2024 End of Year Report

• In late March, nearly halfway through the 2024 fiscal year (FY), President Biden signed into law a spending package that included the Departments of Labor, Health and Human Services and Education (Labor-HHS) appropriations bill. The bill provided NIH with total base funding of $47.081 billion, $378 million (0.8%) below the comparable FY 2023 funding level, though the reduction is mainly the result of a scheduled decrease in funding available to NIH in FY 2024 through the 21st Century Cures Act. The bill also provided $1.5 billion in new funding to the Advanced Research Projects Agency for Health (ARPA-H), the same level as provided in FY 2023. The CDC received $9.2 billion in funding, including $6 million for the Sickle Cell Data Collection program, the same level provided in FY 2023. Congress previously finalized funding for parts of the federal government, including the Food and Drug Administration (FDA), on March 8, 2024.
• In response to the bill’s enactment, the Ad Hoc Group for Medical Research, of which ASH is a member, issued a statement, expressing appreciation that Congress continues to recognize the NIH as a key national priority despite strict discretionary spending caps. The statement, however, also noted that sustained, robust growth in NIH funding must be resumed in order to maximize the full potential of medical research.

• On March 11, 2024, the White House released President Biden’s proposed FY 2025 budget, including an accompanying “Budget in Brief” document for the Department of Health and Human Services (HHS). In FY 2025, the President proposed $48.3 billion in discretionary funding for the NIH base budget. Additionally, the budget proposes $1.5 billion in mandatory funding for the Cancer Moonshot, $2.7 billion in mandatory funding for biodefense research, and $1.5 billion for ARPA-H.
• In March, ASH joined nearly 400 organizations and institutions across the NIH stakeholder community to recommend an appropriation of at least $51.3 billion for the NIH’s foundational work in FY 2025. This funding level would allow the NIH’s base budget to keep pace with biomedical inflation and allow meaningful growth of roughly 5%. The recommendation urges lawmakers to maintain investments in the NIH as a key bipartisan national priority and to continue supporting patients and discovery.
• Although both the House and Senate Appropriations Committees made progress in advancing their FY 2025 Labor-HHS appropriations bills through the committee process, neither chamber was able to advance the bills to floor consideration. The House version of the spending bill maintains overall funding for NIH at the FY 2024 level. The Senate version of the spending bill provides a net increase in funding for NIH of $1.770 billion over the comparable FY 2024 level.
• The Senate bill also includes an overall funding increase for the CDC, which received a 22 percent cut in funding in the House committee approved bill. Funding for the Sickle Cell Data Collection program within the CDC is maintained at the current funding level of $6 million in the Senate bill (funding for the program in the House bill is unclear).
• In late September, Congress averted a government shutdown before the start of the federal fiscal year by approving a Continuing Resolution (CR) that will keep the government funded through December 20, 2024.
• NIH issued guidance in October stating that, as it has done in the past, under this CR, current awards will be funded at a level below what was indicated on the most recent Notice of Award, and that no new awards will be made until a FY 2025 appropriations bill is finalized and signed into law.
• Proposals to enact structural reforms to NIH and restrict certain types of research and related activities were also included in the House funding bill. The proposed reforms mirror the framework of recommendations for new policies at NIH and the request for information from stakeholders that was released on June 14 by House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA).
  
  
  • ASH submitted comments on the request for information, which noted that any structural changes to the NIH should only occur after a deliberative process that has a strong scientific rationale and incorporates relevant expertise from within the NIH, the federal government, and the broader research community. ASH’s comments also expressed concern with several proposals put forward in the framework, including proposals to combine institutes and impose term limits for institute and center leaders.

Over the past few years, ASH has expanded its engagement with the U.S. Department of Defense (DoD) Congressionally Directed Medical Research Program (CDMRP) and advocated for CDMRP funding.

• In 2024, ASH met with representatives from the CDMRP programs that have hematology-related research in their portfolios, ASH representatives were invited to provide the hematologic perspective at CDMRP strategy meetings, and the Society has promoted CDMRP’s funding opportunities.
• In March, members of the Committee on Government Affairs encouraged Congress to increase funding for the CDMRP program and to retain critical hematologic research areas and programs for FY 2025.
• In May, ASH along with the Defense Health Research Consortium (DHRC) sent a letter to Congressional leadership to support increased funding for CDMRP in FY25; and in December. the Society joined a DHRC letter encouraging Congress to enact the FY25 Defense Appropriations Act.

• ASH is grateful for the engagement of its Grassroots Network members who, throughout the year, urged Congress to support federal medical research and public health program funding, as well as additional ASH advocacy priorities. Members utilized the ASH Advocacy Center to find sample letters and tweets supporting ASH’s advocacy priorities. ASH encourages members interested in advocacy to join the Grassroots Network to receive regular updates about the Society’s advocacy efforts impacting hematology and information about how to contact their members of Congress.
• One of the most visible ways for the Society to advocate for hematology issues continues to be through meetings with Members of Congress and their staff. In 2024, ASH staff and members of the Society held more than 150 in-person and virtual meetings with congressional offices throughout the year to advocate for the Society’s policy priorities.
  
  
  • On March 12, members of the Committee on Government Affairs met with more than 25 congressional offices in support of ASH’s federal funding priorities, including funding for the NIH and funding for the CDC Sickle Cell Data Collection program.
  • In September 2024, ASH sponsored the 12th annual Rally for Medical Research Hill Day. Participants from more than 350 partnering organizations, including ASH, met in-person with congressional offices in support of funding for NIH.
  • On September 25, ASH hosted the annual ASH Advocacy Leadership Institute, co-chaired by Drs. Jennifer Holter Chakrabarty and Bart Scott (who also serve as the Chair and Vice Chair of the Committee on Government Affairs, respectively). Twenty-five ASH members from across the U.S., with diverse experience and hematologic interests and representing both practice and research settings, spent the first day of the workshop at ASH headquarters, learning about the legislative process and health policy, and receiving training on how to be an effective advocate. The following day, the participants visited nearly 50 congressional offices to advocate for three of ASH’s policy priorities: sustained and consistent increases in funding for the NIH; increased funding for the CDC Sickle Cell Data Collection program; and recruitment of additional co-sponsors for the Sickle Cell Disease Comprehensive Care Act (H.R. 7432/S. 5097). Applications for the 2025 cohort will open in early 2025.

Medical Education

• In April, ASH joined 26 other medical societies in sending a letter  to Congress opposing legislative efforts, including the Embracing Anti-Discrimination, Unbiased Curriculum, and Advancing Truth in Education (EDUCATE) Act (H.R. 7725), that seek to prohibit medical schools from receiving federal funding (including participating in federal student loan programs), if they adopt policies and requirements relating to diversity, equity, and inclusion (DEI).
• In early May, ASH joined a number of medical societies and organizations in endorsing a resolution introduced by Congresswoman Joyce Beatty (OH-03), co-chair of the Congressional Black Caucus’ Diversity, Equity, and Inclusion (DEI) Task Force, and Congresswoman Kathy Castor (FL-14), Co-chair of the Congressional Academic Medicine Caucus. The resolution affirms the need for a healthcare workforce that mirrors the nation’s diverse patient populations to advance health equity throughout the United States. To that end, the resolution commits to supporting DEI programs and academic freedom at medical education institutions.

ASH Supports Medicare GME Reform

• In June, ASH provided comments in response to the Senate Finance Committee’s policy outline describing improvements to the Medicare Graduate Medical Education (GME) program to address physician workforce shortages across the country. ASH encouraged the Committee to expand and improve the distribution of Medicare-supported GME training positions to rural areas and specialties in shortage, highlighting the shortages in hematology, particularly in rural and non-metropolitan areas.

ASH Expresses Interest in Physician Payment Reform

• Throughout the year, Congress began deliberations on long-term physician payment reform. In the spring, the Senate Finance Committee held a hearing on “Bolstering Chronic Care through Medicare Physician Payment.”  Witnesses and members of the Committee highlighted concerns with the Medicare physician payment structure leading to a worsening physician shortage and patient access issues, and they discussed the need for reforms in physician payment, quality programs, care coordination, prior authorization, telehealth, and other payment related reforms.
• Additionally, Senators Ron Wyden (D-OR) and Mike Crapo (R-ID) released a white paper discussing the issue. ASH submitted comments focusing on the need for annual inflation-based updates to payments and elevating the unique challenges cognitive specialties face in the valuation of their work.
• Furthermore, Senators Sheldon Whitehouse (D-RI) and Bill Cassidy (R-LA) released a request for information (RFI) accompanying the senators’ bipartisan Pay PCPs Act. The legislation aims to better support and improve pay for high-quality primary care providers by encouraging the Centers for Medicare & Medicaid Services (CMS) to adopt a hybrid payment model for primary care providers, reduce beneficiary cost sharing for primary care services, and establish a time-limited technical advisory committee (TAC) to advise CMS on methods to more accurately value Medicare Physician Fee Schedule (MPFS) services. ASH met with staff for both Senators Whitehouse and Cassidy to share our feedback and recommendations and submitted comments in response to the RFI.
• In the fall, ASH joined the American Medical Association and other medical specialty societies to circulate several letters to Congress advocating for physician payment reform. ASH joined this coalition in support of a "Dear Colleague" letter from Representatives Miller-Meeks, Panetta, Murphy, Ruiz, Bucshon, Schrier, Joyce, and Bera 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 also joined 129 medical societies in an AMA Federation letter urging Congress to both prevent the scheduled 2.83 percent Medicare physician payment cut and, critically, provide a positive payment update for 2025.

CY 2025 Medicare Physician Fee Schedule

• The Centers for Medicare & Medicaid Services (CMS) released the 2025 Medicare Physician Fee Schedule (MPFS) proposed rule on July 10. ASH submitted comments on the MPFS proposal responding to several provisions: updates to the conversion factor and practice expense data, payment for telehealth services including audio-only in the telehealth 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).
• On November 1, CMS released the MPFS final rule for Calendar Year 2025. The rule in its entirety and the addenda, including Addendum B, which lists the proposed RVUs for every CPT® code, can be found here.  Notably, CMS finalized the conversion factor for 2025, which is set to decrease by approximately 2.83% from $33.2875 to $32.3465. CMS also finalized several significant policy changes, including bundling payment for certain services associated with CAR T-cell therapy administration, redefining telehealth services to include audio-only services, and declining to accept and pay for the new 16 of the 17 telemedicine E/M codes. More information about the provisions the Society commented on and the policies that CMS finalized can be found here. 

CY 2025 Medicare Hospital Outpatient Prospective Payment System

• On July 10, the Centers for Medicare & Medicaid Services released the proposed rule for the CY 2025 Hospital Outpatient Prospective Payment System (OPPS) and the Ambulatory Surgical Center (ASC) Payment System.
• ASH submitted comments on the OPPS proposed rule focusing on reimbursement policies for cell and gene therapy bundled payments. The Society recommended separate payments for these therapies reflective of the unique nature of each therapy.
• On November 1, CMS released the OPPS final rule for CY 2025, accompanied by a fact sheet. The Agency finalized policy for CAR T-cell therapy treatment by continuing to bundle payment for the services associated with the collection, preparation, and transport CAR T-cells. Of note, payment for CAR T-cell therapy administration is paid separately under the OPPS.

FY 2025 Inpatient Prospective Payment System (IPPS) Rule

• In June, ASH submitted comments to the Centers for Medicare & Medicaid Services (CMS) responding to several provisions in the Hospital Inpatient Prospective Payment System (IPPS) proposed rule. The proposal included a major policy win for ASH, creating new ICD-10-CM codes to describe Duffy phenotype, which ASH requested through the ICD-10-CM public code request process in 2023. ASH member, Maureen Achebe, MD, MPH, participated in a public meeting to advocate, on behalf of ASH, for inclusion of Duffy phenotype codes in the ICD-10-CM code listing. CMS lists new ICD-10-CM codes in the tables released with the IPPS proposed rule, which were available for use as of October 1, 2024. Table 6A includes four codes to capture Duffy phenotype status. The new codes are:
  
  
  • Z67.A1: Duffy Null
  • Z76.A2: Duffy a positive
  • Z76.A3: Duffy b positive
  • Z76.A4: Duffy a and b positive
• The Society’s comments on the proposed rule cover topics related to the new codes for Duffy Null status, proposed changes to codes capturing housing status, various payment provisions for the newly approved cell and gene therapies in general and for sickle cell disease (SCD), and payment for graduate medical education (GME).
• On August 1, CMS issued the FY 2025 IPPS final rule updating Medicare payments and policies for inpatient hospitals and long-term care hospitals. The final rule included the ICD-10-CM codes for Duffy null status, codes denoting housing status, payment for CAR-T therapy, and feedback about GMS. Notably, the IPPS proposed rule was the first released after the approval for the two gene therapies for sickle cell disease (SCD). CMS proposed to increase the New Technology Add-On Payment (NTAP) for gene therapies indicated for SCD from 65% to 75%. ASH’s comments focused on ensuring appropriate access for patients; while ASH appreciated the Agency’s intention to provide additional support for these therapies, we urged the Agency to rethink their proposal and implement the NTAP at 100%. Despite our comments, CMS finalized the policy as proposed and the NTAP for gene therapies for SCD will be 75%.  Additionally, CMS determined that Casgevy and Lyfgenia meet the criteria for approval for NTAP, which ASH supported.

National Coverage Determination for Allogenic Hematopoietic Stem Cell Transplantation for MDS 

• On January 5, ASH, along with the American Society for Transplantation and Cellular Therapy (ASTCT), the Blood and Marrow Transplant Clinical Trials Network, the Center for International Blood and Marrow Transplantation, and the National Marrow Donor Program (NMDP), submitted a comment letter expressing support, while also offering edits for consideration on the Centers for Medicare & Medicaid Services’ (CMS) proposed coverage decision memo for Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) for Myelodysplastic Syndromes (MDS).  The comment letter included supporting evidence for the use of cord blood stem cell products as a donor source and the use of additional recognized scoring systems and risk designations.
• On March 6, the Centers for Medicare & Medicaid Services released a final decision memo on the national coverage determination (NCD) for HSCT for MDS. The final decision memo outlined the inclusion of cord blood as a donor source, and CMS will allow the use of other recognized risk scoring systems.  ASH views this as an important win for Medicare patients with MDS, who will now have greater access to this treatment option.
• On March 29, ASH, ASTCT, and the NMDP sent a letter to all Medicare Advisory Carrier (MAC) Medical Directors to inform them that they may be experiencing an influx of (HSCT) for MDS cases that were covered under a previous CMS policy, and that the MACs have the discretion to cover these cases under the new National Coverage Decision (NCD) on HSCT for MDS that was released on March 6.

ASH Comments on Medicare Programs CY 2025 Technical and Policy Changes Proposed Rule 

• The Centers for Medicare & Medicaid Services (CMS) released a Medicare Programs Contract Year 2025 Policy and Technical Changes proposed rule for several programs. On January 5, ASH commented on two provisions in this proposed rule about prior authorization: the Annual Health Equity Analysis of Utilization Management (UM) Policies and Procedures, and the Biosimilar Biological Product Maintenance Changes and Timing of Substitutions. ASH expressed support for CMS’ actions to improve health equity considerations in UM policies and procedures and support for reducing the administrative burden of prescription drug modifications and substitutions by allowing biosimilars to be treated as maintenance changes.

CMS Finalizes Policies on Prior Authorization

• On January 17, the Centers for Medicare & Medicaid Services (CMS) released a final rule that outlines policy changes to the prior authorization (PA) process for Medicare Advantage (MA) organizations, state Medicaid and Children’s Health Insurance Program (CHIP) Fee-for-Service (FFS) programs, Medicaid managed care plans, CHIP managed care entities, and Qualified Health Plan (QHP) insurers on the Federally Facilitated Exchanges (FFEs). The provisions of the final rule streamline the PA process, alleviate administrative burden for providers, and apply only to PA for items and services. Drugs of any type are not covered by the rule. A summary of the rule with a comment comparison chart and ASH’s comment letter are available that provide additional detail.

Senior’s Timely Access to Care Act

• In the summer, ASH shared support for the reintroduction of the Senior’s Timely Access to Care Act. This bipartisan and bicameral piece of legislation aligns with ASH’s advocacy work to improve prior authorization (PA) processes in Medicare Advantage (MA) plans by increasing transparency around determinations, supporting electronic infrastructure for PA to expedite determinations, and expanding protections for beneficiaries. ASH continued to support this legislation as it moved through the legislative process and joined over 500 organizations to advocate for the passage of the bipartisan Senior’s Timely Access to Care Act.

Efforts to Support Palliative Blood Transfusions for Medicare Hospice Beneficiaries

• On Monday, July 29, the Centers for Medicare & Medicaid Services (CMS) released the FY 2025 Hospice Wage Index and Payment Rate Update, Hospice Conditions of Participation Updates, and Hospice Quality Reporting Program Requirements. The final rule implements policy changes and update hospice payment rates beginning October 1, 2024.
• In May, the Society submitted comments on the proposed rule, responding to a request for information on payment mechanisms for high intensity palliative care services, including the use of blood transfusions. CMS did not respond to specific comments in its final rule; however, CMS noted that it will consider recommendations made by stakeholders if the Agency develops a future payment policy for high intensity palliative care services.
• ASH has continued to advocate for this important issue through other means, including supporting S. 2186, the Improving Access to Transfusion Care for Hospice Patients Act. This bipartisan bill aims to increase access to palliative blood transfusions for patients receiving end-of-life care through the Medicare hospice benefit by establishing a demonstration program to provide a separate payment for blood transfusions in addition to the daily reimbursement rate for hospice care services. The creation of innovative reimbursement models such as this is one of the recommendations of the ASH Statement in Support of Palliative Blood Transfusions in Hospice Setting.

ASH Submits Comments on Medicare Prescription Payment Plan Communication Documents

• In February, the Centers for Medicare & Medicaid Services (CMS) released the draft Part Two Guidance for the Medicare Prescription Payment Plan (MPPP). The MPPP was part of several improvements to Medicare Part D in the Inflation Reduction Act, and caps out of pocket (OOP) costs for beneficiaries to $2,000 in a plan year. The second guidance outlined CMS’ communication strategy to support patient education and outreach, and in March, CMS released six model communication documents to support the MPPP. ASH submitted feedback on the model communication documents, supporting the program and outreach efforts and building on ASH’s earlier comments to CMS on the draft Part Two Guidance. 

Sickle Cell Disease Comprehensive Care Act 2024

• A revised version of the Sickle Cell Disease Comprehensive Care Act (H.R. 7432) was introduced in the House of Representatives by Congressmen Michael Burgess (R-TX) and Danny Davis (D-IL) in late February 2024. This bipartisan legislation, which is strongly supported by ASH, aims to ensure that individuals with 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. The legislation was included in an Energy and Commerce Committee hearing on rare diseases on February 29, 2024. A Senate version of the legislation (S. 5097) was introduced by Senators Cory Booker (D-NJ) and Tim Scott (R-SC) in September 2024.
  
  
  • ASH members and staff continued to meet with congressional offices throughout 2024 to gain support for the legislation. The Committees on Government Affairs and Practice, as well as participants in the 2024 ASH Advocacy Leadership Institute (ALI) met with over 120 congressional offices on Capitol Hill to urge Members of Congress to support and cosponsor the Sickle Cell Disease Comprehensive Care Act.
• In June, ASH led a group of 85 organizations in sending a letter to the House Energy and Commerce Committee, urging them to markup the Sickle Cell Disease Comprehensive Care Act (H.R. 7432). ASH sent emails to staffers in the House of Representatives and Senate to encourage support for this legislation ahead of World Sickle Cell Day.
• In November, ASH joined over 90 organizations in sending a letter to congressional leaders urging them to include the Sickle Cell Disease Comprehensive Care Act in any year-end legislative package that may be considered by Congress.
• For additional information about ASH’s 2024 advocacy to urge Congress to support funding for the CDC’s Sickle Cell Data Collection program and other federal SCD programs, please see the 2024 ASH Research and Public Health Funding Advocacy Highlights.

In 2024, ASH continued to collaborate with and advise the US Department of Health and Human Services (HHS) on sickle cell-related matters. As a result of a series of ASH and HHS-convened Sickle Cell Disease (SCD) Registry Leaders Roundtables over the past few years, the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (hereafter ASTP)) and the Office of the Assistant Secretary for Health (OASH) launched a project to create an SCD minimum core dataset under the United States Core Data for Interoperability Plus (USCDI+) program. The USCDI+ SCD project intends to establish minimum core data elements and definitions that can be implemented within certified EHR systems.

ASH also continues to engage in discussions with the Centers for Medicare & Medicaid Services (CMS) and the Agency’s various Centers about SCD.

• In early June, ASH submitted feedback on CMS’ proposed provisions in the Medicare Inpatient Prospective Payment System proposed rule to increase the New Technology Add-On Payment (NTAP) percentage from 65% to 75% for a gene therapy that is indicated for the treatment of SCD (NOTE: NTAPs are provided for new technologies for a three-year period). ASH urged the agency to implement the NTAP at 100% to allow better access to this innovative therapy. Although CMS recognized ASH’s comments, the Agency finalized the policy as proposed and the NTAP for SCD gene therapies will be set at 75%.
• In May, ASH met with the CMS Center for Clinical Standards and Quality to discuss the ASH-developed electronic clinical quality measure to address timely treatment of pain in the emergency department, and CMS leaders shared positive feedback. This measure was then officially submitted to CMS for consideration for the Hospital Outpatient Quality Reporting and Rural Emergency Hospital Quality Reporting Programs. The measure is proceeding through the Measures Under Consideration process; and in December, a public comment period was open for the measure as part of the Pre-Rulemaking Measure Review process.
• As a follow-up to ASH’s ongoing advocacy and positive discussion with CMS related to SCD, the Agency invited ASH to co-sponsor a Town Hall on SCD Quality Measurement. During the September 4 Town Hall, ASH representatives and SCD experts Robert Liem, MD and Titilope Fasipe, MD, PhD presented on the Society’s related work, and on opportunities for future quality measures and other interventions that can improve the quality of care for SCD patients through federal programs and policies. The Town Hall provided a unique opportunity for ASH to advise leaders from several arms of the Agency on key actionable solutions in this area of policy.
• On January 30, the Centers for Medicare & Medicaid Services Innovation Center (CMMI) launched the Cell & Gene Therapy (CGT) Access Model for individuals with Sickle Cell Disease. The model aligns with several ASH policy priorities, including the ASH Sickle Cell Disease Initiative and access to care.
  
  
  • The Society has continued to engage the CMMI team on other priorities related to SCD, including the Town Hall on SCD Quality Measurement, as the CMMI team has moved through securing agreements with the manufacturers.
  • In early December, CMMI announced that the model secured agreements with both LYFGENIA and CASGEVY, and the team is moving onto the next stage, engaging states to help them decide whether to participate in the model.
• Please see ASH’s 2024 Year-end Physician Practice Advocacy Highlights for more information regarding ASH’s engagement with CMS regarding payment for SCD-related activities, which included continuing advocacy to expand dental services for individuals with SCD, and various payment provisions for the newly approved cell and gene therapies in general and for SCD.

• In February, ASH joined 24 other provider and patient organizations in sending an amicus brief urging the United States Supreme Court to reverse the Fifth Circuit’s decision in Alliance for Hippocratic Medicine et al. v. the U.S Food and Drug Administration (FDA) et al., which called into question the FDA’s approval of mifepristone. The joint statement also expressed serious concern regarding legal interference with the federal agency’s ability and authority to review and approve drugs that are critical to health care access for all Americans
  
  
  • In mid-June, ASH and the same twenty-four organizations, released a press statement applauding the Supreme Court’s unanimous ruling reversing the Fifth Circuit’s decision in Alliance for Hippocratic Medicine et al. v FDA et al., on the grounds that the plaintiffs do not have standing in their challenge concerning the use and availability of Mifepristone. The statement also underscored remaining concerns that different plaintiffs will continue to pursue dangerous and unfounded arguments that undermine FDA decisions about drug safety.
• In April, ASH submitted comments to the National Academies of Sciences, Engineering, and Medicine Committee on the Assessment of National Institutes of Health’s (NIH) Research on Women’s Health, which noted the Society’s perspective on gaps in maternal health research across NIH institutes and centers, consistent with the comments shared in response to the White House initiative mentioned above.
• In April, the Society published the ASH Policy Statement on Coverage of Fertility Treatment in Hematologic Care. Fertility preservation is a critical aspect of reproductive health care to safeguard an individual's ability to have children in the future. It is especially in hematology given that several malignant and classical hematological conditions and related treatments can potentially cause infertility or impair fertility.
• Engagement with Leaders of the White House Initiative on Women’s Health Research
  
  
  • In August, ASH leaders Drs. Belinda Avalos (President-Elect), Sarah O’Brien (Chair, Working Group on Maternal Health and Hematology), and Kelsey Martin (Committee on Practice) met with Dr Carolyn Mazure, Chair of the White House Initiative on Women’s Health Research, and members of the White House Gender Policy Council as a follow-up to the comments ASH submitted to the White House on this initiative.
  • On September 19, the ASH Officers were invited to the White House to speak further with staff on these issues. ASH leadership explained the prevalence of iron deficiency anemia in women and the impact inequities can have on access to treatment, and research gap in iron deficiency anemia.

Addressing Drug Cost

• On August 15, 2024, the Biden-Harris administration released the agreements for new, lower, prices for all 10 drugs selected for negotiations, and three of the ten listed drugs have hematologic indications:
  
  
  • Eliquis (apixaban): List Price $521, Negotiated Price $231, 56% reduction
  • Imbruvica (ibrutinib): List Price $14,934, Negotiated Price $9,319, 38% reduction
  • Xarelto (rivaroxaban): List Price $517, Negotiated Price $197, 62% reduction
• The Medicare Drug Negotiation Program is in line with the ASH Policy Statement in Support of Patient Access to Safe and Effective Drugs, which states ASH's support of the Federal government's ability to negotiate Part D drug prices with pharmaceutical companies. ASH has continued to support this program through a series of Amicus briefs being filed in cases across several states and as they move through the court system. ASH is continuing to monitor the status and progress of these cases. Additionally, ASH is engaging with CMS in conversations for considerations the Agency should think about as the program expands the number of prescription drugs and includes Part B medications.

Drug Shortages

• On May 7, 2024, members of the Committee on Practice discussed the importance of combatting drug shortages with members of congress, advocating for legislation to include transparency around drug shortages, authorize the FDA to support a resilient supply chain, and provide incentives to realign hospital purchasing practices to promote the purchases of high-quality drugs.
• ASH joined a stakeholder group of health associations to develop a consensus policy statement on combatting cancer drug shortages and to engage in collective advocacy.
• ASH continues to have dialogue with the FDA about drug shortages, alerting the Agency to critical shortages and ways to access these therapies, and underscoring the impact these shortages are having on patients with hematologic conditions.

FDA Advocacy and Collaboration

ASH continues to respond to the FDA’s draft guidance that intersects with hematology and the Society’s priorities, including the following comment letters:

• March 2024 letter re: FDA’s March 15th Oncologic Drugs Advisory Committee’s (ODAC) review of T-cell malignancy risk and other topics related to the safety and efficacy of these therapies
• April 2024 letter re: FDA’s draft guidance on the Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products
• June 2024 letter re: FDA’s Draft Guidance on Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products
• September 2024 letter re: FDA’s draft guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies

ASH also partnered with the FDA on the following joint educational programs.

• In September, ASH hosted the third annual ASH/FDA Collaboration: A Workshop on Regulatory Science in Hematology, which helped successfully facilitate information sharing in various engaging formats, and networking between a select group of ASH members and FDA representatives.
• In conjunction with the ASH Annual Meeting in early December, the Society and Agency co-hosted the annual ASH-FDA Joint Symposia on (1) Accelerating Drug Development for Hematologic Malignancies; and (2) Challenges and Innovations in Rare Diseases in Non-Malignant Hematology.