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Background on SCIG Treatment for the PI Community

In December 2016, Congress passed the 21st Century Cures Act (Cures Act) that increased funding for the National Institutes of Health and the Food and Drug Administration, and enacted several reforms to speed the development of breakthrough medical advances. To “pay for” the provisions of the Cures Act, however, effective January 1, 2017, Congress significantly reduced Medicare provider reimbursement for a small number of drugs that are administered using durable medical equipment, such as a pump, including infusion of subcutaneous immunoglobulin replacement therapy (SCIG). The reduction does not account for the additional costs incurred for the provision of training, monitoring and other services to beneficiaries.

The reduction in payment made it difficult for home infusion providers to deliver the necessary services for the education and training of patients on how to self-administer immunoglobulin (Ig) correctly and to deliver the ongoing monitoring of such patients. To address this problem, the Immune Deficiency Foundation (IDF) supported, and Congress included in the bill, a policy to establish Medicare coverage of home infusion services, including a services payment for education, training and monitoring. Unfortunately, under the law, the new payments will not start until 2021, even though the payment reductions went into effect in January 2017. Thus, a coverage gap was created.

Fortunately, in 2017, Congress passed and the President signed the nation’s Continuing Resolution. In that spending deal was language fixing the Medicare reimbursement problem for the administration of SCIG, by mandating that the Centers for Medicare and Medicaid (CMS) create a temporary services payment for providers to make sure that people with PI are able to receive SCIG during the period before the Cures Act takes effect, temporarily addressing the coverage gap, until the permanent benefit takes effect.

Since that mandate, IDF has been actively engaging with CMS in an effort to ensure that reimbursement for services associated with home infusions provides meaningful coverage to Medicare beneficiaries with PI. IDF is concerned that without an adequate services payment providers will not be willing to provide SCIG to Medicare beneficiaries with PI. IDF is engaged with the National Home Infusion Association in advocating for congress to take actions to ensure all necessary services to provide for home infusions are covered as part of the Medicare benefit.

The Preserving Patient Access to Home Infusion Act (S.3457/H.R.6218)

In January 2021, the permanent home infusion services benefit will begin, supporting access to nursing, training and other services needed to deliver drugs infused using pumps in beneficiaries’ homes. When the permanent benefit is implemented in January, certain medications classified as self-administered drugs will be excluded from coverage, even if the temporary services payment provided reimbursement for such products. This includes one product commonly used by individuals with PI. The Preserving Patient Access to Home Infusions Act is bipartisan legislation introduced to address these concerns by ensuring adequate Part B coverage and reimbursement for home infusion medications and services used by Medicare beneficiaries, including individuals with PI.

Passage of this legislation will help ensure that individuals with PI can continue to receive their SCIG treatment in the home. This provides another option for vulnerable individuals to avoid facilities with other patients to decrease risk of exposure to pathogens, including COVID-19. Enabling adequate reimbursement ensures that patients are provided training and support needed to administer SCIG at home. The bill also ensures that PI beneficiaries are able to continue to access the specific Ig medications prescribed by their physician, including those classified as self-administered drugs.

To Show Support for Adequate Coverage for the Medicare SCIG Home Infusion Benefit

Take part in IDF Virtual Advocacy Day 2020 on April 23 to reach out to your elected representatives urging them to cosponsor the Preserving Patient Access to Home Infusion Act.

Sign up for IDF Action Alerts! When your voice needs to be heard to support legislation regarding this benefit, we will notify you. Click here to sign up.

Additional Information and Resources

Preserving Patient Access to Home Infusion Act Handout, IDF Virtual Advocacy Day 2020

21st Century Cures Act as enacted

Bipartisan Budget Act of 2018

S.3457 – Preserving Patient Access to Home Infusion Act

H.R.6218 – Preserving Patient Access to Home Infusion Act

IDF Letter to Senate Leadership Regarding the Medicare Home Infusion Therapy Access Act, Dated 1.9.18

IDF Letter to CMS Regarding Home Health Rule, Dated 8.23.18

Stakeholder Letter to Congressional Leadership Regarding Home Health Rule, Dated 1.31.19

IDF Letter to CMS Regarding Home Health Rule, Dated  8.28.19

IDF Letter to Senate Regarding Preserving Patient Access to Home Infusion Act, Dated 3.17.20

Stakeholder Letter to Senate Leadership Regarding Preserving Patient Access to Home Infusion Act, Dated 3.17.20