged to a SNF for recovery. SNFs can also serve as ‘step-down’ facilities for those recovering from hospitalization for acute medical needs, such as severe infections. 

Why skilled nursing facilities won’t administer immunoglobulin 

The reason SNFs won’t administer immunoglobulin stems from how Medicare pays SNFs for their services. Because private insurance payers frequently model their own policies after Medicare, this flawed policy affects those insured through private plans as well. 

When a Medicare beneficiary is admitted to a SNF, Medicare pays a bundled per diem rate to the facility instead of reimbursing for each independent service or procedure (which is how Medicare reimburses hospitals). The per diem is intended to cover all medical care the patient receives at the SNF.  

However, immunoglobulin is an expensive medication, so those who need Ig therapy cost the SNF more than the facility receives in per diem payments. SNFs are not legally required to accept patients, so they turn away patients on Ig therapy. These individuals instead languish in hospitals, costing the healthcare system more money and increasing the patient’s risk of contracting a hospital-acquired infection. 

Sometimes, a SNF will accept a patient, but then refuse to administer their Ig therapy. In this case, the patient is at risk of infection because they are not receiving the necessary treatment for their PI.  

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.  

Listen to experts discuss Ig and SNFs on The IDF Podcast

 

Tell us your SNF story

Please tell us your story if you:  

  • Use SCIG or IVIG to treat your PI and have struggled to find a SNF that will admit you, or  
  • Have been admitted to a SNF and then denied your SCIG or IVIG therapy, or 
  • Are a healthcare provider who has struggled to find a SNF that will accept your PI patient. 

Tell us your story

Coverage for the Ig formulation that works best

IDF advocates with private and public insurance payers to ensuring that PI patients who need Ig therapy have access to the specific formulation they require using the mode of administration (i.e., SCIG or IVIG) and site of care (e.g., home, infusion suite) that they and their doctor have determined they need.

Ig therapy is not interchangeable and 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, which states, “the choice of product and route of administration, e.g., intravenous or subcutaneous, should be determined by the prescribing physician in consultation with the patient, based on his/her individual needs.” This document was developed to support proactive advocacy so that payers adopt medically appropriate policies around Ig therapy for the treatment of PI.

Payers not covering 16.5% or 20% immunoglobulin formulations 

Recently, IDF has become aware of both private and public health insurance plans that have removed 16.5% and/or 20% immunoglobulin formulations from their formulary lists entirely. Individuals covered by these plans are essentially being denied the option to infuse subcutaneously because the high-concentration formulations preferred for SCIG are not covered by their insurance plans. 

While three 10% Ig formulations are approved for SCIG in the U.S., these lower-concentration products require greater infusion volume. Large infusion volumes are not tolerable for many SCIG users, as they require more infusion sites and are not compatible with a biweekly SCIG regimen. IDF's 2018 Treatment Survey found that only 13% of PI patients using SCIG used 10% formulations. 

There is no medical justification for dropping coverage of 16.5% and/or 20% Ig formulations. SCIG is an important option for patients when IVIG is not well tolerated, when there is poor venous access (as in the elderly or in small children), or when the patient’s lifestyle is not compatible with IVIG. When 16.5% and/or 20% Ig formulations are not covered, patients may be forced to switch to lower-concentration SCIG or to IVIG, increasing their risk of adverse events and negatively affecting their quality of life.

Tell us your formulary story

Please reach out via Ask IDF and tell us your story if you:  

  • Have had to switch formulations/brands of Ig and/or route of administration due to insurance formulary changes, or
  • Are a healthcare provider who has patients that no longer have the option for 16.5% and/or 20% Ig formulations.

Medicare benefit for home access to IVIG

Advocating for a Permanent Benefit

Medicare coverage for home IVIG infusion under the current demonstration project is scheduled to end at the end of 2023. Thanks to the efforts of the PI community and IDF's advocacy team, a permanent Medicare benefit covering the medication, services, and supplies required for home IVIG therapy was passed on December 23, 2022. This permanent benefit will take effect on January 1, 2024 and provide coverage with no gap for all Medicare beneficiaries currently enrolled in the demonstration project. 

Medicare Home IVIG Benefit: FAQs

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.

Timeline of Medicare home IVIG demonstration project.
Source: Updated Interim Report to Congress, Evaluation of the Medicare Patient Intravenous Immunoglobulin
Demonstration Project, https://innovation.cms.gov/data-and-reports/2022/ivig-updatedintrtc
 

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.

Additional Resources

What you can do

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. Sign up for Action Alerts below to be notified when we need your voice.