In January 2013, the Medicare IVIG Access Act (HR 1845) was signed into law by President Barack Obama, creating a three-year demonstration project allowing for the payment of home infusion services for Medicare patients with primary immunodeficiency (PI) to be implemented within one year of its signing. The demonstration project should prove the cost effectiveness of allowing Medicare patients with PI access to home infusions of IVIG, thus paving the way for a permanent fix to this issue.
Until the Medicare IVIG Access Act (HR 1845) is implemented, Medicare beneficiaries are effectively denied intravenous immunoglobulin replacement therapy (IVIG) in the home setting, forcing patients with primary immunodeficiency diseases to seek care in other settings even when the most appropriate site of care would be the home. While Medicare Part B includes a special provision for patients with PI to receive home infusions of IVIG, the Medicare law included only reimbursement for the immunoglobulin (Ig) product, not allowing for Medicare payment for nursing services or other items necessary for infusions in the home setting. IDF believes that patients with primary immunodeficiency diseases should have the right to access to all sites of care including the right to be infused in the home setting if that is medically appropriate. With this belief in mind, IDF strived for years to have legislation passed that would correct this hollow benefit in the Medicare law and allow Medicare patients with PI to access IVIG home infusions.
The Medicare IVIG Access Act was championed for many years by Representatives Kevin Brady (R-TX) and Doris Matsui (D-CA) in the House and Senators John Kerry (D-MA) and Lamar Alexander (R-TN) in the Senate, ultimately passing by a margin of 401-3 in the U.S. House of Representatives and by unanimous consent in the Senate. With the strong leadership of the policymakers who signed on to support this legislation, the Medicare IVIG Access Act will improve access to treatment and the quality of life of the countless patients who struggle with negative health outcomes, increased intervals of care, change in site of infusion, difficulty finding providers, and denial of treatment.
CMS has announced that the demonstration project will not begin in January 2014 as anticipated as there are numerous system changes still needed to implement the project. CMS plans to start taking applications later in 2014 and begin delivering services after an enrollment period of about one month. IDF is continuing its meetings and discussions with CMS about implementation, and although everyone is disappointed about the delay, all involved understand that it is important for this demonstration project to be executed correctly. Although there is no new anticipated start date, it is likely that the demonstration project will be live sometime in the latter part of 2014.
Check back here for additional information about the implementation process and timeline including enrollment date and details for the demonstration project. For more information about the implementation process, please visit http://innovation.cms.gov/initiatives/ivig/.
If you would like to be a part of the Medicare IVIG Demonstration Project, please contact IDF at http://primaryimmune.org/services/ask-idf/ and indicate your interest in participating in the demonstration project. We will contact you when we know more about the updated timeline and enrollment procedure.
Additional information and resources about the Medicare IVIG Access Act: