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21st Century Cures Initiative

January 19, 2017

Final Version of 21st Century Cures Act Causes Concern for SCIG Patient Access

On December 12, 2016, President Obama signed the bipartisan bill known as the 21st Century Cures Act into law. This legislation includes several of AAAAI’s advocacy priorities, and AAAAI joined many other patient and provider advocacy groups in supporting the bill’s aim to accelerate the pace of biomedical discoveries.

To offset the cost of the 21st Century Cures Act, a provision was added to the bill to change how much Medicare Part B pays for infusion services reimbursed under Durable Medical Equipment (DME), which includes infusions that utilize a pump, such as subcutaneous immunoglobulin (SCIG). This provision would result in a reduction in reimbursement rates to specialty pharmacies providing SCIG in the home. This reimbursement reduction, unfortunately, did not account for the costs incurred from providing infusion training, education and monitoring.

Altering the Part B reimbursement for infusion drugs furnished through DME concerns immunologists and our patients due to our collective previous experience of a similar Medicare payment transition. When Medicare transitioned payment for Part B drugs from the average wholesale price (AWP) to the average sales price (ASP) plus six percent (following enactment of the Medicare Modernization Act of 2003), our patients experienced serious disruptions in access to needed treatment. In particular, the previous transition dramatically affected our patients with primary immunodeficiency (PI) diseases, who would be impacted by this new provision.  

Due to these concerns, AAAAI began advocating for additional safeguards to ensure appropriate patient training, follow up and care. As the 21st Century Cures legislation advanced through Congress, AAAAI educated lawmakers about the importance of a Medicare benefit for SCIG home infusions which includes coverage for the education, training and monitoring necessary for patients receiving such infusions. As a result of this advocacy by stakeholders like AAAAI, Congress included in the final 21st Century Cures bill reimbursement for training, monitoring and nursing services that could make it more affordable for specialty pharmacies to continue to provide these services in the home. At the last minute, however, Congress changed the implementation dates for the home infusion benefit to delay it to 2021, while allowing the above reimbursement cut to take place beginning on January 1, 2017.

AAAAI has serious concerns about the affect this reimbursement cut will have on patient access to SCIG in the years before beneficiaries will have explicit new Medicare coverage for home infusion services. Along with organizations like the National Home Infusion Association and the Immune Deficiency Foundation, AAAAI has mobilized to urge Congress to correct the law and be consistent in the implementation of the two provisions affecting SCIG services. As it currently stands, the discrepancy in dates could affect the willingness of some specialty pharmacies to provide SCIG, and thus threaten patient access to these critical therapies.

If you or your practice is notified by a specialty pharmacy about changes in patient coverage for SCIG or another Part B DME infusion drug, please share this information with AAAAI so that we can continue to monitor potential access to care problems.  If you are notified about such coverage changes, contact Sheila Heitzig, JD, MNM, CAE, AAAAI Director of Practice and Policy, at (414) 272-6071 or

December 12, 2016
21st Century Cures Act Passed by Congress

On December 12, President Obama signed the bipartisan supported 21st Century Cures Act. This legislation includes several advocacy priorities for the AAAAI, including:

• Coverage for the education, training and monitoring necessary for personnel providing in-home infusions to immune deficient patients
• Efforts supportive of antimicrobial resistance and antibiotic stewardship activities
• Establishment of a task force to research drug safety in pregnant and lactating women
• Increased funding for the National Institutes of Health
After it received House approval, the AAAAI sent a letter to Senate leadership and Senate health affairs staff to communicate our support for the Act and specifically for these provisions.

View the letter here.

November 2016

Letter to the House of Representatives on treatment of infusion drugs furnished through durable medical equipment.

Letter to the Senate on treatment of infusion drugs furnished through durable medical equipment.

July 14, 2015

The 21st Century Cures Act, authored by Representative Fred Upton and Energy and Commerce Committee members, promises to profoundly affect our nation’s innovations in health care, its investments in medical research and the delivery of life saving and life improving therapies. The legislation aims to eliminate gaps between advances in scientific knowledge and the regulatory process. The House of Representatives recently voted in favor of its passage. Now before the Senate, the 21st Century Cures Act also promises to affect the practice of allergy and immunology. Key aspects of it include:

  • Reauthorizing the National Institutes of Health, including providing additional funding through an Innovation Fund
  • Standardizing data in clinical trial registry data banks
  • Revamping the FDA’s advisory committee process, and
  • Improving the Medicare Local Coverage Determination (LCD) process


June 2014

Earlier this year, the House Committee on Energy and Commerce announced the 21st Century Cures Initiative "to take a comprehensive look at what steps we can take to accelerate the pace of cures in America." The Committee solicited comments from medical and patient groups regarding the key questions the Committee will examine.

The AAAAI submitted comments focused on research needs in a variety of areas including allergen immunotherapy, asthma, food allergy, drug allergy, and immunologic diseases. In response to a question about the major barriers to progress in biomedical research, the AAAAI stated: "The major barriers to advancing breakthroughs in our field and others are: 1) the shrinking population of active physician scientists, particularly those focused on patient-oriented research; and 2) the difficulty of getting translational research funded by the NIH."

Read the full AAAAI statement here.

The 21st Century Cures Discussion Document