On September 23, 2024, the U.S. House of Representatives passed the Seniors’ Access to Critical Medications Act of 2024 (H.R. 5526), which would make permanent a waiver put in place during the COVID-19 pandemic that allowed Medicare patients to receive medications dispensed by in-office pharmacies by mail or to have a caregiver or family member pick them up. The bill would also amend the Social Security Act to clarify that these practices do not violate the Stark Law. The bill now heads to the Senate.
Delegates from the Association for Clinical Oncology (ASCO) gathered in Chicago to participate in the 2023 Annual Meeting of the American Medical Association’s (AMA) House of Delegates (HOD) from June 9 to 14. The AMA HOD is the principal policy-making body of AMA and meets twice a year to discuss pressing issues and establish AMA policies.
ASCO-Sponsored Resolutions
The AMA HOD adopted two ASCO-sponsored resolutions and reaffirmed another during the meeting:
Modification of CMS Interpretation of Stark Law: ASCO called for the AMA to ask the Centers for Medicare and Medicaid Services (CMS) to retract the determination that delivery of medicine to a patient using the postal service or other trusted service violates the in-office exception of the Stark Law. The delegates also called on the AMA to advocate for legislation to clarify that a surrogate may deliver medicine dispensed at a physician-owned pharmacy without violating the law if the CMS does not change its position. This modification promotes the use of integrated pharmacy services, which studies have shown may increase patient adherence to medication.
Prior Authorization Costs: In its submission of practice expense data and methodology information submitted to the CMS, ASCO asked the AMA to include costs associated with prior authorization, which have become excessive as an unfunded mandate on practices. Studies and surveys by the AMA and ASCO have shown that physicians and other medical support staff spend a disproportionate amount of time on prior authorization requests and that these processes can cause harm to patients, including disease progression and loss of life.
Approval Authority of the FDA: ASCO called on the AMA to consider filing an amicus brief if the Supreme Court hears a case about access to mifepristone. ASCO emphasized the role of the U.S. Food and Drug Administration (FDA) to provide accurate and unbiased assessments of drugs and that the unprecedented ruling to invalidate the FDA’s approval of mifepristone could put access to future drugs at risk and “may lead to chilling effects” on research and medical innovation. The AMA noted that this resolution is in line with existing legal advocacy efforts, and the HOD voted to reaffirm existing policy to continue supporting the AMA’s ability to engage in court cases.
The HOD also considered an ASCO resolution related to biosimilar/interchangeable terminology that asked the AMA to repeal its existing policy and instead advocate for state and federal laws or regulations that support patient and physician choice of biosimilars without using the FDA’s “interchangeable” designation. Delegates cited that interchangeability has led to issues in accessing safe and effective treatments and has caused confusion among the medical community. After receiving feedback from other delegations, ASCO delegates asked the AMA to review the data that already exist and make recommendations to the House on the topic of biosimilar interchangeability status that takes all specialties and interested parties into account. ASCO will submit materials on biosimilars to the AMA for consideration during the review.
ASCO Cosponsored Resolutions
The AMA HOD also adopted two ASCO co-sponsored resolutions:
Coverage of Routine Costs in Clinical Trials by Medicare Advantage Organizations: This resolution, led by the New Hampshire Medical Society and the entire delegation from New England and cosponsored by ASCO, called on the AMA to advocate that the CMS require Medicare Advantage organizations to pay for routine care costs provided as part of clinical trials. Current policies inhibit patients from entering clinical trials due to processes that require them to seek reimbursement for qualified clinical trial items and services, which can also exacerbate existing disparities in access to care.
National Institutes of Health (NIH) Public Access Plan: This resolution, led by the American College of Rheumatology and cosponsored by ASCO, requested the AMA to work with publishing and professional organizations, as well as Congress, to raise awareness of the proposed NIH Public Access Plan’s potential adverse consequences. The impact includes public access to federally funded research without embargo, which may jeopardize the financial underpinnings of scholarly publishing.
During the AMA HOD meeting, ASCO led two meetings of the HOD’s Cancer Caucus (which is assembled and led by ASCO and voted to change its name to the Cancer Care Caucus moving forward). The Cancer Care Caucus provides a forum to address cancer-specific issues that are either being discussed or should be discussed by the delegates. The meeting also included discussions around other ASCO priority issues, including interventions to prevent human papillomavirus–related cancers and the Medicare hospice benefit.
ASCO had five delegates in attendance at this meeting: Ray D. Page, DO, PhD, FACOI, FASCO; Barbara L. McAneny, MD, MACP, FASCO; Steve Y. Lee, MD, FACP; Kristina L. Novick, MD, MS; and Erin L. Schwab, MD, MPH. In addition, ASCO had two alternate delegates in attendance: David Savage, MD, PhD, and Ashley L. Sumrall, MD, FACP. Jill Gilbert, MD, FACP, FASCO, also serves as one of -ASCO’s alternate delegates and participated virtually.
© American Society of Clinical Oncology. ASCO in Action. September 24, 2024. All rights reserved.
