Current Initiatives and Advocacy History

2020

• Issued communication to the U.S. Food and Drug Administration to share patient Perspectives on Current Treatment Options for Eosinophilic Esophagitis (EoE), outlining that administration of a medication that is targeted for EoE, has adequate effectiveness, minimal and manageable side effects and cost burden, which would improve quality of life were the most commonly mentioned things that should be evaluated when considering new therapies.
• Signed onto a support letter generated in collaboration with allergy and asthma patient advocacy groups to Chairpersons and Ranking Members of federal Appropriations Committees urging prioritization of resources to the U.S. Food and Drug Administration to carry out vital work related to allergen labeling, including required ingredient labeling for foods containing sesame.
• Signed onto support letters  to elected officials, government program directors, insurance commissioners, and others on a variety of important issues, including to urge protection of rare disease patients and high-risk populations during the COVID-19 crisis by: Issuing an emergency regulation allowing one-time 90-day refill of covered prescription medications and lift barriers to obtaining medication from out-of-network pharmacies; preparing for potential supply chain disruptions by requiring insurers to cover off-formulary prescription drugs if there is not a formulary drug available to treat the insured; ensuring prior authorization and reauthorization requirements do not impede access to care and treatment; facilitating authorization of home infusion services and ensuring reimbursement rates appropriately reimburse for such services; requesting authority to extend appeal and fair hearing deadlines to ensure important protections for patients who are seeking access to care and treatment; and seeking flexibilities afforded under section 1135(b)(1)(C) of the Social Security Act.
• Issued a letter of support to members of the U.S. Senate and House of Representatives for the Pediatricians Accelerate Childhood Therapies (PACT) Act – S. 3023 and H.R. 4519, which is proposed legislation that would establish a new trans-NIH career development award to support individual early-career pediatric researchers.
• Communicated community concerns to the U.S. Food and Drug Administration regarding its guidance to provide temporary flexibility in food labeling requirements during the COVID-19 pandemic, including allergen labeling and communicating substitutions to consumers who are avoiding less commonly known allergenic ingredients for medical reasons.
• Continued active participation with the Patients and Providers for Medical Nutrition Equity coalition, working in support of the Medical Nutrition Equity Act (MNEA, HR2501). In addition to sending written communication to lawmakers to describe about the need for national legislation for the insurance coverage of medical foods and asking for co-sponsorship of HR2501, APFED also participated in a number of virtual meetings with legislative staff on Capitol Hill. APFED also encouraged community participation in a grassroots National Medical Nutrition Action Day in May to encourage our community members to reach out to their elective officials in support of medical nutrition equity.
• New ICD 10-CM codes for subsets of eosinophil-associated diseases, including but not limited to eosinophilic asthma, eosinophilic pneumonia, and hypereosinophilic syndromes went into effect thanks to APFED's multi-year effort in partnership with the International Eosinophil Society. These medical codes are necessary for billing, insurance and medical records, and are critical in furthering our understanding of epidemiology, related costs, and outcomes for specific diseases.

2019

• The ICD-10-CM coding system is an international classification system that groups related disease and procedures for the purpose of reporting statistical information. These codes provide a uniform language and serve as an effective means for reliable nationwide communication among physicians, patients, and third parties. These codes are necessary for billing, insurance and medical records, and national statistics. Codes also have substantial benefits to the patient community, including promoting research into these diseases, new clinical trials, and successful insurance reimbursement for patients. APFED and the International Eosinophil Society (IES) partnered to propose and jointly advocate for eight distinct ICD-10-CM Codes for subsets of eosinophilic diseases and for four amendments to existing codes. The proposal for the new codes/amendments was well received and a decision is expected to be made in 2020.
• Continued educating federal lawmakers about the importance of medical foods to our community and barriers to access, APFED and several members of our community visited Capitol Hill in May 2019 to share our experiences with lack of insurance coverage, and to encourage Congressional support of the Medical Nutrition Equity Act (HR 2501).
  The event was organized by Patients and Providers for Medical Nutrition Equity (PPMNE), a coalition of which APFED is a member. APFED provided financial support to help defray the costs of the event.
• Hosted a workgroup meeting in Phoenix, AZ in January 2019 to gather and document perspectives and gaps in care in regards to EGID transitioning from pediatric to adult health care. Participants included adolescents with EGID, pediatric and adult gastroenterologists, allergists, a dietitian, and nurses. The workgroup identified challenges and needs, and provided input into future tools for patients and providers to better facilitate transition of care from pediatric to adult EGID health services.
  Findings from a related survey conducted by APFED, along with perspective shared at this workgroup meeting were presented as a research poster at the annual meeting of the American College of Gastroenterology in October.
• Published a Voice of the Patient Report in August 2019 that summarized the Hypereosinophilic Syndromes Patient Education and Drug Development Conference that the organization hosted in 2018 in Rockville, MD. The report reflects the perspectives of patients and caregivers who attended the event to share their perspectives with other patients, the U.S. Food and Drug Administration, and other key stakeholders about the impact the condition has had on them and their loved ones, and their views on current treatment approaches. Patient perspective is critical in helping the FDA understand hypereosinophilic syndromes in context as they make regulatory decisions for new treatments. The FDA linked to APFED’s Voice of the Patient Report from its webpage of externally-led patient focused drug development meetings so that other stakeholders can access this insightful summary.

2018

• APFED, working in partnership with other organizations dedicated to rare disease, issued a call to action in January urging families to request that members of Congress vote to extend long-term funding for the Children’s Health Insurance Program (CHIP). Failure to act would have resulted in putting approximately 9 million children at risk of losing healthcare coverage. APFED’s Medical Advisory Panel also signed on to a letter APFED sent to key Congressional leaders urging a funding extension. We are pleased to announce that Congress voted to extend CHIP funding for another six years.
• To support federal legislation that would provide insurance coverage of medical foods for certain conditions, such as EGID, APFED worked collaboratively with a coalition known as Patients & Providers for Medical Nutrition Equity(MNEA). APFED attended numerous meetings on Capitol Hill to meet with members of Congress and their staff to share with them the importance of medical foods coverage to our patient community, and to urge support of the Medical Nutrition Equity Act. On June 1, APFED financially supported and participated in a “Hill Day,” where we invited community members to join us for a day of meetings at the House and Senate offices in Washington, DC.

2017

• Continued to serve as a resource for advocates around the U.S. who are working on the state level to introduce legislation that would mandate insurance coverage of medical foods in areas where no such mandate currently exists.
• Continued work in support of Medical Nutrition Equity Act, which was reintroduced into Congress earlier this year. The legislation would require medical foods, such as elemental formula prescribed to treat eosinophilic disorders to be covered under Medicaid, Medicare, the Federal Employee Health Benefit Program, and private insurance.
• In addition to launching grassroot campaigns to encourage Congressional co-sponsorship of the legislation, APFED also made a number of visits to Capitol Hill to meet with elected officials and their staff to share patient stories and encourage support of this legislation.
• Advocated for protections for rare disease patients as Congress revises the Affordable Care Act. To date, there have been a number of legislation proposals that could negatively impact rare disease patients by undermining patient protections, increasing costs, decreasing coverage, cutting Medicaid, and removing crucial pre-existing condition protections. APFED contacted elected officials to voice concerns, signed onto letters of support as part of a larger initiative of rare disease-focused patient and professional groups, and issued a Legislative Call to Action to urge families to voice their concerns, as well. APFED joined several other patient and professional organizations to make our voices heard on issues that affect the rare disease community, such as:

  - Ending the NIH/FDA hiring freeze to avoid significantly hampering research into rare disease treatments and the subsequent approval process.

  - Opposition of H.R. 1313, the Preserving Employee Wellness Programs Act, legislation that would attempt to tie financial incentives to employee wellness programs at the expense of the crucial privacy and anti-discrimination protections afforded employees with genetically-detectable diseases, including eosinophil-associated diseases and other rare diseases.

-Support of the Orphan Drug Tax Credit (ODTC), urging Congress to keep this critical tax credit in place to provide incentives for drug companies to develop products for rare diseases.

-Support for Addendum Guidelines for the Prevention of Peanut Allergy in the United States, compiled this year by the National Institute of Allergy and Infectious Diseases. APFED served as a participant on the coordinating committee.

2016

• Supported efforts that led to the successful passage of legislation to improve insurance coverage of medical foods in Colorado, Kentucky, and Missouri.
• To support federal efforts for improved coverage of medically-necessary foods for TRICARE recipients, APFED met with leaders on Capitol Hill to advocate for our patient community. TRICARE is the health care program for uniformed service members and their families. Current TRICARE coverage policy for medically-necessary foods has been reported to be open to interpretation, often resulting in delayed or denied coverage of nutrition therapy for TRICARE recipients. Passage of legislative language requiring TRICARE to cover medically-necessary foods for digestive and inherited metabolic disorders is currently a priority of APFED’s, as successful passage will serve as a much-needed rallying point for future efforts around the country.

2015

• Educated legislators in Washington, D.C. about the struggles that families with eosinophil-associated diseases face and asking their help to ease the burden.
• 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 RDCRN 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).

2014

• Continued efforts to educate legislators in Washington, D.C. about the importance and need of federal funding to support the research of eosinophil-associated disease.
• Organized a trip for APFED community members to meet with members of Congress in Washington, DC to ask for increased NIH funding for research. A federal grant was awarded later in 2014 to support the work of the Consortium of Eosinophilic Gastrointestinal Disease Researchers (CEGIR).
• Supported volunteers working to pass state 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.
• Disseminated an instructional video for volunteers to provide the nuts and bolts to organize local efforts.
• 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.

2013

• APFED leadership and families met with members of Congress in Washington, D.C. to speak about the challenges patients with eosinophil associated diseases face, and the need for more research that would lead to less invasive testing and therapies. 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.
• 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.
• Continued discussion with the National Institute of Allergy and Infectious Diseases to develop programs that act on the recommendations of the TREAD document.
• Supported volunteers around the country who were actively working to pass state legislation and/or educate legislators on the need for improved access to medical foods as a treatment for eosinophilic gastrointestinal diseases.
• Expanded advocacy resources on the website 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.
• Developed a medical foods advocacy toolkit 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.  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.
• This year saw 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.

2012

• Created an agenda for the Taskforce on the Research Needs of Eosinophil Associated Diseases (TREAD) Workshop that was held in June 2012 in Bethesda, Maryland at the National Institutes of Health (NIH). On this day, the 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
• Continued efforts in 2012 to educate legislators in Washington, D.C. about the importance of eosinophil-associated disease 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 2012, 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)
• 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.

• 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 more than 13 states.
• 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.
• Organized our first Capitol Hill Day in May 2007 and arranged for families to meet with legislators to educate them about eosinophil associated diseases and the challenges faced by families coping with these diseases.
• Hosted a Congressional Briefing and Luncheon at the Library of Congress on May 17, 2007 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 codes went into effect in 2018. 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.
• 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.
• Educated members of Congress 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.”
• Represented the eos community by participating in and presenting at NORD’s medical foods conference in Washington DC.
• 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. 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.
• 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.