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ASH Officers Visit the White House Initiative on Women’s Health Research to Discuss Women’s Health and Hematology

On September 18, ASH leaders met with staff from the White House Gender Policy Council and First Lady’s Office to discuss the , focusing on the link between women’s health and hematology. The meeting addressed issues such as iron deficiency anemia in women and the challenges posed by , including low socioeconomic status and food insecurity, which can limit access to treatment. Although it's estimated that 50% of women with anemia could benefit from iron supplementation, there is still evidence on the effectiveness of screening and supplementation due to a lack of available data. The attendees advocated for more research on iron deficiency in women and for greater inclusion of women in clinical trials for hematological diseases. ASH hope to continue collaboration with the White House by discussing actionable next steps to improving care in iron deficiency anemia and increasing diversity in clinical trials.

Updated SCD Legislation Introduced in Senate

A revised version of the ASH-supported Sickle Cell Disease Comprehensive Care Act () was introduced in the Senate on September 18. ASH leadership learned of the bill’s introduction when they visited Senator Scott’s staff during their annual advocacy visits to Capitol Hill. The legislation, which closely resembles legislation that was introduced in the House earlier this year (), aims to ensure that individuals with sickle cell disease (SCD) have better access to comprehensive, high quality outpatient care, including recommended clinical, mental health, ancillary, and support services by allowing states to establish Medicaid Health Home programs with SCD as the single qualifying condition for eligibility. Please visit the ASH Advocacy Center and send a message to your Senators and Representative urging their support for this important legislation.

ASH and CMS Host a Town Hall on Quality Measurement for Sickle Cell Disease

On September 4th, ASH partnered with the Centers for Medicare & Medicaid Services (CMS) to host a . ASH and federal partners from CMS, including the Center for Medicaid and CHIP Services and the Center for Clinical Standards and Quality, the Office of the Assistant Secretary for Health, and the Health Resources Services and Administration provided updates on current programs to support individuals with SCD. The session also included a discussion portion in which attendees submitted questions related to quality measurement opportunities, such as time to analgesia, transcranial Doppler screenings, transition of care between pediatrics and adult care, and implementation strategies. ASH and CMS are continuing this collaboration by discussing actionable next steps to improve the quality of SCD care.

ASH and FDA Host Workshop on Regulatory Science in Hematology

On September 10th and 11th, ASH and FDA cohosted the ASH-FDA Collaboration: A Workshop on Regulatory Science in Hematology at ASH Headquarters. This two-day meeting included a select group of ASH members who joined to gain a better understanding of the FDA and allow for an exchange on regulatory issues in hematology drug development. ASH was pleased to welcome the Workshop Co-Chairs, Drs. Grzegorz Nowakowski (Co-chair, ASH Subcommittee on Clinical Trials, Mayo Clinic), Irene Ghobrial (Co-chair, ASH Subcommittee on Clinical Trials, Dana-Farber Cancer Institute), and Richard Pazdur (Director, FDA Oncology Center of Excellence) and over 60 FDA staff to educate participants on topics such as clinical and translational research, trial design, and drug development.

ASH Continues Advocacy for Physician Payment Reform

In mid-September, ASH joined the American Medical Association and other medical specialty societies in support of a "Dear Colleague" letter from Representatives Miller-Meeks, Panetta, Murphy, Ruiz, Bucshon, Schrier, Joyce, and Bera. The Dear Colleague is being circulated to House Congressional leadership urging Congressional action and encouraging members to cosponsor key legislation to not only stop the 2.8% cut, but also provide physicians with a payment update that reflects inflationary pressures prior to January 1, 2025. ASH is continuing to advocate for physician payment reform and will share updates as developments occur.

ASH Submits Comments to CMS in Response to Two Payment Schedule Proposed Rules

On Monday September 9^th, ASH submitted comments on the CY 2025 Medicare Physician Fee Schedule proposed rule. ASH commented on several provisions in the proposed rule, including continued support for updates to the conversion factor and Practice Expense data, payment for telehealth services and expanding the telehealth provision to include audio-only in the definition, the valuation and implementation of various codes that impact our members, and continuing advocacy to expand dental services for individuals with Sickle Cell Disease (SCD).

ASH also submitted comments on the CY 2025 Hospital Outpatient Prospective Payment System proposed rule. ASH focused comments on reimbursement policies for cell and gene therapy bundled payments, recommending separate payments for these therapies reflective of the unique nature of each therapy, and reimbursement for CAR T-cell therapy, similarly recommending separate payments to reflect each stage of treatment.

ASH will share updates on the finalized policies when they are released.

ASH Letter to FDA re Draft Guidance on Diversity Action Plans for Clinical Studies

The US Food and Drug Administration (FDA) released a draft guidance on Diversity Action Plans meant to improve the enrollment of participants from underrepresented populations in clinical studies. In a letter, ASH encouraged the FDA to clarify enrollment requirements and promote compliance with the Diversity Action Plan by highlighting the ASH Diversity Equity and Inclusion Toolkit for Clinical Trial Sponsors.