APFED’s Advocacy Work
Since its inception in 2001, APFED has worked diligently to advocate for patients who have eosinophil associated disease. On this page, we outline our efforts over the years, which include working to obtain federal funding for research, proper medical coding of eosinophilic gastrointestinal diseases, insurance coverage of medical foods, and more.
Current Keys Issues
Increase Federal Funding for Research
Increase the priority of eosinophil associated disease research among funding agencies, including the National Institutes of Health (NIH). NIH is the nation’s medical research agency comprising 27 components called “Institutes” or “Centers,” each with their own research agenda. NIH is the agency within the Department of Health and Human Services (HHS) responsible for biomedical and health related research. We need less invasive diagnostic testing for eosinophil associated diseases, to have better treatments developed, and ultimately, a cure!
The cost of elemental formula is a financial burden for some families. APFED continues to coordinate efforts to increase coverage for medical foods at both the national and state level.
Compassionate Allowances allow Social Security to target the most obviously disabled individuals for allowances based on objective medical information that can be quickly obtained. APFED would like to see Churg Strauss Syndrome and Hypereosinophilic Syndrome as diseases that qualify for allowances.
In 2015, APFED continued its long tradition of educating legislators in Washington, D.C. about the struggles that families with eosinophil-associated diseases face and asking their help to ease the burden.
In 2015, APFED joined members of the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) for a day of meetings on Capitol Hill. We met with legislative staff to share how financially burdensome out-of-pocket expenses are for patients who have been prescribed specialty formula to treat a disease, such as EGID.
The meetings were the first of several planned in the coming months, as we work toward legislation that introduces improved language regarding insurance coverage for medical foods for TRICARE recipients. Passage of this legislation would serve as a much-needed rallying point for future federal efforts that would benefit families all over the nation.
In state-by-state efforts, APFED continued to support volunteers this year who were actively working to pass legislation and/or educate legislators on the need for improved access to medical foods as a treatment for EGIDs.
This year saw the passage of medical foods legislation in Missouri. Passed in August 2015, Senate Bill 354 SB 354 requires the Missouri Department of Health and Senior Services to provide coverage for the full cost of amino acid-based elemental formulas for children under 19 years with a medical diagnosis of eosinophilic disorders or other specified conditions.
With the passage of Missouri’s legislation, the total number of states that have mandates on medical foods is now 18 states.
In addition to the ongoing efforts above, APFED also expanded its online resources to include a template letter to assist patients with the appeals process through their medical insurance appeals.
APFED is proud to actively participate in the Coalition of Patient Advocacy Groups (CPAG), representing CEGIR. This coalition represents the perspective and interests of all patient advocacy organizations associated with the clinical research consortia of the Rare Disease Clinical Research Network (RDCRN).
In 2014, APFED continued efforts to educate legislators in Washington, D.C. about the importance and need of federal funding to support the research of EADs.
APFED organized a trip to Capitol Hill during National Eosinophil Awareness Week in May, and again for a round of follow-up visits in June to ask legislators for support for increased NIH funding for research. We invited families struggling with EADs to join us and share their stories.
The families visited Senators Ben Cardin, Saxby Chambliss, Lindsey Graham, Johnny Isakson, Tim Kaine, Barbara Mikulski, Tim Scott, and Mark Warner, and Representatives Trey Gowdy and Steny Hoyer.
After meeting these families and learning more about challenges patients with eosinophil-associated diseases face, these legislators agreed to do what they could to support efforts for federally-funded research.
APFED’s advocacy at the federal level over the years came to fruition in 2014 with the announcement of federal grant to support the work of the Consortium of Eosinophilic Gastrointestinal Disease Researchers (CEGIR).
In 2014, APFED continued to support volunteers around the country who were actively working to pass legislation and/or educate legislators on the need for improved access to medical foods as a treatment for eosinophilic gastrointestinal diseases. Thank to efforts of state-based advocates and grassroots support that APFED helped to facilitate, this year saw the passage of medical foods legislation in Nebraska (Amendment 2773 to LB799), and Pennsylvania (HB 1436), bringing the total number of states in the U.S. that have mandates for insurance coverage for medical foods to 16 states.
To help advocates spearhead initiatives to introduce similar legislation in other states, APFED disseminated an instructional video for volunteers to provide the nuts and bolts to organize local efforts.
In 2014, APFED leadership attended the second College Summit hosted by the Food Allergy Research & Education (FARE) to develop pilot guidelines for managing food allergy in higher education.
Experts and stakeholders from across the nation convened for the Summit in Tucson, AZ to discuss best practices for the management of food allergy in the college setting, and to develop training resources for dining services and resident advisors, and educational materials for students and their families. The pilot guidelines were released in 2015.
One of the highlights of National Eosinophil Awareness Week this year was an announcement that united our patient community. Patient advocacy groups from around the world joined together to form the Coalition of Eosinophil Patient Advocacy Groups (C-EOS), an initiative spearheaded by APFED to support patients living with eosinophil-associated diseases and to advance key issues of importance to our community.
The mission of C-EOS is two-fold:
1. To encourage, promote, and support scientific research toward improved treatment, medical care, and cures of eosinophil-associated diseases and their complications.
2. To educate the public, patients, families, policymakers, healthcare professionals, and other stakeholders about eosinophil-associated diseases and resulting problems for these patients, including the need for better diagnostic testing, further research for treatments, and a cure.
As an organization dedicated to serving patients and families living with these diseases, APFED is thrilled to join C-EOS and be an active participant in carrying out the mission of the coalition. We are excited to see so many organizations work together in support of patients and researchers who are paving the way to a cure.
For more information about the coalition and to see other participating organizations, please visit www.c-eos.org.
During National Eosinophil Awareness Week, APFED leadership joined three families in Washington, D.C. to speak to legislators about the challenges patients with eosinophil associated diseases face, and the need for more research that would lead to less invasive testing and therapies. The group visited the offices of Senators Tammy Baldwin (D-WI), Chuck Schumer (D-NY), Kirsten Gillibrand (D-NY), and Saxby Chambliss (R-GA), as well as Congressmen Reid Ribble (R-WI), Eliot Engel (D-NY), Jack Kingston (R-GA), Tom Petri (R-WI), and Nita Lowey (D-NY). APFED representatives took the opportunity to thank Representative Lowey, senior Democrat on the House Appropriations Committee, for her recent letter to NIH Director Francis Collins to encourage initiation of a multi-Institute research program focused on eosinophilic disorders.
We were encouraged by the response from influential Members of the House and Senate. In addition, when the Senate Appropriations Committee approved its FY 2014 funding bill in mid-July this year, language encouraged the NIH to support research as recommended in a report published by the Task Force on Research Needs of Eosinophil-Associated Diseases (TREAD), in which APFED played a large role. This pivotal report includes specific areas of opportunity for eosinophil-related research.
APFED continues discussion with the National Institute of Allergy and Infectious Diseases to develop programs that act on the recommendations of the TREAD document.
In 2013, APFED continued to support volunteers around the country who were actively working to pass legislation and/or educate legislators on the need for improved access to medical foods as a treatment for eosinophilic gastrointestinal diseases.
Advocacy resources on the website were expanded to include the history of APFED’s advocacy work, detailed information on medical foods, summaries of state insurance mandates for elemental formula, an advocacy glossary of terms, and an expanded list of resources for financial assistance.
A medical foods advocacy toolkit was also developed in 2013 to support volunteers who are working to expand coverage for this treatment. This toolkit was put together by a cooperative effort between leadership from Georgia Medical Foods Coalition; Utah Food Allergy Network Division of Eosinophilic Support; and APFED. Available upon request from APFED, the toolkit contains information on how to get started in medical foods advocacy, helpful links, frequently asked questions, fiscal impact information, data from APFED’s medical foods survey, and much more.
In 2013, 14 states required insurance coverage for medical foods used to diagnose and treat food intolerance and absorption disorders. This year, APFED educated volunteers and supported efforts for legislation and/or education of legislators on this topic across the country, including California, Connecticut, Georgia, Kansas, Louisiana, Massachusetts, Missouri, Montana, Nebraska, New Jersey, New York, Pennsylvania, South Carolina, New Jersey, Tennessee, Utah, Virginia, Washington, West Virginia, and Wisconsin.
2013 brought the passing of “Hannah’s Law” in New York, requiring coverage for enteral formulas, whether administered orally or via feeding tube, that are medically necessary. APFED worked with Assemblywoman Amy Paulin in support of this important legislation.
In Washington State, APFED supported volunteers through the Sunrise Review process, a thorough and impartial review required by the Washington State Department of Health, as they developed materials to support the need for medical foods insurance coverage for the treatment of eosinophilic gastrointestinal disorders and encouraged families from across the U.S. to submit public comments.
APFED leadership worked to create an agenda for the Taskforce on the Research Needs of Eosinophil Associated Diseases (TREAD) Workshop that was held in June in Bethesda, Maryland at the National Institutes of Health (NIH).
NIH is the nation’s medical research agency comprising 27 components called “Institutes” or “Centers,” each with their own research agenda. On that day in June, NIH gathered researchers from across the country who specialize in cardiac, hematologic, skin, gastrointestinal, pulmonary, and other EADs, in a forum where each presented findings for the EOS community’s unmet research needs.
APFED President Dr. Wendy Book opened the workshop by presenting the patient’s viewpoint. The researchers then presented the unmet research needs within their specific specialty areas. The workshop closed with a strong commitment from NIH.
Working in tandem with members of APFED’s medical advisory panel and the working group, APFED President Dr. Wendy Book participated in the authorship of the TREAD document (Bochner BS, Book W, Busse WW, et al. J Allergy Clin Immunol, 2012; 130(3):587-596). This pivotal paper guides APFED, federal agencies, and other private organizations how to direct research dollars for greatest impact.
“The TREAD document represents another outstanding collaborative document that will set the stage for the research agenda for future governmental funding. This multi-disciplinary report highlights the areas of need for research in all eosinophil related diseases and hopefully will be used to help guide the distribution of funds when they are available for future research. APFED initiated this effort and brought together a team of experts that worked over a series of months to discuss and write this document, which was ultimately published in a peer reviewed journal.” – Glenn Furuta, Director of the Gastrointestinal Eosinophilic Diseases Program at Children’s Hospital Colorado
APFED continued its efforts in 2012 to educate legislators in Washington, D.C. about the importance of EAD research. Activities culminated in the development of report language that was included in the FY 2013 Senate Health and Human Services (HHS) bill. This report language requests an update from the National Institutes of Health (NIH) in Fiscal Year 2014 and provides congressional justification regarding program initiatives based on the TREAD recommendations, noted above.
“Eosinophil-Associated Disorders.—The Committee is pleased that a NIAID working group is developing a research agenda eosinophilic disorders. The Committee requests an update in the fiscal year 2014 congressional budget justification regarding programmatic initiatives being undertaken based on the working group’s recommendations. In addition to NIAID and NIDDK, the Committee urges NHLBI, NICHD, NIMH, and other relevant Institutes to participate in these efforts. Further, NIH should seek opportunities to collaborate with private sector organizations on this initiative.”
In September, the FDA sponsored a workshop titled “Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT)” to provide a forum to consider issues related to endpoints that can support drug development. APFED participated in the meeting by presenting the impact EoE has on patients and their families.
The workshop was attended by approximately 150 stakeholders, industry sponsors, academicians, and FDA representatives. While the workshop was held over a series of days and focused on several diseases, the first day focused on EoE. There are currently no FDA-approved therapies for the disease, even though several medications have shown positive results in clinical trials. The workshop was an important step to bring together stakeholders to discuss efforts and paths to securing FDA approval. Several APFED medical advisors took part in the workshop and published recommendations. (“Working with the US Food and Drug Administration: progress and timelines in understanding and treating patients with eosinophilic esophagitis.” Rothenberg ME, Aceves S, Bonis PA, Collins MH, Gonsalves N, Gupta SK, Hirano I, Liacouras CA, Putnam PE, Spergel JM, Straumann A, Wershil BK, Furuta GT. J Allergy Clin Immunol. 2012 Sep;130(3):617-9)
APFED devoted additional resources to medical foods advocacy efforts at the state level. Volunteers from around the country were brought together to support one another and share materials. APFED supports volunteers by guiding them through the legislative process, assisting them in forming coalitions with partner organizations, connecting volunteers from other states who have worked on similar efforts, providing supporting materials and data to volunteers and legislators, and issuing calls to action as needed.
APFED represented the eos community by participating in and presenting at NORD’s medical foods conference in Washington DC.
APFED advocated on Capitol Hill for Senate Health and Human Services (HHS) Appropriations report language urging the NIH to prioritize research for eosinophil associated diseases and develop a trans-institute strategy to address the unmet research needs of those with EADs.
In 2011, APFED leadership approached the National Institutes of Health (NIH) to form a working group to address the unmet research needs of rare eosinophil associated diseases. To that end, APFED worked with the NIH to form a working group to address the unmet research needs of rare eosinophil associated diseases and was an active participant in this working group known as the Taskforce on Research in Eosinophil Associated Diseases (TREAD).
The role of APFED leadership in TREAD in 2011-2012 was participation in monthly conference calls, manuscript preparation and review, and presentation of the patient perspective at an NIH conference related to the unmet needs across a broad multi-disciplinary spectrum of eosinophil diseases research. Read more about the advancement of TREAD in 2012.
From 2011 to 2012, APFED participated in the Food and Drug Administration (FDA) Steering Committee: Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT) Workshop, designed to address endpoints for registration trials, and issues related to selection of endpoints, and assessment of methodologies in registration trials for products intended to treat inflammatory bowel disease. The role of APFED leadership involved participation in monthly conference calls to plan the topics, speakers and format of this meeting. When the meeting was held in 2012, APFED leadership participated by discussing the patient perspective as related to needs for better diagnostic tools and treatments for eosinophilic esophagitis.
APFED continued to bring awareness to legislators with its goal of obtaining NIH funding for eosinophil associated diseases. APFED appointed a Legislative Coordinator to oversee the direction of the organization’s legislative efforts, as well as educate patients and families before they meet with elected officials on how to best present the needs of the eos community.
APFED educated congressmen on eosinophil associated diseases and advocated for the following report language to be included in the 2011 Senate Health and Human Services (HHS) Appropriations bill.
“Eosinophil-associated Disorders.—The Committee urges the NIAID, in consultation with the NIDDK, NICHD, and NIMH, to convene a working group to develop a research agenda aimed at improving the diagnosis and treatment of eosinophil-associated diseases. The Committee requests an update on this effort in the fiscal year 2012 congressional budget justification. The Committee understands that a number of private sector organizations are interested in funding research in this area and encourages the NIAID to collaborate with these organizations as well as other NIH Institutes in supporting relevant research activities.”
In early 2007, APFED worked with Legislators to draft HR 296. The resolution passed on May 15, 2007, forever designating the third week of May as National Eosinophil Awareness Week (NEAW). The purpose of NEAW is to create awareness and educate both the general public and medical community about eosinophil associated disorders. Read related press release.
APFED organized its first Capitol Hill Day in May 2007. It has since become an annual event for APFED leadership and eos families to meet with legislators to educate them about eosinophil associated diseases and the challenges faced by families coping with these diseases.
On May 17, 2007, APFED hosted a Congressional Briefing and Luncheon at the Library of Congress with physicians and patients educating attendees about eosinophil associated diseases. Afterward, families and patients met with legislators individually in both the House and Senate to discuss the needs of the eos community.
Even though suggestions for ICD-9-CM codes are normally not initiated by patient advocacy organizations, APFED, in keeping with its progressive mission to create awareness of EGID and the goal of obtaining NIH funding, was at the forefront of these requests. For two years, APFED worked with the Centers for Disease Control and Prevention’s Center for National Health Statistics to create unique ICD-9-CM diagnosis codes for EGIDs.
The ICD-9-CM coding system is an international classification system which groups related diseases and procedures for the purpose of reporting statistical information. ICD-9-CM codes provide a uniform language, and thereby serve as an effective means for reliable nationwide communication among physicians, patients, and third parties. ICD-9-CM codes are necessary for billing, insurance and medical records, disease management, treatment advances, research and national statistics.
To address food allergy concerns, the National Institute of Allergy and Infectious Disease worked with 34 professional organizations, federal agencies, and patient advocacy groups to develop clinical guidelines for healthcare professionals on the diagnosis, management and treatment of food allergy. APFED was the only organization specific to eosinophil associated disease that was invited to serve on the coordinating committee, participating in discussion and development of these guidelines specifically as they relate to eosinophil associated gastrointestinal diseases. The product of this committee resulted in a published document, entitled Guidelines for the Diagnosis and Management of Food Allergy in the United States, and multiple education materials for providers and the public.
APFED developed and put into place a long term strategic plan with specific steps necessary to obtain NIH funding for eosinophil associated disease research.
APFED was an invited charter member of Children’s Milk Allergy and Gastrointestinal Coalition (MAGIC), which is committed to “promoting healthcare coverage and reimbursement of amino acid-based elemental formulas for children who are unable to consume a natural, life-sustaining diet due to various allergies or diseases.” Since 2006 Children’s MAGIC has passed formula legislation in AZ, CT, IL, ME, MD, MA, MN, NH, NJ, TX, NY, RI, and OR.
Thank you to all of APFED’s advocacy volunteers and families who take the time to educate legislators about these diseases. If you would like to assist APFED with legislative efforts, sign up to be an advocacy volunteer.
Please help APFED continue to make advances in advocacy, education, and research initiatives: