2021 ASH Advocacy Efforts to Ensure Patient Access to Care

COVID-19

The COVID-19 crisis continues to play a significant role in ASH’s advocacy and practice-related efforts.  Below is a list of ASH’s key advocacy and practice-related efforts related to COVID-19.

• In early March, ASH sent a letter to Dr. Rochelle Walensky, Director of the Centers for Disease Control and Prevention (CDC), urging the Agency to work with states that are not placing necessary emphasis on providing COVID-19 vaccine access to those who are immunocompromised, particularly individuals living with SCD and others with hematologic malignancies.
  
  In April, ASH provided expert input to the U.S. Food and Drug Administration (FDA) and the CDC when the Agencies paused the administration of the Johnson & Johnson (Janssen) COVID-19 Vaccine in the United States to allow investigation of several cases of a severe thrombosis with thrombocytopenia occurring post-vaccination (also known as thrombosis with thrombocytopenia syndrome (TTS).  After the pause was lifted, ASH partnered with the CDC to provide clinicians with immediate, relevant, and actionable information on TTS.
  

  In April, ASH hosted a webinar, titled Telehealth: One Year Later, highlighting what has changed in telehealth since the start of the COVID-19 pandemic.
• In July, ASH signed a joint statement supporting vaccine mandates for health care workers; in November, ASH signed onto a joint statement supporting the Occupational Safety and Health Administration's vaccine mandate for businesses with more than 100 employees.  Additionally, ASH joined an amicus brief with other medical specialty societies in December, in support of the Centers for Medicare & Medicaid Services’ interim final rule requiring vaccination of covered healthcare facility staff.
• The 2021 ASH Practice Partnership (APP) Lunch, How COVID-19 Changed the Practice Model, focused on issues related to telehealth, recruitment and retention, lessons learned on disparities and developing new delivery points of care, the changing methods of training fellows and residents, and the use of CME for hematologists in practice, and how these things have been altered due to COVID-19.

Addressing Diversity, Equity and Inclusion in Hematology

• In August, ASH released a Policy Statement Addressing Diversity, Equity, and Inclusion in Hematology Research, Practice, and Training, which outlines the Society’s support for addressing and reversing historic inequities in hematology, supporting scientists and clinicians from backgrounds underrepresented in medicine, and elevating diverse voices across our patient and healthcare communities. The statement acknowledges existing inequities in hematology research, practice, and training, and identifies opportunities that the Society can take to support policies and programs that aim to eliminate health disparities in the care of hematology patients.
• In November, Dr. Jennifer Holter Chakrabarty, Chair of the ASH Committee on Government Affairs, joined representatives from other member organizations of the Coalition for Health Funding in a panel discussion for congressional staff on social determinants of health and health equity.
• In November, ASH announced support for the Diversifying Investigations Via Equitable Research Studies for Everyone (DIVERSE) Trials Act (S. 2706/H.R. 5030) introduced by Senators Robert Menendez (D-NJ) and Tim Scott (R-SC) and Representatives Raul Ruiz (D-CA) and Larry Bucshon (R-IN). The legislation aims to improve access to and diversity of clinical drug and treatment trials.
• The December 11, 2021 ASH Grassroots Network Lunch featured CDC Director Dr. Rochelle Walensky, who discussed efforts by the CDC to highlight and address health disparities and racism as a threat to the nation's health, as well as the important role hematologists can play in furthering this goal.

Oral Chemotherapy Parity

While oral and patient-administered forms of chemotherapy have become more prevalent and represent the standard of care for many types of cancers for their convenience, efficacy, and low rate of side effects, they are covered differently than IV drugs, leaving many patients responsible for unsustainable high monthly co-payments.

• In July 2021, bipartisan legislation was reintroduced in the U.S. House of Representatives that would ensure that patients enrolled in certain federally regulated health plans have access and insurance coverage for all anti-cancer regimens; companion legislation was reintroduced in the Senate in October 2021. The Cancer Drug Coverage Parity Act (H.R. 4385/S. 3080), which ASH has supported as part of the Coalition to Improve Access to Cancer Care (CIACC), would require any health plan that provides coverage for cancer chemotherapy treatment to provide coverage for orally administered and self-injectable anticancer medications at a cost no less favorable than the cost of IV, port administered, or injected anticancer medications.
• ASH will continue to work with CIACC partners to gain cosponsors on the House and Senate bills, with the ultimate goal of passing the legislation before the end of the 117th Congress.

Palliative Care 

On July 30, Senators Rosen (D-NV), Barrasso (R-WY), and Baldwin (D-WI) introduced bipartisan legislation to increase access to palliative blood transfusions for patients receiving end-of-life care through the Medicare hospice benefit. The bill, the Improving Access to Transfusion Care for Hospice Patients Act, would establish a demonstration program that would provide a separate payment model to promote the provision of palliative blood transfusions outside of the hospice bundled payment. ASH released a statement in support of the bill and the legislation is in-line with ASH’s 2019 policy statement, ASH Statement in Support of Palliative Blood Transfusions in Hospice Setting. 

In early October, members of the ASH Palliative Care Working Group participated in 14 virtual Hill visits in support of the bill and an additional 259 letters were sent by ASH’s Grassroots Network.

Drug Pricing 

• In mid-November, the House of Representatives passed the Build Back Better Act. The legislation included provisions related to price negotiations for Medicare Part B and Part D. Although Medicare price negotiation is something ASH has supported for a number of years, the way the Part B policy is written could have a significant negative impact on how physicians are reimbursed and ultimately on patient access to care. Changes will likely be made to the bill prior to it being voted on in the Senate. ASH will continue to monitor the legislation and any provisions impacting ASH members.
• On August 6, the Centers for Medicare and Medicaid Services (CMS) released a proposed rule to rescind the November 2020 Most Favored Nation (MFN) model interim final rule. The MFN model had aimed to lower Medicare Part B payments for certain drugs by paying no more for high-cost Medicare Part B drugs and biologicals than the lowest price that manufacturers receive in similar countries. ASH submitted comments in support of the proposed rule. While ASH supports efforts to lower the price of very expensive drugs for patients with blood cancers, hemophilia, thalassemia, and other hematologic conditions and the high out-of-pocket costs patients experience, the Society had grave concerns about the potential for harmful impacts of the MFN model on both patients’ access to treatments and on the practice of hematology.

Work with FDA

ASH continued to partner with the FDA to offer the following educational programs:

• 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. Catherine Wu, from the Dana-Faber Cancer Institute, presented the most recent session on the treatment landscape and sequencing of therapy in chronic lymphocytic leukemia.
• The 2021 ASH Annual Meeting and Exposition featured ASH-FDA Joint Symposium on New Approved Drugs on (1) Treatment Landscape in the Era of Novel Therapies; and (2) Treatment Advances in Rare Disease. 

ASH also submitted comment letters to FDA to advise the Agency on the following draft guidance with hematologic implications.

• Letter re: Core Patient-Reported Outcomes (PROs) in Cancer Clinical Trials
• Letter re: Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings

Additional Efforts to Ensure Access

• Addressing Voter Restrictions that will Affect Communities Hematologists Serve In response to ASH member concern about holding the 2021 ASH Annual Meeting in Atlanta given the passage of Georgia’s restrictive voter rights legislation, ASH led an effort, joined by 16 other non-profit organizations representing more than 21.1 million health care providers and patients, in having a letter published in the Atlanta Journal-Constitution on August 26, 2021 highlighting the impact of recently enacted voting restrictions that are expected to disproportionately affect minority communities.
• Addressing Threats to the Confidential Relationship between Patient and Physician In September 2021, ASH joined 38 medical organizations in endorsing a statement led by the American College of Physicians, the American Academy of Family Physicians, the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, the American Osteopathic Association, and the American Psychiatric Association, opposing Texas SB8 (the Texas law threatening access to reproductive patient care). The statement stresses the groups’ opposition to any laws and regulations that interfere in the confidential relationship between a patient and their physician.