2022 ASH Advocacy Efforts to Ensure Patient Access to Care
ASH continues to advocate for issues impacting hematology research and practice, including research and public health funding, access to quality care for patients, physician payment and coverage for hematologists, and policy issues related to sickle cell disease (SCD). The following overview provides information on advocacy highlights on ensure patient access to care.
As part of ASH’s comprehensive effort to help improve maternal healthcare outcomes in hematology and in response to the Supreme Court decision on Dobbs v. Jackson Women’s Health Organization, the Society expanded its advocacy to oppose any laws or regulations that seek to interfere in the confidential relationship between a patient and their physician and to prevent physicians from providing necessary medical care or offering evidence-based information to their patients. The following summary highlights examples of ASH’s related advocacy on the topic and resources developed to help members with advocacy to protect access to maternal health care.
- ASH signed onto letters in February 2022 and May 2022 supporting the Women’s Health Protection Act. This legislation supports the ability of physicians to provide evidence-based care to their patients that is free from legislative intrusion.
- In late June 2022, ASH issued a press statement in response to the Supreme Court decision to overturn Roe v. Wade, in addition to a more extensive ASH policy statement on The Right to Maternal Health Care, which outlines the many blood disorders that put pregnant women at risk of severe, even fatal, health complications.
- To prepare ASH members for advocacy in this area, a toolkit was published on the ASH website that members used to tell their local officials to protect access to maternal health care and the physician/patient relationship, along with an advocacy campaign geared toward both federal and state elected officials.
- ASH staff met with the American Medical Association (AMA), ACOG, Society for Women’s Health Research (SWHR), Society for Maternal-Fetal Medicine (SMFM), American Society for Reproductive Medicine (ASRM), and American Society of Clinical Oncology (ASCO) and discussed opportunities for joint action and ASH member involvement, focused on preserving the physician/patient relationship.
- On September 23, ASH members met with Louisiana Governor John Bel Edwards to discuss concerns related to maternal health access in Louisiana, and the impact of the ASH annual meeting on New Orleans and the state. ASH President Dr. Jane Winter, and two Louisiana constituents, Drs. Chancellor Donald (Tulane University), Chair of the Committee on Practice, and Laura Finn (Ochsner Health), member of the Committee on Government Affairs, attended the meeting in person, while staff joined virtually.
- In November, ASH submitted a letter to congressional leaders in support of Let Doctors Provide Reproductive Health Care Act (S. 4723/H.R. 8650). This legislation aims to protect health care providers in states where abortion is legal from being subject to laws that try to prevent them from providing reproductive health care services to a patient from another state where such services are not allowed under law. The legislation also prohibits federal funds from being used to pursue legal cases against individuals who access legal reproductive health care services or against health care providers in states where abortion is legal.
- Maternal health and hematology was also featured at the 2022 ASH Annual Meeting, including two sessions devoted to maternal health advocacy:
- Over the past year, ASH expanded the Society’s engagement with federal agencies regarding maternal health and hematology.
- ASH and leaders from the Centers for Disease Control and Prevention (CDC) met in 2022 to discuss Society’s interest in maternal health and its intersection with hematology. CDC expressed interest in collaborating with ASH; the discussions focused on opportunities to ensure the hematologic perspective is included in cross-CDC discussions about maternal health, and how the CDC’s Sickle Cell Disease (SCD) Data Collection program could be expanded to close knowledge gaps related to the impact of SCD on women’s health.
- In October, ASH submitted comments to the National Institutes of Health’s (NIH) request for information on updates to its Strategic Plan for Women’s Health Research FY 2019-2023. The Society commended the NIH for working to enhance the current strategic plan and highlighted areas of potential improvement, such as: (1) new research opportunities that account for recent scientific advances; (2) emerging research needs that reflect changes in the study of the health of women; and (3) including cross-cutting scientific themes as a component of all future scientific goals and objectives.
ASH continued to support the Improving Access to Transfusion Care for Hospice Patients Act (S. 2566), legislation introduced in July 2021 that would promote the provision of palliative blood transfusions for Medicare hospice patients by establishing a demonstration program to provide a separate payment for transfusions outside of the hospice bundled payment.
- ASH members, including members of the ASH Committee on Practice, met with numerous congressional offices throughout 2022 to urge support for the bill.
- In December 2022, ASH presented the bill’s sponsors – Senators Jacky Rosen (D-NV), John Barrasso (R-WY), and Tammy Baldwin (D-WI) – with the 2022 ASH Public Service Award to recognize their efforts to ensure that patients with blood diseases have access to high quality end-of-life care.
- ASH will continue to work the bill’s sponsors to reintroduce and gain support for the bill in the 118th Congress.
In 2022, ASH’s stature as a resource to the Administration, Department of Health and Human Services (HHS), and federal agencies continued to grow. The White House, HHS, and the Centers for Disease Control and Prevention (CDC) continued to reach out to ASH for feedback about COVID-19 interventions for immunocompromised patients, including requests about related communication, guidance, and availability of these therapies.
- ASH led a group of nine other organizations that also represent physicians who care for immunocompromised/suppressed patients in sending letters to the House of Representatives and the Senate voicing the critical need to prioritize this vulnerable population as additional COVID-19 relief funds were considered.
Food and Drug Administration (FDA)
Throughout 2022, the ASH Officers met with FDA leaders, including FDA Administrator, Dr. Robert Califf, and directors of the FDA’s hematology-focused divisions to discuss a variety of issues, including diversity in hematologic trials, and efforts to advance real-world evidence generation. ASH leaders also met with the FDA’s Center for Biologics Evaluation and Research (CBER) Director, Dr. Peter Marks, to discuss the evolution of COVID-19 and booster vaccines; FDA’s review of donor deferral criteria; efforts to advance cell and gene therapies; and the ASH Research Collaborative efforts to advance real-world data. ASH also continued to partner with the FDA to offer the following new and ongoing programs:
- The inaugural ASH|FDA Collaboration: A Workshop on Regulatory Science in Hematology was hosted at ASH Headquarters in mid-October. The ASH and FDA workshop co-chairs, Drs. Grzegorz S. Nowakowski (Mayo Clinic) and Richard Pazdur (Director, FDA Oncology Center of Excellence), along with a faculty of FDA staff, presented an engaging two-day overview of regulatory medicine with a focus on clinical and translational research, trial design, and drug development. The participants gained a better understanding of the FDA, hematologic programs at the Agency, and how to further engage with FDA staff.
- The ASH-FDA Speaker Series, a program where an ASH expert presents an educational seminar to Agency staff on important topics in hematology, continued to be well received. Dr. Nirali Shah, from the National Institutes of Health (NIH), presented the most recent session on CAR T-cell trials for hematologic malignancies in children and the adolescent and young adult population.
- The 2022 ASH Annual Meeting and Exposition featured ASH-FDA Joint Symposium on New Approved Drugs on (1) Something Old, Something New - Recent Immunotherapy and Targeted Agent Approvals; and (2) Novel Approvals in Non-Malignant Hematology.
ASH also submitted feedback to FDA on draft guidance that intersects with hematology and is directly related to the Society’s priorities.
- ASH Comment Letter re: Draft Guidance on Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials
- ASH Comment Letter re: Draft Guidance on Considerations for the Development of Chimeric Antigen Receptor T Cell Products
- ASH Comment Letter re: Draft Guidance on Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products.
Additional Advocacy to Ensure Access
- In September, ASH released a new policy Statement on a Strong Blood Supply, which supports steps to ensure a safe and adequate blood supply and to further encourage donations from all healthy people capable of donating.