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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 February 2018, 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. Beginning January 1, 2019, the Centers for Medicare and Medicaid (CMS) was mandated to come up with 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.

In response to this mandate, on October 31, 2018, CMS issued a CY 2019 Home Health Rule (CMS-1689-FC) detailing the Medicare policy for reimbursement of home infusion services. As written, this final rule is very restrictive in reimbursement for services associated with home infusions that is contrary to the explicit legislative intent “to provide meaningful coverage.” 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.

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Additional Information and Resources

21st Century Cures Act as enacted

Bipartisan Budget Act of 2018