Medicare IVIG Access Act and Demonstration Project



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Enrollment for the Medicare IVIG Demonstration Project will begin on August 8, 2014, and the enrollment period ends September 12, 2014 at 5 p.m. EST. This three-year demonstration project for Medicare Part B recipients with a primary immunodeficiency disease (PI) will study the impact of paying for intravenous immunoglobulin (IVIG) home infusions. Up to 4,000 Medicare beneficiaries nationwide may enroll into the demonstration project on a first-come, first-served basis. If enrolled in the demonstration project and approved, a beneficiary receiving an IVIG home infusion on or after October 1, 2014 will be covered. Medicare will inform all applicants by September 30, 2014 of their status.

The goal of the Medicare IVIG Demonstration Project is to prove the cost effectiveness of allowing Medicare patients with PI access to home infusions of IVIG. 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. Medicare beneficiaries are effectively denied IVIG in the home setting, forcing patients with PI to seek care in other settings even when their most appropriate site of care might be the home. The Medicare IVIG Demonstration Project will provide reimbursement for all infusion costs, thus paving the way for a permanent fix to this issue. This demonstration project resulted from years of successful advocacy by the Immune Deficiency Foundation on behalf of the PI community for a law allowing Medicare to reimburse for IVIG home infusions.

The demonstration project only applies to situations where the beneficiary has been diagnosed with a PI and requires intravenous immunoglobulin (IVIG) for the treatment of PI, or is currently receiving subcutaneous immunoglobulin (SCIG) to treat PI and wishes to switch to IVIG. Only beneficiaries who participate under the original Medicare fee-for-service program (not enrolled in a Medicare Advantage plan), have Part B and require IVIG for the treatment of PI are eligible to participate.

For full and complete information about the demonstration project and how to participate, go to www.medicarenhic.com.

Tips on Participation

  • You must complete an enrollment application and have it signed by a physician. There is an Enrollment Application Guide on the demonstration website. The form then must be submitted to Medicare by mail or fax. Submission does not guarantee that the beneficiary will be accepted.
  • If approved, a beneficiary receiving an IVIG home infusion on or after October 1, 2014 will be covered. Medicare has indicate that they will tell all applicants by September 30, 2014 of their status.
  • Your physician is extremely important to the enrollment process. Her/his signature is required before submitting an enrollment form.
  • Because of the limitation of 4,000 beneficiaries in the demonstration and a one month initial enrollment period, acting quickly is extremely important. Patients interested in participating in the demonstration should contact their physician’s offices as soon as possible, and remember many physicians may be on vacation during the month of August.

Where Can I Find Out More Information?

The Medicare Intravenous Immune Globulin (IVIG) Demonstration site has resources for you:

  1. Go to http://www.medicarenhic.com and click on “Beneficiary” under the Medicare Intravenous Immune Globulin (IVIG) Demonstration section.
  2. Then click “Agree” on the CPT Agreement page. The IVIG Demonstration: Information for Beneficiaries page will then appear. The Medicare Intravenous Immune Globulin Demonstration webpage has helpful information such as: Enrollment Application, Enrollment Application Guide, Frequently Asked Questions, and Helpful links to other websites.

Important Dates

  • August 8 – Enrollment Begins
  • September 12 – Enrollment Deadline by 5 pm EST
  • September 30 – All applicants will be told by Medicare by of their status
  • October 1 – If approved, a beneficiary receiving an IVIG home infusion after this date will be covered

More about Medicare IVIG Access Act

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 PI to be implemented within one year of its signing. 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 PI to seek care in other settings even when their most appropriate site of care might 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 PI 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.

Check back here for additional information about the implementation process and timeline including enrollment date and details for the demonstration project.

Additional information and resources about the Medicare IVIG Access Act