With more than 350 types of primary immunodeficiencies (PI), in many cases, payers have been slow to keep pace with all of the diagnostic codes that are clinically appropriate for use of immunoglobulin (Ig) replacement therapy in a variety of settings.
This has been a particular concern for Medicare beneficiaries with some PI diagnoses who have not been able to qualify for in-home Ig replacement therapy, either intravenous immunoglobulin (IVIG) or subcutaneous immunoglobulin (SCIG), under the Part B benefit. Individuals with several forms of PI have only been eligible to receive Ig replacement therapy in a hospital or community infusion center and have been ineligible to participate in the Medicare IVIG in-home demonstration. The PI diagnoses and ICD codes that are affected include:
Over the past year, the Immune Deficiency Foundation (IDF) has been working to rectify this problem. Beginning in 2018, IDF reached out to leadership at the Centers for Medicare and Medicaid Services (CMS) to discuss this and related Ig replacement therapy access concerns. This request led to a productive session with several agency leaders in which IDF raised the concern that many beneficiaries with clinical diagnoses of PI were not receiving access to in-home coverage under Medicare Part B. The agency was receptive to our concerns and agreed to a further review of the codes in question by CMS clinical staff.
In late February 2019, CMS clinical staff informed IDF that they had conducted preliminary reviews of the codes and agreed that appropriate evidence exists confirming five additional PI diagnoses eligible for coverage. This development has set in motion a process over the past several months to update the necessary Medicare documentation so that these changes be put into practice. Once completed and approved, beneficiaries with the diagnoses in question will be eligible for SCIG in their home and could also participate in the in-home demonstration.
At present, CMS is continuing to make updates to the manuals. Once these materials are revised, the new coverage policies would take effect 30 days from their issuance. IDF remains actively engaged with the officials at CMS and is working to advance the process as quickly as possible. If we encounter any impediments or delays, we will respond aggressively and will also contemplate the use of additional tools, including potential legislative engagement if warranted.
We are confident, based on our discussions with CMS leaders, that the updates will be completed shortly and that Medicare beneficiaries with additional forms of PI will soon be able to receive greater access to home-based care.
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