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IDF Fights for Medicare Beneficiaries with PI to Ensure Their Access to SCIG

The focus of the Immune Deficiency Foundation (IDF) advocacy efforts has always been to ensure that all patients with a primary immunodeficiency disease (PI) have full access to the mode of treatment and site of care option that best suits their needs. Right now, patients are asking questions about how a recently enacted law, the 21st Century Cures Act (Cures Act), could impact the willingness of specialty pharmacies to treat subcutaneous immunoglobulin (SCIG) Medicare beneficiaries going forward. IDF has been deeply engaged on this issue over the past several months, and the following post summarizes the issue and current landscape.

About the 21st Century Cures Act (Cures Act)

The Cures Act was bipartisan legislation that was aimed at advancing healthcare treatment and research benefiting all patient communities. As such, IDF joined most other patient advocacy groups in supporting this legislation. Unfortunately, as this legislation moved through Congress, provisions were added to the bill as a way of paying for part of its cost, by changing how much Medicare Part B will pay for infusion services reimbursed under the Durable Medical Equipment (DME). This category includes infusions that utilize a pump, such as SCIG. The change reduced the reimbursement rate to specialty pharmacies providing SCIG and did not account for the additional costs incurred for providing training, monitoring and other services to beneficiaries. This reimbursement rate change first surfaced in summer of 2015, and IDF immediately engaged in vocal opposition. As a result of 18 months of advocacy, Congress included in the final bill a provision to establish a Medicare benefit for SCIG home infusions, including such training and monitoring services.

To achieve this goal, IDF:

  • Met with senior staff of all Congressional committees that were working on the Cures Act;
  • Brought our advocate and board member, Carol Ann Demaret, to meet with the Chair of the House Ways and Means Committee, Congressman Kevin Brady;
  • Collaborated with the National Home Infusion Association to advocate for amended bill language;
  • Compiled and presented data to the Congressional Budget Office (CBO) as to the modest fiscal impact of provisions covering training and education services would have on the overall costs; and
  • Asked the PI community through the IDF Action Alert system to contact members of Congress to ask them to make sure that language for reimbursement of professional services, training and monitoring are included if there was a reduction in reimbursement for immunoglobulin.

IDF was one of the only patient communities that mobilized at this level to protect access to part B Medicare DME infusion services. As a result of our work, the Cures Act included reimbursement for training, monitoring and nursing services that could make it more affordable for pharmacies to continue to provide services.

However, at the last minute, Congress delayed implementation of the reimbursement of the home infusion benefit until 2021, while allowing the reimbursement cut to go into effect on January 1, 2017. The two provisions should be implemented at the same time as this discrepancy in dates is having an impact on the willingness of some specialty pharmacies to continue to provide SCIG services.

IDF and other stakeholders immediately mobilized before and after the bill passed in mid-December 2016 to urge Congress to undo what they had done. Meetings with Congressional leadership have already occurred to explain the terrible problems that can occur and how to correct the law, especially since our community experienced a similar challenge more than a decade ago in establishing an incomplete benefit for intravenous immunoglobulin (IVIG).

The senior committee members and their staff are receptive to ways to change the law. As we move further into 2017, we will continue advocating for legislative fixes to address this problem, ideally through an acceleration of the home infusion benefit start date along with a delay in the payment reduction. Indicators from the House and Senate committees so far are positive and achieving an earlier implementation date is a top legislative priority for IDF in 2017. In the coming weeks, we will be in touch via IDF Action Alerts on specific steps all IDF stakeholders can take to help us fix this problem.

History of Impact on Medicare Beneficiaries with PI Receiving IVIG

As mentioned earlier, in 2003, Congress passed the Medicare Modernization Act (when Part D drug program began). In that bill a similar reduction in reimbursement for all Medicare Part B drugs, including IVIG, was implemented. The language in that law established a new benefit for patients with PI who wanted to have IVIG in the home setting. In that case, however, the language did not allow for reimbursement for the professional services and items necessary to have an infusion. IDF’s six-year advocacy in that instance led to the 2012 enactment of the Medicare IVIG Access Act and the implementation of the three-year demonstration project that currently allows Medicare beneficiaries to have IVIG in the home setting.

How You Can Help

In addition to advocating for a legislative solution, IDF is also working to ensure that SCIG continues to be available to patients who need this treatment. If a specialty pharmacy has indicated that they will not provide a product that you are using, please let us know and we will do all that we can to assist you. In the meantime, please sign up for IDF Action Alerts to notify you when we can advocate for a fix to this situation. Sign up at:

Please remember that we are a rare disease population, and every voice counts.

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