SFA Expands Its Public Policy Advocacy for the Sarcoma Community
By Kelley Argraves
Public policy decisions can directly affect sarcoma research, access to testing and treatment, clinical trial opportunities, and the development of new therapies. In recent months, the Sarcoma Foundation of America has increased its engagement with federal agencies to ensure that the needs of people affected by sarcoma are represented as these policies are developed.
SFA submitted comments to the Centers for Medicare & Medicaid Services regarding prior authorization requirements for medically necessary laboratory and biomarker testing. For people with sarcoma, timely testing may be essential to confirming a diagnosis, selecting treatment, monitoring disease, and identifying clinical trial opportunities. SFA urged CMS to prevent timing-based denials and unnecessary repeat testing, establish expedited review pathways for time-sensitive oncology testing, allow appropriate retroactive authorizations, and protect patients from financial liability when delays result from administrative processing issues beyond their control.
SFA has also worked at the state level to protect access to biomarker testing. In Maryland, where state law requires coverage of medically necessary biomarker testing, SFA joined more than 35 advocacy organizations in calling on insurers to comply fully with the law. SFA also sent an action alert to members of the Maryland sarcoma community explaining how to report delays or denials and raise concerns about enforcement of these patient protections.
SFA also responded to the Food and Drug Administration’s request for information on drug repurposing. Because many sarcoma subtypes have few or no specifically approved therapies, evaluating existing medicines for new uses may offer an important route to expanding treatment options. SFA encouraged the FDA to prioritize rare cancers and consider evidence from investigator-initiated studies, academic research, patient registries, natural-history studies, multi-institutional collaborations, and real-world data—particularly when conventional large clinical trials are not feasible. SFA also emphasized the importance of involving patients, clinicians, researchers, and disease-specific advocacy organizations in identifying promising opportunities.
In a separate submission supporting the Haystack Project citizen petition, SFA encouraged the FDA to adopt scientifically rigorous but appropriately flexible approaches to evidence generation in rare and ultra-rare diseases. The comments highlighted innovative trial designs, external controls, natural-history comparisons, real-world evidence, and outcomes that reflect what matters most to patients. SFA made clear that regulatory flexibility does not mean lowering standards for safety or effectiveness; rather, it recognizes that strong evidence may need to be generated differently when patient populations are extremely small and biologically diverse.
SFA also commented on proposed revisions to federal grant regulations. The Foundation urged the Office of Management and Budget to preserve independent, merit-based scientific review; maintain stable and predictable support for ongoing research; protect the research infrastructure that rare cancers depend upon; and avoid policies that could unnecessarily limit international scientific collaboration. Rare cancer research often relies on long-term studies, patient registries, tissue repositories, shared data resources, clinical trial networks, and collaboration across institutions and countries. Disruptions to this ecosystem can delay research progress and the development of new treatments.
These federal policy efforts are complemented by SFA’s annual Advocacy Weekend. Advocates receive education about research, drug development, access to care, and the policymaking process before bringing the priorities of the sarcoma community directly to congressional offices. Together, regulatory engagement and grassroots advocacy help ensure that the perspectives of patients, caregivers, clinicians, researchers, and advocates inform decisions that shape the future of sarcoma care.
Through this growing body of work, SFA is advocating for policies that reduce barriers to care, strengthen rare cancer research, encourage innovation, and accelerate the development of better treatments for people living with sarcoma.